FrancophonIA/ELRC3.0 huggingface dataset:
English: Recurrent airway obstruction (RAO) is a commonly occurring respiratory disease in mature horses.
Danish: Recidiverende luftvejsobstruktion er almindelig hos modne hopper.
English: 300 mg prednisolone (9 g sachet)
Danish: 300 mg prednisolon (brev á 9 g)
English: Number of sachets
Danish: Antal breve
English: Use of corticosteroids in horses has been reported to induce severe lameness of (especially) the front hooves (see section Adverse reactions).
Danish: Hos heste er binyrebarkhormon indberettet for at fremkalde svær forfangenhed af især forhove (se afsnittet”Bivirkninger”).
English: 100 mg prednisolone (3 g sachet)
Danish: 100 mg prednisolon (brev á 3 g)
English: Equisolon 33 mg/g oral powder for horses Prednisolone
Danish: Equisolon, oralt pulver, 33 mg/g, til heste prednisolon
English: The safety of the veterinary medicinal product has not been established in horses during pregnancy, and the product is contraindicated for use in pregnant horses (please see section 4.3).
Danish: Lægemidlets sikkerhed er ikke fastlagt hos drægtige hopper, og produktet er kontraindiceret til anvendelse hos drægtige heste (se pkt.
English: Equisolon 33 mg/g oral powder for horses
Danish: Equisolon, oralt pulver, 33 mg/g, til heste
English: Use of corticosteroids in horses has been reported to severe lameness of (especially) the front hooves (see section Adverse reactions).
Danish: Hos heste er binyrebarkhormon indberettet for at fremkalde svær forfangenhed af især forhove (se afsnittet ”Bivirkninger”).
English: Deutschland Boehringer Ingelheim Vetmedica GmbH Binger Str. 173
Danish: Boehringer Ingelheim GmbHAnimal Health UK Ltd
English: Република България Boehringer Ingelheim RCV GmbH & Co KG Animal Health Dr. Boehringer-Gasse 5-11 1121 Виена
Danish: Република България Boehringer Ingelheim RCV GmbH & Co KG Animal Health
English: NO ENTRY
Danish: INGEN ANGIVELSE
English: Equidae
Danish: Beholder
English: Boehringer Ingelheim RCV GmbH & Co KG Animal Health Dr. Boehringer-Gasse 5-11 1121 Viena
Danish: Boehringer Ingelheim RCV GmbH & Co KG Animal Health
English: Date of first authorisation: 25 October 2012
Danish: Dato for første markedsføringstilladelse: 25. oktober 2012
English: Talk to your doctor about this.
Danish: Tal med lægen om det.
English: Blue Box
Danish: Blå boks
English: Before launch of the product in each country
Danish: Før markedsføring af produktet i hvert land
English: The long term consequences of this cellular infiltration are not known.
Danish: De langsigtede konsekvenser af denne cellulære infiltration er ikke kendt.
English: Syringes must not be used more than once.
Danish: Sprøjter må ikke anvendes mere end én gang.
English: 15 years follow-up is recommended for every patient treated.
Danish: Der anbefales 15 års opfølgning for hver behandlet patient.
English: All interventional studies continued into long term follow up studies.
Danish: Alle interventionsstudier fortsatte som langvarige opfølgningsstudier.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Danish: Det muliggør løbende overvågning af risk/benefit-forholdet for lægemidlet.
English: Details of the operation of the registry shall be agreed with the National Competent Authorities in each Member State.
Danish: Enkelthederne vedrørende føring af registret aftales med de nationale kompetente myndigheder i hver medlemsstat.
English: In addition, an updated RMP should be submitted
Danish: Desuden skal der fremsendes en opdateret RMP:
English: Results from the study to be reviewed annually.
Danish: Studiets resultater skal gennemgås hvert år.
English: The Marketing Authorisation Holder should be informed immediately.
Danish: Indehaveren af markedsføringstilladelsen skal omgående underrettes.
English: 18 months for frozen vials.
Danish: 18 måneder for nedfrosne hætteglas.
English: Strict compliance with dietary fat restriction was difficult.
Danish: Streng overholdelse af begrænsningen af kostens fedtindtag var vanskelig.
English: Information on the back:
Danish: Oplysninger på bagsiden:
English: Information for patients: Carry this card with you at all times!
Danish: Information til patienten: Hav altid dette kort på dig!
English: Do not stop taking these without talking to your doctor.
Danish: Du må ikke holde op med at tage denne medicin uden at tale med lægen.
