FrancophonIA/ELRC3.0 huggingface dataset:
English: When using a hormonal contraceptive like <invented name> you are strongly advised to stop smoking, especially if you are older than 35 years; if one of your close relatives has had a blood clot in the leg, lung or other organ at a young age; if you are overweight; if you must have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a plaster cast.
Danish: Når du bruger et hormonalt svangerskabsforebyggende middel som <produktnavn>, rådes du på det kraftigste til at holde op med at ryge, især hvis du er over 35 år, hvis en af dine nære slægtninge har haft en blodprop i benene, lungerne eller andre organer i en ung alder, hvis du er overvægtig, hvis du skal opereres, eller hvis du er sengeliggende i lang tid på grund af en skade eller sygdom, eller hvis du har dit ben i gips.
English: • The risk of venous thromboembolic events increases with: - increasing age; - smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age.
Danish: • Risikoen for venøse tromboemboliske hændelser øges med: - øget alder, - rygning (ved mere massiv rygning og øget alder øges risikoen yderligere, især hos kvinder over 35 år.
English: A blood clot in an artery can cause serious problems.
Danish: En blodprop i en arterie kan være alvorlig.
English: Due to its contraceptive properties it should only be prescribed for you if your doctor considers that treatment with a hormonal contraceptive is appropriate.
Danish: På grund af præparatets svangerskabsforebyggende egenskaber må det kun ordineres, hvis lægen anser behandling med hormonale svangerskabsforebyggende midler for hensigtsmæssig.
English: • Hereditary or acquired predisposition for venous or arterial thrombosis, such as activated protein C (APC) resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant)
Danish: • Arvelig eller erhvervet disposition for vene- eller arteriel trombose, såsom aktiveret protein Cresistens (APC-resistens), antithrombin-III-mangel, protein C-mangel, protein S-mangel, hyperhomocysteinæmi og antifosfolipid-antistoffer (anticardiolipin-antistoffer, lupus-antikoagulans)
English: • if you have (or have ever had) a disease that may be an indicator of a heart attack in the future
Danish: • hvis du har (eller tidligere har haft) en sygdom, der kan være en forløber for et senere hjerteanfald
English: Blood clots (thrombosis)
Danish: Blodpropper (trombose)
English: Stop taking tablets and see your doctor immediately if you notice possible signs of a blood clot, such as:
Danish: Hold op med at tage tabletterne og kontakt straks en læge, hvis du bemærker symptomer, der kan væretegn på en eventuel blodprop, såsom:
English: You should only take <invented name> if your skin condition has not improved after use of other antiacne treatments, including topical treatments and antibiotics.
Danish: Du skal kun tage <produktnavn>, hvis din hudsygdom ikke er blevet bedre efter anvendelse af andre behandlinger mod akne, herunder lokalbehandling af huden og behandling med antibiotika.
English: The risk of arterial thromboembolic complications or of a cerebrovascular accident increases with: - increasing age; - smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age.
Danish: Risikoen for arterielle tromboemboliske komplikationer eller for en cerebrovaskulær hændelse øges med: - øget alder, - rygning (ved mere massiv rygning og øget alder øges risikoen yderligere, især hos kvinder over 35 år.
English: Women over 35 years of age should be strongly advised not to smoke if they wish to use <invented name>); - a positive family history (i.e. venous thromboembolism ever in a sibling or parent at a relatively early age).
Danish: Kvinder over 35 år bør på det kraftigste rådes til ikke at ryge, hvis de gerne vil bruge <produktnavnet>), - en positiv familieanamnese (dvs. venetromboembose hos søskende eller forældre i en relativt ung alder).
English: [This section should replace any existing one and should read as follows:]
Danish: [De aktuelt godkendte indikationer slettes og erstattes med følgende:]
English: Duration of Use
Danish: Behandlingsvarighed
English: Your doctor will also tell you when you can start using <invented name> again after you are back on your feet.
Danish: Din læge vil også fortælle dig, hvornår du kan begynde at tage <produktnavn> igen, efter du ikke længere er sengeliggende.
English: Following a blood clot, recovery is not always complete.
Danish: Der opnås ikke altid fuldstændig helbredelse efter en blodprop.
