FrancophonIA/ELRC3.0 huggingface dataset:
English: - skin cancer; - lack of red blood cells so you are pale and feel tired; being more prone to infections because of a lack of white blood cells; lack of blood platelets which can lead to bruising and a tendency to bleed; - decreased appetite; - confusion; hallucinations; depression; anxiety; bad dreams; unable to sleep; abnormal thinking and perceptions, losing touch with reality; feeling agitated; suicidal; being disorientated; exaggerated feeling of happiness; increased sex drive; grinding of teeth; feeling paranoid and delusional; - movement disorder in which a person's muscles contract uncontrollably; sudden, sometimes unpredictable changes in symptoms, due to the return of Parkinson's disease symptoms; sleepiness; dizziness; worsening of Parkinson's disease; pins and needles; headache; tremors; seizure; sudden onset of sleep; restless legs syndrome; ataxia (disorder affecting co-ordination, balance and speech); distorted sense of taste; mental health disorders that affecting learning, memory, perception, and problem solving; Horner's syndrome (an eye disorder); dementia;
Danish: - hudcancer, - mangel på røde blodlegemer, så du er bleg og føler dig træ;, øget modtagelighed for infektioner på grund af mangel på hvide blodlegemer; mangel på blodplader, der kan føre til blå mærker på huden og blødningstendens, - nedsat appetit, - forvirring, hallucination, depression, angst, dårlige drømme, manglende evne til at sove, unormal tankegang og sanseopfattelse, tab af kontakt med virkeligheden, urofølelse, selvmordtanker, desorientering, overdreven lykkefølelse, forøget kønsdrift, tænderskæren, paranoia og vrangforestilling,
English: Blood bilirubin increased, Blood glucose increased, Blood creatinine increased, Blood uric acid increased, Haemoglobin decreased, Haematocrit decreased, Blood urine present, Blood urea increased, Blood alkaline phosphatase increased,
Danish: Forhøjet aspartataminotransferase, forhøjet alaninaminotransferase, forhøjet lactatdehydrogenase i blodet, forhøjet bilirubin i blodet, forhøjet glucose i blodet, forhøjet creatinin i blodet, forhøjet urinsyre i blodet, reduceret hæmoglobin, reduceret hæmatokrit, blod i urinen, forhøjet urinstof i blodet, forhøjet alkalisk phosphatase i blodet, positiv Coombs test, positiv test for hvide blodlegemer i urinen, positiv bakterietest, reduceret vægt, forøget vægt
English: Ink
Danish: Blæk
English: Do not swallow capsules.
Danish: Kapslerne må ikke sluges.
English: Twist and pull off the mouthpiece.
Danish: Drej og træk mundstykket af.
English: Subject features
Danish: Forsøgsperson-karakteristika
English: Blue Handle Capsule Chamber White Mouthpiece Blue Cap
Danish: Blåt håndtag Kapselkammer
English: Levodopa has been associated with somnolence and episodes of sudden sleep onset (see section 4.7).
Danish: Somnolens og episoder med pludseligt opstået søvnanfald Levodopa har været forbundet med somnolens og episoder med pludseligt opstået søvnanfald (se pkt.
English: Step 1: Gather supplies
Danish: Klargør din dosis Trin 1: Saml materialerne
English: - medicines for your Parkinson's disease called selective MAO inhibitors such as rasagiline, selegiline and safinamide, COMT inhibitors such as entacapone, tolcapone and opicapone, or anticholinergics such as orphenadrine and trihexyphenidyl;
Danish: selegilin og safinamid, COMT-hæmmere, såsom entacapon, tolcapon og opicapon, eller antikolinergika, såsom orphenadrin og trihexyphenidyl, - lægemidler mod mentale tilstande, herunder skizofreni, såsom benperidol, haloperidol,
English: Step 3: Twist and pull off white mouthpiece Twist and pull off the mouthpiece to separate it from the handle.
Danish: Trin 3: Drej og træk det hvide mundstykke af
English: Step 7: Hold inhaler away and breathe out Stand or sit with your head and chest upright.
Danish: Stå eller sid med dit hoved og bryst ret op. Hold inhalatoren vandret og væk fra munden.
English: Talk to your doctor or pharmacist if you develop any of the symptoms below whilst using Inbrija: - sudden sleep attacks or sometimes feeling very sleepy; - changes in or worsening of your mental state, which may be severe such as psychotic and suicidal behaviour; - hallucinations, along with being confused, unable to sleep and excessive dreaming.
