Extraneal

Страна: Новая Зеландия

Язык: английский

Источник: Medsafe (Medicines Safety Authority)

Активный ингредиент:

Calcium chloride dihydrate 257 mg/L; Icodextrin 75 g/L; Magnesium chloride hexahydrate 51 mg/L; Sodium chloride 5.4 g/L; Sodium lactate 4.5 g/L

Доступна с:

Vantive Limited

ИНН (Международная Имя):

Calcium chloride dihydrate 257 mg/L

дозировка:

7.5% w/v

Фармацевтическая форма:

Dialysis solution

состав:

Active: Calcium chloride dihydrate 257 mg/L Icodextrin 75 g/L Magnesium chloride hexahydrate 51 mg/L Sodium chloride 5.4 g/L Sodium lactate 4.5 g/L Excipient: Hydrochloric acid Sodium hydroxide Water for injection

Штук в упаковке:

Bag, plastic, Twin bag (not marketed), 1500 mL

класс:

General sale

Тип рецепта:

General sale

Производитель:

Baxter Healthcare Pty Ltd

Обзор продуктов:

Package - Contents - Shelf Life: Bag, plastic, Twin bag - 1500 mL - 2 years from date of manufacture stored at or below 30°C - Bag, plastic, Single bag - 1500 mL - 2 years from date of manufacture stored at or below 30°C - Bag, plastic, Twin bag - 2000 mL - 2 years from date of manufacture stored at or below 30°C - Bag, plastic, Single bag - 2000 mL - 2 years from date of manufacture stored at or below 30°C - Bag, plastic, Twin bag - 2500 mL - 2 years from date of manufacture stored at or below 30°C - Bag, plastic, Single bag - 2500 mL - 2 years from date of manufacture stored at or below 30°C - Bag, plastic, Twin bag - 3000 mL - 2 years from date of manufacture stored at or below 30°C - Bag, plastic, Single bag - 3000 mL - 2 years from date of manufacture stored at or below 30°C - Bag, plastic, Single bag - 5000 mL - 2 years from date of manufacture stored at or below 30°C - Bag, plastic, Single bag - 6000 mL - 2 years from date of manufacture stored at or below 30°C

Дата Авторизация:

2000-03-17

Характеристики продукта

NEW ZEALAND DATA SHEET
EXTRANEAL Data Sheet 18 July 2018
Page 1 of 15
Baxter Healthcare Ltd
1 EXTRANEAL (7.5% w/v dialysis solution)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EXTRANEAL is a sterile peritoneal dialysis fluid containing icodextrin
as the active ingredient at a
concentration of 7.5% w/v in an electrolyte solution.
Icodextrin is an

(1‐4) linked glucose polymer which contains 5 ‐ 10%

(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 is sterile, non‐pyrogenic and contains no bacteriostatic
or antimicrobial agents or added
buffers.
Each 1000mL of EXTRANEAL solution contains:
Active substances
Icodextrin
75g
Sodium Chloride
5.4g
Sodium Lactate
4.5g
Calcium Chloride
257mg
Magnesium Chloride
51mg
Electrolyte content per 1000mL:
Sodium
133mmol
Calcium
1.75mmol
Magnesium
0.25mmol
Chloride
96mmol
Lactate
40mmol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution, dialysis.
Solution for peritoneal dialysis.
EXTRANEAL is a clear solution presented in a flexible PVC bag.
Theoretical osmolarity is 284
milliosmoles per litre.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
EXTRANEAL (7.5% icodextrin) is indicated for use as an alternative
osmotic agent in dialysis solutions
for the long dwell exchange in patients treated with peritoneal
dialysis.
NEW ZEALAND DATA SHEET
EXTRANEAL Data Sheet 18 July 2018
Page 2 of 15
Baxter Healthcare Ltd
4.2
Dose and method of administration
_Dosage in adults and elderly _
By intraperitoneal administration limited to a single exchange in each
24 hour‐period, as part of a
CAPD or APD regimen.
_Paediatric population _
Not recommended for use in children (less than 18 years).
_Method of administration _
EXTRANEAL is recommended for use during the longest dwell period, that
is in CAPD usually overnight
and in Automated Peritoneal Dialysis (APD