Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
GALANTAMINE HBR20.51 MG EQV GALANTAMINE BASE
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
N06DA04
16 MG
CAPSULE, COATED, EXTENDED RELEASE
GALANTAMINE HBR20.51 MG EQV GALANTAMINE BASE 16 MG
ORAL
Prescription Only
JANSSEN PHARMACEUTICA NV
ACTIVE
2004-08-10
PRODUCT NAME REMINYL ® (galantamine hydrobromide) DOSAGE FORMS AND STRENGTHS ORAL SOLUTION Clear, colourless solution containing galantamine hydrobromide, equivalent to 4 mg/ml galantamine base. PROLONGED-RELEASE CAPSULES FOR ORAL USE _8 MG CAPSULES _ White opaque, size 4 hard gelatin capsules with the inscription “GAL 8”, containing white to off-white pellets. Each capsule contains galantamine hydrobromide, equivalent to 8 mg galantamine base. _16 MG CAPSULES _ Pink opaque, size 2 hard gelatin capsules with the inscription “GAL 16”, containing white to off-white pellets. Each capsule contains galantamine hydrobromide, equivalent to 16 mg galantamine base. _24 MG CAPSULES _ Caramel opaque, size 1 hard gelatin capsules with the inscription “GAL 24”, containing white to off-white pellets. Each capsule contains galantamine hydrobromide, equivalent to 24 mg galantamine base. For excipients, see _List of Excipients_. CLINICAL INFORMATION INDICATIONS REMINYL ® is indicated for the treatment of mild to moderately severe dementia of the Alzheimer type. DOSAGE AND ADMINISTRATION DOSAGE – ADULTS Ensure adequate fluid intake during treatment. _STARTING DOSE _ The recommended starting dose of REMINYL ® oral solution is 4 mg twice a day for 4 weeks. The recommended starting dose of REMINYL ® prolonged-release capsules is 8 mg once daily for 4 weeks. The dose of REMINYL ® should be gradually increased to the maintenance dose to minimize side effects. _MAINTENANCE DOSE _ The initial maintenance dose is 16 mg/day (8 mg twice a day) and patients should be maintained on 16 mg/day fo Les hele dokumentet
PRODUCT NAME REMINYL ® (galantamine hydrobromide) DOSAGE FORMS AND STRENGTHS PROLONGED-RELEASE CAPSULES FOR ORAL USE _ _ _8 MG CAPSULES _ White opaque, size 4 hard gelatin capsules with the inscription “GAL 8”, containing white to off-white pellets. Each capsule contains galantamine hydrobromide, equivalent to 8 mg galantamine base. _16 MG CAPSULES _ Pink opaque, size 2 hard gelatin capsules with the inscription “GAL 16”, containing white to off-white pellets. Each capsule contains galantamine hydrobromide, equivalent to 16 mg galantamine base. _24 MG CAPSULES _ Caramel opaque, size 1 hard gelatin capsules with the inscription “GAL 24”, containing white to off-white pellets. Each capsule contains galantamine hydrobromide, equivalent to 24 mg galantamine base. For excipients, see _List of Excipients_ . CLINICAL INFORMATION INDICATIONS REMINYL ® is indicated for the treatment of mild to moderately severe dementia of the Alzheimer type. DOSAGE AND ADMINISTRATION DOSAGE – ADULTS Ensure adequate fluid intake during treatment. _ _ _STARTING DOSE _ The recommended starting dose of REMINYL ® prolonged-release capsules is 8 mg once daily for 4 weeks. The dose of REMINYL ® should be gradually increased to the maintenance dose to minimize side effects. _MAINTENANCE DOSE _ The initial maintenance dose is 16 mg/day (16 mg once a day with capsules) and patients should be maintained on 16 mg/day for at least 4 weeks. An increase to the maximum recommended maintenance dose of 24 mg/day (24 mg once a day with capsules) should be considered after appropriate assessment including evaluation of clinical benefit and tolerability. TREATMENT WITHDRAWAL There is no rebound effect after abrupt discontinuation of treatment (e.g. in preparation for surgery). _ _ RE-INITIATION OF THERAPY If the treatment is interrupted for longer than several days, treatment should be re- initiated with the lowest daily dose and gradually increased to the maximum tolerated dose to achieve the desired clinical effect. The incidence and seve Les hele dokumentet