Danish: Kontakt lægen eller apotekspersonalet, hvis du udvikler et eller flere af følgende symptomer nedenfor, mens du bruger Inbrija: - pludselige søvnanfald, eller du af og til føler dig meget søvnig,
English: It is recommended to administer this medicinal product cautiously to patients with severe renal disease (see section 4.2).
Danish: Det anbefales, at dette lægemiddel administreres med forsigtighed til patienter med svær nyresygdom (se pkt.
English: It is recommended to administer this medicinal product cautiously to patients with severe hepatic impairment (see section 4.2).
Danish: Det anbefales, at dette lægemiddel administreres med forsigtighed til patienter med svært nedsat leverfunktion (se pkt.
English: Step 6: Attach white mouthpiece Align arrows on mouthpiece and handle
Danish: Trin 6: Påsæt det hvide mundstykke
English: Release the mouthpiece.
Danish: Giv slip på mundstykket.
English: Prepare your dose
Danish: Påsæt mundstykket
English: Step 2: Remove blue cap from inhaler
Danish: Trin 2: Tag den blå hætte af inhalatoren Træk hætten lige af.
English: If you use more Inbrija than you should
Danish: Hvis du har brugt for meget Inbrija
English: Euphoric mood, Libido increased, Bruxism,
Danish: 4.4), desorientering, dopamindysreguleringssyndrom, euforisk humør, øget libido, bruksisme, paranoia, vrangforestilling
English: Hyperhidrosis, Rash,
Danish: Angioødem, hyperhidrose, udslæt, pruritus,
English: Adverse reactions reported with oral levodopa
Danish: Bivirkninger i kliniske studier med Inbrija Bivirkninger rapporteret med oral levodopa
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Inbrija.
Danish: Tal med lægen eller apotekspersonalet, før du bruger Inbrija, hvis du er i tvivl, om noget af ovennævnte gælder for dig.
English: Step 8: Breathe in deeply to inhale powder While keeping the inhaler level, close your lips firmly around the mouthpiece.
Danish: Trin 8: Tag en dyb indånding for at inhalere pulveret
English: Inbrija has not specifically been studied in patients with renal impairment.
Danish: Inbrija er ikke blevet specifikt undersøgt hos patienter med nedsat leverfunktion.
English: Compress mouthpiece only once
Danish: Pres kun mundstykket sammen én gang
English: Breast-feeding
Danish: COMT-hæmmere
English: Posology
Danish: Resumé
English: Hold the inhaler level and away from your mouth.
Danish: Inhalatoren holdes vandret, og læberne lukkes fast omkring mundstykket.
English: Abnormal thinking including anxiety, depression, being agitated, being paranoid, delusional, or disorientated, aggressive behaviour and delirious;
Danish: Konfusionstilstand, hallucination, depression, angst, unormale drømme, insomni,
English: Inbrija has not been studied in patients with renal impairment.
Danish: Inbrija er ikke blevet undersøgt hos patienter med nedsat nyrefunktion.
English: Inbrija has not been studied in patients with hepatic impairment.
Danish: Inbrija er ikke blevet undersøgt hos patienter med nedsat leverfunktion.
English: Adverse reactions in clinical trials with Inbrija
Danish: Der er dog ikke identificeret nogen tilfælde i kliniske studier med Inbrija.
English: - urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Danish: Unormale tanker, herunder angst, depression, uro, paranoia, vrangforestilling eller desorientering, aggressiv adfærd og delirium, - forværring af eventuelle åndedrætssymptomer, eller du får en luftvejsinfektion, - en trang til at opføre dig på en måde, som er usædvanlig for dig, eller du ikke kan modstå impulsen, trangen eller fristelsen til at udføre bestemte aktiviteter, som kan skade dig selv eller andre.
English: Attach mouthpiece
Danish: Mave-tarm-kanalen
English: It is best to take tablets at the same time each day.
Danish: Det er bedst at tage tabletterne på samme tid hver dag.
English: This is shown in the table below.
Danish: Dette er vist i tabellen nedenfor.
English: Date of latest renewal: 9 July 2011
Danish: Dato for seneste fornyelse: 9. juli 2011
English: - hallucination (seeing or hearing things that are not there)
Danish: - Hallucinationer (man ser eller hører ting, der ikke er der)
English: The combination should be used with caution.
