FrancophonIA/ELRC3.0 huggingface dataset:
English: If absence of withdrawal bleeding occurs and IOA 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 IOA er blevet taget i henhold til instruktionerne beskrevet i pkt.
English: The apparent clearance at steady state is
Danish: Den tilsyneladende clearance ved steady-state er 26 l/t.
English: If she is more than 12 hours late in taking any active tablet, contraceptive protection may be reduced.
Danish: Hvis det er mere end 12 timer siden at kvinden skulle have taget en tablet, kan den kontraceptive beskyttelse være nedsat.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION White active film-coated tablets: Each film-coated tablet contains 2.5 mg nomegestrol acetate and Yellow placebo film-coated tablets: The tablet does not contain active substances.
Danish: - Aktive stoffer: i de hvide aktive filmovertrukne tabletter: Hver tablet indeholder 2,5 mg nomegestrolacetat og 1,5 mg estradiol (som hemihydrat) i de gule filmovertrukne placebo-tabletter: Tabletterne indeholder ingen aktive stoffer.
English: No data on efficacy and safety are available in adolescents below 18 years.
Danish: Der foreligger ingen resultater vedrørende IOAs sikkerhed og virkning hos børn under 18 år (se pkt.
English: Yellow tablets from the last (4th) row of the blister can be disregarded.
Danish: Gule tabletter fra den sidste (4.)
English: Each white active tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hvid aktiv tablet indeholder 2,5 mg nomegestrolacetat og 1,5 mg estradiol (som hemihydrat).
English: This includes any possible side You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V*.
English: Symptoms of pulmonary embolism (PE) can include: - sudden onset of unexplained shortness of breath or rapid breathing; - sudden coughing which may be associated with haemoptysis;
Danish: Symptomer på lungeemboli (PE) kan omfatte: - pludselig opstået uforklarlig åndenød eller hurtig vejrtrækning; - pludselig opstået hoste, som kan være forbundet med hæmoptyse; - stærke brystsmerter; - svær ørhed eller svimmelhed; - hurtige eller uregelmæssige hjerteslag.
English: You can start taking IOA 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 IOA dagen efter du har taget den sidste tablet fra dit nuværende p-pille blisterkort (dette betyder ingen tablet-fri pause).
English: After finishing the 4 yellow placebo tablets from the second blister,
Danish: Efter du har taget de 4 gule placebotabletter fra det andet blisterkort, så start på det tredje blisterkort.
English: • Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of
Danish: • Kvinder med hypertriglyceridæmi eller familiær disposition herfor, kan have en øget risiko for pancreatitis, når de anvender p-piller.
English: • It is estimated that out of 10,000 women who use a levonorgestrel-containing CHC about 61 will
Danish: • Det estimeres, at ud af 10.000 kvinder, som anvender kombinerede hormonelle præventionsmidler indeholdende levonorgestrel, vil ca. 61 udvikle VTE inden for et år.
English: - HIV infections (e.g. ritonavir, nevirapine, nelfinavir, efavirenz); - other infectious diseases (e.g. griseofulvin); - high blood pressure in the blood vessels in the lungs (bosentan).
Danish: Dette omfatter lægemidler til behandling af: epilepsi (f.eks. primidon, phenytoin, fenobarbital, carbamazepin, oxcarbazepine, topiramat, felbamat); tuberkulose (f.eks. rifampicin); hiv-infektioner (f.eks. ritonavir, nevirapin, nelfinavir og efavirenz); andre smitsomme sygdomme (f.eks. griseofulvin): højt blodtryk i blodkarrene i lungerne (bosentan).
English: • harmful blood clots in a vein or artery, for example: o in a leg or foot (i.e., DVT) o in a lung (i.e., PE) o heart attack o stroke o mini-stroke or temporary stroke-like symptoms known as a transient ischaemic attack (TIA) o blood clots in the liver, stomach/intestine, kidneys or eye.
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: IOA 2.5 mg/1.5 mg film-coated tablets Nomegestrol acetate/estradiol
Danish: IOA 2,5 mg/1,5 mg filmovertrukne tabletter nomegestrolacetat/estradiol
English: Symptoms of deep vein thrombosis (DVT) can include: - unilateral swelling of the leg and/or foot or along a vein in the leg; - pain or tenderness in the leg which may be felt only when standing or walking; - increased warmth in the affected leg; red or discoloured skin on the leg.
