FrancophonIA/ELRC3.0 huggingface dataset:
English: Masican was expected to be used to treat gastrointestinal stromal tumour (GIST), a cancer of the stomach and bowel, in adults whose cancer cannot be removed surgically or has spread and is getting worse despite treatment with imatinib, another medicine used to treat this cancer.
Danish: Masican forventedes anvendt til behandling af mave-tarm-kræft (gastrointestinal stromal tumor (GIST)) hos voksne, hos hvem kræften ikke kan fjernes ved operation eller har bredt sig og er blevet værre trods behandling med imatinib, der er et andet lægemiddel mod kræft.
English: These enzymes can be found in some receptors on the
Danish: Disse enzymer findes i visse receptorer på kræftcellernes overflade,
English: During the re-examination, although the medicine's safety was of less concern, the Committee still had major concerns about the medicine's benefits.
Danish: Ved revurderingen havde udvalget stadig store betænkeligheder ved lægemidlets fordele, skønt lægemidlets sikkerhed kun gav anledning til mindre betænkelighed.
English: It is given to newborn calves once a day for one week.
Danish: Det gives til nyfødte kalve én gang dagligt i en uge.
English: The full EPAR for Halagon can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Halagon findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The withdrawal period for meat from newborn calves treated with Halagon is 13 days.
Danish: Tilbageholdelsestiden for kød fra nyfødte kalve, der behandles med Halagon, er 13 dage.
English: This is a summary of the European public assessment report (EPAR) for Halagon.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Halagon.
English: The company provided data on the quality and manufacture of Halagon.
Danish: Virksomheden fremlagde oplysninger om kvaliteten og fremstillingen af Halagon.
English: Halagon halofuginone
Danish: Halagon halofuginon
English: Halagon is a ‘generic medicine'.
Danish: Halagon er et "generisk lægemiddel".
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom stadium i parasittens livscyklus, der udskilles i afføringen.
English: The infection is known as cryptosporidiosis.
Danish: Infektionen kaldes cryptosporidiose.
English: Halagon should be given after feeding.
Danish: Halagon skal gives, efter at dyret har indtaget føde.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Halagon has been shown to have comparable quality to Halocur.
Danish: Udvalget for Lægemidler til dyr (CVMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Halagon er af sammenlignelig kvalitet med Halocur.
English: What are the benefits and risks of Halagon?
Danish: Hvilke fordele og risici er der forbundet med Halagon?
English: This means that Halagon is similar to a ‘reference medicine' already authorised in the EU called Halocur.
Danish: Det betyder, at Halagon er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Halocur.
English: The Committee recommended that Halagon be approved for use in the EU.
Danish: Udvalget anbefalede, at Halagon godkendes til anvendelse i EU.
English: No additional studies were needed as Halagon is a water based oral solution containing the same active substance and other ingredients as the reference medicine, in the same concentrations.
Danish: Der krævedes ingen supplerende undersøgelser, eftersom Halagon er en vandbaseret oral opløsning, der indeholder samme aktive stof og øvrige indholdsstoffer som referencelægemidlet, i samme koncentrationer.
English: What is Halagon and what is it used for?
Danish: Hvad er Halagon, og hvad anvendes det til?
English: The medicine contains the active substance halofuginone.
Danish: Lægemidlet indeholder det aktive stof halofuginon.
English: It is not intended to provide practical advice on how to use Halagon.
Danish: Det er ikke en praktisk vejledning i, hvordan Halagon bør anvendes.
English: The active substance in Halagon, halofuginone, prevents the growth of Cryptosporidium parvum.
Danish: Det aktive stof i Halagon, halofuginon, hæmmer væksten af Cryptosporidium parvum.
English: Halagon is a medicine used to treat newborn calves to prevent or reduce diarrhoea caused by an organism called Cryptosporidium parvum.
Danish: Halagon er et lægemiddel, der anvendes hos nyfødte kalve til forebyggelse eller reduktion af diarré forårsaget af organismen Cryptosporidium parvum.
English: For prevention of diarrhoea, treatment should start within 24 to 48 hours of birth; for reducing diarrhoea, treatment should start within 24 hours of the start of diarrhoea.
