Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
rivastigmine
Novartis Europharm Limited
N06DA03
rivastigmine
Psychoanaleptics,
Dementia; Alzheimer Disease; Parkinson Disease
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Revision: 46
Authorised
1998-05-11
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Exelon 1.5 mg hard capsules Exelon 3.0 mg hard capsules Exelon 4.5 mg hard capsules Exelon 6.0 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Exelon 1.5 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine. Exelon 3.0 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 3.0 mg rivastigmine. Exelon 4.5 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine. Exelon 6.0 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 6.0 mg rivastigmine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules Exelon 1.5 mg hard capsules Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “EXELON 1,5 mg” on body. Exelon 3.0 mg hard capsules Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “EXELON 3 mg” on body. Exelon 4.5 mg hard capsules Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “EXELON 4,5 mg” on body. Exelon 6.0 mg hard capsules Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “EXELON 6 mg” on body. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of mild to moderately severe Alzheimer’s dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia or dementia associated with Parkinson’s disease. Diagnosis should be made according to current guidelines. Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of th Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Exelon 1.5 mg hard capsules Exelon 3.0 mg hard capsules Exelon 4.5 mg hard capsules Exelon 6.0 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Exelon 1.5 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine. Exelon 3.0 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 3.0 mg rivastigmine. Exelon 4.5 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine. Exelon 6.0 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 6.0 mg rivastigmine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules Exelon 1.5 mg hard capsules Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “EXELON 1,5 mg” on body. Exelon 3.0 mg hard capsules Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “EXELON 3 mg” on body. Exelon 4.5 mg hard capsules Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “EXELON 4,5 mg” on body. Exelon 6.0 mg hard capsules Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “EXELON 6 mg” on body. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of mild to moderately severe Alzheimer’s dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia or dementia associated with Parkinson’s disease. Diagnosis should be made according to current guidelines. Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of th Pročitajte cijeli dokument