Argesun 120 Powder and solvent for solution for injection

Pajjiż: Tanżanija

Lingwa: Ingliż

Sors: Tanzania Medicinces & Medical Devices Authority

Ingredjent attiv:

Artesunate

Disponibbli minn:

Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd, CHINA

Kodiċi ATC:

Antimalarials

INN (Isem Internazzjonali):

Artesunate

Dożaġġ:

120

Għamla farmaċewtika:

Powder and solvent for solution for injection

Manifatturat minn:

GUILIN PHARMACEUTICALS CO., LTD, CHINA

Sommarju tal-prodott:

Physical description: White crystalline powder for solution for injection; Local technical representative: Tridem Pharma Tanzania Limited (69513)

L-istatus ta 'awtorizzazzjoni:

Registered/Compliant

Data ta 'l-awtorizzazzjoni:

2020-09-25

Karatteristiċi tal-prodott

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