FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zytiga have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Zytiga.
English: How does Zytiga work?
Danish: Hvordan virker Zytiga?
English: What benefits of Zytiga have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zytiga?
English: Patients treated with Zytiga lived for an average of around 16 months without their disease getting worse, compared with around 8 months in patients given placebo.
Danish: De patienter, som havde fået behandling med Zytiga, levede i gennemsnit ca. 16 måneder, uden at sygdommen forværredes, sammenlignet med ca. 8 måneder for de patienter, som havde fået placebo.
English: Patients treated with Zytiga lived for an average of 33 months without their disease getting worse, compared with around 15 months for patients given placebo.
Danish: De patienter, som havde fået behandling med Zytiga, levede i gennemsnit ca. 33 måneder, uden at sygdommen forværredes, sammenlignet med ca. 15 måneder for de patienter, som havde fået placebo.
English: The active substance in Zytiga, abiraterone acetate, is changed in the body to abiraterone which stops the body producing testosterone, a male hormone.
Danish: Det aktive stof i Zytiga, abirateronacetat, omdannes til abirateron i kroppen.
English: • when the cancer is newly diagnosed, high risk and still sensitive to hormones; Zytiga is then used in combination with a treatment called androgen deprivation therapy;
Danish: Zytiga anvendes da i kombination med en behandling kaldet androgen deprivationsbehandling
English: Frequency ‘Not known': Kounis syndrome
Danish: Hyppighed "Ikke kendt": Kounis syndrom
English: Adopted at the 28-31 October 2019 PRAC
Danish: Vedtaget på PRAC's møde 28.-31. oktober 2019
English: Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes.
Danish: Der er også rapporteret overfølsomhedsreaktioner efter tidligere uproblematiske doser af parenterale jernkomplekser.
English: Iron sucrose; iron carboxymaltose; iron isomaltoside; iron dextran; sodium ferric gluconate - Arteriospasm coronary (EPITT no 19408)
Danish: Jernsaccharose; jerncarboxymaltose; jernisomaltosid; jerndextran; natriumferrigluconat - koronararteriespasme (EPITT nr. 19408)
English: There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see section 4.8).
Danish: Der har været rapporter om overfølsomhedsreaktioner, som progredierede til Kounis syndrom (akut allergisk koronararteriespasme, der kan resultere i myokardieinfarkt; se pkt.
English: Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions.
Danish: Parenteralt administrerede jernpræparater kan forårsage overfølsomhedsreaktioner, herunder alvorlige og potentielt dødelige anafylaktiske/anafylaktoide reaktioner.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/580133/2019
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger vedrørende signaler EMA/PRAC/601870/2019
English: Tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a serious allergic reaction ………….
Danish: Fortæl det straks til lægen, hvis du oplever et eller flere af følgende symptomer, som kan være tegn på en alvorlig allergisk reaktion ... Og brystsmerter, der kan være tegn på en potentielt alvorlig allergisk reaktion, der kaldes Kounis syndrom.
English: The procedure started on 24 May 2007.
Danish: Proceduren indledtes den 24. maj 2007.
English: A Decision was issued by the European Commission on 28 November 2008.
Danish: Europa-Kommissionen traf en afgørelse den 28. november 2008.
English: London, 02 December 2008 Doc.
Danish: London, den 2. december 2008 Dok.
English: The Marketing Authorisation Holder provided supplementary information on 26 September 2007.
Danish: Indehaveren af markedsføringstilladelsen fremsendte yderligere oplysninger den 26. september 2007.
English: Efexor, 25 mg, 37.5 mg, 50 mg, 75 mg, tablets, is an antidepressant indicated for the treatment of major depressive episodes and for the prevention of recurrence of major depressive episodes.
Danish: Efexor, 25 mg, 37,5 mg, 50 mg, 75 mg, tabletter, er et antidepressivt lægemiddel til behandling af svære depressive episoder og forebyggelse af recidiverende svære depressive episoder.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Efexor and associated names International Non-Proprietary Name (INN): venlafaxine
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 30 OM Efexor og tilknyttede navne Internationalt fællesnavn (INN): venlafaxin
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Efexor approved across EU Member States, with respect to the treatment of major depressive episodes and for the prevention of recurrence of major depressive episodes.
