País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Pergolide mesilate
CP-Pharma Handelsgesellschaft mbH
QN04BC02
Pergolide mesilate
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
pergolide
2023-07-14
2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Prasequine 1 mg tablets for horses (AT, BE, DE, EE, EL, ES, FR, HU, IE, IT, LT, LV, NL, PT, SK, UK-NI) Prasequin vet. 1 mg tablets for horses (DK, FI, NO, PL, SE) Pras-equine 1 mg tablets for horses (CZ) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Pergolide 1.0 mg equivalent to 1.31 mg pergolide mesilate EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS Lactose monohydrate Croscarmellose sodium Povidone Magnesium stearate Iron oxide yellow (E172) Off-white round and convex tablet with a cross-shaped break line on one side. Tablets can be divided into 2 or 4 equal parts. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Horses (non food-producing) 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Symptomatic treatment of clinical signs associated with Pituitary Pars Intermedia Dysfunction (PPID) (Equine Cushing’s Disease). 3.3 CONTRAINDICATIONS Do not use in horses with known hypersensitivity to pergolide mesilate or other ergot derivatives or to any of the excipients. Do not use in horses less than 2 years of age. 3.4 SPECIAL WARNINGS Appropriate endocrinologic laboratory tests should be conducted as well as evaluation of clinical signs in order to establish a diagnosis of PPID. 3.5 SPECIAL PRECAUTIONS FOR USE 3 Special precautions for safe use in the target species: As the majority of cases of PPID are diagnosed in aged horses, other pathological processes are frequently present. For monitoring and frequency of testing, see section 3.9. Special precautions to be taken by the person administering the veterinary medicinal product to animals: This veterinary medicinal product may cause eye irritation, an irritating smell, or headache after dividing the tablets. Avoid contact with the eyes and inhalation when handling the tablets. Minimise exposure risks when dividing or dissolving tablets, e.g. tablets should not be crushed. In case of contact with skin, wash exposed skin with water. In the event of eye exposure, f Llegiu el document complet