Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed)
Merck Sharp & Dohme B.V.
J07BM03
human papillomavirus 9-valent vaccine (recombinant, adsorbed)
Papillomavirus vaccines
Condylomata Acuminata; Papillomavirus Infections; Immunization; Uterine Cervical Dysplasia
Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases:Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV typesGenital 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.
Revision: 22
Authorised
2015-06-10
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE USER GARDASIL 9 SUSPENSION FOR INJECTION Human Papillomavirus 9 - valent Vaccine ( 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, pharmacist or nurse. - If you or your child get any side effects, talk to your doctor, pharmacist or nurse. T his includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Gardasil 9 is and what it is used for 2. What you need to know before you or your child receive Gardasil 9 3. How Gardasil 9 is given 4. Possible side effects 5. How to store Gardasil 9 6. Contents of the pack and other info rmation 1. WHAT GARDASIL 9 IS AND WHAT IT IS USED FOR Gardasil 9 is a vaccine for children and adolescents from 9 years of age and adults. It is given to protect against diseases caused by Human Papillomavirus ( HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58. These diseases 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 has been studied in males 9 to 26 years of age and females 9 to 45 years of age. Gardasil 9 protects against the HPV types that cause most cases of these diseases. 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 prot ect against diseases associated with the other HPV types in the vaccine. Gardasil 9 cannot cause HPV-related diseases. When an individual is vaccinated with Gardasil Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Gardasil 9 suspension for injection . Gardasil 9 suspension for injection in a pre -filled syringe. 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 Huma n 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 A dsorbed on amorphous alumin i um hydroxyphosphate sul f ate adjuvant ( 0.5 milligrams Al). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Clear liquid with white precipitate. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gardasil 9 is indicated for active immuni sation of individuals from the age of 9 years 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 ADMINISTRATI ON 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) Lestu allt skjalið