Երկիր: Մալթա
Լեզու: անգլերեն
Աղբյուրը: Medicines Authority
IMMUNOGLOBULIN RABIES, HUMAN
Bio Products Laboratory Limited Dagger Lane, Elstree Hertfordshire, WD6 3BX, United Kingdom
J06BB05
IMMUNOGLOBULIN RABIES, HUMAN 150 IU/ml
SOLUTION FOR INJECTION
IMMUNOGLOBULIN RABIES, HUMAN 150 IU/ml
POM
IMMUNE SERA AND IMMUNOGLOBULINS
Withdrawn
2007-10-04
BPL 0791 28.05.12 PROOF: THREE 90 x 290MM COLOURS: Black BPL PO No.: 261148 PMS 273 PMS 430 PATIENT INFORMATION LEAFLET HUMAN RABIES IMMUNOGLOBULIN NOT LESS THAN 150 IU/ML SOLUTION FOR INJECTION SRCNL2 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 020 8258 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. 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. 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. 2. BEFORE YOU ARE GIVEN HUMAN RABIES IMMUNOGLOBULIN SPECIAL CARE MUST BE TAKEN WITH HUMAN RABIES IMMUNOGLOBULIN IF YOU: • DEVELOP AN Կարդացեք ամբողջական փաստաթուղթը
_ _ _ _ _ _ _ _ _ _ _ _ Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF PRODUCT: Human Rabies Immunoglobulin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Human Rabies Immunoglobulin Ph.Eur.* Human Rabies Immunoglobulin is presented as a vial size of 500 iu. Each millilitre contains: 40-180 mg/ml human protein of which at least 95% are gammaglobulins. This product is prepared from plasma from screened donors. Donors are selected from the USA. * One millilitre contains not less than 150 iu of rabies antibody. 3. PHARMACEUTICAL FORM: Solution for injection. 4. CLINICAL PARTICULARS: 4.1 THERAPEUTIC INDICATIONS The use of Human Rabies Immunoglobulin is specified in the World Health Organisation (WHO) guidelines for specific systemic treatment. These guidelines are outlined in the table below: STATUS OF BITING ANIMAL (IRRESPECTIVE OF ANY EARLIER VACCINATION) NATURE OF EXPOSURE AT TIME OF EXPOSURE DURING NEXT 10 DAYS A RECOMMENDED TREATMENT Healthy None Healthy None Contact, but no lesions; indirect contact; non contact Suspected as rabid b Rabid None Healthy None Healthy Rabid Start vaccination schedule c Suspected as rabid b Healthy Start vaccination schedule; stop treatment if animal remains healthy for 5 days a, d Licks on the skin; scratches or abrasions; Minor bites (on covered areas of arms, trunk and legs) Rabid Start vaccination schedule; upon positive diagnosis, complete the course of vaccine _ _ _ _ _ _ _ _ _ _ _ _ Page 2 of 6 Rabid; wild animal e or animal unavailable for observation Give complete course of vaccination Licks of mucosa; major bites Կարդացեք ամբողջական փաստաթուղթը