FrancophonIA/ELRC3.0 huggingface dataset:
English: Alunbrig 90 mg film-coated tablets 2 years
Danish: Alunbrig 90 mg filmovertrukne tabletter 2 år
English: • If no concomitant medicinal product known to cause bradycardia is identified, or if contributing concomitant medications are not discontinued or dose modified, Alunbrig should be resumed at the next lower dose level per Table 1 upon recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above.
Danish: • Hvis der ikke er identificeret et samtidigt anvendt lægemiddel, der vides at forårsage bradykardi, eller hvis bidragende samtidigt anvendt medicin ikke seponeres, eller dosis af disse ikke justeres, skal behandling med Alunbrig genoptages med det nærmeste lavere dosistrin iht.
English: Alunbrig 180 mg film-coated tablets
Danish: Alunbrig 180 mg filmovertrukne tabletter
English: Each film-coated tablet contains 336 mg of lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på En filmovertrukken tablet indeholder 336 mg lactosemonohydrat.
English: Creatine phosphokinase (CPK) elevation
Danish: Forhøjet kreatinkinase (CK)
English: Pregnancy
Danish: Udslætm
English: • Alunbrig 90 mg: 7 or 28 film-coated tablets
Danish: • Alunbrig 90 mg: 7 eller 28 filmovertrukne tabletter
English: Inform your doctor of any visual disturbance that occurs during treatment, such as seeing flashes of light, blurry vision or light hurting your eyes.
Danish: • synsforstyrrelser Fortæl lægen om alle tegn på synsforstyrrelser, så som lysglimt, sløret syn, lysfølsomhed, der forekommer under behandlingen.
English: Women of reproductive potential should be advised to use effective non-hormonal contraception during treatment with Alunbrig and for at least 4 months following the final dose.
Danish: Fertile kvinder skal rådes til at benytte en effektiv ikke-hormonel kontraception under behandling med Alunbrig og minimum 4 måneder efter den sidst indtagede dosis.
English: Based on the severity of the laboratory abnormalities, treatment should be withheld, and the dose modified accordingly (see section 4.2).
Danish: Alt efter sværhedsgraden af afvigende resultater af laboratorieprøver skal behandlingen indstilles og dosis justeres tilsvarende (se pkt.
English: Each 30 mg film-coated tablet contains 30 mg brigatinib.
Danish: En 30 mg filmovertrukken tablet indeholder 30 mg brigatinib.
English: • If Grade 3 elevation of lipase or amylase recurs, Alunbrig should be withheld until recovery to Grade ≤ 1 (≤ 1.5 × ULN) or to baseline, then resumed at the next lower dose level per Table 1.
Danish: • I tilfælde af recidiv af Grad 3-forhøjet lipase eller amylase skal behandling med Alunbrig afbrydes indtil opnået bedring til Grad ≤ 1 (≤ 1,5 × ULN) eller til baseline og derefter genoptages med nærmeste lavere dosistrin iht.
English: • Alunbrig should be withheld until recovery to Grade ≤ 1 (≤ 1.5 × ULN) or to baseline, then resumed at same dose.
Danish: • Behandling med Alunbrig skal afbrydes indtil opnået bedring til Grad ≤ 1 (≤ 1,5 × ULN) eller til baseline og derefter genoptages med samme dosis.
English: Very common Blood CPK increased Myalgian
Danish: Forhøjet CK i blodet Myalgin
English: • vision disturbance
Danish: • smagsforstyrrelser
English: Tell your doctor if you get headaches, dizziness, blurred vision, chest pain or shortness of breath.
Danish: • for højt blodtryk Fortæl det til lægen, hvis du får hovedpine, sløret syn, brystsmerter eller åndenød.
English: Film-coated tablets 28 film-coated tablets
Danish: 28 filmovertrukne tabletter
English: In ALTA, visual disturbance adverse reactions were reported in 18% of patients treated with Alunbrig at the 180 mg regimen.
Danish: I ALTA blev synsforstyrrelser rapporteret hos 18 % af patienterne i behandling med Alunbrig behandlet med 180 mg-regimet.
English: Each film-coated tablet contains 168 mg of lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på En filmovertrukken tablet indeholder 168 mg lactosemonohydrat.
