Full Prescribing Info
Contents
Haemophilus influenzae type b polysaccharide conjugated to tetanus protein.
Description
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).
The powder is white and the solvent is colourless.
Excipients/Inactive Ingredients: For the powder: trometamol and sucrose and concentrated hydrochloric acid for pH adjustment.
For the solvent: sodium chloride and water for injections.
Indications/Uses
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/Direction for Use
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.
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 should never be administered into a blood vessel.
The following information is intended for healthcare professionals only: 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 vaccine or a 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.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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.
If the patient forgets to use Act-HIB: If the patient forgets to take one dose of the vaccine, the doctor will decide when to administer this dose.
If the patient has further question on the use of this medicine, ask the doctor or pharmacist.
Contraindications
Do not use Act-HIB: If the child is allergic (hypersensitive) to any of the vaccine components (listed in Excipients/Inactive Ingredients under Description), to the tetanus protein, to formaldehyde, or if the child had an allergic reaction following injection of a vaccine containing the same substances.
If the child had an allergic reaction following prior injection of an Haemophilus influenzae type b conjugate vaccine.
If the child has a fever or a disease that occurred suddenly, without warning (acute disease), in this case it is preferable to postpone the vaccination.
Special Precautions
Talk to the doctor before using Act-HIB: If the child has a weakened immune system, or if the 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 the 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.
Other medicines and Act-HIB: 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.
Please tell the doctor or pharmacist if the child is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Use in pregnancy & lactation: Ask the doctor or pharmacist for advice before taking any medicines.
Use In Pregnancy & Lactation
Ask the doctor or pharmacist for advice before taking any medicines.
Side Effects
Like all medicines, Act-HIB can cause side effects, although not everybody gets them.
Very common side effect (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 (uncontrollable 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 a not known 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 an itchy (urticaria, rash, pruritus).
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 the child gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed in the leaflet. By reporting side effects, the patient can help provide more information on the safety of this medicine.
Drug Interactions
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.
Storage
Store in a refrigerator (2°C - 8°C). Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Do not use Act-HIB after the expiry date which is stated on the box after EXP. This expiry date refers to the last day of that month.
ATC Classification
J07AG51 - haemophilus influenzae B, combinations with toxoids ; Belongs to the class of hemophilus influenzae B bacterial vaccines.
Presentation/Packing
Vial 1 dose (10 mcg) + pre-filled syringe of 0.5 mL (diluent).
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