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

Medetomidine may not provide analgesia throughout the entire sedation period;
therefore, the use of additional analgesics should be considered during painful
surgical 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.
When the veterinary medicinal product is used for premedication, the dose of the
anaesthetic should be reduced accordingly and titrated to response, due to the
considerable variability in requirements between patients. Before using any
combinations, the warnings and contraindications in the product literature for the
other product(s) should be observed.
Medetomidine can produce respiratory depression; in such cases, manual ventilation
and administration of oxygen may be required.
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. Animals should be fasted 12
hours before anaesthesia.
The animal should be placed in a calm and quiet environment to reach a maximum
sedative effect. This takes about 10-15 minutes. Do not start any procedure or
administer other medicines before maximum sedation is reached.
Treated animals should be kept warm and at a constant temperature, both during the
procedure and during recovery. Vomiting and perianesthetic reflux may occasionally
lead to regurgitation of gastric contents to the mouth.
Due to decreased tear flow, the eyes should be protected by a suitable lubricant
(appropriate ophthalmic ointment or artificial tear solution).
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 old or in general poor health. Liver and kidney function should
be evaluated prior to use.
In order to reduce the recovery time after anaesthesia or sedation, the effect of the
veterinary medicinal product can be reversed by the administration of an alpha-2-
antagonist such as atipamezole.
Atipamezole does not reverse the effect of ketamine. As ketamine alone can elicit
convulsions in dogs and cramps in cats, alpha-2 antagonists should not be given less
AN: 04155/2025 & 04156/2024
than 30-40 min. after the administration of ketamine. It should be considered that
bradycardia might persist after reversal.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
This veterinary medicinal product is a sedative. Care should be taken to avoid skin,
eye, mucosal
contact and self-injection.
In the case of accidental contact of the veterinary medicinal 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 medical advice.
In case of accidental ingestion or self-injection, seek medical advice immediately and
show the package leaflet or the label to the physician. DO NOT DRIVE as sedation
and changes in blood pressure may occur.
Pregnant women should handle the veterinary medicinal product with special care to
avoid self-injection. Uterine contractions and decreased foetal blood pressure may
occur after accidental systemic exposure.
Advice to physicians:
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.