Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
BLEOMYCIN SULFATE
MEGAPHARM LTD
L01DC01
POWDER FOR SOLUTION FOR INJECTION
BLEOMYCIN SULFATE 15000 IU/VIAL
INTRAPLEURAL, INTRA-ARTERIAL, I.V, S.C, I.M, INTRA-TUMORAL, INTRA-CAVITARY
Required
BAXTER ONCOLOGY GmbH, GERMANY
BLEOMYCIN
BLEOMYCIN
Bleomycin is useful in the management of the following neoplasms: Squamous cell carcinoma affecting the mouth, nasopharynx and paranasal sinuses, larynx, oesaphagus, cervix, vagina, penis and skin. Well differentiated tumors usually respond better than anaplastic ones.Hodgkin's disease and other malignant lymphomas, including mycosis fungoides. Testicular carcinoma (seminoma and no seminoma) .Malignant effusions of serous cavities (intrapleural and intraperitoneal).Secondary indications in which bleomycin has been shown to be of some value include metastatic malignant melanoma, carcinoma of the thyroid lung and bladder. Local treatment of refractory warts. Bleomycin can be used as a single agent, but is generally used in combination with other cytotoxics and/or with radiation therapy.
2020-09-30
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bleomycin PFI 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains Bleomycin sulphate, equivalent to bleomycin 15 units (USP) or 15 000 I.U. One unit (USP) equivalent to 1 000 I.U. is equivalent to the biological activity of 1 mg. Note: 1 mg active substance is determined by bioassay and is not identical to 1 mg dry substance. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to yellowish white powder for solution for infusion, injection or instillation. Warning: It is recommended that BLEOMYCIN be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. Pulmonary fibrosis is the most severe toxicity associated with BLEOMYCIN. The most frequent presentation is pneumonitis occasionally progressing to pulmonary fibrosis. Its occurrence is higher in elderly patients and those receiving greater than 400 units total dose, but pulmonary toxicity has been observed in young patients and those treated with low doses. A severe idiosyncratic reaction consisting of hypotension, mental confusion, fever, chills and wheezing has been reported in approximately 1% of lymphoma patients treated with BLEOMYCIN. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BLEOMYCIN is useful in the management of the following neoplasms: 1) Squamous cell carcinoma affecting the mouth, nasopharynx and paranasal sinuses, larynx, esophagus, cervix, vagina, penis and skin. Well-differentiated tumors usually respond better than anaplastic ones. 2) Hodgkin's disease and other malignant lymphomas, including mycosis fungoides. 3) Testicular carcinoma (seminoma and non-seminoma). 4) Malignant effusions of serous cavities (intrapleural and intraperitoneal) 5) Additional indications in which BLEOMYCIN has been shown to be of some value include metasta Baca dokumen lengkap