Danish: Grundlaget for indbringelsen af sagen var, at der var afvigelser mellem de produktresuméer, der var godkendt for Efexor i EU-medlemsstaterne, med hensyn til behandling af svære depressive episoder og forebyggelse af recidiverende svære depressive episoder.
English: During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Danish: På sit møde i juli 2008 var CHMP på baggrund af alle de foreliggende oplysninger og de faglige drøftelser i udvalget af den opfattelse, at forslaget om harmonisering af produktresumé, etikettering og indlægsseddel var acceptabelt, og at ændringerne burde foretages.
English: This medicinal product belongs to the 2007 list of products identified for SPC harmonisation.
Danish: Dette lægemiddel er opført på 2007-listen over lægemidler, for hvilke produktresuméet skal harmoniseres.
English: On 3 May 2007, the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Efexor.
Danish: Den 3. maj 2007 indbragte Kommissionen en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer, med henblik på harmonisering af de nationalt godkendte produktresuméer, etikettering og indlægsseddel for lægemidlet Efexor.
English: The CHMP gave a positive opinion on 24 July 2008 with a subsequent revision on 25 September 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Efexor.
Danish: CHMP afgav en positiv udtalelse den 24. juli 2008 efterfulgt af en revideret udtalelse den 25. september 2008, hvori udvalget anbefalede harmonisering af produktresumé, etikettering og indlægsseddel for Efexor Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II og det ændrede produktresumé og den ændrede etikettering og indlægsseddel i bilag III.
English: Take your next dose at the right time.
Danish: Tag din næste dosis på det rigtige tidspunkt.
English: • A need to pass water frequently
Danish: • Behov for ofte at lade vandet
English: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, United Kingdom: Plendil
Danish: Belgien, Bulgarien, Cypern, Danmark, Estland, Finland, Grækenland, Holland, Irland, Island, Italien, Kroatien, Letland, Litauen, Luxembourg, Malta, Norge, Polen, Portugal, Rumænien, Slovakiet, Spanien, Storbritannien, Sverige, Den Tjekkiske republik, Ungarn, Østrig: Plendil
English: The following definitions of frequencies are used:
Danish: Følgende definitioner af hyppigheder anvendes:
English: The dose should be adjusted individually.
Danish: Dosis bør justeres individuelt.
English: {Name and Address} {tel} {fax} {e-mail}
Danish: {Navn og adresse} {tlf.} {fax} {e-mail}
English: Plendil with food and drink
Danish: Brug af Plendil sammen med mad og drikke
English: Therefore, it is very important that you take the number of doses prescribed by your doctor.
Danish: Derfor er det meget vigtigt, at du tager den dosis, som din læge har ordineret.
English: Volume of distribution at steady state is 10 L/kg.
Danish: Fordelingsvolumen ved steady state er 10 l/kg.
English: Your doctor will advise you how long to take your medicine.
Danish: Din læge kan fortælle dig, hvor længe du skal tage din medicin.
English: If you stop taking this medicine your condition may return.
Danish: Hvis du holder op med at tage dette lægemiddel, kan din sygdom vende tilbage.
English: Additional interactions
Danish: Yderligere interaktioner
English: Felodipine should not be given during pregnancy.
Danish: Felodipin bør ikke gives under graviditet.
English: • Skin reactions due to increased sensitivity to sunlight
Danish: • Hudreaktioner på grund af øget følsomhed for sollys
English: Caution is recommended especially at the start of treatment.
Danish: Forsigtighed anbefales, især i begyndelsen af behandlingen.
English: If severe hypotension occurs, symptomatic treatment should be instituted.
Danish: Hvis der opstår alvorlig hypotension, bør symptomatisk behandling indledes.
English: The long-term effects of felodipine on growth, puberty and general development have not been studied.
Danish: Langtidseffekten af felodipin på vækst, pubertet og generel udvikling er ikke blevet undersøgt.
English: Do not drink grapefruit juice if you are treated with Plendil, as this may increase the effect of Plendil and the risk of side effects.
Danish: Du må ikke drikke grapefrugtjuice, hvis du får Plendil, da det kan forstærke Plendils virkning og øge risikoen for bivirkninger.
English: Talk to your doctor before taking Plendil, especially if you have problems with your liver.
Danish: Tal med lægen, inden du tager Plendil, især hvis du har problemer med leveren.
English: Plendil is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.
Danish: Plendil anbefales ikke til mødre, som ammer, og din læge kan vælge en anden behandling til dig, hvis du ønsker at amme.
