FrancophonIA/ELRC3.0 huggingface dataset:
English: 49% of women receiving 5 mg Esmya (95 out of the 195 women who were assessed) had no more than one day of spotting (minimal uterine bleeding) within a 35-day interval after each treatment course, and 70% had no more than one day of spotting within a 35-day interval at the end of the fourth treatment course.
Danish: 49 % af de kvinder, der fik 5 mg Esmya (95 af de 195 kvinder, der blev vurderet), havde højst 1 dag med pletblødning i en 35-dages periode efter hver behandlingsforløb, og 70 % havde højst 1 dag med pletblødning i en 35-dages periode ved slutningen af det fjerde behandlingsforløb.
English: What is Esmya and what is it used for?
Danish: Hvad er Esmya, og hvad anvendes det til?
English: The most common side effects with Esmya (which may affect more than 1 in 10 patients) are amenorrhea (absence of menstrual period) and endometrial thickening (thickening of the lining of the womb).
Danish: De hyppigste bivirkninger med Esmya (som kan forekomme hos flere end 1 ud af 10 patienter) er amenoré (manglende menstruation) og fortykkelse af livmoderslimhinden.
English: The company that markets Esmya will ensure that doctors who are expected to prescribe this medicine receive educational material with information about the safety of Esmya, including recommendations for monitoring liver function and endometrial changes during treatment.
Danish: Den virksomhed, der markedsfører Esmya, skal sørge for, at læger, der forventes at udskrive dette lægemiddel, modtager oplysningsmateriale med vigtige sikkerhedsoplysninger om Esmya, herunder anbefalinger om overvågning af leverfunktionen og slimhindeforandringer i livmoderen under behandling med Esmya.
English: Why is Esmya authorised?
Danish: Hvorfor er Esmya godkendt?
English: Esmya must not be used in women who are pregnant or breastfeeding, have bleeding from the genital region of unknown cause or for reasons other than uterine fibroids, have cancer of the womb, cervix (the neck of the womb), ovary or breast, or have liver problems.
Danish: Esmya må ikke anvendes hos kvinder, der er gravide eller ammer, som har blødninger fra skeden af ukendt årsag eller af anden årsag end knuder i livmoderen, eller som har livmoder-, livmoderhals-, æggestok- eller brystkræft eller har problemer med leveren.
English: In the second study, Esmya taken for three months was as effective as leuprorelin (another medicine for fibroids) in reducing heavy uterine bleeding, with bleeding reduced in 90% of women treated with Esmya compared with 89% of women treated with leuprorelin.
Danish: I det andet studie var Esmya efter tre måneders behandling lige så effektivt som leuprorelin (et andet lægemiddel mod knuder i livmoderen) til at nedsætte kraftige blødninger fra livmoderen, idet blødningen blev mindsket hos 90 % af de kvinder, der blev behandlet med Esmya, sammenholdt med 89 % af dem, der blev behandlet med leuprorelin.
English: What are the risks associated with Esmya?
Danish: Hvilke risici er der forbundet med Esmya?
English: When progesterone activity is blocked, fibroid cells stop dividing and eventually die, which reduces the size of the fibroids and the symptoms caused by them.
Danish: Når progesteronets virkning blokeres, ophører knudernes celler med at dele sig og dør til sidst, hvorved knuderne og de tilknyttede symptomer aftager.
English: Esmya can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in the diagnosis and treatment of uterine fibroids.
Danish: Esmya udleveres kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i diagnose og behandling af muskelknuder i livmoderen.
English: Esmya improved the symptoms of uterine fibroids in two main studies involving 549 women who were to have surgery to remove the fibroids.
Danish: Esmya gav bedring i symptomerne på knuder i livmoderen i to hovedundersøgelser med 549 kvinder, som skulle have fjernet knuderne ved operation.
English: Esmya has been shown to be effective in reducing symptoms as well as the size of the fibroids in women who were to have surgery for their fibroids and when used intermittently for longer periods (up to 4 treatment courses).
Danish: Esmya er påvist at være effektivt til at reducere symptomerne på muskelknuder i livmoderen og knudernes størrelse hos kvinder, der skulle opereres for knuder, desuden til lejlighedsvis anvendelse i længere perioder (op til 4 behandlingsforløb).
English: The active substance in Esmya, ulipristal acetate, blocks the activity of progesterone, a hormone in the body involved in controlling the growth of the lining of the womb.
