Irinotecan HCl-3-water CF 20 mg/ml concentraat voor oplossing voor infusie

देश: नीदरलैंड

भाषा: डच

स्रोत: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

सक्रिय संघटक:

IRINOTECANHYDROCHLORIDE 3-WATER SAMENSTELLING overeenkomend met ; IRINOTECAN

थमां उपलब्ध:

Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR

ए.टी.सी कोड:

L01XX19

INN (इंटरनेशनल नाम):

IRINOTECANHYDROCHLORIDE 3-WATER COMPOSITION corresponding to ; IRINOTECAN

फार्मास्यूटिकल फॉर्म:

Concentraat voor oplossing voor infusie

रचना:

MELKZUUR (D,L,+- VORM) (E 270) ; NATRIUMHYDROXIDE (E 524) ; SORBITOL (D-)(E 420) ; WATER VOOR INJECTIE,

प्रशासन का मार्ग:

Intraveneus gebruik

चिकित्सीय क्षेत्र:

Irinotecan

उत्पाद समीक्षा:

Hulpstoffen: MELKZUUR (D,L,+- VORM) (E 270); NATRIUMHYDROXIDE (E 524); SORBITOL (D-)(E 420); WATER VOOR INJECTIE;

प्राधिकरण की तारीख:

2009-10-07

सूचना पत्रक

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
IRINOTECAN HCL-3-WATER CF 20 MG/ML, CONCENTRAAT VOOR OPLOSSING VOOR
INFUSIE
Irinotecan hydrochloride trihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Irinotecan HCl-3-water CF is and what it is used for
2.
What you need to know before you use Irinotecan HCl-3-water CF
3.
How to use Irinotecan HCl-3-water CF
4.
Possible side effects
5.
How to store Irinotecan HCl-3-water CF
6.
Contents of the pack and other information
1.
WHAT IRINOTECAN HCL-3-WATER CF IS AND WHAT IT IS USED FOR
Irinotecan belongs to a group of medicines called cytostatics
(anti-cancer medicines).
Irinotecan is used for the treatment of advanced cancer of the colon
and rectum in adults, either in a
combination with other medicines or alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IRINOTECAN HCL-3-WATER CF
DO NOT USE IRINOTECAN HCL-3-WATER CF IF YOU

are allergic to irinotecan hydrochloride trihydrate or any of the
other ingredients of this medicine
(listed in section 6),

have any other bowel disease or a history of bowel obstruction,

are breast feeding,

have increased levels of bilirubin in the blood (more than 3 times the
upper limit of normal),

have severe bone marrow failure,

have a poor general health (evaluated by an international standard),

are using the natural remedy St John’s Wort (Hypericum perforatum).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using any medicine.
This medicine is intended for adults only. Check wit

उत्पाद विशेषताएं

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Irinotecan HCl-3-water CF 20 mg/ml concentraat voor oplossing voor
infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate contains 20 mg irinotecan hydrochloride
trihydrate equivalent to 17.33
mg/ml irinotecan.
Each vial with 2 ml concentrate contains 40 mg of irinotecan
hydrochloride trihydrate.
Each vial with 5 ml concentrate contains 100 mg of irinotecan
hydrochloride trihydrate.
Each vial with 15 ml concentrate contains 300 mg of irinotecan
hydrochloride trihydrate.
Each vial with 25 ml concentrate contains 500 mg of irinotecan
hydrochloride trihydrate.
Excipients with known effect:
Sorbitol E420
Vials with 2 ml concentrate contain 90 mg of sorbitol.
Vials with 5 ml concentrate contain 225 mg of sorbitol.
Vials with 15 ml concentrate contain 675 mg of sorbitol.
Vials with 25 ml concentrate contain 1125 mg of sorbitol.
Sodium hydroxide E 524
Vials with 2 ml concentrate contain 0.4 mg of sodium hydroxide.
Vials with 5 ml concentrate contain 1.0 mg of sodium hydroxide.
Vials with 15 ml concentrate contain 3 mg of sodium hydroxide.
Vials with 25 ml concentrate contain 5 mg of sodium hydroxide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear colourless to pale yellow solution.
pH 3.2 – 3.8
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Irinotecan HCl-3-water CF is indicated for the treatment of patients
with advanced colorectal
cancer:

in combination with 5-fluorouracil and folinic acid in patients
without prior chemotherapy for
advanced disease,

as a single agent in patients who have failed an established
5-fluorouracil containing treatment
regimen.

Irinotecan in combination with cetuximab is indicated for the
treatment of patients with epidermal
growth factor receptor (EGFR)-expressing metastatic colorectal cancer
after failure of irinotecan-
including cytotoxic therapy.
Irinotecan in combination with 5-fluorouracil, folinic acid and
b