Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
maropitant citrate
Zoetis Belgium SA
QA04AD90
maropitant
Dogs; Cats
Alimentary tract and metabolism
Tablets Dogs:For the prevention of nausea induced by chemotherapy.For the prevention of vomiting induced by motion sickness.For the prevention and treatment of vomiting, in conjunction with Cerenia solution for injection and in combination with other supportive measures.Solution for injectionDogs:For the treatment and prevention of nausea induced by chemotherapy.For the prevention of vomiting except that induced by motion sickness.For the treatment of vomiting, in combination with other supportive measures.For the prevention of perioperative nausea and vomiting and improvement in recovery from general anaesthesia after use of the μ-opiate receptor agonist morphine.Cats:For the prevention of vomiting and the reduction of nausea, except that induced by motion sickness.For the treatment of vomiting, in combination with other supportive measures.
Revision: 21
Authorised
2006-09-28
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cerenia 16 mg tablets for dogs Cerenia 24 mg tablets for dogs Cerenia 60 mg tablets for dogs Cerenia 160 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each tablet contains 16 mg, 24 mg, 60 mg or 160 mg maropitant as maropitant citrate monohydrate. EXCIPIENTS: Each tablet contains 0.075% w/w Sunset Yellow (E110) as a colorant. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pale orange tablet The tablets have a score line allowing the tablet to be halved, with the letters “MPT” and figures denoting the quantity of maropitant on one side, the reverse side is blank. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES • For the prevention of nausea induced by chemotherapy. • For the prevention of vomiting induced by motion sickness. • For the prevention and treatment of vomiting, in conjunction with Cerenia solution for injection and in combination with other supportive measures. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vomiting can be associated with serious, severely debilitating conditions including gastrointestinal obstructions; therefore, appropriate diagnostic evaluations should be employed. Cerenia tablets have been shown to be effective in the treatment of emesis, however where the frequency of vomiting is high, orally administered Cerenia may not be absorbed before the next vomiting event occurs. It is therefore recommended to initiate the treatment of emesis with Cerenia solution for injection. Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary and supportive measures, such as dietary control and fluid replacement therapy while addressing the underlying causes of the vomiting. The safety of maropitant during treatment beyond 5 days has not been explored in the target population (i.e. young dogs suffering from vira Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cerenia 16 mg tablets for dogs Cerenia 24 mg tablets for dogs Cerenia 60 mg tablets for dogs Cerenia 160 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Each tablet contains 16 mg, 24 mg, 60 mg or 160 mg maropitant as maropitant citrate monohydrate. Excipients: Each tablet contains 0.075% w/w Sunset Yellow (E110) as a colorant. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pale orange tablet . The tablets have a score line allowing the tablet to be halved , with the letters “MPT” and figures denoting the quantity of maropitant on one side, the reverse side is blank. 4. CLINICAL PARTICULARS 4.1 Target species Dogs. 4.2 Indications for use, specifying the target species • For the prevention of nausea induced by chemotherapy. • For the prevention of vomiting induced by motion sickness. • For the prevention and treatment of vomiting, in conjunction with Cerenia solution for injection and in combination with other supportive measures. 4.3 Contraindications None. 4.4 Special warnings for each target species Vomiting can be associated with serious, severely debilitating conditions includ ing gastrointestinal obstructions; therefore, appropriate diagnostic evaluations should be employed. Cerenia tablets have been shown to be effective in the treatment of emesis, however where the frequency of vomiting is high, orally administered Cerenia may not be absorbed before the next vomiting event occurs. It is therefore recommended to initiate the treatment of emesis with Cerenia s olution for injection. Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary and supportive measures, such as dietary control and fluid replacement therapy while addressing the underlying causes of the vomiting. The safety of maropitant during treatment beyond 5 days has not been explored in the target population (i.e. young dogs suffering from Прочетете целия документ