FrancophonIA/ELRC3.0 huggingface dataset:
English: The diagnosed cases of breast cancer in users of oral contraceptives, have a tendency to be clinically less advanced, compared to the diagnosed cases of breast cancer in non-users.
Danish: De diagnosticerede tilfælde af brystcancer hos brugere af oral prævention tenderer i retning af at være mindre klinisk avancerede end de cancertilfælde, der blev diagnosticeret hos ikke-brugere.
English: In the case of acute or chronic impairment of liver function the use of the preparation should be stopped until liver function tests return to normal.
Danish: Ved akut eller kronisk nedsat leverfunktion bør præparatet seponeres, indtil leverfunktionsværdierne vender tilbage til normalen.
English: However, if this is not the case, or if more than 1 tablet has been forgotten, the woman should be advised to use another contraceptive method for 7
Danish: eller hvis der er glemt mere end 1 tablet, bør kvinden tilrådes at benytte en anden præventionsmetode i
English: Because of marked species differences preclinical results possess a limited predictive value for the application of estrogens in humans.
Danish: På grund af markedsspecifikke forskelle har prækliniske resultater en begrænset prædiktiv værdi for anvendelse af østrogener på mennesker.
English: Periodic medical assessments are also important since contraindications (e.g. transient cerebral ischaemia) or risk factors (e.g. hereditary venous or arterial thrombotic disorders) may occur for the first time during oral contraceptive use.
Danish: Jævnlige lægelige vurderinger er også vigtige, idet kontraindikationerne (f.eks. forbigående cerebral iskæmi) eller risikofaktorerne (f.eks. arvelig forekomst af venøs eller arteriel tromboselidelse) kan forekomme for første gang under anvendelse af oral prævention.
English: The physician must then decide, whether the use of oral contraceptives should be discontinued.
Danish: Lægen skal derefter beslutte, om anvendelse af oral prævention skal seponeres.
English: Metabolism is mainly by reduction of the Δ4-3-oxo group and hydroxylation at the positions 2α, 1β and 16β, followed by conjugation.
Danish: Nedbrydning: Metabolisme sker hovedsagelig ved nedbrydning af Δ4-3-oxo-gruppen og hydroxylering i positionerne 2α, 1β og 16β efterfulgt af konjugation.
English: Herbal preparations containing St John's wort (Hypericum perforatum) should not be used while taking Rigevidon due to the risk of decreased plasma concentrations and reduced clinical effects of Rigevidon (see section 4.5).
Danish: Helsekostpræparater, der indeholder prikbladet perikum (Hypericum perforatum) bør ikke indtages samtidigt med Rigevidon på grund af risikoen for mindskede plasmakoncentrationer og reduceret virkning af Rigevidon (se afsnit 4.5).
English: If the patient does not have a withdrawal bleed at the end of the second pack, she must return to her doctor to exclude the possibility of pregnancy.
Danish: Hvis patienten ikke får nogen pauseblødning efter den anden pakning, bør kun vende tilbage til sin læge for at udelukke muligheden for graviditet.
English: The efficacy of oral contraceptives may be reduced in the case of missed tablets or vomiting (see section 4.2) or concomitant use of other medicinal product (see section 4.5).
Danish: Effekten af p-piller kan reduceres i tilfælde af oversprungne tabletter, opkastning (se afsnit 4.2) eller samtidig indtagelse af andre lægemidler (se afsnit 4.5).
English: The primary route of metabolism of ethinylestradiol is cytochrome P-450-mediated hydroxylation, where the primary metabolites are 2-OH-Ethinylestradiol and 2-methoxy-Ethinylestradiol.
Danish: Den primære vej for etinylestradiols metabolisme er cytochrome P-450-formidlet hydroxylering, hvor de primære metabolitter er 2-OH-Etinylestradiol og 2-metoxy-Etinylestradiol.
English: If it is of longer duration, it should be examined for pituitary disorders , before further prescription.
