Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Rabies vaccine 2.5 [iU]
Seqirus (NZ) Ltd
Rabies vaccine 2.5 IU
2.5 IU
Injection with diluent
Active: Rabies vaccine 2.5 [iU] Excipient: Disodium edetate Potassium L-glutamate Polygeline Sodium chloride Sucrose Trometamol Water for injection
Prescription
GSK Vaccines GmbH
Active immunisation against rabies virus, including (a) pre-exposure immunisation, (b) post-exposure treatment following exposure to rabies virus
Package - Contents - Shelf Life: Combination pack, 1 vial vaccine + 1 diluent (syringe) - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, Diluent - 1 mL - 60 months from date of manufacture stored stored between 2 to 30 deg C - Vial, glass, Vaccine component - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
2014-01-13
1 RABIPUR _(Rab-ee-per)_ Inactivated Rabies Virus Vaccine CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about RABIPUR (Inactivated Rabies Virus Vaccine). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of you or your child having RABIPUR against the benefits they expect it will have. IF YOU HAVE ANY CONCERNS ABOUT THIS VACCINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT RABIPUR IS USED FOR RABIPUR is a vaccine used to help prevent rabies infection in people who either: • have been; or • are at risk of being bitten, licked or scratched by an animal infected with rabies virus. Rabies is a very serious infection. The rabies virus attacks the nerves and the brain. Rabies infection can be fatal if not treated as early as possible. _HOW IT WORKS_ RABIPUR works by encouraging your body to protect itself against rabies. The body makes substances called antibodies that fight the rabies virus. If the rabies virus gets into someone who has been vaccinated against rabies, the antibodies kill the virus before it can cause damage. After vaccination your body takes several weeks to develop enough antibodies to successfully fight rabies_._ For vaccination against rabies you need a course of 3 to 5 injections. After this course, most people produce enough antibodies against rabies_. _ However, as with all vaccines, RABIPUR may not fully protect all people who are vaccinated. For people at risk, further booster injections of rabies vaccine may be needed every few years to ensure enough antibodies are present. The vaccine will not give you or your child rabies. The chance of a severe reaction from RABIPUR is very small, but the risks from not being vaccinated against rabies may be very serious. BEFORE YOU ARE GIVEN RABIPUR _WHEN YOU OR YOUR CHILD _ _MUST NOT BE GIVEN Prečítajte si celý dokument
NEW ZEALAND DATA SHEET 1. PRODUCT NAME RABIPUR Inactivated Rabies Virus Vaccine Powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION RABIPUR is an inactivated rabies virus vaccine, derived from the fixed-virus strain, Flury LEP. The virus is propagated in a Purified Chick Embryo Cell (PCEC) culture, inactivated using β-propiolactone and purified via centrifugation. It is supplied in a single-dose presentation consisting of a vial containing lyophilised powder (vaccine component), accompanied by a diluent (Water for Injections). Each 1.0 mL dose of the reconstituted vaccine contains no less than 2.5 International Units (IU) of inactivated rabies virus, in accordance with the World Health Organization requirements. This vaccine contains residues of polygeline, chicken proteins (e.g., ovalbumin) and human serum albumin. The antibiotics neomycin, chlortetracycline and amphotericin B (amphotericin) are used in the manufacturing process of this vaccine and may be present in trace amounts. The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalitis) has resulted from the administration of any vaccine product. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For active immunisation against rabies virus in individuals of all ages, including: a) Pre-exposure immunisation, b) Post-exposure treatment following exposure to rabies virus. 4.2 DOSE AND METHOD OF ADMINISTRATION Dose Recommended dosages, as outlined below, are the same for children, adolescents and adults. Administration The vaccine must be given by intramuscular injection (IM) into the deltoid muscle, or into the anterolateral region of the thigh in small children. The vaccine must not be given by intragluteal injection. For instructions on reconstitution of the Prečítajte si celý dokument