FrancophonIA/ELRC3.0 huggingface dataset:
English: Risk of developing a blood clot (VTE) in a year Women not using a combined hormonal pill/patch/ring and are not pregnant
Danish: Risiko for at udvikle en blodprop (venøs tromboembolisme) i løbet af et år Kvinder, som ikke bruger kombineret hormonal p-pille/plaster/vaginalring og ikke er gravide
English: • The risk of blood clots in the veins varies between CHCs, depending on the type of progestogen (a hormone) they contain, and ranges from 5 to 12 cases of blood clots per 10,000 women who use them for a year (see table below).
Danish: • Risikoen for blodpropper i venerne med de forskellige kombinerede hormonale præventionsmidler afhænger af den type progestogen (et hormon), de indeholder, og udgør mellem 5 og 12 tilfælde af blodpropper pr. 10 000 kvinder, der bruger dem i et år (se tabellen nedenfor).
English: These are sometimes referred to as ‘third generation' or ‘fourth generation' contraceptives and are available as pills, skin patches and vaginal rings.
Danish: De kaldes undertiden “tredjegenerations” eller “fjerdegenerations” præventionsmidler og fås som p-piller, hudplastre og vaginalringe.
English: The review also looked at the risk of arterial thromboembolism (ATE, blood clots in arteries, which can potentially cause a stroke or heart attack).
Danish: Gennemgangen vedrørte desuden risikoen for arteriel tromboembolisme (blodpropper i arterierne, som kan medføre slagtilfælde eller hjerteanfald).
English: It is important that women are made aware of the risk of VTE and its signs and symptoms, and that doctors take into consideration a woman's individual risk factors when prescribing a contraceptive.
Danish: Det er vigtigt, at kvinden gøres opmærksom på risikoen for venøs tromboemboli og tegn og symptomer derpå, og at lægerne tager hensyn til den enkelte kvindes risikofaktorer, når de ordinerer et præventionsmiddel.
English: Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks
Danish: Fordelene ved kombinerede hormonale præventionsmidler opvejer stadig risiciene
English: Your risk of a blood clot is also higher in the first year of using a CHC.
Danish: Din risiko for blodprop er desuden højere i det første år, hvor du bruger et kombineret hormonalt præventionsmiddel.
English: Risk factors include being very overweight, increasing age, having a member of your family who has had a blood clot at a relatively young age (e.g. below 50), having migraine or being immobilised for a long time (e.g. because of an illness or injury).
Danish: Til risikofaktorerne hører stærk overvægt, øget alder, blodprop hos en beslægtet person i forholdsvis ung alder (f.eks. under 50 år), migræne og længerevarende immobilisering (f.eks. ved sygdom eller tilskadekomst).
English: The review included all contraceptives containing low-dose oestrogen and the following progestogens: chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromin and norgestimate.
Danish: Gennemgangen omfattede alle præventionsmidler, der indeholder lavdosis-østrogen og følgende progestogener: chlormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestoden, nomegestrol, norelgestromin og norgestimat.
English: A review of the data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Danish: Gennemgangen af data blev først foretaget af Udvalget For Risikovurdering inden for Lægemiddelovervågning (PRAC), der har ansvar for vurdering af sikkerhedsspørgsmål vedrørende humanmedicinske lægemidler, og som fremsatte et sæt anbefalinger.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the Agency's final opinion.
Danish: Anbefalingerne fra PRAC blev overgivet til Udvalget for Lægemidler til Mennesker (CHMP), der har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
English: • This Europe-wide review looked at the benefits and risks of combined hormonal contraceptives (CHCs), particularly the risk of blood clots associated with these medicines.
Danish: • Denne Europa-dækkende gennemgang drejede sig om fordele og risici ved kombinerede hormonale præventionsmidler, navnlig den risiko for blodpropper, der er forbundet med disse lægemidler.
English: On 21 November 2013, the European Medicines Agency completed its review of combined hormonal contraceptives (CHCs), particularly of the risk of venous thromboembolism (VTE or blood clots in veins) associated with their use.
Danish: Den 21. november 2013 afsluttede Det Europæiske Lægemiddelagentur sin gennemgang af kombinerede hormonale præventionsmidler, navnlig den risiko for blodpropper i venerne (venøs tromboembolisme), der er forbundet med anvendelsen af dem.
English: This compares with 2 cases of blood clots in the veins each year per 10,000 women who are not using CHCs.
Danish: Dette skal sammenholdes med de to årlige tilfælde af blodpropper i venerne, som vil forekomme pr. 10 000 kvinder, der ikke bruger kombinerede hormonale præventionsmidler.