English: Alunbrig 90 mg film-coated tablets Each film-coated tablet contains 90 mg of brigatinib.
Danish: Alunbrig 90 mg filmovertrukne tabletter En filmovertrukken tablet indeholder 90 mg brigatinib.
English: Round wide mouth high density polyethylene (HDPE) bottles with two-piece polypropylene child resistant screw cap with foil induction seal liner closures, containing either 7 or 30 film-coated tablets, together with one HDPE canister containing a molecular sieve desiccant.
Danish: Beholder af polyethylen med høj densitet (HDPE) med bred åbning og todelt, børnesikret skruelåg med folieforsegling indeholdende enten 7 eller 30 filmovertrukne tabletter og én HDPE-tørrekapsel med tørremiddel.
English: Common Blood lactate dehydrogenase increased
Danish: Forhøjet alkalisk phosphatase Almindelig Forhøjet lactatdehydrogenase i blodet
English: Alunbrig 180 mg film-coated tablets Each film-coated tablet contains 180 mg of brigatinib.
Danish: Alunbrig 180 mg filmovertrukne tabletter En filmovertrukken tablet indeholder 180 mg brigatinib.
English: • Alunbrig should be withheld until hypertension has recovered to Grade ≤ 1 (SBP < 140 mmHg and DBP < 90 mmHg), then resumed at the next lower dose level per Table 1 or permanently discontinued.
Danish: • Behandling med Alunbrig skal afbrydes, indtil bedring af hypertension til Grad ≤ 1 (SYS < 140 mmHg og DIA < 90 mmHg) og derefter enten genoptages med nærmeste lavere dosisniveau iht.
English: Alunbrig 30 mg film-coated tablets EU/1/18/1264/001 60 tablets in bottle EU/1/18/1264/002 120 tablets in bottle EU/1/18/1264/011 28 tablets in carton EU/1/18/1264/003 56 tablets in carton EU/1/18/1264/004 112 tablets in carton Alunbrig 90 mg film-coated tablets EU/1/18/1264/005 7 tablets in bottle EU/1/18/1264/006 30 tablets in bottle EU/1/18/1264/007 7 tablets in carton EU/1/18/1264/008 28 tablets in carton Alunbrig 180 mg film-coated tablets EU/1/18/1264/009 30 tablets in bottle EU/1/18/1264/010 28 tablets in carton Alunbrig treatment initiation pack EU/1/18/1264/012 7 x 90 mg + 21 x 180 mg tablets in carton
Danish: EU/1/18/1264/001 60 tabletter i beholder EU/1/18/1264/002 120 tabletter i beholder EU/1/18/1264/011 28 tabletter i æske EU/1/18/1264/003 56 tabletter i æske EU/1/18/1264/004 112 tabletter i æske
English: The primary route of excretion of brigatinib is in faeces.
Danish: Brigatinib udskilles primært i fæces.
English: Each film-coated tablet contains 56 mg of lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på En filmovertrukken tablet indeholder 56 mg lactosemonohydrat.
English: Round wide mouth high density polyethylene (HDPE) bottles with two-piece polypropylene child resistant screw cap with foil induction seal liner closures, containing 30 film-coated tablets, together with one HDPE canister containing a molecular sieve desiccant.
Danish: Beholder af polyethylen med høj densitet (HDPE) med bred åbning og todelt, børnesikret skruelåg med folieforsegling indeholdende 30 filmovertrukne tabletter og én HDPE-tørrekapsel med tørremiddel.
English: Tell your doctor if you experience any visual disturbances, such as seeing flashes of light, blurry vision or light hurting eyes.
Danish: • problemer med synet Fortæl det til lægen, hvis dit syn ændres og du oplever sysnforstyrrelser som for eksempel lysglimt, sløret syn eller lysfølsomhed.
English: Takeda Pharma A/S.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Takeda Pharma A/S.
English: In ALTA, elevations of CPK were reported in 50% of patients treated with Alunbrig at the 180 mg regimen.
Danish: I ALTA blev forhøjet CK rapporteret hos 50 % af patienterne i behandling med Alunbrig i behandling med 180 mg-regimet.
English: Alunbrig 90 mg film-coated tablets
Danish: Alunbrig 90 mg filmovertrukne tabletter
English: Hypertension Hypertension has occurred in patients treated with Alunbrig (see section 4.8).
