Contraindications
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.
Special warnings for each target species
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.
Special precautions for use in animals
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 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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.
Advice to doctor:
Do not leave patient unattended. Maintain airways and give symptomatic and supportive treatment.
Adverse reactions
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
Use during pregnancy and lactation
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.
Interaction with other medicinal products and other forms of interaction
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.
Overdose
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.
Incompatibilities
In the absence of compatibility studies, this veterinary product must not be mixed with other veterinary medicinal products.
Withdrawal period
Horse and cattle:
Meat and offal: zero days
Milk: zero hours
Pig:
Meat and offal: zero days