Kraj: Singapur
Język: angielski
Źródło: HSA (Health Sciences Authority)
CARBIDOPA MONOHYDRATE EQV CARBIDOPA; Entacapone; Levodopa
ORION PHARMA (SG) PTE. LTD.
40.5 mg (corresponds to 37.5 mg carbidopa)
TABLET, FILM COATED
CARBIDOPA MONOHYDRATE EQV CARBIDOPA 37.5 mg; Entacapone 200 mg; Levodopa 150 mg
ORAL
Prescription Only
Orion Corporation, Orion Pharma (Espoo site)
ACTIVE
2005-08-29
STALEVO Pharmacotherapeutic group: Anti-parkinsonian dopaminergic medicinal product (ATC code: N04B A03). COMPOSITION AND PHARMACEUTICAL FORM Stalevo 50 mg/12.5 mg/200 mg each tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone. They are brownish- or greyish-red, round, convex, unscored film-coated tablets marked with ‘LCE 50’ on one side. Stalevo 100 mg/25 mg/200 mg each tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone. They brownish- or greyish-red, oval-shaped, unscored film-coated tablets marked with ‘LCE 100’ on one side. Stalevo 150 mg/37.5 mg/200 mg each tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone. They are brownish- or greyish-red, elongated-ellipse shaped unscored film-coated tablets marked with ‘LCE 150’ on one side. Stalevo 200 mg/50 mg/200 mg each tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone. They are dark brownish- or greyish-red, oval-shaped unscored film coated tablets marked with ‘LCE 200’ on one side. For a full list of excipients, see section EXCIPIENTS. Certain dosage strengths may not be available in all countries. INDICATIONS Stalevo is indicated for the treatment of patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment. DOSAGE AND ADMINISTRATION METHOD OF ADMINISTRATION Each tablet is to be taken orally either with or without food (see section PHARMACOKINETICS). One tablet contains one treatment dose. The tablets should always be swallowed whole. The optimum daily dosage must be determined by careful titration of levodopa in each patient. The daily dose should preferably be optimised using one of the four available tablet strengths (50/12.5 Przeczytaj cały dokument
NAME OF THE MEDICINAL PRODUCT Stalevo ® COMPOSITION AND PHARMACEUTICAL FORM Stalevo 50 mg/12.5 mg/200 mg each tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone. They are brownish- or greyish-red, round, convex, unscored film-coated tablets marked with ‘LCE 50’ on one side. Stalevo 100 mg/25 mg/200 mg each tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone. They brownish- or greyish-red, oval- shaped, unscored film-coated tablets marked with ‘LCE 100’ on one side. Stalevo 150 mg/37.5 mg/200 mg each tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone. They are brownish- or greyish-red, elongated-ellipse shaped unscored film-coated tablets marked with ‘LCE 150’ on one side. Stalevo 200 mg/50 mg/200 mg each tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone. They are dark brownish- or greyish-red, oval-shaped unscored film coated tablets marked with ‘LCE 200’ on one side. For a full list of excipients, see section LIST OF EXCIPIENTS. Certain dosage strengths may not be available in all countries. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Stalevo is indicated for the treatment of patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment. POSOLOGY AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION Each tablet is to be taken orally either with or without food (see section PHARMACOKINETICS PROPERTIES). One tablet contains one treatment dose. The tablets should always be swallowed whole. The optimum daily dosage must be determined by careful titration of levodopa in each patient. The daily dose should preferably be optimised using one of the four available tablet strengths (50/12.5/200 mg, 100/25/200 mg, 150/37.5/200 mg or 200/50/200mg levodopa/ carbidopa/ entacapone). Patients should be instructed to take only one Stalevo tablet per dose administration. Patients receiving less than 70-100 mg carbid Przeczytaj cały dokument