natgillin/translations-raw huggingface dataset:
I kliniske studier med nyretransplanterede patienter, der fik Envarsus, var de hyppigste bivirkninger (hos mindst 2 % af patienter) tremor, diabetes mellitus, forhøjet blodkreatinin, urinvejsinfektion, hypertension, BK-virus infektion, nedsat nyrefunktion, diarré, toksicitet over for forskellige midler og toksisk nefropati, som alle vides at forekomme hos den pågældende patientpopulation i immunsuppressiv behandling.
In clinical studies in kidney transplant patients receiving Envarsus, the most frequent adverse reactions (at least in 2% of patients) were tremor, diabetes mellitus, blood creatinine increased, urinary tract infection, hypertension, BK virus infection, renal impairment, diarrhoea, toxicity to various agents, and toxic nephropathy all of which are known to occur in the respective patient population under immunosuppressive treatment.
Der bør udvises forsigtighed, når patienter skifter fra ciclosporinbaseret til tacrolimusbaseret behandling (se pkt.
Care should be taken when converting patients from ciclosporin-based to tacrolimus-based therapy (see sections 4.4 and 4.5).
Utilsigtet, uforsætlig eller uovervåget substitution af øjeblikkeligt udløste eller depotformuleringer af tacrolimus er farlig.
Inadvertent, unintentional, or unsupervised switching of immediate- or prolonged-release formulations of tacrolimus is unsafe.
Doseringen af Envarsus skal primært baseres på kliniske vurderinger af afstødning og tolerance hos den enkelte patient vejledt af monitorering af dalkoncentrationen af tacrolimus i fuldblod.
Dosing should primarily be based on clinical assessments of rejection and tolerability in each individual patient aided by whole blood tacrolimus trough level monitoring.
Profylakse af transplantatafstødning hos voksne patienter, der har fået nyre- eller leverallograft.
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.
Levertransplantation
Liver transplantation
Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 behandlede): - Muskelsvækkelse - Nedsat hørelse - Unormal hjertescanning - Leversvigt - Smertefuld vandladning med blod i urinen - Øget fedtvæv
Very rare side effects (may affect up to 1 in 10,000 people): - Muscular weakness - Impaired hearing - Abnormal heart scan - Liver failure - Painful urination with blood in the urine - Increase of fat tissue
Bivirkningsraten for centralt aflæst, biopsibekræftet akut afstødning (BPAR) under det 360 dages studie var 13,1 % i Envarsus-gruppen (N=268) og 13,5 % i Prografgruppen (N=275).
The event rate for centrally read, biopsy-confirmed acute rejection (BPAR) during the 360-day study was 13.1% in the Envarsus group (N=268) and 13.5% in the Prograf group (N=275).
Toksicitetsstudier med rotter og bavianer viste, at de primære organer, der blev påvirket, var nyrer og pancreas.
The kidneys and the pancreas were the primary organs affected in toxicity studies performed in rats and baboons.
• Produktresumé og indlægsseddel
• Summary of Product Characteristics and Patient Information Leaflet
Mens du tager Envarsus, skal din læge også vide det, hvis du tager kaliumtilskud eller visse typer vanddrivende medicin, der anvendes mod hjertesvigt, forhøjet blodtryk eller nyresygdom (f.eks. amilorid, triamteren eller spironolakton), ikke-steroide betændelseshæmmende lægemidler (NSAID'er, f.eks. ibuprofen), der anvendes mod feber, betændelse og smerter, blodfortyndende lægemidler (antikoagulantia) eller orale lægemidler mod sukkersyge.
While you take Envarsus your doctor also needs to know if you are taking potassium supplements or certain diuretics used for heart failure, hypertension and kidney disease (e.g. amiloride, triamterene, or spironolactone), nonsteroidal anti-inflammatory substances (NSAIDs, e.g. ibuprofen) used for fever, inflammation and pain, anticoagulants (blood thinners), or oral medicines for diabetes.
Hos alle lader der ikke til at være nogen signifikant forskel i mønsteret af bivirkninger, som formodes at være kausalt relateret til forsøgslægemidlet, mellem Envarsustabletter, der indtages én gang dagligt og tacrolimus-kapsler med øjeblikkelig udløsning (Prograf).
In all, there appears to be no significant difference in the pattern of adverse events suspected to be causally related to study drug between once daily Envarsus and tacrolimus immediate-release capsules (Prograf).
