Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
varicella-zoster virus (live, attenuated)
Merck Sharp & Dohme B.V.
J07BK02
shingles (herpes zoster) vaccine (live)
Viral vaccines
Herpes Zoster; Immunization
Zostavax is indicated for prevention of herpes zoster ('zoster' or shingles) and herpes-zoster-related post-herpetic neuralgia. Zostavax is indicated for immunisation of individuals 50 years of age or older.,
Revision: 33
Authorised
2006-05-19
34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: IN FORMATION F OR THE USER ZOSTAVAX POWDER AND SOLV E NT FOR SUSPENSION FOR INJECTION shingles (herpes zoster) vaccine (live) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE VAC CINATED BECA USE IT CONT AINS IMPOR TANT INFORMATION FOR YOU . - Keep this leafle t. You may need t o read it again. - If you have any furt h er questions, ask your doctor or pharmacist. - This vaccine has been prescribed for you only. Do not pass it on to others. - If you get any of the side effects, talk to your doctor or pharm acist. This incl udes any possible side effects not listed in this leaf let. See section 4. WHAT IS IN THIS LEAFLET 1. What ZOSTAVAX is and what it is used fo r 2. What you need to know be fore y ou receive ZOSTAVAX 3. How to use ZOSTAVAX 4. Possible side eff ects 5. How to store ZOSTAVAX 6. Contents of the pack and other inform ation 1. WHAT ZOSTAVAX IS AND WHAT IT IS USED FOR ZOSTAVAX is a vaccine used t o prevent shingles (zoster) and zoster -related post-herpetic neuralgia (PHN), the long- lasting nerve pain that follows sh ingles. ZOSTAVAX is used to vaccinate individuals 50 y ears of age or older. ZOSTAVAX cannot be used to treat exist ing shingles or the pain associated with existing shingles. DISEASE INFORM ATION ON SHINGLES: What is shingles? Shingles is a painful, blistering rash. It usually occurs in one part of the bod y and can last for several w eeks. It may lead to severe and long- lasting pain and scarring. Less commonly, bacterial skin infections, wea kness, musc le paralysis, l oss of hearing or visio n can occur . Shingles is caused by the same virus that causes chickenp o x. After you have had chic k enpox, the virus that caused it stays in your body in nerve cells. Sometimes, after many years, the virus bec omes active again and causes shingles. What is PHN? After the shingles blister s heal, pain can last for months or ye a rs and may be severe. Thi s long-lasting nerve pain is called post- herpetic neuralgia or PHN. 2. WHAT YOU NEED TO KNOW BEFORE Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ZOSTAVAX powder and solvent for suspension for injection ZOSTAVAX powder and solvent for suspension for injecti on in a pre-filled syringe shingles (herpe s zoster) vaccine (live) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, one dose (0.65 mL) contains: Varicella-zoster virus 1 , Oka/Merck strain, (live, att enuated) not less than 19 ,400 PFU 2 1 produced in human diploid (MRC-5) cells 2 PFU = Plaque - forming units This vaccine may contain traces of neomycin . See sections 4.3 and 4.4. For the full list of excipient s, see section 6.1. 3. PHARMACEUTICAL FORM Pow der and solvent for suspension for injection. T he powder is a wh ite to off-w hite compact crystalline plug. The solvent is a clear, colourless liquid. 4. CLINI CAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZOSTAVAX is indicated for prevention of herpe s zo ster (“zoster” or shingles) and her pes zoster-related post-herpetic neuralgia (PHN). ZOSTAVAX is indicated for i mmu nization of individua ls 50 years of age or older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATIO N Posology Individuals should receive a sin gle dose (0.65 mL). The need for a boo ster dose is not known. S ee sections 4.8 and 5.1. Paediatric population The saf ety and efficacy of ZOSTAVAX in children and adolescents have not been established. No data are available. There is no relevant use of ZOSTAVAX in children and adolescents fo r prevention of primary varicella infectio n (chickenpox). 3 Method of administr ation The vaccine can be injected subcutaneously (SC) or intramuscularly (IM) , preferably in the deltoid region (see sections 4.8 and 5.1) . T he vaccine should be administered s ub cutaneously in patients with severe thro mbocytopenia or any coagulation disorder (see section 4.4). THE V ACCINE SHOULD UNDER NO CIRCUMSTANCES BE INJECTED INTRAVASCULARLY . For precautions to be taken before handlin g or administering the medicinal produc t, see section 6.6. For instructions on r econ Прочетете целия документ