natgillin/translations-raw huggingface dataset:
De hyppigste bivirkninger, der blev rapporteret gennem det kortvarige og langvarige studie, var generelt de samme i det kortvarige studie. 
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.
Dosisjustering er ikke nødvendig, men samtidig indtagelse af sildenafil og grapefrugtjuice anbefales ikke. 
No dose adjustment is required but the concomitant use of sildenafil and grapefruit juice is not recommended.
Gennemsnitlig pulmonalt systolisk blodtryk faldt med 9%. 
Mean pulmonary systolic blood pressure decreased by 9%.
Forskellen mellem resultaterne i disse randomiseringsundergrupper kan være opstået ved en tilfældighed, når den begrænsede forsøgsstørrelse tages i betragtning. 
The difference in results between these randomisation subgroups may have arisen by chance in view of their limited sample size.
Patienter med venstre ventrikulær uddrivningsfraktion <45% eller venstre ventrikulær forkortningsfraktion <0,2% blev ikke undersøgt. 
Patients with left ventricular ejection fraction <45% or left ventricular shortening fraction <0.2 were not studied.
Hver tablet indeholder også 0,2 mg lactose (som monohydrat). 
Each tablet also contains 0.2 mg of lactose (as monohydrate).
Hvis De pludseligt stopper med at tage Granpidam, kan Deres symptomer blive forværret. 
Suddenly stopping your treatment with Granpidam may lead to your symptoms getting worse.
Bortset fra tilstedeværelsen af dette enzym i corpus cavernosum i penis, er PDE5 også tilstede i muskulaturen i de pulmonale kar. 
Apart from the presence of this enzyme in the corpus cavernosum of the penis, PDE5 is also present in the pulmonary vasculature.
Patienter, som havde tidligere behandlingssvigt med bosentan, blev udelukket fra studiet. 
Patients who previously failed bosentan therapy were excluded from the study.
Den gennemsnitlige absolutte orale biotilgængelighed er 41% (fra 25-63%). 
The mean absolute oral bioavailability is 41% (range 25-63%).
De må ikke tage mere medicin, end Deres læge har foreskrevet. 
You should not take more medicine than your doctor tells you to.
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. 
There is an 80-fold selectivity over PDE1, and over 700-fold over PDE 2, 3, 4, 7, 8, 9, 10 and 11.
tager medicin for impotens (erektil dysfunktion). 
- take medicines for erectile dysfunction.
Der blev rapporteret alvorlige bivirkninger hos 94 (41%) af de 229 forsøgspersoner, som fik sildenafil. 
Serious adverse events were reported in 94 (41%) of the 229 subjects receiving sildenafil.
Maksimale plasmakoncentrationer nås inden for 30-120 minutter (gennemsnitligt 60 minutter) efter oral indgift i fastende tilstand. 
Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Granpidam udskilles i modermælken i meget små mængder og forventes ikke at skade barnet. 
Granpidam passes into your breast milk at very low levels and would not be expected to harm your baby.
I tilfælde af klinisk forværring på trods af Granpidam-behandling, bør alternative behandlingsmuligheder overvejes. 
In case of clinical deterioration in spite of Granpidam treatment, alternative therapies should be considered.
Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona Spanien 
Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona Spain
Derfor kan hæmmere af disse isoenzymer nedsætte clearance af sildenafil, og induktorer af disse isoenzymer kan øge clearance af sildenafil. 
Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance.
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. 
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.
In vitro studier har vist, at sildenafil er selektiv for PDE5. 
Studies in vitro have shown that sildenafil is selective for PDE5.
Den væsentligste cirkulerende metabolit er resultatet af en N-demethylering af sildenafil. 
The major circulating metabolite results from N-demethylation of sildenafil.
Behandling bør kun initieres og monitoreres af en læge med erfaring i behandling af pulmonal arteriel hypertension (PAH). 
Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension.
Det gennemsnitlige steady-state fordelingsvolumen (VSS) for sildenafil er 105 l, hvilket tyder på fordeling i vævet. 
The mean steady state volume of distribution (Vss) for sildenafil is 105 l, indicating distribution into the tissues.
Sildenafil bør derfor kun anvendes til disse patienter efter omhyggelig risk/benefit-vurdering. 
Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment.
Dyreforsøg har påvist toksicitet med hensyn til den postnatale udvikling (se pkt. 
Studies in animals have shown toxicity with respect to postnatal development (see section 5.3).
Resultaterne af hovedanalysen (sildenafilgrupperne vs. placebo) var ikke statistisk signifikante (p=0,056) (se tabel 2). 
The results of the main analysis (combined dose groups versus placebo) were not statistically significant (p = 0.056) (see Table 2).
Behandling af voksne patienter med pulmonal arteriel hypertension klassificeret som WHOfunktionsklasse II og III, til at forbedre det fysiske funktionsniveau. 
Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity.
Ordinerende læger bør nøje vurdere moderens kliniske behov for sildenafil samt eventuelle potentielle bivirkninger hos det ammede barn. 
