Contraindications
Do not use for anaesthetic purposes.
Do not use for intracoelomic injection in chelonia as the time to death may be unnecessarily prolonged compared with intravenous administration.
Special warnings for each target species
To reduce the risk of CNS excitement, it is recommended to perform euthanasia in a quiet area.
In pigs, it was shown that there is a direct correlation between restraint and level of excitation and agitation. Therefore, injection in swine should be done with the least amount of restraint necessary.
In individual cases – especially in restrained animals – agitation/excitation could occur during administration resulting in accidental paravenous administration of the product. Due to the difficulty of safe intravenous injections in swine adequatesedation of the animal before IV administration of pentobarbital is recommended.
Application via marginal ear vein should at least initially be performed without fixation. The animals should be restrained between the legs of an assisting person. If fixation is necessary, a snout rope should be used.
In horses and cattle, premedication with an appropriate sedative must be used to produce profound sedation before euthanasia, and an alternative method of
euthanasia should be available should it become necessary.
When euthanasia of poikilotherms is undertaken, the animal must be maintained at its preferred optimum temperature, otherwise efficacy may be unreliable. Species appropriate measures (e.g. pithing) should be taken to ensure that euthanasia is complete and that spontaneous recovery does not occur.
Venomous snakes are best euthanized by injecting pentobarbital solution into the body cavity near the heart, with judicious use of prior sedation in order to minimise danger to humans.
Intravenous injection of pentobarbital has the ability to cause CNS excitement in several species of animal and adequate sedation should be administered if deemed necessary by the veterinary surgeon. Measures must be taken to avoid perivascular administration (e.g. by using an intravenous catheter).
The intraperitoneal route of administration may cause a prolonged onset of action with an increased risk of CNS excitement. Intraperitoneal administration must only be used following appropriate sedation. Measures must 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 mammals.
Intracardiac injection must only be used if the animal is heavily sedated, unconscious or anaesthetised.
The intrapulmonary route of administration may cause a prolonged onset of action with an increased risk of adverse effects noted in 4.6 and must be reserved for cases where other routes of administration are not possible. Intrapulmonary administration may only be used in chickens, pigeons, ornamental birds, snakes, tortoises, lizards and frogs. Animals must be heavily sedated, unconscious or anaesthetized before this route of administration is employed. Do not use intrapulmonary administration in any other target animal species.
Check regularly, up to about 10 minutes post-administration, in case signs of life return (respiration, heartbeat, corneal reflex). In clinical trials it has been established that signs of life may return. If this occurs, it is advised to repeat the administration using between 0.5 and 1 times the recommended dose.
Special precautions for use in animals
This veterinary medicinal product does not contain any antimicrobial preservative. When an aggressive animal is to undergo euthanasia, premedication with a more easily administered (oral, subcutaneous or intramuscular) sedative is recommended.
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.
Pigs and small animals: See also section Dosage and Administration for recommendations regarding dilution of product.
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 drug which is toxic in humans – particular care must be taken to avoid accidental ingestion and self-injection. Only carry this veterinary medicinal product in an unarmed syringe to avoid accidental injection. Systemic uptake (including absorption via skin or eye) of pentobarbital causes sedation, sleep induction, and CNS and respiratory depression. The concentration of pentobarbital in the 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 product) has been reported to be fatal in humans.
Avoid direct contact with the skin and eyes, including hand-to-eye contact. Wear suitable protective gloves when handling this product – pentobarbital can be absorbed via skin and mucosa.
Moreover, this 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 and benzyl alcohol). People with known hypersensitivity to pentobarbital or to any other ingredient should avoid contact with the veterinary medicinal product.
This product should only be used in the presence of another person that can assist in case of accidental exposure. Instruct that person if not a medical professional about the risks of the product. After administration of this 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.
In the event of accidental exposure the following action should be taken:
Skin – Wash immediately with water and then thoroughly with soap and water. Seek medical advice immediately and show the package leaflet or the label to the physician.
Eyes – Rinse immediately with plenty of cold water. Seek medical advice immediately and show the package leaflet or the label to the physician.
Ingestion –Wash out mouth. Seek medical advice immediately and show the package leaflet or the label to the physician. Keep warm and rest.
Accidental self-injection – Obtain URGENT medical attention (take the package leaflet with you), advising medical services of barbiturate poisoning. Do not leave the patient unattended.
DO NOT DRIVE as sedation may occur. This product is flammable. Keep away from sources of ignition. Do not smoke.
To the physician: Urgent care should be taken to maintain airways and cardiac function. In case of severe intoxication, additional measures should be taken to
enhance the elimination of the barbiturate. Give symptomatic and supportive treatment.
Information for the health professional in case of exposure
The concentration of pentobarbital in the 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 1g (equivalent to 2 ml of product) has been reported to be fatal in humans. Treatment should be supportive with appropriate intensive therapy and maintenance of respiration.
Other precautions
Due to the risk of secondary intoxication animals euthanized with the veterinary medicinal product should not be fed to other animals, but should be disposed of in accordance with national legislation and in a manner securing that other animals cannot have access to the carcasses.
Adverse reactions
Minor muscle twitching may occur after injection. In cattle, gasping may occur if pentobarbital is administered below the recommended dose. Use of the product may result in transient agitation and symptoms of shortness of breath. Death may be delayed if the injection is administered perivascularly or into organs/tissues with low capacity for absorption.
Barbiturates can cause irritation when administered subcutaneously or perivascularly.
Administration by the intrapulmonary route causes coughing, gasping and respiratory distress.
Frequencies of adverse reactions
Vocalisation, minor muscle twitching after injection are commonly observed.
One or few gasps after cardiac arrest are uncommonly reported. Excitation, leg movements, defecation and urine loss, gasping (in cattle), mostly due
to under-dosing were noted in rare cases. Convulsions, contraction of the diaphragm and vomiting are reported in very rare cases.
The frequency of adverse reactions is defined using the following convention:
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Use during pregnancy, lactation or lay
If euthanasia is necessary, the 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 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.
Interaction with other medicinal products and other forms of interaction
Although premedication with sedatives may delay the desired effect of the 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.
Major Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products except sterile, isotonic sodium chloride (0.9%) solution.