EXTRANEAL 7.5% w/v icodextrin peritoneal dialysis solution twin bag with drainage bag

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

icodextrin, Quantity: 75 g/L; sodium chloride, Quantity: 5.4 g/L; sodium lactate, Quantity: 4.5 g/L; calcium chloride dihydrate, Quantity: 257 mg/L; magnesium chloride hexahydrate, Quantity: 51 mg/L

Fáanlegur frá:

Vantive Pty Ltd

INN (Alþjóðlegt nafn):

calcium chloride dihydrate,Icodextrin,magnesium chloride hexahydrate,sodium chloride,sodium lactate

Lyfjaform:

Solution, dialysis

Samsetning:

Excipient Ingredients: water for injections; sodium hydroxide; hydrochloric acid

Stjórnsýsluleið:

Intraperitoneal

Einingar í pakka:

3000mL, 2000mL, 1500mL, 2500mL

Gerð lyfseðils:

Not scheduled. Not considered by committee

Ábendingar:

Indicated as "an alternative osmotic agent in dialysis solution for the long dwell exchange in patients treated with peritoneal dialysis."

Vörulýsing:

Visual Identification: EXTRANEAL IS PRESENTED INA FLEXABLE PVC CONTAINER. IT IS A CLEAR SOLUTION, FREE FROM VISIBLE PARTICULATES.; Container Type: Bag; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Leyfisstaða:

Licence status A

Leyfisdagur:

2002-10-29

Upplýsingar fylgiseðill

PRODUCT INFORMATION
CONSUMER MEDICINE INFORMATION
EXTRANEAL (ICODEXTRIN 7.5%)
BLOOD GLUCOSE MANAGEMENT WITH EXTRANEAL MUST BE DONE WITH A
GLUCOSE-SPECIFIC
METHOD TO AVOID INTERFERENCE RESULTING IN UNRECOGNISED HYPOGLYCEMIA.
IF NON-
SPECIFIC
GLUCOSE
TEST
METHODS
(GDH-PQQ)
ARE
USED,
LOSS
OF
CONSCIOUSNESS,
NEUROLOGICAL DAMAGE AND DEATH MAY OCCUR.
WHAT IS IN THIS LEAFLET
THIS LEAFLET ANSWERS SOME MORE COMMON QUESTIONS ABOUT EXTRANEAL. IT
DOES NOT
CONTAIN ALL OF THE AVAILABLE INFORMATION.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
Extraneal against the benefit they expect it will have for you.
It does not take the place of talking to your Doctor.
If you have any concerns about taking the medicine, ask your doctor or
Renal nurse.
Keep this leaflet with the medicine, as you may need to read it again.
WHAT EXTRANEAL IS USED FOR
Extraneal is used as a replacement for a single glucose exchange (e.g.
Dianeal product),
as part of a Continuous Ambulatory Peritoneal Dialysis (CAPD) or
Automated Peritoneal
Dialysis (APD) regimen for chronic renal failure.
BEFORE THE USE OF EXTRANEAL FORMULA
DO NOT USE EXTRANEAL IF:
You have a known allergy to any of the ingredients listed at the end
of this leaflet or to
starch.
You have a glycogen storage disease.
Additionally tell your Doctor if you have recently had surgery on your
stomach or if you
have any other stomach complaints.
PRECAUTIONS:
Blood glucose measurement must be done with a glucose-specific method
to prevent
maltose interference with test results. Since falsely elevated glucose
levels have been
observed with blood glucose monitoring devices and test strips that
use glucose
dehydrogenase pyrroloquinolinequinone (GDH PQQ)-based methods, GDH
PQQ-based
methods should not be used to measure glucose levels in patients
administered
EXTRANEAL.
Tell your doctor if you:
•
Have a condition that restricts normal nutrition (you do not eat well)
•
Have a lung or breathing problem
•
Have low potassium levels in your blood
•
Have high cal

Vara einkenni

EXTRANEAL Peritoneal Dialysis Solution
Version 1.2
1 of 17
AUSTRALIAN PRODUCT INFORMATION –
EXTRANEAL PERITONEAL DIALYSIS SOLUTIONS
(ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE,
CALCIUM CHLORIDE DIHYDRATE AND
MAGNESIUM CHLORIDE HEXAHYDRATE)
BLOOD GLUCOSE MANAGEMENT WITH EXTRANEAL PERITONEAL DIALYSIS (PD)
SOLUTION MUST
BE DONE WITH A GLUCOSE-SPECIFIC METHOD TO AVOID INTERFERENCE RESULTING
IN UNRECOGNISED
HYPOGLYCAEMIA.
IF
NON-SPECIFIC
GLUCOSE
TEST
METHODS
GLUCOSE
DEHYDROGENASE
PYRROLOQUINOLINEQUINONE (GDH-PQQ), GLUCOSE-DYE- OXIDOREDUCTASE (GDO)
OR GLUCOSE
DEHYDROGENASE FLAVIN-ADENINE DINUCLEOTIDE (GDH-FAD)) - BASED METHODS
ARE USED, LOSS
OF CONSCIOUSNESS, NEUROLOGICAL DAMAGE AND DEATH MAY OCCUR (SEE SECTION
4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
1
NAME OF THE MEDICINE
Icodextrin, sodium chloride, sodium lactate, calcium chloride
dihydrate and magnesium
chloride hexahydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EXTRANEAL PD solution contains icodextrin as the active ingredient at
a concentration of
7.5% w/v in an electrolyte solution. Icodextrin is an α
(1-4)
linked glucose polymer which
contains 5 - 10% α
(1-6)
links. It is produced by the hydrolysis of starch and fractionated by
membrane separation technology to produce material with the desired
molecular weight
distribution (85% w/w within the molecular weight range 1,640 -
45,000).
EXTRANEAL PD solution is presented in a flexible PVC bag and is
sterile, non-pyrogenic
and contains no bacteriostatic or antimicrobial agents or added
buffers.
Each 1000mL of EXTRANEAL PD solution contains:
ACTIVE INGREDIENT
QUANTITY
Icodextrin
75 g
Sodium chloride
5.4 g
Sodium lactate
4.5 g
Calcium chloride dihydrate
257 mg
Magnesium chloride hexahydrate
51 mg
EXCIPIENT
Sodium hydroxide
pH adjustment
Hydrochloric acid
pH adjustment
Water for Injections
q.s. to 1000 mL
SOLUTION PROPERTIES
Osmolarity
284 mOsm/L
EXTRANEAL Peritoneal Dialysis Solution
Version 1.2
2 of 17
Electrolyte Solution Content per 1000mL:
Sodium
132 mmol
Calcium
1.75 mmol
Magnesium
0.25 mmol
Chlo