FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Voriconazole Hikma, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Voriconazole Hikma, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The Committee recommended that Voriconazole Hikma be approved for use in the EU.
Danish: Udvalget anbefalede, at Voriconazole Hikma godkendes til anvendelse i EU.
English: Because Voriconazole Hikma is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Voriconazole Hikma er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: This means that Voriconazole Hikma is similar to a ‘reference medicine' already authorised in the European Union
Danish: Det betyder, at Voriconazole Hikma er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Vfend.
English: • other serious invasive Candida infections when the fungus is resistant to fluconazole (another antifungal medicine);
Danish: • andre alvorlige invasive Candida-infektioner, hvor svampen er resistent over for et andet svampemiddel, fluconazol,
English: Voriconazole Hikma is an antifungal medicine used for the treatment of adults and children over the age of two years who have the following infections caused by a fungus:
Danish: Voriconazole Hikma er et svampemiddel, der anvendes til behandling af voksne og børn over to år med følgende svampeinfektioner:
English: For more information about treatment with Voriconazole Hikma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Voriconazole Hikma, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: When used for treating fungal infections, Voriconazole Hikma is intended mainly for patients with infections that are worsening and possibly life-threatening.
Danish: Til behandling af svampeinfektioner er Voriconazole Hikma hovedsagelig beregnet til patienter med fremadskridende og muligt livstruende svampeinfektioner.
English: • serious fungal infections caused by Scedosporium or Fusarium (two different types of fungus).
Danish: • alvorlige svampeinfektioner forårsaget af svampearterne Scedosporium eller Fusarium.
English: What measures are being taken to ensure the safe and effective use of Voriconazole Hikma?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Voriconazole Hikma?
English: The active substance in Voriconazole Hikma, voriconazole, belongs to the ‘triazole' class of antifungal medicines.
Danish: Det aktive stof i Voriconazole Hikma, voriconazol, tilhører triazolgruppen af svampemidler.
English: Voriconazole Hikma voriconazole
Danish: Voriconazole Hikma voriconazol
English: For practical information about using Voriconazole Hikma, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Voriconazole Hikma, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What are the benefits and risks of Voriconazole Hikma?
Danish: Hvilke fordele og risici er der forbundet med Voriconazole Hikma?
English: Other information about Voriconazole Hikma
Danish: Andre oplysninger om Voriconazole Hikma
English: It is not intended to provide practical advice on how to use Voriconazole Hikma.
Danish: Det er ikke en praktisk vejledning i, hvordan Voriconazole Hikma bør anvendes.
English: What is Voriconazole Hikma and what is it used for?
Danish: Hvad er Voriconazole Hikma, og hvad anvendes det til?
English: The list of fungi against which Voriconazole Hikma is active can be found in the summary of product characteristics (also part of the EPAR).
Danish: En liste over de svampearter, som Voriconazole Hikma virker mod, fremgår af produktresuméet, der også er en del af denne EPAR.
English: Voriconazole Hikma is available as a powder to be made up into a solution for infusion (drip) into a vein.
Danish: Voriconazole Hikma fås som et pulver, der anvendes til at fremstille en væske, som gives med drop i en vene (infusion).
English: Why is Voriconazole Hikma approved?
Danish: Hvorfor blev Voriconazole Hikma godkendt?
English: How has Voriconazole Hikma been studied?
Danish: Hvordan blev Voriconazole Hikma undersøgt?
English: How is Voriconazole Hikma used?
Danish: Hvordan anvendes Voriconazole Hikma?
English: How does Voriconazole Hikma work?
Danish: Hvordan virker Voriconazole Hikma?
English: The median follow-up for both groups was 359 days.
Danish: Median opfølgning for begge grupper var 359 dage.
English: Date of first authorisation: 16.10.2009 Date of latest renewal: 18.09.2014
Danish: Dato for første tilladelse: 16.10.2009 Dato for sidste fornyelse: 18.09.2014
English: Risk Management Plan(RMP)
Danish: • Risikostyringsplan (RMP)
English: All patients were continued on aspirin and were followed for one year.
Danish: Alle patienter fortsatte på aspirin og blev fulgt i ét år.
English: The characteristics of the studied cohort were similar in the 2 groups.
Danish: Karakteristika for den undersøgte kohorte var de samme i de 2 grupper.
English: • Your doctor may order blood tests.
Danish: • Kan din læge bede om blodprøver
English: arthralgia,
Danish: arthralgi,
English: Do not use this medicine if you notice any visible sign of deterioration.
Danish: Brug ikke lægemiddel, hvis du bemærker synlige tegn på nedbrydning.
English: The patient population included 41.8 % women.
Danish: Patientpopulationen inkluderede 41,8% kvinder.
