FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Levetiracetam Teva.
English: For more information about treatment with Levetiracetam Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Levetiracetam Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Patients unable to swallow should be given a solution containing levetiracetam.
Danish: Patienter, der ikke kan synke, skal have en opløsning, der indeholder levetiracetam.
English: This means that Levetiracetam Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Danish: Det betyder, at Levetiracetam Teva er identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU), og som hedder Keppra.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levetiracetam Teva.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet for at kunne anbefale udstedelse af en markedsføringstilladelse i EU og fastlægge anvendelsesbetingelserne for Levetiracetam Teva.
English: Other information about Levetiracetam Teva
Danish: Andre oplysninger om Levetiracetam Teva
English: The CHMP concluded that, in accordance with EU requirements, Levetiracetam Teva has been shown to have comparable quality and to be bioequivalent to Keppra.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Levetiracetam Teva er af sammenlignelig kvalitet og er bioækvivalent med Keppra.
English: This helps Levetiracetam Teva to stabilise electrical activity in the brain and prevent seizures.
Danish: På denne måde stabiliserer Levetiracetam Teva den elektriske aktivitet i hjernen og forhindrer anfald.
English: What measures are being taken to ensure the safe and effective use of Levetiracetam Teva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Levetiracetam Hospira?
English: Levetiracetam Teva can also be used as an add-on to other epilepsy medicines to treat:
Danish: Levetiracetam Teva kan også anvendes som en tillægsbehandling til andre antiepileptika til behandling af:
English: Levetiracetam Teva can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Danish: Levetiracetam Teva kan uden supplerende behandling anvendes til patienter over 16 år med nydiagnosticeret epilepsi til behandling af partielle anfald med eller uden sekundær generalisering.
English: The active substance in Levetiracetam Teva, levetiracetam, is an epilepsy medicine.
Danish: Det aktive stof i Levetiracetam Teva, levetiracetam, er et antiepileptikum.
English: Levetiracetam Teva is a ‘generic medicine'.
Danish: Levetiracetam Teva er et "generisk lægemiddel".
English: What are the benefits and risks of Levetiracetam Teva?
Danish: Hvilken fordel og risiko er der forbundet med Levetiracetam Teva?
English: Levetiracetam Teva is a medicine that contains the active substance levetiracetam.
Danish: Levetiracetam Teva er et lægemiddel, der indeholder det aktive stof levetiracetam.
English: Because Levetiracetam Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Levetiracetam Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: When Levetiracetam Teva is added to another epilepsy treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Danish: Når Levetiracetam Teva anvendes som tillægsbehandling til en anden behandling med antiepileptika, er startdosis til patienter over 12 år, som vejer over 50 kg, 500 mg to gange dagligt.
English: Levetiracetam Teva tablets are swallowed with liquid.
Danish: Levetiracetam Tevatabletterne synkes hele med væske.
English: Because Levetiracetam Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Danish: Da Levetiracetam Teva er et generisk lægemiddel, har patientundersøgelserne været begrænset til tests for at påvise, at stoffet er bioækvivalent med referencelægemidlet Keppra.
English: When Levetiracetam Teva is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Danish: Når Levetiracetam Teva anvendes alene, er startdosis 250 mg to gange dagligt, som efter to uger øges til 500 mg to gange dagligt.
English: Why has Levetiracetam Teva been approved?
Danish: Hvorfor blev Levetiracetam Teva godkendt?
English: The Committee recommended that Levetiracetam Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Levetiracetam Teva.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Levetiracetam Teva have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indført anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Levetiracetam Teva.
English: What is Levetiracetam Teva?
Danish: Hvad er Levetiracetam Teva?
English: How has Levetiracetam Teva been studied?
Danish: Hvordan blev Levetiracetam Teva undersøgt?
English: How is Levetiracetam Teva used?
Danish: Hvordan anvendes Levetiracetam Teva?
English: What is Levetiracetam Teva used for?
Danish: Hvad anvendes Levetiracetam Teva til?
