Target species
Dogs and cats.
Indications for use, specifying the target species
General anaesthesia.
Contraindications
Do not use in cases of hypersensitivity to the active substances, or to any of the excipients.
Do not use the product in animals with severe cardiac or respiratory disease, or in animals with renal, pancreatic or hepatic insufficiency.
Do not use the product in the event of severe hypertension.
Do not use in rabbits.
Do not use in patients with head trauma or intracranial tumours.
Do not use for caesarean section.
Do not use in pregnant bitches and queens.
Special warnings for each target species
In dogs, since zolazepam is eliminated more quickly than tiletamine, there is a shorter duration of tranquilisation than there is of anaesthesia.
Special precautions for use
i) Special precautions for use in animals
Animals should be fasted for 12 hours prior to anaesthesia.
Remove anti-parasite collar 24 hours before anaesthesia.
If necessary, hypersalivation can be controlled with the administration of anticholinergic agents, such as atropine, before the anaesthesia according to a benefit/risk assessment by the responsible veterinarian.
Please refer to section “Interaction with other medicinal products and other forms of interaction” in case of the use of pre-anaesthetic agents.
Keep anaesthetised animals away from excessive noise and visual stimuli.
Apneustic breathing may be observed more commonly in cats after intravenous injection than after intramuscular injection. Especially for high dosages, such abnormal breathing patterns last for up to 15 minutes and then breathing returns to normal. In case of prolonged apnea respiratory assistance should be provided.
Close observation of dogs during the first 5-10 minutes after induction is recommended especially in animals with cardiopulmonary disease.
The product may cause hypothermia, in susceptible animals (small body surface area, low ambient temperature) supplemental heat should be applied if needed.
In dogs and cats the eyes remain open after receiving the product and should be protected from injury and excessive drying of the cornea.
Dosage may need to be reduced in geriatric, debilitated, or animals with renal dysfunction.
Reflexes (e.g. palpebral, pedal, laryngeal) are not abolished during anaesthesia and therefore use of this product alone may not be adequate if surgery is performed on these areas.
Redosing may prolong and worsen recovery.
In the event of reinjections, side effects (hyper-reflexia, neurological problems) can be produced due to tiletamine. It is recommended that the recovery phase occurs in a calm environment.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
In cases of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician. Do not drive due to risk of sedation.
Wash splashes from skin and eyes immediately. In case of eye irritation, seek medical advice.
Wash hands after use.
This product may cross the placenta and be harmful to the foetus, therefore women who are pregnant, or are suspected to be pregnant, should not use the product.
Adverse reactions (frequency and seriousness)
Upon injection, pain has sometimes been reported in cats.
Very rare (less than 1 animals in 10 000 animals, including isolated reports) cases of neurological signs (prostrations, convulsions, coma, …) associated or not with cardio-respiratory signs (dyspnoea, tachypnoea, bradypnoea, tachycardia, cyanosis, … that can appear from 20 mg/kg in dogs) and some systemic signs (hypothermia, hyperthermia, pupillary disorders, hypersalivation, hypersensitivity towards external stimuli, agitation, vocalisation) have been observed principally during the awakening phase in the dog and during the surgery and the awakening phase in the cat.
In the recovery phase, it is possible to observe prolonged anaesthesia and difficulties awakening (myoclonus, restlessness, ataxia, paresis, etc.). All reactions are reversible and disappear once the active substance is eliminated from the body.
Use during pregnancy, lactation or lay
Studies conducted on laboratory animals did not reveal any teratogenic effect.
The product crosses the placenta and may cause respiratory depression in newborns that can be fatal for puppies and kittens. The safety of the product during pregnancy or lactation has not been established.
Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
The benefit-risk assessment for using the product with other pre-anaesthetic or anaesthetic agents must take into consideration the dosages of the agents used, the nature of the intervention and the ASA (American Society of Anaesthesiologists) class to which the animal belongs. The required dosage of tiletamine-zolazepam is likely to change depending on which agents are concurrently used.
The dosage of tiletamine – zolazepam may need to be reduced when used concomitantly with pre-anaesthetic and other anaesthetic agents. Premedication with phenothiazine tranquilisers (e.g. acepromazine) can cause increased cardio-respiratory depression and an increased hypothermic effect that occurs in the last phase of anaesthesia.
Do not use medications containing chloramphenicol during the pre- or intra-operative period, as this slows down elimination of the anaesthetics.
Vat Rate: 20%
