FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency and nature of these assessments should be adapted to the individual woman, but should, in general, include special reference to blood pressure, breasts, abdomen and abdominal organs, including cervical cytology and relevant laboratory tests.
Danish: Hyppigheden og arten af disse vurderinger skal tilpasses til den enkelte kvinde, men de bør generelt omfatte speciel henvisning til blodtryk, bryster, abdomen og abdominale organer, herunder cervikal cytologi og relevante laboratorieanalyser.
English: Therefore, by following one of the following two alternatives, it is not necessary to take further contraceptive precautions, provided that all tablets have been taken correctly during the 7 days preceding the forgotten tablet.
Danish: Ved at følge et af følgende to alternativer er det derfor ikke nødvendigt at træffe yderligere præventionsforanstaltninger, forudsat at alle tabletter er taget korrekt i de 7 dage forud for den glemte tablet.
English: This bleeding will usually start on the 2nd or 3rd day after the last tablet has been taken and it may not have stopped, before the next blister pack is started.
Danish: Denne blødning vil i reglen starte den 2. eller 3. dag efter indtagelse af den sidste tablet, og den vil måske ikke være ophørt, før den næste blisterpakning påbegyndes.
English: The increased risk of thromboembolism during the puerperal period should be taken into consideration (for further information - see section 4.6).
Danish: Den øgede risiko for tromboemboli i puerperium skal tages i betragtning (for yderligere oplysninger - se afsnit 4.6.
English: Elimination: Ethinylestradiol disappears from plasma with a T½ of approximately 29 hours (26-33 hours), plasma clearance varies from 10-30 l/hour.
Danish: Etinylestradiol forsvinder fra plasma med en halveringstid på cirka 29 timer (26-33 timer), plasmaclearance varierer fra 10 til 30 l/time.
English: 1.Circulatory disorders
Danish: 1.Kredsløbslidelser
English: The shorter the interval, the greater the risk that she will not have a withdrawal bleed and she may have break through bleeding or spotting during the second blister pack (which is also the case when delaying a period).
Danish: Jo kortere intervallet er, desto større risiko er der for, at hun ikke får en ophørsblødning og kan opleve gennembrudsblødning eller pletblødning under den anden blisterpakning (hvilket også er tilfældet ved forsinkelse af en blødning).
English: The woman should be advised to start on day 21-28 after delivery or abortion in the 2nd trimester, because there is an increased risk of thromboembolic disorders during the post partum period.
Danish: Kvinden skal tilrådes at starte på dag 21-28 efter fødslen eller aborten i 2. trimester, eftersom der er en øget risiko for tromboemboli i puerperium.
English: Women with a tendency to chloasma should avoid exposure to sunlight or ultraviolet radiation while taking oral contraceptives.
Danish: Kvinder med tendens til chloasma bør undgå eksponering for sollys eller ultraviolet stråling, når de anvender orale præventionsmidler.
English: 2-OH-Ethinylestradiol is further metabolised to chemically reactive metabolites.
Danish: 2-OH-Etinylestradiolmetaboliseres yderligere til kemisk reaktive metabolitter.
English: Thus, the current prerequisite for bioequivalence, i.e. the demonstration of bioequivalence within 80 - 125%, is considered appropriate for Rigevidon.
Danish: Den nugældende forudsætning for bioækvivalens, dvs. påvisning af bioækvivalens inden for 80-125 %, anses således for hensigtsmæssig for Rigevidon.
English: It is acceptable to start the tablets on day 2-5, but during the first cycle the concomitant use of a barrier method for the first 7 days is recommended.
Danish: Det er acceptabelt at påbegynde tabletterne på dag 2-5, men under den første cyklus anbefales samtidig anvendelse af barrieremetode i de første 7 dage.
English: In the case of suspected hereditary predisposition, the woman should be referred to a specialist before she decides to use oral contraception.
Danish: Dersom der foreligger mistanke om en arvelig disposition, bør kvinden henvises til en specialist, før der træffes beslutning om anvendelse af oral prævention.
English: Rigevidon contains lactose and sucrose.
Danish: Rigevidon indeholder laktose og sakkarose.
English: In this case, it is not necessary to take further contraceptive precautions.
Danish: I så fald kræves ingen yderligere præventionsforanstaltninger.
English: Special precautions for storage This medicinal product does not require any special storage conditions.
Danish: Der kræves ingen specielle opbevaringsbetingelser for dette lægemiddel.
English: Oral contraceptives may have an influence on the peripheral insulin resistance and glucose tolerance.
Danish: Orale præventionsmidler kan påvirke den perifere insulinresistens og glukosetolerancen.
