FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding safety, the side effects associated with Ofev were considered manageable with dose interruptions or reductions.
Danish: Hvad sikkerheden angår, blev bivirkningerne ved Ofev anset for at kunne håndteres ved at afbryde behandlingen eller nedsætte dosis.
English: FVC is the maximum amount of air the patient can breathe out forcefully after taking in a deep breath and this decreases as the condition gets worse.
Danish: FVC er den maksimale mængde luft, patienten kan puste ud efter at have taget en dyb indånding.
English: For more information about treatment with Ofev, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ofev, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The most common side effects with Ofev (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), abdominal pain (stomach ache) and raised levels of liver enzymes in the blood (a sign of liver problems); vomiting, decreased appetite and weight loss are also common.
Danish: De hyppigste bivirkninger ved Ofev (som optræder hos mere end 1 ud af 10 patienter) er diarré, kvalme, mavesmerter og tegn på leverproblemer (forhøjede leverenzymer i blodet).
English: Ofev is a medicine used to treat adults with idiopathic pulmonary fibrosis (IPF).
Danish: Ofev er et lægemiddel til behandling af idiopatisk lungefibrose (IPF) hos voksne.
English: The active substance in Ofev, nintedanib, blocks the activity of some enzymes known as tyrosine kinases.
Danish: Det aktive stof i Ofev, nintedanib, blokerer visse enzymer af typen tyrosinkinase.
English: IPF is a long-term disease in which hard fibrous tissue continuously forms in the lungs, causing persistent cough and severe shortness of breath.
Danish: IPF er en langvarig sygdom, hvor der til stadighed dannes hårdt, fiberholdigt væv i lungerne.
English: In the first study, the average decrease in FVC over 1 year was 115 ml in patients taking Ofev compared with a decrease of 240 ml in patients taking placebo.
Danish: I den første undersøgelse faldt FVC i løbet af 1 år gennemsnitligt med 115 ml hos de patienter, der fik Ofev, sammenholdt med et fald på 240 ml hos dem, der fik placebo.
English: For the full list of all side effects reported with Ofev, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Ofev fremgår af indlægssedlen.
English: For practical information about using Ofev, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ofev, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Ofev have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ofev?
English: In both studies, patients taking Ofev had a smaller decline in FVC than patients taking placebo, meaning that Ofev slowed down the worsening of the condition.
Danish: I begge undersøgelser aftog FVC mindre hos de patienter, der fik Ofev, end hos dem, der fik placebo.
English: How does Ofev work?
Danish: Hvordan virker Ofev?
English: How is Ofev used?
Danish: Hvordan anvendes Ofev?
English: A further analysis of the results of the 2 main studies, which took into account that some patients stopped treatment, confirmed the benefits of Ofev over placebo, although the difference in FVC between the two was less pronounced.
Danish: Dette bekræftede fordelene ved Ofev i forhold til placebo, dog var forskellen i FVC mindre udtalt.
English: a recent serious injury.
Danish: en nylig alvorlig kvæstelse.
English: 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: See section 4. .
Danish: Se afsnit 4.
English: • Adults and elderly population
Danish: • Voksne og ældre personer
English: Do not use this medicine if you notice any visible signs of deterioration
Danish: Brug ikke lægemidlet, hvis du bemærker synlige tegn på nedbrydning
English: You should specifically tell your doctor if you take
Danish: Du skal fortælle lægen, hvis du tager
English: The tablets have a length of 14.0 mm and a width of 6.8 mm.
Danish: Tabletterne har en længde på 14,0 mm og en bredde på 6,8 mm.
English: Caution required due to ASA
Danish: Forsigtighed er påkrævet på grund af ASA
English: Pliva Croatia Ltd Prilaz baruna Filipovica 25 10 000 Zagreb Croatia
Danish: Pliva Croatia Ltd Prilaz baruna Filipovica 25 10 000 Zagreb Kroatien
English: It is preferable not to take this product during first and second trimesters of pregnancy.
Danish: Det er bedst ikke at tage dette produkt under graviditetens første og andet trimester.
English: Moreover, the safety profile of clopidogrel in this subgroup of patients did not raise any particular concern.
Danish: Derudover gav sikkerhedsprofilen for clopidogrel hos denne patientundergruppe ikke anledning til særlig betænkelighed.