Danish: Hvis dette er af længere varighed, bør der undersøges for hypofyselidelser, før der ordineres yderligere.
English: A liver tumour must be taken into consideration as a differential diagnosis when severe pain occurs in the upper abdomen, if there is hepatomegaly, or if there are signs of intra-abdominal haemorrhage in women taking oral contraceptives.
Danish: En levertumor skal tages i betragtning som en differentialdiagnosen, hvis der forekommer alvorlige smerter i det øvre abdomen, hvis der forekommer hepatomegali eller hvis der er tegn på intra-abdominal blødning hos kvinder, der anvender oral prævention.
English: The herbal preparation St John's wort (Hypericum perforatum) should not be taken concomitantly with this medicine as this could potentially lead to a loss of contraceptive effect.
Danish: Helsekostpræparatet prikbladet perikum (Hypericum perforatum) bør ikke indtages samtidigt med dette lægemiddel, da det muligvis kan medføre tab af den præventive effekt.
English: Maximal enzyme induction is generally not observed until 2-3 weeks after start of treatment, but may then persist for at least 4
Danish: Maksimal enzympåvirkning ses generelt ikke før 2-3 uger efter påbegyndt behandling, men varer ved i mindst 4 uger efter ophør med behandlingen.
English: There have been case reports of retinal thrombosis with the use of oral contraceptives.
Danish: Der har været kliniske rapporter om retinal-thrombose ved anvendelse af orale præventionsmidler.
English: 4.6 Pregnancy and lactation Rigevidon is not indicated during pregnancy.
Danish: Rigevidon er ikke indiceret under graviditet.
English: In all these cases the woman should be advised to use a concomitant barrier method for the first 7 days of the tablet intake.
Danish: I alle disse tilfælde bør kvinden rådes til at benytte en barrieremetode i de første 7 dage af tabletindtagelsen.
English: A withdrawal bleed is unlikely until the end of the second blister pack, but she may experience spotting or break through bleeding on the days she is taking tablets.
Danish: Det er usandsynligt, at der vil forekomme en pauseblødning før efter afslutningen af den anden blisterpakning, men hun kan opleve pletblødning eller gennembrudsblødning de dage, hun tager tabletterne.
English: If such a condition should occur for the first time during use of oral contraceptives, the use of oral contraceptives must be discontinued immediately:
Danish: Dersom en sådan betingelse skulle opstå for første gang, mens der tages orale præventionsmidler, skal den orale prævention omgående seponeres.
English: Women who get severely depressed during the use of contraceptive pills should stop taking the pills and be advised to use an alternative contraceptive method while trying to determine if the symptoms are due to the oral contraceptive preparation.
Danish: Kvinder, der bliver alvorligt deprimerede under anvendelse af p-piller, bør ophøre med pillerne og tilrådes at anvende en anden præventionsmetode, mens de søger at finde frem til, om symptomerne skyldes p-pillepræparatet.
English: White, biconvex, circular tablets
Danish: Overtrukne tabletter Hvide, bikonvekse, runde tabletter
English: An increase in the frequency or severity of migraine (which may be prodromal for a cerebrovascular condition) during use of oral contraceptives must lead to consideration of immediate discontinuation of oral contraceptives.
Danish: En øget frekvens eller grad af migræne under anvendelse af oral prævention (som kan være prodrom for en cerebrovaskulær blødning) kan føre til overvejelse af umiddelbar seponering af oral prævention.
English: During the extension the woman may experience break through bleeding or spotting.
Danish: Under forlængelsen kan kvinden opleve gennembrudsblødninger eller pletblødninger.
English: Concomitant use of ritonavir may also induce the liver enzymes with a similar negative effect on contraceptive efficacy.
Danish: Samtidig anvendelse af ritonavir kan også påføre leverenzymerne med en tilsvarende negativ effekt på præventionens effekt.