English: EU/1/19/1365/001 Cufence
Danish: EU/1/19/1365/001
English: 200 mg Capsule, hard
Danish: 200 mg Kapsel, hård
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Paknings-størrelse
English: Oral use
Danish: Cufence
English: Bottle (glass)
Danish: Oral anvendelse Flaske (glas) 100 kapsler
English: 90 (3 x 30) tablets
Danish: 245 mg Film-overtrukken tablet Oral anvendelse Beholder (HDPE) 90 (3 x 30) tabletter
English: 30 tablets
Danish: 245 mg Film-overtrukken tablet Oral anvendelse Beholder (HDPE) 30 tabletter
English: These trials are briefly described below.
Danish: Disse undersøgelser er beskrevet kort nedenfor.
English: There was no increased benefit thereafter, up to 1 year.
Danish: Der var ikke yderligere effekt derefter i op til 1 år.
English: The dose given is based on your weight.
Danish: Den givne dosis er baseret på din vægt.
English: A target aPTT of 50-70 seconds was recommended.
Danish: Et mål for aPTT på 50-70 sekunder blev anbefalet.
English: • or increased CK-MB.
Danish: • eller forhøjet CK-MB.
English: Monitor these patients closely with regard to bleeding.
Danish: Overvåg disse patienter omhyggeligt for blødninger.
English: Warfarin and dipyridamole
Danish: Warfarin og dipyridamol
English: This should be taken into consideration by patients on a controlled sodium diet.
Danish: Dette bør tages i betragtning ved patienter, der er på en natriumkontrolleret diæt.
English: Take care to ensure that only the anterior wall of the femoral artery is punctured.
Danish: Vær omhyggelig med at sikre, at der kun stikkes gennem den forreste væg af den femorale arterie.
English: This recommendation is based on pharmacodynamic and pharmacokinetic data.
Danish: Denne anbefaling er baseret på farmakodynamiske og farmakokinetiske data.
English: It is not recommended for use in children and adolescents below 18 years of age, due to a lack of data on safety and efficacy.
Danish: Anbefales ikke til børn og unge under 18 år på grund af utilstrækkelige oplysninger om sikkerhed og effekt.
English: Monitoring of laboratory values
Danish: Overvågning af laboratorieværdier
English: Wessling Hungary Kft Fòti ùt 56, Budapest 1047, Hungary
Danish: Wessling Hungary Kft Fòti ùt 56, Budapest 1047, Ungarn
English: Thus, changes in laboratory parameters associated with bleeding (e.g. bleeding time) are common and expected.
Danish: Ændringer i de laboratorieparametre, der associeres med blødninger (som blødningstiden) er således almindelige og forventelige.
English: Emergency or semi-elective surgery
Danish: Akut eller semi-elektiv kirurgi
English: 30 days
Danish: 30 dage
English: Arterial procedures
Danish: Arterielle procedurer
English: Similar results were also obtained for the 2 secondary endpoints assessed at 30 days: a triple composite of death, MI and UTVR, and the more robust combination of death and MI.
Danish: Lignende resultater blev også opnået for de 2 sekundære effektmål vurderet efter 30 dage: en tresidet sammensætning af død, MI og UTVR, og den stærkere kombination af død og MI.
English: The first bolus and the infusion were started simultaneously, immediately before the PCI procedure and were followed by a second bolus 10 minutes after the first.
Danish: Den første bolus og infusionen blev startet samtidigt, umiddelbart før PCI-proceduren og blev efterfulgt af en yderligere bolus 10 minutter efter den første.
English: The carcinogenic potential of eptifibatide has not been evaluated in long-term studies.
Danish: Det karcinogene potentiale for eptifibatid er ikke blevet vurderet i langtidsundersøgelser.
English: The extent of eptifibatide binding to human plasma protein is about 25 %.
Danish: Graden af eptifibatid-binding til humant plasmaprotein er omkring 25 %.
English: Table 1: Incidence of Death/CEC-Assessed MI («Treated as Randomised» Population)
Danish: Tabel 1: Hyppigheden af dødsfald/CEC-vurderede MI (“Behandlet som randomiseret” population)
English: This product is for hospital use only.
Danish: Dette produkt er udelukkende beregnet til hospitalsbrug.
English: The clinical relevance of such enzymatic MIs is still controversial.
Danish: Den kliniske relevans af sådanne enzymatiske myokardieinfarkter er stadig kontroversiel.
English: Please refer to the Normosol R Summary of Product Characteristics for details on its composition.
Danish: Se produktresumé for Normosol R for detaljer om sammensætning.