Prescribers should carefully assess the mother's clinical need for sildenafil and any potential adverse effects on the breast fed child.
Sildenafil har ingen effekt på synsskarphed eller kontrastfølsomheden. 
Sildenafil has no effect on visual acuity or contrast sensitivity.
For at undgå en potentiel pludselig klinisk forværring under seponering af behandling bør gradvis dosisreduktion overvejes. 
However to avoid the possible occurrence of sudden clinical deterioration during withdrawal, a gradual dose reduction should be considered.
Sildenafil har ingen signifikant effekt på atorvastatins eksponering (AUC steg 11%), hvilket tyder på at sildenafil ikke har en relevant klinisk effekt på CYP3A4. 
Sildenafil had no significant effect on atorvastatin exposure (AUC increased 11%), suggesting that sildenafil does not have a clinically relevant effect on CYP3A4.
Behandling af pædiatriske patienter i alderen 1-17 år med pulmonal arteriel hypertension. 
Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension.
Blødningsforstyrrelser 
Bleeding disorders
Denne type medicin gives ofte til lindring af smerter i brystet (eller “angina pectoris”). 
These medicines are often given for relief of chest pain (or “angina pectoris”).
Som følge af aldersforskelle i plasmaproteinbindingen er den tilsvarende stigning i plasmakoncentration af fri sildenafil ca. 40 %. 
Due to age-differences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately
Initial dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion, inklusiv svært nedsat nyrefunktion (kreatininclearance <30 ml/min). 
Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance <30 ml/min).
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). 
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).
Stop ikke med at tage Granpidam, medmindre det sker i samråd med lægen. 
Do not stop taking Granpidam unless your doctor tells you to.
Generelt bør enhver dosisjustering kun foretages efter en omhyggelig vurdering af risk/benefit. 
In general, any dose adjustment should be administered only after a careful benefit-risk assessment.
Hvis De er gravid eller ammer, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De tager Granpidam. 
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.
Der er ingen data vedrørende interaktion af sildenafil og ikke-specifikke fosfodiesterasehæmmere, såsom teophyllin eller dipyridamol. 
There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
Tilfælde af livstruende lungeødem er imidlertid rapporteret ved brug af vasodilatorer (hovedsagelig prostacyclin) hos disse patienter. 
However, cases of life threatening pulmonary oedema have been reported with vasodilators (mainly prostacyclin) when used in those patients.
Granpidam nedsætter blodtrykket i lungerne ved at udvide blodkarrene i lungerne. 
Granpidam brings down blood pressure in the lungs by widening the blood vessels in the lungs.
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%). 
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%).
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. 
In the long term paediatric extension study, an increase in deaths was observed in patients administered doses higher than the recommended dose.
De må ikke drikke grapefrugtjuice, mens De er i behandling med Granpidam. 
Granpidam with food and drink You should not drink grapefruit juice while you are being treated with Granpidam.
Bivirkningsprofilen i det pædiatriske studie stemte stort set overens med den for voksne (se skemaet ovenfor). 
The adverse reactions profile seen in this paediatric study was generally consistent with that in adults (see table above).
Sildenafil påvirker i moderat grad evnen til at føre motorkøretøj eller betjene maskiner. 
Sildenafil has moderate influence on the ability to drive and use machines.
Enkeltdoser af antacida (magnesiumhydroxid/aluminiumhydroxid) påvirker ikke biotilgængeligheden af sildenafil. 
Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the bioavailability of sildenafil.
Der findes ingen tilgængelige kliniske data vedrørende bivirkninger hos ammede spædbørn, men de indtagne mængder forventes ikke at forårsage bivirkninger. 
No clinical data are available regarding adverse events in breast-fed infants, but amounts ingested would not be expected to cause any adverse effects.
Lægen bør informere patienten om, hvad han/hun skal gøre i tilfælde af ortostatiske hypotensive symptomer. 
Physicians should advise patients what to do in the event of postural hypotensive symptoms.
Sildenafil har ingen virkning på saquinavirs farmakokinetik. 
Sildenafil had no effect on saquinavir pharmacokinetics.
Effekt hos voksne patienter med PAH (ved anvendelse sammen med epoprostenol) 
Efficacy in adult patients with PAH (when used in combination with epoprostenol)
Disse var de eneste faktorer med statistisk signifikant indvirkning på sildenafils farmakokinetik hos patienter med pulmonal arteriel hypertension. 
These were the only factors with a statistically significant impact on sildenafil pharmacokinetics in patients with pulmonary arterial hypertension.
Begge fund antyder en lavere clearance og/eller en højere oral biotilgængelighed af sildenafil hos patienter med pulmonal arteriel hypertension sammenlignet med raske frivillige forsøgspersoner. 