English: Hearing loss* or tinnitus*
Danish: Nedsat hørelse* eller tinnitus*
English: Interactions with the following medicinal products have been reported with ASA:
Danish: Der er rapporteret interaktioner med følgende lægemidler og ASA:
English: In any case, you should take it for as long as your doctor continues to prescribe it.
Danish: Under alle omstændigheder skal du fortsætte med at tage det, så længe din læge udskriver det til dig.
English: Although no formal carcinogenicity studies have been performed with ASA, it has been shown that it is not a tumour promoter.
Danish: Selvom der ikke er udført formelle karcinogenicitetsstudier med ASA, er det blevet vist, at det ikke er en tumor-promoter.
English: 74770 Opava-Komarov Czech Republic
Danish: 305 74770 Opava-Komarov Tjekkiet
English: If you have been told by your doctor to stop treatment temporarily, ask your doctor when to restart the treatment.
Danish: Hvis din læge har bedt dig om at stoppe behandlingen midlertidigt, skal du spørge lægen, hvornår behandlingen skal genoptages.
English: Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres i henhold til følgende konvention: almindelig (≤ 1/100 til < 1/10), ikke almindelig (≤ 1/1.000 til < 1/100), sjælden (≤ 1/10.000 til < 1/1.000), meget sjælden < 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: You should not breast-feed while using this medicine.
Danish: Du må ikke amme, mens du bruger dette lægemiddel.
English: None of these analyses were adequately sized to detect differences in outcome in poor metabolisers.
Danish: Ingen af disse analyser var tilstrækkeligt store til at kunne detektere forskelle i outcome hos personer med ringe metabolisme.
English: • sudden life-threatening allergic reactions
Danish: • pludselige, livstruende, allergiske reaktioner
English: ASA is poorly bound to plasma proteins and its apparent volume of distribution is low (10 l).
Danish: ASA bindes dårligt til plasmaproteiner, og dets tilsyneladende fordelingsvolumen er lavt (10 l).
English: Side effects with unknown frequency (frequency cannot be estimated from the available data):
Danish: Bivirkninger med ikke kendt hyppighed (hyppigheden kan ikke estimeres ud fra forhåndenværende data)
English: Cross-reactions among thienopyridines
Danish: Krydsreaktioner blandt thienopyridiner
English: • worsening of food allergies.
Danish: • forværring af madallergi.
English: It is unknown whether ASA alters fertility.
Danish: Det er ukendt, hvorvidt ASA påvirker fertiliteten.
English: • breathing difficulties sometimes associated with cough
Danish: • åndedrætsbesvær ind imellem ledsaget af hoste
English: a planned surgery (including dental) in the next seven days.
Danish: et planlagt kirurgisk indgreb (gælder også tandoperationer) inden for de næste 7 dage.
English: The marketing authorisation holder shall submit PSURs for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel
English: TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Danish: TTP er en potentielt letal tilstand, der kræver øjeblikkelig behandling inklusive plasmaferese.
English: Acetylsalicylic Acid: Single-dose studies have shown that the oral toxicity of ASA is low.
Danish: Acetylsalicylsyre: Enkeltdosisstudier har vist, at den orale toksicitet af ASA er lav.
English: These may be due to rare decrease of some blood
Danish: Dette kan ske på grund af et sjældent fald i visseblodlegemer.
English: A patient with poor metaboliser status will possess two loss-of-function alleles as defined above.
Danish: En patient med status som poor metabolisers vil besidde to ikke-funktionelle alleler, som beskrevet ovenfor.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår graviditet, embryonal/føtal udvikling, fødsel eller postnatal udvikling (se pkt.
English: Reproduction toxicity data show that ASA is teratogenic in several laboratory animals.
Danish: Studier af reproduktionstoksicitet viser, at ASA er teratogent i adskillige forsøgsdyr.
English: Bleeding is the most common reaction reported both in clinical studies as well as in the post-marketing experience where it was mostly reported during the first month of treatment.
Danish: Blødning er den hyppigst indrapporterede bivirkning fra både kliniske studier såvel som fra postmarketing-erfaring, hvor den mestendels blev indrapporteret i løbet af behandlingens første måned.