English: These effects are dose-dependent.
Danish: Disse virkninger er dosisafhængige.
English: Your doctor may lower the dose.
Danish: Lægen kan nedsætte dosis.
English: It does not negatively affect the heart function.
Danish: Det har ingen negativ virkning på hjertet.
English: If you have liver problems The level of felodipine in your blood may be increased.
Danish: Hvis du har leverproblemer Niveauet af felodipin i dit blod kan være øget.
English: If necessary, your doctor may increase the dose or add another blood-pressure lowering medicine.
Danish: Om nødvendigt kan din læge øge dosis eller tillægge et andet blodtrykssænkende lægemiddel.
English: The half-life of felodipine in the elimination phase is approximately 25 hours and steady state is reached after 5 days.
Danish: Felodipins halveringstid i eliminationsfasen er ca. 25 timer, og steady state nås efter 5 dage.
English: The study showed benefits of lowering SBP and DBP down to 139 and 83 mmHg, respectively.
Danish: Studiet viste fordele ved at sænke SBP og DBP til henholdsvis 139 og 83 mmHg.
English: You should tell your doctor as soon as possible if you become pregnant while using this medicine.
Danish: Du skal straks fortælle det til lægen, hvis du bliver gravid, mens du tager denne medicin.
English: Felodipine tablets should not be taken together with grapefruit juice.
Danish: Felodipintabletter bør ikke tages sammen med grapefrugtjuice.
English: If you forget to take a tablet, leave out that dose completely.
Danish: Hvis du glemmer at tage en tablet, skal du springe den dosis helt over.
English: Sympathomimetic medicinal products with predominant effect on the α1-adrenoceptor may be given if the above-mentioned measures are insufficient.
Danish: Der kan gives sympatomimetika med overvejende effekt på α1-receptoren, hvis ovennævnte foranstaltninger ikke er tilstrækkelige.
English: Therefore such combinations should be avoided.
Danish: Derfor skal sådanne kombinationer undgås (se pkt.
English: Please consult your doctor and seek advice before you stop taking Plendil.
Danish: Kontakt lægen og få rådgivning, inden du holder op med at tage Plendil.
English: Felodipine has been detected in breast milk, and due to insufficient data on potential effect on the infant, treatment is not recommended during breastfeeding.
Danish: Felodipin er blevet påvist i mælk, og på grund af utilstrækkelige data om den potentielle virkning på spædbørn anbefales behandlingen ikke under amning.
English: The plasma protein binding of felodipine is approximately 99%.
Danish: Plasmaproteinbindingen af felodipin er ca. 99 %.
English: Do not use this medicine if you notice the packaging is torn or damaged.
Danish: Brug ikke lægemidlet, hvis du bemærker, at pakningen er beskadiget.
English: The anomalies in the foetuses were induced when felodipine was administered during early foetal development (before day 15 of pregnancy).
Danish: Anomalierne hos fostrene blev fremkaldt, når felodipin blev administreret under den tidlige føtale udvikling (før dag 15 i drægtighedsperioden).
English: Plendil can have minor or moderate influence on your ability to drive and use machines.
Danish: Plendil kan have mindre eller moderat indflydelse på din evne til at køre bil og betjene maskiner.
English: The tablets should be taken in the morning and be swallowed with water.
Danish: Tabletterne skal tages om morgenen og synkes med vand.
English: Very common ≥ 1/10
Danish: Meget almindelig ≥ 1/10
English: (see section 4.5).
Danish: (angivet i punkt 6).
English: • Hypersensitivity reactions such as fever or swelling of the lips and tongue
Danish: • Overfølsomhedsreaktioner såsom feber eller hævelse af læber og tunge
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Danish: Produktresumé, etikettering og indlægsseddel er resultatet af indbringelse (referral) som denne kommissionbeslutning vedrører.
English: If necessary another antihypertensive agent may be added.
Danish: Om nødvendigt kan der tillægges et andet antihypertensivum.
English: A total of 18,790 hypertensive patients (DBP 100-115 mmHg), aged 50-80 years were followed for a mean period of 3.8 years (range 3.3-4.9).
Danish: I alt 18.790 hypertensive patienter (DBP 100-115 mmHg) i alderen 50-80 år blev fulgt i gennemsnitligt 3,8 år (interval 3,3-4,9).
