FrancophonIA/ELRC3.0 huggingface dataset:
English: Least squares mean adjusted for baseline value c
Danish: Mindste kvadraters gennemsnit justeret for baselineværdi c
English: Removal of dapagliflozin by haemodialysis has not been studied.
Danish: Fjernelse af dapagliflozin ved hæmodialyse er ikke undersøgt.
English: In a dedicated study in diabetic patients with an eGFR ≥ 45 to < 60 mL/min/1.73 m2, treatment with dapagliflozin demonstrated reductions in seated systolic blood pressure at Week 24: -4.8 mmHg compared to -1.7 mmHg for placebo (p < 0.05).
Danish: I et dedikeret studie med diabetespatienter med en eGFR ≥ 45 til < 60 ml/min/1,73 m2 viste behandling med dapagliflozin reduktioner i siddende systolisk blodtryk ved uge 24: -4,8 mmHg sammenlignet med -1,7 mmHg for placebo (p < 0,05).
English: •Xigduo5mg/850mg are 9.5x20mm oval, brown film-coated tablets.
Danish: • Xigduo 5 mg/850 mg er 9,5 x 20 mm ovale, brune filmovertrukne tabletter.
English: In a dedicated study in diabetic patients with an eGFR ≥ 45 to < 60 mL/min/1.73 m2, treatment with dapagliflozin demonstrated reductions in FPG at Week 24: -1.19 mmol/L (-21.46 mg/dL) compared to -0.27 mmol/L (-4.87 mg/dL) for placebo (p=0.001).
Danish: I et dedikeret studie med diabetespatienter med en eGFR ≥ 45 til < 60 ml/min/1,73 m2 viste behandling med dapagliflozin reduktioner i FPG ved uge 24: -1,19 mmol/l (-21,46 mg/dl) sammenlignet med -0,27 mmol/l (-4,87 mg/dl) for placebo (p=0,001).
English: Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with metformin (see sections 4.2 and 4.8)
Danish: Derfor kan det være nødvendigt at give en lavere dosis af insulin eller et ß-cellestimulerende middel for at nedsætte risikoen for hypoglykæmi, når det anvendes sammen med metformin (se pkt.
English: At Week 104, adjusted mean change from baseline in HbA1c was -0.32% for dapagliflozin and -0.14% for glipizide, respectively.
Danish: I uge 104 var den justerede gennemsnitlige ændring i HbA1c fra baseline henholdsvis -0,32 % for dapagliflozin og -0,14 % for glipizid.
English: In the dapagliflozin cardiovascular outcomes study (see section 5.1), 8,574 patients received dapagliflozin 10 mg and 8,569 received placebo for a median exposure time of 48 months.
Danish: 5.1) fik 8.574 patienter dapagliflozin 10 mg, og 8.569 fik placebo med median-eksponeringstid på 48 måneder.
English: Dapagliflozin as an add-on with either metformin alone, metformin in combination with sitagliptin, sulphonylurea or insulin (with or without additional oral glucose-lowering medicinal products, including metformin) resulted in statistically significant mean reductions in HbA1c at 24 weeks compared with subjects receiving placebo (p < 0.0001; Tables 4, 5 and 6).
Danish: Dapagliflozin som tillægsbehandling enten med metformin alene, metformin i kombination med sitagliptin, sulfonylurinstof eller insulin (med eller uden yderligere oral glukosesænkende medicin, herunder metformin) resulterede i statistisk signifikant gennemsnitlig reduktion i HbA1c efter 24 uger sammenlignet med forsøgspersoner, der fik placebo (p < 0,0001; Tabel 4, 5 og 6).
English: • redness of the skin (erythema), itching or an itchy rash (hives)
Danish: • rødme af huden (erytem), kløe eller kløende udslæt (nældefeber)
English: At Week 208, adjusted mean change from baseline in HbA1c was -0.10% for dapagliflozin and 0.20% for glipizide, respectively.
