Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
tacrolimus
Laboratories Cinfa S.A.
tacrolimus
5mg
capsules
Prescription
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT TACNI 0.5 mg hard capsules TACNI 1 mg hard capsules TACNI 5 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 mg hard capsule contains 0.5 mg tacrolimus Each 1 mg hard capsule contains 1 mg tacrolimus Each 5 mg hard capsule contains 5 mg tacrolimus Excipient(s): Each 0.5 mg hard capsule contains 109.1 mg lactose anhydrous Each 1 mg hard capsule contains108.6 mg lactose anhydrous Each 5 mg hard capsule contains 104.6 mg lactose anhydrous For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules, hard. TACNI 0.5 mg hard capsule: Ivory cap and ivory body hard shell capsules with white powder. TACNI 1 mg hard capsule: White cap and white body hard shell capsules with white powder. TACNI 5 mg hard capsule: Red cap and red body hard shell capsules with 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 TACNI 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 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 conversio Прочитать полный документ