FrancophonIA/ELRC3.0 huggingface dataset:
English: If the pre-filled pen is not used within 3 minutes of cap removal, you must dispose of it in a puncture resistant container and use a new pre-filled pen.
Danish: Hvis den fyldte pen ikke anvendes indenfor 3 minutter efter at hætten er fjernet, skal du bortskaffe den fyldte pen i en affaldsbeholder til skarpe genstande og en ny fyldt pen skal anvendes.
English: It is important to choose the correct angle to ensure the medication is delivered under the skin (into fatty tissue), otherwise the injection could be painful and the medication may not work.
Danish: Det er vigtigt at kanylen har den rigtige vinkel for at sikre, at medicinen gives under huden (i fedtvæv).
English: Rotate Injection Site
Danish: Skift indsprøjtningssted
English: Do not use if the medicine is cloudy or contains particles, is any colour besides colourless to slightly yellowish, or any part of the pre-filled syringe appears to be damaged.
Danish: Brug ikke medicinen hvis den er uklar eller indeholder partikler, ikke er farveløs til svagt lysegul, eller én eller flere dele af injektionssprøjten ser ud til at være beskadiget.
English: Interrupt RoActemra dosing
Danish: Afbryd behandlingen med RoActemra
English: the decision to discontinue tocilizumab for a laboratory abnormality should be based upon the medical assessment of the individual patient.
Danish: Beslutningen om at seponere RoActemra på grund af en laboratorieanormalitet skal baseres på en medicinsk vurdering af den enkelte patient
English: In tocilizumab-treated patients, decreases in the levels of CRP to within normal ranges were seen as early as week 2, with decreases maintained while on treatment.
Danish: Der blev allerede i uge 2 set fald i CRP-koncentrationerne indenfor referenceintervallet hos de patienter, som blev behandlet med tocilizumab.
English: If the pre-filled syringe is not used within 5 minutes of cap removal, you must dispose of it in a puncture resistant container and use a new pre-filled syringe.
Danish: Hvis den fyldte injektionssprøjte ikke anvendes indenfor 5 minutter efter at hætten er fjernet, skal du bortskaffe den fyldte injektionssprøjte i en affaldsbeholder til skarpe genstande og en ny fyldt injektionssprøjte skal anvendes.
English: After removing the cap the injection must be started within 5 minutes, to prevent the medicine from drying out and blocking the needle.
Danish: Når kanylehætten er fjernet, skal injektionen påbegyndes inden for 5 minutter for at forhindre at medicinen tørrer ud og blokerer kanylen.
English: Patients with CRS
Danish: Patienter med reumatoid artrit
English: In the 6-month controlled trials decreases in platelet counts below 100 x 103/ μL occurred in 1.7% of patients on RoActemra 8 mg/kg plus DMARDs compared to < 1% on placebo plus DMARDs.
Danish: I de 6-måneders kontrollerede studier blev der set fald i trombocyttal til under 100 x 103/µl hos 1,7 % af de patienter, der fik RoActemra 8 mg/kg plus DMARDs, sammenlignet med < 1 % hos de patienter, der fik placebo plus DMARDs.
English: weeks (patients weighing ≥30 kg), 12 mg/kg IV every 2 weeks (patients weighing below 30 kg), 162 mg SC every week (patients weighing ≥30 kg), 162 mg SC every 10 days or every 2 weeks (patients weighing below 30 kg).
Danish: I 52 uger fik patienter, der vejede ≥ 30 kg (n = 26) doseret 162 mg RoActemra hver uge, mens patienter, der vejede under 30 kg (n = 25) fik doseret 162 mg RoActemra hver 10. dag (n = 8) eller hver 2. uge (n = 17).
English: DAS28 < 2.6, n (%) 17 (10.5)
Danish: ACR n (%) 142 (49,0)*** 115 (39,4)
English: Doses of 4 or 8 mg/kg RoActemra or placebo were given every four weeks in combination with stable MTX (10 mg to 25 mg weekly).
