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

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Glucose monohydrate; Sodium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium lactate; Sodium bicarbonate

Fáanlegur frá:

Baxter Healthcare Limited

ATC númer:

B05DB

INN (Alþjóðlegt nafn):

Glucose monohydrate; Sodium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium lactate; Sodium bicarbonate

Skammtar:

1.36 percent weight/volume

Lyfjaform:

Solution for peritoneal dialysis

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

Hypertonic solutions

Leyfisstaða:

Not marketed

Leyfisdagur:

2004-01-09

Upplýsingar fylgiseðill

CB-30-02-288
4
ENGLISH – UK/IRE
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 ac

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Physioneal 35 Glucose 1.36% w/v / 13.6 mg/ml
Solution for peritoneal dialysis
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Before mixing
1000 ml of final solution after mixing corresponds to 362.5 ml of
solution A and 637.5 ml of solution B.
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
1000 ML OF ELECTROLYTE SOLUTION (SMALL CHAMBER
A )
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
B )
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
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
H
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