국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tetanus immunoglobulin human
Bio Products Laboratory Ltd
J06BB02
Tetanus immunoglobulin human
250unit
Solution for injection
Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 14050200; GTIN: 5019943000362
PATIENT INFORMATION LEAFLET HUMAN TETANUS IMMUNOGLOBULIN 100 IU/ML SOLUTION FOR INJECTION STDNL5 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 Tetanus Immunoglobulin is and what it is used for 2. Before you are given Human Tetanus Immunoglobulin 3. How you are given Human Tetanus Immunoglobulin 4. Possible side effects 5. How to store Human Tetanus Immunoglobulin 6. Further information 1. WHAT HUMAN TETANUS IMMUNOGLOBULIN IS AND WHAT IT IS USED FOR This product is a solution containing a large quantity of tetanus antibodies. It is prepared from blood plasma from screened donors and virally-inactivated during manufacture. It is used to protect you against tetanus and is normally given with tetanus vaccine. Your doctor will explain further why this medicine has been given to you. This product is usually given to you if: • you have not had previous vaccination to tetanus, or have not been properly vaccinated, or do not know whether you have been vaccinated to tetanus but may have recently been exposed to tetanus because you have been wounded e.g by a cut, bite or pierced by a foreign body • you have had a full course of vaccination to tetanus but have recently had a severe injury with a high risk of being infected by tetanus germs Human Tetanus Immunoglobulin is given by injection into a muscle (intramuscular) such as the buttock or thigh. Your doctor or nurse will give you the injection. 2. BEFORE YOU ARE GIVEN HUMAN TETANUS IMMUNOGLOBULIN You must not be given this medicine if you are: • SUFF 전체 문서 읽기
OBJECT 1 HUMAN TETANUS IMMUNOGLOBULIN Summary of Product Characteristics Updated 05-Oct-2016 | Bio Products Laboratory Limited 1. Name of the medicinal product Human Tetanus Immunoglobulin, 100 IU/ml sterile solution 2. Qualitative and quantitative composition Human Tetanus Immunoglobulin Ph.Eur. contains human protein, 40-180 g/L of which at least 95% is IgG. The concentration of specific IgG to tetanus toxin is not less than 100 IU/ml in nominal 250 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: Immediate prophylaxis after tetanus prone injuries in patients not adequately vaccinated, in patients whose immunisation status is not known with certainty, and in patients with severe deficiency in antibody production or vaccinated patients with high risk wounds. 4.2 Posology and method of administration 4.2.1 POSOLOGY Prophylaxis of tetanus prone wounds: • 250 IU, unless the risk is thought to be extremely high • The dose may be increased to 500 IU in: • Infected wounds, where surgically appropriate treatment cannot be achieved within 24 hours • Deep or contaminated wounds with tissue damage and reduced oxygen supply, as well as foreign body injury (e.g. bites, stings or shots) The volume of solution that needs to be administered to give 250 IU is stated on the label. DO NOT EXCEED THE RECOMMENDED DOSE. 4.2.2 METHOD OF ADMINISTRATION Human Tetanus Immunoglobulin should be administered via the intramuscular route. If a large volume (> 2mL for children or > 5 mL for adults) is required, it is recommended to administer this in divided doses at different sites. When simultaneous vaccination is necessary, the immunoglobulin and the vaccine should be administered at two different sites. If intramuscular administration is contra-ind 전체 문서 읽기