Act-HIB

Haemophilus influenzae type b polysaccharide conjugated to tetanus protein.

The powder is white and the solvent is a clear and colourless solution.
The active substance is: Haemophilus influenzae type b polysaccharide (10 micrograms per 0.5 ml dose) conjugated to tetanus protein (18-30 micrograms per 0.5 ml dose).
This vaccine comes in the form of a vial of powder and a solution for injection of solvent (0.5 ml in pre-filled syringe with needles).
Excipients/Inactive Ingredients: The other ingredients are: For the powder: trometamol and sucrose and concentrated hydrochloric acid for pH adjustment.
For the solvent: sodium chloride and water for injections.

Pharmacotherapeutic group: Bacterial vaccines. ATC code: J07AG01.
Act-HIB is a vaccine. Vaccines are used to protect against infectious diseases.
When Act-HIB is injected, the body's natural defenses develop a protection against those diseases.

This vaccine is indicated for the prevention of Haemophilus influenzae type b invasive infections (meningitis, septicaemia, cellulitis, arthritis, epiglottitis, etc.) in children from the age of 2 months.
This vaccine does not protect against infections due to other types of Haemophilus influenzae, or against meningitis of other origins.
Under no circumstances can the tetanus protein contained in this vaccine be used to replace the usual tetanus vaccination.

Dosage: Before 6 months of age, 3 successive doses of 0.5 ml administered one or two months apart, followed by a booster injection (0.5 ml) one year after the third injection.
Between 6 and 12 months of age, 2 doses of 0.5 ml administered one month apart, followed by a booster injection (0.5 ml) at 18 months of age.
From 1 to 5 years of age, a single dose of 0.5 ml.
For contact cases: In the event of a contact with a case of invasive Haemophilus influenzae type b infection (family or childcare), vaccination should be implemented according to the schedule for the contact case's age.
The index case (the first case identified in an organisation or a community) must also be vaccinated.
If the patient forgets to use Act-HIB 10 micrograms/0.5 ml, powder and solvent for solution for injection in pre-filled syringe: If the patient forgets to take one dose of the vaccine, the doctor will decide when to administer this dose.
If the patient stops using Act-HIB 10 micrograms/0.5 ml, powder and solvent for solution for injection in pre-filled syringe: Not applicable.
If the patient/parent has any further questions on the use of this medicine, advise the patient/parent to ask the doctor or pharmacist.
Method of administration: This vaccine will be administered to the child by a healthcare professional preferably into a muscle or deep under the skin, into a thigh or into an arm.
This vaccine must never be administered into a blood vessel.
Additional information: Reconstitute the solution, either by injecting the content of the syringe of solvent into the vial of powder or by injecting the content of a syringe of combined diphtheria-tetanus-pertussis vaccine or a diphtheria-tetanus-pertussis-poliomyelitis vaccine.
Shake until the powder is completely dissolved.
The whitish, cloudy appearance of the suspension following reconstitution by a syringe of diphtheria-tetanus-pertussis or diphtheria-tetanus-pertussis-poliomyelitis vaccine is normal.
For syringes without attached needle, the separate needle must be fitted firmly to the syringe, rotating it by one quarter turn.
Do not inject by the intravascular route.
Administer via the intramuscular (preferably) or the deep-subcutaneous route: the recommended injection sites are the antero-lateral aspect of the thigh (middle third) for infants and toddlers and the deltoid region for older children.

Not applicable.

Do not use Act-HIB 10 micrograms/0.5 ml powder and solvent for solution for injection in pre-filled syringe: If child is allergic (hypersensitive) to any of vaccine components (listed in Description), to the tetanus protein, to formaldehyde, or if child had an allergic reaction following injection of a vaccine containing the same substances; If child had an allergic reaction following prior injection of a Haemophilus influenzae type b conjugate vaccine; If child has a fever or a disease that occurred suddenly, without warning (acute disease), in this case it is preferable to postpone the vaccination.

Advise the patient/parent to talk to the doctor before using Act-HIB: If child has a weakened immune system, or if child is treated with corticosteroids, cytotoxic drugs, radiotherapy of other drugs likely to weaken the immune system. The doctor may wait until the end of the treatment; If child has bleeding disorders such as a decrease in platelets (thrombocytopenia) or clotting disorders, because of the risk of bleeding which may occur during intramuscular administration; If child is allergic (hypersensitive) to latex. The tip caps of the syringes without a needle attached contain a natural latex derivative that could cause allergic reactions; Fainting can occur following, or even before, any needle injection. Also, advise the patient/parent to inform the doctor or nurse if the child has fainted with previous injection.
Act-HIB 10 micrograms/0.5 ml, powder and solvent for solution for injection in pre-filled syringe contains sodium: Act-HIB contains less than 1 mmol (23 mg) of sodium per dose, which means that it is essentially "sodium free".
Driving and using machines: Not applicable.
Use in Children: Not applicable.

Patients must be advised by the doctor or pharmacist before taking any medicines.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (reported by more than 1 in 10 people): Injection site reactions such as pain, redness, swelling and/or inflammation, hardening (induration); irritability.
Common side effects (reported by less than 1 in 10 people but more than 1 in 100 people): crying (incontrollable or abnormal); fever; vomiting.
Uncommon side effects (reported by less than 1 in 100 people but more than 1 in 1000 people): fever (higher than 39°C).
Side effects with unknown frequency (because reported voluntarily and very rarely): Extensive swelling (large oedema) of the vaccinated limb that may spread to the whole arm or leg into which the vaccine was administered; Large injection site reactions, larger than 5 cm, such as pain, redness (erythema), swelling (oedema) and/or inflammation, or hardening of the skin (induration); Swelling of legs and feet (oedematous reactions affecting lower limbs). These reactions may be associated with crying, bluish skin colour (cyanosis) or redness and small transient red spots (purpura) occurring in the first hours of vaccination, resolving quickly without treatment (within 24 hours) and without sequelae; Swelling of the face and/or neck, allergic reactions (hypersensitivity reactions); Convulsions associated or not with fever; Skin eruption, sometimes swollen and itchy (urticaria, rash, pruritus), skin eruption over the whole body (rash generalised).
In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Reporting of side effects: If child gets any side effects, advise the parent to talk to the doctor, pharmacist or nurse. This includes any possible side effects not previously listed in this monograph. By reporting side effects, more information can be provided on the safety of this medicine.

In case of concomitant administration of this vaccine with a measles, mumps and rubella vaccine or with vaccines against diphtheria, tetanus, pertussis and poliomyelitis, the two injections will be performed at two separate sites, which means in another part of the body such as the other arm or the other leg.
Advise the parent/patient to inform the doctor or pharmacist if child is taking, has recently taken or might take any other medicines.
Since the Hib capsular polysaccharide antigen is excreted in urine, a positive urine test can be observed within 1 to 2 weeks following vaccination. Other tests must be performed in order to confirm Hib infection during this time.
Act-HIB with food and drink: Not applicable.

Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Store in a refrigerator (between 2°C-8°C).
Do not freeze.

Vaccines, Antisera & Immunologicals

J07AG51 - haemophilus influenzae B, combinations with toxoids ; Belongs to the class of hemophilus influenzae B vaccines.

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