Danish: I uge 208 var den justerede gennemsnitlige ændring i HbA1c i forhold til baseline hhv. -0,10 % for dapagliflozin og 0,20 % for glipizid.
English: The starting dose is at most half of the maximum dose.
Danish: Maksimal daglig dosis er 1000 mg. Startdosis er højst halvdelen af den maksimale dosis.
English: Treatment with dapagliflozin 10 mg plus metformin showed a numerical decrease in visceral adipose tissue compared with placebo plus metformin treatment in a magnetic resonance imaging substudy.
Danish: I et supplerende studie med MR-scanning viste behandling med dapagliflozin 10 mg plus metformin en numerisk reduktion i mængden af visceralt adipøst væv sammenlignet med behandling med placebo plus metformin.
English: The combination of dapagliflozin 10 mg and prolonged-release exenatide demonstrated significantly greater weight reductions compared to either agent alone (Table 8).
Danish: Kombinationen af dapagliflozin 10 mg og depotformulering af exenatid viste signifikant større vægtreduktion sammenlignet med stofferne hver for sig (tabel 8).
English: In the 13-study safety pool, reactions suggestive of volume depletion (including, reports of dehydration, hypovolaemia or hypotension) were reported in 1.1% and 0.7% of subjects who received dapagliflozin 10 mg and placebo, respectively; serious reactions occurred in < 0.2% of subjects balanced between dapagliflozin 10 mg and placebo (see section 4.4).
Danish: I de 13 puljede sikkerhedsstudier blev der rapporteret bivirkninger, der tydede på volumendepletering (inklusive indberetninger om dehydrering, hypovolæmi eller hypotension), hos 1,1 % og 0,7 % af forsøgspersoner, som fik behandling med henholdsvis dapagliflozin 10 mg og placebo.
English: Body weight (kg) Baseline (mean) Change from baseline
Danish: Kropsvægt (kg) Baseline (gennemsnit) Ændring fra baseline
English: Urine glucose
Danish: Glukose i urinen
English: The pharmacodynamics of 5 mg dapagliflozin twice daily and 10 mg dapagliflozin once daily were compared in healthy subjects.
Danish: Farmakodynamikken for 5 mg dapagliflozin to gange dagligt og 10 mg dapagliflozin én gang dagligt blev sammenlignet hos raske forsøgspersoner.
English: The pharmacokinetics of 5 mg dapagliflozin twice daily and 10 mg dapagliflozin once daily were compared in healthy subjects.
Danish: Farmakokinetikken for 5 mg dapagliflozin to gange dagligt og 10 mg dapagliflozin én gang dagligt blev sammenlignet for raske forsøgspersoner.
English: • Lactic acidosis, seen very rarely (may affect up to 1 in 10,000 people) Xigduo may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Danish: Xigduo kan forårsage en meget sjælden, men meget alvorlig bivirkning, der kaldes laktatacidose (se afsnittet ”Advarsler og forsigtighedsregler”).
English: Hepatic impairment This medicinal product must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and
Danish: Nedsat leverfunktion Dette lægemiddel må ikke anvendes til patienter med nedsat leverfunktion (se pkt.
English: Xigduo must be discontinued prior to, or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.2 and 4.4).
Danish: Behandling med Xigduo skal afbrydes forud for eller på tidspunktet for billeddiagnostiske procedurer og først genoptages mindst 48 timer herefter, forudsat at nyrefunktionen er blevet vurderet og fundet stabil, se pkt.
English: Xigduo 5 mg/850 mg film-coated tablets
Danish: Xigduo 5 mg/850 mg filmovertrukne tabletter
English: Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.
Danish: Behandling med Xigduo skal afbrydes på tidspunktet for kirurgi under generel, spinal eller epidural anæstesi og må tidligst genoptages 48 timer efter kirurgi eller genoptagelse af oral ernæring og under forudsætning af, at nyrefunktionen er blevet vurderet og fundet stabil.
