Oxitan Injection 5mgml

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

Oxaliplatin

זמין מ:

FRESENIUS KABI (SINGAPORE) PTE LTD

קוד ATC:

L01XA03

כמות:

5mg/ml

טופס פרצבטיות:

INJECTION

הרכב:

Oxaliplatin 5mg/ml

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

Prescription Only

תוצרת:

FRESENIUS KABI ONCOLOGY LIMITED

מצב אישור:

ACTIVE

תאריך אישור:

2012-09-20

מאפייני מוצר

1
NAME OF THE MEDICINAL PRODUCT
Oxitan 5 mg/ml Injection
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml injection contains 5 mg oxaliplatin.
10 ml of injection contains 50 mg of oxaliplatin
20 ml of injection contains 100 mg of oxaliplatin
40 ml of
injection contains 200 mg of oxaliplatin
For full list of excipients see, see section
_List of excipients_
_ _
PHARMACEUTICAL FORM
Injection.
Clear, colourless liquid
CLINICAL PARTICULARS
THERAPEUTIC INDICATION
s
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.
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 dose should be adjusted according to tolerability (see section
_Special warnings and precautions for use_
).
OXALIPLATIN SHOULD ALWAYS BE ADMINISTERED BEFORE FLUOROPYRIMIDINES –
I.E. 5-FLUOROURACIL (5-FU).
Oxaliplatin is administered as a 2-to 6-hour intravenous infusion in
250 to 500 ml of glucose 5% (50mg/ml)
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/m
2
.
Oxaliplatin has mainly been used in combination with continuous
infusion 5-fluorouracil (5-FU) based
regimens. For
the two-weekly treatment schedule 5-fluorouracil (5-FU) regimens
combining bolus and
continuous infusion were
used.
Special Populations
_Renal impairment_
Oxaliplatin
must
not
be
administered
in
patients
with
severe
renal
impairment
(see
section
_Contraindications _
and
_Pharmacokinetic properties_
). In patients with mild to moderate renal impairment,
t