natgillin/translations-raw huggingface dataset:
11,7 timer og 12,4 timer og hos voksne nyretransplanterede fandt man en værdi på 15,6 timer.
In adult and paediatric liver transplant patients, it averaged 11.7 hours and 12.4 hours, respectively, compared with 15.6 hours in adult kidney transplant recipients.
Patienter bør fastholdes på én lægemiddelform af tacrolimus med det tilsvarende dosisregime; ændringer i lægemiddelform eller regime bør kun ske under nøje supervision fra en transplantationsspecialist (se pkt.
Patients should be maintained on a single formulation of tacrolimus with the corresponding 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).
Stevens-Johnsons syndrom Knogler, led, muskler og bindevæv Almindelig:
Stevens Johnson syndrome Musculoskeletal and connective tissue disorders common:
Psykiske forstyrrelser Meget almindelig:
Psychiatric disorders very common:
4.5) - især stærke CYP3A4-hæmmere (såsom telaprevir, boceprevir, ritonavir, ketoconazol, voriconazol, itraconazol, telithromycin eller clarithromycin) eller CYP3A4-inducere (såsom rifampicin, rifabutin) - kombineres med tacrolimus, bør tacrolimus' blodkoncentration overvåges, og om nødvendigt justeres dosis for at vedligeholde den systemiske eksponering for tacrolimus.
When substances with a potential for interaction (see section 4.5) - particularly strong inhibitors of CYP3A4 (such as telaprevir, boceprevir, ritonavir, ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or inducers of CYP3A4 (such as rifampicin, rifabutin) - are being combined with tacrolimus, tacrolimus blood levels should be monitored to adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure.
hovedpine, tremor
headache, tremor common:
Af disse grunde kan det ikke anbefales at administrere ciclosporin sammen med tacrolimus, og man bør udvise forsigtighed ved administration af tacrolimus til patienter, der tidligere er blevet behandlet med ciclosporin (se pkt.
For these reasons, the combined administration of ciclosporin and tacrolimus is not recommended and care should be taken when administering tacrolimus to patients who have previously received ciclosporin (see sections 4.2 and 4.4).
nefropati, hæmaturi Det reproduktive system og mammae Ikke almindelig:
nephropathy, cystitis haemorrhagic Reproductive system and breast disorders uncommon:
encefalopati, blødning i centralnervesystemet og hjerneblødning, koma, tale- og sprogforstyrrelser, paralyse og pareser, amnesi
encephalopathy, central nervous system haemorrhages and cerebrovascular accidents, coma, speech and language abnormalities, paralysis and paresis, amnesia rare:
CYP3A4-hæmmere som potentielt kan øge tacrolimus' blodkoncentrationer Det er påvist, at de følgende midler øger tacrolimus' blodkoncentration: Der er set kraftige interaktioner med svampemidler som ketoconazol, fluconazol, itraconazol, voriconazol og isavuconazol, det macrolide antibiotikum erythromycin, HIV-protease-hæmmere (f.eks. ritonavir, nelfinavir, saquinavir), HCV-proteasehæmmere (f.eks. telaprevir, boceprevir og en kombination af ombitasvir og paritaprevir sammen med ritonavir, når det anvendes med og uden dasabuvir), eller det CMV antivirale letermovir, den farmakokinetiske forstærker cobicistat og tyrosinkinasehæmmerne nilotinib og imatinib.
CYP3A4 inhibitors potentially leading to increased tacrolimus blood levels Clinically the following substances have been shown to increase tacrolimus blood levels: Strong interactions have been observed with antifungal agents such as ketoconazole, fluconazole, itraconazole, voriconazole, and isavuconazole, the macrolide antibiotic erythromycin, HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), HCV protease inhibitors (e.g. telaprevir, boceprevir, and the combination of ombitasvir and paritaprevir with ritonavir, when used with and without dasabuvir), or the CMV antiviral letermovir, the pharmacokinetic enhancer cobicistat, and the tyrosine kinase inhibitors nilotinib and imatinib.
Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 behandlede): - Muskelsvaghed - Unormalt resultat af hjerteundersøgelse - Leversvigt - Smertefuld vandladning med blod i urinen - Øget fedtvæv
Very rare side effects (may affect up to 1 in 10,000 people): - Muscular weakness - Abnormal heart scan - Liver failure - Painful urination with blood in the urine - Increase of fat tissue
trombotisk trombocytopenisk purpura, hypoprotrombinæmi, trombotisk mikroangiopati
thrombotic thrombocytopenic purpura, hypoprothrombinaemia, thrombotic microangiopathy not known:
Tilsvarende skal den totale daglige Modigrafdosis helst være den samme som den totale daglige Prografdosis ved skift af patienter fra Prografkapsler til Modigrafgranulat.
Similarly, for conversion of patients from Prograf capsules to Modigraf granules, the total daily Modigraf dose should preferably be equal to the total daily Prograf dose.
dysmenoré og uterin blødning Almene symptomer og reaktioner på administrationsstedet Almindelig:
dysmenorrhoea and uterine bleeding General disorders and administration site conditions common:
Hvert brev indeholder 473 mg lactose (som monohydrat).
Each sachet contains 473 mg lactose (as monohydrate).
En begyndelsesdosis på 0,30 mg/kg/dag bør administreres i 2 separate doser (f.eks. morgen og aften).
An initial oral dose of 0.30 mg/kg/day should be administered in 2 divided doses (e.g. morning and evening).
Benigne, maligne og uspecificerede tumorer (inkl.cyster og polypper) Patienter i immunsuppressiv behandling har en øget risiko for at få maligne lidelser.
cysts and polyps) Patients receiving immunosuppressive therapy are at increased risk of developing malignancies.
Sådan skal De tage Modigraf
How to take Modigraf
Kombinationsbehandling med ciclosporin og tacrolimus bør undgås, og der skal udvises forsigtighed ved behandling af patienter med tacrolimus, som tidligere har fået ciclosporin (se pkt.
The combined administration of ciclosporin and tacrolimus should be avoided and care should be taken when administering tacrolimus to patients who have previously received ciclosporin (see sections 4.2 and 4.5).
Hvert brev indeholder 94,7 mg lactose (som monohydrat).
Each sachet contains 94.7 mg lactose (as monohydrate).
Da farmakokinetikken for tacrolimus er uafhængig af nyrefunktionen (se pkt.
As the pharmacokinetics of tacrolimus are unaffected by renal function (see section 5.2), no dose adjustment is required.
akut og kronisk pancreatitis, paralytisk ileus, gastroøsofagal refluks, nedsat tømning af mavesækken
acute and chronic pancreatitis, ileus paralytic, gastrooesophageal reflux disease, impaired gastric emptying rare:
Modigraf 0,2 mg granulat til oral suspension Modigraf 1 mg granulat til oral suspension
Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension
Vaskulære sygdomme Meget almindelig:
Vascular disorders very common:
dyb venetrombose, shock, infarkt Luftveje, thorax og mediastinum Almindelig:
venous thrombosis deep limb, shock, infarction Respiratory, thoracic and mediastinal disorders common:
Indlægsseddel: Information til brugeren Modigraf 0,2 mg, granulat til oral suspension Modigraf 1 mg, granulat til oral suspension tacrolimus
Package leaflet: Information for the user Modigraf 0.2 mg, granules for oral suspension Modigraf 1 mg, granules for oral suspension
Hvis tacrolimusbehandling er initieret intravenøst hos patienter uden antistofinduktion er den anbefalede startdosis 0,03 - 0,05 mg/kg/dag (med Prograf 5 mg/ml koncentrat til infusionsvæske, opløsning) som en kontinuert 24-timers infusion, idet man forsøger at opnå tacrolimusfuldblodskoncentrationer på 15 - 25 nanogram/ml.
