Extraneal Clear-Flex Solution for peritoneal dialysis

国: イギリス

言語: 英語

ソース: myHealthbox

有効成分:

Icodextrin

から入手可能:

Baxter Healthcare Limited

ATCコード:

B05DA

INN（国際名）:

Icodextrin

投薬量:

7.5% w/v

医薬品形態:

Solution for peritoneal dialysis

投与経路:

intraperitoneal administration

パッケージ内のユニット:

1, 3, 4, 5, 6 unit box

処方タイプ:

POM - Prescription Only Medicine

製:

Baxter Healthcare S.A

治療群:

Peritoneal dialytics, Isotonic solutions

適応症:

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.

認証ステータス:

Authorised

承認日:

2015-05-15

情報リーフレット

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 any of the side effects gets
serious, or if you notice any side effects not listed in this
leaflet, 
please tell your doctor or nurse. 

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 ABOUT 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
or any of the other ingredients of 
EXTRA

製品の特徴

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. 

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 
      0.257 
g/l 
Magnesium 
chloride 
      0.051 
g/l 

Theoretical osmolarity 284 (milliosmoles per litre) 
Theoretical osmolality 301 (milliosmoles per kg) 

Contents per 1000 ml electrolyte solution: 

Sodium   133 
mmol/l 
Calcium   1.75 
mmol/l 
Magnesium  
0.25 
mmol/l 
Chloride   96 
mmol/l 
Lactate  
40  mmol/l 

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 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. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Posology: 
Extraneal Clear-Flex is recommended for use during the longest dwell
period, 
i.e. in CAPD usually overnight and 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