Physioneal 40 Glucose 1.36% w/v/13.6 mg/mL CLEAR-FLEX

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Calcium chloride dihydrate 0.184 g/L;  ;  ; Glucose monohydrate 15 g/L equivalent to anhydrous glucose 13.6 g/L;  ; Magnesium chloride hexahydrate 0.051 g/L;  ; Sodium bicarbonate 2.1 g/L;  ; Sodium chloride 5.38 g/L; Sodium lactate 1.68 g/L

Disponible depuis:

Vantive Limited

DCI (Dénomination commune internationale):

Calcium chloride dihydrate 0.184 g/L

forme pharmaceutique:

Dialysis solution

Composition:

Active: Calcium chloride dihydrate 0.184 g/L     Glucose monohydrate 15 g/L equivalent to anhydrous glucose 13.6 g/L   Magnesium chloride hexahydrate 0.051 g/L   Sodium bicarbonate 2.1 g/L   Sodium chloride 5.38 g/L Sodium lactate 1.68 g/L Excipient: Hydrochloric acid Sodium hydroxide Water for injection

Type d'ordonnance:

General sale

Fabriqué par:

Merck KGaA

indications thérapeutiques:

For use in peritoneal dialysis in patients with acute or chronic kidney failure

Descriptif du produit:

Package - Contents - Shelf Life: Bag, plastic, Three layer ClearFlex film two compartment bag in overpouch - 5 L - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at or below 25°C

Date de l'autorisation:

2013-02-13

Résumé des caractéristiques du produit

NEW ZEALAND DATA SHEET
PHYSIONEAL Data Sheet 26 January 2023
Page 1 of 14
Baxter Healthcare Ltd
1 PHYSIONEAL 40
Physioneal 40, 1.36%w/v solution dialysis
Physioneal 40, 2.27%w/v solution dialysis
Physioneal 40, 3.86%w/v solution dialysis
PHYSIONEAL 40 GLUCOSE CLEAR FLEX
Physioneal 40 Glucose 1.36%w/v / 13.6mg/mL CLEAR‐FLEX solution
dialysis
Physioneal 40 Glucose 2.27%w/v / 22.7mg/mL CLEAR‐FLEX solution
dialysis
Physioneal 40, Glucose 3.86%w/v / 38.6mg/mL CLEAR‐FLEX solution
dialysis.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition of the solution in each compartment before mixing in g/L
Viaflex Bag
CLEAR FLEX Bag
Active Ingredients
Glucose
1.36%
Glucose
2.27%
Glucose
3.86%
Glucose
1.36%
Glucose
2.27%
Glucose
3.86%
Glucose Bag "A"
Glucose Monohydrate
37.50
62.60
106.50
18.2
30.3
51.5
Calcium Chloride Dihydrate
0.507
0.507
0.507
0.245
0.245
0.245
Magnesium Chloride
Hexahydrate
0.140
0.140
0.140
0.068
0.068
0.068
Buffer Bag "B"
Sodium Chloride
8.43
8.43
8.43
19.95
19.95
19.95
Sodium Bicarbonate
3.29
3.29
3.29
9.29
9.29
9.29
Sodium Lactate
2.63
2.63
2.63
6.73
6.73
6.73
Final Solution After Mixing
Glucose Monohydrate
13.6
22.7
38.6
Sodium Chloride
5.38
5.38
5.38
Calcium Chloride
Dihydrate
0.184
0.184
0.184
Magnesium Chloride
Hexahydrate
0.051
0.051
0.051
Sodium Bicarbonate
2.10
2.10
2.10
Sodium Lactate
1.68
1.68
1.68
NEW ZEALAND DATA SHEET
PHYSIONEAL Data Sheet 26 January 2023
Page 2 of 14
Baxter Healthcare Ltd
1000mL of final solution after mixing corresponds to:

Viaflex Bag: 362.5mL of solution A (Glucose) and 637.5mL of solution B
(Buffer).

CLEAR FLEX Bag: 750mL of solution A (Glucose) and 250mL of solution B
(Buffer).

The pH of the final solution is 7.4.

Hydrochloric acid (Solution A) and Sodium hydroxide (Solution B) are
used for pH adjustment in
the CLEAR FLEX presentation.
Composition of the final solution after mixing in mmol/L
Glucose 1.36%
Glucose 2.27%
Glucose 3.86%
Glucose (C
6
H
12
O
6
)
75.5
126
214
Sodium (Na
+
)
132
132
132
Calcium (Ca
++
)
1.25
1.25
1.25
Magnesium (Mg
++
)