United States - English - NLM (National Library of Medicine)

merck sharp & dohme llc - human papillomavirus type 6 l1 capsid protein antigen (unii: 61746o90dy) (human papillomavirus type 6 l1 capsid protein antigen - unii:61746o90dy), human papillomavirus type 11 l1 capsid protein antigen (unii: z845vhq61p) (human papillomavirus type 11 l1 capsid protein antigen - unii:z845vhq61p), human papillomavirus type 16 l1 capsid protein antigen (unii: 6lte2dnx63) (human papillomavirus type 16 l1 capsid protein antigen - unii:6lte2dnx63), human papillomavirus type 18 l1 capsid protein antigen (unii: - human papillomavirus type 6 l1 capsid protein antigen 20 ug in 0.5 ml - gardasil® is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by human papillomavirus (hpv) types included in the vaccine: - cervical, vulvar, vaginal, and anal cancer caused by hpv types 16 and 18 - genital warts (condyloma acuminata) caused by hpv types 6 and 11 and the following precancerous or dysplastic lesions caused by hpv types 6, 11, 16, and 18: - cervical intraepithelial neoplasia (cin) grade 2/3 and cervical adenocarcinoma in situ (ais) - cervical intraepithelial neoplasia (cin) grade 1 - vulvar intraepithelial neoplasia (vin) grade 2 and grade 3 - vaginal intraepithelial neoplasia (vain) grade 2 and grade 3 - anal intraepithelial neoplasia (ain) grades 1, 2, and 3 gardasil is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases caused by hpv types included in the vaccine: - anal cancer caused by hpv types 16 and 18 - genital warts (condyloma acuminata) caused by hpv types 6 and

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - human papillomavirus (hpv) 11 l1 protein 80 µg/ml;  ; human papillomavirus (hpv) 16 l1 protein 80 µg/ml;  ; human papillomavirus (hpv) 18 l1 protein 40 µg/ml;  ; human papillomavirus (hpv) 6 l1 protein 40 µg/ml;   - solution for injection - active: human papillomavirus (hpv) 11 l1 protein 80 µg/ml   human papillomavirus (hpv) 16 l1 protein 80 µg/ml   human papillomavirus (hpv) 18 l1 protein 40 µg/ml   human papillomavirus (hpv) 6 l1 protein 40 µg/ml   excipient: aluminium as amorphous aluminum hydroxyphosphate sulphate borax histidine polysorbate 80 sodium chloride water for injection - gardasil is indicated in females aged 9 through 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 and 18 (which are included in the vaccine). gardasil is indicated in males 9 through 26 years of age for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions and infections caused by hpv types 6, 11, 16 and 18 (which are included in the vaccine). *immunogenicity studies have been conducted to link efficacy in females and males aged 16 to 26 years to the younger populations.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - human papillomavirus (hpv) 11 l1 protein 40ug;  ; human papillomavirus (hpv) 16 l1 protein 60ug;  ; human papillomavirus (hpv) 18 l1 protein 40ug;  ; human papillomavirus (hpv) 31 l1 protein 20ug;  ; human papillomavirus (hpv) 33 l1 protein 20ug;  ; human papillomavirus (hpv) 45 l1 protein 20ug;  ; human papillomavirus (hpv) 52 l1 protein 20ug;  ; human papillomavirus (hpv) 58 l1 protein 20ug;  ; human papillomavirus (hpv) 6 l1 protein 30ug;   - suspension for injection - 0.5 ml - active: human papillomavirus (hpv) 11 l1 protein 40ug   human papillomavirus (hpv) 16 l1 protein 60ug   human papillomavirus (hpv) 18 l1 protein 40ug   human papillomavirus (hpv) 31 l1 protein 20ug   human papillomavirus (hpv) 33 l1 protein 20ug   human papillomavirus (hpv) 45 l1 protein 20ug   human papillomavirus (hpv) 52 l1 protein 20ug   human papillomavirus (hpv) 58 l1 protein 20ug   human papillomavirus (hpv) 6 l1 protein 30ug   excipient: aluminium as amorphous aluminium hydroxyphosphate sulfate adjuvant histidine polysorbate 80 sodium borate sodium chloride water for injection - gardasil 9 is indicated in females aged 9 through 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 (which are included in the vaccine). gardasil 9 is indicated in males 9 through 45 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 (which are included in the vaccine).

