Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein
Merck Sharp & Dohme B.V. Waarderweg 39
J07BM01
human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein
20mcg/dose+ 40mcg/dose+ 40mcg/dose+ 20mcg/dose
suspension for i/m injection
0,5ml/dose glass vial
Prescription
Registered
2016-06-22
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 _ _ Alterna Прочитать полный документ