Tacforius

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-01-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
10-01-2023
Public Assessment Report Public Assessment Report (PAR)
26-01-2018

Active ingredient:

takrolimus monohidrat

Available from:

Teva B.V.

ATC code:

L04AD02

INN (International Name):

tacrolimus

Therapeutic group:

imunosupresivi

Therapeutic area:

Liver Transplantation; Kidney Transplantation

Therapeutic indications:

Profilaksa odbacivanja transplantata kod odraslih primatelja bubrega ili jetrenih transplantata. Liječenje odbacivanja alografta otpornih na liječenje drugim imunosupresivnim lijekovima u odraslih bolesnika.

Product summary:

Revision: 7

Authorization status:

odobren

Authorization date:

2017-12-08

Patient Information leaflet

                                51
B. UPUTA O LIJEKU
52
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
Tacforius 0,5 mg tvrde kapsule s produljenim oslobađanjem
Tacforius 1 mg tvrde kapsule s produljenim oslobađanjem
Tacforius 3 mg tvrde kapsule s produljenim oslobađanjem
Tacforius 5 mg tvrde kapsule s produljenim oslobađanjem
takrolimus
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE UZIMATI OVAJ
LIJEK JER SADRŽI VAMA VAŽNE
PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
-
Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im
naškoditi, čak i ako su
njihovi znakovi bolesti jednaki Vašima.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika ili ljekarnika. To
uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.
Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI
:
1.
Što je Tacforius i za što se koristi
2.
Što morate znati prije nego počnete uzimati Tacforius
3.
Kako uzimati Tacforius
4.
Moguće nuspojave
5.
Kako čuvati Tacforius
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE TACFORIUS I ZA ŠTO SE KORISTI
Tacforius sadrži djelatnu tvar takrolimus. Tacforius je
imunosupresivni lijek. Nakon presađivanja
organa (jetre, bubrega), Vaš imunološki sustav pokušat će odbaciti
novi organ. Tacforius se
primjenjuje za obuzdavanje imunološkog odgovora tijela, čime mu se
omogućuje da prihvati presađeni
organ.
Tacforius možete primiti i kad već imate reakciju odbacivanja
presatka jetre, bubrega, srca ili nekog
drugog organa, kada se terapijom koju ste prethodno uzimali nije mogao
obuzdati imunološki odgovor
nakon presađivanja.
Tacforius se primjenjuje u odraslih.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI TACFORIUS
NEMOJTE UZIMATI TACFORIUS
-
ako ste alergični na takrolimus ili neki drugi sastojak ovog lijeka
(naveden u dijelu 6).
-
ako ste alergični na sirolimus ili neki makrolidni antibiotik (npr.
eritromicin, klaritromicin,
josamicin).
UPOZORENJA I MJERE OPREZA
Takrol
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Tacforius 0,5 mg tvrde kapsule s produljenim oslobađanjem
Tacforius 1 mg tvrde kapsule s produljenim oslobađanjem
Tacforius 3 mg tvrde kapsule s produljenim oslobađanjem
Tacforius 5 mg tvrde kapsule s produljenim oslobađanjem
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Tacforius 0,5 mg tvrde kapsule s produljenim oslobađanjem
Jedna tvrda kapsula s produljenim oslobađanjem sadrži 0,5 mg
takrolimusa (u obliku hidrata).
_ _
_Pomoćna tvar s poznatim učinkom _
Jedna kapsula sadrži 53,725 mg laktoze.
Tacforius 1 mg tvrde kapsule s produljenim oslobađanjem
Jedna tvrda kapsula s produljenim oslobađanjem sadrži 1 mg
takrolimusa (u obliku hidrata).
_ _
_Pomoćna tvar s poznatim učinkom _
Jedna kapsula sadrži 107,45 mg laktoze.
Tacforius 3 mg tvrde kapsule s produljenim oslobađanjem
Jedna tvrda kapsula s produljenim oslobađanjem sadrži 3 mg
takrolimusa (u obliku hidrata).
_ _
_Pomoćna tvar s poznatim učinkom: _
Jedna kapsula sadrži 322,35 mg laktoze.
Tacforius 5 mg tvrde kapsule s produljenim oslobađanjem
Jedna tvrda kapsula s produljenim oslobađanjem sadrži 5 mg
takrolimusa (u obliku hidrata).
_ _
_Pomoćne tvari s poznatim učinkom _
Jedna kapsula sadrži 537,25 mg laktoze i 0,0154 mg bojila ponceau 4R.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Tvrda kapsula s produljenim oslobađanjem (kapsula s produljenim
oslobađanjem)
Tacforius 0,5 mg tvrde kapsule s produljenim oslobađanjem
Želatinske kapsule s otisnutom oznakom „TR” na svijetložutoj
kapici kapsule i „0,5 mg” na
svijetlonarančastom tijelu kapsule.
Tacforius 1 mg tvrde kapsule s produljenim oslobađanjem
Želatinske kapsule s otisnutom oznakom „TR” na bijeloj kapici
kapsule i „1 mg” na
svijetlonarančastom tijelu kapsule.
Tacforius 3 mg tvrde kapsule s produljenim oslobađanjem
3
Želatinske kapsule s otisnutom oznakom „TR” na
svijetlonarančastoj kapici kapsule i „3 mg” na
svijetlonarančastom tijelu kapsule.
Tacforius 5 mg tvr
                                
                                Read the complete document

Similar products

Active ingredient takrolimus monohidrat

takrolimus monohidrat

ATC code L04AD02

L04AD02

Marketed by Teva B.V.

Teva B.V.

INN (International Name) tacrolimus

tacrolimus

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Patient Information leaflet Patient Information leaflet Bulgarian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 10-01-2023
Public Assessment Report Public Assessment Report Bulgarian 26-01-2018
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Summary of Product characteristics Summary of Product characteristics Spanish 10-01-2023
Public Assessment Report Public Assessment Report Spanish 26-01-2018
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Public Assessment Report Public Assessment Report Czech 26-01-2018
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Public Assessment Report Public Assessment Report Danish 26-01-2018
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Public Assessment Report Public Assessment Report German 26-01-2018
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Public Assessment Report Public Assessment Report Estonian 26-01-2018
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Public Assessment Report Public Assessment Report English 26-01-2018
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