GARDASIL 9

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

HPV TYPE 11 L1 PROTEIN; HPV TYPE 16 L1 PROTEIN; HPV TYPE 18 L1 PROTEIN; HPV TYPE 31 L1 PROTEIN; HPV TYPE 33 L1 PROTEIN; HPV TYPE 45 L1 PROTEIN; HPV TYPE 52 L1 PROTEIN; HPV TYPE 58 L1 PROTEIN; HPV TYPE 6 L1 PROTEIN

Dostępny od:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

Kod ATC:

J07BM03

Forma farmaceutyczna:

SUSPENSION FOR INJECTION

Skład:

HPV TYPE 58 L1 PROTEIN 20 MCG / 0.5 ML; HPV TYPE 52 L1 PROTEIN 20 MCG / 0.5 ML; HPV TYPE 45 L1 PROTEIN 20 MCG / 0.5 ML; HPV TYPE 33 L1 PROTEIN 20 MCG / 0.5 ML; HPV TYPE 31 L1 PROTEIN 20 MCG / 0.5 ML; HPV TYPE 18 L1 PROTEIN 40 MCG / 0.5 ML; HPV TYPE 16 L1 PROTEIN 60 MCG / 0.5 ML; HPV TYPE 11 L1 PROTEIN 40 MCG / 0.5 ML; HPV TYPE 6 L1 PROTEIN 30 MCG / 0.5 ML

Droga podania:

I.M

Typ recepty:

Required

Wyprodukowano przez:

MERCK SHARP & DOHME LLC, USA

Dziedzina terapeutyczna:

PAPILLOMAVIRUS (HUMAN TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58)

Wskazania:

Gardasil 9 is indicated for active immunisation of individuals at the age of 9-45 years old 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.

Data autoryzacji:

2021-11-30

Ulotka dla pacjenta

1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine is marketed upon physician's prescription only
GARDASIL
®
9
SUSPENSION FOR INJECTION
1 DOSE (0.5 ML) CONTAINS:
Protein L1 (HPV type 6)* 30 mcg
Protein L1 (HPV type 11) 40 mcg
Protein L1 (HPV type 16) 60 mcg
Protein L1 (HPV type 18) 40 mcg
Protein L1 (HPV type 31) 20 mcg
Protein L1 (HPV type 33) 20 mcg
Protein L1 (HPV type 45) 20 mcg
Protein L1 (HPV type 52) 20 mcg
Protein L1 (HPV type 58) 20 mcg
For the list of the inactive ingredients see section 6 "FURTHER
INFORMATION". See also section 2.6
“Important information about some of the ingredients of the
medicine”.
*HPV = HUMAN PAPILLOMAVIRUS
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED
•
This leaflet contains concise information about the medicine. If you
have any further questions, refer to the
doctor, pharmacist or nurse.
•
This vaccine has been prescribed for you. Do not pass it on to others.
It may harm them, even if it seems
to you that their medical condition is similar.
•
The medicine is intended for children, adolescents and adults from 9
through 45 years.
1. WHAT GARDASIL 9 IS AND WHAT IS IT INTENDED FOR?
GARDASIL 9 is a vaccine intended to prevent diseases caused by Human
Papillomavirus (HPV) types 6,
11, 16, 18, 31, 33, 45, 52 and 58 in children, adolescents and adults
from 9 through 45 years of age.
These diseases caused by Human Papillomavirus (HPV) 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 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 types, GARDASIL 9 can still protect
against d

Charakterystyka produktu

1
1.
NAME OF THE MEDICINAL PRODUCT
Gardasil
®
9
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
30 micrograms
Human Papillomavirus
1
Type 11 L1 protein
2,3
40 micrograms
Human Papillomavirus
1
Type 16 L1 protein
2,3
60 micrograms
Human Papillomavirus
1
Type 18 L1 protein
2,3
40 micrograms
Human Papillomavirus
1
Type 31 L1 protein
2,3
20 micrograms
Human Papillomavirus
1
Type 33 L1 protein
2,3
20 micrograms
Human Papillomavirus
1
Type 45 L1 protein
2,3
20 micrograms
Human Papillomavirus
1
Type 52 L1 protein
2,3
20 micrograms
Human Papillomavirus
1
Type 58 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 sulfate 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 at the
age of 9 - 45 years old 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 information on the data that
support these indications.
The use of Gardasil 9 should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Individuals 9 to and including 14 years of age at time of first
injection _
Gardasil 9 can be administered according to a 2-dose (0, 6
–
12 months) schedule (see section 5.1).
2
The second dose should be administered between 5 and 13 months after
the first