OXALIPLATIN TEVA

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

OXALIPLATIN

Beschikbaar vanaf:

ABIC MARKETING LTD, ISRAEL

ATC-code:

L01XA03

farmaceutische vorm:

CONCENTRATE FOR SOLUTION FOR INFUSION

Samenstelling:

OXALIPLATIN 5 MG/ML

Toedieningsweg:

I.V

Prescription-type:

Required

Geproduceerd door:

PHARMACHEMIE BV, HOLLAND (TEVA GROUP)

Therapeutische categorie:

OXALIPLATIN

Therapeutisch gebied:

OXALIPLATIN

therapeutische indicaties:

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 the 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 NCCNguidelines, version 2.2014).

Autorisatie datum:

2014-11-30

Bijsluiter

_ _
_ :ךיראת_
_רבמבונ_
_ _
_2019_
_ _ ה/דבכנ ת/חקור ,ה/אפור העידומ עבט תרבח
ןולעב םיאבה םינוכדעה לע
אפורל
רישכתה לש
_ _
ןיטלפילסקוא
עבט ,
זיכרת
תנכהל
הסימת
היזופניאל
OXALIPLATIN TEVA,
CONCENTRATE FOR SOLUTION FOR INFUSION
CONTAINS: OXALIPLATIN 5 MG/ML
ל ןולעב םינוכדע
אפור
------------------------------------------------------------------------------------------------------------ :םושירה תדועתב הרשואש יפכ היוותה
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 the 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 NCCNguidelines, version
2.2014). ןולעהש עידוהל וננוצרב אפורל
( דבלב םיירקיעה םינוכדעה םילולכ ןלהלש
טוריפב ,ןכדוע תופסות תונמוסמ
םודאב
)קוחמ טסקטכ עדימ תורסהו :)
POSOLOGY
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).
SPE

Productkenmerken

Oxaliplatin Teva EM Notification 09/2023
SUMMARY OF PRODUCT CHARACTERISTICS
Oxaliplatin Teva
Concentrate for solution for infusion
1.
NAME OF THE MEDICINAL PRODUCT
Oxaliplatin Teva
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for solution for infusion contains 5 mg
oxaliplatin.
4 ml of concentrate for solution for infusion contain 20 mg
oxaliplatin.
10 ml of concentrate for solution for infusion contain 50 mg
oxaliplatin.
20 ml of concentrate for solution for infusion contain 100 mg
oxaliplatin.
40 ml of concentrate for solution for infusion contain 200 mg
oxaliplatin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to 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 the 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).
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 imme