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - hpv type 6 l1 protein, quantity: 20 microgram; hpv type 11 l1 protein, quantity: 40 microgram; hpv type 16 l1 protein, quantity: 40 microgram; hpv type 18 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: aluminium; histidine; polysorbate 80; borax; water for injections; sodium chloride - gardasil is indicated in females aged 9 through 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, and 18 (which are included in the vaccine). gardasil is indicated in males 9 through 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, and 18 (which are included in the vaccine). *immunogenicity studies have been conducted to link efficacy in females and males aged 16 to 26 years to the younger populations.

United States - English - NLM (National Library of Medicine)

a-s medication solutions - human papillomavirus type 6 l1 capsid protein antigen (unii: 61746o90dy) (human papillomavirus type 6 l1 capsid protein antigen - unii:61746o90dy), human papillomavirus type 11 l1 capsid protein antigen (unii: z845vhq61p) (human papillomavirus type 11 l1 capsid protein antigen - unii:z845vhq61p), human papillomavirus type 16 l1 capsid protein antigen (unii: 6lte2dnx63) (human papillomavirus type 16 l1 capsid protein antigen - unii:6lte2dnx63), human papillomavirus type 18 l1 capsid protein antigen (unii: - gardasil® is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by human papillomavirus (hpv) types included in the vaccine: - cervical, vulvar, vaginal, and anal cancer caused by hpv types 16 and 18 - genital warts (condyloma acuminata) caused by hpv types 6 and 11 and the following precancerous or dysplastic lesions caused by hpv types 6, 11, 16, and 18: - cervical intraepithelial neoplasia (cin) grade 2/3 and cervical adenocarcinoma in situ (ais) - cervical intraepithelial neoplasia (cin) grade 1 - vulvar intraepithelial neoplasia (vin) grade 2 and grade 3 - vaginal intraepithelial neoplasia (vain) grade 2 and grade 3 - anal intraepithelial neoplasia (ain) grades 1, 2, and 3 gardasil is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases caused by hpv types included in the vaccine: - anal cancer caused by hpv types 16 and 18 - genital warts (condyloma acuminata) caused by hpv types 6 and

United States - English - NLM (National Library of Medicine)

a-s medication solutions - human papillomavirus type 6 l1 capsid protein antigen (unii: 61746o90dy) (human papillomavirus type 6 l1 capsid protein antigen - unii:61746o90dy), human papillomavirus type 11 l1 capsid protein antigen (unii: z845vhq61p) (human papillomavirus type 11 l1 capsid protein antigen - unii:z845vhq61p), human papillomavirus type 16 l1 capsid protein antigen (unii: 6lte2dnx63) (human papillomavirus type 16 l1 capsid protein antigen - unii:6lte2dnx63), human papillomavirus type 18 l1 capsid protein antigen (unii: - human papillomavirus type 6 l1 capsid protein antigen 30 ug in 0.5 ml - gardasil® 9 is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases: - cervical, vulvar, vaginal, and anal cancer caused by human papillomavirus (hpv) types 16, 18, 31, 33, 45, 52, and 58 - genital warts (condyloma acuminata) caused by hpv types 6 and 11 and the following precancerous or dysplastic lesions caused by hpv types 6, 11, 16, 18, 31, 33, 45, 52, and 58: - cervical intraepithelial neoplasia (cin) grade 2/3 and cervical adenocarcinoma in situ (ais) - cervical intraepithelial neoplasia (cin) grade 1 - vulvar intraepithelial neoplasia (vin) grade 2 and grade 3 - vaginal intraepithelial neoplasia (vain) grade 2 and grade 3 - anal intraepithelial neoplasia (ain) grades 1, 2, and 3 gardasil 9 is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases: - anal cancer caused by hpv types 16, 18, 31, 33, 45, 52, and 58 - genital warts (condyloma acuminata) caused by hpv types 6 and 11 and the following

