natgillin/translations-raw huggingface dataset:
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). 
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).
Neutropeni/agranulocytose 
Neutropenia/Agranulocytosis
Det skal du vide, før du begynder at tage Ferriprox 
What you need to know before you take Ferriprox
Eksempler på legemsvægt i 10 kg trin er anført. 
Sample body weights at 10 kg increments are listed.
Se nedenstående skemaer for anbefalede doser for legemsvægt i 10 kg trin. 
See tables below for recommended doses for body weights at 10 kg increments.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) Ferriprox 500 mg filmovertrukne tabletter EU/1/99/108/001 
MARKETING AUTHORISATION NUMBER Ferriprox 500 mg film-coated tablets EU/1/99/108/001
Indehaver af virksomhedsgodkendelse: Eurofins PROXY Laboratories B.V. 
Manufacturing Authorisation Holder: Eurofins PROXY Laboratories B.V. Archimedesweg 25
ALMINDELIG 
COMMON
Klar, rød-orange væske. 
Clear, reddish orange-coloured liquid.
Kombineret brug sammen med andre jernkelerende stoffer Brugen af kombinationsterapi bør overvejes i hvert enkelt tilfælde. 
The use of combination therapy should be considered on a case-by-case basis.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 August 1999
Dosisjustering er ikke nødvendig hos patienter med let, moderat eller svær nyreinsufficiens (se pkt. 
Dose adjustment is not required in patients with mild, moderate, or severe renal impairment (see section 5.2).
Hver 1000 mg tablet indeholder 1000 mg deferipron. 
Each 1000 mg tablet contains 1000 mg deferiprone.
Tabletterne er forsynet med rille og kan brækkes over i to dele. 
The tablets are scored and breakable in half.
Ferriprox oral opløsning er en klar, rød-orange væske. 
What Ferriprox looks like and contents of the pack Ferriprox oral solution is a clear, reddish orange coloured liquid.
Koncentreret saltsyre, til pH-regulering Kunstig kirsebærsmag Pebermynteolie 
Hydrochloric acid, concentrated, for pH adjustment Artificial cherry flavour
Tabletovertræk: Hypromellose, hydroxypropylcellulose, macrogol, titandioxid. 
Coating: Hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide.
Øvrige indholdsstoffer: Tabletkerne: Mikrokrystallinsk cellulose, magnesiumstearat, kolloid silica. 
The other ingredients are: Tablet core: Microcrystalline cellulose, Magnesium stearate, Colloidal silicon dioxide.
Pakkninger med 50 tabletter. 
Pack size of 50 tablets.
Tabletovertræk: Hypromellose, macrogol, titandioxid. 
Coating: Hypromellose, Macrogol, Titanium dioxide.
Mikrokrystallinsk cellulose Magnesiumstearat 
Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide
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. 
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
Hydroxyethylcellulose Glycerol (E422) 
Glycerol (E422)
Ferriprox 1000 mg filmovertrukne tabletter Hver tablet indeholder 1000 mg deferipron. 
Ferriprox 1000 mg film-coated tablets Each tablet contains 1000 mg deferiprone.
Ferriprox bruges til at behandle jernophobning som følge af hyppige blodtransfusioner hos talassæmipatienter, hvor nuværende kelationsterapi er kontraindiceret eller utilstrækkelig. 
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.
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. 
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.
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). 
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).
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. 
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.
Pakninger med 100 tabletter. 
Pack size of 100 tablets.
Der sås en alvorlig bivirkning med akut lever- og nyreskade hos én forsøgsdeltager med moderat leverinsufficiens. 
A serious adverse event of acute liver and renal injury was seen in one subject with moderate hepatic impairment.
Hver ml oral opløsning indeholder 100 mg deferipron. 
Each ml of oral solution contains 100 mg deferiprone.
INFORMATION I BRAILLE-SKRIFT Ferriprox 1000 mg 
INFORMATION IN BRAILLE Ferriprox 1000 mg
- 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. 
- 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).
