Tacni

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

tacrolimus

Доступна с:

Laboratories Cinfa S.A.

ИНН (Международная Имя):

tacrolimus

дозировка:

1mg

Фармацевтическая форма:

capsules

Тип рецепта:

Prescription

Характеристики продукта

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