GELOFUSINE succinylated gelatin 20g/500mL

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

succinylated gelatin, Quantity: 40 g/L

Available from:

B Braun Australia Pty Ltd

INN (International Name):

succinylated gelatin

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; sodium hydroxide; water for injections

Administration route:

Intravenous

Units in package:

10 x 500mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Gelofusine is indicated as a collodial plasma volume substitute in:Treatment and prevention of hypovolaemia: Absolute hypovolaemia from haemorrhage or other cases of intravascular fluid loss or perioperative intravascular fluid maintenance; and Relative hypovolaemia secondary to induction of epidural or spinal anaesthesia, non-hypovolaemic shock. 2.Haemodilution (perioperative, therapeutic venesection); 3.Extra-corporeal circulation (cardiac surgery, plasma exchange, haemodialysis).

Product summary:

Visual Identification: Clear, faintly yellow solution free from particles.; Container Type: Bag; Container Material: Other composite material; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2001-05-23

Patient Information leaflet

B.Braun Australia Pty Ltd
Page
1
CONSUMER MEDICINE INFORMATION
GELOFUSINE®
SUCCINYLATED GELATIN SOLUTION 4% FOR INTRAVENOUS INFUSION
1.WHAT IS IN THIS LEAFLET
This leaflet contains some common questions about Gelofusine.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist
All medicines have risks and benefits. Your doctor or pharmacist has
weighed the risk of
you taking this medicine against the benefits they expect it will have
for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
2. WHAT IS GELOFUSINE USED FOR?
Gelofusine is a plasma volume substitute. This means, it replaces
fluid lost from the
circulation.
Gelofusine is used to replace blood and body fluid, which have been
lost as a result of, for
example, an operation, an accident or a burn. It can be used instead
of, or as well as, a blood
transfusion.
It may also be used for filling up the circulating blood volume during
use of the heart-lung
machine or artificial kidney.
3. BEFORE YOU ARE GIVEN GELOFUSINE
_WHEN YOU MUST NOT BE GIVEN GELOFUSINE _
_ _
DO NOT USE GELOFUSINE
● if you are allergic (hypersensitive) to gelatin or any of the
other ingredients of Gelofusine.
● if your circulating blood volume is too large
● if you have excess fluid in your body
● if you are at markedly increased risk of bleeding because your
blood clotting is severely
impaired.
TAKE SPECIAL CARE WITH GELOFUSINE
PLEASE INFORM YOUR DOCTOR
● if you have problems with your heart or your kidneys because
giving large amounts of
liquids through an intravenous drip may affect these organs
● if you are suffering from allergic diseases such as asthma,
because you may be at a greater
risk to experience an allergic reaction.
All plasma substitutes carry a slight risk of allergic reactions that
are mostly mild or moderate
but can in very few cases also become severe. Such reactions are
assumed to be more
frequent in patients with known allergic c

Summary of Product characteristics

0d1d1d1d1d0d1
340/NP34041/0403
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PHYSICAL AND CHEMICAL CHARACTERISTICS
Gelofusine® contains:
per 500 mL
per 1000 mL
Succinylated Gelatin
20.0 g
40.0 g
(Modified Fluid Gelatin)
Sodium Chloride
3.51 g
7.01 g
Sodium Hydroxide
0.68 g
1.36 g
_Electrolytes_
Na
+
77.0 mmol
154.0 mmol
Cl
–
60.0 mmol
120.0 mmol
_Physico-Chemical Properties:_
Weight average molecular weight (Mw)
30,000 Dalton
Number average molecular weight (Mn)
23,200 Dalton
pH
7.4 ± 0.3
Relative viscosity (at 37 °C)
1.9
Iso-electric point
pH 4.5 ± 0.3
Colloid osmotic pressure (at 37 °C)
453 mm H
2
O
33.3 mm Hg
Gel point
≤
3 °C
Osmolarity
274 mOsm/L
_Description_
Gelofusine® is manufactured from gelatin derived from bovine material
sour-
ced only from BSE-free cattle in the USA. It is a 4 % colloidal
solution of suc-
cinylated gelatin (also known as Modified Fluid Gelatin) in
physiological sali-
ne. The resultant solution is clear. The weight average molecular
weight (Mw)
of the succinylated gelatin is 30,000 Dalton.
PHARMACOLOGY
_Pharmacodynamic Properties_
Succinylation of the gelatin molecule results in a negatively charged
molecu-
le with consequent spatial expansion. Due to this property it fills
more volu-
me than non-succinylated protein chains of the same molecular weight.
_Pharmacokinetic Properties_
Gelofusine® has a volume effect lasting approximately 3–4 hours.
The major
route of elimination is urinary excretion, with only a very small
amount excre-
ted in the faeces. Only about 1 % of the infused drug is metabolised.
ANIMAL TOXICOLOGY
Limited studies of the toxicity of Gelofusine® in animals have been
underta-
ken. The animal studies available indicate that the maximum dosage of
Gelo-
fusine® is limited by the volume infused and its haemodiluting
effects.
INDICATIONS
Gelofusine® is indicated as a colloidal plasma volume substitute in:
1. Treatment and prevention of hypovolaemia
- absolute hypovolaemia from haemorrhage or other cases of
intravascular
fluid loss or perioperative intravascular fluid maintenance; and