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Species: Cats, Dogs Therapeutic indication: Pharmaceuticals: Neurological preparations: General anaesthetics Active ingredient: Propofol Product:PropoFlo® Plus Product index: PropoFlo Plus
PropoFlo Plus is a white emulsion for injection containing 10 mg/ml propofol and 20 mg/ml benzyl alcohol (E1519) as excipient.
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 of general anaesthesia where maintenance is provided by inhalation anaesthetic agents. For induction and short-term maintenance of general anaesthesia by administration of incremental doses of the product to effect for approximately half an hour (30 minutes), not to exceed the total dose stated below.
The veterinary medicinal product 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 vial gently but thoroughly before opening.
The induction dose is calculated according to bodyweight and may be administered to effect over a period of 10-40 seconds. The use of pre-anaesthetic drugs may markedly reduce propofol requirements. As with other sedative hypnotic agents, the amount of opioid, aâ€‘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 aâ€‘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 aâ€‘2 agonist). The average induction dose for dogs and cats, either unpremedicated or when premedicated with a nonâ€‘aâ€‘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.
|Dose mg/kg bodyweight||Dose volume ml/kg bodyweight|
|Unpremedicated||6.5 mg/kg||0.65 ml/kg|
|- with non-α-2 agonist||4.0 mg/kg||0.40 ml/kg|
|- with an α-2 agonist||1.0 mg/kg||0.10 ml/kg|
|Unpremedicated||8.0 mg/kg||0.80 ml/kg|
|- with non-α-2 agonist||6.0 mg/kg||0.60 ml/kg|
|- with an α-2 agonist||1.2 mg/kg||0.12 ml/kg|
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.
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.
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.
Use only according to the risk/benefit assessment by the responsible veterinarian.
Use only according to the risk/benefit assessment by the responsible veterinarian. Accidental overdosage is likely to cause cardioâ€‘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.
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.
No special storage conditions required. Do not freeze. Keep the vial in the outer carton. Shelf-life after first opening the immediate packaging: 28 days. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any other veterinary medicinal products. Keep out of the sight and reach of children. For animal treatment only.
Legal category: POM-V
Supplied in 20 ml (5 vials per carton) or 50 ml (1 vial per carton) Type 1 glass vials. Not all pack sizes may be marketed.
Propofol has been used after premedication with commonly used premedicants, e.g. atropine, acepromazine, diazepam, αâ€‘2 adrenoceptor agents, prior to maintenance with inhalational agents, e.g. halothane, nitrous oxide, sevoflurane, 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 PropoFlo Plus required to produce and maintain anaesthesia.
GTIN description:5 x 20 ml: GTIN:05414736031323
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