Metabolisme og ernæring diabetes mellitus, hyperglykæmiske tilstande, hyperkaliæmi anoreksi, metabolisk acidose, andre elektrolytforstyrrelser, hyponatræmi, overhydrering, hyperurikæmi, hypomagnesiæmi, hypokaliæmi, hypokalcæmi, nedsat appetit, hyperkolesterolæmi , hyperlipidæmi, hypertriglyceridæmi, hypofosfatæmi dehydrering, hypoglykæmi, hypoproteinæmi, hyperfosfatæmi
Metabolism and nutrition disorders diabetes mellitus, hyperglycaemic conditions, hyperkalaemia anorexia, metabolic acidoses, other electrolyte abnormalities, hyponatraemia, fluid overload, hyperuricaemia, hypomagnesaemia, hypokalaemia, hypocalcemia, appetite decreased, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hypophosphateaemia dehydration, hypoglycaemia, hypoproteinaemia, hyperphosphataemia
Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 behandlede): - Forhøjet blodsukker, sukkersyge, øget kalium i blodet - Søvnproblemer - Rysten, hovedpine - Forhøjet blodtryk - Unormal leverfunktionstest - 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
Den øgede clearance, der observeres efter transplantation, anses for at skyldes faktorer som f.eks. lave hæmatokrit- og proteinniveauer, som medfører en øget ubunden fraktion af tacrolimus, eller kortikosteroidinduceret øget metabolisme.
Factors such as low haematocrit and protein levels, which result in an increase in the unbound fraction of tacrolimus, or corticosteroid-induced increased metabolism, are considered to be responsible for the higher clearance rates observed following transplantation.
Virkning og anvendelse 2.
What Envarsus is and what it is used for 2.
Medicineringsfejl, herunder utilsigtet, uforsætlig eller uovervåget substitution af tacrolimusformuleringer med øjeblikkelig udløsning eller depottabletter, er observeret med tacrolimus.
Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate- or prolonged-release tacrolimus formulations, have been observed with tacrolimus.
Blandt de hyppigste bivirkninger (hos mindst 2 % af patienter) i kliniske studier med levertransplanterede patienter, der fik Envarsus, var tremor, hovedpine, træthed, hyperkaliæmi, hypertension, nyresvigt, forhøjet blodkreatinin, svimmelhed, hepatitis C, muskelkramper, tineainfektion, leukopeni, sinusitis og infektion i de øvre luftveje, som alle vides at forekomme hos den pågældende patientpopulation i immunsuppressiv behandling.
Among the most frequent adverse reactions (at least in 2% of patients) in clinical studies in liver transplant patients receiving Envarsus were tremor, headache, fatigue, hyperkalaemia, hypertension, renal failure, blood creatinine increased, dizziness, hepatitis C, muscle spasms, tinea infection, leukopenia, sinusitis, and upper respiratory tract infections (URTI), all of which are known to occur in the respective patient population under immunosuppressive treatment.
Envarsus indeholder lactose
Envarsus contains lactose
Mave-tarmkanalen diarré, kvalme gastrointestinale tegn og symptomer, opkastning, gastrointestinale og abdominalsmerter, gastrointestinale betændelsestilstande, gastrointestinale blødninger, gastrointestinal ulceration og perforation, ascites, stomatitis og ulceration, obstipation, dyspeptiske tegn og symptomer, flatulens, oppustethed og udspilethed, løs afføring akut og kronisk pankreatitis, peritonitis, paralytisk ileus, gastroøsofageal reflukssygdom, nedsat ventrikeltømning pseudocyster i pancreas, subileus
Gastrointestinal disorders diarrhoea, nausea 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 acute and chronic pancreatitis, peritonitis, ileus paralytic, gastrooesophageal reflux disease, impaired gastric emptying pancreatic pseudocyst, subileus
Medicineringsfejl, herunder utilsigtet, uforsætlig eller uovervåget substitution af tacrolimusformuleringer med øjeblikkelig udløsning eller depottabletter, er observeret.
Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate- or prolonged-release tacrolimus formulations, have been observed.
Da tacrolimus' farmakokinetik er upåvirket af nyrefunktionen (se pkt.
As the pharmacokinetics of tacrolimus are unaffected by renal function (see section 5.2), no dose adjustment is required.
