MabCampath 30mg / ml concentrate for solution for infusion

MabCampath 30 mg/ml concentrate for solution for infusion

Alemtuzumab

Read all of this leaflet carefully before you start taking this medicine

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What MabCampath is and what it is used for


• 2. Before you are given MabCampath


• 3. How MabCampath is used


• 4. Possible side effects


• 5. How to store MabCampath


• 6. Further information

What Mabcampath Is And What It Is Used For

MabCampath is used to treat patients with chronic lymphocytic leukaemia (CLL), a cancer of the lymphocytes (a type of white blood cell). It is used in patients for whom treatment combinations including fludarabine (another medicine used in leukaemia) are not appropriate.

The active substance in MabCampath, alemtuzumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells in the body. In CLL, too many lymphocytes are produced. Alemtuzumab has been designed to bind to a glycoprotein (a protein that is coated with sugar molecules) that is found on the surface of lymphocytes. As a result of this binding, the lymphocytes die, and this helps to control the CLL.

Before You Are Given Mabcampath

Do not use MabCampath if you:

• are allergic to alemtuzumab or to proteins of a similar origin or to any of the other ingredients of MabCampath (see section 6 “Further Information”). Your doctor will inform you accordingly


• have an infection


• have HIV


• have an active second malignancy


• are pregnant (see also “Pregnancy”).

Take special care with MabCampath:

When you first receive MabCampath, you may experience side effects soon after the first infusions (see section 4 “Possible side effects”). These effects will gradually reduce as treatment is continued.

You may also be given

• 
  steroids, antihistamines or analgesics (treatment for fever) to help to reduce some of the side effects.

The dosage of MabCampath will not be increased until the effects are reduced.

MabCampath treatment may reduce your natural resistance to infections

• 
  antibiotics and antivirals may be given to provide you with extra protection.

You will be examined for symptoms of a certain type of viral infection called CMV (cytomegalovirus) during your MabCampath therapy and for at least 2 months afterwards.

Your doctor will monitor you carefully if you

• have heart disease or chest pains and/or you are receiving treatment to reduce high blood pressure, as MabCampath may make these conditions worse.
  
  Patients with these conditions may be at higher risk of a heart attack.

• have been treated in the past with chemotherapies or general medications that have a high risk of causing heart damage, your doctor may wish to monitor your cardiac function (ECG, heart rate, body weight) while receiving MabCampath.

• have other side effects, most often blood disorders from taking MabCampath.
  
  Your doctor will be monitoring the effects of treatment and your progress carefully by examining you and by taking blood samples for analysis on a regular basis.

• are over 65 years of age as you may be more intolerant to the medicine than other patients.

You may experience an allergic or hypersensitivity reaction to MabCampath solution, especially against the protein contained in it, while the infusion is given to you. Your doctor will treat you for this, if this happens.

Because of the potential for a fatal reaction to transfusion of any blood products following treatment with MabCampath, it is recommended that you speak to your doctor regarding the irradiation of blood products prior to receiving the transfusion.

MabCampath is not recommended in children below 17 years of age or in patients who have kidney or liver disorders.

Taking other medicines

You should inform your doctor if you are taking or have recently taken any other medicines, even those not prescribed.

In particular, you should not be given MabCampath within 3 weeks of taking any other anti-cancer agents.

Also, you should not be vaccinated with live viral vaccines during treatment and for at least 12 months after you have finished your treatment. Speak to your doctor before receiving any vaccinations.

Pregnancy

MabCampath must not be administered to patients who are pregnant, therefore if you:

• are pregnant or you think you may be pregnant, you should tell your doctor immediately.


• are of childbearing potential, then you should avoid becoming pregnant by using effective contraceptive methods before you start treatment, during treatment and for 6 months after treatment.

Breast-feeding

You should stop breast-feeding when you start your treatment and you should not begin breast-feeding again until at least 4 weeks after you have finished your treatment and you have consulted your doctor on the matter.

Driving or using machines

No studies of the effects of MabCampath on the ability to drive and use machines have been performed. However you should be cautious as confusion and sleepiness have been seen. You should ask your doctor for advice.

How Mabcampath Is Used

MabCampath goes into one of your veins via a drip (see also ‘information intended for medical or healthcare professionals’).

Each time you are given MabCampath, it will take about 2 hours for all the solution to enter your blood.

MabCampath treatment may continue for up to 12 weeks depending on your progress.

During the first week, your doctor will increase the dose of MabCampath slowly to reduce the possibility of you having side effects and to allow your body to tolerate MabCampath better.

If you experience early side effects the initial smaller doses may be repeated until the effects go away or reduce. The doctor will carefully monitor you and decide what are the appropriate amounts of MabCampath to give during your whole treatment period.

If more MabCampath is given than recommended

Your doctor will treat you, as appropriate, if you have any side effects.

Possible Side Effects

Like all medicines, MabCampath can cause side effects, although not everybody gets them.

Your doctor may give you other medicines or change your dosage to help to reduce any side effects (see section 2 “Take Special care”).

Serious side effects, including difficulty in breathing, inflammation of the lungs, extreme shortness of breath, fainting, heart attack, autoimmune phenomena, low red blood cell and low blood platelet levels, infections, bleeding in the brain (intracranial haemorrhage) have occurred with fatal outcome. Tell your doctor immediately if you experience any of these side effects.

In addition, testing indicating the presence of antibodies that may destroy red blood cells (Coombs test) has been reported.

Very common side effects (seen in at least 1 in every 10 patients treated in clinical trials):

Usually one or more of these effects happen during the first week after the start of treatment:

• fever, shivering/chills, sweating, nausea (feeling sick), vomiting, low blood pressure, low white/red blood cell levels, infections including pneumonia and blood poisoning, irritation and/or blistering of the mouth region, low blood platelet levels, tiredness, rash, itching, red raised lesions on the skin, shortness of breath, headache, diarrhoea and loss of appetite.

They are usually only mild or moderate problems and they gradually diminish during the course of treatment.