English: CHCs contain two types of hormones, an oestrogen and a progestogen.
Danish: Kombinerede hormonale præventionsmidler indeholder to forskellige typer hormoner, et østrogen og et progestogen.
English: • The EU-wide review of combined hormonal contraceptives (CHCs) has confirmed that the known risk of venous thromboembolism (VTE) with all low-dose CHCs (ethinylestradiol < 50 mcg) is small.
Danish: • Den EU-dækkende gennemgang af kombinerede hormonale kontraceptiva har bekræftet, at den kendte risiko for venøs tromboembolisme er lav med alle kombinerede hormonale kontraceptiva af lavdosistypen (ethinylestradiol < 50 µg).
English: The CHMP opinion, in agreement with the previous recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), was sent to the European Commission, which adopted on 16 January 2014 a legally binding decision to update the product information of all CHCs throughout the EU.
Danish: CHMP's udtalelse var i overensstemmelse med den tidligere anbefaling fra Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC) og blev overgivet til Europa-Kommissionen, som den 16. januar 2014 vedtog en retligt bindende beslutning om ajourføring af produktinformationen for alle kombinerede hormonale præventionsmidler i EU.
English: It confirmed that the benefits of CHCs outweigh the risk of blood clots, which has been known for many years and is very low.
Danish: Gennemgangen bekræftede, at fordelene ved kombinerede hormonale præventionsmidler opvejer risikoen for blodpropper, som har været kendt i mange år og er meget lav.
English: CHCs are contraindicated if a woman has one serious or multiple risk factors that put her at high risk of blood clots.
Danish: Kombinerede hormonale kontraceptiva er kontraindiceret hos kvinder med en alvorlig risikofaktor eller flere forskellige risikofaktorer, der medfører høj risiko for blodpropper.
English: The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of CHCs in preventing unwanted pregnancies continue to outweigh their risks, and that the well-known risk of VTE with all CHCs is small.
Danish: Det Europæiske Lægemiddelagenturs Udvalg for Lægemidler til Mennesker konkluderede, at kombinerede hormonale præventionsmidler til forebyggelse af uønsket graviditet fortsat har større fordele end risici, og at den kendte risiko for venøs tromboemboli er lav for alle de kombinerede hormonale præventionsmidler.
English: During the review, the risk of VTE with these medicines was compared with that of CHCs containing levonorgestrel and norethisterone (also known as ‘second generation' contraceptives).
Danish: Ved gennemgangen blev risikoen for venøs tromboembolisme med disse lægemidler sammenlignet med risikoen ved kombinerede hormonale præventionsmidler indeholdende levonorgestrel og norethisteron (også kaldet “andengenerations” præventionsmidler).
English: • When prescribing a CHC, careful consideration should be given to the individual woman's current risk factors, particularly those for VTE, and the difference in risk of VTE between products.
Danish: • Ved ordination af et kombineret hormonalt kontraceptivum bør der tages nøje hensyn til den enkelte kvindes aktuelle risikofaktorer, navnlig for venøs tromboembolisme, og til forskellen i risiko for venøs tromboembolisme mellem de forskellige præparater.
English: • When taking CHCs, you should be alert for the signs and symptoms of blood clots, which may include severe pain or swelling in the legs, sudden unexplained breathlessness, rapid breathing or cough, chest pain, and weakness or numbness of the face, arm or leg.
Danish: Det kan være stærk smerte eller hævelse af benene, pludselig uforklarlig stakåndethed, hurtig vejrtrækning eller hoste, brystsmerter og svaghed eller følelsesløshed af ansigtet, en arm eller et ben.
English: Product information updated to help women make informed decisions about their choice of contraception
Danish: Produktinformationen er blevet ført ajour, så det er lettere for kvinder at vælge præventionsmiddel
English: Doctors should also consider how the risk of VTE with a particular CHC compares with other CHCs (see table below).
Danish: Lægerne bør desuden tage hensyn til den relative risiko for venøs tromboembolisme med et givet kombineret hormonalt præventionsmiddel i forhold til andre tilsvarende midler (se tabellen nedenfor).
English: • If you have any questions or concerns, speak with your doctor, pharmacist or nurse.
Danish: • Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er mere, du vil vide.
English: Women using a CHC containing drospirenone, gestodene or desogestrel
Danish: Kvinder, der anvender et kombineret hormonalt kontraceptivum indeholdende drospirenon, gestoden eller desogestrel
English: Currently available data indicate that CHCs containing the progestogens levonorgestrel, norethisterone or norgestimate have the lowest risk of VTE (see table below).