English: • It is important that you fully understand the benefits and risks associated with the treatment by discussing with your doctor
Danish: • Det er vigtigt, at du fuldstændig forstår fordele og risici ved behandlingen efter at have drøftet den med lægen
English: PSUR/ annual reassessment
Danish: PSUR/ årlig revurdering
English: 3) Dietary diary and quality of life data should also be recorded.
Danish: 3) Desuden føres diætdagbog, og livskvalitetsdata registreres.
English: The studies shall enroll at least 4 subjects per year starting in June 2015.
Danish: Studierne skal indrullere mindst 4 forsøgspersoner årligt og begynde i juli
English: • sensation like that of insects crawling on (or under) the skin
Danish: • fornemmelse af, at insekter kravler på (eller under) huden
English: After this time, triglyceride levels reverted back to baseline.
Danish: Derefter vendte triglyceridniveauet tilbage til baseline.
English: These effects were dose-dependent but showed regression with time.
Danish: Disse virkninger var dosisafhængige, men aftog med tiden.
English: This will fade after a short time.
Danish: Farven vil forsvinde efter kort tid.
English: Read it carefully and follow the related
Danish: Læs det omhyggeligt, og følg dets anvisninger.
English: It is important that you ask your doctor about the side effects of these other medicines.
Danish: Det er vigtigt, at du udspørger lægen om bivirkningerne ved disse andre lægemidler.
English: • Information about the signs and symptoms to be monitored after treatment including:
Danish: • Information om tegn og symptomer, der skal overvåges efter behandling, herunder:
English: The biodistribution pattern was very similar in the other tested species (cats and rabbits).
Danish: Et nøje tilsvarende biodistributionsmønster sås i de andre testede arter (katte og kaniner).
English: Non-clinical biodistribution
Danish: Ikke-klinisk biodistribution
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Danish: Dette er en godkendelse under særlige omstændigheder, og i henhold til artikel 14, stk. 8, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme udføre følgende foranstaltninger:
English: • Detailed instructions on the dose, number and localization of the injections
Danish: • Detaljerede anvisninger for dosis, antal og placering af injektionerne
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Danish: • når der modtages nye oplysninger, der kan have indflydelse på den gældende sikkerhedsspecifikation eller lægemiddelovervågningsplan eller på risikominimeringsaktiviteter
English: • raised body temperature
Danish: • forhøjet temperatur
English: You will need to stay in hospital for a few hours or overnight to make sure that you have not had any side effects from the medicine or the anaesthetic.
Danish: Du skal blive på hospitalet i nogle timer eller natten over for at sikre, at du ikke har fået bivirkninger af lægemidlet eller af bedøvelsen.
English: The most commonly reported adverse reaction is pain in extremity occurring in approximately one third of patients.
Danish: Den hyppigst indberettede bivirkning er smerter i ekstremiteterne, der optræder hos ca. en tredjedel af patienterne.
English: Dose of immunosuppressant may need to be adjusted.
Danish: Det kan være nødvendigt at justere dosis af immunosuppressiva.
English: Once thawed, the medicinal product should not be re-frozen.
Danish: Efter optøning må produktet ikke nedfryses igen.
English: • Glybera is a gene therapy product.
Danish: • Glybera er et genterapiprodukt.
English: • If you do become pregnant during treatment with Glybera, tell your doctor.
Danish: • Hvis du bliver gravid under behandlingen med Glybera, skal du fortælle det til lægen.
English: All but two patients received immunosuppressant for 12 weeks.
Danish: Alle patienterne undtagen to fik immunosuppressiv behandling i 12 uger.
English: • Information on the need to avoid pregnancy
Danish: • oplysning om nødvendigheden af at undgå graviditet
English: EXP Shelf life after first opening in the syringes: 8 hours (if space permitted)
Danish: EXP Holdbarhed i sprøjterne efter første åbning: 8 timer (hvis der er plads).
English: Given the small patient population and size of the cohorts, captured adverse reactions and serious adverse reactions do not provide a complete perspective on the nature and frequency of these events.
Danish: På grund af den lille patientpopulation og størrelsen af kohorterne giver de indsamlede data om bivirkninger og alvorlige bivirkninger ikke et fuldstændigt overblik over arten og hyppigheden af disse hændelser.
English: Only clear and colourless solutions without visible particles should be used.
Danish: Der må kun anvendes klare og farveløse opløsninger uden synlige partikler.
English: • It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to get pregnant.
Danish: • Det er vigtigt, at du fortæller det til lægen, hvis du er gravid, hvis du har mistanke om, at du er gravid, eller hvis du planlægger at blive gravid.