Common side effects (affects 1 to 10 patients in every 100 patients treated in clinical trials):

• high blood pressure, fast or slow heart rate, feeling your heart racing, blood vessel spasm


• becoming red in the face, bruising of the skin


• taste changes


• decreased sense of touch


• dizziness, sensation of spinning, fainting, shaking or trembling movements, feeling restless


• eye inflammation (e.g. conjunctivitis)


• pins and needles or burning sensation of the skin


• abnormal liver function, constipation, indigestion, passing abdominal gas


• inflammation, irritation and/or tightness of the lungs, throat and/or sinuses, too little oxygen reaching the body organs, coughing, coughing up of blood


• abdominal bleeding (e.g. in the stomach and intestine)


• injection site reactions including redness, swelling, pain, bruising, inflammation


• generally feeling unwell, weakness, pain in various parts of the body (muscle, back, chest, bones, joints, stomach and intestine)


• weight loss, dehydration, thirst, swelling of the lower legs, temperature change sensation, low calcium or sodium blood levels


• flu-like symptoms


• abscess, skin redness or allergic skin reaction, blistering of the skin


• confusion, anxiety, depression, sleeplessness

Uncommon side effects (affects 1 to 10 in every patients in 1,000 patients treated in clinical trials):

• bone marrow disorders


• heart disorders (heart stopping, heart attack, heart congestion, irregular heart rate)


• blood disorders (abnormal clotting, decreased protein, low potassium levels)


• high blood sugar, worsening diabetes


• bleeding and inflammation of the gums, blisters on the tongue, nosebleeds


• fluid in the lungs, difficulty breathing, harsh sound when breathing, runny nose, abnormal findings in the lungs, lymph gland disorders


• nervousness, abnormal thinking


• swelling around the eye


• ringing sound in the ears, deafness


• hiccups, burping


• hoarseness


• abnormal kidney function


• paralysis of the small bowel


• impotence


• unsteadiness, increased muscle tone


• unusual increased or altered sensitivity to touch’


• abnormal sensation/feeling or movement


• pain when urinating, decreases in urine flow, increased frequency in urination, blood in urine, incontinence


• tumour lysis syndrome (a metabolic disorder, which may begin with pains in the side and blood in the urine)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.

How To Store Mabcampath

Keep out of the reach and sight of children.

Do not use MabCampath after the expiry date (EXP) which is stated on the outer carton and the vial label.

Store in a refrigerator (2°C-8°C).

Do not freeze.

Store in the original packaging in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Your healthcare professional will dispose of medicines no longer required. These measures will help protect the environment.

Further Information

What MabCampath contains

The active substance is alemtuzumab.

One ml contains 30 mg of alemtuzumab. Each vial contains 30 mg of alemtuzumab.

The other ingredients are disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate and water for injections.

What MabCampath looks like and contents of the pack

MabCampath is a concentrate for solution for infusion that comes in a glass vial.

Each pack of MabCampath contains 3 vials.

Marketing Authorisation Holder

Genzyme Europe BV

Gooimeer 10

1411 DD Naarden

Netherlands

Manufacturer

Genzyme Ltd.

37 Hollands Road

Haverhill

Suffolk

CB9 8PU

United Kingdom

Genzyme Ireland Limited.

IDA Industrial Park

Old Kilmeaden Road

Waterford

Ireland

Bayer Schering Pharma AG

Müllerstrasse 178

D-13342 Berlin

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom/Ireland

Genzyme Therapeutics

United Kingdom

Tel: +44 1865 405200

This leaflet was last approved in 11/2009

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu.

Maxitrol Eye Drops

1. Name Of The Medicinal Product

MAXITROL EYE DROPS

2. Qualitative And Quantitative Composition

1 ml suspension contains 1 mg dexamethasone, 6000 IU polymyxin B sulphate, 3500 IU neomycin sulphate (as base)

Excipients: 1 ml suspension contains 0.04 mg benzalkonium chloride

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Eye drops, suspension

White sterile suspension for topical ocular administration.

4. Clinical Particulars

4.1 Therapeutic Indications

MAXITROL eye drops, suspension is indicated for the short-term treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of fungal and viral disease.

4.2 Posology And Method Of Administration

Children and Adults (including the Elderly)

Apply one or two drops to each affected eye up to six times daily or, more frequently if required.

4.3 Contraindications

• Hypersensitivity to the active substances or to any component of the preparation.

• Epithelial herpes simplex keratitis.

• Vaccinia, varicella, or other viral infection of cornea and conjunctiva (except herpes zoster keratitis).

• Fungal disease s of ocular structures.

• Mycobacterial ocular infections.

4.4 Special Warnings And Precautions For Use

• For ocular use only. Not for injection or ingestion.

• As with all antibacterial preparation prolonged use may lead to overgrowth of non-susceptible bacterial strains or fungi. If superinfection occurs, appropriate therapy should be initiated.

• Sensitivity to topically applied aminoglycosides may occur in some patients. Cross-sensitivity to other aminoglycosides may also occur. If signs of serious reactions or hypersensitivity occur, discontinue the use of this product.

• Patients using ophthalmic preparations containing neomycin sulphate should be advised to consult a physician if ocular pain, redness, swelling, or irritation worsens or persists.

• Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic neomycin or when applied topically to open wounds or damaged skin. Nephrotoxic and neurotoxic reactions have also occurred with systemic polymyxin B. Although these effects have not been reported following topical ocular use of this product, caution is advised when used concomitantly with systemic aminoglycoside or polymyxin B therapy.

• Prolonged use of ophthalmic steroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity and visual field defects, and posterior subcapsular cataract formation. In patients receiving prolonged ophthalmic corticosteroid therapy, intraocular pressure should be checked routinely and frequently.

• In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids.

• Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral, or fungal infections and mask the clinical signs of infection, preventing recognition of ineffectiveness of the antibiotic, or may suppress hypersensitivity reactions to MAXITROL eye drops, suspension. Fungal infection should be suspected in patients with persistent corneal ulceration who have been or are receiving these drugs; corticosteroid therapy should be discontinued if fungal infection occurs.

• To avoid the risk of enhancement of herpetic corneal disease, frequent slit lamp examination is essential.

• Contact lens wear is not recommended during treatment of an ocular infection. Therefore patients should be advised not to wear contact lenses during treatment with MAXITROL eye drops, suspension.

• MAXITROL eye drops, suspension contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Patients must be instructed to remove contact lenses prior to application of MAXITROL eye drops, suspension and wait 15 minutes after instillation of the dose before reinsertion.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed.

