Gardasil 9

Gardasil 9

vaccine, human papillomavirus 9-valent

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Recombinant human papillomavirus 9-valent (types 6, 11, 16, 18, 31, 33, 45, 52, 58) vaccine
Indications/Uses
Prevention of cervical, vulvar, vag & anal cancer, precancerous or dysplastic lesions & genital warts caused by HPV in girls & women 9-45 yr. Prevention of anal cancer, anal precancerous or dysplastic lesions & external genital lesions (ie, genital warts) caused by HPV in boys & men 9-45 yr.
Dosage/Direction for Use
3-dose schedule: 0.5 mL IM inj at 0, 2 & 6 mth. Alternative schedule: 1st dose: At elected date; 2nd dose: At least 1 mth after 1st dose; 3rd dose: At least 3 mth after 2nd dose; all to be given w/in 1 yr.
Contraindications
Special Precautions
Anaphylactic reactions. Not to be inj intravascularly, SC or intradermally. Not to be used for active external genital lesions; cervical, vulvar, vag or anal cancers; CIN, VIN, VaIN or AIN. Not intended for prevention of other established HPV-related lesions progression. Not for protection against diseases not caused by HPV. Syncope, current or recent febrile illness, impaired immune responsiveness, thrombocytopenia or any coagulation disorder. Avoid use during pregnancy. Childn <9 yr. Elderly ≥65 yr.
Adverse Reactions
Inj site pain, swelling, erythema; headache; cellulitis; idiopathic thrombocytopenic purpura, lymphadenopathy; acute disseminated encephalomyelitis, dizziness, Guillain-Barre syndrome, syncope; nausea, vomiting; arthralgia, myalgia; asthenia, chills, fatigue, malaise; hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, urticaria.
Drug Interactions
Reduced immune response to vaccine w/ immunosuppressive therapies ie, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids.
ATC Classification
J07BM03 - papillomavirus (human types 6, 11, 16, 18, 31, 33, 45, 52, 58) ; Belongs to the class of papillomavirus vaccines.
Presentation/Packing
Form
Gardasil 9 susp for inj
Packing/Price
0.5 mL x 10 × 1's;0.5 mL x 1's
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