FrancophonIA/ELRC3.0 huggingface dataset:
English: 225 mg hard capsules Capsule cap
Danish: 225 mg hårde kapsler Kapseloverdel
English: 75 mg hard capsules Capsule cap
Danish: 75 mg hårde kapsler Kapseloverdel
English: 300 mg hard capsules Capsule cap
Danish: 300 mg hårde kapsler Kapseloverdel
English: than you should Call your doctor or go to the nearest hospital emergency unit immediately.
Danish: kapsler Kontakt omgående lægen eller skadestuen.
English: The following events have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness, suggestive of physical dependence.
Danish: Følgende symptomer er set: søvnløshed, hovedpine, kvalme, angst, diarré, influenzalignende symptomer, nervøsitet, depression, smerter, kramper, hyperhidrose og svimmelhed, hvilket kan være tegn på fysisk afhængighed.
English: Excipient with known effect: Each hard capsule also contains 22.5 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver kapsel indeholder også 22,5 mg lactosemonohydrat.
English: 150 mg hard capsules
Danish: 150 mg hårde kapsler.
English: Oedema peripheral, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue
Danish: Perifere ødemer, ødem, gangforstyrrelser, faldtendens, følelse af beruselse, føle sig unormal, træthed
English: Joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness
Danish: Ledhævelser, myalgi, muskeltrækninger, nakkesmerter, muskelstivhed
English: Dose adjustment in patients with reduced renal function or undergoing haemodialysis is necessary (see section 4.2 table 1).
Danish: Dosisjustering er nødvendig hos patienter med nedsat nyrefunktion eller patienter, som er i dialyse (se pkt.
English: Other medicines and Pregabalin Zentiva k.s.
Danish: Brug af anden medicin sammen med Pregabalin Zentiva k.s.
English: You should take Pregabalin Zentiva k.s.
Danish: Du skal tage Pregabalin Zentiva k.s.
English: Black iron oxide (E172) Titanium dioxide (E171) Gelatin
Danish: − Titandioxid (E171)
English: 300 mg hard capsules
Danish: 300 mg hårde kapsler
English: Take your box of Pregabalin Zentiva k.s.
Danish: Medbring pakningen med Pregabalin Zentiva k.s.
English: 225 mg hard capsules Pregabalin
Danish: 225 mg hårde kapsler Pregabalin
English: Jaundice
Danish: Prægeblæk
English: Generalised anxiety disorder Pregabalin Zentiva k.s.
Danish: Generaliseret angst Pregabalin Zentiva k.s.
English: • Dilated pupils, cross eyes.
Danish: • Udvidede pupiller, skelen.
English: 225 mg hard capsules: EU/1/16/1166/023
Danish: 225 mg hårde kapsler: EU/1/16/1166/023
English: 200 mg hard capsules Pregabalin Zentiva k.s.
Danish: 200 mg hårde kapsler Pregabalin Zentiva k.s.
English: Each hard capsule contains 225 mg of pregabalin.
Danish: 225 mg hårde kapsler Hver hård kapsel indeholder 225 mg pregabalin.
English: 100 mg capsules Red cap and red body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “100”, containing almost white powder.
Danish: 100 mg kapsler Rød overdel og rød underdel; ca. 15,9 mm lang, hård gelatinekapsel mærket ”100”, som indeholder et næsten hvidt pulver.
English: Each hard capsule contains 75 mg of pregabalin.
Danish: 75 mg hårde kapsler Hver hård kapsel indeholder 75 mg pregabalin.
English: Red cap and light grey body; approx. 21,7 mm in length, hard gelatin capsule with imprinting “300”, containing almost white powder.
Danish: Rød overdel og lysegrå underdel; ca. 21,7 mm lang, hård gelatinekapsel mærket ”300”, som indeholder et næsten hvidt pulver.
English: 150 mg hard capsules: EU/1/16/1166/017
Danish: 150 mg hårde kapsler: EU/1/16/1166/017
English: Excipient with known effect: Each hard capsule also contains 7.5 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver kapsel indeholder også 7,5 mg lactosemonohydrat.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 225 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 225 mg pregabalin.
English: 150 mg capsules Light grey cap and light grey body; approx. 18,0 mm in length, hard gelatin capsule with imprinting “150”, containing almost white powder.
Danish: 150 mg kapsler Lysegrå overdel og lysegrå underdel; ca. 18,0 mm lang, hård gelatinekapsel mærket ”150”, som indeholder et næsten hvidt pulver.