Danish: De nuværende foreliggende data viser, at risikoen for venøs tromboembolisme er lavest for kombinerede hormonale kontraceptiva indeholdende progestogenerne levonorgestrel, norethisteron eller norgestimat (se tabellen nedenfor).
English: • It is also important to raise awareness of the signs and symptoms of VTE and ATE when prescribing a CHC.
Danish: • Det er ligeledes vigtigt at gøre kvinden opmærksom på tegn og symptomer på venøs tromboembolisme og arteriel tromboembolisme ved ordination af kombinerede hormonale kontraceptiva.
English: Women using a CHC containing chlormadinone, dienogest or nomegestrol
Danish: Kvinder, der anvender et kombineret hormonalt kontraceptivum indeholdende chlormadinon, dienogest eller nomegestrol
English: The product information of CHCs has been updated to help women make informed decisions about their choice of contraception together with their healthcare professional.
Danish: Produktinformationen for kombinerede hormonale præventionsmidler er blevet bragt ajour, så det er lettere for kvinden at træffe et velbegrundet valg af prævention i samråd med sin sundhedsperson.
English: Women using a CHC containing etonogestrel or norelgestromin
Danish: Kvinder, der anvender et kombineret hormonalt kontraceptivum indeholdende etonogestrel eller norelgestromin
English: • Differences exist between CHCs in their risk of VTE depending on the type of progestogen they contain.
Danish: • Der er forskel i risikoen for venøs tromboembolisme med de forskellige kombinerede hormonale kontraceptiva, afhængigt af den type progestogen, de indeholder.
English: Women using a CHC containing levonorgestrel, norethisterone or norgestimate
Danish: Kvinder, der anvender et kombineret hormonalt kontraceptivum indeholdende levonorgestrel, norethisteron eller norgestimat
English: With the exception of Zoely (nomegestrol acetate/estradiol), Ioa (nomegestrol acetate/estradiol) and Evra (norelgestromin/ethinylestradiol), which have been authorised centrally through the EMA, all other combined contraceptives in the EU have been authorised via national procedures.
Danish: (norelgestromin/ethinylestradiol), der er godkendt centralt gennem EMA.
English: • There is no evidence for differences between low-dose CHCs in their risk of arterial thromboembolism (ATE).
Danish: • Hvad angår risiko for arteriel tromboembolisme er der ingen evidens for forskelle mellem kombinerede hormonale kontraceptiva af lavdosistypen.
English: • Healthcare professionals should always consider the possibility of a CHC-associated thromboembolism when presented with a woman who has symptoms.
Danish: • Når en kvinde udviser sådanne symptomer, bør sundhedspersoner altid være opmærksomme på muligheden af tromboembolisme i forbindelse med kombinerede hormonale kontraceptiva.
English: Then go on as before.
Danish: Fortsæt derefter som normalt.
English: • The content of the bottle is stable for 2 months after opening.
Danish: • Indholdet i flasken er stabilt i 2 måneder efter åbning.
English: Serious and/or fatal outcomes have been reported.
Danish: Alvorlige og/eller dødelige tilfælde er blevet rapporteret.
English: Subsequent use Commence at point 5.
Danish: Efterfølgende brug Begynd ved punkt 5.
English: After 2 months, you should use a new bottle.
Danish: Efter 2 måneder skal du åbne en ny flaske.
English: This may affect your baby.
Danish: Dette kan påvirke dit barn.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne:
English: • Your doctor will monitor you more closely for a short time.
Danish: • Din læge vil overvåge dig grundigere i en kort periode.
English: This is very important if you have had a transplant.
Danish: Det er meget vigtigt, hvis du har fået en transplantation.
English: This combination should therefore be given with caution with an interval of at least 3 hours.
Danish: Denne kombination skal derfor gives med forsigtighed med et interval på mindst 3 timer.
English: Both generalised and localised infections can occur.
Danish: Både generaliserede og lokale infektioner kan opstå.
English: Some examples are listed below:
Danish: Nogle eksempler er beskrevet nedenfor:
English: These recommendations apply even if the patient`s values still lie within the laboratory`s normal range.
Danish: Disse anbefalinger gælder, selvom patientens værdier stadig ligger inden for laboratoriets normale interval.
English: After the Commission Decision the National Competent Authorities will update the product information as required.
Danish: Efter Kommisionsbeslutningen vil de nationale myndigheder opdatere produktinformationen som påkrævet.
English: • Wearing appropriate protective clothing.
