CARBOPLATIN injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

carboplatin (UNII: BG3F62OND5) (carboplatin - UNII:BG3F62OND5)

제공처:

Meitheal Pharmaceuticals Inc.

INN (국제 이름):

carboplatin

구성:

carboplatin 10 mg in 1 mL

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 previously trea

제품 요약:

Carboplatin Injection is supplied as follows: Store the unopened vials of Carboplatin Injection at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 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 20° to 25°C (68° to 77°F) following multiple needle entries. Solutions for infusion should be discarded 8 hours after preparation. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. 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 or solutions containing Carboplatin Injection contact the skin, immediately wash the skin thoroughly with soap and water. If Carboplatin Injection or solutions containing Carboplatin Injection contact mucous membranes, the membranes should be flushed immediately and thoroughly with water. More information is available in the references listed below.

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

CARBOPLATIN- CARBOPLATIN INJECTION, SOLUTION
Meitheal Pharmaceuticals Inc.
----------
PATIENT INFORMATION
CARBOPLATIN INJECTION
Rx only
Read this entire leaflet carefully. Keep it for future reference.
This information will help you learn more about carboplatin injection.
It cannot, however, cover all the
possible warnings or side effects relating to carboplatin, and it does
not list all of the benefits and risks of
carboplatin. Your doctor should always be your first choice for
detailed information about your medical
condition and your treatment. Be sure to ask your doctor about any
questions you may have.
What is cancer?
Under normal conditions, the cells in your body divide and grow in an
orderly, controlled fashion. Cell
division and growth are necessary for the human body to perform its
functions and to repair itself. Cancer
cells are different from normal cells because they are not able to
control their own growth. The reasons for
this abnormal growth are not yet fully understood.
A tumor is a mass of unhealthy cells that are dividing and growing
fast and in an uncontrolled way. When a
tumor invades surrounding healthy body tissue it is known as a
malignant tumor. A malignant tumor can
spread (metastasize) from its original location to other parts of the
body.
What is carboplatin injection?
Carboplatin injection is a medicine that is used to treat cancer of
the ovaries. It acts by interfering with the
division of rapidly multiplying cells, particularly cancer cells.
Who should not take carboplatin injection?
Treatment with carboplatin injection is not recommended if you:
•
are allergic to carboplatin injection or other platinum-containing
products, or to mannitol;
•
have a weakened blood-forming system (bone marrow depression) or
significant bleeding;
•
are pregnant, intend to become pregnant, or are breast-feeding a baby.
How is carboplatin injection used?
Only a professional experienced in the use of cancer drugs should give
you this medication. Carboplatin
injection is given by dripping the medicin

제품 특성 요약

CARBOPLATIN- CARBOPLATIN INJECTION, SOLUTION
MEITHEAL PHARMACEUTICALS INC.
----------
CARBOPLATIN INJECTION
(CARBOPLATIN AQUEOUS SOLUTION)
meitheal™
Rx 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 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, nonpyrogenic, 10 mg/mL
aqueous solution
of carboplatin.
Carboplatin is a platinum coordination compound that is used as a
cancer
chemotherapeutic agent. The chemical name for carboplatin is platinum,
diammine[1,1-
cyclobutanedicarboxylato(2-)-_O_,_O_']-, (_SP_-4-2), and 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.
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
6
12
2
4
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-