English: Caution should be exercised in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk, such as patients on anti-hypertensive therapy with a history of hypotension or elderly patients.
Danish: Lægemidlet bør anvendes med forsigtighed til patienter, hvor det blodtryksfald, som dapagliflozin kan fremkalde, kan udgøre en risiko for patienten.
English: - hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis); - diabetic pre-coma; - severe renal failure (GFR < 30 mL/min) (see sections 4.2, 4.4 and 5.2); - acute conditions with the potential to alter renal function such as: - dehydration, - severe infection, - shock; - acute or chronic disease which may cause tissue hypoxia such as: - cardiac or respiratory failure, - recent myocardial infarction, - shock; - hepatic impairment (see sections 4.2, 4.4 and 5.2); - acute alcohol intoxication, alcoholism (see section 4.5).
Danish: 4.2, 4.4 og 5.2); - akutte tilstande med potentiale til at ændre nyrefunktionen såsom: dehydrering, svær infektion, shock; akut eller kronisk sygdom som kan forårsage vævshypoksi såsom: hjerte- eller respirationssvigt, nyligt overstået myokardieinfarkt, shock; nedsat leverfunktion (se pkt.
English: Change from baseline Difference from glipizide + metformin c
Danish: Baseline (gennemsnitligt) Ændring fra baseline Forskel fra glipizid + metformin c
English: Xigduo 5 mg/850 mg tablets dapagliflozin/metformin HCl
Danish: Xigduo 5 mg/850 mg tabletter dapagliflozin/metformin HCl
English: Xigduo 5 mg/1,000 mg film-coated tablets
Danish: Xigduo 5 mg/1000 mg filmovertrukne tabletter
English: Each Xigduo 5 mg/850 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg metformin hydrochloride.
Danish: Hver Xigduo 5 mg/850 mg filmovertrukket tablet (tablet) indeholder dapagliflozinpropandiolmonohydrat svarende til 5 mg dapagliflozin og 850 mg metforminhydrochlorid.
English: • Before initiation of treatment and regularly thereafter (see sections 4.2, 4.8, 5.1 and 5.2).
Danish: 4.2, 4.8, 5.1 og 5.2).
English: Xigduo 5 mg/1,000 mg tablets dapagliflozin/metformin HCl
Danish: Xigduo 5 mg/1000 mg tabletter dapagliflozin/metformin HCl
English: Xigduo 5 mg/850 mg film-coated tablets Xigduo 5 mg/1,000 mg film-coated tablets
Danish: Xigduo 5 mg/850 mg filmovertrukne tabletter Xigduo 5 mg/1000 mg filmovertrukne tabletter
English: As an add-on therapy to metformin in an active-controlled non-inferiority study, dapagliflozin resulted in a statistically significant body weight change compared with glipizide of -4.65 kg at 52 weeks (p < 0.0001, Table 3) that was sustained at 104 and 208 weeks (-5.06 kg and -4.38 kg, respectively).
Danish: I et aktivt kontrolleret non-inferioritetsstudie resulterede dapagliflozin som tillægsbehandling til metformin i en statistisk signifikant vægtændring sammenlignet med glipizid på -4,65 kg efter 52 uger (p < 0,0001, tabel 3).
English: Musculoskeletal and
Danish: • muskelkramper
English: Body weight (kg) Baseline (mean) Change from baseline Difference from placebo c
Danish: Legemsvægt (kg) Baseline (gennemsnitlig) Ændring fra baseline Forskel fra placebo c
English: Posology Adults with normal renal function (glomerular filtration rate [GFR] ≥ 90 mL/min)
Danish: Voksne med normal nyrefunktion (glomerulær filtrationshastighed [GFR] ≥ 90 ml/min) Den anbefalede dosis er én tablet to gange dagligt.
