Zycortal 25 mg/ml Prolonged-Release Injection 4ml

Clinical particulars Target species Dogs Indications for use For use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison's disease). Contraindications Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 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. 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. 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 adverse developmental effects on unborn children and neonates. Pregnant and breast-feeding women should avoid administration of this veterinary medicinal product. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Adverse reactions Polydipsia and polyuria were very common adverse reactions in a clinical trial. Inappropriate urination, lethargy, alopecia, panting, vomiting, decreased appetite, anorexia, decreased activity, depression, diarrhoea, polyphagia, 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 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). Use during pregnancy, lactation or lay The safety of the veterinary medicinal product has not been established during breeding, pregnancy or lactation. Therefore, use only according to the benefit/risk assessment by the responsible veterinarian. Interactions Use with caution when administering Zycortal concurrently with medicinal products which affect either serum sodium or potassium concentrations, or cellular transportation of sodium or potassium, for example: trimethoprim, amphotericin B, digoxin or insulin.
Vat Rate: 20%