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

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

CALCIUM CHLORIDE, DIHYDRATE, GLUCOSE MONOHYDRATE, MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE, SODIUM LACTATE

Commercializzato da:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

Codice ATC:

B05DB

INN (Nome Internazionale):

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

Forma farmaceutica:

SOLUTION FOR PERITONEAL DIALYSIS

Composizione:

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

Tipo di ricetta:

POM

Area terapeutica:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2006-03-06

Foglio illustrativo

1
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 substances or any of the other
i

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Physioneal 40 Glucose
2.27% w/v / 22.7 mg/ml Solution for peritoneal dialysis
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Before mixing
1000 ML OF ELECTROLYTE SOLUTION (SMALL CHAMBER
″
A
″
)
Glucose Monohydrate
equivalent to Anhydrous Glucose
Calcium Chloride Dihydrate
Magnesium Chloride Hexahydrate
68.85 g/l
62.6 g/l
0.507 g/l
0.140 g/l
1000 ML OF BUFFER SOLUTION (LARGE CHAMBER
″
B
″
)
Sodium Chloride
Sodium Bicarbonate
Sodium Lactate
8.43 g/l
3.29 g/l
2.63 g/l
After mixing
1000 ML OF THE MIXED SOLUTION CONTAINS:
Glucose monohydrate
equivalent to Anhydrous Glucose
Sodium Chloride
Calcium Chloride Dihydrate
Magnesium Chloride Hexahydrate
Sodium Bicarbonate
Sodium Lactate
25.0 g/l
22.7 g/l
5.38 g/l
0.184 g/l
0.051 g/l
2.10 g/l
1.68 g/l
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
Anhydrous Glucose (C
6
H
12
O
6
)
Sodium (Na+)
Calcium
(Ca
++
)
Magnesium (Mg
++
)
Chloride (Cl
-
)
Bicarbonate (HCO
3
-
)
Lactate (C
3
H
5
O
3
-
)
126 mmol/l
132 mmol/l
1.25 mmol/l
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.
Osmolarity (MOSMOL/L)
395
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 intoxication with dialysable substances, when a more adequate
therapeutic alternative is not
available.
Bicarbonate/lactate
_ _
based Physioneal 40 peritoneal dialysis solutions with a physiological
pH are
particularly indicated in patients in whom solutions