ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Tessie 0.3 mg/ml oral solution for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

0.3 mg tasipimidine equivalent to 0.427 mg tasipimidine sulfate Excipients:

Qualitative composition of excipients and other constituents	Quantitative composition if that information is essential for proper administration of the veterinary medicinal product
Sodium benzoate (E211)	0.5 mg
Tartrazine (E102)
Brilliant blue (E133)
Sodium citrate
Citric acid monohydrate
Purified water

Clear green solution.

3. CLINICAL INFORMATION

3.1 Target species

Dogs

3.2 Indications for use for each target species

Short term alleviation of situational anxiety and fear in dogs triggered by noise or owner departure. 3.3 Contraindications

Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs with moderate or severe systemic disease (graded as ASA III or greater), e.g. moderate to severe renal, liver or cardiovascular disease.

Do not use in dogs obviously sedated (shows signs of e.g. drowsiness, uncoordinated movements, decreased responsiveness) from previous dosing.

3.4 Special warnings

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.

3.5 Special precautions for use

Special precautions for safe use in the target species:

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 accidental spillage onto skin, 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.

Special precautions for the protection of the environment:

Not applicable. 3.6 Adverse events Dogs:

Very common (> 1 animal / 10 animals treated):	Emesis Lethargy
Common (1 to 10 animals / 100 animals treated):	Behavioural disorder (Barking, Avoidance, Increased reactivity) Diarrhoea, Gastroenteritis, Nausea Hypersensitivity reaction Leucopenia Ataxia, Sedation, Somnolence, Disorientation Urinary incontinence Anorexia, Pale mucous membranes, Polydipsia
Undetermined frequency (cannot be estimated for the available data):	Decreased heart rate1, Low blood pressure1 Decreased body temperature1

¹observed in non-anxious animals

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Laboratory studies in rats have shown evidence of developmental toxicity at maternotoxic doses causing clear sedation-related clinical signs, decreased food consumption, and decreased body weight gain of the dam.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation in the target species.

Do not use during pregnancy and lactation.

3.8 Interaction with other medicinal products and other forms of interaction

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.

Tasipimidine has been studied in combination with clomipramine, fluoxetine, dexmedetomidine, methadone, propofol and isoflurane.

In studies on laboratory dogs receiving a combination of fluoxetine (1.1–1.6 mg/kg daily administration for 12 days) and tasipimidine (20 mcg/kg once, at day 12, N = 4 dogs) or tasipimidine (20 mcg/kg) and clomipramine (1.2–2.0 mg/kg) both administered twice daily during 4 days to 6 dogs, no clinical interactions have been observed. When tasipimidine is used concomitantly with clomipramine or fluoxetine, tasipimidine dose should be reduced to 20 mcg/kg bodyweight. Should the dog have earlier required a dose reduction of tasipimidine to 20 mcg/kg, this dose may be maintained. However, a test dose should be given according to the instructions in section 3.9 when starting the combination use. Lower doses of tasipimidine have not been studied in combination use.

Tasipimidine induced mild to moderate cardiovascular depression when given alone or in combination with methadone or methadone and dexmedetomidine in healthy dogs. If a dog treated with tasipimidine requires general anaesthesia, the required propofol induction dose and isoflurane concentration will need to be reduced. 3.9 Administration routes and dosage

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 mcg/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 3.5).

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 mcg/kg bodyweight. Dose reduction should be implemented following veterinary advice only.

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:

1. REMOVE CAP

Remove the cap from the bottle (press down and twist). Save the cap for reclosure.

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.

3.10 Symptoms of overdose (and where applicable, emergency procedures and 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 mcg/kg body weight, an atipamezole dose of 300 mcg/kg bodyweight, corresponding to 0.06 ml/kg bodyweight of solution containing 5 mg/ml, was administered intravenously. 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.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3.12 Withdrawal periods

Not applicable.

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code: QN05CM96

4.2 Pharmacodynamics

The veterinary medicinal product contains tasipimidine as the active substance. Tasipimidine is a potent and selective alpha-2A adrenoceptor agonist (as demonstrated in human adrenoceptors) that inhibits the release of noradrenaline from noradrenergic neurons, blocks the startle reflex and thus counteracts arousal.

