BLEOMYCIN- bleomycin sulfate powder, for solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

BLEOMYCIN SULFATE (UNII: 7DP3NTV15T) (BLEOMYCIN - UNII:40S1VHN69B)

Disponível em:

Meitheal Pharmaceuticals Inc.

Via de administração:

INTRAMUSCULAR

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Bleomycin for Injection, USP 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: Squamous Cell Carcinoma: 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 for Injection, USP is poorer in patients with previously irradiated head and neck cancer. Lymphomas: Hodgkin's disease, non-Hodgkin's lymphoma. Testicular Carcinoma: Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin for Injection, USP has also been shown to be useful in the management of: Malignant Pleural Effusion: Bleomycin for Injection, USP is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions. Bleomycin for injection is contraindicated in patients who ha

Resumo do produto:

Bleomycin for Injection, USP is supplied as follows: Store refrigerated between 2° and 8°C (36° and 46°F). The sterile powder is stable under refrigeration and should not be used after the expiration date is reached. Bleomycin for Injection, USP should not be reconstituted or diluted with D5 W or other dextrose containing diluents. When reconstituted in D5 W 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 Sodium Chloride for Injection, 0.9%, USP. Bleomycin for Injection, USP is stable for 24 hours at room temperature in Sodium Chloride. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

BLEOMYCIN- BLEOMYCIN SULFATE POWDER, FOR SOLUTION
MEITHEAL PHARMACEUTICALS INC.
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BLEOMYCIN FOR INJECTION, USP
meitheal
Rx only
WARNING
IT IS RECOMMENDED THAT BLEOMYCIN FOR INJECTION, USP 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 is provided as a sterile lyophilized
powder for reconstitution
containing 15 units per vial and 30 units per vial, which are intended
for intramuscular,
intravenous, subcutaneous or intrapleural administration.
Its chemical name is N'-[3-(dimethylsulphonio)propyl]bleomycin-amide
(bleomycin A )
and N'-[4-(guaniodobutyl)]bleomycin-amide (bleomycin B ).
2
2
(Main component: Bleomycin A , in which _R_ is [CH ] S CH CH CH -)
NOTE: A unit of bleomycin is equal to the formerly used milligram
activity. The term
milligram activity is a misnomer and was changed to units to be more
precise.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Although the exact mechanism of action of bleomycin is unknown,
available evidence
indicates that the main mode of action is the inhibition of DNA
synthesis with some
evidence of lesser inhibition of R