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SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of Veterinary Medicinal Product
Rupinal®

2. Qualitative and quantitative composition
Active ingredient
Grade mg/ml
propofol PhEur 10

3. Pharmaceutical form
Emulsion for injection

4. Pharmacological properties
Propofol is a substituted phenol which, when given by intravenous injection, is a
short-acting anaesthetic with a rapid rate of onset.
Pharmacodynamic properties Propofol produces unconsciousness by its doserelated depressant effect on the central nervous system, possibly by enhancement of the effects of the inhibitory neurotransmitter g-aminobutyric acid. Like other injectable anaesthetics, propofol causes dose-related depression of the respiratory and cardiovascular systems.

Pharmacokinetic properties. Propofol, as a general anaesthetic, is characterised by rapid onset and short duration of action as well as rapid recovery and non
accumulation, resulting from its pharmacokinetic properties.
As a highly lipophilic drug, propofol is highly bound to plasma proteins and, after
intravenous injection, is rapidly and widely distributed throughout the body. After
cessation of the administration of the drug, the concentration of propofol in the blood rapidly decreases due to redistribution to more highly lipophilic tissues and
continuous rapid ****bolism in the liver.
Propofol is rapidly ****bolised in the liver to glucuronide and sulphate ****bolites.
In the dog, approximately 70% of the administered dose is eliminated in the urine
and the remainder in bile/faeces.

5. Clinical Particulars

5.1 Target species
Dogs and cats.

5.2 Indications for use
A short-acting, intravenous, general anaesthetic for procedures of short duration,
lasting up to five minutes.
For induction and maintenance of general anaesthesia using incremental doses to effect.
For induction of general anaesthesia where maintenance is provided by inhalation anaesthetics.
Rupinal is particularly suitable for patients where a short recovery period is
desirable.

5.3 Contraindications
None.

5.4 Undesirable Effects (frequency and seriousness)
Side-effects during induction, maintenance and recovery are uncommon. Induction is generally smooth, with minimal evidence of excitation. During the recovery phase, vomiting and evidence of excitation have been observed in a small proportion of animals.
In clinical trials in cats, transient apnoea during induction 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.

5.5 Special Precautions for use
During induction of anaesthesia, mild hypotension and transient apnoea, similar to effects with other intravenous anaesthetic agents, may occur. When using Rupinal, 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 Rupinal is injected very slowly, an inadequate plane of anaesthesia can occur.

5.6 Use during pregnancy and lactation
Propofol has not been used in dogs and cats where the pregnancy is to be
maintained, but has been used successfully for induction prior to Caesarean section in bitches.

5.7 Interactions with other medicaments and other forms of interaction.
Propofol has been used in association with commonly used premedicants, e.g.
atropine, acepromazine, diazepam; inhalational agents, e.g. halothane, nitrous oxide, enflurane; and analgesic agents, e.g. pethidine, buprenorphine. No pharmacological incompatibility has been encountered.
The emulsion should not be mixed with other therapeutic agents or infusion fluids
prior to administration.

5.8 Dosage and Method of administration
Administration : For intravenous use only. The container should be shaken
thoroughly before opening. Each container is intended for single use only. The
product does not contain an antimicrobial preservative. The product should be
used immediately and not stored. Any product remaining in the container following withdrawal of the required dose should be discarded.

Induction of general anaesthesia using Rupinal® : The induction dose should be
calculated according to bodyweight and may be given in full as a single dose, or
administered to effect over a period of 10 – 40 seconds. The induction dose is
reduced when using a pre-medicant tranquilliser such as acepromazine.
It should be noted that the dose rates shown are for guidance and in practice the
dose rate should be based on response.

Dogs
Unpremedicated 6.5 6.5 ml/10 kg
Premedicated 4.0 4.0 ml/10 kg

Cats
Unpremedicated 8.0 2.0 ml/2.5 kg
Premedicated 6.0 1.5 ml/2.5 kg

Maintenance of general anaesthesia using Rupinal ® : Where anaesthesia is
maintained by incremental injections, the dose rate will vary between animals.
Incremental doses should be given to effect. Experience in clinical trials has shownthat doses of around 1 ml per 4.0-8.0 kg bodyweight sustain anaesthesia for periods of up to five minutes.

Maintenance of general anaesthesia 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.

5.9 Overdosage (symptoms, emergency procedures, antidotes)(if necessary)
Accidental overdosage is likely to cause cardio-respiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression requires the use of plasma expanders and pressor agents.

5.10 Special warnings for each target species
Inadvertent perivascular administration is unlikely to cause local tissue reactions.

5.11 Withdrawal periods
Not applicable.

5.12 Special Safety Precautions to be taken by the person administering the product
Rupinal ® is a potent drug; particular care should be taken to avoid accidental selfadministration.
Preferably use a guarded needle until the moment of injection.
Wash off splashes from the skin and eyes immediately.
Ampoules should be opened with care to avoid cutting oneself.

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

6. Pharmaceutical data

6.1 Major Incompatibilities
None reported.

6.2 Shelf life, if necessary after reconstitution of the product, or when the container is
opened for the first time
Shelf life : 2 years
Any solution remaining in the container following withdrawal of the required dose
should be discarded.

6.3 Special storage precautions
Store below 25°C. Do not freeze. Protect from light.

6.4 Nature and content of container
White aqueous isotonic emulsion for intravenous injection contained in 20 ml clear colourless tuype II glass ampoules or 50 ml clear, colourless type I glass vials.

6.5 Special Precautions for disposal of unused product or waste materials, if any
Unused product and containers should be disposed of in accordance with any
guidance from an appropriate waste regulation authority.

7.0 Name and permanent address or registered place of business of the holder of the authorisation to place the product on the market

Boehringer Ingelheim Ltd
Ellesfield Avenue,
Bracknell
Berks,
RG12 8YS, UK



Marketing authorisation number
Vm 00015/4057

Legal category
Veterinary medicinal product subject to prescription. POM

Date of first approval : 25 September 2002