Geloplasma, Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Modified liquid gelatine; Sodium chloride; Magnesium chloride hexahydrate; Potassium chloride; Sodium lactate solution

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

B05AA

INN (International Name):

Modified liquid gelatine; Sodium chloride; Magnesium chloride hexahydrate; Potassium chloride; Sodium lactate solution

Dosage:

3 gram(s)

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:

Not marketed

Authorization date:

2007-04-20

Summary of Product characteristics

Health Products Regulatory Authority
03 December 2020
CRN00C26W
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Geloplasma, Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
* 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.
The dose and infusion rate depend upon the patient's needs and blood
volume to be replaced and haemodynamic status of
the patient.
The dose administered is 500 to 1000 ml on average (1 to 2 bags),
so