FrancophonIA/ELRC3.0 huggingface dataset:
English: - Cardboard box with 1 and 10 glass vials of 25 doses.
Danish: - Papkasse med 1 og 10 glasflasker à 25 doser.
English: Cardboard box with 10 glass vials of 1 dose.
Danish: - Papkasse med 10 glasflasker à 1 dosis.
English: - Cardboard box with 1 and 10 glass vials of 5 doses.
Danish: - Papkasse med 1 og 10 glasflasker à 5 doser.
English: Cardboard box with 10 glass vials of 25 doses.
Danish: - Papkasse med 10 glasflasker à 25 doser.
English: Cardboard box with 1 glass vial of 25 doses.
Danish: - Papkasse med 1 glasflaske à 25 doser.
English: Cardboard box with 10 glass vials of 5 doses.
Danish: - Papkasse med 10 glasflasker à 5 doser.
English: Cardboard box with 1 glass vial of 5 doses.
Danish: - Papkasse med 1 glasflaske à 5 doser.
English: WITHDRAWAL PERIODS
Danish: TILBAGEHOLDELSESTID(er)
English: - Cardboard box with 1 PET vial of 5 doses.
Danish: - Papkasse med 1 PET hætteglas à 5 doser.
English: Cardboard box with 1 glass vial of 1 dose.
Danish: Pakningsstørrelser: - Papkasse med 1 glasflaske à 1 dosis.
English: - Cardboard box with 1 PET vial of 25 doses.
Danish: - Papkasse med 1 PET hætteglas à 25 doser.
English: Special warnings for each target species: The whole herd should be immunised.
Danish: Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til
English: An additional 5 deaths were reported subsequently.
Danish: Yderligere 5 dødsfald blev efterfølgende rapporteret.
English: Date of first authorisation: 14th November 2016
Danish: Dato for første tilladelse: 14 november 2016
English: 5 years
Danish: 5 år.
English: It is not possible to determine whether these events are related directly to these factors or to other factors.
Danish: Det har ikke været muligt at fastslå, om disse hændelser er direkte forbundet med disse eller andre faktorer.
English: Estimated difference
Danish: Estimeret forskel
English: In vivo studies
Danish: In vivo studier
English: Most, but not all, of these patients had pre-existing cardiovascular risk factors.
Danish: De fleste, men ikke alle, af disse patienter havde allerede eksisterende kardiovaskulære risikofaktorer.
English: 1047 Budapest Hungary
Danish: 1047 Budapest Ungarn
English: - have a severe heart problem.
Danish: har et alvorligt hjerteproblem.
English: The causes of deaths were related to PAH.
Danish: Dødsårsagerne var relateret til PAH.
English: Elderly (≥65 years)
Danish: Ældre (≥ 65 år)
English: Intensified monitoring is recommended during the discontinuation period.
Danish: Tæt monitorering er anbefalet i seponeringsperioden.
English: Paediatric population (1 year to 17 years)
Danish: Pædiatrisk population (1-17 år)
English: Long-term survival data in naive population
Danish: Data for langtidsoverlevelse i naiv population
English: The improvement in 6MWD was apparent after 4 weeks of treatment and this effect was maintained at weeks 8 and 12.
Danish: Forbedring i 6MWD var synlig efter 4 ugers behandling, og denne virkning blev opretholdt ved uge 8 og 12.
English: Sildenafil is rapidly absorbed.
Danish: Sildenafil absorberes hurtigt.
English: Granpidam is for oral use only.
Danish: Granpidam er kun beregnet til oral anvendelse.
English: MedDRA system organ class (V.14.0)
Danish: MedDRA-system organklasse (V 14.0)
English: The subsequent effect on efficacy is unknown.
Danish: Den efterfølgende effekt på virkningen er ukendt.
English: Not known hypotension
Danish: Ikke kendt hypotension
English: There are no adequate and well controlled studies in lactating women.
Danish: Der findes ikke tilstrækkelige og velkontrollerede studier med ammende kvinder.
English: During the conduct of the study, there were a total of 42 deaths reported, whether on treatment or reported as part of the survival follow-up.
Danish: Under studiet blev der rapporteret i alt 42 dødsfald, enten under behandlingen eller rapporteret i forbindelse med opfølgningen vedrørende overlevelse.
English: 90 tablets 300 tablets 15x1 tablet 90x1 tablet 300x1 tablet
Danish: 90 tabletter 300 tabletter 15x1 tablet 90x1 tablet 300x1 tablet
English: These reports included dizziness and lightheadedness, but not syncope.
