Phoxilium 1.2mmol/litre phosphate solution for haemofiltration 5litre two-chamber bags

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Disodium phosphate dihydrate; Magnesium chloride hexahydrate; Sodium chloride; Sodium bicarbonate; Potassium chloride; Calcium chloride dihydrate

Dostępny od:

Baxter Healthcare Ltd

Kod ATC:

n/a

INN (International Nazwa):

Disodium phosphate dihydrate; Magnesium chloride hexahydrate; Sodium chloride; Sodium bicarbonate; Potassium chloride; Calcium chloride dihydrate

Dawkowanie:

213.75mg/1litre ; 122mg/1litre ; 6.12gram/1litre ; 2.77gram/1litre ; 298.3mg/1litre ; 184mg/1litre

Forma farmaceutyczna:

Solution for haemofiltration

Droga podania:

Haemodialysis; Haemofiltration

Klasa:

No Controlled Drug Status

Typ recepty:

Never Valid To Prescribe As A VMP

Podsumowanie produktu:

BNF: ; GTIN: 07332414107123

Charakterystyka produktu

OBJECT 1
PHOXILIUM 1.2 MMOL/L PHOSPHATE SOLUTION FOR
HAEMODIALYSIS/ HAEMOFILTRATION
Summary of Product Characteristics Updated 07-Feb-2018 | Baxter
Healthcare Ltd
1. Name of the medicinal product
PHOXILIUM 1.2 mmol/l phosphate Solution for haemodialysis/
haemofiltration
2. Qualitative and quantitative composition
Phoxilium is presented in a two-compartment bag. The final
reconstituted solution is obtained after
breaking the frangible pin or the peel seal and mixing both solutions.
BEFORE RECONSTITUTION
1000 ml of solution in the small compartment (A) contains:
Calcium chloride, 2 H
2
O
3.68 g
Magnesium chloride, 6 H
2
O
2.44 g
1000 ml of solution in the large compartment (B) contains:
Sodium chloride
6.44 g
Sodium hydrogen carbonate
2.92 g
Potassium chloride
0.314 g
Disodium phosphate, 2 H
2
O
0.225 g
AFTER RECONSTITUTION
1000 ml of the reconstituted solution contains:
Active substances
mmol/l
mEq/l
Calcium
Ca
2+
1.25
2.50
Magnesium
Mg
2+
0.600
1.20
Sodium
Na
+
140.0
140.0
Chloride
Cl
-
115.9
115.9
Hydrogen phosphate
HPO
4
2-
1.20
2.40
Hydrogen carbonate
HCO
3
-
30.0
30.0
Potassium
K
+
4.00
4.00
EACH 1000 ML OF THE FINAL RECONSTITUTED SOLUTION CORRESPONDS TO 50 ML
OF SOLUTION A AND 950 ML OF
SOLUTION B.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for haemodialysis/ haemofiltration.
Clear and colourless solutions.
Theoretical osmolarity: 293 mOsm/l
pH of the reconstituted solution: 7.0 – 8.5
4. Clinical particulars
4.1 Therapeutic indications
Phoxilium is 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.
Phoxilium may also be used in cases of drug poisoning or intoxications
when the poisons are dialysable
or pass through the membrane.
Phoxilium is indicated for use in patients with normal kalaemia and
normal or hypophosphataemia.
4.2 Posol