Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Tetracosactide
Dechra Regulatory BV
QH01AA02
Tetracosactide
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Hormone
Authorized
2019-12-16
Issued: December 2019 AN: 01107/2018 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cosacthen 0.25 mg/ml solution for injection for dogs Cosacthen (EE, LT, LV) Cosacthen vet 0.25 mg/ml solution for injection for dogs (DK, FI, NO, SE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Active substance: Tetracosactide 0.25 mg (equivalent to 0.28 mg tetracosactide hexaacetate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the evaluation of adrenocortical function in dogs. 4.3 CONTRAINDICATIONS Do not use in pregnant animals, see section 4.7. Do not use in cases of hypersensitivity to the active substances, or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in ani m als The safety of the product has not been established in dogs under 5 months of age, or weighing less than 4.5 kg. Safety of the product has not been established in dogs with diabetes mellitus or hypothyroidism. Page 1 of 5 Issued: December 2019 AN: 01107/2018 Use only according to the benefit /risk assessment by the responsible veterinarian. Special precautions to be taken by the person ad m inistering the veterinary m edicinal product to ani m als Tetracosactide can cause hypersensitivity in people, particularly those with existing allergic disorders, such as asthma. People with such allergic disorders, or a known hypersensitivity to tetracosactide, ACTH or any of the excipients, should avoid contact with the product. If you develop clinical symptoms following exposure, such as skin reactions, nausea, vomiting, oedema and dizziness, or any signs of anaphylactic shock, you should seek medical advice immediately and show the package leaflet or label to the physician. Wash hands after use. Tetracosactide has not been tested in reproductive or dev Read the complete document