English: From the beginning of the sixth month of pregnancy, all prostaglandin synthesis inhibitors may expose:
Danish: Fra begyndelsen af sjette måned af graviditeten kan alle prostaglandinsyntesehæmmere:
English: - In patients with ST segment elevation acute myocardial infarction: Therapy should be started as early as possible after symptoms start and continued for at least four weeks.
Danish: - Hos patienter med akut myokardieinfarkt med elevation af ST-segmentet: Behandling bør startes så tidligt som muligt, efter symptomerne viser sig, og fortsættes i mindst 4 uger.
English: Repeat-dose toxicity studies have shown that levels up to 200 mg/kg/day are well tolerated in rats; dogs appear to be more sensitive, probably due to the high sensitivity of canines to the ulcerogenic effects of NSAIDs.
Danish: Studier af toksicitet ved gentagne doser har vist, at niveauer op til 200 mg/kg/dag er veltolererede i rotter; hunde er tilsyneladende mere sensitive, sandsynligvis grundet hundes høje følsomhed for ulcerogene effekter af NSAID'er.
English: Clopidogrel: Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications.
Danish: Clopidogrel: Overdosering efter administration af clopidogrel kan medføre forlænget blødningstid og efterfølgende blødningskomplikationer.
English: Aluminium + Dessicant - Aluminium blisters.
Danish: Aluminium + tørremiddel - aluminiumblisters.
English: If acetylsalicylic acid is used by a woman attempting to conceive, or until the 24th amenorrhea week (5th month of pregnancy), the dose should be kept as low and duration of treatment as short as possible.
Danish: Hvis acetylsalicylsyre anvendes af en kvinde der forsøger at blive gravid, eller indtil den 24. uge med amenorré (graviditetens 5. måned), bør dosis holdes så lav som muligt, og behandlingsvarigheden så kort som muligt.
English: Caution is required because ASA may inhibit the effect of uricosuric agents through competitive elimination of uric acid.
Danish: Der bør udvises forsigtighed, da ASA kan hæmme effekten af urikosurika via kompetitiv elimination af urinsyre.
English: • blisters of the skin
Danish: • blister på huden
English: Clopidogrel has been tested in a range of in vitro and in vivo genotoxicity studies, and showed no genotoxic activity.
Danish: Clopidogrel er testet in vitro og in vivo i en række genotoksicitetsstudier og udviste ingen genotoksisk aktivitet.
English: Uricosurics (benzbromarone, probenecid, sulfinpyrazone)
Danish: Urikosurika (benzbromaron, probenecid, sulfinpyrazon)
English: • generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting)
Danish: • generelle allergiske reaktioner (f.eks. varmefølelse over hele kroppen med pludselig almen utilpashed og eventuelt besvimelse)
English: Its metabolite, salicylic acid, is highly bound to plasma proteins, but its binding is concentration dependent (nonlinear).
Danish: Dets metabolit, salicylsyre, bindes i høj grad til plasmaproteiner, men dets binding er koncentrationsafhængig (nonlineær).
English: Colitis (including ulcerative or lymphocytic colitis)
Danish: Colitis (inklusive colitis ulcerosa og lymfocytisk colitis)
English: An appropriate dose regimen for this patient population has not been established in clinical outcome trials.
Danish: Der er ikke etableret et passende dosisregime for denne patientpopulation i kliniske outcome-studier.
English: At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%.
Danish: Ved steady-state var den gennemsnitlige hæmningsgrad, der blev iagttaget ved en dosis på 75 mg/dag, mellem 40 % og 60 %.
English: Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (see section 5.1).
Danish: Kliniske studiedata understøtter anvendelse i op til 12 måneder, og det største udbytte blev set efter 3 måneder (se pkt.
English: The binding is non-saturable in vitro over a wide concentration range.
Danish: Bindingen er umættet in vitro over et bredtkoncentrationsområde.
English: No genotoxicity or clastogenicity issues of concern have been found with ASA.
Danish: Der er ikke fundet problemer med genotoksicitet eller klastogenicitet med ASA.
English: In cases of confirmed isolated activated Partial Thromboplastin Time (aPTT) prolongation with or without bleeding, acquired haemophilia should be considered.
