País: Tanzânia
Língua: inglês
Origem: Tanzania Medicinces & Medical Devices Authority
Artemether
Dafra Pharma GmbH, SWITZERLAND
Artemether
80 mg/ml
Injection
Rotexmedica GmbH Arzneimittelwerk, GERMANY
Physical description: Clear, colourless to slightly yellowish oily; Local technical representative: Harleys (T) Limited (4194)
Registered/Compliant
2020-11-19
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 Leia o documento completo