IntramuscularProphylaxis of tetanus in wound managementAdult: As tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap): 0.5 mL as a single dose via IM inj into the deltoid muscle. Dose administration should be based on the patient's immunisation status (including the time from the last tetanus-containing vaccine) and the type or condition of the wound. Available products and recommendations for vaccination may vary between countries (refer to specific local immunisation guidelines).
Child: As diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP): 6 weeks to 6 years Dose administration should be based on the patient's current primary immunisation status. If a dose is given, this is considered the next dose in the series. As tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap): ≥7 years Same as adult dose. Available products and recommendations for vaccination may vary between countries (refer to specific local immunisation guidelines).
IntramuscularBooster immunisation against diphtheria, tetanus and pertussisAdult: As tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap): 0.5 mL as a single dose via IM inj into the deltoid muscle. Booster doses may be administered at 5-10-year intervals. Available products and recommendations for vaccination may vary between countries (refer to specific local immunisation guidelines).
Child: As tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap): ≥4 years 0.5 mL as a single dose. Booster doses may be administered at 5-10-year intervals. Alternative booster immunisation recommendation (for children who have completed their primary immunisation series): ≥10 years 0.5 mL as a single dose (preferably given at age 11-12 years). Subsequent booster doses may be administered every 10 years. All doses are given via IM inj into the deltoid muscle. Available products and recommendations for vaccination may vary between countries (refer to specific local immunisation guidelines).
IntramuscularActive immunisation against diphtheria, tetanus and pertussisChild: As diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP): 6 weeks to 6 years (before the 7th birthday) Primary immunisation: 5 dose series given as 3 primary doses followed by 2 booster doses. Primary series (doses 1-3): 0.5 mL given at 2, 4, and 6 months of age at intervals of 4-8 weeks; the 1st dose may be given as early as 6 weeks of age. 1st booster (dose 4): 0.5 mL given at 15-20 months of age; the 4th dose may be given as early as 12 months of age if at least 6 months have elapsed after the 3rd dose. 2nd booster (dose 5): 0.5 mL given at 4-6 years of age; the 5th dose may be omitted if the 4th dose is given at ≥4 years of age. Doses are given via IM inj into the anterolateral aspect of the thigh (for infants <12 months of age) or the deltoid muscle of the upper arm (for children 12 months to 6 years of age). Available products and recommendations for vaccination may vary between countries (refer to specific local immunisation guidelines).
IntramuscularPassive immunisation against pertussisAdult: For the prophylaxis of pertussis in early infancy through transplacental antibody transfer from the pregnant woman to the fetus: As tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap): 0.5 mL as a single dose via IM inj into the deltoid muscle of pregnant women during the 2nd or 3rd trimester of pregnancy. Pregnant women should receive a single dose of Tdap during each pregnancy regardless of prior vaccination history. Available products and recommendations for vaccination may vary between countries (refer to specific local immunisation guidelines).
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Hypersensitivity to diphtheria, tetanus or pertussis containing vaccines. History of encephalopathy (e.g. reduced level of consciousness, prolonged seizures, coma) 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 the condition is stabilised).
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Patient with bleeding disorders (e.g. thrombocytopenia, haemophilia); history of fever (≥40.5°C) of unknown cause, collapse or shock-like state (hypotonic-hyporesponsive episode), persistent, inconsolable crying lasting ≥3 hours which occurred within 48 hours after administration of any pertussis-containing vaccine; seizures (with or without fever) which occurred within 3 days after administration of pertussis-containing vaccine; Guillain-Barre syndrome which occurred within 6 weeks of receiving a prior tetanus toxoid-containing vaccine. Patient with a history of an Arthus-type hypersensitivity reaction after a previous dose of a tetanus toxoid-containing vaccine should not be given this vaccine more frequently than every 10 years, even if tetanus prophylaxis during wound management is indicated. Delay vaccination in patients with moderate or severe acute illness (with or without fever) and during periods of severe immunosuppression (e.g. patients receiving chemotherapy, radiation therapy, or other immunosuppressive treatment [including high-dose corticosteroids]), if appropriate. Patient receiving anticoagulant therapy. Diphtheria, tetanus and pertussis vaccine is available in multiple formulations, certain preparations may be identified as tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) or diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) which contain varying concentrations of diphtheria toxoid, tetanus toxoid and pertussis antigens; certain products are only used for specific age groups; these vaccines are not interchangeable. Verify the product and refer to specific product and local immunisation guidelines prior to administration. Infants (especially those born prematurely), children and the elderly. Pregnancy and lactation.
