Contraindications
Do not use in animals with
- Severe cardiovascular disease or respiratory diseases or impaired liver or kidney function.
- Mechanical disturbances of the gastro-intestinal tract (torsio ventriculi, incarcerations, oesophageal obstructions).
- Pregnancy, Diabetes mellitus.
- State of shock, emaciation or serious debilitation.
Do not use concomitantly with sympathomimetic amines.
Do not use in cases of hypersensitivity to the active substance or to any other excipients.
Do not use in animals with ocular problems where an increase in intraocular pressure would be detrimental.
Special warnings
Medetomidine may not provide analgesia throughout the entire period of sedation, therefore consideration should be given to providing additional analgesia for painful procedures.
Special precautions for use
Special precautions for safe use in the target species:
A clinical examination should be carried out in all animals before the use of veterinary medicinal products for sedation and/or general anaesthesia. Higher doses of medetomidine should be avoided in large breed dogs. Care should be taken when combining medetomidine with other anaesthetics or sedatives because of its marked anaesthetic sparing effects. The dose of the anaesthetic should be reduced accordingly and titrated to response due to considerable variability in requirements between patients. Before using any combinations, the warnings and contra-indications in the product literature for the other products should be observed.
Animals should be fasted 12 hours before anaesthesia.
The animal should be placed in a calm and quiet surrounding to let the sedation gain its maximum effect. This takes about 10 - 15 minutes. One should not start any procedure or give other medicines before maximum sedation is reached. Treated animals should be kept warm and at a constant temperature, both during the procedure and recovery.
The eyes should be protected by a suitable lubricant.
Nervous, aggressive or excited animals should be given the possibility to calm down before initiation of treatment. Sick and debilitated dogs and cats should only be premedicated with medetomidine before induction and maintenance of general anaesthesia based on a risk-benefit assessment. Care should be taken with use of medetomidine in animals with cardiovascular disease, or which are elderly or in general poor health. Liver and kidney function should be evaluated prior to use. As ketamine alone can elicit cramps, alpha-2 antagonists should be administered not before 30 - 40 min. after ketamine.
Medetomidine may cause respiratory depression and under these circumstances, manual ventilation and oxygen may be administered.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection or ingestion, seek medical advice immediately and show the package leaflet to the physician. DO NOT DRIVE as sedation and changes in blood pressure may occur.
Avoid skin, eye or mucosal contact.
Wash the exposed skin immediately after exposure with large amounts of water.
Remove contaminated clothes that are in direct contact with skin.
In the case of accidental contact of the veterinary medicinal product with eyes, rinse abundantly with fresh water. If symptoms occur, seek the advice of a physician.
If pregnant women handle the veterinary medicinal product, special caution should be observed not to self-inject as uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.
To the physician:
Medetomidine is an alpha2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia. Ventricular arrhythmias have also been reported.
Respiratory and haemodynamic symptoms should be treated symptomatically.
Adverse events
Dog and cat:
Common (1 animal to 10 animals / 100 animals treated): | Vomiting1 |
Rare (1 to 10 animals / 10,000 animals treated): | Pulmonary oedema |
Undetermined frequency (cannot be estimated from the available data) | Increased sensitivity to sound Hyperglycaemia2 Bradycardia, Heart block 1st degree, Heart block 2nd degree, Extrasystole3 , Vasoconstriction4 , High blood pressure5 Decreased cardiac output6,7 Respiratory depression7 Increased urine volume Hypothermia Mydriasis Cyanosis Injection site pain Muscle tremor |
1Some dogs and most cats will vomit within 5-10 minutes of injection. Cats may also vomit on recovery.
2Reversible, due to depression of insulin secretion
3Occasionally
4Of coronary artery
5Blood pressure will increase initially after administration and then return to normal, or slightly below normal.
6Atropine may increase the cardiac rate.
7Manual ventilation and an oxygen supplement may be indicated.
Dogs with a body weight of less than 10 kg may show the undesirable effects mentioned above more often.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the product has not been established during pregnancy and lactation. Therefore it should not be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
The concomitant use of other CNS depressants should be expected to potentiate the effect of either active substance. Appropriate dose adjustments should be made. Medetomidine has marked anaesthetic sparing effects. See also section 'Special precautions for use'. The effects of medetomidine may be antagonized by administration of atipamezole or yohimbine.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
In the case of overdose the main signs are prolonged anaesthesia or sedation. In some cases cardio-respiratory effects may occur. For treatment of these cardio-respiratory effects of an overdose it is recommended to administer an alpha-2 antagonist e.g. atipamezole or yohimbine, provided that reversal of sedation is not dangerous to the patient (atipamezole does not reverse the effects of ketamine which may cause seizures in dogs and elicit cramps in cats when used alone). Use atipamezole hydrochloride 5 mg/ml intramuscularly in the dog in the same volume as the veterinary medicinal product, in the cat use half the volume. The required dose of atipamezole hydrochloride corresponds in dogs to the 5-fold dose of the medetomidine hydrochloride dose in mg administered before and in cats to the 2.5-fold dose. Alpha-2 antagonists should be administered not before 30 - 40 min. after ketamine.
If it is imperative to reverse bradycardia but maintain sedation, atropine may be used.