Gardasil 9 vaccine suspension for injection 0.5ml pre-filled syringes

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Human papillomavirus type 6 L1 protein; Human papillomavirus type 31 L1 protein; Human papillomavirus type 58 L1 protein; Human papillomavirus type 52 L1 protein; Human papillomavirus type 11 L1 protein; Human papillomavirus type 16 L1 protein; Human papillomavirus type 18 L1 protein; Human papillomavirus type 33 L1 protein; Human papillomavirus type 45 L1 protein

থেকে পাওয়া:

Merck Sharp & Dohme Ltd

এটিসি কোড:

J07BM03

INN (আন্তর্জাতিক নাম):

Human papillomavirus type 6 L1 protein; Human papillomavirus type 31 L1 protein; Human papillomavirus type 58 L1 protein; Human

ফার্মাসিউটিকাল ফর্ম:

Suspension for injection

প্রশাসন রুট:

Intramuscular

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF:

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
GARDASIL® 9 SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE
Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU OR YOUR CHILD.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor, pharmacist
or nurse.
-
If you or your child get any side effects, talk to your doctor,
pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Gardasil 9 is and what it is used for
2.
What you need to know before you or your child receive Gardasil 9
3.
How Gardasil 9 is given
4.
Possible side effects
5.
How to store Gardasil 9
6.
Contents of the pack and other information
1.
WHAT GARDASIL 9 IS AND WHAT IT IS USED FOR
Gardasil 9 is a vaccine for children and adolescents from 9 years of
age and adults. It is given to
protect against diseases caused by Human Papillomavirus (HPV) types 6,
11, 16, 18, 31, 33, 45, 52
and 58.
These diseases include pre-cancerous lesions and cancers of the female
genitals (cervix, vulva, and
vagina), pre-cancerous lesions and cancers of the anus and genital
warts in males and females.
Gardasil 9 has been studied in males and females 9 to 26 years of age.
Gardasil 9 protects against the HPV types that cause most cases of
these diseases.
Gardasil 9 is intended to prevent these diseases. The vaccine is not
used to treat HPV related diseases.
Gardasil 9 does not have any effect in individuals who already have a
persistent infection or disease
associated with any of the HPV types in the vaccine. However, in
individuals who are already infected
with one or more of the vaccine HPV

পণ্য বৈশিষ্ট্য

OBJECT 1
GARDASIL 9
Summary of Product Characteristics Updated 01-Mar-2017 | Merck Sharp &
Dohme Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Gardasil® 9 suspension for injection.
Gardasil® 9 suspension for injection in a pre-filled syringe.
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
Human Papillomavirus
1
Type 11 L1 protein
2,3
Human Papillomavirus
1
Type 16 L1 protein
2,3
Human Papillomavirus
1
Type 18 L1 protein
2,3
Human Papillomavirus
1
Type 31 L1 protein
2,3
Human Papillomavirus
1
Type 33 L1 protein
2,3
Human Papillomavirus
1
Type 45 L1 protein
2,3
Human Papillomavirus
1
Type 52 L1 protein
2,3
Human Papillomavirus
1
Type 58 L1 protein
2,3
30 micrograms
40 micrograms
60 micrograms
40 micrograms
20 micrograms
20 micrograms
20 micrograms
20 micrograms
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.
Suspension for injection in a pre-filled syringe.
Clear liquid with white precipitate.
4. Clinical particulars
4.1 Therapeutic indications
Gardasil 9 is indicated for active immunisation of individuals from
the age of 9 years against the
following HPV diseases:
• Premalignant lesions and cancers affecting the cervix, vulva,
vagina and anus caused by vaccine HPV
types
• Genital warts (_Condyloma acuminata_) caused by specific HPV
types.
See sections 4.4 and 5.1 for important informa