Dogs

To provide restraint, sedation and analgesia during conduct of non-invasive, non-painful or mildly painful procedures and examinations intended to last no more than 30 minutes.

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

Do not use in animals with cardiovascular disease, respiratory disease or impaired liver or kidney function.

Do not use in animals that are in shock or severely debilitated.

Do not use in animals that have hypoglycaemia or are at risk of developing hypoglycaemia.

Do not use as pre-anaesthetic medicine.

Do not use in cats.

Nervous or excited dogs with high levels of endogenous catecholamines may exhibit a reduced pharmacological response to alpha-2 adrenoceptor agonists like medetomidine (ineffectiveness). In agitated animals, the onset of sedative/analgesic effects could be slowed, or the depth and duration of effects could be diminished or non-existent. Therefore, the dog should be given the possibility to calm down before initiation of the treatment and rest quietly after administration of the product until evidence of sedation has occurred.

In the absence of available data, treatment of puppies less than 4.5 months of age should be based on a benefit-risk assessment by the responsible veterinarian.

It is recommended that dogs should be fasted in accordance with currently recommended best practice (e.g. 4–6 hours for healthy dogs), prior to treatment with this veterinary medicinal product. Water can be given.

Animals should be frequently monitored for cardiovascular function and body temperature during sedation and recovery.

Some cardiovascular effects (e.g. bradycardia, cardiac arrhythmias such as second-degree AV block or ventricular escape complexes) may be observed after treatment.

Over the period of 15–45 minutes post treatment, blood pressure is likely to decrease by approximately 30–50% from pre-treatment levels. Tachycardia with normal blood pressure may be observed from approximately one hour post-treatment and lasting up to six hours. Therefore, frequent monitoring of cardiovascular function should preferably be performed until tachycardia has resolved.

A decrease in body temperature of approximately 1–2°C is likely to occur after administration.

Once established, hypothermia may persist longer than sedation and analgesia. To prevent hypothermia, treated animals should be kept warm and at a constant temperature during the procedure and until fully recovered.

Medetomidine can cause apnoea and/or hypoxaemia. This effect is likely to be potentiated if used in combination with opioid medicines. Frequent monitoring of respiratory function should be performed in all cases. It is also advisable to have oxygen readily available, should hypoxaemia be detected or suspected.

Analgesia provided by the veterinary medicinal product may be shorter than the sedative effect. Additional pain management should be provided as needed. Spontaneous muscle trembling or twitching can be expected in some dogs.

Accidental exposure may cause sedation and changes in blood pressure. Caution is required during treatment administration to avoid accidental self-injection, or skin, eye or mucosal contact. Adequate restraint of the animal is recommended, as some animals may react to the injection (e.g., defence reaction).

Pregnant women should administer the veterinary medicinal product with special caution to avoid self-injection since uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.

People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution.

In case of accidental self-injection or ingestion, seek medical advice immediately and show the package leaflet to the physician but DO NOT DRIVE.

In case of skin or mucosal contact, wash the exposed skin immediately after exposure with large amounts of water and remove contaminated clothes that are in direct contact with skin. In case of eye contact, rinse abundantly with fresh water. If symptoms occur, seek the advice of a physician.

To the physician: The veterinary medicinal product contains medetomidine, an alpha2 adrenoceptor agonist, in combination with vatinoxan, a peripherally selective alpha2 adrenoceptor antagonist. Symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia. Ventricular arrhythmias have also been reported. Respiratory and haemodynamic symptoms should be treated symptomatically.

Hypothermia, bradycardia and tachycardia were very commonly observed in safety and clinical studies. Diarrhoea/colitis and muscle tremor were commonly observed. Vomiting/nausea and involuntary defaecation were uncommonly observed. Cardiac arrhythmias, such as second-degree AV block and ventricular escape complexes, were seen very commonly in laboratory safety studies. Injected sclera were observed very rarely in laboratory safety studies.

All of the above adverse reactions were transient/resolved without treatment, although external warming was provided where required in cases of hypothermia.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- 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).

The safety of the veterinary medicinal product has not been established in dogs during pregnancy or lactation or in dogs intended for breeding. No data are available on the use of vatinoxan in breeding animals. Published data in laboratory animals do not show direct reproductive or developmental toxicity of medetomidine. The use of the veterinary medicinal product is therefore not recommended in pregnant or lactating animals.

The use of other central nervous system depressants and/or vasodilating medicines are expected to potentiate the effects of the veterinary medicinal product and an appropriate dose reduction should be made after benefit-risk assessment by the veterinarian.

Due to the rapid recovery from sedation expected with the veterinary medicinal product, routine administration of atipamezole is not indicated after the veterinary medicinal product. The intramuscular administration of atipamezole (30 minutes after the administration of the veterinary medicinal product) has been investigated in a study involving a limited number of animals. As tachycardia was observed in 50% of the animals following the administration of atipamezole, close monitoring of the heart rate during recovery is therefore advised in those cases where administration of atipamezole is deemed clinically necessary.

For intramuscular use.

The dose is based on body surface area. The dose will result in administration of 1 mg medetomidine and 20 mg vatinoxan per square metre of body surface area (m2 ).

Use of an appropriately graduated syringe is recommended to ensure accurate dosing when administering small volumes.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Table 1. Dose volume based on body weight

Re-administration of the veterinary medicinal product during the same procedure has not been evaluated and therefore the veterinary medicinal product should not be re-administered during the same procedure.

The number of permissible stopper broachings is limited to a maximum of 15.

The veterinary medicinal product given 3 and 5 times the recommended dose, showed a slightly prolonged sedation and greater degree of reduction in mean arterial pressure and rectal temperature. Overdose can increase incidence of sinus tachycardia during recovery.

Atipamezole can be administered to reverse the central nervous system effects and most of the cardiovascular effects of medetomidine, excluding hypotension. Appropriate cardiopulmonary support should be initiated if required.