Danish: Det aktive stof i Esmya, ulipristalacetat, blokerer aktiviteten af hormonet progesteron, der medvirker til at kontrollere livmoderslimhindens vækst.
English: In the first study, uterine bleeding was reduced in 92% of women taking Esmya for three months (one treatment course) compared with 19% of women taking placebo (a dummy treatment).
Danish: I det første studie blev blødning fra livmoderen reduceret hos 92 % af de kvinder, der fik Esmya i tre måneder (ét behandlingsforløb), sammenholdt med 19 % af dem, der fik virkningsløs behandling (placebo).
English: Esmya is a medicine used to treat moderate to severe symptoms of uterine fibroids in adult women who have not yet reached the menopause.
Danish: Esmya er et lægemiddel, der anvendes til behandling af moderate til svære symptomer på muskelknuder i livmoderen hos voksne kvinder, der ikke har nået overgangsalderen.
English: In some women, progesterone may promote the growth of fibroids, which can cause symptoms such as heavy uterine bleeding (bleeding from the womb during or outside the menstrual period), anaemia (low red blood cell counts, due to bleeding) and abdominal pain (such as period pain).
Danish: Hos nogle kvinder kan progesteron fremme væksten af godartede knuder, der kan give symptomer som kraftige blødninger fra livmoderen under menstruationen eller uden for den normale menstruationscyklus, anæmi (lavt antal røde blodlegemer forårsaget af blødninger) og mavesmerter (menstruationssmerter eller smerter i maven).
English: A card will also be given to patients to inform them about the need for liver monitoring and to contact their doctor if they develop symptoms of liver injury (such as tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting).
Danish: nødvendigheden af at overvåge leveren og kontakte lægen, hvis de får symptomer på leverskade (såsom træthed, gulsot, mørk urin, kvalme og opkastning).
English: For the full list of all side effects reported with Esmya, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Esmya fremgår af indlægssedlen.
English: Rare but serious cases of liver injury have been reported with the medicine and measures have been put in place to minimise this risk.1 Although endometrial thickening was seen in some patients, it normally disappeared after stopping treatment.
Danish: Der er indberettet sjældne, men alvorlige tilfælde af leverskade med lægemidlet, og der er truffet foranstaltninger til at minimere denne risiko.
English: • as intermittent treatment for women in whom surgery is not suitable.
Danish: • som periodisk behandling af kvinder, hos hvem operation ikke er egnet Lægemidlet indeholder det aktive stof ulipristalacetat.
English: What benefits of Esmya have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Esmya?
English: Uterine fibroids are non-cancerous (benign) tumours of the womb (uterus).
Danish: Muskelknuder er godartede svulster i livmoderen (uterus).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Esmya have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Esmya.
English: How is Esmya used?
Danish: Hvordan anvendes Esmya?
English: How does Esmya work?
Danish: Hvordan virker Esmya?
English: The three-month treatment course can be repeated in women in whom surgery is not suitable.
Danish: Hvis operation ikke er egnet til den pågældende, kan det tre måneders behandlingsforløb gentages.
English: Medicinal product no longer authorised
Danish: Læ gemidlet er ikke længere autoriseret
English: MA (EU) Number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size blister (PVC/alu)
Danish: Blisterpakning (PVC/alu) 13 kapsler
English: The review of fusafungine-containing medicines was initiated on 11 September 2015 at the request of Italy, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af fusafunginholdige lægemidler blev iværksat den 11. september 2015 på Italiens foranledning, jf. artikel 31 i direktiv 2001/83/EF.
English: Fusafungine-containing medicines have been available in several EU countries for over 50 years.
Danish: Fusafunginholdige lægemidler har været tilgængelige i mange EU-lande i over 50 år.
English: In some Member States, these medicines were available without prescription.
Danish: I nogle medlemsstater har disse lægemidler kunnet fås uden recept.
English: They were authorised through national approval procedures under various trade names (Bioparox, Fusaloyos, Locabiotal and Locabiosol) in the following countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Portugal, Romania, Slovakia and Spain.
Danish: De blev godkendt ved nationale godkendelsesprocedurer under forskellige handelsnavne (Bioparox, Fusaloyos, Locabiotal og Locabiosol) i følgende lande: Østrig, Belgien, Bulgarien, Cypern, Tjekkiet, Estland, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Portugal, Rumænien, Slovakiet og Spanien.
