FrancophonIA/ELRC3.0 huggingface dataset:
English: In viral nucleic acid replication, incorporation of this 2', 3'-dideoxynucleoside prevents chain extension, and thereby inhibits viral replication.
Danish: I den virale nukleinsyrereplikation blokerer indbygningen af dette 2', 3'-dideoxynukleosid for kædeforlængelsen, hvorved det hæmmer den virale replikation.
English: Chicago 2001 La Porte C et al. Pharmacokinetic interaction study of indinavir/ritonavir and the enteric-coated capsule formulation of didanosine in healthy volunteers.
Danish: 9 La Porte C et al. Pharmacokinetic interaction study of indinavir/ritonavir and the enteric-coated capsule formulation of didanosin in healthy volunteers.
English: Hence, both test and reference products can be considered as having similar food effect in terms of reduction in Cmax and AUC.
Danish: Fødeindtagelse kan derfor anses for at have samme effekt på test- og referenceproduktet i form af reduktion af Cmax og AUC.
English: Relationship between dideoxyinosine exposure, CD4 counts and p24 antigen levels in HIV infection.
Danish: 6 Drusano GL et al. Relationship between dideoxyinosine exposure, CD4 counts and p24 antigen levels in HIV infection.
English: The primary pharmacokinetic parameters (Cmax and AUC) were satisfactory in the fasting study with the 90% confidence interval (CI) falling within the standard criteria of 80.00 - 125.00%.
Danish: De primære farmakokinetiske parametre (Cmax og AUC) var tilfredsstillende i undersøgelsen ved fastende betingelser, idet 90 % sikkerhedsintervallet (SI) var inden for standardkriteriet på 80,00
English: The Committee acknowledged that the conventional criterion for bioequivalence for maximum plasma concentration (Cmax) was outside the 80-125% acceptability limits.
Danish: Udvalget vedgik, at den maksimale plasmakoncentration (Cmax) var uden for acceptgrænserne 80-125 % ifølge det konventionelle kriterium for bioækvivalens.
English: Therefore, for both the test and the reference product in the fed state the absorption of didanosine decreases which indicate that both products possess similar food effect in terms of reduction in Cmax and AUC with no evidence of dose-dumping.
Danish: Absorptionen af didanosin er således nedsat under postprandiale betingelser både for testproduktet og referenceproduktet, hvilket tyder på, at de to produkter påvirkes på samme måde af fødeindtagelse hvad angår reduktion af Cmax og AUC, uden at der er tegn på dose-dumping.
English: • The Committee noted that in the fed study, both formulations were subject to a food effect reducing plasma concentrations.
Danish: • udvalget bemærkede, at fødeindtagelse nedsatte plasmakoncentrationerne for begge formuleringer i den postprandiale undersøgelse.
English: In the current application, the AUC under both fasted and fed conditions was within the acceptance criteria of 80
Danish: I den aktuelle ansøgning var AUC både under fastende og postprandiale betingelser inden for acceptkriteriet på 80-125 %.
English: Hernandez-novoa B et al. Effect of food on the antiviral activity of didanosine enteric-coated capsules: A pilot comparative study.
Danish: 2006; 7: 155-162 11 Hernandez-novoa B et al. Effect of food on the antiviral activity of didanosin enteric-coated capsules: A pilot comparative study.
English: Patients on HAART Containing Didanosine Enteric-Coated Capsules (FOODDIe Study).
Danish: 10 Lopez JC et al. A Cohort Study of the Food Effect on Virological Failure and Treatment Discontinuation in Patients on HAART Containing Didanosine Enteric-Coated Capsules (FOODDIe Study).
English: Medicinal product no longer authorise©EMEA 2007
Danish: Lægemidlet er ikke længere autoriseret til salg©EMEA 2007
English: The European Commission granted a marketing authorisation valid throughout the EU for Velosulin to Novo Nordisk A/S on 7 October 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse for Velosulin med gyldighed i hele Den Europæiske Union til Novo Nordisk A/S den 7. oktober 2002.
English: It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede de gennemførte undersøgelser og nåede frem til sine anbefalinger om, hvordan lægemidlet skal
English: Velosulin was effective for both type 1 and type 2 diabetes.
Danish: Velosulin var effektivt til behandling af såvel type 1- som type 2-diabetes.
English: The Committee for Medicinal products for Human Use (CHMP) decided that Velosulin's benefits are greater than its risks for the treatment of diabetes.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Velosulin er større end risiciene ved behandling af diabetes.
