FrancophonIA/ELRC3.0 huggingface dataset:
English: No apparent differences were observed between patients treated with eptifibatide or with placebo in values for liver function (SGOT/AST, SGPT/ALT, bilirubin, alkaline phosphatase) or renal function (serum creatinine, blood urea nitrogen).
Danish: Hvad angår værdierne for leverfunktionen (SGOT/ASAT, SGPT/ALAT, bilirubin, alkalisk fosfatase) og værdierne for nyrefunktionen (serumkreatinin, blod-urea-nitrogen), observeredes der ingen tilsyneladende forskelle på de patienter, der blev behandlet med eptifibatid og dem, der fik placebo.
English: Distrobution
Danish: Distribution
English: What is in this leaflet:
Danish: Hyppigheden er defineret som:
English: TIMI major bleeding occurred in 2.7 % of patients who received a reduced dose (1microgram/kg/min) vs 4.2 % of patients who received the standard dose (2 microgram/kg/min) when eptifibatide was administered in the early routine fashion (p=0.36).
Danish: Der forekom TIMI major blødning hos 2,7 % af de patienter, der fik nedsat dosis (1 mikrogram /kg/min.
English: There was no consistent evidence that eptifibatide increased the risk of major or minor bleeding associated with tissue plasminogen activator in either a PCI or an acute myocardial infarction study.
Danish: Hverken i et PCI-studie eller i et akut myokardieinfarkt-studie observeredes der konsistente tegn på, at eptifibatid øger risikoen for større og mindre blødninger associeret til vævsplasminogen-aktivator.
English: Eptifibatide Accord is an inhibitor of platelet aggregation.
Danish: Eptifibatid Accord hæmmer sammenklumpning af blodplader.
English: One vial of 100 ml of solution for infusion contains 75 mg of eptifibatide.
Danish: Et hætteglas med 100 ml infusionsvæske indeholder 75 mg eptifibatid.
English: One vial of 10 ml solution for injection contains 20 mg of eptifibatide.
Danish: Et hætteglas med 10 ml injektionsvæske indeholder 20 mg eptifibatid.
English: The primary endpoint event rate was 11.9 % in patients who received a reduced dose (1microgram/kg/min) vs 11.2 % in patients who received the standard dose (2 microgram/kg/min) when eptifibatide was administered in the early routine fashion (p=0.81).
Danish: Ved administration af tidlig rutinemæssig eptifibatid (p = 0,81) var hændelsesraten for det primære endepunkt henholdsvis 11,9 % hos de patienter, der fik en nedsat dosis (1 mikrogram/kg/min.
English: These may affect up to 1 in 10,000 people - serious bleeding (for example, bleeding inside the abdomen, inside the brain, and into the lungs).
Danish: Dette kan forekomme hos op til 1 ud af 10.000 patienter - alvorlig blødning (fx blødende mavesår, hjerneblødning, eller blødning i lungerne) - blødning med dødelig udgang - alvorligt nedsat antal blodplader (celler der får blodet til at størkne) - kløende udslæt, såsom nældefeber - pludselig, alvorlig allergisk reaktion.
English: In patients with previous immune-mediated thrombocytopenia from other parenteral GP IIb/IIIa inhibitors, there are no data with the use of eptifibatide.
Danish: Der er ingen data for anvendelse af eptifibatid til patienter, der tidligere har fået immunmedieret trombocytopeni som følge af brug af andre parenterale GP IIb/IIIa-hæmmere.
English: If you have any questions, ask your doctor or hospital pharmacist or nurse.
Danish: Kontakt lægen eller sundhedspersonalet, hvis du har spørgsmål.
English: - if you have been treated with another medicine of the same type as Eptifibatide Accord.
Danish: (undtagen den medicin, du kan få som en del af behandlingen med Eptifibatid Accord).
