FrancophonIA/ELRC3.0 huggingface dataset:
English: During the initial post-transplant period, monitoring of the following parameters should be undertaken on a routine basis: blood pressure, ECG, neurological and visual status, fasting blood glucose levels, electrolytes (particularly potassium), liver and renal function tests, haematology parameters, coagulation values, and plasma protein determinations.
Danish: I den første postoperative periode kontrolleres regelmæssigt med måling af blodtryk, EKG, neurologisk og visuel status, fastende blodsukker, elektrolytter (specielt kalium), lever- og nyrefunktion, hæmatologiske parametre, koagulationsstatus og plasmaprotein.
English: A lower incidence of acute rejection episodes for tacrolimus- versus ciclosporintreated patients (11.5% versus 22.6%) and a lower incidence of chronic rejection, the bronchiolitis obliterans syndrome (2.86% versus 8.57%), was reported within the first year after transplantation.
Danish: Det første år efter transplantationen blev der rapporteret en lavere incidens af akutte afstødningsepisoder for tacrolimus- versus ciclosporinbehandlede patienter (11,5% versus 22,6%) og en lavere incidens af kronisk afstødning, bronchiolitis obliterans syndromet (2,86% versus 8,57%).
English: Subsequently, during maintenance therapy, blood concentrations have generally been in the range of 5 - 15 ng/ml in liver, kidney and heart transplant recipients.
Danish: Efterfølgende har fuldblodskoncentrationerne generelt ligget på 5-15 ng/ml for lever-, nyre- og hjertetransplanterede ved vedligeholdelsesbehandling.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER INDGIVELSESVEJ(E)
English: Blood trough levels of tacrolimus should also be monitored following dose adjustment, changes in the immunosuppressive regimen, or following co-administration of substances which may alter tacrolimus whole blood concentrations (see section 4.5).
Danish: Tacrolimus dalkoncentrationer bør også måles ved dosisjustering, ændring i immunsuppressionen eller ved samtidig administration af stoffer, der kan ændre koncentrationerne af tacrolimus (se afsnit 4.5).
English: • Efficacy issues
Danish: • Spørgsmål vedrørende virkning
English: It is necessary to consider the clinical condition of the patient when interpreting whole blood levels.
Danish: Det er imidlertid også nødvendigt at tage den kliniske tilstand i betragtning ved vurdering af blodkoncentrationerne.
English: In head to head comparisons with ciclosporin it appears to have a modest efficacy advantage.
Danish: I direkte sammenligninger med cyklosporin ser tacrolimus ud til have moderat bedre virkning.
English: Mechanism of action and pharmacodynamic effects At the molecular level, the effects of tacrolimus appear to be mediated by binding to a cytosolic protein (FKBP12) which is responsible for the intracellular accumulation of the compound.
Danish: På molekylært niveau synes virkningen af tacrolimus at være medieret af binding til cytosol protein (FKBP12), som også er ansvarlig for den intracellulære akkumulering af præparatet.
English: What <Invented name> is and what it is used for Before you take <Invented name> How to take <Invented name> Possible side effects
Danish: Hvad <[(Sær)navn]> er, og hvad det anvendes til Hvad De skal gøre, før De begynder at tage <[(Sær)navn]> Hvordan De tager <[(Sær)navn]> Hvilke mulige bivirkninger <[(Sær)navn]> har Hvordan De opbevarer <[(Sær)navn]> Yderligere oplysninger
English: Possible interactions with other medicinal products known to have high affinity for plasma proteins should be considered (e.g., NSAIDs, oral anticoagulants, or oral antidiabetics).
Danish: Man bør derfor overveje interaktioner med andre lægemidler, der har høj affinitet for plasmaproteiner (f.eks. NSAID's, perorale antikoagulantia og perorale antidiabetika).
English: In this leaflet:
Danish: Ud fra følgende betragtninger:
English: dehydration, hypoproteinaemia, hyperphosphataemia, hypoglycaemia
Danish: dehydrering, hypoproteinæmi, hyperfosfatæmi, hypoglykæmi
English: As tacrolimus treatment may be associated with hyperkalaemia, or may increase pre-existing hyperkalaemia, high potassium intake, or potassium-sparing diuretics (e.g., amiloride, triamterene, or spironolactone) should be avoided.
Danish: Da tacrolimus kan give hyperkaliæmi eller forstærke en allerede eksisterende hyperkaliæmi, bør man undgå høj kaliumindtagelse eller kaliumbesparende diuretika (f.eks. amilorid, triameteren og spirolakton).
English: [To be implemented nationally] <<Invented name> 5 mg/ml Concentrate for Solution for Infusion contains polyoxyethylene hydrogenated castor oil, which has been reported to cause anaphylactoid reactions.