English: • Healthcare professionals should advise patients on alternative treatments, if needed.
Danish: • Sundhedspersoner skal om nødvendigt rådgive patienterne om andre behandlingsmuligheder.
English: The CMDh is a regulatory body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Danish: CMDh er en lægemiddelmyndighed, der repræsenterer EU's medlemsstater samt Island, Liechtenstein og Norge.
English: Medicines to be withdrawn due to serious allergic reactions and limited evidence of benefit
Danish: Lægemidler, der skal tilbagetrækkes på grund af alvorlige overfølsomhedsreaktioner og begrænset dokumentation for gavnlig virkning
English: Although the review found that serious allergic reactions are rare, they can be life-threatening and no measures have been identified to sufficiently reduce or manage this risk.
Danish: Selv om gennemgangen viste, at alvorlige allergiske reaktioner er sjældne, kan de være livstruende, og der er ikke identificeret nogen forholdsregler, der i tilstrækkelig grad kan reducere eller tage højde for denne risiko.
English: The benefit-risk balance for fusafungine-containing medicines is therefore negative for all currently authorised uses.
Danish: Benefit/risk-forholdet for fusafunginholdige lægemidler er derfor negativt for alle aktuelt godkendte indikationer.
English: As fusafungine-containing medicines are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position on 31 March 2016.
Danish: Da alle de fusafunginholdige lægemidler er godkendt nationalt, har PRAC sendt sine anbefalinger til CMDh (koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker), der vedtog et endeligt standpunkt den 31. marts 2016.
English: In addition, there were concerns about the potential for fusafungine to promote antibiotic resistance (the ability of bacteria to grow in the presence of an antibiotic that would normally kill them or limit their growth).
Danish: Desuden er man bekymret for fusafungins eventuelle potentiale til at fremme antibiotikaresistens (dvs. risikoen for, at bakterierne kan vokse, selv om der anvendes et antibiotikum, som normalt burde slå dem ihjel eller begrænse deres vækst).
English: • Patients with any questions should speak to their healthcare professional.
Danish: • Patienter, der har spørgsmål, bør tale med lægen eller apotekspersonalet.
English: During its review the PRAC consulted EMA's paediatric scientific committee as well as experts in the field of anti-infective medicines.
Danish: I forbindelse med gennemgangen har PRAC rådført sig med EMA's pædiatriske udvalg og eksperter inden for lægemidler til behandling af infektioner.
English: Although there is insufficient evidence to establish that fusafungine can increase the risk of resistance, this risk could not be ruled out.
Danish: Selv om der ikke foreligger tilstrækkelig dokumentation til at fastslå, om fusafungin kan øge risikoen for resistens, kan det ikke udelukkes.
English: • Fusafungine nose and mouth sprays have been used to treat upper airway infections.
Danish: • Fusafungin-sprays til næse og mund er blevet anvendt til behandling af øvre luftvejsinfektioner.
English: This follows a review by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) which concluded that the benefits of fusafungine do not outweigh its risks, particularly the risk of serious allergic reactions.
Danish: Dette sker efter en gennemgang, som er foretaget af EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC), og som har vist, at fordelene ved fusafungin ikke opvejer risiciene, navnlig risikoen for alvorlige allergiske reaktioner.
English: The CMDh1 has endorsed by consensus the revocation of marketing authorisations for fusafungine sprays in the EU.
Danish: CMDh1 har enstemmigt vedtaget at støtte tilbagekaldelsen af markedsføringstilladelserne for fusafungin-sprays i EU.
English: • Upper airway infections are usually mild and self-limiting.
Danish: • Øvre luftvejsinfektioner er typisk milde og selvbegrænsende.
English: • These sprays are being taken off the market in the EU because of rare cases of serious allergic reactions and the lack of strong evidence that these medicines work.
Danish: • Disse sprays fjernes nu fra markedet i EU på grund af sjældne tilfælde af alvorlige allergiske reaktioner og manglende dokumentation for gavnlig virkning.
English: Serious allergic reactions have occurred soon after the use of these sprays and involved bronchospasm (excessive and prolonged contractions of the airway muscles leading to difficulty breathing).
Danish: Alvorlige allergiske reaktioner er set kort tid efter anvendelse af disse sprays og har omfattet bronkospasmer (voldsomme og langvarige sammentrækninger af musklerne i luftvejene, der giver vejrtrækningsbesvær).