Hver ml oral opløsning indeholder 100 mg deferipron (25 g deferipron i 250 ml og 50 g deferipron i 500 ml). 
Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml and 50 g deferiprone in 500 ml).
Brug ikke Ferriprox, hvis du ammer. 
Do not use Ferriprox if you are breast-feeding.
Følgelig reducerer øget myokardial jern de myokardiale MRI T2*-værdier. 
Iron overload causes concentration-dependent MRI T2* signal loss, thus, increased myocardial iron reduces myocardial MRI T2* values.
Øvrige indholdsstoffer: Tabletkerne: Methylcellulose, crospovidon, magnesiumstearat. 
Tablet core: Methylcellulose, crospovidone, magnesium stearate.
INFORMATION I BRAILLE-SKRIFT Ferriprox 100 mg/ml 
INFORMATION IN BRAILLE Ferriprox 100 mg/ml
Vis dette kort til lægen, hvis du udvikler symptomer på infektion, f.eks. feber, ondt i halsen eller influenzalignende symptomer. 
Provide this card to your doctor if you develop infection symptoms such as a fever, sore throat or flu-like symptoms.
Dosisjustering er ikke nødvendig hos patienter med let eller moderat leverinsufficiens (se pkt. 
Dose adjustment is not required in patients with mildly or moderately impaired hepatic function (see section 5.2).
Ferriprox monoterapi er indiceret til behandling af jernophobning hos talassæmi-patienter, hvor nuværende kelationsterapi er kontraindiceret eller utilstrækkelig. 
Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
INFORMATION I BRAILLE-SKRIFT Ferriprox 500 mg 
INFORMATION IN BRAILLE Ferriprox 500 mg
De neurologiske forstyrrelser svandt gradvist efter seponering af deferipron (se pkt. 
The neurological disorders progressively regressed after deferiprone discontinuation (see sections 4.4 and 4.9).
Ferriprox 100 mg/ml oral opløsning deferipron 
Ferriprox 100 mg/ml oral solution deferiprone
Deferipron har vist sig at forårsage neutropeni, herunder agranulocytose (se pkt. 
Deferiprone has been shown to cause neutropenia, including agranulocytosis (see section 4.8 ‘Description of selected adverse reactions').
Tag ikke Ferriprox, hvis du ammer. 
Do not take Ferriprox if you are breast-feeding.
Doseringsskema for Ferriprox 1000 mg filmovertrukne tabletter Kropsvægt (kg) 
Dose table for Ferriprox 1000 mg film-coated tablets Body weight (kg)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 500 mg deferipron. 
STATEMENT OF ACTIVE SUBSTANCE(S) One tablet contains 500 mg deferiprone.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 1000 mg deferipron. 
STATEMENT OF ACTIVE SUBSTANCE(S) One tablet contains 1000 mg deferiprone.
FLASKER À 250 ML ELLER 500 ML 
BOTTLES OF 250 ML AND 500 ML ORAL SOLUTION
HDPE-flaske med et børnesikret polypropylenlåg. 
High density polyethylene (HDPE) bottle with a child resistant polypropylene cap.
Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (jf. bilag I: Produktresumé; pkt. 
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).
Hver ml oral opløsning indeholder 100 mg deferipron (25 g deferipron i 250 ml). 
Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml).
LÆGEMIDLETS NAVN Ferriprox 500 mg filmovertrukne tabletter Ferriprox 1000 mg filmovertrukne tabletter 
NAME OF THE MEDICINAL PRODUCT Ferriprox 500 mg film-coated tablets Ferriprox 1000 mg film-coated tablets
Du må ikke tage medicin, der vides at forårsage neutropeni eller agranulocytose (se pkt. 
Do not take medicines known to cause neutropenia or agranulocytosis (see “Do not take Ferriprox”).
Tabletten har delekærv. 
The tablet is scored.
Hver ml oral opløsning indeholder 100 mg deferipron (50 g deferipron i 500 ml). 
Each ml of oral solution contains 100 mg deferiprone (50 g deferiprone in 500 ml).
