Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Inactivated Rabies Virus Strain PM/WI 38 1503 3M
Sanofi Pasteur
J07BG; J07BG01
Inactivated Rabies Virus Strain PM/WI 38 1503 3M
2.5 international unit(s)/millilitre
Powder and solvent for suspension for injection
Product subject to prescription which may not be renewed (A)
Rabies vaccines; rabies, inactivated, whole virus
Not marketed
1994-12-12
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER RABIES VACCINE BP ≥ 2.5 IU/ML POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE VACCINATED. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, nurse or pharmacist. - This vaccine has been prescribed for you. Do not pass it on to others. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. IN THIS LEAFLET : 1. What Rabies Vaccine BP is and what it is used for 2. Before you are given Rabies Vaccine BP 3. How Rabies Vaccine BP is given 4. Possible side effects 5. How to store Rabies Vaccine BP 6. Further information 1. WHAT RABIES VACCINE BP IS AND WHAT IT IS USED FOR Rabies Vaccine BP is indicated for pre-exposure prophylaxis and for post-exposure prophylaxis against rabies in all age groups. Rabies Vaccine BP is one of a general group of medicines called vaccines. Vaccines are used to protect against infectious diseases. This vaccine helps to protect adults and children against rabies. Rabies Vaccine BP can be used in two ways: • Vaccinating you before you come into contact with rabies virus (pre-exposure prophylaxis). • Vaccinating you after you have come into contact with rabies virus (post-exposure prophylaxis). Rabies Vaccine BP is a preparation containing very small amounts of a modified form of the virus that causes rabies. When an injection of Rabies Vaccine BP is given, the body's natural defences will produce protection against R abies. 2. BEFORE YOU ARE GIVEN RABIES VACCINE BP To make sure that this vaccine is suitable for you or your child, it is important to tell the doctor, nurse or pharmacist if any points below apply. If there is anything you do not understand, ask your doctor, nurse or pharmacist to explain. DO NOT HAVE RABIES VACCINE BP IF YOU OR YOUR CHILD IS: • allergic (hypersensitive) to Rabies Vaccine BP or any of its in Прочетете целия документ
Health Products Regulatory Authority 05 October 2022 CRN00CJMV Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rabies Vaccine BP > 2.5 IU/ml, Powder and solvent for suspension for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (1ml) contains : Rabies virus* (inactivated, strain PM/WI 38 1503-3M)…………≥2.5 IU *produced in human diploid MRC-5 cells. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for suspension for injection. The powder is pinkish beige to orangey yellow. The solvent is a clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rabies Vaccine BP is indicated for pre- exposure prophylaxis and for post-exposure prophylaxis against rabies in all age groups (see Sections 4.2 and 5.1). The use of Rabies Vaccine BP should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 1mL of reconstituted vaccine. _Pre-exposure prophylaxis_ The primary pre-exposure immunisation course consists of 3 doses: one at D0, D7 and either D21 or D28. Alternatively, in immunocompetent individuals, the one-week regimen with 2 doses can be used: at D0 and at D7. Individuals should be vaccinated according to local official recommendations when available. For individuals at continued risk, booster doses should be given in line with official recommendations. The need for serology testing to detect the presence of rabies virus-neutralising antibodies (≥0.5 IU/ml) should be assessed and conducted, if appropriate, in accordance with official recommendations. _Post-exposure prophylaxis_ Post-exposure prophylaxis should be initiated as soon as possible after suspected rabies exposure and should comprise proper wound care, vaccination, and if necessary, RIG treatment. In all cases, proper wound care (thorough flushing and washing of all bite wounds and scratches with soap or detergent and copious amounts of water and/or virucidal agents) mu Прочетете целия документ