Страна: Індонезія
мова: індонезійська
Джерело: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
ORGANON PHARMA INDONESIA TBK - Indonesia
HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
20 MCG /40 MCG /40 MCG /20 MCG
SUSPENSI INJEKSI
DUS, 10 VIAL @ 0,5 ML
MERCK SHARP & DOHME CORP. - United States of America
2021-06-23
GARDASIL™ , suspension for injection. [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] I. THERAPEUTIC CLASS Gardasil is a recombinant, quadrivalent vaccine that protects against Human Papillomavirus (HPV) II. COMPOSITION 1 dose (0.5 ml) contains approximately: Human Papillomavirus 1 Type 6 L1 protein 2,3 20 micrograms Human Papillomavirus 1 Type 11 L1 protein 2,3 40 micrograms Human Papillomavirus 1 Type 16 L1 protein 2,3 40 micrograms Human Papillomavirus 1 Type 18 L1 protein 2,3 20 micrograms. 1 Human Papillomavirus = HPV. 2 L1 protein in the form of virus-like particles produced in yeast cells ( Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology. 3 adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (225 micrograms Al). LIST OF EXCIPIENTS Sodium chloride L-histidine Polysorbate 80 Sodium borate Water for injections III. PHARMACEUTICAL FORM Suspension for injection. Prior to agitation, Gardasil may appear as a clear liquid with a white precipitate. After thorough agitation, it is a white, cloudy liquid. IV. INDICATIONS DISETUJUI BPOM 6 JUNI 2022 ID REG : EREG10037312100552 _ _ Gardasil is a vaccine indicated in girls and women 9 through 45 years of age for the prevention of cervical cancer, low grade and high grade cervical, vulvar and vaginal dysplasia; and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18. Gardasil is indicated in boys and men 9 through 26 years of age for the prevention of external genital lesions including genital warts (condyloma acuminata), anal intraepithelial neoplasia (AIN 1/2/3), and infection caused by HPV types 6, 11, 16, and 18. The use of Gardasil should be in accordance with official recommendations. V. DOSAGE AND ADMINISTRATION The primary vaccination series consists of 3 separate 0.5 ml doses administered according to the following schedule: 0, 2, 6 months. The second dose should be administered at least one month after the first dose and Прочитайте повний документ