Malacef 60, artesunate 60 mg, powder and solvent for solution for injection (i.v.)
Orphan Drug Designation EU/3/07/430 (2007)
Artesunate 60 mg
Severe or complicated malaria (hospital treatment), caused by P. falciparum
Below 25 ⁰C
Artesunate is a bicarbonate soluble artemisinin derivative for the emergency treatment of severe and/or complicated malaria caused by Plasmodium falciparum (malaria tropica).
Publications* about the treatment outcome of intravenous artesunate prove the efficacy of artesunate over quinine in treatment of severe malaria tropica.
Malacef is an unlicensed medicine in the Netherlands. The Dutch Health Care Inspectorate (IGJ) has given permission for the supply.
Malacef is supplied solely to hospitals (on named patient basis). An order signed by the pharmacist and a physician’s statement from the prescribing physician are required with every order.
In France, Malacef has an ATU Nominative. Distribution to hospital pharmacies in France is carried out by Laboratoire Intsel Chimos.
In the United Kingdom, hospital pharmacies that require Malacef can contact Mawdsleys.
Hospital Pharmacists that would like to know more about the availability of this product outside these countries are welcome to contact us via our contact form. If you have ordered Malacef with us before, please use our order form to place a new order.
ACE Pharmaceuticals/ARTECEF has cooperated in the creation of publications about artesunate. An overview with links to these publications is available on the website of ACE Pharmaceuticals.
* South East Asian Quinine Artesunate Malaria Trial (SEQUAMAT): Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial. The Lancet 2005, 366:717-725
* Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial. The Lancet 2010, 376:1647-1657