PropoFlo Plus

The veterinary medicinal product is a sterile product for intravenous administration.

General handling procedures

Prior to use, the product should be inspected visually for absence of particulate matter and discolouration and discarded if present.

Shake the vial gently but thoroughly before opening. See sections 4.4 and 6.3.

Dosage for Induction

The induction dose is calculated according to bodyweight and may be administered to effect over a period of 10-40 seconds. See section 4.4. The use of preanaesthetic drugs may markedly reduce propofol requirements. As with other sedative hypnotic agents, the amount of opioid, α-2 agonist and/or benzodiazepine premedication will influence the response of the patient to an induction dose of the product.

Where animals have been premedicated with an α-2 agonist such as medetomidine, the dose of propofol (as with any other intravenous anaesthetic agent) should be reduced by up to 85% (e.g. from 6.5 mg/kg for unpremedicated dogs to 1.0 mg/kg for dogs premedicated with an α-2 agonist).

The average induction dose for dogs and cats, either unpremedicated or when premedicated with a non-α-2 agonist tranquilliser such as acepromazine, is given in the following table.

These doses are for guidance only; the actual dose should be based on the response of the particular animal. See section 4.3.

Dosage for Maintenance

When anaesthesia is maintained by incremental injections, the dose rate will vary between animals. Administer incremental doses of the product to effect by giving small doses of around 0.1 ml/kg bodyweight (1.0 mg/kg bodyweight) of the induction dose when anaesthesia becomes too light. These doses may be repeated as often as required, allowing 20-30 seconds to assess the effect before further increments are given. Experience has shown that doses of approximately 1.25-2.5 mg (0.125-0.25 ml) per kg bodyweight sustain anaesthesia for periods of up to 5 minutes.

Continuous and prolonged exposure (greater than 30 minutes) may lead to slower recovery, particularly in cats. See section 4.3 and 4.10.

Maintenance by inhalation agents

When inhalation agents are used to maintain general anaesthesia, experience indicates that it may be necessary to use a higher initial concentration of the inhalant anaesthetic than is usually required following induction with barbiturate agents such as thiopentone. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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 in section 4.3, 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.