Envarsus

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
23-01-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
23-01-2023
Public Assessment Report Public Assessment Report (PAR)
31-07-2014

Active ingredient:

takrolimus

Available from:

Chiesi Farmaceutici S.p.A.

ATC code:

L04AD02

INN (International Name):

tacrolimus

Therapeutic group:

imunosupresivi

Therapeutic area:

Odbacivanje transplantata

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: 12

Authorization status:

odobren

Authorization date:

2014-07-18

Patient Information leaflet

                                42
B. UPUTA O LIJEKU
43
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
ENVARSUS 0,75 MG TABLETE S PRODULJENIM OSLOBAĐANJEM
ENVARSUS 1 MG TABLETE S PRODULJENIM OSLOBAĐANJEM
ENVARSUS 4 MG TABLETE S PRODULJENIM OSLOBAĐANJEM
takrolimus _(tacrolimus)_
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 Envarsus i za što se koristi
2.
Što morate znati prije nego počnete uzimati Envarsus
3.
Kako uzimati Envarsus
4.
Moguće nuspojave
5.
Kako čuvati Envarsus
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE ENVARSUS I ZA ŠTO SE KORISTI
Envarsus sadrži djelatnu tvar takrolimus. Envarsus je imunosupresivni
lijek. Nakon presađivanja
bubrega ili jetre Vaš imunološki sustav pokušat će odbaciti novi
organ.
Envarsus se primjenjuje za kontrolu imunološkog odgovora Vašeg
tijela, čime se Vašem tijelu
omogućuje da prihvati presađeni organ.
Envarsus možete dobiti i kad je odbacivanje presatka jetre, bubrega,
srca ili nekog drugog
organa već započelo, a kada se liječenjem koje ste do tada primali
ne može kontrolirati
imunološki odgovor nakon presađivanja.
Envarsus se primjenjuje u odraslih.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI ENVARSUS
NEMOJTE UZIMATI ENVARSUS
-
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
Envarsus sadrži djelatnu tvar takrolimus, u farmaceutskom obliku s
prod
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
_ _
Envarsus 0,75 mg tablete s produljenim oslobađanjem
Envarsus 1 mg tablete s produljenim oslobađanjem
Envarsus 4 mg tablete s produljenim oslobađanjem
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
_ _
Envarsus 0,75 mg tablete s produljenim oslobađanjem
Jedna tableta s produljenim oslobađanjem sadrži 0,75 mg takrolimusa
_(tacrolimus)_ (u obliku
hidrata).
_Pomoćna tvar s poznatim učinkom _
Jedna tableta sadrži 41,7 mg laktoza hidrata.
Envarsus 1 mg tablete s produljenim oslobađanjem
Jedna tableta s produljenim oslobađanjem sadrži 1 mg takrolimusa
_(tacrolimus)_ (u obliku
hidrata).
_Pomoćna tvar s poznatim učinkom _
Jedna tableta sadrži 41,7 mg laktoza hidrata.
Envarsus 4 mg tablete s produljenim oslobađanjem
Jedna tableta s produljenim oslobađanjem sadrži 4 mg takrolimusa
_(tacrolimus)_ (u obliku
hidrata).
_Pomoćna tvar s poznatim učinkom _
Jedna tableta sadrži 104 mg laktoza hidrata.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Tableta s produljenim oslobađanjem.
Envarsus 0,75 mg tablete s produljenim oslobađanjem
Ovalna, bijela do bjelkasta neobložena tableta, s utisnutom oznakom
„0.75“ na jednoj strani i
„TCS“ na drugoj strani.
Envarsus 1 mg tablete s produljenim oslobađanjem
Ovalna, bijela do bjelkasta neobložena tableta, s utisnutom oznakom
„1“ na jednoj strani i
„TCS“ na drugoj strani.
Envarsus 4 mg tablete s produljenim oslobađanjem
Ovalna, bijela do bjelkasta neobložena tableta, s utisnutom oznakom
„4“ na jednoj strani i
„TCS“ na drugoj strani.
3
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Sprječavanje reakcija odbacivanja transplantata u odraslih primatelja
alogenih presadaka
bubrega ili jetre.
Liječenje odbacivanja alogenog presatka koje je rezistentno na
terapiju drugim
imunosupresivnim lijekovima u odraslih bolesnika.
4.2
DOZIRANJE I NAČIN PRIMJENE
Envarsus je peroralni farmaceutski oblik takrolimusa koji se
primjenjuje jedanput na dan.
Liječenje takrolimusom m
                                
                                Read the complete document

Similar products

Active ingredient takrolimus

takrolimus

ATC code L04AD02

L04AD02

Marketed by Chiesi Farmaceutici S.p.A.

Chiesi Farmaceutici S.p.A.

INN (International Name) tacrolimus

tacrolimus

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