Tessie

1 x 15 ml
Oral solution
PO

Species

Dogs

Indications

Short term alleviation of situational anxiety and fear in dogs triggered by noise or owner departure.

Dose to be administered and administration route

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 (see section 4.8).

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.

Instructions for administration:

image1. 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.

image3. 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.

image4. 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.

image5. 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.

Adverse reactions

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).

References

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Art. Nr.
PACKAGES
Tessie
Dômes Pharma
1 x 15 ml
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