Danish: Til forebyggelse af diarré påbegyndes behandlingen inden for 24 til 48 timer efter kælvningen.
English: Why is Halagon approved?
Danish: Hvorfor blev Halagon godkendt?
English: Halagon can only be obtained with a prescription and is available as an oral solution (liquid to be given by mouth).
Danish: Halagon udleveres kun efter recept og fås som en væske til indgivelse gennem munden (en oral opløsning).
English: Halagon EMA/664633/2016
Danish: EMA/848948/2016 Halagon
English: Therefore, the CVMP's view was that, as for Halocur, the benefits outweigh the identified risks.
Danish: Det var derfor CVMP's opfattelse, at fordelene opvejer de identificerede risici som for Halocur.
English: Other information about Halagon?
Danish: Andre oplysninger om Halagon
English: Safety information has been included in the summary of product characteristics and the package leaflet for Halagon, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers when using Halagon.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Halagon, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: Because Halagon is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Halagon er et generisk lægemiddel, anses det for at have de samme fordele og risici som referencelægemidlet.
English: It also limits the spread of the disease by preventing the formation of oocysts, which are a stage in the lifecycle of the parasite that are passed in the faeces.
Danish: Det begrænser desuden sygdommens udbredelse ved at forhindre dannelsen af parasittens frugtbare ægceller, som er et
English: Because Halagon is a generic medicine and is bioequivalent to the reference medicine the precautions are the same as for the reference medicine.
Danish: Eftersom Halagon er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses forholdsreglerne for at være det samme som for referencelægemidlet.
English: The European Commission granted a marketing authorisation valid throughout the EU for Halagon on 13 December 2016.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Halagon den
English: How has Halagon been studied?
Danish: Hvordan er Halagon blevet undersøgt?
English: How is Halagon used?
Danish: Hvordan anvendes Halagon?
English: For more information about treatment with Halagon, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Halagon, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: This is a parasite belonging to the ‘protozoa' family that invades the digestive system, causing diarrhoea.
Danish: Den invaderer fordøjelsessystemet og fremkalder diarré.
English: How does Halagon work?
Danish: Hvordan virker Halagon?
English: For practical information about using Halagon, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer af eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Halagon, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states
Danish: Betingelser eller begrænsninger, vedrørende sikker og effektiv anvendelse af lægemidlet, til implementering i medlemsstaterne
English: The Healthcare Professional Guide should contain the following key messages:
Danish: Vejledningen til sundhedspersonalet bør indeholde følgende centrale budskaber:
English: The Member States shall agree with the MAH the communication plan for
Danish: Medlemsstaterne skal være enige med MAH om kommunikationsplanen for
English: • The existence and scope of the pregnancy register and details of how to
Danish: • Eksistensen af og omfanget af graviditetsregisteret og detaljer om hvordan
English: • That there is a risk of infusion related reactions including red man syndrome-like reactions.
Danish: • At der er en risiko for infusionsrelaterede reaktioner, herunder 'red man syndrome
English: • That Vibativ has a risk of nephrotoxicity including increased risk of mortality in patients with pre existing acute renal failure and is therefore contraindicated in patients with pre-existing acute renal failure and in patients with creatinine clearance < 30ml/min, including patients undergoing haemodialysis.
Danish: • At Vibativ giver risiko for nefrotoksicitet, herunder øget risiko for dødelighed hos patienter med allerede eksisterende akut nyresvigt, og er derfor kontraindiceret hos patienter med allerede eksisterende akut nyresvigt og hos patienter med kreatininclearance < 30 ml/min, herunder patienter i hæmodialysebehandling.
English: • That there is a potential risk of teratogenicity and Vibativ is contraindicated during pregnancy.
Danish: • At der er en potentiel risiko for teratogenicitet, og at Vibativ er kontraindiceret under graviditet.
English: • That there is an identified risk of ototoxicity and patients developing ototoxicity signs or symptoms or patients receiving other drugs with ototoxic potential should be carefully evaluated and monitored.
Danish: • At der er en identificeret risiko for ototoksicitet, og patienter, der udvikler tegn eller symptomer på ototoksicitet, eller patienter, der får andre lægemidler med ototoksisk potentiale, bør omhyggeligt evalueres og overvåges.
