Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
rabies immunoglobulin, Quantity: 150 IU/mL
Sanofi-Aventis Australia Pty Ltd
Injection
Excipient Ingredients: glycine; sodium chloride; water for injections
Intramuscular
2mL vial, 10mL vial
(S4) Prescription Only Medicine
Imogam Rabies pasteurized is indicated in subjects who are thought to have been exposed to rabies virus, especially cases of major exposure, in accordance with W.H.O. recommendations as specified in the International Product Information.
Visual Identification: Clear, pale yellow to light brown liquid. During storage it may show formation of slight turbidity or a small amount of particulate matter.; Container Type: Vial; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2000-02-24
IMOGAM RABIES PASTEURIZED ® _Human rabies immunoglobulin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about IMOGAM RABIES pasteurized (IMOGAM). It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you taking IMOGAM against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR. KEEP THIS LEAFLET. You may need to read it again. WHAT IMOGAM IS USED FOR IMOGAM is used to help prevent rabies infection in people who have been bitten, licked or scratched by a rabies-infected animal. Rabies is an infection caused by a virus which affects the brain and is fatal if not treated early. IMOGAM is prepared from blood obtained from voluntary donors. It contains protein substances called antibodies, which can provide protection against rabies. BEFORE IMOGAM IS USED _SPECIAL WARNING_ This product is made from human plasma obtained from voluntary donors immunized against rabies. When products are made from human blood and injected into you, it is possible that viruses or other substances could be present in the product and cause an illness. These could be viruses such as hepatitis, HIV (human immunodeficiency virus), or parvovirus B19. There could also be other infectious agents some of which may not yet have been discovered. To reduce the risk of this happening, extra steps are taken when manufacturing this product. Strict controls are applied to the selection of blood donors and donations. The product is specially treated to remove and kill certain viruses. This special treatment is considered effective against viruses known as enveloped viruses such as HIV and hepatitis B and C viruses, and the non-enveloped virus, hepatitis A. The effect against the non-enveloped virus, human parvovirus B19 is limited. However, the product contains specific antibodies which can provide some protection ag Lugege kogu dokumenti
SANOFI PASTEUR, SA 194 IMOGAM ® RABIES – HT CONFIDENTIAL/PROPRIETARY INFORMATION 1 AHFS Category: 80:04 RIG RABIES IMMUNE GLOBULIN (HUMAN) USP, HEAT TREATED IMOGAM ® RABIES – HT FOR WOUND INFILTRATION AND INTRAMUSCULAR USE ONLY DESCRIPTION Rabies Immune Globulin (Human) USP, Heat Treated, Imogam ® Rabies – HT, is a sterile solution of antirabies immunoglobulin (10-16% protein) for wound infiltration and intramuscular administration. Rabies immune globulin (RIG) is prepared by cold alcohol fractionation from pooled venous plasma of individuals immunized with Rabies Vaccine prepared from human diploid cells (HDCV). The product is stabilized with 0.3 M glycine. The immune globulin solution has a pH of 6.8 ± 0.4 adjusted with sodium hydroxide or hydrochloric acid. No preservatives are added. Imogam Rabies – HT is a clear or slightly opalescent, colorless or pale- yellow or light-brown liquid. During storage it may show formation of slight turbidity or a small amount of visible particulate matter. A heat-treatment process step (58° to 60°C, 10 hours) to inactivate viruses is used to further reduce any risk of blood-borne viral transmission. The inactivation and removal of model laboratory strains of enveloped and non-enveloped viruses during the manufacturing and heat treatment processes for Imogam Rabies – HT have been validated by spiking experiments. Human immunodeficiency virus, type 1 (HIV-1) and type 2 (HIV-2) were selected as relevant viruses for plasma derived products. Bovine viral diarrhea virus and Sindbis virus were chosen to model hepatitis C virus. Porcine pseudorabies virus was selected to model hepatitis B virus and herpes virus. Avian reovirus was used to model non-enveloped RNA viruses and for its relative resistance to inactivation by chemical and physical methods. Finally, porcine parvovirus was selected to model human parvovirus B19 and its notable resistance to inactivation by heat treatment. Removal and/or inactivation of the spiked model viruses was demonstrated at the precipita Lugege kogu dokumenti