English: 75 mg hard capsules: EU/1/16/1166/011
Danish: 75 mg hårde kapsler: EU/1/16/1166/011
English: 150 mg hard capsules Capsule cap and body
Danish: 150 mg hårde kapsler Kapseloverdel og -underdel
English: 100 mg hard capsules Pregabalin Zentiva k.s.
Danish: 100 mg hårde kapsler Pregabalin Zentiva k.s.
English: 200 mg hard capsules
Danish: 200 mg hårde kapsler.
English: Excipient with known effect: Each hard capsule also contains 20 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver kapsel indeholder også 20 mg lactosemonohydrat.
English: 200 mg hard capsules: EU/1/16/1166/020
Danish: 200 mg hårde kapsler: EU/1/16/1166/020
English: 50 mg hard capsules: EU/1/16/1166/006
Danish: 50 mg hårde kapsler: EU/1/16/1166/006
English: 200 mg capsules Flesh opaque cap and Flesh opaque body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “200”, containing almost white powder.
Danish: 200 mg kapsler Hudfarvet, uigennemsigtig overdel og hudfarvet, uigennemsigtig underdel; ca. 19,4 mm lang, hård gelatinekapsel mærket ”200”, som indeholder et næsten hvidt pulver.
English: Each hard capsule contains 300 mg of pregabalin.
Danish: 300 mg hårde kapsler Hver hård kapsel indeholder 300 mg pregabalin.
English: 75 mg hard capsules
Danish: 75 mg hårde kapsler.
English: Each hard capsule contains 200 mg of pregabalin.
Danish: 200 mg hårde kapsler Hver hård kapsel indeholder 200 mg pregabalin.
English: 225 mg hard capsules
Danish: 225 mg hårde kapsler.
English: 300 mg hard capsules: EU/1/16/1166/026
Danish: 300 mg hårde kapsler: EU/1/16/1166/026
English: Red cap and red body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “100”, containing almost white powder.
Danish: Rød overdel og rød underdel; ca. 15,9 mm lang, hård gelatinekapsel mærket ”100”, som indeholder et næsten hvidt pulver.
English: Each hard capsule contains 150 mg of pregabalin.
Danish: 150 mg hårde kapsler Hver hård kapsel indeholder 150 mg pregabalin.
English: 100 mg hard capsules: EU/1/16/1166/014
Danish: 100 mg hårde kapsler: EU/1/16/1166/014
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 75 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 75 mg pregabalin.
English: 50 mg hard capsules
Danish: 50 mg hårde kapsler.
English: 150 mg hard capsules Pregabalin
Danish: 150 mg hårde kapsler Pregabalin
English: 100 mg hard capsules Pregabalin
Danish: 100 mg hårde kapsler Pregabalin
English: 25 mg hard capsules
Danish: 25 mg hårde kapsler.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 300 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 300 mg pregabalin.
English: Each hard capsule contains 25 mg of pregabalin.
Danish: 25 mg hårde kapsler Hver hård kapsel indeholder 25 mg pregabalin.
English: Red cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “75”, containing almost white powder.
Danish: Rød overdel og lysegrå underdel; ca. 14,3 mm lang, hård gelatinekapsel mærket ”75”, som indeholder et næsten hvidt pulver.
English: If you take more Pregabalin Zentiva k.s.
Danish: Hvis du har taget for mange Pregabalin Zentiva k.s.
English: 100 mg hard capsules
Danish: 100 mg hårde kapsler.
English: Strong ammonia solution Potassium hydroxide
Danish: − Natriumhydroxid
English: 25 mg hard capsules Pregabalin
Danish: 25 mg hårde kapsler Pregabalin
English: Excipient with known effect: Each hard capsule also contains 30 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver kapsel indeholder også 30 mg lactosemonohydrat.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 150 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 150 mg pregabalin.
English: Flesh opaque cap and light grey body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “225”, containing almost white powder.
Danish: Hudfarvet uigennemsigtig overdel og lysegrå underdel; ca. 19,4 mm lang, hård gelatinekapsel mærket ”225”, som indeholder et næsten hvidt pulver.
English: 150 mg hard capsules Pregabalin Zentiva k.s.
Danish: 150 mg hårde kapsler Pregabalin Zentiva k.s.
English: Each hard capsule contains 100 mg of pregabalin.
Danish: 100 mg hårde kapsler Hver hård kapsel indeholder 100 mg pregabalin.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 200 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 200 mg pregabalin.
English: 225 mg hard capsules Pregabalin Zentiva k.s.
Danish: 225 mg hårde kapsler Pregabalin Zentiva k.s.
English: As pregabalin clearance is directly proportional to creatinine clearance (see section 5.2), dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in table 1 determined using the following formula.
