PHOXILIUM 1.2 MMOLL PHOSPHATE

Valsts: Izraēla

Valoda: angļu

Klimata pārmaiņas: Ministry of Health

Aktīvā sastāvdaļa:

CALCIUM CHLORIDE DIHYDRATE; DISODIUM PHOSPHATE DIHYDRATE; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM HYDROGEN CARBONATE

Pieejams no:

BAXTER HEALTHCARE DISTRIBUTION LTD., ISRAEL

ATĶ kods:

B05CB10

Zāļu forma:

SOLUTION FOR HEAMODIALYSIS/HAEMOFILTRATION

Kompozīcija:

DISODIUM PHOSPHATE DIHYDRATE 0.225 G/L; POTASSIUM CHLORIDE 0.314 G/L; SODIUM CHLORIDE 6.44 G/L; MAGNESIUM CHLORIDE HEXAHYDRATE 2.44 G/L; CALCIUM CHLORIDE DIHYDRATE 3.68 G/L; SODIUM HYDROGEN CARBONATE 2.92 G/L

Ievadīšanas:

FOR INTRAVENOUSE USE AND/OR HAEMODIALYSIS, FOR INTRAVENOUSE USE AND/OR HAEMODIALYSIS

Receptes veids:

Required

Ražojis:

BIEFFE MEDITAL S.P.A., ITALY

Ārstniecības joma:

COMBINATIONS

Ārstēšanas norādes:

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.

Autorizācija datums:

2019-12-31

Lietošanas instrukcija

Baxter Healthcare Distribution Ltd
34 Jerusalem st. Ra'anana entrance B
Israel
545656443
-
Tel:972
רבמצד
2021
,ה/דבכנ ,ת/חקור ,ה/אפור
:ןודנה
PHOXILIUM 1.2 MMOL/L PHOSPHATE
:םיליעפ םיביכרמ
Disodium Phosphate Dihydrate
Potassium Chloride
Sodium Chloride
Magnesium Chloride Hexahydrate
Calcium Chloride Dihydrate
Sodium Hydrogen Carbonate
:ןונימ תרוצ
Solution for heamodialysis/haemofiltration
:תורשואמ תויוותה
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.
תרבח
רטסקב
תקפסא
יתוריש
ב
ר
תואי
עב
"
מ
תשקבמ
םכעידוהל
לע
םינוכדע
ןולעב
אפורל
לש
שכתה
ןודנב רי
.
ולעה
ן
אפורל
כדוע
ן
ךיראתב
רבמצד
2021
עדימב הרמחה םיווהמה םינוכדעה ןלהל.
יתוחיטבה
(
םינמוסמ
תועצמאב
יתחת וק
)
:
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
The volume and rate at which Phoxilium is administered depends on the
blood
concentration of phosphate and other electrolytes, acid–base
balance, fluid balance
and overall clinical condition of the patient. The volume of
replacement solution
and/or dialysate to be administered will also depend on the desired
intensity (dose) of
the treatment. Administration (dose, infusion rate and cumulative
volume) of
Phoxilium should only be established by a physician experienced
in critical care
medicine and CRRT (Continuous Renal Replacement Therapy).
The range of flow rates for the replacement solution in
haemofiltration and
haem

Produkta apraksts

PHYSICIAN'S PRESCRIBING INFORMATION
1. NAME OF THE MEDICINAL PRODUCT
PHOXILIUM 1.2 mmol/l phosphate.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Phoxilium is presented in a two-compartment bag. The final
reconstituted solution is obtained
after breaking 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 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
The volume and rate at which Phoxilium is administered depends on the
blood concentration
of phosphate and other electrolytes, acid–base balance,