FrancophonIA/ELRC3.0 huggingface dataset:
English: Disorientation Apathy
Danish: Tænderskæren Desorientering Apati
English: • decreased thyroid gland activity which can cause tiredness or weight gain
Danish: • nedsat aktivitet af skjoldbruskkirtlen, hvilket kan medføre træthed og vægtøgning
English: YENTREVE contains sucrose.
Danish: YENTREVE indeholder saccharose.
English: • feeling the heart pumping in the chest, fast and/or irregular heart beat
Danish: • hjertebanken, hurtig og/eller uregelmæssig puls
English: The use of YENTREVE while breastfeeding is not recommended.
Danish: Det anbefales ikke at bruge YENTREVE, mens De ammer.
English: Tel: +372 6 817 280
Danish: Eesti Tel: +3726817 280
English: YENTREVE 20 mg Gelatin
Danish: YENTREVE 20 mg Gelatine
English: Absorption: Duloxetine is well absorbed after oral administration with a Cmax occurring 6 hours post dose.
Danish: Absorption: Duloxetin absorberes godt efter peroral indgift med Cmaks.
English: - If you get any of the side effects talk to your doctor or pharmacist.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket.
English: The pharmacokinetics of duloxetine in patients who are poor metabolisers with respect to CYP2D6 has not been specifically investigated.
Danish: Duloxetins farmakokinetiske egenskaber er ikke blevet specifikt undersøgt hos kvinder, som har en ringe CYP2D6 metabolisering.
English: • large pupils (the dark centre of the eye), problems with eyesight, eyes feel dry
Danish: • store pupiller, synsforstyrrelser, følelse af tørre øjne
English: Convulsions1,6 Myoclonus Akathisia6
Danish: Myoclonus Akatisi6
English: • muscle pain, muscle tightness, muscle spasm, contraction of the jaw muscle
Danish: • muskelsmerter, muskelstivhed, muskelkramper, sammenbidte kæber
English: Renal impairment: End stage renal disease (ESRD) patients receiving dialysis had 2-fold higher duloxetine Cmax and AUC values compared with healthy subjects.
Danish: Nedsat nyrefunktion: Patienter med terminal nyresygdom (ESRD) i dialysebehandling havde et dobbelt så højt duloxetin-Cmaks.
English: • diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion
Danish: • diarré, mavesmerter, opkastning, halsbrand eller fordøjelsesbesvær
English: How to take YENTREVE
Danish: Sådan skal De tage YENTREVE
English: Eosinophilic pneumonia6
Danish: Epistaxis Interstitiel lungesygdom10 Eosinofil pneumoni6
English: Feeling abnormal Feeling cold Thirst
Danish: Perifer kulde fornemmelse
English: If this happens to your baby you should contact your midwife and/or doctor immediately.
Danish: De skal omgående kontakte Deres jordemoder og/eller læge, hvis dette sker for Deres barn.
English: Do not stop taking YENTREVE, or change your dose, without talking to your doctor.
Danish: De må kun stoppe behandlingen eller ændre dosis efter aftale med lægen.
English: Nervousness Disturbance in attention
Danish: Nervøsitet Koncentrationsbesvær
English: YENTREVE must not be used in women with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Danish: YENTREVE bør ikke gives til kvinder med leversygdomme resulterende i nedsat leverfunktion (se pkt.
English: Each capsule may contain up to 37 mg sucrose.
Danish: Hjælpestof som behandleren skal være opmærksom på Hver kapsel kan indeholde op til 37 mg saccharose.
English: • headache, dizziness, feeling sluggish, feeling sleepy, tremor, numbness, including numbness,
Danish: • hovedpine, svimmelhed, følelse af ugidelighed, søvnighed, rysten, følelsesløshed inklusive følelsesløshed eller prikken/snurren i huden
English: Orthostatic hypotension2 Peripheral coldness
Danish: Ortostatisk hypotension2
English: YENTREVE 40 mg hard gastro-resistant capsules Duloxetine
Danish: YENTREVE 40 mg hårde enterokapsler Duloxetin
English: Each capsule may contain up to 74 mg sucrose.
