Physioneal 35 Glucose 3.86% w/v / 38.6 mg/ml Clear-Flex,Solution 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 (s)-lactate solution; Sodium bicarbonate

Available from:

Baxter Holding B.V.

ATC code:

B05DB

INN (International Name):

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

Dosage:

3.86 percent weight/volume

Pharmaceutical form:

Solution for peritoneal dialysis

Therapeutic area:

Hypertonic solutions

Authorization status:

Marketed

Authorization date:

2004-09-10

Patient Information leaflet

1
PACKAGE LEAFLET
2
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 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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Physioneal35Glucose3.86%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 ²A²) 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 ²B²) 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.
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