English: Hence, from a pharmacokinetic point of view there is no evidence to suggest that a COC such as Rigevidon should be categorised as a narrow therapeutic index product.
Danish: Fra et farmakokinetisk synspunkt taler derfor intet for, at et COC-produkt som f.eks. Rigevidon bør kategoriseres som et produkt med snævert terapeutisk indeks.
English: Medimpex France SA 1-3 rue Caumartin
Danish: Medimpex France S.A. 1-3 rue Caumartin
English: Inadequate exposure to the active components of a combined oral contraceptive (COC) may lead to therapeutic failure, i.e. pregnancy, which has a large impact on people's life.
Danish: Utilstrækkelig eksponering for de aktive komponenter i kombinerede orale kontraceptiva (COC) kan medføre behandlingssvigt, dvs. graviditet, hvilket kan gribe stærkt ind i de pågældendes liv.
English: Provided that the tablets have been taken correctly during the 7 days preceding the forgotten tablet, it is not necessary to take further contraceptive precautions.
Danish: Forudsat at tabletterne er taget korrekt i de 7 dage forud for den glemte tablet, er det ikke nødvendigt at træffe yderligere præventive foranstaltninger.
English: The risk for development of thromboembolism (venous and/or arterial) increases with:
Danish: Risikoen for at udvikle tromboemboli (venøs og/eller arteriel) øges med:
English: More frequent but smaller events that usually do not demand interruption of treatment, but in which a change to another combined oral contraceptive may be considered:
Danish: Hyppigere, men mindre hændelser, som i reglen ikke kræver seponering af behandlingen, men hvor skift til et andet oralt præventionsmiddel af kombinationstypen kan overvejes:
English: Hereafter, she continues taking the tablets at the usual time point.
Danish: Derefter fortsætter hun med at tage tabletterne på det sædvanlige tidspunkt.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or with rare hereditary problems of fructose intolerance should not take this medicinal product.
Danish: Patienter med sjældne arvelige problemer med galaktoseintolerance, Lapp laktasedefekt eller dårlig absorption af glukose-galaktose eller med sjældne arvelige problemer med fruktoseintolerance bør ikke indtage dette lægemiddel.
English: For short-term use of any of these enzyme-inducing active substances, additional use of barrier methods is recommended from the time of commencing the concurrent active substance, during treatment and for 4 weeks after cessation of treatment.
Danish: For korttidsbrug af ethvert af disse enzym-inducerende aktive stoffer anbefales supplerende anvendelse af barrieremetoder fra tidspunktet for påbegyndelse af det samtidige aktive lægemiddel, under behandlingen og i 4 uger efter behandlingens ophør.
English: − Malignant endometrial tumours or other known or suspected estrogen-dependent neoplastic disorder
Danish: Maligne endometrietumorer eller anden kendt eller mistænkt østrogenafhængig neoplasi lidelse
English: Preclinical data based on conventional studies of repeated dose toxicity, genotoxicity and carcinogenic potential revealed no particular human risks beyond those discussed in other sections of the SPC.
Danish: Prækliniske data baseret på konventionelle undersøgelser af gentagen dosis-toksicitet, genotoksicitet og karcinogent potentiale viste ingen specifikke humane risici ud over det, der er drøftet i andre afsnit af SPC'en.
English: If bleeding irregularities persist or occur after previously regular cycles, then non-hormonal causes should be considered, and adequate diagnostic measures are indicated to exclude malignancy or pregnancy.
Danish: Hvis de uregelmæssige blødninger fortsætter eller forekommer tidligere regelmæssige cykler, bør man tage højde for non-hormonale årsager og egnede diagnostiske foranstaltninger er indiceret for at udelukke maligne forekomster eller graviditet.
English: The observed pattern of an increased risk may be caused by an earlier diagnosing of breast cancer in users of oral contraceptives, the biological effects of oral contraceptives or a combination of both.
Danish: Det observerede mønster af en øget risiko kan være forårsaget af en tidligere diagnosticering af brystcancer hos brugere af oral prævention, de biologiske virkninger af oral prævention eller en kombination af begge.
English: A meta-analysis from 54 epidemiological studies has shown that women using combined oral contraceptives have a slightly increased relative risk (RR=1.24) of having breast cancer diagnosed.
Danish: En meta-analyse fra 54 epidemiologiske undersøgelser har vist, at kvinder, der anvender oral prævention af kombinationstypen har en let forøget risiko (RR=1.24) for at få diagnosticeret brystcancer.
English: Levonorgestrel and its metabolites are primarily excreted in the urine (40%-68%) and approximately 16%-48% is excreted in the faeces.
