BLEOMYCIN injection, powder, lyophilized, for solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Teva Parenteral Medicines, Inc.

INN (Tên quốc tế):

BLEOMYCIN SULFATE

Thành phần:

BLEOMYCIN 15 [USP'U]

Tuyến hành chính:

INTRAMUSCULAR

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

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.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

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