PROGRAF Hard capsule Ref.[7767] 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 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.

Qualitative and quantitative composition

Prograf 0.5 mg hard capsules

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).

Prograf 1 mg hard capsules

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).

Prograf 5 mg hard capsules

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 capsules

Capsule content:

Hypromellose
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate

Capsule shell:

Titanium dioxide (E171)
Yellow iron oxide (E172)
Gelatine

Printing ink of Capsule shell: Shellac, lecithin (soya), hydroxypropyl cellulose, simeticone, red iron oxide (E172).

Prograf 1 mg hard capsules

Capsule content:

Hypromellose
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate

Capsule shell:

Titanium dioxide (E171)
Gelatine

Printing ink of Capsule shell: Shellac, lecithin (soya), hydroxypropyl cellulose, simeticone, red iron oxide (E172).

Prograf 5 mg hard capsules

Capsule content:

Hypromellose
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate

Capsule shell:

Titanium dioxide (E171)
Red iron oxide (E172)
Gelatine

Printing ink of Capsule shell: Shellac, titanium dioxide (E171) and propylene glycol.

Pack sizes and marketing

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.

Marketing authorization holder

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

Marketing authorization dates and numbers

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

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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