FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Ferriprox 500 mg film-coated tablets Each tablet contains 500 mg deferiprone.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Ferriprox 500 mg filmovertrukne tabletter Hver tablet indeholder 500 mg deferipron.
English: An open-label, non-randomized, parallel group clinical study was conducted to evaluate the effect of impaired renal function on the safety, tolerability, and pharmacokinetics of a single 33 mg/kg oral dose of Ferriprox.
Danish: Et åbent, ikke-randomiseret klinisk studie med parallelle grupper blev udført med henblik på at vurdere effekten af leverinsufficiens på sikkerhed, tolerabilitet og farmakokinetik for en enkelt oral dosis på 33 mg/kg Ferriprox.
English: Caution must be exercised in patients with end stage renal disease or severe hepatic dysfunction.
Danish: Der skal udvises forsigtighed hos patienter med nyresygdom i slutstadiet eller svær nyreinsufficiens.
English: − Attached to this leaflet you will find a patient/carer reminder card. You should detach,
Danish: − Sammen med denne folder finder du et informationskort til patient/plejer.
English: Peak serum concentration occurs 45 to 60 minutes following a single dose in fasted patients.
Danish: Maksimal serumkoncentration ses 45 til 60 minutter efter en enkeltdosis hos fastende patienter, men kan være forsinket til 2 timer hos patienter, der har indtaget føde.
English: See table below for recommended doses for body weights at 10 kg increments.
Danish: Se nedenstående skema for anbefalede doser for legemsvægt i 10 kg trin.
English: PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 100 filmovertrukne tabletter
English: After one year of study therapy, patients on concurrent chelation therapy had experienced a significantly greater reduction in serum ferritin (1574 µg/l to 598 µg/l with concurrent therapy vs. 1379 µg/l to 1146 µg/l with deferoxamine monotherapy, p<0.001), significantly greater reduction in myocardial iron overload, as assessed by an increase in MRI T2* (11.7 ms to 17.7 ms with concurrent therapy vs. 12.4 ms to 15.7 ms with deferoxamine monotherapy, p=0.02) and significantly greater reduction in liver iron concentration, also assessed by an increase in MRI T2* (4.9 ms to 10.7 ms with concurrent therapy vs. 4.2 ms to 5.0 ms with deferoxamine monotherapy, p< 0.001).
Danish: oplevet en signifikant større reduktion i serumferritin (1574 µg/l til 598 µg/l med samtidig terapi vs. 1379 µg/l til 1146 µg/l med deferoxamin monoterapi, p<0.001), signifikant større reduktion i myokardial jernophobning som vurderet ved en stigning i MRI T2* (11,7 ms til 17,7 ms med samtidig terapi vs. 12,4 ms til 15,7 ms med deferoxamin monoterapi, p=0,02) og signifikant større reduktion i jernkoncentrationen i leveren, også vurderet ved en stigning i MRI T2* (4,9 ms til 10,7 ms ved samtidig terapi vs. 4,2 ms til 5,0 ms med deferoxamin monoterapi, p<0,001).
English: Neutropenia/Agranulocytosis
Danish: Neutropeni/agranulocytose
English: What you need to know before you take Ferriprox
Danish: Det skal du vide, før du begynder at tage Ferriprox
English: Sample body weights at 10 kg increments are listed.
Danish: Eksempler på legemsvægt i 10 kg trin er anført.
English: See tables below for recommended doses for body weights at 10 kg increments.
Danish: Se nedenstående skemaer for anbefalede doser for legemsvægt i 10 kg trin.
English: MARKETING AUTHORISATION NUMBER Ferriprox 500 mg film-coated tablets EU/1/99/108/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) Ferriprox 500 mg filmovertrukne tabletter EU/1/99/108/001
English: Manufacturing Authorisation Holder: Eurofins PROXY Laboratories B.V. Archimedesweg 25
Danish: Indehaver af virksomhedsgodkendelse: Eurofins PROXY Laboratories B.V.