Concomitant and/or sequential use of an aminoglycoside (neomycin) and other systemic, oral, or topical drugs that have neurotoxic, ototoxic, or nephrotoxic effects may result in additive toxicity and should be avoided, whenever possible.

If more than one ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart.

4.6 Pregnancy And Lactation

Pregnancy

There are no or limited amount of data from the use of MAXITROL eye drops, suspension in pregnant women. Studies in animals with some active components of MAXITROL eye drops, suspension have shown reproductive toxicity (see section 5.3).

MAXITROL eye drops, suspension is not recommended during pregnancy.

Lactation

It is unknown whether topical ophthalmic dexamethasone, neomycin or polymyxin B are excreted in human milk. Because systemic corticosteroids and aminoglycosides may be distributed into milk, a risk to the suckling child cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue therapy with MAXITROL eye drops, suspension taking into account the benefit of breast-feeding for the child and the benefit of the product to the woman.

4.7 Effects On Ability To Drive And Use Machines

MAXITROL eye drops, suspension has no or negligible influence on the ability to drive and use machines. As with any other eye drop, temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If transient blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery.

4.8 Undesirable Effects

Tabulated summary of adverse reactions

The following adverse effects are classified according to the following convention: very common (

System Organ Classification	MedDRA Preferred Term (v.12.0)
Immune system disorders	Not known: hypersensitivity (systemic or ocular)
Nervous system disorders	Not known: headache
Eye disorders	Uncommon: keratitis, intraocular pressure increased, eye irritation, eye pruritus, ocular discomfort Not known: corneal thinning, photophobia, blurred vision, mydriasis, eye pain, eye swelling, ptosis, foreign body sensation in eyes, increased lacrimation, ocular hyperaemia

Description of selected adverse event

Due to the steroid component, in diseases causing thinning of the cornea or sclera there is a higher risk for perforation especially after long treatments (See Section Special warnings and precautions for use).

Topical ophthalmic steroid use may result in increased intraocular pressure with damage to the optic nerve, reduced visual acuity and visual field defects. Also it may lead to posterior subcapsular cataract formation (See Section Special warnings and precautions for use).

Sensitivity to topically administered aminoglycosides may occur in some patients (See Section Special warnings and precautions for use). Systemic side effects may occur with extensive use.

4.9 Overdose

No case of overdose has been reported.

Signs and symptoms of an overdosage of MAXITROL eye drops, suspension may be similar to adverse reaction effects seen in some patients (punctuate keratitis, erythema, increased lacrimation, oedema and lid itching).

A topical ophthalmic overdose of MAXITROL eye drops, suspension may be flushed from the eye(s) with lukewarm water.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: ophthalmologicals; anti-infectives

ATC code: S01CA01

Mechanism of Action

MAXITROL eye drops, suspension has a dual effect: suppression of inflammation symptoms by the corticosteroidal component dexamethasone, and an anti

Dexamethasone is a synthetic glucorticoid with potent anti-inflammatory activity. Polymyxin B is a cyclic lipopeptide that penetrates the cell wall of gram-negative bacilli to destabilize the cytoplasmic membrane. It is generally less active against gram-positive bacteria. Neomycin is an aminoglycoside antibiotic that primarily exerts its effect on bacterial cells by inhibiting polypeptide assembly and synthesis on the ribosome.

Mechanism of Resistance

Resistance of bacteria to polymyxin B is of chromosomal origin and is uncommon. A modification of the phospholipids of the cytoplasmic membrane appears to play a role.

Resistance to neomycin occurs by several different mechanisms including (1) alterations of the ribosomal subunit within the bacterial cell; (2) interference with the transport of neomycin into the cell, and (3) inactivation by an array of adenylating, phosphorylating, and acetylating enzymes. Genetic information for production of inactivating enzymes may be carried on the bacterial chromosome or on plasmids.

Breakpoints

Each gram of MAXITROL eye drops, suspension contains 6000 IU polymyxin B sulphate and 3500 IU neomycin sulphate. The breakpoints and the in vitro spectrum as mentioned below are based on the dual activity of either polymyxin B or neomycin. The breakpoints listed here are based upon acquired resistance for specific species found in ocular infections and the ratio in International Units of polymyxin B to neomycin in MAXITROL eye drops, suspension:

Resistance breakpoints:>5:2.5 to>40:20 depending upon the bacterial species

Susceptibility

The information listed below provides guidance on the approximate probabilities on the susceptibility of microorganisms to polymyxin B or neomycin in MAXITROL eye drops, suspension. The presentation below lists bacterial species recovered from external ocular infections of the eye.

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the combination of polymyxin B or neomycin as in MAXITROL eye drops, suspension in at least some types of infections is questionable.

COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive microorganisms Bacillus cereus Bacillus megaterium Bacillus pumilus Bacillus simplex Corynebacterium accolens Corynebacterium bovis Corynebacterium macginleyi Corynebacterium propinquum Corynebacterium pseudodiphtheriticum Staphylococcus aureus (methicillin susceptible - MSSA) Staphylococcus capitis Staphylococcus epidermidis (methicillin susceptible - MSSE) Staphylococcus pasteuri Staphylococcus warneri Streptococcus mutans Aerobic Gram-negative microorganisms Haemophilus influenzae Klebsiella pneumoniae Moraxella catarrhalis Moraxella lacunata Pseudomonas aeruginosa Serratia species

SPECIES FOR WHICH ACQUIRED RESISTANCE MIGHT BE A PROBLEM Staphylococcus epidermidis (methicillin resistant - MRSE) Staphylococcus hominis Staphylococcus lugdunensis

INHERENTLY RESISTANT ORGANISMS Aerobic Gram-positive microorganisms Enterococci faecalis Staphylococcus aureus (methicillin resistant - MRSA) Streptococcus mitis Streptococcus pneumoniae Anaerobic Bacteria Propionibacterium acnes

Dexamethasone is a moderately powerful corticosteroid having good penetration in ocular tissue. Corticosteroids have an anti

5.2 Pharmacokinetic Properties

Dexamethasone, like other corticosteroids, is absorbed rapidly after oral administration and has a biological half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects. Intraocular penetration of dexamethasone occurs in significant amounts and contributes to the effectiveness of dexamethasone in anterior segment inflammatory disease.