Tasipimidine as an alpha-2 adrenoceptor agonist reduces the over activation of noradrenergic neurotransmission (increased release of noradrenaline in the locus coeruleus), which is shown to induce anxiety and fear in experimental animals exposed to stressful situations.

In summary, tasipimidine exerts its effects by decreasing central noradrenergic neurotransmission. In addition to the anxiolytic effect, tasipimidine can cause other known dose dependent alpha-2 adrenoceptor-mediated pharmacological effects such as sedation, analgesia and lowering of heart rate, blood pressure and rectal temperature.

The onset of effect is usually seen within 1 hour after treatment administration. The duration of effect shows some individual variation, and it can last for up to 3 hours or longer.

4.3 Pharmacokinetics

Absorption

After oral administration in solution, tasipimidine is rapidly absorbed in fasted dogs. In a pharmacokinetic study in fasted dogs, a moderate oral bioavailability of tasipimidine was observed being on average 60 %. After oral administration of 30 mcg/kg to dogs in fasted state, the maximum plasma concentration of tasipimidine is approximately 5 ng/ml and occurs at 0.5–1.5 hours. When the dosing is repeated 3 hours later, the following maximum plasma concentration is shown to be moderately (30 %) higher but there is no effect on the time of maximum concentration. Feeding at the time of dosing slows down the absorption and decreases the maximum plasma levels. In fed state the peak concentration is lower being 2.6 ng/ml and comes later at 0.7–6 hours. The total plasma exposure to tasipimidine is comparable in fasted and fed states. Systemic exposure increases approximately in a dose proportional manner within the dose range of 10–100 mcg/kg. No signs of accumulation are seen after repeated administration.

Distribution

Tasipimidine is a highly distributed compound, the volume of distribution in dogs is 3 l/kg. Tasipimidine penetrates the brain tissue in dogs and the drug concentration after repeated administration is higher in brain than in plasma. The in vitro binding of tasipimidine to dog plasma proteins is low, approximately 17 %.

Metabolism

The metabolism of tasipimidine occurs mainly through demethylation and dehydrogenation and the most abundant circulating metabolites are demethylation and dehydrogenation products. The demethylated dehydrogenation product of tasipimidine is found in trace levels in dog plasma after high doses. The circulating metabolites are much less potent than the parent drug, as demonstrated in human and rat adrenoceptors.

Excretion

Tasipimidine is a highly cleared compound being rapidly eliminated from the circulation of dogs. The total clearance is 21 ml/min/kg after 10 mcg/kg intravenous bolus dose. The mean terminal half-life is 1.7 hours after oral administration in fasted state. The portion of tasipimidine excreted unchanged in urine is 25 %. All the circulating metabolites are excreted in urine much less compared to tasipimidine.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

5.2 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening the immediate packaging: 1 year in a refrigerator (2 °C – 8 °C) or 1 month below 25 °C.

5.3 Special precautions for storage

Store in a refrigerator (2 °C – 8 °C). Keep the bottle in the outer carton in order to protect from light.

5.4 Nature and composition of immediate packaging

15 ml clear glass type III bottle with a polypropylene child-resistant closure and a low-density polyethylene adapter and a high-density polyethylene liner. An oral low-density polyethylene/polystyrene syringe is included in the pack.

Pack sizes:

Cardboard box with 1 bottle and an oral syringe.

5.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Orion Corporation

7. MARKETING AUTHORISATION NUMBER

EU/2/21/276/001

8. DATE OF FIRST AUTHORISATION

Date of first authorisation: 16/08/2021

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).

ANNEX II

OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

None

ANNEX III LABELLING AND PACKAGE LEAFLET

A. LABELLING

1.	NAME OF THE VETERINARY MEDICINAL PRODUCT

Tessie 0.3 mg/ml oral solution

2.	STATEMENT OF ACTIVE SUBSTANCES

1 ml contains: 0.3 mg tasipimidine.

