FrancophonIA/ELRC3.0 huggingface dataset:
English: inflammations or ulcers causing abdominal pain or diarrhoea, bleedings in the stomach, inflammations or ulcers in the mouth, collection of fluid in the belly, vomiting, abdominal pains, indigestion, constipation, flatulence, bloating, loose stools, stomach problems uncommon:
Danish: betændelse eller mavesår som giver mavesmerter eller diarré, maveblødning, betændelse eller sår i munden, væskeansamling i bughulen, opkastning, mavesmerter, fordøjelsesbesvær, forstoppelse, flatulens, oppustethed, løs afføring, maveproblemer
English: coagulopathies, coagulation and bleeding analyses abnormal, pancytopenia, neutropenia rare:
Danish: koagulationsforstyrrelser, unormale koagulations- og blødningsanalyser, pancytopeni, neutropeni
English: The medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients.
Danish: Behandlingen bør udelukkende foretages af speciallæger med særlig indsigt i immunosuppressiv behandling af organtransplanterede patienter.
English: infarction, venous thrombosis deep limb, shock Respiratory, thoracic and mediastinal disorders common:
Danish: infakt, dyb venetrombose, shock Sygdomme i åndedrætsorganer, brysthule og mediastinum Almindelige:
English: psychotic disorder Nervous system disorders very common:
Danish: psykotiske forstyrrelser Sygdomme i nervesystemet Meget almindelige:
English: Kidney transplantation:
Danish: Nyretransplantation:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt]
English: In treatment of acute rejection the therapeutic regimen with tacrolimus has been proven to provide either a significantly improved histological endomyocardial biopsy grading of rejection or a resolution of rejection.
Danish: Ved akut afstødning har behandling med tacrolimus vist sig enten at resultere i en væsentligt lettere grad af afstødning, bedømt ved histologisk undersøgelse af en biopsi af endomyokardiet, eller i resolution af afstødningen.
English: Prograf 5 mg Capsules
Danish: ALUMINIUMPOSER 5 mg KAPSLER
English: obstruction of the gut, increased blood level of the enzyme amylase, reflux of stomach content in your throat, delayed emptying of the stomach rare:
Danish: tarmslyng , øget blodniveau af enzymet amylase, tilbageløb af maveindhold, forsinket tømning af mavesækken
English: Marketing Authorisation Holder and Manufacturer [To be completed nationally]
Danish: Indehaveren af markedsføringstilladelsen og fremstiller [Udfyldes nationalt]
English: Administration should commence within 24 hours after the completion of surgery.
Danish: Doseringen skal indledes inden 24 timer efter indgrebet.
English: 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 rare:
Danish: uregelmæssig hjerteslag, hjertestop, hjertesvigt, forstyrrelser i hjertemuskulaturen, forstørret hjertemuskulatur, øget puls, unormalt EKG, unormal hjerteslag og puls
English: STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally]
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER [Udfyldes nationalt]
English: Herbal preparations containing St. John's wort (Hypericum perforatum) or other herbal preparations should be avoided when taking <Invented name> due to the risk of interactions that lead to decrease in blood concentrations of tacrolimus and reduced clinical effect of tacrolimus (see section 4.5
Danish: Urtemedicin indeholdende prikbladet hyperikum eller anden urtemedicin bør undgås ved behandling med <[(Sær)navn]> pga. risikoen for inetraktioner, som kan medføre fald i blodkoncentrationen af tacrolimus og nedsat klinisk effekt (se afsnit 4.5 Interaktion med andre lægemidler og andre former for interaktion).
English: increased blood sugar, diabetes mellitus, increased potassium in the blood common:
Danish: forhøjet blodsukker, sukkersyge, øget kaliumindhold i blodet
English: Concentrate for Solution for Infusion
Danish: Koncentrat till infusionsvaeske, opløsning
English: Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CPMP considered that the benefit/risk ratio of Prograf and associated names is favourable for use relating to:
Danish: På grundlag af den dokumentation, der er forelagt af indehaverne af markedsføringstilladelserne, og de faglige drøftelser i udvalget anser CHMP benefit/risk-forholdet for Prograf og tilhørende navne for gunstigt ved anvendelse til: - Profylakse af transplantatafstødning hos patienter med lever-, nyre- og hjerte-allotransplantat - Behandling af allotransplantat afstødning, der er resistent over for behandling med andre immunosupressive lægemidler
English: Astellas Pharma GmbH Neumarkter Str. 61 81673 München Germany
Danish: Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München Tyskland
English: The use of ibuprofen, amphotericin B, antivirals (e.g. aciclovir), may worsen kidney or nervous system problems when taken together with <Invented name>.