Polymyxin B sulphate is not absorbed from the gastrointestinal tract or through intact skin, although the intact corneal epithelium prevents penetration into the corneal stroma, therapeutic concentrations do enter the stroma after epithelial damage. Good stromal penetration occurs after epithelial abrasion following topical instillation, subconjunctival injection, or corneal bath. No significant polymyxin B penetration into the vitreous is demonstrable after parenteral or local administration of the drug.

Neomycin is poorly absorbed from the gastrointestinal tract and after topical administration an insufficient amount is absorbed to produce systemic effects. Absorption has been reported to occur from wounds and inflamed skin. After absorption neomycin is rapidly excreted by the kidneys in active form.

5.3 Preclinical Safety Data

Mutagenicity and Carcinogenicity

Genotoxicity studies performed with neomycin and polymyxin B, with and without metabolic activation, were negative in bacterial (Ames test) or mammalian cells (chromosomal aberration assay in CHO cells). Dexamethasone was clastogenic in vivo in the mouse micronucleus assay at doses in excess of those obtained following topical application. Conventional long term carcinogenicity studies with MAXITROL or its active constituents have not been performed.

Teratogenicity

Pregnant rats treated daily with high doses of neomycin produced offspring that exhibited significant ototoxicity. The teratogenic dose is far greater (> 10,000-fold) than the clinical daily exposure from MAXITROL. Dexamethasone has been found to be teratogenic in animal models. Dexamethasone induced abnormalities of foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development.

Local Tolerance and Systemic Effects

Systemic exposure to dexamethasone is associated with its pharmacological effects as a potent glucocorticoid. Prolonged exposure to the steroid can result in glucocorticoid imbalance. Topical ocular safety studies with dexamethasone in rabbits have shown systemic effects after 1 month of treatment. In rabbits, MAXITROL was shown to have minimal irritation potential after administration to either control or irritated eyes.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium chloride

Polysorbate 20

Benzalkonium chloride

Hydroxypropyl methylcellulose

Hydrochloric acid/sodium hydroxide

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

Unopened 24 months.

Discard 28 days after first opening

6.4 Special Precautions For Storage

Do not store above 25°C. Keep away from direct sunlight. Do not refrigerate. Keep the container tightly closed.

6.5 Nature And Contents Of Container

5 ml & 10 ml DROP-TANIER, natural LDPE bottles and plugs with polystyrene or polypropylene caps.

6.6 Special Precautions For Disposal And Other Handling

Do not touch the tip of the bottle to any surface as this may contaminate the contents.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Alcon Laboratories (UK) Ltd

Pentagon Park

Boundary Way

Hemel Hempstead

HP2 7UD

8. Marketing Authorisation Number(S)

PL 0649/5915R

9. Date Of First Authorisation/Renewal Of The Authorisation

24 January 1991

10. Date Of Revision Of The Text

26/07/2010

Medifen 3+ Months

1. Name Of The Medicinal Product

Medifen 3+ Months 100mg/5ml Oral Suspension

2. Qualitative And Quantitative Composition

Ibuprofen 100mg / 5ml

For excipients see 6.1

3. Pharmaceutical Form

Oral Suspension. White, opaque smooth suspension

4. Clinical Particulars

4.1 Therapeutic Indications

For reduction of fever (including post immunisation fever); and relief of mild to moderate pain such as headache, sore throat, teething pain and toothache, cold and flu symptoms, minor aches and sprains.

4.2 Posology And Method Of Administration

For oral administration and short term use only, as required:

• Children 8 to 12 years: 10ml three to four times daily.

• Children 3 to 8 years: 5ml three to four times daily.

• Children 1 to 3 years: 2.5ml three to four times daily.

• Infants 6 months to 1 year: 2.5ml three times daily.

If the child's symptoms persist for more than 3 days, consult your doctor.

• Babies 3 to 6 months: 2.5ml three times daily.

Do not give to babies aged 3 to 6 months for more than 24 hours.

Doses should usually be given every 6-8 hours. Leave at least four hours between doses.

Not to be given to children under 3 months of age. Not recommended for children weighing less than 5kg.

For post immunisation fever: 2.5ml followed by one further 2.5ml 6 hours later, if necessary. No more than 2 doses (5ml) in 24 hours. If fever is not reduced, consult your doctor.

4.3 Contraindications

Hypersensitivity to ibuprofen or any of the excipients in the product.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs.

Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Severe heart failure, renal failure or hepatic failure (see section 4.4 Special Warnings and Precautions for Use).

Last trimester of pregnancy (see section 4.6 Pregnancy and lactation).

4.4 Special Warnings And Precautions For Use

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below).

The elderly have an increased frequency of adverse reactions to NSAID's especially gastrointestinal bleeding and perforation which may be fatal.

Respiratory:

Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.

Other NSAIDs:

The use of Junior Ibuprofen Suspension with concomitant NSAIDs including cyclooxengenase-2-selective inhibitors should be avoided.

SLE and mixed connective tissue disease:

Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8 Undesirable effects).

Renal:

Renal impairment as renal function may further deteriorate (see section 4.3 Contraindications and section 4.8 Undesirable effects).

Hepatic:

Hepatic dysfunction (see section 4.3 Contraindications and section 4.8 Undesirable effects).

Cardiovascular and cerebrovascular effects:

Caution (discussion with doctor or pharmacist ) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g.

Impaired female fertility:

There is limited evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.

Gastrointestinal:

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) – as these conditions may be exacerbated (see section 4.8 Undesirable effects).

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3 Contraindications) and in the elderly. These patients should commence treatment on the lowest dose available.

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of gastrotoxicity or bleeding, such as oral corticosteroids, or anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or anti-platelet agents such as aspirin (see section 4.5 Interactions).

Where GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

Dermatological:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8 Undesirable Effects). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Junior Ibuprofen Suspension should be discontinued at the first appearance of skin rash mucosal lesions, or any other sign of hypersensitivity.

Information about some of the ingredients in this medicine:

Contains Liquid Maltitol (E965). Patients with rare hereditary problems of fructose intolerance should not take this medicine.

The label will include:

Please read the enclosed leaflet carefully before using this product.