English: Hydrolysis of the direct conjugates of ethinylestradiol by the intestinal flora gives ethinylestradiol,
Danish: Hydrolyse af de direkte konjugater af etinylestradiol ved hjælp af tarmfloraen giver etinylestradiol,
English: Thrombosis in other blood vessels has very rarely been reported, i.e. hepatic, mesenteric, renal or retinal veins and arteries, in users of oral contraceptives.
Danish: Trombose i andre blodkar er yderst sjældent rapporteret, dvs. hepatiske, mesenteriske, renale eller retinale vener og arterier hos brugere af oral prævention.
English: Women with hypertriglyceridaemia, or a family history thereof, may be at increased risk of pancreatitis when taking oral contraceptives.
Danish: Kvinder med hypertriglyceridæmi eller som har det i familiens sygehistorie, kan være udsat for øget risiko for pankreatitis ved anvendelse af orale præventionsmidler.
English: The Pearl Index (number of pregnancies/100 woman years) for combined low-dose monophasic oral contraceptives containing 0.15 mg levonorgestrel and 0.03 mg ethinylestradiol is 0.1 (method failure).
Danish: Pearl Index (antallet af graviditeter/100 kvindeår) for lavdosis monofasiske orale præventionsmidler af kombinationstypen indeholdende 0,15 mg levonorgestrel og 0,03 mg etinylestradiol, er 0,1 (metodesvigt).
English: The excretion of conjugates of ethinylestradiol and its metabolites takes place via urine and faeces.
Danish: Udskillelse af konjugaterne af etinylestradiol og dets metabolitter sker via urin og fæces.
English: If she starts later than this, she should be advised to use a concomitant barrier method during the first 7 days of tablet intake.
Danish: Hvis hun starter senere end dette, bør hun tilrådes samtidig anvendelse af en barrieremetode i de første 7 dage af tabletindtagelsen.
English: Rigevidon has no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkninger på evnen til at føre bil eller betjene maskiner Rigevidon har ingen eller ubetydelig indflydelse på evnen til at føre bil eller betjene maskiner:
English: Levonorgestrel displayed a virilising effect in female fetuses.
Danish: Levonorgestrel viste en viriliserende effekt på hunfostre.
English: treatment should be withdrawn immediately.
Danish: Rigevidon, bør behandlingen omgående seponeres.
English: Venous thromboembolism (VTE), manifesting itself as deep venous thrombosis and/or pulmonary embolic disorder, may occur with any oral contraceptive.
Danish: Venøs tromboemboli (VTE), der viser sig som dyb venetrombose og/eller lungeemboli, kan forekommer i forbindelse med ethvert oralt præventionsmiddel.
English: silica, colloidal anhydrous povidone K30
Danish: Vandfrit kolloid silica Povidon K30
English: There is no consensus concerning the possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism.
Danish: Der er ingen konsensus vedrørende varikøse veners og overfladisk tromboflebitis' eventuelle rolle i forbindelse med varikøse vener og overfladisk venøs tromboemboli.
English: Luxemburg
Danish: Luxembourg
English: − Undiagnosed vaginal bleeding
Danish: Udiagnosticeret vaginal blødning
English: The use of contraceptive steroids may have an influence on the results of certain laboratory tests, including biochemical parameters for liver, thyroid, adrenal and renal function; on the plasma levels for (transport)proteins, e.g. corticosteroid-binding globulin and lipid/lipoprotein fractions; on parameters for carbohydrate metabolism and parameters for coagulation and fibrinolysis.
Danish: Anvendelse af præventionssteroider kan påvirke resultaterne af visse laboratorieprøver, herunder biokemiske parametre for lever-, skjoldbrusk-, binyre- og nyre-funktion; plasmaniveauer for (transport)-proteiner, f.eks. corticosteroid-bindende globulin og lipid/lipoproteinfraktioner; parametre for kulhydratstofskifte og parametre for koagulation og fibrinolyse.
English: Rigevidon coated tablets.
Danish: Overtrukne Rigevidon-tabletter.
English: Combined contraceptives must not be used in the presence of the conditions mentioned below.