English: The prasugrel-only patients were continued on prasugrel for 11.5 months.
Danish: Patienterne med kun prasugrel fortsatte på prasugrel i 11,5 måneder.
English: Children and adolescents Do not give this medicine to children because it does not work.
Danish: Børn og teenagere Anvend ikke dette lægemiddel til børn, da det er uden effekt på dem.
English: At Day 14, platelet function testing (PFT) was performed.
Danish: På dag 14 blev der udført trombocytfunktion testning (PFT).
English: TOPIC and TROPICAL-ACS were designed to study how to mitigate the bleeding events while maintaining efficacy.
Danish: TOPIC og TROPICA-ACS var designet til at studere, hvorledes blødningshændelserne kunne mildnes, mens effektiviteten blev opretholdt.
English: anti-retroviral medicines (medicines to treat HIV infections).
Danish: - antiretrovirale lægemidler (hiv-medicin).
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: Hyppighed defineres i henhold til følgende konvention: almindelig (1/100 til<1/10), ikke almindelig (1/1000 til <1/100), sjælden (1/10000 til <1/10000), meget sjælden<1/10000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: However, due to the lack of interaction studies with other NSAIDs it is presently unclear whether there is an increased risk of gastrointestinal bleeding with all NSAIDs.
Danish: Imidlertid er det på grund af manglen på interaktionsstudier med andre NSAID'er ikke umiddelbart klart, om der er øget risiko for gastrointestinal blødning med alle NSAID-præparater.
English: • Adults and elderly Clopidogrel should be given as a single daily dose of 75 mg.
Danish: • Voksne og ældre personer Clopidogrel bør gives som en enkelt daglig dosis på 75 mg.
English: (including ulcerative or lymphocytic colitis), stomatitis
Danish: (inklusive ulcerosa eller lymfocytisk colitis), stomatitis
English: Marketing Authorisation Holder and Manufacturers:
Danish: Indehaver af markedsføringstilladelsen og fremstillere:
English: The elimination half-life of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Danish: Halveringstiden for elimination af den cirkulerende (inaktive)hovedmetabolit var 8 timer efter en enkelt og efter gentagen administration.
English: Although the ischaemic benefit was consistent throughout the first year, greater reduction in ischaemic recurrence after ACS was observed during the initial days following the treatment initiation.
Danish: Selvom den iskæmiske fordel var konsistent i løbet af det første år, blev der observeret større reduktion i iskæmisk recidiv efter ACS i løbet af de første dage efter indledning af behandlingen.
English: You have been prescribed Clopidogrel Apotex to help prevent blood clots and reduce the risk of these severe events because:
Danish: Du har fået recept på Clopidogrel Apotex til forebyggelse af blodpropper og nedsættelse af risikoen for disse alvorlige hændelser, fordi:
English: De-escalation of P2Y12 Inhibitor Agents in ACS
Danish: De-eskalering af P2Y12 hæmmer-midler ved ACS
English: - a planned surgery (including dental) in the next seven days.
Danish: - et planlagt kirurgisk indgreb (gælder også tandoperationer) inden for de næste syv dage.
English: Therefore, the guided de-escalation arm had patients on either prasugrel (40%) or clopidogrel (60%).
Danish: Den guidede de-eskaleringsarm havde derfor patienter på enten prasugrel (40 %) eller clopidogrel (60 %).
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Secondary prevention of atherothrombotic events
Danish: Sekundær forebyggelse af aterotrombotiske hændelser
English: This leaflet was last revised in {MM/YYYY} .
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: This randomized, open-label trial included 2,610 biomarker-positive ACS patients after successful PCI.
Danish: Dette randomiserede, ublindede forsøg omfattede 2.610 biomarkør-positive ACS-patienter efter vellykket PCI.
English: Refer to the storage conditions on the carton.
Danish: Se opbevaringsbetingelserne på æsken.
English: The mean age was 71 years, 41.6% of patients were ≥75 years.
Danish: Gennemsnitligsalderen var 71 år, 41,6% af patienterne var ≥ 75 år.
English: • If you suffer from severe liver disease.
Danish: • hvis du lider af alvorlig leversygdom
English: Clopidogrel Apotex with food and drink Clopidogrel Apotex may be taken with or without food.
Danish: Brug af Clopidogrel Apotex sammen med mad og drikke Clopidogrel Apotex kan tages med eller uden mad.
English: • If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for clopidogrel eller et af de øvrige indholdsstoffer i dette lægemiddel(angivet i punkt 6)
English: In contrast, post-hoc analyses demonstrated statistically significant increases in the bleeding risk with the more potent P2Y12 inhibitors, occurring predominantly during the maintenance phase, after the first month post-ACS.
