Revised: February 2010
(ATCVet code amended)
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gelofusine Veterinary 4 % w/v Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gelofusine Veterinary 4 % w/v
Solution for Infusion contains
Succinylated Gelatin (Modified Fluid
Gelatin)
Sodium Chloride
Water for Injections
Electrolyte concentration
Na+
Cl-
Per 1000 ml
40.0 g
7.01 g
to 1000 ml
154 mmol/l
120 mmol/l
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for infusion
A clear, colourless or slightly yellowish aqueous solution.
4.
CLINICAL PARTICULARS
4.1
Target Species
Horse, dog and cat.
4.2
Indications for use, specifying the target species
Plasma volume substitute for use in the initial management of
hypovolaemic shock due to, for example, haemorrhage, acute trauma or
surgery, burns, sepsis, peritonitis or crush injury.
4.3
Contra-indications
Do not use in animals with known hypersensitivity to gelatin.
4.4
Special warnings
Should not be used to prevent falls in arterial pressure consequent on
spinal or epidural anaesthesia.
Revised: February 2010
(ATCVet code amended)
4.5
Special precautions for use
i.
Special precautions for use in animals
To be given with care to animals who are susceptible to
circulatory overloading (ie severe congestive cardiac failure or
renal failure with oliguria or anuria) since excessive volumes
may give rise to circulatory overload and electrolyte imbalance.
Treatment
The infusion should be stopped and the animal treated
symptomatically. Electrolytes should be monitored. If
necessary a diuretic may be given to promote fluid loss.
Decreased urinary output secondary to shock is not a
contraindication unless there is no improvement in urine output
after the initial dose of the product.
ii.
Special precautions to be taken by the person
administering the veterinary medicinal product to animals
None
iii.
Other precautions
None
4.6
Adverse reactions
In common with other plasma volume expanders, mild urticarial reactions
have been reported.
Severe anaphylactoid reactions following use of the product occur in
humans with a reported incidence of between one in 6,000 and one in
13,000 units administered. Such reactions are related to the release of
vasoactive substances and can be assumed to be more frequent and
particularly hazardous in animals with known allergic conditions such as
asthma.
Treatment
The infusion of gelatin should be stopped. Further treatment will depend
upon the severity of the anaphylactic reaction. Administration of
supplemental oxygen; an alternative intravenous fluid; and the parenteral
administration of adrenaline and an antihistamine should be considered.
4.7
Use during pregnancy and lactation
There is very little information available on the use of plasma substitutes
in pregnant or lactating animals. As with all drugs, the benefits and risks
of use should be assessed in the light of the animal's condition. The
product may be used in the initial treatment of blood loss during
pregnancy where plasma volume replacement is needed.
Revised: February 2010
(ATCVet code amended)
4.8
Interaction with other medicinal products and other forms of
interaction
None known
4.9
Amounts to be administered and administration route
Dosage recommendations for horses, cats and dogs
Administer intravenously. Use aseptic precautions. The volume and rate
of administration will depend upon the condition of the animal, its species
and body weight. In general the dose required is approximately
equivalent to the calculated volume loss.
The rate of administration can be increased by the application of pressure
to the container or by use of a giving set pump. When given rapidly it
should be warmed to no more than 37°C if possible. In severe acute
blood loss, a volume equivalent to 1% of body weight may be given in 510 minutes until signs of hypovolaemia are relieved. When large volumes
are infused suitable monitoring should be employed to ensure that an
adequate haematocrit is maintained (the haematocrit should not be
allowed to fall below 25%), and that dilutional effects upon coagulation are
avoided. (Expert haematological advice should be sought especially in
cases of massive blood loss).
For massive fluid loss, the product may be used concomitantly with blood,
the rate and amount of which would depend upon the clinical condition of
the animal. The haemodynamic status of the animal should be monitored.
If blood is to be given at the same time, it can be given through the same
giving set since the product has a negligible calcium content and therefore
does not clot blood. It can also be used to reconstitute packed red cells.
4.10
Overdose (symptoms, emergency procedures, antidotes)
Overdose will be manifested as circulatory overload and electrolyte
imbalance. See 'Special Precautions for Use' for treatment.
4.11
Withdrawal period(s)
Not to be used in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horses must have been declared as not intended for human
consumption under national horse passport legislation.
5.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group:
Blood Substitutes and perfusion solutions, Blood and related products,
Blood substitutes and plasma protein fractions.
Revised: February 2010
(ATCVet code amended)
ATCvet code: QB05AA06
Succinylated gelatin solution is a colloidal plasma volume substitute.
Blood substitute and plasma protein fractions - gelatin agents
5.1
Pharmacodynamic Properties
When used in the treatment of hypovolaemia, plasma substitutes like
gelatin produce significant increases in blood volume, cardiac output,
stroke volume, blood pressure, urinary output and oxygen delivery.
5.2
Pharmacokinetic Particulars
The half life is about four hours, with the majority of the dose being
eliminated by renal excretion within 24 hours.
Colloidal gelatin promotes an osmotic diuresis, thereby helping protect the
kidneys from the adverse effects of hypovolaemia.
Environmental Properties
Not applicable.
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Water for injections
Sodium Chloride
Sodium Hydroxide, for pH adjustment
6.2
Incompatibilities
Although water soluble drugs can be given concomitantly, experience is
limited. If essential, they may be given through the giving set, close to the
IV cannula. The small calcium content does not give rise to clotting in the
giving set when citrated blood precedes or follows its administration.
The product does not interfere with blood grouping or cross-matching.
6.3
Shelf-life
Shelf-life of the veterinary product as packaged for sale
Low density polyethylene bottles - 3 years
Shelf-life after dilution or reconstitution according to directions
Not applicable.
Shelf-life after first opening the container
Revised: February 2010
(ATCVet code amended)
The infusion should commence immediately after connecting the
container to the giving set.
Dispose of any unused product.
6.4
Special precautions for storage
Do not store above 25°C. Do not freeze.
Only clear solution should be used; it contains no preservative and any
unused product should be discarded once the seal has been opened.
6.5
Nature and composition of immediate packaging
Available in plastic bottles (polyethylene) of 500 ml.
Pack size: 10 bottles of 500ml
6.6
Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from
such veterinary medicinal products should be disposed of in accordance
with local requirements.
7.
MARKETING AUTHORISATION HOLDER
B Braun Vet Care GmbH
Am Aesculap-Platz
78532 Tuttlingen
Germany
8.
MARKETING AUTHORISATION NUMBER(S)
Vm 30026/4000
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
09.04.1985 / 03.06.2002
10.
DATE OF REVISION OF THE TEXT
February 2010