国家: 以色列
语言: 英文
来源: Ministry of Health
IMMUNOGLOBULIN RABBIT ANTI-HUMAN THYMOCYTE
SANOFI ISRAEL LTD
L04AA04
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
IMMUNOGLOBULIN RABBIT ANTI-HUMAN THYMOCYTE 25 MG/VIAL
I.V
Required
GENZYME EUROPE B.V., THE NETHERLANDS
ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT)
ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT)
Immunosuppression in transplantation: prevention and treatment of graft rejection. Treatment of acute graft versus host disease (GvHD). Hematology treatment of aplastic anemia.
2021-08-31
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת ________ 05.05.2015 _______________ םש רישכת תילגנאב THYMOGLOBULINE רפסמ םושיר 123-24-25723-00 םש לעב םושירה סיטנווא-יפונאס__ לארשי __________________________ ספוט הז דעוימ טורפל תורמחהה דבלב ! תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח SPECIAL WARNINGS AND PRECAUTIONS FOR USE ןמוסמ הרמחה הווהמו ףסוותהש עדימ ב בוהצ , אלמ עדימ :)אלמה ןולעב אוצמל ןתינ הז ףיעס לש Thymoglobulin should be used under strict medical supervision in a hospital setting, and patients should be carefully monitored during the infusions. Infusion-Associated Reactions (IARs) may occur following the administration of Thymoglobulin and may occur as soon as the first or second infusion during a single course of Thymoglobulin treatment . UNDESIRABLE EFFECTS ןמוסמ הרמחה הווהמו ףסוותהש עדימ ב בוהצ , אלמ עדימ אלמה ןולעב אוצמל ןתינ הז ףיעס לש): In addition: HEPATOCELLULAR INJURY, HEPATOTOXICITY, HEPATIC FAILURE (cases have been reported secondary to allergic hepatitis and reactivation of hepatitis in patients with hematologic disease and/or stem cell transplant as confounding factors)… … ………………………………………………………………… In addition: DISSEMINATED INTRAVASCULAR COAGULOPATHY AND COAGULOPATHY have also been reported. . ב"צמ ובש ,ןולעה נמוסמ תו תורמחהה שקובמה תו לע עקר בוהצ . םייוניש םניאש רדגב תורמחה ונמוס )ןולעב( עבצב קורי וא , םודא םע וק הקיחמ רובע( עדימ ונאש םישקבמ .)דירוהל רבעוה ראודב ינורטקלא .......ךיראתב 05.0 阅读完整的文件
THYM-SPC-15.1 1 Thymoglobuline Powder for concentrate for solution for infusion 1. NAME OF THE MEDICINAL PRODUCT Thymoglobuline 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Rabbit anti-human thymocyte immunoglobulin 25 mg per vial. 1 ml reconstituted solution contains 5 mg rabbit, anti-human thymocyte immunoglobulin. Excipient(s) with known effect: Each 10 ml vial contains 0.171 mmol of sodium, which is 4 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Immunosuppression in transplantation: prevention and treatment of graft rejection. Treatment of acute graft versus host disease (GvHD). Hematology treatment of aplastic anemia. 4.2 Posology and method of administration Posology The posology depends on the indication, the administration regimen and the possible combination with other immunosuppressive agents. The following dosage recommendations may be used as reference. Treatment can be discontinued without gradual tapering of the dose. Immunosuppression in transplantation Prophylaxis of acute graft rejection: 1 to 1.5 mg/kg/day for 2 to 9 days after transplantation of a kidney, pancreas or liver and for 2 to 5 after heart transplantation, corresponding to a cumulative dose of 2 to 7.5 mg/kg in heart transplantation and 2 to 13.5 mg/kg for other organs. THYM-SPC-15.1 2 Treatment of acute graft rejection: 1.5 mg/kg/day for 3 to 14 days, corresponding to a cumulative dose of 4.5 to 21 mg/kg. Treatment of acute graft versus host disease The dosage must be defined depending on individual basis. It is usually between 2 and 5 mg/kg/day for 5 days. Treatment of aplastic anaemia 2.5 to 3.5 mg/kg/day for 5 consecutive days, corresponding to a cumulative dose of 12.5 to 17.5mg/kg. The indication for aplastic anaemia has not been established by controlled trials carried out with this medicinal product. Method of administration Thymoglobuline is usually administered within the context of a 阅读完整的文件