Danish: Hypertension Der er set hypertension hos patienter i behandling med Alunbrig (se pkt.
English: • memory impairment
Danish: • hukommelsesbesvær
English: Takeda Oy
Danish: Suomi/Finland Takeda Oy
English: Each 90 mg film-coated tablet contains 90 mg brigatinib.
Danish: En 90 mg filmovertrukken tablet indeholder 90 mg brigatinib.
English: • If a concomitant medicinal product known to cause bradycardia is identified and discontinued, or its dose is adjusted, Alunbrig should be resumed at same dose upon recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above.
Danish: Eller hvis dosis af dette lægemiddel er justeret, skal behandling med Alunbrig genoptages med samme dosis efter opnået bedring til asymptomatisk bradykardi eller en hvilepuls på 60 bpm eller derover.
English: • Alunbrig should be withheld until recovery to Grade ≤ 1 (≤ 1.5 × ULN), then resumed at the next lower dose level per Table 1.
Danish: • Behandling med Alunbrig skal afbrydes indtil opnået bedring til Grad ≤ 1 (≤ 1,5 × ULN) og derefter skal den genoptages med det nærmeste lavere dosistrin iht.
English: Film-coated tablets 30 film-coated tablets
Danish: 30 filmovertrukne tabletter
English: Tell your doctor if you have chest pain or discomfort, changes in heartbeat, dizziness, light-headedness or fainting.
Danish: • langsom puls Fortæl det til lægen, hvis du har smerter eller ubehag i brystet, hvis din puls ændres, eller hvis du bliver svimmel eller ør eller besvimer.
English: Alunbrig 30 mg film-coated tablets brigatinib
Danish: LÆGEMIDLETS NAVN Alunbrig 30 mg filmovertrukne tabletter brigatinib
English: • If Grade 3 elevation of CPK recurs, Alunbrig should be withheld until recovery to Grade ≤ 1 (≤ 2.5 × ULN) or to baseline, then resumed at the next lower dose level per Table 1.
Danish: • I tilfælde af recidiv af grad 3-forhøjet CK skal behandling med Alunbrig afbrydes indtil bedring til Grad ≤ 1 (≤ 2,5 × ULN) eller til baseline og derefter genoptages med nærmeste lavere dosisniveau iht.
English: Upon recovery, Alunbrig may either be resumed at the next lower dose per Table 1 or permanently discontinued.
Danish: Efter bedring kan behandling med Alunbrig enten genoptages med det nærmeste lavere dosistrin iht.
English: Patients should be advised to keep the desiccant canister in the bottle and not to swallow it. Any unused medicinal product or waste material should be disposed of in accordance with local requirements
Danish: Patienten skal instrueres om at lade tørremidlet blive i beholderen og ikke sluge det.
English: Vascular disorders
Danish: Synsforstyrrelsere
English: Each 180 mg film-coated tablet contains 180 mg brigatinib.
Danish: Hver 180 mg filmovertrukken tablet indeholder 180 mg brigatinib.
English: Clear thermoformable poly-chloro-tri-fluoro-ethylene (PCTFE) blister with heat sealable paper-laminated foil lidding in a carton, containing either 7 or 28 film-coated tablets.
Danish: Blisterkort bestående af gennemsigtig, termoformbart polychlortrifluorethylen (PCTFE) med bagside af varmeforseglet papirlamineret folie i en pakning med enten 7 eller 28 filmovertrukne tabletter.
English: Alunbrig 90 mg film-coated tablets Alunbrig 180 mg film-coated tablets brigatinib
Danish: Alunbrig 30 mg filmovertrukne tabletter Alunbrig 90 mg filmovertrukne tabletter Alunbrig 180 mg filmovertrukne tabletter brigatinib
English: • Alunbrig should be withheld until recovery to Grade 1 or baseline, then resumed at the next lower dose level per Table 1.
Danish: • Behandling med Alunbrig skal afbrydes indtil opnået bedring til Grad ≤ 1 eller baseline og derefter genoptages den med det nærmeste lavere dosistrin iht.
