País: Unión Europea
Idioma: inglés
Fuente: EMA (European Medicines Agency)
Dexmedetomidine hydrochloride
Orion Corporation
QN05CM18
dexmedetomidine
Dogs
Nervous system, Other hypnotics and sedatives
Alleviation of acute anxiety and fear associated with noise in dogs.
Revision: 8
Authorised
2015-06-10
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: SILEO 0.1 MG/ML OROMUCOSAL GEL 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 Sileo 0.1 mg/ml oromucosal gel for dogs dexmedetomidine hydrochloride 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) ACTIVE SUBSTANCE: Dexmedetomidine hydrochloride 0.1 mg/ml (equivalent to 0.09 mg/ml dexmedetomidine). Other ingredients: Brilliant blue (E133) and tartrazine (E102). Sileo is a translucent, green oromucosal gel. 4. INDICATION(S) For the alleviation of acute anxiety and fear associated with noise in dogs. 5. CONTRAINDICATIONS Your dog should not be given Sileo if it: - has severe liver, kidney or heart disease. - is hypersensitive to the active substance or to any of the excipients. - is drowsy due to previous medication. 6. ADVERSE REACTIONS Sileo may cause the following adverse reactions. Common reactions: - paleness of the mucous membranes at the application site - tiredness (sedation) - vomiting - uncontrolled urination. Uncommon reactions: - distress 22 - swelling around the eyes - drowsiness - loose stools. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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). 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. 7. TARGET SPECIES Dogs 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Oromucosal gel. Sileo is administere Leer el documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Sileo 0.1 mg/ml oromucosal gel for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of the oromucosal gel contains: ACTIVE SUBSTANCE: Dexmedetomidine hydrochloride 0.1 mg (equivalent to 0.09 mg dexmedetomidine). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oromucosal gel. Translucent, green gel. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Alleviation of acute anxiety and fear associated with noise in dogs. 4.3 CONTRAINDICATIONS Do not use in dogs with severe cardiovascular disorders. Do not use in dogs with severe systemic disease (graded as ASA III-IV) e.g. end stage renal or liver failure. Do not use in known cases of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs obviously sedated from previous dosing. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals If the oromucosal gel is swallowed it will become ineffective. Therefore feeding the dog or giving it treats within 15 minutes after administration of the gel should be avoided. In case the gel is swallowed the dog can be given another dose if necessary 2 hours after the previous dose. In extremely nervous, excited or agitated animals, the levels of endogenous catecholamines are often high. The pharmacological response elicited by alpha-2 agonists (e.g. dexmedetomidine) in such animals may be reduced. 3 The safety of administering dexmedetomidine to puppies younger than 16 weeks and dogs over 17 years of age has not been studied. Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental ingestion or prolonged mucosal contact, 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. Avoid skin, eye or mu Leer el documento completo