1 ml contains: Active substance: Ketamine (as hydrochloride) 100 mg

Excipient: Benzethonium chloride 0.1 mg

Clear, colourless to nearly colourless solution.

To be used as a sole agent for restraint and minor surgical procedures in the cat, where muscle relaxation is not required.

To be used to induce anaesthesia:

a) in combination with detomidine in the horse.

b) in combination with xylazine in the horse, in cattle, dog and in the cat.

c) in combination with azaperone in the pig.

d) in combination with medetomidine in the dog and cat.

e) in combination with diazepam in the dog.

Ketamine can show large inter-individual variation in effect, and therefore dose rates administered should be tailored to the individual animal, dependant on factors such as age, condition, and the depth and duration of anaesthesia required. Prolongation of effect is possible by repeated administration of an optionally reduced initial dose.

Administration is possible intravenously (horse and cattle), intramuscularly (pig, dog and cat) or in cats also subcutaneously.

In adult farm animals intravenous application is recommended.

For combination use: before ketamine is administered, please ensure that the animals are adequately sedated.

Pre-medication with a sedative is required for a sufficient anaesthetic effect:

Detomidine 20 μg/kg IV,

after 5 minutes

Ketamine 2.2 mg/kg fast IV (2.2 ml/100 kg)

Onset of action is gradual, taking approximately 1 minute to attain recumbency, with duration of anaesthetic effect lasting approximately 10 - 15 minutes.

Xylazine 1.1 mg/kg IV, followed by

Ketamine 2.2 mg/kg IV (2.2 ml/100 kg)

Onset of action is gradual, taking approximately 1 minute, with duration of anaesthetic effect being variable and lasting 10 - 30 minutes but usually less than 20 minutes.

After injection the horse lays down spontaneously without any further help. If a distinct muscle relaxation is required simultaneously, muscle relaxants can be administered to the recumbent animal, until the horse shows first symptoms of relaxation.

To avoid uncontrolled lying down and possible symptoms of excitation or for potentiation of anaesthesia a sedative premedication is recommended. To avoid hypoxia due to lateral or dorsal recumbency, oxygen can be administered through a nasal tube.

Xylazine 0.14 - 0.22 mg/kg IV/IM, followed by

Ketamine 2 - 5 mg/kg IV (2 - 5 ml/100 kg)

Onset of action is approximately 1 minute, with duration of anaesthetic effect lasting approximately 30 minutes.

The lower end of the stated dose range should be used when administering xylazine via the intravenous route.

Ketamine 15 - 20 mg/kg IM (1.5 - 2 ml/10 kg)

and 2 mg/kg azaperone IM.

In 4 – 5 month old pigs, following administration of 2 mg/kg azaperone and 20 mg/kg ketamine IM the onset of anaesthesia took on average 29 minutes and duration of effect lasted about 27 minutes.

Ketamine can not be used as a mono-anaesthetic in dogs, as it causes an increased muscle tone and uncoordinated muscle contractions.

Medetomidine 40 μg/kg IM, followed by

Ketamine 5 - 7.5 mg/kg IM (0.5 - 0.75 ml/10 kg)

Duration of effect varies between 30 - 50 minutes and is dose related.

Xylazine 2 mg/kg IM, after 10 minutes

Ketamine 10 mg/kg IM (1 ml/10 kg).

In dogs weighing more than 25 kg bodyweight reduce xylazine dosage to 1.3 mg/kg.

Onset of action is usually within 10 minutes and duration of effect lasts for approximately 30 minutes.

With diazepam

Administer diazepam 0.25 mg/kg IV, immediately followed by Ketamine 5 mg/kg IV (0.5 ml/10 kg). Ketamine should be injected slowly and generally administered to effect, when used intravenously. Appropriate premedication should be used to ensure adequate sedation before administration of the diazepam-ketamine combination and to facilitate intubation. The optimal dosing regimen should be individually based on the pre-medication used. Average duration of effect is 10-20 minutes.

Mono-anaesthetic use of ketamine is possible, but to avoid undesired psychomotoric effects combined anaesthesia is recommended. Ketamine on its own may be used by intravenous injection, but intramuscular injection is the recommended route. Ketamine should be injected slowly when administered intravenously.

11 mg/kg ketamine IM for minor restraint,

22 - 33 mg/kg ketamine IM for minor surgery and restraint of fractious cats.

Duration of ketamine anaesthesia is 20 – 40 minutes and recovery takes place over a 1 – 4 hour period. .

Medetomidine 80 μg/kg IM, followed by

Ketamine 5 – 7.5 mg/kg IM (0.25 - 0.4 ml/5 kg)

Onset of action is usually 3 - 4 minutes and duration of effect varies between 30 - 60 minutes and is dose related.

Xylazine 1 - 2 mg/kg IM/SC and

Ketamine 10 - 20 mg/kg IM/SC (0.5 - 1 ml/5 kg)

The lowest dose of xylazine (1 mg/kg) should be used, if ketamine is used at the highest dose (20 mg/kg).

Onset of action is usually within 5 minutes of ketamine administration and duration of effect lasts for at least 30 minutes.

Due to low dose volumes, it is recommended to use an insulin type syringe to accurately measure dosages. The rubber stopper can be punctured safely a maximum of 25 times.

When using the product in combination with other products, the SPCs should be read carefully and all warnings and contraindications observed.

Do not reverse ketamine-medetomidine combinations in dogs and cats with atipamezole until 45 minutes after ketamine administration, when ketamine action has ceased.

