Gardasil suspension for i/m injection

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein

Dostupné s:

Merck Sharp & Dohme B.V. Waarderweg 39

ATC kód:

J07BM01

INN (Mezinárodní Name):

human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein

Dávkování:

20mcg/dose+ 40mcg/dose+ 40mcg/dose+ 20mcg/dose

Léková forma:

suspension for i/m injection

Jednotky v balení:

0,5ml/dose pre-filled syringe, (1) or (2) needles

Druh předpisu:

Prescription

Stav Autorizace:

Registered

Datum autorizace:

2016-06-22

Charakteristika produktu

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
_ _
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), cervical
cancer 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 earlier than 6 months after
the first dose, a third dose should
always be administered.
3
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Alterna