FrancophonIA/ELRC3.0 huggingface dataset:
English: Lactose monohydrate (see section 2 ‘Zoely contains lactose'), microcrystalline cellulose (E460), crospovidone (E1201), talc (E553b), magnesium stearate (E572) and colloidal anhydrous silica Tablet coat (white active film-coated tablets):
Danish: Lactosemonohydrat (se punkt 2 'Zoely indeholder lactose'), mikrokrystallinsk cellulose (E460), crospovidon (E1201), talcum (E553b), magnesiumstearat (E572) og kolloid vandfri silica.
English: See ‘Cycle control' in section 4.4.
Danish: Se også ”cykluskontrol” i pkt.
English: • Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia.
Danish: • Nuværende pancreatitis eller tidligere pancreatitis med samtidig svær hypertriglyceridæmi.
English: • in veins (referred to as ‘venous thrombosis', ‘venous thromboembolism' or VTE)
Danish: • i vener (kaldes ‘venøs trombose', ‘venøs tromboemboli' eller VTE)
English: • sweating, nausea, vomiting or dizziness;
Danish: • svedtendens, kvalme, opkastning eller svimmelhed;
English: What can happen if a blood clot forms in an artery?
Danish: Hvad kan der ske, hvis der dannes en blodprop i en pulsåre?
English: She then continues to take tablets at her usual time.
Danish: Derefter fortsætter hun med at tage tabletterne til sædvanlig tid,
English: • if you have unusual, heavy vaginal bleeding;
Danish: • hvis du har usædvanlig, kraftig menstruation;
English: Each white active tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate).
Danish: Hver hvid aktiv tablet indeholder 2,5 mg nomegestrolacetat og 1,5 mg estradiol (som hemihydrat).
English: The yellow tablets are placebo tablets which do not contain active substances.
Danish: De gule tabletter er placebo-tabletter, som ikke indeholder aktive stoffer.
English: • Presence or history of liver tumours (benign or malignant).
Danish: • Nuværende eller tidligere levertumorer (benigne eller maligne).
English: When you should not use Zoely
Danish: Hvornår du ikke skal tage Zoely
English: Day 8-17 of white active tablet intake (see picture and schedule) Take the last missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time.
Danish: Dag 8-17 for indtagelse af hvide aktive tabletter (se billede og skema) Tag den sidste glemte tablet, så snart du husker det (selvom det betyder, at du tager to tabletter på samme tid), og tag den næste tablet på det sædvanlige tidspunkt.
English: Changing from a progestogen-only-method (minipill, implant, injectable) or from a hormone-medicated intra uterine system (IUS)
Danish: Ved skift fra rene gestagenpræparater (minipiller, implantat, injektion) eller fra et hormonholdigt intrauterint indlæg.
English: Yellow placebo film-coated tablets: The tablet does not contain active substances.
Danish: Gule filmovertrukne placebo-tabletter: Tabletten indeholder ikke aktive stoffer.
English: If you start later than day 28, you should also use a barrier method of contraception during the first 7 days of Zoely use.
Danish: Hvis du starter senere end dag 28, skal du bruge barriereprævention såsom kondom i de første 7 dage, du tager Zoely.
English: Gastrointestinal disorders nausea abdominal distension dry mouth
Danish: Mave-tarm-kanalen kvalme abdominal udspiling tør mund
English: Vascular disorders hot flush venous thromboembolism
Danish: Vaskulære sygdomme hedeture venøs tromboemboli
English: Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 and talc (E553b) Tablet coat (yellow placebo film-coated tablets):
Danish: Poly(vinylalkohol) (E1203), titandioxid (E171), macrogol 3350 og talcum (E553b) Filmovertræk (gule filmovertrukne placebo-tabletter):
English: Tablet coating (yellow placebo film-coated tablets) Poly(vinyl alcohol) (E1203) Titanium dioxide (E171)
Danish: Filmovertræk (gule filmovertrukne placebo-tabletter) Poly(vinyl alkohol) (E1203) Titandioxid (E 171)
English: It is important to note that the risk of a heart attack or stroke from using Zoely is very small but can increase:
Danish: Forhold der kan øge din risiko for en blodprop i en pulsåre Det er vigtigt at bemærke, at risikoen for et hjerteanfald eller et slagtilfælde, mens du tager Zoely er meget lille, men den kan stige:
English: Day 1-7 of white active tablet intake (see picture and schedule) Take the last white active missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablet at the usual time.