English: Baseline (mean) Change from baseline Difference from placebo d
Danish: Baseline (gennemsnit) Ændring fra baseline Forskel fra placebo d
English: What you need to know before you take Xigduo 3.
Danish: Det skal du vide, før du begynder at tage Xigduo Sådan skal du tage Xigduo Bivirkninger
English: Xigduo has been demonstrated to be bioequivalent with coadministered dapagliflozin and metformin (see section 5.2).
Danish: Der er påvist bioækvivalens mellem Xigduo og samtidig administration af dapagliflozin og metformin (se pkt.
English: Each Xigduo 5 mg/1,000 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg metformin hydrochloride.
Danish: Hver Xigduo 5 mg/1000 mg filmovertrukket tablet (tablet) indeholder dapagliflozinpropandiolmonohydrat svarende til 5 mg dapagliflozin og 1000 mg metforminhydrochlorid.
English: Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride.
Danish: Hver tablet indeholder dapagliflozinpropandiolmonohydrat svarende til 5 mg dapagliflozin og 850 mg metforminhydrochlorid.
English: Dysuria Polyuria
Danish: Dysuri Polyuri
English: Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.
Danish: Hver tablet indeholder dapagliflozinpropandiolmonohydrat svarende til 5 mg dapagliflozin og 1000 mg metforminhydrochlorid.
English: Percent change from baseline Difference in percent change from placebo c
Danish: Baseline (gennemsnit) Ændring i procent fra baseline Forskel i ændring i procent fra placebo c
English: In case of suspected symptoms, the patient should stop taking Xigduo and seek immediate medical attention.
Danish: Patienterne skal informeres om at stoppe med at tage metformin og øjeblikkeligt søge lægehjælp ved symptomer, der kan give mistanke om laktatacidose.
English: Xigduo 5 mg/850 mg film-coated tablets Xigduo 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
Danish: Xigduo 5 mg/850 mg filmovertrukne tabletter Xigduo 5 mg/1000 mg filmovertrukne tabletter dapagliflozin/metforminhydrochlorid
English: Mean daily insulin dose (IU) Baseline (mean) Change from baseline Difference from placebo c
Danish: Gennemsnitlig daglig insulindosis (IE) Baseline (gennemsnitlig) Ændring fra baseline Forskel fra placebo c
English: Neither maternal nor developmental toxicities were observed in rabbits at any dose tested; the highest dose tested is associated with a systemic exposure multiple of approximately 1,191 times the maximum recommended human dose.
Danish: I yderligere studier af embryo-føtal udvikling hos rotter og kaniner blev der givet dapagliflozin i intervaller, der faldt sammen med de vigtigste perioder for organogenesen i hver art. Der blev ikke observeret hverken maternel eller udviklingsmæssig toksicitet hos kaniner ved nogen af de testede doser; den højeste dosis testet er forbundet med en multipel af systemisk eksponering, som er ca.
English: Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in the case of fasting, malnutrition or hepatic impairment due to the metformin active substance of this medicinal product (see section 4.4).
Danish: Intoksikationen forårsages af den aktive substans metformin i dette lægemiddel (se pkt.
English: • Low blood sugar levels (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people) - when taking this medicine with a sulphonylurea or other medicines that lower the amount of sugar in your blood, such as insulin.
Danish: • Lavt blodsukker (hypoglykæmi) - en meget almindelig bivirkning (kan forekomme hos mere end 1 ud af 10 personer) - når denne medicin tages sammen med et sulfonylurinstof eller anden medicin, der sænker mængden af sukker i dit blod, som f.eks. insulin Følgende er tegn på lavt blodsukker: - rysten, svedtendens, stærk angstfølelse, hurtig hjerterytme (puls) - sultfornemmelse, hovedpine, synsforstyrrelser - humørsvingninger eller forvirring.
