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Advagraf 0.5mg, 1mg, 3mg and 5mg Prolonged-release hard caps(一)
2013-07-04 20:12:33 来源: 作者: 【 】 浏览:6316次 评论:0

Drug Description
Advagraf 0.5 mg prolonged-release hard capsulesEach prolonged-release hard capsule contains 0.5 mg tacrolimus (as monohydrate).Excipients: Each capsule contains 53.64 mg lactose monohydrate.The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).Advagraf 1 mg prolonged-release hard capsulesEach prolonged-release hard capsule contains 1 mg tacrolimus (as monohydrate). Excipients: Each capsule contains 107.28 mg lactose monohydrate.The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).Advagraf 3 mg prolonged-release hard capsulesEach prolonged-release hard capsule contains 3 mg tacrolimus (as monohydrate).Excipients: Each capsule contains 321.84 mg lactose monohydrate. The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).Advagraf 5 mg prolonged-release hard capsulesEach prolonged-release hard capsule contains 5 mg tacrolimus (as monohydrate). Excipients: Each capsule contains 536.4 mg lactose monohydrate.The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).

Presentation
Advagraf 0.5 mg prolonged-release hard capsulesProlonged-release hard capsule.Gelatin capsules imprinted in red with “0.5 mg” on the light yellow capsule cap and 647” on the orange capsule body, containing white powder.Advagraf 1 mg prolonged-release hard capsulesProlonged-release hard capsule.Gelatin capsules imprinted in red with “1 mg” on the white capsule cap and “ 677 on the orange capsule body, containing white powder.Advagraf 3 mg prolonged-release hard capsulesProlonged-release hard capsule.Gelatin capsules imprinted in red with “3 mg” on the orange capsule cap and “ 637” on the orange capsule body, containing white powder.Advagraf 5 mg prolonged-release hard capsulesProlonged-release hard capsule.Gelatin capsules imprinted in red with “5 mg” on the greyish red capsule cap and ” 687” on the orange capsule body, containing white powder.

Indications
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.

Adult Dosage
Advagraf is a once-a-day oral formulation of tacrolimus. Advagraf 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 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 overimmunosuppression, 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. Following conversion to any alternative formulation, therapeuti

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