FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission issued the decisions on 3 July 2012 (Yaz 24+4) and 6 July 2012 (Ethinylestradiol-Drospirenone 24+4).
Danish: Europa-Kommissionen udstedte afgørelserne den 3. juli 2012 (Yaz 24+4) og den 6. juli 2012 (Ethinylestradiol-Drospirenone 24+4).
English: Therefore, based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP considered that the benefits of Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 did not outweigh their risks in the proposed new indication.
Danish: Efter vurdering af de foreliggende data og den videnskabelige drøftelse i udvalget fandt CHMP derfor, at fordelene ved Yaz 24+4 og Ethinylestradiol-Drospirenone 24+4 i forhold til den ansøgte nye indikation ikke opvejer risiciene.
English: On 19 April 2012, the European Medicines Agency completed an arbitration procedure for Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4.
Danish: Den 19. april 2012 gennemførte det europæiske Lægemiddelagentur en voldgiftsprocedure for Yaz 24+4 og Ethinylestradiol-Drospirenone 24+4.
English: Questions and answers on Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) EMA/550781/2012
Danish: Spørgsmål og svar om Yaz 24+4 og Ethinylestradiol-Drospirenone 24+4 (ethinylestradiol/drospirenon, tabletter, 0,02 mg/3 mg) EMA/257547/2012
English: Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 work by changing the body's hormonal balance to prevent ovulation, by altering the mucus in the cervix (neck of the womb) and by thinning the endometrium (the lining of the womb).
Danish: Yaz 24+4 og Ethinylestradiol-Drospirenone 24+4 virker ved at ændre kroppens hormonbalance, så ægløsning hindres, fordi slimen i livmoderhalsen ændres, og livmoderslimhinden bliver tyndere.
English: The Committee also considered the known risks with Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4, including VTE.
Danish: Udvalget gennemgik også de kendte risici med Yaz 24+4 og Ethinylestradiol-Drospirenone 24+4, herunder VTE.
English: Women not seeking contraception would therefore be unnecessarily exposed to the risks of Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 when alternative acne treatments are available.
Danish: Kvinder uden behov for oral svangerskabsforebyggelse vil derfor unødigt blive udsat for risiciene ved Yaz 24+4 og Ethinylestradiol-Drospirenone 24+4, skønt der findes andre midler mod acne.
English: Since acne is a common problem in young women, the CHMP was concerned that the measures proposed by the company to ensure that these medicines would be used to treat acne only in women seeking oral contraception were not sufficient.
Danish: Derfor var der i CHMP bekymring for, at virksomhedens påtænkte foranstaltninger ikke er tilstrækkelige til at sikre, at disse lægemidler udelukkende vil blive anvendt til behandling af kvinder med behov for oral svangerskabsforebyggelse.
English: This change was to be recognised in the Netherlands and all other
Danish: Ændringen skulle godkendes i
English: Questions and answers on Yaz 24+4 and EthinylestradiolDrospirenone 24+4 (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets)
Danish: Spørgsmål og svar om Yaz 24+4 og EthinylestradiolDrospirenone 24+4 (ethinylestradiol/drospirenon, tabletter, 0,02 mg/3 mg)
English: The company that markets Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 is Bayer B.V.
Danish: Den virksomhed, der markedsfører Yaz 24+4 og Ethinylestradiol-Drospirenone 24+4, er Bayer B.V.
English: The CHMP noted the overall effectiveness of Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 compared with placebo in the treatment of acne.
Danish: CHMP konstaterede, at Yaz 24+4 og Ethinylestradiol-Drospirenone 24+4 overordnet er effektivt i forhold til placebo til behandling af acne.
English: What are Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4?
Danish: Hvad er Yaz 24+4 og Ethinylestradiol-Drospirenone 24+4?
English: Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 are combined contraceptive pills.
Danish: Yaz 24+4 og Ethinylestradiol-Drospirenone 24+4 er kombinerede p-piller.
English: Why were Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 reviewed?
Danish: Hvorfor blev Yaz 24+4 og Ethinylestradiol-Drospirenone 24+4 vurderet igen?
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan siden blive opdateret af kompetente myndigheder i medlemsstaten, i samarbejde med referencemedlemsstaten, i overensstemmelse med de procedurer, der er fastlagt i kapitel 4 af titel III i direktiv 2001/83/EF.
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Danish: Denne produktinformation er resultatet af den decentrale procedure, som denne Kommissions beslutning henfører til.
English: The valid product information is the final version achieved during the Coordination group procedure.
