Oral use.
The product is intended for short term use but it can be safely administered for up to 9
consecutive days.
The product should be administered orally at a dose of 0.1 ml/kg bodyweight (equivalent to 30
µg/kg) in situational anxiety and fear in dogs triggered by noise or owner departure.
If the product is intended for use in situations where the dog is meant to be alone following the
administration, a test dose should be given. Following administration of the test dose the dog
should be observed for 2 hours to make sure the selected dose of the product is not associated with
adverse reactions and that it is safe for the treated dog to be left alone (see section 4.5).
Do not feed the dog for one hour before to one hour after treatment as absorption may be delayed. A
small treat can be given to ensure that the dog swallows the solution. Water can be freely
available.
Observe the dog. If the fear triggering event continues and the dog starts to show signs of anxiety
and fear again, re-dosing can be done when at least 3 hours has passed from the previous dose. The
product can be dosed up to 3 times within every 24 hours.
Dose reduction
If the dog appears drowsy, its movements are uncoordinated or it responds to its owner’s call
abnormally slowly after receiving treatment, the dose could be too high. The subsequent dose should
be reduced to 2/3 of the volume of the previous dose, corresponding to 20 µg/kg bodyweight. Dose
reduction should be implemented following veterinary advice only. When used concomitantly with
clomipramine or
fluoxetine, tasipimidine dose should be reduced to 20 µg/kg bodyweight.
Anxiety and fear triggered by noise:
The first dose should be given one hour before expected start of an anxiety triggering stimulus, as
soon as the dog shows the first signs of anxiety, or when the owner detects a typical stimulus for
eliciting anxiety or fear in the respective dog.
Anxiety and fear triggered by owner departure:
The dose should be given one hour before expected owner departure.
1. REMOVE CAP
Remove the cap from the bottle (press down and twist). Save the cap for reclosure.
2. CONNECT SYRINGE
Push the syringe tightly into the adapter located at the top of the bottle. Use only the syringe
provided with the product.
3. SELECT DOSE
Turn the bottle with the syringe in place upside down. Pull the plunger out until the black line of
correct dose (ml) can be seen under the grip plate of the syringe barrel.
If the dog weighs more than 30 kg, the total dose will be given in two separate doses as the
syringe holds maximally 3.0 ml of solution.
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.
Don’t leave the filled dosing syringe unattended while preparing the
dog for administration.
4. GIVE DOSE
Gently place the syringe in the mouth of the dog and administer the dose to the base of the tongue
by gradually pressing the plunger until the syringe is empty. Give the dog a small treat to ensure
that the dog swallows the solution.
5. BACK TO PACKAGE
Replace the cap and rinse the syringe with water when finished. Put the syringe and bottle back to
the secondary package and put them in
the refrigerator.
Overdose (symptoms, emergency procedures, antidotes)
The level and duration of sedation is dose dependent, and signs of sedation may therefore
particularly occur in case the dose is exceeded. Dogs receiving a high overdose of the product have
a higher risk of aspirating vomit due to the emetic and CNS depressant effects associated with the
active substance. A very high overdose can potentially be life-threatening.
Reduced heart rate may be seen after administration of higher than recommended doses of
tasipimidine oral solution. Blood pressure decreases slightly below normal levels. Respiration rate
can occasionally decrease. Higher than recommended doses of tasipimidine oral solution may also
induce a number of other alpha-2 adrenoceptor mediated effects, which include increase in blood
pressure, decrease in body temperature, lethargy, vomiting and a QT prolongation.
As demonstrated in a preclinical study, the effects of tasipimidine can be reversed using a
specific antidote, atipamezole (alpha-2 adrenoceptor antagonist). One hour after treatment with
tasipimidine at 60 µg/kg body weight, an atipamezole dose of 300 µg/kg bodyweight, corresponding to
0.06 ml/kg bodyweight of solution containing 5 mg/ml, was administered i.v. Results of this study
demonstrated that the effects of tasipimidine could be reversed. However, as the half-life of
tasipimidine exceeds that of atipamezole, some signs of tasipimidine effects may reappear.