Do not give this product if your child:

• has or has had a stomach ulcer, perforation or bleeding of the stomach

• is allergic to ibuprofen or any other ingredient of the product, aspirin or other related painkillers

• is taking other NSAID painkillers, or aspirin with a daily dose above 75mg

Talk to a pharmacist or your doctor before giving this product if your child:

• has or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney, stomach or bowel problems

If you are an adult:

• if you are pregnant do not take this product and ask your doctor for advice

• consult your doctor or pharmacist before taking this product if you are elderly or if you are a smoker

Do not exceed the stated dose. Keep all medicines out of the reach and sight of children. If your child's symptoms persist for more than 3 days, or if new symptoms occur, talk to your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Ibuprofen should not be used in combination with:

Aspirin: Unless low-dose aspirin (not above 75mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (see section 4.3 Contraindications).

Other NSAIDs including cyclooxegenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.3 Contraindications).

Ibuprofen should be used with caution in combination with:

Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4 Special Warnings and Precautions for Use).

Antihypertensives and diuretics: NSAIDs may diminish the effect of these drugs. Diuretics can increase the risk of nephrotoxicity to NSAID's.

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4 Special Warnings and Precautions for Use).

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.

Cardiac Glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Lithium: There is evidence for potential increases in plasma levels of lithium.

Methotrexate: There is a potential for an increase in plasma methotrexate.

Cyclosporin: Increased risk of nephrotoxicity

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone. Administration of NSAID's can reduce the effect of mifepristone.

Tacrolimus: Possible risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine: Increased risk of haematological activity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Quinolone antibiotics: Animal data indicate that NSAID's can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increase risk of developing convulsions.

Aspirin: Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dose concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation ex-vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

4.6 Pregnancy And Lactation

Children under 9 years are unlikely to become pregnant or breast feed. However, whilst no teratogenic effects have been demonstrated in animal experiments, the use of the suspension should, if possible, be avoided during the first 6 months of pregnancy.

During the 3rd trimester, there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see section 4.3 Contraindications).

In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.

See section 4.4 regarding female fertility.

4.7 Effects On Ability To Drive And Use Machines

None expected at recommended doses and duration of therapy.

4.8 Undesirable Effects

The following list of adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Blood and Lymphatic System Disorders:

Very rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.

Immune System Disorders:

Non-specific allergic reactions. Respiratory tract reactivity (e.g. asthma, aggravated asthma and bronchospasm). Various skin reactions including exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme). Uncommon: Hypersensitivity reactions with urticaria and pruritus. Very rare: Severe hypersensitivity reactions. Symptoms could include: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).

In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (see section 4.4 Special Warnings and Precautions for Use).

Nervous System Disorders:

Uncommon: Headache. Vary rare: Aseptic Meningitis – single cases have been reported very rarely.

Cardiac Disorders and Vascular Disorders:

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4 Special Warnings and Precautions for Use).

Gastrointestinal Disorders:

The most commonly observed side effects of ibuprofen are gastrointestinal in nature. Uncommon: Abdominal pain, nausea and dyspepsia. Rare: Diarrhoea, flatulence, constipation and vomiting. Very rare: Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly, ulcerative stomatitis, gastritis.

Exacerbation of ulcerative colitis and Crohn's disease (see section 4.4 Special Warnings and Precautions for Use).

Hepatobiliary Disorders:

Very rare: Liver disorders.

Skin and Subcutaneous Tissue Disorders:

Uncommon: Various skin rashes. Very rare: Severe forms of skin reactions such as bullous reactions, including Stevens Johnson syndrome, erythema multiforme and toxic epidermal necrolysis can occur.

Renal and Urinary Disorders:

Very rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.

4.9 Overdose

In children ingestion of more than 400mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.

Symptoms

Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management

Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids, propionic acid derivatives.

ATC code: M01A E01

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever, furthermore Ibuprofen reversibly inhibits platelet aggregation.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8h before or within 30min after immediate release aspirin dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred.

However, the limitations of these data and the uncertainties regarding extrapolation ex-vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.

5.2 Pharmacokinetic Properties

Ibuprofen is rapidly absorbed following administration and is rapidly distributed throughout the whole body. The excretion is rapid and complete via the kidneys.

Maximum plasma concentrations are reached 45 minutes after ingestion if taken on an empty stomach. When taken with food, high peak levels are observed after 1 to 2 hours. These times may vary with different dosage forms.

The half life of ibuprofen is about 2 hours.

In limited studies, ibuprofen appears in the breast milk in very low concentrations.

5.3 Preclinical Safety Data

No relevant information additional to that contained elsewhere in the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium Methylparahydroxybenzoate (E219) Sodium Propylparahydroxybenzaote (E217) Citric Acid Anhydrous Saccharin Sodium Sodium Benzoate (E211) Dispersible Cellulose Juicy Orange Flavour Polysorbate 80 Liquid Maltitol (E965) Xanthan Gum Purified Water

6.2 Incompatibilities

None.

6.3 Shelf Life

Amber glass or PET bottles with PP closures: 2 years.

6.4 Special Precautions For Storage

Do not store above 25^oC. Store in the original container.

6.5 Nature And Contents Of Container

Amber glass or PET bottles with polypropylene child resistant screw closures, containing 100ml.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Galpharm Healthcare Limited

Hugh House

Galpharm Way

Upper Cliffe Road

Dodworth Business Park

Dodworth

South Yorkshire

S75 3SP

8. Marketing Authorisation Number(S)

PL 16028/0034

9. Date Of First Authorisation/Renewal Of The Authorisation

10/02/2006

10. Date Of Revision Of The Text

06/11/2009

Mengivac A+C (Sanofi Pasteur MSD Limited)

1. Name Of The Medicinal Product

Mengivac A+C^®

Meningococcal Polysaccharide Vaccine BP

2. Qualitative And Quantitative Composition

Each 0.5 millilitre dose of vaccine contains:

Active Ingredients:

Neisseria meningitidis serogroup A polysaccharide……………50 micrograms

Neisseria meningitidis serogroup C polysaccharide……………50 micrograms

3. Pharmaceutical Form

Lyophilised powder for injection following reconstitution with isotonic buffered diluent.

