Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
ropinirole hydrochloride
Orion Corporation
QN04BC04
ropinirole
Dogs
Dopaminergic agents, Dopamine agonists
Induction of vomiting in dogs.,
Revision: 1
Authorised
2018-04-13
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: CLEVOR 30 MG/ML EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINER FOR DOGS 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 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution in single-dose container for dogs Ropinirole (ropinirol) 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. 4. INDICATION(S) For induction of vomiting in dogs. 5. CONTRAINDICATIONS Your dog must not be given this medicine if it: - 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 - 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) - 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. 19 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) Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution in single-dose container for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains: ACTIVE SUBSTANCE: Ropinirole (ropinirol) 30 mg (equivalent to 34.2 mg ropinirole hydrochloride) EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops solution in single-dose container. Very slightly yellow to yellow clear solution. pH 3.8–4.5 and osmolality 300–400 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Induction of vomiting in dogs. 4.3 CONTRAINDICATIONS Do not use in dogs with depression of the central nervous system, seizures or other marked neurologic impairments that could lead to aspiration pneumonia. Do not use in dogs which are hypoxic, dyspnoeic or lacking pharyngeal reflexes. Do not use in cases of the ingestion of sharp foreign objects, corrosive agents (acids or alkalis), volatile substances or organic solvents. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES 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. Based on the clinical trial results, most dogs are expected to respond to a single dose of the veterinary medicinal product; however, a small proportion of dogs will require a second dose to induce vomiting. A very small proportion of dogs may fail to respond to the treatment despite administration of a second dose. It is not recommended to administer further doses to these dogs. Please refer to sections 4.9 and 5.1 for further information. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals This veterinary medicinal product may cause a transient in Aqra d-dokument sħiħ