Dogs and cats.

PropoFlo is indicated for therapeutic use in dogs and cats as a short-acting,

intravenous general anaesthetic with a short recovery period:

For procedures of short duration, lasting up to approximately 5 minutes.

For induction and maintenance of general anaesthesia by administration of incremental doses of the product to effect.

For induction of general anaesthesia where maintenance is provided by inhalation anaesthetic agents.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

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. See Special precautions for use. Induction is generally smooth, with minimal evidence of excitation (paddling of limbs, nystagmus, focal muscle twitching, opistotonus). During the recovery phase, vomiting and evidence of excitation has been observed in a small proportion of animals.

In clinical trials in cats, transient apnoea during induction. Sneezing, occasional retching and a paw/face licking characteristic during recovery have been observed in a small proportion 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.

During induction of anaesthesia, mild hypotension and transient apnoea, similar to effects with other intravenous anaesthetic agents, may occur. When using the product facilities for the maintenance of a patent airway, artificial ventilation and oxygen enrichment should be 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.

Use aseptic techniques when administering the product as it does not contain an antimicrobial preservative.

The product is a potent drug, exercise caution to avoid accidental self-injection. Preferably use a guarded needle until the moment of injection. Ampoules should be opened with care to avoid cutting oneself. In case of accidental self-administration, seek medical advice immediately and show the package leaflet or 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.

The safety of this product has not been established during pregnancy and lactation.

Pregnancy: Use only accordingly to the benefit/risk assessment by the responsible veterinarian. Successful use of this product for induction prior to Caesarean section in bitches has been reported.

Lactation: Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

The product has been used after premedication with commonly used premedicants, e.g. atropine, acepromazine, diazepam, alpha-2 adrenoceptor agents, prior to maintenance with inhalational agents, e.g. halothane, nitrous oxide, enflurane, isoflurane and prior to administration of analgesic agents, e.g. pethidine, buprenorphine. No pharmacological incompatibility has been encountered.

The concurrent use of sedative or analgesic drugs is likely to reduce the dose of the product requiredto produce and maintain anaesthesia. See: Amounts to be administered and administration route.

PropoFlo is a sterile product for intravenous administration.

Prior to use, the product should be inspected visually for absence of particulate matter and discolouration and discarded if present.Shake the ampoule or vial gently but thoroughly before opening. See sections, Special warnings for target species and Shelf life.

The induction dose is calculated according to bodyweight and may be administered to effect over a period of 10-40 seconds. If the product is injected very slowly, an inadequate plane of anaesthesia can occur. 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 the animals have been premedicated with an a-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 6.5mg/kg for unpremedicated dogs to 1.0 mg/kg for dogs premedicated with an a-2 agonist).

The average induction dose for dogs and cats, either unpremedicated or when premedicated with a non a-2 agonist tranquiliser such as acepromazine, is given in the table below. These doses are for guidance only. The actual dose should be based on the response of the particular animal.

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 0.1ml/kg bodyweight (1.0mg/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.

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.

Accidental overdosage is likely to cause cardio-respiratory depression. 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.

This product is a stable emulsion. Do not use if evidence of phase separation remains after gentle shaking.

If this product is injected very slowly, an inadequate plane of anaesthesia can occur.

Not applicable.