Danish: Dag 1-7 for indtagelse af hvide aktive tabletter (se billede og skema) Tag den sidste af de hvide aktive glemte tabletter, så snart du husker det (selvom det betyder, at du tager to tabletter på samme tid), og tag den næste tablet til sædvanlig tid.
English: For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”.
Danish: Se ”Sådan opdager du en blodprop” for en beskrivelse af symptomerne på disse alvorlige bivirkninger.
English: These substances are represented mostly with anticonvulsants (e.g. carbamazepine, topiramate, phenytoin, phenobarbital, primidone, oxcarbazepine, felbamate); anti-infective drugs (e.g. rifampicin, rifabutin, griseofulvin); St. John's wort; bosentan and HIV or Hepatitis C virus (HCV) protease inhibitors (e.g. ritonavir, boceprevir, telaprevir) and non-nucleoside reverse transcriptase inhibitors (e.g. efavirenz).
Danish: Disse stoffer forekommer hovedsageligt ved antiepileptika (f.eks. carbamazepin, topiramat, phenytoin, phenobarbital, primidon, oxcarbazepin, felbamat); antiinfektiva (f.eks. rifampicin, rifabutin, griseofulvin); naturlægemidlet perikon, bosentan og hiv- eller hcvproteasehæmmere (f.eks. ritonavir, boceprevir, telaprevir) og non-nukleosid revers transskriptasehæmmere (f.eks. efavirenz).
English: If you are unable to stop smoking and are older than 35 your doctor may advise you to use a different type of contraceptive;
Danish: 35 år, kan din læge råde dig til at anvende en anden type prævention;
English: An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischaemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs, which are discussed in more detail in section 4.4.
Danish: Der er observeret en øget risiko for arterielle og venøse trombotiske og tromboemboliske hændelser, herunder myokardieinfarkt, apopleksi, transitorisk cerebral iskæmi, venøs trombose og lungeemboli, hos kvinder, der anvender kombinerede hormonelle præventionsmidler.
English: The woman should take the tablet as soon as she remembers and should take further tablets at the usual time.
Danish: Kvinden skal tage tabletten, så snart hun husker det, og de resterende tabletter tages som normalt.
English: 4.6 % of the women did not have a withdrawal bleeding in the first three cycles of use and the occurrences of absence of withdrawal bleeding in the later cycles of use were high in this subgroup, ranging from 76 % to 87 % of women.
Danish: Hyppigheden af udeblivelse af menstruationsblødning i senere cyklusser var høj og strakte sig fra 76 % til 87 % af kvinderne i denne undergruppe.
English: Nomegestrol acetate
Danish: Nomegestrolacetat
English: • The Hepatitis C virus (HCV) combination drug regimen ombitasvir/paritaprevir/ritonavir with or without dasabuvir may cause increases in liver function blood test results (increase in ALT liver enzyme) in women using CHCs containing ethinylestradiol.
Danish: • Det kombinerede behandlingsregimen ombitasvir/paritaprevir/ritonavir med eller uden dasabuvir til hepatitis C-virus (hcv) kan medføre forhøjede niveauer i blodprøveresultaterne vedrørende leverfunktionen (forhøjet niveau af leverenzymet ALAT) hos kvinder, der tager kombinerede hormonelle præventionsmidler, der indeholder ethinylestradiol.
English: How to take Zoely
Danish: Hvordan tages Zoely
English: Nomegestrol acetate is excreted via urine and faeces.
