CARBOPLATIN- carboplatin injection, solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

CARBOPLATIN (UNII: BG3F62OND5) (CARBOPLATIN - UNII:BG3F62OND5)

Предлага се от:

Fresenius Kabi USA, LLC

INN (Международно Name):

CARBOPLATIN

Композиция:

CARBOPLATIN 10 mg in 1 mL

Начин на приложение:

INTRAVENOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 be

Каталог на резюме:

The container closure is not made with natural rubber latex. Unopened vials of Carboplatin Injection are stable to the date indicated on the package when stored at 25°C (77°F); [excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].  Protect from light. Carboplatin Injection multidose 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. 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 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.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

CARBOPLATIN - CARBOPLATIN INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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CARBOPLATIN INJECTION
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, pyrogen-free solution
available in 10 mg per
mL multiple dose vials containing 50 mg, 150 mg, 450 mg or 600 mg of
carboplatin for
administration by intravenous infusion. Each mL contains: carboplatin
10 mg, and water
for injection to volume.
Carboplatin is a platinum coordination compound. The chemical name for
carboplatin is
platinum, diammine [1,1-cyclobutane-dicarboxylato(2-)-0,0’]-,
(SP-4-2), and has the
following structural formula:
C H N O PT M.W. 371.25
Carboplatin 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.
CLINICAL PHARMACOLOGY:
6
12
2
4
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 biolo