Danish: Kombinationen skal anvendes med forsigtighed.
English: The mechanisms are incompletely known.
Danish: Mekanismerne er ikke fuldstændigt kendt.
English: The above serious side effects may require urgent medical attention.
Danish: Ovennævnte alvorlige bivirkninger kan kræve øjeblikkelig lægehjælp.
English: Interaction studies have only been performed in adults.
Danish: Der er udelukkende udført interaktionsstudier med voksne.
English: Not known (cannot be estimated from the available data)*
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenvære nde data)*
English: Clostridium difficile-associated disease
Danish: Clostridium difficile-associeret sygdom
English: Your doctor will tell you how many Ketek tablets to take, at what time and for how long.
Danish: Din læge vil fortælle dig, hvor mange Ketek-tabletter du skal tage, og hvornår du skal tage dem.
English: It may happen again when you take the next dose of Ketek.
Danish: Det kan ske igen, når du tager den næste dosis af Ketek.
English: Ketek should not be used during pregnancy unless clearly necessary.
Danish: Ketek bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: There are no adequate data from the use of Ketek in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af Ketek til gravide kvinder.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 July 2001
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 9. juli 2001
English: The tablets should be swallowed whole with a sufficient amount of water.
Danish: Tabletterne bør synkes hele med tilstrækkelig mængde vand.
English: Most events were mild to moderate; however, severe cases have been reported.
Danish: De fleste hændelser var lette til moderate; imidlertid har alvorlige tilfælde været rapporteret.
English: This should be taken into account when treating infections caused by H. influenzae.
Danish: Dette bør medtages når infektioner forårsaget af H. influenzae skal behandles.
English: MARKETING AUTHORISATION NUMBERS EU/1/01/191/001-004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/191/001-004
English: Oral administration of midazolam concomitantly with Ketek should be avoided.
Danish: Oral administration af midazolam samtidig med Ketek bør undgås.
English: You may experience this within a few hours of taking your daily dose of Ketek the first or second time.
Danish: Du kan opleve dette inden for få timer efter at have taget din daglige dosis af Ketek første eller anden gang.
English: No patient in either group developed a ΔQTc >60 msec.
Danish: Ingen patienter i nogen af grupperne viste en ΔQTc> 60 msek.
English: Erythema multiforme
Danish: Eksem Erythema multiforme
English: If you are pregnant do not take Ketek as the safety of this medicine in pregnancy is insufficiently established.
Danish: Du må ikke tage Ketek, hvis du er gravid, da sikkerheden af denne medicin under graviditet ikke er tilstrækkeligt fastslået.
English: These visual disturbances may happen suddenly and last several hours.
Danish: Disse synsforstyrrelser kan opstå pludseligt og vare flere timer.
English: The absolute bioavailability is about 57% after a single dose of 800 mg.
Danish: Den absolutte biotilgængelighed er ca. 57% efter en enkelt dosis på 800 mg.
English: Antibiotics stop the growth of bacteria which cause
Danish: Antibiotika stopper væksten af bakterier, som er skyld i
English: The volume of distribution is 2.9±1.0 l/kg.
Danish: Fordelingsvolumen er 2,9 ± 1,0 l/kg.
English: The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Danish: Forekomsten af resistens kan variere geografisk og over tid for udvalgte arter, og lokal information om resistensudviklingen er ønskelig, specielt ved behandling af alvorlige infektioner.
English: Hypokalaemia and quinidine had additive/supraadditive effects in vitro while potentiation was evident with sotalol.
Danish: Hypokaliæmi og quinidin havde additive / supraadditive virkninger in vitro, mens potenseringen var åbenbar med sotalol.
English: The other side effects listed below are given with an estimation of the frequency with which they may occur with Ketek:
Danish: De andre bivirkninger listet i det følgende er anført med den estimerede hyppighed, de kan forekomme i med Ketek:
English: Caution should be taken when S. aureus is the suspected pathogen and there is a likelihood of erythromycin resistance based on local epidemiology.
Danish: Der bør udvises forsigtighed, når S. aureus er mistænkt patogen og der er sandsynlighed for erythromycin resistens baseret på lokal epidiomologi.
English: The midazolam halflife was increased about 2.5-fold.
Danish: Midazolam halveringstiden steg ca. 2,5 gange.
English: The correlation between macrolide MICs and clinical outcome is weak for H. influenzae.