Danish: - smerter eller ømhed i benet, som eventuelt kun kan mærkes, når kvinden står eller går; - øget varme i det berørte ben; rød eller misfarvet hud på benet.
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 IOA”.
Danish: Se punkt 2, “Det skal du vide, før du begynder at tage IOA” for nærmere oplysninger om de forskellige risici ved at tage kombinerede hormonelle præventionsmidler.
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: Magnesium stearate (E572) Silica, colloidal anhydrous
Danish: Magnesiumstearat (E572)
English: • change in colour of the skin on the leg e.g. turning pale, red or
Danish: Huden bliver f.eks. bleg, rød eller blå
English: • chest pain, discomfort, pressure, heaviness • sensation of squeezing or fullness in the chest, arm or below the
Danish: • brystsmerter, ubehag, trykken, tyngdefornemmelse i brystet
English: No studies were performed to evaluate the effect of renal disease on the pharmacokinetics of IOA.
Danish: Virkning af nedsat nyrefunktion Der er ikke udført studier for at evaluere effekten af nyresygdom på farmakokinetikken af IOA.
English: • golden brown pigment patches, mostly in the face; excessive hair growth • vaginal smell; discomfort in the vagina or vulva
Danish: • gylden brune pigmentpletter, oftest i ansigtet, kraftig hårvækst
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Marketing Authorisation Holder:
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: • regular but scanty periods; larger breasts; breast lump; milk production while not pregnant;
Danish: • regelmæssig, men sparsom menstruation, større bryster, bryst knude, mælkeproduktion, uden graviditet, præmenstruelt syndrom, smerter under samleje, tørhed i skeden eller vulva, krampe i livmoderen
English: Factors that increase your risk of a blood clot in an artery It is important to note that the risk of a heart attack or stroke from using IOA is very small but can
Danish: Det er vigtigt at lægge mærke til, at risikoen for et hjerteanfald eller et slagtilfælde, mens du tager IOA er meget lille, men den kan stige:
English: Rarely, there may be serious lasting effects or, very
Danish: Der kan i sjældne tilfælde indtræffe alvorlige varige men, og i meget sjældne tilfælde kan blodproppen være dødelig.
English: • if you have any of the following diseases that may increase your risk of a clot in the arteries: - severe diabetes with blood vessel damage - very high blood pressure - a very high level of fat in the blood (cholesterol or triglycerides); - a condition known as hyperhomocysteinaemia
Danish: • hvis du har en eller flere af følgende sygdomme, der kan øge din risiko for en blodprop i pulsårerne: - alvorlig sukkersyge (diabetes) med beskadigede blodkar.
English: • if you are less than 12 hours late in taking a tablet, the reliability of the pill is maintained.
Danish: • hvis der er gået mindre end 12 timer fra du skulle have taget en tablet, er sikkerheden af ppillen uændret.
English: Changes generally remain
Danish: Ændringen af værdierne forbliver dog sædvanligvis indenfor normalvariationerne.
English: 4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed with IOA.
Danish: Der er ikke foretaget studier på IOA vedrørende påvirkning af evnen til at føre motorkøretøj og betjene maskiner.
English: • The herbal product St. John's wort may also stop IOA from working properly.
Danish: • Naturlægemidlet perikon kan også nedsætte IOAs virkning.
English: NAME OF THE MEDICINAL PRODUCT IOA 2.5 mg/1.5 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN IOA 2,5 mg/1,5 mg filmovertrukne tabletter Nomegestrolacetat/estradiol
English: 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: - Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: The contraceptive effect of IOA 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: Other medical conditions associated with
Danish: Andre medicinske tilstande, som er forbundet med uønskede vaskulære hændelser
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig at du ikke tåler visse sukkerarter.
English: When you stop IOA your risk of a blood clot returns to normal within a few weeks.
Danish: Når du stopper med at tage IOA, går der et par uger, hvorefter din risiko for at udvikle blodpropperikke længere er forhøjet.
