País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Megestrol acetate 40mg
Apotex NZ Ltd
Megestrol acetate 40 mg
40 mg
Tablet
Active: Megestrol acetate 40mg Excipient: Brilliant blue FCF Colloidal silicon dioxide Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose
Bottle, plastic, HDPE, PP cap & seal, 100 tablets
Prescription
Prescription
Farmabios SpA
Apo-Megestrol is indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e. recurrent, inoperable or metastatic diseases). It should not be used in lieu of currently accepted procedures such as surgery, radiation or chemotherapy. Apo-Megestrol is indicated for the treatment of anorexia, cachexia, or a significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
Package - Contents - Shelf Life: Bottle, plastic, HDPE, PP cap & seal - 100 tablets - 24 months from date of manufacture stored at or below 25°C
2001-12-03
NEW ZEALAND DATA SHEET APO-MEGESTROL USP Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 of 8 1. PRODUCT NAME APO-MEGESTROL 40mg & 160mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Megestrol acetate 40mg Megestrol acetate 160mg EXCIPIENT(S) WITH KNOWN EFFECT Contains lactose. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM APO-MEGESTROL 40mg: light blue, round, flat-faced, bevelled edge, scored tablets, engraved “APO” over “40” on one side, containing 40mg megestrol acetate APO-MEGESTROL 160 mg: white, oval, biconvex, scored tablets, engraved “APO 160" on one side, containing 160mg megestrol acetate. Please note: Not all strengths are marketed. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS APO-MEGESTROL is indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e. recurrent, inoperable or metastatic diseases). It should not be used in lieu of currently accepted procedures such as surgery, radiation or chemotherapy. APO-MEGESTROL is indicated for the treatment of anorexia, cachexia, or a significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE BREAST CANCER 160mg/day (160mg taken once daily). At least two months of continuous treatment is considered an adequate period for determining the efficacy of megestrols Best results are obtained in previously untreated receptor-positive cases that are more than five years post-menopausal (approximately 40% response rate). In patients with less favourable characteristics the response rate could be 15% or less. ENDOMETRIAL CARCINOMA 40 – 320mg/day in divided doses (40 – 80mg one to four times daily or one to two 160mg tablets daily). At least two months of continuous treatment is considered an adequate period for determining the efficacy of megestrol APO-MEGESTROL Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 2 of 8 CACH Leia o documento completo