Extraneal Clear Flex Solution for peritoneal dialysis

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

ICODEXTRIN

Dostupné z:

Baxter Healthcare Limited Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom

ATC kód:

B05DA

INN (Medzinárodný Name):

ICODEXTRIN 7.5 % (W/V)

Forma lieku:

SOLUTION FOR PERITONEAL DIALYSIS

Zloženie:

ICODEXTRIN 7.5 % (W/V)

Typ predpisu:

POM

Terapeutické oblasti:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2015-07-23

Príbalový leták

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 ingredients of EXTRANEAL CLEAR-FLEX.

if you are intolerant to maltose or isomaltose (sugar coming from
starch).

if you have glycogen storage disease.

if you already have severe lactic acidosis (too much acid in the
blood).

if you have a surgically uncorrectable problem affe

Súhrn charakteristických

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 dihydrate
0.257 g/l
Magnesium chloride hexahydrate
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 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
Page 2 of 12
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.
The volume to be instilled should be given over a period of
approximately 10 to 20 minutes at a
rate, which the patient finds comfortable. For adult patients of
normal body size the instilled
volume should not exceed 2.0 L. For larger patients (more than 70-75
kg), a fill volume of 2.5 L
may be used.
If the instilled volume causes