Danish: Den gældende produktinformation er den endelige version, der blev nået til enighed om under Koordinationsgruppens procedure
English: VTE may be fatal in 1-2% of cases.
Danish: VTE kan være dødelig i 1-2 % af tilfældene.
English: You may get pregnant if you do not follow these instructions.
Danish: Du kan blive gravid, hvis du ikke følger disse instruktioner.
English: The following interactions have been reported in the literature.
Danish: Følgende interaktioner er blevet rapporteret i litteraturen.
English: These include medicines used for the treatment of:
Danish: Dette omfatter lægemidler til behandling af:
English: • Wait until you get your menstrual period.
Danish: • Vent, til du får din menstruation.
English: Always use condoms to protect yourself from these diseases.
Danish: Brug altid kondom for at beskytte dig mod disse sygdomme.
English: The net effect of these changes may be clinically relevant in some cases.
Danish: Nettoeffekten af disse ændringer kan i visse tilfælde være klinisk relevant.
English: However, this may be due to other causes including sexually-transmitted disease.
Danish: Men dette kan skyldes andre årsager som f.eks. seksuelt overførte sygdomme.
English: Seek urgent medical attention
Danish: Søg akut lægehjælp
English: EVRA may make some other medicines less effective, such as:
Danish: EVRA kan gøre visse lægemidler mindre effektive, f.eks.:
English: Date of latest renewal: 22 August 2012.
Danish: Dato for seneste fornyelse: 22. august 2012.
English: There was no significant effect of cool water on these parameters.
Danish: Koldt vand havde ingen signifikant indflydelse på disse parametre.
English: • Talk to your doctor.
Danish: • Tal med lægen.
English: In both cases, the number of VTEs per year is fewer than the number expected in women during pregnancy or in the postpartum period.
Danish: I begge tilfælde er antallet af VTE'er pr. år mindre end det forventede antal hos kvinder under graviditet eller i post partum-perioden.
English: Risk increases substantially as BMI rises.
Danish: Risikoen stiger væsentligt med stigningen i BMI.
English: Seek urgent medical attention if you notice any of the following signs or symptoms.
Danish: Søg akut lægehjælp, hvis du bemærker nogle af følgende tegn eller symptomer.
English: The frequency and nature of examinations should be based on established practice guidelines and be adapted to the individual woman.
Danish: Undersøgelsernes hyppighed og art skal baseres på etablerede retningslinjer i praksis og tilpasses den enkelte kvinde.
English: • Week 4:
Danish: • Uge 4:
English: • Do not try to put a patch back on if:
Danish: • Forsøg ikke at sætte et plaster på igen, hvis:
English: • medicines containing ciclosporin
Danish: • lægemidler, der indeholder ciclosporin
English: These spots may not go away completely, even after you stop using EVRA.
Danish: Disse pletter går muligvis ikke helt væk, selv efter at du holder op med at tage EVRA.
English: He/she may be able to make patch changing easier for you.
Danish: Han/hun kan muligvis gøre dit plasterskifte lettere for dig.
English: This might mean that there is a better chance of the breast cancer being noticed.
Danish: Dette kan betyde, at der er en større chance for at brystkræft opdages.
English: • if you gave birth less than a few weeks ago.
Danish: • hvis du har født for under et par uger siden
English: Are you experiencing any of these signs?
Danish: Har du nogle af disse tegn?
English: The interfering effect of some of these medicines can last for up to 28 days after you have stopped taking them.
Danish: For nogle af disse lægemidler kan påvirkningen vare i op til 28 dage, efter at du er holdt op med at tage dem.
English: Everyday activities while using the patches
Danish: Hverdagsaktiviteter mens du bruger plastrene
English: Particularly important in women with additional risk factors.
Danish: Især vigtig hos kvinder med yderligere risikofaktorer.
English: • The patch is designed to stay in place during these types of activities.
Danish: • Plasteret er beregnet til at blive siddende under disse former for aktivitet.
English: If you do you are more likely to cause irritation.
Danish: Hvis du gør det, kan det lettere medføre irritation.
English: For this reason, a medical opinion on irregular blood loss will only be useful after an adjustment period of approximately three cycles.
Danish: Derfor vil en lægelig udtalelse vedrørende uregelmæssige blødninger kun være til nytte efter en tilpasningsperiode på cirka tre cyklusser.
English: If this happens to you, talk to your doctor immediately.
Danish: Hvis det sker for dig, skal du omgående kontakte din læge.
English: If this is the first time you are using EVRA, wait until the day you get your menstrual period.
