Patient leaflet - Clevor
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Clevor 30 mg/ml eye drops, solution in single-dose container 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
Orion Corporation
Orionintie 1
FI-02200 Espoo
FINLAND
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Clevor 30 mg/ml eye drops, solution in single-dose container for dogs
Ropinirole (ropinirol)
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Clevor is a very slightly yellow to yellow clear solution containing 30 mg/ml ropinirole, equivalent to 34.2 mg/ml ropinirole hydrochloride.
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4. INDICATION(S)
For induction of vomiting in dogs.
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5. CONTRAINDICATIONS
Your dog must not be given this medicine if it:
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– has decreased consciousness, seizures or other similar neurologic symptoms or difficulties in breathing or swallowing that could make the dog inhale a part of the vomit potentially causing aspiration pneumonia
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– has ingested sharp foreign objects, acids or alkalis (e.g. drain or toilet bowl cleaners, household detergents, battery fluids), volatile substances (e.g. petroleum products, essential oils, air fresheners) or organic solvents (e.g. antifreeze, windshield wiper fluids, nail polish remover)
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– is hypersensitive to ropinirole or to any of the excipients.
6.
ADVERSE REACTIONS
This veterinary medicinal product may cause the following adverse reactions:
Very common reactions: temporary mild or moderate redness of the eye, increased tear production, increased visibility of the third eyelid and/or squinting; temporary mild tiredness and/or increased heart rate.
Common reactions: temporary, mild swelling of the mucous membranes of the eyelids, itching of the eyes, rapid breathing, shivering, diarrhoea and/or irregular or uncoordinated bodily movements.
Extended vomiting (for more than 60 minutes) which should be evaluated by the responsible veterinarian as it might need appropriate treatment.
In dogs with protracted vomiting (more than 60 minutes) and other clinical signs related to the pharmacological action of the active substance (e.g. ocular hyperaemia, tachycardia, tremors or shaking), dopamine antagonists such as metoclopramide or domperidone may be used to manage these clinical signs.
Maropitant does not reverse the clinical signs related to the pharmacological action of ropinirole.
Uncommon reactions: corneal ulceration.
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 reaction(s)
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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 veterinarian.
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7. TARGET SPECIES
Dogs
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Clevor is administered as eye drops into one or both of the dog’s eyes at a dose of 1–8 eye drops, depending on the dog’s bodyweight. If the dog does not vomit within 15 minutes after administration of the initial dose, a second dose may be given 15 to 20 minutes after administration of the initial dose. The second dose should be the same number of drops as the initial dose. It is recommended to record the time of first administration.
Be careful not to touch the dropper tip after opening the container in case a second dose is necessary.
The following dosing table provides the dose volume in drops to be administered corresponding to the dog’s bodyweight.
When a quantity of 2 to 4 drops is to be administered, the dose should be divided between both eyes. For example, for the administration of 3 drops: administer 2 drops into the right eye and 1 drop into the left eye.
When a quantity of 6 or 8 drops is to be administered, the dose should be divided into 2 alternate administrations given 1–2 minutes apart. For example, for the administration of 6 drops: administer 2 drops into the right eye and 2 drops into the left eye, then after 1–2 minutes pause administer a further 1 drop into each eye.
| Dog bodyweight (kg) | Number of eye drops |
| 1.8–5 | 1 |
| 5.1–10 | 2 |
| 10.1–20 | 3 |
| 20.1–35 | 4 |
| 35.1–60 | 6 |
| 60.1–100 | 8 |
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9. ADVICE ON CORRECT ADMINISTRATION
The veterinary medicinal product should only be administered by a veterinarian or under their close supervision. ________________________________________________________________________________________
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.
This veterinary medicinal product does not require any special temperature storage conditions.
Store the container in the pouch in order to protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the label or carton after “EXP”. The expiry date refers to the last day of that month.
Shelf life after first opening the immediate packaging (pouch and container): 30 minutes.
After opening the pouch, the container should be kept in the pouch to protect from light.
Discard any opened individual pouch or container with any remaining liquid after 30 minutes.
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12. SPECIAL WARNING(S)
Special precautions for use in animals :
The efficacy of the veterinary medicinal product has not been established in dogs weighing less than 1.8 kg, or in dogs under 4.5 months of age or in elderly dogs. Use only according to the benefit-risk assessment by the responsible veterinarian.
This veterinary medicinal product may cause a transient increase in heart rate up to 2 hours after administration. The safety of the product has not been studied in dogs with diagnosed cardiac disease/dysfunction. Use only according to the benefit-risk assessment by the responsible veterinarian.
The safety of this product in dogs with clinical signs due to the ingestion of foreign materials has not been investigated.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
People with known hypersensitivity to ropinirole should avoid contact with the veterinary medicinal product. Administer the veterinary medicinal product with caution.
The veterinary medicinal product should not be administered by pregnant or breast-feeding women. Ropinirole might reduce the level of prolactin, a hormone that stimulates milk production in pregnant or breast-feeding women.
This veterinary medicinal product can cause eye irritation. Administer the product with caution. In case of accidental eye or skin contact, rinse immediately the affected area with plenty of fresh water. If symptoms occur, seek medical advice and show the package leaflet or the label to the physician.
Pregnancy and lactation :
The safety of this veterinary medicinal product has not been established during pregnancy and lactation in the target species. Ropinirole might reduce the level of prolactin, a hormone that stimulates milk production in pregnant or suckling females. Therefore, use of the product is not recommended during pregnancy or lactation.
Interaction with other medicinal products and other forms of interaction: Inform your veterinarian if your dog is given other medicines.
Other medicines that have antiemetic properties, such as metoclopramide, chlorpromazine, acepromazine, maropitant or antihistamines may diminish the effectiveness of ropinirole.
Overdose (symptoms, emergency procedures, antidotes) :
The tolerance of this veterinary medicinal product has been tested in dogs up to 5 times the recommended dose. Symptoms of overdose consist of the same signs seen as adverse reactions.
If vomiting or some of the adverse reactions (e.g. redness of the eye, increased heart rate or shivering) are prolonged, contact your veterinarian. The effects of ropinirole can be reversed using a specific antidote such as metoclopramide or domperidone. Maropitant does not reverse the clinical signs related to the pharmacological action of ropinirole.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Ask your veterinarian 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 ( . europa. eu/).
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15. OTHER INFORMATION