GARDASIL (human papillomavirus quadrivalent- types 6, 11, 16, and 18 vaccine, recombinant injection, suspension

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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:

Disponible des:

Merck Sharp & Dohme LLC

Designació comuna internacional (DCI):

HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN

Composición:

HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN 20 ug in 0.5 mL

Vía de administración:

INTRAMUSCULAR

indicaciones terapéuticas:

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

Resumen del producto:

All presentations for GARDASIL contain a suspension of 120 mcg L1 protein from HPV types 6, 11, 16, and 18 in a 0.5-mL dose. GARDASIL is supplied in vials and syringes. Carton of one 0.5-mL single-dose vial. NDC 0006-4045-00. Carton of ten 0.5-mL single-dose vials. NDC 0006-4045-41. Carton of six 0.5-mL single-dose prefilled Luer-Lok® syringes with tip caps. NDC 0006-4109-09. Carton of ten 0.5-mL single-dose prefilled Luer-Lok® syringes with tip caps. NDC 0006-4109-02. Store refrigerated at 2 to 8°C (36 to 46°F). Do not freeze. Protect from light. GARDASIL should be administered as soon as possible after being removed from refrigeration. GARDASIL can be out of refrigeration (at temperatures at or below 25°C/77°F), for a total time of not more than 72 hours.

Estat d'Autorització:

Biologic Licensing Application

Fitxa tècnica

GARDASIL- HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18)
VACCINE, RECOMBINANT INJECTION, SUSPENSION
MERCK SHARP & DOHME LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GARDASIL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GARDASIL.
GARDASIL®
[HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE,
RECOMBINANT]
SUSPENSION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
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. (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, and 18:
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 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. (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, and 18:
Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. (1.2)
Limitations of GARDASIL Use and Effectiveness:
GARDASIL does not eliminate the necessity for women to continue to
undergo recommended cervical
cancer screening. (1.3, 17)
Recipients of GARDASIL should not discontinue anal cancer screening if
it has been recommended by a
health care provider. (1.3, 17)
GARDASIL ha