Danish: Hjælpestof som behandleren skal være opmærksom på Hver kapsel kan indeholde op til 74 mg saccharose.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK INNER CARTON FOR 40 MG HARD GASTRO-RESISTANT CAPSULES (WITHOUT BLUE BOX)
Danish: MULTIPAKNING INDRE KARTON TIL 40 MG HÅRDE ENTEROKAPSLER (UDEN BLÅ BOKS)
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible black ink
Danish: Natriumlaurilsulfat Titandioxid (E171) Indigotin (E132) Edible black ink
English: YENTREVE 20 mg hard gastro-resistant capsules Duloxetine
Danish: YENTREVE 20 mg hårde enterokapsler Duloxetin
English: • vomiting blood, or black tarry stools (faeces), gastroenteritis, inflammation of the mouth, burping, difficulty swallowing, breaking wind, bad breath
Danish: • opkastning af blod eller sort, tjærefarvet afføring (på grund af blod i afføringen), mave-tarm katar, betændelseslignende tilstand (inflammation) i mundhulen, bøvsen, synkebesvær, luft i maven, dårlig ånde
English: • dizziness, tingling feelings like pins and needles or electric shock-like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.
Danish: • svimmelhed, prikkende følelse som når noget sover eller følelse af elektriske stød (især i hovedet), søvnforstyrrelser (livagtige drømme, mareridt, søvnløshed), træthed, søvnighed, rastløshed eller uro, angst, kvalme eller opkastning, rystelser (tremor), hovedpine, muskelsmerter, irritation, diaré, forøget tendens til at svede eller svimmelhed.
English: • Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals),
Danish: • Stevens-Johnsons syndrom (en alvorlig lidelse med blærer i huden, munden, øjnene og på kønsorganerne), alvorlige allergiske reaktioner, som kan forårsage hævelse i ansigtet eller halsen (angioødem), øget følsomhed over for sollys
English: Anaphylactic reaction
Danish: Overfølsomhed Anafylaktisk reaktion
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK-OUTER CARTON FOR 40 MG HARD GASTRO-RESISTANT CAPSULES (WITH BLUE BOX)
Danish: MULTIPAKNING - YDRE KARTON TIL 40 MG HÅRDE ENTEROKAPSLER (MED BLÅ BOKS)
English: • low levels of sodium in the blood (mostly in elderly people; the symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling or being sick, more serious symptoms are fainting, fits or falls), syndrome of inappropriate secretion of anti-diuretic hormone (SIADH)
Danish: • lavt indhold af natrium i blodet (oftest hos ældre mennesker; symptomerne omfatter bl.a. svimmelhed, svaghed, forvirring, søvnighed eller udpræget træthed eller kvalme og opkastning; mere alvorlige symptomer er besvimelse, krampeanfald eller fald), syndrom med uhensigtsmæssig sekretion af anti-diuretisk hormon (SIADH) selvmordshandlinger og -tanker, mani (overaktivitet, tanker, der løber løbsk, nedsat søvnbehov), hallucinationer, aggressivitet og vrede
English: Česká republika Eli Lilly ČR, s.r.o.
Danish: Eli Lilly ČR, s.r.o.
English: Talk to your doctor before you take Yentreve if you: - are taking medicines to treat depression (see ‘Other medicines and YENTREVE') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see ‘Pregnancy and breast-feeding‘) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage.
Danish: tager et naturlægemiddel, som indeholder perikon (Hypericum perforatum) - har en nyresygdom - tidligere har haft krampeanfald - har haft mani - lider af bipolar sygdom - har øjenproblemer såsom visse typer af grøn stær (glaukom - forøget tryk i øjet) - tidligere har lidt af blødningsforstyrrelser (tendens til blå mærker) især hvis De er gravid (se
English: clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome
Danish: • ”Serotoninsyndrom” (en sjælden bivirkning, der kan forårsage unormal opstemthed, døsighed, klodsethed, rastløshed, en følelse af at være beruset, feber, tendens til at svede eller muskelstivhed), krampeanfald, pludselig, ufrivillig spjætten eller sitren i musklerne, følelse af rastløshed eller manglende evne til at sidde eller stå stille, problemer med at styre sine bevægelser f.eks. koordinationsbesvær eller ufrivillige muskelbevægelser, restless legs syndrom (stærk uro og krybende fornemmelse i underbenene)
English: Dizziness, sensory disturbances (including paraesthesia or electric shock-like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Danish: De almindeligste bivirkninger er svimmelhed, sensoriske forstyrrelser (inklusiv paraesthesier og følelsen af elektriske stød, især i hovedet), søvnforstyrrelser (inklusiv søvnløshed og intense drømme), træthed, søvnighed, opstemthed eller angst, kvalme og/eller opkastning, rysten, hovedpine, myalgi, irritabilitet, diarré, hyperhidrosis og vertigo.