English: • That patients' renal function should be assessed and monitored and initial dose and dosage adjustments should be calculated based on the creatinine
Danish: • At patienternes nyrefunktion bør vurderes og overvåges, og at initialdosis og dosistilpasning bør beregnes på baggrund af kreatininclearance.
English: • There is a risk of QTc prolongation and Vibativ should be used with caution in patients taking drugs known to prolong the QT interval.
Danish: • Der er en risiko for en forlængelse af QTc, og at Vibativ bør anvendes med forsigtighed til patienter, der tager medicin, som er kendt for at forlænge QT-intervallet.
English: The pregnancy status of women of childbearing potential must be established prior to dosing with telavancin and women of childbearing potential must use effective contraception
Danish: Graviditetsstatus hos kvinder i den fødedygtige alder skal fastslås før dosering af televancin, og at kvinder i den fødedygtige alder skal anvende effektiv
English: • The need to counsel patients on important risks associated with Vibativ therapy and appropriate precautions when using the medicine.
Danish: • Nødvendigheden af at rådgive patienterne om vigtige risici ved behandling med Vibativ og passende forholdsregler ved brug af dette lægemiddel.
English: • Healthcare professionals should be aware that the administration of Vibativ may interfere with some coagulation laboratory tests and qualitative and quantitative urine protein tests.
Danish: • Sundhedspersonalet skal være opmærksom på, at anvendelse af Vibativ kan interferere med visse koagulations-laboratorieprøver og kvalitative og kvantitative
English: The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Vibativ a health care professional educational pack
Danish: Medlemsstaterne skal sikre, at MAH tildeler alle læger, som forventes at ordinere eller anvende Vibativ, en uddannelsespakke til sundhedspersonale indeholdende:
English: • The role and use of the Prescriber Checklist sticker included in the product package to document the established pregnancy status prior to dosing.
Danish: • Formålet med og anvendelsen af lægens tjeklistemærkat i pakningen til dokumentation af den fastslåede graviditetsstatus inden dosering.
English: The Member States shall agree the final educational material with the Marketing Authorization Holder (MAH) prior to launch of the product in their territory.
Danish: Medlemsstaterne skal, forud for lancering af lægemidlet i deres land, være enige med indehaveren af markedsføringstilladelsen (MAH) om form og inhold af vejledningen til
English: Vibativ should be used with caution with other
Danish: Vibativ bør anvendes med forsigtighed sammen med andre nefrotoksiske lægemidler.
English: The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Vibativ a Direct Healthcare Professional Communication letter, the text of which is appended to the CHMP assessment report.
Danish: Medlemsstaterne skal sikre, at MAH sender et brev med direkte information (DHPC), hvor brevets tekst er vedhæftet CHMP-vurderingen, til alle læger, som forventes at ordinere eller anvende Vibativ.
English: • That the benefit risk balance for the Complicated Skin and Soft Tissue Infections indication was assessed as negative by the Committee for Medicinal Products for Human Use (CHMP), therefore Vibativ should not be used in this or other indications not approved.
Danish: • At den videnskabelige komite for medicin til mennesker (CHMP) vurderede balancen mellem risk/benefit for indikationen komplicerede hud og bløddelsinfektioner som negativ.
English: (often referred to as PCP)
Danish: (ofte omtalt som PCP).
English: No fatalities occurred, and all patients recovered.
Danish: Der var ingen dødsfald, og alle patienter kom sig.
English: Date of first authorisation: 02 March 2011 Date of latest renewal: 19 November 2015
Danish: Dato for første tilladelse: 2. marts 2011 Dato for seneste fornyelse: 19. november 2015
English: • if they drink alcohol
Danish: • hvis du drikker alkohol.
English: (neutropenia).
Danish: (neutropeni).
English: • if you are seriously overweight (especially if you're a woman).
Danish: • hvis du er svært overvægtig (særligt hvis du er kvinde).
English: Look out for important symptoms
Danish: Hold øje med vigtige symptomer
English: These events have often been transitory.
Danish: Bivirkningerne har ofte været forbigående.
English: • if their immune systems are very weak
Danish: • hvis dit immunsystem er meget svækket.
English: So it is very important to talk to your doctor about any changes in your health.
