PENTAXIM Powder and suspension for suspension for injection Ref.[28288] Active ingredients: Diphtheria toxoid Haemophilus influenzae B, combinations with toxoids Pertussis filamentous hemagglutinin Pertussis toxoid Poliomyelitis, serotype 1 Poliomyelitis, serotype 2 Poliomyelitis, serotype 3 Tetanus toxoid

Posology

Pentaxim must be used in accordance with official recommendations.

Primary vaccination: 3 injections given at an interval of one month, i.e. according to the official schedule, at the age of 2, 3, 4 months.

Booster vaccination: 1 injection one year after primary vaccination, i.e. usually between 16 and 18 months.

Method of administration

Administer via the intramuscular route (IM).

Administration should preferably be performed in the anterolateral side of the thigh (middle third) in infants and in the deltoid area in children.

For instructions on reconstitution, see Section 6.6.

Once reconstituted, the suspension is cloudy and whitish.

Not documented.

3 years.

The vaccine must be administered immediately after reconstitution.

Store in a refrigerator (2°C-8°C).

Do not freeze.

For storage conditions of the reconstituted medicinal product, see Sections 6.3.

• Powder in vial (type I glass) equipped with a stopper (chlorobutyl) + 0.5 mL of suspension in prefilled syringe (type I glass) equipped with a plunger-stopper (bromobutyl or chlorobutyl or bromochlorobutyl). Box of 1, 10 or 20.
• Powder in vial (type I glass) equipped with a stopper (chlorobutyl) + 0.5 mL of suspension in prefilled syringe (type I glass) equipped with a plunger-stopper (bromobutyl or chlorobutyl or bromochlorobutyl), a tip-cap, without needle. Box of 1 or 20.
• Powder in vial (type I glass) equipped with a stopper (chlorobutyl) + 0.5 mL of suspension in prefilled syringe (type I glass) equipped with a plunger-stopper (bromobutyl or chlorobutyl or bromochlorobutyl), a tip-cap, with two separate needles. Box of 1 or 10.

Not all pack sizes may be marketed.

For syringes without attached needles, the needle must be fitted firmly to the syringe, rotating it by a one-quarter turn.

Reconstitute the solution by injecting the suspension of the combined diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine into the vial with the powder of the Haemophilus type b conjugate vaccine. Shake until complete dissolution of the powder. After reconstitution, the whitish-turbid appearance of the suspension is normal.

The vaccine must be used immediately after reconstitution.

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