1. Name of the medicinal product
Prograf 0.5 mg hard capsules

Prograf 1 mg hard capsules

Prograf 5 mg hard capsules

2. 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

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

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

For the full list of excipients, see section 6.1.

3. 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.

4. Clinical particulars
4.1 Therapeutic indications
Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients.

Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.

4.2 Posology and method of administration
Prograf therapy requires careful monitoring by adequately qualified and equipped personnel. The medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients.

Inadvertent, unintentional or unsupervised switching of immediate- or prolonged-release formulations of tacrolimus is unsafe. This can lead to graft rejection or increased incidence of side effects, including under- or over-immunosuppression, due to clinically relevant differences in systemic exposure to tacrolimus. Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.4 and 4.8). Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose adjustments made to ensure that systemic exposure to tacrolimus is maintained.

General considerations

The recommended initial dosages presented below are intended to act solely as a guideline. Prograf dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below for recommended target whole blood trough concentrations). If clinical signs of rejection are apparent, alteration of the immunosuppressive regimen should be considered.

Prograf can be administered intravenously or orally. In gener