Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
MELPHALAN AS HYDROCHLORIDE
RAZ PHARMACEUTICS LTD, ISRAEL
L01AA03
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION
MELPHALAN AS HYDROCHLORIDE 50 MG
I.V
Not required
TILLOMED LABORATORIES LIMITED, UK
MELPHALAN
For the palliative treatment of multiple myeloma and for the palliation of non resectable epithelial cancer of the ovary.
2020-12-06
SUMMARY OF PRODUCT CHARACTERISTICS 1. Name of the medicinal product MELPHALAN RAZ 50 MG 2. Qualitative and quantitative composition Each vial of powder contains melphalan hydrochloride equivalent to 50 mg melphalan. Each vial of solvent contains 10 ml of solvent. Each ml of the reconstituted solution contains 5 mg melphalan. Excipient(s) with known effect: Each vial of solvent contains 0.4243 g ethanol and 6.2148 g propylene glycol. Each vial of solvent contains 53.5 mg sodium. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Powder and solvent for solution for injection/infusion. Powder: White to pale yellow lyophilized powder/cake. Solvent: A clear colourless solution . 4. Clinical particulars 4.1Therapeutic indications For the palliative treatment of multiple myeloma and for the palliation of non resectable epithelial cancer of the ovary. 4.2 Posology and method of administration Melphalan is a cytotoxic drug which falls into the general class of alkylating agents. It should be prescribed only by physicians experienced in the management of malignant disease with such agents. Since melphalan is myelosuppressive, frequent blood counts are essential during therapy and the dosage should be delayed or adjusted if necessary (See section 4.4) P osology P arenteral administration: For intravenous administration, it is recommended that MELPHALAN RAZ 50 MG solution is injected slowly into a fast-running infusion solution via a swabbed injection port. If direct injection into a fast-running infusion is not appropriate, MELPHALAN RAZ 50 MG solution may be administered diluted in an infusion bag. Melphalan is not compatible with infusion solutions containing dextrose, and it is recommended that ONLY Sodium Chloride intravenous infusion 0.9% w/v is used. When further diluted in an infusion solution, MELPHALAN RAZ 50 MG has reduced stability and the rate of degradation increases rapidly with rise in temperature. If administration occurs at a room temperature of approximately 25°C, the total time from Đọc toàn bộ tài liệu