Danish: Der blev givet doser på 4 eller 8 mg/kg RoActemra eller placebo hver 4. uge i kombination med stabil dosis MTX (10 mg - 25 mg ugentligt).
English: Posology
Danish: Nyresten
English: Cmin (µg/mL)
Danish: Cmax (µg/ml) Cmin (µg/ml)
English: Doses of 4 or 8 mg/kg tocilizumab or placebo were given every four weeks in combination with stable MTX (10 mg to 25 mg weekly).
Danish: Der blev givet doser på 4 eller 8 mg/kg tocilizumab eller placebo hver 4. uge i kombination med stabil dosis MTX (10 mg - 25 mg ugentligt).
English: 162 mg Q3W below 30 kg
Danish: 162 mg hver 2. uge ≥ 30 kg 162 mg hver 3. uge, under 30 kg
English: • Do not try to take apart the pre-filled pen at any time.
Danish: • Skil aldrig den fyldte pen ad.
English: The pharmacokinetics of RoActemra were determined using a population pharmacokinetic analysis on a database composed of 3552 RA patients treated with a one-hour infusion of 4 or 8 mg/kg RoActemra every 4 weeks for 24 weeks or with 162 mg tocilizumab given subcutaneously either once a week or every other week for 24 weeks.
Danish: RoActemras farmakokinetik blev bestemt ved en populationsfarmakokinetisk analyse af en database, som omfattede 3.552 patienter med reumatoid artrit, som fik af 4 eller 8 mg/kg RoActemra som i.v.infusion over 1 time hver 4. uge i 24 uger eller 162 mg tocilizumab subkutant enten ugentligt eller hver anden uge i 24 uger.
English: The total clearance of tocilizumab was concentration-dependent and is the sum of the linear clearance and the nonlinear clearance.
Danish: Den totale clearance for tocilizumab var koncentrationsafhængig og er summen af den lineære og den nonlineære clearance.
English: • Never reattach the needle-cap after removal.
Danish: • Sæt aldrig kanylehætten tilbage på kanylen.
English: After removing the cap the injection must be started within 3 minutes, to prevent the medicine from drying out and blocking the needle.
Danish: Når hætten er fjernet, skal indsprøjtningen påbegyndes indenfor 3 minutter for at forhindre, at medicinen tørrer ud og blokerer kanylen.
English: During the double-blind controlled period and with long-term exposure, the pattern and incidence of elevations in lipid parameters remained consistent with what was seen in the 6-month controlled trials.
Danish: I den dobbeltblindede, kontrollerede periode og ved langtidseksponering var mønstret og forekomsten af stigninger i lipidparametre i overensstemmelse med det, der blev set i de 6-måneders kontrollerede kliniske studier.
English: Keep the pre-filled syringes in the outer carton in order to protect from light and moisture.
Danish: Opbevar de fyldte injektionssprøjter i den ydre karton for at beskytte mod lys og fugt.
English: You can press a cotton ball or gauze over the injection site.
Danish: • Hvis det bløder lidt fra injektionsstedet, kan du presse et stykke vat eller gaze mod injektionsstedet.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/492/010
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/492/010
English: • If the patient weighs 30 kg or more: the dose is 162 mg (the content of 1 pre-filled syringe), once every 2 weeks.
Danish: • 30 kg eller derover: Dosis er 162 mg (indholdet i en forfyldt sprøjte) 1 gang hver anden uge
English: The recommended posology in patients above 2 years of age is subcutaneous 162 mg once every 2 weeks in patients weighing greater than or equal to 30 kg or subcutaneous 162 mg once every 3 weeks in patients weighing less than 30 kg.
Danish: Den anbefalede dosis for patienter over 2 år er 162 mg subkutant én gang hver 2. uge hos patienter, der vejer 30 kg eller mere.
English: Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection from a 100 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions.