English: What is the risk associated with Velosulin?
Danish: Hvilke risici er der forbundet med Velosulin?
English: Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose.
Danish: Diabetes er en sygdom, hvor kroppen ikke producerer tilstrækkeligt insulin til at kontrollere blodsukkeret.
English: The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.
Danish: Patientens blodsukker skal kontrolleres regelmæssigt for at fastsætte den effektive minimumsdosis.
English: By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Danish: Ved at holde bloksukkeret under kontrol mindskes sukkersygesymptomerne og -komplikationerne.
English: Velosulin should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Danish: Velosulin bør ikke anvendes hos personer, som kan være overfølsomme (allergiske) over for insulin human (rDNA) eller et af de øvrige stoffer.
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose to enter cells from the blood.
Danish: Erstatningsinsulinen fungerer på samme måde som naturligt produceret insulin og hjælper glukosen til at trænge ind i cellerne fra blodet.
English: The studies used to support Velosulin are those that have been used to support Actrapid, another insulin approved in the European Union (EU).
Danish: De undersøgelser, der understøtter brugen af Velosulin er de samme, som er blevet anvendt til at understøtte brugen af Actrapid, et andet insulinpræparat, der er godkendt i EU.
English: Velosulin led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with the other human insulin.
Danish: Velosulin medførte et fald i HbA1c-niveauet, hvilket tyder på, at blodsukkeret var blevet holdt under kontrol på et niveau, der svarede til det, der var observeret for andet humant insulin.
English: Velosulin is intended for continuous subcutaneous infusion (under the skin) using an insulin infusion pump.
Danish: Velosulin indgives ved konstant subkutant infusion (under huden) ved hjælp af en insulininfusionspumpe.
English: The studies measured the level of fasting blood sugar or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Danish: I undersøgelserne målte man blodsukkeret i fastende tilstand eller mængden af et stof (glykosyleret hæmoglobin, HbA1c), der viser, hvor godt blodsukkeret reguleres.
English: It contains the active substance insulin human (rDNA).
Danish: Velosulin indeholder det aktive stof insulin human (rDNA).
English: Velosulin is a replacement insulin that is identical to the insulin made by the pancreas.
Danish: Velosulin er et erstatningsinsulin, der er identisk med det insulin, der produceres af bugspytkirtlen.
English: The solution of insulin in Velosulin is specially prepared to make it stable for the duration of administration in an infusion pump.
Danish: Opløsningen af insulin i Velosulin er specielt fremstillet, så den er stabil under varigheden af administrationen i en
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) VELOSULIN EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) VELOSULIN
English: Velosulin has also been studied used in an insulin pump.
Danish: Velosulin anvendt i en insulinpumpe er også blevet undersøgt.
English: Velosulin is a fast-acting insulin and may be used with longer-acting insulin products.
Danish: Velosulin er hurtigtvirkende insulin og kan anvendes sammen med langtidsvirkende insulinpræparater.
English: For the full list of all side effects reported with Velosulin, see the Package Leaflet.
Danish: Den fuldstændige beskrivelse af indberettede bivirkninger ved Velosulin fremgår af indlægssedlen.
English: Velosulin may also be injected into a vein or given subcutaneously by injection.
Danish: Velosulin kan også injiceres i en vene eller indsprøjtes subkutant.
English: As with all insulins, Velosulin may cause hypoglycaemia (low blood glucose).
Danish: Velosulin kan medføre hypoglykæmi (for lavt blodsukker).
English: Velosulin doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose.
Danish: Det kan også være nødvendigt at justere doseringen af Velosulin, når det gives sammen med en række andre lægemidler, der kan indvirke på blodsukkeret (den fuldstændige liste fremgår af indlægssedlen).
English: What benefit has Velosulin shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Velosulin?
English: The full EPAR for Velosulin is available here.
Danish: Den europæiske offentlige vurderingsrapport (EPAR) for Velosulin kan ses i sin helhed her.
English: The active substance in Velosulin, insulin human (rDNA), is produced by a method known as ‘recombinant DNA technology': the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Danish: Det aktive stof i Velosulin, insulin human (rDNA), produceres via en metode, der er kendt som "rekombinant teknologi".
English: Velosulin should be given before meals.
Danish: Velosulin skal indgives før et måltid (nøjagtige tidsangivelser findes i indlægssedlen).
English: Velosulin is a solution for injection or infusion (drip).
Danish: Velosulin er en klar, farveløs opløsning af insulin i hætteglas til injektion eller infusion.
