This vaccine is indicated in the prevention of invasive infections in Haemophilus influenzae type b (meningitis, septicemia, cellulitis, arthritis, epiglottitis …) in children, from 2 months
< Br>

This vaccine does not protect against infections caused by other types of Haemophilus influenzae, nor against meningitis due to other causes.

Under no circumstances may the tetanus protein contained in this vaccine replace the usual tetanus vaccination.

Dosage

Before the age of 6 months, 3 successive doses of 0.5 ml at one or two months interval followed by a booster injection (4th dose) one year after the 3 rd injection. Code>
Between 6 and 12 months, 2 doses of 0.5 ml at 1 month interval followed by a booster injection (0.5 ml) at the age of 18 months.

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

For contact cases: In the case of contact with a case of invasive Haemopilus influenzae infection (family or nursery), vaccination should be carried out in accordance with the age-appropriate scheme. Br>

The index case must also be vaccinated.

Administration mode

Intramuscular or deep subcutaneous use

Recommended injection sites are the anterolateral side of the thigh (third, middle) in the infant and the deltoid region, in children
< Code>
Do not inject intravascularly.

For the reconstitution instructions see section Special precautions for disposal and other handling

Suspension bleached whitening, after reconstitution.

VACCINE AGAINST HAEMOPHILUS INFLUENZAE TYPE B INFECTIONS.

(J: Anti-infectives)

Haemophilus influenzae type b vaccine confers immunity against invasive Haemophilus Influenzae type b infection

The capsular polysaccharide (polyribosyl ribitol phosphate: PRP) induces an anti-PRP serological response in humans. However, as with all polysaccharide antigens, the nature of the immune response is thymus independent, characterized by the absence of a boosting effect in iterative injections and low immunogenicity in the infant. The covalent binding of the capsular polysaccharide of Haemophilus influenzae type b to a tetanus protein allows the conjugate vaccine to behave as a thymodependent antigen resulting in a specific serum anti-PRP response in infants with the induction of IgG Specific and setting up of an immune memory.

The study of the functional activity of anti-PRP-specific antibodies induced by the Haemophilus influenzae type b conjugated vaccine in infants and children showed their bactericidal activity as well as their opsonizing activity. >

Immunogenicity studies in the vaccinated infant as early as 2 months showed that virtually all children had anti-PRP antibody titer, ≥ 0.15 μg / ml after the 3 rd dose, and ≥ 1 μg / ml for about 90% of them. In infants prior to the age of 6 months receiving three doses of Haemophilus influenzae type b conjugated vaccine, a booster injection 8 and 12 months later resulted in a very significant increase in mean antibody titer; Anti-PRP.

Not applicable.

Known hypersensitivity to one of the components of the vaccine, in particular to tetanus protein or appeared after a prior injection of a Haemophilus influenzae type b conjugate vaccine. >

Warnings

Do not inject intravascularly, making sure that the needle does not enter a blood vessel.

In case of acute fever or disease, it is preferable to postpone the vaccination.

As for all injectable vaccines, which are likely to induce a possible immediate anaphylactic reaction, it is advisable to have appropriate medical treatment.

Vaccination may be carried out in children with a congenital or acquired immunosuppressive condition, the vaccine response being lower depending on the state of the immune system. In children treated with immunosuppressive agents (corticosteroids, antimitotic chemotherapy, etc.) it is recommended to wait until the end of the treatment, to vaccinate
< Code>
The potential risk of apnea with the need for respiratory monitoring during 48-72 hours should be carefully considered when administering primary immunization doses in large premature infants (born at 28 weeks of pregnancy or less) And particularly in those with a history of respiratory immaturity. Because of the high benefit of vaccination in these infants, the administration should not be suspended or postponed.


The medicinal product must not be mixed with other medicinal products, except those mentioned in the paragraph, instructions for use, handling and disposal: solvent syringe, vaccine syringe, diphtheria- Tetanus-pertussis, or diphtheria-tetanus-pertussis-poliomyelitis.
Not applicable.

Not applicable.

In accordance with the pediatric vaccine schedules, the WHO (World Health Organization) and ACIP (Advisory Committee on Immunization), Act-HIB recommendations are rarely given alone, but often in combination or combination With concomitant vaccines, such as vaccines containing valences, diphtheria, tetanus and pertussis (with whole or acellular germs).


Adverse reactions reported in clinical trials or since marketing are listed below according to MedDRA terminology (by organ systems and by frequency) for all age groups. The frequency is defined as: very common (≥ 10%), frequent (≥ 1% and

None of the following adverse reactions have been reported with a frequency greater than 0.01% (very rare). The frequencies are based on the rates of spontaneous notifications and calculated from the number of notifications and the number of doses distributed over the same period.
Disorders, General and Site Anomalies, Administration

Very rare: edema of the lower limbs with transient cyanosis or purpura, occurring within the first few hours after vaccination, and disappearing rapidly 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 valencies, diphtheria, tetanus and pertussis).

Immune system disorders

Very rare: reactions, hypersensitivity

Disorders of the nervous system

Very rare: convulsions, with or without fever

Skin and subcutaneous tissue disorders

Very rare: urticaria, rash, pruritus.
Apnea in large premature babies (born at 28 weeks of pregnancy or less) (see Warnings, Special and Precautions for Use)

This vaccine is indicated in the prevention of invasive infections with Haemophilus influenzae type b (meningitis, septicemia, cellulitis, arthritis, epiglottitis ...) in children, from 2 months. Infections due to other types of Haemophilus influenzae, or against meningitis due to other origins In no case can the tetanus protein contained in this vaccine replace the usual tetanus vaccination. Br>