> THERAPEUTIC INDICATION
Curative treatment of severe malaria caused by Plasmodium falciparum.
> DOSAGE AND METHOD OF ADMINISTRATION
Dosage :
Adults and children over 20 kg: 2.4 mg artesunate per kg, to be administered by intravenous (IV) or intramuscular (IM) injection; at intervals of 0, 12, and 24 hours, and then once daily until oral treatment can be given in relay.
Adults and children under 20 kg: 3 mg artesunate per kg, administered by intravenous (IV) or intramuscular (IM) injection; at intervals of 0, 12, and 24 hours, then once daily until oral therapy can be initiated.
MALAVAN should be administered for a minimum of 24 hours (in 3 doses), regardless of the patient’s ability to tolerate earlier oral therapy.
Treatment may be extended for a total of up to 7 days.
Reconstitution of MALAVAN :
- Add the 1 ml ampoule of sodium bicarbonate to the vial containing the artesunate powder.
- Shake the bottle for a few minutes to mix well, until the powder is completely dissolved and the solution is clear.
- Remove excess air with the syringe.
- Dilute the solution according to the type of injection chosen, as described below (then inject immediately, the reconstituted solution must be discarded if not used within one hour):
Intravenous (IV) injection
Add the 5 ml ampoule of sodium chloride injection to the vial containing the reconstituted artesunate solution. This will create a 6 ml solution, containing artesunate 10mg/ml. Shake to mix well, the resulting solution should remain clear.
The volume required is equal to :
For people under 20 kg: V = 3.0 mg x body weight (kg)/10
For people over 20 kg: V = 2.4 mg x body weight (kg)/10
Withdraw the required volume of artesunate solution from the vial with a syringe and inject slowly by intravenous route (3 or 4 ml per minute).
Not to be given as an IV infusion.
Intramuscular (IM) injection:
Add 2 ml of 0.9% Sodium Chloride Injection to the vial containing the reconstituted artesunate solution. This will give a 3 ml solution, containing 20 mg/ml artesunate. Shake to mix well, the solution obtained must remain clear.
The necessary volume is equal to :
For people under 20 kg: V = 3.0 mg x body weight (kg)/20
For people over 20 kg: V = 2.4 mg x body weight (kg)/20
Take the necessary volume of artesunate solution from the vial with a syringe and inject slowly by intramuscular route.
Prescription medicine. Ask your doctor for advice.