Danish: 5.2), skal dosis individuelt tilpasses patienter med nedsat nyrefunktion i henhold til kreatininclearance.
English: 25 mg hard capsules: EU/1/16/1166/001
Danish: 25 mg hårde kapsler: EU/1/16/1166/001
English: In the post-marketing experience, the most commonly reported adverse reactions observed when pregabalin was taken in overdose included somnolence, confusional state, agitation, and restlessness.
Danish: Efter markedsføring er døsighed, konfus tilstand, agitation og rastløshed blandt de hyppigst rapporterede bivirkninger, når pregabalin tages i overdosis.
English: Light grey cap and light grey body; approx. 18,0 mm in length, hard gelatin capsule with imprinting “150”, containing almost white powder.
Danish: Lysegrå overdel og lysegrå underdel; ca. 18,0 mm lang, hård gelatinekapsel mærket ”150”, som indeholder et næsten hvidt pulver.
English: Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm
Danish: Muskelkramper, artralgi, rygsmerter, ekstremitetssmerter, spasmer i cervikalmuskulaturen.
English: Each hard capsule contains 50 mg of pregabalin.
Danish: 50 mg hårde kapsler Hver hård kapsel indeholder 50 mg pregabalin.
English: 200 mg hard capsules Capsule cap and body
Danish: 200 mg hårde kapsler Kapseloverdel og -underdel
English: 200 mg hard capsules Pregabalin
Danish: 200 mg hårde kapsler Pregabalin
English: 75 mg hard capsules Pregabalin Zentiva k.s.
Danish: 75 mg hårde kapsler Pregabalin Zentiva k.s.
English: Light grey cap and light grey body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “25”, containing almost white powder.
Danish: Lysegrå overdel og lysegrå underdel; ca. 15,9 mm lang, hård gelatinekapsel mærket ”25”, som indeholder et næsten hvidt pulver.
English: Excipient with known effect: Each hard capsule also contains 5 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver kapsel indeholder også 5 mg lactosemonohydrat.
English: Black iron oxide (E172) Propylene glycol
Danish: − Sort jernoxid (E172)
English: Excipient with known effect: Each hard capsule also contains 15 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver kapsel indeholder også 15 mg lactosemonohydrat.
English: looks like and contents of the pack 25 mg capsules Light grey cap and light grey body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “25”, containing almost white powder.
Danish: 25 mg kapsler Lysegrå overdel og lysegrå underdel; ca. 15,9 mm lang, hård gelatinekapsel mærket ”25”, som indeholder et næsten hvidt pulver.
English: Excipient with known effect: Each hard capsule also contains 10 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver kapsel indeholder også 10 mg lactosemonohydrat.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 25 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 25 mg pregabalin.
English: Light grey cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “50”, containing almost white powder.
Danish: Lysegrå overdel og lysegrå underdel; ca. 14,3 mm lang, hård gelatinekapsel mærket ”50”, som indeholder et næsten hvidt pulver.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 100 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 100 mg pregabalin.
English: Renal failure, oliguria, urinary retention Reproductive system and breast disorders Common
Danish: Nyresvigt, oliguri, urinretention
English: 50 mg hard capsules Pregabalin
Danish: 50 mg hårde kapsler Pregabalin
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 50 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 50 mg pregabalin.
English: Fertility
Danish: − Gelatine
English: 300 mg hard capsules Pregabalin
Danish: 300 mg hårde kapsler Pregabalin
English: 50 mg hard capsules Pregabalin Zentiva k.s.
Danish: 50 mg hårde kapsler Pregabalin Zentiva k.s.
English: 100 mg hard capsules Capsule cap and body
Danish: 100 mg hårde kapsler Kapseloverdel og -underdel
English: 25 mg hard capsules Pregabalin Zentiva k.s.
Danish: 25 mg hårde kapsler Pregabalin Zentiva k.s.
English: until your doctor tells you to stop.
Danish: Fortsæt med at tage Pregabalin Zentiva k.s., indtil din læge beder dig om at stoppe.
English: LIST OF EXCIPIENTS Contains lactose monohydrate.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder lactosemonohydrat: Se indlægssedlen for yderligere oplysninger.
English: Generalised anxiety disorder
Danish: Generaliseret angst
English: contains
Danish: BATCHNUMMER
English: • There have been reports of heart failure in some patients when taking pregabalin; these patients were mostly elderly with cardiovascular conditions.
Danish: • Hos nogle patienter, der tager pregabalin, er der set kronisk venstresidig hjertesvigt.
English: Flesh opaque cap and Flesh opaque body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “200”, containing almost white powder.
