Država: Tanzanija
Jezik: angleščina
Source: Tanzania Medicinces & Medical Devices Authority
Artesunate
Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd, CHINA
Antimalarials
Artesunate
120
Powder and solvent for solution for injection
GUILIN PHARMACEUTICALS CO., LTD, CHINA
Physical description: White crystalline powder for solution for injection; Local technical representative: Tridem Pharma Tanzania Limited (69513)
Registered/Compliant
2020-09-25
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Argesun ® 120 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains: Artesunate powder 120 mg Each ampoule of 6 ml solvent contains: Sodium Bicarbonate 8.4mg/ml; Arginine 20mg/ml; H2O For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Artesunate for injection: White crystalline powder Solvent (Sodium Bicarbonate and Arginine injection): Clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1 Therapeutic indication Argesun ® 120mg, administered intravenously or intramuscularly, is indicated for the treatment of severe malaria caused by Plasmodium falciparum, in adults and children. 4.2 Posology and method of administration Dose: Adults and children weighing more 20 kg or more: Argesun® 120mg is administered at a dose of 2.4 mg of artesunate / kg body weight, by intravenous (IV) or intramuscular (IM) injection, at 0, 12 and 24 hours, then once daily until oral treatment can be substituted. Children weighing less than 20 kg: Argesun® 120mg is administered at a dose of 3 mg of artesunate / Kg body weight, by intravenous (IV) or intramuscular (IM) injection, at 0, 12 and 24 hours, then once daily until oral treatment can be substituted (see section 5.1). Argesun® 120mg should be administered for a minimum of 24 hours (3 doses), regardless of the patient’s ability to tolerate oral medication earlier. After at least 24 hours of Argesun® 120mg and when able to tolerate oral medication, the patient should be switched to a complete treatment course of an oral antimalarial regimen. Preparation Because of the instability of artesunate in aqueous solutions, the reconstituted solution must be used within one hour of preparation. Therefore, the required dose of artesunate should be calculated (dose in mg = patient’s weight in kg x 2.4 for patients weighing more than 20 kg; or dose in mg = patient’s weight in kg x 3 for children weighing less than 20 kg) and the number of vials of artesunate needed should be determined Preberite celoten dokument