CONJUGATE VACCINE
COMPOSITION
| ■ Powder: | |
|---|---|
| - Hoemophilus influenzae* type b polysaccharides conjugated to tetanus protein | 10 µg** |
| -Trometamol | 0.6 mg |
| -Sucrose | 42.5 mg |
| for one Immunizing dose | |
| * strain IM 2164 | |
| ** corresponding to the quantity of purified polysaccharides | |
| ■ Diluent: | |
| - Sodium chloride | 2.0 mg |
| - Water for injections | |
| for one 0.5 ml immunizing dose |
PHARMACEUTICAL DOSAGE FORM
Solution for injection, obtained by reconstituting the powder in the single-dose vial with a syringe of diluent (0.5 ml).
Sanofi Pasteur SA
avenue Font Pasteur, 69007 Lyon - France
This vaccine is indicated for the prevention of invasive Hoemophilus influenzae type b infections (meningitis, septicaemia, cellulitis, arthritis, epiglottitis, ...) in infants from 2 months of age.
It does not provide protection against infections due to other types of Haemophilus influenzae, nor against meningitis caused by other microorganisms.
This medicinal product MUST NOT BE USED in the following cases:
- Known allergy to one of the ingredients of the vaccine, particularly tetanus protein or allergy appearing after a previous injection of conjugate Haemophilus influenzae type b vaccine.
- Do not inject by the intravascular route : make sure that the needle does not penetrate a blood vessel.
- Vaccination should be postponed in those suffering from fever or acute disease, particularly infectious disease or progressive chronic disease.
- An immunosuppressive treatment or immune deficiency may induce a decrease in the immune response to the vaccine.
- If the vaccine is coadministered with the Measles-Mumps-Rubella vaccine, and the Diphtheria, Tetanus, Pertussis, Poliomyelitis vaccines, the vaccines will be administered at two separate injection sites.
If there is any doubt, do not hesitate to consult your doctor or your pharmacist.
Keep out of the reach of children.
In order to avoid possible interactions between several medicinal products any other ongoing treatment should be systematically reported to your doctor or to your pharmacist.
In any case, strictly conform to your doctor's prescription.
- Before 6 months of age, 3 successive 0.5 ml doses at one or two month intervals followed by a booster injection (0.5 ml) at 18 months of age.
- Between 6 and 12 months, two 0.5 ml doses at a one month interval followed by a booster injection (0.5 ml) at 18 months of age.
- From 1 to 5 years, a single 0.5 ml dose.
Reconstitute the powder in the Act-HIB vial (I dose) with a diluent syringe (4%. sodium chloride solution) or a syringe of D.T.COQ/D.T.P (adsorbed diphtheria, tetanus and pertussis vaccine) or TETRACOQ (adsorbed diphtheria, tetanus, pertussis and inactivated poliomyelitis vaccine).
Administer preferably via the intramuscular route or via the deep subcutaneous route; the recommended injection sites are the antero-lateral side of the thigh (middle third) or the superoexternal gluteal region in infants and the deltoid region in children.
Do not inject by the intravascular route.
Like any active product, this medicinal product may in certain persons cause effects which are disturbing to a greater or lesser extent.
Report to your doctor or to your pharmacist any unwanted and disturbing effects which might not be mentioned in this leaflet.
Do not exceed the expiry date stated on the external packaging.
This medicinal product should be stored at a temperature of between + 2ºC and + 8ºC (in a refrigerator).
Do not freeze.
PT Aventis Pharma,
Indonesia
For PT Bio Farma, Bandung
Reg. no DK10259701544A1
Rev. 03/99
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