FrancophonIA/ELRC3.0 huggingface dataset:
English: 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
Danish: 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
English: Each sachet of Modigraf 1 mg granules contains 1 mg of tacrolimus (as monohydrate).
Danish: Hvert brev Modigraf 1 mg granulat indeholder 1 mg tacrolimus (som monohydrat).
English: Each sachet contains 1 mg tacrolimus (as monohydrate).
Danish: Hvert brev indeholder 1 mg tacrolimus (som monohydrat).
English: bile duct disorders, hepatocellular damage and hepatitis, cholestasis and jaundice rare:
Danish: galdegangssygdomme, skade på leverceller og hepatitis, cholestase og gulsot
English: - if you feel strong abdominal pain accompanied or not with other symptoms, such as chills,
Danish: - hvis De får stærke mavesmerter med eller uden andre symptomer, som kulderystelser, feber, kvalme eller opkastning.
English: Care should be taken when converting patients from ciclosporin-based to tacrolimus-based therapy (see sections 4.4 and 4.5).
Danish: Man bør udvise forsigtighed, når patienter skifter fra behandling med ciclosporin til tacrolimusbaseret behandling (pkt.
English: 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).
Danish: 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).
English: renal failure, renal failure acute, nephropathy toxic, renal tubular necrosis, urinary abnormalities, oliguria, bladder and urethral symptoms uncommon:
Danish: nyresvigt, akut nyresvigt, toksisk nefropati, renal tubulær nekrose, vandladningsproblemer, oliguri, symptomer fra blære og urinveje
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Modigraf til Dem personligt.
English: nervous system disorders, seizures, disturbances in consciousness, peripheral neuropathies, dizziness, paraesthesias and dysaesthesias, writing impaired uncommon:
Danish: forstyrrelser i nervesystemet, krampeanfald, bevidsthedsforstyrrelser, perifer neuropati, svimmelhed, paræstesier og dysæstesier, nedsat skriveevne
English: 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).
Danish: Efter antistofinduktion bør oral Modigrafbehandling begynde med en dosis på 0,075 mg/kg/dag fordelt på 2 doser (f.eks. morgen og aften).
English: Treatment of allograft rejection
Danish: Afstødningsbehandling
English: 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).
Danish: målinger af serum-kreatininkoncentrationer, beregning af kreatinin-clearance og kontrol af diurese).
English: 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).
Danish: 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).
English: Immune system disorders
Danish: unormale leverfunktionstests
English: acute respiratory distress syndrome Gastrointestinal disorders very common:
Danish: akut respiratory distress syndrome
English: Talk to your doctor or pharmacist before taking Modigraf
Danish: Kontakt lægen eller apoteket, før De tager Modigraf - hvis De har eller har haft leverproblemer.
English: arthralgia, back pain, muscle spasms, pain in extremity uncommon:
Danish: artralgi, rygsmerter, muskelspasmer, smerte i ekstremiteterne
English: Prophylaxis of kidney transplant rejection
Danish: Profylakse mod nyretransplantatafstødning
English: 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:
Danish: 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
English: and combination tablets, used to treat HIV infection - HCV protease inhibitors (e.g. telaprevir, boceprevir, and the combination ombitasvir/paritaprevir/ritonavir with or without dasabuvir), used to treat hepatitis C infection - nilotinib and imatinib (used to treat certain cancers) - mycophenolic acid, used to suppress the immune system to prevent transplant rejection - medicines for stomach ulcer and acid reflux (e.g. omeprazole, lansoprazole or cimetidine) - anti-emetics, used to treat nausea and vomiting (e.g. metoclopramide) - cisapride or the antacid magnesium-aluminium-hydroxide, used to treat heartburn - the contraceptive pill, hormone treatments with ethinylestradiol, or hormone treatments with danazol - medicines used to treat high blood pressure or heart problems (e.g. nifedipine, nicardipine,
Danish: infektion - nilotinib og imatinib (bruges til behandling af visse typer cancer) - mycophenolsyre, som bruges til at undertrykke immunsystemet for at forhindre afstødning af et transplantat - medicin til forebyggelse og behandling af mavesår og spiserørskatar (f.eks. omeprazol, lansoprazol eller cimetidin) - antiemetika, der anvendes til behandling af kvalme og opkastning (f.eks. metoclopramid) - cisaprid eller det syreneutraliserende middel magnesium-aluminium-hydroxid, der anvendes til behandling af halsbrand - p-piller, hormonbehandling med ethinylestradiol eller hormonbehandling med danazol - medicin mod forhøjet blodtryk eller hjerteproblemer (f.eks. nifedipin, nicardipin, diltiazem og verapamil) - antiarytmika (amiodaron), som bruges til behandling af arytmier (uregelmæssig hjerterytme) - lægemidler kendt som ”statiner” til behandling af forhøjet kolesterol og triglycerider - phenytoin og phenobarbital til behandling af epilepsi - kortikosteroiderne prednisolon og methylprednisolon, der anvendes til behandling af betændelsestilstande eller til at undertrykke immunsystemet (f.eks. ved afstødning af organ efter transplantation) - nefazodon til behandling af depression - naturmedicin, der indeholder perikon (Hypericum perforatum) eller ekstrakt af Schisandra sphenanthera.
