FrancophonIA/ELRC3.0 huggingface dataset:
English: Possible signs of severe allergic reaction may include:
Danish: Mulige tegn på alvorlig allergisk reaktion kan omfatte:
English: Ask about ways to prevent dehydration.
Danish: Spørg om hvordan du kan forebygge dehydrering.
English: Possible signs of losing too much fluid from your body are listed in section 4.
Danish: De mulige tegn på, at du mister for meget væske fra kroppen, er anført i afsnit 4.
English: Appropriate diet and exercise help your body use its blood sugar better.
Danish: Hensigtsmæssig diæt og motion hjælper din krop med at forbruge blodsukkeret bedre.
English: Severe allergic reaction, seen with unknown frequency (frequency cannot be estimated from the available data )
Danish: Alvorlig allergisk reaktion, der er set med en ikke kendt hyppighed (hyppigheden kan ikke estimeres ud fra forhåndenværende data)
English: • if you are taking medicines that increase urine production (diuretics).
Danish: • hvis du tager lægemidler, der øger urinproduktionen (diuretika).
English: Thereby Jardiance lowers the amount of sugar in your blood.
Danish: Derved sænker Jardiance mængden af sukker i blodet.
English: • if you have serious kidney or liver problems - your doctor may ask you to take a different medicine.
Danish: • hvis du har alvorlige nyre- eller leverproblemer - din læge vil måske sige, at du skal tage en anden medicin.
English: Possible signs are listed in section 4 under ‘dehydration'.
Danish: Tegn på dehydrering er anført i afsnit 4 under ‘dehydrering'.
English: If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same day.
Danish: Glemt dosis bør tages, når patienten kommer i tanker om dette, men en dobbeltdosis må ikke tages på samme dag.
English: If Fournier´s gangrene is suspected, Jardiance should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Danish: Hvis der er mistanke om Fourniers gangræn, bør Jardiance seponeres, og øjeblikkelig behandling (herunder antibiotika og kirurgisk debridement) bør iværksættes.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 May 2014
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 22. maj 2014 Dato for seneste fornyelse: 14. februar 2019
English: This causes blood sugar (glucose) to be removed in your urine.
Danish: Dette får blodsukkeret (glucose) til at blive fjernet med urinen.
English: Based on in vitro studies, empagliflozin is considered unlikely to cause interactions with active substances that are P-gp substrates.
Danish: Baseret på in vitro-studier betragtes det som usandsynligt, at empagliflozin forårsager interaktioner med aktive stoffer, der er P-gp-substrater.
English: Co-treatment with known inducers of UGT enzymes should be avoided due to a potential risk of decreased efficacy.
Danish: Samtidig behandling med kendte UGT-enzym-induktorer bør undgås på grund af en potentiel risiko for nedsat virkning.
English: Like for all diabetic patients it is important to counsel patients on routine preventative foot-care.
Danish: Det gælder for alle diabetespatienter, at det er vigtigt at rådgive patienterne om rutinemæssig forebyggende fodpleje.
English: Pruritus (generalised) Rash
Danish: Pruritus (generaliseret) Udslæt
English: • might be at risk of dehydration, for example: o if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink o if you are taking medicines that increase urine production [diuretics] or lower blood pressure o if you are over 75 years old.
Danish: • hvis du har risiko for væskemangel (dehydrering), for eksempel: o hvis du kaster op, har diarré eller har feber, eller hvis du ikke kan spise eller drikke o hvis du tager lægemidler, der øger urinproduktionen (diuretika) eller sænker blodtrykket o hvis du er over 75 år gammel.
English: Jardiance works by blocking the SGLT2 protein in your kidneys.
Danish: Jardiance virker ved at blokere SGLT2-proteinet i nyrerne.
English: Necrotising fasciitis of the perineum (Fournier´s gangrene)*
Danish: Nekrotiserende fasciitis i perineum (Fourniers gangræn)
English: Temporary interruption of empagliflozin should be considered in patients with complicated urinary tract infections.
