IntramuscularActive immunisation against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type BChild: ≥6 weeks Primary immunisation: 0.5 mL for 2 or 3 doses, given at intervals of at least 1 month. Booster dose may be given at least 6 months after the last primary dose and in accordance with the local guidelines. Alternative primary immunisation recommendation: 6 weeks to 4 years (before the 5th birthday) 0.5 mL for 3 doses to be given at 2, 4, and 6 months of age; 1st dose may be given as early as 6 weeks of age. Recommendations may vary between individual products or local immunisation guidelines (refer to specific product or country guidelines).
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Powder and susp for susp for inj: Shake the pre-filled syringe containing diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis susp until a homogenous turbid white suspension is obtained. Add the entire contents of the pre-filled syringe to the vial containing the Haemophilus influenzae type B (HIB) powder. Shake well until the powder is completely dissolved. Instructions for reconstitution may vary among countries and individual products (refer to specific product guidelines).
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Hypersensitivity. History of encephalopathy of unknown cause occurring within 7 days after previous vaccination with pertussis-containing vaccine. Progressive neurologic disorders, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy (until a treatment plan is determined and condition is stabilised).
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Patient with history of fever (≥40°C) of unknown cause, collapse or shock-like state (hypotonic-hyporesponsive episode), or persistent, inconsolable crying lasting ≥3 hours which occurred within 48 hours of vaccination of pertussis-containing vaccine; convulsions (with or without fever) which occurred within 3 days of vaccination of pertussis-containing vaccine; thrombocytopenia or bleeding disorder; history of febrile convulsions; Guillain-Barre syndrome which occurred within 6 weeks of receipt of prior tetanus toxoid-containing vaccine. Delay vaccination in patients with moderate or severe acute illness (with or without fever) or during periods of severe immunosuppression (e.g. patients receiving chemotherapy or radiation therapy or other immunosuppressive treatment including high-dose corticosteroids), if appropriate. Infants (particularly those born prematurely) and children.
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Significant: Syncope, anaphylactoid or hypersensitivity reactions; bleeding or haematoma; apnoea (after IM vaccination in very premature infants born ≤28 weeks of gestation).
Gastrointestinal disorders: Vomiting, diarrhoea.
General disorders and administration site conditions: Fever ≥38°C, inj site reactions (e.g. pain, erythema, swelling, induration).
Metabolism and nutrition disorders: Decreased appetite.
Nervous system disorders: Somnolence.
Psychiatric disorders: Irritability, restlessness, abnormal crying, nervousness.
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Monitor for hypersensitivity reactions for 15 minutes after vaccination.
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Increased incidence of febrile reactions with pneumococcal vaccine.
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Potential interference with the interpretation of urine antigen detection tests for Haemophilus influenzae.
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Description:
Mechanism of Action: Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type B vaccine, a non-live combination vaccine, induces production of specific antibodies and antitoxins which promotes active immunity to diphtheria, tetanus, pertussis, hepatitis B, poliovirus (types 1, 2, and 3) and Haemophilus influenzae type B.
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Store between 2-8°C. Do not freeze. Protect from light.
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J07CA09 - diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B ; Belongs to the class of combined bacterial and viral vaccines.
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Oliver SE and Moore KL. Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type b Conjugate, and Hepatitis B Vaccine, and Guidance for Use in Infants. MMWR. Morbidity and Mortality Weekly Report. 2020 Feb;69(5):136-139. doi: 10.15585/mmwr.mm6905a5. Accessed 01/04/2024. PMID: 32027629 Buckingham R (ed). Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, and Haemophilus influenzae Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 27/03/2024. Diphtheria and Tetanus Toxoids, Acellular Pertussis, Hepatitis B (Recombinant), Poliovirus (Inactivated), and Haemophilus influenzae B Conjugate (Adsorbed) Vaccine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 27/03/2024. Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Haemophilus influenzae Type B Conjugate Vaccine; Hepatitis B Vaccine, Recombinant; Inactivated Poliovirus Vaccine, IPV. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 16/05/2024. Infanrix Hexa Powder and Suspension for Suspension for Injection (GlaxoSmithKline Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 27/03/2024. Infanrix Hexa, Powder and Suspension for Suspension for Injection (GlaxoSmithKline UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 27/03/2024. Joint Formulary Committee. Diphtheria with Tetanus, Pertussis, Hepatitis B, Poliomyelitis and Haemophilus Influenzae Type B Vaccine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 16/05/2024. Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics. Hexaxim 0.5 mL, Suspension for Injection data sheet 15 February 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 27/03/2024. Vaxelis Injection, Suspension (MSP Vaccine Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 27/03/2024.
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