English: COMMON
Danish: ALMINDELIG
English: Clear, reddish orange-coloured liquid.
Danish: Klar, rød-orange væske.
English: The use of combination therapy should be considered on a case-by-case basis.
Danish: Kombineret brug sammen med andre jernkelerende stoffer Brugen af kombinationsterapi bør overvejes i hvert enkelt tilfælde.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 August 1999
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Dose adjustment is not required in patients with mild, moderate, or severe renal impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let, moderat eller svær nyreinsufficiens (se pkt.
English: Each 1000 mg tablet contains 1000 mg deferiprone.
Danish: Hver 1000 mg tablet indeholder 1000 mg deferipron.
English: The tablets are scored and breakable in half.
Danish: Tabletterne er forsynet med rille og kan brækkes over i to dele.
English: What Ferriprox looks like and contents of the pack Ferriprox oral solution is a clear, reddish orange coloured liquid.
Danish: Ferriprox oral opløsning er en klar, rød-orange væske.
English: Hydrochloric acid, concentrated, for pH adjustment Artificial cherry flavour
Danish: Koncentreret saltsyre, til pH-regulering Kunstig kirsebærsmag Pebermynteolie
English: Coating: Hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide.
Danish: Tabletovertræk: Hypromellose, hydroxypropylcellulose, macrogol, titandioxid.
English: The other ingredients are: Tablet core: Microcrystalline cellulose, Magnesium stearate, Colloidal silicon dioxide.
Danish: Øvrige indholdsstoffer: Tabletkerne: Mikrokrystallinsk cellulose, magnesiumstearat, kolloid silica.
English: Pack size of 50 tablets.
Danish: Pakkninger med 50 tabletter.
English: Coating: Hypromellose, Macrogol, Titanium dioxide.
Danish: Tabletovertræk: Hypromellose, macrogol, titandioxid.
English: Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide
Danish: Mikrokrystallinsk cellulose Magnesiumstearat
English: Due to the unknown mechanism of deferiprone-induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section
Danish: Da mekanismen for neutropeni fremkaldt af deferipron ikke er kendt, bør patienterne ikke indtage medicin, der vides at være forbundet med neutropeni, eller medicin, der kan medføre agranulocytose (se pkt.
English: Glycerol (E422)
Danish: Hydroxyethylcellulose Glycerol (E422)
English: Ferriprox 1000 mg film-coated tablets Each tablet contains 1000 mg deferiprone.
Danish: Ferriprox 1000 mg filmovertrukne tabletter Hver tablet indeholder 1000 mg deferipron.
English: Ferriprox is used to treat iron overload caused by frequent blood transfusions in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Danish: Ferriprox bruges til at behandle jernophobning som følge af hyppige blodtransfusioner hos talassæmipatienter, hvor nuværende kelationsterapi er kontraindiceret eller utilstrækkelig.
English: However, neurological disorders (such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia) have been observed in children who had been voluntarily prescribed more than 2.5 times the maximum recommended dose of 100 mg/kg/day for several years.
Danish: Der er dog observeret neurologiske forstyrrelser (såsom cerebellare symptomer, diplopi, lateral nystagmus, nedsat psykomotorisk tempo, håndbevægelser og aksial hypotoni) hos børn, som igennem flere år frivilligt har fået ordineret mere end 2,5 gange den maksimalt anbefalede dosis på 100 mg/kg dagligt.
English: Subjects were categorized into 4 groups based on estimated glomerular filtration rate (eGFR): healthy volunteers (eGFR ≥ 90 mL/min/1.73m2), mild renal impairment (eGFR 60-89 mL/min/1.73m2), moderate renal impairment (eGFR 30-59 mL/min/1.73m2), and severe renal impairment (eGFR 15-29 mL/min/1.73m2).
