Dormostart 1 mg/ml Solution for Injection for Dogs and Cats

When medetomidine 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 medetomidine. Allowing animals to rest
quietly for 10 to 15 minutes after injection may improve the response to
medetomidine.

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 anaesthesia.
Care should be taken when using medetomidine 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.
Medetomidine, 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 medetomidine 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.
In cats, when medetomidine is used in combination with ketamine, laryngeal
and pharyngeal reflexes are retained during anaesthesia.

Issued: February 2024
AN: 01697/2022
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
This product is a sedative. Care should be taken to avoid oral intake and/or
accidental self-injection.
In the case of accidental oral intake or self-injection, seek medical advice
immediately and show the package insert to the physician, but DO NOT DRIVE
as sedation and changes in blood pressure may occur.
Avoid skin, eye or mucosal contact. In the case of accidental contact of the
product with the skin or eyes, rinse with large amounts of fresh water. Remove
contaminated clothes that are in direct contact with skin. 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.
People with known hypersensitivity to parabens should administer the
veterinary medicinal product with caution.
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.
Special precautions for the protection of the environment:
Not applicable.
Other precautions
Not applicable.