Physioneal 35 Glucose Clear-Flex 3.86% w/v/38.6mg/ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

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

Available from:

Baxter Healthcare Limited

ATC code:

B05DB

INN (International Name):

CALCIUM CHLORIDE; GLUCOSE MONOHYDRATE; MAGNESIUM CHLORIDE HEXAHYDRATE; SODIUM CHLORIDE; SODIUM HYDROGEN CARBONATE; SODIUM LACTAT

Pharmaceutical form:

SOLUTION FOR PERITONEAL DIALYSIS

Composition:

CALCIUM CHLORIDE 0.257 g/l; GLUCOSE MONOHYDRATE 42.5 g/l; MAGNESIUM CHLORIDE HEXAHYDRATE 0.051 g/l; SODIUM CHLORIDE 5.67 g/l; SODIUM HYDROGEN CARBONATE 2.1 g/l; SODIUM LACTATE 1.12 g/l

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2014-10-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PHYSIONEAL 35 GLUCOSE 1.36% W/V / 13.6 MG/ML CLEAR-FLEX, SOLUTION FOR
PERITONEAL DIALYSIS
PHYSIONEAL 35 GLUCOSE 2.27% W/V / 22.7 MG/ML CLEAR-FLEX, SOLUTION FOR
PERITONEAL DIALYSIS
PHYSIONEAL 35 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 of the 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 35 is and what it is used for
2.
What you need to know before you use PHYSIONEAL 35
3.
How to use PHYSIONEAL 35
4.
Possible side effects
5.
How to store PHYSIONEAL 35
6.
Contents of the pack and other information
1.
WHAT PHYSIONEAL 35 IS AND WHAT IT IS USED FOR
PHYSIONEAL 35 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 35 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 35 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 35 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 35
1
Your doctor must supervise you the first time you use this product.
DO NOT USE PHYSIONEAL 35
-
If you are allergic to the active sub

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PHYSIONEAL 35 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
0.343 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
21.12 g
9.29 g
4.48 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
5.67 g
0.257 g
0.051 g
2.10 g
1.12 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
1.75 mmol/l
0.25 mmol/l
101 mmol/l
25 mmol/l
10 mmol/l
For the full list of excipients, see section 6.1.
The number ‘35’ in the name specifies the buffer concentration of
the solution (10 mmol/l of
lactate + 25 mmol/l of hydrogen carbonate = 35 mmol/l).
3.
PHARMACEUTICAL FORM
Solution for peritoneal dialysis.
Sterile, clear, colourless solution.
The pH of the final solution is 7.4.
Osmolarity 484 mOsmol/l
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PHYSIONEAL 35 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 35 hydrogen carbonate/lactate_ _b