Sterofundin ISO, solution for infusion

Država: Malta

Jezik: angleščina

Source: Malta Medicines Authority

Aktivna sestavina:

CALCIUM CHLORIDE, DIHYDRATE, POTASSIUM CHLORIDE, MALIC ACID, MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM ACETATE, TRIHYDRATE, SODIUM CHLORIDE

Dostopno od:

B Braun Melsungen AG Carl-Braun-Strasse 1, D34212 Melsungen, Germany

Koda artikla:

B05BB01

INN (mednarodno ime):

CALCIUM CHLORIDE DIHYDRATE 0.37 g/l POTASSIUM CHLORIDE 0.3 g/l L-MALIC ACID 0.67 g/l MAGNESIUM CHLORIDE HEXAHYDRATE 0.2 g/l SODIUM ACETATE TRIHYDRATE 3.27 g/l SODIUM CHLORIDE 6.8 g/l

Farmacevtska oblika:

SOLUTION FOR INFUSION

Sestava:

CALCIUM CHLORIDE DIHYDRATE 0.37 g/l POTASSIUM CHLORIDE 0.3 g/l L-MALIC ACID 0.67 g/l MAGNESIUM CHLORIDE HEXAHYDRATE 0.2 g/l SODIUM ACETATE TRIHYDRATE 3.27 g/l SODIUM CHLORIDE 6.8 g/l

Tip zastaranja:

POM

Terapevtsko območje:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Status dovoljenje:

Authorised

Datum dovoljenje:

2013-03-15

Navodilo za uporabo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
STEROFUNDIN ISO SOLUTION FOR INFUSION
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 or pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. this
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sterofundin ISO is and what it is used for
2.
What you need to know before you receive Sterofundin ISO
3.
How to use Sterofundin ISO
4.
Possible side effects
5.
How to store Sterofundin ISO
6.
Contents of the pack and other information
1.
WHAT STEROFUNDIN ISO IS AND WHAT IT IS USED FOR
Sterofundin ISO is a solution for infusion into a vein.
This solution replaces fluid that has been lost from the circulation.
It can be used in conditions where
your blood may become or has become slightly acidic.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE STEROFUNDIN ISO
YOU WILL NOT BE GIVEN STEROFUNDIN ISO
if you have
–
too much fluid in the circulation,
–
severe heart disease with shortness of breath and swelling of the feet
or the legs,
–
severe kidney disease and you are unable or almost unable to pass
urine,
–
swelling of your body tissues due to fluid accumulation,
–
high levels of potassium or calcium in your blood,
–
or if your blood is too alkaline.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Sterofundin ISO.
Special care will be taken with Sterofundin ISO Solution for infusion,
if you have
–
any disease that makes it necessary to reduce your salt intake, such
as mild or moderately
impaired heart function, tissue swelling or fluid accumulation in the
lungs
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–
sarcoidosis (a chronic immune system disorder involving the lymph
nodes and the connective
tissue)
–
mildly or moderately increased blood pressure
–
acute water deficit e.g. following extensive tissue

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sterofundin ISO, solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml Sterofundin ISO solution for infusion contain:
Sodium chloride
6.80 g
Potassium chloride
0.30 g
Magnesium
chloride
hexahydrate
0.20 g
Calcium
chloride
dihydrate
0.37 g
Sodium
acetate
trihydrate
3.27 g
L-Malic acid
0.67 g
Electrolyte
concentrations:
mmol/l
Sodium
145.0
Potassium
4.0
Magnesium
1.0
Calcium
2.5
Chloride
127.0
Acetate
24.0
Malate
5.0
Excipients with known effect:
1000 ml Sterofundin ISO solution contain 0.2 g Sodium hydroxide (0.115
g Sodium).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for infusion.
A clear, colourless aqueous solution free from visible particles.
pH: 5.1 – 5.9
Theoretical osmolarity: 309 mosm/l.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Replacement of extracellular fluid losses in the case of isotonic
dehydration, where acidosis is
present or imminent.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, the elderly, adolescents and children:
The dosage depends on the age, weight, clinical and biological
conditions of the patient and
concomitant therapy.
Recommended dosage:
The recommended dosage is:
-
for adults, the elderly and adolescents : 500 ml to 3 litres /24h,
corresponding to 1 to 6 mmol
sodium / kg / 24 h and 0.03 to 0.17 mmol potassium / kg / 24 h.
_ _
-
for toddlers, infants and children : 20 ml to 100 ml / kg / 24 h,
corresponding to 3 to 14 mmol
sodium / kg / 24 h and 0.08 to 0.40 mmol potassium / kg / 24 h.
Administration rate:
The
maximum
infusion
rate
depends
on
the
needs
of
the
patient
in
fluid
replacement
and
electrolytes, his weight, clinical condition, and biological status.
In paediatric patients the infusion rate is 5 ml/kg/h on average but
the value varies with age: 6-8
ml/kg/h for infants, 4-6 ml/kg/h for toddlers, and 2-4 ml/kg/h for
children.
Note:
•
infants and toddlers: age ranges from about 28 days to 23 months (a
toddler is an infant who