natgillin/translations-raw huggingface dataset:
Der er påvist overfølsomhedsreaktioner, herunder angioødem og urticaria, i forbindelse med anvendelse af Mimpara efter markedsføring.
Hypersensitivity reactions including angioedema and urticaria have been identified during post- marketing use of Mimpara.
Der er påvist reduktion af androstenon og skatol fra 4 til 6 uger efter den anden vaccination.
Reduction of androstenone and skatole levels has been demonstrated from 4 to 6 weeks post second vaccination.
Der er påvist signifikant teratogenicitet og/eller fosterdød hos alle dyrearter efter eksponering for ribavirin, hvorfor det er yderst vigtigt at undgå graviditet hos kvindelige patienter samt hos mandlige patienters kvindelige partnere.
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin, therefore, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Der er rapporter om almindeligt forekommende, men generelt asymptomatiske tilfælde af splenomegali og om ikke almindeligt forekommende tilfælde af miltruptur hos raske donorer (og hos patienter) efter administration af granulocyt-kolonistimulerende faktorer (G-CSF).
Common but generally asymptomatic cases of splenomegaly and uncommon cases of splenic rupture have been reported in healthy donors (and patients) following administration of granulocyte-colony stimulating factors (G-CSFs).
Der er rapporter om bivirkninger associeret med demyelinisering og ascenderende perifere neuropatier, der ligner Guillain-Barré syndrom
There have been reports of events associated with demyelination and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome.
Der er rapporter om intrakraniel hypertension (IH) med papilødem, synsforstyrrelser, hovedpine, kvalme og/eller opkastning hos patienter i behandling med INCRELEX, ligesom det også er rapporteret ved terapeutisk GH-indgivelse.
Intracranial hypertension (IH) with papilloedema, visual changes, headache, nausea and/or vomiting has been reported in patients treated with INCRELEX, as has been reported with therapeutic GH administration.
Der er rapporter om knoglemarvsdepression og andre hæmatologiske bivirkninger.
Dehydration and pulmonary oedema have rarely been reported.
Der er rapporter om meget sjældne tilfælde af akut myeloid leukemi og myelodyplasisk syndrom, når docetaxel blev administreret i kombination med andre kemoterapeutiske stoffer og/eller radioterapi.
Very rare cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy.
Der er rapporter om nedsat nyrefunktion i forbindelse med Zoledronsyre Teva.
Zoledronic acid has been associated with reports of renal dysfunction.
Der er rapporter om nedsat nyrefunktion i forbindelse med zoledronsyre.
Zoledronic acid has been associated with reports of renal dysfunction.
Der er rapporter om nedsat nyrefunktion i forbindelse med Zometa.
Zometa has been associated with reports of renal dysfunction.
Der er rapporter om overdosering med Prevenar, inkl. tilfælde med indgivelse af en højere dosis end den anbefalede, og tilfælde hvor efterfølgende doser blev indgivet efter kortere tid i forhold til tidligere dosis end anbefalet.
There have been reports of overdose with Prevenar, including cases of administration of a higher than recommended dose and cases of subsequent doses administered closer than recommended to the previous dose.
Der er rapporter om overfølsomhedslignende reaktioner, herunder anafylaksi, udslæt, urticaria, angioødem, dyspnø og hypotension efter initial eller senere behandling i kliniske studier og efter markedsføringen.
Hypersensitivity-type reactions including anaphylaxis, rash, urticaria, angioedema, dyspnoea and hypotension occurring on initial or subsequent treatment have been reported in clinical studies and in post marketing experience.
Der er rapporter om patienter, som har taget den anbefalede dosis i mere end 5 dage (op til 64 dage), med bivirkninger, som inkluderede knoglemarvssuppression, med eller uden infektion, i nogle tilfælde alvorlige og langvarige og resulterende i død.
There are reports of patients who have taken the recommended dose for more than 5 days of treatment (up to 64 days) with adverse reaction reported including bone marrow suppression, with or without infection, in some cases severe and prolonged and resulting in death.
Der er rapporter om sjælden forekomst af dehydrering som en konsekvens af gastrointestinale hændelser, gastrointestinal perforation, iskæmisk colitis, colitis og neutropenisk enterocolitis.
Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported.
Der er rapporter om sjældne tilfælde af ototoksicitet, nedsat hørelse og/eller tab af hørelse.