English: Eptifibatide p-Value
Danish: Eptifibatid p-værdi
English: This means that it helps to prevent blood clots from forming.
Danish: Det betyder, at det hjælper med at forebygge blodpropper.
English: These are absolute reporting frequencies without taking into account placebo rates.
Danish: Disse er absolutte bivirkningsfrekvenser uden hensyntagen til placebofrekvens.
English: The data sources used to determine adverse reaction frequency descriptors included two phase III clinical studies (PURSUIT and ESPRIT).
Danish: Datakilder anvendt til at bestemme hyppighed af bivirkninger inkluderede to kliniske fase III undersøgelser (PURSUIT og ESPRIT).
English: Note that causality has not been determined for all adverse reactions.
Danish: Bemærk at årsagssammenhæng ikke er fastlagt for alle bivirkninger.
English: Shock, hypotension, phlebitis.
Danish: Shock, hypotension, flebitis.
English: Please tell your doctor if you have had any of these conditions.
Danish: Fortæl det til lægen, hvis du lider af en af disse tilstande.
English: It is not known whether eptifibatide is excreted in human milk.
Danish: Det vides ikke, om eptifibatid udskilles i human mælk.
English: No formal pharmacokinetic interaction studies have been conducted.
Danish: Der er ikke blevet udført nogen egentlige farmakokinetiske interaktionsundersøgelser.
English: Consequently these studies are not suitable to evaluate the toxicity of eptifibatide on reproductive function (see section 4.6).
Danish: Ovennævnte undersøgelser er således ikke velegnede til at vurdere toksiciteten af eptifibatid på reproduktionsfunktionen (se pkt 4.6).
English: Results on the primary endpoint were principally attributed to the occurrence of myocardial infarction.
Danish: Resultaterne af det primære endepunkt blev hovedsageligt tillagt forekomsten af myokardieinfarkt.
English: Date of first authorisation: 11th January 2016
Danish: Dato for første markedsføringstilladelse: 11th januar 2016
English: Other potential bleeding sites such as central and peripheral nervous system and retroperitoneal sites, must be carefully considered too.
Danish: Andre mulige blødningssteder, såsom det centrale og perifere nervesystem og retroperitoneale steder, skal også kontrolleres nøje.
English: Thus, although eptifibatide can be dialysed, the need for dialysis is unlikely.
Danish: Selv om eptifibatid kan dialyseres, er det usandsynligt, at der skulle opstå behov for dialyse.
English: MI was identified per the CK-MB core laboratory criteria.
Danish: MI blev påvist ved CK-MB-laboratorieundersøgelseskriterier.
English: GUSTO severe/life threatening bleeding was uncommon and comparable in both treatment groups (0.8 %).
Danish: GUSTO svær/livstruende blødning var ikke almindelig og sammenlignelig i de to behandlingsgrupper (0,8 %).
English: Anaphylactic reactions.
Danish: Anafylaktiske reaktioner.
English: Very rarely, bleeding has become severe and even fatal.
Danish: Blødning har i sjældne tilfælde vist sig at være meget alvorlig eller endog livstruende.
English: Tell your doctor if you are pregnant, think you might be pregnant or are planning to have a baby.
Danish: Fortæl det til lægen, hvis du er gravid, har mistanke om at du er gravid, eller planlægger at blive gravid.
English: Eptifibatide Accord should not be used during pregnancy unless clearly necessary.
Danish: Eptifibatid Accord bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Eptifibatide -treated patients who had a prothrombin time (PT) > 14.5 seconds and received warfarin concomitantly did not appear to be at an increased risk of bleeding.
Danish: Eptifibatid-behandlede patienter, der havde en protrombintid (PT) > 14,5 sekunder og fik warfarin samtidig, syntes ikke at have øget risiko for blødning.
English: Discard any unused medicinal product after opening.
Danish: Bortskaf al ikke anvendt lægemiddel efter åbning.
English: Patients could be enrolled only if they had experienced cardiac ischemia at rest (≥ 10 minutes) within the previous 24 hours and had:
Danish: Patienterne kunne kun inkluderes, hvis de havde haft hjerteiskæmi i hvile (≥ 10 minutter) inden for de sidste 24 timer og havde:
English: Other events that may occur in patients, who require this type of treatment, include those that are related to the condition you are having treated, such as rapid or irregular heartbeat, low blood pressure, shock or cardiac arrest.