Danish: Forsøgsdeltagerne blev opdelt i 4 grupper ud fra estimeret glomerulær filtrationshastighed (eGFR): raske frivillige (eGFR) ≥ 90 ml/min/1,73m2), let nyreinsufficiens (eGFR 60-89 ml/min/1,73m2), moderat nyreinsufficiens (eGFR 30-59 ml/min/1,73m2) og svær nyreinsufficiens (eGFR 15-29 ml/min/1,73m2).
English: Neurological disorders (such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia) have been observed in children who had been voluntarily prescribed more than 2.5 times the maximum recommended dose of 100 mg/kg/day for several years.
Danish: Der er observeret neurologiske forstyrrelser (såsom cerebellare symptomer, diplopi, lateral nystagmus, nedsat psykomotorisk tempo, håndbevægelser og aksial hypotoni) hos børn, som igennem flere år frivilligt har fået ordineret mere end 2,5 gange den maksimalt anbefalede dosis på 100 mg/kg/dag.
English: Pack size of 100 tablets.
Danish: Pakninger med 100 tabletter.
English: A serious adverse event of acute liver and renal injury was seen in one subject with moderate hepatic impairment.
Danish: Der sås en alvorlig bivirkning med akut lever- og nyreskade hos én forsøgsdeltager med moderat leverinsufficiens.
English: Each ml of oral solution contains 100 mg deferiprone.
Danish: Hver ml oral opløsning indeholder 100 mg deferipron.
English: INFORMATION IN BRAILLE Ferriprox 1000 mg
Danish: INFORMATION I BRAILLE-SKRIFT Ferriprox 1000 mg
English: - Due to the unknown mechanism of deferiprone-induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section 4.5).
Danish: - Da mekanismen for neutropeni fremkaldt af deferipron ikke er kendt, bør patienterne ikke indtage medicin, der vides at være forbundet med neutropeni, eller medicin, der kan medføre agranulocytose (se pkt.
English: Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml and 50 g deferiprone in 500 ml).
Danish: Hver ml oral opløsning indeholder 100 mg deferipron (25 g deferipron i 250 ml og 50 g deferipron i 500 ml).
English: Do not use Ferriprox if you are breast-feeding.
Danish: Brug ikke Ferriprox, hvis du ammer.
English: Iron overload causes concentration-dependent MRI T2* signal loss, thus, increased myocardial iron reduces myocardial MRI T2* values.
Danish: Følgelig reducerer øget myokardial jern de myokardiale MRI T2*-værdier.
English: Tablet core: Methylcellulose, crospovidone, magnesium stearate.
Danish: Øvrige indholdsstoffer: Tabletkerne: Methylcellulose, crospovidon, magnesiumstearat.
English: INFORMATION IN BRAILLE Ferriprox 100 mg/ml
Danish: INFORMATION I BRAILLE-SKRIFT Ferriprox 100 mg/ml
English: Provide this card to your doctor if you develop infection symptoms such as a fever, sore throat or flu-like symptoms.
Danish: Vis dette kort til lægen, hvis du udvikler symptomer på infektion, f.eks. feber, ondt i halsen eller influenzalignende symptomer.
English: Dose adjustment is not required in patients with mildly or moderately impaired hepatic function (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat leverinsufficiens (se pkt.
English: Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Danish: Ferriprox monoterapi er indiceret til behandling af jernophobning hos talassæmi-patienter, hvor nuværende kelationsterapi er kontraindiceret eller utilstrækkelig.
English: INFORMATION IN BRAILLE Ferriprox 500 mg
Danish: INFORMATION I BRAILLE-SKRIFT Ferriprox 500 mg
English: The neurological disorders progressively regressed after deferiprone discontinuation (see sections 4.4 and 4.9).
Danish: De neurologiske forstyrrelser svandt gradvist efter seponering af deferipron (se pkt.
English: Ferriprox 100 mg/ml oral solution deferiprone
Danish: Ferriprox 100 mg/ml oral opløsning deferipron
English: Deferiprone has been shown to cause neutropenia, including agranulocytosis (see section 4.8 ‘Description of selected adverse reactions').
