MultiLac 4mmoL/L Potassium Solution for Haemofiltration

Land: Malta

Tungumál: enska

Heimild: Medicines Authority

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Upplýsingar fylgiseðill (PIL)

26-06-2023

Vara einkenni (SPC)

26-06-2023

Virkt innihaldsefni:

CALCIUM, CALCIUM CHLORIDE, DIHYDRATE, POTASSIUM, POTASSIUM CHLORIDE, GLUCOSE, GLUCOSE MONOHYDRATE, LACTATE, MAGNESIUM, MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM, SODIUM CHLORIDE, SODIUM LACTATE

Fáanlegur frá:

Fresenius Medical Care Deutschland GmbH D-61346 Bad Homburg, Germany

ATC númer:

B05ZB

INN (Alþjóðlegt nafn):

SODIUM LACTATE 0.2205 g/l CALCIUM 0.5 mmol/l CALCIUM CHLORIDE DIHYDRATE 0.1017 g/l CHLORIDE 38 mmol/l POTASSIUM 1.5 mmol/l POTASSIUM CHLORIDE GLUCOSE 5.961 mmol/l GLUCOSE MONOHYDRATE 140 g/l LACTATE 5.5 mmol/l MAGNESIUM 110 mmol/l MAGNESIUM CHLORIDE HEXAHYDRATE 1.1 g/l SODIUM 4 mmol/l SODIUM CHLORIDE 0.2982 mmol/l

Lyfjaform:

SOLUTION FOR HAEMOFILTRATION

Samsetning:

Gerð lyfseðils:

POM

Lækningarsvæði:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Leyfisstaða:

Withdrawn

Leyfisdagur:

2008-12-18

Upplýsingar fylgiseðill

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
MULTILAC 4 MMOL/L POTASSIUM, SOLUTION FOR
HAEMODIALYSIS/HAEMOFILTRATION
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 nurse.

If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What multiLac 4 mmol/l potassium is and what it is used for
2.
What you need to know before you use multiLac 4 mmol/l potassium
3.
How to use multiLac 4 mmol/l potassium
4.
Possible side effects
5.
How to store multiLac 4 mmol/l potassium
6.
Contents of the pack and other information
1.
WHAT MULTILAC 4 MMOL/L POTASSIUM IS AND WHAT IT IS USED FOR
multiLac 4 mmol/l potassium is a continuous Renal Replacement Therapy
solution for removal of
waste products from the body in people with kidney disease. It is used
in patients with kidney injury
and also for the treatment of poisoning. The type of solution you are
given depends on the amount
of potassium (a salt) in your blood. Your doctor will check your
potassium levels regularly.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MULTILAC 4 MMOL/L POTASSIUM
DO NOT USE MULTILAC 4 MMOL/L POTASSIUM IF

you are allergic to any of the active substances or any of the other
ingredients of this medicine
(listed in section 6)

you have metabolic alkalosis (a condition where there is too much
bicarbonate in the blood)

you have hyperlactataemia (the amount of lactate in your blood is too
high) or a pre-existing
liver disease with significantly reduced liver function

you have a pre-existing significant cardiac disease

you are concomitantly treated with metformin (antidiabetic agent)
WARNINGS AND PRECAUTIONS
Talk to your doctor before using multiLac 4 mmol/l potassium

Must not be used under any circumstances below room temperature.

You

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Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
multiLac potassium-free solution for haemodialysis/haemofiltration
multiLac 2 mmol/l potassium solution for haemodialysis/haemofiltration
multiLac 3 mmol/l potassium solution for haemodialysis/haemofiltration
multiLac 4 mmol/l potassium solution for haemodialysis/haemofiltration
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
multiLac potassium-free/2/3/4 mmol/l potassium is provided in a
one-compartment bag containing
5000 ml solution for haemodialysis/haemofiltration.
1000 ML SOLUTION CONTAIN:
multiLac
potassium-free
multiLac
2 mmol/l
potassium
multiLac
3 mmol/l
potassium
multiLac
4 mmol/l
potassium
POTASSIUM CHLORIDE
0.1491 G
0.2237 G
0.2982 G
Sodium chloride
5.961 g
5.961 g
5.961 g
5.961 g
Sodium (S)-lactate
solution 50 %
8.520 g
8.520 g
8.520 g
8.520 g
(Sodium (S)-lactate)
(4.260 g)
(4.260 g)
(4.260 g)
(4.260 g)
Calcium chloride
dihydrate
0.2205 g
0.2205 g
0.2205 g
0.2205 g
Magnesium chloride
hexahydrate
0.1017 g
0.1017 g
0.1017 g
0.1017 g
Glucose monohydrate
1.100 g
1.100 g
1.100 g
1.100 g
(Glucose)
(1.000 g)
(1.000 g)
(1.000 g)
(1.000 g)
K
+
0 MMOL/L
2.0 MMOL/L
3.0 MMOL/L
4.0 MMOL/L
Na
+
140 mmol/l
140 mmol/l
140 mmol/l
140 mmol/l
(S)-lactate
-
38 mmol/l
38 mmol/l
38 mmol/l
38 mmol/l
Ca
2+
1.5 mmol/l
1.5 mmol/l
1.5 mmol/l
1.5 mmol/l
Mg
2+
0.50 mmol/l
0.50 mmol/l
0.50 mmol/l
0.50 mmol/l
Cl
-
106 mmol/l
108 mmol/l
109 mmol/l
110 mmol/l
Glucose
5.5 mmol/l
5.5 mmol/l
5.5 mmol/l
5.5 mmol/l
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for haemodialysis/haemofiltration
The solution is clear and colourless and free from visible particles.
Theoretical osmolarity
multiLac potassium-free
292 mOsm/l
Page 2 of 10
multiLac 2 mmol/l potassium
296 mOsm/l
multiLac 3 mmol/l potassium
298 mOsm/l
multiLac 4 mmol/l potassium
300 mOsm/l
pH 4.5 – 6.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
multiLac potassium-free/2/3/4 mmol/l potassium is indicated for
intravenous use as substitution
solution in haemofi

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