Danish: Hvis man samtidig med <[(Sær)navn]> tager ibuprofen, amphotericin B, antivirale midler (f.eks. aciclovir) kan problemer med nyrer eller centralnervesystemet forværres.
English: Whereas,
Danish: : {nummer}
English: Caution is therefore necessary in patients who have previously received preparations containing polyoxyethylene castor oil derivatives either by intravenous injection or infusion, and in patients with an allergenic predisposition.
Danish: injektion eller infusion af lægemidler indeholdende polyoxyethylenhydrogeniseret ricinusolie og patienter med allergi.
English: hepatic enzymes and function abnormalities, cholestasis and jaundice, hepatocellular damage and hepatitis, cholangitis rare:
Danish: unormal leverenzymtal og funktion, cholestase og gulsot, skade på leverceller og hepatitis, cholangitis
English: subileus, pancreatic pseudocyst Hepatobiliary disorders common:
Danish: subileus, cyster i pancreas Sygdomme i lever og galdeveje Almindelige:
English: If you have previously had such a problem, please inform your doctor.
Danish: Kontakt lægen, hvis De tidligere har haft dette problem.
English: Always take <Invented name> exactly as your doctor has told you.
Danish: <[(Sær)navn]> bør altid tages i nøje overensstemmelse med din læges instruktioner.
English: anxiety symptoms, confusion and disorientation, depression, mood changes, nightmare, hallucination, mental disorders
Danish: ængstelse, forvirring og disorientering, depression, humørsvingninger, mareridt, hallucination, forstyrret sindstilstand
English: It is possible in some cases to withdraw concomitant immunosuppressive therapy, leading to <Invented name> monotherapy.
Danish: Det er i nogle tilfælde muligt at seponere anden immunosuppressiv behandling således, at langtidsbehandlingen kan fortsætte som <[(Sær)navn]> baseret monoterapi.
English: hirsutism
Danish: hirsutisme
English: dyspnoea, parenchymal lung disorders, pleural effusion, pharyngitis, cough, nasal congestion and inflammations uncommon:
Danish: dyspnø, parenkym lungelidelse , pleural ekssudation, pharyngitis, hoste, tilstopning og inflammation i næsen
English: The dose recommendations for lung, pancreas and intestinal transplantation are based on limited prospective clinical trial data.
Danish: Doseringsvejledning - behandling af afstødning, andre allotransplantater Dosisrekommandationerne for lunge-, pankreas- og intestinal transplantationer er baseret på begrænsede prospektive kliniske data.
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: Fødeindtagelse nedsætter både hastighed og absorberet mængde tacrolimus.
English: The steady-state volume of distribution based on plasma concentrations is approximately 1300 l (healthy subjects).
Danish: På basis af måling af plasmakoncentrationer hos raske forsøgspersoner, fandt man et gennemsnitligt steady-state distributionsvolumen på ca. 1300 l. Det tilsvarende tal baseret på fuldblod var 47,6 l.
English: Hypersensitivity to any of the excipients.
Danish: Kendt overfølsomhed overfor andre indholdsstoffer.
English: The effect of a high-carbohydrate meal is less pronounced.
Danish: Effekten er størst efter et meget fedtholdigt måltid, hvorimod effekten er mindre udtalt efter et kulhydrat rigt måltid.
English: multi-organ failure, influenza like illness, temperature intolerance, chest pressure sensation, feeling jittery, feeling abnormal, blood lactate dehydrogenase increased, weight decreased rare:
Danish: multiorgan svigt, influenza lignende symptomer, temperaturintolerans, trykken for brystet, nevøsitet, fremmedfølelse, øget blod lactatdehydrogenase, vægtfald
English: Lung transplantation
Danish: Lungetransplantation
English: Renal and urinary disorders very common:
Danish: Sygdomme i nyre og urinveje Meget almindelige:
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 mg - 0,03 mg/kg/dag derpå blev peroral tacrolimus administreret i doser på 0,05 - 0,3 mg/kg/dag.
English: In man, the disposition of tacrolimus after intravenous infusion may be described as biphasic.
Danish: Tacrolimus farmakokinetik efter intravenøs infusion kan bedst beskrives med en to-compartment model.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt]
English: blurred vision, increased sensitivity to light, eye disorders uncommon:
Danish: sløret syn, øget lysfølsomhed, problemer med øjnene
English: Astellas Pharma S.p.A.
Danish: Astellas Pharma S.A.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 1 mg CAPSULES
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON 1 mg KAPSLER
English: Your doctor will then prescribe <Invented name> capsules for you instead.