3.	PACKAGE SIZE

15 ml bottle

Oral syringe

4.	TARGET SPECIES

Dogs

5.	INDICATIONS
6.	ROUTES OF ADMINISTRATION

Oral use.

7.	WITHDRAWAL PERIODS
8.	EXPIRY DATE

Exp. {mm/yyyy}

Once opened use within 1 year.

9.	SPECIAL STORAGE PRECAUTIONS

Store in a refrigerator. Keep the bottle in the outer carton in order to protect from light.

10.	THE WORDS “READ THE PACKAGE LEAFLET BEFORE USE”

Read the package leaflet before use.

11.	THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

12.	THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

13.	NAME OF THE MARKETING AUTHORISATION HOLDER

Orion Corporation

14.	MARKETING AUTHORISATION NUMBERS

EU/2/21/276/001

15.	BATCH NUMBER

Lot

1.	NAME OF THE VETERINARY MEDICINAL PRODUCT

Tessie

2.	QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES

0.3 mg/ml

3.	BATCH NUMBER
Lot
4.	EXPIRY DATE

Exp. {mm/yyyy}

Once opened use within 1 year.

B. PACKAGE LEAFLET

PACKAGE LEAFLET

1. Name of the veterinary medicinal product

Tessie 0.3 mg/ml oral solution for dogs

2. Composition

Each ml contains:

Active substance:

0.3 mg tasipimidine equivalent to 0.427 mg tasipimidine sulfate

Excipients:

Sodium benzoate (E211) 0.5 mg Clear green solution.

3. Target species

Dogs

4. Indications for use

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

5. Contraindications

The dog should not be given Tessie if it:

- 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 dosing.

6. Special warnings

Special precautions for safe use in the 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 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.

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.

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 micrograms/kg body weight, an atipamezole dose of 300 micrograms/kg bodyweight, corresponding to 0.06 ml/kg bodyweight of solution containing 5 mg/ml, was administered into a vein. 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 for the protection of the environment: Not applicable.

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.

Tasipimidine has been studied in combination with clomipramine, fluoxetine, dexmedetomidine, methadone, propofol and isoflurane.

In studies on laboratory dogs receiving a combination of fluoxetine (1.1–1.6 mg/kg daily administration for 12 days) and tasipimidine (20 micrograms/kg once, at day 12, N = 4 dogs) or tasipimidine (20 micrograms/kg) and clomipramine (1.2–2.0 mg/kg) both administered twice daily during 4 days to 6 dogs, no clinical interactions have been observed. When tasipimidine is used concomitantly with clomipramine or fluoxetine, tasipimidine dose should be reduced to 20 micrograms/kg bodyweight.

Should the dog have earlier required a dose reduction of tasipimidine to 20 micrograms/kg, this dose may be maintained. However, a test dose should be given according to the instructions in section 9 when starting the combination use. Lower doses of tasipimidine have not been studied in combination use.

Tasipimidine induced mild to moderate cardiovascular depression when given alone or in combination with methadone or methadone and dexmedetomidine in healthy dogs. If a dog treated with tasipimidine requires general anaesthesia, the required propofol induction dose and isoflurane concentration will need to be reduced.

Overdose:

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).

Special restrictions for use and special conditions for use:

Not applicable.

7. Adverse events Dogs:

Very common (> 1 animal / 10 animals treated):	Emesis Lethargy
Common (1 to 10 animals / 100 animals treated):	Behavioural disorder (Barking, Avoidance, Increased reactivity) Diarrhoea, Gastroenteritis, Nausea Hypersensitivity reaction Leucopenia Ataxia, Sedation, Somnolence, Disorientation Urinary incontinence Anorexia, Pale mucous membranes, Polydipsia
Undetermined frequency (cannot be estimated for the available data):	Decreased heart rate[1], Low blood pressure1 Decreased body temperature1

Reporting adverse events is important. It allows continuous safety monitoring of a product. 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 contact, in the first instance, your veterinarian. You can also report any adverse events to the marketing authorisation holder or the local representative of the marketing authorisation holder using the contact details at the end of this leaflet, or via your national reporting system: {national system details}

8. Dosage for each species, routes 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.

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.

