Dorbene Vet 1 mg/ml Solution for Injection for Dogs and Cats

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 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 (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.
AN: 03796/2024, 03798/2024, 04136/2024 & 03959/2024
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 the
veterinary medicinal product 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. For
dosage directions, see section 3.9.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
In case of accidental oral intake or self-injection, seek medical advice immediately
and show the package leaflet or label to the physician but DO NOT DRIVE as
sedation and changes in blood pressure may occur.
Care should be taken to avoid accidental self-injection, as well as contact with the
skin, eyes and mouth.
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.
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.
Special precautions for the protection of the environment:
Not applicable.
AN: 03796/2024, 03798/2024, 04136/2024 & 03959/2024