Det endokrine system hirsutisme
Endocrine disorders hirsutism
(ujævnt hjerteslag) - lægemidler kendt som “statiner”, der anvendes til behandling af forhøjet kolesteroltal og triglycerider - fenytoin eller fenobarbital, der anvendes til behandling af epilepsi - prednisolon og methylprednisolon, der tilhører gruppen af kortikosteroider og anvendes til at behandle betændelse og undertrykke immunforsvaret (f.eks. mod afstødning af transplantat) - carbamazepin, der anvendes til at forebygge og kontrollere krampeanfald - metamizol, der anvendes til behandling af smerter og høj feber - nefazodon, der anvendes til behandling af depression - naturlægemidler, der indeholder prikbladet perikum (Hypericum perforatum).
- medicines known as “statins”, used to treat elevated cholesterol and triglycerides - phenytoin or phenobarbital, used to treat epilepsy - prednisolone and methylprednisolone, belonging to the class of corticosteroids and used to treat inflammations or suppress the immune system (e.g. in transplant rejection) - carbamazepine, used to prevent and control seizures - metamizole, used to treat pain and high fever - nefazodone, used to treat depression - herbal preparations containing St. John's Wort (Hypericum perforatum)
Nervesystemet hovedpine, tremor forstyrrelser i nervesystemet, krampeanfald, bevidsthedsforstyrrelser, perifer neuropati, svimmelhed, paræstesi og dysæstesi, nedsat evne til at skrive encefalopati, blødninger i centralnervesystemet, og slagtilfælde, koma, tale- og sprogforstyrrelser, paralyse og parese, amnesi hypertoni myasteni
Nervous system disorders headache, tremor nervous system disorders seizures, disturbances in consciousness, peripheral neuropathies, dizziness, paraesthesias and dysaesthesias, writing impaired encephalopathy, central nervous system haemorrhages and cerebrovascular accidents, coma, speech and language ab-normalities, paralysis and paresis, amnesia hypertonia myasthenia
Blod og lymfesystem anæmi, trombocytopeni, leukopeni, abnorme analyser af røde blodlegemer, leukocytose koagulopatier, pancytopeni, neutropeni, abnorme analyser af koagulation og blødning trombotisk trombocytopenisk purpura, hypoprotrombinæmi, trombotisk mikroangiopati ren erytrocyt aplasi, agranulocytose, hæmolytisk anæmi
Blood and lymphatic system disorders anaemia, thrombocytopenia, leukopenia, red blood cell analyses abnormal, leukocytosis coagulopathies, pancytopenia, neutropenia, coagulation and bleeding analyses, abnormal thrombotic thrombocytopenic purpura, hypoprothrombinaemia, thrombotic microangiopathy pure red cell aplasia, agranulocytosis, haemolytic anaemia
Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and herbal preparations.
Kun læger med erfaring i immunsuppressiv behandling og behandling af transplanterede patienter må ordinere dette lægemiddel og initiere ændringer i den immunsuppressive behandling.
This medicinal product should only be prescribed, and changes in immunosuppressive therapy be initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients.
nifedipin, nicardipin, diltiazem og verapamil) - lægemidler mod arytmi (f.eks. amiodaron), der anvendes til behandling af rytmeforstyrrelser
diltiazem and verapamil) - anti-arrhythmic substances (e.g. amiodarone) used to control arrhythmia (uneven beating of the heart)
Derfor kan samtidig brug af tacrolimus med andre lægemidler, der vides at blive metaboliseret af CYP3A4, påvirke metabolismen af sådanne lægemidler.
Tacrolimus is a known CYP3A4 inhibitor; thus, concomitant use of tacrolimus with medicinal products known to be metabolised by CYP3A4 may affect the metabolism of such medicinal products.
Allograft-transplanterede patienter vedligeholdt på dosering med Prograf (øjeblikkelig udløsning) to gange dagligt eller Advagraf (én gang dagligt), som skal skifte til Envarsus én gang dagligt, skal skifte i forholdet 1:0,7 (mg:mg) total daglig dosis, så Envarsus-vedligeholdelsesdosen skal derfor være 30 % lavere end Prograf- eller Advagraf-dosen.
Allograft transplant patients maintained on twice daily Prograf (immediate-release) or Advagraf (once daily) dosing requiring conversion to once daily Envarsus should be converted on a 1:0.7 (mg:mg)
Blodkoncentationer af Envarsus kan påvirkes af anden medicin, du tager, og koncentrationer af anden medicin kan påvirkes af at tage Envarsus.
Envarsus blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Envarsus, which may require interruption, an increase or a decrease in Envarsus dose.
