FrancophonIA/ELRC3.0 huggingface dataset:
English: This study A47505 was not assessed as in this study YAZ FlexMB was intended for the treatment of dysmenorrhoea instead of contraceptive efficacy) The following dose regimens were studied in the two pivotal 3-armed clinical Phase III studies: YAZ Flex Managed Bleeding (YAZ FlexMB) regimen; each cycle comprises 120 days of intended treatment followed by a 4-day tablet-free interval to induce withdrawal bleeding.
Danish: Følgende dosisregimer blevet undersøgt i de to 3-armede kliniske fase III-hovedundersøgelser (undersøgelse A47505 blev ikke vurderet, da YAZ FlexMB i denne var bestemt til behandling af dysmenorré i stedet for som antikonceptivum): Yaz Flex Managed Bleeding (Yaz FlexMB)-regime: Hver cyklus består af 120 dages tilsigtet behandling efterfulgt af et 4 dages tabletfrit interval til fremkaldelse af bortfaldsblødning.
English: The key studies should be at least large enough to give the overall PI (number of pregnancies per 100 woman years) with a two-sided 95% confidence interval such that the difference between the upper limit of the 95% confidence interval and the point estimate does not exceed 1.
Danish: Hovedundersøgelserne skal være mindst så store, at det totale Pearl-indeks (antal graviditeter pr. 100 kvindeår) kan estimeres med et 95 % tosidet sikkerhedsinterval, hvis øvre grænse ikke overstiger punktestimatet med mere end 1.
English: Further, the total number of bleeding days per year decreased from 66 (YAZ 24+4) to 41-47 days (YAZ Stop & Go and YAZ Flex MB).
Danish: Desuden aftog det årlige antal blødningsdage fra 66 (YAZ 24+4) til 41-47 dage (YAZ Stop & Go og YAZ Flex MB).
English: Moreover, with considerably less 4-day tablet-free intervals and longer periods of active treatment in both variants, it is highly likely that the efficacy will be at least as good as established for YAZ 24+4.
Danish: Med væsentligt færre 4-dages tabletfri intervaller og længere perioder med aktiv behandling i begge varianter vil virkningen desuden højst sandsynligt være mindst lige så god som påvist for YAZ 24+4.
English: Moreover, with considerably less tablet-free intervals and longer periods of active treatment in both variants, efficacy will be at least as good as established for the currently authorised YAZ 24+4.
Danish: Med betydeligt færre tabletfrie intervaller og længere perioder med aktiv behandling i begge varianter vil virkningen desuden være mindst lige så god som dokumenteret for det godkendte YAZ 24+4.
English: YAZ Flex MB in 1400 women for 1 year (contraceptive efficacy + bleeding)
Danish: YAZ Flex MB hos 1 400 kvinder i 1 år (antikonceptiv virkning + blødning)
English: During days 25-120, the woman can decide to take tablets continuously up to a maximum of
Danish: På dag 25-120 kan kvinden beslutte at tage tabletterne uafbrudt i op til højst 120 dage.
English: When looking at the results of the YAZ Stop and Go regimen, it was noted that the PI was higher (3.52; 95% CI; 1.29 - 7.67) compared to the YAZ Flex MB regimen in the same study (1.67 95% CI; upper limit 2.67).
Danish: Ved betragtning af resultaterne af Yaz Stop and Go-regimet blev det bemærket, at Pearl-indeks (PI) for Yaz Stop and Go-regimet var højere (3,52 med 95 % SI [1,29; 7,67]) end PI for Yaz Flex MBregimet i samme undersøgelse (1,67 med 95 % øvre sikkerhedsgrænse 2,67).
English: The reason for the break (bleeding occurrence or woman's own choice) will not influence the contraceptive efficacy, as long as the general rules of intake will be adhered to, that is regular uninterrupted daily tablet intake for at least 24 days and tablet-free intervals of a maximum of 4 days between intake cycles.
