Zenalpha 0.5 mg/ml + 10 mg/ml Solution for Injection for Dogs

When Domitor is administered, the animal should be allowed to rest in a
maximally quiet place. Before any procedure is started or other drugs are
administered, sedation should be allowed to reach its peak effect, which occurs at
about 10 to 30 min, depending on route of administration.
In extremely nervous, excited or agitated animals, the levels of endogenous
catecholamines may be high. The pharmacological response elicited by alpha-2
agonists (e.g. medetomidine) in such animals is often reduced, with depth and
duration of sedative and analgesic effects ranging from slightly diminished to non-
existent. Highly agitated animals should therefore be put at ease and allowed to
rest quietly prior to receiving Domitor. Allowing animals to rest quietly for 10 to
15 minutes after injection may improve the response to Domitor.

i. Special precautions for use in animals
A clinical examination should be carried out in all animals before the use of
drugs for sedation and/or general anesthesia.
Care should be taken when using Domitor in animals with cardiovascular
disease.
Care should be taken when combining medetomidine with other
anaesthetics or sedatives. Before using any combinations consult the
contraindications and warnings that appear on the concomitant product’s
data sheet.
Medetomidine has marked anaesthetic sparing effects. The dose of the
anaesthetic should be reduced accordingly (see section 4.9).
Special care is recommended when treating very young animals and older
animals.
Domitor, ketamine and propofol are metabolised in the liver and excreted
primarily via the kidneys. Pre-existing liver or kidney pathology should be
carefully evaluated to confirm adequate function prior to using these
products.
Fasting is recommended before Domitor administration. After treatment,
the animal should not be given water or food before it is able to swallow
properly.
Treated animals should be kept in a warm and even temperature during
the procedure and for 12 hours after sedation.
During prolonged procedures an ophthalmic preparation should be
administered at regular intervals to lubricate the cornea especially in cats
and sometimes also in dogs if their eyes remain open.

Revised: June 2016
AN: 00139/2016
In cats, when Domitor is used in combination with ketamine, laryngeal and
pharyngeal reflexes are retained during anaesthesia.
ii. Special precautions to be taken by the person administering the veterinary
medicinal product to animals.
In the case of accidental oral intake or self-injection, seek medical advice
immediately and show the package leaflet to the doctor but DO NOT DRIVE
as sedation and changes in blood pressure may occur.
Avoid skin, eye or mucosal contact.
Immediately after exposure, wash the exposed skin with large amounts of
fresh water.
Remove contaminated clothes that are in direct contact with skin.
In the case of accidental contact of the product with eyes, rinse with large
amounts of fresh water. If symptoms occur, seek the advice of a doctor.
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 hydrochloride is an alpha-2 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.