4. Clinical Particulars

4.1 Therapeutic Indications

Active immunisation against meningococcal meningitis caused by N.meningitidis serogroups A and C.

a. Travel: Vaccination should be offered to travellers visiting parts of the world where the risk of contracting meningococcal meningitis is high. These regions include countries within the African meningitis belt (countries whose borders are between The Equator and latitude 15° North), parts of the Middle East and parts of the Indian Sub-Continent.

b. Contacts of cases: Family members and close contacts of disease cases of group A and group C meningococcal meningitis should be immunised. The vaccine does not protect against group B disease.

c. Local outbreaks: To help control local outbreaks of meningococcal group A and group C disease, vaccination may be recommended by appropriate Public Health Authorities.

Post vaccination immunity lasts at least 3 years.

4.2 Posology And Method Of Administration

Administer by deep subcutaneous or intramuscular injection.

Adults, elderly and children over 18 months of age: a single dose of 0.5 millilitre of reconstituted vaccine.

Children under 18 months of age: Mengivac A+C^® should not generally be given to children under 18 months except during epidemics (see Section 4.4).

4.3 Contraindications

Hypersensitivity to the vaccine or any component of the vaccine.

Vaccination should be delayed in the presence of acute infectious illness.

4.4 Special Warnings And Precautions For Use

As with any vaccine, appropriate medical treatment, including epinephrine (adrenaline) should be readily available for immediate use in case of anaphylactic reaction following injection.

Mengivac A+C^® confers protection against meningitis caused by meningococci of serogroups A and C. Immunisation does not protect against meningococci of other serogroups or against meningitis caused by other organisms.

Mengivac A+C^® should not generally be given to children under 18 months except during epidemics. Clinical data has confirmed the efficacy of the A component over 3 months of age. The response to the C component is only transitory but can be of limited value during a severe epidemic.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No studies have been performed in pregnant animals. There is insufficient data in humans to recommend the use of the vaccine in pregnancy and lactation unless the benefit outweighs the risk, e.g. in the event of an epidemic.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

The adverse reactions reported during clinical trials and post-marketing surveillance studies were generally mild and transient.

Local reactions at the injection site: Transient local pain sometimes associated with oedema or erythema are reported. More severe local reactions are uncommon.

Systemic adverse events: Allergic-type reactions (urticaria, erythematous rash), fever, headache, myalgia or arthralgia and gastro-intestinal disorders are very rarely observed. Exceptionally, more severe hypersensitivity reactions such as anaphylaxis were reported. Very rare cases of neurological reactions (paraesthesia, meningism, convulsions or blurred vision) were observed. No causal relationship with the vaccine could be established.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Mengivac A+C^® contains purified polysaccharides from Neisseria meningitidis serogroups A and C, and confers protection against meningococcal meningitis caused by N. meningitidis serogroup A and serogroup C.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

No further information.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months when stored between +2ºC and +8ºC.

6.4 Special Precautions For Storage

Store between +2ºC and +8ºC. Do not freeze diluent.

6.5 Nature And Contents Of Container

Lyophilised vaccine	single or multidose (ten dose) type 1 glass vial with a siliconised rubber stopper and aluminium overcap.
Diluent	single dose prefilled syringe (type 1 glass) or multidose type 1 glass vial.

6.6 Special Precautions For Disposal And Other Handling

After reconstitution, use within one hour. Shake well immediately before use.

7. Marketing Authorisation Holder

Aventis Pasteur MSD Limited

Mallards Reach

Bridge Avenue

Maidenhead

Berkshire

SL6 1QP

8. Marketing Authorisation Number(S)

PL 6745/0048 - Lyophilised vaccine

PL 6745/0029 - Diluent

9. Date Of First Authorisation/Renewal Of The Authorisation

7 February 1994

10. Date Of Revision Of The Text

March 2000

11. LEGAL CATEGORY

POM

^® Registered trademark

4006241/MGV/RA271/0300/A

Marcain Polyamp Steripack 0.25% and 0.5%

Marcain Polyamp Steripack 0.25% and 0.5%

bupivacaine hydrochloride

Read all of this leaflet carefully before Marcain Polyamp Steripack is given to you.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or nurse.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:

• 1. What Marcain Polyamp Steripack is and what it is used for


• 2. Before Marcain Polyamp Steripack is given to you


• 3. How Marcain Polyamp Steripack is given to you


• 4. Possible side effects


• 5. How to store Marcain Polyamp Steripack


• 6. Further information

What Marcain Polyamp Steripack is and what it is used for

Marcain Polyamp Steripack contains a medicine called bupivacaine hydrochloride. It belongs to a group of medicines called local anaesthetics.

Marcain Polyamp Steripack is used to numb (anaesthetise) parts of the body. It is used to stop pain happening or to provide pain relief. It can be used to:

• Numb parts of the body during surgery (operations).


• Relieve pain during childbirth.

Before Marcain Polyamp Steripack is given to you

You must not be given Marcain Polyamp Steripack if:

• You are allergic (hypersensitive) to bupivacaine hydrochloride or any of the other ingredients of Marcain Polyamp Steripack (see Section 6: Further information).


• You are allergic to any other local anaesthetics of the same class (such as lidocaine or ropivacaine).


• You have a skin infection near to where the injection will be given.


• You have something called cardiogenic shock (a condition where the heart is unable to supply enough blood to the body).


• You have something called hypovolaemic shock (very low blood pressure leading to collapse).


• You have problems with clotting of your blood.


• You have diseases of the brain or spine such as meningitis, polio or spondylitis.


• You have a severe headache caused by bleeding inside the head (intracranial haemorrhage).


• You have problems with your spinal cord due to anaemia.


• You have blood poisoning (septicaemia).


• You have had a recent trauma, tuberculosis or tumours of the spine.

You must not be given Marcain Polyamp Steripack if any of the above apply to you. If you are not sure, talk to your doctor before you are given Marcain Polyamp Steripack.

Take special care with Marcain Polyamp Steripack

Check with your doctor before having Marcain Polyamp Steripack if:

• You have heart, kidney or liver problems. This is because your doctor may need to adjust the dose of Marcain Polyamp Steripack.


• You have a swollen stomach due to more fluid than normal.


• You have a stomach tumour.


• You have been told that you have decreased volume of blood (hypovolaemia).


• You have fluid in your lungs.

If you are not sure if any of the above apply to you, talk to your doctor before you are given Marcain Polyamp Steripack

Taking other medicines

Please tell your doctor if you are taking, or have recently taken, any other medicines.

This includes medicines that you buy without a prescription and herbal medicines. This is because Marcain Polyamp Steripack can affect the way some medicines work and some medicines can have an effect on Marcain Polyamp Steripack.

