MITOMYCIN injection, powder, lyophilized, for solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Mitomycin (UNII: 50SG953SK6) (Mitomycin - UNII:50SG953SK6)

Dostupno od:

Sagent Pharmaceuticals

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Mitomycin for Injection is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy. Mitomycin is contraindicated in patients who have demonstrated a hypersensitive or idiosyncratic reaction to it in the past. Mitomycin is contraindicated in patients with thrombocytopenia, coagulation disorder, or an increase in bleeding tendency due to other causes.

Proizvod sažetak:

Mitomycin for Injection, USP is supplied in amber vials as follows: Store dry powder at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F). Protect from light. Avoid excessive heat, over 40°C (104°F). Protect reconstituted solution from light. Store solution under refrigeration 2° to 8°C (36° to 46°F), discard after 14 days. If unrefrigerated, discard after 7 days. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

MITOMYCIN- MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
SAGENT PHARMACEUTICALS
----------
MITOMYCIN FOR INJECTION, USP
40 MG PER VIAL
(FOR INTRAVENOUS USE)
SAGENT
Rx only
WARNING
Mitomycin should 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.
Bone marrow suppression, notably thrombocytopenia and leukopenia,
which may
contribute to overwhelming infections in an already compromised
patient, is the
most common and severe of the toxic effects of mitomycin (see WARNINGS
and
ADVERSE REACTIONS sections).
Hemolytic Uremic Syndrome (HUS) a serious complication of
chemotherapy,
consisting primarily of microangiopathic hemolytic anemia,
thrombocytopenia, and
irreversible renal failure has been reported in patients receiving
systemic
mitomycin. The syndrome may occur at any time during systemic therapy
with
mitomycin as a single agent or in combination with other cytotoxic
drugs, however,
most cases occur at doses ≥60 mg of mitomycin. Blood product
transfusion may
exacerbate the symptoms associated with this syndrome.
The incidence of the syndrome has not been defined.
DESCRIPTION
Mitomycin (also known as mitomycin and/or mitomycin-C) is an
antibiotic isolated from
the broth of Streptomyces caespitosus which has been shown to have
antitumor
activity. The compound is heat stable, has a high melting point, and
is freely soluble in
organic solvents.
Mitomycin for Injection, USP is a sterile dry mixture of mitomycin and
mannitol, which
when reconstituted with Sterile Water for Injection provides a
solution for intravenous
administration. Each Single-Dose vial contains mitomycin 40 mg and
mannitol 80 mg.
Each mL of reconstituted solution will contain 0.5 mg mitomycin and
have a pH between
6.0 and 8.0.
Mitomycin is a blue-violet crystalline powder with the molecular
formula of C
H
N O ,
and a molecular weig