English: if you have chest pain of recent onset, or angina pectoris that is lasting for more than 15 minutes or longer or is more severe than usual.
Danish: - hvis du har smerter i brystet, som er begyndt for nylig, eller hvis du har angina pectoris, som varer længere end 15 minutter eller mere, eller hvis anfaldet er voldsommere end normalt.
English: Gingival hyperplasia, gingivitis
Danish: Gingival hyperplasi, gingivitis
English: About 70% of a given dose is excreted as metabolites in the urine; the remaining fraction is excreted in the faeces.
Danish: Ca. 70 % af en given dosis udskilles som metabolitter i urinen; den resterende fraktion udskilles i fæces.
English: Elderly patients and patients with reduced liver function have on average higher plasma concentrations of felodipine than younger patients.
Danish: Ældre patienter og patienter med nedsat leverfunktion har gennemsnitligt en højere plasmakoncentration af felodipin end yngre patienter.
English: • Too low blood pressure (hypotension)
Danish: For lavt blodtryk (hypotension) Kvalme
English: The patient should be placed supine with the legs elevated.
Danish: Patienten anbringes i rygleje med benene hævet.
English: Overdosage may cause excessive peripheral vasodilatation with marked hypotension and sometimes bradycardia.
Danish: Overdosering kan medføre voldsom perifer vasodilatation med markant hypotension og i nogle tilfælde bradykardi.
English: It lowers blood pressure by dilating small blood vessels.
Danish: Det sænker blodtrykket ved at udvide små blodkar.
English: The efficacy and safety of felodipine in the treatment of hypertensive emergencies has not been studied.
Danish: Felodipins virkning og sikkerhed ved behandling af hypertensive nødsituationer er ikke undersøgt.
English: Children The use of Plendil is not recommended in children.
Danish: Børn Plendil anbefales ikke til børn.
English: The relevance of these findings for patients receiving felopidine is unknown.
Danish: Relevansen af disse fund for patienter, der får felodipin, er ukendt.
English: The rate but not the extent of absorption of felodipine is increased when taken simultaneously with food with a high fat content.
Danish: Absorptionshastigheden, men ikke absorptionsfraktionen, af felodipin øges, når det tages samtidig med fødevarer med et højt fedtindhold.
English: Management If justified: activated charcoal, gastric lavage if performed within one hour after ingestion.
Danish: Behandling Hvis det er begrundet: aktivt kul, maveskylning, hvis dette udføres inden for én time efter indtagelse.
English: DATE OF REVISION OF THE TEXT <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}> [To be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN <MM/ÅÅÅÅ> <{DD/MM/ÅÅÅÅ}> <{DD måned ÅÅÅÅ}> [Udfyldes nationalt]
English: There is no risk of accumulation during long-term treatment.
Danish: Der er ingen risiko for akkumulering ved langvarig behandling.
English: Antihypertensive treatment with felodipine is associated with significant regression of pre-existing left ventricular hypertrophy.
Danish: Antihypertensiv behandling med felodipin er forbundet med signifikant regression af allerede eksisterende venstre ventrikel-hypertrofi.
English: There are no data on the effects of felodipine on patient fertility.
Danish: Der foreligger ingen data om felodipins påvirkning af patientens fertilitet.
English: Germany: Modip Italy: Feloday, Prevex Portugal: Preslow Sweden: Felodipin AstraZeneca
Danish: Frankrig: Flodil Italien: Feloday, Prevex Portugal: Preslow Sverige: Felodipin AstraZeneca Tyskland: Modip
English: Plendil contains lactose that is a type of sugar.
Danish: Plendil indeholder lactose, der er en sukkerart.
English: This belongs to a group of medicinces called calcium antagonists.
Danish: Det tilhører en lægemiddelgruppe kaldet calciumantagonister.
English: if you have acute myocardial infarction (heart attack).
Danish: - hvis du har akut myokardieinfarkt (hjerteanfald).
English: Medicines containing St John's wort (Hypericum perforatum) (herbal product used to treat depression) may reduce the effect of Plendil and should therefore be avoided.
Danish: Medicin, der indeholder perikon (Hypericum perforatum) (naturlægemiddel til behandling af depression) kan nedsætte virkningen af Plendil og bør derfor undgås.
English: There is no significant accumulation during long-term treatment.
Danish: Der er ingen akkumulering af betydning under langtidsbehandling.
English: Felodipine may also improve early renal graft function.
