CARBOPLATIN injection, solution

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Ingenus Pharmaceuticals, LLC

INN (Միջազգային անվանումը):

CARBOPLATIN

Կազմը:

CARBOPLATIN 50 mg in 5 mL

Կառավարման երթուղին:

INTRAVENOUS

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 patient

Ապրանքի ամփոփագիր:

Each mL of carboplatin injection, USP contains 10 mg of carboplatin, USP in water for injection and is available as follows:

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

CARBOPLATIN- CARBOPLATIN INJECTION, SOLUTION
INGENUS PHARMACEUTICALS, LLC
----------
CARBOPLATIN INJECTION, USP
RX ONLY
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 injection administration. Epinephrine,
corticosteroids, and
antihistamines have been employed to alleviate symptoms.
DESCRIPTION
Carboplatin injection, USP is supplied as a sterile, pyrogen-free, 10
mg/mL aqueous
solution of carboplatin, 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 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 equal numbers of drug -DNA
cross-links, causing
equivalent lesions and biological effects. The differences in
potencies for carboplatin and
cisplatin appear to be directly related to the difference in aquation
rates.
In patien