FrancophonIA/ELRC3.0 huggingface dataset:
English: Aranesp 100 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL).
Danish: Aranesp 100 mikrogram injektionsvæske, opløsning i fyldt injektionssprøjte Hver fyldt injektionssprøjte indeholder 100 mikrogram darbepoetin alfa i 0,5 ml (200 mikrog/ml).
English: Aranesp 300 micrograms solution for injection in vial.
Danish: Aranesp 300 mikrogram injektionsvæske, opløsning i hætteglas.
English: Aranesp 40 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 1.52 mg of sodium in 0.4 mL.
Danish: Aranesp 40 mikrogram injektionsvæske, opløsning i fyldt injektionssprøjte Hver fyldt injektionssprøjte indeholder 1,52 mg natrium i 0,4 ml.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.5 mL pre-filled syringe contains 50 micrograms darbepoetin alfa (100 micrograms/mL).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver 0,5 ml fyldt injektionssprøjte indeholder 50 mikrogram darbepoetin alfa (100 mikrogram/ml).
English: Aranesp 300 micrograms solution for injection in pre-filled syringe 0.6 mL solution for injection (500 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Danish: Aranesp 300 mikrogram injektionsvæske, opløsning i fyldt injektionssprøjte 0,6 ml injektionsvæske, opløsning (500 mikrog/ml darbepoetin alfa) i en fyldt injektionssprøjte af type 1-glas med en 27 gauge kanyle af rustfrit stål.
English: • Keep used syringes out of the reach and sight of children.
Danish: • Opbevar de brugte sprøjte utilgængeligt for børn.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.5 mL pre-filled syringe contains 100 micrograms darbepoetin alfa (200 micrograms/mL).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver 0,5 ml fyldt injektionssprøjte indeholder 100 mikrogram darbepoetin alfa (200 mikrogram/ml).
English: A sustained haemoglobin level of greater than 12 g/dL (7.5 mmol/L) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dL (7.5 mmol/L) are observed are described below.
Danish: Et vedvarende hæmoglobinniveau, som er højere end 12 g/dl (7,5 mmol/l) bør undgås.
English: Aranesp 60 micrograms solution for injection in vial.
Danish: Aranesp 60 mikrogram injektionsvæske, opløsning i hætteglas.
English: Aranesp 100 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 1.90 mg of sodium in 0.5 mL.
Danish: Aranesp 100 mikrogram injektionsvæske, opløsning i fyldt injektionssprøjte Hver fyldt injektionssprøjte indeholder 1,90 mg natrium i 0,5 ml.
English: Aranesp 50 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 1.90 mg of sodium in 0.5 mL.
Danish: Aranesp 50 mikrogram injektionsvæske, opløsning i fyldt injektionssprøjte Hver fyldt injektionssprøjte indeholder 1,90 mg natrium i 0,5 ml.
English: Keep the vial in the outer carton in order to protect from light.
Danish: Opbevar hætteglasset i den ydre pakning for at beskytte mod lys.
English: 4 single use vials
Danish: 4 hætteglas til engangsbrug
English: Aranesp 100 micrograms solution for injection in pre-filled syringe 0.5 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Danish: Aranesp 100 mikrogram injektionsvæske, opløsning i fyldt injektionssprøjte 0,5 ml injektionsvæske, opløsning (200 mikrog/ml darbepoetin alfa) i en fyldt injektionssprøjte af type 1-glas med en 27 gauge kanyle af rustfrit stål.
English: Anaemia is when your blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and shortness of breath.
Danish: Blodmangel vil sige, at Deres blod ikke indeholder et tilstrækkeligt antal røde blodlegemer.
English: Thigh
Danish: Iht.
English: - If you are a patient with chronic renal failure, and particularly if you do not respond properly to Aranesp, your doctor will check your dose of Aranesp because repeatedly increasing your dose of Aranesp if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
Danish: Det skyldes, at risikoen for at få problemer med hjerte eller blodkar og risikoen for hjerteanfald (myokardieinfarkt), hjerneblødning og død kan blive større, hvis Deres dosis af Aranesp gentagne gange forhøjes.
English: Subcutaneous use pre-filled syringe (glass)
Danish: Subkutan anvendelse fyldt injektionssprøjte (glas)
English: 6 mg
Danish: 6 mg Injektionsvæske, opløsning
English: London, 16 August 2007 Doc.
