Land: Israel
Språk: engelska
Källa: Ministry of Health
DACARBAZINE AS CITRATE
TZAMAL BIO-PHARMA LTD
L01AX04
POWDER FOR SOLUTION FOR INJ/INF
DACARBAZINE AS CITRATE 200 MG/VIAL
I.V
Required
MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY
DACARBAZINE
DACARBAZINE
Decarbazine is indicated for the treatment of patients with metastatic malignant melanoma. Further indications for dacarbazine as part of a combination chemotherapy in advanced Hodgkin's disease as a second line.
2011-06-30
העדוה לע הרמחה ( עדימ ןולעב )תוחיטב אפורל ךיראת רושיא ןולעה : 27.11.2016 םש רישכתה תילגנאב רפסמו םושירה DACARBAZINE MEDAC 200 MG (31170) DACARBAZINE MEDAC 500 MG (31171) DACARBAZINE MEDAC 1000 MG (31172) םש לעב םושירה TZAMAL BIO-PHARMA LTD . !דבלב תורמחהה טורפל דעוימ הז ספוט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט ADVERSE EVENTS --- Infections and infestations Uncommon (>1/1,000, <1/100) Infections Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form at the following link : https://forms.gov.il/globaldata/getsequence/getsequence. spx?formType=AdversEffectMedic@moh.gov.il In addition, you may report by sending an e-mail message to safety@tzamal-medical.co.il or by visiting the "Contact Us" webpage at: http://www.tzamal-medical.co.il/69601.html or by phone: +972-73-7151107 ב"צמ ןולעה ובש םינמוסמ תורמחהה תושקובמה לע עקר בוהצ . דומע 1 ךותמ 1 BPS-Safety update form SPC-01 Läs hela dokumentet
Page 1 of 8 PRESCRIBING INFORMATION DACARBAZINE MEDAC 500 MG / 1000 MG 1. NAME OF THE MEDICINAL PRODUCT Dacarbazine medac 500 mg Dacarbazine medac 1000 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose vial of Dacarbazine medac 500 mg contains 500 mg dacarbazine (as dacarbazine citrate, formed in situ). After reconstitution and final dilution Dacarbazine medac 500 mg contains 1.4 – 2.0 mg/ml dacarbazine. Each single-dose vial of Dacarbazine medac 1000 mg contains 1000 mg dacarbazine (as dacarbazine citrate, formed in situ). After reconstitution and final dilution Dacarbazine medac 1000 mg contains 2.8 - 4.0 mg/ml dacarbazine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dacarbazine medac 500 mg / 1000 mg: Powder for solution for injection/infusion. Dacarbazine medac is a white or pale-yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dacarbazine is indicated for the treatment of patients with metastatic malignant melanoma. Further indication for dacarbazine as part of a combination chemotherapy in advanced Hodgkin’s disease, as a second line. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology The use of dacarbazine should be confined to physicians experienced in oncology or haematology. Dacarbazine is sensitive to light exposure. All reconstituted solutions should be suitably protected from light also during administration (light-resistant infusion set). Care should be taken when administering the injection to avoid extravasation into tissues since this will cause local pain and tissue damage. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should be introduced into another vein. The following regimes may be used. For further details see current scientific literature. _Malignant melanoma _ Dacarbazine can be administered as single agent in doses of 200 to 250 mg/m² body surface area/day as an i.v. injection for 5 days every 3 weeks. As an alternative to an intravenous bolus injectio Läs hela dokumentet