Danish: Grunden til pausen (optræden af blødning eller kvindens eget valg) har ingen indflydelse på den antikonceptive virkning, så længe de generelle regler for indtag er overholdt, dvs. regelmæssigt uafbrudt dagligt tabletindtag i mindst 24 dage og tabletfrie intervaller på højst 4 dage mellem cyklusserne med tabletindtag.
English: No significant differences in number of cycles and mean cycle length were observed when a 4-day tablet-free interval was allowed irrespective of bleeding and/or spotting (Stop & Go regimen).
Danish: Der var ingen væsentlige forskelle i cyklusantal eller gennemsnitlig cykluslængde, når der blev givet mulighed for et 4-dages tabletfrit interval uafhængigt af blødning og/eller pletblødning (Stop & Go-regime).
English: Evidence is primarily based on the pearl indices obtained in an EU/Canada study that allowed a 4-day tablet-free interval in case of 3 consecutive days of bleeding and/or spotting (Flex MB regimen).
Danish: Dokumentationen bygger primært på det opnåede Pearl-indeks i EU/Canada-undersøgelsen, der tillod et 4-dages tabletfrit interval i tilfælde af 3 på hinanden følgende dage med blødning og/eller pletblødning (Flex MB-regime).
English: In general, the reason for the break (bleeding occurrence or woman's own choice) will not influence the contraceptive efficacy, as long as the general rules of intake will be adhered to, that is regular uninterrupted daily tablet intake for at least 24 days and tablet-free intervals of a maximum of 4 days between intake cycles.
Danish: Sædvanligvis har årsagen til pausen (optræden af blødning eller kvindens eget valg) ingen betydning for den antikonceptive virkning, så længe de generelle regler for indtag overholdes, dvs. regelmæssig uafbrudt dagligt tabletindtag i mindst 24 dage og tabletfrie intervaller på højst 4 dage mellem cyklusser med tabletindtag.
English: The Pearl Index (PI) calculated as the pregnancy rate in the study population divided by 100 years of user exposure, was used to assess contraceptive efficacy.
Danish: Til bestemmelse af den antikonceptive virkning anvendtes Pearl-indekset (PI), beregnet som graviditetsrate i undersøgelsens population divideret med 100 års brugereksponering.
English: On the other hand, the number of withdrawal bleedings decreased from 12 times/year (YAZ 24+4) to 4.6 and 4.5 times/year (YAZ Stop & Go and YAZ Flex MB).
Danish: På den anden side aftog antallet af bortfaldsblødninger fra 12 gange årligt (YAZ 24+4) til 4,6 og 4,5 gange årligt (YAZ Stop & Go og YAZ Flex MB).
English: In the conventional YAZ 24+4 arm, the number of 4-day tablet-free intervals within one year is 10.1, as the tablet-free intervals are mandatory (i.e. 24 days of tablet intake followed by a 4 day break (YAZ 24+4)), versus 4.2 and 4.6 breaks for YAZ Flex MB and YAZ Stop & Go respectively.
Danish: I den konventionelle YAZ 24+4-arm er der 10,1 tabletfrie 4-dages intervaller i løbet af et år, da de tabletfrie intervaller er obligatoriske (dvs. 24 dages tabletindtag efterfulgt af en 4dages pause (YAZ 24+4)).
English: Further supportive evidence of adequate contraceptive efficacy of Yvidually was obtained from the interim analysis of an ongoing trial with Yvidually where the calculated PI was 0 with an upper limit of the 95% confidence interval of 1.0, which is considered conclusive in terms of precision of the Pearl Index.
Danish: Den antikonceptive virkning af Yvidually blev yderligere dokumenteret ved interimanalyse af en igangværende undersøgelse med Yvidually, hvor det beregnede PI var 0 med en øvre 95 % sikkerhedsgrænse på 1,0, hvilket anses for konklusivt hvad angår nøjagtigheden af Pearl-indekset.
English: Whereas
Danish: n
English: The YAZ Stop & Go arm (in the US study only), the YAZ fixed extended arm (in the EU/Canada study) and the YAZ 24+4 arm (both studies) were included in the two studies to compare different bleeding patterns.
