Physioneal 40 Glucose 3.86%w/v /38.6mg/ml Clear-Flex Solution for peritoneal dialysis

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

SODIUM HYDROGEN, CARBONATE, SODIUM LACTATE, CALCIUM CHLORIDE, GLUCOSE MONOHYDRATE, MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM CHLORIDE

Inapatikana kutoka:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

ATC kanuni:

B05DB

INN (Jina la Kimataifa):

SODIUM HYDROGEN CARBONATE 2.1 g/l SODIUM LACTATE 1.68 g/l CALCIUM CHLORIDE 0.184 g/l GLUCOSE MONOHYDRATE 42.5 g/l MAGNESIUM CHLORIDE HEXAHYDRATE 0.051 g/l SODIUM CHLORIDE 5.38 g/l

Dawa fomu:

SOLUTION FOR PERITONEAL DIALYSIS

Tungo:

SODIUM HYDROGEN CARBONATE 2.1 g/l SODIUM LACTATE 1.68 g/l CALCIUM CHLORIDE 0.184 g/l GLUCOSE MONOHYDRATE 42.5 g/l MAGNESIUM CHLORIDE HEXAHYDRATE 0.051 g/l SODIUM CHLORIDE 5.38 g/l

Dawa ya aina:

POM

Eneo la matibabu:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Idhini hali ya:

Authorised

Idhini ya tarehe:

2014-10-02

Taarifa za kipeperushi

PAGE 1 OF 9
PACKAGE LEAFLET_ _
2
PACKAGE LEAFLET : INFORMATION FOR THE USER
PHYSIONEAL 40 GLUCOSE 1.36% W/V / 13.6 MG/ML CLEAR-FLEX, SOLUTION FOR
PERITONEAL DIALYSIS
PHYSIONEAL 40 GLUCOSE 2.27% W/V / 22.7 MG/ML CLEAR-FLEX, SOLUTION FOR
PERITONEAL DIALYSIS
PHYSIONEAL 40 GLUCOSE 3.86% W/V / 38.6 MG/ML CLEAR-FLEX, SOLUTION FOR
PERITONEAL DIALYSIS
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.
-
If you get any side effects talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What PHYSIONEAL 40 is and what it is used for
2.
What you need to know before you use PHYSIONEAL 40
3.
How to use PHYSIONEAL 40
4.
Possible side effects
5.
How to store PHYSIONEAL 40
6.
Contents of the pack and other information
1.
WHAT PHYSIONEAL 40 IS AND WHAT IT IS USED FOR
PHYSIONEAL 40 is a solution for peritoneal dialysis. It removes water
and waste products
from the blood. It also corrects abnormal levels of different blood
components. PHYSIONEAL
40 contains varying levels of glucose (1.36%, 2.27% or 3.86%). The
higher the strength of
glucose in the solution, the greater the amount of water that will be
removed from the blood.
PHYSIONEAL 40 may be prescribed to you if you have:
-
either temporary or permanent kidney failure;
-
severe water retention;
-
severe disturbances in the acidity or alkalinity (pH) and the level of
salts in your blood;
-
certain types of drug intoxication where no other treatments are
available.
PHYSIONEAL 40 solution has an acidity (pH) close to that of your
blood. Therefore it may be
particularly useful if you experience inflow pain or discomfort with
other more acidic Peritoneal
Dialysis solutions.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
PHYSIONEAL 40
Your doctor must supervise you the first time you use this product.
DO NOT USE PHYSIONEAL 40
-
If you are

Tabia za bidhaa

PAGE 1OF 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PHYSIONEAL 40 Glucose 3.86% w/v / 38.6 mg/ml Clear-Flex,
Solution for peritoneal dialysis.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Before mixing
1000 ML OF ELECTROLYTE SOLUTION (LARGE CHAMBER

A

) CONTAINS:
Active substances:
Glucose monohydrate
equivalent to Glucose anhydrous
Calcium chloride dihydrate
Magnesium chloride hexahydrate
56.6 g
51.5 g
0.245 g
0.068 g
1000 ML OF BUFFER SOLUTION (SMALL CHAMBER

B

) CONTAINS:
Active substances:
Sodium chloride
Sodium hydrogen carbonate
Sodium (S)-lactate solution
equivalent to sodium (S)-lactate
19.95 g
9.29 g
6.73 g
After mixing
1000 ML OF THE MIXED SOLUTION CONTAINS:
Active substances:
Glucose monohydrate
equivalent to Glucose anhydrous
Sodium chloride
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium hydrogen carbonate
Sodium (S)-lactate solution
equivalent to sodium (S)-lactate
42.5 g
38.6 g
5.38 g
0.184 g
0.051 g
2.10 g
1.68 g
1000 ml of final solution after mixing corresponds to 750 ml of
solution A and 250 ml of
solution B.
COMPOSITION OF THE FINAL SOLUTION AFTER MIXING IN MMOL/L
Glucose anhydrous (C
6
H
12
O
6
)
Na
+
Ca
++
Mg
++
Cl
-
HCO
3
-
C
3
H
5
O
3
-
214 mmol/l
132 mmol/l
1.25 mmol/l
0.25 mmol/l
95 mmol/l
25 mmol/l
15 mmol/l
For the full list of excipients, see section 6.1.
The number ‘40’ in the name specifies the buffer concentration of
the solution (15 mmol/l of
lactate + 25 mmol/l of hydrogen carbonate = 40 mmol/l).
PAGE 2OF 11
3.
PHARMACEUTICAL FORM
Solution for peritoneal dialysis.
Sterile, clear, colourless solution.
The pH of the final solution is 7.4.
Osmolarity 483 mOsmol/l
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PHYSIONEAL 40 is indicated whenever peritoneal dialysis is employed,
including:
•
Acute and chronic renal failure;
•
Severe water retention;
•
Severe electrolyte imbalance;
•
Drug intoxication with dialysable substances, when a more adequate
therapeutic
alternative is not available.
PHYSIONEAL 40 hydroge