GARDASIL 9- human papillomavirus 9-valent vaccine, recombinant injection, suspension

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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:

Saatavilla:

A-S Medication Solutions

INN (Kansainvälinen yleisnimi):

HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN

Koostumus:

HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN 30 ug in 0.5 mL

Antoreitti:

INTRAMUSCULAR

Käyttöaiheet:

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

Tuoteyhteenveto:

Product: 50090-2443 NDC: 50090-2443-0 10 mL in a CARTON

Valtuutuksen tilan:

Biologic Licensing Application

Valmisteyhteenveto

GARDASIL 9- HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT
INJECTION, SUSPENSION
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GARDASIL 9 SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR GARDASIL 9.
GARDASIL 9
(HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT)
SUSPENSION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 2014
INDICATIONS AND USAGE
GARDASIL 9 is a vaccine indicated in girls and women 9 through 26
years of age for the prevention of the following
dise ase s:
Cervical, vulvar, vaginal, and anal cancer caused by Human
Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58.
(1.1)
Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
(1.1)
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). (1.1)
Cervical intraepithelial neoplasia (CIN) grade 1. (1.1)
Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3. (1.1)
Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3. (1.1)
Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. (1.1)
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. (1.2)
Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
(1.2)
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. (1.2)
Limitations of Use and Effectiveness:
GARDASIL 9 does not eliminate the necessity for women to continue to
undergo recommended cervical cancer
screening. (1.3, 17)
Recipients of GARDASIL 9 should not discontinue anal cancer screening
if it has been recommended by a health care
provider. (1.3, 17)
GARDASIL 9 has not been demonstrated to provide protection against
di