In particular, tell your doctor if you are taking any of the following medicines:

• Medicines used to treat an uneven heart beat (arrhythmia) such as lidocaine, mexiletine or amiodarone.


• Medicines used to stop blood clots (anti-coagulants).

Your doctor needs to know about these medicines to be able to work out the correct dose of Marcain Polyamp Steripack for you.

Pregnancy and breast-feeding

Before you are given Marcain Polyamp Steripack, tell your doctor if you are pregnant, planning to get pregnant, or if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

Marcain Polyamp Steripack may make you feel sleepy and affect the speed of your reactions.

After you have been given Marcain Polyamp Steripack, you should not drive or use tools or machines until the next day.

Important information about some of the ingredients of Marcain Polyamp Steripack

Marcain Polyamp Steripack contains up to 3.15 milligrams (mg) of sodium in each millilitre (ml), equivalent to 31.4 mg per 10 ml ampoule. Your doctor will take this into account if you are on a sodium controlled diet.

How Marcain Polyamp Steripack is given to you

Marcain Polyamp Steripack will be given to you by a doctor. Your doctor will know the correct way to give you this medicine.

The dose that your doctor gives you will depend on the type of pain relief that you need and the part of your body that the medicine will be injected into. It will also depend on your body size, age, and physical condition. Usually one dose will last long enough but more doses may be given if the surgery takes a long time.

Marcain Polyamp Steripack will be given to you as an injection. The part of the body where you are injected will depend on why you are being given Marcain Polyamp Steripack. Your doctor will give you Marcain Polyamp Steripack in one of the following places:

• Near to the part of the body that needs to be numbed.


• In an area away from the part of the body that needs to be numbed. This is the case if you are given an epidural injection (an injection around the spinal cord).

When Marcain Polyamp Steripack is injected into the body in one of these ways, it stops the nerves from being able to pass pain messages to the brain. It will slowly wear off when the medical procedure is over.

If you have been given too much Marcain Polyamp Steripack

Serious side effects from getting too much Marcain Polyamp Steripack are unlikely. They need special treatment and the doctor treating you is trained to deal with these situations. The first signs of being given too much Marcain Polyamp Steripack are usually as follows:

• Feeling dizzy or light-headed.


• Numbness of the lips and around the mouth.


• Numbness of the tongue.


• Hearing problems.


• Problems with your sight (vision).

To reduce the risk of serious side effects, your doctor will stop giving you Marcain Polyamp Steripack as soon as these signs appear. This means that if any of these happen to you, or you think you have received too much Marcain Polyamp Steripack, tell your doctor immediately.

More serious side effects from being given too much Marcain Polyamp Steripack include twitching of your muscles, fits (seizures), and loss of consciousness.

Possible side effects

Like all medicines, Marcain Polyamp Steripack may cause side effects although not everybody gets them.

Severe allergic reactions (rare, affects less than 1 in 1,000 people)

If you have a severe allergic reaction, tell your doctor immediately. The signs may include sudden onset of:

• Swelling of your face, lips, tongue or throat. This may make it difficult to swallow.


• Severe or sudden swelling of your hands, feet and ankles.


• Difficulty breathing.


• Severe itching of the skin (with raised lumps).

Other possible side effects:

Very common (affects more than 1 in 10 people)

• Low blood pressure. This might make you feel dizzy or light-headed.


• Feeling sick (nausea).

Common (affects less than 1 in 10 people)

• Being sick (vomiting).


• Feeling dizzy.


• Pins and needles.


• High blood pressure (hypertension).


• Slow heart beat.


• Problems passing water.

Uncommon (affects less than 1 in 100 people)

• Feeling light-headed.


• Fits (seizures).


• Numbness of the tongue or around the mouth.


• Ringing in the ears or being sensitive to sound.


• Difficulty speaking.


• Blurred sight (vision).


• Loss of consciousness.


• Shaking (tremors).


• Twitching of your muscles.

Rare (affects less than 1 in 1,000 people)

• Double vision.


• Nerve damage that may cause changes in sensation or muscle weakness (neuropathy). This may include peripheral nerve damage.


• A condition called arachnoiditis (inflammation of the membrane that surrounds the spinal cord). The signs include a stinging or burning pain in the lower back or legs and tingling, numbness or weakness in the legs.


• Weak or paralysed legs.


• Uneven heart beat (arrhythmias). This could be life-threatening.


• Slowed or stopped breathing or stopped heart beat. This could be life-threatening.

Possible side effects seen with other local anaesthetics which might also be caused by Marcain Polyamp Steripack include:

• Problems with your liver enzymes. This may happen if you have long-term treatment with this medicine.


• Damaged nerves. Rarely this may cause permanent problems.


• Blindness which is not permanent or problems with the muscles of the eyes that are
  long-lasting. This may happen with some injections given around the eyes.

Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

How to store Marcain Polyamp Steripack

• Keep out of the reach and sight of children.


• Do not use after the expiry date which is stated on the container after EXP. The expiry date refers to the last day of that month.


• Store below 30°C. Do not freeze.


• Your doctor or the hospital will normally store Marcain Polyamp Steripack and they are responsible for the quality of the product when it has been opened if it is not used immediately. They are also responsible for disposing of any unused Marcain Polyamp Steripack correctly.

Further information

What Marcain Polyamp Steripack contains

The active ingredient is bupivacaine hydrochloride. Marcain Polyamp Steripack comes in two strengths: 2.5 mg or 5 mg of bupivacaine hydrochloride per ml of solution.

The other ingredients are sodium chloride, sodium hydroxide, and water for injections.

What Marcain Polyamp Steripack looks like and contents of the pack

Marcain Polyamp Steripack is a solution for injection. It comes in 10 ml or 20 ml plastic ampoules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisations for Marcain Polyamp Steripack 0.25% and 0.5% are held by

AstraZeneca UK Ltd

600 Capability Green

Luton

LU1 3LU

UK

Marcain Polyamp Steripack 0.25% and 0.5% is manufactured by

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire

SK10 2NA

UK

and

AstraZeneca AB

S-151 85 Södertälje

Sweden

To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Reference number

Marcain Polyamp Steripack 0.25%: 17901/0144

Marcain Polyamp Steripack 0.5%: 17901/0145

This is a service provided by the Royal National Institute of Blind People.

