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Gelofusine

Modified fluid gelatin

Volume Therapy

Gelofusine
Worldwide tried and tested
Gelofusine is a colloidal volume replacement fluid based on
4% modified fluid gelatin.
Several decades of experience in production and use of modified
fluid gelatins recommend B. Braun as the partner of choice in
the field of volume therapy.
Over the years, B. Braun has put together an impressive track
record with Gelofusine with proven pharmaceutical quality
and demonstrated therapeutical value.
Important advantages in comparison with other gelatins make
Gelofusine the most often used gelatin for modern volume
therapy.

Efficient and reliable volume effect when compared


to modern HES 130
Due to the special molecular structure with negative charges
on the surface, Gelofusine results in an efficient and reliable
volume effect when compared to modern HES 130 products:
Over the 6 hours following infusion, the magnitude and duration
of the volume effect of 4% modified fluid gelatin was similar
compared to Voluven and significantly greater than volume
effect produced by 0.9% NaCl in healthy volunteers (Fig. 2)1.
Due to its stretched polypeptide chains and the negative charge,
retention of Gelofusine in the circulation is prolonged.
Like albumin, Gelofusine is repelled by negatively charged capillary endothelium and provide a colloid osmotic pressure (COP)
that is comparable with albumin for effective treatment of
hypovolemia (Fig. 3)3.

Fig. 1: Molecular shape of different types of gelatin. Compare 4.

Polypeptide chains of
succinylated gelatin with strong
negative charge repel one another

Gelofusine (G) 4%
modified fluid gelatin
Voluven (V) 6% HES 130/0.4
Saline (S)

600
500
400
300
200
100
0

0.4

COP50/COP10 ratio

Change in blood volume

[ml] 700

Small and globular


polypeptide chains of
urea-linked gelatin

5
6
Time [hours]

Fig. 2: Changes in blood volume and extravascular fluid volume after infusion of
1 litre of 0.9% saline (S), 4% modified fluid gelatin (G) and 6% HES 130 (V)
over 1 hour 1.
p values S vs G < 0.0001; S vs V < 0.0001; G vs V = 0.70

0.3

0.2

0.1

Urea-linked
Gelatin

Human
Albumin

Gelofusine

Fig. 3: COP50 /COP10 ratios (as indicator for plasma retention). Adapted from3.

Voume Therapy

worldwide tried and tested


Not all gelatins are the same
As you cannot compare apples and oranges it is as well misleading
to equate different kinds of gelatins. Gelatins differ in their main
physicochemical properties which, in turn, have a significant impact
on clinical efficacy:
Succinylated or modified fluid gelatin (MFG): MWw of 30,000
Dalton, characterized by long stretched polypeptide chains
and a significant negative charge created by the succinylation.
n Urea-linked gelatin or Polygelin: MWw of 35,000 Dalton, small
and globular polypeptide chains, that are crosslinked by urea
bridges, only slight negative charge.
n

No risk of hyperchloremic acidosis


Some other gelatins contain a higher concentration of chloride,
when compared to plasma. The additional chloride intake increases the chloride level within the plasma and may lead to a
hyperchloremic acidosis. Hyperchloremic acidosis may cause
postoperative confusion, headache, abdominal pain, nausea and
vomiting, thereby hindering the patients recovery4,5. Due to its
plasma-like chloride content (120 mmol/L), Gelofusine is not
associated with the above mentioned clinical consequences.

Gelofusine is a modified fluid gelatin. Gelofusines polypeptide


chains have been stretched and negatively charged during the
succinylation process, so that they repel one another and occupy
considerably more space than other gelatins. These differences
result in a longer effect duration of Gelofusine compared to
other gelatins (Fig. 1 and Fig. 3)2,3.