English: • sweating, nausea, vomiting or dizziness; • extreme weakness, anxiety, or shortness of breath;
Danish: • svedtendens, kvalme, opkastning eller svimmelhed;
English: What IOA contains - The active substances are: in the white active film-coated tablets: Each 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: • fullness, indigestion or choking feeling; • upper body discomfort radiating to the back, jaw, throat, arm and
Danish: • ubehag i overkroppen strålende ud i ryggen, kæben, halsen, armen og maven;
English: Hepatobiliary disorders cholelithiasis, cholecystitis hyperhydrosis, alopecia, pruritus, dry skin, seborrhea chloasma, hypertrichosis sensation of heaviness hypomenorrhoea, breast swelling, galactorrhoea, uterine spasm, premenstrual syndrome, breast mass, dyspareunia, vulvovaginal dryness vaginal odour, vulvovaginal discomfort irritability, oedema hunger weight increased hepatic enzyme increased
Danish: Hud og subkutane væv akne hyperhydrose, alopeci, pruritus, tør hud, seborre chloasma, hypertrikose
English: • as you get older (particularly above about 35 years); • if you gave birth less than a few weeks ago
Danish: • med alderen (hvis du er over 35 år);
English: Slovenská republika Merck Sharp & Dohme, s.r.o.
Danish: Merck Sharp & Dohme, s.r.o.
English: Hepatic impairment
Danish: • svær hypertension
English: If any of the above conditions change while you are using IOA, 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: If you want to use herbal products containing St. John's wort while you are already using IOA you should
Danish: Hvis du ønsker at bruge naturlægemidler, der indeholder perikon, mens du tager IOA, skal du kontakte din læge først.
English: This will help you to determine when the baby will be
Danish: Dermed får du bedre mulighed for at beregne barnets forventede fødselsdato.
English: premenstrual syndrome; pain during intercourse; dryness in the vagina or vulva; spasm of the uterus
Danish: • vaginal lugt, ubehag i skeden eller vulva
English: What IOA is and what it is used for What you need to know before you use IOA
Danish: Oversigt over indlægssedlen: Virkning og anvendelse Det skal du vide, før du begynder at tage IOA Hvornår skal du ikke tage IOA Hvornår skal du være særlig opmærksom, mens du tager IOA Hvornår skal du kontakte din læge
English: Tel: + 386 1 5204201 msd_slovenia@merck.com
Danish: Tel: + 385 1 6611 333 croatia_info@merck.com
English: Other medicines and IOA
Danish: Brug af anden medicin sammen med IOA Graviditet og amning
English: Rare increased appetite, fluid retention decreased appetite increased libido cerebrovascular accident, transient ischaemic attack, disturbance in attention
Danish: Nervesystemet hovedpine, migræne cerebrovaskulær hændelse, transitorisk cerebral iskæmi, opmærksomhedsforstyrrelser
English: Tel: + 40 21 529 29 00 msdromania@merck.com
Danish: Tel: +353 (0)1 2998700 medinfo_ireland@merck.com
English: Tel: + 421 2 58282010 dpoc_czechslovak@merck.com
Danish: Τηλ: + 30 210 98 97 300 dpoc_greece@merck.com
English: Common (may affect up to 1 in 10 people): • decreased interest in sex; depression/depressed mood; mood changes
Danish: • nedsat sexlyst, depression/nedtrykthed, humørsvingninger
English: Merck Sharp & Dohme, Lda Tel: + 351 21 4465808 clic@merck.com
Danish: Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com
English: Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Administration Emballage Paknings-størrelse
English: This soon disappears.
Danish: Dette forsvinder hurtigt.
English: Therefore, no specific frequency can be presented.
Danish: Der kan derfor ikke angives en specifik frekvens.
English: Ask your doctor about this.
Danish: Spørg Deres læge til råds om dette.
English: • if signs of allergy spread to other parts of the body, or
Danish: • Hvis allergisymptomerne spreder sig til andre dele af kroppen, eller
English: EXP/ During use: use within 6 weeks
Danish: EXP/ Efter ibrugtagning: Bruges inden 6 måneder
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first suthorisation: 07 October 2002
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF Dato for første markedsføringstilladelse: 7. oktober 2002
English: Intravenous administration should only be carried out by health care professionals.
