Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
maropitant
Dechra Regulatory B.V.
QA04AD90
maropitant
Cats; Dogs
Alimentary tract and metabolism, Other antiemetics
Dogs:For the treatment and prevention of nausea induced by chemotherapyFor the prevention of vomiting except that induced by motion sicknessFor the treatment of vomiting, in combination with other supportive measuresFor the prevention of perioperative nausea and vomiting and improvement in recovery from general anaesthesia after use of the μ-opiate receptor agonist morphineCats:For the prevention of vomiting and the reduction of nausea, except that induced by motion sicknessFor the treatment of vomiting, in combination with other supportive measures.
Revision: 6
Authorised
2017-06-19
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: PREVOMAX 10 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: Dechra Regulatory B.V. Handelsweg 25 5531 AE Bladel The Netherlands Manufacturer responsible for batch release: Produlab Pharma B.V. Forellenweg 16 4941 SJ Raamsdonksveer The Netherlands Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml solution for injection for dogs and cats Maropitant 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 1 ml contains: ACTIVE SUBSTANCE: Maropitant 10 mg EXCIPIENTS: Benzyl alcohol (E1519) 11.1 mg A clear, colourless to light yellow solution. 4. INDICATION(S) Dogs • 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. 17 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS Pain at injection site may occur when injected subcutaneously. In cats, moderate to severe response to injection is very commonly observed (in approximately one third of cats). In very rare cases, anaphylactic type reactions (allergic oedema, urticaria, erythema, collapse, dyspnoea, pale mucous membranes) may occur. 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 Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml solution for injection for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Maropitant 10 mg EXCIPIENTS: Benzyl alcohol (E1519) 11.1 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection A clear, colourless to light yellow solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Dogs • 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. 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. 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. 3 The use of the veterinary medicinal product against vomiting due to motion sickness is not recommended. Dogs: Although maropitant has been demonstrated to be effective in both the treatment and prevention of emesis induced by chemotherapy, it was found more efficacious if used preventively. Therefore, it is recommended to administer the veterinary medicinal product prior to administration of the chemotherapeutic agent Прочетете целия документ