LÆGEMIDLETS NAVN Ferriprox 100 mg/ml oral opløsning 
NAME OF THE MEDICINAL PRODUCT Ferriprox 100 mg/ml oral solution
Indehaveren af markedsføringstilladelsen skal sørge for, at der ligge et patientkort i hver pakning. 
The MAH should provide a patient/carer reminder card in each pack, the text of which is included in the Package Leaflet.
HDPE-flaske med et børnesikret polypropylenlåg og et tørremiddel. 
High density polyethylene (HDPE) bottle with a child resistant polypropylene cap and a desiccant.
Sådan skal du tage Ferriprox 
How to take Ferriprox
Hvide til off-white, kapselformede, filmovertrukne tabletter påtrykt “APO” på den ene halvdel og “1000” på den anden, uden påtryk på bagsiden. 
White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “1000” on one side, plain on the other.
Hvide til off-white, kapselformede, filmovertrukne tabletter påtrykt “APO” på den ene halvdel og “500” på den anden, uden påtryk på bagsiden. 
White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “500” on one side, plain on the other.
LÆGEMIDLETS NAVN Ferriprox 100 mg/ml oral opløsning deferipron 
NAME OF THE MEDICINAL PRODUCT Ferriprox 100 mg/ml oral solution deferiprone
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. 
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.
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. 
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.
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. 
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.
Almene symptomer og reaktioner på administrationsstedet 
Renal and urinary disorders Chromaturia General disorders and administration site conditions
Det skal du vide, før du begynder at tage Ferriprox Sådan skal du tage Ferriprox Bivirkninger 
What Ferriprox is and what it is used for What you need to know before you take Ferriprox How to take Ferriprox
Forsøgsdeltagerne blev opdelt i 4 grupper ud fra estimeret glomerulær filtrationshastighed (eGFR): raske frivillige (eGFR) ≥ 90 ml/min/1,73m2), let nyreinsufficiens (eGFR 
(eGFR): healthy volunteers (eGFR ≥ 90 mL/min/1.73m2), mild renal impairment (eGFR
Sikkerhed og farmakokinetik for Ferriprox hos patienter med nyresygdom i slutstadiet er ikke kendt. 
The safety and pharmacokinetics of Ferriprox in patients with end stage renal disease are unknown.
Ferriprox 1000 mg filmovertrukne tabletter 
Ferriprox 1000 mg film-coated tablets
− hvis du tager medicin, der vides at kunne forårsage neutropeni eller agranulocytose (se pkt. 
− if you are currently taking medicines known to cause neutropenia or agranulocytosis (see “Other medicines and Ferriprox”).
LÆGEMIDLETS NAVN Ferriprox 1000 mg filmovertrukne tabletter deferipron 
NAME OF THE MEDICINAL PRODUCT Ferriprox 1000 mg film-coated tablets deferiprone
Kontakt straks din læge, hvis du har symptomer på infektion såsom feber, ondt i halsen eller influenza-lignende symptomer. 
Report immediately to your doctor any symptoms of infection such as: fever, sore throat or flu-like symptoms.
Ferriprox 500 mg filmovertrukne tabletter 
Ferriprox 500 mg film-coated tablets
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/108/004 
MARKETING AUTHORISATION NUMBER(S) EU/1/99/108/004
Nyre- eller leverinsufficiens og leverfibrose 
Renal or hepatic impairment and liver fibrosis
Ferriprox 1000 mg filmovertrukne tabletter deferipron 
Ferriprox 1000 mg film-coated tablets deferiprone
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/108/002 
MARKETING AUTHORISATION NUMBER(S) EU/1/99/108/002
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/108/001 
MARKETING AUTHORISATION NUMBER(S) EU/1/99/108/001
LÆGEMIDLETS NAVN Ferriprox 500 mg filmovertrukne tabletter deferipron 
NAME OF THE MEDICINAL PRODUCT Ferriprox 500 mg film-coated tablets deferiprone
Sikkerheden og farmakokinetikken for Ferriprox hos patienter med svær leverinsufficiens er ikke kendt. 
