Repose 500 mg/ml Solution for Injection

(equivalent to 500 mg pentobarbital sodium)
Excipients:
Qualitative composition of excipients
and other constituents
Quantitative composition if that
information is essentialfor proper
administration of the veterinary
medicinal product
Patent blue V (E131)0.01 mgEthanol (96 per cent) Hydrochloric acid, dilute (for pH
adjustment)
Sodium hydroxide (for pH adjustment) Water for injections
Clear, blue aqueous solution.
3. CLINICAL INFORMATION
3.1 Target species
Dogs, cats, rodents, rabbits, cattle, sheep, goats, pigs, horses and minks.
3.2 Indications for use for each target species
Euthanasia.
3.3 Contraindications
Do not use for anaesthesia.
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3.4 Special warnings
Intravenous injection of pentobarbital has the ability to cause induction excitement in
several species of animal and adequate sedation should be applied if deemed
necessary by the veterinary surgeon. In horses, cattle and pigs, premedication with
an appropriate sedative is mandatory to produce profound sedation before
euthanasia. Measures should be taken to avoid perivascular administration (e.g. by
using an intravenous catheter).
In pigs, it was shown that there is a direct correlation between restraint and level of
excitation and agitation. Therefore, injection in pigs should be done with the least
amount of restraint necessary.
Due to the difficulty of safe intravenous injections in pigs, adequate sedation of the
animal before IV administration of pentobarbital is mandatory.
The intraperitoneal route of administration may cause a prolonged onset of action
with an increased risk of induction excitement. Intraperitoneal administration must
only be used following appropriate sedation. Measures should be taken to avoid
administration into the spleen or organs/tissue with low capacity for absorption. This
route of administration is only suitable for small animals.
Intracardiac injection must only be used if the animal is heavily sedated,
unconscious, or anesthetised.
3.5 Special precautions for use
Special precautions for safe use in the target species:
In the event of accidental administration to an animal not presented for euthanasia,
measures such as artificial respiration, administration of oxygen and the use of
analeptics are appropriate.
When an aggressive animal is to undergo euthanasia, premedication with a more
easily administered (oral, subcutaneous or intramuscular) sedative is recommended.
To reduce the risk of induction excitement, euthanasia should be performed in a quiet
area.
In horses and cattle, an alternative method of euthanasia should be available should
it become necessary.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
For use by a veterinary surgeon only.
Pentobarbital is a potent hypnotic and a sedative which is toxic in humans. It can be
absorbed systemically through the skin or eye and if swallowed. Systemic uptake
(including absorption via skin or eye) of pentobarbital causes sedation, sleep, CNS
and respiratory depression. Particular care should be taken to avoid accidental
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ingestion and self-injection. Only carry this veterinary medicinal product in an
unarmed syringe to avoid accidental injection.
In the case of accidental ingestion, wash out mouth and obtain medical attention
immediately.
Accidental spillage on the skin or in the eye must be washed off immediately with
plenty of water.
Avoid accidental self-injection or accidental injection of other persons when
administering the veterinary medicinal product.
In case of accidental self-injection or serious skin and/or eye contact, seek medical
advice immediately and show the package leaflet or the label to the physician. But
DO NOT DRIVE as sedation may occur.
Embryotoxic effects cannot be excluded.
Pregnant and breastfeeding women must take extra precautions when handling this
veterinary medicinal product.
This veterinary medicinal product may be irritating to the eye and can cause irritation
to the skin as well as hypersensitivity reactions (due to the presence of
pentobarbital). People with known hypersensitivity to pentobarbital should avoid
contact with the veterinary medicinal product.
Avoid direct contact with the skin and eyes, including hand-to-eye contact.
This medicine should only be administered by veterinarians and should only be used
in the presence of another professional that can assist in case of accidental
exposure. Instruct the professional if not a medical professional about the risks of the
veterinary medicinal product.
Personal protective equipment consisting of impervious gloves should be worn when
handling the veterinary medicinal product.
Do not smoke, eat or drink while handling the veterinary medicinal product.
