Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
BLEOMYCIN SULFATE (UNII: 7DP3NTV15T) (BLEOMYCIN - UNII:40S1VHN69B)
Teva Parenteral Medicines, Inc.
BLEOMYCIN SULFATE
BLEOMYCIN 15 [USP'U]
INTRAMUSCULAR
PRESCRIPTION DRUG
Bleomycin for injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to bleomycin is poorer in patients with previously irradiated head and neck cancer. Hodgkin's Disease, non-Hodgkin's lymphoma. Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin for injection has also been shown to be useful in the management of: Bleomycin for injection is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions. Bleomycin is contraindicated in patients who have demonstrated a hypersensitive or an idiosyncratic reaction to it.
Bleomycin for Injection USP contains sterile bleomycin sulfate equivalent to 15 units or 30 units of bleomycin. Bleomycin for Injection USP is supplied as follows: NDC Number 0703-3154-01 15 Units per Vial Individually packaged 0703-3155-01 30 Units per Vial Individually packaged Stability The sterile powder is stable under refrigeration 2° to 8°C (36° to 46°F) and should not be used after the expiration date is reached. Bleomycin for Injection USP should not be reconstituted or diluted with 5% dextrose injection or other dextrose containing diluents. When reconstituted in 5% dextrose injection and analyzed by HPLC, Bleomycin for Injection USP demonstrates a loss of A2 and B2 potency that does not occur when Bleomycin for Injection USP is reconstituted in 0.9% sodium chloride for injection, 0.9%, USP. Bleomycin for Injection USP is stable for 24 hours at room temperature in 0.9 % sodium chloride injection. Vial stoppers do not contain natural rubber latex.
Abbreviated New Drug Application
BLEOMYCIN- BLEOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION TEVA PARENTERAL MEDICINES, INC. ---------- BLEOMYCIN FOR INJECTION USP 3154 3155 RX ONLY WARNING It is recommended that bleomycin for injection 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 in 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. DESCRIPTION Bleomycin for Injection USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of _Streptomyces verticillus_. It is freely soluble in water. Bleomycin for Injection USP contains sterile bleomycin sulfate equivalent to 15 units or 30 units of bleomycin. Sulfuric acid or sodium hydroxide can be used, if necessary, to adjust pH. Bleomycin for Injection USP may be given by the intramuscular, intravenous or subcutaneous routes. Its chemical name is N’-[3-(dimethylsul-phonio)propyl]bleomycin-amide (bleomycin A ) and N’-[4-(guaniodobutyl)]bleomycin-amide (bleomycin B ). (Main component: Bleomycin A , in which _R _is [CH ] S+CH CH CH -) The molecular formula of bleomycin A is C H N O S and a calculated molecular weight of 1414. The molecular formula of bleomycin B is C H N O S and a calculated molecular weight of 1425. The structural formula of bleomycins A and B are shown below. 2 2 2 3 2 2 2 2 2 55 84 17 21 3 2 55 84 20 21 2 2 2 NOTE: A unit of bleomycin is equal to the forme Đọc toàn bộ tài liệu