国家: 新加坡
语言: 英文
来源: HSA (Health Sciences Authority)
TOPOTECAN HCl EQV TOPOTECAN
NOVARTIS (SINGAPORE) PTE LTD
L01XX17
4 mg/vial
INJECTION, POWDER, FOR SOLUTION
TOPOTECAN HCl EQV TOPOTECAN 4 mg/vial
INTRAVENOUS
Prescription Only
GlaxoSmithKline Manufacturing S.p.A.
ACTIVE
1997-07-23
1 of 21 HYCAMTIN TOPOTECAN HYDROCHLORIDE TM QUALITATIVE AND QUANTITATIVE COMPOSITION Topotecan hydrochloride A sterile, lyophilised powder in single-dose vials for intravenous ( i.v.) infusion following reconstitution and further dilution. Powder for solution for infusion, 4 mg. Each 4 mg vial contains 4 mg topotecan as topotecan hydrochloride. PHARMACEUTICAL FORM Powder for i.v. infusion. CLINICAL PARTICULARS INDICATIONS HYCAMTIN is indicated for the treatment of: • metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. • small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase III study) or at least 90 days (in the Phase II studies) after chemotherapy (_See Clinical _ _Studies Section_). HYCAMTIN in combination with cisplatin is indicated for the treatment of patients with histologically confirmed Stage IV-B, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy (_See Clinical _ _Studies Section_). For efficacy data see Clinical Studies. DOSAGE AND ADMINISTRATION HYCAMTIN must be reconstituted and further diluted before use (_see Instructions for _ _Use/Handling_). Prior to administration of the first course of HYCAMTIN, patients must have a baseline neutrophil count of more than or equal to 1.5 x 10 9 /L and a platelet count of more than or equal to 100 x 10 9 /L and a haemoglobin level of more than or equal to 9g/dL. 2 of 21 POPULATIONS ADULTS OVARIAN AND SMALL CELL LUNG CARCINOMA INITIAL DOSE The recommended dose of HYCAMTIN is 1.5 mg/m 2 SUBSEQUE 阅读完整的文件
CONFIDENTIAL 1 HYCAMTIN TM TOPOTECAN HYDROCHLORIDE TRADENAME(S) HYCAMTIN™ DESCRIPTION AND COMPOSITION CHEMICAL STRUCTURE Topotecan hydrochloride: _S_ )-10-[(dimethylamino) methyl]-4-ethyl-4,9-dihydroxy-1 _H_ - pyrano[3',4':6,7]indolizino[1,2- _b_ ]-quinoline-3, 14-(4 _H_ ,12 _H_ )-dione monohydrochloride. PHARMACEUTICAL FORM(S) CAPSULES: Hard capsules for oral administration, 0.25 mg and 1 mg. Topotecan hard capsule, 0.25 mg: Opaque white to yellowish white, imprinted with HYCAMTIN 0.25 mg. Each hard capsule contains topotecan hydrochloride equivalent to 0.25 mg topotecan free base. Topotecan hard capsule, 1 mg: Opaque pink, imprinted with HYCAMTIN 1 mg. Each hard capsule contains topotecan hydrochloride equivalent to 1 mg topotecan free base. EXCIPIENTS CAPSULES Hydrogenated vegetable oil Glyceryl monostearate Gelatin Titanium dioxide Black printing ink containing black iron oxide, shellac, anhydrous alcohol, propylene glycol, isopropyl alcohol, butanol, concentrated ammonia solution and potassium hydroxide. 1 mg capsules also contain red iron oxide. INDICATIONS CONFIDENTIAL 2 Indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. For efficacy data see _Clinical Studies_ _ _ DOSAGE REGIMEN AND ADMINISTRATION Prior to administration of the first course of HYCAMTIN, patients must have a baseline neutrophil count of more than or equal to 1.5 x 10 9 /L, a platelet count of more than or equal to 100 x 10 9 /L and a haemoglobin level of more than or equal to 9 g/dL (after transfusion if necessary). Hycamtin capsule(s) must be swallowed whole, and must not be chewed, crushed or divided. Hycamtin capsules may be taken with or without food _(see Clinical Pharmacology.)_ CONFIDENTIAL 3 INITIAL DOSE The recommended dose of oral HYCAMTIN is 2.3 mg/m 2 daily for 5 consecutive days every 21 days. SUBSEQUENT DOSES For patients who experience Grade 3 or 4 diarrhoea, the oral HYCAMTIN dose shou 阅读完整的文件