In patients without antibody induction, if tacrolimus therapy is initiated intravenously, the recommended starting dose is 0.03 - 0.05 mg/kg/day (with Prograf 5 mg/ml concentrate for solution for infusion) as a continuous 24-hour infusion targeted to achieve tacrolimus whole blood concentrations of 15 - 25 nanogram/ml.
diabetes mellitus, hyperglykæmi, hyperkaliæmi
diabetes mellitus, hyperglycaemic conditions, hyperkalaemia common:
Indholdet af Modigraf i blodet kan påvirkes af anden medicin, og Modigraf kan påvirke indholdet af anden medicin i blodet.
Modigraf blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Modigraf, which may require interruption, an increase or a decrease in Modigraf dose.
Overfølsomhed over for tacrolimus eller over for et eller flere af hjælpestofferne anført i pkt.
Hypersensitivity to tacrolimus or to any of the excipients listed in section 6.1.
Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 behandlede): - Forhøjet blodsukker, sukkersyge, øget kaliumindhold i blodet - Søvnløshed - Rysten, hovedpine - Forhøjet blodtryk - Unormale leverfunktionstests - Diarré, kvalme - Nyreproblemer
Very common side effects (may affect more than 1 in 10 people): - Increased blood sugar, diabetes mellitus, increased potassium in the blood - Difficulty in sleeping - Trembling, headache - Increased blood pressure - Liver function tests abnormal - Diarrhoea, nausea - Kidney problems
øjenlidelser, sløret syn, fotofobi
eye disorders, vision blurred, photophobia uncommon:
Modigraf er en granulatformulering af tacrolimus, som skal tages to gange dagligt.
Modigraf is a granular formulation of tacrolimus, for twice-a-day administration.
Tacrolimus metaboliseres i udstrakt grad i leveren, primært af CYP-3A4.
Tacrolimus is widely metabolised in the liver, primarily by the cytochrome P450-3A4.
Lactosemonohydrat Hypromellose (E464) Croscarmellosenatrium (E468).
Croscarmellose sodium (E468)
Undgå høj kaliumindtagelse og kaliumbesparende diuretika (se pkt.
High potassium intake or potassium-sparing diuretics should be avoided (see section 4.5).
På basis af måling af plasmakoncentrationer hos raske forsøgspersoner, fandt man et gennemsnitligt distributionsvolumen ved steady state på ca. 1300 l. Det tilsvarende tal baseret på fuldblod var 47,6 l.
The steady-state volume of distribution based on plasma concentrations is approximately 1300 l (healthy subjects).
For at sikre en fyldestgørende eksponering i begyndelsen af den post-transplanterede periode anbefales det at overvåge tacrolimus' dalværdier omhyggeligt og hyppigt de første 2 uger efter transplantationen.
Careful and frequent monitoring of tacrolimus trough levels is recommended in the first 2 weeks post-transplant to ensure adequate exposure to the active substance in the immediate post-transplant period.
Profylakse mod hjertetransplantatafstødning
Prophylaxis of heart transplant rejection
Kun læger med erfaring i immunsuppressiv behandling og behandling af organtransplanterede patienter bør ordinere dette lægemiddel og initiere ændringer i den immunsuppressive behandling.
This medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients.
- hvis De har en ændring i hjerterytmen, som kaldes ”QT-forlængelse”.
fever, nausea or vomiting - if you have an alteration of the electrical activity of your heart called “QT prolongation”.
Øjne Almindelig:
Eye disorders common:
Suspensionen bør indtages umiddelbart efter fremstillingen.
