Sandimmun/Sandimmun Neoral Description

Sandimmun Neoral soft-gelatin capsules: Each capsule contains 25 or 100 mg of ciclosporin.
25 mg: blue-grey oval shaped gelatin capsule, soft, imprinted with "NVR 25mg" in red.
100 mg: blue-grey oblong shaped gelatin capsule, soft, imprinted with "NVR 100mg" in red.
Sandimmun Neoral oral solution: clear, faintly yellow to browning yellow solution for oral administration. The formulation of Sandimmun Neoral is a microemulsion preconcentrate.
The oral solution contains 100 mg of ciclosporin per mL. Each bottle of 50 mL contains 5000 mg of ciclosporin.
Sandimmun concentrate for solution for infusion: clear, brown-yellow, oleaginous concentrate to be diluted before parenteral administration.
The concentrate for solution for infusion contains 50 mg per mL. Each ampoule of 1 mL contains 50 mg of ciclosporin. Each ampoule of 5 mL contains 250 mg of ciclosporin.
Active substance: Sandimmun Neoral is a pharmaceutical form of the active ingredient ciclosporin based on the microemulsion principle, which reduces the variability of pharmacokinetic parameters and provides dose linearity of ciclosporin exposure with a more consistent absorption profile and less influence from concomitant food intake. The Sandimmun Neoral formulation is a microemulsion preconcentrate, which in pharmacokinetic and clinical studies has demonstrated that the correlation between trough concentration and exposure to ciclosporin is much stronger when ciclosporin is given as Sandimmun Neoral than when it is given as Sandimmun. The formation of the microemulsion itself takes place in the presence of water, either in the form of a beverage or in the form of the gastric fluid.
Excipients/Inactive Ingredients: Soft gelatin capsules: Capsule content: alpha-tocopherol, ethanol anhydrous, propylene glycol, corn oil-mono-di-triglycerides, macrogolglycerol hydroxystearate (Ph.Eur)/polyoxyl 40 hydrogenated castor oil (NF). Sandimmun Neoral soft gelatin capsules contain 11.8% v/v ethanol (9.4% w/v) (see Precautions).
Capsule shell: Iron oxide black (E 172) (25- and 100-mg capsules), titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin.
Imprint: carminic acid (E 120).
Oral solution: Alpha-tocopherol, ethanol anhydrous, propylene glycol, corn oil-mono-di-triglycerides, macrogolglycerol hydroxystearate (Ph.Eur)/polyoxyl 40 hydrogenated castor oil (USP). Sandimmun Neoral oral solution contains 12% v/v ethanol (9.5% w/v) (see Precautions).
Sandimmun concentrate for solution for infusion: Ethanol anhydrous, macrogolglycerol ricinoleate (Ph.Eur)/polyoxyl 35 castor oil (NF) (see Precautions). Sandimmun concentrate for solution for infusion contains 34.4% v/v ethanol (27.8% w/v).