Gardasil vaccine suspension for injection 0.5ml pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Human papillomavirus type 6 L1 protein; Human papillomavirus type 18 L1 protein; Human papillomavirus type 16 L1 protein; Human papillomavirus type 11 L1 protein

Available from:

Merck Sharp & Dohme Ltd

ATC code:

J07BM01

INN (International Name):

Human papillomavirus type 6 L1 protein; Human papillomavirus type 18 L1 protein; Human papillomavirus type 16 L1 protein; Human

Pharmaceutical form:

Suspension for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 14040000; GTIN: 5015973721017

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GARDASIL®, SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE
Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant,
adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor or
pharmacist.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Gardasil is and what it is used for
2.
What you need to know before you receive Gardasil
3.
How Gardasil is given
4.
Possible side effects
5.
How to store Gardasil
6.
Contents of the pack and other information
1.
WHAT GARDASIL IS AND WHAT IT IS USED FOR
Gardasil is a vaccine. Vaccination with Gardasil is intended to
protect against diseases caused by
Human Papillomavirus (HPV) types 6, 11, 16, and 18.
These diseases include pre-cancerous lesions of the female genitals
(cervix, vulva, and vagina); pre-
cancerous lesions of the anus and genital warts in males and females;
cervical and anal cancers. HPV
types 16 and 18 are responsible for approximately 70% of cervical
cancer cases, 75-80% of anal
cancer cases; 70% of HPV-related pre-cancerous lesions of the vulva
and vagina, 75% of HPV related
pre-cancerous lesions of the anus. HPV types 6 and 11 are responsible
for approximately 90% of
genital wart cases.
Gardasil is intended to prevent these diseases. The vaccine is not
used to treat HPV related diseases.
Gardasil 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 types, Gardasil can still protect
against diseases associated with
the other HPV types in the vaccine.
Gardasil cannot cause the diseases it protects against.
Gardasil produces type-specific antibodies and has been sho

Summary of Product characteristics

OBJECT 1
GARDASIL
Summary of Product Characteristics Updated 25-Apr-2017 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Gardasil®, suspension for injection.
Gardasil®, suspension for injection in a pre-filled syringe.
Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant,
adsorbed).
2. Qualitative and quantitative 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
(0.225 milligrams Al).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Gardasil, suspension for injection.
Gardasil, suspension for injection in a pre-filled syringe.
Prior to agitation, Gardasil may appear as a clear liquid with a white
precipitate. After thorough agitation,
it is a white, cloudy liquid.
4. Clinical particulars
4.1 Therapeutic indications
Gardasil is a vaccine for use from the age of 9 years for the
prevention of:
– premalignant genital lesions (cervical, vulvar and vaginal),
premalignant anal lesions, cervical cancers
and anal cancers causally related to certain oncogenic Human
Papillomavirus (HPV) types
– genital warts (condyloma acuminata) causally related to specific
HPV types.
See sections 4.4 and 5.1 for important information on the data that
support this indication.
The use of Gardasil should be in accordance with official
recommendations.
4.2 Posology and method of administration
Posology
_Individuals 9 to and including 13 years of age _
Gardasil can be administered according to a 2-dose schedule (0.5 ml at
0, 6 months) (see section 5.1).
If the second vaccine dose is administered ear