Danish: I modsætning demonstrerede post-hoc analyserstatistisk signifikante øgninger i blødningsrisikoen med de mere potente P2Y12-hæmmere, hvilket hovedsagelig forekom under vedligeholdelsesfasen, efter den første måned post-ACS.
English: In addition to clinical studies experience, adverse reactions have been spontaneously reported.
Danish: Ud over erfaringerne fra de kliniske studier, erder spontant blevet rapporteret bivirkninger.
English: If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
Danish: Hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter (f.eks. lactose), skal du kontakte lægen, før du tager denne medicin
English: You should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.
Danish: Du bør også få acetylsalicylsyre (et stof, som indgår i mange lægemidler, og som anvendes til at afhjælpe smerter og sænke feber såvel som til at forebygge dannelse af blodpropper) af lægen.
English: Platelets are very small structures in the blood which clump together during blood clotting.
Danish: Blodplader er meget små bestanddele i blodet, som klumper sig sammen i forbindelse med, at blodet størkner.
English: Clopidogrel is indicated in:
Danish: Clopidogrel er indiceret hos:
English: During non-clinical studies in rat and baboon, the most frequently observed effects were liver changes.
Danish: I ikke-kliniske forsøg på rotter og bavianer var den hyppigst forekommende effekt leverforandringer.
English: In addition, a subgroup analysis by age suggested that the benefit of clopidogrel in patients over 75 years was less than that observed in patients 75 years.
Danish: Endvidere tydede en analyse af aldersbaserede delgrupper på, at fordelen ved clopidogrel hos patienter over 75 år var mindre end hos patienter ≤75 år.
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 poor metabolisers fik 600 mg/150 mg regimet var eksponeringen for den aktive metabolit større end ved300 mg/75 regimet.
English: The de-escalated patients underwent high platelet reactivity (HPR) testing.
Danish: De de-eskalerede patienter gennemgik høj trombocytreaktivitet (HPR) testning.
English: 2333 CN Leiden The Netherlands
Danish: 2333 CN Leiden Nederlandene
English: 4.7 Effects on ability to drive and use machines Clopidogrel has no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner Clopidogrel påvirker ikke, eller i ubetydelig grad evnen til at føre bil eller betjene maskiner.
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 genotoksicitetsforsøg og udviste ingen genotoksisk aktivitet.
English: Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
Danish: Den publicerede forekomst af poor metaboliser CYP2C19-genotyper er ca. 2 % for kaukasiske personer, 4 % for negroide og 14 % for kinesiske.
English: repaglinide, medicine to treat diabetes, paclitaxel, medicine to treat cancer.
Danish: - repaglinid, medicin til behandling af diabetes - paclitaxel, medicin til behandling af kræft.
English: • if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days.
Danish: • hvis du har haft en blodprop i en åre (arterie) i hjernen (iskæmisk slagtilfælde), inden for de seneste 7 dage.
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister, after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på æsken og blisterpakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette gælder også mulige bivirkninger, som ikke er medtaget denne indlægsseddel.
English: The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2 CYP2B6 and CYP3A4.
Danish: Den aktive metabolit dannes hovedsageligt af CYP2C19 med bidrag fra flere andre CYP-enzymer, inklusive , CYP1A2 CYP2B6 og CYP3A4.
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 et interval på 120 timer efter dosering.
English: This randomized, open-label trial included ACS patients requiring PCI.
Danish: Dette randomiserede, ikke-blindede forsøg omfattede ACS-patienter, der krævede PCI.
English: The ACTIVE-W and ACTIVE-A studies, separate trials in the ACTIVE program, included patients with atrial fibrillation (AF) who had at least one risk factor for vascular events.
Danish: ACTIVE-W- og ACTIVE-A-studierne, der er separate forsøg i ACTIVE-programmet, inkluderede patienter med atrieflimren (AF), der havde mindst én risikofaktor for vaskulære hændelser.
English: Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Danish: Absorptionen er mindst 50 % baseret på urindudskillelse af clopidogrels metabolitter.
English: You should take Clopidogrel Apotex for as long as your doctor continues to prescribe it.
Danish: Du skal fortsætte med at tage Clopidogrel Apotex, så længe din læge udskriver det til dig.
English: If you forget to take a dose of Clopidogrel Apotex, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Danish: Hvis du glemmer at tage en dosis Clopidogrel Apotex til sædvanlig tid, men kommer i tanke om det i løbet af 12 timer, skal du omgående tage tabletten og dernæst tage den næste tablet til sædvanlig tid.
