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
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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
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