Danish: Hvis det er første gang, du bruger EVRA, så vent til den dag, du får din menstruation.
English: Frequency MedDRA convention: 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); not known (cannot be estimated from the available data).
Danish: Hyppighed ifølge MedDRAkonventionen: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: It is important to tell your doctor if any of these conditions apply to you, even if you are unsure.
Danish: Det er vigtigt at fortælle din læge, hvis nogle af disse tilstande gælder for dig, også hvis du ikke er sikker.
English: • Do this no matter when your period begins or ends.
Danish: • Gør dette uanset, hvornår din blødning starter eller slutter.
English: Before you start using EVRA you should read the information on blood clots in section 2.
Danish: Inden du begynder at bruge EVRA, skal du læse oplysningerne om blodpropper i punkt 2.
English: Date of first authorisation: 22 August 2002.
Danish: Dato for første markedsføringstilladelse: 22. august 2002.
English: Table 1: Frequency of adverse reactions System Organ Class
Danish: Tabel 1: Hyppighed af bivirkninger Systemorgan-klasse
English: For more than one day (24 hours or more) or if you are not sure for how long:
Danish: I mere end en dag (24 timer eller mere), eller hvis du ikke er sikker på hvor længe:
English: This may include curettage.
Danish: Dette kan omfatte udskrabning.
English: • If you do not, you may increase your risk of getting pregnant.
Danish: • Hvis du ikke gør det, kan det øge din risiko for at blive gravid.
English: The use of EVRA may need to be stopped several weeks before surgery or while you are less mobile.
Danish: Det kan være nødvendigt at stoppe med EVRA flere uger før operationen, eller mens du er mindre mobil.
English: Safety was evaluated in 3,322 sexually active women who participated in three Phase III clinical trials, which were designed to evaluate contraceptive efficacy.
Danish: Sikkerheden blev bedømt hos 3.322 seksuelt aktive kvinder, der deltog i tre kliniske fase III-studier, som var udformet med henblik på at bedømme den præventive virkning.
English: The relevance of these data for human exposure is unknown as these effects have been seen as related to well-known pharmacodynamic or species-specific actions.
Danish: Relevansen af disse data for human eksponering er ikke kendt, da disse virkninger anses som relateret til velkendte farmakodynamiske eller artsspecifikke handlinger.
English: Particularly important to consider if other risk factors also present.
Danish: Især vigtig at tage hensyn til, hvis der også er andre risikofaktorer.
English: • This usually stops after the first few cycles.
Danish: • Det stopper sædvanligvis efter de første par menstruationscyklusser.
English: For less than one day (up to 24 hours):
Danish: I mindre end en dag (op til 24 timer):
English: Using too many patches may cause you to have the following:
Danish: Brug af for mange plastre kan medføre følgende:
English: • Problems sleeping (insomnia)
Danish: • Søvnproblemer (insomni)
English: Sometimes loss of vision can occur almost immediately.
Danish: Synstab kan også forekomme næsten øjeblikkeligt.
English: Changes generally remain within the normal laboratory range.
Danish: Ændringerne forbliver sædvanligvis inden for det normale referenceinterval.
English: Clinical efficacy and safety Pearl Indices (see table):
Danish: Klinisk virkning og sikkerhed Pearl-indeks (se tabel):
English: For more than 2 days (48 hours or more):
Danish: I mere end 2 dage (48 timer eller mere):
English: Chloasma is often not fully reversible.
Danish: Kloasma er ofte ikke helt reversibelt.
English: Hormonal contraceptives may affect the metabolism of certain other active substances.
Danish: Hormonale kontraceptiva kan påvirke metabolismen af visse andre aktive substanser.
English: It is recommended that users visually check their transdermal patch daily to ensure continued proper adhesion.
Danish: Det anbefales, at brugerne visuelt kontrollerer deres depotplaster dagligt for at sikre, at det stadig klæber korrekt.
English: nevirapine, efavirenz)
Danish: nevirapin, efavirenz)
English: • Sensitivity to sunlight.
Danish: • Overfølsomhed over for sollys
English: • You do not need to use extra contraception if you have an upset stomach.
Danish: • Du behøver ikke anvende ekstra prævention, hvis du har dårlig mave.
English: • Keep using the patches even if you do not have sex very often.
Danish: • Hold ikke op med at bruge plastrene, selv om du ikke dyrker sex særligt ofte.
English: Choose a place on your body to put the patch.
Danish: Vælg et sted på kroppen at sætte plasteret på.
English: It is used to prevent pregnancy.
