البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
desvenlafaxine, Quantity: 100 mg
Medis Pharma Pty Ltd
Desvenlafaxine
Tablet, modified release
Excipient Ingredients: purified talc; microcrystalline cellulose; alginic acid; magnesium stearate; hypromellose; povidone; citric acid monohydrate; titanium dioxide; macrogol 8000; iron oxide red; iron oxide black
Oral
1000, 14, 7, 28
(S4) Prescription Only Medicine
For the treatment of major depressive disorder, including the preventiton of relapse. Not indicated for paediatric use.
Visual Identification: Dark brown to red colored, diamond shaped, biconvex tablets, debossed with 'Ll90' on one side and plain on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-11-26
_Product Information Page 1 _ _Desvenlafaxine Sandoz 50 mg, 100 mg tablet _ _04/2019 _ _Sandoz Pty Ltd _ _Version 11 Nov 2019 _ AUSTRALIAN PRODUCT INFORMATION - DESVENLAFAXINE SANDOZ ® (DESVENLAFAXINE) 50MG, 100MG TABLET 1. NAME OF THE MEDICINE Desvenlafaxine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Two strengths of DESVENLAFAXINE SANDOZ tablets are available, containing 50 mg and 100 mg of desvenlafaxine. For the full list of excipients, see section 6.1 List of excipients 3. PHARMACEUTICAL FORM DESVENLAFAXINE SANDOZ is formulated as a modified release tablet for once-a-day oral administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder, including the prevention of relapse. Not indicated for paediatric use. 4.2 DOSE AND METHOD OF ADMINISTRATION Desvenlafaxine should be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved. _INITIAL TREATMENT_ The recommended dose for desvenlafaxine is 50 mg once daily, with or without food. In clinical trials, no additional benefit was demonstrated at doses greater than 50 mg/day. Based on clinical judgment, if dose increases are indicated for individual patients, they should occur gradually and at intervals of not less than 7 days. The maximum dose should not exceed 200 mg/day. When discontinuing therapy, gradual dose reduction is recommended whenever possible to minimise discontinuation symptoms (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and Section 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)) . _MAINTENANCE/CONTINUATION/EXTENDED TREATMENT_ It is generally agreed that acute episodes of major depressive disorder require several months or _Product Information Page 2 _ _Desvenlafaxine Sandoz 50 mg, 100 mg tablet _ _04/2019 _ _Sandoz Pty Ltd _ _Version 11 Nov 2019 _ longer of sustained pharmacological therapy. Patients should continue on the same dose at which they were stabilised. They should be periodically reassessed to determine the اقرأ الوثيقة كاملة