Tacforius

Country: European Union

Language: Danish

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:

tacrolimusmonohydrat

Available from:

Teva B.V.

ATC code:

L04AD02

INN (International Name):

tacrolimus

Therapeutic group:

immunosuppressiva

Therapeutic area:

Liver Transplantation; Kidney Transplantation

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: 7

Authorization status:

autoriseret

Authorization date:

2017-12-08

Patient Information leaflet

                                50
B. INDLÆGSSEDDEL
51
INDLÆGSSEDDEL: INFORMATION TIL PATIENTEN
TACFORIUS 0,5 MG DEPOTKAPSLER, HÅRDE
TACFORIUS 1 MG DEPOTKAPSLER, HÅRDE
TACFORIUS 3 MG DEPOTKAPSLER, HÅRDE
TACFORIUS 5 MG DEPOTKAPSLER, HÅRDE
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 Tacforius 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.
OVERSIGT OVER INDLÆGSSEDLEN
1.
Virkning og anvendelse
2.
Det skal du vide, før du begynder at tage Tacforius
3.
Sådan skal du tage Tacforius
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelse og yderligere oplysninger
1.
VIRKNING OG ANVENDELSE
Tacforius indeholder det aktive stof tacrolimus. Det er et
immundæmpende lægemiddel. Efter en
organtransplantation (lever, nyre), vil kroppens immunsystem forsøge
at afstøde det nye organ.
Tacforius benyttes til at kontrollere din krops immunreaktion,
således at kroppen kan acceptere det nye
transplanterede organ.
Du kan også få ordineret Tacforius ved en igangværende afstødning
af den transplanterede lever, nyre,
hjerte eller andet organ, hvis din tidligere behandling ikke kunne
kontrollere immunreaktionen efter
transplantationen.
Tacforius anvendes til voksne.
2.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE TACFORIUS
_ _
TAG IKKE TACFORIUS_ _
-
hvis du er allergisk over for tacrolimus eller et af de øvrige
indholdsstoffer i Tacforius
(angivet i punkt 6).
-
hvis du er allergisk over for sirolimus eller over for
makrolidantibiotika (f.eks. erythomycin,
clarithromycin, josamycin).
ADVARSLER OG FORSIGTIGHEDSREGLER
Almindelige tacrolimus kapsler, der virker umiddelbart (f
                                
                                Read the complete document

Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUMÉ
2
1.
LÆGEMIDLETS NAVN
Tacforius 0,5 mg depotkapsler, hårde
Tacforius 1 mg depotkapsler, hårde
Tacforius 3 mg depotkapsler, hårde
Tacforius 5 mg depotkapsler, hårde
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Tacforius 0,5 mg depotkapsler, hårde
Hver depotkapsel, hård, indeholder 0,5 mg tacrolimus (som
monohydrat).
_Hjælpestof, som behandleren skal være opmærksom på _
Hver kapsel indeholder 53,725 mg lactose.
Tacforius 1 mg depotkapsler, hårde
Hver depotkapsel, hård, indeholder 1 mg tacrolimus (som monohydrat).
_Hjælpestof, som behandleren skal være opmærksom på _
Hver kapsel indeholder 107,45 mg lactose.
Tacforius 3 mg depotkapsler, hårde
Hver depotkapsel, hård, indeholder 3 mg tacrolimus (som monohydrat).
_Hjælpestof, som behandleren skal være opmærksom på _
Hver kapsel indeholder 322,35 mg lactose.
Tacforius 5 mg depotkapsler, hårde
Hver depotkapsel, hård, indeholder 5 mg tacrolimus (som monohydrat).
_Hjælpestoffer, som behandleren skal være opmærksom på _
Hver kapsel indeholder 537,25 mg lactose og 0,0154 mg ponceau 4R.
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Depotkapsel, hård (depotkapsel)
Tacforius 0,5 mg depotkapsler, hårde
Gelatinekapsler præget med ”TR” på den lysegule kapseltop og med
”0.5 mg” på den lysorange
kapselbund.
Tacforius 1 mg depotkapsler, hårde
Gelatinekapsler præget med ”TR” på den hvide kapseltop og med
”1 mg” på den lysorange
kapselbund.
Tacforius 3 mg depotkapsler, hårde
3
Gelatinekapsler præget med ”TR” på den lysorange kapseltop og
med ”3 mg” på den lysorange
kapselbund.
Tacforius 5 mg depotkapsler, hårde
Gelatinekapsler præget med ”TR” på den grå-røde kapseltop og
med ”5 mg” på den lysorange
kapselbund.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Profylakse af transplantatafstødning hos voksne nyre- eller
levertransplanterede patienter.
Behandling af transplantatafstødning der er resistent for behandling
med andre immunsuppressive
lægemidler ho
                                
                                Read the complete document

Similar products

Active ingredient tacrolimusmonohydrat

tacrolimusmonohydrat

ATC code L04AD02

L04AD02

Marketed by Teva B.V.