Danish: Det bruges til at forebygge graviditet.
English: Note: temporary immobilisation including air travel > 4 hours can also be a risk factor for VTE, particularly in women with other risk factors
Danish: Bemærk: Midlertidig immobilisering inklusive flyrejse >4 timer kan også udgøre en risikofaktor for VTE, især hos kvinder med andre risikofaktorer
English: Non-hormonal causes should be considered and, if necessary, adequate diagnostic measures taken to rule out organic disease or pregnancy.
Danish: Ikke-hormonale årsager skal tages i betragtning, og der skal om nødvendigt træffes diagnostiske foranstaltninger til at udelukke organisk sygdom eller graviditet.
English: Enzyme induction may be observed after a few days of treatment.
Danish: Enzyminduktion kan observeres efter få dages behandling.
English: • as you get older (particularly above about 35 years);
Danish: • efterhånden som du bliver ældre (især over ca. 35 år);
English: If you forget to change your patch for one or two days (up to 48 hours):
Danish: Hvis du glemmer at skifte plaster i en eller to dage (op til 48 timer):
English: Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.
Danish: Symptomerne på et slagtilfælde kan nogle gange være kortvarige med en næsten øjeblikkelig og fuldstændig bedring, men du skal alligevel søge akut lægehjælp, da du kan have risiko for at få et nyt slagtilfælde.
English: The most commonly reported adverse reactions in clinical trials were headache, nausea, and breast tenderness, occurring in approximately 21.0%, 16.6%, and 15.9% of patients, respectively.
Danish: De hyppigst rapporterede bivirkninger i kliniske studier var hovedpine, kvalme og brystømhed, som forekom hos henholdsvis ca. 21,0 %, 16,6 % og 15,9 % af patienterne.
English: * Post-marketing reports.
Danish: * Rapporteret efter markedsføringen.
English: Erythema (multiforme, nodosum)* Chloasma†
Danish: Erytem (multiforme, nodosum)* Chloasma†
English: For initiation instructions see ‘How to start EVRA' below.
Danish: For startvejledning se "Hvordan du begynder at anvende EVRA" nedenfor.
English: • If you forget to change your patch for more than 2 days, you may become pregnant.
Danish: • Hvis du glemmer at skifte dit plaster i mere end 2 dage, kan du blive gravid.
English: Women over 35 who continue to smoke should be strongly advised to use a different method of contraception.
Danish: Kvinder over 35, der fortsætter med at ryge, skal stærkt tilrådes at bruge en anden præventionsmetode.
English: This medicine will not protect you against HIV infection (AIDS) or any other sexually transmitted disease.
Danish: Dette lægemiddel beskytter dig ikke mod hiv-infektion (aids) eller andre seksuelt overførte sygdomme.
English: With respect to the reproductive toxicity norelgestromin showed foetal toxicity in rabbits, but the safety margin for this effect was sufficiently high.
Danish: Med hensyn til reproduktionstoksicitet viste norelgestromin føtal toksicitet hos kaniner, men sikkerhedsmarginalen for denne effekt var tilstrækkeligt høj.
English: Women who are not using a combined hormonal pill/patch/ring and are not pregnant
Danish: Kvinder, der ikke bruger en kombineret hormonelt pille/plaster/ring, og som ikke er gravide
English: it is no longer sticky it has become stuck to itself or another surface it has other material stuck to it it is the second time it has become loose or has fallen off.
Danish: det ikke længere klæber det klæber fast til sig selv eller en anden overflade andet materiale klæber til det det er anden gang, at det løsner sig eller falder af.
English: • with increasing age (beyond about 35 years);
Danish: • med stigende alder (efter ca. 35 år);
English: • Then take off the other half of the covering
Danish: • Fjern derefter den anden halvdel af filmen
English: However, diabetic women should be carefully observed, particularly in the early stage of EVRA use.
Danish: Imidlertid bør kvinder med diabetes nøje observeres, specielt i starten af EVRA-behandlingen.
English: Below 90 kg there was no association between body weight and pregnancy.
Danish: Ved legemsvægt under 90 kg var der ingen forbindelse mellem legemsvægt og graviditet.
English: If you have more than one of these conditions or if any of them are particularly severe the risk of developing a blood clot may be increased even more.
Danish: Hvis du har mere end én af disse tilstande, eller hvis én af tilstandene er særligt alvorlig, kan risikoen for at udvikle en blodprop være endnu større.
English: Your “Patch Change Day” will be on this day of the week every week.
