CARBOPLATIN injection, solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Hospira, Inc.

INN (Alþjóðlegt nafn):

CARBOPLATIN

Samsetning:

CARBOPLATIN 10 mg in 1 mL

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 Injection 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 prev

Vörulýsing:

Carboplatin Injection 10 mg/mL sterile solution is available in the following presentations: NDC 61703-339-18 Carton containing 1 multiple-dose vial (Blue flip-off seals) 50 mg/5 mL (10 mg/mL) NDC 61703-339-22 Carton containing 1 multiple-dose vial (Blue flip-off seals) 150 mg/15 mL (10 mg/mL) NDC 61703-339-50 Carton containing 1 multiple-dose vial (Blue flip-off seals) 450 mg/45 mL (10 mg/mL) NDC 61703-339-56 Carton containing 1 multiple-dose vial (Blue flip-off seals) 600 mg/60 mL (10 mg/mL) 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 multiple-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.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

CARBOPLATIN- CARBOPLATIN INJECTION, SOLUTION
HOSPIRA, INC.
----------
CARBOPLATIN INJECTION
R 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 Injection 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, aqueous
solution available in
50 mg/5 mL, 150 mg/15 mL, 450 mg/45 mL or 600 mg/60 mL multiple-dose
vials
containing 10 mg/mL of carboplatin for administration by intravenous
infusion. Each mL
contains 10 mg carboplatin and Water for Injection, USP.
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:
X
Carboplatin is a crystalline powder with the molecular formula of C H
N 0 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.
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