English: Galactorrhoea Hyperprolactinae mia
Danish: Menstruationsforstyrrelser Galaktorré Hyperprolaktinæmi
English: Haematochezia Microscopic colitis9
Danish: Hæmatokeksi Mikroskopisk kolitis9
English: 98 hard gastro-resistant capsules.
Danish: 98 hårde enterokapsler
English: Store in the original package to protect from moisture.
Danish: Skal opbevares i den originale emballage beskyttet mod fugt.
English: Musculoskeletal and connective tissue disorders Musculo-skeletal pain
Danish: Muskuloskeletale smerter Muskelstivhed Muskelspasmer Trismus
English: Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Danish: De skal også være klar over at selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (overvejende aggression, modsættende adfærd og vrede) hyppigere er blevet observeret hos børn og unge behandlet med medicin af denne gruppe.
English: YENTREVE 40 mg Opaque orange body, imprinted with '40 mg' and an opaque blue cap, imprinted with ‘9545'.
Danish: YENTREVE 40 mg Mat orange kapselbund med påskriften ”40 mg” og mat blå kapseltop med påskriften ”9545”.
English: Sleep disorder
Danish: Søvnforstyrrelser
English: • muscle twitching
Danish: • muskelsitren
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Red iron oxide (E172) Yellow iron oxide (E172) Edible black ink
Danish: Natriumlaurilsulfat Titandioxid (E171) Indigotin (E132) Rød jernoxid (E172) Gul jernoxid (E172) Edible black ink
English: Gastrointestinal haemorrhage7 Gastroenteritis Stomatitis
Danish: Gastroenteritis Stomatitis Opstød Gastritis Dysfagi
English: YENTREVE 20 mg hard gastro-resistant capsules.
Danish: YENTREVE 20 mg hårde enterokapsler.
English: What you need to know before you take YENTREVE DO NOT take YENTREVE if you:
Danish: Det skal De vide, før De begynder at tage YENTREVE
English: YENTREVE 40 mg hard gastro-resistant capsules.
Danish: YENTREVE 40 mg hårde enterokapsler.
English: • weakness, shivering
Danish: • svaghed, kulderystelser
English: Blurred vision Mydriasis Visual impairment
Danish: Mydriasis Nedsat syn Tørre øjne
English: Black iron oxide - synthetic (E172) Propylene glycol
Danish: Syntetisk sort jernoxid (E172) Propylenglycol Shellac
English: In pre/postnatal toxicity study in the rat, duloxetine induced adverse behavioural effects in the offspring at systemic exposure levels below maximum clinical exposure (AUC).
Danish: Duloxetin fremkaldte adfærdsmæssige bivirkninger hos afkommet i et præ-/postnatal toxicitetstudie med rotter, hvor hunrotter blev udsat for systemiske påvirkninger under den maksimale kliniske eksponering (AUC).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 40 MG HARD GASTRO-RESISTANT CAPSULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 40 MG HÅRDE ENTEROKAPSLER
English: Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132), red iron oxide and yellow iron oxide, edible black ink.
Danish: 2 for yderligere information om saccharose) Kapsellåg og -bund: Gelatine, natriumlaurilsulfat, titandioxid (E171), indigotin (E132), rød jernoxid (E172), gul jernoxid (E172) og Edible black ink.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 20 MG HARD GASTRO-RESISTANT CAPSULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 20 MG HÅRDE ENTEROKAPSLER
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING YENTREVE 20 mg
English: Feeling hot
Danish: Føler sig syg Varmefølelse
English: Hypertension3,7 Flushing
Danish: Vaskulære sygdomme Hypertension3,7
English: • dehydration
Danish: • dehydrering (væskemangel)
English: Agitation
Danish: Gangforstyrrelse
English: • increased yawning
Danish: • øget tendens til at gabe
English: Each capsule contains 20 or 40 mg of duloxetine (as hydrochloride).
Danish: Hver kapsel indeholder 20 eller 40 mg duloxetin (som hydrochlorid).
English: The efficacy of YENTREVE is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT).
Danish: Virkningen af YENTREVE forstærkes, når behandlingen kombineres med bækkenbundstræning.
English: EU/1/04/280/006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/280/006
English: If you take more YENTREVE than you should
Danish: Hvis De har taget for meget YENTREVE
English: Chest pain7
Danish: Brystsmerter7 Fald8
English: The 40 mg capsules are orange and blue and are printed with '40 mg' and the code ‘9545'.
