Phoxilium 1.2 mmol/l phosphate Solution for haemodialysis/ haemofiltration

Država: Malta

Jezik: engleski

Izvor: Malta Medicines Authority

Aktivni sastojci:

CALCIUM CHLORIDE, POTASSIUM CHLORIDE, DISODIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE

Dostupno od:

Gambro Lundia AB

ATC koda:

B05ZB

INN (International ime):

CALCIUM CHLORIDE, POTASSIUM CHLORIDE, DISODIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE

Farmaceutski oblik:

SOLUTION FOR HAEMODIALYSIS

Sastav:

CALCIUM CHLORIDE 3.68 gram(s) ; POTASSIUM CHLORIDE 0.314 gram(s) ; DISODIUM PHOSPHATE 0.225 gram(s) ; MAGNESIUM CHLORIDE 2.44 gram(s) ; SODIUM CHLORIDE 6.44 gram(s) ; SODIUM HYDROGEN CARBONATE 2.92 gram(s)

Tip recepta:

POM

Područje terapije:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Status autorizacije:

Authorised

Datum autorizacije:

2009-12-09

Uputa o lijeku

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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 po

Svojstava lijeka

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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 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
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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 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
The volume and rate at which Phoxilium is adm