CARBOPLATIN- 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:

Alvogen Inc.

INN (International ime):

CARBOPLATIN

Sastav:

CARBOPLATIN 10 mg in 1 mL

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Initial Treatment of Advanced Ovarian Carcinoma 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 (seeCLINICAL 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. Secondary Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the palliative treatment of

Proizvod sažetak:

Carboplatin Injection is available in the following strengths: STORAGE Unopened vials of carboplatin injection are stable to the date indicated on the package when stored at 20° to 25°C (68° to 77°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 25°C following multiple needle entries. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Solutions for infusion should be discarded 8 hours after preparation. HANDLING AND DISPOSAL Caution should be exercised in handling and preparing carboplatin injection. Several guidelines on this subject have been published1-4 . To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing carboplatin injection. If carboplatin injection contacts the skin, immediately wash the skin thoroughly with soap and water. If carboplatin injection contacts 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
ALVOGEN INC.
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CARBOPLATIN INJECTION
(FOR INTRAVENOUS USE ONLY)
RX ONLY
BOXED 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 injection administration. Epinephrine, corticosteroids,
and antihistamines have been
employed to alleviate symptoms.
DESCRIPTION
Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg
per mL aqueous solution of
carboplatin, USP. Carboplatin, USP is a platinum coordination
compound. The chemical name for
carboplatin, USP is platinum, diammine
[1,1-cyclobutanedicarboxylato(2-)-0,0’]-,(SP-4-2), and
carboplatin, USP has the following structural formula:
C H N O PT M.W. 371.25
Carboplatin, USP is a crystalline powder. 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.
6
12
2
4
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
and cisplatin appear to be directly related to the differenc