OXALIPLATIN injection

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

OXALIPLATIN (UNII: 04ZR38536J) (OXALIPLATIN - UNII:04ZR38536J)

Saadav alates:

Cipla USA Inc.

INN (Rahvusvaheline Nimetus):

OXALIPLATIN

Koostis:

OXALIPLATIN 5 mg in 1 mL

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Oxaliplatin injection, in combination with infusional fluorouracil and leucovorin, is indicated for: -   adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. -   treatment of advanced colorectal cancer. Oxaliplatin injection is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. Reactions have included anaphylaxis [see Warnings and Precautions (5.1)] . Risk Summary Based on its direct interaction with DNA, oxaliplatin can cause fetal harm when administered to a pregnant woman. The available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of oxaliplatin injection. Reproductive toxicity studies demonstrated adverse effects on embryo-fetal development in rats at maternal doses that were below the recommended human dose based on body surface area (see Data) . Advise a pregnant woman of the potential risk to a fetus. In the

Toote kokkuvõte:

Oxaliplatin injection, USP is supplied in clear, glass, single-dose vials with gray elastomeric stoppers and aluminum flip-off seals containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL. Water for Injection, USP is present as an inactive ingredient. NDC 69097-274-37: 50 mg single-dose vial with green flip-off seal individually packaged in a carton. NDC 69097-353-78: 100 mg single-dose vial with dark blue flip-off seal individually packaged in a carton. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze and protect from light (keep in original outer carton). Discard unused portion. Oxaliplatin injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 The use of gloves is recommended. If a solution of oxaliplatin contacts the skin, wash the skin immediately and thoroughly with soap and water. If oxaliplatin contacts the mucous membranes, flush thoroughly with water.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

OXALIPLATIN- OXALIPLATIN INJECTION
CIPLA USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXALIPLATIN INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXALIPLATIN
INJECTION.
OXALIPLATIN INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2002
WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
SERIOUS AND FATAL HYPERSENSITIVITY ADVERSE REACTIONS, INCLUDING
ANAPHYLAXIS, CAN OCCUR WITH OXALIPLATIN
INJECTION WITHIN MINUTES OF ADMINISTRATION AND DURING ANY CYCLE.
OXALIPLATIN INJECTION IS CONTRAINDICATED
IN PATIENTS WITH HYPERSENSITIVITY REACTIONS TO OXALIPLATIN AND OTHER
PLATINUM-BASED DRUGS. IMMEDIATELY
AND PERMANENTLY DISCONTINUE OXALIPLATIN INJECTION FOR HYPERSENSITIVITY
REACTIONS AND ADMINISTER
APPROPRIATE TREATMENT. (4, 5.1)
INDICATIONS AND USAGE
Oxaliplatin injection is a platinum-based drug used in combination
with infusional fluorouracil and leucovorin, which is
indicated for:
adjuvant treatment of stage III colon cancer in patients who have
undergone complete resection of the primary tumor.
(1)
treatment of advanced colorectal cancer. (1)
DOSAGE AND ADMINISTRATION
Administer Oxaliplatin injection 85 mg/m as an intravenous infusion
over 120 minutes concurrently with leucovorin
over 120 minutes in separate bags, followed by fluorouracil on Day 1
of each 14-day cycle. Administer fluorouracil and
leucovorin on Day 2 as recommended. (2.1)
Adjuvant Treatment: Continue treatment for up to 12 cycles or
unacceptable toxicity. (2.1)
Advanced Colorectal Cancer : Continue treatment until disease
progression or unacceptable toxicity. (2.1)
DOSAGE FORMS AND STRENGTHS
Injection: 50 mg (5 mg/mL) or 100 mg (5 mg/mL) in a single-dose vial
(3)
CONTRAINDICATIONS
History of hypersensitivity reaction to oxaliplatin or other
platinum-based drugs. (4, 5.1)
WARNINGS AND PRECAUTIONS
Peripheral Sensory Neuropathy : Acute and delayed neuropathy can
occur. Avoid topical