CARBOPLATIN injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Accord Healthcare, Inc.

INN (Kansainvälinen yleisnimi):

CARBOPLATIN

Koostumus:

CARBOPLATIN 10 mg in 1 mL

Antoreitti:

INTRACAVERNOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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. Carboplatin injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been

Tuoteyhteenveto:

Each mL of carboplatin injection contains 10 mg of carboplatin, USP in water for injection and is available in individual cartons as follows: Unopened vials of carboplatin injection are stable to the date indicated on the package when stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Carboplatin injection multidose 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. Caution  should be exercised in handling and preparing carboplatin injection. Several guidelines on this subject have been published. 1-4 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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

CARBOPLATIN- CARBOPLATIN INJECTION
ACCORD HEALTHCARE, INC.
----------
CARBOPLATIN INJECTION
RXONLY
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 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:
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 patients with creatinine clearances of about 60 mL/min o