GNH USA

Europe — EMA

Hiberix

Learn about Hiberix, the EU‑approved Haemophilus influenzae type b conjugate vaccine, its uses, mechanism, side effects, precautions, and FAQs.

Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate)

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What is Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate)?

Hiberix is a prescription injectable solution that contains the Haemophilus influenzae type b (Hib) conjugate vaccine, a tetanus toxoid‑conjugated polysaccharide. The vaccine is supplied in a standard strength (strength not specified) for intramuscular or subcutaneous administration. It is marketed in the European Union and is used to stimulate active immunity against invasive Hib disease in infants and children. The product is classified under ATC code J07AG and intended for immunization schedules.

What is Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate) used for?

Hiberix is indicated for the prevention of invasive disease caused by Haemophilus influenzae type b in infants and children.

- Primary series of three doses given at 2, 4, and 12‑15 months of age. - A single booster dose administered at 12‑15 months or later, according to local schedule. - Recommended for children from 6 weeks up to 5 years of age who have not previously received Hib vaccine. - Administered by intramuscular or subcutaneous injection into the anterolateral thigh or deltoid muscle. - Can be co‑administered with other routine pediatric vaccines such as DTaP, IPV, or pneumococcal conjugate vaccine.

What are the side effects of Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate)?

Like all vaccines, Hiberix may cause local or systemic reactions, most of which are mild and transient.

Common: - Pain, redness, or swelling at the injection site. - Low‑grade fever (≤38.5 °C) within 24‑48 hours after vaccination. - Irritability or fussiness in infants. - Mild fatigue or decreased appetite.

Serious: - Severe allergic reaction (anaphylaxis) with hives, airway swelling, or hypotension. - High fever (>40 °C) persisting more than 24 hours. - Seizure (febrile convulsion) associated with fever. - Persistent crying or inconsolable behavior lasting >3 hours.

What precautions apply to Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate)?

Healthcare providers should assess individual risk factors before administering Hiberix and follow recommended safety guidelines.

- Do not vaccinate children with a known severe allergy to any vaccine component, including tetanus toxoid. - Postpone vaccination in persons experiencing moderate or severe acute illness with fever. - Observe the patient for at least 15 minutes after injection to monitor for immediate allergic reactions. - Use caution in individuals with a history of seizures or neurologic disorders; discuss benefits versus risks. - Consider deferring vaccination in immunocompromised patients until clinical stability is achieved. - Ensure proper storage and handling of the vaccine according to the manufacturer’s instructions.

What does Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate) interact with?

Hiberix generally has a low potential for drug interactions, but certain circumstances warrant caution.

Avoid: - Concurrent administration of live bacterial vaccines (e.g., oral typhoid) within 4 weeks, as immune response may be altered. - Simultaneous use of immunosuppressive therapies (e.g., high‑dose corticosteroids) that could diminish vaccine efficacy.

Use with caution: - Administration with other inactivated vaccines; monitor for increased local reactogenicity. - Patients receiving antipyretics (e.g., acetaminophen) prophylactically; may reduce antibody response. - Individuals on biologic agents targeting B‑cell function; assess timing relative to vaccination.

Frequently asked questions

What age groups are eligible for Hiberix vaccination?+
Hiberix is approved for use in infants and children from 6 weeks up to 5 years of age who have not previously received a Hib vaccine.
How many doses are required in the primary series of Hiberix?+
The primary series consists of three separate injections, typically administered at 2, 4, and 12‑15 months of age.
Can Hiberix be given together with other routine childhood vaccines?+
Yes, Hiberix may be co‑administered with other inactivated pediatric vaccines such as DTaP, IPV, and pneumococcal conjugate vaccine.
What is the recommended route of administration for Hiberix?+
Hiberix is administered by intramuscular or subcutaneous injection, usually into the anterolateral thigh in infants or the deltoid muscle in older children.
What are the most common side effects after receiving Hiberix?+
Common reactions include pain, redness, or swelling at the injection site, low‑grade fever, irritability, and mild fatigue.
What serious adverse reactions should be reported after Hiberix vaccination?+
Serious events such as anaphylaxis, high fever lasting more than 24 hours, febrile seizures, or prolonged inconsolable crying should be reported to a healthcare professional immediately.
Should Hiberix be postponed if a child has a mild fever?+
Vaccination can be delayed if the child has a moderate or severe acute illness with fever; mild illness without fever generally does not require postponement.
Is there any contraindication for Hiberix related to tetanus toxoid allergy?+
Yes, children with a known severe allergy to tetanus toxoid or any component of the vaccine should not receive Hiberix.
Can immunosuppressive medications affect the effectiveness of Hiberix?+
Immunosuppressive therapies, especially high‑dose corticosteroids or biologics that affect B‑cell function, may reduce the immune response to Hiberix and should be considered when scheduling vaccination.
What storage conditions are required for Hiberix?+
Hiberix should be stored in a refrigerator between 2 °C and 8 °C, protected from light, and not frozen.
Is prophylactic use of acetaminophen recommended with Hiberix?+
Routine prophylactic use of antipyretics like acetaminophen is not recommended, as it may diminish the antibody response; they can be used after vaccination if needed for symptom relief.
What is the ATC classification code for Hiberix?+
The ATC code for Hiberix is J07AG, indicating it is a bacterial vaccine.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate)
Route
Intramuscular Use , Subcutaneous Use
Manufacturer
Glaxosmithkline (Ireland) Limited
Origin
EU

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