Pre-surgical preparation: As for all anaesthetics animals should be fasted for at least 12 hours before ketamine anaesthesia.

Anaesthetic period: Under ketamine anaesthesia the eyes of treated animals remain open, therefore to prevent desiccation in case of longer lasting procedures they should be protected accordingly (by use of appropriate ointments).

Recovery period: It is important that both premedication and recovery should occur in quiet and calm surroundings. Recovery usually is complete after 2 hours, but may occasionally take longer. In dogs, states of psychomotoric excitation with howling can rarely be observed.

Do not use:

− in animals with severe cardiac de-compensation, suspected pulmonary disease, apparent high blood pressure, or cerebrovascular insults.

− in animals with pre-existing liver and kidney pathology.

− in eclampsia, pre-eclampsia, glaucoma and seizure disorders (e.g. epilepsy).

− for surgical intervention on pharynx, larynx, trachea or bronchial tree, if sufficient relaxation is not ensured by administration of a muscle relaxant (intubation obligatory).

− in animals undergoing a myelogram procedure.

Do not use in cases of hypersensitivity to the active substance or to the excipient.

Do not use the product as a sole anaesthetic agent in any other species apart from the cat.

For very painful and major surgical interventions, as well as for maintenance of anaesthesia, a combination with injectable- or inhalation-anaesthetics is necessary. As muscle relaxation required for surgical procedures cannot be achieved with ketamine alone, additional muscle-relaxants should be used concomitantly. For improvement of anaesthesia or prolongation of effect ketamine can be combined with α2-receptor-agonists, anaesthetics, neuroleptanalgesics, tranquilizers and inhalational anaesthetic agents.

A small proportion of animals have been reported to be unresponsive to ketamine as an anaesthetic agent at normal dosages.

It should be noted that time-to-full-effect may be prolonged when using the subcutaneous administration route in cat.

Do not reverse ketamine-medetomidine combinations in dogs and cats with atipamezole until 45 minutes after ketamine administration, when ketamine action has ceased.

As for all anaesthetics animals should be fasted for 12 hours before ketamine anaesthesia.

Under ketamine anaesthesia the eyes of treated animals remain open, therefore to prevent desiccation in case of longer lasting procedures they should be protected accordingly (by use of appropriate ointments).

It is important that both premedication and recovery should occur in quiet and calm surroundings. Recovery usually is complete after 2 hours, but may occasionally take longer. In dogs, states of psychomotoric excitation with howling can rarely be observed.

People with known hypersensitivity to ketamine or to the excipient should avoid contact with the veterinary medicinal product.

Avoid contact with the skin and eyes. Wash any splashes from skin and eyes immediately with large amounts of water.

Adverse effects on the foetus cannot be excluded. Pregnant women should avoid handling the product.

This is a potent drug - particular care should be taken to avoid accidental self-administration.

In cases of accidental self-injection or if symptoms occur after ocular/oral contact, seek medical advice immediately and show the package leaflet or the label to the physician, but DO NOT DRIVE.

Do not leave patient unattended. Maintain airways and give symptomatic and supportive treatment.

Use of the intramuscular route of administration may be associated with pain.

Increased muscle tonus (due to disinhibition of the extra pyramidal system), rarely tachycardia and increase of blood pressure, salivation (due to brainstem stimulation).

When no concomitant muscle relaxant is administered the increased muscle tonus may cause tremors or tonic-clonic convulsions. Concomitant effects of ketamine use may be motoric excitations, opened eyes, nystagmus (rhythmic eye movement), mydriasis (dilation of pupil) as well as increased sensibility especially against acoustic stimuli during anaesthesia and in the recovery period.

Ketamine causes a dose-related respiratory depression, which may lead to respiratory arrest particularly in cats. Combination with respiratory depressant products may increase this respiratory effect.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon

Ketamine crosses the placental barrier. Use only according to the benefit-risk assessment by the responsible veterinarian. Ketamine should not be used in the periparturient period.

Use during lactation only according to the benefit-risk assessment by the responsible veterinarian.

Neuroleptanalgesics, tranquilizers, morphine analogues, cimetidine and chloramphenicol potentiate ketamine anaesthesia.

Barbiturates and opiates or diazepam can prolong the recovery period. Effects may be additive; dosage reduction of one or both agents may be required. Potential for increased risk for arrhythmias when used in combination with thiopental or halothane. Halothane prolongs the half-life of ketamine.

Simultaneously administered intravenous spasmolytics can provoke a collapse. Theophylline with ketamine can cause an increased incidence of seizures. The use of detomidine in combination with ketamine gives a slow recuperation.

In case of overdose, cardiac arrhythmia and respiratory depression up to paralysis may occur. If necessary, suitable artificial aids to maintain ventilation and cardiac output should be used until sufficient detoxification has taken place. Pharmacological cardiac stimulants are not recommended, unless no other supportive measures are available.

In the absence of compatibility studies, this veterinary product must not be mixed with other veterinary medicinal products.

Horse and cattle:

Meat and offal: zero days

Milk: zero hours

Meat and offal: zero days

Keep out of the sight and reach of children. Keep the container in the outer carton in order to protect from light.

Shelf life after first opening the immediate packaging: 28 days. After first opening do not store above 25°C. Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton.

1 x 10 ml, 5 x 10 ml, 1 x 50 ml. Not all pack sizes may be marketed.

Richter Pharma AG, Feldgasse 19, 4600 Wels, Austria