Danish: [Udfyldes nationalt] <[(Sær)navn]> 5 mg/ml koncentrat till infusionsvæske, opløsning indeholder polyoxyethylenhydrogeniseret ricinusolie, der kan give anafylaktiske reaktioner.
English: <Invented name> is often used in combination with other medicines that also suppress the immune system.
Danish: <[(Sær)navn]> anvendes ofte i kombination med anden immundæmpende medicin.
English: Allergic and anaphylactoid reactions have been observed in patients receiving tacrolimus (see section
Danish: Allergiske og anafylaktoide reaktioner er observeret i patienter, der fik tacrolimus (se afsnit 4.4) Endokrine sygdomme
English: Pharma Swiss d.o.o.
Danish: PharmaSwiss d.o.o.
English: - The alcohol content (638 mg per ml) of <Invented name> 5mg/ml Concentrate for Infusion should be taken into account.
Danish: - Der bør tages hensyn til alkoholindholdet (638 mg/ml) i <[(Sær)navn]> 5 mg/ml koncentrat till infusionsvæske, opløsning.
English: fits, disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous system disorders uncommon:
Danish: anfald, bevidsthedsforstyrrelser, prikken og følelsesløshed (nogle gange smertefuld) i hænder og fødder, svimmelhed, nedsat skriveevne, forstyrrelser i nervesystemet
English: Stevens Johnson syndrome Musculoskeletal and connective tissue disorders common:
Danish: Stevens-Johnson syndrom Sygdomme i bevægeapparatet og bindevæv Almindelige:
English: In clinical practice, whole blood trough levels have generally been in the range 5 - 20 ng/ml in liver transplant recipients and 10 - 20 ng/ml in kidney and heart transplant patients in the early posttransplant period.
Danish: I klinisk praksis har fuldblods dalkoncentrationerne generelt ligget fra 5 - 20 ng/ml for leverplanterede og fra 10 - 20 ng/ml for nyre- og hjertetransplanterede i den tidlige postoperative periode.
English: <Invented name> blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking <Invented name> which may require and increase or decrease in <Invented name> dose.
Danish: <[(Sær)navn]> indholdet i blodet kan påvirkes af anden medicin, og <[(Sær)navn]> kan påvirke indholdet i blodet af anden medicin, hvilket kan nødvendiggøre en øgning eller sænkning af <[(Sær)navn]> dosering.
English: Therefore you may be more prone to infections than usual while you are taking <Invented name>.
Danish: Af denne grund vil din krop ikke kunne bekæmpe infektioner så godt som før, og De vil være mere tilbøjelig til at få infektioner når De tager <[(Sær)navn]>.
English: Hard Capsules
Danish: Kapsel, hård
English: Prophylaxis of transplant rejection - children
Danish: Profylakse af transplantatafstødning - børn
English: 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).
Danish: Af disse grunde kan samtidig administrering af ciclosporin og tacrolimus ikke tilrådes og der bør udvises forsigtighed når der administreres tacrolimus til patienter, der tidligere er blevet behandlet med ciclosporin (se afsnit 4.2 og 4.4).
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal remedies.
Danish: Hvis De tager eller for nylig har taget andre lægemidler, bør De oplyse din læge eller apotek herom, også hvis der er tale om ikke-receptpligtige lægemidler og naturmedicin.
English: 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).
Danish: Kombinationsbehandling med ciclosporin og tacrolimus bør undgås og der skal udvises forsigtighed ved behandling med tacrolimus af patienter, som tidligere har fået ciclosporin (se afsnit 4.2 og 4.5).
English: Do not use <Invented name> - If you are allergic (hypersensitive) to tacrolimus or to any antibiotic belonging to the subgroup of macrolide antibiotics.
Danish: De bør ikke anvende <[(Sær)navn]>: - Hvis De er allergisk (overfølsom ) overfor tacrolimus eller et antibiotikum tilhørende makrolidgruppen.
English: If abnormalities develop, dose reduction of <Invented name> therapy, or change of treatment to another immunosuppressive agent should be considered.
Danish: Ved tegn på anomalier bør reduktion af <[(Sær)navn]> dosering eller skift til anden immunosuppressiv behandling overvejes.
English: In rats and rabbits, tacrolimus caused embryofoetal toxicity at doses which demonstrated maternal toxicity (see section 5.3).
Danish: Tacrolimus udviser embryoføtal toksicitet hos rotter og kaniner ved doser som var toksiske for moderen (se afsnit 5.3).
