PHOXILIUM 1.2 MMOLL PHOSPHATE SOLUTION FOR HAEMODIALYSISHAEMOFILTRATION

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

유효 성분:

(Large Compartment) Disodium Phosphate Dihydrate; (Large Compartment) Potassium Chloride; (Large Compartment) Sodium Chloride; (Large Compartment) Sodium Hydrogen Carbonate; (Small Compartment) Calcium Chloride Dihydrate; (Small Compartment) Magnesium Chloride Hexahydrate

제공처:

VANTIVE PTE. LTD.

ATC 코드:

B05ZB

약제 형태:

SOLUTION, STERILE

구성:

(Large Compartment) Disodium Phosphate Dihydrate 0.225 g/L; (Large Compartment) Potassium Chloride 0.314 g/L; (Large Compartment) Sodium Chloride 6.435 g/L; (Large Compartment) Sodium Hydrogen Carbonate 2.918 g/L; (Small Compartment) Calcium Chloride Dihydrate 3.675g/L; (Small Compartment) Magnesium Chloride Hexahydrate 2.440 g/L

관리 경로:

INTRAVENOUS

처방전 유형:

Prescription Only

Manufactured by:

Bieffe Medital S.p.A.

승인 상태:

ACTIVE

승인 날짜:

2019-06-27

제품 특성 요약

07-19-00-5823
BN, HK, MY, SG
Package
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Part Number: 0719005823
Date: 20FEB2023
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PHOXILIUM
07-19-00-5823
PACKAGE INSERT
SG
MY
HK
BN
1 NAME OF THE MEDICINAL
PRODUCT
PHOXILIUM 1.2 mmol/l phosphate
Solution for haemodialysis/
haemofiltration
2 QUALITATIVE AND QUANTITATIVE
COMPOSITION
PHOXILIUM solution 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 solution 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
supp