Maa: Singapore
Kieli: englanti
Lähde: HSA (Health Sciences Authority)
Vortioxetine hydrobromide eqv Vortioxetine
LUNDBECK SINGAPORE PTE. LTD.
N06AX26
TABLET, FILM COATED
Vortioxetine hydrobromide eqv Vortioxetine 10 mg
ORAL
Prescription Only
H. Lundbeck A/S
ACTIVE
2022-07-20
H. Lundbeck A/S Vortioson ® 5mg, 10mg, 20mg film-coated tablets 1. NAME OF THE MEDICINAL PRODUCT Vortioson 5 mg film-coated tablets Vortioson 10 mg film-coated tablets Vortioson 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5 MG FILM-COATED TABLETS Each film-coated tablet contains vortioxetine hydrobromide equivalent to 5 mg vortioxetine. 10 MG FILM-COATED TABLETS Each film-coated tablet contains vortioxetine hydrobromide equivalent to 10 mg vortioxetine. 20 MG FILM-COATED TABLETS Each film-coated tablet contains vortioxetine hydrobromide equivalent to 20 mg vortioxetine- For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) 5 mg Film-coated Tablets Pink, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “5” on the other side. 10 mg Film-coated Tablets Yellow, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “10” on the other side. 20 mg Film-coated Tablets Red, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “20” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vortioson is indicated for the treatment of major depressive episodes in adults. H. Lundbeck A/S 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The starting and recommended dose of Vortioson is 10 mg vortioxetine once daily in adults less than 65 years of age. Depending on individual patient response, the dose may be increased to a maximum of 20 mg vortioxetine once daily or decreased to a minimum of 5 mg vortioxetine once daily. After the depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the antidepressive response. Treatment discontinuation A gradual reduction in dosage may be considered to avoid the occurrence of discontinuation symptoms (see section 4.8). However, there is insufficient data to provide specific recommendations for a tapering schedule for patients treated with Vortioson. Speci Lue koko asiakirja