Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Alfasigma S.p.A., Via Ragazzi del '99, n. 5, 40133 Bologna, Italy Tel: +39 051 6489602 Fax: +39 051 388689 Email: antonietta.pazardjiklian@alfasigma.com
Eurartesim is indicated for the treatment of uncomplicated Plasmodium falciparum malaria in adults, adolescents, children and infants 6 months and over and weighing 5 kg or more.
Consideration should be given to official guidance on the appropriate use of antimalarial medicinal products, including information on the prevalence of resistance to artenimol/piperaquine in the geographical region where the infection was acquired (see section 4.4).
Eurartesim should be administered over three consecutive days for a total of three doses taken at the same time each day.
Dosing should be based on body weight as shown in the table below.
| Body weight (kg) | Daily dose (mg) | Tablet strength and number of tablets per dose | |
|---|---|---|---|
| PQP | Artenimol | ||
| 5 to <7 | 80 | 10 | ½ x 160 mg/20 mg tablet |
| 7 to <13 | 160 | 20 | 1 × 160 mg/20 mg tablet |
| 13 to <24 | 320 | 40 | 1 × 320 mg/40 mg tablet |
| 24 to <36 | 640 | 80 | 2 × 320 mg/40 mg tablets |
| 36 to <75 | 960 | 120 | 3 × 320 mg/40 mg tablets |
| >75* | 1.280 | 160 | 4 × 320 mg/40 mg tablets |
* see section 5.1
If a patient vomits within 30 minutes of taking Eurartesim, the whole dose should be re-administered; if a patient vomits within 30-60 minutes, half the dose should be re-administered. Re-dosing with Eurartesim should not be attempted more than once. If the second dose is vomited, alternative antimalarial therapy should be instituted.
If a dose is missed, it should be taken as soon as realised and then the recommended regimen continued until the full course of treatment has been completed.
There is no data on a second course of treatment.
No more than two courses of Eurartesim may be given within a 12 month period (see sections 4.4 and 5.3).
A second course of Eurartesim should not be given within 2 months after the first course due to the long elimination half-life of piperaquine (see sections 4.4 and 5.2).
Clinical studies of Eurartesim did not include patients aged 65 years and over, therefore no dosing recommendation can be made. Considering the possibility of age-associated decrease in hepatic and renal function, as well as a potential for heart disorders (see sections 4.3 and 4.4), caution should be exercised when administering the product to the elderly.
Eurartesim has not been evaluated in subjects with moderate or severe renal or hepatic insufficiency. Therefore, caution is advised when administering Eurartesim to these patients (see section 4.4).
The safety and efficacy of Eurartesim in infants aged less than 6 months and in children weighing less than 5 kg has not been established. No data are available for these paediatric subsets.
Eurartesim should be taken orally with water and without food.
Each dose should be taken no less than 3 hours after the last food intake.
No food should be taken within 3 hours after each dose.
For patients unable to swallow the tablets, such as infants and young children, Eurartesim may be crushed and mixed with water. The mixture should be used immediately after preparation.
In clinical trials, nine patients received double the cumulative intended dose of Eurartesim. The safety profile of these patients did not differ from that of patients receiving the recommended dose, with no patient reporting SAEs.
In cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate, including ECG monitoring because of the possibility of QTc interval prolongation (see section 4.4).
2 years.
Do not store above 30°C.
Store in the original package in order to protect from light and moisture.
Eurartesim tablets are packaged in PVC/PVDC/aluminium blisters containing 3, 6, 9, 12, 270 or 300 tablets.
No special requirements.
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