English: <Invented name> is used to treat skin conditions such as acne, very oily skin and excessive hair growth in women of reproductive age.
Danish: <Produktnavn> anvendes til at behandle hudsygdomme som akne, meget fedtet hud og kraftig hårvækst hos frugtbare kvinder.
English: Other medical conditions, which have been associated with adverse circulatory events, include diabetes mellitus, systemic lupus erythematosus, hemolytic uraemic syndrome, chronic inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) and sickle cell disease.
Danish: Andre medicinske sygdomme, som er blevet forbundet med uønskede kredsløbshændelser, omfatter diabetes mellitus, systemisk lupus erythematosus, hæmolytisk uræmisk syndrom, kronisk inflammatorisk tarmsygdom (f.eks. Crohns sygdom eller ulcerativ kolitis) og seglcelleanæmi.
English: Your chances of having a blood clot are only increased slightly by taking <invented name> compared with women who do not take <invented name> or any contraceptive pill.
Danish: Din risiko for at få en blodprop er kun let øget, når du tager <produktnavn>, sammenlignet med kvinder, der ikke tager <produktnavn> eller p-piller.
English: Taking <invented name> may slightly increase your risk of having a blood clot (called a thrombosis).
Danish: Når du tager <produktnavn>, kan du få en let øget risiko for en blodprop (som kaldes trombose).
English: • Extremely rarely, thrombosis has been reported to occur in other blood vessels, e.g. hepatic, mesenteric, renal, cerebral or retinal veins and arteries, in hormonal contraceptive users.
Danish: • I ekstremt sjældne tilfælde er der rapporteret om trombose i andre blodkar, f.eks. hepatiske, mesenteriale, renale, cerebrale og retinale vener og arterier, hos brugere af hormonale kontraceptiva.
English: Women over 35 years of age should be strongly advised not to smoke if they wish to use <invented name>); - dyslipoproteinemia; - obesity (body mass index over 30 kg/m2);
Danish: Kvinder over 35 år bør på det kraftigste rådes til ikke at ryge, hvis de gerne vil bruge <produktnavnet>), - dyslipoproteinæmi, - overvægt (body mass index over 30 kg/m2), - hypertension,
English: Stop taking tablets and contact your doctor immediately if you notice possible signs of a blood clot.
Danish: Hold op med at tage tabletterne og kontakt straks en læge, hvis du bemærker symptomer, der kan være tegn på en blodprop.
English: Blood clots in an artery
Danish: Blodpropper i en arterie
English: For the treatment of acne, <invented name> should only be used after topical therapy or systemic antibiotic treatments have failed.
Danish: Til behandling af akne bør <produktnavn> først anvendes, når topikal behandling eller behandling med systemisk antibiotika har fejlet.
English: (e.g angina pectoris which cases severe pain in the chest) or ‘mini-stroke' (transient ischaemic attack)
Danish: (f.eks. angina pectoris, som forårsager svære smerter i brystet) eller et 'mini-slagtilfælde' (forbi gående iltmangel i hjerten)
English: The physician should then decide on whether the use of <invented name> should be discontinued.
Danish: Lægen skal så beslutte, om <produktnavn> skal seponeres.
English: - hypertension; - migraine; - valvular heart disease; - atrial fibrillation; - a positive family history (arterial thrombosis ever in a sibling or parent at a relatively early age).
Danish: - migræne, - hjerteklap-sygdom, - atrieflimmer, - en positiv familieanamnese (arteriel trombose hos søskende eller forældre i en relativt ung alder).
English: • Concomitant use with another hormonal contraceptive (see section 4.1)
Danish: • Samtidig anvendelse af andre hormonale kontraceptiva (se pkt.
English: Section 4.3 Contraindications [The following contraindications related to thromboembolism should be included in this section]
Danish: Kontraindikationer [Følgende relaterede kontraindikationer skal nævnes i dette punkt]
English: • if you have (or have ever had) a blood clot in your leg (thrombosis), lung (pulmonary embolism)
Danish: • hvis du har (eller tidligere har haft) en blodprop i benet (trombose), i lungerne (lungeemboli) eller i andre dele af din krop
English: [The following to be included below the table of adverse reactions]
Danish: [Følgende skal medtages i tabellen over bivirkninger]
English: Section 4.4 Special warnings and precautions for use [The wording below should be inserted in this section] <invented name> is composed of the progestogen cyproterone acetate and the oestrogen ethinylestradiol and is administered for 21 days of a monthly cycle.