Danish: Disse rapporter omfatter svimmelhed og uklarhed, men ikke synkope.
English: Protein binding is independent of total drug concentrations.
Danish: Proteinbindingen er uafhængig af de totale lægemiddelkoncentrationer.
English: Your doctor may tell you to reduce the dose over a few days before stopping completely.
Danish: Lægen vil bede Dem om, at nedsætte dosis over nogle få dage, førend De standser behandlingen fuldstændigt.
English: Tablets should be taken approximately 6 to 8 hours apart with or without food.
Danish: Tabletterne skal tages med ca. 6-8 timers mellemrum med eller uden mad.
English: The duration of treatment was 12 weeks.
Danish: Behandlingsvarigheden var 12 uger.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy and embryonal/foetal development.
Danish: Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår ved graviditet og embryonets/fosterets udvikling.
English: Cardiovascular risk factors
Danish: Kardiovaskulære risikofaktorer
English: Not known priapism, erection increased
Danish: Ikke kendt priapisme, kraftigere erektion
English: Not known sudden hearing loss
Danish: Ikke kendt pludseligt høretab
English: Children Granpidam should not be given to children below 1 year of age.
Danish: Granpidam bør ikke gives til børn under 1 år.
English: Higher doses should not be used in children.
Danish: Der må ikke anvendes højere doser til børn.
English: The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated:
Danish: Sikkerheden af sildenafil er ikke undersøgt hos følgende patientundergrupper, og dets anvendelse er derfor kontraindiceret:
English: The effect of sildenafil on mortality is unknown.
Danish: Effekten af sildenafil på mortalitet er ukendt.
English: Nicorandil is a hybrid of potassium channel activator and nitrate.
Danish: Nicorandil er en hybrid af kaliumkanalaktivator og nitrat.
English: - if you are taking riociguat.
Danish: hvis De tager riociguat.
English: If you forget to take Granpidam, take a dose as soon as you remember, then continue to take your medicine at the usual times.
Danish: Hvis De glemmer at tage Granpidam, så tag en dosis, så snart De kommer i tanke om det, og fortsæt så med at tage Deres medicin til den sædvanlige tid.
English: There are no data from the use of sildenafil in pregnant women.
Danish: Der er ingen data fra anvendelse af sildenafil til gravide kvinder.
English: Clinical efficacy as measured by 6-minute walk distance could be less in elderly patients.
Danish: Klinisk effekt målt på en 6 minutters gangdistance kan være mindre hos ældre patienter.
English: Accord Healthcare Polska Sp.z o.o.,
Danish: Accord Healthcare Polska Sp.z o.o., ul.
English: The duration of treatment was 16 weeks.
Danish: Behandlingsvarigheden var 16 uger.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og blisterpakningen (efter EXP).
English: 6.6 Special precautions for disposal and other handling No special requirements for disposal.
Danish: 6.6 Regler for destruktion og anden håndtering Ingen særlige forholdsregler for destruktion.
English: Granpidam can cause dizziness and can affect vision.
Danish: Granpidam kan give svimmelhed og kan påvirke synet.
English: - have a rare inherited eye disease (retinitis pigmentosa).
Danish: har en sjælden, arvelig øjensygdom (retinitis pigmentosa).
English: Galactose intolerance
Danish: Galactoseintolerans
English: Taking more Granpidam than you should may increase the risk of known side effects.
Danish: Hvis De tager mere Granpidam, end De skal, kan det øge risikoen for bivirkninger.
English: Wessling Hungary Kft Fòti ùt 56., Budapest 1047, Hungary or
Danish: Wessling Hungary Kft Fòti ùt 56., Budapest 1047, Ungarn eller
English: Peak VO2 was assessed 1 year after the start of the placebo-controlled study.
Danish: Maksimal VO2 blev vurderet 1 år efter, det placebokontrollerede studie startede.
English: Of the 278 patients randomised, 277 patients received at least 1 dose of study drug.
Danish: Af de 278 randomiserede patienter fik 277 patienter mindst 1 dosis af studiemedicinen.
English: This can happen if you are sick with a fever, vomiting, or diarrhoea.
Danish: Det kan ske, hvis De er syg med feber, kaster op eller har diarré.
English: Its effect is more potent on PDE5 than on other known phosphodiesterases.
Danish: Dets effekt er mere potent for PDE5 end for andre kendte fosfodiesteraser.
