SANDIMMUN Concentrate for solution for infusion

Product name and form

SANDIMMUN Concentrate for Solution for Infusion 50mg/ml.

Pharmaceutical Form

Concentrate for solution for infusion

Clear, brown-yellow oleaginous concentrate.

Qualitative and quantitative composition

The concentrate for solution for infusion contains 50 mg/ml. Each ampoule of 1 ml contains 50 mg of ciclosporin. Each ampoule of 5 ml contains 250 mg of ciclosporin.

Excipients with known effect:

Ethanol: 278 mg/ml. Sandimmun 50 mg/ml concentrate for solution for infusion contains around 34% v/v ethanol (27.8% m/v ethanol).

Macrogolglycerol ricinoleate/Polyoxyl 35 castor oil: 650 mg/ml

For the full list of excipients, see section 6.1.

List of Excipients

Ethanol anhydrous
Macrogolglycerol ricinoleate/polyoxyl 35 castor oil

Pack sizes and marketing

Sandimmun Concentrate for Solution for Infusion is available in 1ml and 5ml uncoloured glass (type I) ampoules.

Marketing authorization holder

Novartis Pharmaceuticals UK Limited

Trading as: SANDOZ PHARMACEUTICALS, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

Marketing authorization dates and numbers

00101/0153

17 February 1983 / 17 February 1998

Drugs

Drug
Countries
Austria, Australia, Brazil, Cyprus, Germany, Spain, Finland, France, Hong Kong, Ireland, Italy, Lithuania, New Zealand, Poland, Singapore, Tunisia, United Kingdom