Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: Novartis Pharmaceuticals UK Limited Trading as: SANDOZ PHARMACEUTICALS, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
SANDIMMUN Concentrate for Solution for Infusion 50mg/ml.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion Clear, brown-yellow oleaginous concentrate. |
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.
| Active Ingredient | 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 |
Sandimmun Concentrate for Solution for Infusion is available in 1ml and 5ml uncoloured glass (type I) ampoules.
Novartis Pharmaceuticals UK Limited
Trading as: SANDOZ PHARMACEUTICALS, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
00101/0153
17 February 1983 / 17 February 1998
| Drug | Countries | |
|---|---|---|
| SANDIMMUN | Austria, Australia, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Nigeria, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa |
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