Physioneal 40 Glucose 2.27% w/v/22.7mg/ml Solution for peritoneal dialysis

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM CHLORIDE DIHYDRATE; 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 DIHYDRATE; GLUCOSE MONOHYDRATE; MAGNESIUM CHLORIDE HEXAHYDRATE; SODIUM CHLORIDE; SODIUM HYDROGEN CARBONATE; SOD

Pharmaceutical form:

SOLUTION FOR PERITONEAL DIALYSIS

Composition:

CALCIUM CHLORIDE DIHYDRATE 0.184 g/l; GLUCOSE MONOHYDRATE 25 g/l; MAGNESIUM CHLORIDE HEXAHYDRATE 0.051 g/l; SODIUM CHLORIDE 5.38 g/l; SODIUM HYDROGEN CARBONATE 2.1 g/l; SODIUM LACTATE 1.68 g/l

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2006-03-06

Patient Information leaflet

CB-30-02-294
1
ENGLISH
Package Leaflet: Information for the user
PHYSIONEAL 40 Glucose 1.36% w/v / 13.6 mg/ml, Solution for Peritoneal
Dialysis
PHYSIONEAL 40 Glucose 2.27% w/v / 22.7 mg/ml, Solution for Peritoneal
Dialysis
PHYSIONEAL 40 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 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 allergic to the active substa

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PHYSIONEAL 40 Glucose 1.36% w/v / 13.6 mg/ml
PHYSIONEAL 40 Glucose 2.27% w/v / 22.7 mg/ml
PHYSIONEAL 40 Glucose 3.86% w/v / 38.6 mg/ml
Solution for peritoneal dialysis
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Before mixing
1000 ML OF ELECTROLYTE SOLUTION (SMALL CHAMBER

A

)
Active substances:
Glucose monohydrate
Equivalent to Anhydrous
glucose
1.36%
2.27%
3.86%
41.25 g
37.5 g
68.85 g
62.6 g
117.14 g
106.5 g
Calcium chloride dihydrate
Magnesium chloride
hexahydrate
0.507 g
0.140 g
1000 ML OF BUFFER SOLUTION (LARGE CHAMBER

B

)
Active substances:
Sodium chloride
Sodium bicarbonate
Sodium (S)-lactate solution
8.43 g
3.29 g
2.63 g
After mixing
1000 ML OF THE MIXED SOLUTION CONTAINS:
1.36%
2.27%
3.86%
Active substances:
Glucose monohydrate
Equivalent to Anhydrous glucose
15.0 g
13.6 g
25.0 g
22.7 g
42.50 g
38.6 g
Sodium chloride
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium bicarbonate
Sodium (S)-lactate solution
5.38 g
0.184 g
0.051 g
2.10 g
1.68 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
1.36%
2.27%
3.86%
Glucose anhydrous (C
6
H
12
O
6
)
75.5 mmol/l
126 mmol/l
214 mmol/l
Na+
Ca
++
132 mmol/l
1.25 mmol/l
2
Mg
++
Cl
-
HCO
3
-
C
3
H
5
O
3
-
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 bicarbonate = 40 mmol/l).
3.
PHARMACEUTICAL FORM
Solution for peritoneal dialysis.
Sterile, clear, colourless solution.
The pH of the final solution is 7.4.
1.36%
2.27%
3.86%
Osmolarity (MOSMOL/L)
344
395
483
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 intoxi