English: The review has been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Danish: Undersøgelsen er gennemført af EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC), som er ansvarlig for vurdering af sikkerhedsmæssige problemstillinger ved lægemidler til mennesker, og som har fremsat en række anbefalinger.
English: As the CMDh adopted its position by consensus, the measures recommended by the PRAC will be implemented directly by the Member States where the medicines are authorised, according to an agreed timetable.
Danish: Da CMDh har vedtaget sit standpunkt enstemmigt, vil de foranstaltninger, som PRAC har anbefalet, blive gennemført direkte af de medlemsstater, hvor lægemidlerne er godkendt, efter en aftalt tidsplan.
English: With regard to the benefits, the evidence for beneficial effects of fusafungine is weak.
Danish: Hvad virkningen angår, foreligger der ikke tilstrækkelig dokumentation for fusafungins gavnlige virkning.
English: Fusafungine is an antibiotic and anti-inflammatory medicine used in the form of a nasal and oromucosal (to be applied to the mouth) spray for the treatment of the following infections of the upper airways: sinusitis (sinus infection), rhinitis (stuffy and runny nose), rhinopharyngitis (common cold), tonsillitis (inflammation of the tonsils caused by an infection) and laryngitis (inflammation of the voice box).
Danish: Fusafungin er et antibiotisk og antiinflammatorisk lægemiddel, der indgives som spray i næsen og mundhulen til behandling af følgende øvre luftvejsinfektioner: sinuitis (bihulebetændelse), rhinitis (tilstoppet og løbende næse) rhinofaryngitis (almindelig forkølelse), tonsillitis (betændelse i mandlerne, der skyldes infektion) og laryngitis (betændelse i strubehovedet).
English: Following the CMDh consensus position, EU Member States will start revoking the marketing authorisations of these medicines in their territories, according to an agreed timetable.
Danish: Efter enstemmig vedtagelse af CMDh's standpunkt vil den enkelte medlemsstat begynde at tilbagekalde markedsføringstilladelserne for disse lægemidler på sit område efter en aftalt tidsplan.
English: Taking into account the mild and self-limiting nature of upper airway infections such as rhinopharyngitis, the benefits of fusafungine were not considered to outweigh the risks.
Danish: I betragtning af, at øvre luftvejsinfektioner som f.eks. almindelige forkølelser typisk er milde og selvbegrænsende, vurderes fordelene ved fusafungin ikke at opveje risiciene.
English: Fusafungine is an antibiotic and anti-inflammatory nose and mouth spray used to treat upper airway infections such as rhinopharyngitis (common cold).
Danish: Fusafungin er en antibiotisk og antiinflammatorisk spray til næse og mund, der anvendes til at behandle infektioner i de øvre luftveje, f.eks. almindelig forkølelse.
English: All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Danish: Alle henvisninger til ovennævnte indikationer skal slettes i de relevante afsnit af indlægssedlerne.
English: • Prophylaxis of migraine headache
Danish: • Forebyggelse af migræne-hovedpine
English: B. Package Leaflet
Danish: B. INDLÆGSSEDLEN
English: A. Summary of Product Characteristics
Danish: A. PRODUKTRESUMÉ
English: • Symptomatic treatment of veno-lymphatic insufficiency All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Danish: Alle henvisninger til ovennævnte indikationer skal slettes i de øvrige afsnit i produktresuméerne.
English: 21 February 2006 EMEA/CHMP/373083/2005
Danish: 21. februar 2006 EMEA/CHMP/373083/2005
English: During its September 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Lansoprazol AbZ-Pharma.
Danish: På sit møde i september 2005 var CHMP på grundlag af de samlede forelagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at benefit/risk-forholdet er gunstigt for Lansoprazol AbZPharma.
English: Lansoprazol AbZ-Pharma (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, gastro-oesophageal reflux disease, treatment and prophylaxis of NSAID-associated gastric and duodenal ulcers, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Danish: Lansoprazol AbZ-Pharma (lansoprazol) er en protonpumpehæmmer, som hæmmer sekretion af mavesyre og anvendes til behandling af duodenalt og gastrisk ulcus, reflux øsofagitis, gastro-øsofageal reflukssygdom, behandling og profylakse af NSAID-relaterede gastriske og duodenale ulcera, Zollinger-Ellisons syndrom og i kombination med passende antibakterielle behandlingsregimener til udryddelse af Helicobacter pylori og forebyggelse af recidiv af peptiske ulcera hos patienter med H. pylori-relaterede ulcera.
