Krajina: Taiwan
Jazyk: čínština
Zdroj: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
MELATONIN
法諾亞生技藥品股份有限公司 臺北市大安區延吉街253巷2弄6號 (54665812)
N05CH01
長效錠
主成分 (每錠含:) ; MELATONIN (6839000100) MG
PVC-PVDC/aluminium鋁箔盒裝
製 劑
須由醫師處方使用
OMAN PHARMACEUTICAL PRODUCTS CO., LLC PLOT NO. 101, RAYSUT INDUSTRIAL ESTATE, P.O. BOX:2240, POSTAL CODE-211, SALALAH, OMAN OM
melatonin
單獨使用於55歲以上睡眠品質差的原發性失眠病人的短期治療。
有效日期: 2025/02/24; 英文品名: Somn Well XR Tablets
2020-02-24
027800 SOMN WELL XR TABLET (MELATONIN 2MG PROLONGED RELEASE TABLETS) Melatonin N-[2-(5-Methoxy-1H-indol-3-y)ethyl]acetamide Melatonin C 13 H 16 N 2 O 2 232.27 Melatonin 2 mg prolonged release tablets melatonin Lactose Monohydrate Calcium hydrogen phosphate dehydrate Methyl alcohol Ammonio methacrylate copolymer Purified Talc Colloidal anhydrous silicaMagnesium Stearate Melatonin Receptor AATC code N05CH01 2-4 Melatonin MT1MT2 MT1 MT2 55 15 50% 2-8 15 85%2.6 T max Melatonin 2 T max 1.62.6AUC 60% 1- P450CYP1A1 CYP1A2 CYP2C19 6-6-S-MT 12 3.5-489 6-2 C max 3-4 C max AUC C max 18-45C max 500 pg/mLC max 1200 pg/mL 55-65AUC3000 pg*h/mL AUC6000 pg*h/mL 1 3 23:002 411.4 ± 56.5432.00 ± 83.2 pg/mL 6-sulfatoxymelatonin 55 N H H H H H O H 3 C CH 2 CH 2 NHCOCH 3 LSEQ 10 LSEQGTSQOS AFSBFW PSG40 2 3 3 9 10 1121 20 Neurim VII17082 88 3 2 QOS 47 27 6mm9mm 334 1691652 3 3 26 15 24.3 12.9 55600400 6 3 7.8p=0.014 13 PSQI<6 10%(WHO-5) 3 16.7%10.6% p=0.044 1325.8%15.7% p=0.006 3 26 96 12 55 2 mg 1-2 13 18 LAPP– 900 900 System Organ Class 900 250 18 AUC 700 CYP3A CYP1ACYP1A CYP1A CYP1A CYP1A2 Carbamazepine and rifampicin - CYP1A2 Carbamazepine rifampicin FluvoxamineFluvoxamine P 4 5 0 CYPCYP1A2 CYP2C19AUC 17C max 12 5-8-5- or 8-methoxypsoralen 5- 8-5 8-MOP CimetidineCimetidine Cimetidine 1.7 CimetidineCYP2D Cimetidine CYP1A2 CYP1A1 CYP1A2 / / zalepon zolpidem zopiclone zolpidem 1 zolpidemzolpidem Thioridazine and imipramine thioridazine imipramine i m i p r a m i n e imipramine tothioridazine tothioridazine“” 19311642 48.8 37.8100 5.743 vs. 3.013 MedDRA 722.9 624.0 ≥1 9.57.4 ≥1/10 ≥1/100 <1/10 ≥ 1/1,000 < 1/100> 1/10,000 < 1/1,000 < 1/10,000 1 5mg 12 300 12 30 25°C Oman Pharmaceutical Products Co. LLC Plot No. 101, Raysut Industrial Estate, P.O. Box: 2240, Postal Code -211, Salalah, Oman. 25326 (N=1931) (N=1642) 1.1 1.0 1.2 3.1 1.8 1.5 0.7 1.2 0.9 1.8 1.7 0.9 1.9 1.2 1.5 1.9 4.0 1.9 2.9 2.1 0.9 1.2 3.0 1.2 1.2 0.7 3.5 3.8 1.1 1.1 1.6 1.8 1.5 0.6 0.6 1.1 1.6 5.7 1.1 1.2 6.2 1.2 1.0 1.2 2.2 1.5 1.1 1.3 0.9 0.9 (N=1931) (N Prečítajte si celý dokument