Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BLEOMYCIN SULFATE
Pharmachemie BV
15 U (USP)/vial %v/v
Pdr for Soln for Injection
2006-10-13
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bleomycin 15,000IU Powder for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains bleomycin 15,000 IU (as bleomycin sulphate). For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion Vials containing a white to cream coloured powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Squamous cell carcinoma affecting the mouth nasopharynx and paranasal sinuses, larynx, oesophagus, external genitalia, cervix or skin. Well-differentiated tumours usually respond better than anaplastic ones. 1. Hodgkin's disease and other malignant lymphomas including mycosis fungoides. 2. Testicular teratoma. 3. Malignant effusions of serous cavities. 4. Secondary indications in which bleomycin has been shown to be of some value (alone or in combination with other drugs) include metastatic malignant melanoma, carcinoma of the thyroid, lung and bladder. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults_ Bleomycin is usually administered intramuscularly but may be given intravenously (bolus or drip), intra-arterially, intrapleurally or intraperitoneally as a solution in physiological saline. Local injection directly into the tumour may occasionally be indicated. 1. _Squamous cell carcinoma and testicular teratoma:_ Used alone the normal dosage is 15 x 10 3 I.U. three times a week or 30 x 10 3 I.U. twice a week, either intramuscularly or intravenously. Treatment may continue on consecutive weeks, or more usually at intervals of 3-4 weeks, up to a total cumulative dose of 500 x 10 3 I.U. although young men with testicular tumours have frequently tolerated twice this amount. Continuous intravenous infusion at a rate of 15 x 10 3 I.U. per 24 hours for up to 10 da Read the complete document