Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
CABERGOLINE
Pharmacia Ireland
1 Milligram
Tablets
1999-10-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cabaser 1 mg Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1mg of Cabergoline. Each tablet also contains 75.4mg of anhydrous lactose. For full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Tablets White, oval, both sides concave tablets, one side scored and engraved “7” on the left of the breakline and “01” on the right of it. The tablet can be divided into equal halves 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TREATMENT OF PARKINSON'S DISEASE If treatment with a dopamine agonist is being considered, Cabaser is indicated as second line therapy in patients who are intolerant or fail treatment with a non-ergot compound, as monotherapy, or as adjunctive treatment to levodopa plus dopa-decarboxylase inhibitor, in the management of the signs and symptoms of Parkinson’s disease. Treatment should be initiated under specialist supervision. The benefit of continued treatment should be regularly reassessed taking into account the risk of fibrotic reactions and valvulopathy (see sections 4.3, 4.4 and 4.8). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cabaser is for oral administration. Since the tolerability of dopaminergic agents is improved when administered with food, it is recommended that Cabaser be taken with meals. Cabaser is intended for chronic, long term treatment. ADULTS AND ELDERLY PATIENTS As expected for dopamine agonists, dose response for both efficacy and side effects appears to be linked to individual sensitivity. Optimization of dose should be obtained through slow initial dose titration, from starting doses of 1 mg daily. The dosage of concurrent levodopa may be gradually decreased, while the dosage of Cabaser is increased, until the optimum balan Przeczytaj cały dokument