Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
desoxycortone pivalate
Dechra Regulatory B.V.
QH02AA03
desoxycortone
Dogs
Corticosteroids for systemic use
For use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison's disease).
Revision: 4
Authorised
2015-11-06
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: ZYCORTAL 25 MG/ML PROLONGED-RELEASE SUSPENSION 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: Dechra Regulatory B.V. Handelsweg 25 5531 AE Bladel The Netherlands Manufacturer responsible for batch release: Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel The Netherlands Dales Pharmaceuticals Limited Snaygill Industrial Estate Keighley Road Skipton North Yorkshire BD23 2RW United Kingdom 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Zycortal 25 mg/ml prolonged-release suspension for injection for dogs Desoxycortone pivalate 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) ACTIVE SUBSTANCE: Desoxycortone pivalate 25 mg/ml EXCIPIENTS: Chlorocresol 1 mg/ml Zycortal is an opaque white suspension. 4. INDICATION(S) For use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison’s disease). 5. CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients. 17 6. ADVERSE REACTIONS Polydipsia (excessive drinking) and polyuria (excessive urination) were very common adverse reactions in a clinical trial. Inappropriate urination, lethargy, alopecia (hair loss), panting, vomiting, decreased appetite, anorexia, decreased activity, depression, diarrhoea, polyphagia (excessive eating), shaking, tiredness and urinary tract infections were common adverse reactions in a clinical trial. . Injection site pain has been reported uncommonly in post-authorisation spontaneous reports following the administration of Zycortal. Pancreas disorders have been reported rarely in post-authorisation spontaneous reports following use of Zycortal. The concurrent administration of glucocorticoids may contribute to these signs. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 anima Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zycortal 25 mg/ml prolonged-release suspension for injection for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Desoxycortone pivalate 25 mg/ml EXCIPIENTS: Chlorocresol 1 mg/ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release suspension for injection. Opaque white suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison’s disease). 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Before starting treatment with the veterinary medicinal product, it is important that Addison’s disease has been definitively diagnosed. Any dog presenting with severe hypovolaemia, dehydration, pre-renal azotaemia and inadequate tissue perfusion (also known as “Addisonian crisis”) must be rehydrated with intravenous fluid (saline) therapy before starting treatment with the veterinary medicinal product. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Use with caution in dogs with congestive heart disease, severe renal disease, primary hepatic failure or oedema. Special precautions to be taken by the person administering the veterinary medicinal product to animals Avoid contact with the eyes and skin. In case of accidental spillage onto the skin or eyes, wash the affected area with water. If irritation occurs, seek medical advice immediately and show the package leaflet or the label to the physician. 3 This veterinary medicinal product may cause pain and swelling at the injection site if accidentally self-administered. This veterinary medicinal product may cause adverse effects on male reproductive organs and, as a result, fertility. This veterinary medicinal product may cause ad Aqra d-dokument sħiħ