Danish: • bære hensigtsmæssigt beskyttende tøj.
English: These findings have not been demonstrated in other species and their relevance for humans is unknown.
Danish: Disse fund er ikke set hos andre arter, og deres relevans for mennesker er ukendt.
English: Sunlight and sun protection
Danish: Sollys og beskyttelse mod solen
English: The neurological status of these patients should be carefully monitored.
Danish: Den neurologiske tilstand hos disse patienter skal monitoreres nøje.
English: Elderly population (65 years of age and older)
Danish: Ældre mennesker (65 år og ældre)
English: Prevention or treatment of graft-versus-host disease (GVHD).
Danish: Forebyggelse eller behandling af graft-versus-host-sygdom (GVHD).
English: This may be associated with blurred vision.
Danish: Dette kan være forbundet med sløret syn.
English: If plasma or serum is used, a standard separation protocol (time and temperature) should be followed.
Danish: Hvis der anvendes plasma eller serum, bør en standardseparationsprotokol (tid og temperatur) anvendes.
English: Sandimmun with food and drink
Danish: Sandimmun sammen med mad og drikke
English: • Do not use this medicine after the expiry date which is stated on the package.
Danish: • Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen.
English: Do not take more than the recommended dose.
Danish: Tag ikke mere end den anbefalede dosis.
English: In such cases, it is recommended to switch to oral administration as soon as feasible.
Danish: I sådanne tilfælde anbefales det at ændre til oral administration, så snart det kan lade sig gøre.
English: • In adults:
Danish: • Voksne:
English: In some patients, continuous maintenance therapy may be necessary.
Danish: Hos visse patienter kan kontinuerlig vedligeholdelsesbehandling være nødvendig.
English: - This will get rid of any large air bubbles.
Danish: - Dette fjerner eventuelle store luftbobler.
English: Time to improvement varies from 3 to 6 months depending on the type of glomerulopathy.
Danish: Tid til forbedring varierer fra 3 til 6 måneder afhængigt af typen af glomerulopati.
English: Clinical studies have included children from 1 year of age.
Danish: Kliniske studier har omfattet børn fra 1 år.
English: The increased risk appears to be related to the degree and duration of immunosuppression rather than to the use of specific agents.
Danish: Den øgede risiko synes at være relateret til graden og varigheden af immunosuppression og ikke til anvendelse af specifikke stoffer.
English: In plasma, approximately 90% is bound to proteins, mostly lipoproteins.
Danish: I plasma er ca. 90 % bundet til proteiner, hovedsageligt lipoproteiner.
English: This will not affect the dose in any way.
Danish: Det påvirker ikke dosis på nogen måde.
English: Renal function and blood pressure in these children were normal.
Danish: Nyrefunktion og blodtryk var normalt hos disse børn.
English: You should limit your exposure to sunlight and UV light by:
Danish: Du bør begrænse udsættelsen for sollys og UV-lys ved at:
English: if you are pregnant.
Danish: • hvis du er gravid.
English: Your dose may need to be changed.
Danish: Din dosis skal muligvis ændres.
English: This is normal and does not mean that there is anything wrong with the capsules.
Danish: Dette er normalt, og betyder ikke, at der er noget i vejen med kapslerne.
English: Some malignancies may be fatal.
Danish: Nogle maligniteter kan være dødelige.
English: Your doctor will also tell you how often to take your medicine.
Danish: Lægen fortæller dig også, hvor ofte du skal tage din medicin.
English: Regular monitoring of blood pressure is required.
Danish: Regelmæssig monitorering af blodtryk er nødvendigt.
English: To do this, your doctor may need to do some blood tests.
Danish: For at kunne gøre dette skal lægen muligvis tage nogle blodprøver.
English: Less than 1% of the administered dose is removed by dialysis.
Danish: Mindre end 1% af den administrerede dosis blev fjernet ved dialyse.
English: It may also affect your sight because of the higher pressure inside your head (benign intracranial hypertension).
Danish: Det kan også påvirke dit syn pga. det højere tryk inden i hovedet (benign intrakraniel hypertension).
English: • Do not store in the refrigerator.
Danish: • Må ikke opbevares i køleskab.
English: Other side effects include:
Danish: Andre bivirkninger kan omfatte:
English: • your blood pressure before the start of your treatment and regularly during treatment,
Danish: • dit blodtryk inden start af behandling og regelmæssigt i løbet af behandlingen
English: • Nifedipine.
Danish: • Nifedipin.
English: This is used to treat high blood pressure and heart pain.
