Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TACROLIMUS MONOHYDRATE
Accord Healthcare Limited
5 Milligram
Capsules Hard
2012-02-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tacrolimus 5mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5 mg of tacrolimus(as tacrolimus monohydrate) Excipients: 98.86 mg of lactose monohydrate For the full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Capsule hard Pink/pink hard gelatin capsules, approximately 14.30mm, size "4" imprinted with “TCR” on cap & “5” on body containing white to off white granular 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 Tacrolimus therapy requires careful monitoring by adequately qualified and equipped personnel. This medicinal product should only be prescribed and changes in immunosuppressive therapy, initiated by physicians experienced in immunosuppressive therapy and the management of transplanted 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 mai Read the complete document