Danish: London, den 16. august 2007 Dok.
English: This may help to treat some types of bacterial infections.
Danish: Dette kan være med til at behandle visse typer bakterielle infektioner.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du er med i en klinisk undersøgelse og har behov for yderligere oplysninger om din behandling, skal du kontakte den læge, som står for behandlingen.
English: In almost all studies, it was compared with other antibiotics (clarithromycin, co-amoxiclav, amoxicillin, levofloxacin, ceftriaxone, erythromycin, azithromycin, piptazobactam or metronidazole).
Danish: I næsten alle undersøgelserne blev lægemidlet sammenlignet med andre antibiotika (clarithromycin, coamoxiclav, amoxicillin, levofloxacin, ceftriaxon, erythromycin, azithromycin, piptazobactam eller metronidazol).
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Danish: Virksomhedens brev, hvori EMEA underrettes om tilbagetrækningen af ansøgningen, kan ses her.
English: International non-proprietary name (INN): garenoxacin mesylate
Danish: Internationalt fællesnavn (INN): garenoxacin
English: The design of some of these studies, which were carried out a few years ago, was not aligned with the latest recommendations for the study of new antibiotics.
Danish: Nogle af disse undersøgelser, der blev udført for nogle få år siden, var ikke tilpasset de nyeste anbefalinger for, hvordan nye antibiotika skulle undersøges.
English: It was also unclear whether the medicine had an effect on the control of glucose (sugar) levels in the body.
Danish: Det var også usikkert, hvorvidt lægemidlet havde en effekt på kontrollen af blodsukkerniveauet i kroppen.
English: What documentation did the company present to support its application to the CHMP?
Danish: Hvilken dokumentation har virksomheden fremlagt for at underbygge sin ansøgning til CHMP?
English: Prior to this withdrawal, the company had already withdrawn its application for some indications, as well as for the solution for infusion.
Danish: Inden tilbagetrækningen havde virksomheden allerede tilbagetrukket sin ansøgning om visse indikationer og om opløsningen til infusion.
English: The CHMP normally takes up to 210 days to evaluate a new application.
Danish: Det tager normalt op til 210 dage for CHMP at vurdere en ny ansøgning.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for GARENOXACIN MESYLATE
Danish: SPØRGSMÅL OG SVAR ANGÅENDE TILBAGETRÆKNING AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for GARENOXACINMESYLAT
English: On 25 July 2007, Schering-Plough Europe officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Garenoxacin mesylate 400 mg and 600 mg film-coated tablets and 2 mg/ml solution for infusion, for the treatment of bacterial infections.
Danish: Den 25. juli 2007 meddelte Schering-Plough Europa officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Garenoxacinmesylat 400 mg og 600 mg filmovertrukne tabletter samt 2 mg/ml opløsning til infusion til behandling af bakterielle infektioner.
English: Furthermore, the CHMP had concerns over the side effects of Garenoxacin mesylate, particularly a risk of low blood pressure.
Danish: Derudover havde CHMP forbehold vedrørende Garenoxacinmesylats bivirkninger, særligt risikoen for lavt blodtryk.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Danish: Efter at CHMP havde vurderet virksomhedens svar på en liste over spørgsmål, var der stadig nogle uafklarede spørgsmål.
English: Following the CHMP's opinion, it usually takes around 2 months for the European Commission to grant a licence.
Danish: Når CHMP har afgivet en udtalelse, tager det normalt ca. to måneder for Europa-Kommissionen at udstede en tilladelse.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with Garenoxacin mesylate?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, som deltager i kliniske undersøgelser med Garenoxacinmesylat?
English: The CHMP was concerned that there was not enough evidence to demonstrate the medicine's effectiveness in treating some of the infections that it was expected to be used for.
Danish: CHMP udtrykte bekymring over, at der ikke forelå tilstrækkelige beviser til at påvise lægemidlets effekt til behandling af nogle af de infektioner, som det var hensigten at bruge det til.
English: The application was at day 180 when the company withdrew.
Danish: Ansøgningen var 180 dage inde i evalueringsperioden, da virksomheden trak den tilbage.
English: By blocking these enzymes, garenoxacin mesylate prevents certain types of bacteria from growing and multiplying.
Danish: Ved at blokere for disse enzymer forhindrer garenoxacinmesylat bestemte typer bakterier i at vokse og formere sig.
