Phoxilium 1.2 mmol/l phosphate Solution for haemodialysis/haemofiltration

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium chloride ph.eur.; Sodium hydrogen carbonate; Potassium chloride; Disodium phosphate dihydrate

Tilgjengelig fra:

Baxter Holding B.V.

ATC-kode:

B05ZB

INN (International Name):

Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium chloride ph.eur.; Sodium hydrogen carbonate; Potassium chloride; Disodium phosphate dihydrate

Dosering :

1.2 mmol/L

Legemiddelform:

Solution for haemodialysis/haemofiltration

Terapeutisk område:

Hemofiltrates

Autorisasjon status:

Marketed

Autorisasjon dato:

2009-04-17

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
PHOXILIUM 1.2 MMOL/L PHOSPHATE
SOLUTION FOR HAEMODIALYSIS AND HAEMOFILTRATION
Calcium chloride dihydrate, magnesium chloride hexahydrate, sodium
chloride, sodium hydrogen
carbonate, potassium chloride, disodium phosphate dihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist
or nurse.
• If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Phoxilium is and what it is used for
2.
What you need to know before you are given Phoxilium
3.
How to use Phoxilium
4.
Possible side effects
5.
How to store Phoxilium
6.
Contents of the pack and other information
1. WHAT PHOXILIUM IS AND WHAT IT IS USED FOR
Phoxilium, belonging to the group of hemofiltrates solution, contains
calcium chloride dihydrate,
magnesium chloride hexahydrate, sodium chloride, sodium hydrogen
carbonate, potassium
chloride, disodium phosphate dihydrate.
Phoxilium is used in hospitals in intensive care treatments to correct
chemical imbalances in the
blood which are caused by kidney injury.
THE TREATMENTS
, using continuous renal replacement therapy, are designed to remove
accumulated waste products from the blood when the kidneys are not
functioning.
THE PHOXILIUM SOLUTION
is particularly used to treat critically ill patients with acute
kidney injury
having:
• a normal concentration of potassium in the blood
_(normal kalaemia) _
or
• a normal or low concentration of phosphate in the blood
_(normal or hypophosphataemia_
).
This medicine may also be used in case of drug poisoning or
intoxications with dialysable or
filterable substances.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PHOXILIUM
DO NOT USE PHOXILIUM IN THE FOLLOWING THREE CASES:
• a high concentration of potassium in t

Preparatomtale

Health Products Regulatory Authority
20 February 2024
CRN00DLH3
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
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 1000ML 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.
Health Products Regulatory Authority
20 February 2024
CRN00DLH3
Page 2 of 9
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 hypophosph