English: The presence of food decreases both the rate and extent of absorption of tacrolimus, the effect being most pronounced after a high-fat meal.
Danish: Fødeindtag nedsætter både hastighed og absorberet mængde tacrolimus.
English: deafness neurosensory very rare:
Danish: neurosensorisk døvhed
English: 6.6 Special precautions for disposal and other handling
Danish: 6.6 Regler for bortskaffelse
English: Modigraf 1 mg granules for oral suspension tacrolimus
Danish: Modigraf 1 mg granulat til oral suspension tacrolimus
English: febrile disorders, pain and discomfort, asthenic conditions, oedema, body temperature perception disturbed uncommon:
Danish: feber, smerter og ubehag, asteni, ødem, ændret opfattelse af kropstemperatur
English: Modigraf 1 mg granules for oral suspension tacrolimus oral use
Danish: Modigraf 1 mg granulat til oral suspension tacrolimus oral anvendelse
English: Oral Modigraf therapy should commence at 0.10 - 0.20 mg/kg/day administered as 2 divided doses (e.g. morning and evening).
Danish: Oral behandling med Modigraf bør påbegyndes med 0,10 - 0,20 mg/kg/dag administreret som 2 separate doser (f.eks. morgen og aften).
English: Tacrolimus therapy should be initiated after considering ciclosporin blood concentrations and the clinical condition of the patient.
Danish: Blodkoncentrationerne af ciclosporin og patientens tilstand skal tages i betragtning, før man indleder behandling med tacrolimusterapi.
English: Modigraf 0.2 mg granules for oral suspension tacrolimus
Danish: Modigraf 0,2 mg granulat til oral suspension tacrolimus
English: Uncommon side effects (may affect up to 1 in 100 people): - Changes in blood clotting, reduction in the number of all types of blood cells (seen in blood tests) - Dehydration, inability to urinate - Abnormal blood test results: reduced protein or sugar, increased phosphate, increase of the enzyme lactate dehydrogenase - Coma, bleeding in the brain, stroke, paralysis, brain disorder, speech and language abnormalities, memory problems - Clouding of the eye lens, impaired hearing - Irregular heartbeat, stop of heartbeat, reduced performance of your heart, disorder of the heart muscle, enlargement of the heart muscle, stronger heartbeat, abnormal ECG, heart rate and pulse abnormal - Blood clot in a vein of a limb, shock - Difficulties in breathing, respiratory tract disorders, asthma
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 behandlede): - Ændret blodstørkning, nedsat antal af alle typer af blodceller (ses i blodprøver) - Dehydrering, ophørt urinproduktion - Unormale resultater af blodprøver: Nedsat protein- og sukkerindhold, øget fosfat, stigning i enzymet lactatdehydrogenase - Koma, blødning i hjernen, slagtilfælde, lammelse, forandringer i hjernen, tale- og sprogforstyrrelser,
English: Modigraf 0.2 mg granules for oral suspension tacrolimus oral use
Danish: Modigraf 0,2 mg granulat til oral suspension tacrolimus oral anvendelse
English: Tacrolimus was started as continuous intravenous infusion at a dose of 0.01 to 0.03 mg/kg/day and oral tacrolimus was administered at a dose of 0.05 to 0.3 mg/kg/day.