English: 37 deaths occurred prior to a decision taken by the Data Monitoring Committee to down titrate subjects to a lower dosage, based on an observed mortality imbalance with increasing sildenafil doses.
Danish: 37 dødsfald forekom før datamonitoreringskomiteens beslutning om at titrere dosen hos forsøgspersoner til et lavere niveau, baseret på en observeret ubalance i mortalitet ved stigende sildenafildoser.
English: Physicians should advise patients who forget to take Granpidam to take a dose as soon as possible and then continue with the normal dose.
Danish: Lægen skal informere patienter, der glemmer at tage Granpidam, om at tage dosis hurtigst muligt og derefter fortsætte med at tage den normale dosis.
English: Across the short-term and long-term studies, the overall duration of treatment from start of double-blind for individual subjects ranged from 3 to 3129 days.
Danish: På tværs af det kortvarige og langvarige studie var den samlede behandlingsvarighed fra starten af den dobbeltblindede behandling af individuelle forsøgspersoner fra 3 til 3.129 dage.
English: You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.
Danish: Fortæl lægen, hvis De har nyre- eller leverproblemer, da dosis måske skal justeres.
English: Alpha-blockers
Danish: Alfa-blokkere
English: Special considerations for patients with kidney or liver problems
Danish: Særlige hensyn i forbindelse med patienter med nyre- eller leverproblemer
English: Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom or
Danish: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Storbritannien eller
English: - if you have recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure (<90/50 mmHg).
Danish: hvis De for nylig har haft et slagtilfælde, eller et hjerteanfald, eller hvis De har svær leversygdom eller meget lavt blodtryk (<90/50 mmHg).
English: Similarly 191 of 229 subjects (83%) who had received sildenafil had either maintained or improved their WHO Functional Class at 1 year assessment.
Danish: Tilsvarende havde 191 af de 229 forsøgspersoner (83%), som havde fået sildenafil, enten holdt eller forbedret deres WHO-funktionsklasse ved vurdering efter 1 år.
English: This is consistent with ritonavir's marked effects on a broad range of P450 substrates.
Danish: Dette er i overensstemmelse med ritonavirs udtalte virkning på et bredt udvalg af P450substrater.
English: Use of sildenafil with bosentan
Danish: Anvendelse af sildenafil sammen med bosentan
English: You should be aware of how you react to the medicine before you drive or use machines.
Danish: Vær opmærksom på, hvordan De reagerer på medicinen, inden bilkørsel eller betjening af maskiner.
English: Sildenafil and its major circulating N-desmethyl metabolite are approximately 96% bound to plasma proteins.
Danish: Sildenafil og dets væsentligste cirkulerende N-desmethylmetabolit er omtrent 96% bundet til plasmaproteiner.
English: There was a doubling of the Cmin compared to healthy volunteers.
Danish: Der er en fordobling af Cmin sammenlignet med raske frivillige forsøgspersoner.
English: Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.
Danish: Renal dialyse forventes ikke at øge clearance, da sildenafil i høj grad er bundet til plasmaproteiner, og ikke udskilles i urinen.
English: The most common adverse reactions reported across the duration of the short-term and long-term studies were generally similar to those observed in the short-term study.
Danish: De hyppigste bivirkninger, der blev rapporteret gennem det kortvarige og langvarige studie, var generelt de samme i det kortvarige studie.
English: No dose adjustment is required but the concomitant use of sildenafil and grapefruit juice is not recommended.
Danish: Dosisjustering er ikke nødvendig, men samtidig indtagelse af sildenafil og grapefrugtjuice anbefales ikke.
English: Mean pulmonary systolic blood pressure decreased by 9%.
Danish: Gennemsnitlig pulmonalt systolisk blodtryk faldt med 9%.
English: The difference in results between these randomisation subgroups may have arisen by chance in view of their limited sample size.
Danish: Forskellen mellem resultaterne i disse randomiseringsundergrupper kan være opstået ved en tilfældighed, når den begrænsede forsøgsstørrelse tages i betragtning.
English: Patients with left ventricular ejection fraction <45% or left ventricular shortening fraction <0.2 were not studied.
Danish: Patienter med venstre ventrikulær uddrivningsfraktion <45% eller venstre ventrikulær forkortningsfraktion <0,2% blev ikke undersøgt.
English: Each tablet also contains 0.2 mg of lactose (as monohydrate).