English: They should both have the same colour.
Danish: De skal begge have den samme farve.
English: He/she will look for the cause and take appropriate measures.
Danish: Han/hun vil undersøge, hvad årsagen er og tage passende forholdsregler.
English: Date of first authorisation: 16 September 2003 Date of latest renewal: 26 August 2013
Danish: Dato for første markedsføringstilladelse: 16. september 2003 Dato for seneste fornyelse: 26. august 2013
English: Two programmes can be operated:
Danish: Der kan anvendes to programmer:
English: Do not use a facial mask.
Danish: Anvend ikke en ansigtsmaske.
English: Your blood pressure may drop much further.
Danish: Dit blodtryk kan falde meget mere.
English: Cases of overdose were reported.
Danish: Tilfælde af overdosering er rapporteret.
English: * Life-threatening and/or fatal cases have been reported.
Danish: * Livstruende og/eller letale tilfælde er set.
English: The following serious side effects may occur.
Danish: Følgende alvorlige bivirkninger kan forekomme.
English: This dose should be maintained.
Danish: Denne dosis skal opretholdes.
English: − Myocardial infarction within the last six months.
Danish: - Myokardieinfarkt inden for de sidste seks måneder.
English: Stand up slowly when you get out of chairs or bed.
Danish: - Rejs dig langsomt, når du skal op af en stol eller ud af sengen.
English: There are two different colour coded medication chambers.
Danish: Der er to forskellige, farvekodede medicineringskamre.
English: The following pharmacological effects have been observed in vitro:
Danish: Følgende farmakologiske virkninger er blevet observeret in vitro:
English: Tell your doctor if you are taking:
Danish: Fortæl din læge, hvis du tager:
English: Please ask your doctor what you should do.
Danish: Spørg din læge om, hvad du skal gøre.
English: • Your blood pressure will be checked before treatment and if it is too low (less than
Danish: • Dit blodtryk vil kontrolleres før behandlingen og hvis det er for lavt (mindre end
English: These concentrations decline with half-lives between approximately 5 and 25 minutes.
Danish: Disse koncentrationer falder med halveringstider på mellem cirka 5 og 25 minutter.
English: A specific antidote is not known.
Danish: En specifik antidot kendes ikke.
English: However, you should avoid taking food or drink during inhalation.
Danish: Men du skal undgå at spise eller drikke under inhalationen.
English: • Low blood pressure (hypotension)
Danish: • Lavt blodtryk (hypotension)
English: The active substance can be delivered more rapidly to your lungs.
Danish: Det aktive stof afgives hurtigere til dine lunger.
English: Do not use this medicine after the expiry date which is stated on the carton and ampoule.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og ampullen.
English: No unchanged substance is eliminated.
Danish: Intet uomdannet stof elimineres.
English: Tell your doctor if they get worse.
Danish: Fortæl lægen, hvis besvimelserne bliver værre.
English: • Fainting episodes may be due to the underlying disease.
Danish: • Besvimelse kan skyldes den underliggende sygdom.
English: Your doctor will advise you.
Danish: Din læge vil rådgive dig.
English: You should continue on this dose.
Danish: Du skal fortsætte på denne dosis.
English: • Stimulation of endogenous fibrinolytic potential
Danish: • Stimulation af det endogene fibrinolytiske potentiale
English: If you stop or wish to stop treatment, discuss it with your doctor first.
Danish: Hvis du stopper eller ønsker at stoppe behandlingen, skal du først drøfte det med din læge.
English: Below we list other possible side effects by how likely they are:
Danish: Nedenfor er en oversigt over andre bivirkninger, ordnet efter hvor sandsynlige de er:
English: The need to adapt and/or change the therapy should be considered (see section 4.8).
Danish: Behovet for at tilpasse og/eller ændre behandlingen bør overvejes (se pkt.
English: It stops after the pre-set dose has been administered.
Danish: Det standser, efter at den forudindstillede dosis er administreret.
English: How much to inhale and for how long
Danish: Hvor meget skal du indånde og hvor lang tid?
English: • Dilatation of arterioles and venules
Danish: • Dilatation af arterioler og venoler
English: The following information is intended for healthcare professionals only: Instructions for use and handling
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: Instruktioner vedrørende brug og håndtering
English: The frequencies of adverse reactions are defined as very common (≥1/10) and common (≥1/100 to <1/10).
Danish: Hyppigheden af bivirkningerne angives som: Meget almindelig (≥1/10) og almindelig (≥1/100 til <1/10).