English: A Marketing Authorisation for Lansoprazol AbZ-Pharma (15 mg and 30 mg) was previously granted to ratiopharm GmbH in Finland on 7 November 2003.
Danish: Der er tidligere udstedt en markedsføringstilladelse for Lansoprazol AbZ-Pharma (15 mg og 30 mg) til ratiopharm GmbH i Finland.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Lansoprazol AbZ-Pharma 15 mg and 30 mg International Non-Proprietary Name (INN): Lansoprazole
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 21, OM Lansoprazol AbZ-Pharma 15 mg og 30 mg Internationalt fællesnavn ( INN): Lansoprazol
English: EU/1/19/1389/001 Epidyolex 100 mg/mL Oral Solution
Danish: EU/1/19/1389/001 Epidyolex 100 mg/ml
English: 1 bottle + 2 syringes of 1 ml + 2 syringes of 5 ml + 2 bottle adaptors
Danish: 1 flaske + 2 sprøtjer med 1 ml + 2 sprøtjer med 5 ml + 2 flaskeadaptere
English: Oral use bottle (glass)
Danish: Oral opløsning Oral anvendelse Flaske (glas) 100 ml
English: Then go on as before.
Danish: Fortsæt derefter som før.
English: Speak to your doctor first.
Danish: Tal med lægen først.
English: (your body is not producing any urine)
Danish: (kroppen producerer ikke urin)
English: Do not use after the expiry date which is stated on the carton.
Danish: Anvend ikke efter udløbsdatoen, som er angivet på kartonen.
English: Do not chew or crush them.
Danish: Lad være med tygge eller knuse dem.
English: Frequencies are defined as very common (≥1/10); common (>1/100 to <1/10); uncommon (>1/1000 to <1/100); rare (>1/10 000 to <1/1000); very rare (<1/10 000).
Danish: Frekvenser defineres som meget almindelig (≥1/10); almindelig (>1/100 til <1/10); usædvanlig (>1/1000 til <1/100); sjælden (>1/10 000 til <1/1000); meget sjælden (<1/10 000).
English: • medicine containing Estrogen
Danish: • medicin der indeholder Estrogen
English: Taking too many tablets at once can make you feel unwell.
Danish: Hvis De tager for mange tabletter på en gang, kan De få det dårligt.
English: The prolonged-release tablets should not be chewed, divided or crushed.
Danish: Tabletterne med forlænget afgivelse må ikke tygges, deles eller knuses.
English: If this happens do not worry but make sure that you do not drive, operate machinery or carry out any activity which might be dangerous should you feel faint.
Danish: Hvis det sker, så tag det roligt og sørg for, at De ikke kører bil, betjener en maskine eller udfører anden aktivitet, som kan være farlig, hvis De skulle besvime.
English: • if you suffer from diabetic autonomic neuropathy, a disease associated with diabetes which affects your nervous system.
Danish: • Hvis De lider af diabetisk autonomneuropati, som er en sygdom, der er forbundet med diabetes og som påvirker nervesystemet.
English: Pack sizes: 28, 30 & 100 tablets Not all pack sizes may be marketed.
Danish: Pakningsstørrelser: 28, 30 & 100 tabletter Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: If you forget to take your tablet, leave the dose out completely.
Danish: Hvis De glemmer at tage en tablet, så spring doseringen helt over.
English: PVC/PVDC/aluminium blister pack.
Danish: PVC/PVDC/aluminiumblisterpakke.
English: Do not change the dose or stop taking your tablets unless you have spoken to your doctor.
Danish: De må ikke ændre doseringen eller holde op med at tage tabletterne uden at have talt med Deres læge først.
English: Winthrop Arzneimittel GmbH Industriestrasse 10 82256 Furstenfeldbruck Germany
Danish: Winthrop Arzneimittel GmbH Industriestrasse 10 82256 Furstenfeldbruck Tyskland
English: Your tablets should be swallowed whole.
Danish: Tabletterne skal sluges hele.
English: Chapeltown Distribution Centre 51 Cart Road, Chapeltown, Sheffield, S35 2PF United Kingdom
Danish: Chapeltown Distribution Centre 51 Cart Road, Chapeltown, Sheffield, S35 2PF Storbritannien