Danish: Levonorgestrel og dets metabolitter udskilles primært i urinen (40% til -68%) og cirka 16% til -48%
English: Rigevidon may increase the plasma concentration of cyclosporin and diazepam (and other benzodiazepines that are hydroxylated), possibly via inhibiting hepatic elimination.
Danish: Rigevidon kan øge plasmakoncentrationen af cyclosporin og diazepam (og andre benzodiazepiner, som er hydroxyleret), muligvis via hæmning af eliminationen via leveren.
English: Rigevidon may increase the bioavailability of imipramin leading to an increased risk of toxicity.
Danish: Rigevidon kan øge biotilgængeligheden af imipramin, hvilket medfører øget risiko for toksicitet.
English: After delivery or abortion in 2nd trimester
Danish: Efter præmatur fødsel eller abort i 2. trimester
English: The woman should take the tablet as soon as she remembers this, and the remaining tablets should be taken as usual.
Danish: Kvinden bør indtage tabletten, så snart hun kommer i tanke om det, og de resterende tabletter skal indtages som sædvanlig.
English: The conclusion is that bioequivalence studies with narrower acceptance limits would not contribute to the ability to extrapolate safety and efficacy data for Rigevidon.
Danish: konkluderes, at bioækvivalensundersøgelser med snævrere acceptgrænser ikke ville forbedre grundlaget for ekstrapolation af data vedrørende sikkerhed og virkning af Rigevidon.
English: Reproduction toxicology studies in rats, mice and rabbits revealed no hint for teratogenicity beyond the effect on sexual differentiation.
Danish: Reproduktionstoksikologiske undersøgelser på rotter, mus og kaniner afslørede ingen tegn på teratogenicitet ud over effekten på seksuel differentiering.
English: She should use a barrier method concomitantly, e.g. a condom, for the next 7 days.
Danish: Hun skal samtidig benytte en barrieremetode, f.eks. kondom, i de næste 7 dage.
English: This should be repeated at least once a year during oral contraceptive use.
Danish: Dette bør gentages mindst en gang om året, så længe der anvendes orale præventiomnsmidler.
English: These tumours have, in isolated cases, lead to life threatening, intra-abdominal haemorrhage.
Danish: Disse tumorer har i isolerede tilfælde ført til livstruende intra-abdominale blødninger.
English: If this is not the case, the woman should be advised to follow the first of the two alternatives and use another contraceptive method concomitantly for the next 7 days.
Danish: Er dette derimod ikke tilfældet, bør kvinden tilrådes at følge den første af de to alternativer og samtidig benytte en anden præventionsmetode i de næste 7 dage.
English: The mechanism of action seems to be based on the liver enzyme inducing properties of these active substances.
Danish: Virkningsmekanismen lader til at være baseret på, at leverenzymet påfører disse aktive lægemidlers egenskaber.
English: Steroid hormones may be poorly metabolised in patients with impaired liver function.
Danish: Steroide hormoner kan metaboliseres dårligt hos patienter med nyreinsufficiens.
English: Oral contraception may be resumed if appropriate, when normotensive values are reached with antihypertensive therapy.
Danish: Det orale præventionsmiddel kan genoptages, hvis det er aktuelt, når normotensive værdier er opnået med antihypertensiv behandling.
English: If any of the risk factors below is present in any individual woman,the benefits of combined oral contraception must be weighed against possible risks in each individual case and discussed with the woman before combined oral contraception is commenced.
Danish: Dersom en af nedennævnte risikofaktorer er til stede hos en enkelt kvinde, skal fordelene ved anvendelse af orale kombinationspræventionsmidler vægtes imod de mulige risici i hvert enkelt tilfælde og drøftes med kvinden, før der indledes behandling med kombinations-præventionsmiddel.
English: Since breast cancer is a rare condition in women below 40 years of age, the increase in number of diagnosed cases of breast cancer in current and previous users of oral contraceptives is small compared to the risk of breast cancer during their entire life time.
Danish: Da brystcancer er sjælden hos kvinder under 40 år, er det forhøjede antal af brystcancer-diagnoser hos aktuelle og tidligere brugere af oral prævention lille i forhold til risikoen for brystcancer i deres samlede levetid.
English: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Progestogens and estrogens, fixed combinations
Danish: 5.1 Farmakodynamiske egenskaber Farmakoterapeutisk klassifikation: Progestogener og østrogener, faste kombinationer
English: Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use.
Danish: Cigaretrygning øger risikoen for alvorlige kardiovaskulære bivirkninger af orale præventionsmidler.
English: Effect at cessation of treatment:
Danish: Effekt ved behandlingsophør:
English: Other active substances suspected of having the capacity to reduce the efficacy of oral contraceptives include oxcarbazepine, topiramate, and griseofulvin.