Danish: Intravenøs administration bør kun foretages af sundhedspersonale.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Danish: Dette kan udgøre en risiko i situationer, hvor disse evner er af speciel vigtighed (f.eks. ved bilkørsel eller
English: If the protective cap is loose or missing.
Danish: Hvis beskyttelseshætten er løs eller mangler.
English: Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Danish: Glucose skal også gives intravenøst, hvis patienten ikke responderer på glucagon inden for 10-15 minutter.
English: Generalised hypersensitivity reactions are potentially lifethreatening.
Danish: Generaliserede hypersensitivitets reaktioner er potentielt livstruende.
English: However, there were differences between age groups in Cmax, stressing the importance of individual dose titration.
Danish: Der var imidlertid forskelle imellem aldersgrupper på Cmax, hvilket understreger betydningen af individuel dosistitrering.
English: Isolated spontaneous cases are presented as very rare defined as <1/10,000 including isolated reports.
Danish: Isolerede spontant rapporterede tilfælde er angivet som meget sjælden, defineret som <1/10.000, herunder enkeltstående indberetninger.
English: The data are limited but suggest that the pharmacokinetic profile in children and adolescents may be similar to that in adults.
Danish: Data er begrænsede, men antyder, at den farmakokinetiske profil for børn og unge ligner profilen for voksne.
English: If you do not respond to glucagon treatment, you will have to be treated in a hospital.
Danish: Hvis De ikke reagerer på glucagonbehandlingen, skal De behandles på hospitalet.
English: It may harm them, even if their symptoms are the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer som De har.
English: Insulin requirements usually fall in the first trimester and subsequently increase during the second and third trimesters.
Danish: Insulinbehovet falder normalt i første trimester og stiger siden i løbet af andet og tredje trimester.
English: Seek medical advice immediately:
Danish: Søg derefter straks lægehjælp.
English: In clinical trials and during marketed use, the frequency varies with patient population and dose regimens.
Danish: I kliniske forsøg og ved markedsføringen varierer frekvensen i forhold til patientpopulation og dosisregime.
English: Like all medicines, Velosulin can cause side effects, although not everybody gets them.
Danish: Velosulin kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Velosulin contains metacresol, which may cause allergic reactions.
Danish: Velosulin indeholder metacresol, som kan forårsage allergiske reaktioner.
English: Changes at the injection site (Lipodystrophy).
Danish: Forandringer på injektionsstedet (lipodystrofi).
English: Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away.
Danish: Fortæl familie, venner og nærmeste kollegaer, at hvis De besvimer (bliver bevidstløs), skal De vendes om på siden, og der skal straks tilkaldes lægehjælp.
English: Insulin solutions should not be used if they do not appear water clear and colourless.
Danish: Insulinopløsninger bør ikke anvendes, hvis de ikke fremstår vandklare og farveløse.
English: Usually, the first symptoms of hyperglycaemia set in gradually, over a period of hours or days.
Danish: De første symptomer på hyperglykæmi kommer normalt gradvist over en periode på timer eller dage.
English: Insulin preparations which have been frozen must not be used.
Danish: Insulinpræparater, som har været frosne, må ikke anvendes.
English: The physician must therefore take possible interactions into account and should always ask his patients about any medicinal products they take.
Danish: Lægen bør derfor overveje mulige interaktioner samt altid spørge sine patienter, om de anvender andre lægemidler.
English: The maximum plasma concentration is reached within 1.5-2.5 hours after subcutaneous administration.
Danish: Maksimal plasmakoncentration opnås 1,5-2,5 time efter subkutan indgivelsesmåde.
English: The individual insulin requirement is usually between 0.3 and 1.0 IU/kg/day.
Danish: Det individuelle insulinbehov ligger normalt mellem 0,3-1,0 IE/kg/dag.
English: Painful neuropathy (nerve related pain).
Danish: Smertefuld neuropati (nerverelateret smerte).
