Do not use for prolonged infusion (see below).
Do not exceed a total dose in one anaesthetic episode of 24 mg/kg (2.4 ml/kg) of propofol in cats or dogs.
This product should not be used for induction and maintenance of general anaesthesia by incremental doses that would exceed total dose limits specified above, due to the potential for toxic effects caused by the preservative, benzyl alcohol.
Do not use in animals with known hypersensitivity to the active substance or to any of the excipients.
This product is a stable emulsion; discard the vial if phase separation is observed. Shake the vial gently but thoroughly before withdrawing a dose.
If this product is injected very slowly, an inadequate plane of anaesthesia can occur.
During induction of anaesthesia in any species, mild hypotension and transient apnoea, similar to effects with other intravenous anaesthetic agents, may occur. Apnoea is most likely to occur within the first 5 minutes of administration of the product and must be treated with oxygen and artificial ventilation. Whenever the product is used, facilities for the maintenance of a patent airway, artificial ventilation and oxygen supplementation must be immediately available.
As with other intravenous anaesthetic agents, caution should be exercised in dogs and cats with cardiac, respiratory, renal or hepatic impairment, or in hypovolaemic or debilitated animals.
The safety of this product has not been established in dogs or cats younger than 5 months and should be used in these animals only according to the risk/benefit assessment by the responsible veterinarian.
Use aseptic techniques when administering the product.
Side effects during induction, maintenance and recovery are uncommon. As with other anaesthetic agents, the possibility of respiratory or cardiovascular depression should be considered. During induction of anaesthesia, mild hypotension and transient apnoea may occur. Induction is generally smooth, with occasional evidence of excitation (paddling of limbs, nystagmus, focal muscle twitching, opisthotonus). During the recovery phase, vomiting and excitation have been observed in a small proportion of animals.
In clinical trials in cats and dogs, transient apnoea has been observed during induction. In cats sneezing, occasional retching and a paw/face licking characteristic during recovery have been observed in a small proportion of cases.
If panting is evident before induction, it may continue throughout the subsequent periods of anaesthesia and recovery.
Inadvertent perivascular administration rarely causes local tissue reactions.
Repeated anaesthesia with propofol in cats may cause oxidative injury and Heinz body production. Recovery may also become prolonged. Limiting repeated anaesthesia to intervals of more than 48 hours will reduce the likelihood.
The safety of this product in foetuses/neonates and during lactation has not been established. In humans parenterally administered benzyl alcohol has been associated with a fatal toxic syndrome in preterm neonates.
Pregnancy
Use only according to the risk/benefit assessment by the responsible veterinarian.
Lactation
Use only according to the risk/benefit assessment by the responsible veterinarian.
Accidental overdosage is likely to cause cardio‑respiratory depression. Overdose is likely to cause apnoea. In cases of respiratory depression, stop drug administration, establish a patent airway, and initiate assisted or controlled ventilation with pure oxygen. Cardiovascular depression should be treated with plasma expanders, pressor agents, anti-arrhythmic agents or other techniques as appropriate for the observed abnormality.
Propofol: A single dose of 19.5 mg/kg (1.95 ml/kg) in dogs and bolus and intermittent doses totalling 24 mg/kg (2.4 ml/kg) in cats did not cause harm. Bolus and intermittent doses totalling 38.6 mg/kg (3.9 ml/kg) produced paraesthesia in one of four cats and prolonged recovery in all four cats treated.
Benzyl Alcohol (preservative): Benzyl alcohol toxicity may lead to prolonged recovery and hyperkinesia in cats, and neurological signs such as tremors in dogs and fatalities in both species. There is no specific antidote; supportive treatment should be given.
In dogs, lethal doses of benzyl alcohol could result from administration of the maximum total dose of propofol stated above, every hour for 9 hours, based on pharmacokinetic modelling and literature reports. In cats, lethal doses of benzyl alcohol could occur within 6.5 hours of administration, based on literature reports, direct estimation and maintenance dose rates.
User warnings
People with known hypersensitivity to any of the ingredients should avoid contact with the veterinary medicinal product.
This veterinary medicinal product is a potent drug, exercise caution to avoid accidental self-injection. Preferably use a guarded needle until the moment of injection.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Advice to the doctor: do not leave the patient unattended. Maintain airways and give symptomatic and supportive treatment. In case of splashes on the skin or in the eyes, wash off immediately.