Vaskulære sygdomme hypertension tromboemboliske og iskæmiske hændelser, vaskulære hypotensive lidelser, blødning, perifere vaskulære lidelser dyb venetrombose, shock, infarkt
Vascular disorders hypertension thromboembolic and ischaemic events, vascular hypotensive disorders, haemorrhage, peripheral vascular disorders venous thrombosis deep limb, shock, infarction
Omhyggelig monitorering af nyrefunktionen (herunder serumkreatinin koncentrationer, beregning af kreatininclearance og monitorering af diurese) anbefales dog på grund af tacrolimus' potentielle nefrotoksicitet.
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).
Envarsus 0,75 mg depottabletter Envarsus 1 mg depottabletter Envarsus 4 mg depottabletter
Envarsus 0.75 mg prolonged-release tablets Envarsus 1 mg prolonged-release tablets Envarsus 4 mg prolonged-release tablets
FKBP12-tacrolimuskomplekset bindes specifikt og kompetitivt til calcineurin, som det hæmmer.
The FKBP12-tacrolimus complex specifically and competitively binds to and inhibits calcineurin, leading to a calcium-dependent inhibition of T-cell signal transduction pathways, thereby preventing transcription of a discrete set of cytokine genes.
vægtstigning øget amylase, abnormt ekg, abnorm hjertefrekvens og puls, vægttab, forhøjet laktatdehydroge nase i blodet,
Investigations liver function tests abnormal blood alkaline phosphatase increased, weight increased amylase increased, ECG abnormal, heart rate and pulse investigations abnormal, weight decreased, blood lactate dehydrogenase increased echocardiogram abnormal,
Hjerte iskæmisk koronararteriesygdom, takykardi hjertesvigt, ventrikulære arytmier og hjertestop, supraventrikulære arytmier, kardiomyopati, ventrikulær hypertrofi, palpitationer,
Cardiac disorders ischaemic coronary artery disorders, tachycardia heart failures, ventricular arrhythmias and cardiac arrest, supraventricular arrhythmias, cardiomyopathies, ventricular hypertrophy, palpitations pericardial effusion
Sådan skal du tage Envarsus
How to take Envarsus
Envarsus 0,75 mg depottabletter er ovale, hvide til grålighvide, uovertrukne tabletter præget med "0.75" på den ene side og "TCS" på den anden side.
Envarsus 0.75 mg prolonged-release tablets are oval, white to off-white uncoated tablet, debossed with “0.75” on one side and “TCS” on the other side.
Tracrolimus havde en negativ virkning på hanrotters fertilitet i form af et nedsat antal sædceller og nedsat sædmotilitet (se pkt.
A negative effect of tacrolimus on male fertility in the form of reduced sperm count and motility was observed in rats (see section 5.3).
Envarsus indeholder lactose.
Envarsus contains lactose.
Luftveje, thorax og mediastinum parenkymatøs lungesygdom, dyspnø, pleuraekssudat, hoste, pharyngitis, tilstoppet næse og betændelse i næsen respirationssvigt, luftvejslidelser, astma akut respiratorisk distresssyndrom
Respiratory, thoracic and mediastinal disorders parenchymal lung disorders, dyspnoea, pleural effusion, cough, pharyngitis, nasal congestion and inflammations respiratory failures, respiratory tract disorders, asthma acute respiratory distress syndrome
Envarsus 0,75 mg depottabletter tacrolimus
Envarsus 0.75 mg prolonged-release tablets tacrolimus
Ren erytrocyt aplasi
Pure red cell aplasia
Der er set kraftige interaktioner med svampemidler såsom ketoconazol, fluconazol, itraconazol, voriconazol og isavuconazol, det makrolide antibiotikum erythromycin, hiv-proteasehæmmere (f.eks. ritonavir, nelfinavir, saquinavir) eller hepatitis C-virus (HCV)-proteasehæmmere (f.eks. telaprevir, boceprevir og kombinationen af ombitasvir og paritaprevir sammen med ritonavir, når det anvendes med og uden dasabuvir), 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) or Hepatitis C Virus (HCV) protease inhibitors (e.g. telaprevir, boceprevir, and the combination of ombitasvir and paritaprevir with ritonavir, when used with and without dasabuvir), the pharmacokinetic enhancer cobicistat, and the tyrosine kinase inhibitors nilotinib and imatinib.
Blodkoncentrationerne af ciclosporin og patientens kliniske tilstand skal tages i betragtning, før behandling med tacrolimus påbegyndes.