Danish: Tacrolimus blev startet som kontinuerlig intravenøs infusion i doser på 0,01 - 0,03 mg/kg/dag.
English: Oral Modigraf therapy should commence at 0.20 - 0.30 mg/kg/day administered as 2 divided doses (e.g. morning and evening).
Danish: Oral behandling med Modigraf bør påbegyndes med 0,20 - 0,30 mg/kg/dag administreret som 2 separate doser (f.eks. morgen og aften).
English: If clinically relevant changes are seen, adjustments of the immunosuppressive regimen should be considered.
Danish: Man skal overveje at justere den immunsuppressive behandling, hvis der forekommer klinisk relevante ændringer.
English: The suspension can be drawn up via a syringe or swallowed directly by the patient.
Danish: Det kan ikke anbefales at anvende væske eller utensilier til at tømme brevene med. Suspensionen kan suges op gennem en sprøjte, eller patienten kan drikke det direkte.
English: What Modigraf is and what it is used for What you need to know before you take Modigraf How to take Modigraf
Danish: Det skal De vide, før De begynder at tage Modigraf Sådan skal De tage Modigraf Bivirkninger
English: Common side effects (may affect up to 1 in 10 people): - Reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell counts, changes in red blood cell counts (seen in blood tests) - Reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid overload,
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 behandlede): - Nedsat antal blodceller (blodplader, røde eller hvide blodlegemer), øget antal hvide blodlegemer,
English: Excipients
Danish: blindhed
English: LIST OF EXCIPIENTS
Danish: perikardial ekssudation
English: Other factors observed to increase the risk of these clinical conditions included pre-existing heart disease, corticosteroid usage,
Danish: Andre faktorer, der kan øge risikoen for disse kliniske tilstande, er allerede eksisterende hjertelidelse, behandling med kortikosteroider, hypertension, nedsat nyre- eller leverfunktion, infektion, væskeretention og ødem.
English: psychotic disorder Nervous system disorders very common:
Danish: Nervesystemet Meget almindelig:
English: optic neuropathy Ear and labyrinth disorders common:
Danish: Øre og labyrint Almindelig:
English: Prophylaxis of liver transplant rejection
Danish: Profylakse mod levertransplantatafstødning
English: renal impairment common:
Danish: Nyre og urinveje Meget almindelig:
English: thromboembolic and ischaemic events, vascular hypotensive disorders, haemorrhage, peripheral vascular disorders uncommon:
Danish: tromboemboliske og iskæmiske tilstande, vaskulært betinget nedsat blodtryk, blødning, perifere kredsløbsforstyrrelser
English: Myasthenia
Danish: myasteni
English: primary graft dysfunction
Danish: Nedsat leverfunktion
English: If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.075 - 0.100 mg/kg/day (with Prograf 5 mg/ml concentrate for solution for infusion) should be administered as a continuous 24-hour infusion.
Danish: Hvis patientens kliniske tilstand hindrer oral dosering, bør en intravenøs begyndelsesdosis med 0,075 - 0,100 mg/kg/dag (med Prograf 5 mg/ml koncentrat til infusionsvæske, opløsning) administreres som en kontinuert infusion over 24 timer.
English: hypertension common:
Danish: Hjerte Almindelig:
English: If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.05 mg/kg/day (with Prograf 5 mg/ml concentrate for solution for infusion) should be administered as a continuous 24-hour infusion.
Danish: Hvis patientens kliniske tilstand hindrer oral dosering, bør en intravenøs begyndelsesdosis med 0,05 mg/kg/dag (med Prograf 5 mg/ml koncentrat til infusionsvæske, opløsning) administreres som en kontinuert 24-timers infusion.
English: Hepatic impairment
Danish: psykotiske forstyrrelser
English: Each sachet of Modigraf 0.2 mg granules contains 0.2 mg of tacrolimus (as monohydrate).
Danish: - Aktivt stof: tacrolimus Hvert brev Modigraf 0,2 mg granulat indeholder 0,2 mg tacrolimus (som monohydrat).
English: If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.01 - 0.05 mg/kg/day (with Prograf 5 mg/ml concentrate for solution for infusion) should be initiated as a continuous 24-hour infusion.