Danish: Formålet med YAZ Stop & Go-armen (kun i USA-undersøgelsen), YAZ fixed extended-armen (i EU/Canada-undersøgelsen) og YAZ 24+4-armen (begge undersøgelser) i de to undersøgelser var at sammenligne forskellige blødningsmønstre.
English: The dispenser which has been designed to be an integral part of Yvidually in order to deliver tablets in line with the proposed dose regimen, has not been used in the pivotal studies.
Danish: Dispenseren er en integreret del af Yvidually og skal sikre, at tabletterne tages i henhold til det ansøgte dosisregime.
English: It is concluded that contraceptive efficacy of Yvidually has been sufficiently demonstrated for the proposed dosing regimen of Yvidually that allows the woman to decide herself to take a 4-day tablet-free interval or not during the flexible phase.
Danish: Som konklusion er den antikonceptive virkning af Yvidually tilfredsstillende godtgjort for det ansøgte doseringsregime for Yvidually, hvor kvinden selv kan vælge at tage et 4-dages tabletfrit interval eller ikke under den fleksible fase.
English: It is known and described in the SmPCs of all COCs that postponing a withdrawal bleed will introduce higher risk of intracyclic bleeding in most women.
Danish: Udsættelse af en bortfaldsblødning medfører højere risiko for intracyklisk blødning hos de fleste kvinder.
English: The YAZ Stop & Go arm (in the US study only), the YAZ fixed extended arm (in the EU/Canada study) and the YAZ 24+4 arm (in both studies) were included in the two studies to compare different bleeding patterns, but were not powered to assess contraceptive efficacy.
Danish: YAZ Stop & Go-armen (kun i USA-undersøgelsen), YAZ fixed extended-armen (i EU-/Canadaundersøgelsen) og YAZ 24+4-armen (i begge undersøgelser) havde til formål at sammenligne forskellige blødningsmønstre i de to undersøgelser, men havde ikke styrke til at vurdere den antikonceptive virkning.
English: The contraceptive efficacy was demonstrated for the YAZ Flex MB regimen in the pivotal EU/Canada study A40196, by a PI of 0.63 with a corresponding upper limit of the 95% confidence interval of 1.24 in women between 18 and 35 years of age, and a PI for method failure (PIA adjusted) of 0.59 (upper limit 95% confidence interval 1.22).
Danish: Den antikonceptive virkning blev dokumenteret for Yaz Flex MB-regimet i EU-/Canadahovedundersøgelsen A40196, hvor Pearl-indeks (PI) var 0,63 med en øvre 95 % sikkerhedsgrænse på 1,24 hos kvinder mellem 18 og 35 år.
English: Postponing a withdrawal bleed will introduce higher risk of intracyclic bleeding in most women, as is already known from current COCs, but the data available do not indicate that the noted bleeding patterns of Yvidually had a negative impact on tolerability of the women.
Danish: Udsættelse af en bortfaldsblødning giver højere risiko for intracyklisk blødning hos de fleste kvinder, således som det allerede kendes fra de nuværende kombinerede orale antikonceptionsmidler.
English: Dose recommendations
Danish: Dosisanbefalinger
English: In summary, Yvidually has been developed for women who want to postpone the monthly withdrawal bleeding, occurring with the marketed combined oral contraceptive YAZ 24+4, by extending the intake cycle up to 120 days.
Danish: Sammenfattende er Yvidually udviklet til kvinder, som ved at forlænge indtagscyklus i indtil 120 dage ønsker at udsætte den månedlige bortfaldsblødning, der optræder med det markedsførte kombinerede orale antikonceptivum YAZ 24+4.
English: Compared to the conventional YAZ 24+4 dosing regimen (6 days/year), the number of days of intracyclic bleeding was comparable in the YAZ Flex MB regimen (5 days/year), but more frequent in the YAZ Stop & Go (14.8 days/year).
