Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Maropitant
CP-Pharma Handelsgesellschaft mbH
QA04AD90
Maropitant
10 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
maropitant
Authorised
2019-02-01
2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetemex 10 mg/ml solution for injection for dogs and cats (AT, CZ, ES, FR, HU, IE, IT, NL, PL, PT, SK, UK) Vetemex vet 10 mg/ml solution for injection for dogs and cats (BE, DK, FI, SE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Maropitant 10 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUC t Benzyl alcohol (E1519) 11.1 mg Betadex sulfobutyl ether sodium Citric acid, anhydrous Sodium hydroxide (for pH-adjustment) Water for injection Clear, colourless to light yellow solution for injection. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Dogs and cats. 3.2 INDICATIONS FOR USE FOR EACH 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. 3.3 CONTRAINDICATIONS None. 3.4 SPECIAL WARNINGS Vomiting can be associated with serious, severely debilitating conditions including gastrointestinal obstructions; therefore, appropriate diagnostic evaluations should be employed. 3 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 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 tre Lue koko asiakirja