Danish: <Produktnavn> indeholder progestogenet cyproteronacetat og østrogenet ethinylestradiol, og det administreres i 21 dage i en månedlig cyklus.
English: Section 4.8 - Undesirable effects [The wording below should be inserted in this section]
Danish: 4.8 Bivirkninger [Nedenstående formulering indsættes i dette punkt]
English: • Venous thrombosis present or in history (deep venous thrombosis, pulmonary embolism)
Danish: • Aktuel eller tidligere venetrombose (dyb venetrombose, lungeemboli)
English: • if you have (or have ever had) a migraine, with visual disturbances
Danish: • hvis du har (eller tidligere har haft) migræne med synsforstyrrelser
English: • Arterial thrombosis present or in history (e.g. myocardial infarction) or prodromal conditions (e.g. angina pectoris and transient ischaemic attack).
Danish: • Aktuel eller tidligere arteriel trombose (f.eks. myokardieinfarkt) eller prodromale sygdomme (f.eks. angina pectoris og transitorisk cerebral iskæmi).
English: Possible side effects [This wording should be added under ‘Rare side effects'] Venous blood clot.
Danish: [Denne formulering bør tilføjes under 'Sjældne bivirkninger']
English: This applies to the following conditions:
Danish: Dette gælder for føl gende sygdomme:
English: • Arterial thromboembolic disorders
Danish: • Arterielle tromboemboliske sygdomme
English: • if you have (or have ever had) a heart attack or stroke
Danish: • hvis du har (eller tidligere har haft) et hjerteanfald eller slagtilfælde
English: Blood clots in a vein
Danish: Blodpropper i en vene
English: • Venous thromboembolic disorders
Danish: • Venøse tromboemboliske sygdomme
English: Section 4.1 Therapeutic indications [The currently approved indications should be deleted and replaced by the following:] Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age.
Danish: Behandling af moderat til svær akne relateret til androgensensitivitet (med eller uden seborré) og/eller hirsutisme hos kvinder i den fertile alder.
English: Section 4.2 Posology and method of administration [The wording below should be inserted in this section]
Danish: Dosering og indgivelsesmåde [Nedenstående formulering indsættes i dette punkt]
English: Tell your doctor if any of the following conditions applies to you before starting to use <invented name>.
Danish: Fortæl det til lægen, før du begynder at tage <Produktnavn>, hvis noget af nedenstående gælder for dig.
English: Package Leaflet
Danish: INDLÆGSSEDDEL
English: • The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (see section 4.4) such as: o diabetes mellitus with vascular symptoms o severe hypertension o severe dyslipoproteinaemia
Danish: • Tilstedeværelsen af svær(e) eller multipel/multiple risikofaktor(er) for venøs eller arteriel trombose (se pkt.
English: [The following to be included in the table of adverse reactions] • Vascular Disorders Rare (≥ 1/10,000 to < 1/1000): Thromboembolism
Danish: • Vaskulære sygdomme Sjældne (≥ 1/10.000 til < 1/1.000): Tromboemboli [Følgende skal medtages i tabellen over bivirkninger] Følgende alvorlige bivirkninger er blevet rapporteret hos kvinder, der bruger <produktnavn> (se pkt.
English: In addition, one main study was carried out in around 1,200 patients with essential hypertension.
Danish: Desuden blev der foretaget en hovedundersøgelse, som omfattede ca. 1 200 patienter med essentiel hypertension.
English: The main measure of effectiveness was the average change in the blood pressure.
Danish: Det primære effektmål var den gennemsnitlige ændring i blodtrykket.
English: What is Rasival?
Danish: Hvad er Rasival?
English: The two active substances in Rasival are anti-hypertensive medicines that are already in use in the European Union (EU).
Danish: De to aktive stoffer i Rasival er antihypertensive lægemidler, som allerede anvendes i Den Europæiske Union (EU).
English: The effects of Rasival were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Rasival blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: It was to be available as film-coated tablets.