Rare cases of ototoxicity, hearing impaired and/or hearing loss have been reported.
Der er rapporter om smerter eller ømhed i musklerne eller muskelsvækkelse efter især antiretroviral kombinationsbehandling med proteasehæmmere og nukleosid-analoger.
There have been reports of muscle pain, tenderness or weakness.
Der er rapporter om tilfælde af akut myeloid leukæmi og myelodysplastisk syndrom, når docetaxel blev administreret i kombination med andre kemoterapeutika og/eller radioterapi.
Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy.
Der er rapporter om tilfælde af akut myeloid leukæmi og myelodysplastisk syndrom, når docetaxel blev administreret i kombination med andre kemoterapeutika og/eller strålebehandling.
Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy.
Der er rapporter om tilfælde af anafylaktisk chok, nogle gange fatale.
Some cases of anaphylactic shock, sometimes fatal, have been reported.
Der er rapporter om tilfælde af anafylaktisk chok, nogle gange fatale.
There were a few reports of overdose.
Der er rapporter om, at samtidig administration af pioglitazon og rifampicin (en inducer af CYP2C8) har resulteret i en 54% nedsættelse af AUC for pioglitazon.
Co- administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone.
Der er rapporter om, at samtidig administration af pioglitazon og rifampicin (en inducer af cytochrom P450 2C8) har resulteret en 54% nedsættelse af AUC for pioglitazon.
Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone.
Der er rapporteret adskillige tilfælde af dexmedetomidinoverdosis, både i kliniske studier og efter markedsføring.
Several cases of dexmedetomidine overdose have been reported both in the clinical trial and the post- marketing data.
Der er rapporteret aktiv og latent tuberkulose hos 0,3 % af de patienter, der blev behandlet med LEMTRADA, oftest i endemiske områder.
Active and latent tuberculosis have been reported in 0.3% of the patients treated with LEMTRADA, most often in endemic regions.
Der er rapporteret aktivering af mani og hypomani hos patienter med affektive sindslidelser, som blev behandlet med andre lignende lægemidler til svære depressioner.
Activation of mania and hypomania have been reported in patients with mood disorders who were treated with other similar medicinal products for major depressive disorder.
Der er rapporteret alvorlige bivirkninger for Humira.
Serious adverse reactions have also been reported for Humira.
Der er rapporteret alvorlige bivirkninger hos pædiatriske patienter efter utilsigtet indtagelse af brimonidin- komponenten i SIMBRINZA.
Serious adverse effects following inadvertent ingestion with the brimonidine component of SIMBRINZA by paediatric subjects have been reported.
Der er rapporteret alvorlige blødningsreaktioner hos ikke-MS-patienter.
Severe bleeding reactions have been reported in non-MS patients.
Der er rapporteret alvorlige overfølsomhedsreaktioner i forbindelse med brug af oritavancin.
Serious hypersensitivity reactions have been reported with the use of oritavancin.
Der er rapporteret alvorlige overfølsomhedsreaktioner som en sjælden komplikation til behandling med interferon beta, inklusive Plegridy.
Serious hypersensitivity reactions have been reported as a rare complication of treatment with interferon beta, including Plegridy.
Der er rapporteret alvorlige, og ind i mellem fatale, overfølsomhedsreaktioner (anafylaktiske reaktioner) hos patienter i behandling med betalaktamer.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams.
Der er rapporteret alvorligt hududslæt, herunder Stevens-Johnsons syndrom, hos patienter, der tager REYATAZ.
Serious skin rash, including Stevens-Johnson syndrome, has been reported in patients taking REYATAZ.
Der er rapporteret anafylaktisk reaktion/shock, inklusive dødelige tilfælde, hos patienter behandlet med i.v. ibandronsyre.
Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with IV ibandronic acid.
Der er rapporteret anafylaktisk reaktion/shock, inklusive dødelige tilfælde, hos patienter behandlet med intravenøs ibandronsyre.
Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Der er rapporteret anafylaktisk reaktion/shock, inklusive dødelige tilfælde, hos patienter behandlet med intravenøs ibandronsyre.
Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with IV ibandronic acid.
Der er rapporteret anafylaktiske reaktioner og andre overfølsomhedsreaktioner efter intravenøs administration af proteiner til patienter.
Anaphylactic and other hypersensitivity reactions have been reported following the intravenous administration of proteins to patients.