English: What <Invented name> is and what it is used for Before you use <Invented name> How to use <Invented name> Possible side effects
Danish: Hvad <[(Sær)navn]> er, og hvad det anvendes til Hvad De skal gøre, før De begynder at anvende <[(Sær)navn]> Hvordan De anvender <[(Sær)navn]> Hvilke mulige bivirkninger <[(Sær)navn]> har Hvordan De opbevarer <[(Sær)navn]> Yderligere oplysninger
English: Benign as well as malignant neoplasms including EBV-associated lymphoproliferative disorders and skin malignancies have been reported in association with tacrolimus treatment.
Danish: Benigne og maligne neoplasmatiske lidelser inklusiv EBV-associerede lymfoproliferative lidelser og maligne tilstande i huden er blevet rapporteret.
English: As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving <Invented name>.
Danish: Da man ikke kan udelukke skadelige virkninger på fosteret, bør kvinder i <[(Sær)navn]>behandling ikke amme.
English: Dosage recommendations - Heart transplantation Prophylaxis of transplant rejection - adults <Invented name> can be used with antibody induction (allowing for delayed start of <Invented name> therapy) or alternatively in clinically stable patients without antibody induction.
Danish: Profylakse af transplantatafstødning - voksne <[(Sær)navn]> kan anvendes med antistofinduktion (hvilket muliggør forsinket start af <[(Sær)navn]> behandling), alternativt hos klinisk stabile patienter uden antistofinduktion.
English: Post-transplant improvement in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments.
Danish: Bedring af patientens tilstand kan medføre ændret farmakokinetik for tacrolimus og nødvendiggøre yderligere dosisjusteringer.
English: The divergences identified at the start of the referral have been resolved.
Danish: De forskelle, som forelå, da indbringelsen fandt sted, eksisterer således ikke mere.
English: insufficient function of the kidneys, reduced production of urine, impaired or painful urination uncommon:
Danish: utilstrækkelig nyrefunktion, nedsat urindannelse, forringet eller smertefuld vandladning
English: Prophylaxis of transplant rejection - children <Invented name> has been used with or without antibody induction in paediatric heart transplantation.
Danish: Profylakse af transplantatafstødning - børn <[(Sær)navn]> er blevet benyttet med og uden antistofinduktion til hjertetransplanterede børn.
English: reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell counts, changes in red blood cell counts uncommon:
Danish: nedsat antal blodceller (plader, røde eller hvide blodlegemer), stigning af hvide blodlegemer, ændret antal røde blodlegemer
English: If you plan to become pregnant or think that you may be pregnant, ask your doctor or pharmacist for advice before taking any medicine.
Danish: Graviditet Spørg din læge eller apotek til råds, inden De tager nogen form for medicin.
English: serious illness with blistering of skin, mouth, eyes and genitals, increased hairiness Bone and joint disorders common:
Danish: alvorlig sygdom med blærer i huden, munden, øjnene og kønsorganerne, øget behåring
English: Patients should be converted from intravenous to oral medication as soon as individual circumstances permit.
Danish: Patienten skal overgå til peroral behandling så snart tilstanden tillader det.
English: Liver transplantation:
Danish: Levertransplantation:
English: Other factors observed to increase the risk of these clinical conditions included pre-existing heart disease, corticosteroid usage, hypertension, renal or hepatic dysfunction, infections, fluid overload, and oedema.
Danish: Andre faktorer, der kan øge risikoen for disse kliniske tilstande, er tidligere eller bestående hjertelidelse, behandling med kortikosteroider, hypertension, nedsat nyre- eller leverfunktion, infektion, væskeretention og ødem.
English: OTHER [To be completed nationally]
Danish: ANDET [Udfyldes nationalt]
English: In lung-transplanted patients <Invented name> has been used at an initial oral dose of 0.10 - 0.15 mg/kg/day, in pancreas-transplanted patients at an initial oral dose of 0.2 mg/kg/day and in intestinal transplantation at an initial oral dose of 0.3 mg/kg/day.
Danish: I lungetransplanterede patienter er <[(Sær)navn]> blevet brugt med en initial peroral dosis på 0,10 - 0,15 mg/kg/dag, i pancreastransplanterede patienter med en initial peroral dosis på 0,2 mg/kg/dag og ved intestinaltransplantation med en initial peroral dosis på 0,3 mg/kg/dag.
English: Prophylaxis of transplant rejection - adults
Danish: Profylakse af transplantatafstødning - voksne
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Spørg din læge eller apotek, hvis De har yderligere spørgsmål.
