Country: Israel
Language: English
Source: Ministry of Health
VINCRISTINE SULFATE
ABIC MARKETING LTD, ISRAEL
L01CA02
SOLUTION FOR INJECTION
VINCRISTINE SULFATE 1 MG/ML
I.V
Required
PHARMACHEMIE B.V., (TEVA GROUP) ,THE NETHERLANDS
VINCRISTINE
VINCRISTINE
Vincristine may be used either as sole agent or in combination therapy in the treatment of acute leukemias. Malignant lymphomas including Hodgkin's disease lymphosarcoma and reticulum cell sarcoma, neuroblastoma, Wilm's tumor, rhabdomyosarcoma.
2015-02-28
לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה עדימ עדימ עדימ ל ןולעב )תוחיטב ל ןולעב )תוחיטב ל ןולעב )תוחיטב אפור אפור אפור ןכדועמ( /102/50 ) _______ ךיראת JANUARY 20, 2015 __ תילגנאב רישכת םש םושירה רפסמו VINCRISTINE SOLUTION FOR INJECTION 115 51 22790 05 םושירה לעב םש SALOMON, LEVIN & ELSTEIN LTD. POBOX 3696, PETACH-TIKVA 49133 _ ! דבלב תורמחה טורפל דעוימ הז ספוט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט INDICATION CONTRAINDICATIONS in patients who are hypersensitive to vincristine sulphate or to one of the excipients; in patients who are hypersensitive to active substance or to any excipient listed in section 6.1 vincristine sulphate or to one of the excipients; POSOLOGY, DOSAGE & ADMINISTRATION SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE VINCRISTINE FOR INTRAVENOUS USE ONLY, FATAL IF GIVEN BY OTHER ROUTES’ Intrathecal administration of vincristine results in fatal neurotoxicity. ‘ VINCRISTINE FOR INTRAVENOUS USE ONLY, FATAL IF GIVEN BY OTHER ROUTES’ Intrathecal administration of vincristine results in fatal neurotoxicity. INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION FERTILITY, PREGNANCY AND LACTATION ADVERSE EVENTS _Nervous system disorders _ Not known: Leukoencephalopathy Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance Any suspected adverse of the medicinal product. events should be reported to the Ministry of Health according to the National Regulation ne form by using an onli (http://forms.gov.il/globaldata/getsequence/ge tsequence.aspx?formType=AdversEffectMedi c@moh.gov.il). Read the complete document
Vincristine Teva NA 06/2023 Notification 1 Vincristine Teva Solution for Injection SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Vincristine Teva Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 1 ml contains 1 mg of vincristine sulfate. Each vial of 2 ml contains 2 mg of vincristine sulfate. Each vial of 5 ml contains 5 mg of vincristine sulfate. 1 ml of solution contains 1 mg vincristine sulfate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for I.V. injection. Clear colourless solution or slightly yellow solution, free of particles other than gas bubbles. The pH is 3.5 – 5.5 and osmolality is approximately 600 mOsm/l. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Vincristine solution 1mg/ml may be used either as sole agent or in combination therapy in the treatment of acute leukaemia. Malignant lymphomas including Hodgkin’s disease lymphosarcoma and reticulum cell sarcoma, neuroblastoma, Wilms' tumour, rhabdomyosarcoma. 4.2 Posology and method of administration _ _ VINCRISTINE SULFATE SHOULD ONLY BE ADMINISTERED INTRAVENOUSLY. FATAL IF GIVEN BY OTHER ROUTES See section 4.4 Special warnings and precautions for use. Posology Extreme care must be used in calculating and administering the dose to be injected, because overdose can have severe and even fatal results. When used as monotherapy, the dose should be administered at 1 week intervals. In combination with other antineoplastic agents, the dosing frequency depends on the protocol. The usual dose for adults is 1.4 mg/m² (maximum of 2 mg) once a week. Children can tolerate a higher dose: 1.5-2.0 mg/m² once per week. For children weighing 10 kg or less, the usual starting dose is 0.05 mg/kg once a week. Vincristine Teva NA 06/2023 Notification 2 Elderly The normal adult dose is still appropriate in the elderly. Hepatic impairment In patients with hepatic impairment or with a direct serum bilirubin value above 3 mg/100 ml a reduction of 50% of the dose of vincristi Read the complete document