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Danish: 7 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 50filmovertrukne tabletter 56 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter
English: Overall, 645 of 646 patients with STEMI or NSTEMI or unstable angina were analyzed (de-escalated DAPT (n=322); unchanged DAPT (n=323)).
Danish: Samlet blev 645 ud af 646 patienter med STEMI eller NSTEMI eller ustabil angina analyseret (deeskaleret DAPT (n=322);uændret DAPT (n=323)).
English: You have a condition of hardening of arteries (also known as atherosclerosis), and
Danish: Du lider af åreforkalkning (også kaldet aterosklerose), og
English: 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 kanogså indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: In the long-term safety follow-up of this study, 26 patients with the shunt still in place at one year of age received clopidogrel up to 18 months of age.
Danish: I den forlængede sikkerhedsopfølgning af studiet fik 26 patienter, der stadig havde shunten indopereret, da de fyldte 1 år, clopidogrel til de var op til18 måneder gamle.
English: The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Danish: De klinisk relevante bivirkninger observeret i CAPRIE-, CURE-, CLARITY-, COMMITog ACTIVE-A-undersøgelserne beskrives nedenfor.
English: Patients on aspirin and a more potent P2Y12 blocker and without adverse event at one month were assigned to switch to fixed-dose aspirin plus clopidogrel (de-escalated dual antiplatelet therapy (DAPT)) or continuation of their drug regimen (unchanged DAPT).
Danish: Patienter på aspirin og en mere potent P2Y12-blokker og uden bivirkninger efter en måned blev udpeget til at skifte til fast dosis aspirin plus clopidogrel (de-eskaleret dobbelt anti-trombocyt terapi (DAPT) eller fortsættelse af deres lægemiddelregime (uændret DAPT).
English: Your doctor should have prescribed Clopidogrel plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Danish: Din læge kan have udskrevet Clopidogrel Apotex plus acetylsalicylsyre, hvis du ikke må tage ”orale antikoagulantia”, og du ikke har risiko for alvorlig blødning.
English: Rare side effect (may affect up to 1 in 1000 people): Vertigo, enlarged breasts in males.
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 patienter): Svimmelhed (vertigo), forstørrede bryster hos mænd.
English: The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Clopidegrel Apotex per day to be taken orally with or without food, and at the same time each day.
Danish: Den anbefalede dosis, inklusive til patienter med en tilstand kaldet “atrieflimmer” (en uregelmæssig hjertefrekvens), er én 75 mg tablet Clopidegrel Apotex pr. dag, som skal tages peroralt med eller uden mad og på samme tidspunkt hver dag.
English: • if you have a risk of bleeding such as - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
Danish: • hvis du har risiko for blødninger f.eks. på grund af: - en medicinsk lidelse, der medfører risiko for indre blødninger (såsom et mavesår).
English: - a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
Danish: - en blødningslidelse, der giver dig tendens til indre blødning (blødning inde i et af kroppens væv, organer eller led).
English: Switching from a more potent P2Y12 receptor inhibitor to clopidogrel in association with aspirin after acute phase in ACS has been evaluated in two randomized investigator-sponsored studies (ISS)TOPIC and TROPICAL-ACS - with clinical outcome data.
Danish: Skiften fra en mere potent P2Y12 receptorhæmmer til clopidogrel i forbindelse med aspirin efter akut fase ved ACS er blevet evalueret i to randomiserede investigator-sponsorerede studier (ISS) - TOPIC og TROPICAL_ACS - med kliniske udfaldsdata.
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel and acetylsalicylic acid for this condition.
Danish: Du bør være blevet informeret om, at ”orale antikoagulantia” er mere effektive mod denne sygdom end acetylsalicylsyre eller kombinationen af Clopidogrel Apotex og acetylsalicylsyre.
English: Hypromellose (E464) Lactose monohydrate Triacetin (E1518) Titanium dioxide (E171) Red iron oxide (E172)
Danish: Hypromellose (E464) Lactosemonohydrat Triacetin (E1518) Titandioxid (E171) Rød jernoxid (E172)
English: If you take more Clopidogrel Apotex than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Danish: Hvis du har taget for meget Clopidogrel Apotex Kontakt din læge eller tag på den nærmeste skadestue på grund af den øgede blødningsrisiko.
English: Clopidogrel Apotex film-coated tablets are pink, round and biconvex.
Danish: Clopidogrel Apotex filmovertrukne tabletter er lyserøde, runde og bikonvekse.
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 indtil 5 dage før bypassoperationen, var forekomsten9,6 % for clopidogrel plus ASA og 6,3 % for placebo plus ASA.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med arvelige galactoseintolerans, en særlig form for arvelig lactasemangel Lapp lactase-mangel eller glucose-/galactosemalabsorption, bør ikke anvende dette lægemiddel.