The safety and pharmacokinetics of Ferriprox in patients with severe hepatic impairment are unknown.
Overtræk 
Excipients
Ferriprox 500 mg filmovertrukne tabletter deferipron 
Ferriprox 500 mg film-coated tablets deferiprone
− Spørg lægen eller på apotekspersonalet, hvis der er mere, du vil vide. 
− If you have any further questions, ask your doctor or pharmacist.
Ferriproxs sikkerhed og farmakokinetik hos patienter med nyresygdom i slutstadiet er ikke kendt. 
The safety and pharmacokinetics of Ferriprox in patients with end stage renal disease is unknown.
Ferriprox 500 mg filmovertrukne tabletter Tabletkerne 
Ferriprox 500 mg film-coated tablets Tablet core
Forhøjede leverenzymer 
Increased liver enzymes
Neutropeni Agranulocytose 
Rash Urticaria
Telefonnr. 
Dose table
Hvis du har taget for meget Ferriprox 
If you take more Ferriprox than you should
Sådanne hændelser er sjældne. 
These events occur rarely.
Oplysninger, der er tilgået efter skæringsdatoen den 30. januar 2013 
Information received after cut-off date 30 January 2013
Produktet blev først godkendt i Tyskland i 1985, derefter i de øvrige EU-lande. 
The product was authorised firstly in Germany in 1985 and followed the rest of the EU countries.
Der blev søgt i en række databaser. 
Several databases were consulted.
Den af PhVWP vedtagne ordlyd er i sin helhed kun indført i 11 medlemsstater. 
The wording agreed by the PhVWP is entirely implemented only in 11 Member States.
Efter en høj initial risiko (det første år) falder denne til et konstant lavere niveau. 
After an initially higher risk (the first year), the risk drops to a constant lower level.
Dette var også blandt de hovedpunkter, som ekspertgruppen anbefalede over for PRAC. 
This was also one of the main points that the expert group meeting recommended to PRAC.
I 30 % af tilfældene blev indikationen for ordinationen ikke oplyst. 
In 30% of cases the indication for prescription was unknown.
I denne undersøgelse var der væsentlig subjektiv bedring i hirsutisme, men der var ingen objektiv evaluering. 
In that study there was a significant subjective improvement in hirsutism, however no objective evaluation was performed.
• PRAC konkluderede også, at der er behov for yderligere risikominimeringsforanstaltninger såsom information til patienter og sundhedspersoner. 
• The PRAC also concluded that there was need for further risk minimisation measures such as information to patients and healthcare professionals.
Af disse 175 tilfælde havde 15 dødeligt udfald (4 lægeligt bekræftede og 11 ikke-lægeligt bekræftede forbrugerindberetninger). 
Of these 175 cases, 15 reported fatal outcome (4 medically confirmed and 11 non-medically confirmed consumer reports).
Tiden til lindring af symptomer er mindst tre måneder, og virkningerne er mere udtalte ved længerevarende behandling. 
The time to relief of symptoms is at least three months and the effects are more pronounced with longer treatment duration.
Som følge af medieopmærksomheden ved indledningen af proceduren for indbringelse af sager blev der indsendt et antal supplerende indberetninger. 
Following the media attention after the initiation of the referral procedure a number of reports were submitted reciprocally.
Dette tyder ikke på højere forekomst i denne aldersgruppe, men kun højere indberetningshyppighed i denne aldersgruppe, da patienteksponeringen ikke er angivet for forskellige alderskategorier. 
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.
I nogle medlemsstater er det desuden godkendt til alopecia androgenetica. 
In some Member States is also authorised for alopecia androgenetica.
De manglende oplysninger ville være afgørende for en vurdering af de ordinerende lægers egentlige motiver til at vælge ét produkt frem for et andet. 
This missing information would be essential to assess the true motives of the prescribers in choosing one product over another.
Patienterne var 13-63 år gamle (gennemsnit 27 år, median 25 år) på tidspunktet for hændelsen. 