English: HbA1c (%) Baseline (mean) Change from baseline
Danish: HbA1c (%) Baseline (gennemsnit) Ændring fra baseline
English: Dosage in patients with renal impairment GFR mL/min
Danish: GFR ml/min
English: Kidney function
Danish: Nedsat nyrefunktion
English: Xigduo 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
Danish: Xigduo 5 mg/1000 mg filmovertrukne tabletter dapagliflozin/metforminhydrochlorid
English: Xigduo 5 mg/850 mg film-coated tablets dapagliflozin/metformin hydrochloride
Danish: Xigduo 5 mg/850 mg filmovertrukne tabletter dapagliflozin/metforminhydrochlorid
English: Dose reduction may be considered in relation to declining renal function.
Danish: Maksimal daglig dosis er 3000 mg. Dosisreduktion kan overvejes i relation til faldende nyrefunktion.
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo d
Danish: HbA1c (%) Baseline (gennemsnit) Ændring fra baseline Forskel fra placebo d
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo b
Danish: HbA1c (%) Baseline (gennemsnit) Ændring fra baseline Forskel fra placebo b
English: Constipation Dry mouth
Danish: Forstoppelse Mundtørhed
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo c
Danish: HbA1c (%) Baseline (gennemsnitlig) Ændring fra baseline Forskel fra placebo c
English: Results at Week 52 (LOCF a) in an active-controlled study comparing dapagliflozin with glipizide as add-on to metformin
Danish: a) i et aktivt kontrolleret studie, der sammenligner dapagliflozin med glipizid som tillægsbehandling til metformin
English: Rash includes the following preferred terms, listed in order of frequency in clinical trials: rash, rash generalised, rash pruritic, rash macular, rash maculo-papular, rash pustular, rash vesicular, and rash erythematous.
Danish: Udslæt inkluderer følgende foretrukne termer i kliniske studier opstillet efter hyppighed: udslæt, generaliseret udslæt, kløende udslæt, makuløst udslæt, makulopapuløst udslæt, pustuløst udslæt, vesikulært udslæt og erytematøst udslæt.
English: Oral use bottle (glass)
Danish: Flaske (glas)
English: Treatment with conventional or biological medicines had not worked in these patients.
Danish: Behandling med konventionelle eller biologiske lægemidler havde ikke virket hos disse patienter.
English: This is a summary of the European public assessment report (EPAR) for Alofisel.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Alofisel.
English: Other information about Alofisel
Danish: Andre oplysninger om Alofisel
English: This is a type of medicine that contains cells or tissues that have been modified so that they can be used to cure, diagnose or prevent a disease.
Danish: Denne type lægemiddel indeholder celler eller væv, der er blevet ændret, så de kan anvendes til at helbrede, diagnosticere eller forebygge en sygdom.
English: Data on the safety of Alofisel are limited but they provide enough information on the pattern of side effects.
Danish: Data for sikkerheden ved Alofisel er begrænsede, men de giver tilstrækkelige oplysninger om bivirkningsmønstret.
English: The European Medicines Agency decided that Alofisel's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Alofisel opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Alofisel?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Alofisel?
English: Because the number of patients with anal fistula is low, the disease is considered ‘rare', and Alofisel was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 October 2009.
Danish: Da antallet af patienter med analfistler er lavt, betragtes sygdommen som "sjælden", og Alofisel blev udpeget som "lægemiddel til sjældne sygdomme" den 8. oktober 2009.
English: To make this medicine, the cells are selected and cultivated in the laboratory to increase their number.
Danish: Lægemidlet fremstilles ved at udvælge og dyrke cellerne i et laboratorium for at øge mængden af dem.
English: The company will also complete a study to continue to collect information on the effectiveness and safety of Alofisel.
Danish: Virksomheden skal også gennemføre en undersøgelse med henblik på indsamling af oplysninger om virkningen og sikkerheden ved Alofisel.
English: When injected into the walls of the fistula, these cells can help to reduce inflammation and support the growth of new tissue.