Danish: Øvrige bivirkninger, der kan forekomme hos patienter, der har behov for denne slags behandling, er forbundet med den sygdom, du behandles for, såsom hurtigt eller uregelmæssigt hjerteslag, lavt blodtryk, shock eller hjertestop.
English: This study was a 726-center, 27-country, double-blind, randomised, placebo-controlled study in 10,948 patients presenting with UA or NQMI.
Danish: Denne undersøgelse var en 726-centre, 27-lande, dobbeltblind, randomiseret, placebokontrolleret undersøgelse af 10.948 patienter, der havde UA eller NQMI.
English: There are no adequate data from the use of eptifibatide in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af eptifibatid hos gravide kvinder.
English: The 180/1.3 arm was stopped after an interim analysis, as prespecified in the protocol, when the two active-treatment arms appeared to have a similar incidence of bleeding.
Danish: Gruppen 180/1,3 blev stoppet efter en interimanalyse, som tidligere anført i protokollen, da de to aktive behandlingsarme syntes at have samme blødningsfrekvens.
English: Reproduction studies in animal species where eptifibatide shows a similar pharmacologic activity as in humans are not available.
Danish: Reproduktionsundersøgelser på dyr, hvor eptifibatid viser en lignende farmakologisk aktivitet som hos mennesker, findes ikke.
English: The decision to use platelet transfusions should be based upon clinical judgment on an individual basis.
Danish: Beslutningen om at foretage trombocyttransfusion bør baseres på en individuel klinisk vurdering.
English: In the PURSUIT trial, there were 9 patients who received bolus and/or infusion doses more than double the recommended dose, or who were identified by the investigator as having received an overdose.
Danish: I PURSUIT-undersøgelsen var der 9 patienter, som fik bolus- og/eller infusionsdoser, der var mere end dobbelt så store som den anbefalede dosis, eller som blev identificeret af investigator til at have modtaget en overdosering.
English: The component MI could be defined as asymptomatic with enzymatic elevation of CK-MB or new Q wave.
Danish: Komponenten MI kunne defineres som asymptomatisk med enzymatisk stigning i CK-MB eller ny Q-tak.
English: The undesirable effects are listed by body system and frequency.
Danish: Bivirkningerne er inddelt efter systemorganklasse og hyppighed.
English: The majority of adverse reactions experienced by patients treated with eptifibatide were generally related to bleeding or to cardiovascular events that occur frequently in this patient population.
Danish: De fleste bivirkninger hos de patienter, der fik behandling med eptifibatid, var generelt relateret til blødninger eller til kardiovaskulære hændelser, der forekommer hyppigt hos denne patientpopulation.
English: - Eptifibatide Accord is not intended for use in children or adolescents less than 18 years of age.
Danish: - Eptifibatid Accord er ikke beregnet til anvendelse hos børn eller unge under 18 år.
English: After removal of the introducer sheath, careful haemostasis must be ensured under close observation.
Danish: Efter fjernelse af indføringsspidsen skal omhyggelig hæmostase sikres under nøje observation.
English: 0.034a a: Pearson's chi-square test of difference between placebo and eptifibatide.
Danish: 0,034a a: Pearsons chi-square-test af forskellen mellem placebo og eptifibatid.
English: Eptifibatide Accord is not compatible with furosemide.
Danish: Eptifibatid Accord er ikke forligeligt med furosemid.
English: Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: De udførte dyreforsøg er utilstrækkelige med hensyn til virkningerne for graviditetens, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: No statistically significant benefit of early routine eptifibatide strategy was demonstrated in the subgroup of patients who were managed medically or during the medical management periods prior to PCI or CABG.
Danish: Der blev ikke påvist statistisk signifikant fordel ved tidlig rutinemæssig eptifibatid-strategi i den subgruppe af patienter, som blev behandlet medicinsk eller i perioderne med medicinsk behandling inden PCI eller CABG.
English: The ESPRIT trial used a simplified regimen of heparin during PCI that consisted of an initial bolus of 60 units/kg, with a target ACT of 200 - 300 seconds.
Danish: ESPRIT-undersøgelsen anvendte et simplificeret heparin-regimen under PCI, som bestod af en initial bolus på 60 enheder/kg, med en målsætning for ACT på 200-300 sekunder.
