Extraneal (Icodextrin 7.5%) Solution for peritoneal dialysis

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE ANHYDROUS; SODIUM CHLORIDE; SODIUM LACTATE

Verfügbar ab:

Baxter Healthcare Limited

ATC-Code:

B05DA

INN (Internationale Bezeichnung):

CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE ANHYDROUS; SODIUM CHLORIDE; SODIUM LACTATE

Darreichungsform:

SOLUTION FOR PERITONEAL DIALYSIS

Zusammensetzung:

CALCIUM CHLORIDE 96 mmol/l; ICODEXTRIN 7.5 % (W/V); MAGNESIUM CHLORIDE ANHYDROUS 40 mmol/l; SODIUM CHLORIDE 1.75 mmol/l; SODIUM LACTATE 0.25 mmol/l

Verschreibungstyp:

POM

Therapiebereich:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2005-12-29

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
EXTRANEAL SOLUTION FOR PERITONEAL DIALYSIS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor.

If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4. .
WHAT IS IN THIS LEAFLET:
1.
What EXTRANEAL is and what it is used for
2.
What you need to know before you use EXTRANEAL
3.
How to use EXTRANEAL
4.
Possible side effects
5.
How to store EXTRANEAL
6.
Contents of the pack and other information
1.
WHAT EXTRANEAL IS AND WHAT IT IS USED FOR
EXTRANEAL 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 solution
is placed into the peritoneal cavity where it removes water and waste
products from the blood. It
also corrects abnormal levels of different blood components.
EXTRANEAL 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
Your doctor must supervise you the first time you use this product.
DO NOT USE EXTRANEAL

if you are allergic to icodextrin or starch derivatives (e.g. maize
starch) or any of the other
ingredients of EXTRANEAL

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 affecting your
abdominal wall or cavity
or uncorrectable problem that increases risk of abdominal infections

if you have documented loss of peritoneal function due to severe
peritoneal scarring
WARNIN

Fachinformation

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
EXTRANEAL (Icodextrin 7.5%)
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
g/L
Sodium Chloride
5.4
g/L
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)
Electrolyte solution content per
1000ml:
Sodium
133
mmol/L
Calcium
1.75
mmol/L
Magnesium
0.25
mmol/L
Chloride
96
mmol/L
Lactate
40
mmol/L
pH = 5 to 6
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for peritoneal dialysis.
Extraneal is a sterile, clear, colorless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Extraneal 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 is recommended for use during the longest dwell period, i.e.
in CAPD usually
Page 2 of 11
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 exchange in each
24 hour-period, as part
of a CAPD or 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