Artesunate Powder for Injection 60mg

● Treatment of severe malaria caused by Plasmodium falciparum, in adults and children [1][2] ● Severe malaria is a medical emergency — parenteral treatment should be started without any delay [1][2] ● After parenteral treatment of the critical phase, the patient must take a complete oral antimalarial regimen to finish the treatment and avoid relapse [1][2] ● Not evaluated for severe malaria due to P. vivax, P. malariae or P. ovale [2] ● Exclusively used in hospitals and clinics, and should only be administered by qualified medical personnel [1]

● Administer by intravenous (IV) or intramuscular (IM) injection only; the product must NOT be given as an intravenous infusion (drip) [1][2] ● Reconstitution: withdraw 1 ml of the supplied sodium bicarbonate solvent and inject into the vial; shake until the powder is completely dissolved and the solution is clear [1][2] ● Discard the solution if it appears cloudy or a precipitate is present [1][2] ● IV injection (10 mg/ml): add 5 ml of sodium chloride 0.9% (or 5% glucose) to the reconstituted solution, to give artesunate 10 mg/ml (6 ml); inject the required volume slowly over 1–2 minutes [1][2] ● IM injection (20 mg/ml): add 2 ml of sodium chloride 0.9% to the reconstituted solution, giving 3 ml containing artesunate 20 mg/ml; the anterior thigh is usually the preferred site, and large volumes may be divided between several sites [1][2] ● Do not use water for injection for reconstitution or dilution [1][2] ● Use a new syringe and needle for each dose [1]

The dose is based on body weight. Calculate the required dose (mg) and number of vials before reconstituting the powder, as the reconstituted solution must be used within one hour [1][2]. ● Hepatic or renal impairment: currently available data do not allow dosing recommendations [2] ● Monitor vital signs regularly, including level of consciousness, temperature, blood glucose, haemoglobin, acid-base status, blood coagulation status, and renal and hepatic function [2] ● Severe malaria may cause hypoglycaemia — frequent monitoring of blood glucose is necessary [2] ● The volume to inject is calculated from the diluted concentration: IV 10 mg/ml (volume ml = dose in mg ÷ 10) or IM 20 mg/ml (volume ml = dose in mg ÷ 20) [1][2]

● Contraindicated in patients allergic to artesunate or to any component of the product [1][2] ● Post-artesunate delayed haemolysis (PADH): delayed haemolytic anaemia, sometimes severe and requiring transfusion, has been reported up to 3 months after treatment, particularly in travellers and young children (7–27% in prospective studies) — follow all patients for at least 4 weeks (monitor blood count within 28 days) and seek care for excessive tiredness, weakness or breathlessness up to 4 weeks after therapy [1][2] ● Allergic reactions with urticarial rash, hypotension, pruritus, oedema and/or dyspnoea have been reported [1][2] ● Risk of neurological sequelae, e.g. convulsions, has been associated with treatment [2] ● Cardiac rhythm and conduction events (bradycardia, QT prolongation, abnormal sinoatrial conduction) have been described — consider ECG monitoring during treatment, especially with cardiovascular disease or risk factors [2] ● Common side effects: dizziness, light-headedness, headache, altered (metallic/bitter) taste, nausea, vomiting, diarrhoea, abdominal pain or cramps, rash, hair loss, cough and/or nasal symptoms, insomnia, tinnitus, injection-site pain, fatigue, malaise and fever [1][2] ● Pregnancy: severe malaria is especially hazardous during pregnancy — give full-dose parenteral artesunate at any stage without delay; animal studies showed embryotoxicity and deformities, but available clinical data in pregnancy do not indicate adverse effects on the foetus/newborn [1][2] ● Breast-feeding: the active metabolite (DHA) is excreted in breast milk; the amount is not expected to harm the breastfed infant, but it does not protect the child from malaria [1][2] ● Dizziness and light-headedness may affect activities requiring mental alertness or coordination, such as driving [2] ● Storage: keep the powder in the original packaging at or below 30 °C, protected from sunlight; do not refrigerate or freeze [1][2] ● After reconstitution, use immediately; if not used immediately, store at or below 30 °C for no more than one hour, then discard [1][2] ● Discard the solution if crystals or cloudiness are visible; keep out of the reach and sight of children [1] For full prescribing information, refer to the WHO prequalification documents / approved product information of the product concerned [1][2].