Danish: Anvendelse i den pædiatriske population sJIA- og pJIA-patienter og patienter med cytokinfrigivelsessyndrom ≥30 kg Et volumen, som svarer til det volumen RoActemra-koncentrat, som er nødvendig til patientens dosis, udtages under aseptiske forhold fra en 100 ml infusionspose, som indeholder steril, pyrogenfri natriumchlorid 9 mg/ml (0,9 %) injektionsvæske.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON (WITH BLUE BOX) - Multipack
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FYLDT INJEKTIONSSPRØJTE KARTON (MED BLÅ BOKS) - MULTIPAKNING
English: Children with pJIA
Danish: Subkutan anvendelse pJIA
English: Laboratory Value
Danish: Laboratorieværdi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/492/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/492/007
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/492/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/492/005
English: Comprehensive instructions for the administration of RoActemra in a pre-filled syringe are given in the package leaflet, see section 6.6.
Danish: Detaljeret vejleding i administration af RoActemra i fyldt injektionssprøjte gives i indlægssedlen, se pkt.
English: NAME OF THE MEDICINAL PRODUCT RoActemra 162 mg solution for injection in pre-filled pen Tocilizumab
Danish: RoActemra 162 mg injektionsvæske, opløsning i en fyldt pen Tocilizumab
English: Accumulation Cmax Accumulation Cmin Accumulation Cmean or AUCτ *
Danish: Akkumulering Cmax Akkumulering Cmin Akkumulering Cgennemsnit eller AUCτ*
English: Accumulation Cmax Accumulation Cmin Accumulation Cmean or AUCτ*
Danish: Akkumulering Cmax Akkumulering Cmin Akkumulering Cgennemsnit eller AUCτ *
English: Predicted mean ± SD PK parameters at steady-state after IV dosing in pJIA RoActemra PK Parameter
Danish: Forventet gennemsnit ± standardafvigelser på farmakokinetiske parametre ved steady-state efter intravenøs dosering hos pJIA patienter
English: 12 mg/kg Q2W below 30 kg
Danish: 8 mg/kg hver 2. uge ≥ 30 kg 12 mg/kg hver 2. uge, under 30 kg
English: 10 mg/kg Q4W below 30 kg
Danish: 8 mg/kg hver 4. uge ≥ 30 kg 12 mg/kg hver 4. uge, under 30 kg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/492/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/492/001
English: The solution is colourless to slightly yellowish.
Danish: Opløsningen er farveløs til svagt lysegul.
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: • Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: Predicted mean ± SD PK parameters at steady-state after subcutaneous dosing in GCA Subcutaneous
Danish: Forventet gennemsnit ± standardafvigelser på farmakokinetiske parametre ved steady-state efter subkutan dosering til sJIA patienter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/492/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/492/003
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/492/008
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/492/008
English: • If you miss your once every 2 weeks dose within 7 days, inject a dose as soon as you remember and take your next dose at your regular scheduled time.
Danish: • Hvis du får RoActemra hver anden uge og inden for en uge opdager, at du har glemt en dosis, skal du tage den glemte dosis med det samme og næste dosis til den planlagte tid.
English: During the double-blind controlled period and with long-term exposure, the pattern and incidence of decreases in platelet counts remained consistent with what was seen in the 6-month controlled clinical trials.
Danish: I den dobbeltblindede, kontrollerede periode og ved langtidseksponering var mønstret og forekomsten af faldet i trombocyttal i overensstemmelse med det, der blev set i de 6-måneders kontrollerede kliniske forsøg.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/492/009
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/492/009
English: x ULN occurred in 9.8% and 4.0% patients treated with RoActemra SC, respectively.
Danish: Der blev observeret en stigning i ALAT eller ASAT til ≥ 3 x øvre normalgrænse hos henholdsvis 9,8 % og 4,0 % af patienterne behandlet med subkutan RoActemra.
English: cholesterol value to ≥ 130 mg/dL and total cholesterol value to ≥ 200 mg/dL at any time during study treatment, respectively.
Danish: I det subkutane studie oplevede henholdsvis 14,3 % og 12,8 % af patienterne en stigning i forhold til baseline i deres LDL-kolesterol værdier til ≥ 130 mg/dl og totalkolesterol værdier til ≥ 200 mg/dl på et hvilket som helst tidspunkt under studiebehandlingen.