Danish: Korrelationen mellem makrolide MIC-værdier og klinisk udfald er svagt for H. influenzae.
English: Ketek is not recommended for use in children less than 12 years old.
Danish: Ketek er ikke anbefalet til børn under 12 år.
English: They typically occurred within a few hours after the first or second dose, recurred upon subsequent dosing, lasted several hours and were fully reversible either during therapy or following the end of treatment.
Danish: Det viste sig typisk indenfor få timer efter den første eller anden dosis, gentog sig efter efterfølgende doser, varede i flere timer og var fuldt reversibelt enten under behandling eller efter ophør af behandling.
English: The onset of the visual reaction may be sudden.
Danish: Den visuelle reaktion kan indtræde pludseligt.
English: This administration corresponds to free active substance systemic exposure levels of at least 9 times the expected levels in human after 1 month and less than the expected level in humans after 6 months, respectively.
Danish: Denne administration svarer til et systemisk påvirkningsniveau af det frie aktive stof på henholdsvis mindst 9 gange det forventede niveau hos mennesker efter 1 måned og mindre end 1 gang det forventede niveau hos mennesker efter 6 måneder.
English: Patients should be cautioned about the potential effects of these events on the ability to drive or operate machinery.
Danish: Patienterne bør manes til forsigtighed overfor de mulige virkninger af disse hændelser på evnen til at køre bil eller til at betjene maskiner.
English: - increase of certain white blood cells, detected by blood test (eosinophilia).
Danish: - Forhøjelse af visse hvide blodlegemer, påvist ved blodprøve (eosinofili)
English: Following oral administration, telithromycin is fairly rapidly absorbed.
Danish: Efter oral administration absorberes telithromycin ganske hurtigt.
English: There were no reports of TdP or other serious ventricular arrhythmias or related syncope in the clinical program and no subgroups at risk were identified.
Danish: Der var ingen rapporter på TdP eller andre alvorlige ventrikulære arytmier eller relateret synkope i det kliniske program, og der blev ikke fundet risiko-subgrupper.
English: The patients should be carefully observed and given symptomatic and supportive treatment.
Danish: Patienten bør observeres nøje og symptomatisk og understøttende behandling kan gives.
English: The safety and efficacy of Ketek in children below 12 years of age have not been established (see section 5.2).
Danish: Sikkerheden og effekten af Ketek hos børn under 12 år er ikke fastlagt (se pkt.
English: They are available in packs of 10, 14, 20 and 100 tablets.
Danish: De fås i pakninger med 10, 14, 20 og 100 tabletter.
English: More than 80% of MRSA express cMLSB.
Danish: Flere end 80 % af MRSA udtrykker cMLSB
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the
Danish: Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de fremsendes
English: There were no significant changes in ECG parameters and no signs of digoxin toxicity were observed.
Danish: Trods dette er der ingen signifikante ændringer i EKG-parametrene, og der er ikke set tegn på digoxin-toksicitet.
English: Ketek is an antibiotic of the type macrolides.
Danish: Ketek er et antibiotikum af typen makrolider.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Danish: Hvis nødvendigt, bør der søges ekspertbistand, hvis lokal prævalens af resistens er af en sådan karakter, at anvendelse af stoffet i det mindste for nogle typer af infektioner er diskutabel.
English: Ketek is indicated for the treatment of the following infections:
Danish: Ketek er indiceret til behandling af følgende:
English: Do not take a double dose to make up
Danish: Du må ikke tage en dobbeltdosis som erstatning for den
English: Swallow the tablets whole with a glass of water.
Danish: Tabletterne synkes hele med et glas vand.
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
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) 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 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: These effects usually disappear during treatment or after completion of treatment with Ketek.
Danish: Disse bivirkninger forsvinder som regel under behandlingen eller efter afslutning af behandling med Ketek.
English: - In adolescents of 12 years and older, Ketek is used to treat infections of the throat.
Danish: - Hos unge på 12 år og opefter anvendes Ketek til behandling af infektioner i halsen.
English: - medicines known to affect the way your heart beats (drugs that prolong the QT interval).
Danish: - medicin der vides at påvirke den måde, dit hjerte slår (medicin, der forlænger QT-intervallet).
English: Most of them are mild and transient, but very rare cases of serious adverse liver reactions and liver failure, including fatal cases, have been reported.
Danish: De fleste er lette og forbigående men meget sjældne tilfælde af alvorlige leverreaktioner og leversvigt, inklusiv dødelige tilfælde, har været rapporteret.