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Significant: Hypersensitivity or anaphylactoid reactions, syncope, shoulder injury associated with vaccine administration (e.g. bursitis or tendinopathy), bleeding or haematoma after IM administration (particularly in patients with bleeding disorders); brachial neuritis; apnoea following IM vaccination (particularly in premature infants); Guillain-Barre syndrome.
Blood and lymphatic system disorders: Lymphadenopathy.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea.
General disorders and administration site conditions: Fatigue, malaise, chills, pyrexia, axillary adenopathy, inj site reactions (e.g. pain, erythema, swelling).
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Headache, somnolence, dizziness, convulsions.
Psychiatric disorders: Irritability.
Skin and subcutaneous tissue disorders: Rash, pruritis, urticaria.
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Review the patient's current health status and medical history including history of immunisation, the presence of any contraindication to immunisation, and the occurrence of adverse reactions following previous immunisation prior to vaccination. Monitor for signs of syncope and hypersensitivity reactions for 15 minutes after vaccination.
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Immunosuppressive therapies (e.g. irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids) may reduce the therapeutic effect of the vaccine or decrease the immune response to the vaccination.
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Description:
Mechanism of Action: Diphtheria, tetanus and pertussis vaccine is a fixed combination preparation containing diphtheria toxoid, tetanus toxoid and acellular pertussis antigens. It induces the production of specific antibodies to promote active immunity to diphtheria, tetanus and pertussis.
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Store between 2-8°C. Do not freeze. Protect from light. Recommendations regarding extended storage information at room temperature may be available (refer to specific product guidelines).
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J07AJ52 - pertussis, purified antigen, combinations with toxoids ; Belongs to the class of pertussis bacterial vaccines.
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Adacel (Sanofi-Aventis [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/06/2024. Adacel Suspension for Injection in Pre-filled Syringe (Sanofi Pasteur Europe). MHRA. https://products.mhra.gov.uk. Accessed 07/06/2024. Adacel TDAP Injection, Suspension (Sanofi Pasteur Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/06/2024. Anon. Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP/Tdap). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 07/06/2024. Boostrix (GlaxoSmithKline Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/06/2024. Boostrix Suspension (GlaxoSmithKline Biologicals SA). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/06/2024. Brayfield A, Cadart C (eds). Diphtheria, Tetanus, and Pertussis Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/06/2024. Daptacel Injection, Suspension (Sanofi Pasteur Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/06/2024. Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 07/06/2024. Diphtheria, Tetanus, and Whooping Cough Vaccination. Centers for Disease Control and Prevention. https://www.cdc.gov. Accessed 03/07/2024. Diphtheria/Tetanus Toxoids; Pertussis Vaccine. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 27/07/2024. GlaxoSmithKline NZ Limited. Boostrix Combined Diphtheria-Tetanus-Acellular Pertussis (dTpa) Suspension for Injection data sheet 21 November 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 07/06/2024. Infanrix Suspension (GlaxoSmithKline Biologicals SA). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/06/2024. Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics. Adacel Pertussis Vaccine-Acellular Combined with Diphtheria and Tetanus Toxoids data sheet 25 March 2024. Medsafe. http://www.medsafe.govt.nz. Accessed 07/06/2024.
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