English: inability to urinate, painful menstruation and abnormal menstrual bleeding very rare:
Danish: ophørt urinproduktion, smertefuld menstruation og unormal menstruationsblødning
English: As tacrolimus may reduce the clearance of steroid-based contraceptives leading to increased hormone exposure, particular care should be exercised when deciding upon contraceptive measures.
Danish: Da tacrolimus kan reducere clearance af steroidbaserede kontraceptive piller med øget hormoneksponering til følge.
English: The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight.
Danish: Lægen vil beregne startdosis udfra din vægt for at undgå afstødning af det transplanterede organ.
English: reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid overload, increased uric acid or lipids in the blood, decreased appetite, increased acidity of the blood, other changes in the blood salts uncommon:
Danish: nedsat indhold af magnesium, fosfat, kalium eller natrium i blodet, væskeophobning, stigning af urinsyre eller fedt i blodet, nedsat appetit, forhøjet surhed af blodet, andre ændringer i blodet salte
English: - In view of the potential risk of malignant skin changes with immunosuppressive therapy, you should wear appropriate protective clothing and use a sunscreen with a high sun protection factor to limit your exposure to sunlight and UV light.
Danish: De skal derfor benytte passende beklædning og benytte solbeskyttende cremer med høj faktorværdi for at beskytte dig mod sollys og UV-lys.
English: Blood and lymphatic system disorders common:
Danish: Sygdomme i blod- og lymfesystem Almindelige:
English: Disorders of kidney, urinary system and genitals very common:
Danish: Sygdomme i nyrer, urinveje og kønsorganer Meget almindelige:
English: The adverse drug reaction profile associated with immunosuppressive agents is often difficult to establish owing to the underlying disease and the concurrent use of multiple medications.
Danish: Det er vanskeligt at fastslå bivirkningsprofilen ved immunosuppressiv behandling som følge af den tilgrundliggende lidelse og samtidig indtagelse af anden medicin.
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Danish: ANVENDELSESMÅDE Læs indlægssedlen inden brug.
English: collection of fluid around the heart very rare:
Danish: væskeansamling omkring hjertet
English: In isolated patients with very high plasma levels, haemofiltration or -diafiltration have been effective in reducing toxic concentrations.
Danish: I nogle få tilfælde med meget høje plasmakoncentrationer har man effektivt kunnet reducere de toxiske koncentrationer med hæmofiltration eller hæmodiafiltration.
English: hyperglycaemic conditions, diabetes mellitus, hyperkalaemia common:
Danish: hyperglykæmi, diabetes mellitus, hyperkaliæmi
English: PHARMACEUTICAL FORM [To be completed nationally]
Danish: LÆGEMIDDELFORM [Udfyldes nationalt]
English: Belgium Fujisawa GmbH Neumarkter Str. 61
Danish: Luxembourg Fujisawa GmbH Neumarkter Str. 61
English: In patients without antibody induction, if <Invented name> therapy is initiated intravenously, the recommended starting dose is 0.03 - 0.05 mg/kg/day as a continuous 24-hour infusion targeted to achieve tacrolimus whole blood concentrations of 15 - 25 ng/ml.
Danish: Hvis <[(Sær)navn]> behandling er initieret intravenøst til patienter uden antistofinduktion er den anbefalede startdosis 0,03 - 0,05 mg/kg/dag som en kontinuerlig infusion over 24 timer, idet man forsøger at opnå tacrolimus fuldblodskoncentrationer på 15-25 ng/ml.
English: Very rare side effects are experienced in less than one per ten thousand patients.
Danish: Meget sjældne bivirkninger forekommer hos færre end 1 ud af 10.000 patienter.
English: - If you have diarrhoea for more than one day, please tell your doctor, because it might be necessary to adapt the dose of <Invented name> that you receive.
Danish: - Kontakt lægen, hvis De har diarré i mere end én dag, da det kan være nødvendigt at justere dosering af <[(Sær)navn]>.
English: Other interactions which have led to clinically detrimental effects Concurrent use of tacrolimus with medicinal products known to have nephrotoxic or neurotoxic effects may increase these effects (e.g., aminoglycosides, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, ganciclovir or aciclovir).
Danish: Samtidig brug af tacrolimus og lægemidler med kendt nefrotoksisk eller neurotoksisk effekt kan øge toksiciteten (f.eks. aminoglycosider, gyrase inhibitorer, vancomysin, cotrimoxazol, NSAID's, gangliclovir og aciclovir).
English: Patients with kidney impairment
Danish: Patienter med nedsat nyrefunktion
English: Dosage adjustments in specific patient populations Patients with liver impairment
Danish: Dosisjustering i specielle patientgrupper
English: - Please avoid taking any herbal remedies, e.g. St. John's wort (Hypericum perforatum) or any other herbal products as this may affect the effectiveness and the dose of <Invented name> that you need to receive.