After administration of this veterinary medicinal product, collapse will occur within 10
seconds. In case the animal is standing at time of administration, care should be
taken by the person administering the veterinary medicinal product and any other
persons present to keep a safe distance from the animal to avoid injury.
This veterinary medicinal product is flammable. Keep away from sources of ignition.
Information for the health professional in case of exposure:
Emergency measures should be directed toward maintenance of respiration and
cardiac function. In severe intoxication measures to enhance elimination of absorbed
barbiturate may be necessary.
The concentration of pentobarbital in the veterinary medicinal product is such that the
accidental injection or ingestion of quantities as small as 1 ml in human adults can
have serious CNS effects. A dose of pentobarbital sodium of 1 g (equivalent to 2 ml
of veterinary medicinal product) has been reported to be fatal in humans. Treatment
should be supportive with appropriate intensive therapy and maintenance of
respiration.
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Special precautions for the protection of the environment:
Not applicable.
Other precautions:
Carcases of animals euthanised with this veterinary medicinal product should be
disposed of in accordance with national legislation. Carcases of animals euthanised
with this veterinary medicinal product should not be fed to other animals due to the
risk of secondary intoxication.
3.6 Adverse events
Dogs, cats, rodents, rabbits, cattle, sheep, goats, pigs, horses and minks:
Common
(1 to 10 animals / 100 animals
treated):
Twitching
a
Uncommon
(1 to 10 animals / 1,000
animals treated):
Agonal breathing
b
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Excitation
c
a
Minor.
b
May occur after cardiac arrest. At this stage the animal is already clinically dead.
c
Premedication/sedation significantly reduces the risk of experiencing induction
excitement.
Death may be delayed if the injection is administered perivascularly or into
organs/tissues with low capacity for absorption. Barbiturates can be irritating when
administered perivascularly or subcutaneously.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See the package leaflet for
respective contact details.
3.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
If euthanasia is necessary, the veterinary medicinal product can be used in pregnant
or lactating animals. The increased body weight of pregnant animals should be taken
into account in the dose calculation. Whenever possible, the veterinary medicinal
product should be injected intravenously. The foetus must not be removed from the
maternal body (e.g. for examination purposes) earlier than 25 minutes after
confirmation of the death of the mother. In this case, the foetus is to be examined for
signs of life and, if necessary, euthanised separately.
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3.8 Interaction with other medicinal products and other forms of interaction
Although premedication with sedatives may delay the desired effect of the veterinary
medicinal product due to decreased circulatory function this may not be clinically
noticeable since CNS depressant drugs (opioids, α2 adrenoreceptor agonists,
phenothiazines etc) can also increase the effect of pentobarbital.
3.9 Administration routes and dosage
Intravenous, intracardiac or intraperitoneal use.
A dose of 140 mg pentobarbital sodium per kg bodyweight, equivalent to 0.28 ml/kg,
is generally considered sufficient for all indicated routes of administration.
In small animals, higher dosages may be applied, especially when using the
intraperitoneal route.
The intravenous route of administration should be the route of choice and adequate
sedation should be applied if deemed necessary by the veterinary surgeon. For
horses, cattle and pigs premedication is mandatory.
When intravenous use is difficult, and only following deep sedation or anaesthesia,
the veterinary medicinal product may alternatively be administered via the
intracardiac route in all species except cattle and horses.
Alternatively, for small animals only - rodents, rabbits, mink and dogs and cats with a
small patient size, such as puppies and kittens, administration via the intraperitoneal
route could be used, but only following appropriate sedation.
The different administration methods for each animal species must be followed
carefully (see schedule).
Horses, cattle
- Rapid intravenous usePremedication is mandatory.
Pigs
- Rapid intravenous use
- The route of administration depends
on the age and weight of the individual
and can be intravenous vena cava
cranialis or ear vein
- Intracardiac use
Premedication is mandatory.
Sheep, goats
- Rapid intravenous injection
- Intracardiac use
When using the intracardiac route,
premedication is mandatory.
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Dogs, cats
- Intravenous injection with a continuous
injection

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