English: - You have been given a patient card by your doctor.
Danish: - Lægen har udleveret et patientkort til dig.
English: • Tell your doctor if you are suffering from diabetes.
Danish: • Sig det til lægen hvis du har sukkersyge.
English: See the end of section 4 for how to report side effects
Danish: Se sidst i punkt 4, hvordan du indberetter bivirkninger.
English: Like all medicines, Glybera can cause side effects, although not everybody gets them.
Danish: Glybera kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Glybera should not be administered to pregnant women unless the possible benefit to the mother outweighs the possible risk to the foetus.
Danish: Glybera bør ikke administreres til gravide kvinder, medmindre den mulige fordel for moderen opvejer den mulige risiko for fostret.
English: The registry should be performed according to an agreed protocol.
Danish: Registret skal føres i overensstemmelse med en godkendt protokol.
English: • Information on the need for long term follow-up for Glybera, including the registry
Danish: • oplysning om nødvendigheden af langsigtet opfølgning vedrørende Glybera, herunder registret
English: If any of the above applies to you, or if you are unsure of any of the above, please talk to your doctor before you receive Glybera.
Danish: Hvis noget af ovenstående gælder for dig, eller hvis du føler dig usikker på noget af ovenstående, skal du tale med lægen, inden du får Glybera.
English: • Guidance on the aftercare of the patient including monitoring for fever
Danish: • Vejledning i efterbehandling af patienten, herunder overvågning for feber
English: Treatment with Glybera does not eliminate attacks of acute pancreatitis.
Danish: Behandling med Glybera eliminerer ikke anfald af akut pankreatitis.
English: The studies should be performed according to an agreed protocol.
Danish: Studierne skal udføres i overensstemmelse med en godkendt protokol.
English: Diabetes mellitus is common in patients who have the most severe symptoms of LPLD.
Danish: Diabetes mellitus er almindelig hos patienter med de sværeste symptomer på LPLD.
English: LPL protein mass should be determined by ELISA or equivalent methods.
Danish: LPL-proteinmassen bestemmes med ELISA eller ækvivalente metoder.
English: An immune response was seen despite the use of immunosuppressants.
Danish: Der er iagttaget immunrespons trods immunosuppressiv behandling.
English: Follow applicable local or international guidelines for prophylaxis (See also section 4.5).
Danish: Følg gældende lokale eller internationale retningslinjer for profylakse (se også pkt.
English: • Patients with increased bleeding risk (such as thrombocytopenia) and muscle disease (such as myositis), must not be treated in view of the large number of intramuscular injections
Danish: • Patienter med øget blødningsrisiko (såsom trombocytopeni) og muskelsygdom (såsom myositis) må ikke behandles på grund af det store antal intramuskulære injektioner, der er
English: In lipoprotein lipase deficiency, this enzyme is missing due to a genetic defect.
Danish: Ved sygdommen lipoproteinlipase-mangel mangler dette enzym på grund af en genetisk fejl.
English: Your doctor will treat this appropriately.
Danish: Lægen vil behandle dette efter behov.
English: The dose you will need is dependent on your weight and is calculated by your doctor.
Danish: Dosis vil afhænge af din vægt og vil blive beregnet af lægen.
English: In a follow-up period of up to 3 years after treatment, there was a decreasing trend in the incidence and severity of pancreatitis in the 12 patients who had multiple attacks during their life time.
Danish: I en opfølgningsperiode på indtil 3 år efter behandlingen var der en faldende tendens i forekomsten og sværhedsgraden af pankreatitis hos de 12 patienter, der havde haft multiple anfald hele livet.
English: This medicine has been authorised under "exceptional circumstances”.
Danish: Dette lægemiddel er godkendt under “særlige omstændigheder”.
English: This medicine contains genetically modified organisms and must be disposed of according to local rules for such medicines.
Danish: Dette lægemiddel indeholder genmodificerede organismer og skal bortskaffes i overensstemmelse med lokale regler for sådanne lægemidler.
English: Number of injection sites
Danish: Antal injektionssteder
English: In case of contraindication for such procedure deep sedation is advised instead.
Danish: Er dette kontraindiceret, anbefales i stedet dyb sedering.
English: It is important that you take these medicines according to the instructions given.
Danish: Det er vigtigt, at du tager disse lægemidler som du får besked på.
English: This is the number of vials that must be dispensed.
Danish: Dette tal er det antal hætteglas, der skal dispenseres.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG ANSVARLIG FOR BATCHFRIGIVELSE
English: One patient was diagnosed with pulmonary embolism 7 weeks after therapy.