Danish: I YAZ Flex MB-regimet svarede antallet af dage med intracyklisk blødning (5 dage/år) til det konventionelle YAZ 24+4-doseringsregime (6 dage/år), hvorimod der var flere i YAZ Stop & Go (14,8 dage/år).
English: Yvidually has been developed for women who want to postpone the monthly withdrawal bleeding, occurring with the marketed combined oral contraceptive YAZ 24+4 by extending the intake cycle up to 120 days.
Danish: Yvidually er udviklet til kvinder, der ved at forlænge indtagscyklus i indtil 120 dage ønsker at udsætte den månedlige bortfaldsblødning, som optræder med det markedsførte kombinerede orale antikonceptionsmiddel YAZ 24+4.
English: It is not expected that these slight differences in mean number of cycles (4.2 versus 4.6 breaks/year) and cycle length (73-78.2 versus 70.4 days of continuous tablet intake per treatment cycle) between YAZ Flex MB and YAZ Stop & Go will lead to a relevant difference in contraceptive efficacy.
Danish: Der er kun små forskelle mellem YAZ Flex MB og YAZ Stop & Go i det gennemsnitlige antal cyklusser (4,2 mod 4,6 pauser/år) og cykluslængden (73-78,2 mod 70,4 dage med uafbrudt tabletindtagelse pr. behandlingscyklus).
English: This treatment arm was included in both EU/Canada study and the US study and considered to be representative for the contraceptive efficacy of Yividually, as well as a comparison of the bleeding pattern with the bleeding pattern of YAZ 24+4 and other dose regimens; YAZ Stop & Go regimen; each cycle comprises 120 days of intended treatment followed by a 4day tablet-free interval to induce withdrawal bleeding.
Danish: Den ene behandlingsarm indgik både i EU-/Canada-undersøgelsen og i USAundersøgelsen og blev anset for repræsentativ for den antikonceptive virkning af Yvidually og anvendt til sammenligning med blødningsmønstret for YAZ 24+4 og de øvrige dosisregimer.
English: The data have adequately demonstrated that compared to YAZ 24+4 (conventional regimen), the number of withdrawal episodes decreases as well as the total number of bleeding days over a period of 1 year, which is the aim of this product.
Danish: Det er tilfredsstillende godtgjort, at der er færre bortfaldsepisoder og lavere samlet antal blødningsdage i løbet af et år end med YAZ 24+4 (konventionelt regime), hvilket er hensigten med produktet.
English: Higher PIs were obtained in the other pivotal study A48294 that was carried out in the US. Higher PIs have also been observed for other COCs in studies performed in the US, which is probably related to problems with compliance.
Danish: Også for andre kombinerede antikonceptionsmidler er fundet højere værdier af Pearl-indeks i undersøgelser udført i USA, formodentlig som følge af kompliansproblemer.
English: This arm was included in the EU/Canada study in order to compare with bleeding patterns of the other treatment arms; YAZ 24+4 (YAZ) regimen; 24 days of continuous tablet-taking followed by a 4-day tablet-free interval (regimen authorised in Europe) included in both studies in order to compare bleeding patterns; Except for the YAZ fixed extended regimen, the minimum treatment period between tablet-free intervals (i.e. minimum cycle length) in each regimen was 24 days (to maintain contraceptive efficacy).
Danish: YAZ 24+4 (YAZ)-regime: 24 dages uafbrudt tabletindtagelse efterfulgt af et 4-dages tabletfrit interval (et regime, der er godkendt i Europa) indgik i begge undersøgelser for at sammenligne blødningsmønstret.
English: The summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Yvidually and associated names (see Annex I).
Danish: navnlig EU-/Canada-undersøgelsen, og udvalget anså benefit/risk-forholdet for Yvidually og tilknyt tede navne til den ansøgte indikation og det udvidede doseringsregime for at være positivt anbefalede CHMP udstedelse af markedsføringstilladelse på de anbefalede betingelser vedrørende sikker og effektiv anvendelse af lægemidlet som angivet i bilag IV. Produktresuméet, etiketteringen og indlægssedlen er uændrede svarende til de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen som anført i bilag III for Yvidually og tilknyttede navne (se bilag I).
