Envarsus

Country: European Union

Language: Danish

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:

tacrolimus

Available from:

Chiesi Farmaceutici S.p.A.

ATC code:

L04AD02

INN (International Name):

tacrolimus

Therapeutic group:

immunosuppressiva

Therapeutic area:

Graft Afvisning

Therapeutic indications:

Profylakse af transplantationsafstødning hos voksne nyre- eller levertransplantationsmodtagere. Behandling af allograft afvisning resistente over for behandling med andre immunosuppressive lægemidler hos voksne patienter.

Product summary:

Revision: 12

Authorization status:

autoriseret

Authorization date:

2014-07-18

Patient Information leaflet

                                41
B. INDLÆGSSEDDEL
42
INDLÆGSSEDDEL: INFORMATION TIL PATIENTEN
ENVARSUS 0,75 MG DEPOTTABLETTER
ENVARSUS 1 MG DEPOTTABLETTER
ENVARSUS 4 MG DEPOTTABLETTER
tacrolimus
LÆS DENNE INDLÆGSSEDDEL GRUNDIGT, INDEN DU BEGYNDER AT TAGE DETTE
LÆGEMIDDEL, DA DEN
INDEHOLDER VIGTIGE OPLYSNINGER.
-
Gem indlægssedlen. Du kan få brug for at læse den igen.
-
Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
-
Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor
være med at give lægemidlet
til andre. Det kan være skadeligt for andre, selvom de har de samme
symptomer, som du har.
-
Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger,
herunder bivirkninger, som
ikke er nævnt i denne indlægsseddel. Se punkt 4.
Se den nyeste indlægsseddel på www.indlaegsseddel.dk.
OVERSIGT OVER INDLÆGSSEDLEN
1.
Virkning og anvendelse
2.
Det skal du vide, før du begynder at tage Envarsus
3.
Sådan skal du tage Envarsus
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelser og yderligere oplysninger
1.
VIRKNING OG ANVENDELSE
Envarsus indeholder det aktive stof tacrolimus. Det er et
immunhæmmende lægemiddel. Efter en nyre-
eller levertransplantation vil din krops immunforsvar forsøge at
afstøde det nye organ.
Envarsus anvendes til at kontrollere kroppens immunreaktion, så
kroppen kan acceptere det
transplanterede organ.
Du kan også få Envarsus ved en igangværende afstødning af den
transplanterede lever, nyre, hjerte
eller andet organ, når din tidligere behandling ikke har kunnet
kontrollere immunforsvarets reaktion
efter transplantationen.
Envarsus anvendes til voksne.
2.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE ENVARSUS
TAG IKKE ENVARSUS
-
hvis du er allergisk over for tacrolimus eller et af de øvrige
indholdsstoffer i Envarsus (angivet i
punkt 6).
-
hvis du er allergisk over for sirolimus eller et makrolid-antibiotikum
(f.eks. erythromycin,
clarithromycin, josamycin).
ADVARSLER OG FORSIGTIGHEDSREGLER
Envarsus indeholder det aktive stof tacrolimus i en depotformulering
(med for
                                
                                Read the complete document

Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUMÉ
2
1.
LÆGEMIDLETS NAVN
Envarsus 0,75 mg depottabletter
Envarsus 1 mg depottabletter
Envarsus 4 mg depottabletter
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Envarsus 0,75 mg depottabletter
Hver depottablet indeholder 0,75 mg tacrolimus (som monohydrat).
_Hjælpestof, som behandleren skal være opmærksom på _
Hver tablet indeholder 41,7 mg lactosemonohydrat.
Envarsus 1 mg depottabletter
Hver depottablet indeholder 1 mg tacrolimus (som monohydrat).
_Hjælpestof, som behandleren skal være opmærksom på _
Hver tablet indeholder 41,7 mg lactosemonohydrat.
Envarsus 4 mg depottabletter
Hver depottablet indeholder 4 mg tacrolimus (som monohydrat).
_Hjælpestof, som behandleren skal være opmærksom på _
Hver tablet indeholder 104 mg lactosemonohydrat.
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Depottablet.
Envarsus 0,75 mg depottabletter
Oval, hvid til grålighvid uovertrukket tablet præget med "0.75" på
den ene side og "TCS" på den
anden side.
Envarsus 1 mg depottabletter
Oval, hvid til grålighvid uovertrukket tablet præget med "1" på den
ene side og "TCS" på den anden
side
Envarsus 4 mg depottabletter
Oval, hvid til grålighvid uovertrukket tablet præget med "4" på den
ene side og "TCS" på den anden
side
3
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Profylakse af transplantatafstødning hos voksne patienter, der har
fået nyre- eller leverallograft.
Behandling af allograft-afstødning hos voksne patienter, der ikke
responderer på behandling med
andre immunsuppressive lægemidler.
4.2
DOSERING OG ADMINISTRATION
Envarsus er en oral formulering af tacrolimus, der tages én gang
dagligt. Behandling med tacrolimus
kræver omhyggelig overvågning af velkvalificeret og specielt
uddannet personale. Kun læger med
erfaring i immunsuppressiv behandling og behandling af transplanterede
patienter må ordinere dette
lægemiddel og initiere ændringer i den immunsuppressive behandling.
Utilsigtet, uforsætlig eller uovervåget substitution af
øjeblikkeligt ud
                                
                                Read the complete document

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Active ingredient tacrolimus

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ATC code L04AD02

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INN (International Name) tacrolimus

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Patient Information leaflet Patient Information leaflet English 23-01-2023
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