Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
lokivetmab
Zoetis Belgium SA
QD11AH91
lokivetmab
Dogs
Other dermatological preparations, Agents for dermatitis, excluding corticosteroids
Treatment of clinical manifestations of atopic dermatitis in dogs.
Revision: 6
Authorised
2017-04-25
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: CYTOPOINT 10 MG SOLUTION FOR INJECTION FOR DOGS CYTOPOINT 20 MG SOLUTION FOR INJECTION FOR DOGS CYTOPOINT 30 MG SOLUTION FOR INJECTION FOR DOGS CYTOPOINT 40 MG SOLUTION FOR INJECTION FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and Manufacturer responsible for batch release: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM 2. NAME OF THE VETERINARY MEDICINAL PRODUCT CYTOPOINT 10 mg solution for injection for dogs CYTOPOINT 20 mg solution for injection for dogs CYTOPOINT 30 mg solution for injection for dogs CYTOPOINT 40 mg solution for injection for dogs lokivetmab 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) ACTIVE SUBSTANCE: Each vial of 1 ml contains: CYTOPOINT 10 mg: Lokivetmab* 10 mg CYTOPOINT 20 mg: Lokivetmab* 20 mg CYTOPOINT 30 mg: Lokivetmab* 30 mg CYTOPOINT 40 mg: Lokivetmab* 40 mg *Lokivetmab is a caninised monoclonal antibody expressed through recombinant techniques in Chinese hamster ovary (CHO) cells 4. INDICATION(S) Treatment of pruritus associated with allergic dermatitis in dogs. Treatment of clinical manifestations of atopic dermatitis in dogs. 5. CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs less than 3 kg bodyweight. 18 6. ADVERSE REACTIONS Hypersensitivity reactions (anaphylaxis, facial oedema, urticaria) have been reported to occur in rare cases from spontaneous reports. In such cases appropriate treatment should be administered immediately. Vomiting and/or diarrhoea have been reported to occur in rare cases from spontaneous reports and may occur in connection with hypersensitivity reactions. Treatment should be administered as needed. Neurological signs (seizure, convulsion or ataxia) have been rarely observed in spontaneous reports following use of the veterinary medicinal product. Applicat Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CYTOPOINT 10 mg solution for injection for dogs CYTOPOINT 20 mg solution for injection for dogs CYTOPOINT 30 mg solution for injection for dogs CYTOPOINT 40 mg solution for injection for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each vial of 1 ml contains: CYTOPOINT 10 mg: Lokivetmab* 10 mg CYTOPOINT 20 mg: Lokivetmab* 20 mg CYTOPOINT 30 mg: Lokivetmab* 30 mg CYTOPOINT 40 mg: Lokivetmab* 40 mg *Lokivetmab is a caninised monoclonal antibody expressed through recombinant techniques in Chinese hamster ovary (CHO) cells EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The product should appear clear to opalescent without any visible particle. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of pruritus associated with allergic dermatitis in dogs. Treatment of clinical manifestations of atopic dermatitis in dogs. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs less than 3 kg bodyweight. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Lokivetmab may induce transient or persistent anti-drug antibodies. The induction of such antibodies is uncommon and may have no effect (transient anti-drug antibodies) or may result in a noticeable 3 decrease in efficacy (persistent anti-drug antibodies) in animals that responded to treatment previously. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Avoidance or elimination of the allergen is an important consideration in the successful treatment of allergic dermatitis. When treating pruritus associated with allergic dermatitis with lokivetmab, investigate and treat any underlying causes (e.g. flea allergic dermatitis, contact dermatitis, food hypersensitivity); this product is not intended to be used as a long-term maintenance therapy if the off Прочетете целия документ