Der er rapporteret både benigne og maligne tumorer i ovarierne og andre dele af det reproduktive system hos kvinder, som er blevet behandlet med flere forskellige lægemiddelregimer for infertilitet.
There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple treatment regimens for infertility.
Der er rapporteret både godartede og ondartede svulster i æggestokkene og andre dele af det reproduktive system hos kvinder, som er blevet behandlet med flere forskellige lægemidler for infertilitet.
There have been reports of tumours in the ovaries and other sex organs, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment.
Der er rapporteret en hurtig hjerterytme (puls) og unormale hjertelyde under behandling med INCRELEX.
A fast heart rate and abnormal heart sounds have been reported with INCRELEX treatment.
Der er rapporteret en højere risiko for nedsat nyrefunktion hos hiv 1-inficerede patienter, der fik tenofovirdisoproxil i kombination med en ritonavir- eller cobicistat-boostet proteasehæmmer.
A higher risk of renal impairment has been reported in HIV-1 infected patients receiving tenofovir disoproxil in combination with a ritonavir or cobicistat boosted protease inhibitor.
Der er rapporteret en højere risiko for nedsat nyrefunktion hos HIV 1-inficerede patienter, der fik tenofovirdisoproxilfumarat i kombination med en ritonavir- eller cobicistat-boostet proteasehæmmer.
A higher risk of renal impairment has been reported in HIV-1 infected patients receiving tenofovir disoproxil fumarate in combination with a ritonavir or cobicistat boosted protease inhibitor.
Der er rapporteret en lidt højere hyppighed af abnormt ekg, primært sinusbradykardi, hos patienter behandlet med tadalafil en gang dagligt end hos patienter behandlet med placebo.
A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo.
Der er rapporteret en mulig forbindelse mellem brugen af metylxantiner og udvikling af nekrotiserende enterocolitis.
There are reports of a possible association between the use of methylxanthines and development of necrotising enterocolitis.
Der er rapporteret enkelte tilfælde af anafylaktisk shock, som i nogle tilfælde har haft dødelig udgang.
Some cases of anaphylactic shock, sometimes fatal, have been reported.
Der er rapporteret forandringer i blodprøveværdierne, herunder en øgning af visse lever- og bugspytkirtelenzymer.
Changes in blood tests have been reported, including an increase in some liver and pancreatic enzymes.
Der er rapporteret forhøjede leverenzymer hos multipel sklerosepatienter i behandling med Gilenya.
Increased hepatic enzymes have been reported in multiple sclerosis patients treated with Gilenya.
Der er rapporteret forhøjede niveauer af alaninaminotransferase, alkalisk fosfatase, laktatdehydrogenase og protrombin
Increase of alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase and prothrombin
Der er rapporteret forstørret milt med en hyppighed på ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) og tilfælde af miltruptur (bristning af milten) med andre lægemidler, der ligner Lonquex.
Increased spleen size has been reported uncommonly (may affect up to 1 in 100 people) and cases of splenic ruptures have been reported with other medicines similar to Lonquex.
Der er rapporteret forværring af nyrefunktion, progression til nyresvigt samt dialyse hos patienter efter indledende dosis eller enkeltdosis af zoledronsyre.
Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of zoledronic acid.
Der er rapporteret følgende alvorlige bivirkninger i forbindelse med langtidsbehandling med VFEND:
The following severe adverse events have been reported in relation with long-term VFEND treatment:
Der er rapporteret følgende alvorlige bivirkninger i forbindelse med langtidsbehandling med voriconazol:
The following severe adverse events have been reported in relation with long-term voriconazole treatment:
Der er rapporteret hepatiske reaktioner (f.eks. let til moderate forhøjelser af ALAT, ASAT, alkalisk fosfatase og total bilirubin og/eller klinisk hepatitis) under behandling med posaconazol.
Hepatic reactions (e.g. mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin and/or clinical hepatitis) have been reported during treatment with posaconazole.
Der er rapporteret hepatitis B-reaktivering hos patienter med non-Hodgkins lymfom, som fik MabThera i kombination med cytotoksisk kemoterapi (se non-Hodgkins lymfom).
In patients with non-Hodgkin’s lymphoma receiving MabThera in combination with cytotoxic chemotherapy, cases of hepatitis B reactivation have been reported (see non-Hodgkin’s lymphoma).
