Medicinal Products

ACT-HIB 10 μg / 0.5 mL

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Polyoside Haemophilus influenzae type b
laboratory: Sanofi Pasteur

Powder and solvent for solution for injection
Box of 1 vial of powder + pre-filled syringe of 0.5 mL
All forms

Indication

This vaccine is indicated for the prevention of invasive Haemophilus influenzae type b infections (meningitis, septicemia, cellulitis, arthritis, epiglottitis, ...) in children from 2 months of age.

This vaccine does not protect against infections caused by other types of Haemophilus influenzae, or against meningitis caused by other origins.

In no case may the tetanus protein contained in this vaccine replace the usual tetanus vaccination.

Dosage ACT-HIB 10 μg / 0.5 mL Powder and solvent for solution for injection Box of 1 vial of powder + pre-filled syringe of 0.5 mL

Dosage

· Before the age of 6 months, 3 successive doses of 0.5 ml at one or two months of interval followed by a booster injection (4th dose) one year after the third injection.

· Between 6 and 12 months, 2 doses of 0.5 ml at 1 month intervals, followed by a booster injection (0.5 ml) at 18 months of age.

· From 1 to 5 years, 1 single dose of 0.5 ml.

For contact cases: when contact with a case of invasive Haemopilus influenzae infection (family or nursery), vaccination should be carried out according to the age-appropriate scheme.

The index case must also be vaccinated.

Administration mode

Intramuscular or deep subcutaneous route.

The recommended sites of injection are the anterolateral aspect of the thigh (middle third) in infants and the deltoid region in children.

Do not inject intravascularly.

For reconstitution instructions, see Special precautions for disposal and other handling .

Against indications

Known hypersensitivity to any component of the vaccine, particularly to tetanus protein, or occurred after prior injection of Haemophilus influenzae type b conjugate vaccine.

Act-Hib side effects

In accordance with the pediatric vaccine schedules, the recommendations of WHO (World Health Organization) and ACIP (Advisory Committee on Immunization) Act-HIB are rarely administered alone, but often in combination or in combination with other concomitant vaccines, such as vaccines containing diphtheria, tetanus and whooping cough (whole cell or acellular).

The tolerance profile of Act-HIB will therefore reflect this joint use.

Adverse reactions reported in clinical trials or since marketing are listed below in the MedDRA terminology (organ system and frequency) for all age groups. Frequency is defined as: very common (≥ 10%), common (≥ 1% and <10%), infrequent (≥ 0.1% and <1%), rare (≥ 0.01% and <0.1%), very rare (<0.01%) including isolated reported cases.

Adverse reactions observed during clinical trials

The safety of the vaccine was evaluated in various controlled clinical studies with active surveillance of adverse events, in which more than 7, 000 healthy children under 2 years of age received an injection of Act-HIB, an injection of almost always combined with a diphtheria-tetanus-pertussis cell-free or acellular vaccine.

In controlled studies, when Act-HIB was administered in combination with DTP vaccines, the frequency and type of systemic vaccine reactions observed were not different from those observed with a DTP vaccine administered alone.

Adverse events that may be vaccine-related, seen> 1%, usually occurred within 6 to 24 hours of vaccination and were mostly transient and mild to moderate.

No increase in the incidence or severity of local or systemic reactions was observed following the administration of successive doses of the primary vaccination schedule.

General disorders and administration site conditions

Very common to frequent: injection site reactions such as pain, erythema, swelling and / or inflammation, induration.

Uncommon: fever (> 39 ° C).

Psychiatric disorders

Very common: irritability.

Frequent to infrequent: cries (uncontrollable or abnormal).

Adverse reactions observed after marketing

During post-marketing surveillance based on extensive experience (several million doses administered worldwide), other reactions have been reported in temporal association with this vaccine.

None of the following side effects have been reported with a frequency greater than 0.01% (very rare). Frequencies are based on spontaneous notification rates and calculated from the number of notifications and the number of doses distributed over the same period.

General disorders and administration site conditions

Very rare: edema of the lower limbs with cyanosis or transient purpura occurring in the first hours after vaccination and disappearing quickly and spontaneously without sequelae. These reactions are not accompanied by cardio-respiratory signs. They were mainly reported when the vaccine was administered simultaneously or in combination with other vaccines (such as vaccines containing diphtheria, tetanus and pertussis).

Immune system disorders

Very rare: hypersensitivity reactions.

Nervous system disorders

Very rare: convulsions associated or not with fever.

Skin and subcutaneous tissue disorders

Very rare: urticaria, rash, pruritus.

Apnea in very preterm infants (born at or below 28 weeks of pregnancy) (see section 4.4 Special warnings and precautions for use ).

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