English: Hypomagnesaemia Hyponatraemia
Danish: Hyperglykæmi Hyperinsulinæmib
English: Adverse reaction Severity*
Danish: Sværhedsgrad*
English: Musculoskeletal chest pain
Danish: Muskel- og knoglesmerter i brystet
English: Alunbrig 30 mg film-coated tablets Each film-coated tablet contains 30 mg of brigatinib.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Alunbrig 30 mg filmovertrukne tabletter En filmovertrukken tablet indeholder 30 mg brigatinib.
English: EU/1/18/1264/009 30 tablets
Danish: EU/1/18/1264/006 30 tabletter
English: Alunbrig 180 mg film-coated tablets brigatinib
Danish: LÆGEMIDLETS NAVN Alunbrig 180 mg filmovertrukne tabletter brigatinib
English: • reduced blood level of sodium
Danish: • nedsat niveau af natrium i blodet
English: Clear thermoformable poly-chloro-tri-fluoro-ethylene (PCTFE) blister with heat sealable paper-laminated foil lidding in a carton, containing 28 film-coated tablets.
Danish: Blisterkort bestående af gennemsigtig, termoformbart polychlortrifluorethylen (PCTFE) med bagside af varmeforseglet papirlamineret folie i en pakning indeholdende 28 filmovertrukne tabletter.
English: Alunbrig 90 mg film-coated tablets brigatinib
Danish: LÆGEMIDLETS NAVN Alunbrig 90 mg filmovertrukne tabletter brigatinib
English: EU/1/18/1264/010 28 tablets
Danish: EU/1/18/1264/008 28 tabletter
English: Elevations of CPK have occurred in patients treated with Alunbrig (see section 4.8).
Danish: Der er forekommet forhøjede CK-værdier hos patienter i behandling med Alunbrig (se pkt.
English: • If Grade 3 hypertension recurs, Alunbrig should be withheld until hypertension has recovered to Grade ≤ 1 then resumed at the next lower dose level per Table 1 or permanently discontinued
Danish: • Hvis Grad 3-hypertension forekommer igen, skal behandling med Alunbrig afbrydes, indtil bedring af hypertension til Grad ≤ 1 og derefter enten genoptages behandling med det nærmeste lavere dosistrin iht.
English: • abdominal (belly) pain
Danish: • mavesmerter, mavepine
English: EU/1/18/1264/001 60 tablets EU/1/18/1264/002 120 tablets
Danish: EU/1/18/1264/002 120 tabletter
English: If adequate hyperglycaemic control cannot be achieved with optimal medical management, Alunbrig should be withheld until adequate hyperglycaemic control is achieved; upon recovery reducing the dose as described in Table 1 may be considered or Alunbrig may be permanently discontinued.
Danish: I tilfælde af utilstrækkelig glykæmisk kontrol med optimal medicinsk behandling, skal behandling med Alunbrig indstilles indtil der er opnået tilstrækkelig glykæmisk kontrol.
English: • Alunbrig should be withheld until recovery to baseline, then resumed at the next lower dose level as per Table 1.
Danish: • Behandling med Alunbrig skal afbrydes indtil opnået bedring til baseline og derefter genoptages den med det nærmeste lavere dosistrin iht.
English: If you take more Alunbrig than you should
Danish: Hvis du har taget for meget Alunbrig
English: Constipation
Danish: Træthedo
English: Myalgian
Danish: Myalgin
English: If concomitant use of strong CYP3A inhibitors cannot be avoided, the dose of Alunbrig should be reduced from 180 mg to 90 mg, or from 90 mg to 60 mg. After discontinuation of a strong CYP3A inhibitor, Alunbrig should be resumed at the dose that was tolerated prior to the initiation of the strong CYP3A inhibitor.
Danish: Hvis samtidig brug af kraftige CYP3A-hæmmere ikke kan undgås, skal dosis af Alunbrig reduceres fra 180 mg til 90 mg eller fra 90 mg til 60 mg.
English: Outer Carton: Alunbrig 30 mg
Danish: INFORMATION I BRAILLESKRIFT Alunbrig 30 mg
English: Neutrophil count decreased
Danish: Nedsat neutrofiltal
English: Hepatic impairment
Danish: Træthedo Ødemp
English: Peripheral neuropathyd Headachec
Danish: Perifer neuropatid Hovedpinec
English: • If the Grade 4 event recurs, Alunbrig should be withheld until recovery to baseline, then resumed at the next lower dose level as per Table 1 or permanently discontinued.