Danish: Hvis dosis, som resultat af patientens kliniske tilstand, ikke kan administreres oralt, bør intravenøs terapi med 0,01 - 0,05 mg/kg/dag (med Prograf 5 mg/ml koncentrat til infusionsvæske, opløsning) opstartes som en kontinuert 24-timers infusion.
English: If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.05 - 0.10 mg/kg/day (with Prograf 5 mg/ml concentrate for solution for infusion) should be initiated as a continuous 24-hour infusion.
Danish: Hvis dosis, som resultat af patientens kliniske tilstand, ikke kan administreres oralt, bør intravenøs terapi med 0,05 - 0,10 mg/kg/dag (med Prograf 5 mg/ml koncentrat til infusionsvæske, opløsning) opstartes som en kontinuert infusion over 24 timer.
English: NN:
Danish: Almindelig:
English: If signs of toxicity such as severe adverse reactions are noted (see section 4.8), the dose of Modigraf may need to be reduced.
Danish: Ved tegn på toksicitet såsom alvorlige bivirkninger (se pkt.
English: Metabolism
Danish: hypoacusis
English: List of adverse reactions
Danish: LISTE OVER HJÆLPESTOFFER
English: venoocclusive liver disease, hepatic artery thrombosis very rare:
Danish: veneokklusiv leversygdom, trombose i leverarterie
English: Gender-specific differences do not occur.
Danish: Der forekommer ikke kønsspecifikke forskelle.
English: Consideration should be given to use of a behavioural modification programme.
Danish: Det skal overvejes at anvende et adfærdsmodifikationsprogram.
English: The product may therefore result in an increase or decrease in aggression levels.
Danish: Produktet kan derfor resultere i et øget eller mindsket aggressionsniveau.
English: This evaluation may include consideration of inciting factors or situations associated with previous aggressive episodes.
Danish: Denne vurdering kan omfatte overvejelse af inducerende faktorer eller situationer associeret med tidligere aggressive episoder.
English: See also section 4.7.
Danish: Se også punkt 4.7.
English: No interaction with highly protein bound compounds is therefore expected.
Danish: Derfor forventes der ingen interaktion med stærkt proteinbundne substanser.
English: Number of tablets per administration
Danish: Antal tabletter pr. administration
English: In comparison, none of the five enzymes increased with increasing doses of imepitoin.
Danish: Til sammenligning steg ingen af de fem enzymer med stigende doser af imepitoin.
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Lægemidler må ikke bortskaffes via spildevand eller husholdningsaffald.
English: These signs are potentially treatment related.
Danish: Disse tegn kan potientielt være relateret til behandlingen.
English: The in-vivo plasma protein binding of imepitoin in dogs is low (60 to 70%).
Danish: Imepitoins in vivo plasmaproteinbinding i hunde er lav (60 til 70%).
English: 25% of dogs did not respond to the treatment with imepitoin (same or increased frequency of seizures).
Danish: 25% af hundene responderede ikke på behandlingen med imepitoin (samme eller øget hyppighed af anfald).
English: Imepitoin is extensively metabolised prior to elimination.
Danish: Imepitoin metaboliseres i stort omfang før elimination.
English: Up to 2 days of pre-treatment may be necessary to achieve optimal anxiolytic efficacy in dogs with noise phobia.
Danish: Op til 2 dages forbehandling kan være nødvendig for at opnå optimal anxiolytisk effekt hos hunde med støjfobi.
English: However, the upper limit of the confidence interval for creatinine remained within the reference range at all visits.
Danish: Dog forblev den øvre grænse for konfidensintervallet for kreatinin indenfor referenceområdet ved alle undersøgelser.
English: Most events are transient, resolving during or shortly after the end of the treatment course.
Danish: De fleste tilfælde er forbigående og går i sig selv under eller kort efter ophør af behandlingen.
English: When transition between different antiepileptic therapies is medically required, this should be done gradually and with appropriate clinical supervision.
Danish: Når det er medicinsk nødvendigt at foretage et skift mellem forskellige anti-epileptiske lægemidler, bør det ske gradvist og med passende klinisk overvågning.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato (EXP), der står på æsken og flasken.
English: Prior to initiating treatment in these cases, behaviour therapy or referral to a behaviour specialist should be considered.
Danish: Før der initieres behandling i disse tilfælde, skal adfærdsterapi eller henvisning til en adfærdsspecialist overvejes.