English: 2.7 % of patients who received a reduced dose (1microgram/kg/min) vs 4.2 % of patients who received the standard dose (2 microgram/kg/min) when eptifibatide was administered in the early routine fashion (p=0.36).
Danish: ), sammenlignet med 11,2 % hos de patienter, der fik standarddosis (2 mikrogram /kg/min.).
English: - if you have had a stroke within the past 30 days or any haemorrhagic stroke (also, be sure your doctor knows if you ever had a stroke).
Danish: 30 dage - hvis du har haft et slagtilfælde inden for de sidste 30 dage eller nogen form for hjerneblødning
English: ESPRIT trial
Danish: ESPRIT-undersøgelsen
English: − if you have or have had difficulty with your blood clotting or a low blood platelet count.
Danish: 6 uger - hvis du har eller har haft blødningsproblemer - hvis du har eller har haft besvær med størkning af blod eller et lavt antal blodplader - hvis du har eller har haft svær hypertension (forhøjet blodtryk) - hvis du har eller har haft alvorlige nyre- eller leversygdomme - hvis du er blevet behandlet med anden medicin af samme type som Eptifibatid Accord.
English: − minor or major bleeding, (for example, blood in urine, blood in stool, vomiting blood, or bleeding with surgical procedures).
Danish: Dette kan forekomme hos flere end 1 ud af 10 patienter: - større eller mindre blødning (fx blod i urin eller afføring, i opkast eller i forbindelse med operation) - blodmangel (nedsat antal røde blodlegemer).
English: This commitment will be reviewed after 5 years.
Danish: Dette tilsagn vil blive gennemgået efter fem år.
English: - pregnant or think you may be pregnant.
Danish: - gravid eller tror, du måske er gravid.
English: Furthermore, the Risk Management Plans of these products should also be harmonised.
Danish: Desuden skulle risikostyringsplanerne for disse produkter også harmoniseres.
English: Treatment consists of appropriate supportive measures.
Danish: Behandlingen består af nødvendige understøttende tiltag.
English: Some patients may require long-term follow up.
Danish: Nogle patienter har brug for en langvarig opfølgning.
English: Your doctor will discuss contraception with you.
Danish: Lægen vil drøfte prævention med dig.
English: The significance of this finding to humans is unknown.
Danish: Betydningen af dette resultat for mennesker er ukendt.
English: These concerns are individually discussed in the following sections.
Danish: Disse problemer drøftes enkeltvis i følgende afsn
English: Risk Management Plans
Danish: Risikostyringsplaner
English: In general there are no signs of teratogenicity in animals.
Danish: Der er generelt ingen tegn på teratogenicitet hos dyr.
English: Cardiovascular status should be carefully monitored.
Danish: Kardiovaskulær status skal monitoreres omhyggeligt.
English: These will include:
Danish: De omfatter:
English: Appropriate educational placement is essential, and psychosocial intervention is generally necessary.
Danish: Relevant pædagogisk støtte er essentiel, og psykosocial intervention er sædvanligvis nødvendig.
English: Tablets should not be chewed, divided, or crushed.
Danish: Tabletterne bør ikke tygges, deles eller knuses.
English: Your doctor will therefore carefully be watching you or your child's height and weight.
Danish: Din læge vil derfor nøje kontrollere din eller dit barns højde og vægt,
English: Use with drugs that elevate blood pressure
Danish: Lægemidler, der øger blodtrykket
English: There is a risk of sudden blood pressure increase during surgery.
Danish: Der er risiko for pludselig blodtryksstigning under operation.
English: MTA Study.
Danish: MTA-undersøgelse.
English: Overall Safety Discussion and Conclusion
Danish: Drøftelse af og konklusion om generel sikkerhed
English: On going studies on sex maturation will also provide new data in this aspect.
Danish: Igangværende undersøgelser af kønsmodning vil også give nye data om dette aspekt.
English: The reviews of the published literature and epidemiological data reached the same conclusion.
Danish: Gennemgangene af den publicerede litteratur og de epidem førte til samme konklusion.