Danish: Én patient blev diagnosticeret med lungeemboli 7 uger efter behandlingen.
English: The PSUR cycle for the medicinal product should follow a half-yearly cycle until otherwise agreed by the CHMP.
Danish: Lægemidlets PSUR-cyklus skal følge en halvårlig cyklus, indtil andet aftales med CHMP.
English: Please ask your doctor for more information about the exact immunosuppressant medicine you will be taking.
Danish: Bed lægen om yderligere oplysninger om netop den immundæmpende medicin, du skal have.
English: • Advice on the need and duration of barrier contraception
Danish: • rådgivning om nødvendigheden af og varigheden af barrierekontraception
English: Assessment of immune response at baseline, 6 months and 12 months in at least 12 newly treated patients.
Danish: Vurdering af immunrespons ved baseline, 6 måneder og 12 måneder hos mindst 12 nybehandlede patienter.
English: With the exception of a case of fever (39.9 °C) in study CT-AMT-011-01 which reversed within a day, no Glybera or immunosuppression related serious adverse events occurred.
Danish: Bortset fra et tilfælde af feber (39,9 °C) i studie CT-AMT-011-01, som forsvandt inden for en dag, var der ingen alvorlige bivirkninger med relation til behandlingen med Glybera eller immunsuppression.
English: Although there is no fully adequate animal model to address the tumourigenic potential, the available toxicological data do not suggest any concern for tumourigenicity
Danish: Der findes ikke helt fyldestgørende dyremodeller til påvisning af det tumorigene potentiale, men de foreliggende toksikologiske data tyder ikke på tumorigenicitet.
English: • The need for regional or spinal anaesthesia
Danish: • Behovet for lokal- eller spinalanæstesi
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using any medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om at du er gravid eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du får dette lægemiddel.
English: Information on the front:
Danish: Oplysninger på forsiden:
English: Work surfaces and material which have potentially been in contact with Glybera must be decontaminated with appropriate virucidal disinfectants with activity for non-enveloped viruses (such as hypochlorite and chlorine releasers) for at least 10 minutes.
Danish: Arbejdsoverflader og materiale, som potentielt kan have været i kontakt med Glybera, skal dekontamineres med et egnet virucidt desinfektionsmiddel, der virker mod vira uden kappe (såsom hypoklorit og klorfrigivende midler) i mindst 10 minutter.
English: Using condoms will reduce the amount of Glybera that may be left in the woman's body.
Danish: Brug af kondom nedsætter den mængde Glybera, der overføres til kvindens krop.
English: In saliva vector DNA was still detectable up to 12 weeks; in urine up to 10 weeks and in semen up to 26 weeks.
Danish: I spyt kunne vektor-DNA fortsat påvises i op til 12 uger, i urin i op til 10 uger og i sæd i op til 26 uger.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Danish: • senest 60 dage efter at en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering)
English: • Guidance on the need for immunosuppressive administration prior to and after treatment
Danish: • Vejledning om nødvendigheden af immunosuppressiv medicinering før og efter behandlingen
English: You should consider this when driving or using machines.
Danish: Vær opmærksom på det, hvis du skal køre bil eller betjene maskiner.
English: Very common (may affects more than 1 in 10 people)
Danish: Meget almindelige (forekommer hos mere end 1 ud af 10 behandlede)
English: Except for the site of injection, the highest vector DNA copy numbers were found in the liver and blood.
Danish: Bortset fra injektionsstedet blev det største antal vektorDNA-kopier fundet i leveren og blodet.
English: • It is important that you tell your doctor if you have an active infection of any sort before you take the medicines you will be given to reduce your body's defences (immunosuppressants) and before you receive Glybera.
Danish: • Det er vigtigt, at du fortæller det til lægen, hvis du har nogen som helst form for aktiv infektion, inden du tager de immundæmpende lægemidler, du får for at dæmpe din krops immunforsvar, og inden du får Glybera.
English: Further follow-up of patients who took part in study CT-AMT-11-03 (to a median of 5.8 years after exposure to Glybera) has shown a reduction in hospital stay of 1 day per patient per year when compared to the same length of time prior to exposure.
Danish: Yderligere opfølgning af patienter, der deltog i studie CT-AMT-11-03 (til median 5,8 år efter eksponering for Glybera) har vist en reduktion i hospitalsophold på 1 dag pr. patient pr. uge ved sammenligning med den samme tidsperiode før eksponering.