English: This arm was included in the US study for comparison of bleeding pattern with bleeding patterns of YAZ 24+4 and YAZ FlexMB; YAZ fixed extended regimen; 120 days of continuous tablet-taking (without any break) followed by a 4-day tablet-free interval.
Danish: Denne arm indgik i USA-undersøgelsen for at sammenligne blødningsmønsteret med blødningsmønsteret for YAZ 24+4 og YAZ FlexMB.
English: Your doctor will decide which strength is best for you.
Danish: Lægen vil afgøre hvilken styrke, der er bedst for Dem.
English: Data from four major trials are presented here.
Danish: Data fra fire større afprøvninger bliver vist her.
English: Date of renewal: 20/11/2006
Danish: Dato for fornyelse: 20/11/2006
English: In addition, ask your doctor for advice on other appropriate sun protection methods.
Danish: Spørg desuden Deres læge til råds om andre passende solbeskyttelsesmetoder.
English: DATE OF REVISION OF THE TEXT {DD/MM/YYYY}
Danish: DATO FOR ÆNDRING AF TEKSTEN {DD/MM/ ÅÅÅÅ }
English: Specific studies have not been conducted in elderly patients.
Danish: Der er ikke blevet foretaget specielle studier med ældre patienter.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28/02/2002
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 28/02/2002
English: Rosacea and rosacea-like dermatitis have also been reported.
Danish: Rosacea og rosacea-lignende dermatitis er også blevet rapporteret.
English: What Protopy contains
Danish: Hvad Protopy indeholder
English: Not all pack sizes may be marketed.
Danish: Det er ikke sikkert, at alle pakningsstørrelser markedsføres.
English: Frequencies are defined as very common (> 1/10), common (> 1/100, < 1/10) and uncommon (> 1/1,000, < 1/100).
Danish: Hyppigheden er defineret som meget almindelig (> 1/10), almindelig (> 1/100, < 1/10) og usædvanlig (> 1/1.000, < 1/100).
English: Burning sensation and itching are very common (> 10%).
Danish: En brændende følelse og kløe er meget almindeligt (> 10%).
English: The response rates at month 6 were comparable to the 3-month results.
Danish: Respons raten ved måned 6 svarede til resultaterne ved måned 3.
English: Treatment should be intermittent and not continuous.
Danish: Behandling skal være periodisk og ikke vedvarende.
English: Like all medicines, Protopy can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan Protopy have bivirkninger, selvom ikke alle får bivirkninger.
English: Treatment with Protopy may be repeated if symptoms reappear.
Danish: Behandling med Protopy kan gentages, hvis symptomerne kommer igen.
English: Protopy ointment should not be used during pregnancy unless clearly necessary.
Danish: Protopy salve bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Acne is an uncommon side effect.
Danish: Acne er en usædvanlig bivirkning.
English: If you do not see any improvement after two weeks, see your doctor about other possible treatments.
Danish: Hvis De ikke ser bedring efter 2 uger skal De tale med lægen om andre mulige behandlinger.
English: There are no adequate data from the use of tacrolimus ointment in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af tacrolimus salve hos gravide kvinder.
English: The safety of using Protopy for a long time is not known.
Danish: Sikkerheden ved langtidsbrug af Protopy er ukendt.
English: Therefore it should not be used in this age group.
Danish: Derfor bør det ikke anvendes til denne
English: Occlusive dressings are not recommended.
Danish: Occlusionsforbinding anbefales ikke.
English: Protopy can be used for short term and intermittent long term treatment.
Danish: Protopy kan benyttes til korttidsbehandling og intermitterende langtidsbehandling.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu.
English: Table 2 Efficacy at week 3
Danish: Tabel 2 Effekt ved uge 3
English: These symptoms are usually mild to moderate and generally go away within one week of using Protopy.
Danish: Disse symptomer er sædvanligvis milde til moderate og forsvinder almindeligvis efter en uges brug af Protopy.