Danish: Nomegestrolacetat udskilles via urin og fæces.
English: Start using Zoely when your next injection is due or on the day that your implant or IUS is removed.
Danish: Når der skiftes fra et rent gestagen injicerbart implantat eller en spiral Begynd at bruge Zoely, når du skal have din næste injektion eller den dag, dit implantat eller spiral bliver fjernet.
English: • extreme weakness, anxiety, or shortness of breath;
Danish: • ekstrem mathed, angstfornemmelse eller åndenød;
English: Heart attack
Danish: Hjerteanfald
English: Available pharmacokinetic data are described in section 5.2.
Danish: 5.2 for farmakokinetiske data).
English: Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b), iron oxide yellow (E172) and iron oxide black (E172)
Danish: Poly(vinylalkohol) (E1203), titandioxid (E171), macrogol 3350, talcum (E553b), gul jernoxid (E172) og sort jernoxid (E172).
English: During clinical trials with the HCV combination drug regimen ombitasvir/paritaprevir/ritonavir with and without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN) were significantly more frequent in women using ethinylestradiol-containing medications such as CHCs.
Danish: I kliniske studier med det kombinerede hcv-behandlingsregimen ombitasvir/paritaprevir/ritonavir med og uden dasabuvir var forhøjede ALAT-niveauer over 5 gange den øvre normalgrænse (ULN) signifikant hyppigere hos kvinder, der tog ethinylestradiol-holdige lægemidler som for eksempel kombinerede hormonelle præventionsmidler.
English: What Zoely is and what it is used for What you need to know before you use Zoely How to use Zoely
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du begynder at tage Zoely Sådan skal du tage Zoely Bivirkninger
English: • Presence or risk of venous thromboembolism (VTE) o Venous thromboembolism - current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]).
Danish: o Venøs tromboemboli - nuværende VTE (behandlet med antikoagulans) eller tidligere (f.eks. dyb venetrombose [DVT] eller lungeemboli [PE]).
English: If you want to use herbal products containing St. John's wort while you are already using Zoely you should consult your doctor first.
Danish: Hvis du ønsker at bruge naturlægemidler, der indeholder perikon, mens du tager Zoely, skal du kontakte din læge først.
English: BLOOD CLOTS IN AN ARTERY
Danish: BLODPROPPER I EN PULSÅRE
English: • disease of the gallbladder
Danish: • sygdom i galdeblæren
English: What Zoely looks like and contents of the pack The active film-coated tablets (tablets) are white and round.
Danish: De aktive filmovertrukne tabletter (tabletter) er hvide og runde.
English: • chest pain, discomfort, pressure, heaviness
Danish: • brystsmerter, ubehag, trykken, tyngdefornemmelse i brystet
English: o Cerebrovascular disease - current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA).
Danish: o Cerebrovaskulær sygdom - nuværende apopleksi, tidligere apopleksi eller prodromalsymptom (f.eks. transitorisk cerebral iskæmi).
English: In all of these cases, the woman should be advised to additionally use a barrier method until she has completed 7 days of uninterrupted white active tablet-taking.
Danish: I alle disse tilfælde skal kvinden rådes til at bruge en barrieremetode, indtil hun har taget de hvide tabletter i 7 sammenhængende dage.
English: Prior to the initiation or reinstitution of Zoely use a complete medical history (including family history) should be taken and pregnancy must be ruled out.
Danish: Før start eller genoptagelse af behandling med Zoely, skal der optages fuldstændig anamnese (inkl.
English: The metabolism of exogenous and endogenous estradiol is similar.
Danish: Oral eksogen estradiol metaboliseres i udstrakt grad. Metabolismen af eksogen og endogen estradiol er den samme.
English: She then continues to take tablets at her usual time until the active tablets are used up.
Danish: indtil de aktive tabletter er brugt op.
English: In the event of symptoms women should be advised to seek urgent medical attention and to inform the healthcare professional that she is taking a CHC.
