Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Dexmedetomidine hydrochloride
Le Vet Beheer B.V.
QN05CM18
dexmedetomidine
Psycholeptics, Hypnotics and sedatives
Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats. Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures. Premedication in dogs and cats before induction and maintenance of general anaesthesia.
Revision: 5
Authorised
2016-08-12
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET Sedadex 0.1 mg/ml solution for injection for dogs and cats 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Le Vet Beheer B.V. Wilgenweg 7 3421 TV Oudewater The Netherlands Manufacturer responsible for batch release: Produlab Pharma B.V. Forellenweg 16 4941 SJ Raamsdonksveer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.1 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 1 ml contains: ACTIVE SUBSTANCE: Dexmedetomidine hydrochloride 0.1 mg (equivalent to dexmedetomidine 0.08 mg) EXCIPIENTS: Methyl parahydroxybenzoate (E 218) 2.0 mg Propyl parahydroxybenzoate 0.2 mg Clear, colourless solution for injection. 4. INDICATION(S) Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats. Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures. Premedication in dogs and cats before induction and maintenance of general anaesthesia. 5. CONTRAINDICATIONS Do not use in animals with cardiovascular disorders. Do not use in animals with severe systemic disease or in animals that are moribund. 31 Do not use in case of known hypersensitivity to the active substance or to any of the excipients. 6. ADVERSE REACTIONS Adverse reactions in dogs and cats Pulmonary oedema has been reported rarely. Corneal opacities during sedation may occur (see also section 4.5). By virtue of its α2-adrenergic activity, dexmedetomidine causes a decrease in heart rate and body temperature, which has been reported very rarely in spontaneous reports. Bradypnoea has been reported very rarely in spontaneous reports. Blood pressure will increase initially and then return to normal or below normal. Due to peripheral vasoconstriction and venou Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.1 mg/ml solution for injection for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Dexmedetomidine hydrochloride 0.1 mg (equivalent to dexmedetomidine 0.08 mg) EXCIPIENTS: Methyl parahydroxybenzoate (E 218) 2.0 mg Propyl parahydroxybenzoate 0.2 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats. Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures. Premedication in dogs and cats before induction and maintenance of general anaesthesia. 4.3 CONTRAINDICATIONS Do not use in animals with cardiovascular disorders. Do not use in animals with severe systemic disease or in animals that are moribund. Do not use in case of known hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The administration of dexmedetomidine to puppies younger than 16 weeks and kittens younger than 12 weeks has not been studied. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Treated animals should be kept warm and at a constant temperature, both during the procedure and recovery. It is recommended that animals are fasted for 12 hours prior to Sedadex administration. Water may be given. After treatment, the animal should not be given water or food before it is able to swallow. Corneal opacities may occur during sedation. The eyes should be protected by a suitable eye lubricant. To be used with precaution in elderly animals. The safety of dexmedetomidine has not been established in males intended for breeding. Nervous, aggressive or excited a Aqra d-dokument sħiħ