GARDASIL

Valsts: Indonēzija

Valoda: indonēziešu

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

Vienības iepakojumā:

DUS, 1 PREFILLED SYRINGE @ 0,5 ML

Autorizācija datums:

2022-05-12

Produkta apraksts

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