CARBOPLATIN injection

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Sun Pharmaceutical Industries, Inc.

INN (আন্তর্জাতিক নাম):

CARBOPLATIN

রচনা:

CARBOPLATIN 10 mg in 1 mL

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 (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. Secondary Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the palliative treatment of patients with ovar

পণ্য সারাংশ:

Carboplatin Injection NDC 47335-150-40 50 mg/ 5 mL aqueous solution in multidose vials (with orange flip-off seals), individually cartoned. NDC 47335-151-40 150 mg/ 15 mL aqueous solution in multidose vials (with orange flip-off seals), individually cartoned. NDC 47335-300-40 450 mg/ 45 mL aqueous solution in multidose vials (with orange flip-off seals), individually cartoned. NDC 47335-284-40 600 mg/ 60 mL aqueous solution in multidose vials (with parrot green flip-off seals), individually cartoned. Storage 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°-30° C (59°-86° 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 published.1 to 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.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

CARBOPLATIN - CARBOPLATIN INJECTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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CARBOPLATIN INJECTION
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, 10 mg/mL
aqueous solution of carboplatin.
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
carboplatin has the following
structural formula:
Carboplatin is a crystalline powder with the molecular formula of C H
N O Pt and a molecular
weight of 371.25. 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.
Each ml of carboplatin injection contains 10 mg of carboplatin USP in
water for injection, with no other
inactive ingredients, pH range is 5 to 7. It is supplied as 5 mL, 15
mL, 45 mL & 60 mL multi dose vials.
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 num