English: • liver failure
Danish: • Leversvigt
English: If you still experience difficulty, you should consult your healthcare provider.
Danish: Du bør kontakte sundhedspersonalet, hvis du fortsat har problemer.
English: Accumulation Cmax Accumulation Ctrough Accumulation Cmean or AUCτ *
Danish: Akkumulering Cmax Akkumulering Ctrough Akkumulering Cgennemsnit eller AUCτ*
English: RoActemra is used for children aged 2 years and over who have active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease that causes pain and swelling in one or more joints as well as fever and rash.
Danish: sJIA er en inflammations (betændelseslignedende)-sygdom, som forårsager smerte og hævelse i et eller flere led, samt feber og udslæt.
English: respectively.
Danish: sekunder.
English: What RoActemra looks like and contents of the pack RoActemra is a concentrate for solution for infusion.
Danish: RoActemra er et koncentrat til infusionsvæske, opløsning.
English: (estimated creatinine clearance based on Cockcroft-Gault formula ) did not impact the pharmacokinetics of RoActemra.
Danish: Cockcroft-Gault) påvirkede ikke tocilizumabs farmakokinetik.
English: All patient data collected will remain anonymous.
Danish: Alle patientdata, som indsamles, vil forblive anonyme.
English: Date of first authorisation: 15 May 2009 Date of latest renewal: 21 March 2014
Danish: Dato for første markedsføringstilladelse: 15. maj 2009 Dato for seneste fornyelse: 21. marts 2014
English: <{DD/MM/YYYY}>
Danish: <{DD/MM/ÅÅÅÅ}>
English: You should do a pregnancy test right away.
Danish: Du skal tage en graviditetsprøve med det samme.
English: The effect on newborn/infants has not been studied.
Danish: Virkningen på nyfødte/spædbørn er ikke undersøgt.
English: NS: non statistically significant †: compared to placebo
Danish: NS: ikke statistisk signifikant †: sammenlignet med placebo
English: There are no antidotes and further treatment should be symptomatic.
Danish: Der er ingen modgifte, og yderligere behandling skal være symptomatisk.
English: The sooner you take emergency contraception, the better the chance of avoiding pregnancy.
Danish: Jo hurtigere du tager nødprævention, jo bedre chance er der for at undgå graviditet.
English: *Symptom which could also be related to an undiagnosed pregnancy (or related complications)
Danish: *Symptom, der også kan være relateret til en udiagnosticeret graviditet (eller til relaterede komplikationer)
English: Of 100 women who take this medicine approximately 2 will become pregnant.
Danish: Ca. 2 ud af 100 kvinder, der tager dette lægemiddel, vil blive gravide.
English: Weekly or monthly methods
Danish: Ugentlige eller månedlige metoder
English: Single doses up to 200 mg have been used in women without safety concern.
Danish: Enkeltdoser på op til 200 mg er blevet anvendt til kvinder uden sikkerhedsovervejelser.
English: Therefore, ellaOne is still recommended for all women regardless of their weight or BMI.
Danish: Derfor anbefales ellaOne fortsat til alle kvinder, uanset vægt eller BMI.
English: By taking them both together, you might make this medicine less effective.
Danish: Hvis du tager disse sammen, kan dette lægemiddel blive mindre effektivt.
English: ATC code: G03AD02.
Danish: ATC-kode: G03AD02.
English: The adverse reactions reported in the phase III program of 2,637 women are provided in the table below.
Danish: De rapporterede bivirkninger i fase III-programmet med 2.637 kvinder er anført i tabellen nedenfor.
English: However, in humans, no such effect has been observed even after repeat administration at the daily dose of 10 mg.
Danish: Der er imidlertid ikke set en lignende virkning hos mennesker, selv efter gentagen administration af en daglig dosis på 10 mg.
English: This is because the sperm can survive up to 5 days in your body after intercourse.
Danish: Dette skyldes, at sædceller kan leve op til 5 dage i din krop efter samleje.
English: Emergency contraception is not effective in every case.
Danish: Nødprævention er ikke effektivt i alle tilfælde.