Danish: Dette bruges til behandling af højt blodtryk og smerter i hjertet.
English: You will be switched to ciclosporin in the form of capsules or oral solution (both of which are taken by mouth) as soon as possible.
Danish: Du vil blive skiftet til ciclosporin som kapsler eller oral opløsning (begge tages gennem munden) så hurtigt som muligt.
English: This interaction can occur for a long time after withdrawal of amiodarone, due to its very long half-life (about 50 days).
Danish: Interaktionen kan forekomme lang tid efter seponering af amiodaron pga. den meget lange halveringstid (omkring 50 dage).
English: This medicinal product does not require any special temperature storage conditions.
Danish: Dette lægemiddel behøver ikke at blive opbevaret ved særlige temperaturforhold.
English: • If you forget to take a dose, take it as soon as you remember it.
Danish: • Hvis du har glemt at tage en dosis, så tag den så snart, du kommer i tanke om det.
English: • Loss of appetite.
Danish: • Manglende appetit.
English: Other side effects with frequency not known: Frequency cannot be estimated from the available data.
Danish: Andre bivirkninger, hvor hyppigheden ikke kendes: Hyppigheden kan ikke anslås ud fra forhåndenværende data.
English: This leaflet was last revised in {MM/YYYY} {month YYYY}.
Danish: Denne indlægsseddel blev senest revideret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}.>
English: It must be remembered that the ciclosporin concentration in blood, plasma, or serum is only one of many factors contributing to the clinical status of the patient.
Danish: Det skal bemærkes, at ciclosporinkoncentrationen i blod, plasma eller serum kun er en af mange faktorer, som bidrager til patientens kliniske tilstand.
English: This belongs to a group of medicines known as immunosuppressive agents.
Danish: Det tilhører en gruppe af lægemidler, der kaldes immunsupprimerende stoffer.
English: However, the pharmacokinetic profile of ciclosporin was not significantly altered.
Danish: Den farmakokinetiske profil af ciclosporin var imidlertid ikke signifikant ændret.
English: Capsule,soft
Danish: Kapsel, blød
English: • if you have or have had alcohol related problems.
Danish: • hvis du har eller har haft alkoholrelaterede problemer.
English: The initial dose should be given on the day before transplantation.
Danish: Initialdosis bør indgives dagen før transplantationen.
English: They may differ from the general information contained in this leaflet.
Danish: De kan afvige fra de generelle oplysninger i denne indlægsseddel.
English: Sandimmun can be used to induce and maintain remissions.
Danish: Sandimmun kan bruges til at inducere og opretholde remission.
English: This will give you the chance to talk to your doctor about your treatment and talk about any problems you may be having.
Danish: Dette vil give dig en chance for at tale med lægen omkring din behandling og tale om eventuelle problemer, du måtte have.
English: Stir and drink the entire mixture right away.
Danish: Rør rundt, og drik hele blandingen med det samme.
English: • If the medicine is put in the refrigerator by mistake, let it reach room temperature before using it again.
Danish: • Hvis medicinen ved en fejl stilles i et køleskab, skal den have stuetemperatur, inden den bruges igen.
English: • the levels of ciclosporin in your blood, especially if you have had a transplant,
Danish: • mængden af ciclosporin i dit blod, særligt hvis du har fået en transplantation
English: Follow all your doctor's instructions carefully.
Danish: Følg alle lægens anvisninger omhyggeligt.
English: Push down and pull up the plunger a few times.
Danish: Træk stemplet op og ned et par gange.
English: If it is not used immediately, the conditions and duration of storage are the responsibility of the user and storage should not be longer than 24 hours at 2 to 8°C, unless dilution has been carried out under controlled and validated aseptic conditions.
Danish: Hvis den ikke anvendes straks, er opbevaringsforhold og varighed brugeres ansvar og bør ikke overstige 24 timer ved 2 til 8°C, medmindre fortynding er sket under kontrollerede og validerede aseptiske forhold.
English: Diluted infusion solutions must be discarded after 24 hours.
Danish: Fortyndede infusionsvæsker skal bortskaffes efter 24 timer.
English: Method of administration Intravenous administration.
Danish: Administration Intravenøs administration.
English: Signs of infection might be fever or sore throat.
Danish: Tegn på infektion kan være feber eller ondt i halsen.
English: Lower doses are used once your transplanted organ or bone marrow has stabilised.
Danish: Lavere doser anvendes, så snart det transplanterede organ eller knoglemarv er stabiliseret.
English: • Leave your capsules in the foil.
Danish: • Lad kapslerne blive i folien.