Страна: Сингапур
Език: английски
Източник: HSA (Health Sciences Authority)
Prednisone
MUNDIPHARMA PHARMACEUTICALS PTE. LTD.
H02AB07
2.00mg/tablet
TABLET, DELAYED RELEASE
ORAL
Prescription Only
Aenova France SAS
2014-02-28
_LODOTRA_ ® Modified-release tablets NAME OF THE MEDICINAL PRODUCT _LODOTRA_ ® Modified-release tablets 1mg _LODOTRA_ ® Modified-release tablets 2mg _LODOTRA_ ® Modified-release tablets 5mg QUALITATIVE AND QUANTITATIVE COMPOSITION _LODOTRA_ ® Modified-release tablets 1mg: Each modified-release tablet contains 1 mg of prednisone. It also contains 40.7 mg of lactose as an excipient. _LODOTRA_ ® Modified-release tablets 2mg: Each modified-release tablet contains 2 mg of prednisone. It also contains 39.7 mg of lactose as an excipient. _LODOTRA_ ® Modified-release tablets 5mg: Each modified-release tablet contains 5 mg of prednisone. It also contains 36.9 mg of lactose as an excipient. For a full list of excipients, see section on _Pharmaceutical Particulars_. PHARMACEUTICAL FORM Modified-release tablet _LODOTRA_ ® Modified-release tablets 1mg: Pale yellowish-white, cylindrical modified-release tablet with “NP1” embossed on one side. _LODOTRA_ ® Modified-release tablets 2mg: Yellowish-white, cylindrical modified-release tablet with “NP2” embossed on one side. _LODOTRA_ ® Modified-release tablets 5mg: Light yellow, cylindrical modified-release tablet with “NP5” embossed on one side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS _LODOTRA_ ® Modified-release tablet is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adults particularly when accompanied by morning stiffness. POSOLOGY AND METHOD OF ADMINISTRATION The appropriate dose depends on the severity of the condition and the individual response of the patient. In general, for the initiation of the therapy 5 mg to 10 mg prednisone is recommended. In certain cases, a higher initial dose might be required (e.g. 15 or 20 mg prednisone). Depending on the clinical symptoms and the patient’s response, the initial dose can be reduced in steps to a lower maintenance dose. When changing over from the Прочетете целия документ