CISPLATIN injection

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

CISPLATIN (UNII: Q20Q21Q62J) (CISPLATIN - UNII:Q20Q21Q62J)

Доступно од:

West-Ward Pharmaceuticals Corp

Пут администрације:

INTRAVENOUS

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Cisplatin Injection is indicated as therapy to be employed as follows: In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of Cisplatin Injection and cyclophosphamide. Cisplatin Injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Cisplatin Injection therapy. Cisplatin Injection is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy. Cisplatin is contraindicated in patients with pre-existi

Резиме производа:

Cisplatin Injection (1 mg/mL) is supplied as follows: NDC 0143-9504-01    Each multiple dose vial contains 50 mg of cisplatin NDC 0143-9505-01    Each multiple dose vial contains 100 mg of cisplatin The above products are multiple dose vials packaged individually. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not refrigerate. Protect from light. This container closure is not made with natural rubber latex. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

CISPLATIN- CISPLATIN INJECTION
WEST-WARD PHARMACEUTICALS CORP
----------
CISPLATIN INJECTION
RX ONLY
WARNING
Cisplatin 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 diagnostic and
treatment facilities are readily
available.
Cumulative renal toxicity associated with cisplatin is severe. Other
major dose-related toxicities
are myelosuppression, nausea, and vomiting.
Ototoxicity, which may be more pronounced in children, and is
manifested by tinnitus, and/or loss
of high frequency hearing and occasionally deafness, is significant.
_Anaphylactic-like_ reactions to cisplatin have been reported. Facial
edema, bronchoconstriction,
tachycardia, and hypotension may occur within minutes of cisplatin
administration. Epinephrine,
corticosteroids, and antihistamines have been effectively employed to
alleviate symptoms
(see WARNINGS and ADVERSE REACTIONS SECTIONS).
EXERCISE CAUTION TO PREVENT INADVERTENT CISPLATIN OVERDOSE. Doses
greater than 100
mg/m /cycle once every 3 to 4 weeks are rarely used. Care must be
taken to avoid inadvertent
cisplatin overdose due to confusion with carboplatin or prescribing
practices that fail to
differentiate daily doses from total dose per cycle.
DESCRIPTION
Cisplatin Injection infusion concentrate is a clear, colorless,
sterile aqueous solution. Each 50 mL or
100 mL amber vial of Cisplatin Injection contains: 1 mg/mL cisplatin,
9 mg/mL sodium chloride,
hydrochloric acid and/or sodium hydroxide to adjust pH, and water for
injection to a final volume of 50
mL or 100 mL, respectively. The pH range of Cisplatin Injection is 3.8
to 5.9.
Cisplatin Injection infusion concentrate must be further diluted prior
to administration (see DOSAGE
AND ADMINISTRATION, ALL PATIENTS).
The active ingredient, cisplatin, is a yellow to orange crystalline
powder with the molecular formula
PtCl
H N , and a molecular weight of 300.1. Cisplatin is