Danish: Deferipron har vist sig at forårsage neutropeni, herunder agranulocytose (se pkt.
English: Do not take Ferriprox if you are breast-feeding.
Danish: Tag ikke Ferriprox, hvis du ammer.
English: Dose table for Ferriprox 1000 mg film-coated tablets Body weight (kg)
Danish: Doseringsskema for Ferriprox 1000 mg filmovertrukne tabletter Kropsvægt (kg)
English: STATEMENT OF ACTIVE SUBSTANCE(S) One tablet contains 500 mg deferiprone.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 500 mg deferipron.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One tablet contains 1000 mg deferiprone.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 1000 mg deferipron.
English: BOTTLES OF 250 ML AND 500 ML ORAL SOLUTION
Danish: FLASKER À 250 ML ELLER 500 ML
English: High density polyethylene (HDPE) bottle with a child resistant polypropylene cap.
Danish: HDPE-flaske med et børnesikret polypropylenlåg.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (jf. bilag I: Produktresumé; pkt.
English: Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml).
Danish: Hver ml oral opløsning indeholder 100 mg deferipron (25 g deferipron i 250 ml).
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 500 mg film-coated tablets Ferriprox 1000 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Ferriprox 500 mg filmovertrukne tabletter Ferriprox 1000 mg filmovertrukne tabletter
English: Do not take medicines known to cause neutropenia or agranulocytosis (see “Do not take Ferriprox”).
Danish: Du må ikke tage medicin, der vides at forårsage neutropeni eller agranulocytose (se pkt.
English: The tablet is scored.
Danish: Tabletten har delekærv.
English: Each ml of oral solution contains 100 mg deferiprone (50 g deferiprone in 500 ml).
Danish: Hver ml oral opløsning indeholder 100 mg deferipron (50 g deferipron i 500 ml).
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 100 mg/ml oral solution
Danish: LÆGEMIDLETS NAVN Ferriprox 100 mg/ml oral opløsning
English: The MAH should provide a patient/carer reminder card in each pack, the text of which is included in the Package Leaflet.
Danish: Indehaveren af markedsføringstilladelsen skal sørge for, at der ligge et patientkort i hver pakning.
English: High density polyethylene (HDPE) bottle with a child resistant polypropylene cap and a desiccant.
Danish: HDPE-flaske med et børnesikret polypropylenlåg og et tørremiddel.
English: How to take Ferriprox
Danish: Sådan skal du tage Ferriprox
English: White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “1000” on one side, plain on the other.
Danish: Hvide til off-white, kapselformede, filmovertrukne tabletter påtrykt “APO” på den ene halvdel og “1000” på den anden, uden påtryk på bagsiden.
English: White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “500” on one side, plain on the other.
Danish: Hvide til off-white, kapselformede, filmovertrukne tabletter påtrykt “APO” på den ene halvdel og “500” på den anden, uden påtryk på bagsiden.
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 100 mg/ml oral solution deferiprone
Danish: LÆGEMIDLETS NAVN Ferriprox 100 mg/ml oral opløsning deferipron
English: What Ferriprox looks like and contents of the pack Ferriprox 500 mg tablets are white to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “500” on one side, plain on the other.
Danish: Ferriprox 500 mg tabletter er hvide til off-white, kapselformede, filmovertrukne tabletter påtrykt “APO” på den ene halvdel og “500” på den anden, uden påtryk på bagsiden.
English: Atrophy of the thymus, lymphoid tissues, and testis, and hypertrophy of the adrenals, were reported at doses of 100 mg/kg/day or greater in non-iron-loaded animals.
Danish: Ved doser på 100 mg/kg/dag eller derover hos ikke-jernbelastede dyr blev der rapporteret om atrofi i thymus, lymfoide væv og testis samt hypertrofi i binyrerne.
English: What Ferriprox looks like and contents of the pack Ferriprox 1000 mg tablets are white to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “1000” on one side, plain on the other.