Danish: Lægen vil derefter give dig <[(Sær)navn]> kapsler.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 0.5 mg CAPSULES
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON 0,5 mg KAPSLER
English: Take special care with <Invented name>
Danish: <Særnavn> <Navn>
English: Your doctor also needs to know if you are taking potassium supplements or potassium-sparing diuretics (e.g., amiloride, triamterene, or spironolactone), certain pain killers (so-called NSAIDs, e.g. ibuprofen), anticoagulants, or oral medication for diabetic treatment, while you receive <Invented name>.
Danish: Lægen skal også vide om De får kaliumtilskud eller kalimbesparende vanddrivende medicin (f.eks. amilorid, triamteren eller spironolakton), særlige smertestillende midler (NSAID f.eks. ibuprofen), antikoagulationsmedicin eller tabletter mod sukkersyge.
English: In healthy subjects, <Invented name> 0.5 mg, <Invented name> 1 mg and <Invented name> 5 mg Capsules, hard have been shown to be bioequivalent, when administered as equivalent dose.
Danish: Hos raske forsøgspersoner er kapsler hårde à <[(Sær)navn]> 0,5 mg, <[(Sær)navn]> 1 mg og <[(Sær)navn]> 5 mg bio-ækvivalente når de administreres i ækvivalente doser.
English: 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 uncommon:
Danish: general svaghed, feber, væskeansamling i kroppen, smerter og ubehag, øget indhold af enzymet basisk fosfatase i blodet, vægtstigning, ændret opfattelse af kropstemperatur
English: - The active substance is tacrolimus - The other ingredients are [To be completed nationally].
Danish: - De øvrige indholdsstoffer er [Udfyldes nationalt].
English: It is recommended that the oral daily dose be administered in two divided doses (e.g. morning and evening).
Danish: Det anbefales at den daglige orale dosis fordeles på 2 doser.(f.eks.
English: As is well known for other potent immunosuppressive agents, patients receiving tacrolimus are frequently at increased risk for infections (viral, bacterial, fungal, protozoal).
Danish: Som det er tilfældet ved behandling med andre potente immunosuppressive midler, øger behandlingen med tacrolimus patienternes modtagelighed for infektioner med vira, bakterier, fungi og/eller protozoer; også forløbet af eksisterende infektionssygdomme kan forværres.
English: diarrhoea, nausea common:
Danish: diarré, kvalme
English: hypocalcaemia, hyponatraemia, fluid overload, hyperuricaemia, appetite decreased, anorexia, metabolic acidoses,
Danish: hypomagnesæmi, hypofosfatæmi, hypokaliæmi, hypocalcæmi, hyponatriæmi, hypervolæmi, hyperurikæmi, nedsat appetit, anoreksi, metabolisk acidose, hyperlipidæmi,hypercholesterolæmi, hypertriglyceridæmi, andre elektrolytforstyrrelser
English: PHARMACEUTICAL FORM AND CONTENTS [To be completed nationally]
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) [Udfyldes nationalt]
English: Nervous system disorders very common:
Danish: Sygdomme i nervesystemet Meget almindelige:
English: ventricular arrhythmias and cardiac arrest, heart failures, cardiomyopathies, ventricular hypertrophy, supraventricular arrhythmias, palpitations, ECG investigations abnormal, heart rate and pulse investigations abnormal rare:
Danish: ventrikulære arytmier og hjertestop, hjertesvigt, kardiomyopati, ventrikulær hypertrofi, supraventrikulær arytmi, palpitationer, EKG forandringer, forandringer i hjerterytme og puls
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 serumkreatinin koncentrationer, beregning af kreatinin clearance og kontrol af diurese).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL 1 mg CAPSULES
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERFOLIE 1 mg KAPSLER
English: Heart disorders common:
Danish: Hjertesygdomme Almindelige:
English: Psychiatric disorders very common:
Danish: Psykiske lidelser Meget almindelige:
English: Tacrolimus was started as continuous intravenous infusion at a dose of 0.05 mg/kg/day and oral tacrolimus was administered at a dose of 0.1 to 0.3 mg/kg/day with subsequent dose adjustments to target trough levels of 12 to 15 ng/ml.
Danish: Tacrolimus startede som kontinuerlig intravenøs infusion med doser på 0,05 mg/kg/dag hvorefter oral tacrolimus blev administreret i doser på 0,1 - 0,3 mg/kg/dag med følgende dosisjustering for at nå dalkoncentrationer på 12 - 15 ng/ml.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL 0.5 mg CAPSULES
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERFOLIE 0,5 mg KAPSLER
English: Tacrolimus was started as continuous intravenous infusion at a dose of 0.025 mg/kg/day and oral tacrolimus was administered at a dose of 0.15 mg/kg/day with subsequent dose adjustments to target trough levels of 10 to 20 ng/ml.
