Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands
Tacforius 0.5 mg prolonged-release hard capsules.
Tacforius 1 mg prolonged-release hard capsules.
Tacforius 3 mg prolonged-release hard capsules.
Tacforius 5 mg prolonged-release hard capsules.
| Pharmaceutical Form |
|---|
|
Prolonged-release hard capsule. Tacforius 0.5 mg prolonged-release hard capsules: Gelatin capsules imprinted with “TR” on the light yellow capsule cap and “0.5 mg” on the light orange capsule body. Tacforius 1 mg prolonged-release hard capsules: Gelatin capsules imprinted with “TR” on the white capsule cap and “1 mg” on the light orange capsule body. Tacforius 3 mg prolonged-release hard capsules: Gelatin capsules imprinted with “TR” on the light orange capsule cap and “3 mg” on the light orange capsule body. Tacforius 5 mg prolonged-release hard capsules: Gelatin capsules imprinted with “TR” on the greyish red capsule cap and “5 mg” on the light orange capsule body. |
Each prolonged-release hard capsule contains 0.5 mg tacrolimus (as monohydrate).
Excipient with known effect: Each capsule contains 53.725 mg lactose.
Each prolonged-release hard capsule contains 1 mg tacrolimus (as monohydrate).
Excipient with known effect: Each capsule contains 107.45 mg lactose.
Each prolonged-release hard capsule contains 3 mg tacrolimus (as monohydrate).
Excipient with known effect: Each capsule contains 322.35 mg lactose.
Each prolonged-release hard capsule contains 5 mg tacrolimus (as monohydrate).
Excipients with known effect: Each capsule contains 537.25 mg lactose and 0.0154 mg ponceau 4R.
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 |
|---|
|
Capsule content: Ethylcellulose Capsule shell: Tacforius 0.5 mg / 1 mg / 3 mg prolonged-release hard capsules: Red iron oxide (E172) Tacforius 5 mg prolonged-release hard capsules: Red iron oxide (E172) Printing ink: Shellac |
Transparent PVC/PVDC aluminium blister or perforated unit-dose blister wrapped in an aluminium pouch with a desiccant containing 10 capsules per blister.
Pack sizes: 30, 50 and 100 prolonged-release hard capsules in blisters or 30x1, 50x1 and 100x1 prolonged-release hard capsules in perforated unit-dose blisters.
Pack sizes: 30, 50, 60 and 100 prolonged-release hard capsules in blisters or 30x1, 50x1, 60x1 and 100x1 prolonged-release hard capsules in perforated unit-dose blisters.
Not all pack sizes may be marketed.
Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands
Tacforius 0.5 mg prolonged-release hard capsules:
EU/1/17/1244/001
EU/1/17/1244/002
EU/1/17/1244/003
EU/1/17/1244/004
EU/1/17/1244/005
EU/1/17/1244/006
Tacforius 1 mg prolonged-release hard capsules:
EU/1/17/1244/007
EU/1/17/1244/008
EU/1/17/1244/009
EU/1/17/1244/010
EU/1/17/1244/011
EU/1/17/1244/012
EU/1/17/1244/013
EU/1/17/1244/014
Tacforius 3 mg prolonged-release hard capsules:
EU/1/17/1244/015
EU/1/17/1244/016
EU/1/17/1244/017
EU/1/17/1244/018
EU/1/17/1244/019
EU/1/17/1244/020
Tacforius 5 mg prolonged-release hard capsules:
EU/1/17/1244/021
EU/1/17/1244/022
EU/1/17/1244/023
EU/1/17/1244/024
EU/1/17/1244/025
EU/1/17/1244/026
Date of first authorisation: 8 December 2017
| Drug | Countries | |
|---|---|---|
| TACFORIUS | Austria, Estonia, Spain, Croatia, Ireland, Italy, Lithuania, Poland |
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