Danish: I tilfælde af bekræftet isoleret forlængelse af aktiveret partiel tromboplastintid (aPTT) med eller uden blødning bør erhvervet hæmofiliovervejes.
English: When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
Danish: Når personer med ringe metabolisme modtog 600 mg/150 mg regimet, var eksponeringen for den aktive metabolit større end for 300 mg/75 mg regimet.
English: Patients should also be told that it might take longer than usual to stop bleeding when they take the combination of clopidogrel/acetylsalicylic acid, and that they should report any unusual bleeding (site or duration) to their physician.
Danish: Patienter bør også informeres om, at det kan tage længere tid end normalt at standse blødninger, når de tager kombinationen clopidogrel/acetylsalicylsyre, samt at de bør kontakte deres læge ved enhver usædvanlig blødning (sted eller varighed).
English: - For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose.
Danish: - Efter mere end 12 timer: Patienten bør tage den næste dosis som planlagt og bør ikke tage dobbelt dosis.
English: The combination of clopidogrel/acetylsalicylic acid should not be used during the first two trimesters of pregnancy unless the clinical condition of the woman requires treatment with clopidogrel/ASA.
Danish: Kombinationen clopidogrel/acetylsalicylsyre bør ikke anvendes i graviditetens første to trimestre, medmindre den kliniske situation for kvinden kræver behandling med clopidogrel/ASA.
English: a recent surgery (including dental).
Danish: et nyligt kirurgisk indgreb (gælder også tandoperationer).
English: The recommended dose is one tablet of Clopidogrel/Acetylsalicylic acid Teva per day, to be taken orally with a glass of water, with or without food.
Danish: Den anbefalede dosis er 1 tablet Clopidogrel/Acetylsalicylsyre Teva daglig, som indtages gennem munden med et glas vand, sammen med eller uden mad.
English: Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Danish: Efter en oral dosis af 14C-mærket clopidogrel hos mennesker blev ca. 50 % udskilt i urinen og ca. 46 % i fæces i løbet af 120 timer efter dosering.
English: Patients who have had developed a previous allergic reaction and/or haematological reaction to one thienopyridine may have an increased risk of developing the same or another reaction to another thienopyridine.
Danish: Patienter, der tidligere har udviklet en allergisk reaktion og/eller en hæmatologisk reaktion over for thienopyridin, kan have en øget risiko for at udvikle den sammen eller en anden reaktion over for andre thienopyridiner.
English: Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised.
Danish: Der rådes til at monitorere for tegn på overfølsomhed hos patienter med en kendt allergi over for thienopyridin.
English: In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
Danish: I CURE, CLARITY, ACTIVE-A og et af kohortestudierne (Trenk) blev der ikke observeret nogen øget forekomst af hændelser, baseret på metabolisk status.
English: • decrease in blood pressure
Danish: • blodtryksfald
English: • If you are in your last trimester of pregnancy
Danish: • hvis du er gravid i tredje trimester.
English: After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Danish: Efter enkelte og gentagne orale doser på 75 mg/dag bliver clopidogrel hurtigt absorberet.
English: The co-primary endpoints were death from any cause and the first occurrence of re-infarction, stroke or death.
Danish: De primære sammensatte endepunkter var død uanset årsag og den første forekomst af re-infarkt, slagtilfælde eller død.
English: In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6% for clopidogrel plus ASA, and 6.3% for placebo plus ASA.
Danish: Hos patienter, som fortsatte med behandlingen inden for 5 dage før bypassoperationen, var forekomsten 9,6 % for clopidogrel plus ASA og 6,3 % for placebo plus ASA.
English: • if you have a history of asthma or allergic reactions including allergy to any medicine used to
Danish: • hvis du har haft tidligere tilfælde af astma eller allergiske reaktioner inklusive allergi mod et lægemiddel, der anvendes til at behandle din sygdom.
English: Other medicinal products: A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic (PK) interactions.
Danish: Andre lægemidler: Der er gennemført en række andre kliniske studier med clopidogrel og anden samtidig medicinering for at undersøge muligheden for farmakodynamisk og farmakokinetisk interaktion.
English: Cytochrome P450 2C19 (CYP2C19)
Danish: CYP2C19 (cytochrom P450 2C19)
English: In one study, when a single dose of ibuprofen 400 mg was taken within 8 hours before or within 30 minutes after immediate release aspirin dosing (81 mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred.