Danish: Midlertidig afbrydelse af empagliflozin skal overvejes hos patienter med komplicerede urinvejsinfektioner.
English: • if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
Danish: • hvis du tager andre lægemidler, der sænker blodsukkeret, som for eksempel insulin eller et “sulfonylurinstof”.
English: • swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing)
Danish: • hævelse af ansigt, læber, mund, tunge eller hals, der kan føre til åndedrætsbesvær eller besvær ved synkning.
English: • blood tests may show a decrease in kidney function (creatinine or urea)
Danish: • blodprøver kan vise en nedsat nyrefunktion (kreatinin eller urinstof)
English: Jardiance is a member of a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors.
Danish: Jardiance tilhører en gruppe lægemidler, der hedder natrium-glucose-co-transporter 2 (SGLT2)-hæmmere.
English: These symptoms could be a sign of “diabetic ketoacidosis” - a rare, but serious, sometimes life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Danish: Disse symptomer kan være tegn på diabetisk ketoacidose - en sjælden, men alvorlig og somme tider livstruende komplikation, du kan få ved diabetes som følge af forhøjet niveau af ketonstoffer i urinen eller blodet, målt ved laboratorieanalyser.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. det er i det væsentlige natrium-frit.
English: Effects of empagliflozin on other medicinal products Based on in vitro studies, empagliflozin does not inhibit, inactivate, or induce CYP450 isoforms.
Danish: Empagliflozins indvirkning på andre lægemidler Empagliflozin hverken hæmmer, inaktiverer eller inducerer CYP-isoformer.
English: A paediatric Phase 1 study examined the pharmacokinetics and pharmacodynamics of empagliflozin (5 mg, 10 mg and 25 mg) in children and adolescents ≥10 to <18 years of age with type 2 diabetes mellitus.
Danish: Et pædiatrisk fase 1-studie undersøgte farmakokinetikken og farmakodynamikken for empagliflozin (5 mg, 10 mg og 25 mg) hos børn og unge i alderen ≥10 til <18 år med type 2 diabetes mellitus.
English: In combination with metformin in drug-naïve patients A factorial design study of 24 weeks duration was conducted to evaluate the efficacy and safety of empagliflozin in drug-naïve patients.
Danish: I kombination med metformin hos lægemiddelnaive patienter Der er gennemført et 24-ugers studie med faktorielt design til vurdering af empagliflozins virkning og sikkerhed hos lægemiddelnaive patienter.
English: • blood tests may show an increase in blood fat (cholesterol) levels in your blood
Danish: • blodprøver kan vise en forhøjelse i blodets indhold af fedt (kolesterol)
English: - The other ingredients are: tablet core: lactose monohydrate (see end of section 2 under ‘Jardiance contains lactose'), microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium (see end of section 2 under ‘Jardiance contains sodium'), colloidal anhydrous silica, magnesium stearate film-coating: hypromellose, titanium dioxide (E171), talc, macrogol (400), iron oxide yellow (E172)
Danish: - Øvrige indholdsstoffer: - tabletkerne: lactosemonohydrat (se sidst i afsnit 2 under ‘Jardiance indeholder lactose'), mikrokrystallinsk cellulose, hydroxypropylcellulose, croscarmellosenatrium (se sidst i afsnit 2 under 'Jardiance indeholder natrium'), kolloid vandfri silica, magnesiumstearat - filmovertræk: hypromellose, titandioxid (E171), talcum, macrogol (400), jernoxid gul (E172)
English: Table 1: Tabulated list of adverse reactions (MedDRA) from reported placebo-controlled studies and from post-marketing experience System organ class
Danish: Tabel 1: Tabel over bivirkninger (MedDRA) indberettet fra placebokontrollerede studier og rapporter efter markedsføring Systemorganklasse Meget almindelig Almindelig
English: Co administration of digoxin, a P-gp substrate, with empagliflozin resulted in a 6% increase in AUC and14% increase in Cmax of digoxin.
