Balance 4.25% Glucose, 1.25mmol/l calcium, solution for peritoneal dialysis

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

CALCIUM, GLUCOSE

Disponible des:

Fresenius Medical Care Deutschland GmbH D-61346 Bad Homburg, Germany

Codi ATC:

B05DB

Designació comuna internacional (DCI):

CALCIUM 1.25 mmol/l GLUCOSE 4.25 % (W/V)

formulario farmacéutico:

SOLUTION FOR PERITONEAL DIALYSIS

Composición:

CALCIUM 1.25 mmol/l GLUCOSE 4.25 % (W/V)

tipo de receta:

POM

Área terapéutica:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Estat d'Autorització:

Withdrawn

Data d'autorització:

2006-04-06

Informació per a l'usuari

Package leaflet
balance 4.25% glucose, 1.25 mmol/l calcium
Page
1
of
9
PACKAGE LEAFLET: INFORMATION FOR THE USER
_balance_
4.25% glucose, 1.25 mmol/l calcium, 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, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What
_balance_
is and what it is used for
2. What you need to know before you use
_balance_
3. How to use
_balance_
4. Possible side effects
5.
How to store
_balance_
6. Contents of the pack and other information
1. WHAT _BALANCE_ IS AND WHAT IT IS USED FOR
_BALANCE_ IS USED FOR CLEANING THE BLOOD
via the peritoneum in patients with end-stage chronic
kidney failure. This type of blood cleaning is called peritoneal
dialysis.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE _BALANCE_
DO NOT USE _BALANCE_ 4.25% GLUCOSE, 1.25 MMOL/L CALCIUM
•
if the level of
POTASSIUM IN YOUR BLOOD IS VERY LOW
•
if the level of
CALCIUM IN YOUR BLOOD IS VERY LOW
•
if the
VOLUME OF YOUR BODY FLUIDS IS TOO LOW
•
if you have
LOW BLOOD PRESSURE
•
if you have a DISORDER OF METABOLISM KNOWN AS LACTIC ACIDOSIS
PERITONEAL DIALYSIS TREATMENT MUST NOT BE STARTED IF YOU HAVE
•
ALTERATIONS IN THE ABDOMINAL REGION
such as
-
injuries or after surgery
-
burns
-
large inflammatory skin reactions
-
inflammation of the peritoneum
-
non-healing weeping wounds
-
umbilical, inguinal or diaphragmatic hernias
-
tumours in the abdomen or bowel
Package leaflet
balance 4.25% glucose, 1.25 mmol/l calcium
Page
2
of
9
•
inflammatory bowel diseases
•
intestinal obstruction
•
lung diseas

Fitxa tècnica

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_balance_
1.5%
glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
_balance_
2.3%
glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
_balance_
4.25% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
_balance_
1.5%
glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
_balance_
2.3%
glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
_balance_
4.25% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_balance_
1.5%/2.3%/4.25% glucose, 1.25/1.75 mmol/l calcium is delivered in a
double chamber bag.
One chamber contains the alkaline lactate solution, the other chamber
contains the acidic glucose-
based electrolyte solution. Mixing of both solutions by opening the
middle seam between the two
chambers results in the neutral ready-to-use solution.
BEFORE RECONSTITUTION
1 litre of acidic glucose based electrolyte solution contains:
_balance_
1.5%
glucose,
1.25
mmol/l
calcium
_balance_
2.3%
glucose,
1.25
mmol/l
calcium
_balance_
4.25%
glucose,
1.25
mmol/l
calcium
_balance_
1.5%
glucose,
1.75
mmol/l
calcium
_balance_
2.3%
glucose,
1.75
mmol/l
calcium
_balance_
4.25%
glucose,
1.75
mmol/l
calcium
Calcium
chloride
dihydrate
0.3675 g
0.3675 g
0.3675 g
0.5145 g
0.5145 g
0.5145 g
Sodium
chloride
11.279 g
11.279 g
11.279 g
11.279 g
11.279 g
11.279 g
Magnesium
chloride
hexahydrate
0.2033 g
0.2033 g
0.2033 g
0.2033 g
0.2033 g
0.2033 g
Glucose
monohydrate
(anhydrous
glucose)
33.0 g
(30.0 g)
50.0 g
(45.46 g)
93.5 g
(85.0 g)
33.0 g
(30.0 g)
50.0 g
(45.46 g)
93.5 g
(85.0 g)
1 litre of alkaline lactate solution contains:
Sodium (S)-lactate solution 15.69 g
(sodium (S)-lactate 7.85 g)
Page 2 of 15
AFTER RECONSTITUTION
1 litre of the neutral
_ _
ready-to-use solution contains:
_balance_
1.5%
glucose,
1.25
mmol/l
calcium
_balance_
2.3%
glucose,
1.25
mmol/l
calcium
_balance_
4.25%
glucose,
1.25
mmol/l
calcium
_balance_
1.5%
glucose,
1.75
mmol/l
calcium