Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
INACTIVATED RABIES VIRUS
GSK Vaccines GmbH
J07BG; J07BG01
INACTIVATED RABIES VIRUS
2.5 international unit(s)/millilitre
Powder and solvent for solution for injection
Product subject to prescription which may not be renewed (A)
Rabies vaccines; rabies, inactivated, whole virus
Not marketed
2004-04-02
492267 POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE RABIES VIRUS (INACTIVATED, STRAIN FLURY LEP) PACKAGE LEAFLET: INFORMATION FOR THE USER RABIPUR READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU/YOUR CHILD RECEIVES RABIPUR. 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, pharmacist, or nurse. - This vaccine has been prescribed for you/your child only. Do not pass it on to others. - If you 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 RABIPUR is and what it is used for 2. What you need to know before you/your child receives RABIPUR 3. How to use RABIPUR 4. Possible side effects 5. How to store RABIPUR 6. Contents of the pack and other information 1 WHAT RABIPUR IS AND WHAT IT IS USED FOR WHAT RABIPUR IS Rabipur is a vaccine containing rabies virus that has been killed. After administration of the vaccine, the immune system (the body's natural defence system) forms antibodies to rabies viruses. These antibodies protect from infections or diseases by the virus that causes rabies. None of the components of the vaccine can cause rabies. WHAT RABIPUR IS USED FOR Rabipur can be used in individuals of all ages. Rabipur can be used to prevent rabies: • before possible risk of exposure to rabies virus (pre-exposure prophylaxis). or • after suspected or proven exposure to rabies virus (post-exposure prophylaxis). Rabies is an infection that can be transmitted when a person is bitten, scratched or even just licked by an infected animal, particularly when the skin is already injured. Even contact with animal traps that were licked or bitten by infected animals can cause infections in humans. 2. WHAT YOU NEED TO KNOW BEFORE YOU/YOUR CHILD RECEIVES RABIPUR YOU/YOUR CHILD MUST NOT RECEIVE RABIPUR BEFORE POSSIBLE RISK OF EXPOSURE TO THE RABIES VIRUS IF YOU/YOUR CHILD: • H Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rabipur Powder and solvent for solution for injection Rabies vaccine (inactivated). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 vial (1.0 ml) contains: Rabies virus* (Inactivated, strain Flury LEP)……………………… 2.5 IU * produced on purified chick embryo cells (PCEC) This vaccine contains residues of chicken proteins (e.g., ovalbumin), human serum albumin, and may contain traces of neomycin, chlortetracycline and amphotericin B. See section 4.4. For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection The powder is white. The solvent is clear and colourless. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rabipur is indicated for active immunization against rabies in individuals of all ages. See Sections 4.2 and 5.1 for detailed information about pre- and post-exposure prophylaxis. Rabipur should be used in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose for both primary immunization and boosters is 1.0 ml. _Pre-exposure prophylaxis_ Primary immunization In previously unvaccinated individuals three doses should be administered according to the conventional or rapid regimen as shown in Table 1. Table 1 Primary immunization regimens *The rapid regimen should only be considered for adults aged 18-65 years not able to complete the conventional PrEP regimen within 21 or 28 days before protection is required. _Conventional regimen_ _Rapid Regimen*_ 1 st dose Day 0 Day 0 2 nd dose Day 7 Day 3 3 rd dose Day 21 (or 28) Day 7 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Διαβάστε το πλήρες έγγραφο