EXTRANEAL CLEAR-FLEX Per Cent Soln for Peritoneal Dialysis

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

ICODEXTRIN, SODIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE, MAGNESIUM CHLORIDE HEXAHYDRATE, SODIUM (S)-LACTATE SOLUTION

Saadav alates:

Baxter Healthcare Limited

ATC kood:

B05DA

INN (Rahvusvaheline Nimetus):

ICODEXTRIN, SODIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE, MAGNESIUM CHLORIDE HEXAHYDRATE, SODIUM (S)-LACTATE SOLUTION

Annus:

Per Cent

Ravimvorm:

Soln for Peritoneal Dialysis

Manustamisviis:

Intraperitoneal administration

Ühikuid pakis:

bag sizes 1500 ml, 2000 ml and 2500 ml; supplied as single bag or twin bag with a PVC or polypropylene transfer Y-line

Retsepti tüüp:

Product subject to prescription which may not be renewed (A)

Valmistatud:

Baxter Healthcare S.A

Terapeutiline rühm:

Peritoneal dialytics, Isotonic solutions

Terapeutiline ala:

Isotonic solutions

Näidustused:

It is recommended as a once daily replacement for a single glucose exchange as part of a continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) regimen for the treatment of chronic renal failure, particularly for patients who have lost ultrafiltration on glucose solutions, because it can extend time on CAPD therapy in such patients.

Volitamisolek:

Authorised

Loa andmise kuupäev:

2015-05-29

Infovoldik

 
1 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

EXTRANEAL CLEAR-FLEX SOLUTION FOR PERITONEAL DIALYSIS 

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 nurse.  
- 
If you get any side effects, talk to
your doctor or nurse. This includes
any possible side effects 
not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET: 
1. 
What EXTRANEAL CLEAR-FLEX is and what it is used for 
2. 
What you need to know before you use EXTRANEAL CLEAR-FLEX 
3. 
How to use EXTRANEAL CLEAR-FLEX 
4. 
Possible side effects 
5. 
How to store EXTRANEAL CLEAR-FLEX 
6. 
Contents of the pack and other information 

1. 
WHAT EXTRANEAL CLEAR-FLEX IS AND WHAT IT IS USED FOR 

EXTRANEAL CLEAR-FLEX is a solution for peritoneal dialysis. The
peritoneal cavity is the cavity 
in your abdomen (belly) between your skin and the peritoneum. The
peritoneum is the membrane 
surrounding your internal organs such as your intestines
and liver. The EXTRANEAL CLEAR-FLEX 
solution is placed into the peritoneal cavity where
it removes water and waste products from your 
blood. It also corrects abnormal levels of different blood
components.  

EXTRANEAL CLEAR-FLEX may be prescribed for you if: 
- 
you are an adult with permanent kidney failure
which needs peritoneal dialysis. 
- 
standard glucose peritoneal dialysis solutions
alone cannot remove sufficient water. 

2. 
WHAT YOU NEED TO KNOW BEFORE YOU USE EXTRANEAL CLEAR-FLEX 

Your doctor must supervise you the first time you use this
product. 

DO NOT USE EXTRANEAL CLEAR-FLEX 


if you are allergic to icodextrin, starch derivatives (e.g.
corn (maize) starch)  or any of the other 
ing

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Extraneal Clear
-Flex Solution for peritoneal dialysis
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
A sterile peritoneal dialysis fluid containing Icodextrin at a concentration of 7.5% w/v in an electrolyte solution.
Theoretical osmolarity 284 (milliosmoles per litre)
Theoretical osmolality 301 (milliosmoles per kg)
Contents per 1000 ml electrolyte solution:
pH = 5,0 to 6,0
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for peritoneal dialysis.
Extraneal Clear-Flex is a sterile, clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Extraneal Clear-Flex is recommended as a once daily replacement for a single glucose exchange as part of an
automated peritoneal dialysis (APD) regimen for the treatment of chronic renal failure, particularly for patients who
have lost ultrafiltration on glucose solutions, because it can extend time on APD therapy in such patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Extraneal Clear-Flex is recommended for use in APD for the long daytime dwell.
The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should
be initiated and supervised by the physician.
_Adults:_
By intraperitoneal administration limited to a single exchange in each 24 hour-period, as part of an APD regimen.
Icodextrin
75.0 g/l
Sodium chloride
5.4 g/l
Sodium (S)-lactate solution equivalent to sodium (S)-lactate
4.5 g/l
Calcium chloride dihydrate
0.257 g/l
Magnesium chloride hexahydrate
0.051 g/l
Sodium
133 mmol/l
Calcium
1.75 mmol/l
Magnesium
0.25 mmol/l
Chloride
96 mmol/l
Lactate
40 mmol/l
HEALTH PRODUCTS REGULATORY AUTHORITY
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