Physioneal 35 Glucose 1.36% w/v / 13.6 mg/mlSolution for peritoneal dialysis

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Glucose monohydrate; Sodium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium bicarbonate; Sodium (s)-lactate solution

Available from:

Baxter Holding B.V.

ATC code:

B05DB

INN (International Name):

Glucose monohydrate; Sodium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium bicarbonate; Sodium (s)-lactate solution

Dosage:

1.36 percent weight/volume

Pharmaceutical form:

Solution for peritoneal dialysis

Therapeutic area:

Hypertonic solutions

Authorization status:

Marketed

Authorization date:

2004-01-09

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
˂PHYSIONEAL 35 GLUCOSE 1.36% W/V / 13.6 MG/ML, SOLUTION FOR
PERITONEAL DIALYSIS
PHYSIONEAL 35 GLUCOSE 2.27% W/V / 22.7 MG/ML, SOLUTION FOR PERITONEAL
DIALYSIS
PHYSIONEAL 35 GLUCOSE 3.86% W/V / 38.6 MG/ML, 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 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
Your doctor must supervise you the first time you use this product.
DO NOT USE PHYSIONEAL 35
•
If you are allergic to the active substances or any of the othe

Summary of Product characteristics

Health Products Regulatory Authority
05 April 2022
CRN00CFPX
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Physioneal 35 Glucose 1.36% w/v / 13.6 mg/mlSolution for peritoneal
dialysis
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Before mixing
1000 ML OF ELECTROLYTE SOLUTION (SMALL
CHAMBER ²A²)
Active substances:
Glucose monohydrate
Equivalent to Anhydrous glucose
Calcium chloride dihydrate
Magnesium chloride hexahydrate
41.25 g
37.5 g
0.710 g
0.140 g
1000 ML OF BUFFER SOLUTION (LARGE
CHAMBER ²B²)
Active substances:
Sodium chloride
Sodium bicarbonate
Sodium (S)-lactate solution
8.89 g
3.29 g
1.76 g
After mixing
1000 ML OF THE MIXED SOLUTION CONTAINS:
Active substances:
Glucose monohydrate
Equivalent to Anhydrous glucose
Sodium chloride
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium bicarbonate
Sodium (S)-lactate solution
15.0 g
13.6 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 362.5 ml of
solution A and 637.5 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
-
75.5 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
bicarbonate = 35 mmol/l).
3 PHARMACEUTICAL FORM
Solution for peritoneal dialysis.
Sterile, clear, colourless solution.
Health Products Regulatory Authority
05 April 2022
CRN00CFPX
Page 2 of 9
The pH of the final solution is 7.4.
Osmolarity (MOSMOL/L)
345
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 bicarbonate/