Haemophilus influenzae type B conjugate vaccine: U...

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

Intramuscular
Active immunisation against diseases caused by Haemophilus influenzae type b

Child: Hiberix or ActHIB Primary immunisation: Infants <6 months 0.5 mL for 3 doses given at intervals of 1-2 months (1st dose may be given as early as 6 weeks of age); infants 6-12 months (previously unvaccinated) 0.5 mL for 2 doses given with an interval of 1 month; children >1-5 years (previously unvaccinated) 0.5 mL as a single dose. Booster dose may be given according to local official guidelines. Liquid PedvaxHIB Primary immunisation: 2-14 months 0.5 mL for 2 doses given at 2 and 4 months of age. If the 2-dose primary immunisation is completed before 12 months of age, a 0.5 mL booster dose must be given at 12-15 months of age (but not earlier than 2 months after the 2nd dose). ≥15 months (previously unvaccinated) 0.5 mL as a single dose. All doses are given via IM inj into the anterolateral thigh or deltoid muscle (older children). Immunisation schedule, approved age and booster dose recommendations may vary among individual products or between countries (refer to specific product or local official guidelines).

What are the brands available for Haemophilus influenzae type B conjugate vaccine in Indonesia?

Other Known Brands

Hiberix
Infanrix-Hib
Pedvax Hib

Reconstitution

Lyophilised powder for solution for inj: Reconstitute the vial with the provided diluent as instructed on the label. Shake the vial well until the powder is completely dissolved. Recommendations for reconstitution may vary between individual products (refer to specific product guidelines).

Contraindications

Hypersensitivity.

Special Precautions

Patient with thrombocytopenia or bleeding disorder; history of Guillain-Barre syndrome (particularly for HIB vaccine conjugated to tetanus toxoid [Hiberix or ActHIB]). Patients receiving anticoagulant treatment. Immunocompromised patients (e.g. patients receiving chemotherapy, radiation therapy, or other immunosuppressive treatment [including high-dose corticosteroids]). Delay vaccination in patients with moderate or severe acute illness (with or without fever) and during periods of severe immunosuppression if appropriate. HIB conjugate vaccine does not protect against diseases caused by other types of Haemophilus influenzae nor against meningitis caused by other organisms. Immunisation using HIB vaccine conjugated to tetanus toxoid (Hiberix or ActHIB) does not substitute for routine tetanus vaccination. Infants (especially those born prematurely) and children.

Adverse Reactions

Significant: Anaphylactoid or hypersensitivity reactions, syncope; bleeding or haematoma (particularly in patients with bleeding disorders); apnoea following vaccination in very premature infants (born ≤28 weeks of gestation).
Gastrointestinal disorders: Vomiting, diarrhoea.
General disorders and administration site conditions: Fever; inj site reactions (e.g. erythema, pain, swelling, tenderness, induration).
Metabolism and nutrition disorders: Anorexia.
Nervous system disorders: Drowsiness.
Psychiatric disorders: Irritability, restlessness, uncontrollable crying.
Skin and subcutaneous tissue disorders: Rash, urticaria.

Pregnancy Category (US FDA)

Parenteral: C

Monitoring Parameters

Monitor for signs or symptoms of hypersensitivity reaction and syncope for 15 minutes after vaccination.

Drug Interactions

May result in reduced immune response when used concomitantly with immunosuppressive treatments (e.g. antimetabolites, alkylating agents, cytotoxic agents, high-dose corticosteroids).

Lab Interference

May interfere with the result of urine antigen detection tests; antigenuria may occur for up to 2 weeks after immunisation.

Action

Description:
Mechanism of Action: Haemophilus influenzae type B (HIB) conjugate vaccine is an inactivated vaccine prepared from the purified capsular polysaccharide of Haemophilus influenzae type B conjugated via covalent linking to varying carrier proteins to improve immunogenicity. Hiberix and ActHIB contain Haemophilus influenzae type B capsular polysaccharide covalently bound to tetanus toxoid. Liquid PedvaxHIB contains Haemophilus influenzae type B capsular polysaccharide covalently bound to the outer membrane protein complex (OMPC) of Neisseria meningitidis. HIB conjugate vaccine promotes active immunity to Haemophilus influenzae type B infection by inducing the production of anticapsular antibodies.
Onset: Immunity: Approx 2 weeks (following completion of initial series).

Storage

Store between 2-8°C. Do not freeze.

MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J07AG - Haemophilus influenzae B vaccines ; Used for active immunizations.

References

Act-HIB 10 micrograms/0.5 mL (Sanofi Hong Kong Limited). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 18/02/2025.

ActHIB (Sanofi Pasteur Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 18/02/2025.

Anon. Haemophilus B Vaccine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 18/02/2025.

Brayfield A, Cadart C (eds). Haemophilus influenzae Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 18/02/2025.

GlaxoSmithKline NZ Ltd. Hiberix Powder and Diluent for Solution for Injection data sheet 20 August 2019. Medsafe. http://www.medsafe.govt.nz. Accessed 18/02/2025.

Haemophilus B Conjugate Vaccine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 18/02/2025.

Haemophilus influenzae Type B Conjugate Vaccine. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 18/02/2025.

Hiberix (GlaxoSmithKline Biologicals SA). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 18/02/2025.

Hiberix Powder and Solvent for Solution for Injection (GlaxoSmithKline Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 18/02/2025.

Hiberix Vaccine (SmithKline Beecham Limited Trading as GlaxoSmithKline UK). MHRA. https://products.mhra.gov.uk. Accessed 18/02/2025.

PedvaxHIB Injection, Suspension (Merck Sharp & Dohme LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 18/02/2025.

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics. Act-HIB 10 mcg/0.5 mL Injection with Diluent data sheet 03 February 2025. Medsafe. http://www.medsafe.govt.nz. Accessed 18/02/2025.

Disclaimer: This information is independently developed by MIMS based on Haemophilus influenzae type B conjugate vaccine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com