CARBOPLATIN injection, solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Teva Parenteral Medicines, Inc.

ИНН (Международная Имя):

CARBOPLATIN

состав:

CARBOPLATIN 10 mg in 1 mL

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические 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 been previously tr

Обзор продуктов:

Carboplatin injection, 10 mg/mL is available in multi-dose vials (with brown flip-off seals), individually cartoned: NDC 0703-4244-81 10 mg/mL, 5 mL Vial NDC 0703-4246-81 10 mg/mL, 15 mL Vial NDC 0703-4248-81 10 mg/mL, 45 mL Vial NDC 0703-4239-81 10 mg/mL, 60 mL Vial 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 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 Авторизация:

Abbreviated New Drug Application

Характеристики продукта

CARBOPLATIN- CARBOPLATIN INJECTION, SOLUTION
TEVA PARENTERAL MEDICINES, INC.
----------
CARBOPLATIN
INJECTION
PREMIERProRx
RX ONLY
4244
4246
4248
4239
WARNING
Carboplatin injection 10 mg/mL 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/mL
aqueous solution of
carboplatin, USP. Each mL contains 10 mg carboplatin, USP, 10 mg
mannitol and water
for injection, 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 5.0 to 7.0. 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.