English: Patient Code number:
Danish: Patientkodenummer:
English: Your doctor will weigh up the benefits to you against the risks to your baby of taking Glybera whilst you are pregnant.
Danish: Lægen vil afveje fordelene for dig i forhold til risikoen for barnet ved at tage Glybera under graviditeten.
English: 1105 BA Amsterdam The Netherlands
Danish: 1105 BA Amsterdam Nederlandene
English: • Guidance to ensure that patients receive the Patient Alert Card included in the pack.
Danish: • Vejledning, der sikrer, at patienterne modtager det patientkort, der indgår i pakken.
English: Women of childbearing potential must be advised to use reliable barrier contraception methods in accordance with the guidelines for immunosuppressants for a minimum of 12 months from the start of therapy (9 months following cessation of immunosuppressants).
Danish: Kvinder i den fødedygtige alder skal tilrådes at anvende pålidelig barrierekontraception efter retningslinjerne for immunosuppressiva i mindst 12 måneder fra behandlingens start (9 måneder efter ophør med immunosuppressiva).
English: One patient developed myoglobinuria in association with raised serum creatine kinase activity.
Danish: Én patient udviklede myoglobinuri i forbindelse med forhøjet serumkreatinkinase-aktivitet.
English: • Guidelines for the safe handling, administration and disposal of Glybera
Danish: • Retningslinjer for sikker håndtering, administration og bortskaffelse af Glybera
English: Doctor name:
Danish: Lægens navn:
English: Glybera should only be administered to patients with an LPL protein mass of at least 5% of normal.
Danish: Glybera må kun administreres til patienter med en LPL-proteinmasse på mindst 5 % af det normale.
English: When reporting possible adverse reactions, please include the individual lot number imprinted on the front of this card.
Danish: Ved indberetning af eventuelle bivirkninger bedes batchnummeret på forsiden af dette kort oplyst.
English: As expected, all animals developed antibodies to the AAV protein shell.
Danish: Som forventet udviklede alle dyr antistoffer mod AAV-proteinskallen.
English: There is the theoretical risk that the co-administration of the immunosuppressant regime leads to longer persistence of virus DNA in serum and as well to longer shedding in saliva, urine and semen.
Danish: Der er en teoretisk risiko for, at samtidig administration af et immunosuppressivt regime medfører øget persistens af virus-DNA i serum og mere vedvarende udskillelse i spyt, urin og sæd.
English: Spinal or regional anaesthesia is advised prior to intramuscular administration, due to the number of injections required.
Danish: Det anbefales at benytte spinal- eller lokalanæstesi inden den intramuskulære administration på grund af antallet af injektioner.
English: LPLD involves a state of hyperviscosity/hypercoagulability.
Danish: Ved LPLD foreligger der hyperviskositet/hyperkoagulabilitet.
English: Lipoprotein lipase (LPL) is a naturally occurring substance in the body (known as an enzyme) that controls the level of certain fats in the blood.
Danish: Lipoproteinlipase (LPL) er et naturligt forekommende stof i kroppen (et enzym), der kontrollerer niveauet af visse fedtstoffer i blodet.
English: The levels of Glybera vector DNA found in gonads were measurable but lower than in other non-target organs.
Danish: Niveauet af Glybera vektor-DNA i gonaderne var måleligt, men lavere end i andre ikke-målorganer.
English: Limited data are available in diabetic patients.
Danish: Der foreligger kun begrænsede data for patienter med diabetes.
English: No drug-related serious adverse events occurred and no dose-limiting toxicity was observed.
Danish: Der var ingen alvorlige lægemiddelrelaterede bivirkninger, og der iagttoges ingen dosisbegrænsende toksicitet.
English: o information on the signs and symptoms of a reduction/loss of efficacy o the use of the events diary and what should be recorded
Danish: o information om tegnene og symptomerne ved nedsat eller manglende virkning o anvendelsen af hændelsesdagbogen og hvad der skal indføres i den
English: T-cell responses were seen in roughly half of the patients without clinical sequelae.
Danish: Der iagttoges T-celle-respons hos ca. halvdelen af patienterne uden kliniske sequelae.
English: Alipogene tiparvovec is produced using insect cells and recombinant baculovirus technology.
Danish: Alipogentiparvovec produceres ved hjælp af insektceller og rekombinant baculovirus-teknologi.
English: Local pain or sensitivity may be managed by symptomatic treatment such as administration of local or systemic pain relievers.
Danish: Lokale smerter eller følsomhed kan behandles symptomatisk med lokale eller systemiske smertestillende midler.