Dianeal 1mmol/L Calcium with 2.5% w/v glucose monohydrate

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Calcium chloride dihydrate 0.1455 g/L;  ;  ; Glucose monohydrate 24.75 g/L;  ; Magnesium chloride hexahydrate 0.0503 g/L;  ; Sodium chloride 5.33 g/L;  ; Sodium lactate 7.4 g/L

Disponível em:

Baxter Healthcare Ltd

DCI (Denominação Comum Internacional):

Calcium chloride dihydrate 0.1455 g/L

Dosagem:

2.5% w/v

Forma farmacêutica:

Dialysis solution

Composição:

Active: Calcium chloride dihydrate 0.1455 g/L     Glucose monohydrate 24.75 g/L   Magnesium chloride hexahydrate 0.0503 g/L   Sodium chloride 5.33 g/L   Sodium lactate 7.4 g/L Excipient: Hydrochloric acid Water for injection

Unidades em pacote:

Bag, plastic, freeline solo twin bag, 2500 mL

Classe:

General sale

Tipo de prescrição:

General sale

Fabricado por:

Merck KGaA

Indicações terapêuticas:

For use in chronic renal failure patients being maintained on Continuous Ambulatory Peritoneal Dialysis

Resumo do produto:

Package - Contents - Shelf Life: Bag, plastic, freeline solo twin bag - 2500 mL - 24 months from date of manufacture stored at or below 30°C - Bag, plastic, single bag - 6000 mL - 24 months from date of manufacture stored at or below 30°C

Data de autorização:

2013-02-04

Características técnicas

NEW ZEALAND DATA SHEET
Dianeal Data Sheet 24 November 2020
Page 1 of 10
Baxter Healthcare Ltd
1 DIANEAL(solution, dialysis)
DIANEAL 1mmol/L Calcium with 1.5%w/v Glucose Monohydrate
DIANEAL 1mmol/L Calcium with 2.5%w/v Glucose Monohydrate
DIANEAL 1mmol/L Calcium with 4.25%w/v Glucose Monohydrate
DIANEAL PD‐4 with 0.55%w/v Glucose Monohydrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dianeal PD‐4 and 1mmol/L Calcium dialysis solutions are sterile,
nonpyrogenic and contain no
bacteriostatic or antimicrobial agents or added buffers.
Each 1000mL of Dianeal dialysis solution contains:
Component
Content
Glucose, BP
0.55% ‐ ‐
5.5g
1.5
% ‐‐
15.0g
2.5
% ‐‐
25.0g or
4.25% ‐ ‐
42.5g
Sodium Chloride, BP
‐
‐
5.38g
Sodium Lactate
‐
‐
4.48g
Magnesium Chloride Hexahydrate, BP
‐
‐
50.8g
Calcium Chloride Dihydrate, BP
PD‐2
‐
257mg,
PD‐4
‐
183mg, or
1mmol/L Calcium
147mg
Water For Injections, BP
QS
_Dianeal 1mmol/L Calcium dialysis solution _
with 1.5%
Glucose
with 2.5%
Glucose
with 4.25%
Glucose
Glucose .H2O
76mmol/L
126mmol/L
214mmol/L
Sodium
132mmol/L
132mmol/L
132mmol/L
Calcium
1.00mmol/L
1.00mmol/L
1.00mmol/L
Magnesium
0.25mmol/L
0.25mmol/L
0.25mmol/L
Chloride
96mmol/L
96mmol/L
96mmol/L
Lactate
40mmol/L
40mmol/L
40mmol/L
Approximate Osmolality
_ _
344mOs
394mOs
482mOs
_ _
_ _
NEW ZEALAND DATA SHEET
Dianeal Data Sheet 24 November 2020
Page 2 of 10
Baxter Healthcare Ltd
_Dianeal PD‐4 dialysis solution_
with 0.55%
Glucose
Glucose .H2O
28mmol/L
Sodium
132mmol/L
Calcium
1.25mmol/L
Magnesium
0.25mmol/L
Chloride
96mmol/L
Lactate
40mmol/L
Approximate Osmolality
297mOs
Potassium is omitted from Dianeal solutions because dialysis may be
performed to correct
hyperkalaemia.
Because average plasma magnesium levels in chronic Continuous
Ambulatory Peritoneal Dialysis
(CAPD) patients have been observed to be elevated (Nolph _et al._
1981), the magnesium concentration
of this formulation has been reduced to 0.25mmol/L.
Because average serum bicarbonate levels in chronic CAPD patients have
been observe