Danish: Hudfarvet, uigennemsigtig overdel og hudfarvet, uigennemsigtig underdel; ca. 19,4 mm lang, hård gelatinekapsel mærket ”200”, som indeholder et næsten hvidt pulver.
English: 75 mg hard capsules Pregabalin
Danish: 75 mg hårde kapsler Pregabalin
English: BID or TID BID or TID Once daily or BID Once daily
Danish: Fordelt på 2 eller 3 daglige doser Fordelt på 2 eller 3 daglige doser 1 gang dagligt eller
English: Breast-feeding
Danish: − Polyethylenglycol
English: Cardiac disorders Uncommon
Danish: Hjerte Ikke almindelig
English: Black iron oxide (E172) Polyethylene glycol
Danish: − Gul jernoxid (E172)
English: How to store Pregabalin Zentiva k.s.
Danish: Brug af Pregabalin Zentiva k.s.
English: The safety for a human embryo is unknown.
Danish: Sikkerheden for et menneskeligt embryo kendes ikke.
English: Date of first authorisation: 23 February 2012 Date of latest renewal: 14 November 2016
Danish: Dato for første markedsføringstilladelse: 23 februar 2012 Dato for seneste fornyelse: 14. november 2016
English: You should discuss this with your doctor.
Danish: Du bør tale om dette med din læge.
English: Median change at week 13
Danish: Median ændring i uge 13
English: b Patients with missing values were exluded from the analysis.
Danish: b Patienter med manglende værdier blev udelukket fra analysen.
English: ATC code: G03XB02.
Danish: ATC-kode: G03XB02.
English: • the indications.
Danish: • indikationerne.
English: See also section 2 Warnings and precautions.
Danish: Se også punkt 2 Advarsler og forsigtighedsregler.
English: Repeated intermittent use:
Danish: Gentaget intermitterende anvendelse:
English: Patients with controlled bleeding b,c, d
Danish: Patienter med kontrolleret blødning b,c,d
English: Gedeon Richter Plc, 1103 Budapest Gyömrői út 19-21 Hungary
Danish: Gedeon Richter Plc, 1103 Budapest Gyömrői út 19-21 Ungarn
English: Tablets should be swallowed with water.
Danish: Tabletterne skal synkes med vand.
English: These were always in favour of ulipristal acetate.
Danish: Disse var altid til fordel for ulipristalacetat.
English: The educational material shall contain the following key elements:
Danish: Informationsmaterialet skal indeholde følgende centrale elementer:
English: Patients starting treatment course 2 or 4
Danish: Patienter, der starter på behandlingsforløb 2 eller 4
English: P values: 1 = <0.001, 2 = 0.037, 3= <0.002, 4 = <0.006.
Danish: P-værdier: 1 = <0,001, 2 = 0,037, 3= <0,002, 4 = <0,006.
English: There have been no reports of serious harmful effects from taking several doses of this medicine at once.
Danish: Der er ikke rapporteret om alvorlige, skadelige virkninger efter indtagelse af flere doser af dette lægemiddel på én gang.
English: The main route of elimination is through faeces and less than 10% is excreted in the urine.
Danish: Den vigtigste eliminationsvej er via fæces, og mindre end 10 % udskilles i urinen.
English: - if you are pregnant or if you are breastfeeding.
Danish: - hvis du er gravid, eller hvis du ammer.
English: The doctor should check your liver immediately and decide if you can continue the treatment.
Danish: Lægen skal straks undersøge din lever og beslutte, om du kan fortsætte med behandlingen.
English: Pre-operative use:
Danish: Præ-operativ anvendelse:
English: • Educational material for patients which contains o Patient card
Danish: • Informationsmateriale til patienter, der indeholder o Patientkort
English: Functional ovarian cysts were observed during and after treatment in 1.0% of patients and in most of the cases spontaneously disappeared within a few weeks.
Danish: Funktionelle ovariecyster blev observeret under og efter behandling hos 1,0 % af patienterne og forsvandt i de fleste tilfælde spontant i løbet af få uger.
English: Median PBAC at baseline
Danish: Median PBAC ved baseline
English: WHAT TO DO BEFORE DURING AND AFTER YOUR TREATMENT?
Danish: DET SKAL DU GØRE FØR, UNDER OG EFTER BEHANDLING
English: Frequencies are defined as very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from available data).
Danish: Hyppigheder er defineret som meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Similar results were obtained for the active mono-N-demethylated metabolite.
Danish: Lignende resultater blev opnået for den aktive mono-N-demethylerede metabolit.
English: The educational material shall consist of the following:
Danish: Informationsmaterialet skal bestå af følgende:
English: The effect on newborn/infants has not been studied.