English: Eptifibatide Accord is not usually recommended for use during pregnancy.
Danish: Eptifibatid Accord anbefales normalt ikke til brug under graviditet.
English: During treatment with eptifibatide there is a significant increase in bleeding rates, especially in the femoral artery area, where the catheter sheath is introduced.
Danish: Under behandling med eptifibatid er der en betydelig stigning i blødningshyppigheden, især i det femorale arterieområde, hvor kateterspidsen indføres.
English: No unexpected toxic effects for an agent with this pharmacologic profile were observed and findings were predictive of clinical experience, with bleeding effects being the principal adverse event.
Danish: Ingen uventede toksiske virkninger for et stof med denne farmakologiske profil blev observeret, og fundene var prediktive for klinisk erfaring med blødningshændelser som værende den hovedsagelige bivirkning.
English: An increased risk of bleeding may also be observed in patients who receive early administration of eptifibatide (e.g. upon diagnosis) compared to receiving it immediately prior to PCI, as seen in the Early ACS trial.
Danish: En øget risiko for blødning kan også observeres hos patienter, som får tidlig administration af eptifibatid (f.eks. ved diagnosticeringen) sammenlignet med patienter, som får det umiddelbart før PCI, som set i EARLY ACS-forsøget.
English: The vast majority of patients received acetylsalicylic acid (75-325 mg once daily).
Danish: De fleste patienter fik acetylsalicylsyre (75-325 mg en gang daglig).
English: Prolongation of bleeding time
Danish: Forlænget blødningstid
English: It should be administered by specialist physicians experienced in the management of acute coronary syndromes.
Danish: Produktet bør administreres af speciallæger med erfaring i behandling af akutte koronarsyndromer.
English: Discontinue unfractionated heparin.
Danish: Seponer ufraktioneret heparin.
English: Thrombocytopenia occurring after first exposure to a GPIIb/IIIa inhibitor may be explained by the fact that antibodies are naturally present in some normal individuals.
Danish: Trombocytopeni, der opstår efter første eksponering for en GP-IIb/IIIa-hæmmer, kan måske forklares ved det faktum, at antistoffer er naturligt til stede hos nogle normale individer.
English: Because of its short half-life and rapid clearance, the activity of eptifibatide may be halted readily by discontinuing the infusion.
Danish: På grund af dets korte halveringstid og hurtige clearance kan virkningen af eptifibatid hurtigt stoppes ved at afbryde infusionen.
English: No genotoxic effects were observed with eptifibatide.
Danish: Ingen genotoksiske virkninger blev observeret med eptifibatid.
English: If the patient requires semi-elective surgery, stop the eptifibatide infusion at an appropriate time to allow time for platelet function to return towards normal.
Danish: Hvis patienten behøver semi-elektiv kirurgi, så stop infusionen med eptifibatid på et passende tidspunkt for at give tid til, at trombocytfunktionen kan vende tilbage til den normale.
English: Women, the elderly, patients with low body weight or with moderate renal impairment (creatinine clearance > 30 - < 50 ml/min) may have an increased risk of bleeding.
Danish: Kvinder, ældre patienter, patienter med lav kropsvægt eller med moderat nyreinsufficiens (kreatininclearance ≥30 - <50 ml/min) kan have en øget blødningsrisiko.
English: When administered alone, eptifibatide has no measurable effect on prothrombin time (PT) or activated partial thromboplastin time (aPTT).
Danish: Eptifibatid, indgivet alene, har ingen målelig effekt på protrombintiden (PT) eller aktiveret partiel tromboplastintid (aPTT).
English: There was no indication of severe adverse reactions associated with administration of accidental large bolus doses, rapid infusion reported as overdose or large cumulative doses.
Danish: Der var ingen tegn på svære bivirkninger forbundet med tilfældig indgift af store bolusdoser, hurtig infusion rapporteret som overdosering eller store kumulative doser.
English: Interruption of breast-feeding during the treatment period is recommended.
Danish: Det anbefales at afbryde amningen i behandlingsperioden.
English: Ask your hospital pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: The available clinical evidence cannot however confirm that this dose modification results in a preserved benefit (see section 5.1).
Danish: Den tilgængelige kliniske dokumentation kan dog ikke stadfæste, at denne dosisjustering resulterer i en vedvarende fordel (se pkt.