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PropoClear 10 mg/ml Emulsion for Injection for Dogs and Cats

Contains active ingredient propofol, a short acting injectable anaesthetic agent for dogs and cats.

PropoClear is a unique nano-droplet micro emulsion that results in an essentially clear and colourless presentation versus all the other available propofol "milky" formulations. Unlike other formulations, PropoClear includes preservatives, which confers a practical benefit - a 28 day broached shelf life. This allows larger presentations to choose from (50 mL, 100 mL), depending upon practice needs, which offers convenience of larger pack sizes. It is also licensed for use with premedicaments such as Acepromazine, Butorphanol, Medetomidine and Midazolam.

Description

Each ml contains:

Active substances:
Propofol 10.00 mg
Excipients:
Methyl parahydroxybenzoate E218 0.18 mg
Propyl parahydroxybenzoate E216 0.02 mg

Indications

CONTRAINDICATIONS

PropoClear injection is contraindicated in cats or dogs with known hypersensitivities to the active substance or to any of the excipients, or when general anaesthesia or sedation are contraindicated.

ADVERSE REACTIONS

Hypothermia, cardiovascular effects (decreased heart rate, decreased blood pressure) and respiratory depression (apnoea, decreased oxygen saturation) have been very commonly reported in dogs.
In cats, cardiovascular effects (decreased heart rate, decreased blood pressure and tachycardia have been commonly reported, as well as respiratory depression (apnoea, hypoxia and bradypnea). Emesis was also commonly observed.
On rare occasions pain on injection has been observed, associated with perivascular administration.

TARGET SPECIES

Dogs and cats.

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Induction:
Dogs: The guidance induction dose for dogs is up to 6.5 mg/kg (0.65 ml/kg) body weight; the dose should be titrated against the response of the patient and may be administered over a period of 30-60 seconds. The use of pre-anaesthetics may significantly reduce propofol requirements.
Cats: The guidance induction dose for cats is up to 8.0 mg/kg (0.80 ml/kg) body weight; the dose should be titrated against the response of the patient and may be administered over a period of 30-60 seconds. The use of pre-anaesthetics may significantly reduce propofol requirements.

Maintenance by PropoClear:
Dogs: The guidance maintenance dose for dogs is 1.6 to 2.2 mg/kg (0.16 to 0.22 ml/kg) body weight; the dose should be titrated against the response of the patient and for individual dogs the dose required may be considerably less; the dose may be administered over a period of 10-30 seconds. The use of pre-anaesthetics may significantly reduce propofol requirements.
Cats: The guidance maintenance dose for cats is 1.1 to 3.3 mg/kg (0.11 to 0.33 ml/kg) body weight; the dose should be titrated against the response of the patient and may be administered over a period of 10-30 seconds. The use of pre-anaesthetics may significantly reduce propofol requirements.

Maintenance by inhalation agents:
Where inhalation agents are used to maintain general anaesthesia, clinical experience indicates that there may be a need to use a higher initial concentration of inhalation agent than is normally the case following induction with barbiturate agents such as thiopentone.

ADVICE ON CORRECT ADMINISTRATION

PropoClear is a sterile product for intravenous administration. Shake thoroughly before opening. Ensure that the product is clear and colourless before administration. Gentle warming and agitation will speed the process. Vial stoppers must not be broached more than 10 times.

WITHDRAWAL PERIOD

Not applicable.

SHELF LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Following the first withdrawal, use within 28 days.

SPECIAL STORAGE PRECAUTIONS

Do not store above 30°C. Do not refrigerate. Exposure for an extended period below 20°C may result in a cloudy appearance. A clear appearance will return upon allowing the product to warm to 20°C to 30°C Gentle agitation will speed the process.

SPECIAL WARNINGS

Appropriate analgesia should be provided for animals undergoing painful procedures.
If PropoClear is injected very slowly, an inadequate plane of anaesthesia can occur.
During induction of anaesthesia, mild hypotension and transient apnoea similar to effects with other intravenous anaesthetic agents may occur. When using PropoClear, 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.
If the product is injected too rapidly, cardiopulmonary depression may occur (apnoea, bradycardia, hypotension).
Elderly and debilitated animals require lower doses and slower injection.
Do not use in animals less than 12 weeks of age.
Pharmacokinetic studies indicate that clearance of propofol is slower in greyhounds compared to other breeds of dog. Sighthounds may, therefore, show a slightly longer duration of recovery from anaesthesia than other dog breeds.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in dogs and cats. Studies in laboratory animals have shown that propofol crosses the placental barrier and therefore embryos are exposed to propofol in a dose-dependent way.
Used only accordingly to the benefit/risk in cases of induction prior to Caesarean section in bitches.
Lactation: Use only accordingly to the risk/benefit assessment by the responsible veterinarian.
The product should not be mixed with other therapeutic agents or infusion fluids prior to administration.
This is a potent drug and particular care should be taken to avoid accidental self-administration. Preferably use a guarded needle until the moment of injection.
Wash off splashes from the skin and eyes immediately.
In the event of accidental self-administration, seek urgent medical attention and show the label.
Advice to doctor: Do not leave patient unattended. Maintain airways and give symptomatic and supportive treatment.
Any unused product or waste material should be disposed of in accordance with national requirements.

OTHER INFORMATION

ATC vet code: QN01 AX 10
Nature and composition of immediate packaging
Clear to translucent solution for intravenous injection contained in hydrolic class type 1 colourless glass bottles.
Presentations:
The product is packaged in 20ml, 50ml and 100ml glass vials.

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