PROGRAF Concentrate for solution for infusion Ref.[7768] Active ingredients: Tacrolimus

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Astellas Pharma Ltd., 2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, United Kingdom

Product name and form

Prograf 5 mg/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

The concentrate is a clear colourless solution.

Qualitative and quantitative composition

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
Dehydrated alcohol

Pack sizes and marketing

1 ml concentrate for solution for infusion in 2 ml, type I Ph. Eur. clear colourless glass ampoules.

Each carton contains 10 ampoules.

Marketing authorization holder

Astellas Pharma Ltd., 2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, United Kingdom

Marketing authorization dates and numbers

PL 00166/0205

Date of first authorisation: 16 February 1996
Date of last renewal: 27 November 2007

Drugs

Drug Countries
PROGRAF Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Malta, Mexico, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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