United States - English - NLM (National Library of Medicine)

a-s medication solutions - human papillomavirus type 6 l1 capsid protein antigen (unii: 61746o90dy) (human papillomavirus type 6 l1 capsid protein antigen - unii:61746o90dy), human papillomavirus type 11 l1 capsid protein antigen (unii: z845vhq61p) (human papillomavirus type 11 l1 capsid protein antigen - unii:z845vhq61p), human papillomavirus type 16 l1 capsid protein antigen (unii: 6lte2dnx63) (human papillomavirus type 16 l1 capsid protein antigen - unii:6lte2dnx63), human papillomavirus type 18 l1 capsid protein antigen (unii: j2d279pem5) (human papillomavirus type 18 l1 capsid protein antigen - unii:j2d279pem5), human papillomavirus type 31 l1 capsid protein antigen (unii: 53jil371ns) (human papillomavirus type 31 l1 capsid protein antigen - unii:53jil371ns), human papillomavirus type 33 l1 capsid protein antigen (unii: 759rac446c) (human papillomavirus type 33 l1 capsid protein antigen - unii:759rac446c), human papillomavirus type 45 l1 capsid protein antigen (unii: 68s8vcn34f) (human papillomavirus type 45 l1 capsid protein antigen - unii:68s8vcn34f), human papillomavirus type 52 l1 capsid protein antigen (unii: 55644w68fd) (human papillomavirus type 52 l1 capsid protein antigen - unii:55644w68fd), human papillomavirus type 58 l1 capsid protein antigen (unii: 94y15hp7lf) (human papillomavirus type 58 l1 capsid protein antigen - unii:94y15hp7lf) - gardasil® 9 is a vaccine indicated in girls and women 9 through 45 years of age for the prevention of the following diseases: - cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (hpv) types 16, 18, 31, 33, 45, 52, and 58 - genital warts (condyloma acuminata) caused by hpv types 6 and 11 and the following precancerous or dysplastic lesions caused by hpv types 6, 11, 16, 18, 31, 33, 45, 52, and 58: - cervical intraepithelial neoplasia (cin) grade 2/3 and cervical adenocarcinoma in situ (ais) - cervical intraepithelial neoplasia (cin) grade 1 - vulvar intraepithelial neoplasia (vin) grade 2 and grade 3 - vaginal intraepithelial neoplasia (vain) grade 2 and grade 3 - anal intraepithelial neoplasia (ain) grades 1, 2, and 3 gardasil 9 is indicated in boys and men 9 through 45 years of age for the prevention of the following diseases: - anal, oropharyngeal and other head and neck cancers caused by hpv types 16, 18, 31, 33, 45, 52, and 58 - genital warts (condyloma acuminata) caused by hpv types 6 and 11 and the following precancerous or dysplastic lesions caused by hpv types 6, 11, 16, 18, 31, 33, 45, 52, and 58: - anal intraepithelial neoplasia (ain) grades 1, 2, and 3 the oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing hpv-related anogenital disease [see clinical studies (14.5)]. continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. - vaccination with gardasil 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider. - gardasil 9 has not been demonstrated to provide protection against disease caused by: hpv types not covered by the vaccine [see description (11)], hpv types to which a person has previously been exposed through sexual activity. - hpv types not covered by the vaccine [see description (11)], - hpv types to which a person has previously been exposed through sexual activity. - not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by hpv, and gardasil 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by hpv 16, 18, 31, 33, 45, 52, and 58. - gardasil 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; cin; vin; vain; or ain. - vaccination with gardasil 9 may not result in protection in all vaccine recipients. hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of gardasil 9 or gardasil [see description (11)]. pregnancy exposure registry there is a pregnancy exposure registry to monitor pregnancy outcomes in women exposed to gardasil 9 during pregnancy. to enroll in or obtain information about the registry, call merck sharp & dohme llc at 1-800-986-8999. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. there are no adequate and well-controlled studies of gardasil 9 in pregnant women. available human data do not demonstrate vaccine-associated increase in risk of major birth defects and miscarriages when gardasil 9 is administered during pregnancy. in one developmental toxicity study, 0.5 ml of a vaccine formulation containing between 1 and 1.5 –fold of each of the 9 hpv antigen types was administered to female rats prior to mating and during gestation. in a second study, animals were administered a single human dose (0.5 ml) of gardasil 9 prior to mating, during gestation and during lactation. these animal studies revealed no evidence of harm to the fetus due to gardasil 9 [see data] . data human data in pre-licensure clinical studies of gardasil 9, women