English: If it does, rinse the skin or your eyes immediately with plenty of water.
Danish: Hvis det skulle ske alligevel, så skyl øjeblikkeligt hud eller øjne med rigelige mængder vand.
English: PPH is a category of pulmonary hypertension where the cause of the high blood pressure is not known.
Danish: PPH er en kategori for pulmonal hypertension, hvor årsagen til det høje blodtryk er ukendt.
English: It cannot be excluded that this is also relevant to humans on prolonged Ventavis therapy.
Danish: Det kan ikke udelukkes, at dette også er relevant for mennesker i forlænget Ventavis-behandling.
English: Animal studies have not shown harmful effect of iloprost on fertility.
Danish: Dyrestudier har ikke vist nogen skadelig virkning af iloprost på fertilitet.
English: Daily dose
Danish: Daglig dosis
English: In case of interruption of Ventavis therapy, the risk of rebound effect is not formally excluded.
Danish: I tilfælde af afbrydelse af Ventavis-behandlingen er risikoen for rebound effekt ikke formelt udelukket.
English: Ventavis with food and drink
Danish: Brug af Ventavis sammen med mad og drikke
English: A mass-balance study was done using 3H-iloprost in healthy subjects.
Danish: Der blev udført et masse-balance-studie med 3H-iloprost hos sunde forsøgspersoner.
English: The metabolites are eliminated from plasma and urine in 2 phases, for which half-lives of about 2 and 5 hours (plasma) and 2 and 18 hours (urine) have been calculated.
Danish: Metabolitterne elimineres fra plasma og urin i 2 faser, for hvilke der er blevet beregnet halveringstider på cirka 2 og 5 timer (plasma) og 2 og 18 timer (urin).
English: Ask your doctor to have someone help you become thoroughly familiar with the use of the nebuliser.
Danish: Bed lægen om at få nogen til at hjælpe dig med at blive fuldstændig fortrolig med at anvende nebulisatoren.
English: Pharmacokinetics after use with different nebulisers
Danish: Farmakokinetik efter brug af forskellige nebulisatorer
English: If you feel that the effect of Ventavis is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du føler, at virkningen af Ventavis er for stærk eller for svag, skal du tale med din læge eller dit apotek herom.
English: It imitates a natural substance in the body called prostacyclin.
Danish: Det efterligner et naturligt stof i kroppen, der kaldes prostacyklin.
English: Your doctor will monitor you and treat any resulting symptoms.
Danish: Din læge vil overvåge dig og behandle eventuelle symptomer.
English: Invasive haemodynamic parameters were assessed at baseline and after 12 weeks treatment.
Danish: De invasive hæmodynamiske parametre blev vurderet ved baseline og efter 12 ugers behandling.
English: The selection of the pre-set programme is made by the doctor.
Danish: Valget af det forudindstillede program foretages af lægen.
English: The main metabolite is tetranor-iloprost, which is found in the urine in free and conjugated form.
Danish: Hovedmetabolitten er tetranor-iloprost, som findes i urinen i fri og i konjugeret form.
English: This is a condition where blood pressure is too high in the blood vessels between the heart and the lungs.
Danish: Det er en tilstand, hvor blodtrykket er for højt i blodkarrene mellem hjertet og lungerne.
English: You should not switch to another nebuliser without consulting the doctor who is treating you.
Danish: Du må ikke skifte til en anden nebulisator uden at tale med den læge, der behandler dig.
English: Systemic toxicity
Danish: Systemisk toksicitet
English: There is a limited amount of data from the use of iloprost in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af iloprost til gravide kvinder.
English: Following intravenous infusion, the recovery of total radioactivity is 81 %, and the respective recoveries in urine and faeces are 68% and 12%.
Danish: Efter intravenøs infusion var recovery af total radioaktivitet 81 %, og recovery i urin og fæces henholdsvis 68 % og 12 %.
English: Common (≥1/100 to <1/10)
Danish: (≥ 1/100 til < 1/10)
English: Ventavis should only be used during pregnancy if your doctor decides that the potential benefit outweighs the potential risk to you and the foetus.
Danish: Ventavis bør kun anvendes under graviditet, hvis din læge beslutter, at de potentielle fordele opvejer den potentielle risiko for dig og fostret.
English: • Increase of capillary density and reduction of increased vascular permeability caused by mediators such as serotonin or histamine in the microcirculation
Danish: • Forøgelse af kapillær densitet og reduktion af forøget vaskulær permeabilitet forårsaget af mediatorer som f.eks. serotonin eller histamin i mikrokredsløbet
English: • If you could get pregnant, use reliable contraception from the time you start treatment and during treatment.