Teva B.V.

INN (International Name) tacrolimus

tacrolimus

Documents in other languages

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
Patient Information leaflet Patient Information leaflet Spanish 10-01-2023
Summary of Product characteristics Summary of Product characteristics Spanish 10-01-2023
Public Assessment Report Public Assessment Report Spanish 26-01-2018
Patient Information leaflet Patient Information leaflet Czech 10-01-2023
Summary of Product characteristics Summary of Product characteristics Czech 10-01-2023
Public Assessment Report Public Assessment Report Czech 26-01-2018
Patient Information leaflet Patient Information leaflet German 10-01-2023
Summary of Product characteristics Summary of Product characteristics German 10-01-2023
Public Assessment Report Public Assessment Report German 26-01-2018
Patient Information leaflet Patient Information leaflet Estonian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Estonian 10-01-2023
Public Assessment Report Public Assessment Report Estonian 26-01-2018
Patient Information leaflet Patient Information leaflet Greek 10-01-2023
Summary of Product characteristics Summary of Product characteristics Greek 10-01-2023
Public Assessment Report Public Assessment Report Greek 26-01-2018
Patient Information leaflet Patient Information leaflet English 10-01-2023
Summary of Product characteristics Summary of Product characteristics English 10-01-2023
Public Assessment Report Public Assessment Report English 26-01-2018
Patient Information leaflet Patient Information leaflet French 10-01-2023
Summary of Product characteristics Summary of Product characteristics French 10-01-2023
Public Assessment Report Public Assessment Report French 26-01-2018
Patient Information leaflet Patient Information leaflet Italian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Italian 10-01-2023
Public Assessment Report Public Assessment Report Italian 26-01-2018
Patient Information leaflet Patient Information leaflet Latvian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Latvian 10-01-2023
Public Assessment Report Public Assessment Report Latvian 26-01-2018
Patient Information leaflet Patient Information leaflet Lithuanian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 10-01-2023
Public Assessment Report Public Assessment Report Lithuanian 26-01-2018
Patient Information leaflet Patient Information leaflet Hungarian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 10-01-2023
Public Assessment Report Public Assessment Report Hungarian 26-01-2018
Patient Information leaflet Patient Information leaflet Maltese 10-01-2023
Summary of Product characteristics Summary of Product characteristics Maltese 10-01-2023
Public Assessment Report Public Assessment Report Maltese 26-01-2018
Patient Information leaflet Patient Information leaflet Dutch 10-01-2023
Summary of Product characteristics Summary of Product characteristics Dutch 10-01-2023
Public Assessment Report Public Assessment Report Dutch 26-01-2018
Patient Information leaflet Patient Information leaflet Polish 10-01-2023
Summary of Product characteristics Summary of Product characteristics Polish 10-01-2023
Public Assessment Report Public Assessment Report Polish 26-01-2018
Patient Information leaflet Patient Information leaflet Portuguese 10-01-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 10-01-2023
Public Assessment Report Public Assessment Report Portuguese 26-01-2018
Patient Information leaflet Patient Information leaflet Romanian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Romanian 10-01-2023
Public Assessment Report Public Assessment Report Romanian 26-01-2018
Patient Information leaflet Patient Information leaflet Slovak 10-01-2023
Summary of Product characteristics Summary of Product characteristics Slovak 10-01-2023
Public Assessment Report Public Assessment Report Slovak 26-01-2018
Patient Information leaflet Patient Information leaflet Slovenian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 10-01-2023
Public Assessment Report Public Assessment Report Slovenian 26-01-2018
Patient Information leaflet Patient Information leaflet Finnish 10-01-2023
Summary of Product characteristics Summary of Product characteristics Finnish 10-01-2023
Public Assessment Report Public Assessment Report Finnish 26-01-2018
Patient Information leaflet Patient Information leaflet Swedish 10-01-2023
Summary of Product characteristics Summary of Product characteristics Swedish 10-01-2023
Public Assessment Report Public Assessment Report Swedish 26-01-2018
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Summary of Product characteristics Summary of Product characteristics Norwegian 10-01-2023
Patient Information leaflet Patient Information leaflet Icelandic 10-01-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 10-01-2023
Patient Information leaflet Patient Information leaflet Croatian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Croatian 10-01-2023
Public Assessment Report Public Assessment Report Croatian 26-01-2018

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