Danish: • Hvis der opstår en Grad 4-hændelse igen, skal behandling med Alunbrig enten afbrydes indtil opnået bedring til baseline og derefter genoptages den med det nærmeste lavere dosistrin iht.
English: Outer Carton: Alunbrig 90 mg
Danish: INFORMATION I BRAILLESKRIFT Alunbrig 90 mg
English: • Alunbrig 180 mg film-coated tablets 3 plastic foil strips (blisters), containing 21 film-coated tablets
Danish: 3 plastfoliestrips (blister) med 21 filmovertrukne tabletter
English: • If contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, Alunbrig should be resumed at the next lower dose level per Table 1 upon recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above, with frequent monitoring as clinically indicated.
Danish: • Hvis et bidragende samtidigt anvendt lægemiddel identificeres og seponeres, eller hvis dosis af dette lægemiddel justeres, skal behandling med Alunbrig genoptages med det nærmeste lavere dosistrin iht.
English: How Alunbrig works
Danish: Alunbrig indeholder
English: • Alunbrig 90 mg film-coated tablets 1 plastic foil strip (blister), containing 7 film-coated tablets
Danish: 1 plastfoliestrip (blister) med 7 filmovertrukne tabletter
English: Visual disturbance adverse reactions have occurred in patients treated with Alunbrig (see section 4.8).
Danish: Der er set synsforstyrrelser som bivirkning hos patienter i behandling med Alunbrig (se pkt.
English: • If the Grade 3 event recurs, Alunbrig should be withheld until recovery to baseline, then resumed at the next lower dose level as per Table 1 or permanently discontinued.
Danish: • Hvis Grad 3 genopstår, skal behandling med Alunbrig indstilles indtil opnået bedring til baseline og derefter kan den enten genoptages med det nærmeste lavere dosistrin iht.
English: Stomatitisl
Danish: • vægttab
English: Very common Lipase increased Nausea
Danish: Forhøjet lipase Kvalme Diarréj
English: Excipient with known effect
Danish: IRC-bedømt effektparameter
English: EU/1/18/1264/007 7 tablets EU/1/18/1264/008 28 tablets
Danish: EU/1/18/1264/005 7 tabletter i beholder EU/1/18/1264/006 30 tabletter i beholder EU/1/18/1264/007 7 tabletter i æske EU/1/18/1264/008 28 tabletter i æske
English: Outer Carton: Alunbrig 180 mg
Danish: INFORMATION I BRAILLESKRIFT Alunbrig 180 mg
English: Renal impairment
Danish: Mundtørhed Stomatitl
English: Film-coated tablets 60 film-coated tablets 120 film-coated tablets
Danish: 120 filmovertrukne tabletter
English: • reduced blood level of potassium
Danish: • nedsat niveau af kalium i blodet
English: Report any unexplained muscle pain, tenderness or weakness to your doctor.
Danish: • problemer med musklerne Fortæl lægen om alle uforklarlige muskelsmerter, -ømhed eller -svækkelse.
English: However, the study had weaknesses.
Danish: Der var dog svagheder ved undersøgelsen.
English: It was first made available in Germany in the 1950s and subsequently in Austria and Hungary.
Danish: Det blev første gang tilgængeligt i Tyskland i 1950'erne og efterfølgende i Østrig og Ungarn.
English: • An observational study involving adolescents and children aged over 4 years did not provide sufficient evidence of efficacy and safety in children and adolescents.
Danish: • En observationsundersøgelse hos unge og børn på over 4 år gav ikke tilstrækkelig evidens for virkningen og sikkerheden hos børn og unge.
English: The review of Symbioflor 2 (and associated names) was initiated on 30 March 2016 at the request of Germany, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af Symbioflor 2 (og relaterede navne) blev iværksat den 30. marts 2016 på Tysklands foranledning i henhold til artikel 31 i direktiv 2001/83/EF.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Danish: Gennemgangen blev foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets udtalelse.
English: • The safety profile of Symbioflor 2 is acceptable.
Danish: • Symbioflor 2's sikkerhedsprofil er acceptabel.
English: Submission of the study report to national authorities will be a condition for maintaining Symbioflor 2's marketing authorisation.
