NEW
GARDASIL ® 9
AVAILABLE NOW
TO HELP PROTECT
AGAINST HPV
CANCERS &
DISEASES1 *
* GARDASIL 9 is indicated for: 1 – Females 9 to 45 years for the prevention of cervical, vulvar, vaginal and anal cancer, dysplasias, genital warts, and infection due to vaccine HPV types. ^
– Males 9 to 26 years for the prevention of anal cancer, dysplasias, external genital lesions and infection due to vaccine HPV types. ^
HPV = Human papillomavirus. ^Vaccine HPV types = 6, 11, 16, 18, 31, 33, 45, 52, 58.
IF YOU DON’ T RECOMMEND GARDASIL 9, WHO WILL?
Importantly, vaccinated women should continue with cervical screening.
Before prescribing, please review the Product Information available at www. seqirus. com. au / PI
MINIMUM PRODUCT INFORMATION. GARDASIL ® 9 [ Human Papillomavirus 9-valent( Types 6, 11, 16, 18, 31, 33, 45, 52, 58) vaccine, Recombinant ] Indications: GARDASIL 9 is indicated in females aged 9 to 45 years * for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by Human Papillomavirus( HPV) Types 6, 11, 16, 18, 31, 33, 45, 52 and 58. GARDASIL 9 is indicated in males 9 to 26 years of age for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions and infection caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58. * Evidence of vaccine efficacy is based on core efficacy population of females 16 to 26 years of age. Immunogenicity studies have been conducted to link efficacy to younger populations( females and males 9 to 15 years of age). Currently there are no data from studies of GARDASIL 9 relating to females over 26 years of age. Contraindications: Hypersensitivity to the active substances of GARDASIL 9 or GARDASIL or to any of the inactive ingredients of either vaccine. Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of GARDASIL 9 or GARDASIL should not receive further doses of GARDASIL 9. Precautions: Febrile illness, impaired immune response, thrombocytopenia or any coagulation disorder. This vaccine is not intended to be used for active treatment. Routine cervical screening and detection and removal of cervical lesions should be continued in individuals who receive the vaccine. Syncope, sometimes associated with falling, has occurred after HPV vaccination. Vaccinees should be carefully observed for approximately 15 minutes after administration of GARDASIL 9. Immunologic response may be diminished in immunocompromised individuals. Use in Pregnancy( Category B2): Not recommended for use in pregnant women. Pregnancy should be avoided during the vaccination regimen for GARDASIL 9. Use in Lactation: May be administered to lactating women. Interactions with other medicines: May be administered concomitantly with Menactra, Adacel Repevax, and Poliomyelities( inactivated) Vaccine. Use of hormonal contraceptives did not appear to affect the immune responses to GARDASIL 9. Immunosuppressive therapies may reduce the immune responses to vaccines. Adverse Effects: Injection site( pain, swelling, erythema, bruising, pruritis, mass, haemorrhage, induration, hematoma, warmth, reaction), headache, fever, nausea, dizziness, fatigue, diarrhoea, myalgia, influenza, upper respiratory tract infection, oropharyngeal and upper abdominal pain. Post-marketing experience: The following adverse experiences have been spontaneously reported during post-approval use of GARDASIL and may also be seen in post-marketing experience with GARDASIL 9: Cellulitis, idiopathic thrombocytopenic purpura, lymphadenopathy, acute disseminated encephalomyelitis, dizziness, Guillain-Barré syndrome, headache, syncope sometimes accompanied by tonic-clonic movements, nausea, vomiting, arthralgia, myalgia, asthenia, chills, fatigue, malaise, hypersensitivity reactions including anaphylactic / anaphylactoid reactions, bronchospasm, and urticaria. Dosage and Administration: Administered intramuscularly at day 0 and then at 2 and 6 months after initial dose. In clinical studies, efficacy has been demonstrated in individuals who have received all 3 doses within a 1-year period. Alternatively, in individuals 9 through 14 years of age, GARDASIL 9 can be administered according to a 2-dose schedule; the second dose should be administered between 5 and 13 months after the first dose. If the second vaccine dose is administered earlier than 5 months after the first dose, a third dose should always be administered. Based on Approved Product Information dated 5 June 2017.
References: 1. GARDASIL ® 9 Approved Product Information, June 2017. Seqirus( Australia) Pty Ltd. ABN 66 120 398 067, 63 Poplar Road Parkville, Victoria 3052. www. seqirus. com. au. Medical Information: 1800 642 865. Distributor for Merck, Sharp and Dohme( Australia) Pty Ltd. GARDASIL ® 9 is a registered trademarks of Merck & Co. Inc Whitehouse Station, NJ, USA. Seqirus™ is a trademark of Seqirus UK Limited or its affiliates. Date of preparation: December 2017. GAR9 / 1017 / 0008. 14650-A-A4.
PBS Information: This product is listed on the National Immunisation Program( NIP) as part of the school based program. Refer to NIP Schedule.
14650 Gardasil 9 HCP Ad Material Resizes-A4 210x297mm _ FA. indd 1 3 / 01 / 2018 2:37 PM