Danish: Kvinderne bør informeres om straks at søge lægehjælp, hvis der opstår symptomer, og fortælle lægen eller sundhedspersonalet, at hun tager et kombineret hormonelt præventionsmiddel.
English: White active film-coated tablets: Each film-coated tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate).
Danish: Hvide aktive filmovertrukne tabletter: Hver filmovertrukket tablet indeholder 2,5 mg nomegestrolacetat og 1,5 mg estradiol (hemihydrat).
English: • During clinical trials with the Hepatitis C virus (HCV) combination drug regimen ombitasvir/paritaprevir/ritonavir with and without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN) were significantly more frequent in women using ethinylestradiol-containing medications such as CHCs.
Danish: • I kliniske studier med det kombinerede behandlingsregimen ombitasvir/paritaprevir/ritonavir med eller uden dasabuvir til hepatitis C-virus (hcv), var forhøjet ALAT-niveau over 5 gange den øvre normalgrænse (ULN) signifikant hyppigere hos kvinder, der tog ethinylestradiolholdige lægemidler som for eksempel kombinerede hormonelle præventionsmidler.
English: However, if you have missed more than 1 tablet, use a barrier method such as a condom as an extra precaution until you have taken your tablets correctly for 7 days in a row.
Danish: Hvis du har glemt mere end 1 tablet, skal du bruge en barrieremetode såsom kondom som ekstra beskyttelse, indtil du har taget dine tabletter korrekt i 7 dage i træk.
English: • if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g., below the age of about 50).
Danish: • hvis en nær slægtning har haft en blodprop i benet, lungen eller et andet organ i en ung alder
English: If any of the above conditions change while you are using Zoely, for example, you start smoking, a close family member experiences a thrombosis for no known reason or you gain a lot of weight, tell your doctor.
Danish: Det kan f.eks. være, hvis du begynder at ryge, en nær slægtning oplever en blodprop uden kendt årsag, eller hvis din vægt stiger meget.
English: If you forget to take Zoely The following advice only refers to missed white active tablets.
Danish: De følgende råd henviser kun til glemte hvide aktive tabletter.
English: Nomegestrol acetate and its hydroxylated metabolites undergo extensive phase 2
Danish: Nomegestrolacetat og dets hydroxylerede metabolitter undergår omfattende fase 2 metabolisme til at danne glucuronid- og sulfatkonjugater.
English: But if you are having intercourse, make sure you also use a barrier method of contraception for the first 7 days that you are taking Zoely.
Danish: Hvis du har samleje, skal du bruge barriereprævention såsom kondom i de første 7 dage, du tager Zoely.
English: Zoely 2.5 mg/1.5 mg film-coated tablets
Danish: Zoely 2,5 mg/1,5 mg filmovertrukket tablet.
English: • if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition.
Danish: • hvis du har forhøjet indhold af fedt i blodet (hypertriglyceridæmi), eller hvis nogen i din nærmeste familie har denne lidelse.
English: • fullness, indigestion or choking feeling;
Danish: • mæthedsfølelse-, fordøjelsesbesvær eller kvælningsfornemmelse;
English: • heaviness in limbs
Danish: • følelse af tyngde i lemmerne
English: The efficacy of COCs may be reduced in the event of e.g., missed tablets (see section 4.2), gastro-intestinal disturbances during active tablet-taking (see section 4.2) or use of concomitant medicinal products that decrease the plasma concentrations of nomegestrol acetate and/or estradiol (see section 4.5).
Danish: 4.2) eller samtidig indtagelse af andre lægemidler, som nedsætter plasmakoncentrationerne af nomegestrolacetat og/eller estradiol (se pkt.
English: You can start taking Zoely the day after you have taken the last tablet from your present pill blister (this means no tablet-free break).
