Gelaspan 4% solution for infusion

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

CALCIUM CHLORIDE, DIHYDRATE, GELATIN, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM ACETATE, TRIHYDRATE, SODIUM CHLORIDE

זמין מ:

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

קוד ATC:

B05AA06

INN (שם בינלאומי):

CALCIUM CHLORIDE DIHYDRATE 0.15 g/l GELATIN 40 g/l POTASSIUM CHLORIDE 0.3 g/l MAGNESIUM CHLORIDE HEXAHYDRATE 0.2 g/l SODIUM ACETATE TRIHYDRATE 3.27 g/l SODIUM CHLORIDE 5.55 g/l

טופס פרצבטיות:

SOLUTION FOR INFUSION

הרכב:

CALCIUM CHLORIDE DIHYDRATE 0.15 g/l GELATIN 40 g/l POTASSIUM CHLORIDE 0.3 g/l MAGNESIUM CHLORIDE HEXAHYDRATE 0.2 g/l SODIUM ACETATE TRIHYDRATE 3.27 g/l SODIUM CHLORIDE 5.55 g/l

סוג מרשם:

POM

איזור תרפויטי:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

מצב אישור:

Authorised

תאריך אישור:

2011-06-17

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
GELASPAN SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE .
● Keep this leaflet. You may need to read it again.
● If you have any further questions, ask your doctor or pharmacist.
● This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
● If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Gelaspan is and what it is used for
2. What you need to know before you use Gelaspan
3. How to use Gelaspan
4. Possible side effects
5. How to store Gelaspan
6. Further information
1.
WHAT GELASPAN IS AND WHAT IT IS USED FOR
Gelaspan is a so-called plasma volume substitute. This means that it
replaces fluid lost from
your blood vessels.
Gelaspan is used to:
●
Replace blood and body fluid, which have been lost following for
example, an operation,
an accident or a burn. It may be combined with blood transfusions, if
necessary.
●
Prevention of low blood pressure (hypotension) which may occur when
you are receiving
spinal or epidural anaesthesia or due to imminent severe blood loss in
a surgical setting.
●
Fill up the circulating blood volume during the use of for example
heart-lung machine in
combination with other fluids for infusion
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE GELASPAN
DO NOT USE GELASPAN
● if you are allergic to gelatin or any of the other ingredients of
this medicine (listed in
section 6)
● if you are allergic to an allergen called
“galactose-α-1,3-galactose (alpha-Gal)” or to red
meat (mammal meat) and offal
● if your circulating blood volume is too large
● if you have too much water in your body
●
if you have certain types of heart failure (acute congestive heart
failure)
● if you have an abnormally high blood potassium level.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before usin

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gelaspan solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml solution contain:
Succinylated gelatine (= modified fluid gelatine)
40.0
g
(Molecular weight, weight average: 26 500 Dalton)
Sodium chloride
5.55
g
Sodium acetate trihydrate
3.27
g
Potassium chloride
0.30
g
Calcium chloride dihydrate
0.15
g
Magnesium chloride hexahydrate
0.20
g
_ _
_Electrolyte concentrations _
Sodium
151
mmol/l
Chloride
103
mmol/l
Potassium
4
mmol/l
Calcium
1
mmol/l
Magnesium
1
mmol/l
Acetate
24
mmol/l
_ _
_Excipients: _
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless or slightly yellowish solution
Theoretical osmolarity: 284 mosmol/l
pH: 7.4 ± 0.3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gelaspan is a colloidal plasma volume substitute in an isotonic, fully
balanced electrolyte
solution for:
•
Treatment of relative or absolute hypovolaemia and shock
•
Prophylaxis of hypotension
- caused by relative hypovolaemia during induction of epidural or
spinal anaesthesia
- due to imminent significant blood loss in a surgical setting
•
Procedures involving extracorporeal circulation as a component of
priming fluid in
combination with crystalloid solutions (e.g. heart-lung machine)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
As with all colloids, Gelaspan
should only be used if hypovolaemia can not be sufficiently
treated with crystalloids alone. In severe hypovolaemia colloids are
usually applied in
combination with crystalloids
.
Volume overload due to overdose or too rapid infusion must always be
avoided. The dosage
must be adjusted carefully, particularly in patients with pulmonary or
cardiocirculatory
problems.
Posology
Dosage and infusion rate are adjusted according to the amount of blood
loss and to individual
needs for restoration and maintenance of a stable haemodynamic
situation, respectively. The
dose administered is initially 500 to 1000 ml on average, in case of
sever