País: Cingapura
Língua: inglês
Origem: HSA (Health Sciences Authority)
Tacrolimus monohydrate 5.1 mg eqv anhydrous Tacrolimus 5.0 mg
ASTELLAS PHARMA SINGAPORE PTE. LTD.
L04AD02
5.0 mg
CAPSULE, EXTENDED RELEASE
Tacrolimus monohydrate 5.1 mg eqv anhydrous Tacrolimus 5.0 mg 5.0 mg
ORAL
Prescription Only
Astellas Ireland Co., Ltd
ACTIVE
2012-04-16
NAME OF THE MEDICINAL PRODUCT 1 ADVAGRAF® 0.5 mg prolonged-release hard capsules 2 ADVAGRAF® 3 mg prolonged-release hard capsules 3 ADVAGRAF® 1 mg prolonged-release hard capsules 4 ADVAGRAF® 5 mg prolonged-release hard capsules 5 6 DESCRIPTION 7 Each prolonged-release hard capsule contains 0.5 mg, 1 mg, 3mg or 5 mg tacrolimus (as 8 monohydrate) 9 Not all strengths may be marketed. 10 11 CLINICAL PARTICULARS 12 THERAPEUTIC INDICATIONS 13 Prophylaxis of transplant rejection in adult kidney or liver allograft recipients and treatment of 14 kidney or liver allograft rejection resistant to treatment with other immunosuppressive 15 medicinal products in adult patients. 16 17 POSOLOGY AND METHOD OF ADMINISTRATION 18 Advagraf is a once-a-day oral formulation of tacrolimus. Advagraf therapy requires careful 19 monitoring by adequately qualified and equipped personnel. This medicinal product should 20 only be prescribed, and changes in immunosuppressive therapy initiated, by physicians 21 experienced in immunosuppressive therapy and the management of transplant patients. 22 23 Inadvertent, unintentional or unsupervised switching of immediate- or prolonged-release 24 formulations of tacrolimus is unsafe. This can lead to graft rejection or increased incidence of 25 side effects, including under- or over-immunosuppression, due to clinically relevant 26 differences in systemic exposure to tacrolimus. Patients should be maintained on a single 27 formulation of tacrolimus with the corresponding daily dosing regimen; alterations in 28 formulation or regimen should only take place under the close supervision of a transplant 29 specialist (see Special warnings and precautions for use and Undesirable effects). Following 30 conversion to any alternative formulation, therapeutic drug monitoring must be performed and 31 dose adjustments made to ensure that systemic exposure to tacrolimus is maintained. 32 33 Posology 34 The recommended initial doses presented below are intended to act solely as a guideline. 35 Advagraf is routinel Leia o documento completo
NAME OF THE MEDICINAL PRODUCT ADVAGRAF ® 0.5 mg prolonged-release hard capsules ADVAGRAF ® 3 mg prolonged-release hard capsules ADVAGRAF ® 1 mg prolonged-release hard capsules ADVAGRAF ® 5 mg prolonged-release hard capsules DESCRIPTION Each prolonged-release hard capsule contains 0.5 mg, 1 mg, 3 mg or 5 mg tacrolimus (as monohydrate) Not all strengths may be marketed. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Prophylaxis of transplant rejection in adult kidney or liver allograft recipients and treatment of kidney or liver allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients. POSOLOGY AND METHOD OF ADMINISTRATION 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 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 Special warnings and precautions for use and Undesirable effects). 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. Posology The recommended initial doses presented below are intended to act solely as a guideline. Advagraf is routinely administered in conjunction with other immunosuppressive agents in the initial post-opera Leia o documento completo