GELOPLASMA 3 Grams Solution for Infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
01-02-2018
Summary of Product characteristics
(SPC)
01-02-2018
Active ingredient:
MODIFIED LIQUID GELATINE, SODIUM CHLORIDE, MAGNESIUM CHLORIDE HEXAHYDRATE, POTASSIUM CHLORIDE, SODIUM LACTATE SOLUTION
Available from:
Fresenius Kabi Limited
ATC code:
B05AA
INN (International Name):
MODIFIED LIQUID GELATINE, SODIUM CHLORIDE, MAGNESIUM CHLORIDE HEXAHYDRATE, POTASSIUM CHLORIDE, SODIUM LACTATE SOLUTION
Dosage:
3 Grams
Pharmaceutical form:
Solution for Infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Blood substitutes and plasma protein fractions
Authorization status:
Authorised
Authorization date:
2007-04-20
Patient Information leaflet
WHAT IS IN THIS LEAFLET
1. What GELOPLASMA, solution for infusion, is and what it is used for
2. What you need to know before you use GELOPLASMA, solution for
infusion
3. How to use GELOPLASMA, solution for infusion
4. Possible side effects
5. How to store GELOPLASMA, solution for infusion
6. Contents of the pack and other information
1. WHAT GELOPLASMA, SOLUTION FOR INFUSION, IS AND WHAT IT IS USED FOR
GELOPLASMA is a solution for intravenous infusion. It contains
gelatin, which belongs to
a group of medicines known as plasma volume expanders. Plasma volume
expanders
work by increasing the fluid in your blood stream, which helps keep
your blood stream and
therefore your blood pressure stable.
This medicine is an emergency treatment in case of low blood volume in
the following
situations:
• Haemorrhage
_(bleeding),_
dehydration,
capillary
leak
_(increased _
_microvascular _
_permeability),_
burns;
• severe vasodilatation _(widening of blood vessels)_ from
traumatic, surgical, septic or toxic
origin.
It is also used in the treatment of low blood volume associated with
hypotension _(low blood_
_pressure)_
in the context of severe vasodilatation related to the effects of
hypotensive
drugs, notably during anesthesia.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GELOPLASMA,SOLUTION FOR
INFUSION
DO NOT USE GELOPLASMA, SOLUTION FOR INFUSION:
• if you are allergic to gelatin or any of the other ingredients of
this medicine (listed in sec-
tion 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 you have an excess of fluid in the body;
• if you have hyperkalaemia _(excess of potassium in the blood)_;
• if you have an high accumulation of alkaline substance (e.g.
bicarbonate, lactate) in your
blood and body fluid;
• if you are at the end of pregnancy (during labour/delivery): see
"Pregnancy, breast-
feeding and fertility" section.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using GELOPLASMA,
solutio
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Geloplasma, Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
* partially hydrolysed and succinylated
For the full list of excipients, see section 6.1.
Ionic formula
Sodium
=
150
mmol/l
Potassium
=
5
mmol/l
Magnesium
=
1.5 mmol/l
Chloride
=
100
mmol/l
Lactate
=
30
mmol/l
Total osmolality: 295 mOsm/kg
pH: 5.8 to 7.0
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear and colourless to slightly yellowish solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Emergency treatment of states of shock:
-
hypovolaemic shock resulting from : haemorrhage, dehydration,
capillary leak, burns;
-
vasoplegic shock of traumatic, surgical, septic or toxic origin.
Treatment of relative hypovolaemia associated with hypotension in the
context of vasoplegia related to the effects of
hypotensive drugs, notably during anesthesia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage volume and rate of administration depend upon the individual
patient status, circumstances and response to
vascular replacement.
Modified liquid gelatin is given by IV infusion (drip infusion). The
infusion rate can be increased using a pump.
Modified liquid gelatin*
amount expressed as anhydrous gelatin
……………………………………....
3.0000 g
Sodium chloride
………………………………………………………………
0.5382 g
Magnesium chloride hexahydrated
…………………………………………...
0.0305 g
Potassium chloride
……………………………………………………………
0.0373 g
Sodium (S)-lactate solution
amount expressed as sodium lactate
………………………………………….
0.3360 g
per 100 ml of solution for infusion
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