Danish: Det er derfor meget vigtigt, at du fortæller lægen om enhver ændring i dit helbred.
English: Titanium dioxide E171
Danish: Titandioxid E171
English: Your doctor will decide if the active substances are suitable for you.
Danish: Din læge vil vurdere, om de aktive stoffer er velegnede til dig.
English: You need to keep taking it every day to stop your illness getting worse.
Danish: Du skal tage medicinen hver dag for at forhindre, at sygdommen bliver værre.
English: The list below should not be considered exhaustive but is representative of the classes studied.
Danish: Listen nedenfor bør ikke betragtes som værende fuldstændig, men er repræsentativ for de lægemiddelklasser, der er undersøgt.
English: If you notice any of these symptoms:
Danish: Hvis du bemærker et eller flere af disse symptomer:
English: The effect of food on the rate and extent of absorption was also studied.
Danish: Desuden blev indvirkningen af mad på hastigheden og omfanget af absorption undersøgt.
English: Stay in regular contact with your doctor
Danish: Hold regelmæssig kontakt med lægen
English: • if they are overweight.
Danish: • hvis du er overvægtig.
English: Old infections may flare up
Danish: Gamle infektioner kan blusse op igen
English: • if they have been taking combination therapy for a long time
Danish: • hvis du har fået kombinationsbehandling i lang tid.
English: You may still develop other infections and illnesses linked to HIV infection.
Danish: Du kan stadig udvikle andre infektioner og sygdomme, der er forbundet med hiv-infektionen.
English: However, absolute bioavailability (approximately 55-65 %) was reduced in paediatric patients below 12 years of age.
Danish: Den absolutte biotilgængelighed (ca. 55-65 %) er dog reduceret hos pædiatriske patienter under 12 år.
English: See Section 4 for more information.
Danish: 4 for yderligere oplysninger.
English: Whether such neurological disorders are transient or permanent is currently unknown.
Danish: I hvilken udstrækning sådanne neurologiske dysfunktioner er forbigående eller permanente er p.t. ikke kendt.
English: • deep, rapid, difficult breathing
Danish: • Dyb, hurtig, besværet vejrtrækning
English: Macrogol 400
Danish: Macrogel 400
English: Zidovudine plasma protein binding is 34 % to 38 %.
Danish: Zidovudins plasmaproteinbinding er 34 % til 38 %.
English: Either of these two patterns of multinucleoside resistance mutations severely limits future therapeutic options.
Danish: Enhver af disse to typer af multinucleosid resistens mutationer begrænser i svær grad de fremtidige terapeutiske muligheder.
English: You may need extra check-ups, including blood tests, while you are taking your medicine.
Danish: Det kan være nødvendigt med ekstra kontrolbesøg, herunder blodprøver, mens du er i behandling.
English: Tell your doctor if you are taking phenytoin.
Danish: Fortæl det til lægen, hvis du tager phenytoin.
English: There are no data on their affect on human female fertility.
Danish: Der foreligger ingen data om påvirkning af fertiliteten hos kvinder.
English: • an increase in an enzyme called amylase
Danish: • Stigning i mængden af et enzym, der kaldes amylase
English: Do not drive or operate machines unless you are feeling well.
Danish: Kør ikke bil, og betjen ikke maskiner, hvis du føler dig utilpas.
English: Your doctor will monitor the effectiveness of your treatment.
Danish: Din læge vil følge virkningen af din behandling.
English: At present, the available data do not suggest that lamivudine is less efficacious in this age group.
Danish: Tilgængelige data indikerer ikke, at lamivudin er mindre effektiv hos denne aldersgruppe.
English: Recent findings indicate that exposure in children <6 years of age may be reduced by about 30 % compared with other age groups.
Danish: Seneste fund tyder på, at eksponeringen hos børn under 6 år er reduceret med ca. 30 % sammenlignet med andre aldersgrupper.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare
Danish: Frekvenserne er defineret som meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1000 til <1/100), sjælden (≥1/10.000 til <1/1000) og meget sjælden (<1/10.000).