Danish: Indsendelse af undersøgelsesrapporten til de nationale myndigheder vil være en betingelse for at opretholde markedsføringstilladelsen for Symbioflor 2.
English: The data included clinical studies, scientific publications, post-marketing experience, as well as information provided by the company and the views of an expert group formed for evaluating Symbioflor 2.
Danish: Dataene omfattede kliniske undersøgelser, videnskabelige publikationer, erfaring efter markedsføring samt oplysninger fremlagt af virksomheden og udtalelser fra en ekspertgruppe, der var nedsat med henblik på at evaluere Symbioflor 2.
English: Escherichia coli bacteria form part of the normal gut flora.
Danish: Escherichia coli-bakterier er en del af den normale tarmflora.
English: The CHMP recommendation was sent to the European Commission which issued a legally binding decision valid throughout the EU.
Danish: CHMP's anbefaling blev indsendt til Europa-Kommissionen, som vedtog en retligt bindende beslutning med gyldighed i hele EU.
English: Since the available data were not sufficiently robust for the CHMP to draw conclusions on how well Symbioflor 2 works and whether it is effective for any particular type of IBS, the CHMP has asked the company to carry out a well-designed study on effectiveness and safety among patients with different features of IBS (e.g. those with diarrhoea or with constipation as an important feature).
Danish: Da de tilgængelige data ikke var tilstrækkeligt solide til, at CHMP kunne drage konklusioner om, hvor godt Symbioflor 2 virker, og hvorvidt det er effektivt ved en bestemt type irritabel tyktarm, har CHMP anmodet virksomheden om at gennemføre en veltilrettelagt undersøgelse af virkningen og sikkerheden hos patienter med irritabel tyktarm og forskellige karakteristika (f.eks. patienter hvor diarré eller forstoppelse er et vigtigt element).
English: Medicines containing Escherichia coli are available as oral drops in Austria, Germany and Hungary under the following invented names: Symbioflor 2, Symbioflor E. Coli and Symbioflor Escherichia.
Danish: Lægemidler, der indeholder Escherichia coli, fås som orale dråber i Østrig, Tyskland og Ungarn under følgende handelsnavne: Symbioflor 2, Symbioflor E. Coli og Symbioflor Escherichia.
English: • Speak with a pharmacist or your doctor if your symptoms of irritable bowel syndrome do not improve with Symbioflor 2 or if they get worse.
Danish: • Tal med apotekspersonalet eller din læge, hvis symptomerne på irritabel tyktarm ikke bliver bedre med Symbioflor 2, eller hvis de bliver værre.
English: Symbioflor 2 and associated names contains Escherichia coli bacteria some of which have been broken down (autolysed) while others are living.
Danish: Symbioflor 2 og relaterede navne indeholder Escherichia coli-bakterier, hvoraf nogle er blevet nedbrudt (autolyseret), mens andre er levende.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 28/08/2017.
Danish: CHMP's udtalelse blev fremsendt til Europa-Kommissionen, som traf en endelig juridisk bindende beslutning med gyldighed i alle EU-medlemsstaterne den 28. august 2017.
English: The medicine has been described as probiotic, which means that it encourages the growth of beneficial organisms (‘flora') in the gut.
Danish: Lægemidlet er blevet beskrevet som et probiotikum, og det betyder, at det fremmer væksten af nyttige organismer ("flora") i tarmene.
English: On 22 June 2017 a review by European Medicines Agency (EMA) concluded that Symbioflor 2 and associated names can continue to be used for treatment of irritable bowel syndrome (IBS) in adults.
Danish: Den 22. juni 2017 konkluderede Det Europæiske Lægemiddelagentur (EMA) efter en gennemgang, at Symbioflor 2 og relaterede navne fortsat kan anvendes til behandling af irritabel tyktarm hos voksne.
English: Benefit has not yet been established in children with IBS.
Danish: Der er endnu ikke påvist fordele hos børn med irritabel tyktarm.
English: However, the medicine should no longer be used more widely to treat so-called functional gastrointestinal disorders, a group of disorders with a variety of causes that may require different treatment approaches.
Danish: Lægemidlet bør dog ikke længere anvendes bredt til behandling af såkaldte funktionelle gastrointestinale lidelser, der er en gruppe af sygdomme med forskellige årsager, som kan kræve forskellige behandlingsmetoder.