EXTRANEAL

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

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

متاح من:

BAXTER HEALTHCARE DISTRIBUTION LTD., ISRAEL

ATC رمز:

B05AA05

الشكل الصيدلاني:

SOLUTION FOR PERITONEAL DIALYSIS

تركيب:

ICODEXTRIN 75 G/L; MAGNESIUM CHLORIDE HEXAHYDRATE 0.051 G/L; CALCIUM CHLORIDE DIHYDRATE 0.257 G/L; SODIUM (S) - LACTATE 4.5 G/L; SODIUM CHLORIDE 5.4 G/L

طريقة التعاطي:

INTRA-PERITONEAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BAXTER HEALTHCARE S.A, IRELAND

المجموعة العلاجية:

DEXTRAN

المجال العلاجي:

DEXTRAN

الخصائص العلاجية:

Once daily replacement of a single glucose exchange as part of Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD) in the treatment of chronic renal failure.

تاريخ الترخيص:

2014-10-31

نشرة المعلومات

Patient leaflet in accordance with the Pharmacists’ Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Extraneal
®
Solution for peritoneal dialysis
Composition:
Each liter of solution contains:
icodextrin
75 g
sodium chloride
5.4 g
sodium (s) - lactate
4.5 g
calcium chloride dihydrate
0.257 g
magnesium chloride hexahydrate
0.051 g
Electrolytes in one liter:
sodium
133 mmol
calcium
1.75 mmol
magnesium
0.25 mmol
chloride
96 mmol
lactate
40 mmol
For information about inactive ingredients see section 6 ‘Additional
information’.
Read the entire leaflet carefully before you start using this
medicine. This
leaflet contains concise information about this medicine. If you have
any further
questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to
others. It may harm them, even if it seems to you that their illness
is similar to
yours.
This medicine is not intended for use in children and adolescents
(under 18
years of old).
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Extraneal is a solution for peritoneal dialysis, to be used once a day
in patients
with chronic kidney failure.
Extraneal solution is placed in the peritoneal cavity.
Extraneal solution makes it possible to remove excess water and waste
products
from the blood, and correct abnormal levels of substances that are
dissolved in
the blood.
Therapeutic group:
isotonic solutions for peritoneal dialysis.
2.
BEFORE USING THIS MEDICINE
You will need medical supervision the first time you use this product.
Do not use this medicine if:
•
you are sensitive (allergic) to icodextrin or starch derivatives or
any of the
other ingredients in Extraneal (see section 6).
•
you are intolerant to maltose or isomaltose (sugar coming from
starch).
•
you have glycogen storage disease.
•
you have severe lactic acidosis (too much acid in the blood).
•
you have a surgically uncorrectable problem affecting your abdominal
wall
or
cavity
or
an
uncorrectable
problem
that

خصائص المنتج

Physician leaflet in accordance with the Pharmacists’ Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Extraneal
®
Solution for peritoneal dialysis
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 (Dihydrate)
0.257
g/L
Magnesium Chloride (Hexahydrate)
0.051
g/L
Theoretical osmolarity: 284 (milliosmoles per litre)
Theoretical osmolality: 301 (milliosmoles per kg)
Electrolyte solution content per 1000 ml:
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 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