AMPHOCIL INFORMATION:

In normal healthy persons, fungal infections usually heal spontaneously, are treatable, or remain latent. However, in persons whose immune systems are suppressed or compromised by disease or medication, or who are weakened by long term chronic illness, fungal infections can spread throughout the body through the bloodstream (fungemia), destroying vital organs. These infections, which would not normally affect healthy persons, are called opportunistic infections. All fungi can become opportunistic if conditions become conducive to their growth. Fungi which are present everywhere and commonly cause opportunistic infections include: Aspergillus, Candida, Mucor, and Cryptococcus.

AMPHOCIL is an FDA approved lipid form of amphotericin B indicated for the treatment of invasive aspergillosis, a life threatening systemic fungal infection. Samaritan Pharmaceuticals is currently taking measures necessary to achieve regulatory approvals for AMPHOCIL in Greece and Cyprus following the Mutual Recognition Procedure (MRP) in the European Union.

UNIQUE LIPID-BASED DELIVERY SYSTEM
Amphotericin B is stabilized with cholesteryl sulfate in AMPHOCIL, a disc-shaped colloidal complex. Liver macrophages break down the AMPHOCIL complex and release amphotericin B, which binds to lipoproteins.

Lipoproteins carry amphotericin B to the site of infection, and the agent binds to ergosterol in cell membranes of infecting fungi. The membranes’ permeability is altered, intracellular contents leak out, and the fungi die.

AMPHOCIL has been evaluated in geriatric patients at least 65 years of age and pediatric patients as young as 2 months of age with no unexpected adverse events reported. AMPHOCIL is recommended for both adult and pediatric patients at 3-4mg/kg as required, once a day.

AMPHOCIL is suitable for use both in patients for whom prior systemic antifungal therapy has failed and for those in whom CAB is not an appropriate choice because of toxicity or renal failure.

COUNTRY RESIDENCY NOTICE
Amphocil is an approved FDA prescription product owned by Three Rivers Pharmaceuticals, Inc. and marketed by Three Rivers Pharmaceuticals, Inc. in the US.

Currently, Samaritan Pharmaceuticals is the Marketing Authorization Holder in Greece.
Market authorization is pending in Cyprus.

If you are a healthcare professional practicing your profession in a country other than Greece and Cyprus, please visit http://www.3riverspharma.com/ to find information about Amphocil®/Amphotec® outside of Greece and Cyprus.