Danish: Når cellerne sprøjtes ind i fistelvæggene, kan de medvirke til at reducere betændelse og understøtte vækst af nyt væv.
English: What is Alofisel and what is it used for?
Danish: Hvad er Alofisel, og hvad anvendes det til?
English: The full EPAR for Alofisel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Alofisel findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Why is Alofisel approved?
Danish: Hvorfor blev Alofisel godkendt?
English: This encourages the fistula to heal and close.
Danish: Dette får fistlen til at hele og lukke sig.
English: It is not intended to provide practical advice on how to use Alofisel.
Danish: Det er ikke en praktisk vejledning i, hvordan Alofisel bør anvendes.
English: Of the patients treated with Alofisel, combined remission occurred in almost 50% of patients (53 out of 107); this compared with 34% of patients (36 out of 105) receiving placebo.
Danish: Næsten 50 % (53 ud af 107) af de patienter, der blev behandlet med Alofisel, opnåede kombineret remission sammenholdt med 34 % af de patienter (36 ud af 105), der fik placebo.
English: Alofisel must not be used in patients with hypersensitivity (allergy) to bovine serum (the clear liquid in blood from cattle) or to any of the ingredients of Alofisel.
Danish: Alofisel må ikke anvendes hos patienter med overfølsomhed for bovin serum (den klare væske i blod fra kvæg) eller nogen af indholdsstofferne i Alofisel.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Alofisel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Alofisel findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Alofisel is given just once.
Danish: Alofisel skal kun administreres én gang.
English: Fistulas are abnormal passages between the lower parts of the gut and the skin near the anus.
Danish: Fistler er unormale kanaler mellem de nedre dele af endetarmen og huden nær endetarmsåbningen.
English: It is a type of advanced therapy medicine called a ‘somatic cell therapy product'.
Danish: Alofisel er et lægemiddel til avanceret terapi, som kaldes et "somatisk celleterapiprodukt".
English: Alofisel is a medicine that is used to treat complex anal fistulas in adults with Crohn's disease (an inflammatory condition of the gut) when a conventional or biological medicine has not worked well enough.
Danish: Alofisel er et lægemiddel, der anvendes til at behandle komplekse analfistler hos voksne med Crohns sygdom (en betændelsestilstand i tarmen), når et konventionelt eller biologisk lægemiddel ikke har virket godt nok.
English: Alofisel is of value in the treatment of complex anal fistulas that have not responded well to other treatments.
Danish: Alofisel er gavnligt ved behandling af komplekse analfistler, der ikke har reageret godt på andre behandlinger.
English: Complex fistulas are those with several abnormal passages and openings, or with passages that go deep inside the body, or where there are other complications such as collection of pus.
Danish: Fistler er komplekse, når der er tale om adskillige kanaler og åbninger, når kanalerne går dybt ind i kroppen, eller når der er andre komplikationer som f.eks. pusansamlinger.
English: After preparing the fistulas for treatment in an operating room, the contents of two vials (each containing 30 million cells) are injected around the internal openings and two further vials through the external openings into the walls of the fistula.
Danish: Når fistlerne er blevet klargjort til behandling på en operationsstue, indsprøjtes indholdet af to hætteglas (hver på 30 mio. celler) omkring de indre åbninger, mens indholdet af to andre hætteglas indsprøjtes i fistelvæggene gennem de ydre åbninger.
English: What are the risks associated with Alofisel?
Danish: Hvilke risici er der forbundet med Alofisel?
English: One main study, involving 212 patients with Crohn's disease and complex anal fistulas, found Alofisel more effective than placebo (a dummy treatment) 24 weeks after treatment.
Danish: Det er i en hovedundersøgelse med 212 patienter med Crohns sygdom og komplekse analfistler påvist, at Alofisel er mere effektivt end placebo (ikke-aktivt stof) 24 uger efter behandlingen.