País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Ropinirole hydrochloride 0.57mg equivalent to 0.5 mg ropinirole
Accord Healthcare NZ Ltd
Ropinirole hydrochloride 0.57 mg (equivalent to 0.5 mg ropinirole)
0.5 mg
Film coated tablet
Active: Ropinirole hydrochloride 0.57mg equivalent to 0.5 mg ropinirole Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 03B82930
Blister pack, Alu-Alu pack of 7's, 42 tablets
Prescription
Prescription
Urquima SA
Ropaccord Tablets is indicated for the treatment of Parkinson's disease.
Package - Contents - Shelf Life: Blister pack, Alu-Alu pack of 7's - 42 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 84 tablets - 24 months from date of manufacture stored at or below 25°C. Store in a dry place, away from direct light 6 months opened stored at or below 25°C
2009-11-03
Ropinirole Tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg and 5 mg Ver 2.0 -2013- Page 1 of 9 DATA SHEET ROPACCORD Ropinirole hydrochloride 0.25mg, 0.5mg, 1mg, 2mg and 5mg tablets _ _ PRESENTATION Ropaccord Tablets are presented as round, biconvex, film coated tablets plain on both sides containing ropinirole hydrochloride equivalent to 0.25, 0.5, 1.0, 2.0 or 5.0mg ropinirole (as hydrochloride). Ropaccord tablets contain lactose, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, hypromellose, macrogol as excipients. The 0.25mg tablets also contain polysorbate. Colouring agents are also contained in the film coating as follows: 0.25mg tablets (White to off white) contains titanium dioxide. 0.5mg tablets (yellow) contains titanium dioxide, iron oxide yellow, iron oxide red, indigo carmine aluminium lake. 1.0mg tablets (green) contains titanium dioxide, iron oxide yellow, indigo carmine aluminium lake. 2.0mg tablets (pink) contains titanium dioxide, iron oxide yellow, iron oxide red. 5.0mg tablets (blue) contains titanium dioxide, indigo carmine aluminium lake. Ropaccord Tablets are presented in Alu/Alu blister pack and HDPE bottle. CLINICAL PARTICULARS _THERAPEUTIC INDICATIONS _ Ropaccord Tablets is indicated for the treatment of Parkinson's disease. Ropinirole is effective as early therapy in patients requiring dopaminergic therapy. In a comparative study, ropinirole was superior to bromocriptine. When these two drugs were administered concomitantly with selegiline there was no difference between them. Ropinirole Tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg and 5 mg Ver 2.0 -2013- Page 2 of 9 Ropaccord Tablets delays the need for initiation of _L_-dopa therapy. As adjunctive treatment of _L_-dopa, Ropaccord Tablets enhances the efficacy of _L_-dopa, including control of "on-off" fluctuations and "end of dose" effects associated with chronic _ L_-dopa therapy and permits reduction in daily _ L_-dopa dose. _POSOLOGY AND METHOD OF ADMINISTRATION _ Individual dose titration against efficacy and to Leia o documento completo