Danish: Hver tablet indeholder også 0,2 mg lactose (som monohydrat).
English: Suddenly stopping your treatment with Granpidam may lead to your symptoms getting worse.
Danish: Hvis De pludseligt stopper med at tage Granpidam, kan Deres symptomer blive forværret.
English: Apart from the presence of this enzyme in the corpus cavernosum of the penis, PDE5 is also present in the pulmonary vasculature.
Danish: Bortset fra tilstedeværelsen af dette enzym i corpus cavernosum i penis, er PDE5 også tilstede i muskulaturen i de pulmonale kar.
English: Patients who previously failed bosentan therapy were excluded from the study.
Danish: Patienter, som havde tidligere behandlingssvigt med bosentan, blev udelukket fra studiet.
English: The mean absolute oral bioavailability is 41% (range 25-63%).
Danish: Den gennemsnitlige absolutte orale biotilgængelighed er 41% (fra 25-63%).
English: You should not take more medicine than your doctor tells you to.
Danish: De må ikke tage mere medicin, end Deres læge har foreskrevet.
English: There is an 80-fold selectivity over PDE1, and over 700-fold over PDE 2, 3, 4, 7, 8, 9, 10 and 11.
Danish: Selektiviteten er 80 gange i forhold til PDE1 og mere end 700-gange i forhold til PDE 2, 3, 4, 7, 8, 9, 10 og 11.
English: - take medicines for erectile dysfunction.
Danish: tager medicin for impotens (erektil dysfunktion).
English: Serious adverse events were reported in 94 (41%) of the 229 subjects receiving sildenafil.
Danish: Der blev rapporteret alvorlige bivirkninger hos 94 (41%) af de 229 forsøgspersoner, som fik sildenafil.
English: Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Danish: Maksimale plasmakoncentrationer nås inden for 30-120 minutter (gennemsnitligt 60 minutter) efter oral indgift i fastende tilstand.
English: Granpidam passes into your breast milk at very low levels and would not be expected to harm your baby.
Danish: Granpidam udskilles i modermælken i meget små mængder og forventes ikke at skade barnet.
English: In case of clinical deterioration in spite of Granpidam treatment, alternative therapies should be considered.
Danish: I tilfælde af klinisk forværring på trods af Granpidam-behandling, bør alternative behandlingsmuligheder overvejes.
English: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona Spain
Danish: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona Spanien
English: Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance.
Danish: Derfor kan hæmmere af disse isoenzymer nedsætte clearance af sildenafil, og induktorer af disse isoenzymer kan øge clearance af sildenafil.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via nationale rapporteringssystem anført i Appendiks V.Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Studies in vitro have shown that sildenafil is selective for PDE5.
Danish: In vitro studier har vist, at sildenafil er selektiv for PDE5.
English: The major circulating metabolite results from N-demethylation of sildenafil.
Danish: Den væsentligste cirkulerende metabolit er resultatet af en N-demethylering af sildenafil.
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension.
Danish: Behandling bør kun initieres og monitoreres af en læge med erfaring i behandling af pulmonal arteriel hypertension (PAH).
English: The mean steady state volume of distribution (Vss) for sildenafil is 105 l, indicating distribution into the tissues.
Danish: Det gennemsnitlige steady-state fordelingsvolumen (VSS) for sildenafil er 105 l, hvilket tyder på fordeling i vævet.
English: Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment.
Danish: Sildenafil bør derfor kun anvendes til disse patienter efter omhyggelig risk/benefit-vurdering.
English: Studies in animals have shown toxicity with respect to postnatal development (see section 5.3).
Danish: Dyreforsøg har påvist toksicitet med hensyn til den postnatale udvikling (se pkt.
English: The results of the main analysis (combined dose groups versus placebo) were not statistically significant (p = 0.056) (see Table 2).
Danish: Resultaterne af hovedanalysen (sildenafilgrupperne vs. placebo) var ikke statistisk signifikante (p=0,056) (se tabel 2).
English: Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity.
Danish: Behandling af voksne patienter med pulmonal arteriel hypertension klassificeret som WHOfunktionsklasse II og III, til at forbedre det fysiske funktionsniveau.
English: Prescribers should carefully assess the mother's clinical need for sildenafil and any potential adverse effects on the breast fed child.
Danish: Ordinerende læger bør nøje vurdere moderens kliniske behov for sildenafil samt eventuelle potentielle bivirkninger hos det ammede barn.
English: Sildenafil has no effect on visual acuity or contrast sensitivity.