Danish: • Hvis du kan blive gravid, skal du bruge sikker prævention fra det tidspunkt, du starter behandling og under behandling.
English: No reliable conclusion could be drawn on efficacy of the association as the sample size was limited and the study was of short duration.
Danish: Der kan ikke drages nogen sikre konklusioner omkring virkningen af kombinationen, da populationsstørrelsen var begrænset og studiet kortvarigt.
English: Systemic exposures exceeded human therapeutic exposures after inhalation by factors of more than 10 (Cmax, cumulative AUC).
Danish: De systemiske eksponeringer overskred de terapeutiske eksponeringer hos mennesker efter inhalation med faktorer på mere end 10 (Cmax, kumulativ AUC).
English: Care should be exercised during initiation of therapy until any effects on the individual have been determined.
Danish: Der skal udvises forsigtighed ved behandlingens start, indtil alle virkninger på den enkelte patient er blevet fastslået.
English: Before physical exertion it might be useful to inhale.
Danish: Inden fysisk udfoldelse kan det hjælpe at inhalere.
English: Other nebulising systems
Danish: Andre nebulisatorsystemer
English: To avoid undesired accumulation over the day, special caution has to be exercised with these patients during initial dose titration.
Danish: For at undgå uønsket akkumulation i løbet af dagen bør der udvises særlig omhyggelighed hos disse patienter under den første dosistitrering.
English: • anticoagulants, such as heparin, oral anticoagulants (either coumarin-type or direct),
Danish: • antikoagulantia som f.eks. - heparin, - orale antikoagulantia (enten af coumarin-typen eller direkte virkende),
English: • if you have a heart problem, such as
Danish: • hvis du har problemer med hjertet, som for eksempel
English: Patients with a creatinine clearance of ≤30 ml/min were not investigated in the clinical trials.
Danish: Patienter med en kreatinin clearance på ≤30 ml/min blev ikke undersøgt i de kliniske studier.
English: The safety and efficacy of Ventavis in children aged up to 18 years have not been established.
Danish: Sikkerhed og virkning af Ventavis til børn og unge op til 18 år er ikke klarlagt.
English: Careful monitoring of the patient should be performed when inhaled iloprost therapy is stopped and an alternative treatment should be considered in critically ill patients.
Danish: Patienten bør monitoreres omhyggeligt, når behandlingen med inhaleret iloprost standses, og en alternativ behandling bør overvejes hos kritisk syge patienter.
English: Do not drive or operate any tools or machines if you feel these effects.
Danish: Du må ikke køre bil, motorcykel, cykle eller arbejde med værktøj eller maskiner, hvis du mærker disse tegn.
English: − Decompensated cardiac failure if not under close medical supervision.
Danish: - Dekompenseret hjerteinsufficiens hvis ikke under nøje medicinsk overvågning.
English: Ventavis inhibits unwanted blocking or narrowing of blood vessels and allows more blood to flow through the vessels.
Danish: Ventavis hæmmer en uønsket blokering eller indsnævring af blodårerne og lader mere blod flyde gennem årerne.
English: • hypersensitivity (i.e. allergy)
Danish: • Overfølsomhed (dvs. allergi)
English: However, the predictive value of these acute haemodynamic data are considered to be of limited value as acute response does not in all cases correlate with long-term benefit of treatment with inhaled iloprost.
Danish: Imidlertid betragtes den forudsagte værdi af disse data vedrørende akut hæmodynamisk virkning som værende af begrænset værdi, da akut respons ikke i alle tilfælde stemmer overens med fordelen på langt sigt af behandlingen med inhaleret iloprost.
English: medication chamber).
Danish: 1 mediceringskammer).
English: No studies performed following inhalation.
Danish: Der er ikke udført studier efter inhalation.
English: Your doctor will monitor you carefully.
Danish: Din læge vil overvåge dig nøje.
English: Prolonged oral treatment with iloprost clathrate in dogs up to one year was associated with slightly increased fasted serum glucose levels.
Danish: Forlænget oral behandling med iloprostclathrate hos hunde op til ét år blev associeret med lettere forøgede fasteværdier for serumglukose.
English: 85 mmHg for the upper value) then therapy with Ventavis should not be started.
Danish: 85 mmHg for den høje værdi), bør behandling med Ventavis ikke startes.