Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Astellas Pharma Ltd., 2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, United Kingdom
Prograf 5 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. The concentrate is a clear colourless solution. |
1 ml concentrate for solution for infusion contains 5 mg of tacrolimus.
Excipients with known effect: 200 mg of polyoxyethylene hydrogenated castor oil and 638 mg of dehydrated alcohol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tacrolimus |
Tacrolimus is a highly potent immunosuppressive agent. In particular, tacrolimus inhibits the formation of cytotoxic lymphocytes, which are mainly responsible for graft rejection. Tacrolimus suppresses T-cell activation and T-helper-cell dependent B-cell proliferation, as well as the formation of lymphokines (such as interleukins-2, -3, and γ-interferon) and the expression of the interleukin-2 receptor. |
| List of Excipients |
|---|
|
Polyoxyethylene hydrogenated castor oil |
1 ml concentrate for solution for infusion in 2 ml, type I Ph. Eur. clear colourless glass ampoules.
Each carton contains 10 ampoules.
Astellas Pharma Ltd., 2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, United Kingdom
PL 00166/0205
Date of first authorisation: 16 February 1996
Date of last renewal: 27 November 2007
| Drug | Countries | |
|---|---|---|
| PROGRAF | Albania, Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Malta, Mexico, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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