English: Some medicines may prevent ellaOne from working effectively.
Danish: Nogle typer medicin kan forhindre, at ellaOne virker effektivt.
English: Safety of ulipristal acetate has been evaluated in 4,718 women during the clinical development program.
Danish: Sikkerheden ved ulipristalacetat er blevet vurderet hos 4.718 kvinder i det kliniske udviklingsprogram.
English: In a majority of cases (88.2%), this bleeding was reported as spotting.
Danish: I størstedelen af tilfældene (88,2 %) blev blødningen rapporteret som pletblødning.
English: There is more information about contraception at the end of this leaflet.
Danish: Der er yderligere information om prævention i slutningen af denne indlægsseddel.
English: Among the women who received ellaOne in the phase III studies, only 0.4% reported heavy intermenstrual bleeding.
Danish: Blandt de kvinder, der fik ellaOne i fase III-studierne, rapporterede kun 0,4 % om en kraftig intermenstruel blødning.
English: A risk to the breastfed child cannot be excluded.
Danish: En risiko for ammede børn kan derfor ikke udelukkes.
English: If your menstrual period is late, there is a possibility that you may be pregnant.
Danish: Hvis din menstruation er forsinket, er der en mulighed for, at du kan være gravid.
English: Pregnancy rate 0.00% 1.23% 1.29% 2.57%
Danish: Graviditetshyppighed 0,00 % 1,23 % 1,29 % 2,57 %
English: The patient should be informed not to drive or use machines if they are experiencing such symptoms (see section 4.8).
Danish: Patienten skal informeres om ikke at føre motorkøretøj og betjene maskiner, hvis hun har disse symptomer (se pkt.4.8).
English: The delay was greater than 20 days in 4 % of the women.
Danish: Forsinkelsen varede i længere tid end 20 dage hos 4 % af kvinderne.
English: 59452 Lys-Lez-Lannoy France
Danish: 59452 Lys-Lez-Lannoy Frankrig
English: - You can take the tablet at any time of the day either before, during or after a meal.
Danish: - Du kan tage tabletten når som helst i løbet af dagen, enten før, under eller efter et måltid.
English: Examples of regular contraception methods:
Danish: Eksempler på almindelige præventionsmetoder:
English: Nevertheless it is important that any pregnancy in a woman who has taken ellaOne be reported to www.hra-pregnancy-registry.com.
Danish: Ikke desto mindre er det vigtigt, at enhver graviditet hos kvinder, der har taget ellaOne, indberettes til www.hra-pregnancy-registry.com.
English: Sharing your information may help women in the future understand the safety or risks of ellaOne during a pregnancy.
Danish: Ved at dele dine oplysninger kan du hjælpe andre kvinder fremover med at forstå sikkerheden eller risiciene ved ellaOne under graviditet.
English: Limited human data regarding pregnancy exposure to ellaOne do not suggest any safety concern.
Danish: Begrænsede humane data vedrørende eksponering for ellaOne antyder ingen sikkerhedsproblemer.
English: It is important to know that the occurrence of uterine bleeding does not rule out ectopic pregnancy.
Danish: Det er vigtigt at vide, at forekomst af uterin blødning ikke udelukker ektopisk graviditet.
English: There are many different types of contraception available, and you should be able to find the right method for you.
Danish: Der er mange forskellige typer prævention, og der burde kunne findes en, som passer til netop dig.
English: The purpose of this web-based registry is to collect safety information from women who have taken ellaOne during pregnancy or who become pregnant after ellaOne intake.
Danish: Formålet med dette webbaserede register er at indsamle sikkerhedsoplysninger fra kvinder, som har taget ellaOne under graviditet, eller som bliver gravide efter indtagelse af ellaOne.
English: This medicine is a contraceptive used to prevent a pregnancy from starting.
Danish: Dette lægemiddel er et præventionsmiddel, som anvendes til at forhindre en graviditet i at begynde.
English: Carcinogenicity studies (in rats and mice) showed that ulipristal acetate is not carcinogenic.
