Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
Dailiport 0.5 mg prolonged-release hard capsules.
| Pharmaceutical Form |
|---|
|
Prolonged-release hard capsule. Gelatin capsule size 5 with a light brown body and a light yellow cap, imprinted in black with “0.5 mg”, containing white to yellowish powder or compacted powder (length 10.7–11.5 mm). |
Each prolonged-release hard capsule contains 0.5 mg of tacrolimus (as monohydrate).
Excipient(s) with known effect:
Dailiport 0.5 mg prolonged-release hard capsules:
Each prolonged-release hard capsule contains 51 mg of lactose (as monohydrate).
Each prolonged-release hard capsule contains 5.4 microgram of Sunset yellow FCF (E110).
Each prolonged-release hard capsule contains 0.4 microgram of Allura red AC (E129).
Each prolonged-release hard capsule contains 3.4 microgram of tartrazine (E102).
The printing ink used to mark the capsule contains trace amounts of:
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: Brilliant blue FCF (E133) Printing ink: Shellac Glaze |
PVC/PVDC // aluminium blister with desiccant sealed in aluminium bag.
Packs sizes: 30, 50, 60 (2x30) and 100 (2x50) prolonged-release hard capsules in blister and 30x1, 50x1, 60x1 (2x30) and 100x1 (2x50) prolonged-release hard capsules in unit-dose perforated blisters.
Not all pack sizes may be marketed.
Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
PL 04416/1566
Date of first authorisation: 14 October 2019
| Drug | Countries | |
|---|---|---|
| DAILIPORT | Austria, Estonia, Finland, Lithuania, Netherlands, Poland, Turkey, United Kingdom |
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