OXALIPLATIN injection, solution OXALIPLATIN injection, solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Qilu Pharmaceutical Co., Ltd.

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Oxaliplatin Injection USP, 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 injection 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

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, 100 mg or 200 mg of oxaliplatin as a clear, colorless, sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL.  NDC 67184-0508-1: 50 mg/10 mL single-dose vial with flip-off seal individually packaged in a carton. NDC 67184-0509-1: 100 mg/20 mL single-dose vial with flip-off seal individually packaged in a carton. NDC 67184-0510-1: 200 mg/40 mL single-dose vial with flip-off seal individually packaged in a carton. Store at 25°C (77°F); excursions permitted between 15 to 30°C (59 to 86°F) [See USP controlled Room temperature]. Do not freeze and protect from light (keep in original outer carton). Discard unused portion. Oxaliplatin Injection USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 The use of gloves is recommended. If a solution of Oxaliplatin Injection USP contacts the skin, wash the skin immediately and thoroughly with soap and water. If Oxaliplatin Injection USP contacts the mucous membranes, flush thoroughly with water.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

OXALIPLATIN- OXALIPLATIN INJECTION, SOLUTION
QILU PHARMACEUTICAL CO., LTD.
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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 USP 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), 100 mg (5 mg/mL) or 200 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 an