Gelofusine product characteristics


User benefits

Isotonic solution for plasma volume replacement


Active ingredient
Concentration

Modified fluid gelatin


40 (4%)

Electrolytes: Sodium (mmol/l)


154

Chloride (mmol/l) 120
pH
Theoretical osmolarity
(mOsm/l)
Volume effect
Clinically relevant duration
of volume expansion

7.4 0.3
n

274
100%
4 hours

Proven efficacy and safety with more than


2 million applications per year worldwide
Appropriate and reliable hemodynamic
stabilization
Compatible with blood and all blood
products
No risks of hyperchloremic acidosis

Gelofusine
Composition
1000 ml solution contain:
Succinylated gelatin
(= modified fluid gelatin)

Therapeutic Indications
Colloidal plasma volume substitute for
40.00 g

(Molecular weight,
weight average:
30.000 Dalton
Molecular weight,
number average: 23.200 Dalton)

Sodium chloride
7.01 g
Electrolyte concentrations
Sodium
154 mmol/l
Chloride
120 mmol/l
Theoretical osmolarity: 274 mOsm/I
pH:
7.4 0.3

Prophylaxis and treatment of relative


or absolute hypovolaemia and of shock;
Prophylaxis of hypotension (e.g. during induction
of epidural or spinal anaesthesia);
- Procedures involving extracorporeal circulation
(e.g. heart-lung machine);
Acute normovolaemic haemodilution.
Contraindications
Gelofusine must not be administered in case of:
hypersensitivity to any of the constituents of
the solution,
hypervolaemia,
hyperhydration,
severe cardiac insufficiency,
severe blood coagulation disorders.

Special warnings and precautions for use


Gelofusine should be administered with caution
to patients with a history of allergic diseases, e.g.
asthma.
Gelofusine should only be administered with
caution to
- elderly patients
- patients at risk due to circulatory overload e.g.
patients with congestive heart failure, right
or left ventricular insufficiency, hypertension,
pulmonary oedema or renal insufficiency with
oligo- or anuria.
In such cases Gelofusine should only be given
under careful monitoring of the patients
haemodynamic situation.

The incidence of undesirable effects of


Gelofusine is as follows:
Rare: anaphylactoid reactions all grades
Very rare: Severe anaphylactoid reactions
Uncommon: Transient mild nausea or abdominal
pain, Transient mild rise of body temperature
B. Braun Melsungen AG
34212 Melsungen, Germany

Brandnames 4% MFG: Gelofusine, Physiogel CH , Gelafundin 4%

1. Lobo DN:
Effect of volume loading with 1 liter intravenous infusions of 0.9%
saline, 4% succinylated gelatine (Gelofusine) and 6% hydroxyethyl starch
(Voluven) on blood volume and endocrine responses: a randomized, three-way
crossover study in healthy volunteers.
Crit Care Med. 2010 Feb; 38(2): 464-70

4. Wilkes N J et al.:
The effects of balanced versus saline-based hetastarch and crystalloid
solutions on acid-base and electrolyte status and gastric mucosal perfusion
in elderly surgical patients
Anesth Analg 93 (2001) 811-816

2. Himpe D et al.:
Priming solutions for cardiopulmonary bypass: comparison of three colloids
Cardiothorac Vasc Anesth 5 (1991) 457-466

, Gelafundina

Undesirable Effects
After the administration of Gelofusine infusions,
just as of any colloidal volume substitutes, anaphylactoid reactions of varying degrees of severity
may occur.

5. Williams E L et al.:
The effect of intravenous Lactated Ringers solution versus 0.9% sodium
chloride solution on serum osmolarity in human volunteers
Anesth Analg 88 (1999) 999-1003

3. Webb A R et al.:
In vitro colloid osmotic pressure of commonly used plasma expanders
and substitutes: a study of the diffusibility of colloid molecules
Intensive Care Med 15 (1989) 116-120

B. Braun Melsungen AG | Hospital Care | 34209 Melsungen | Germany


Tel. +49 5661 71-0 | www.bbraun.com

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