Country: Европска Унија
Језик: Енглески
Извор: EMA (European Medicines Agency)
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.
J07BM01
human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Vaccines
Papillomavirus Infections; Uterine Cervical Dysplasia; Condylomata Acuminata; Immunization
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.
Revision: 48
Authorised
2006-09-20
37 B. PACKAGE LEAFLET (VIAL) 38 PACKAGE LEAFLET: INFORMATION FOR THE USER GARDASIL SUSPENSION FOR INJECTION Huma n Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE VACCINATED BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU OR YOUR CHILD . - Keep this leaflet. You may need to read it again. - If you have any further questions, please ask your doctor or pharmacist. - If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Gardasil is and what it is used for 2. What you need to know b efore you or your child receive Gardasil 3. How Gardasil is given 4. Possible side effects 5. How to st ore 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-cancero us lesions of the vulva and vagina; 80 % 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 HP V 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 disease s associated with the other HPV types in the vaccine. Garda Прочитајте комплетан документ
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. Huma n 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 alumin i um hydroxyphosphate sul f ate adjuvant ( 0.225 milligrams Al). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gardasil s uspension 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 va ccine 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 o n 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 In dividuals 9 to and including 13 years of age Gardasil can be administered acco rding 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 Прочитајте комплетан документ