OXALIPLATIN MEDAC 150 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

OXALIPLATIN

Available from:

TZAMAL BIO-PHARMA LTD

ATC code:

L01XA03

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION

Composition:

OXALIPLATIN 150 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY

Therapeutic group:

OXALIPLATIN

Therapeutic area:

OXALIPLATIN

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. 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).

Authorization date:

2012-10-31

Patient Information leaflet

וי
ל
י
2019
ה/דבכנ ת/חקור ,ה/אפור
,
:ןודנה
mg
50
medac
Oxaliplatin
-
ןיטלפילסקוא
קאדמ
50
ג"מ
00 mg
1
medac
Oxaliplatin
-
ןיטלפילסקוא
קאדמ
00
1
ג"מ
mg
0
5
1
medac
Oxaliplatin
-
ןיטלפילסקוא
קאדמ
0
15
ג"מ
ליעפ ביכרמ
:
Oxaliplatin medac 50 mg: 50 mg Oxaliplatin
Oxaliplatin medac 100 mg: 100 mg Oxaliplatin
Oxaliplatin medac 150 mg: 150 mg Oxaliplatin
ןונימ תרוצ
:
Powder For Solution For Infusion
תויוותה
תורשואמ
:
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.
Oxaliplatin in combination with leucovorin, irinotecan and
5-fluorouracil is indicated
for the firstline treatment of patients with metastatic pancreatic
adenocarcinoma
(based on NCCN guidelines, version 2.2014).
תרבח
מצ
ויב ל
-
המראפ
מ"עב
תשקבמ
עידוהל
םכ
לע
ה
םינוכדע
םיאבה
ןולעב
אפורל
ה לש
רישכת
.
רוקמה רישכת ןולע לש ונושלכ ץומיא
תובקעב
Eloxatin
ןפוא ןונימה ףיעסו תויוותהה ףיעס ןכדוע
ןתמה
ו רישכתה לש
ופסונ
.תורמחה
תועצמאב תנמוסמ הרמחהה
תחת וק
י
ש ,
ועמשמ
תפסות איה ות
הל רושקה עדימ
הרמח
.
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 oxa

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OXALIPLATIN MEDAC 50 MG
OXALIPLATIN MEDAC 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 infusion
White to off-white 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.
2
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