After preparation, the suspension should be taken immediately.
influenzalignende symptomer - Maveproblemer såsom betændelse eller mavesår som giver mavesmerter eller diarré, maveblødning,
inflammation of the throat, cough, flu-like symptoms - Stomach problems such as inflammation or ulcer causing abdominal pain or diarrhoea, bleeding in the stomach, inflammation or ulcer in the mouth, collection of fluid in the belly, vomiting,
Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1000 behandlede): - Små blødninger i huden - Øget muskelstivhed - Blindhed, døvhed - Væskeansamling omkring hjertet - Akut åndenød - Cystedannelse på bugspytkirtlen - Problemer med blodcirkulation i leveren - Alvorlig sygdom med blærer i huden, munden, øjnene og kønsorganerne, øget behåring - Tørst, øget tendens til at falde, trykken for brystet, nedsat bevægelighed, sår
Rare side effects (may affect up to 1 in 1,000 people): - Small bleedings in your skin due to blood clots - Increased muscle stiffness - Blindness, deafness - Collection of fluid around the heart - Acute breathlessness - Cyst formation in your pancreas - Problems with blood flow in the liver - Serious illness with blistering of skin, mouth, eyes and genitals; increased hairiness - Thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer
hypervolæmi, hyperurikæmi, hypomagnesæmi, hypokaliæmi, hypokalcæmi, nedsat appetit, hyperkolesterolæmi, hyperlipidæmi, hypertriglyceridæmi, hypofosfatæmi
metabolic acidoses, other electrolyte abnormalities, hyponatraemia, fluid overload, hyperuricaemia, hypomagnesaemia, hypokalaemia, hypocalcaemia, appetite decreased, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hypophosphataemia uncommon:
forhøjet amylase, EKG-forandringer, forandringer i hjerterytme og puls, vægttab, forhøjet blodlactatdehydrogenase
amylase increased, ECG investigations abnormal, heart rate and pulse investigations abnormal, weight decreased, blood lactate dehydrogenase increased very rare:
Tacrolimusbehandling begyndte som kontinuerlig intravenøs infusion med doser på 0,025 mg/kg/dag, og oral tacrolimus blev administreret i doser på 0,15 mg/kg/dag med følgende dosisjustering for at nå dalkoncentrationer på 10-20 nanogram/ml.
Tacrolimus was started as continuous intravenous infusion at a dose of 0.025 mg/kg/day and oral tacrolimus was administered at a dose of 0.15 mg/kg/day with subsequent dose adjustments to target trough levels of 10 to 20 nanogram/ml.
Derefter skylles koppen en gang med den samme mængde vand, som patienten efterfølgende drikker.
Thereafter the cup is rinsed once with the same quantity of water and the rinsings consumed by the patient.
Hvert brev indeholder 0,2 mg tacrolimus (som monohydrat).
Each sachet contains 0.2 mg tacrolimus (as monohydrate).
Deres læge vil, ud fra Deres vægt, beregne den rigtige startdosis for at undgå afstødning af det transplanterede organ.
The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight.
Effekten er størst efter et meget fedtholdigt måltid, hvorimod effekten er mindre udtalt efter et kulhydratrigt måltid.
The effect of a high-carbohydrate meal is less pronounced.
influenzalignende symptomer, nervøsitet, fremmedfølelse, multiorgansvigt, trykken for brystet, temperaturintolerans
influenza like illness, feeling jittery, feeling abnormal, multi-organ failure, chest pressure sensation, temperature intolerance rare:
forstyrret sindstilstand - Anfald, bevidsthedsforstyrrelser, prikken og følelsesløshed (nogle gange smertefuld) i hænder og fødder, svimmelhed, nedsat skriveevne, forstyrrelser i nervesystemet - Sløret syn, øget lysfølsomhed, problemer med øjnene - Ringen for ørene - Nedsat blodgennemstrømning i hjertets blodkar, øget puls - Blødning, delvis eller fuldstændig blokering af blodkar, nedsat blodtryk - Stakåndethed, forandring i lungevæv, væskeansamling omkring lungen, betændelse i svælget, hoste,
hallucination, mental disorders - Fits, disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous system disorders - Blurred vision, increased sensitivity to light, eye disorders - Ringing sound in your ears - Reduced blood flow in the heart vessels, faster heartbeat - Bleeding, partial or complete blocking of blood vessels, reduced blood pressure - Shortness in breath, changes in the lung tissue, collection of liquid around the lung,
lidelse i lungeparenkymet, dyspnø, pleura-effusion, hoste, pharyngitis, tilstopning og inflammation i næsen
parenchymal lung disorders, dyspnoea, pleural effusion, cough, pharyngitis, nasal congestion and inflammations uncommon:
Tacrolimus startede som kontinuerlig intravenøs infusion med doser på 0,05 mg/kg/dag, hvorefter oral tacrolimus blev administreret i doser på 0,1 - 0,3 mg/kg/dag med følgende dosisjustering for at nå dalkoncentrationer på 12 - 15 nanogram/ml.