Danish: Tacrolimus blev startet som kontinuerlig intravenøs infusion med doser på 0,025 mg/kg/dag , peroral tacrolimus blev administreret i doser på 0,15 mg/kg/dag med følgende dosisjustering for at nå dalkoncentrationer på10-20 ng/ml.
English: Fujisawa GmbH* Neumarkter Str. 61 81673 München Germany
Danish: Fujisawa GmbH Neumarkter Str. 61 81673 München Tyskland
English: Whilst you are taking <Invented name> your doctor may want to carry out a number of tests (including blood, urine, heart function, visual and neurological tests) from time to time.
Danish: analysering af blod- og urinprøver, undersøgelse af hjertefunktionen, visuelle og neurologiske tests).
English: Following antibody induction, if <Invented name> therapy is initiated orally, the recommended starting dose is 0.10 - 0.30 mg/kg/day administered as two divided doses (e.g. morning and evening).
Danish: Hvis <[(Sær)navn]> behandling er initieret peroralt efter antistofinduktion er den anbefalede dosis 0,10 - 0,30 mg/kg/dag fordelt på 2 doser (f.eks. morgen og aften).
English: Following antibody induction, oral <Invented name> therapy should commence at a dose of 0.075 mg/kg/day administered as two divided doses (e.g. morning and evening).
Danish: Efter antistofinduktion bør peroral <[(Sær)navn]> behandling begynde med en dosis på 0,075 mg/kg/dag fordelt på 2 doser (f.eks. morgen og aften).
English: blood clot in a vein of a limb, shock Respiratory tract disorders common:
Danish: blodprop i vene i lemmerne, chok Sygdomme i åndedrætsorganerne Almindelige:
English: hypokalaemia,
Danish: hypoacusis
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 5 mg CAPSULES
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON 5 mg KAPSLER
English: After reconstitution: [To be completed nationally]
Danish: Udløbsdato: {MM/YYYY} Efter rekonstitution: [Udfyldes nationalt]
English: changes in blood clotting, reduction in all blood cell counts rare:
Danish: ændret blodstørkning, nedsat antal blodceller
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL 5 mg CAPSULES
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERFOLIE 5 mg KAPSLER
English: shortness in breath, changes in the lung tissue, collection of liquid around the lung, inflammation of the pharynx, cough, flu-like symptoms uncommon:
Danish: stakåndethed, forandring i lungevæv, væskeansamling omkring lungen, betændelse i svælget, hoste, influenzalignende symptomer
English: renal failure, renal failure acute, oliguria, renal tubular necrosis, nephropathy toxic, urinary abnormalities, bladder and urethral symptoms uncommon:
Danish: nyresvigt, akut nyresvigt, oliguri, renal tubulær nekrose, toksisk neuropati, vandladningsproblemer , symptomer fra blære og urinveje
English: myasthenia
Danish: myastenia
English: NAME OF THE MEDICINAL PRODUCT Prograf and associated names (see Annex I) 0.5 mg hard capsules Prograf and associated names (see Annex I) 1 mg hard capsules Prograf and associated names (see Annex I) 5 mg hard capsules [See Annex I - To be completed nationally]
Danish: Prograf og tilknyttede navne (se bilag I) 0,5 mg kapsler, hårde Prograf og tilknyttede navne (se bilag I) 1 mg kapsler, hårde Prograf og tilknyttede navne (se bilag I) 5 mg kapsler, hårde [Se bilag I - Udfyldes nationalt]
English: What <Invented name> looks like and contents of the pack [To be completed nationally]
Danish: Hvad <[(Sær)navn]> indeholder [Udfyldes nationalt]
English: opacity of the lens rare:
Danish: uklarhed af linsen
English: An initial oral dose of 0.30 mg/kg/day should be administered in two divided doses (e.g. morning and evening).
Danish: Der skal gives en initial peroral dosis på 0,30 mg/kg/dag, fordelt på 2 doser (f.eks morgen og aften).
English: Oral administration appears to be associated with a lower incidence of adverse drug reactions compared with intravenous use.
Danish: Peroral behandling synes at give anledning til de færreste bivirkninger i sammenligning med parenteral anvendelse.
