Special warnings for each target species
Typical signs of anxiety and fear are panting, trembling, pacing (frequent change of place, running
around, restlessness), seeking people (clinging, hiding behind, pawing, following), hiding (under
furniture, in dark rooms), trying to escape, freezing (absence of movements), refusing to eat food
or treats, inappropriate urination, inappropriate defecation, salivation, etc. These signs may be
alleviated but may not be completely eliminated.
In extremely nervous, excited or agitated animals, the levels of endogenous catecholamines are
often high. The pharmacological effect induced by alpha-2 agonists in such animals may be reduced.
Consideration should be given to use of a behavioural modification programme,
especially when dealing with a chronic condition such as separation anxiety.
Special precautions for use
Special precautions for use in animals
If the dog is sedated (shows signs of e.g. drowsiness, uncoordinated movements,
decreased responsiveness), do not leave the dog alone and withhold food and water.
The safety of administering tasipimidine to dogs younger than 6 months and older
than 14 years of age or weighing less than 3 kg has not been studied. Use only
according to a benefit-risk assessment by the responsible veterinarian.
The accuracy of the syringe is demonstrated only for doses of 0.2 ml and higher.
Dogs requiring doses lower than 0.2 ml can therefore not be treated.
As a decrease of body temperature can occur after the administration, the treated
animal should be kept at a suitable ambient temperature.
Tasipimidine may indirectly induce an increase of glycaemia. In diabetic animals, use
according to a benefit-risk assessment by the veterinarian.
In case of vomiting after intake of the oral solution, maintain the usual recommended interval between two administrations (at least 3 hours) before administering the
product again.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Exposure to tasipimidine may cause adverse effects such as sedation, respiratory
depression, bradycardia and hypotension.
Avoid oral ingestion and skin contact including hand-to-mouth contact.
In order to prevent children from getting access to the product, don’t leave the filled
dosing syringe unattended while preparing the dog for administration. The used
syringe and the closed bottle should be returned to the original carton and stored out
of the sight and reach of children.
In case of skin contact, wash the exposed skin immediately with water and remove
contaminated clothes. In case of accidental ingestion, 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.
This product may cause slight eye irritation. Avoid eye contact including hand-to-eye
contact. In case of eye contact, rinse the eyes immediately with water.
This veterinary medicinal product may cause hypersensitivity (allergy). People with
known hypersensitivity to tasipimidine or any of the excipients should avoid contact
with the veterinary medicinal product.
Wash hands after use.
Adverse reactions (frequency and seriousness)
Lethargy and emesis were very common adverse reactions in clinical trials.
Sedation, behavioural disorders (barking, avoidance, disorientation, increased
reactivity), pale mucous membranes, ataxia, diarrhoea, urinary incontinence, nausea,
gastroenteritis, polydipsia, leucopenia, hypersensitivity reactions, somnolence and
anorexia were common adverse reactions in clinical trials.
Additionally, decrease in heart rate, blood pressure and body temperature were
observed in preclinical studies in non-anxious animals.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated
reports).