Der er rapporteret hovedpine og diarré kort tid efter indledning af filgrastimterapi – typisk hos færre end 10 % af patienterne.
Headache and diarrhoea have been reported shortly after starting filgrastim therapy, typically in less than 10 % of patients.
Der er rapporteret hovedpine og diarré kort tid efter indledning af filgrastimterapi – typisk hos færre end 10 % af patienterne.
Headache and diarrhoea have been reported shortly after starting filgrastim therapy, typically in less than 10% of patients.
Der er rapporteret hypotension, syncope, apopleksi, hyperkaliæmi og ændringer i nyrefunktionen
Hypotension, syncope, stroke, hyperkalaemia, and changes in renal function (including acute renal
Der er rapporteret hypotension, syncope, apopleksi, hyperkaliæmi og ændringer i nyrefunktionen (herunder akut nyresvigt) hos følsomme patienter, specielt ved anvendelse af flere lægemidler, der påvirker dette system (se pkt.
Hypotension, syncope, stroke, hyperkalaemia, and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system (see section 5.1).
Der er rapporteret højere hyppighed af hypoglykæmiske episoder hos patienter med pNET sammenlignet med patienter med Mrcc eller GIST.
A higher incidence rate of hypoglycemia events was reported in patients with pNET in comparison to MRCC and GIST.
Der er rapporteret ikke almindelige ( 1/1.000 til < 1/100) pulmonale bivirkninger, især interstitial pneumoni, efter administration af G-CSF.
Uncommon (≥1/1,000 to < 1/100) pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration.
Der er rapporteret infusionsreaktioner primært i form af udslæt, urticaria, periorbitalt ødem eller pruritus hos patienter i ONIVYDE-behandling.
Infusion reactions primarily consisting of rash, urticaria, periorbital oedema or pruritus were reported in patients receiving ONIVYDE treatment.
Der er rapporteret infusionsrelaterede bivirkninger med anidulafungin i kliniske studier, herunder ansigtsrødme, hedeture, pruritus , udslæt og urticaria, som anført i skema 1.
Infusion-related adverse reactions have been reported with anidulafungin in clinical studies, including flushing, hot flush, pruritus, rash, and urticaria, summarized in Table 1.
Der er rapporteret infusionsrelaterede reaktioner efter brug af anidulafungin, herunder udslæt, urticaria, flushing, pruritus, dyspnø, bronkospasmer og hypotension.
Infusion-related adverse events have been reported with anidulafungin, including rash, urticaria, flushing, pruritus, dyspnea, bronchospasm and hypotension.
Der er rapporteret kliniske tilfælde, hvor der var en tilsvarende stigning i docetaxels toksicitet, når det blev kombineret med ritonavir.
Clincal cases consistent with an increase in docetaxel toxicity were reported when it was combined with ritonavir.
Der er rapporteret krampeanfald hos 5 ud af hver 1.000 personer, der har fået Xtandi, og hos færre end én ud af hver 1.000 personer, der har fået placebo (inaktivt middel) (se også "Brug af anden medicin sammen med Xtandi" i dette punkt og punkt 4, "Bivirkninger").
Seizures were reported in 5 in every 1,000 people taking Xtandi, and fewer than one in every 1,000 people taking placebo (see also ‘Other medicines and Xtandi’ in this section and section 4 ‘Possible side effects’).
Der er rapporteret krampeanfald hos 5 ud af hver 1.000 personer, der har fået Xtandi, og hos færre end én ud af hver 1.000 personer, der har fået placebo.
Seizures were reported in 5 in every 1,000 people taking Xtandi, and fewer than one in every 1,000 people taking placebo.
Der er rapporteret laktatacidose (i nogle tilfælde med dødelig udgang) hos gravide kvinder, der fik Zerit i kombination med anden antiretroviral behandling.
Lactic acidosis (sometimes fatal) has been reported in pregnant women who received Zerit in combination with other antiretroviral treatment.
Der er rapporteret let til moderat udslæt i kliniske studier med efavirenz, og dette forsvinder sædvanligvis ved fortsat behandling.
Mild -to-moderate rash has been reported in clinical studies with efavirenz and usually resolves with continued therapy.
Der er rapporteret let til moderat udslæt i kliniske studier med efavirenz, og dette forsvinder sædvanligvisved fortsat behandling.
Mild-to-moderate rash has been reported in clinical studies with efavirenz and usually resolves with continued therapy.