Danish: Samtidig administration af digoxin, et P-gp-substrat, og empagliflozin medførte en 6 % stigning i AUC og en 14 % stigning i Cmax for digoxin.
English: Each tablet contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium free'.
Danish: Hver tablet indeholder mindre end 1 mmol (23 mg) natrium, dvs. den er i det væsentlige natrium-fri.
English: Jardiance contains sodium
Danish: Jardiance indeholder natrium
English: What Jardiance is Jardiance contains the active substance empagliflozin.
Danish: Virkning Jardiance indeholder det aktive stof empagliflozin.
English: • rash or red skin - this may be itchy and include raised bumps, oozing fluid or blisters
Danish: • udslæt eller rød hud, som muligvis klør og omfatter knopper, sivende væske eller blærer
English: Other medicines and Jardiance
Danish: Brug af anden medicin sammen med Jardiance
English: Time to first event of CV death, non-fatal MI, or non-fatal stroke N (%) Hazard ratio vs. placebo (95.02% CI) p−value for superiority CV Death N (%) Hazard ratio vs. placebo (95% CI) p-value Non-fatal MI N (%) Hazard ratio vs. placebo (95% CI) p−value Non-fatal stroke N (%) Hazard ratio vs. placebo (95% CI) p−value All-cause mortality N (%) Hazard ratio vs. placebo (95% CI) p-value Non-CV mortality N (%) Hazard ratio vs. placebo (95% CI) CV = cardiovascular, MI = myocardial infarction Treated set (TS), i.e. patients who had received at least one dose of study drug Pooled doses of empagliflozin 10 mg and 25 mg Since data from the trial were included in an interim analysis, a two-sided 95.02% confidence interval applied which corresponds to a p-value of less than 0.0498 for significance.
Danish: Tid til første hændelse af CV død, ikkedødeligt MI eller ikke-dødelig apopleksi, N (%) Hazard ratio vs. placebo (95,02 % CI) p-værdi for superioritet CV død, N (%) Hazard ratio vs. placebo (95 % CI) p-værdi Ikke-dødeligt MI, N (%) Hazard ratio vs. placebo (95 % CI) p-værdi Ikke-dødelig apopleksi, N (%) Hazard ratio vs. placebo (95 % CI) p-værdi Mortalitet uanset årsag, N (%) Hazard ratio vs. placebo (95 % CI) p-værdi Ikke-CV mortalitet, N (%) Hazard ratio vs. placebo (95 % CI) CV = kardiovaskulær, MI = myokardieinfarkt Behandlet sæt, dvs. patienter, der har fået mindst én dosis forsøgslægemiddel Puljede doser af empagliflozin 10 mg og 25 mg Da data fra studiet indgår i en interim-analyse, er der anvendt et to-sidet 95,02 %-konfidensinterval, hvilket svarer til p < 0,0498 for signifikans.
English: Post-marketing cases of complicated urinary tract infections including pyelonephritis and urosepsis have been reported in patients treated with empagliflozin.
Danish: Tilfælde af komplicerede urinvejsinfektioner, herunder pyelonefritis og urosepsis, er blevet rapporteret hos patienter behandlet med empagliflozin efter markedsføring.
English: Empagliflozin should not be used in patients with ESRD or in patients on dialysis as it is not expected to be effective in these patients (see sections 4.2 and 5.2).
Danish: Patienter med terminal nyresygdom (ESRD) eller patienter, der er i dialyse, bør ikke anvende empagliflozin, da det ikke forventes at virke hos disse patienter (se pkt.
English: Each tablet contains lactose monohydrate equivalent to 154.3 mg lactose anhydrous.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver tablet indeholder lactosemonohydrat svarende til 154,3 mg lactose, vandfri.
