Gardasil™ Vaccine Syringe

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

Human Papillomavirus Type 11 L1 Protein; Human Papillomavirus Type 16 L1 Protein; Human Papillomavirus Type 18 L1 Protein; Human Papillomavirus Type 6 L1 Protein

זמין מ:

MSD PHARMA (SINGAPORE) PTE. LTD.

קוד ATC:

J07BM01

כמות:

40 mcg

טופס פרצבטיות:

SOLUTION, STERILE

הרכב:

Human Papillomavirus Type 11 L1 Protein 40 mcg; Human Papillomavirus Type 16 L1 Protein 40 mcg; Human Papillomavirus Type 18 L1 Protein 20 mcg; Human Papillomavirus Type 6 L1 Protein 20 mcg

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

Prescription Only

תוצרת:

MERCK SHARP & DOHME LLC

מצב אישור:

ACTIVE

תאריך אישור:

2006-12-05

עלון מידע

Copyright© 2013 Merck Sharp & Dohme, a subsidiary of Merck
& Co. Inc., Whitehouse Station, NJ, USA. 
All Rights Reserved. 

SG-V501-I-112013 
PRODUCT 
CIRCULAR 

GARDASIL™ 
[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. INDICATIONS 

GARDASIL is a vaccine indicated in girls and women aged 9
through 26 years for the 
prevention of cervical, vulvar and vaginal cancer, premalignant
genital lesions (cervical, 
vulvar and vaginal), HPV infection, cervical adenocarcinoma _in
situ_ (AIS) and external 
genital warts (condyloma acuminata) causally related to Human
Papillomavirus (HPV) types 
6, 11, 16 and 18. For efficacy data, see section XIV CLINICAL
PHARMACOLOGY. 

GARDASIL is indicated in boys and men 9 through 26 years
of age for the prevention of 
HPV infection caused by HPV types 6, 11, 16 and 18 and
genital warts (condyloma 
acuminata) caused by HPV types 6 and 11.
For efficacy data, see section XIV CLINICAL 
PHARMACOLOGY.  

GARDASIL is also indicated in individuals 9 through 26 years of
age for the prevention of 
anal cancer and premalignant lesions due to HPV types 6, 11, 16
and 18. For efficacy data, 
see section XIV CLINICAL PHARMACOLOGY.  

III. DOSAGE AND ADMINISTRATION 

_Dosage _
GARDASIL should be administered intramuscularly as 3 separate
0.5-mL doses according 
to the following schedule: 

First dose: at elected date 
Second dose: 2 months after the first dose 
Third dose: 6 months after the first dose 

Individuals are encouraged to adhere to the 0, 2, and 6
months vaccination schedule.  
However, in clinical
studies, efficacy has been demonstrated in individuals who
have 
received all 3 doses within a 1-year period. The second
dose should be administer

מאפייני מוצר

SG-V501-I-012021
PRODUCT CIRCULAR
GARDASIL™
[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. INDICATIONS
GARDASIL is a vaccine indicated in girls and women aged 9 through 26
years for the
prevention of cervical, vulvar and vaginal cancer, premalignant
genital lesions (cervical,
vulvar and vaginal), HPV infection, cervical adenocarcinoma
in situ
(AIS) and external
genital warts (condyloma acuminata) causally related to Human
Papillomavirus (HPV) types
6, 11, 16 and 18. For efficacy data, see section XIV CLINICAL
PHARMACOLOGY.
GARDASIL is indicated in boys and men 9 through 26 years of age for
the prevention of
HPV infection caused by HPV types 6, 11, 16 and 18 and genital warts
(condyloma
acuminata) caused by HPV types 6 and 11. For efficacy data, see
section XIV CLINICAL
PHARMACOLOGY.
GARDASIL is also indicated in individuals 9 through 26 years of age
for the prevention of
anal cancer and premalignant lesions due to HPV types 6, 11, 16 and
18. For efficacy data,
see section XIV CLINICAL PHARMACOLOGY.
III. DOSAGE AND ADMINISTRATION
Dosage
GARDASIL should be administered intramuscularly as 3 separate 0.5-mL
doses according
to the following schedule:
First dose: at elected date
Second dose: 2 months after the first dose
Third dose: 6 months after the first dose
Individuals are encouraged to adhere to the 0, 2, and 6 months
vaccination schedule.
However, in clinical studies, efficacy has been demonstrated in
individuals who have
received all 3 doses within a 1-year period. The second dose should be
administered at least
1 month after the first dose, and the third dose should be
administered at least 3 months
after the second dose. All three doses should be given within a 1-year
period.
Alternatively, in individuals 9 through 13 years of age, GARDASIL can
be administered
according to a 2-dose (0, 6 months) schedule.
The use of GARDASIL should be in accordance with of