Danish: Ferriprox 1000 mg tabletter er hvide til off-white, kapselformede, filmovertrukne tabletter påtrykt “APO” på den ene halvdel og “1000” på den anden, uden påtryk på bagsiden.
English: Renal and urinary disorders Chromaturia General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet
English: What Ferriprox is and what it is used for What you need to know before you take Ferriprox How to take Ferriprox
Danish: Det skal du vide, før du begynder at tage Ferriprox Sådan skal du tage Ferriprox Bivirkninger
English: (eGFR): healthy volunteers (eGFR ≥ 90 mL/min/1.73m2), mild renal impairment (eGFR
Danish: Forsøgsdeltagerne blev opdelt i 4 grupper ud fra estimeret glomerulær filtrationshastighed (eGFR): raske frivillige (eGFR) ≥ 90 ml/min/1,73m2), let nyreinsufficiens (eGFR
English: The safety and pharmacokinetics of Ferriprox in patients with end stage renal disease are unknown.
Danish: Sikkerhed og farmakokinetik for Ferriprox hos patienter med nyresygdom i slutstadiet er ikke kendt.
English: Ferriprox 1000 mg film-coated tablets
Danish: Ferriprox 1000 mg filmovertrukne tabletter
English: − if you are currently taking medicines known to cause neutropenia or agranulocytosis (see “Other medicines and Ferriprox”).
Danish: − hvis du tager medicin, der vides at kunne forårsage neutropeni eller agranulocytose (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 1000 mg film-coated tablets deferiprone
Danish: LÆGEMIDLETS NAVN Ferriprox 1000 mg filmovertrukne tabletter deferipron
English: Report immediately to your doctor any symptoms of infection such as: fever, sore throat or flu-like symptoms.
Danish: Kontakt straks din læge, hvis du har symptomer på infektion såsom feber, ondt i halsen eller influenza-lignende symptomer.
English: Ferriprox 500 mg film-coated tablets
Danish: Ferriprox 500 mg filmovertrukne tabletter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/108/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/108/004
English: Renal or hepatic impairment and liver fibrosis
Danish: Nyre- eller leverinsufficiens og leverfibrose
English: Ferriprox 1000 mg film-coated tablets deferiprone
Danish: Ferriprox 1000 mg filmovertrukne tabletter deferipron
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/108/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/108/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/108/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/108/001
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 500 mg film-coated tablets deferiprone
Danish: LÆGEMIDLETS NAVN Ferriprox 500 mg filmovertrukne tabletter deferipron
English: The safety and pharmacokinetics of Ferriprox in patients with severe hepatic impairment are unknown.
Danish: Sikkerheden og farmakokinetikken for Ferriprox hos patienter med svær leverinsufficiens er ikke kendt.
English: Excipients
Danish: Overtræk
English: Ferriprox 500 mg film-coated tablets deferiprone
Danish: Ferriprox 500 mg filmovertrukne tabletter deferipron
English: − If you have any further questions, ask your doctor or pharmacist.
Danish: − Spørg lægen eller på apotekspersonalet, hvis der er mere, du vil vide.
English: The safety and pharmacokinetics of Ferriprox in patients with end stage renal disease is unknown.
Danish: Ferriproxs sikkerhed og farmakokinetik hos patienter med nyresygdom i slutstadiet er ikke kendt.
English: Ferriprox 500 mg film-coated tablets Tablet core
Danish: Ferriprox 500 mg filmovertrukne tabletter Tabletkerne
English: Increased liver enzymes
Danish: Forhøjede leverenzymer
English: Rash Urticaria
Danish: Neutropeni Agranulocytose
English: Dose table
Danish: Telefonnr.
English: If you take more Ferriprox than you should
Danish: Hvis du har taget for meget Ferriprox
English: These events occur rarely.
Danish: Sådanne hændelser er sjældne.