English: Limited data, obtained in paediatric patients 13 to 17 years of age, showed that telithromycin concentrations in this age group were similar to the concentrations in patients 18 to 40 years of age.
Danish: Begrænsede data fra studier hos pædiatriske patienter i alderen 13-17 år viser, at koncentrationen af telithromycin i denne aldersgruppe svarer til koncentrationerne hos patienter i alderen 18-40 år.
English: In both studies, higher renal elimination was observed in the hepatically impaired patients.
Danish: I begge studier blev observeret højere nyre elimination hos patienter med nedsat leverfunktion.
English: Atrial arrhythmia, hypotension, bradycardia
Danish: Atriel arytmi, hypotension, bradykardi
English: These symptoms may appear as early as after the first dose of Ketek.
Danish: Disse symptomer kan forekomme så tidligt som efter den første dosis af
English: - if you suffer from myasthenia gravis, a rare disease which causes muscle weakness.
Danish: - hvis du lider af myasthenia gravis, en sjælden sygdom, som giver muskelsvaghed.
English: In community acquired pneumonia, efficacy has been demonstrated in a limited number of patients with risk factors such as pneumococcal bacteraemia or age higher than 65 years.
Danish: Ved pneumoni er der påvist effekt hos et begrænset antal patienter med risikofaktorer såsom pneumococ bacteriæmi eller alder mere end 65 år.
English: Very common side effects (may affect more than 1 in 10 people) - diarrhoea, usually mild and temporary.
Danish: Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 patienter) - Diarré, sædvanligvis let og midlertidig.
English: As for macrolides, H. influenzae is classified as intermediately susceptible.
Danish: Som for macrolider, er H. influenzae klassificeret som intermediært følsom.
English: These hepatic reactions were observed during or immediately after treatment, and in most cases were reversible after discontinuation of telithromycin.
Danish: Disse leverreaktioner blev observeret under eller umiddelbart efter behandling og var i de fleste tilfælde reversible efter seponering af telithromycin.
English: Previous history of hepatitis and/or jaundice associated with the use of telithromycin.
Danish: Tidligere hepatitis og/eller gulsot forbundet med anvendelse af telithromycin.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release:
Danish: FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på fremstillerne ansvarlige for batchfrigivelse:
English: In 2,461 patients treated by Ketek in phase III clinical trials, and during post-marketing experience, the following undesirable effects possibly or probably related to telithromycin have been reported.
Danish: Hos 2.461 patienter behandlet med telithromycin i fase III kliniske studier samt igennem postmarketing erfaring blev følgende bivirkninger, der muligvis eller sandsynligvis kunne relateres til telithromycin, rapporteret.
English: At high doses embryotoxicity was apparent and an increase in incomplete ossification and in skeletal anomalies was seen.
Danish: Ved høje doser var embryotoksiciteten åbenbar og en stigning i ufuldstændig ossifikation og skeletale anomalier sås.
English: In patients of 18 years and older, according to the indication, the treatment regimen will be:
Danish: For patienter på 18 år og opefter, alt efter indikation, er behandlingen som følger:
English: Effects were evident at plasma levels of free drug 8 to 13 times the expected clinical level.
Danish: Virkningerne var åbenbare ved plasmakoncentrationer af det frie lægemiddel på 8 til 13 gange af det forventede kliniske niveau.
English: The recommended European Committee for Antimicrobial Susceptibility Testing (EUCAST) MIC clinical breakpoints are presented below:
Danish: De anbefalede Europæiske Referencekomité (EUCAST) MIC kliniske grænseværdier for telithromycin ses nedenfor:
English: The increase exposure to metoprolol may be of clinical importance in patients with heart failure treated with metoprolol.
Danish: Den øgede eksponering af metoprolol kan være klinisk vigtig for patienter med hjertefejl i behandling med metoprolol.
English: Ketek is used to treat infections due to bacteria against which the medicine is active.
Danish: Ketek anvendes til behandling af infektioner forårsaget af bakterier, som lægemidlet virker imod.
English: If you forget to take a dose, take it as soon as possible.
Danish: Hvis du har glemt en dosis, så tag den så snart du kommer i tanke om det.
English: After oral administration, two-thirds of the dose is eliminated as metabolites and one-third unchanged.
Danish: Efter oral administration udskilles 2/3 af en dosis som metabolitter og 1/3 uomdannet.