English: A risk to the suckling child cannot be excluded.
Danish: Det kan ikke udelukkes, at der er en risiko for det ammende barn.
English: Anxiety, agitation or tension
Danish: Angst, agitation eller anspændthed
English: • whether there is a family history of sudden unexplained death in the family.
Danish: • om der i jeres familie har været pludselige, uforklarlige dødsfald
English: The likelihood of having a side effect is as follows:
Danish: Sandsynligheden for at få bivirkninger er som følger:
English: U Nákladového nádraží 10 130 00 Praha 3, Czech Republic
Danish: U Nákladového nádraží 10 130 00 Praha 3, Den Tjekki Republik
English: Post-marketing reports included cases of central, peripheral and unspecified cyanosis.
Danish: De indberettede hændelser efter markedsføringen omfattede tilfælde med central, perifer og ikke-specificeret cyanose.
English: It may harm other people, even if they have the same symptoms as your child
Danish: for andre, selvom de har de samme symptomer, som dit barn har.
English: Where indication was reported, this was most commonly ADHD, but there were also a significant proportion of reports with other indications reported.
Danish: I de tilfælde, hvor indikationen blev angivet, var der hyppigst tale om men der var også en markant andel af indberetninger med andre indikationer.
English: Dose titration should be started at the lowest possible dose.
Danish: Dosistitrering skal indledes ved den lavest mulige dosis.
English: The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present.
Danish: Patienten skal beskyttes mod at gøre skade på sig selv og mod eksterne stimuli, der v overstimulering, som allerede er til stede.
English: “Effects of stimulant medication on growth in the MTA (Multimodal Treatment Study of ADHD)” follow-up, carried out by the MTA Cooperative Group.
Danish: "Effects of stimulant medication on growth in the MTA (Multimodal Treatment Study of ADHD) (Virkningerne af stimulerende lægemidler på vækst i undersøgelse af multimodal behandling af ADHD)" opfølgning, foretaget af MTA Cooperative Group.
English: In addition risk minimisation measures need to be in place in order to continuously identify and evaluate potential risks.
Danish: Derudover skal tiltag til risikominimering være på plads, så potentielle risici løbende kan identificeres og evalueres.
English: • severe changes in mood or personality
Danish: • alvorlige ændringer i stemningsleje eller personlighed
English: Drug testing This medicine may give a positive result when testing for drug use.
Danish: Narkotikatest Dette lægemiddel kan give et positivt resultat ved test for brug af narkotika.
English: Drug utilisation studies, including evaluation of Off-Label Use/ Abuse
Danish: Undersøgelser af lægemiddelanvendelse, herunder evaluering af brug uden for den godkendte indikation/misbrug
English: There is little evidence to suggest that patients at higher risk can be identified and the initial onset of symptoms may be the first indication of an underlying clinical problem.
Danish: Der er noget, der tyder på, at patienter med højere risiko kan identificeres, og initial indsættelse af symptomer kan være den første indikation på et underliggende klinisk problem.
English: Smartinska 53, 1000 Ljubljana, Slovenia
Danish: Smartinska 53, 1000 Ljubljana, Slovenien
English: The text differed among MAHs, but the recommendation of baseline assessment and monitoring of growth was common to most products.
Danish: Tekste blandt de forskellige indehavere af markedsføringstilladelserne, men anbefalingen af en vurdering ved baseline og overvågning af vækst var fælles for de fleste af produkterne.
English: SE - Sweden Novartis Sverige AB Box 1150
Danish: SE - Sverige Novartis Sverige AB Box 1150
English: • how you or your child are feeling e.g. are you feeling emotional, having strange thoughts or if you have had any of these feelings in the past.
Danish: • hvordan du eller dit barn har det, om du for eksempel er emotionel, har sær tidligere har haft nogen af disse følelser
English: Children with severe ADHD can develop poor self-esteem, emotional and social problems.