Danish: Påvirkningen af nyfødte/spædbørn er ikke undersøgt.
English: Esmya is used in adult women (over 18 years of age) before they reach the menopause.
Danish: Esmya anvendes til voksne kvinder (over 18 år), før de kommer i overgangsalderen.
English: Concomitant treatments
Danish: Samtidige behandlinger
English: * see section "Description of selected adverse reactions" ** The verbatim term “mild hair loss” was coded to the term “alopecia”
Danish: * Se afsnittet ”Beskrivelse af udvalgte bivirkninger” ** Den ordrette term let hårtab blev kodet til termen ”alopeci”
English: Treatment whilst pregnant might affect your pregnancy (it is not known if Esmya might harm your baby or whether can cause miscarriage).
Danish: Behandling under graviditet kan påvirke graviditeten (det vides ikke, om Esmya kan skade barnet, eller om det kan forårsage abort).
English: These changes are reversible after treatment cessation.
Danish: Disse ændringer er reversible efter behandlingophør.
English: Pregnancy should be precluded prior to treatment.
Danish: Graviditet skal udelukkes forud for behandlingen.
English: These tests need to happen every month, including a few weeks after you finish a course of treatment (see schedule below).
Danish: Det skal ske hver måned, samt få uger efter, at du har afsluttet et behandlingsforløb (se skemaet nedenfor).
English: Esmya should not be taken by children under 18 years of age since safety and efficacy of ulipristal acetate has not been established in this age group.
Danish: Esmya bør ikke anvendes til børn under 18 år, da ulipristalacetats sikkerhed og virkning ikke er klarlagt for denne aldersgruppe.
English: Do not drive or use machines if you experience these symptoms.
Danish: Kør ikke bil eller motorcykel, og lad være med at arbejde med værktøj eller maskiner, hvis du oplever disse symptomer.
English: During each course of treatment, do not stop taking your tablets without the advice of your doctor even if you feel better, as symptoms may re-occur later.
Danish: I hvert behandlingsforløb må du ikke holde op med at tage tabletterne, medmindre din læge beder dig om det, heller ikke selvom du har det bedre, eftersom symptomerne kan komme igen senere.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as a result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at der er nået en vigtig milepæl (lægemiddelovervågning eller risikominimering).
English: You should know that most women have no menstrual bleeding (period) during the treatment and for a few weeks afterwards.
Danish: Du skal vide, at de fleste kvinder ikke har menstruation under behandlingen og i nogle få uger derefter.
English: The observed frequency is in line with control groups and prevalence reported in literature for symptomatic premenopausal women of this age group (mean of 40 years).
Danish: Den observerede frekvens svarer til kontrolgrupper og den almindelige forekomst, der er rapporteret i litteraturen for symptomatiske præmenopausale kvinder i denne aldersgruppe (gennemsnitsalder på 40 år).
English: Such a pattern has been observed in approximately 60% of patients treated with ulipristal acetate for 3 months.
Danish: Et sådant mønster er observeret hos ca. 60 % af de patienter, som er blevet behandlet med ulipristalacetat i 3 måneder.
English: The safety and efficacy of ulipristal acetate was only established in women of 18 years and older.
Danish: Sikkerhed og virkning af ulipristalacetat blev kun fastlagt hos kvinder på 18 år og derover.
English: Headache Mild or moderate severity headache was reported in 5.8% of patients.
Danish: Hovedpine Hovedpine af mild eller moderat grad blev indberettet hos 5,8 % af patienterne.
English: • yellow skin/eyes
Danish: • gulfarvning af hud/øjne
English: Have regular blood tests
Danish: Jævnlige blodprøver
English: You should always start taking Esmya within the first week of your menstrual period.
Danish: Du skal altid starte med at tage Esmya i løbet af menstruationens første uge.
English: Frequency Not known
Danish: Almindelig Ikke almindelig Sjælden Hyppighed ikke kendt
English: Simultaneous administration of ulipristal acetate and a P-gp substrate has not been studied and an interaction cannot be excluded.
Danish: Samtidig administration af ulipristalacetat og et P-gp-substrater ikke undersøgt, og interaktion kan ikke udelukkes.
English: 28 tablets 30 tablets 84 tablets
Danish: 28 tabletter 30 tabletter 84 tabletter
English: In Study 2, a double-dummy method was used to maintain the blind.
Danish: I studie 2 blev der anvendt en dobbeltblind metode for at bevare blindingen.
English: A PBAC >100 within the first 8 days of menses is considered to represent excessive menstrual blood loss.
Danish: Et PBAC >100 i løbet af de første 8 dage af menstruationen blev anset for at repræsentere et kraftigt blodtab under menstruationen.