CARBOPLATIN injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

carboplatin (UNII: BG3F62OND5) (carboplatin - UNII:BG3F62OND5)

Dostupno od:

Sagent Pharmaceuticals

INN (International ime):

carboplatin

Sastav:

carboplatin 10 mg in 1 mL

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Carboplatin Injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES ). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor <2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup. Carboplatin Injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously trea

Proizvod sažetak:

Carboplatin Injection is supplied as follows: Store the unopened vials of Carboplatin Injection at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light. Carboplatin Injection multi-dose vials maintain microbial, chemical, and physical stability for up to 14 days at 20° to 25°C (68° to 77°F) following multiple needle entries. Solutions for infusion should be discarded 8 hours after preparation. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Caution should be exercised in handling and preparing Carboplatin Injection. Several guidelines on this subject have been published.1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing Carboplatin Injection. If Carboplatin Injection or solutions containing Carboplatin Injection contact the skin, immediately wash the skin thoroughly with soap and water. If Carboplatin Injection or solutions containing Carboplatin Injection contact mucous membranes, the membranes should be flushed immediately and thoroughly with water. More information is available in the references listed below.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CARBOPLATIN- CARBOPLATIN INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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CARBOPLATIN INJECTION
(CARBOPLATIN AQUEOUS SOLUTION)
SAGENT™
Rx only
WARNING
Carboplatin Injection 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 treatment facilities
are readily available.
Bone marrow suppression is dose related and may be severe, resulting
in infection and/or
bleeding. Anemia may be cumulative and may require transfusion
support. Vomiting is another
frequent drug-related side effect.
Anaphylactic-like reactions to carboplatin have been reported and may
occur within minutes of
carboplatin administration. Epinephrine, corticosteroids, and
antihistamines have been employed to
alleviate symptoms.
DESCRIPTION
Carboplatin Injection is supplied as a sterile, nonpyrogenic, 10 mg/mL
aqueous solution of carboplatin.
Carboplatin is a platinum coordination compound that is used as a
cancer chemotherapeutic agent. The
chemical name for carboplatin is platinum,
diammine[1,1-cyclobutanedicarboxylato(2-)-_O_,_O_']-, (_SP_-4-2),
and has the following structural formula:
Carboplatin is a crystalline powder with the molecular formula of C H
N O Pt and a molecular
weight of 371.25. It is soluble in water at a rate of approximately 14
mg/mL, and the pH of a 1% solution
is 5 to 7. It is virtually insoluble in ethanol, acetone, and
dimethylacetamide.
CLINICAL PHARMACOLOGY
Carboplatin, like cisplatin, produces predominantly interstrand DNA
cross-links rather than DNA-
protein cross-links. This effect is apparently cell-cycle nonspecific.
The aquation of carboplatin, which
is thought to produce the active species, occurs at a slower rate than
in the case of cisplatin. Despite
this difference, it appears that both carboplatin and cisplatin induce
equal numbers of drug-DNA cross-
links, causing equivalent lesions and biological effects. The
differences in potencies for carboplatin