Act-Hib

Act-Hib – Indications, Posology, Against indications, Undesirable effects
Source RESIP-BCB
ACT-HIB 10 µg/0,5 ml Powder and solvent for injectable solution Boîte of 1 powder Bottle + syringe préremplie of 0,5 ml
Therapeutic class:   Infectiology – Parasitology
Active ingredients:   Polyoside Haemophilus influenzae standard B, Combined with, tetanic Protein
Statute:   Drug not subjected to medical regulation
Rate of refunding S:   65%
Laboratory:   Sanofi Pasteur

Indications

This vaccine is indicated in the prevention of the invasive infections to Haemophilus influenzae standard B (meningitides, septicaemias, cellulitises, arthritis, epiglottitises,…) in the child as from 2 months.

This vaccine does not protect from the infections due to the other types of Haemophilus influenzae, nor against meningitides due to other origins.

To in no case, the tetanic protein contained in this vaccine cannot replace usual tetanic vaccination.

Posology

Posology

·         Before the 6 months, 3 successive amounts of 0,5 ml to one or two months age of interval followed by an injection of recall (4th amount) one year after the 3rd injection.

·         Between 6 and 12 months, 2 amounts of 0,5 ml 1 months from interval, followed by an injection of recall (0,5 ml) to the 18 months age.

·         From 1 to 5 years, 1 only amount of 0,5 ml.

For the cases contacts: at the time of a contact with a case of invasive infection in Haemopilus influenzae (family or crib), vaccination must be implemented while following the diagram adapted to the age.

The case index must also be vaccinated.

Mode of administration

Intramuscular or subcutaneous way major.

The sites of injection recommended are the antéro-side face of the thigh (average third) at the infant and the area deltoïdienne in the child.

Not to inject by intravascular way.

For the instructions of reconstitution, to see heading Special precautions of elimination and handling.

Against indications

Known over-sensitiveness with the one of the components of the vaccine, in particular with protein tetanic or appeared after a former injection of a vaccine anti-Haemophilus influenzae standard B combined.

Undesirable effects

In accordance with the pediatric vaccine calendars, the recommendations of WHO (the World Health Organization) and ACIP (Advisory Committee one Immunization), Act-HIB is seldom managed only, but often in partnership or combination with other concomitant vaccines, such as the vaccines containing the valences diphteric, tetanic and coquelucheuse (with whole germs or acellulaire).

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

The undesirable effects reported during the clinical trials or since the marketing are listed hereafter according to the MedDRA terminology (by systems of bodies and frequency) for all the groups of ages. The frequency is defined like: very frequent (≥ 10%), frequent: (≥ 1% and < 10%), not very frequent (≥ 0.1% and < 1%), rare (≥ 0.01% and < 0.1%), very rare (< 0.01%) including the isolated brought back cases.

Undesirable effects observed during the clinical trials

The tolerance of the vaccine was evaluated during various clinical studies controlled with an active monitoring of the undesirable effects, and during which more than 7.000 children of less than 2 years in good health received an injection of Act-HIB, injection almost always combined with a vaccine with whole germs or acellulaire Diphteric-Tetanic-Coquelucheux.

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

The undesirable effects being able to be connected to the vaccine, observed with a frequency > 1% generally appeared in the 6 to 12 midnight following vaccination and were for the majority transients and of light intensity to moderate.

No increase in the incidence or the severity of the local or systemic reactions was observed after the administration of the successive amounts of the diagram of firstly-vaccination.

General disorders and anomalies with the site of administration

Very frequent with frequent: reactions to the site of injection such as pain, erythema, swelling and/or ignition, induration.

Not very frequent: fever (>à 39°C).

Psychiatric affections

Very frequent: irritability.

Frequent with not very frequent: cries (unverifiable or abnormal).

Undesirable effects observed after marketing

During the monitoring after marketing based on a broad experiment (several million administered doses in the world), other reactions were reported in temporal partnership with this vaccine.

None the following undesirable effects was brought back with a frequency higher than 0.01% (very rare). The frequencies are based on the rates of notifications spontaneous and calculated starting from the number of notifications and the number of amounts distributed over the same period.

General disorders and anomalies with the site of administration

Very rare: edema of the lower extremities with cyanosite or will purpura transitory occurring in the first hours following vaccination and disappearing quickly and spontaneously without after-effects. These reactions are not accompanied by cardiorespiratory signs. They were mainly brought back when the vaccine was managed simultaneously or in combination with other vaccines (such as the vaccines containing the valences diphteric, tetanic and coquelucheuse).

Affections of the immune system

Very rare: reactions of over-sensitiveness.

Affections of the nervous system

Very rare: convulsions associated or not with fever.

Affections of the skin and subcutaneous fabric

Very rare: urticaria, rash, prurit.