Phoxilium 1.2 mmol/l phosphate Solution for haemodialysis/haemofiltration

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

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

थमां उपलब्ध:

Gambro Lundia AB

ए.टी.सी कोड:

B05ZB

INN (इंटरनेशनल नाम):

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

डोज़:

1.2 mmol/L

फार्मास्यूटिकल फॉर्म:

Solution for haemodialysis/haemofiltration

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may not be renewed (A)

चिकित्सीय क्षेत्र:

Hemofiltrates

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2009-04-17

सूचना पत्रक

07-19-00-0480
UK, IE, MT
PT
ES
UK, IE, MT
PT
ES
Package leaflet: Information for the user
................................3
Folheto informativo: Informação para o utilizador
..................6
Prospecto: Información para el usuario
..................................9
The following information is intended
for healthcare professionals only
..........................................13
A informação que se segue destina-se
apenas aos profissionais de saúde
......................................15
Esta información está destinada
únicamente a profesionales del sector sanitario ..................17
THIS PAGE IS INTENTIONALLY LEFT BLANK
3
PHOXILIUM 07-19-00-0480
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

उत्पाद विशेषताएं

Health Products Regulatory Authority
07 November 2018
CRN008JVZ
Page 1 of 12
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.
Health Products Regulatory Authority
07 November 2018
CRN008JVZ
Page 2 of 12
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
hypophos