Danish: Det var meningen, at det skulle kunne fås som filmovertrukne tabletter.
English: The company presented results of studies designed to show that the tablet containing the two substances is absorbed in the body in the same way as the separate tablets.
Danish: Virksomheden fremlagde resultaterne af undersøgelser, der skulle vise, at tabletten indeholdende begge stoffer absorberes på samme måde i kroppen som de separate tabletter.
English: The CHMP wanted further studies to be carried out on how Rasival behaved in the body, specifically after a patient has eaten food.
Danish: CHMP ønskede, at der blev foretaget yderligere undersøgelser af, hvordan Rasival virkede i kroppen, navnlig efter at patienten havde indtaget et måltid.
English: What was Rasival expected to be used for?
Danish: Hvad forventedes Rasival anvendt til?
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Danish: Brevet fra virksomheden, hvori EMEA underrettes om tilbagetrækning af ansøgningen, kan ses under fanen "All documents".
English: In addition, the CHMP was not convinced that the company had demonstrated that the combination of aliskiren and valsartan is widely used in clinical practice.
Danish: Desuden var CHMP ikke overbevist om, at virksomheden havde påvist, at brugen af en kombination af aliskiren og valsartan er udbredt i klinisk praksis.
English: Aliskiren reduces the production of the angiotensin II (a hormone that narrows blood vessels), while valsartan blocks the receptors to which angiotensin II normally attaches.
Danish: Aliskiren mindsker produktionen af angiotensin II (et hormon, der forsnævrer blodkarrene), mens valsartan blokerer de receptorer, som angiotensin II normalt binder sig til.
English: How is Rasival expected to work?
Danish: Hvordan forventes Rasival at virke?
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Rasival could not have been approved for the treatment of essential hypertension.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Rasival ikke kunne være blevet godkendt til behandling af essentiel hypertension.
English: Patients received either Rasival or a medicine containing only one of the active substances, aliskiren or valsartan, for eight weeks.
Danish: Patienterne fik enten Rasival eller et lægemiddel, der kun indeholdt ét af de aktive stoffer (aliskiren eller valsartan) i otte uger.
English: Rasival is a medicine that contains the active substances aliskiren and valsartan.
Danish: Rasival er et lægemiddel, der indeholder de aktive stoffer aliskiren og valsartan.
English: On 15 September 2010, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Rasival, for the treatment of essential hypertension in adults whose blood pressure is already adequately controlled with a combination of aliskiren and valsartan taken separately.
Danish: Den 15. september 2010 meddelte Novartis Europharm Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Rasival til behandling af essentiel hypertension hos voksne, hvis blodtryk allerede kontrolleres tilstrækkeligt med en kombination af aliskiren og valsartan, der tages separat.
English: By blocking the activity of angiotensin II, Rasival acts to widen blood vessels and so lower blood pressure.
Danish: Ved at blokere angiotensin II-aktiviteten udvider Rasival blodkarrene og sænker dermed blodtrykket.
English: Rasival was expected to be used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of aliskiren and valsartan taken separately.
Danish: Rasival forventedes anvendt til behandling af essentiel hypertension (højt blodtryk) hos voksne, hvis blodtryk allerede kontrolleres tilstrækkeligt med en kombination af aliskiren og valsartan, der tages separat.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion the company had not provided enough scientific data to support the application for Rasival.
Danish: På tilbagetrækningstidspunktet var CHMP derfor af den opfattelse, at virksomheden ikke havde fremlagt tilstrækkelige videnskabelige data til støtte for ansøgningen om markedsføringstilladelse for Rasival.
English: The company informed the CHMP that there are no consequences for patients in clinical trials or compassionate use programmes, as there are no ongoing trials with Rasival.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ikke vil få nogen konsekvenser for patienter, som deltager i kliniske undersøgelser med Rasival, eftersom der ikke er nogen igangværende undersøgelser med Rasival.
English: The application was withdrawn at ‘day 180'.
Danish: Ansøgningsproceduren var ved dag 180, da virksomheden trak sin ansøgning tilbage.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Rasival eller i programmer for anvendelse af Rasival med særlig udleveringstilladelse?
English: Withdrawal of the marketing authorisation application for Rasival (aliskiren / valsartan) EMA/584655/2010
Danish: EMA/584655/2010
English: Daliresp will not help you in this situation.
