Product Description
Contains:
Artesunate 20mg/40mg/60mg/80mg vial
Package
40mg per vial with Sodium bicarbonate solution+Water for injection in box
60mg per vial with Sodium bicarbonate solution+Water for injection in box
80mg per vial with Sodium bicarbonate solution+Water for injection in box
Indications
Treatment of severe malaria
Initial treatment of uncomplicated malaria, when persistent vomiting precludes oral therapy
Forms and strengths, route of administration
Powder for injection, in 60 mg-vial, with one 1 ml-ampoule of 5% sodium bicarbonate and one 5 mlampoule of 0.9% sodium chloride, for slow IV injection (3 to 5 minutes) or slow IM injection. NEVER ADMINISTER BY IV INFUSION.
Dissolve the powder in the entire volume of 5% sodium bicarbonate and shake the vial until the solution becomes clear. Then, add the 0.9% sodium chloride into the vial:
5 ml of 0.9% sodium chloride to obtain 6 ml of artesunate solution containing 10 mg/ml, for IV injection
2 ml of 0.9% sodium chloride to obtain 3 ml of artesunate solution containing 20 mg/ml, for IM injection
Dosage and duration
Child under 20 kg: 3 mg/kg/dose
Child 20 kg and over and adult: 2.4 mg/kg/dose
One dose on admission (H0) then 12 hours after admission (H12) then 24 hours after admission (H24) then, once daily.
Administer parenterally at least 24 hours (3 doses), then, if the patient can tolerate the oral route, change to a complete 3-day course of an artemisinin-based combination. If not, continue parenteral treatment once daily until the patient can change to oral route (without exceeding 7 days of parenteral treatment).
| Weight | IV injection artesunate solution 10 mg/ml | IM injection artesunate solution 20 mg/ml |
| 3 kg | 1 ml | 0.5 ml (a) |
| 3 to < 4 kg | 1.2 ml | 0.6 ml (a) |
| 4 to < 5 kg | 1.5 ml | 0.8 ml (a) |
| 5 to < 6 kg | 2 ml | 1 ml |
| 6 to < 8 kg | 2.5 ml | 1.2 ml |
| 8 to < 10 kg | 3 ml | 1.5 ml |
| 10 to < 13 kg | 4 ml | 2 ml |
| 13 to < 15 kg | 4.5 ml | 2.5 ml |
| 15 to < 17 kg | 5 ml | 2.5 ml |
| 17 to < 20 kg | 6 ml | 3 ml |
| 20 to < 25 kg | 6 ml | 3 ml |
| 25 to < 29 kg (b) | 7 ml | 3.5 ml |
| 29 to < 33 kg | 8 ml | 4 ml |
| 33 to < 37 kg | 9 ml | 5 ml |
| 37 to < 41 kg | 10 ml | 5 ml |
| 41 to < 45 kg | 11 ml | 6 ml |
| 45 to < 50 kg | 12 ml | 6 ml |
| 50 to < 55 kg (b) | 13 ml | 7 ml |
| 55 to < 62 kg | 15 ml | 8 ml |
| 62 to < 67 kg | 16 ml | 8 ml |
| 67 to < 71 kg | 17 ml | 9 ml |
| 71 to < 76 kg | 18 ml | 9 ml |
| 76 to 81 kg (b) | 20 ml | 10 ml |
- (a)Use a 1 ml syringe graduated in 0.01 ml when the dose required is less than 1 ml.
- (b)For patients over 25 kg, a 2nd vial must be prepared to obtain the volume needed, a 3rd vial for patients over 50 kg and a 4th vial for patients over 76 kg.
