Phoxilium™ 1.2 mmol/L, phosphate

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Calcium chloride dihydrate 3.68 g/L;  ; Magnesium chloride hexahydrate 2.44 g/L;  ; Dibasic sodium phosphate dihydrate 0.225 g/L;  ; Potassium chloride 0.314 g/L; Sodium bicarbonate 2.92 g/L; Sodium chloride 6.44 g/L;  

Предлага се от:

Vantive Limited

INN (Международно Name):

Calcium chloride dihydrate 3.68 g/L

Лекарствена форма:

Dialysis solution

Композиция:

Active: Calcium chloride dihydrate 3.68 g/L   Magnesium chloride hexahydrate 2.44 g/L   Excipient: Hydrochloric acid Water for injection Active: Dibasic sodium phosphate dihydrate 0.225 g/L   Potassium chloride 0.314 g/L Sodium bicarbonate 2.92 g/L Sodium chloride 6.44 g/L   Excipient: Carbon dioxide Water for injection

Вид предписание :

General sale

Произведено от:

Macco Organiques sro

Терапевтични показания:

· Used for CRRT (Continuous Renal Replacement Therapy) in critically ill patients with ARF (Acute Renal Failure) when pH and kalaemia have been restored to normal and when the patients need phosphate supplementation for loss of phosphate in the ultrafiltrate or to the dialysate during CRRT. · May also be used in case of drug poisoning or intoxications when the poisons are dialysable or pass through the membrane. · For use in patients with normal kalaemia and normal or hypophosphataemia

Каталог на резюме:

Package - Contents - Shelf Life: Bag, plastic, 5000mL Two compartment PVC with peel seal separation - 2 dose units - 18 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at or below 30°C - Bag, plastic, 5000mL Two compartment polyolefin bag with frangible pin - 2 dose units - 18 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at or below 30°C - Bag, plastic, 5000mL Two compartment polyolefin bag with peel seal separation - 2 dose units - 18 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at or below 30°C - Bag, plastic, 5000mL Two compartment PVC bag with frangible pin - 2 dose units - 18 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at or below 30°C

Дата Оторизация:

2013-03-14

Данни за продукта

NEW ZEALAND DATA SHEET
PHOXILIUM 1.2mmol/L PHOSPHATE Data Sheet 4 September 2017
Page 1 of 12
Baxter Healthcare Ltd
1 PHOXILIUM 1.2MMOL/L, PHOSPHATE (solution, dialysis)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Phoxilium 1.2mmol/L phosphate solution for haemodialysis and
haemofiltration consists of a mixture
of the following six active ingredients: Calcium chloride dihydrate,
Magnesium chloride hexahydrate,
Sodium bicarbonate, Sodium chloride, Potassium chloride and Dibasic
sodium phosphate dihydrate.
Phoxilium 1.2mmol/L phosphate solution for haemodialysis and
haemofiltration is clear and colourless
when reconstituted. It is packaged in a two‐compartment bag
containing a small (250mL) and a large
(4750mL) compartment. The final reconstituted solution is obtained
after opening the peel seal and
mixing both solutions.
_Before reconstitution _
_1000mL of solution (small compartment A) contains: _
_Active substances _
Calcium chloride dihydrate
Magnesium chloride hexahydrate
3.68g
2.44g
_1000mL of solution (large compartment B) contains: _
_Active substances_
Sodium chloride
Sodium carbonate
Potassium chloride
Disodium sodium phosphate dihydrate
6.44g
2.92g
0.314g
0.225g
_ _
_After reconstitution _
_1000mL of the reconstituted solution contains: _
_Active substances _
_mmol/L _
_mEq/L _
Sodium
Na
+
Potassium
K
+
Calcium
Ca
2+
Magnesium
Mg
2+
Chloride
Cl
─
Hydrogen phosphate
HPO
4
2─
Hydrogen carbonate
HCO
3
─
140
4.0
1.25
0.6
115.9
1.20
30
140
4.0
2.5
1.2
115.9
2.4
30
Each litre of the final reconstituted solution corresponds to 50mL of
solution A & 950mL of solution B.
pH of the reconstituted solution:
7.0 – 8.5.
Theoretical osmolarity:
293mOsm/L.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution, dialysis.
Phoxilium 1.2mmol/L phosphate solution is clear and colourless when
reconstituted as a solution.
NEW ZEALAND DATA SHEET
PHOXILIUM 1.2mmol/L PHOSPHATE Data Sheet 4 September 2017
Page 2 of 12
Baxter Healthcare Ltd
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Phoxil