国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
human papillomavirus1 type 16 L1 protein, human papillomavirus type 18 L1 protein
GlaxoSmithKline Biologicals S.A.
J07BM02
human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
Vaccines
Papillomavirus Infections; Uterine Cervical Dysplasia; Immunization
Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant ano-genital lesions (cervical, vulvar, vaginal and anal) and cervical and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types. See sections 4.4 and 5.1 for important information on the data that support this indication.The use of Cervarix should be in accordance with official recommendations.
Revision: 39
Authorised
2007-09-20
36 B. PACKAGE LEAFLET 37 PACKAGE LEAFLET: INFORMATION FOR THE USER CERVARIX SUSPENSION FOR INJECTION IN A VIAL Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS VACCINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Cervarix is and what it is used for 2. What you need to know before you receive Cervarix 3. How Cervarix is given 4. Possible side effects 5. How to store Cervarix 6. Contents of the pack and other information 1. WHAT CERVARIX IS AND WHAT IT IS USED FOR Cervarix is a vaccine intended to protect from the age of 9 years against the diseases caused by infection with Human Papillomaviruses (HPV). These diseases include: - cervical cancer (cancer of the cervix i.e. lower part of the uterus or womb) and anal cancer, - precancerous cervical, vulvar, vaginal and anal lesions (changes in genital or anal cells that have a risk of turning into cancer). The Human Papillomavirus (HPV) types contained in the vaccine (HPV types 16 and 18) are responsible for approximately 70% of cervical cancers, 90% of anal cancers, 70% of HPV-related pre- cancerous lesions of the vulva and vagina and 78% of HPV-related pre-cancerous lesions of the anus. Other HPV types can also cause ano-genital cancers. Cervarix does not protect against all HPV types. When a female or a male individual is vaccinated with Cervarix, the immune system (the body’s natural defence system) will make antibodies against HPV types 16 and 18. Cervarix is not infectious and so, it cannot cause HPV related diseases. Cervarix is not used to treat HPV related diseases already present a 阅读完整的文件
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Cervarix suspension for injection in pre-filled syringe Cervarix suspension for injection in a vial Cervarix suspension for injection in multidose container Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: Human Papillomavirus 1 type 16 L1 protein 2,3,4 20 micrograms Human Papillomavirus 1 type 18 L1 protein 2,3,4 20 micrograms 1 Human Papillomavirus = HPV 2 adjuvanted by AS04 containing: 3- _O_ -desacyl-4’- monophosphoryl lipid A (MPL) 3 50 micrograms 3 adsorbed on aluminium hydroxide, hydrated (Al(OH) 3 ) 0.5 milligrams Al 3+ in total 4 L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from _Trichoplusia ni_ . For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Turbid white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant ano-genital lesions (cervical, vulvar, vaginal and anal) and cervical and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types. See sections 4.4 and 5.1 for important information on the data that support this indication. The use of Cervarix should be in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The vaccination schedule depends on the age of the subject. 3 AGE AT THE TIME OF THE FIRST INJECTION IMMUNIZATION AND SCHEDULE 9 to and including 14 years* Two doses each of 0.5 ml. The second dose given between 5 and 13 months after the first dose From 15 years and above Three doses each of 0.5 ml at 0, 1, 6 months** *If the second vaccine dose is administered before the 5 th month after the first dose, a third dose should always be administered. **If flexibility 阅读完整的文件