English: The primary endpoint was the response rate at month 3 defined as the proportion of patients with at least 60% improvement in the mEASI (modified Eczema Area and Severity Index) between baseline and month 3.
Danish: Den primære parameter var respons raten ved måned 3, defineret som delen af patientgruppen med mindst 60% forbedring i mEASI (modified Eczema Area and Severity Index) fra baseline til måned 3.
English: However, the clinical experience available in this patient population has not shown the necessity for any dosage adjustment.
Danish: De kliniske erfaringer med denne patientpopulation tyder imidlertid ikke på at det er nødvendigt at justere doseringen.
English: Manufacturer: Astellas Ireland Co. Ltd., Killorglin, County Kerry, Ireland.
Danish: Fremstiller: Astellas Ireland Co. Ltd., Killorglin, County Kerry, Irland.
English: The efficacy and safety of Protopy was assessed in more than 13,500 patients treated with tacrolimus ointment in Phase I to Phase III clinical trials.
Danish: Effekt og tolerabilitet er blevet undersøgt i mere end 13.500 patienter behandlet med tacrolimus salve i fase I til fase III kliniske afprøvninger.
English: Pharmacotherapeutic group: Other dermatologicals, ATC code: D11AX14
Danish: Farmakoterapeutisk klassifikation: Dermatologiske midler, andre, ATC-kode: D11AX14
English: Because of the potential risk of vaccination failure, vaccination should be administered prior to commencement of treatment, or during a treatment-free interval with a period of 14 days between the last application of Protopy and the vaccination.
Danish: På grund af risikoen for manglende effekt at vaccinationer, bør man vaccinere før start på behandling eller i behandlingsfri intervaller med en periode på 14 dage mellem den sidste påsmøring af Protopy salve og vaccination.
English: It is unclear whether the effect of tacrolimus is due to systemic immunosuppression or a local effect.
Danish: Det er uklart om effekten skyldes en systemisk immunosuppression eller en lokal effekt.
English: If no signs of improvement are seen after two weeks of treatment, further treatment options should be considered.
Danish: Hvis der ikke er tegn på bedring efter 2 ugers behandling, bør anden behandling overvejes.
English: If the ointment gets on any of these areas, it should be thoroughly wiped off and/or rinsed off with water.
Danish: Hvis der alligevel kommer salve på disse områder, skal salven tørres grundigt af og/eller skylles af med vand.
English: Apply Protopy twice a day for up to three weeks, once in the morning and once in the evening.
Danish: Påsmør Protopy 2 gange om dagen i op til 3 uger, en gang om morgenen og en gang om aftenen.
English: Afterwards the frequency of application should be reduced to once a day until clearance of the lesion (see section 4.4).
Danish: Derefter bør hyppigheden af applikationer reduceres til en gang om dagen indtil læsionen er helet (se pkt.
English: Wash your hands after applying Protopy unless your hands are also being treated.
Danish: Vask hænder efter påsmøring af Protopy, med mindre hænderne også skal behandles.
English: Physicians should advise patients on appropriate sun protection methods, such as minimisation of the time in the sun, use of a sunscreen product and covering of the skin with appropriate clothing.
Danish: Lægen bør anvise patienterne egnede solbeskyttelsesmetoder, som f.eks. minimering af den tid, der tilbringes i solen, brug af solbeskyttende cremer samt tildækning af huden med passende beklædning.
English: There was no evidence of systemic accumulation of tacrolimus in patients (adults and children) treated for prolonged periods (up to one year) with tacrolimus ointment.
Danish: Der har ikke været tegn på systemisk akkumulation af tacrolimus i patienter (voksne og børn), der er blevet behandlet med tacrolimus salve i længere perioder (op til 1 år).
English: The risk for humans cannot be completely ruled out as the potential for local immunosuppression with the long-term use of tacrolimus ointment is unknown.
Danish: Risikoen for mennesker kan ikke fuldstændig udelukkes da potentialet for lokal immunosuppression ved langtidsbrug af tacrolimus salve er ukendt.