Danish: Kombinations-præventionsmidler bør ikke anvendes, hvor en af nedennævnte lidelser er til stede.
English: - Prolonged immobilisation, major surgery, surgery on the legs or major trauma.
Danish: Øget immobilisering, større kirurgisk indgreb, ethvert indgreb på benene eller større traume.
English: Amenorrhoea with anovulation (more frequent in women with irregular cycles in medical history) may be observed at termination of treatment It usually disappears spontaneously.
Danish: Amenorré med anovulation (hyppigere hos kvinder med uregelmæssige cykles i anamnesen) kan observeres ved behandlingsophør.
English: In order to delay a period, the woman should continue the next blister pack of Rigevidon, after taking the last tablet in the current pack, without.
Danish: For at forsinke en blødning bør kvinden fortsætte med den næste blisterpakning med Regevidon efter indtagelse af den sidste tablet i den aktuelle pakning, uden en tabletfri periode.
English: Hypericum perforatum (St. John's wort)
Danish: Hypericum perforatum (Prikbladet perikum)
English: If the woman has missed tablets and does not get a withdrawal bleed during the first, normal tablet-free interval, the possibility of pregnancy must be considered.
Danish: Hvis kvinden har sprunget tabletter over og derefter ikke får en pauseblødning under den første tabletfri periode herefter, skal muligheden for graviditet tages i betragtning.
English: Women who have previously suffered from depression should be closely monitored and stop the use of the oral contraceptive preparation if the symptoms of depression relapse.
Danish: Kvinder, der tidligere har lidt af depression, bør nøje monitoreres og skal ophøre med anvendelsen af p-pillepræparater, hvis depressionssymptomerne vender tilbage.
English: Pharmacokinetic properties Levonorgestrel
Danish: Farmakokinetiske egenskaber Levonorgestrel
English: The occurrence of VTE during oral contraceptive use is, however, much lower than the occurrence related to pregnancy (i.e. 6/10,000 woman years).
Danish: Forekomsten af VTE under anvendelse af oral prævention er dog meget lavere end forekomsten i forbindelse med graviditet (dvs.
English: Lactation may be influenced by COCs as they may reduce the amount and change the composition of human milk.
Danish: Amning kan påvirkes af kombinationshormonale præventionsmidler, da de kan reducere mængden og ændre sammensætningen af modermælken.
English: Used COCs for 5 years
Danish: Anvendt hormonale præventionsmidler af kombinationstypen i 5 år
English: Pharmaceutical form
Danish: LÆGEMIDDELFORM
English: Furthermore, high contraceptive efficacy has been demonstrated with lower doses in marketed products than those found in Rigevidon and high contraceptive efficacy has also been shown for progestogenonly methods with considerably lower doses than those found in COCs.
Danish: Desuden er der i markedsførte produkter godtgjort høj antikonceptionsvirkning ved lavere doser end dem, der findes i Rigevidon, ligesom der er påvist høj antikonceptionsvirkning af produkter, der udelukkende indeholder gestagen i betydeligt lavere doser end dem, der findes i COC-produkter.
English: Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions.
Danish: Orale præventionsmidler bør seponeres, dersom der forekommer uforklarligt delvist eller helt tab af synet, eksoftalmus eller diplopia, papilødem eller retinale vaskulære læsioner.
English: How to start Rigevidon
Danish: Sådan påbegyndes indtagelse af Rigevidon
English: Other medical conditions which have been related to circulatory disorders, include diabetes mellitus, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or colitis ulcerosa) and sickle cell anaemia.
Danish: Andre medicinske tilstande, der har været forbundet med kredsløbsproblemer, herunder diabetes mellitus, systemisk lupus erytematosus, hæmolytisk uræmisk syndrom, kronisk inflammatorisk tarmsygdom (f.eks. Crohns sygdom eller colitis ulcerosa) og seglcelleanæmi.
English: The treatment must cease if symptoms indicating imminent complications occur: serious abnormal headache, visual disturbances, increased blood pressure, clinical signs of deep venous thrombosis or pulmonary embolic disorders.