Danish: Andre aktive stoffer, der mistænkes at have kapacitet til at reducere effekten af orale præventionsmidler, omfatter oxcarbazepin, topiramat og griseofulvin.
English: To shift her period to another day of the week, rather than the one the woman is used to with the present tablet intake, she may be advised to shorten the forthcoming tablet-free interval by as many days as she likes.
Danish: For at flytte sin menstruation til en anden ugedag, end kvinden plejer med den aktuelle tabletindtagelse, kan hun rådes til at forkorte den kommende tabletfri periode med så mange dage, hun har behov for.
English: One tablet contains 150 micrograms levonogestrel and 30micrograms ethinylestradiol.
Danish: En tablet indeholder 150 mikrogram levonorgestrel og 30 mikrogram etinylestradiol.
English: Therefore, diabetics should be monitored closely during use of oral contraceptives.
Danish: Diabetikere bør derfor nøje monitoreres under anvendelse af orale præventionsmidler.
English: In this case, a withdrawal bleed should not be expected until the end of the second pack.
Danish: I så fald bør der ikke forventes nogen pauseblødning før afslutningen af den anden paknking.
English: In this case, she should keep a tablet-free interval of up to 7 days, including the days she forgot to take her tablets, and thereafter continue with the next blister pack.
Danish: I så fald skal kun holde en tabletfri periode på op til 7 dage, inklusive de dage, hvor hun glemte at tage sine tabletter, hvorefter hun fortsætter med en ny blisterpakning.
English: Tumours: In some epidemiological studies an increased risk of cervical cancer has been reported in longterm users of oral contraceptives, but it is still not clear to which extent this finding may be influenced by impacts of sexual behaviour and other factors, such as human papilloma virus (HPV).
Danish: I visse epidemiologiske forsøg er der rapporteret en øget risiko for cervikal cancer hos langtidsbrugere af oral prævention, men det er stadig ikke klart, i hvor høj grad dette resultat kan være påvirket af virkninger af seksuel adfærd og andre faktorer, så som humant papilloma-virus (HPV).
English: - Hereditary predisposition (e.g. venous or arterial thromboembolism in siblings or parents at a relatively young age).
Danish: Arvelig disposition (dvs. venøs eller arteriel tromboemboli hos en søskend eller forælder i relativt ung alder).
English: If the woman has forgotten tablet intake for less than 12 hours, the contraceptive protection is not reduced.
Danish: Dersom kvinden har glemt at indtage en tablet i mindre end 12 timer, er præventionsbeskyttelsen ikke reduceret.
English: Clinically, data on a limited number of exposed pregnancies indicate no adverse effects of levonorgestrel alone on the fetus.
Danish: Klinisk viser data vedrørende et begrænset antal eksponerede graviditeter ingen bivirkninger af levonorgestrel alene på fosteret.
English: The approximate occurrence of VTE in users of oral contraceptives with a low content of estrogen (less than 50 microgram ethinylestradiol) is up to 4/10,000 woman years compared to 0.5-1/10,000 woman years in non-users.
Danish: Den omtrentlige forekomst af VTE hos brugere af orale præventionsmidler med et lavt indhold af østrogen (under 50 mikrogram etinylestradiol) er op til 4/10.000 kvindeår sammenlignet med 0,5-1/10.000 kvindeår hos ikke-brugere.
English: Levonorgestrel is eliminated with a mean T½ of approximately 36 hours at steady state.
Danish: Levonorgestrel elimineres med en gennemsnitlig halveringstid på 36 timer ved steady state.
English: If nonhormonal causes are excluded, oral contraceptives with a higher hormonal content may need to be considered.
Danish: Hvis non-hormonale årsager er udelukket, kan det være nødvendigt at overveje p-piller, med et større hormonindhold.
English: Thus, the current prerequisite for bioequivalence, i.e. the demonstration of bioequivalence within 80 - 125%, is considered appropriate for Rigevidon as it will sufficiently prove its performance as an essentially similar product in terms of rate and extent of absorption.
Danish: Den nugældende forudsætning for bioækvivalens, dvs. at bioækvivalens skal godtgøres at være inden for 80-125 %, anses således for at være velegnet for Rigevidon, da den vil give tilstrækkeligt bevis for, at der er tale om et produkt, der i det væsentlige er tilsvarende hvad angår absorptionshastighed og -omfang.
English: Hyperlipidaemic women should be closely monitored if they choose to use contraceptive pills.
Danish: Kvinder med hyperlipidæmi bør monitoreres nøje, hvis de vælger at anvende p-piller.
