Oxaliplatin 5mg/ml concentrate for solution for infusion concentrate for solution for infusion

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

oxaliplatin

זמין מ:

SEACROSS PHARMACEUTICALS LIMITED

קוד ATC:

L01XA03

INN (שם בינלאומי):

oxaliplatin

כמות:

5mg/ml

טופס פרצבטיות:

concentrate for solution for infusion

יחידות באריזה:

20ml glass vial

סוג מרשם:

Prescription

מצב אישור:

Registered

תאריך אישור:

2022-06-22

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Oxaliplatin 5mg/ml concentrate for solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml concentrate for solution for infusion contains 5mg oxaliplatin
10ml of concentrate for solution for infusion contains 50mg of
oxaliplatin
20ml of concentrate for solution for infusion contains 100mg of
oxaliplatin
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless liquid, pH = 4.5 – 6.5.
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 (Dukes C) colon cancer after complete
resection of primary tumour.
•
Treatment of metastatic colorectal cancer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
FOR ADULTS ONLY
The recommended dose for oxaliplatin in adjuvant setting is 85 mg/m²
intravenously repeated every two weeks for 12 cycles (6 months).
The recommended dose for oxaliplatin in treatment of metastatic
colorectal
cancer is 85mg/m² intravenously repeated every 2 weeks until disease
progression or unacceptable toxicity.
Dosage given should be adjusted according to tolerability (see section
4.4).
OXALIPLATIN SHOULD ALWAYS BE ADMINISTERED BEFORE FLUOROPYRIMIDINES –
I.E.
5-FLUOROURACIL.
Oxaliplatin is administered as a 2- to 6-hour intravenous infusion in
250 to
500 ml of 5% glucose solution to give a concentration between 0.2
mg/ml and
0.70 mg/ml; 0.70 mg/ml is the highest concentration in clinical
practice for an
oxaliplatin dose of 85 mg/m².
Oxaliplatin was mainly used in combination with continuous infusion 5-
fluorouracil based regimens. For the two-weekly treatment schedule 5-
fluorouracil regimens combining bolus and continuous infusion were
used.
_Special Populations _
_ _
•
_Renal impairment: _
Oxaliplatin must not be administered in patients with severe renal
impairment
(see sections 4.3 and 5.2). In patients with mild to moderate