Danish: Felodipin kan også forbedre tidlig nyretransplantatfunktion.
English: Symptoms of excessive low blood pressure and inadequate blood supply to the heart itself, frequently include dizziness and chest pain.
Danish: Symptomer på meget lavt blodtryk og utilstrækkelig blodtilførsel til selve hjertet omfatter ofte svimmelhed og smerter i brystet.
English: When used together, the tacrolimus serum concentration should be followed and the tacrolimus dose may need to be adjusted.
Danish: Ved samtidig administration bør serumkoncentrationen af tacrolimus følges, og det kan være nødvendigt at justere tacrolimusdosis.
English: Maximum blood plasma levels (tmax) are achieved with the prolonged-release form after 3 to 5 hours.
Danish: Det maksimale plasmaniveau (tmax) nås efter 3 til 5 timer med depotformuleringen.
English: Do not take Plendil if you are pregnant.
Danish: Tag ikke Plendil - hvis du er gravid.
English: This leaflet was last revised in {MM/YYYY} {month YYYY}
Danish: Denne indlægsseddel blev senest revideret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}.>
English: Most of these reactions appear at start of treatment or after a dose increase.
Danish: De fleste af disse reaktioner ses i starten af behandlingen eller efter, dosis er sat op.
English: In case of accompanying bradycardia, atropine 0.5-1 mg should be administered intravenously.
Danish: Ved samtidig bradykardi gives atropin 0,5-1 mg intravenøst.
English: Should such adverse reactions occur, they are usually transient and diminish with time.
Danish: Skulle sådanne bivirkninger opstå, er de sædvanligvis forbigående og aftager med tiden.
English: Felodipine is a high clearance medicinal product with an average blood clearance of 1200 ml/min.
Danish: Felodipin er et høj-clearance lægemiddel med en gennemsnitlig blod-clearance på 1.200 ml/minut.
English: This results from precapillary vasodilatation and is not related to any generalised fluid retention.
Danish: Det skyldes prækapillær vasodilatation og har ingen sammenhæng med generel væskeretention.
English: Less than 0.5% of a dose is recovered unchanged in urine.
Danish: Under 0,5 % af en dosis genfindes uomdannet i urinen.
English: The systemic availability of felodipine is approximately 15% and is independent of dose in the therapeutic dose range.
Danish: Felodipins systemiske tilgængelighed er ca. 15 % og uafhængig af dosis inden for det terapeutiske dosisinterval.
English: If any of the following happen to you, stop taking Plendil and tell a doctor straight away:
Danish: Hvis noget af følgende sker for dig, skal du stoppe med at tage Plendil og straks kontakte lægen:
English: Do not use this medicine after the expiry date which is stated on the carton, blister and bottle after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken, blisterpakningen og flasken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Reproduction studies in rabbits have shown a dose-related reversible enlargement of the mammary glands of the parent animals and dose-related digital anomalies in the foetuse.
Danish: Reproduktionsstudier med kaniner har vist en dosisrelateret reversibel forstørrelse af mammakirtlerne hos forældrene og dosisrelaterede digitale anomalier hos fostrene.
English: Renal effects
Danish: Renale virkninger
English: The adverse reactions listed below have been identified from clinical trials and from post marketing surveillance.
Danish: Bivirkningerne nedenfor er identificeret fra kliniske studier og fra erfaring efter markedsføring.
English: If you stop taking Plendil
Danish: Hvis du holder op med at tage Plendil
English: If you take more than the recommended number of doses of Plendil, you may suffer from very low blood pressure and sometimes palpitations, high or, rarely, slow heart rate.
Danish: Hvis du tager flere end det anbefalede antal Plendil-tabletter, kan du få meget lavt blodtryk og sommetider hjertebanken, høj puls eller i sjældne tilfælde langsom puls.
English: Impotence/sexual dysfunction
Danish: Impotens/seksuel dysfunktion
English: Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000
Danish: Ikke almindelig ≥ 1/1.000 til < 1/100 Sjælden ≥ 1/10.000 til < 1/1.000
English: Enzyme interactions
Danish: Enzyminteraktioner
English: Pharmacotherapeutic group: calcium channel blockers, dihydropyridine derivatives; ATC code: C08CA02
Danish: Farmakoterapeutisk klassifikation: calciumantagonister, dihydropyridinderivater, ATC-kode: C08CA02