देश: यूरोपीय संघ
भाषा: अंग्रेज़ी
स्रोत: EMA (European Medicines Agency)
Dexmedetomidine hydrochloride
Orion Corporation
QN05CM18
dexmedetomidine
Dogs; Cats
Psycholeptics
Noninvasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.Premedication in cats before induction and maintenance of general anaesthesia with ketamine.Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.Premedication in dogs before induction and maintenance of general anaesthesia.
Revision: 20
Authorised
2002-08-30
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET DEXDOMITOR 0.1 mg/ml solution for injection 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland 2. NAME OF THE VETERINARY MEDICINAL PRODUCT DEXDOMITOR 0.1 mg/ml solution for injection dexmedetomidine hydrochloride 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance: One ml contains 0.1 mg dexmedetomidine hydrochloride equivalent to 0.08 mg dexmedetomidine. List of excipients: Methyl parahydroxybenzoate (E 218) 2.0 mg/ml Propyl parahydroxybenzoate (E 216) 0.2 mg/ml 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. Do not use in case of known hypersensitivity to the active substance or to any of the excipients. 6. ADVERSE REACTIONS By virtue of its a 2 -adrenergic activity, dexmedetomidine causes decreases in heart rate and body temperature. In some dogs and cats a decrease in respiratory rate may occur. Rare instances of pulmonary oedema have been reported. Blood pressure will increase initially and then return to normal or below normal. Due to peripheral vasoconstriction and venous desaturation in the presence of normal arterial oxygenation, the mucous membranes may appear pale and/or with a blue tinge. 31 Vomiting may occur 5–10 minutes after injection. Some dogs and cats may also vomit at the time of recovery. Muscle tremors may occur during sedation. When dexmedetomidine and ketamine are used sequentially, with a 10 minute पूरा दस्तावेज़ पढ़ें
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT DEXDOMITOR 0.1 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: One ml contains 0.1 mg dexmedetomidine hydrochloride equivalent to 0.08 mg dexmedetomidine. EXCIPIENTS: Methyl parahydroxybenzoate (E 218) 2.0 mg/ml Propyl parahydroxybenzoate (E 216) 0.2 mg/ml 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. The safety of dexmedetomidine has not been established in males intended for breeding. In cats, corneal opacities may occur during sedation. The eyes should be protected by a suitable eye lubricant. 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 Dexdomitor administration. Water may be given _._ After treatment, the animal should not be given water or food before it is able to swallow. The eyes should be protected by a suitable lubricant. To be used w पूरा दस्तावेज़ पढ़ें