Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Astellas Pharma Ltd., 2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, United Kingdom
Prograf 0.5 mg hard capsules.
Prograf 1 mg hard capsules.
Prograf 5 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Prograf 0.5 mg hard capsules: Capsule, hard. Opaque light yellow hard gelatin capsules imprinted in red with “0.5 mg” and “[f] 607”, containing white powder. Prograf 1 mg hard capsules: Capsule, hard. Opaque white hard gelatin capsules imprinted in red with “1 mg” and “[f] 617”, containing white powder. Prograf 5 mg hard capsules: Capsule, hard. Opaque greyish red hard gelatin capsules imprinted in white with “5 mg” and “[f] 657”, containing white powder. |
Each capsule contains 0.5 mg of tacrolimus (as monohydrate).
Excipient with known effect: 62.85 mg of lactose monohydrate
Each capsule contains less than 1 mmol sodium (23 mg).
The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).
Each capsule contains 1 mg of tacrolimus (as monohydrate).
Excipient with known effect: 61.35 mg of lactose monohydrate
Each capsule contains less than 1 mmol sodium (23 mg).
The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).
Each capsule contains 5 mg of tacrolimus (as monohydrate).
Excipient with known effect: 123.60 mg of lactose monohydrate
Each capsule contains less than 1 mmol sodium (23 mg).
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 |
|---|
Prograf 0.5 mg hard capsulesCapsule content: Hypromellose Capsule shell: Titanium dioxide (E171) Printing ink of Capsule shell: Shellac, lecithin (soya), hydroxypropyl cellulose, simeticone, red iron oxide (E172). Prograf 1 mg hard capsulesCapsule content: Hypromellose Capsule shell: Titanium dioxide (E171) Printing ink of Capsule shell: Shellac, lecithin (soya), hydroxypropyl cellulose, simeticone, red iron oxide (E172). Prograf 5 mg hard capsulesCapsule content: Hypromellose Capsule shell: Titanium dioxide (E171) Printing ink of Capsule shell: Shellac, titanium dioxide (E171) and propylene glycol. |
PVC/PVDC/Aluminium blisters or PVC/PVDC/Aluminium perforated unit-dose blisters. Ten capsules per blister. Two, three, five, six, nine or ten blisters with a desiccant in an aluminium wrapper.
Prograf 0.5 mg hard capsules
Packs of 20, 30, 50, 60 and 100 hard capsules in blisters.
Packs of 20×1, 30×1, 50×1, 60×1 and 100×1 hard capsules in perforated unit-dose blisters.
Prograf 1 mg hard capsules
Packs of 20, 30, 50, 60, 90 and 100 hard capsules in blisters.
Packs of 20×1, 30×1, 50×1, 60×1, 90×1 and 100×1 hard capsules in perforated unit-dose blisters.
Prograf 5 mg hard capsules
Packs of 30, 50, 60 and 100 hard capsules in blisters.
Packs of 30×1, 50×1, 60×1 and 100×1 hard capsules in perforated unit-dose blisters.
Not all pack sizes may be marketed.
Astellas Pharma Ltd., 2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, United Kingdom
Prograf 0.5 mg hard capsules: PL 00166/0206
Prograf 1 mg hard capsules: PL 00166/0203
Prograf 5 mg hard capsules: PL 00166/0204
Prograf 0.5 mg hard capsules:
Date of first authorisation: 10 December 1998
Date of last renewal: 27 November 2007
Prograf 1 mg hard capsules:
Date of first authorisation: 16 February 1996
Date of last renewal: 27 November 2007
Prograf 5 mg hard capsules:
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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