Danish: Behandlingen skal seponeres, dersom der opstår symptomer, der tyder på overhængende komplikationer: alvorlig, unormal hovedpine, synsforstyrrelser, forhøjet blodtryk, kliniske tegn på dyb venetrombose eller lungeemboli.
English: Occasionally withdrawal bleeding during the tablet-free interval may not occur at all.
Danish: Sommetider vil der slet ikke forekomme nogen pauseblødning under den tabletfrie periode.
English: − Migraine with focal neurological symptoms − Hypersensitivity to the active substances or to any of the excipients
Danish: Migræne i anamnesen med fokale neurologiske symptomer Overfølsomhed over for de aktive indholdsstoffer eller et eller flere af hjælpestofferne.
English: Epidemiological studies indicate a relationship between the use of oral contraceptives and an increased risk of arterial and venous thrombosis and thromboembolic disorders, such as myocardial infarction, stroke, deep venous thrombosis (DVT) and pulmonary embolic disorders.
Danish: Epidemiologiske forsøg tyder på en forbindelse mellem anvendelsen af oral prævention og en øget risiko for arteriel og venøs trombose og tromboemboliske lidelser som myokardieinfarkt, apopleksi, dyb venetrombose (DVT) og lungeemboli.
English: Estimated cumulative numbers of breast cancers per 10,000 women diagnosed in 5 years of use and up to 10 years after stopping COCs, compared with numbers of breast cancers diagnosed in 10,000 women who had never used COCs
Danish: Skønnet kumulativt antal brystcancertilfælde pr.10.000 kvinder diagnosticeret efter 5 års anvendelse og op til 10 år efter seponering af hormonale præventionsmidler af kombinationstypen sammenlignet med antal brystcancertilfælde diagnosticeret pr.10.000 kvinder, der aldrig har anvendt hormonale præventionsmidler af kombinationstypen.
English: Changing from a progestogen-only method (progestogen-only or mini-pills, injection, implant) The woman may switch from progestogen-only pills on any day (from an implant on the day the implant is removed or from injection, when the next injection should have been given).
Danish: Kvinden kan når som helst skifte fra rene progestogen-piller (fra implantat på dagen for udtagelsen af implantatet; eller fra injektion, når den næste injektion skulle være indgivet).
English: − Diabetes, complicated with micro or macro angiopathy
Danish: Diabetes kompliceret ved mikro- eller makro-angiopati Okulær lidelse af vaskulær oprindelse
English: However, if the oral contraceptive has not been taken according to the instructions, before the first absent withdrawal bleed, or if two withdrawal bleeds are overdue, pregnancy should be excluded before the oral contraceptive is continued.
Danish: Men hvis p-pillerne ikke er blevet taget i overensstemmelse med vejledningen forud for den første udeblevne ophørsblødning, eller hvis to ophørsblødninger er udeblevet, skal graviditet udelukkes, før der fortsættes med p-pillerne.
English: − Cardiovascular disorders, i.e. cardiac diseases, valvulopathy, arrhythmic disturbances
Danish: Cardiovaskulære lidelser, dvs. hjertelidelser, valvulopati, arrytmiske forstyrrelser Alvorlig hypertension
English: ⇒ There are no safety issues placing COCs with 0.030 mg ethinyloestradiol and 0.150 mg levonorgestrel in the category of narrow therapeutic index drugs.
Danish: at der ikke er sikkerhedsproblemer, der bevirker, at COC-produkter indeholdende 0,030 mg ethinyloestradiol og 0,150 mg levonorgestrel skal kategoriseres som lægemidler med snævert terapeutisk indeks,
English: The woman should take the last missed tablet as soon as she remembers this, even if this means that she has to take 2 tablets at the same time.
Danish: Kvinden skal tage den sidste oversprungne tablet, så snart hun kommer i tanke om det, selv om det betyder, at hun skal tage 2 tabletter på en gang.