English: Garenoxacin mesylate is a medicine that was to be available as tablets (400 mg and 600 mg) and as a solution for infusion (drip into a vein).
Danish: Garenoxacinmesylat er et lægemiddel, der skulle kunne fås som tabletter (400 mg og 600 mg) og som en opløsning til infusion (drop i en vene).
English: Garenoxacin mesylate is an antibiotic that belongs to the ‘quinolone' class.
Danish: Garenoxacinmesylat er et antibiotikum, der tilhører gruppen af quinoloner.
English: The effects of Garenoxacin mesylate were first tested in experimental models before being studied in humans.
Danish: Garenoxacinmesylats effekt blev undersøgt i eksperimentelle modeller, før det blev undersøgt hos mennesker.
English: The company informed the CHMP that no further patients are being enrolled into clinical trials with Garenoxacin mesylate, and that there are no consequences for patients already included in these trials.
Danish: Virksomheden underrettede CHMP om, at der ikke blev inddraget flere patienter i kliniske undersøgelser med Garenoxacinmesylat, og at der ikke er nogen konsekvenser for de patienter, som allerede indgår i disse undersøgelser.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Garenoxacin mesylate could not have been approved for the treatment of bacterial infections.
Danish: CHMP havde på grundlag af gennemgangen af dataene og virksomhedens svar på listen over spørgsmål nogle forbehold på tidspunktet for tilbagetrækningen og var af den foreløbige opfattelse, at Garenoxacinmesylat ikke kunne være blevet godkendt til behandling af bakterielle infektioner.
English: It works by blocking the action of enzymes that are necessary for the bacteria to make DNA.
Danish: Det virker ved at blokere effekten af bestemte enzymer, som er nødvendige for, at bakterierne kan fremstille DNA.
English: Garenoxacin mesylate was examined in 19 studies involving a total of over 7,000 patients with the types of bacterial infection that the medicine was expected to be used to treat.
Danish: Garenoxacinmesylat blev undersøgt i 19 undersøgelser, hvor der medvirkede over 7.000 patienter med de typer bakterielle infektioner, som det var hensigten at behandle med dette lægemiddel.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Danish: På basis af gennemgangen af den indledende dokumentation opstiller CHMP efter 120 dage en liste over spørgsmål, som sendes til virksomheden.
English: • complicated intra-abdominal infections, including infections after surgery and acute infections of the pelvis.
Danish: • komplicerede intraabdominale infektioner, herunder infektioner efter operation og akutte infektioner i pelvis.
English: Garenoxacin mesylate was only to be used when these infections were known to be caused by bacteria that are susceptible to the medicine.
Danish: Garenoxacinmesylat skulle kun bruges, når det var påvist, at disse infektioner skyldtes bakterier, som er følsomme over for lægemidlet.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Danish: Når virksomheden har besvaret spørgsmålene, gennemgår CHMP svarene og stiller muligvis yderligere spørgsmål efter 180 dage, før der afgives en udtalelse.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Garenoxacin mesylate had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: Derfor var CHMP's holdning på tilbagetrækningstidspunktet, at Garenoxacinmesylats gavnlige effekt ikke var tilstrækkeligt påvist, og at eventuelle fordele ikke opvejede de identificerede risici.
English: Garenoxacin mesylate was expected to be used to treat adults with the following infections:
Danish: Det påregnedes, at Garenoxacinmesylat skulle anvendes til behandling af voksne med følgende infektioner:
English: • infections of the skin and the tissue just below the skin, including foot infections in patients with diabetes,
Danish: • infektioner i huden og vævet lige under huden, herunder fodinfektioner hos diabetikere
English: • acute bacterial exacerbation (flare-up) of chronic bronchitis (long-lasting inflammation of the airways in the lungs),
Danish: • akut bakteriel eksacerbation (forværring) af kronisk bronkitis (langvarig inflammation i luftvejene i lungerne)
English: • acute bacterial sinusitis (short-lived infection of the sinuses, air-filled passageways in the bones around the nose and eyes),
Danish: • akut bakteriel sinuitis (kortvarig infektion i bihulerne, som er de luftfyldte passager i knoglerne omkring næsen og øjnene)
English: In all studies, the main measure of effectiveness was the proportion of patients whose infection had been cured, at least five days after the end of treatment, although time at which the effectiveness was assessed depended on the type of infection being treated.
