Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rabies immunoglobulin human
Bio Products Laboratory Ltd
J06BB05
Rabies immunoglobulin human
500unit
Solution for injection
Intramuscular; Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 14050200; GTIN: 5019943000355
PATIENT INFORMATION LEAFLET HUMAN RABIES IMMUNOGLOBULIN NOT LESS THAN 150 IU/ML SOLUTION FOR INJECTION SRCNL4 PLEASE READ ALL OF THIS LEAFL ET CAREFULLY BEFORE USING THIS MEDICINE. • Keep this leafl et. You may need to read it again. • If you have any further questions, please ask your doctor. • This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leafl et, please tell your doctor. Is this leafl et hard to see or read? Phone +44 (0)20 8957 2200. IN THIS LEAFL ET: 1. What Human Rabies Immunoglobulin is and what it is used for 2. Before you are given Human Rabies Immunoglobulin 3. How you are given Human Rabies Immunoglobulin 4. Possible side effects 5. How to store Human Rabies Immunoglobulin 6. Further information 1. WHAT HUMAN RABIES IMMUNOGLOBULIN IS AND WHAT IT IS USED FOR This product is a solution containing a large quantity of rabies antibodies. It is prepared from blood plasma from screened donors and virally-inactivated during manufacture. It is used to protect you against rabies and is given with fi rst dose of rabies vaccine, or not more than 7 days later. Your doctor will explain further why this medicine has been given to you. This product is usually given to you if: • you have been bitten, scratched or received any other injury from a suspected rabid animal or you may have swallowed or breathed in tissue such as saliva from a suspected rabid animal. Human Rabies Immunoglobulin is given by injection around the wound and into the muscle at the side of the thigh (intramuscular). Your doctor or nurse will give you the injection. 2. BEFORE YOU ARE GIVEN HUMAN RABIES IMMUNOGLOBULIN SPECIAL CARE MUST BE TAKEN WITH HUMAN RABIES IMMUNOGLOBULIN IF YOU: • DEVELOP AN ALLERGIC REACTION _(see Section 4 ‘Possible Side Effects’ for a list of _ _these)._ IF YOU SUFFER FROM ANY OF THESE, OR JUST FEEL UNWELL, TELL Lue koko asiakirja
OBJECT 1 HUMAN RABIES IMMUNOGLOBULIN Summary of Product Characteristics Updated 05-Oct-2016 | Bio Products Laboratory Limited 1. Name of the medicinal product Human Rabies Immunoglobulin, not less than 150 IU/mL solution for injection 2. Qualitative and quantitative composition Human Rabies Immunoglobulin contains human protein, 40-180 g/L of which at least 95% is IgG. The concentration of specific IgG to Rabies virus is not less than 150 IU/mL in nominal 500 IU vials. The correct volume to give the stated potency is overprinted on the label. This product is prepared from plasma from screened donors. Donors are selected from the USA. For excipients, see section 6.1. 3. Pharmaceutical form Solution for injection. 4. Clinical particulars 4.1 Therapeutic indications Post-exposure prophylaxis of rabies infection in persons after exposure to scratches, bites or other injuries including mucous membrane contamination with infectious tissue, such as saliva, caused by a suspected rabid animal. Human Rabies Immunoglobulin must always be used in combination with a rabies vaccine. 4.2 Posology and method of administration POSOLOGY Post-exposure prophylaxis consists of a regimen of one dose of immunoglobulin and full courses of rabies vaccination. Rabies immunoglobulin and the first dose of rabies vaccine should be given as soon as possible after exposure. Additional doses of rabies vaccine should be given according to official guidelines or the manufacturer's instructions. Rabies prophylaxis exclusively with simultaneous vaccination: recommended dose of rabies immunoglobulin is 20 IU/kg body weight. If vaccine is given but treatment with human rabies immunoglobulin is delayed, human rabies immunoglobulin should still be given up to seven days after starting the course of vaccine. Because of the risk of interference with antibody production related to vaccination, neither the dose should be increased nor repeat rabies immunoglobulin be given (even if the onset of the simultaneous prophylaxis is delayed). The volume of solutio Lue koko asiakirja