국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rivastigmine hydrogen tartrate
Sandoz Ltd
N06DA03
Rivastigmine hydrogen tartrate
1.5mg
Capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04110000; GTIN: 5050650080018 5050650080025
OBJECT 1 RIVASTIGMINE SANDOZ 1.5 MG HARD CAPSULES Summary of Product Characteristics Updated 26-Aug-2016 | Sandoz Limited 1. Name of the medicinal product Rivastigmine Sandoz 1.5 mg hard capsules Rivastigmine Sandoz 3 mg hard capsules Rivastigmine Sandoz 4.5 mg hard capsules Rivastigmine Sandoz 6 mg hard capsules 2. Qualitative and quantitative composition Each capsule contains rivastigmine hydrogen tartrate corresponding to 1,5mg rivastigmine. Each capsule contains rivastigmine hydrogen tartrate corresponding to 3mg rivastigmine. Each capsule contains rivastigmine hydrogen tartrate corresponding to 4,5mg rivastigmine. Each capsule contains rivastigmine hydrogen tartrate corresponding to 6mg rivastigmine. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Hard capsule Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint RIV 1.5 mg on the body. Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint RIV 3 mg on the body. Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint RIV 4.5 mg on the body. Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint RIV 6 mg on the body. 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 the medicinal product by the patient. Posology Rivastigmine should be administered twice a day, with morning and evening meals 전체 문서 읽기