Danish: infektion var blevet helbredt mindst fem dage efter behandlingens afslutning, selvom det tidspunkt, ved hvilket effekten blev vurderet, afhang af den type infektion, som blev behandlet.
English: What is Garenoxacin mesylate?
Danish: Hvad er Garenoxacinmesylat?
English: • community-acquired pneumonia (an infection of the lungs that is caught outside of hospital),
Danish: • pneumoni erhvervet uden for sygehus (en infektion i lungerne, som er pådraget uden for et hospital)
English: What was Garenoxacin mesylate expected to be used for?
Danish: Hvad forventedes Garenoxacinmesylat anvendt til?
English: How is Garenoxacin mesylate expected to work?
Danish: Hvordan forventes Garenoxacinmesylat at virke?
English: PC: {number} SN: {number} < NN: {number} >
Danish: PC: {nummer} SN: {nummer} NN: {nummer}
English: After that carry on as normal.
Danish: Herefter kan du fortsætte som normalt.
English: Not known (cannot be estimated from the available data)
Danish: Ikke kendt (kan ikke beregnes ud fra tilgængelige data)
English: Accordingly, to date there has been no indication of such interactions.
Danish: Til dato er der derfor ingen tegn på sådanne interaktioner.
English: Date of first authorisation: 24 August 2011 Date of latest renewal: 26 May 2016
Danish: Dato for første markedsføringstilladelse: 24 august 2011 Dato for seneste fornyelse: 26 maj 2016
English: Your doctor may need to review your treatments.
Danish: Din læge bliver måske nødt til at revurdere din behandling.
English: - You should take only one tablet each time.
Danish: - Du skal kun tage én tablet ad gangen.
English: [carton only]:
Danish: [kun karton]:
English: If it is less than 1 hour until your next dose:
Danish: Hvis der er mindre end 1 time til næste dosis:
English: In individual cases, only some of these symptoms and/or findings may be evident.
Danish: I individuelle tilfælde vil der kun være nogle af disse symptomer og/eller fund tilstede.
English: Review of treatment is recommended if such symptoms develop.
Danish: En evaluering af behandlingen anbefales, hvis sådanne symptomer opstår.
English: The Package leaflet is updated accordingly.
Danish: Indlægssedlen opdateres i overensstemmelse hermed.
English: Patients with past or current psychosis should be treated with caution.
Danish: Patienter med tidligere eller eksisterende psykoser bør behandles med forsigtighed.
English: - Depending on how you respond to treatment, your doctor may suggest a higher or lower dose.
Danish: - Afhængigt af hvordan behandlingen virker på dig, kan lægen foreslå en højere eller lavere dosis.
English: The early diagnosis is important for the appropriate management of NMS.
Danish: En tidlig diagnose er vigtig for korrekt håndtering af MNS.
English: After taking one of them, wait at least 2 to 3 hours before taking the other.
Danish: Efter du har indtaget ét af præparaterne, skal du vente mindst 2-3 timer, før du tager det andet.
English: Otherwise, you may put yourself and others at risk of serious injury or death.
Danish: Ellers risikerer du at være til alvorlig fare for dig selv og andre.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web portal.
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: One tablet contains one treatment dose and the tablet may only be administered as whole tablets.
Danish: En tablet indeholder én behandlingsdosis og tabletterne må kun administreres som hele tabletter.
English: Dose reduction may be needed (see section 5.2).
Danish: Dosisreduktion kan være nødvendig (se pkt.
English: - The tablets are not intended to be split or broken into smaller pieces.
Danish: - Tabletterne er ikke beregnet til at deles eller knuses.
English: The use of glucose oxidase methods may give false negative results for glycosuria.
Danish: Anvendelse af glucoseoxidasemetoder kan medføre falsk negative resultater for glykosuri.
English: This corresponded to an 8.3% increase in the proportion of daily ON time.
Danish: Dette svarer til en øgning på 8,3% i andel af daglig ”on-tid”.
English: - Patients should be regularly monitored for the development of impulse control disorders.
Danish: - Patienter skal kontrolleres regelmæssigt for udvikling af impulskontrolforstyrrelser.
English: According to in vitro studies, significant displacement is not anticipated at therapeutic concentrations of the medicinal products.