10. Withdrawal periods

Not applicable.

11. Special storage precautions

Keep out of the sight and reach of children.

Store in a refrigerator (2 °C – 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 1 year in a refrigerator (2 °C – 8 °C) or 1 month below 25 °C.

12. Special precautions for disposal

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any applicable national collection systems. These measures should help to protect the environment.

Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.

13. Classification of veterinary medicinal products Veterinary medicinal product subject to prescription.

14. Marketing authorisation numbers and pack sizes

Marketing authorisation number: EU/2/21/276/001

Pack size:

Cardboard box containing one 15 ml bottle and an oral syringe.

15. Date on which the package leaflet was last revised

Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).

16. Contact details

Marketing authorisation holder:

Orion Corporation

Orionintie 1

FI-02200 Espoo Finland

Manufacturer responsible for batch release:

Orion Corporation Orion Pharma

Tengströminkatu 8

FI-20360 Turku

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo Finland

Local representatives and contact details to report suspected adverse reactions:

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien V.M.D. nv

Hoge Mauw 900

BE-2370 Arendonk

Tél/Tel: +32 14 67 20 51

Česká republika

Orion Pharma s.r.o. Na Strži 2102/61a

CZ-140 00-Praha

Tel: +420 227 027 263

Danmark

Orion Pharma A/S

Ørestads Boulevard 73

DK-2300 København S Tlf: +45 86 14 00 00

Deutschland

Domes Pharma GmbH

Reuchlinstrasse 10-11

DE-10553 Berlin

Tel: +49 30 23 59 23 200

Eesti

Orion Pharma UAB

Ukmergės g. 126

08100 Vilnius

Leedu

Tel: +370 5 2769 499

España

Dômes Pharma Iberia SL

Edificio Net Pharma

Ctra Fuencarral 22

ES-28108 Alcobendas, Madrid Tel. +34 913 301 651

France

Laboratoires Biové

3 Rue de Lorraine FR-62510 Arques

Tél: +33 3 21 98 21 21

Hrvatska

Iris Farmacija d.o.o. Bednjanska 12

HR-10000 Zagreb

Tel: +385 (0)91 2575 785 Ireland Slovenská republika

Royal Veterinary Supplies Ltd. Orion Pharma s.r.o.

Unit 5, Block 13 Oaktree Business Park Na strži 2102/61a

IE-C15 WK2E Trim, Co.Meath 140 00 Praha

Tel: + 353 46 9484665 Česko

Tel: +420 227 027 263

Italia						Suomi/Finland
Alivira Italia S.R.L.						Orion Pharma Eläinlääkkeet
Corso della Giovecca 80						PL/PB 425
IT-44121 Ferrara						FI-20101 Turku/Åbo
Tel: +39 3492642910						Puh/Tel: + 358 10 4261

Latvija Sverige

Orion Pharma UAB Orion Pharma AB, Animal Health

Ukmergės g. 126 Golfvägen 2

08100 Vilnius SE-182 31 Danderyd Lietuva Tel: +46 8 623 64 40

Tel: +370 5 2769 499

Lietuva United Kingdom (Northern Ireland)

Orion Pharma UAB Royal Veterinary Supplies Ltd.

Ukmergės g. 126 Unit 5, Block 13 Oaktree Business Park

LT-08100 Vilnius Trim, Co. Meath C15 WK2E

Tel: +370 5 2769 499 Ireland

Tel: +353 46 9484665

Luxembourg/Luxemburg

V.M.D. nv

Hoge Mauw 900

2370 Arendonk

Belgique

Tél/Tel: +32 14 67 20 51

Република България Ελλάδα Ísland Κύπρος Malta

Tel: + 358 10 4261

17. Other information

INSTRUCTIONS FOR ADMINISTRATION:

1. REMOVE CAP

Remove the cap from the bottle (press down and twist). Save the cap for reclosure.

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.

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.