Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
CARMUSTINE
RAZ PHARMACEUTICS LTD, ISRAEL
L01AD01
POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION
CARMUSTINE 100 MG
I.V
Required
EMCURE PHARMACEUTICALS LTD., INDIA
CARMUSTINE
Carmustine is indicated as palliative therapy as a single agent or in established combination therapy with other approved agents in the following:• Brain tumors - glioblastoma, medulloblastoma, astrocytoma and metastatic brain tumors.• Multiple myeloma - in combination with glucocorticoid such as prednisone. • Hodgkin’s disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.• Non-Hodgkin’s lymphomas - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.
2019-08-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CARMUSTINE RAZ 100MG 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 100 mg carmustine. Each vial of solvent contains 3 ml dehydrated alcohol (that is equivalent to 2,37 g). For excipients, see 6.1 3 PHARMACEUTICAL FORM Powder and solvent for concentrated solution for infusion. Appearance of powder for reconstitution: Yellowish. Appearance of solvent: Clear, colorless, mobile liquid. Appearance of reconstituted solution: colorless to light yellow pH: 4.0 to 6.8. The osmolarity of the solution for infusion that is reconstituted with dehydrated ethanol and sterilized water is 15.6 mOsmol/l. The solution for infusion that is diluted with physiological saline or with 5% glucose solution is isotonic with the plasma. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carmustine is indicated as palliative therapy as a single agent or in established combination therapy with other approved agents in the following: • Brain tumors - glioblastoma, medulloblastoma, astrocytoma and metastatic brain tumors. • Multiple myeloma - in combination with glucocorticoid such as prednisone. • Hodg kin’ s disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. • Non-Hodg kin’ s lymphomas - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Posology of intravenous administration: The recommended dose of Carmustine as a single agent in previously untreated patients is 150 to 200 mg/m 2 intravenously every 6 weeks. This may be given as a single dose or divided into two daily injections such as 75 to 100 mg/m 2 on two successive days. When Carmustine is used in combination with other myelosuppressive medicinal products or in patients in whom bone marr Прочитайте повний документ