English: Uncommon - Peripheral neuropathy
Danish: Ikke almindelig - Perifer neuropati
English: You may have a very rare serious allergic reaction to Velosulin or one of its ingredients (called a systemic allergic reaction).
Danish: De kan have fået en meget sjælden, alvorlig allergisk reaktion på Velosulin eller et af de øvrige indholdsstoffer (også kaldet systemisk allergisk reaktion).
English: If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information).
Danish: Hvis De er overfølsom (allergisk) over for dette insulinpræparat, metacresol eller et af de øvrige indholdsstoffer (se 7 Yderligere oplysninger).
English: This means that it will start to lower your blood sugar about half an hour after you take it.
Danish: Det betyder, at det begynder at nedsætte blodsukkeret ca. 30 minutter efter indgivelsen.
English: Novo Nordisk A/S Novo Nordisk A/S Novo Allé Hallas Allé DK-2880 Bagsværd DK-4400 Kalundborg Denmark Denmark
Danish: Novo Nordisk A/S Novo Nordisk A/S Novo Allé Hallas Allé DK-2880 Bagsværd DK-4400 Kalundborg Danmark Danmark
English: Follow the instructions of your doctor or diabetes nurse concerning the correct mixing procedure.
Danish: Følg lægens eller diabetessygeplejerskens instruktioner vedrørende korrekt blandingsprocedure.
English: When Velosulin is administered as a bolus injection onset of action is within ½ hour, reaches a maximum effect within 1.5-3.5 hours and the entire duration of action is approximately 7-8 hours.
Danish: Når Velosulin administreres som bolusinjektion, indtræder virkningen inden for 30 minutter, maksimal virkning opnås indenfor 1,5-3,5 time, og virkningsvarigheden er ca. 7-8 timer.
English: Monitoring of the patient's blood glucose during infusion is therefore recommended.
Danish: Det anbefales derfor at overvåge patientens blodglucose under infusion.
English: It is recommended that you measure your blood glucose regularly.
Danish: Det anbefales, at De måler Deres blodsukker jævnligt.
English: Causes of hyperglycaemia
Danish: Årsager til hyperglykæmi
English: The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
Danish: Insulinprodukters farmakokinetiske egenskaber påvirkes derfor af betydelige intra- og interpatient variationer.
English: Fast improvement in blood glucose control may be associated with a condition termed “acute painful neuropathy”, which is usually reversible.
Danish: Hurtig forbedring i blodglucosekontrollen kan være forbundet med en tilstand kaldet ”akut smertefuld neuropati”, som sædvanligvis er reversibel.
English: If repeated or severe low blood glucose levels occur, the patient should notify the health care professional and the need to reduce or stop the insulin administration should be considered.
Danish: Hvis gentagne eller alvorligt lave blodglucoseniveauer forekommer, bør patienten informere sundhedspersonalet samtidig med, at behovet for at reducere eller standse insulinbehandlingen bør overvejes.
English: Dosage is individual and determined in accordance with the needs of the patient.
Danish: Dosering er individuel og bestemmes i overensstemmelse med patientens behov.
English: Read all of this leaflet carefully before you start using your insulin.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at bruge Deres insulin.
English: The frequencies are defined as: uncommon (≥ <1/100).
Danish: Frekvenserne er defineret således: ikke almindelig (≥1/1.000 til, <1/100).
English: Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Danish: Patienter bør rådes til at tage forholdsregler for at undgå hypoglykæmi, når de fører motorkøretøj.
English: The thigh, the gluteal region or the deltoid region may also be used.
Danish: Også låret, bagsiden af hoften eller deltoidregionen kan anvendes.
English: This is called acute painful neuropathy and it usually disappears.
Danish: Dette kaldes akut smertefuld neuropati og er normalt forbigående.
English: 30 months when stored between 2°C - 8°C.
Danish: 30 måneder hvis det opbevares mellem 2°C - 8°C.
English: If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
Danish: Hvis De bemærker, at huden sprækker eller bliver tyk på injektionsstedet, skal De oplyse det til Deres læge eller diabetessygeplejerske, da sådanne reaktioner kan blive mere alvorlige, eller måske ændre optagelsen af Deres insulin, hvis De injicerer på det sted.