IntramuscularPrevention of human papillomavirus infectionAdult: For 18-26 years women to prevent cervical, vulvar, vaginal and anal cancer (caused by HPV types 16 and 18) and genital warts (caused by HPV types 6 and 11), and prevent precancerous or dysplastic lesions (grade 2/3 cervical intraepithelial neoplasia and adenocarcinoma in situ; grade 1 cervical intraepithelial neoplasia; grade 2 and grade 3 vulvar or vaginal intraepithelial neoplasia; grades 1, 2, and 3 anal intraepithelial neoplasia) caused by HPV types 6, 11, 16 and 18; for 18-26 years men to prevent anal cancer (caused by HPV types 16 and 18) and genital warts (caused by HPV types 6 and 11), and precancerous or dysplastic lesions (grades 1, 2, and 3 anal intraepithelial neoplasia) caused by HPV types 6, 11, 16 and 18: As 3-dose schedule: 0.5 mL for 3 doses given at 0, 2, and 6 months in the deltoid area (preferred) or higher anterolateral area of the thigh. Administer the 2nd dose at least 1 month following the 1st dose, and give the 3rd dose at least 3 months after the 2nd dose. All 3 doses should be administered within 1 year. Use must be in accordance with the official recommendations.
Child: For girls and boys aged 9-<18 years As 3-dose schedule: Same as adult dose. Alternatively, in 9-13 years As 2-dose schedule: 0.5 mL for 2 doses given at 0 and 6 months; ≥14 years As 3-dose schedule: Same as adult dose. Use must be in accordance with the official recommendations.
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Hypersensitivity to human papillomavirus (type 6, 11, 16, 18) recombinant vaccine or any component of the formulation (e.g. polysorbate 80, yeast).
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Patient with history of bleeding disorder (e.g. thrombocytopenia) or any coagulation disorder. Patients receiving anticoagulant therapy. Immunocompromised patients (e.g. HIV infection, receiving immunosuppressive therapy). For maximum efficacy, the entire 3-dose regimen must be completed. Defer administration in patients with moderate to severe acute illness (with or without fever); vaccination may be given in patients with mild acute illness (e.g. minor upper respiratory tract infection, low-grade fever). Not indicated for the treatment of active HPV infection or established HPV-related diseases, cervical cancer, high-grade cervical, vulvar and vaginal dysplastic lesions or genital warts. Not intended to prevent the progression of other established HPV-related lesions. Not a substitute for routine cervical screening. Children. Pregnancy and lactation.
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Significant: Hypersensitivity or anaphylactoid reactions, bleeding/haematoma (after IM inj in patients with bleeding disorders); syncope which may result in falling with injury, or associated with tonic-clonic movements and other seizure-like disorder; shoulder injury (e.g. shoulder bursitis, tendinitis) following vaccine administration.
Blood and lymphatic system disorders: Lymphadenopathy, idiopathic thrombocytopenic purpura.
Gastrointestinal disorders: Nausea, diarrhoea, vomiting, toothache.
General disorders and administration site conditions: Inj site reactions (e.g. pain, erythema, swelling, pruritus, haematoma, cellulitis), fever, fatigue, chills, asthenia, malaise.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia, pain in the extremity.
Nervous system disorders: Headache, dizziness, Guillain-Barre syndrome, acute disseminated encephalomyelitis.
Respiratory, thoracic and mediastinal disorders: Oropharyngeal pain, upper respiratory tract infection.
Skin and subcutaneous tissue disorders: Rarely, urticaria.
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This drug will only protect against diseases caused by HPV types 6, 11, 16, and 18; ensure to continue appropriate precautions against STDs.
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Monitor for anaphylaxis and syncope 15 minutes following administration. Perform gynaecological examination, papillomavirus test, and cervical cancer screening regularly as per current guidelines after vaccination (females).
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May cause bleeding or bruising after IM administration in patients receiving anticoagulant therapy. Immune response to the vaccine may be decreased by immunosuppressive therapies (e.g. radiation therapy, alkylating agents, antimetabolites, high-dose corticosteroids).
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Description:
Mechanism of Action: Human papillomavirus (type 6, 11, 16, 18) recombinant vaccine is an adjuvanted non-infectious recombinant quadrivalent vaccine. It contains highly purified virus-like particles (VLPs) of the major capsid L1 protein of human papillomavirus (HPV) type 6, 11, 16 and 18 which produce neutralising antibodies to prevent cervical cancer, cervical adenocarcinoma, cervical, vaginal and vulvar neoplasia, and genital warts caused by HPV.
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Store between 2-8°C. Do not freeze. Protect from light. After removing from the refrigerator, vaccines are stable for 72 hours below 25°C. Stability recommendations may vary between countries (refer to specific product guidelines).
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J07BM01 - papillomavirus (human types 6, 11, 16, 18) ; Belongs to the class of papillomavirus vaccines.
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Anon. Human Papillomavirus Vaccine (Quadrivalent). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/09/2022. Buckingham R (ed). Human Papillomavirus Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/09/2022. Gardasil Injection, Suspension (Merck Sharp & Dohme LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/09/2022. Gardasil Suspension for Injection (Merck Sharp & Dohme [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 09/09/2022. Gardasil Suspension for Injection and Gardasil Suspension for Injection in a Pre-filled Syringe (Merck Sharp & Dohme B.V). European Medicines Agency [online]. Accessed 09/09/2022. Joint Formulary Committee. Human Papillomavirus Vaccines. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/09/2022.
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