Der er rapporteret leverpåvirkninger i kliniske studier med trametinib som monoterapi og i kombination med dabrafenib.
Hepatic adverse events have been reported in clinical trials with trametinib as monotherapy and in combination with dabrafenib.
Der er rapporteret medicineringsfejl som omfatter forveksling med subkutane Insuman-formuleringer eller andre subkutane insuliner.
Medication errors involving mix-up between subcutaneous Insuman formulations or other subcutaneous insulins have been reported.
Der er rapporteret meget sjældne tilfælde af apopleksi i globale post-marketing erfaringer hos kvindelige patienter.
Very rare cases of stroke have been reported from world-wide post marketing experience in female patients.
Der er rapporteret meget sjældne tilfælde af T-takinversion hos patienter behandlet med fingolimod.
Very rare cases of T-wave inversion have been reported in patients treated with fingolimod.
Der er rapporteret nye primære melanomer i kliniske studier med dabrafenib som monoterapi og i kombination med trametinib.
New primary melanomas have been reported in clinical trials with dabrafenib as monotherapy and in combination with trametinib.
Der er rapporteret om adskillige tilfælde af utilsigtet overdosering med tacrolimus som: Tremor, hovedpine, kvalme og opkastninger, infektioner, urticaria, letargi og forhøjet blodurinstof, serumkreatininkoncentrationer og alanin-aminotransferase.
Several cases of accidental overdose have been reported with tacrolimus; symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy and increases in blood urea nitrogen, serum creatinine concentrations and alanine aminotransferase levels.
Der er rapporteret om allergiske reaktioner (hyppighed kan ikke estimeres ud fra forhåndenværende data) hos patienter, der tager Tandemact.
Allergic reactions have been reported (frequency cannot be estimated from the available data) in patients taking Tandemact.
Der er rapporteret om allergiske reaktioner (hyppighed kan ikke vurderes ud fra de tilgængelige data) hos patienter, der tager Glustin.
Allergic reactions have been reported (frequency cannot be estimated from the available data) in patients taking Glustin.
Der er rapporteret om allergiske reaktioner (hyppigheden kan ikke vurderes ud fra de tilgængelige data) hos patienter, der tager Actos.
Allergic reactions have been reported (frequency cannot be estimated from the available data) in patients taking Actos.
Der er rapporteret om allergiske reaktioner (hyppigheden kan ikke vurderes ud fra de tilgængelige data) hos patienter, der tager Glubrava.
Allergic reactions have been reported (frequency cannot be estimated from available data) in patients taking Competact.
Der er rapporteret om allergiske reaktioner (hyppigheden kan ikke vurderes ud fra de tilgængelige data) hos patienter, der tager Glubrava.
Allergic reactions have been reported (frequency cannot be estimated from the available data) in patients taking Glubrava.
Der er rapporteret om allergiske reaktioner (overfølsomhed) hos brugere af IOA, men hyppigheden kan ikke vurderes ud fra forhåndenværende data.
Allergic (hypersensitive) reactions have been reported in users of IOA, but the frequency cannot be estimated from the available data.
Der er rapporteret om almindeligt forekommende tilfælde af splenomegali, der dog oftest er asymptomatiske, samt om ikke almindeligt forekommende tilfælde af miltruptur hos raske donorer (og patienter) efter administration af G-CSF'er.
Common but generally asymptomatic cases of splenomegaly and uncommon cases of splenic rupture have been reported in healthy donors (and patients) following administration of G-CSFs.
Der er rapporteret om alvorlige infektioner i forbindelse med overvågning efter markedsføringen, herunder device-relateret infektion, device-relateret sepsis, pneumoni, sepsis, bakteriæmi og urinvejsinfektioner.
Reports of serious infection have been received in post-marketing surveillance including device- related infection, device-related sepsis, pneumonia, sepsis, bacteraemia, and urinary tract infection.
Der er rapporteret om alvorlige og livstruende hudreaktioner og overfølsomhedsreaktioner hos nogle patienter, der tager raltegravir (et af lægemidlerne i Dutrebis).
Severe and life-threatening skin reactions and allergic reactions have been reported in some patients taking raltegravir (one of the medicines in DUTREBIS).
Der er rapporteret om bivirkninger associeret med demyelinisering og om ascenderende perifer neuropati, der ligner Guillain-Barré syndrom.
There have also been reports of reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré Syndrome.