English: However, if she already has had intercourse, pregnancy must be excluded, before she starts the tablets, or she should wait for her first menstrual bleed.
Danish: Hvis hun allerede har haft samleje, skal graviditet dog udelukkes, før hun påbegynder tabletindtagelsen, eller hun skal afvente den første efterfølgende menstruation.
English: She should start on the next blister pack immediately after taking the last tablet in the current blister pack, i.e. there will be no tablet-free interval between the blister packs.
Danish: Hun bør påbegynde den næste blisterpakning umiddelbart efter indtagelse af den sidste tablet i den aktuelle blisterpakning, dvs. der vil ikke være nogen tabletfri periode mellem blisterpakningerne.
English: COCs generally exhibit wide variation with regard to pharmacokinetics.
Danish: COC-produkter er i almindelighed vidt forskellige med hensyn til farmakokinetik.
English: Levonorgestrel is rapidly and completely absorbed after oral administration of Rigevidon.
Danish: Levonorgestrel absorberes hurtigt og komplet efter oral indgivelse af Rigevidon.
English: Crohn's disease and colitis ulcerosa have been associated with the use of combined oral contraceptives.
Danish: Crohn's sygdom og colitis ulcerosa har været tilskrevet anvendelse af orale præventionsmidler af kombinationstypen.
English: The results of most epidemiological studies to date neither show an increased risk of birth defects in children born to women taking contraceptive pills before pregnancy, nor any teratogenic or fetotoxic effect in case of inadvertent fetal exposure to combinations of estrogens and progestagens.
Danish: Resultaterne af de fleste epidemiologiske undersøgelser til dato viser hverken øget risiko for fødselsskader på børn født af kvinder, der tog p-piller før graviditeten eller nogen teratogene eller føtotoksiske virkninger i tilfælde af utilsigtet føtal eksponering for kombinationer af østrogener og progestagener.
English: For lactating women - see section 4.6.
Danish: For kvinder, der ammer, se afsnit 4.6.
English: The majority of the metabolites circulating in the blood are sulphates of 3α, 5β-tetrahydro-levonorgestrel, while excretion mainly takes place as glucuronides.
Danish: Hovedparten af de metabolitter, der cirkulerer i blodet, er sulfater af 3α, 5β-tetrahydro-levonorgestrel, mens udskillelsen hovedsagelig finder sted som glucuronider.
English: Even though slight increases in blood pressure have been reported in many women taking oral contraceptives, clinically important increases in blood pressure are rare.
Danish: Selv om mindre stigninger i blodtrykket er rapporteret hos mange kvinder, der anvender p-piller, er klinisk væsentlige blodtryksstigninger sjældne.
English: Every subsequent blister pack is started after a 7 day tablet-free interval during which time a withdrawal bleed usually occurs.
Danish: Hver efterfølgende blisterpakning startes efter en 7-dages tabletfri periode, hvorunder der i reglen forekommer en pauseblødning.
English: - Dyslipoproteinaemia.
Danish: Dyslipoproteinæmi.
English: Acute toxicity of ethinylestradiol and levonorgestrel is low.
Danish: Den akutte tokscitet for etinyletradiol og levonorgestrel er lav.
English: Aluminium-PVC/PVDC blister
Danish: Emballage (art og indhold) Aluminium-PVC/PVDC blisterpakning
English: The symptoms which may occur in connection with overdose are: Nausea, vomiting, and in young girls a slight vaginal bleeding.
Danish: Symptomer, der kan forekomme i forbindelse med overdosering: Kvalme, opkastning - hos unge piger - let vaginal blødning.
English: The risk of contraceptive failure is imminent because of the ensuing tablet-free interval.
Danish: Risikoen for præventionssvigt er overhængende på grund af den efterfølgende tabletfri periode.
English: The contraceptive effect of Rigevidon is based on the interaction between various factors, the most important of which are the inhibition of ovulation and changes in the cervical mucus.
Danish: Rigevidons antikonceptionelle virkning er baseret på interaktion mellem forskellige faktorer, hvoraf de vigtigste er hæmning af ægløsningen og ændringer i den cervikale slimhinde.
English: With all combined oral contraceptives, irregular bleeding (spotting or break through bleeding) may occur, especially during the first months.
Danish: Ved alle orale præventionsmidler af kombinationstypen kan der forekomme uregelmæssige blødninger (pletblødning og gennembrudsblødning), især i de første måneder.
English: Ethinylestradiol undergoes presystemic conjugation both in the small intestinal mucosa and in the liver.
Danish: Etinylestradiol underkastes præsystemisk konjugation både i tyndtarmens slimhinde og i leveren.