English: Took the Pill at these ages:
Danish: Anvendt p-piller i alderen:
English: Changing from another combined hormonal contraceptive (combined oral pills, vaginal ring or transdermal patch): The woman should start with Rigevidon on the day after she took the last active tablet in her previous blister pack of contraceptive pills (or removed the vaginal ring or transdermal patch) but, no later than on the day after the usual tablet-free (or placebo, patch-free or ring-free) interval with her previous contraceptive.
Danish: Kvinden bør starte med Rigevidon dagen efter, at hun tog den sidste aktive tablet i den foregående blisterpakning med præventionstabletter (eller fjernede p-ringen eller p-plasteret), men senest dagen efter den normale pille-fri (eller placebo, plasterfri eller ring-fri) pause sammen med hendes tidligere præventionsmiddel."
English: If persistent clinical hypertension develops during treatment with oral contraceptives they should be discontinued and the hypertension treated.
Danish: Under behandling med orale præventionsmidler, bør disse seponeres, og hypertensionen behandles.
English: The inducing effect may persist for at least 2 weeks after cessation of treatment with St John's wort.
Danish: Den påførte effekt kan vedvare i mindst 2 uger efter ophør med behandlingen med perikum.
English: Inadequate exposure could also lead to disruption of cycle control and increase the occurrence of breakthrough bleeding, which may affect compliance and cause discontinuation of COC use.
Danish: og at forekomsten af gennembrudsblødning øges, hvilket kan påvirke compliance og føre til seponering af COC.
English: This has been demonstrated with hydantoins (e.g. phenytoin, barbiturates, primidone, carbamazepine and rifampicin.
Danish: barbiturater, primidon, carbamazepin og rifampicin).
English: In experimental animals estrogens displayed an embryolethal effect already at relatively low doses;
Danish: På forsøgsdyr viste østrogener en embryoletal effekt allerede ved relativt lave doser; misdannelser af urinvejen og feminisering af hanfostre.
English: Benign and malignant liver tumours have been reported in users of combined oral contraceptives.
Danish: Der er indberettet godartede og ondartede levertumorer hos brugere af orale præventionsmidler af kombinationstypen.
English: sucrose talc calcium carbonate titanium dioxide (E171)
Danish: Titaniumdioxid (E171) Copovidon K90
English: If pregnancy occurs during medication with Rigevidon,
Danish: Hvis der forekommer graviditet under behandling med
English: Biochemical factors indicating hereditary or acquired predisposition for venous or arterial thrombosis, include activated protein C (APC) resistance, hyperhomocysteinaemia, antithrombin III deficiency, protein C
Danish: Biokemiske faktorer, som kan være tegn på arvelig disposition eller erhvervet disposition for veneeller arterietrombose, så som aktiveret C-protein (APC-) resistens, hyperhomocysteinæmia, antitrombin-III mangel, C-protein mangel, S-protein mangel, antifosfolipid-antistoffer (anticardiolipin antistoffer, lupus-antikoagulant).
English: - Age.
Danish: Alder.
English: Women on short term treatment with these antibiotics must temporarily use a barrier method concomitantly with the contraceptive pills, i.e. during the period of other concomitant active substance intake and for 7 days after cessation of this active substance.
Danish: Kvinder, der korttidsbehandles med disse antibiotika, skal midlertidigt anvende en barrieremetode samtidigt med p-pillen, dvs. i den periode,
English: carmellose sodium
Danish: Calciumkarbonat
English: Metabolism:
Danish: Tumorer:
English: − Serious or recent hepatic disorders, in which liver function tests are not normalised
Danish: Alvorlige eller nylige leverlidelser, hvor leverfunktionstests ikke er normaliseret Aktuelle eller tidligere benigne eller maligne levertumorer
English: Medimpex France S.A. Rigevidon
Danish: Medimpex France S.A. Rigevidon 0,03 mg etinylestradiol
English: − acne, seborrhoea, hypertricosis
Danish: acne, seborré, hypertrikose depressioner, opkastninger, allergiske reaktioner.