Danish: - Undgå at tage urtemedicin som f.eks. prikbladet hyperikum eller anden urtemedicin da disse kan påvirke virkningen og dosis af <[(Sær)navn]> som De har behov for.
English: tremor, headache common:
Danish: tremor, hovedpine
English: The initial oral per protocol dose of tacrolimus was 0.2 mg/kg/day with subsequent dose adjustments to target trough levels of 8 to 15 ng/ml by Day 5 and 5 to 10 ng/mL after Month 6.
Danish: Den initiale orale per protokol dosis af tacrolimus var 0,2 mg/kg/dag med følgende dosisjustering for at opnå dalkoncentrationer på 8 - 15 ng/ml på 5. dagen og 5 - 10 ng/ml efter 6. måned.
English: Target whole blood trough concentration recommendations Dosing should primarily be based on clinical assessments of rejection and tolerability in each individual patient.
Danish: Dosering skal baseres primært på kliniske vurderinger af afstødning og tolerabilitet hos den enkelte patient.
English: A negative effect of tacrolimus on male fertility in the form of reduced sperm counts and motility was observed in rats.
Danish: I rotter havde tacrolimus en negativ effekt på hannernes fertilitet i form af spermtal og motilitet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 5 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON 5 mg/ml KONCENTRAT TILL INFUSIONSVÆSKE, OPLØSNING
English: ileus paralytic, peritonitis, acute and chronic pancreatitis, blood amylase increased, gastrooesophageal reflux disease, impaired gastric emptying rare:
Danish: paralytisk ileus, peritonitis, akut og kronisk pankreatitis, øget blod amylase, gastroøsofagal refluks, nedsat tømning af mavesækken
English: coma, bleeding in the brain, stroke, paralysis, brain disorder, speech and language abnormalities, memory problems rare:
Danish: koma, blødning i hjernen, slagtilfælde, lammelse, forandringer i hjernen, tale og sprogforstyrrelser, hukommelsesproblemer
English: In the systemic circulation, tacrolimus binds strongly to erythrocytes resulting in an approximate 20:1 distribution ratio of whole blood/plasma concentrations.
Danish: Tacrolimus er kraftigt bundet til erythrocytterne, således at helblod/plasmakvotienten er ca. 20:1.
English: It is possible in some cases to withdraw concomitant immunosuppressive therapy, leading to <Invented name>-based dualtherapy.
Danish: Det er i visse tilfælde muligt at seponere anden samtidig immunosuppressiv behandling, resulterende i <[(Sær)navn]>baseret behandling med 2 lægemidler.
English: Very common side effects are experienced in more than one in ten patients.
Danish: Meget almindelige bivirkninger forekommer hos flere end 1 ud af 10 patienter.
English: In cases of oral intoxication, gastric lavage and/or the use of adsorbents (such as activated charcoal) may be helpful, if used shortly after intake.
Danish: Ved peroral overdosering kan maveskylning og/eller indgift aborberende sfoffer (så som medicinsk kul) forsøges kort tid efter indtagelse.
English: Metabolism and nutrition disorders very common:
Danish: Stofskiftesygdom og ernæringsbetingede sygdomme Meget almindelige:
English: In man tacrolimus has been shown to be able to be absorbed throughout the gastrointestinal tract.
Danish: I mennesker er det vist, at tacrolimus kan absorberes i hele mave-tarmkanalen.
English: Several cases of accidental overdosage have been reported; symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy, increased blood urea nitrogen and elevated serum creatinine concentrations, and increase in alanine aminotransferase levels.
Danish: I rapporterede tilfælde af overdosering har symptomerne været: Tremor, hovedpine, kvalme og opkastninger, infektioner, urticaria, lethargi, forhøjet blodurinstof samt forhøjet serumkreatinin og øget alanin-aminotransferase.
English: small bleedings in your skin due to blood clots Metabolism and nutrition disorders very common:
Danish: små blødninger i huden Stofskifte- og ernæringsbetingede sygdomme Meget almindelige:
English: The ethanol content (638 mg per ml) of <Invented name> 5mg/ml Concentrate for Solution for Infusion should be taken into account.>
Danish: Ethanolindholdet (638 mg/ml) i <[(Sær)navn]> 5 mg/ml koncentrat till infusionsvæske, opløsning bør tages i betragtning.
English: Dosage recommendations - Liver transplantation
Danish: Doseringsvejledning - Lever transplantation
English: Administration should commence approximately 12 hours after the completion of surgery.
Danish: Doseringen skal indledes ca. 12 timer efter indgrebet.