Danish: I et studie, hvor en enkelt dosis ibuprofen 400 mg blev indtaget inden for 8 timer før eller 30 minutter efter dosering af hurtigtopløsende aspirin (81 mg), forekom en nedsat virkning af ASA på dannelsen af tromboxan eller trombocythæmningen.
English: Marketing Authorisation Holder: Teva Pharma B.V.
Danish: Indehaver af markedsføringstilladelsen: Teva Pharma B.V.
English: An occasional use of ASA (no more than 1,000 mg in any 24-hour period) should generally not cause a problem, but prolonged use of ASA in other circumstances should be discussed with your doctor or pharmacist.
Danish: Lejlighedsvis anvendelse af acetylsalicylsyre (ikke over 1.000 mg over en periode på 24 timer) burde generelt ikke give problemer, men hvis du tager acetylsalicylsyre gennem længere tid under andre omstændigheder, skal du diskutere det med lægen eller apoteketspersonalet.
English: The plasma concentrations of the active metabolite was 20% reduced (loading dose) and 14% reduced (maintenance dose) during concomitant treatment with pantoprazole 80 mg once daily.
Danish: Plasmakoncentrationerne af den aktive metabolit blev reduceret med 20 % (støddosis) og 14 % (vedligeholdelsesdosis) ved samtidig behandling med 80 mg pantoprazol en gang daglig.
English: There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).
Danish: Der var ikke tegn på karcinogen virkning, når clopidogrel blev administreret i 78 uger til mus og 104 uger til rotter og givet i doser op til 77 mg/kg/dag (hvilket repræsenterer mindst 25 gange eksponeringen hos mennesker, der får den kliniske dosis på 75 mg/dag).
English: In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.
Danish: Desuden er der beskrevet øgede forekomster af forskellige misdannelser, inklusive kardiovaskulære misdannelser, ved indgift af prostaglandinsyntesehæmmere i dyr under den organogenetiske periode.
English: • Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) and syndrome of asthma, rhinitis, and nasal polyps.
Danish: • Overfølsomhed over for non-steroide antiinflammatoriske stoffer (NSAID) samt syndromet astma/rhinitis/nasale polypper.
English: TEVA UK Limited BRAMPTON ROAD HAMPDEN PARK EASTBOURNE, EAST SUSSEX,BN22 9AG, United Kingdom
Danish: TEVA UK Limited BRAMPTON ROAD HAMPDEN PARK EASTBOURNE, EAST SUSSEX, BN22 9AG, Storbritannien
English: The population included 27.8% women, 58.4% patients ≥60 years (26% ≥70 years) and 54.5% patients who received fibrinolytics.
Danish: Populationen inkluderede 27,8 % kvinder, 58,4 % af patienterne var ≤ 60 år (26 % ≤ 70 år), og 54,5 % af patienterne fik fibrinolytika.
English: Based on the pharmacokinetic and metabolic characteristics of both compounds, clinically significant PK interactions are unlikely
Danish: Baseret på de farmakokinetiske og metaboliske karakteristika af begge stoffer er klinisk signifikante farmakokinetiske interaktioner ikke sandsynlige.
English: Therefore, the combination of clopidogrel/acetylsalicylic acid should be used with caution in these patients.
Danish: Derfor bør kombinationen clopidogrel/acetylsalicylsyre anvendes med forsigtighed hos disse patienter.
English: If you experience prolonged bleeding when taking Clopidogrel/Acetylsalicylic acid Teva If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Danish: Hvis du får langvarige blødninger, mens du tager Clopidogrel/Acetylsalicylsyre Teva: Hvis du skærer dig eller kommer til skade, kan det tage lidt længere end normalt, før blødningen stopper.
English: In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
Danish: Hos personer med ringe metabolisme (poor metabolisers) var eksponeringen nedsat med 63-71 %, sammenlignet med personer med udtalt metabolisme.
English: The decrease was associated with a 39% (loading dose) and 21% (maintenance dose) reduction of inhibition of platelet aggregation.
Danish: Denne nedgang var associeret med en 39 % (støddosis) og 21 % (vedligeholdelsesdosis) reduktion i hæmning af trombocytaggregation.