Danish: Ved skift fra et hormonelt præventionsmiddel af kombinationstypen (p-pille, p-ring eller p-plaster) Du kan begynde at tage Zoely dagen efter, du har taget den sidste tablet fra dit nuværende p-pille blisterkort (dette betyder ingen tablet-fri pause).
English: For more detailed information on the different risks from taking combined hormonal contraceptives, please see section 2, “What you need to know before you use Zoely”.
Danish: Se punkt 2 “Det skal du vide, før du begynder at tage Zoely” for nærmere oplysninger om de forskellige risici ved at tage kombinerede hormonelle præventionsmidler.
English: • if you are less than 24 hours late in taking a tablet, the reliability of the pill is maintained.
Danish: • hvis der er gået mindre end 24 timer, fra du skulle have taget en tablet, er sikkerheden af ppillen uændret.
English: If the balance of benefits and risks is considered to be negative a CHC should not be prescribed (see section 4.3).
Danish: Et kombineret hormonelt præventionsmiddel bør ikke ordineres, hvis balancen mellem fordele og risici anses for at være negativ (se pkt.
English: The contraceptive effect of Zoely is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in the cervical secretion.
Danish: Heraf er den vigtigste, der ses, hæmningen af ægløsningen og ændringer i den cervikale sekretion.
English: How to start Zoely
Danish: Hvordan påbegyndes indtagelse af Zoely
English: This will help you to determine when the baby will be due.
Danish: Dermed får du bedre mulighed for at beregne barnets forventede fødselsdato.
English: • severe light headedness or dizziness;
Danish: • svær ørhed eller svimmelhed;
English: o A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as:
Danish: 4.4) eller pga. tilstedeværelse af én alvorlig risikofaktor såsom:
English: • regular but scanty periods; larger breasts; breast lump; milk production while not pregnant;
Danish: • regelmæssig, men sparsom menstruation, større bryster, brystknude, mælkeproduktion uden graviditet, præmenstruelt syndrom, smerter under samleje, tørhed i skeden eller vulva, krampe i livmoderen
English: Each white active film-coated tablet contains 57.71 mg of lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på En hvid filmovertrukket aktiv tablet indeholder 57,71 mg lactosemonohydrat.
English: Zoely 2.5 mg/1.5 mg tablets nomegestrol acetate/estradiol
Danish: Zoely 2,5 mg/1,5 mg tabletter nomegestrolacetat/estradiol
English: When using a combined hormonal contraceptive like Zoely you are advised to stop smoking.
Danish: Når du bruger et kombineret hormonelt præventionsmiddel som Zoely,
English: Merck Sharp & Dohme BV Tel: 0800 9999 000 (+ 31 23 515
Danish: Merck Sharp & Dohme BV Tel: 0800 9999 000 (+ 31 23 515 3153) medicalinfo.nl@merck.com
English: No data on efficacy and safety are available in adolescents below 18 years.
Danish: Der foreligger ingen resultater vedrørende Zoelys sikkerhed og virkning hos børn under 18 år (se pkt.
English: Tablet coat (white active film-coated tablets) Poly(vinyl alcohol) (E1203) Titanium dioxide (E171) Macrogol 3350
Danish: Filmovertræk (hvide aktive filmovertrukne tabletter) Poly(vinyl alkohol) (E1203) Titandioxid (E 171)
English: Merck Sharp and Dohme Cyprus Limited
Danish: Merck Sharp & Dohme Ireland (Human Health) Limited
English: Drug drug interactions
Danish: Lægemiddelinteraktioner
English: Other medicines and Zoely Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines.
Danish: Brug af anden medicin sammen med Zoely Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Zoely 2.5 mg/1.5 mg film-coated tablets nomegestrol acetate/estradiol
Danish: Zoely 2,5 mg/1,5 mg filmovertrukne tabletter nomegestrolacetat/estradiol
English: For breast-feeding women see section 4.6.
Danish: For ammende kvinder - se pkt.
English: BLOOD CLOTS
Danish: ”Blodpropper”)
English: • The herbal product St. John's wort may also stop Zoely from working properly.
