Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
HUMAN-RABIES IMMUNOGLOBULIN
KAMADA LTD, ISRAEL
J06BB05
SOLUTION FOR INJECTION
HUMAN-RABIES IMMUNOGLOBULIN 150 IU/ML
I.M
Required
KAMADA LTD, ISRAEL
RABIES IMMUNOGLOBULIN
RABIES IMMUNOGLOBULIN
KamRAB IM is indicated for passive, transient post-exposure prevention of rabies infection when given immediately to individuals in cases of contact with rabid or possibly rabid animal.
2023-06-30
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת _______________ 13-11-13 ________ םש רישכת תילגנאב רפסמו םושירה ______ KAMRAB 138- 88-31771- 00 __ םש לעב םושירה ___ KAMADA LTD _________________________________ דבלב תורמחהה טורפל דעוימ הז ספוט ! תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח QALITATIVE AND QUANTITATIVE COMPOSITION Human rabies immunoglobulin (for intramuscular or subcutaneous use only) . Human rabies immunoglobulin ) עיפומ טוריפב ףיעסב Method of (administration INDICATION Human rabies immunoglobulin must always be used in combination with a rabies vaccine as part of the post-exposure prophylaxis of rabies infection in patients exposed to animals suspected of being rabid, provided the patient was not previously vaccinated with rabies vaccine. Rabies virus is usually transmitted by the bite of a rabid animal but can occasionally penetrate abraded skin contaminated with the saliva of infected animals. Progress of the virus after exposure is believed to follow a neural pathway and the time between exposure and clinical rabies is a function of the proximity of the bite (or abrasion) to the central nervous system and the dose of virus injected. The incubation is usually 2-6 weeks but can be longer. After severe bites about the face and neck and arms, it may be as short as 10 days. After initiation of the vaccine series it takes approximately one week for development of immunity to rabies; therefore, the value of immediate passive immunization with rabies antibodies in the form of rabies immune globulin (human) cannot be overemphasized . תת לטוב ףיעס RATIONALE OF TREATMENT, TABLE A1 . Human rabies immunoglobulin must always be used in combination with a rabies vaccine as part of the post- exposure prophylaxis of rabies i Διαβάστε το πλήρες έγγραφο
1 FULL PRESCRIBING INFORMATION 1 NAME OF THE MEDICINAL PRODUCT Kam _RAB_ , Human-Rabies Immunoglobulin (HRIG) 150 IU/mL, Solution for i.m. Injection. 2 THERAPEUTIC INDICATIONS Passive, transient post-exposure prophylaxis of rabies infection, when given immediately to individuals in cases of contact with rabid or possibly rabid animal. Human rabies immunoglobulin must always be used in combination with a rabies vaccine as part of the post-exposure prophylaxis of rabies infection in patients exposed to animals suspected of being rabid. Local or state public health officials should be consulted if questions arise about the need for rabies prophylaxis. Recommendations for passive and/or active immunization after exposure to an animal suspected of having rabies have been outlined, among others by the World Health Organization (WHO) and by the U.S. public health Advisory Committee on Immunization Practices (ACIP). 3 DOSAGE AND 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, preferably at the time of the first vaccine dose. It may also be given through the seventh day after the first dose of vaccine is given. Kam _RAB_ should never be administered in the same syringe or into the same anatomical site as the vaccine. Because of the risk of interference with antibody production related to vaccination, neither the dose should be increased, nor a repeated rabies immunoglobulin dose be given (even if the onset of the simultaneous prophylaxis is delayed). METHOD OF ADMINISTRATION Human rabies immunoglobulin should be administered via the intramuscular route. If a large volume (>2 Διαβάστε το πλήρες έγγραφο