Tacrolimus therapy should be initiated after considering ciclosporin blood concentrations and the clinical condition of the patient.
mavesmerter, fordøjelsesbesvær, forstoppelse, flatulens, oppustethed, løs afføring - Galdevejslidelser, gulfarvning af huden på grund af leverproblemer, ødelæggelse af levervæv og leverbetændelse - Kløe, udslæt, hårtab, akne, øget svedafsondring - Smerter i led, lemmer eller ryg, muskelkramper - Utilstrækkelig nyrefunktion, nedsat urindannelse, forringet eller smertefuld vandladning - Almen svækkelse, feber, væskeansamling i kroppen, smerter og ubehag, stigning i enzymet alkalin-fosfatase i blodet, vægtstigning, ændret opfattelse af legemstemperatur - 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 or back, muscle cramps - 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
Data fra raske forsøgspersoner tyder dog på, at samme skifterate gælder som ved skift fra Prograf til Envarsus.
No studies have been conducted with conversion of patients from Advagraf to Envarsus; however, data from healthy volunteers would suggest that the same conversion rate is applicable as with the conversion from Prograf to Envarsus.
Profylakse af levertransplantatafstødning
Prophylaxis of liver transplant rejection
Hos rotter havde tracrolimus en negativ virkning på hannernes fertilitet i form af et nedsat antal sædceller og nedsat sædmotilitet.
A negative effect of tacrolimus on male fertility in the form of reduced sperm count and motility was observed in rats.
Oval, hvid til grålighvid uovertrukket tablet præget med "0.75" på den ene side og "TCS" på den anden side.
Oval, white to off-white uncoated tablet, debossed with “0.75” on one side and “TCS” on the other side.
Ikke kendte bivirkninger (hyppighed ikke kendt):
Excipient with known effect:
Hvis du oplever alvorlige bivirkninger, bør du straks kontakte din læge.
Please contact your doctor immediately, should you experience severe effects.
Profylakse af nyretransplantatafstødning
Prophylaxis of kidney transplant rejection
Envarsus 4 mg depottabletter tacrolimus
Envarsus 4 mg prolonged-release tablets tacrolimus
Envarsus 4 mg depottabletter er ovale, hvide til grålighvide, uovertrukne tabletter præget med "4" på den ene side og "TCS" på den anden side.
Envarsus 4 mg prolonged-release tablets are oval, white to off-white uncoated tablet, debossed with “4” on one side and “TCS” on the other side.
Envarsus 1 mg depottabletter tacrolimus
Envarsus 1 mg prolonged-release tablets tacrolimus
- hvis du får kraftige mavesmerter enten med eller uden andre symptomer, såsom kulderystelser, feber, kvalme og opkastning.
- if you feel strong abdominal pain accompanied or not with other symptoms, such as chills,
- Vigtigheden af at ordinering og udlevering skal tage hensyn til lægemiddelform (depotpræparat) og dosering (administration én gang dagligt).
The educational material for Healthcare Professionals should include information on the following key elements: - The authorised indications - The need for prescribing and dispensing with attention to pharmaceutical form (prolonged-release) and posology (once daily administration).
hallucinationer, forstyrret sindstilstand - Anfald, bevidsthedsforstyrrelser, prikken og følelsesløshed (undertiden smertefuld) i hænder og fødder, svimmelhed, nedsat skriveevne, forstyrrelser i nervesystemet - Sløret syn, øget lysfølsomhed, problemer med øjnene - Ringen for øret - Nedsat blodgennemstrømning i hjertets blodkar, øget puls - Blødning, delvis eller fuldstændig blokering af blodkar, nedsat blodtryk - Kortåndethed, lidelser i lungevæv, væskeansamling omkring lungen, betændelse i svælget,
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, disorders of the respiratory tissues in the lung, collection of liquid around the lung, inflammation of the pharynx, 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,
Envarsus 1 mg depottabletter er ovale, hvide til grålighvide, uovertrukne tabletter præget med "1" på den ene side og "TCS" på den anden side.
Envarsus 1 mg prolonged-release tablets are oval, white to off-white uncoated tablet, debossed with “1” on one side and “TCS” on the other side
Lever og galdeveje galdevejslidelser, hepatocellulær skade og hepatitis, kolestase og gulsot venookklusiv leversygdom, hepatisk arterietrombose leversvigt
Hepatobiliary disorders bile duct disorders, hepatocellular damage and hepatitis, cholestasis and jaundice venoocclusive liver disease, hepatic artery thrombosis hepatic failure