Oxaliplatin-Teva

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv bestanddel:

oxaliplatin

Tilgængelig fra:

Teva Pharmaceutical Works Private Limited Company

INN (International Name):

oxaliplatin

Dosering:

5mg/ml

Lægemiddelform:

concentrate for solution for infusion

Recept type:

Prescription

Produktets egenskaber

TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY
OXALIPLATIN - TEVA, 5 MG/ML,
CONCENTRATE FOR SOLUTION FOR INFUSION
Version:
0028
September 2012
Replaces:
0027
July 2012
MODULE 1
ADMINISTRATIVE INFORMATION AND
PRESCRIBING INFORMATION
Page: 1
1.3.1
SUMMARY OF PRODUCT CHARACTERISTICS IN ENGLISH
1.3.1
SUMMARY OF PRODUCT CHARACTERISTICS IN ENGLISH
1.
NAME OF THE MEDICINAL PRODUCT
Oxaliplatin - Teva 5 mg/ml, concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for solution for infusion contains 5 mg
oxaliplatin.
10 ml of concentrate for solution for infusion contains 50 mg of
oxaliplatin.
20 ml of concentrate for solution for infusion contains 100 mg of
oxaliplatin.
Excipient: lactose monohydrate.
1 ml of concentrate for solution for infusion contains 45 mg of
lactose monohydrate.
10 ml of concentrate for solution for infusion contains 450 mg of
lactose monohydrate.
20 ml of concentrate for solution for infusion contains 900 mg of
lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless or almost colourless solution.
pH: 4.0 – 6.0
Osmolarity: 0.200 osmol/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oxaliplatin in combination with 5-fluorouracil (5-FU) and folinic acid
(FA) is indicated for:
-
Adjuvant treatment of stage III (Duke’s C) colon cancer after
complete resection of
primary tumor.
-
Treatment of metastatic colorectal cancer.
TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY
OXALIPLATIN - TEVA, 5 MG/ML,
CONCENTRATE FOR SOLUTION FOR INFUSION
Version:
0028
September 2012
Replaces:
0027
July 2012
MODULE 1
ADMINISTRATIVE INFORMATION AND
PRESCRIBING INFORMATION
Page: 2
1.3.1
SUMMARY OF PRODUCT CHARACTERISTICS IN ENGLISH
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The preparation of injectable solutions of cytotoxic agents must be
carried out by trained
specialist personnel with knowledge of the medicinal product used, in
conditions that
guarantee the integrity of