Patient leaflet - Tessie
B. PACKAGE LEAFLET
PACKAGE LEAFLET
Tessie 0.3 mg/ml oral solution for dogs
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder :
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturers responsible for batch release :
Orion Corporation Orion Pharma
Tengstrominkatu 8
FI-20360 Turku
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Tessie 0.3 mg/ml oral solution for dogs tasipimidine
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains:
Active substance:
Tasipimidine 0.3 mg
(equivalent to 0.427 mg tasipimidine sulfate)
Excipients:
Sodium benzoate (E211) 0.5 mg
Tartrazine (E102)
Brilliant blue (E133)
Clear green solution.
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4. INDICATION(S)
Short term alleviation of situational anxiety and fear in dogs triggered by noise or owner departure.
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5. CONTRAINDICATIONS
The dog should not be given Tessie if it:
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– is allergic to tasipimidine or any of the other ingredients of this medicine
has a severe disease such as liver, kidney or heart disease
is obviously sedated (shows signs of e.g. drowsiness, uncoordinated movements, decreased responsiveness) due to previous medication.
See section 12 Pregnancy and lactation.
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6. ADVERSE REACTIONS
Tessie may cause the following adverse reactions:
Very common:
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– tiredness
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– vomiting.
Common:
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– drowsiness
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– behavioural disorders (barking, avoidance, disorientation, increased reactivity)
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– paleness of the mucous membranes
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– ataxia
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– diarrhoea
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– uncontrolled urination
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– nausea
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– gastroenteritis
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– excessive thirst
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– low white blood cell count
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– allergic reactions
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– loss of appetite.
In addition, decrease in heart rate, blood pressure and body temperature may occur.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reactions)
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Dogs
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
The recommended dose is 0.1 ml/kg. The veterinarian has prescribed the correct dose for the dog. Administer the product orally.
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9. ADVICE ON CORRECT ADMINISTRATION
The product is intended for short term use. If needed, it can be safely administered for up to 9 consecutive days.
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.
Test dose:
When giving the very first dose, observe the dog for 2 hours to make sure that the dose is not too high for the dog. If the dog appears drowsy, its movements are uncoordinated or it responds to your call abnormally slowly after receiving treatment, the dose could be too high. In such case do not leave the dog alone and contact your veterinarian for possible dose reduction for the next use.
Anxiety and fear triggered by noise:
Give the first dose one hour before expected start of the noise or as soon as the dog shows the first signs of anxiety. Observe the dog. If the noise continues and the dog starts to show signs of anxiety and fear again, a new dose can be given when at least 3 hours has passed from the previous dose. The product can be given up to 3 times within every 24 hours.
Anxiety and fear triggered by owner departure:
Give the dose one hour before leaving the dog alone. A new dose can be given when at least 3 hours has passed from the previous dose. The product can be given up to 3 times within every 24 hours.
See the detailed instructions for administration at the end of this leaflet.
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10. WITHDRAWAL PERIOD(S)
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store in a refrigerator (2°C to 8°C). Keep the bottle in the outer carton in order to protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month.
Shelf life after first opening the bottle is 12 months in a refrigerator (2°C to 8°C) or 1 month below 25°C.
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12. SPECIAL WARNINGS
Special precautions for use in animals :
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 response to the medicine 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.
The safety of administering tasipimidine to puppies younger than 6 months and dogs over 14 years of age or weighing less than 3 kg has not been studied.
If the dog is drowsy, do not leave it alone, do not give food or water and keep it warm.
Always maintain the minimum interval (3 hours) between two doses even if the dog vomits after receiving Tessie.
Pregnancy and lactation :
The safety of this veterinary medicinal product has not been established during pregnancy and lactation in the dog. Do not use the product during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction:
Inform your veterinary surgeon if the dog is using other medicines.
The use of other central nervous system depressants is expected to potentiate the effects of tasipimidine and therefore an appropriate dose adjustment should be made by the veterinary surgeon.
Overdose (symptoms, emergency procedures, antidotes) :
Overdose can cause drowsiness, lowering of heart rate, blood pressure and body temperature. If this occurs the animal should be kept warm.
If an overdose occurs, contact a veterinary surgeon as soon as possible.
The effects of tasipimidine can be eliminated using a specific antidote (reversal medicine).
Information for the veterinary surgeon:
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 Tessie. Blood pressure decreases slightly below normal levels. Respiration rate can occasionally decrease. Higher than recommended doses of Tessie 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 gg/kg body weight, an atipamezole dose of 300 gg/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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals :
Exposure to tasipimidine may cause adverse effects such as drowsiness, decrease in respiratory rate and volume, lowering of heart rate and blood pressure.
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 (in the refrigerator) 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 drowsiness 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.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.
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15. OTHER INFORMATION
INSTRUCTIONS FOR ADMINISTRATION:
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1. REMOVE CAP
Remove the cap from the bottle (press down and twist). Save the cap for reclosure.
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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.
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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) (prescribed by your veterinarian) 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.
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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.
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5. BACK TO PACKAGE