Leaflet prepared: May 2009.

© AstraZeneca 2009.

Marcain is a trade mark of the AstraZeneca group of companies.

PAI 08 0014b

8135105

Magnesium Sulphate Injection 50% w / v (UCB Pharma Ltd)

Magnesium sulphate injection 50% w/v

This leaflet is to help you get the most from your medicine.

Please read this leaflet carefully BEFORE you take your medicine. If you have any questions or you want to know more about this medicine, please ask the staff looking after you.

What is your medicine?

Your medicine is called Magnesium Sulphate Injection 50% w/v. It is a sterile solution for injection and contains 1g of magnesium sulphate (the active ingredient) in each 2ml of injection. It also contains sodium hydroxide, sulphuric acid and water for injections.

Magnesium Sulphate Injection 50% w/v is supplied in cartons of 1, 5 or 10 glass ampoules each containing 2ml of solution.

Magnesium Sulphate belongs to a group of medicines called mineral supplements.

Who makes it?

The Marketing Authorisation Holder is

UCB Pharma Ltd

208 Bath Road

Slough

Berkshire

SL1 3WE

UK

It is made by

Ashton Pharmaceuticals Ltd

Vale of Bardsley

Ashton-under-Lyne

OL7 9RR

UK

What is this medicine used for?

Magnesium Sulphate Injection 50% w/v is used to treat magnesium deficiency (lack of magnesium), where it is not possible for the medicine to be taken by mouth. This could be due to malabsorption, severe diarrhoea, chronic alcoholism, malnutrition or having to have all nutrients by injection.

Before using this medicine

Please tell your doctor if the answer to any of the following questions is “yes”.

• Are you suffering from any form of heart disease, for example, have you had a heart attack or heart block (where your heart beat signals are delayed)?


• Are you receiving drugs for heart disease called cardiac glycosides, e.g. digitoxin?


• Do you suffer from poor kidney function?


• Have you been prescribed any of the following medicines: opioids (e.g. morphine); barbiturates (e.g. amylobarbitone); or hypnotics (e.g. nitrazepam)?


• Are you going to have an anaesthetic where a muscle relaxant will be used?


• Are you pregnant, likely to be pregnant, or breast feeding?


• Are you taking any medicines containing nifedipine (a calcium channel blocker) for angina or high blood pressure?

If the answer to any of these questions is YES, tell your doctor before taking this medicine. They may want to change your treatment or give you special advice.

How will I be given Magnesium Sulphate Injection 50% w/v?

Magnesium sulphate is to be injected into a muscle or a vein, as directed by the doctor. For injection into a vein, the solution should be diluted to 20% or less, and the rate of injection should be less than 1.5ml per minute of a 10% solution. In children the solution should also be diluted to 20% if being injected into a muscle.

The doctor may want to perform regular blood or other tests to monitor your condition.

For mild magnesium deficiency: 1 gram every 6 hours for 4 doses injected into a muscle.

For severe magnesium deficiency: Up to 250 milligrams per kilogram of body weight injected into a muscle every 4 hours, or 5 grams per litre of solution is given intravenously as an infusion over 3 hours.

What if I take too much?

If you think you have been given too much of this medicine, tell your doctor immediately. Signs of too much magnesium include flushing, thirst, drowsiness, feeling sick or being sick, confusion, muscle weakness, loss of reflexes, slow and/or shallow breathing, low blood pressure and irregular heartbeat.

After using Magnesium Sulphate Injection 50% w/v

Side effects after Magnesium Sulphate Injection are usually a sign that your body has now got more than enough magnesium. Signs of too much magnesium include flushing, thirst, drowsiness, felling sick or being sick, confusion, muscle weakness, loss of reflexes, slow and/or shallow breathing, low blood pressure and irregular heartbeat.

If you think this medicine has upset you in any way please tell your doctor.

How to store this medicine

Magnesium Sulphate Injection 50% w/v must be stored below 25°C.

Do not use this medicine after the expiry date shown on the pack.

KEEP THIS AND ALL MEDICINES OUT OF THE REACH OF CHILDREN.

Further information

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor (or pharmacist), who will have access to further information.

YOU MAY WANT TO READ THIS LEAFLET AGAIN. PLEASE DO NOT THROW IT AWAY UNTIL YOU HAVE FINISHED YOUR MEDICINE.

This leaflet only applies to Magnesium Sulphate Injection 50% w/v.

Date of preparation of leaflet: October 2005

P1060C

Metanium Nappy Rash Ointment

1. Name Of The Medicinal Product

Metanium Ointment

Metanium Nappy Rash Ointment

2. Qualitative And Quantitative Composition

Titanium Dioxide	20.0% w/w
Titanium Peroxide	5.0% w/w
Titanium Salicylate	3.0% w/w

3. Pharmaceutical Form

Ointment for topical administration.

4. Clinical Particulars

4.1 Therapeutic Indications

As a treatment for nappy rash

4.2 Posology And Method Of Administration

Posology:

Topical.

Adults:

Not applicable.

Elderly:

Not applicable.

Children:

Dab a small amount of Metanium over the sore area. Spread the ointment thinly so the skin texture can be clearly seen through it. Repeat at each nappy change.

4.3 Contraindications

Hypersensitivity to the drug formulation.

4.4 Special Warnings And Precautions For Use

If no response occurs, or the condition worsens, consult your doctor.

For external use only.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not known.

4.6 Pregnancy And Lactation

Not known.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Rarely: skin irritations.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The combination of titanium salts with a water repellent siliconised base forms a tenacious non-occlusive film on the skin which protects against irritation and repeated hydration.

5.2 Pharmacokinetic Properties

Metanium is indicated for topical use and has an action similar to zinc oxide preparations.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Dimethicone 350

Light Liquid Paraffin

Tincture of Benzoin

White Soft Paraffin.

6.2 Incompatibilities

Not known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Aluminium collapsible tube with membrane seal and spiked polypropylene cap.

Pack sizes: 25 g, 30 g.

6.6 Special Precautions For Disposal And Other Handling

No special precautions necessary.

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite

Huddersfield

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0366

9. Date Of First Authorisation/Renewal Of The Authorisation

30/04/02.

10. Date Of Revision Of The Text

8^th April 2010