English: Blood creatinine increased/ Glomerular filtration rate decreased Haematocrit increased a see subsections below for additional information Mean percent increases from baseline for empagliflozin 10 mg and 25 mg versus placebo, respectively, were total cholesterol 4.9% and 5.7% versus 3.5%; HDL-cholesterol 3.3% and 3.6% versus 0.4 %; LDL-cholesterol 9.5% and 10.0% versus 7.5%; triglycerides 9.2% and 9.9% versus 10.5%.
Danish: baseline for henholdsvis empagliflozin 10 mg og 25 mg versus placebo var for total kolesterol 4,9 % og 5,7 % versus 3,5 %; for HDL-kolesterol 3,3 % og 3,6 % versus 0,4 %; for LDL-kolesterol 9,5 % og 10,0 % versus 7,5 %; for triglycerider 9,2 % og 9,9 % versus 10,5 %.
English: The steady state mean plasma AUC and Cmax were 1870 nmol.h/l and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h/l and 687 nmol/l with empagliflozin 25 mg once daily.
Danish: Middel-AUC for plasma i steady state og Cmax var 1870 nmol x time/l og 259 nmol/l for empagliflozin 10 mg én gang dagligt og 4740 nmol x time/l og 687 nmol/l for empagliflozin 25 mg og én gang dagligt.
English: Each tablet contains lactose monohydrate equivalent to 107.4 mg lactose anhydrous.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver tablet indeholder lactosemonohydrat svarende til 107,4 mg lactose, vandfri.
English: How Jardiance works
Danish: Sådan virker Jandiance
English: Uncommon Rare
Danish: Ikke almindelige
English: Jardiance 10 mg film-coated tablets Each tablet contains 10 mg empagliflozin.
Danish: Jardiance 10 mg filmovertrukne tabletter Hver tablet indeholder 10 mg empagliflozin.
English: Jardiance 25 mg film-coated tablets Each tablet contains 25 mg empagliflozin.
Danish: Jardiance 25 mg filmovertrukne tabletter Hver tablet indeholder 25 mg empagliflozin.
English: An increase in cases of lower limb amputation (primarily of the toe) has been observed in long-term clinical studies with another SGLT2 inhibitor.
Danish: I kliniske langtidsstudier med en anden SGLT2-hæmmer er der observeret et øget antal amputationer af en underekstremitet (især af en tå).
English: Table 2: Efficacy results of a 24 week placebo-controlled study of empagliflozin as monotherapy Placebo
Danish: Tabel 2: Effektresultater af et 24 ugers placebokontrolleret studie med empagliflozin som monoterapi
English: 16.1%, empagliflozin 25 mg: 11.5%, placebo: 8.4%), add-on to basal insulin with or without metformin and with or without a sulphonylurea (empagliflozin 10 mg: 19.5%, empagliflozin 25 mg: 28.4%, placebo: 20.6% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg and 25 mg: 36.1%, placebo 35.3% over the 78-week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 39.8%, empagliflozin 25 mg: 41.3%, placebo: 37.2% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 51.1%, empagliflozin 25 mg: 57.7%, placebo: 58% over the 52-week trial).
Danish: En øget hyppighed blev bemærket ved administration som supplement til metformin og et sulfonylurinstof (empagliflozin 10 mg: 16,1 %, empagliflozin 25 mg: 11,5 %, placebo: 8,4 %), som supplement til basal-insulin med eller uden metformin og med eller uden et sulfonylurinstof (under de indledende 18 ugers behandling, hvor insulin ikke kunne justeres: empagliflozin 10 mg: 19,5 %, empagliflozin 25 mg: 28,4 %, placebo: 20,6 %; henover det 78 uger lange studie: empagliflozin 10 mg og 25 mg: 36,1 %, placebo 35,3 %), og som supplement til insulin flere gange daglig (MDI) med eller uden metformin (under de indledende 18 ugers behandling, hvor insulin ikke kunne justeres: empagliflozin 10 mg: 39,8 %, empagliflozin 25 mg: 41,3 %, placebo: 37,2 %; henover det 52 uger lange studie: empagliflozin 10 mg: 51,1 %, empagliflozin 25 mg: 57,7 %, placebo: 58 %).