Danish: Karcinogenicitetsstudier (hos rotter og mus) viste, at ulipristalacetat ikke er karcinogent.
English: Unprotected sex at any time during your cycle can lead to pregnancy.
Danish: Ubeskyttet sex når som helst i løbet af din cyklus kan medføre graviditet.
English: This medicine is suitable for any woman of childbearing age, including adolescents.
Danish: Dette lægemiddel er egnet til alle kvinder i den fødedygtige alder, herunder teenagere.
English: Long lasting methods
Danish: Langvarige metoder
English: In the phase III studies, 82 women entered a study more than once and therefore received more than one dose of ellaOne (73 women enrolled twice and 9 enrolled three times).
Danish: I fase III-studiet deltog 82 kvinder i studiet mere end én gang, og de fik derfor mere end én dosis ellaOne (73 rekrutteredes to gange, og 9 rekrutteredes tre gange).
English: As for any pregnancy, your doctor may want to check that the pregnancy is not outside the womb.
Danish: Som ved enhver graviditet kan det være, at din læge ønsker at tjekke, at graviditeten ikke er uden for livmoderen.
English: As with any pregnancy, the possibility of an ectopic pregnancy should be considered.
Danish: Som ved enhver graviditet skal muligheden for ekstrauterin graviditet overvejes.
English: Contents of the pack and other information - Useful information about contraception
Danish: Pakningsstørrelser og yderligere oplysninger - Nyttige oplysninger om prævention
English: This medicine will not affect your future fertility.
Danish: Dette lægemiddel påvirker ikke din frugtbarhed fremover.
English: After the tablet intake menstrual periods can sometimes occur a few days earlier or later than expected.
Danish: Efter indtagelse af tabletten kan menstruationen somme tider starte nogle få dage tidligere eller senere end forventet.
English: Use in women with severe asthma treated by oral glucocorticoid is not recommended.
Danish: Anvendelse hos kvinder med svær astma, der behandles med orale glukokortikoider, anbefales ikke.
English: When the data from the two trials were combined via meta- analysis, the risk of pregnancy with ulipristal acetate was significantly reduced compared to levonorgestrel (p=0.046).
Danish: Når dataene fra de to studier blev kombineret via metaanalyse, var risikoen for graviditet med ulipristalacetat signifikant mindre end med levonorgestrel (p=0,046).
English: Thus, administration of ulipristal acetate is unlikely to alter the clearance of medicinal products that are metabolised by these enzymes.
Danish: Det er derfor usandsynligt, at administration af ulipristalacetat vil ændre clearance af lægemidler, som metaboliseres vha. disse enzymer.
English: There is some evidence that this medicine may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.
Danish: Der foreligger nogen dokumentation for, at dette lægemiddel kan være mindre effektivt ved stigende legemsvægt eller body mass index (BMI), men disse data er begrænsede og utilstrækkelige.
English: 1: Brache et al, Contraception 2013 §: defined as presence of unruptured dominant follicle five days after late follicular-phase treatment *: compared to levonorgestrel
Danish: 1: Brache et al, Contraception 2013 §: defineret som tilstedeværelse af ikke-rumperet dominerende follikel fem dage efter behandling i sen follikulær fase.
English: USEFUL INFORMATION ABOUT CONTRACEPTION MORE ABOUT EMERGENCY CONTRACEPTION
Danish: NYTTIGE OPLYSNINGER OM PRÆVENTION MERE OM NØDPRÆVENTION
English: Prevention of ovulation1,§
Danish: Forebyggelse af ægløsning1,§
English: However, it is important that you see your doctor.
Danish: Det er vigtigt, at du kontakter din læge.
English: In approximately 7% of the women, menstrual periods occurred more than 7 days earlier than expected.
Danish: Hos cirka 7 % af kvinderne kom menstruationen mere end 7 dage tidligere end forventet.
English: Information from reproductive toxicity studies is limited due to the absence of exposure measurement in these studies.
Danish: Data fra studier af reproduktionstoksicitet er begrænsede, da eksponeringen ikke blev målt i disse studier.