underwent pregnancy testing immediately prior to administration of each dose of gardasil 9 or control vaccine (gardasil). (data from gardasil are relevant to gardasil 9 because both vaccines are manufactured using the same process and have overlapping compositions.) subjects who were determined to be pregnant were instructed to defer vaccination until the end of their pregnancy. despite this pregnancy screening regimen, some subjects were vaccinated very early in pregnancy before human chorionic gonadotropin (hcg) was detectable. an analysis was conducted to evaluate pregnancy outcomes for pregnancies with onset within 30 days before or after vaccination with gardasil 9 or gardasil. among such pregnancies, there were 62 and 55 with known outcomes (excluding ectopic pregnancies and elective terminations) for gardasil 9 and gardasil, respectively, including 44 and 48 live births, respectively. the rates of pregnancies that resulted in a miscarriage were 27.4% (17/62) and 12.7% (7/55) in subjects who received gardasil 9 or gardasil, respectively. the rates of live births with major birth defects were 0% (0/44) and 2.1% (1/48) in subjects who received gardasil 9 or gardasil, respectively. a five-year pregnancy registry enrolled 2,942 women who were inadvertently exposed to gardasil within one month prior to the last menstrual period (lmp) or at any time during pregnancy, 2,566 of whom were prospectively followed. after excluding elective terminations (n=107), ectopic pregnancies (n=5) and those lost to follow-up (n=814), there were 1,640 pregnancies with known outcomes. rates of miscarriage and major birth defects were 6.8% of pregnancies (111/1,640) and 2.4% of live born infants (37/1,527), respectively. these rates of assessed outcomes in the prospective population were consistent with estimated background rates. in two postmarketing studies of gardasil (one conducted in the u.s., and the other in nordic countries), pregnancy outcomes among subjects who received gardasil during pregnancy were evaluated retrospectively. among the 1,740 pregnancies included in the u.s. study database, outcomes were available to assess the rates of major birth defects and miscarriage. among the 499 pregnancies included in the nordic study database, outcomes were available to assess the rates of major birth defects. in both studies, rates of assessed outcomes did not suggest an increased risk with the administration of gardasil during pregnancy. animal data developmental toxicity studies were conducted in female rats. in one study, animals were administered 0.5 ml of a vaccine formulation containing between 1 and 1.5 –fold of each of the 9 hpv antigen types 5 and 2 weeks prior to mating, and on gestation day 6. in a second study, animals were administered a single human dose (0.5 ml) of gardasil 9, 5 and 2 weeks prior to mating, on gestation day 6, and on lactation day 7. no adverse effects on pre- and post-weaning development were observed. there were no vaccine-related fetal malformations or variations. risk summary available data are not sufficient to assess the effects of gardasil 9 on the breastfed infant or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for gardasil 9 and any potential adverse effects on the breastfed child from gardasil 9 or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. safety and effectiveness have not been established in pediatric patients below 9 years of age. the safety and effectiveness of gardasil 9 have not been evaluated in a geriatric population, defined as individuals aged 65 years and over. the immunologic response to gardasil 9 may be diminished in immunocompromised individuals [see drug interactions (7.1)] .

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme australia pty ltd - hpv type 11 l1 protein; hpv type 18 l1 protein; hpv type 6 l1 protein; hpv type 16 l1 protein -

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - human papillomavirus type 6 l1 protein; human papillomavirus type 31 l1 protein; human papillomavirus type 58 l1 protein; human papillomavirus type 52 l1 protein; human papillomavirus type 11 l1 protein; human papillomavirus type 16 l1 protein; human papillomavirus type 18 l1 protein; human papillomavirus type 33 l1 protein; human papillomavirus type 45 l1 protein - suspension for injection

Singapore - English - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - human papillomavirus type 11 l1 protein; human papillomavirus type 16 l1 protein; human papillomavirus type 18 l1 protein; human papillomavirus type 6 l1 protein - solution, sterile - 40 mcg - human papillomavirus type 11 l1 protein 40 mcg; human papillomavirus type 16 l1 protein 40 mcg; human papillomavirus type 18 l1 protein 20 mcg; human papillomavirus type 6 l1 protein 20 mcg