Danish: Børn med svær ADHD kan udvikle lavt selvværd og følelsesmæssige og sociale problemer.
English: The risk of carcinogenicity, effects on growth and the effects of long-term treatment were also evaluated.
Danish: Risikoen for carcinogenicitet, virkninger på vækst og langtidsbehandling blev også vurderet.
English: 2.6 Effects of long term treatment
Danish: 2.6 Virkninger af langtidsbehandling
English: • Checklists for actions before prescribing, and for ongoing monitoring for prescribers and, if possible, carers
Danish: Tjeklister for handlinger, der skal foretages inden ordination, og for løbende overvågning for ordinerende læger og, hvis det er muligt, plejepersonale
English: Conversely, the d- and l- enantiomers of methylphenidate do not relevantly inhibit cytochrome P450 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A.
Danish: Omvendt hæmmer d- og l-enantiomerene af methylphenidat ikke cytochrom P450 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 eller 3A i relevant grad.
English: Physicians should evaluate the need for adjustment of the treatment regimen in patients experiencing behaviour changes.
Danish: Lægen bør vu behov for justering af behandlingen hos patienter, der oplever sådanne ændringe
English: The MAHs agree to evaluate suitable comparator groups.
Danish: Indehaverne af markedsføringstilladelserne har indvilliget i at evaluere passende sammenligningsgrupper.
English: The effects of methylphenidate on final height and final weight are currently unknown and being studied.
Danish: Virkningen af methylphenidat på endelig højde og vægt er i øjeblikket ukendt og
English: Very common (more than 1 out of 10 persons) Common (more than 1 out of 100 persons and less than 1 out of 10 persons) Uncommon (more than 1 out of 1,000 persons and less than 1 out of 100 persons) Rare (more than 1 out of 10,000 persons and less than 1 out of 1,000 persons) Very rare (less than 1 out of 10,000 persons) Not known (cannot be estimated from the available data).
Danish: Meget almindelig (mere end 1 ud af 10 personer) Almindelig (mere end 1 ud af 100 personer og mindre end 1 ud af 10 personer) Ikke almindelig (mere end 1 ud af 1.000 personer og mindre end 1 ud af 100 personer) Sjælden (mere end 1 ud af 10.000 personer og mindre end 1 ud af 1.000 personer)
English: Methylphenidate is not recommended for use during pregnancy unless a clinical decision is made that postponing treatment may pose a greater risk to the pregnancy.
Danish: Methylphenidat frarådes under graviditet, med mindre der tages en klinisk beslutning om, at udskydelse af behandlingen kan udgøre en større risiko for graviditeten.
English: This product contains methylphenidate which may induce a false positive laboratory test for amphetamines, particularly with immunoassay screen test.
Danish: Dette produkt indeholder methylphenidat, hvilket kan inducere en falsk positiv labor amfetamin, især ved immunoassay-screenings-test.
English: It must only be prescribed by a doctor and must therefore not be passed on to anyone else.
Danish: Denne medicin er beregnet udelukkende til d Medicinen skal ordineres af en læge og må derfor ikke gives videre til andre.
English: Growth, Development and Sexual Maturation
Danish: Vækst, udvikling og kønsmodning
English: Methyphenidate should be used together with other forms of treatment, as part of a comprehensive treatment programme.
Danish: Methylphenidat bør anvendes sammen med andre former for behandling som del af behandlingsprogram.
English: Attention-Deficit/Hyperactivity Disorder (ADHD)
Danish: ADHD (Attention-deficit hyperactivity disorder)
English: • to measure you or your child's height and weight, heart rate and blood pressure and will record these on a chart
Danish: • måling af din eller dit barns højde og vægt, hjerterytme og blodtryk og re resultaterne i et skema
English: The proposed patient enrolment age will be as young as possible consistent with the age restrictions of the label (i.e. children aged 6 years or more).
