metadata toggle
Contra-indications, warnings, etc
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). Diabetes mellitus. State of shock, emaciation or serious debilitation.
Do not use concomitantly with sympathomimetic amines.
Do not use in cases of known 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.
A decrease in heart rate and rate of respiration should be expected following administration. Bradycardia with atrioventricular block (1st and 2nd degree) and occasionally extrasystolia. Vasoconstriction of coronary artery. Decreased cardiac output. Blood pressure will increase initially after administration and then return to normal, or slightly below normal.
The product may have an emetic effect, particularly in cats. This occurs within a few minutes of administration. Cats may also vomit on recovery. Hypersensitivity to loud noise may also occur. Increased diuresis, hypothermia, respiratory depression, cyanosis, pain at injection site and muscle tremor may be seen. In individual cases reversible hyperglycaemia due to depression of insulin secretion has been observed. Pulmonary oedema has been reported as a rare adverse reaction after use of medetomidine. In circulatory and respiratory depression manual ventilation and an oxygen supplement may be indicated. Atropine may increase the cardiac rate. Dogs with a body weight of less than 10 kg may show the undesirable effects mentioned above more often.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Medetomidine may not provide analgesia throughout the entire period of sedation, therefore consideration should be given to providing additional analgesia for painful procedures.
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 (e.g. ketamine, thiopental, propofol, halothane), 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 allowed 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. Medetomidine may cause respiratory depression and under these circumstances, manual ventilation and oxygen may be administered. To reduce the recovery time following anaesthesia or sedation the effect of Dorbene can be reversed by administration of an alpha-2 antagonist e.g. atipamezole or yohimbine. As ketamine alone can elicit cramps, alpha-2 antagonists should be administered not before 30-40 min. after ketamine.
The safety of this veterinary medicinal product has not been established during pregnancy and lactation. Therefore it should not be used during pregnancy and lactation.
Overdose will cause delayed recovery after sedation or anaesthesia. In some cases circulatory or respiratory depression may also 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). Alpha-2 antagonists should be administered not before 30-40 min. after ketamine. In dogs, the dose of atipamezole is 5 times that for medetomidine. For example, if 1ml Dorbene (1mg medetomidine) has been administered, a dose of 5 mg atipamezole is required. In cats, the dose of atipamezole is 2.5 times that for medetomidine. For example, if 1 ml Dorbene (1 mg medetomidine) has been administered, a dose of 2.5 mg atipamezole is required. If it is imperative to reverse bradycardia but maintain sedation, atropine may be used. In cases of delayed recovery, care should be taken to ensure that the animal remains quiet and warm. Depending on the situation, the animal may also be ventilated with oxygen and receive intravenous fluids to prevent hypovolaemia. The maintenance of body temperature during sedation and recovery is especially important; in cases of hypothermia, increasing the body to temperature to the normal level for the particular species will hasten recovery.
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. The effects of medetomidine may be antagonized by administration of atipamezole or yohimbine. Do not use concomitantly with sympatomimetic amines or sulfamides + trimethoprim.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
The safety of this veterinary medicinal product has not been established during pregnancy and lactation. Therefore it should not be used during pregnancy and lactation.
Operator warnings
In case of accidental oral intake or self-injection, seek medical advice immediately and show the package insert or label to the physician but 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 product with eyes, rinse abundantly with fresh water. If symptoms occur, seek the advice of a physician. If pregnant women handle the product, special caution should be observed not to self-inject as uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure. Advice to doctors: 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.