GARDASIL 9

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN, HUMAN PAPI

Tersedia dari:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (Nama Internasional):

HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN, HUMAN PAPI

Dosis:

30 MCG /40 Mcg /60 MCG /40 MCG /20 MCG /20 MCG /20 MCG /20 MCG /20 Mcg

Bentuk farmasi:

SUSPENSI INJEKSI

Unit dalam paket:

DUS, 1 PREFILLED SYRINGE @ 0,5 ML

Diproduksi oleh:

MERCK SHARP & DOHME CORP. - United States of America

Tanggal Otorisasi:

2021-09-11

Karakteristik produk

GARDASIL9 [Human Papillomavirus 9-valent Vaccine, Recombinant]
Suspension for Injection
1.
NAME OF THE MEDICINAL PRODUCT
GARDASIL 9 suspension for injection
Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains approximately:
Human Papillomavirus
1
Type 6 L1 protein
2,3
30 micrograms
Human Papillomavirus
1
Type 11 L1 protein
2,3
40 micrograms
Human Papillomavirus
1
Type 16 L1 protein
2,3
60 micrograms
Human Papillomavirus
1
Type 18 L1 protein
2,3
40 micrograms
Human Papillomavirus
1
Type 31 L1 protein
2,3
20 micrograms
Human Papillomavirus
1
Type 33 L1 protein
2,3
20 micrograms
Human Papillomavirus
1
Type 45 L1 protein
2,3
20 micrograms
Human Papillomavirus
1
Type 52 L1 protein
2,3
20 micrograms
Human Papillomavirus
1
Type 58 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
(0.5 milligrams Al).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Clear liquid with white precipitate.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Girls and Women
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, 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 intraepithe