Danish: Den foreslåede aldersgrænse for inklu undersøgelsen vil være så lav som muligt inden for de aldersbegrænsninger, der er f etiketteringen (dvs. børn fra 6 år).
English: <you or your child should take the next dose when it is due.
Danish: <Du eller dit barn skal tage den næste dosis på det normale tidspunkt.
English: Member State (EU/EEA)
Danish: (EU/EØS)
English: - breast-feeding or planning to breast-feed.
Danish: - ammer eller planlægger at amme.
English: ADHD is defined by ‘core' signs of lack of attention, hyperactivity and impulsiveness.
Danish: ADHD er kendetegnet ved "grundlæggende" tegn på opmærksomhedsmangel, hy impulsivitet.
English: The choice of formulation of methylphenidate-containing product will have to be decided by the treating specialist on an individual basis and depends on the intended duration of effect.
Danish: Valget af methylphenidatformulering skal foretages af den behandlende specialist på individuel basis og afhænge af den forventede varighed af virkningen.
English: Important information about some of the ingredients of methylphenidate {To be completed nationally, as appropriate]
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i methylphenidat [Udfyldes nationalt, hvis relevant]
English: It is important that you provide all information so your doctor can decide if methylphenidate is the correct medicine for you or your child.
Danish: Det er vigtigt, at du giver alle oplysninger, så din læge kan beslutte, om methylphe korrekte medicin for dig eller dit barn.
English: Methylphenidate is not considered to be teratogenic in rats and rabbits.
Danish: Methylphenidat anses ikke som værende teratogen i rotter og kaniner.
English: The difficulty in determining the effects of methylphenidate in most of the studies due to the co-morbidity between ADHD and psychiatric disorders was also noted.
Danish: Vanskeligheden med at bestemme virkningerne af methylphenidat i de fleste af undersøgelserne på grund af komorbiditeten mellem ADHD og psykiatriske lidelser blev også bemærket.
English: If you or your child do not feel better with this medicine, your doctor may decide a different treatment is needed.
Danish: Hvis du eller dit barn ikke får det bedre med denne medicin, kan lægen beslu anvendes en anden behandling.
English: If surgery is planned using a halogenated anaesthetic (a certain type of anaesthetic), you or your child should not take methylphenidate on the day of surgery, due to the risk of a sudden rise in blood pressure during surgery.
Danish: Hvis der er planlagt en operation med halogeneret anæstesi (en bestemt type narkose), må du eller dit barn ikke tage methylphenidat på dagen for operationen på grund af risikoen for en pludselig stigning i blodtrykket under operationen.
English: • Hyperthyroidism or Thyrotoxicosis
Danish: • Hyperthyreosis eller tyrotoksikose
English: Effects on growth and maturation
Danish: Indvirkning på vækst og modning
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET OG INDLÆGSSEDLERNE FREMLAGT AF EMEA
English: The most common side effects are nervousness, sleeplessness and headache.
Danish: De mest almindelige bivirkninger er nervøsitet, søvnløshed og hovedpine.
English: When used for a long period of time, methylphenidate may cause reduced growth (weight gain and/or height) in some children.
Danish: Når methylphenidat anvendes i en lang periode, kan det hos nogle børn forårsage reduceret vækst (vægtøgning og/eller højde).
English: This scientific assessment on methylphenidate has reviewed the available safety data from clinical trials, preclinical studies, spontaneous reports and published literature.
Danish: I denne videnskabelige vurdering af methylphenidat har man gennemgået de t sikkerhedsdata fra kliniske undersøgelser, prækliniske undersøgelser, spontane ind publiceret litteratur.
English: or cardiovascular status, growth, appetite, development of de novo or worsening of pre-existing psychiatric symptoms
Danish: karstatus, vækst, appetit, udvikling af nye eller forværring af tidligere eksisterende psy symptomer.