Danish: YENTREVE findes i to styrker: 40 mg og 20 mg 40 mg kapslerne er orange og blå og har påskriften "40 mg" og koden "9545".
English: OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF
English: Component of a multipack, can't be sold seperately.
Danish: Del af en multipakning.
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: - Kontakt lægen eller apotekspersonalet, hvis De får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: Each capsule contains 40 mg of duloxetine (as hydrochloride).
Danish: Hver kapsel indeholder 40 mg duloxetin (som hydrochlorid).
English: Constipation
Danish: • træthed
English: Each capsule contains 20 mg of duloxetine (as hydrochloride).
Danish: Hver kapsel indeholder 20 mg duloxetin (som hydrochlorid).
English: • feeling sick (nausea), dry mouth, constipation • fatigue
Danish: • kvalme, mundtørhed, forstoppelse
English: Blood pressure increase3
Danish: Synkope2 Øget blodtryk3
English: YENTREVE 20 mg Opaque blue body, imprinted with ‘20 mg' and an opaque blue cap, imprinted with ‘9544'.
Danish: Mat blå kapselbund med påskriften ”20 mg” og mat blå kapseltop med påskriften ”9544”.
English: Ελλάδα
Danish: NN:
English: Malaise
Danish: Nykturi
English: Dizziness
Danish: Dyskinesi
English: If your baby has any of these symptoms when it is born, or you are concerned about your baby's health, contact your doctor or midwife who will be able to advise you.
Danish: De skal kontakte Deres læge eller jordemoder med henblik på råd og vejledning, hvis Deres barn udviser nogle af disse symptomer efter fødslen, eller hvis De er bekymret for Deres barns helbred.
English: EU/1/04/280/001 (56 hard gastro-resistant capsules) EU/1/04/280/007 (28 hard gastro-resistant capsules) EU/1/04/280/008 (98 hard gastro-resistant capsules)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/280/001 (56 hårde enterokapsler)
English: YENTREVE 40 mg hard gastro-resistant capsules YENTREVE 20 mg hard gastro-resistant capsules
Danish: Indlægsseddel: Information til brugeren YENTREVE 40 mg hårde enterokapsler YENTREVE 20 mg hårde enterokapsler duloxetin (som hydrochlorid)
English: Sugar spheres
Danish: Asteni Kuldegysninger
English: pricking or tingling of the skin
Danish: Uro i benene
English: Muscle tightness
Danish: Saccharosekugler Talcum
English: Postpartum haemorrhage6
Danish: Leversvigt6 Ikterus6
English: Pollakiuria Urine odour abnormal
Danish: Pollakisuri Abnorm urinlugt
English: Eructation Gastritis Dysphagia Flatulence Breath odour
Danish: Hovedpine Svimmelhed Letargi Søvnighed Tremor Paræstesier
English: Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800
Danish: Tel: + 31(0)30 6025800
English: Paraesthesia
Danish: Hallucinationer
English: 64331 Weiterstadt Germany
Danish: 64331 Weiterstadt Tyskland
English: Overall summary of the scientific evaluation of Norsed Combi D and associated names (see Annex I)
Danish: Samlet resumé af den faglige vurdering af Norsed Combi D og tilknyttede navne (se bilag I)
English: Procter & Gamble Pharmaceuticals France 163-165 Quai Aulagnier 92600 Asnières-sur-Seine France
Danish: Procter & Gamble Pharmaceuticals France 163-165 Quai Aulagnier 92600 Asnières-sur-Seine Frankrig
English: According to the CHMP Guideline on combination products, “combination packs would only be acceptable in exceptional cases, when there would be clear public health benefits of the treatment regimen and/or compliance, taking into account the required justifications set-out in section 5 of this guideline”.
Danish: Ifølge CHMP's retningslinjer for kombinationslægemidler er "kombinationspakninger kun acceptable i særlige tilfælde, hvor der er klare fordele for folkesundheden ved behandlingsregimet og/eller overensstemmelse, idet der tages højde for de nødvendige begrundelser i afsnit 5 i disse retningslinjer."
English: The Applicant submitted an application for mutual recognition of the marketing authorisation granted by Sweden in 2006 for Norsed Combi D, a combination product consisting of risedronate sodium 35 mg film-coated tablets together with 1000 mg calcium carbonate and 880 IU colecalciferol effervescent granules.