English: You may have problems with your bones
Danish: Du kan få knogleproblemer
English: Lactic acidosis is a rare but serious side effect
Danish: Laktacidose er en sjælden, men alvorlig bivirkning
English: • tiredness, lack of energy
Danish: • træthed, manglende energi
English: • irritated or runny nose
Danish: • irriteret eller løbende næse
English: Zidovudine had a similar effect in both species, but only at very high systemic exposures.
Danish: Zidovudin havde en lignende effekt hos begge arter, men kun ved meget høje systemiske koncentrationer.
English: Patients at increased risk should be followed closely.
Danish: Patienter, der er i risikogruppen, skal følges tæt.
English: However it is not clear whether these cases were due to the antiretroviral treatment or to the underlying HIV disease.
Danish: Det er dog usikkert, om tilfældene skyldtes den antiretrovirale behandling eller den underliggende hiv-sygdom.
English: Recommendation concerning co-administration
Danish: Anbefalinger vedrørende samtidig administration
English: In vitro susceptibility testing has not been standardised and results may vary according to methodological factors.
Danish: Test af følsomheden in vitro er ikke blevet standardiseret, og resultaterne kan variere afhængig af de anvendte metoder.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis der er tegn på forværring i leversygdommen hos disse patienter, bør afbrydelse eller ophør med behandlingen overvejes.
English: Additionally, lamivudine has activity against hepatitis B virus (HBV).
Danish: Derudover har lamivudin en aktivitet overfor hepatitis B-virus (HBV).
English: In addition, two transplacental carcinogenicity studies have been conducted in mice.
Danish: Derudover er der gennemført to transplacentale karcinogenicitetsundersøgelser hos mus.
English: These haematological effects are not usually observed before four to six weeks therapy.
Danish: Disse hæmatologiske påvirkninger observeres sædvanligvis først efter 4 til 6 ugers behandling.
English: Therefore, there is little potential for interactions with antiretroviral protease inhibitors, non-nucleosides and other medicinal products metabolised by major P450 enzymes.
Danish: Der er derfor ringe risiko for interaktioner med antiretrovirale proteaseinhibitorer, non-nukleosider og andre lægemidler, som metaboliseres af væsentlige P450-enzymer.
English: If you get side effects
Danish: Hvis du får bivirkninger
English: Lamivudine was not teratogenic in animal studies.
Danish: Lamivudin var ikke teratogent i dyreforsøg.
English: Consider more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided.
Danish: Overvej hyppigere overvågning af hiv-1 virusmængde, når vedvarende samtidig administration ikke kan undgås.
English: The adverse reactions profile appears similar for adults and adolescents.
Danish: Bivirkningsprofilen synes ens hos voksne og unge.
English: Mutagenicity and carcinogenicity
Danish: Mutagenitet og karcinogenicitet
English: Take the tablets at regular times, leaving approximately 12 hours between each tablet.
Danish: Tabletterne skal tages regelmæssigt med ca. 12 timers mellemrum.
English: The second study thus provided no evidence that zidovudine acts as a transplacental carcinogen.
Danish: Den anden undersøgelse frembragte således ingen tegn på, at zidovudin optræder som transplacental karcinogen.
English: Clinical Experience
Danish: Klinisk erfaring
English: Abbreviations: ↑ = Increase; ↓=decrease; ↔= no significant change; AUC=area under the concentration versus time curve; Cmax=maximum observed concentration; CL/F=apparent oral clearance
Danish: Forkortelser: ↑ = Stigning; ↓ = Fald; ↔ = Ingen signifikant ændring; AUC = Arealet under kurven koncentration versus tid; Cmax= Maksimalt observeret koncentration; CL/F = Tilsyneladende oral clearance.
English: Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Germany
Danish: Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Tyskland
English: With this condition, parts of the bone tissue die because of reduced blood supply to the bone.
Danish: Med denne sygdom dør dele af knoglevævet på grund af nedsat blodtilførsel til knoglerne.
English: In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Danish: For de børn, hvis mødre har taget NRTI'er i løbet af graviditeten, opvejede fordelen ved beskyttelsen mod hiv risikoen ved bivirkningerne.
English: These symptoms are probably caused by the body's immune system becoming stronger, so that the body starts to fight these infections.
Danish: Disse symptomer vil ofte opstå, fordi kroppens immunsystem bliver stærkere, og kroppen begynder at bekæmpe disse infektioner.