GARDASIL SUSPENSION

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN; RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN; RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN; RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN

থেকে পাওয়া:

MERCK CANADA INC

এটিসি কোড:

J07BM01

INN (আন্তর্জাতিক নাম):

PAPILLOMAVIRUS (HUMAN TYPES 6,11,16,18)

ডোজ:

20MCG; 40MCG; 40MCG; 20MCG

ফার্মাসিউটিকাল ফর্ম:

SUSPENSION

রচনা:

RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN 20MCG; RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN 40MCG; RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN 40MCG; RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN 20MCG

প্রশাসন রুট:

INTRAMUSCULAR

প্যাকেজ ইউনিট:

1X0.5ML

প্রেসক্রিপশন টাইপ:

Schedule D

থেরাপিউটিক এলাকা:

VACCINES

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0451650001; AHFS:

অনুমোদন অবস্থা:

CANCELLED POST MARKET

অনুমোদন তারিখ:

2019-08-22

পণ্য বৈশিষ্ট্য

_GARDASIL_
_®_
_9 [Human Papillomavirus 9-valent Vaccine, Recombinant] _
_Page 1 of 49_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
GARDASIL®9
[Human Papillomavirus 9-valent Vaccine, Recombinant]
Each 0.5 mL sterile dose contains approximately:
30 mcg of HPV 6 L1 protein
40 mcg of HPV 11 L1 protein
60 mcg of HPV 16 L1 protein
40 mcg of HPV 18 L1 protein
20 mcg of HPV 31 L1 protein
20 mcg of HPV 33 L1 protein
20 mcg of HPV 45 L1 protein
20 mcg of HPV 52 L1 protein
20 mcg of HPV 58 L1 protein
Suspension for intramuscular injection
Active Immunizing Agent
ATC code: J07BM03
GARDASIL®9, is a vaccine indicated for:
•
individuals 9 through 45 years of age for the prevention of infection
caused by the Human
Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 and
the following diseases
associated with the HPV types included in the vaccine:
o
Oropharyngeal and other head and neck cancers caused by HPV types 16,
18, 31, 33, 45,
52, and 58
has been issued market authorization WITH CONDITIONS, pending the
results of trials to verify its clinical
benefit. Patients should be advised of the nature of the
authorization. For further information for
GARDASIL®9 please refer to Health Canada’s Notice of Compliance
with conditions - drug products
web site:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-
products/notice-compliance/conditions.html.
GARDASIL®9, is a vaccine indicated for:
•
individuals 9 through 45 years of age for the prevention of infection
caused by the Human
Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 and
the following diseases
associated with the HPV types included in the vaccine:
o
Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16, 18,
31, 33, 45, 52, and
58
o
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:
o
Cervical adenocarcinoma _in situ_ (AIS)
o
Cervical intraepithelial neoplasia (CI