Tacrolimus was started as continuous intravenous infusion at a dose of 0.05 mg/kg/day and oral tacrolimus was administered at a dose of 0.1 to 0.3 mg/kg/day with subsequent dose adjustments to target trough levels of 12 to 15 nanogram/ml.
Modigraf 1 mg granulat til oral suspension Hvert brev indeholder 1 mg tacrolimus (som monohydrat).
Modigraf 1 mg granules for oral suspension Each sachet contains 1 mg tacrolimus (as monohydrate).
Der er rapporteret om øget risiko for udvikling af lymfoproliferative lidelser hos EBV-Viral Capsid Antigen (VCA)-negative patienter.
EBV-Viral Capsid Antigen (VCA)-negative patients have been reported to have an increased risk of developing lymphoproliferative disorders.
Tacrolimus påvirkede fertiliteten hos hanrotter (se pkt.
Tacrolimus affected fertility in male rats (see section 5.3).
Hud og subkutane væv Almindelig:
hepatic failure Skin and subcutaneous tissue disorders common:
Modigraf 0,2 mg granulat til oral suspension Hvert brev indeholder 0,2 mg tacrolimus (som monohydrat).
Modigraf 0.2 mg granules for oral suspension Each sachet contains 0.2 mg tacrolimus (as monohydrate).
fordøjelsesbesvær, forstoppelse, luftafgang fra tarmen, oppustethed, løs afføring - Galdegangssygdomme, gulsot, ødelæggelse af levervæv og leverbetændelse - Kløe, udslæt, hårtab, akne, svedudbrud - Smerter i led, lemmer, ryg og fødder, muskelspasmer - Utilstrækkelig nyrefunktion, nedsat urindannelse, forringet eller smertefuld vandladning - Generel svaghed, feber, væskeansamling i kroppen, smerter og ubehag, øget indhold af basisk fosfatase i blodet, vægtstigning, ændret opfattelse af kropstemperatur - Utilstrækkelig funktion af det transplanterede organ
abdominal pain, indigestion, constipation, passing wind, bloating, loose stools - Bile duct disorders, yellowing of the skin due to liver problems, liver tissue damage and inflammation of the liver - Itching, rash, hair loss, acne, increased sweating - Pain in joints, limbs, back and feet, muscle spasms - Insufficient function of the kidneys, reduced production of urine, impaired or painful urination - General weakness, fever, collection of fluid in your body, pain and discomfort, increase of the enzyme alkaline phosphatase in your blood, weight gain, feeling of temperature disturbed - Insufficient function of your transplanted organ
Hvert brev Modigraf 1 mg granulat indeholder 1 mg tacrolimus (som monohydrat).
Each sachet of Modigraf 1 mg granules contains 1 mg of tacrolimus (as monohydrate).
Hvert brev indeholder 1 mg tacrolimus (som monohydrat).
Each sachet contains 1 mg tacrolimus (as monohydrate).
galdegangssygdomme, skade på leverceller og hepatitis, cholestase og gulsot
bile duct disorders, hepatocellular damage and hepatitis, cholestasis and jaundice rare:
- hvis De får stærke mavesmerter med eller uden andre symptomer, som kulderystelser, feber, kvalme eller opkastning.
