OXALIPLATIN MYLAN 100 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

OXALIPLATIN

متاح من:

GENMEDIX , ISRAEL

ATC رمز:

L01XA03

الشكل الصيدلاني:

POWDER FOR SOLUTION FOR INFUSION

تركيب:

OXALIPLATIN 5 MG/ML

طريقة التعاطي:

I.V

نوع الوصفة الطبية :

Required

المصنعة من قبل:

MYLAN S.A.S., FRANCE

المجال العلاجي:

OXALIPLATIN

الخصائص العلاجية:

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 tumour. • Treatment of metastatic colorectal cancer. Oxaliplatin in combination with leucovorin, irinotecan and 5-fluorouracil is indicated for the first line treatment of patients with metastatic pancreatic adenocarcinoma (based on NCCN guidelines, version 2.2014).

تاريخ الترخيص:

2018-11-30

خصائص المنتج

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OXALIPLATIN MYLAN 50 MG
OXALIPLATIN MYLAN 100 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with powder for solution for infusion contains 50 mg or 100
mg oxaliplatin. One ml of
reconstituted concentrate solution contains 5 mg oxaliplatin.
50 mg vial : Each vial contains 50 mg oxaliplatin for reconstitution
in 10 ml of solvent .
100 mg vial : Each vial contains 100 mg oxaliplatin for reconstitution
in 20 ml of solvent.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for IV
infusion
White lyophilised powder.
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 tumour
•
Treatment of metastatic colorectal cancer.
Oxaliplatin in combination with leucovorin, irinotecan and
5-fluorouracil is indicated for the first-line
treatment of patients with metastatic pancreatic adenocarcinoma (based
on NCCN guidelines, version
2.2014).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
FOR ADULTS ONLY
The recommended dose for oxaliplatin in adjuvant setting is 85 mg/m
2
intravenously, repeated every two
weeks for 12 cycles (6 months).
The recommended dose for oxaliplatin in treatment of metastatic
colorectal cancer is 85 mg/m
2
intravenously,
repeated every 2 weeks until disease progression or unacceptable
toxicity.
The recommended dose of oxaliplatin for the treatment of metastatic
pancreatic adenocarcinoma is 85 mg/m
2
given as a 2-hour intravenous infusion, immediately followed by
leucovorin (400 mg/m
2
, 2-hour intravenous
2
infusion) with the addition after 30 minutes of irinotecan (180 mg/m
2
, 90-minute intravenous infusion
through a Y-connector) and immediately followed by 5-fluorouracil (400
mg/m
2
intravenous bolus followed
by 2,400 mg/m
2
continuous intravenous infusion for 46 hours), in 2-week cycles up t