Danish: Daliresp vil ikke hjælpe dig i den situation.
English: Daliresp has been studied in clinical trials for up to one year.
Danish: Daliresp er undersøgt i kliniske studier i op til et år.
English: Children and adolescents Daliresp should not be used by children and adolescents under 18 years of age.
Danish: Børn og teenagere Daliresp bør ikke bruges til børn og teenagere under 18 år.
English: It is important to continue taking Daliresp for as long as prescribed by your doctor, even when you have no symptoms, in order to maintain control of your lung function.
Danish: Det er vigtigt at fortsætte med at tage Daliresp så længe, som din læge har foreskrevet, selv når du ingen symptomer har, for at fastholde kontrollen over din lungefunktion.
English: If on one day you have forgotten to take a tablet of Daliresp, just carry on the next day with the next tablet as usual.
Danish: Hvis du en dag har glemt at tage en tablet Daliresp, fortsætter du bare den næste dag med den næste tablet som sædvanligt.
English: There is a lack of relevant experience with Daliresp under these conditions.
Danish: Der mangler relevante erfaringer med Dalirespbehandling under disse omstændigheder.
English: You should not become pregnant during treatment with this medicine and should use an effective method of contraception during therapy, because Daliresp may be harmful for the unborn baby.
Danish: Du bør ikke blive gravid under behandling med dette lægemiddel, og du skal benytte sikker prævention under behandlingen, da Daliresp kan være skadeligt for det ufødte barn.
English: There is no relevant use of Daliresp in the paediatric population (under 18 years) in the indication COPD.
Danish: Det er ikke relevant at anvende Daliresp i den pædiatriske population (under 18 år) til indikationen KOL.
English: Placebo (N=966)
Danish: Placebo (N=966) Rate (n)
English: You may need to take Daliresp for several weeks to achieve its beneficial effect.
Danish: Det kan være nødvendigt at tage Daliresp i flere uger, for at opnå den ønskede virkning.
English: (N=969)
Danish: (N=969) Rate (n)
English: The need to inform patients about the risks of Daliresp and the precautions for safe use including:
Danish: Nødvendigheden af, at informere patienter om risici ved Daliresp og forholdsregler for sikker brug inklusive:
English: The potential risk of infections: Dalirespshould not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
Danish: Den potentielle risiko for infektioner: Dalirespbehandling bør ikke påbegyndes eller skal stoppes hos patienter med svære akutte smitsomme sygdomme.
English: Thus Daliresp eases breathing problems.
Danish: Dermed vil Daliresp lette åndedrætsbesvær.
English: Daliresp may need to be taken for several weeks to achieve its effect (see section 5.1).
Danish: Daliresp skal muligvis tages i flere uger for at opnå effekt (se pkt.
English: The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Daliresp are provided with an updated Educational pack.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, der forventes at ordinere Daliresp, er forsynet med en opdateret uddannelsespakke.
English: The fact that Daliresp is not indicated for the treatment of COPD patients outside of the approved indication, nor for use in patients with asthma or alpha-1 antitrypsin deficiency.
Danish: Den omstændighed, at Daliresp hverken er indiceret til behandling af KOL-patienter uden for den godkendte indikation eller er til brug til patienter med astma eller alfa-1-antitrypsinmangel.
English: Before starting treatment with Daliresp, inform your doctor if you are suffering from any symptoms of this kind and of any additional medicines you may take since some of those could increase the probability of these side effects.
Danish: Før du begynder behandling med Daliresp, skal du fortælle din læge, hvis du allerede har sådanne symptomer, eller hvis du tager anden medicin, da noget af denne medicin måske kan øge risikoen for, at disse symptomer opstår.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Daliresp
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apoteket, før du tager Daliresp
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Daliresp kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daliresp and the potential risk of suicide.
Danish: Risikoen for psykiske forstyrrelser, såsom søvnløshed, angst eller depression hos patienter, der tager Daliresp og den potentielle risiko for selvmord.
English: • Copies of the patient card to be given to patients or caregivers before they receive Daliresp
Danish: • Kopier af patientkortet, der skal udleveres til patienter eller plejere ved udskrivning af Daliresp