GARDASIL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PROTEIN L1 (TYPE 11); PROTEIN L1 (TYPE 16); PROTEIN L1 (TYPE 18); PROTEIN L1 (TYPE 6)

Available from:

MERCK SHARP & DOHME ISRAEL LTD

ATC code:

B05BA10

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

PROTEIN L1 (TYPE 18) 20 MCG / 0.5 ML; PROTEIN L1 (TYPE 6) 20 MCG / 0.5 ML; PROTEIN L1 (TYPE 11) 40 MCG / 0.5 ML; PROTEIN L1 (TYPE 16) 40 MCG / 0.5 ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

MERCK SHARP & DOHME CORP., USA

Therapeutic group:

COMBINATIONS

Therapeutic area:

COMBINATIONS

Therapeutic indications:

GARDASIL is indicated in females aged 9 through 45 years* for the prevention of cervical, vulvar, vaginal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18 (which are included in the vaccine). GARDASIL is indicated in males 9 through 26 years* of age for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions and infection caused by HPV types 6, 11, 16, and 18 (which are included in the vaccine). *Immunogenicity studies have been conducted to link efficacy in females and males aged 16 to 26 years to the younger populations..

Authorization date:

2012-05-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS
(PREPARATIONS) 1986
This medicine can be sold under doctor's prescription only
GARDASIL
®
SUSPENSION FOR INJECTION
1 DOSE (0.5 ML) CONTAINS:
Protein L1 (type 18) 20 mcg
Protein L1 (type 6) 20 mcg
Protein L1 (type 11) 40 mcg
Protein L1 (type 16) 40 mcg
For a list of inactive ingredients see section 6.1, ”WHAT GARDASIL
CONTAINS”.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

This leaflet contains concise information about GARDASIL. If you have
any further questions, ask your
doctor or pharmacist.

This vaccine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their
medical condition seems similar to yours.

This vaccine is intended for girls and women 9 through 45 years of age
and for boys and men 9 through
26 years of age.
1. WHAT IS GARDASIL AND WHAT IS IT USED FOR?
GARDASIL is indicated in females aged 9 through 45 years for the
prevention of cervical, vulvar, and
vaginal cancer, precancerous or dysplastic lesions, genital warts, and
infection caused by Human
Papillomavirus (HPV) Types 6, 11, 16, and 18 (which are included in
the vaccine).
GARDASIL is indicated in males 9 through 26 years of age for the
prevention of anal cancer, precancerous
or dysplastic lesions, external genital lesions and infection caused
by HPV types 6, 11, 16, and 18 (which
are included in the vaccine).
PHARMACOTHERAPEUTIC GROUP: Viral Vaccine, Human Papillomavirus
vaccines.
HPV types 16 and 18 are responsible for approximately 70% of cervical
cancer cases and, 75-80% of anal
cancer cases; 70% of HPV-related pre-cancerous lesions of the vulvar
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 have a persistent
infection or disease associated
wi

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Gardasil, suspension for injection.
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
Suspension for injection.
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 indicated in females aged 9 through 45 years* for the
prevention of cervical, vulvar, and
vaginal cancer, precancerous or dysplastic lesions, genital warts, and
infection caused by Human
Papillomavirus (HPV) Types 6, 11, 16, and 18 (which are included in
the vaccine).
GARDASIL is indicated in males 9 through 26 years* of age for the
prevention of anal cancer,
precancerous or dysplastic lesions, external genital lesions and
infection caused by HPV types 6, 11, 16,
and 18 (which are included in the vaccine).
*Immunogenicity studies have been conducted to link efficacy in
females and males aged 16 to 26 years to the younger
populations.
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).
2
If the second vaccine dose is administered earlier than 6 months after
the first dose, a third