Danish: • Naturlægemidlet perikon kan også nedsætte Zoelys virkning.
English: Tumours
Danish: Tumorer
English: If 24 or more hours have passed since last tablet intake, the advice concerning missed tablets, as given in section 4.2 "Management of missed tablets", is applicable.
Danish: Hvis der er gået 24 timer eller mere siden sidste tabletindtagelse, er rådet i pkt.
English: Tel: 8007 4433 (+356 99917558) malta_info@merck.com
Danish: Merck Sharp and Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@merck.com
English: Investigations weight increased hepatic enzyme increased
Danish: Undersøgelser vægtøgning forhøjelse af leverenzymer
English: • if you have varicose veins.
Danish: • hvis du har åreknuder;
English: Musculoskeletal and connective tissue disorders sensation of heaviness
Danish: Knogler, led, muskler og bindevæv følelse af tyngde
English: Following first-trimester abortion The woman may start immediately.
Danish: Kvinden kan påbegynde tabletindtagelsen straks.
English: • harmful blood clots in a vein or artery, for example:
Danish: • skadelige blodpropper i en vene eller pulsåre, for eksempel: o i et ben eller en fod (dvs. DVT) o i en lunge (dvs.
English: • weight gain
Danish: • vægtøgning
English: If absence of withdrawal bleeding occurs and Zoely has been taken according to the instructions as described in section 4.2, it is unlikely that the woman is pregnant.
Danish: Hvis fravær af menstruationsblødning indtræffer og Zoely er blevet taget i henhold til instruktionerne beskrevet i pkt.
English: When starting later, the woman should be advised to additionally use a barrier method until she has completed 7 days of uninterrupted white active tablet-taking.
Danish: Starter kvinden senere, bør hun rådes til at benytte en barrieremetode samtidig i de første 7 dage af den hvide tablet-indtagelse.
English: When you stop Zoely your risk of a blood clot returns to normal within a few weeks.
Danish: Når du stopper med at tage Zoely, går der et par uger, hvorefter din risiko for at udvikle blodpropper ikke længere er forhøjet.
English: o heart attack o stroke o mini-stroke or temporary stroke-like symptoms known as a transient ischaemic attack
Danish: PE) o hjerteanfald o slagtilfælde o mini-slagtilfælde eller midlertidige symptomer som et slagtilfælde kaldet et forbigående iskæmisk anfald (TIA) o blodpropper i leveren, maven/tarmene, nyrerne eller øjet.
English: Posology
Danish: Kommentar
English: If you are not sure what to do, consult your doctor.
Danish: Kontakt din læge, hvis du ikke er sikker på, hvad du skal gøre.
English: • dry mouth
Danish: • mundtørhed
English: If any of the above conditions change while you are using Zoely, for example a close family member experiences a thrombosis for no known reason or you gain a lot of weight, tell your doctor.
Danish: Det kan f.eks. være, hvis en nær slægtning oplever en blodprop uden kendt årsag, eller hvis din vægt stiger meget.
English: Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 medinfo_ireland@merck.com
Danish: Tel: +353 (0)1 2998700 medinfo_ireland@merck.com
English: Rare
Danish: Generelt
English: • severe pain in your stomach;
Danish: • stærke mavesmerter;
English: • painless blurring of vision which can progress to loss of vision
Danish: • sløret syn uden smerter.
English: They may be taken with or without food.
Danish: De kan tages med eller uden mad.
English: These data show that the efficacy of the combination would be lower in these patients.
Danish: Disse data viser, at effektiviteten af kombinationen ville være lavere hos disse patienter.
English: This medicine has not been studied in this age group.
Danish: Dette lægemiddel er ikke blevet undersøgt i denne aldersgruppe.
English: There is no specific treatment for overdose.
Danish: Der er ingen specifik behandling for overdosering.
English: If possible, show them this leaflet and the medicine package.
Danish: Vis dem om muligt denne indlægsseddel og pakningen.