English: An increased frequency was noted when given as add-on to basal insulin with or without metformin and with or without a sulfonylurea (empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, placebo: 0% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, placebo 0% over the 78-week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 0.5%, empagliflozin 25 mg: 0.5%, placebo: 0.5% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 1.6%, empagliflozin 25 mg: 0.5%, placebo: 1.6% over the 52-week trial).
Danish: Som supplement til basal-insulin med eller uden metformin samt insulin med eller uden et sulfonylurinstof, sås en øget hyppighed af svær hypoglykæmi (under de indledende 18 ugers behandling, hvor insulin ikke kunne justeres: empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1,3 %, placebo: 0 %; henover det 78 uger lange studie: empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1,3 %, placebo 0 %), og som supplement til insulin flere gange daglig (MDI) med eller uden metformin (under de indledende 18 ugers behandling, hvor insulin ikke kunne justeres: empagliflozin 10 mg: 0,5 %, empagliflozin 25 mg: 0,5 %, placebo: 0,5 %; henover det 52 uger lange studie: empagliflozin 10 mg: 1,6 %, empagliflozin 25 mg: 0,5 %, placebo: 1,6 %).
English: Pharmacotherapeutic group: Drugs used in diabetes, Other blood glucose lowering drugs, excl. insulins, ATC code: A10BK03
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, andre blodglucosesænkende midler, ekskl.
English: Low blood sugar (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people) If you take Jardiance with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher.
Danish: Hvis du tager Jardiance sammen med andre lægemidler, der kan give for lavt blodsukker, som for eksempel et sulfonylurinstof eller insulin, har du højere risiko for at få for lavt blodsukker.
English: NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg tablets empagliflozin
Danish: LÆGEMIDLETS NAVN Jardiance 10 mg tabletter empagliflozin
English: NAME OF THE MEDICINAL PRODUCT Jardiance 25 mg tablets empagliflozin
Danish: LÆGEMIDLETS NAVN Jardiance 25 mg tabletter empagliflozin
English: NAME OF THE MEDICINAL PRODUCT Jardiance 25 mg film-coated tablets empagliflozin
Danish: LÆGEMIDLETS NAVN Jardiance 25 mg filmovertrukne tabletter empagliflozin
English: NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg film-coated tablets empagliflozin
Danish: LÆGEMIDLETS NAVN Jardiance 10 mg filmovertrukne tabletter empagliflozin
English: Study BIG 1-98
Danish: Studie BIG 1-98
English: Maximum suppression is achieved in 48-78 hours.
Danish: Maksimal suppression opnås efter 48-78 timer.
English: You may not experience any of them.
Danish: Du vil muligvis ikke få nogen af dem.
English: Study D2407
Danish: Studie D2407
English: Time to progression Median
Danish: Tid til progression Median
English: Adult and elderly patients
Danish: Voksne og ældre patienter
English: The analyses presented here ignore the selective crossover.
Danish: Analysen, som præsenteres her, ignorerer det selektive crossover.
English: Your doctor will regularly monitor your condition to check whether the treatment is having the right effect.
Danish: Din læge vil undersøge dig jævnligt for at tjekke, om behandlingen har den rette effekt.
English: Do not be alarmed by this list of possible side effects.
Danish: Bliv ikke forskrækket over denne liste af bivirkninger.
English: Children and adolescents (below 18 years) Children and adolescents should not use this medicine.
Danish: Børn og teenagere (under 18 år) Børn og unge må ikke bruge dette lægemiddel.
English: They may differ from the general information in this leaflet.
Danish: Den kan være forskellig fra den generelle information i denne indlægsseddel.
English: Systemic exposure to metabolites is therefore low.
Danish: Den systemiske eksponering for metabolitter er derfor lav.
English: Your doctor will take this into account during your treatment with {Invented Name}.
Danish: Din læge vil tage det i betragtning under din behandling med {X}.