Danish: Sildenafil har ingen effekt på synsskarphed eller kontrastfølsomheden.
English: However to avoid the possible occurrence of sudden clinical deterioration during withdrawal, a gradual dose reduction should be considered.
Danish: For at undgå en potentiel pludselig klinisk forværring under seponering af behandling bør gradvis dosisreduktion overvejes.
English: Sildenafil had no significant effect on atorvastatin exposure (AUC increased 11%), suggesting that sildenafil does not have a clinically relevant effect on CYP3A4.
Danish: Sildenafil har ingen signifikant effekt på atorvastatins eksponering (AUC steg 11%), hvilket tyder på at sildenafil ikke har en relevant klinisk effekt på CYP3A4.
English: Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension.
Danish: Behandling af pædiatriske patienter i alderen 1-17 år med pulmonal arteriel hypertension.
English: Bleeding disorders
Danish: Blødningsforstyrrelser
English: These medicines are often given for relief of chest pain (or “angina pectoris”).
Danish: Denne type medicin gives ofte til lindring af smerter i brystet (eller “angina pectoris”).
English: Due to age-differences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately
Danish: Som følge af aldersforskelle i plasmaproteinbindingen er den tilsvarende stigning i plasmakoncentration af fri sildenafil ca. 40 %.
English: Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance <30 ml/min).
Danish: Initial dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion, inklusiv svært nedsat nyrefunktion (kreatininclearance <30 ml/min).
English: By sildenafil treatment group, median duration of sildenafil treatment was 1696 days (excluding the 5 subjects who received placebo in double-blind and were not treated in the long-term extension study).
Danish: I sildenafil-gruppen var den gennemsnitlige varighed af sildenafil-behandlingen 1.696 dage (eksklusive de 5 forsøgspersoner, som fik placebo i en dobbeltblindet fase, og som ikke blev behandlet i det langvarige forlængelsesstudie).
English: Do not stop taking Granpidam unless your doctor tells you to.
Danish: Stop ikke med at tage Granpidam, medmindre det sker i samråd med lægen.
English: In general, any dose adjustment should be administered only after a careful benefit-risk assessment.
Danish: Generelt bør enhver dosisjustering kun foretages efter en omhyggelig vurdering af risk/benefit.
English: If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De tager Granpidam.
English: There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
Danish: Der er ingen data vedrørende interaktion af sildenafil og ikke-specifikke fosfodiesterasehæmmere, såsom teophyllin eller dipyridamol.
English: However, cases of life threatening pulmonary oedema have been reported with vasodilators (mainly prostacyclin) when used in those patients.
Danish: Tilfælde af livstruende lungeødem er imidlertid rapporteret ved brug af vasodilatorer (hovedsagelig prostacyclin) hos disse patienter.
English: Granpidam brings down blood pressure in the lungs by widening the blood vessels in the lungs.
Danish: Granpidam nedsætter blodtrykket i lungerne ved at udvide blodkarrene i lungerne.
English: When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in Tmax of 60 minutes and a mean reduction in Cmax of 29% however, the extent of absorption was not significantly affected (AUC decreased by 11%).
Danish: Når sildenafil tages sammen med føde reduceres absorptionshastigheden med en gennemsnitlig forsinkelse i tmax på 60 minutter og en gennemsnitlig sænkning af Cmax på 29%, men absorptionsgraden er imidlertid ikke signifikant påvirket (AUC faldt med 11%).
English: In the long term paediatric extension study, an increase in deaths was observed in patients administered doses higher than the recommended dose.
Danish: I det langvarige pædiatriske studie, der blev forlænget, blev der observeret en øget forekomst af dødsfald hos patienter, der fik højere doser end de anbefalede.
English: Granpidam with food and drink You should not drink grapefruit juice while you are being treated with Granpidam.
Danish: De må ikke drikke grapefrugtjuice, mens De er i behandling med Granpidam.
English: The adverse reactions profile seen in this paediatric study was generally consistent with that in adults (see table above).
Danish: Bivirkningsprofilen i det pædiatriske studie stemte stort set overens med den for voksne (se skemaet ovenfor).
English: Sildenafil has moderate influence on the ability to drive and use machines.
Danish: Sildenafil påvirker i moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the bioavailability of sildenafil.
Danish: Enkeltdoser af antacida (magnesiumhydroxid/aluminiumhydroxid) påvirker ikke biotilgængeligheden af sildenafil.