OXALIPLATIN- oxaliplatin injection, solution

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Alvogen Inc.

INN (Միջազգային անվանումը):

oxaliplatin

Կազմը:

oxaliplatin 5 mg in 1 mL

Կառավարման երթուղին:

INTRAVENOUS

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Oxaliplatin Injection, USP used in combination with infusional 5-fluorouracil/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, USP should not be administered to patients with a history of known allergy to Oxaliplatin Injection, USP or other platinum compounds [see Warnings and Precautions (5.1)] . Pregnancy Category D Based on direct interaction with DNA, Oxaliplatin Injection, USP may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of Oxaliplatin Injection, USP in pregnant women. Reproductive toxicity studies in rats demonstrated adverse effects on fertility and embryo-fetal development at maternal doses that were below the recommended human dose based on body surface area. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should

Ապրանքի ամփոփագիր:

Oxaliplatin Injection, USP is supplied in clear, glass, single-use, moulded vials with dark grey colored bromobutyl omni flex plus coated rubber 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 47781-591-22: 50 mg single-dose vial with yellow flip-off seal individually packaged in a carton. NDC 47781-592-29: 100 mg single-dose vial with royal blue flip-off seal individually packaged in a carton. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Do not freeze. Protect from light (keep in outer carton). Discard unused portion. As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of infusion solutions prepared from Oxaliplatin Injection, USP. 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. Procedures for the handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published [see References (15)] . There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

OXALIPLATIN- OXALIPLATIN INJECTION, SOLUTION
ALVOGEN INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXALIPLATIN INJECTION, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXALIPLATIN
INJECTION, USP
OXALIPLATIN INJECTION, USP FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2002
WARNING: ANAPHYLACTIC REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ANAPHYLACTIC REACTIONS TO OXALIPLATIN INJECTION, USP HAVE BEEN
REPORTED, AND MAY OCCUR WITHIN MINUTES
OF OXALIPLATIN INJECTION, USP ADMINISTRATION. EPINEPHRINE,
CORTICOSTEROIDS, AND ANTIHISTAMINES HAVE BEEN
EMPLOYED TO ALLEVIATE SYMPTOMS. (5.1)
RECENT MAJOR CHANGES
Dosage and Administration (2.2)
10/2015
Warnings and Precautions (5.3, 5.4, 5.7, 5.8, 5.9)
10/2015
INDICATIONS AND USAGE
Oxaliplatin Injection, USP is a platinum-based drug used in
combination with infusional 5-fluorouracil/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, USP in combination with
5-fluorouracil/leucovorin every 2 weeks. (2.1):
-
-
Reduce the dose of Oxaliplatin Injection, USP to 75 mg/m (adjuvant
setting) or 65 mg/m (advanced colorectal cancer)
(2.2):
-
-
For patients with severe renal impairment (creatinine clearance <30
mL/min), the initial recommended dose is 65
mg/m . (2.2)
Discontinue Oxaliplatin Injection, USP if there are persistent Grade 3
neurosensory events. (2.2)
Never prepare a final dilution with a sodium chloride solution or
other chloride-containing solutions. (2.3)
DOSAGE FORMS AND STRENGTHS
Single-dose vials of 50 mg or 100 mg oxaliplatin as a sterile,
preservative-free, aqueous solution at a concentration of 5 mg
per mL. (3)
CONTRAINDICATIONS
Known allergy to Oxaliplatin Injection, USP or other platinum
compounds. (4, 5.1)
Day 1: Oxaliplatin Injection, USP 85 m