English: Information received after cut-off date 30 January 2013
Danish: Oplysninger, der er tilgået efter skæringsdatoen den 30. januar 2013
English: The product was authorised firstly in Germany in 1985 and followed the rest of the EU countries.
Danish: Produktet blev først godkendt i Tyskland i 1985, derefter i de øvrige EU-lande.
English: Several databases were consulted.
Danish: Der blev søgt i en række databaser.
English: The wording agreed by the PhVWP is entirely implemented only in 11 Member States.
Danish: Den af PhVWP vedtagne ordlyd er i sin helhed kun indført i 11 medlemsstater.
English: After an initially higher risk (the first year), the risk drops to a constant lower level.
Danish: Efter en høj initial risiko (det første år) falder denne til et konstant lavere niveau.
English: This was also one of the main points that the expert group meeting recommended to PRAC.
Danish: Dette var også blandt de hovedpunkter, som ekspertgruppen anbefalede over for PRAC.
English: In 30% of cases the indication for prescription was unknown.
Danish: I 30 % af tilfældene blev indikationen for ordinationen ikke oplyst.
English: In that study there was a significant subjective improvement in hirsutism, however no objective evaluation was performed.
Danish: I denne undersøgelse var der væsentlig subjektiv bedring i hirsutisme, men der var ingen objektiv evaluering.
English: • The PRAC also concluded that there was need for further risk minimisation measures such as information to patients and healthcare professionals.
Danish: • PRAC konkluderede også, at der er behov for yderligere risikominimeringsforanstaltninger såsom information til patienter og sundhedspersoner.
English: Of these 175 cases, 15 reported fatal outcome (4 medically confirmed and 11 non-medically confirmed consumer reports).
Danish: Af disse 175 tilfælde havde 15 dødeligt udfald (4 lægeligt bekræftede og 11 ikke-lægeligt bekræftede forbrugerindberetninger).
English: The time to relief of symptoms is at least three months and the effects are more pronounced with longer treatment duration.
Danish: Tiden til lindring af symptomer er mindst tre måneder, og virkningerne er mere udtalte ved længerevarende behandling.
English: Following the media attention after the initiation of the referral procedure a number of reports were submitted reciprocally.
Danish: Som følge af medieopmærksomheden ved indledningen af proceduren for indbringelse af sager blev der indsendt et antal supplerende indberetninger.
English: This does not indicate a higher incidence in this age group but only a higher reporting rate in this age group, as patient exposure has not been provided in age categories.
Danish: Dette tyder ikke på højere forekomst i denne aldersgruppe, men kun højere indberetningshyppighed i denne aldersgruppe, da patienteksponeringen ikke er angivet for forskellige alderskategorier.
English: In some Member States is also authorised for alopecia androgenetica.
Danish: I nogle medlemsstater er det desuden godkendt til alopecia androgenetica.
English: This missing information would be essential to assess the true motives of the prescribers in choosing one product over another.
Danish: De manglende oplysninger ville være afgørende for en vurdering af de ordinerende lægers egentlige motiver til at vælge ét produkt frem for et andet.
English: Patients were between 13 and 63 years old (mean 27 years, median 25 years) at the time of the event.
Danish: Patienterne var 13-63 år gamle (gennemsnit 27 år, median 25 år) på tidspunktet for hændelsen.
English: Cyproterone has the strongest anti-androgen activity.
Danish: Cyproteron har den stærkeste antiandrogene aktivitet.
English: Seborrhoea has mainly been evaluated in the context of acne.
Danish: Seborré er hovedsagelig blevet vurderet i forbindelse med acne.
English: One of these 968 cases was reported from clinical trial ME94162 / AI58.
Danish: Et af disse 968 tilfælde blev indberettet fra den kliniske undersøgelse ME94162 / AI58.
English: Total number of cycles number of pregnancies Pearl Index two-sided 95% confidence interval
Danish: I alt antal cyklusser antal graviditeter Pearl-indeks tosidet 95 %-sikkerhedsinterval