Dogs, cats, rodents, rabbits, cattle, sheep, goats, horses and mink.

Euthanasia

Do not use for anaesthesia.

- 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. Measures should be taken to avoid perivascular administration (e.g. by using intravenous catheter).

- 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 anaesthetised.

To reduce the risk of induction excitement, euthanasia should be performed in a quiet area.

- 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 and cattle premedication is mandatory.

Where intravenous administration is impossible, and only following deep sedation, the product may be administered via the intracardiac route in all named species. Alternatively, for small animals only, administration via the intraperitoneal route could be used, following appropriate sedation.

- 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.

- 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.

Pentobarbital is a potent hypnotic and a sedative, and thus potentially toxic in man. It can be absorbed systemically through the skin and if swallowed. Particular care should be taken to avoid accidental ingestion and self-injection. Only carry this product in an unarmed syringe to avoid accidental injection.

Systemic uptake (including absorption via skin or eye) of pentobarbital causes sedation, sleep, CNS and respiratory depression. 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). Embryotoxic effects cannot be excluded.

Avoid direct contact with the skin and eyes, including hand-to-eye contact.

This product is flammable. Keep away from sources of ignition.

Do not smoke, eat or drink while handling the product.

Avoid accidental self-injection or accidental injection of other persons when administering the product.

People with known hypersensitivity to pentobarbital should avoid contact with the veterinary medicinal product.

Handle the product with utmost care, especially pregnant and breastfeeding women. Wear protective gloves. 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 product.

Accidental spillage on the skin or in the eye must be washed off immediately with plenty of water. If there has been serious skin or eye contact or in the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. In the case of accidental ingestion, wash out mouth and obtain medical attention immediately. But DO NOT DRIVE as sedation may occur.

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 product is such that the accidental injection or ingestion of quantities as small as 1ml in human adults can have serious CNS effects. A dose of pentobarbital sodium of 1g (equivalent to 2.5ml of product) has been reported to be fatal in humans. Treatment should be supportive with appropriate intensive therapy and maintaining the respiration.

Ingestion of euthanased animals by other animals may lead to intoxication, anaesthesia and even death. Barbiturates are highly persistent in carcasses and also stable to cooking temperature. Due to the risk of secondary intoxication animals euthanised 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.

Minor muscle twitching may occur after injection.

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.

Pentobarbital sodium has the ability to cause induction excitement. Premedication/sedation significantly reduces the risk of experiencing induction excitement.

Very occasionally one or a few gasping respirations occur after cardiac arrest. At this stage the animal is already clinically dead.

The safety of the veterinary medicinal product has not been established during pregnancy, lactation or lay. Use accordingly to the benefit-risk assessment by the responsible veterinarian.

When an aggressive animal is to undergo euthanasia, premedication with a more easily administered (oral, subcutaneous or intramuscular) sedative is recommended.

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.

A dose of 140mg/kg, equivalent to 0.35ml/kg, is considered sufficient for all indicated routes of administration.

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 and cattle premedication is mandatory.

When intravenous administration is difficult, and only following deep sedation or anaesthesia, the product may be administered via the intracardiac route.

Alternatively, for small animals only, administration via the intraperitoneal route could be used, but only following appropriate sedation.

The intravenous injection in companion animals should be carried out with a continuous injection rate until unconsciousness occurs.

In horses and cattle, pentobarbital should be injected rapidly.

The stopper should not be punctured more than 20 times.

Adequate measures should be taken to ensure that carcasses of animals treated with this product and the by-products of these animals do not enter the food chain and are not used for human or animal consumption.