English: muscular weakness
Danish: øget muskelstivhed
English: gastrointestinal inflammatory conditions, gastrointestinal ulceration and perforation, gastrointestinal haemorrhages, stomatitis and ulceration, ascites, vomiting, gastrointestinal and abdominal pains, dyspeptic signs and symptoms, constipation, flatulence, bloating and distension, loose stools, gastrointestinal signs and symptoms uncommon:
Danish: inflammatoriske og ulcerative lidelser i mave-tarmkanalen, blødning i mavetarmkanalen, ulcerøs stomatitis, ascites, opkastning, smerter i abdomen, dyspepsi, obstipation, flatulens, oppustethed, tynd afføring, symptomer fra mave-tarmkanalen
English: dysmenorrhoea and uterine bleeding General disorders and administration site conditions common:
Danish: dysmennoré og uterin blødning Almene lidelser og reaktioner på indgivelsesstedet Almindelige:
English: vision blurred, photophobia, eye disorders uncommon:
Danish: sløret syn, fotofobi, øjenlidelser
English: anxiety symptoms, confusion and disorientation, depression, depressed mood, mood disorders and disturbances, nightmare, hallucination, mental disorders uncommon:
Danish: ængstelse, forvirring og disorientering, depression, humørsvingninger, mareridt, hallucination, forstyrret sindstilstand Sygdomme i nervesystemet Meget almindelige:
English: Inducers of metabolism
Danish: Metaboliske inducere
English: deafness
Danish: tinnitus
English: If in doubt please consult your doctor prior to taking any herbal products or remedies.
Danish: Spørg din læge eller apotek til råds, inden De tager nogen form for medicin.
English: Skin disorders common:
Danish: Hudsygdomme Almindelige:
English: increase of fat tissue Disorders of your transplanted organ common:
Danish: Sygdom i det transplanterede organ Almindelige:
English: pain in joints, limbs or back, muscle cramps uncommon:
Danish: smerter i led, lemmer eller ryg, muskelkramper
English: failure of some organs, influenza like illness, increased sensitivity to heat and cold, feeling of pressure on your chest, jittery or abnormal feeling, increase of the enzyme lactate dehydrogenase in your blood, weight loss rare:
Danish: organsvigt, influenzalignende sygdom, øget temperaturfølsomhed, trykken for brystet, nervøsitet eller fremmedfølelse, stigning i blodets indhold af enzymet lactatdehydrogenase, vægttab
English: Prograf and associated names (see Annex I) 0.5 mg hard capsules Prograf and associated names (see Annex I) 1 mg hard capsules Prograf and associated names (see Annex I) 5 mg hard capsules
Danish: Prograf og tilknyttede særnavne (se bilag I) 0,5 mg kapsler, hårde Prograf og tilknyttede særnavne (se bilag I) 1 mg kapsler, hårde Prograf og tilknyttede særnavne (se bilag I) 5 mg kapsler, hårde [Se bilag I- udfyldes nationalt] Tacrolimus
English: In adult patients converted to <Invented name>, an initial oral dose of 0.15 mg/kg/day should be administered in two divided doses (e.g. morning and evening).
Danish: Voksne patienter, der overgår til <[(Sær)navn]> behandling, bør initialt få perorale doser på 0,15 mg/kg/dag fordelt på 2 doser (f.eks. morgen og aften).
English: cyst formation in your pancreas Liver and gall bladder disorders common:
Danish: cystedannelse på bugspytkirtlen Sygdomme i lever og galdeveje Almindelige:
English: seizures, disturbances in consciousness, paraesthesias and dysaesthesias, peripheral neuropathies, dizziness, writing impaired, nervous system disorders uncommon:
Danish: krampeanfald, bevidsthedsforstyrrelser, ændringer i følesansen (f.eks.paræstesier), perifere neuropati, svimmelhed, nedsat skriveevne, forstyrrelser i nervesystemet
English: In particular, you should tell your doctor if you are taking or have recently taken medicines with active substances like: - antifungal medicines and antibiotics, particularly so-called macrolide antibiotics, used to treat infections e.g. ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole,
Danish: De skal i særdeleshed oplyse lægen, hvis De tager medicin, der indeholder aktivt stof som: - svampemidler og antibiotika, især såkaldte makrolider til behandling af infektioner f.eks.
English: Paediatric patients
Danish: Patienter med nedsat leverfunktion
English: If administered accidentally either arterially or perivasally, the reconstituted <Invented name> 5 mg/ml Concentrate for Solution for Infusion may cause irritation at the injection site.
Danish: Infusionsvæsken kan give irritation på injektionsstedet, hvis det rekonstituerede <[(Sær)navn]> 5 mg/ml koncentrat till infusionsvæske, opløsning fejlagtigt gives intraarterielt eller perivasalt.
English: BEFORE YOU TAKE <INVENTED NAME>
Danish: HVAD DE SKAL GØRE, FØR DE BEGYNDER AT TAGE <[(SÆR)NAVN]>