CISPLATIN injection, solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

FOSUN PHARMA USA INC

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radio therapeutic procedures. Metastatic Ovarian Tumors 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 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. Advanced Bladder Cancer Cisplatin Injection is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, s

Bidhaa muhtasari:

CISplatin Injection (1 mg/mL) is supplied as follows: 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.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

CISPLATIN- CISPLATIN INJECTION, SOLUTION
FOSUN PHARMA USA INC
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CISPLATIN INJECTION
RX ONLY
BOXED WARNING
Cisplatin 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 WARNINGSand ADVERSE
REACTIONS).
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 is a clear, colorless, sterile aqueous solution.
Each 100 mL amber vial
of Cisplatin Injection contains: 1 mg/mL cisplatin USP, 9 mg/mL sodium
chloride,
hydrochloric acid and/or sodium hydroxide to adjust pH, and water for
injection USP to a
final volume of 50 mL and 100 mL respectively. The pH range of
Cisplatin Injection is 3.8
to 5.9.
Cisplatin Injection must be further diluted prior to administration
(see _DOSAGE AND_
_ADMINISTRATION , ALL PATIENTS_).
The active ingredient, cisplatin USP, is a yellow to orange
crystalline powder. Cisplatin is a
heavy metal complex containing a central atom of platinum surrounded
by two chloride
atoms and two ammonia molecules