Χώρα: Σιγκαπούρη
Γλώσσα: Αγγλικά
Πηγή: HSA (Health Sciences Authority)
Asenapine maleate 14.06mg eqv asenapine
MSD PHARMA (SINGAPORE) PTE. LTD.
N05AH05
10mg
TABLET, ORALLY DISINTEGRATING
ORAL
Prescription Only
Catalent UK Swindon Zydis Limited
2011-11-18
__________________________________________________________________________ _Copyright © 2013 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., _ _Whitehouse Station, NJ, USA _ All rights reserved. RA 1040 CCDS 4 (REF 4) CCDS-MK8274-ASP-SB-102012 1. NAME OF THE MEDICINAL PRODUCT Saphris 5 mg sublingual tablets Saphris 10 mg sublingual tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Saphris 5 mg sublingual tablet contains 5 mg asenapine (as maleate) Each Saphris 10 mg sublingual tablet contains 10 mg asenapine (as maleate) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM SAPHRIS 5 MG SUBLINGUAL TABLETS Round, white to off-white, fast dissolving, sublingual tablets debossed with “5” on one side. SAPHRIS 10 MG SUBLINGUAL TABLETS Round, white to off-white, fast dissolving, sublingual tablets debossed with “10” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Saphris is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Manic episode: __________________________________________________________________________ _Copyright © 2013 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., _ _Whitehouse Station, NJ, USA _ All rights reserved. Monotherapy: The recommended starting dose of Saphris as monotherapy is 10 mg twice daily. One dose should be taken in the morning and one dose should be taken in the evening. The dose can be reduced to 5 mg twice daily, according to clinical assessment. Combination Therapy: A starting dose of 5 mg twice daily is recommended. Depending on the clinical response and tolerability in the individual patient, the dose can be increased to 10 mg twice daily. Additional information on special populations _Paediatr Διαβάστε το πλήρες έγγραφο