Danish: Din 'plasterskiftedag' vil være denne ugedag hver uge.
English: • sudden trouble seeing in one or both eyes;
Danish: • pludseligt opstået synsbesvær på et eller begge øjne;
English: • Check each day to make sure the patch has not fallen off.
Danish: • Kontrollér hver dag, at plasteret ikke er faldet af.
English: • Your “Patch Change Day” should remain the same.
Danish: • Din 'plasterskiftedag' skal forblive den samme.
English: The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in COC users, the biological effects of COCs or a combination of both.
Danish: Det observerede mønster af øget risiko kan skyldes en tidligere diagnosticering af brystkræft hos COC-brugere, de biologiske virkninger af COC'er eller en kombination af begge.
English: • Take it off as soon as you remember.
Danish: • Fjern det, så snart du kommer i tanke om det.
English: Symptoms most commonly occur in one eye:
Danish: Symptomer, som normalt kun forekommer i det ene øje:
English: Sexually transmitted disease
Danish: Seksuelt overførte sygdomme
English: Norelgestromin is bound to albumin and not to SHBG, while norgestrel is bound primarily to SHBG, which limits its biological activity.
Danish: Norelgestromin er bundet til albumin og ikke til SHBG, mens norgestrel primært er bundet til SHBG, hvilket begrænser dets biologiske aktivitet.
English: • You may start this medicine right away.
Danish: • Du kan begynde at bruge lægemidlet med det samme.
English: • Problems when wearing contact lenses
Danish: • Problemer med brug af kontaktlinser
English: Exploratory analyses were performed to determine whether in the Phase III studies (n=3,319) the population characteristics of age, race and weight were associated with pregnancy.
Danish: Der blev gennemført eksploratoriske analyser for at bestemme, hvorvidt populationsegenskaberne i Fase III-studierne (n = 3319) med hensyn til alder, race og vægt var forbundet med graviditet.
English: Combined hormonal contraceptives and cancer
Danish: Kombinerede hormonale præventionsmidler og kræft
English: If this happens you could get pregnant, or may experience unexpected bleeding.
Danish: Hvis dette sker, kan du blive gravid eller få uventede blødninger.
English: Following this, the regular application of EVRA is resumed.
Danish: Derefter genoptages den almindelige påsætning af EVRA.
English: The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.
Danish: Risikoen afhænger af din naturlige risiko for VTE, og hvilken type kombineret hormonelt præventionsmiddel du tager.
English: EVRA must not be used in children and adolescents who have not yet had their first menstrual period.
Danish: EVRA må ikke anvendes til børn og unge, der endnu ikke har haft deres første menstruation.
English: You should ask your doctor how soon after delivery you can start taking EVRA;
Danish: Du skal spørge din læge, hvor hurtigt efter fødslen, du kan begynde at tage EVRA.
English: Particularly above 35 years.
Danish: Især over 35 år.
English: All combined birth control pills have risks, which may lead to disability or death.
Danish: Alle kombinations-p-piller er forbundet med risici, der kan medføre invaliditet eller død.
English: • Premenstrual syndrome
Danish: • Præmenstruelt syndrom
English: EVRA can be restarted approximately 2 weeks after completion of this treatment.
Danish: EVRA kan startes igen cirka 2 uger efter afslutningen af denne behandling.
English: Using your fingers, open the foil sachet.
Danish: Brug fingrene til at åbne folieposen.
English: Sachets are packaged in a cardboard carton.
Danish: Poserne er pakket i en æske af karton.
English: It is important to remember that the overall risk of a harmful blood clot due to EVRA is small.
Danish: Det er vigtig at huske på, at den samlede risiko for en skadelig blodprop på grund af EVRA er lille.
English: Your doctor will prescribe another type of contraceptive prior to start of the treatment with these medicinal products.
Danish: Din læge vil ordinere en anden type prævention, før du påbegynder behandlingen med sådanne lægemidler.
English: in a leg or foot (i.e. DVT)
Danish: i et ben eller en fod (dvs. DVT)
English: For example, it can cause a heart attack or a stroke.
Danish: Det kan f.eks. forårsage et hjerteanfald eller et slagtilfælde.
English: • However, you should check that the patch has not fallen off after doing these activities.
Danish: • Det anbefales dog, at du alligevel kontrollerer, at plasteret ikke er faldet af efter at have udført disse aktiviteter.
English: The excess risk gradually disappears during the course of the 10 years after cessation of COC use.
Danish: Den forhøjede risiko forsvinder gradvist i løbet af 10 år efter ophør med brug COC.