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SANDIMMUN Concentrate for solution for infusion (2015)

Active ingredients: Ciclosporin

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.

Chemical substance
Description
Ciclosporin

Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide immunomodulator with immunosuppressant properties. It has been shown to prolong survival of allogeneic transplants in animals and significantly improved graft survival in all types of solid organ transplantation in man. Ciclosporin has also been shown to have an anti-inflammatory effect.

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
Authorization dates

Novartis Pharmaceuticals UK Limited

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

17 February 1983 / 17 February 1998

Marketing authorization number:

00101/0153