- if you feel strong abdominal pain accompanied or not with other symptoms, such as chills,
Man bør udvise forsigtighed, når patienter skifter fra behandling med ciclosporin til tacrolimusbaseret behandling (pkt.
Care should be taken when converting patients from ciclosporin-based to tacrolimus-based therapy (see sections 4.4 and 4.5).
Til pædiatriske patienter, som er blevet overført til Modigraf, bør den initiale orale dosis på 0,20 - 0,30 mg/kg/dag administreres som 2 separate doser (f.eks. morgen og aften).
In paediatric patients converted to tacrolimus, an initial oral dose of 0.20 - 0.30 mg/kg/day should be administered in 2 divided doses (e.g. morning and evening).
nyresvigt, akut nyresvigt, toksisk nefropati, renal tubulær nekrose, vandladningsproblemer, oliguri, symptomer fra blære og urinveje
renal failure, renal failure acute, nephropathy toxic, renal tubular necrosis, urinary abnormalities, oliguria, bladder and urethral symptoms uncommon:
- Lægen har ordineret Modigraf til Dem personligt.
- This medicine has been prescribed for you only.
forstyrrelser i nervesystemet, krampeanfald, bevidsthedsforstyrrelser, perifer neuropati, svimmelhed, paræstesier og dysæstesier, nedsat skriveevne
nervous system disorders, seizures, disturbances in consciousness, peripheral neuropathies, dizziness, paraesthesias and dysaesthesias, writing impaired uncommon:
Efter antistofinduktion bør oral Modigrafbehandling begynde med en dosis på 0,075 mg/kg/dag fordelt på 2 doser (f.eks. morgen og aften).
Following antibody induction, oral Modigraf therapy should commence at a dose of 0.075 mg/kg/day administered as 2 divided doses (e.g. morning and evening).
Afstødningsbehandling
Treatment of allograft rejection
målinger af serum-kreatininkoncentrationer, beregning af kreatinin-clearance og kontrol af diurese).
However, owing to the nephrotoxic potential of tacrolimus careful monitoring of renal function is recommended (including serial serum creatinine concentrations, calculation of creatinine clearance and monitoring of urine output).
Hvis Modigrafbehandling er initieret oralt efter antistofinduktion, er den anbefalede dosis 0,10 - 0,30 mg/kg/dag administreret som 2 separate doser (f.eks. morgen og aften).
Following antibody induction, if Modigraf therapy is initiated orally, the recommended starting dose is 0.10 - 0.30 mg/kg/day administered as 2 divided doses (e.g. morning and evening).
unormale leverfunktionstests
Immune system disorders
akut respiratory distress syndrome
acute respiratory distress syndrome Gastrointestinal disorders very common:
Kontakt lægen eller apoteket, før De tager Modigraf - hvis De har eller har haft leverproblemer.
Talk to your doctor or pharmacist before taking Modigraf
artralgi, rygsmerter, muskelspasmer, smerte i ekstremiteterne
arthralgia, back pain, muscle spasms, pain in extremity uncommon:
Profylakse mod nyretransplantatafstødning
Prophylaxis of kidney transplant rejection
symptomer fra mave-tarmkanalen, opkastning, abdominalsmerter, inflammatoriske lidelser i mave-tarmkanalen, blødning i mave tarmkanalen, ulceration og perforation i mave-tarmkanalen, ascites,ulcerøs stomatitis, obstipation, dyspepsi, flatulens, oppustethed, tynd afføring
gastrointestinal signs and symptoms, vomiting, gastrointestinal and abdominal pains, gastrointestinal inflammatory conditions, gastrointestinal haemorrhages, gastrointestinal ulceration and perforation, ascites, stomatitis and ulceration, constipation, dyspeptic signs and symptoms, flatulence, bloating and distension, loose stools uncommon: