DIANEAL 1mmol Calcium in 2.5% Glucose Peritoneal dialysis solution

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

glucose, Quantity: 25 g/L; sodium chloride, Quantity: 5.38 g/L; sodium lactate, Quantity: 4.48 g/L; magnesium chloride hexahydrate, Quantity: 0.0508 g/L; calcium chloride dihydrate, Quantity: 0.147 g/L

Предлага се от:

Vantive Pty Ltd

Лекарствена форма:

Solution, dialysis

Композиция:

Excipient Ingredients: water for injections

Начин на приложение:

Intraperitoneal

Броя в опаковка:

1.5L,2L,2.5L,3L-freeline solo twin bag

Вид предписание :

Not scheduled. Not considered by committee

Терапевтични показания:

Dianeal PD-2, PD-4 and 1mmol Calcium Peritoneal Dialysis Solution is indicated for use in chronic renal failure patients being maintained on Continuous Ambulatory Peritoneal Dialysis.

Каталог на резюме:

Visual Identification: Clear colourless to straw coloured aqueous solutions, free from visible particulate matter.; Container Type: Bag; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Статус Оторизация:

Registered

Дата Оторизация:

1997-09-18

Данни за продукта

DIANEAL
Peritoneal Dialysis Solutions
Version 1.2
1 of 12
AUSTRALIAN PRODUCT INFORMATION –
DIANEAL PERITONEAL DIALYSIS SOLUTIONS (SODIUM CHLORIDE, GLUCOSE MONOHYDRATE,
SODIUM LACTATE, MAGNESIUM CHLORIDE
HEXAHYDRATE AND CALCIUM CHLORIDE DIHYDRATE)
1
NAME OF THE MEDICINE
Sodium chloride, glucose monohydrate, sodium lactate, magnesium
chloride hexahydrate and
calcium chloride dihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DIANEAL PD-2, PD-4 and 1 mmol/L Calcium Peritoneal Dialysis Solutions
are sterile,
nonpyrogenic and contain no bacteriostatic or antimicrobial agents or
added buffers.
The compositions of the DIANEAL Peritoneal Dialysis (PD) Solutions are
provided in:
•
Table 1 - Ingredient concentration (mg/L or g/L) and
•
Table 2 – Ingredient concentration (mmol/L) and Osmolarity.
TABLE 1: DIANEAL PD SOLUTION - INGREDIENT CONCENTRATION (MG/L OR G/L)
INGREDIENTS
DIANEAL
1 MMOL/L CALCIUM
DIANEAL
PD-4
DIANEAL
PD-2
with Glucose
monohydrate
with Glucose
monohydrate
with Glucose
monohydrate
0.55% 1.5% 2.5% 4.25%
0.55% 1.5% 2.5% 4.25%
0.55%
1.5% 2.5%
4.25%
GLUCOSE
MONOHYDRATE
(G/L)
5.5
15
25
42.5
5.5
15
25
42.5
5.5
15
25
42.5
SODIUM
CHLORIDE
(G/L)
5.38
5.38
5.38
SODIUM
LACTATE
(G/L)
4.48
4.48
4.48
MAGNESIUM
CHLORIDE
HEXAHYDRATE
(MG/L)
50.8
50.8
50.8
CALCIUM
CHLORIDE
DIHYDRATE
(MG/L)
147
183
257
WATER FOR
INJECTIONS
QS
QS
QS
DIANEAL
Peritoneal Dialysis Solutions
Version 1.2
2 of 12
TABLE 2: DIANEAL PD SOLUTION - INGREDIENT CONCENTRATION (MMOL/L) AND
OSMOLARITY
DIANEAL
1 MMOL/L CALCIUM
DIANEAL
PD-4
DIANEAL
PD-2
with Glucose
monohydrate
with Glucose
monohydrate
with Glucose
monohydrate
0.55%
1.5%
2.5%
4.25%
0.55%
1.5%
2.5%
4.25%
0.55%
1.5%
2.5%
4.25%
GLUCOSE
(MMOL/L)
28
76
126
214
28
76
126
214
28
76
126
214
SODIUM
(MMOL/L)
132
132
132
MAGNESIUM
(MMOL/L)
0.25
0.25
0.25
CALCIUM
(MMOL/L)
1
1.25
1.75
CHLORIDE
(MMOL/L)
95
95
96
LACTATE
(MMOL/L)
40
40
40
APPROXIMATE
OSMOLARITY
(MOSMOL/L)
296
344
394
482
297
345
395
483
298
346
396
485
Potassium is omitted from DIANEAL Solutions because dialysis may be
performed t