Country: Niġerja
Lingwa: Ingliż
Sors: NAFDAC (National Agency for Food and Drugs Administration and Control)
ARTEMETHER
Dafra Pharma GmbH
ARTEMETHER
ROTEXMEDICA
Artemether is indicated for the curative treatment of malaria caused by all forms of Plasmodium including severe malaria caused by multiple drug resistant strains of P. falciparum.
ARTESIANE 20: Artemether 20 mg/ml in fractionated coconut oil ARTESIANE 40: Artemether 40 mg/ml in fractionated coconut oil ARTESIANE 80: Artemether 80 mg/ml in fractionated coconut oil ARTESIANE 100: Artemether 100 mg/ml in fractionated coconut oil ARTESIANE 300: Artemether 300 mg/3ml ARTESIANE 40 mg Suppogel for Rectal Administration: Artemether 40 mg Refined soya oil, glycerine, gelatine, water.
ARTESIANE ® (ARTEMETHER) 1. NAME OF THE MEDICINAL PRODUCT ARTESIANE ® 20 ARTESIANE ® 40 ARTESIANE ® 80 ARTESIANE ® 100 ARTESIANE ® 300 ARTESIANE ® 40 mg Suppogel for Rectal Administration 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ARTESIANE ® 20: Artemether 20 mg/ml in fractionated coconut oil. ARTESIANE ® 40: Artemether 40 mg/ml in fractionated coconut oil . ARTESIANE ® 80: Artemether 80 mg/ml in fractionated coconut oil. ARTESIANE ® 100: Artemether 100 mg/ml in fractionated coconut oil . ARTESIANE ® 300: Artemether 300 mg/3ml. ARTESIANE ® 40 mg Suppogel for Rectal Administration: Artemether 40 mg Refined soya oil, glycerine, gelatine, water. 3. PHARMACEUTICAL FORMS ARTESIANE ® 20: Artemether 20 mg/ml paediatric ampoules. Box of 10 ampoules of 1 ml containing Artemether 20 mg/ml in fractionated coconut oil. Sterile and colourless solution. ARTESIANE ® 40: Artemether 40 mg/ml paediatric ampoules. Box of 10 ampoules of 1 ml containing Artemether 40 mg/ml in fractionated coconut oil. Sterile and colourless solution. ARTESIANE ® 80: Artemether 80 mg/ml ampoules. Box of 5 ampoules of 1 ml containing Artemether 80 mg/ml in fractionated coconut oil. Sterile and colourless solution. ARTESIANE ® 100: Artemether 100 mg/ml ampoules. Box of 10 ampoules of 1 ml containing Artemether 100 mg/ml in fractionated coconut oil. Sterile and colourless solution. ARTESIANE ® 300: Artemether 300 mg/3ml ampoules. Box of 1 ampoule of 3 ml containing Artemether 300 mg in 3 ml (or 100 mg/ml), in fractionated coconut oil. Sterile and colourless solution. Additionally sterile syringe + needle and pre-injection skin cleansing swab is added. ARTESIANE ® 40 mg Suppogel for Rectal Administration: One blister of six suppogels packed in one cardboard box with a package insert. Each suppogel contains 40 mg of beta-Artemether (Artemether) dissolved in soya oil. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Artemether is indicated for the treatment of malaria in children and in adults caused by all species of _Plasmodium_, i Aqra d-dokument sħiħ