English: Very common: insomnia, nervousness
Danish: Meget almindelig: søvnløshed, nervøsitet
English: 41470 Neuss, Germany
Danish: 41470 Neuss, Ty
English: Patients should be warned of these possible effects and advised that if affected, they should avoid potentially hazardous activities such as driving or operating machinery.
Danish: Patienter bør advares om disse mulige bivirkninger og å potentielt farlige aktiviteter, såsom føre motorkøretøj eller betjene maskiner, hvis de påvirkes.
English: Foetal toxicity (i.e. total litter loss) and maternal toxicity was noted in rats at maternally toxic doses.
Danish: Føtal toksicitet (f.eks. totalt tab af kuld) og maternel toksicitet blev observeret i rotter ved maternelt toksiske doser.
English: Cardiovascular status
Danish: Kardiovaskulær status
English: A review of all available data found that the more specific terms “over-focussing” and “repetitive behaviours” reflect the observed effects of methylphenidate and should be added as possible adverse effects in the Product Information.
Danish: En gennemgang af de tilgængelige data viste, at de mere specifikke udtryk "overfokusering" og "repetetiv adfærd" afspejler de observerede virkninger af methylphenidat og bør tilføjes under bivirkninger i produktinformationen.
English: The product information (PI) of most products contains key elements on the above safety concerns of methylphenidate.
Danish: Produktinformationen (PI) for de fleste af produkterne omfatter nøgleelementer sikkerhedsproblemer ved methylphenidat.
English: Metabolism and nutritional disorders*
Danish: Metabolisme og ernæring*
English: The PL wording agreed by the CHMP should be revised to improve patient readability, and will then be user-tested.
Danish: MP godkendte ordlyd i indlægssedlen skal revideres, så den bliver mere patientvenlig, hvorefter den skal brugertestes.
English: Use with centrally acting alpha-2 agonists (e.g. clonidine) Serious, adverse events, including sudden death, have been reported in concomitant use with clonidine.
Danish: Centralt virkende alfa-2-agonister (f.eks. clonidin) Alvorlige bivirkninger, herunder pludselig død, har været indberettet ved samtidig anvendelse af clonidin.
English: Pregnancy There is a limited amount of data from the use of methylphenidate in pregnant women.
Danish: Graviditet Der foreligger begrænsede data om anvendelsen af methylphenidat hos gravide kvinder.
English: Careful supervision is required during withdrawal from abusive use since severe depression may occur.
Danish: Der kræves omhyggelig kontrol under seponering ved misbrug, da der kan opstå alvorlig depression.
English: The safety of using methylphenidate in combination with clonidine or other centrally acting alpha-2 agonists has not been systematically evaluated.
Danish: Sikkerheden ved anvendelsen af methylphenidat sammen med clonidin o virkende alfa-2-agonister er ikke blevet systematisk undersøgt.
English: MAHs are requested to list these terms in the PI for those products where the information is missing.
Danish: Indehaverne af markedsføringstilladelserne anmodes om at angive en liste med disse reaktioner i PI'en for de produkter, hvor disse oplysninger mangler.
English: • whether there is a family history of tics
Danish: • om der i familien har været tics (ansigtstrækninger).
English: The MAHs should include, in the core safety specification, the final core table of identified and potential risks as requested by the CHMP.
Danish: Indehaverne af markedsføringstilladelserne skal i kernepunkterne i deres sikkerhedsspecifikationer inkludere den endelige tabel med identificerede og potentielle risici i henhold til CHMP's krav.
English: Like all medicines, methylphenidate can cause side effects, although not everybody gets them.
Danish: Methylphenidat kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: B-2600 BERCHEM
Danish: B-2600 BERCHE
English: In terms of the suicidality the MAHs committed to make use of the current knowledge and to conduct a meta-analysis on the available results from different clinical studies.
Danish: Med hensyn til suicidalitet har indehaverne af markedsføringstilladelserne indvilliget i at bruge deres nuværende viden og gennemføre en meta-analyse af de tilgængelige resultater fra forskellige kliniske undersøgelser.