English: See also section "Overdose".
Danish: Se også punktet ”Overdosering”.
English: Metabolite profiles in urine and faeces revealed four major inactive metabolites which are formed by oxidative modification.
Danish: Metabolitprofiler i urin og fæces viste fire væsentlige inaktive metabolitter, der dannes via oksidativ modifikation.
English: Imepitoin is a centrally acting substance with anxiolytic and antiepileptic properties which crosses the blood brain barrier without involvement of active transport or active clearance, resulting in immediate equilibrium between plasma and brain.
Danish: Imepitoin er en centralt virkende substans med anxiolytiske og antiepileptiske egenskaber, der krydser blod-hjernebarrieren uden involvering af aktiv transport eller aktiv clearance , hvilket resulterer i umiddelbar ligevægt mellem plasma og hjerne.
English: The timing of tablet administration in relation to feeding should be kept consistent.
Danish: Timing af tabletadministrering i relation til fodring bør holdes konsistent.
English: Imepitoin has a relatively high volume of distribution (579 to 1548 ml/kg).
Danish: Imepitoin har en relativt høj distributionsvolumen (579 til 1548 ml/kg).
English: Though efficacy may not be complete, imepitoin is considered to be a suitable treatment option in some dogs because of its safety profile.
Danish: Selvom effekten kan være ufuldstændig anses imepitoin alligevel for at være et passende valg til behandling af nogle hunde pga sikkershedsprofilen.
English: See also section "Pregnancy and lactation".
Danish: Se også sektion ”Drægtighed og laktation”.
English: Pharmacotherapeutic group: Antiepileptics, Other antiepileptics, imepitoin ATCvet code: QN03AX90
Danish: Farmakoterapeutisk gruppe: Antiepileptika, andre antiepileptica, imepitoin ATCvet-kode: QN03AX90
English: Idiopathic epilepsy
Danish: Idiopatisk epilepsi
English: In more than half of the dogs that experienced ataxia during this clinical trial the signs resolved spontaneously within 24 hours in spite of continued treatment and in half of the remaining dogs within 48 hours.
Danish: Hos mere end halvdelen af hundene, som oplevede ataksi under dette kliniske forsøg, forsvandt tegnene spontant inden for 24 timer trods fortsat behandling og hos halvdelen af de resterende hunde inden for 48 timer.
English: Any remaining half-tablet should be used for the next dose.
Danish: Eventuelt resterende delte tabletter bør anvendes ved næste dosering.
English: The anxiolytic effect of imepitoin is mediated via the GABAA receptor.
Danish: Imepitoins anxiolytiske virkning medieres via GABAA-receptoren.
English: The pharmacological response to imepitoin may vary and efficacy may not be complete.
Danish: Den farmakologiske respons på imepitoin kan variere og effekten kan være ufuldstændig.
English: No accumulation of imepitoin in plasma occurs after repeated administration, once steady state is reached.
Danish: Der forekommer ingen akkumulation af imepitoin i plasma efter gentagen administrering, når først steady-state er opnået.
English: Increasing doses of phenobarbital were associated with increasing levels of the liver enzymes ALT, AP, AST, GGT, and GLDH.
Danish: Stigende doser af phenobarbital blev forbundet med stigende niveauer af leverenzymerne ALT, AP, AST, GGT, og GLDH.
English: Pharmacokinetic studies indicate that imepitoin is well absorbed (> 92%) after oral administration and that no pronounced first pass effect occurs.
Danish: Farmakokinetiske studier indikerer, at imepitoin absorberes godt (> 92%) efter oral administrering, og at der ikke forekommer nogen udtalt first pass-metabolisme.
English: Imepitoin is rapidly cleared from blood (Cl = 260 to 568 ml/hours/kg) with an elimination half-life of approximately 1.5 to 2 hours.
Danish: Imepitoin fjernes hurtigt fra blodet (Cl = 260 til 568 ml/timer/kg) med en eliminationshalveringstid på ca. 1,5 til 2 timer.
English: Because of the nature of epilepsy, the pharmacological response to treatment may vary.
Danish: Epilepsiens karakter medfører, at den kliniske respons på behandlingen kan variere.
English: EXPIRY DATE EXP {month/year}
Danish: EXP {måned/år}