Land: Tansania
Sprache: Englisch
Quelle: Tanzania Medicinces & Medical Devices Authority
Artemether
Dafra Pharma GmbH, SWITZERLAND
Antimalarials
Artemether
20 mg/mL
Solution for injection
Anfarm Hellas S.A, GREECE
Physical description: Clear, colourless to slightly yellowish oily; Local technical representative: Harleys (T) Limited (4194)
Registered/Compliant
2022-07-19
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT (FPP) Artesiane® _Artemether _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION • Artesiane 20: each ampoule (1 ml) contains 20 mg artemether • Artesiane 40: each ampoule (1 ml) contains 40 mg artemether • Artesiane 80: each ampoule (1 ml) contains 80 mg artemether • Artesiane 100: each ampoule (1 ml) contains 100 mg artemether • Artesiane 300: each ampoule (3 ml) contains 300 mg artemether 3. PHARMACEUTICAL FORM Solution for injection Sterile, clear, colourless to slightly yellow oily solution 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Artesiane is indicated for the treatment of malaria in children and in adults caused by all species of Plasmodium, including severe malaria caused by multiple drug resistant strains of Plasmodium falciparum. Artesiane 20 and Artesiane 40 are indicated for use in children. Artesiane 80 is indicated for use in children and adults. Artesiane 100 and Artesiane 300 are indicated for use in adults. 4.2. POSOLOGY AND MODE OF ADMINISTRATION 4.2.1. POSOLOGY The dosage depends on the severity of the case and the clinical state of the patient. _LOADING DOSE FOR CHILDREN AND ADULTS: _ 3.2 mg/kg body weight administered as a single intramuscular injection on the first day. _MAINTENANCE DOSE FOR CHILDREN AND ADULTS: _ 1.6 mg/kg/day administered as intramuscular injection once a day during the following four days. Maintenance treatment can also be continued by oral artemisinin-based combination therapy (ACT), if the patient’s condition does not require injections. _PERIOD OF USE _ A full course therapy of five days is essential in order to avoid recrudescence. In case of severe malaria it may be necessary to increase the loading dose and to prolong treatment for seven days if parasitaemia is not cleared during the first few days. 4.2.2. SPECIAL POPULATIONS see posology 4.2.1. Patients with acute renal failure might reach higher maximal concentrations ; in these patients the elimination half-life of artemether c Lesen Sie das vollständige Dokument