PLATINOX-V

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Bahan aktif:

OXALIPLATIN

Boleh didapati daripada:

VITAMED PHARMACEUTICAL INDUSTRIES LTD

Kod ATC:

L01XA03

Borang farmaseutikal:

CONCENTRATE FOR SOLUTION FOR INFUSION

Komposisi:

OXALIPLATIN 5 MG / 1 ML

Laluan pentadbiran:

I.V

Jenis preskripsi:

Required

Dikeluarkan oleh:

GENEPHARM S.A., GREECE

Kawasan terapeutik:

OXALIPLATIN

Tanda-tanda terapeutik:

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).

Tarikh kebenaran:

2018-11-05

Ciri produk

This leaflet format has been determined by the Ministry of Health and
the content thereof has been
checked and approved
in
NOVEMBER 2018
1. NAME OF THE MEDICINAL PRODUCT
PLATINOX-V
concentrate for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml concentrate for solution for infusion contains 5 mg oxaliplatin.
For excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless solution.
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 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 to
6
months.
Dosage given should be adjusted according to tolerability (see section
4.4).
OXALIPLATIN SHOULD ALWAYS BE ADMINISTERED BEFORE FLUOROPYRIMIDINES –
I.E. 5-FLUOROURACI