English: 9.4 months
Danish: 9,4 måneder
English: Extended adjuvant treatment (MA-17)
Danish: Forlænget adjuverende behandling (MA-17)
English: Older people (age 65 years and over) People aged 65 years and over can use this medicine at the same dose as for other adults.
Danish: Ældre (65 år og derover) Patienter over 65 år kan bruge dette lægemiddel med samme dosering som for øvrige voksne.
English: 6.0 months
Danish: 6,0 måneder
English: It is used to prevent cancer from happening again.
Danish: Det bruges til at forhindre brystkræft i at opstå igen.
English: Do not take a double dose to make up for the one that you missed.
Danish: - Tag aldrig dobbeltdosis for at erstatte den dosis, du har glemt.
English: (5.4, 6.3 months)
Danish: (5,4-6,3 måneder)
English: Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment.
Danish: De fleste af bivirkningerne er lette til moderate og vil almindeligvis forsvinde efter få dage til få uger.
English: If you feel dizzy, tired, drowsy or generally unwell, do not drive or operate any tools or machines until you feel normal again.
Danish: Hvis du føler dig svimmel, træt eller generelt utilpas, må du ikke køre bil eller betjene værktøj og maskiner, før du føler dig frisk igen.
English: The tablet can be taken with or without food and should be swallowed whole with a glass of water or another liquid.
Danish: Tabletten kan tages sammen med eller uden mad og skal synkes hel med et glas vand eller anden væske.
English: Since steady-state levels are maintained over time, it can be concluded that no continuous accumulation of letrozole occurs.
Danish: Eftersom steady state-koncentrationen opretholdes over tid, kan man konkludere, at der ikke sker vedvarende akkumulering af letrozol.
English: (95% CI for median) (8.9, 11.6 months)
Danish: (95% KI for median) (8,9-11,6 måneder)
English: No dose adjustment is required for elderly patients.
Danish: Dosisjustering til ældre patienter er ikke nødvendig.
English: The results are summarised in Table 9:
Danish: Opsummerede resultater findes i Tabel 9.
English: Oestrogen suppression was maintained throughout treatment in all these patients.
Danish: Østrogensuppressionen blev opretholdt gennem hele behandlingsforløbet hos alle disse patienter.
English: The apparent terminal elimination half-life in plasma is about 2 days.
Danish: Den tilsyneladende terminale plasmahalveringstid er ca. 2 dage.
English: Its apparent volume of distribution at steady state is about 1.87  0.47 l/kg.
Danish: Det tilsyneladende fordelingsvolumen ved steady state er ca. 1,87 ± 0,47 l/kg.
English: The absence of an advantage for {Invented Name} on overall survival could be explained by the crossover design of the study.
Danish: Den manglende fordel for {X} på den totale overlevelse kan skyldes studiets crossover design.
English: {Invented Name} contains lactose {Invented Name} contains lactose (milk sugar).
Danish: {X} indeholder lactose {X} indeholder lactose (mælkesukker).
English: Limited data are available and no recommendation on a posology can be made.
Danish: Der foreligger begrænsede data, og der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Sequential Treatments Analysis (STA)
Danish: Analyse af sekvensbehandling (STA)
English: Thus, glucocorticoid and mineralocorticoid supplementation is not necessary.
Danish: Supplement af glukokortikoid eller mineralkortikoid er derfor ikke nødvendig.
English: Study design allowed patients to cross over upon progression to the other therapy or discontinue from the study.
Danish: Studiedesignet tillod patienterne at overgå til den anden behandlingsarm ved progression eller at udgå af studiet.
English: You must not take {Invented Name} if you are pregnant or breast feeding as it may harm your baby.
Danish: - Du må ikke tage {X}, hvis du er gravid eller ammer, da det kan skade dit barn.
English: Otherwise, take the dose as soon as your remember, and then take the next tablet as you would normally.
Danish: - Tag ellers den næste dosis, så snart du kommer i tanker om det, og tag derefter næste tablet, som du normalt ville have gjort.