Patients were between 13 and 63 years old (mean 27 years, median 25 years) at the time of the event.
Cyproteron har den stærkeste antiandrogene aktivitet. 
Cyproterone has the strongest anti-androgen activity.
Seborré er hovedsagelig blevet vurderet i forbindelse med acne. 
Seborrhoea has mainly been evaluated in the context of acne.
Et af disse 968 tilfælde blev indberettet fra den kliniske undersøgelse ME94162 / AI58. 
One of these 968 cases was reported from clinical trial ME94162 / AI58.
I alt antal cyklusser antal graviditeter Pearl-indeks tosidet 95 %-sikkerhedsinterval 
Total number of cycles number of pregnancies Pearl Index two-sided 95% confidence interval
Arterielle tromboemboliske hændelser kan være livstruende eller have dødeligt udfald. 
Arterial thromboembolic events may be lifethreatening or may have a fatal outcome.
Ligesom ved acnebehandling varierer den procentuelle bedring mellem undersøgelserne og afhænger af de anvendte metoder til vurdering af virkningerne. 
Similar to acne treatment, percentages of improvement vary per study, and depend on the methods applied for evaluation of effects.
Begrundelse for PRAC's anbefaling 
Grounds for PRAC recommendation Whereas
Ordinationsdata fra IMS har begrænset værdi, da de mangler kategorien “antikonception i fravær af acne”. 
The IMS prescription data have limited value because they do not include a category of “contraception in the absence of acne”.
Fejldiagnose er en reel mulighed, da tromboemboliske hændelser giver diffuse symptomer og er en sjælden hændelse i populationen af raske unge kvinder. 
Misdiagnosis is a realistic possibility since TE has diffuse symptoms and is a rare event in population of healthy young women.
Konklusioner vedrørende sikkerhed 
Conclusions on safety
Acne uden androgene kendetegn 
Acne without androgenic features
Dette på trods af, at undersøgelsens inklusionskriterier overvejende udvalgte patienter, hos hvem antikonception måtte formodes at have været den oprindelige grund til konsultationen. 
This is despite the fact that the study enrolment criteria overwhelmingly selected for patients in whom contraception would have been the original reason for consultation.
Totalt er tromboemboli dødbringende i 1-2 % af tilfældene. 
Overall, VTE could be fatal in 1-2% of the cases.
*beregnet som samlet antal cyklusser, n=21 196, minus antal cyklusser, n=450, hvor medicineringen blev oversprunget. 
*calculated as the total number of cycles, n=21,196, minus the number of cycles, n=450, in which medication was missed.
Som led i risikominimeringsforanstaltningerne vedtog PRAC en opdateret indikation, hvor alle data tages i betragtning, og hvor det præciseres, under hvilke betingelser, disse produkter er indiceret. 
As part of the risk minimisation measures the PRAC adopted an updated indication taking all the data into account, and making clear the conditions for which these products are indicated.
Indberetning efter markedsføring 
Post-marketing reporting
Samlet konklusion og betingelser for markedsføringstilladelserne Efter gennemgang af sagen som beskrevet i den vedføjede vurderingsrapport om indbringelsen anbefaler PRAC, at a. indehaverne af markedsføringstilladelse sponsorerer en sikkerhedsundersøgelse efter markeds føring foruden opfølgende evaluering af resultaterne af denne undersøgelse, 
Overall conclusion and conditions to the Marketing Authorisations The PRAC, having considered the matter as set out in the appended referral assessment report recommends that a. the marketing authorisation holders should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study;
Dette er forventeligt i betragtning af forskellene i antiandrogene egenskaber mellem cyproteron, drospirenon og desogestrel. 
This is expected in view of the differences in anti-androgenic properties of cyproterone, drospirenone and desogestrel.
Vægt og højde blev oplyst for 258 (26,7 %) af 968 patienter. 
Weight and height were reported for 258 (26.7%) of 968 patients.
Størstedelen af indberetningerne omhandlede patienter i alderen 18-35 år (66 %). 
Most reports were from patients between 18-35 years of age (66%).