Danish: Ifølge in vitro studier er signifikant forskydning ikke forekommet ved terapeutiske koncentrationer af lægemidlet.
English: Many of the side effects can be relieved by adjusting the dose.
Danish: Mange bivirkninger kan mindskes ved at justere dosis.
English: If it is more than 1 hour until your next dose: Take one tablet as soon as you remember, and the next tablet at the normal time.
Danish: Hvis der er mere end 1 time til næste dosis: Tag én tablet, så snart du kommer i tanker om det, og den næste tablet til sædvanlig tid.
English: The INR values increased on average by 13% [CI90 6-19%].
Danish: INR-værdierne øgedes i gennemsnit med 13% [CI90 6-19%].
English: Take a tablet as soon as you remember, wait 1 hour, then take another tablet.
Danish: Tag én tablet, så snart du kommer i tanker om det, vent 1 time og tag så en ny tablet.
English: Therefore, be particularly careful when you drive or when you use any tools or machines.
Danish: Du må derfor være specielt forsigtig, når du kører bil eller bruger værktøj og maskiner.
English: Before initiation of treatment, patients and caregivers should be warned of the potential risk of developing DDS (see also section 4.8).
Danish: Før initiering af behandling skal patienter og plejere advares om den potentielle risiko for udvikling af DDS (se også pkt.
English: Gender: Bioavailability of levodopa is significantly higher in women than in men.
Danish: Køn: Biotilgængeligheden af levodopa er signifikant højere hos kvinder end hos mænd.
English: Prolonged or persistent diarrhoea appearing during use of entacapone may be a sign of colitis.
Danish: Længevarende eller vedvarende diarré, der optræder ved anvendelse af entacapon, kan være tegn på colitis.
English: Both levodopa and entacapone are rapidly absorbed and eliminated.
Danish: Både levodopa og entacapon absorberes og elimineres hurtigt.
English: ECG monitoring should be started and the patient carefully monitored for the possible development of arrhythmias.
Danish: Ekg-overvågning bør igangsættes, og patienten bør følges nøje for mulig udvikling af arytmier.
English: Suicidal behaviour, Dopamine dysregulation syndrome
Danish: Suicidal adfærd, dopaminergt dysreguleringssyndrom
English: In the event of prolonged or persistent diarrhoea, the drug should be discontinued and appropriate medical therapy and investigations considered.
Danish: I tilfælde af længerevarende eller vedvarende diarré bør lægemidlet seponeres og passende behandling og undersøgelser overvejes.
English: Dopamine does not cross the blood-brain barrier.
Danish: Dopamin krydser ikke blodhjernebarrieren.
English: Contains sucrose.
Danish: Indeholder saccharose.
English: Reduction of levodopa dose decreases the severity and frequency of these dopaminergic reactions.
Danish: Reduktion af levodopadosis nedsætter sværhed og hyppighed af disse dopaminerge reaktioner.
English: Rash*, hyperhidrosis
Danish: Udslæt*, hyperhidrose
English: Meals rich in large neutral amino acids may delay and reduce the absorption of levodopa.
Danish: Måltider, der er rige på store, neutrale aminosyrer, kan forsinke og reducere absorptionen af levodopa.
English: Patients receiving less than 70-100 mg carbidopa a day are more likely to experience nausea and vomiting.
Danish: Patienter, der får mindre en 70-100 mg carbidopa pr. dag, oplever oftere kvalme og kaster op.
English: This may cause difficulties in breathing or swallowing.
Danish: Dette kan medføre vejrtræknings- eller synkebesvær.
English: This medicinal product does not require any special storage conditions.
Danish: Dette lægemiddel kræver ingen særlige forholdregler vedrørende opbevaringen.
English: The main metabolic pathway is glucuronidation of entacapone and its active metabolite, the cis-isomer, which accounts for about 5% of plasma total amount.
Danish: Hovedmetaboliseringsvejen er glukoronidering af entacapon og den aktive metabolit, cis-isomeren, som udgør ca. 5% af den totale plasmamængde.
English: The value of dialysis in the treatment of overdose is not known.
Danish: Effekten af dialysebehandling ved overdosering er ukendt.
English: To open the bottle for the first time: open the closure, and then press with your thumb on the seal until it breaks.
Danish: Når du skal åbne beholderen første gang: Åben låget og tryk derefter tommelfingeren nedad på forseglingen indtil den brydes.