Danish: Ansøgeren fremsendte en ansøgning om gensidig anerkendelse af den markedsføringstilladelse, som Sverige udstedte i 2006 for Norsed Combi D, som er et kombinationslægemiddel, der består af risedronatnatrium 35 mg filmovertrukne tabletter sammen med 1000 mg calciumcarbonat og 880 IE colecalciferol brusegranulat.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: De gældende tekster til produktresume, etikettering og indlægsseddel er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen.
English: The objecting CMS considered the benefit-risk balance of Norsed Combi D to be unfavourable and presented specific points for objection to the application.
Danish: Den berørte medlemsstat, der gjorde indsigelse, var af den opfattelse, at benefit/riskforholdet for Norsed Combi D var negativt, og medlemsstaten fremlagde specifikke punkter, hvor den gjorde indsigelse mod ansøgningen.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicants and marketing authorisation holder in the Member States
Danish: FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: • the CHMP was convinced of the clear public health benefits and improved compliance resulting from the this product, the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Norsed Combi D and associated names (see Annex I).
Danish: som dette lægemiddel medfører, anbefalede CHMP udstedelse af de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel bevares som i de endelige udgaver, der blev fastlagt under koordinationsgruppens procedure som nævnt i bilag III for Norsed Combi D og tilknyttede navne (se bilag I).
English: Marketing authorisation holder
Danish: Medlemsstat Indehaver af markedsføringstil ladelse
English: Italy sanofi-aventis S.p.A. viale Luigi Bodio, 37/B 20158 Milan Italy
Danish: viale Luigi Bodio, 37/B 20158 Milan Italien
English: Sweden sanofi-aventis S.p.A. Viale Luigi Bodio, 37/b 20158 Milano Italy
Danish: Viale Luigi Bodio, 37/b 20158 Milano Italien
English: (Invented) Name
Danish: Navn
English: What you need to know before you <take> <use> X:
Danish: Det skal du vide, før du begynder at <tage> <bruge> <X>:
English: Adopted at the 7-10 September 2015 PRAC
Danish: Vedtaget 7.-10. september 2015, PRAC
English: Possible side effects Tell your doctor immediately if you experience:
Danish: Fortæl omgående lægen hvis du oplever:
English: Frequency ‘not known': pulmonary hypertension
Danish: Hyppighed "ikke kendt": pulmonal hypertension
English: • Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Danish: • Sig det til lægen, hvis du får øresmerter, udflåd fra øret og/eller betændelse i øret.
English: Leflunomide - Pulmonary hypertension (EPITT no 18221)
Danish: Leflunomid - Pulmonal hypertension (EPITT nr. 18221)
English: Bisphosphonates (alendronic acid; alendronic acid, colecalciferol; clodronic acid; etidronic acid; ibandronic; neridronic acid; pamidronic acid; risedronic acid; tiludronic acid; zoledronic acid) - Osteonecrosis of the external auditory canal (EPITT no 18256)
Danish: Bisfosfonater (alendronsyre; alendronsyre, cholecalciferol; clodronsyre; etidronsyre; ibandronsyre; neridronsyre; pamidronsyre; risedronsyre; tiludronsyre; zoledronsyre)Osteonekrose af øregangen (EPITT nr. 18256)
English: Interstitial lung disease is a potentially fatal disorder, which may occur acutely during therapy.
Danish: Interstitiel lungesygdom er en potentielt dødelig sygdom, som kan opstå akut under behandlingen.
English: - a cough or breathing problems as these may indicate inflammation problems of the lung (interstitial lung disease or pulmonary hypertension);
Danish: - hoste eller åndedrætsproblemer, da disse kan være tegn på lungeproblemer (interstitiel lungesygdom eller pulmonal hypertension).
English: Patients with human leukocyte antigen genotype such as HLA-DRB1*04:06 and HLA-DRB1*04:03 alleles, are more susceptible to develop IAS when treated with thioctic acid.
Danish: Patienter med leukocytantigen-genotype såsom HLA-DRB1*04:06- eller HLA-DRB1*04:03-alleler er mere tilbøjelige til at udvikle IAS ved behandling med alfaliponsyre.
English: Trabectedin - Capillary leak syndrome (EPITT no 18115)
Danish: Trabectedin - kapillærlækage-syndrom (EPITT nr. 18115)
English: Frequency unknown: Disorder of the blood glucose regulating hormones with pronounced lowering of blood sugar levels (insulin autoimmune syndrome).
Danish: Ukendt hyppighed: Forstyrrelse i de hormoner, der regulerer blodsukkeret, med udtalt sænkning af blodsukkeret (insulin autoimmun syndrom).