Both findings suggest a lower clearance and/or a higher oral bioavailability of sildenafil in patients with pulmonary arterial hypertension compared to healthy volunteers.
hvis De på noget tidspunkt tidligere har haft tab af synet på grund af problemer med blodtilførslen til nerven i øjet, tilstanden kaldes non-arteritis anterior iskæmisk opticusneuropati (NAION). 
- if you have ever had loss of vision because of a problem with blood flow to the nerve in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).
Data fra en enkelt ammende kvinde indikerer, at sildenafil og dets aktive metabolit N-desmethylsildenafil udskilles i meget små mængder i human mælk. 
Data from one lactating woman indicate that sildenafil and its active metabolite N-desmethylsildenafil are excreted into breast milk at very low levels.
Sildenafil (eller placebo) blev adderet patienternes standardbehandling, som kunne omfatte en kombination af antikoagulantia, digoxin, calciumkanalblokkere, diuretika eller oxygen. 
Sildenafil (or placebo) was added to patients' background therapy which could have included a combination of anticoagulation, digoxin, calcium channel blockers, diuretics or oxygen.
Sildenafil øger derfor cGMP i de pulmonale vaskulære glatte muskelceller, med deraf følgende afslapning. 
Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation.
Nervesystemet Meget almindelig hovedpine 
Nervous system disorders Very common headache
Pædiatrisk population Sildenafil sikkerhed og virkning hos børn under 1 år er ikke klarlagt. 
The safety and efficacy of sildenafil in children below 1 year of age has not been established.
Da der er rapporteret svimmelhed og ændret syn i kliniske studier med sildenafil, bør patienter være opmærksomme på, hvordan de reagerer på Granpidam, inden de kører bil eller betjener maskiner. 
As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they might be affected by Granpidam, before driving or using machines.
Der ses ingen interaktioner mellem sildenafil (100 mg enkeltdosis) og acenocoumarol. 
No interactions were observed between sildenafil (100 mg single dose) and acenocoumarol.
PAH-patienterne inkluderede dem med primær pulmonal arteriel hypertension (212/267, 79%) og PAH associeret med bindevævssygdom (55/267, 21%). 
The PAH patients included those with Primary Pulmonary Arterial Hypertension (212/267, 79%) and PAH associated with connective tissue disease (55/267, 21%).
hvis De tager medicin til behandling af svampeinfektioner som f.eks. ketoconazol eller itraconazol eller medicin som indeholder ritonavir (mod hiv). 
- if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV).
I alt 134 patienter blev behandlet med sildenafil i det indledende studie, og deres langtidsoverlevelse blev vurderet i minimum 3 år. 
A total of 134 patients were treated with sildenafil in the initial study, and their long term survival status was assessed for a minimum of 3 years.
På grund af nitratkomponenten kan det muligvis give alvorlig interaktion med sildenafil (se pkt. 
Due to the nitrate component it has the potential to have serious interaction with sildenafil (see section 4.3).
Dosisjustering til 20 mg 2 gange dagligt bør overvejes efter omhyggelig risk/benefit-vurdering, og kun hvis behandlingen ikke er veltolereret. 
A downward dose adjustment to 20 mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated.
Veneokklusiv sygdom 
Veno-occlusive disease
Sekundære endepunkter inkluderede hæmodynamisk monitorering, symptomvurdering, WHOfunktionsklasse, ændring i baggrundsbehandling og måling af livskvalitet. 
Secondary endpoints included haemodynamic monitoring, symptom assessment, WHO functional class, change in background treatment, and quality of life measurements.
De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne dosis, genotoksicitet, karcinogenicitet, reproduktionstoksicitet og udvikling. 
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential, toxicity to reproduction and development.
Initial dosisjustering er ikke nødvendig hos patienter med nedsat leverfunktion (Child-Pugh klasse A og B). 
Initial dose adjustments are not required in patients with hepatic impairment (Child-Pugh class A and B).
Disse yderligere blodtryksfald var af samme størrelsesorden, som når sildenafil blev givet alene til raske frivillige forsøgspersoner. 
These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers.
Prækliniske data tyder ikke på særlig risiko for mennesker baseret på konventionelle fertilitetsstudier (se pkt. 
Non-clinical data revealed no special hazard for humans based on conventional studies of fertility (see section 5.3).
Hvis De holder op med at tage Granpidam 
If you stop taking Granpidam
Patienterne må ikke tage dobbelt dosis for at kompensere for den glemte dosis. 
Patients should not take a double dose to compensate for the missed dose.
Analyse af den farmakokinetiske profil for sildenafil til patienter, der indgik i kliniske forsøg med pædiatriske patienter, viser, at legemsvægt er en god parameter til at forudsige eksponeringen hos børn. 
From the analysis of the pharmacokinetic profile of sildenafil in patients involved in the paediatric clinical trials, body weight was shown to be a good predictor of drug exposure in children.
For at mindske risikoen for udvikling af ortostatisk hypotension, bør patienterne være hæmodynamisk stabile på alfa-blokker-behandling, førend sildenafilbehandling initieres. 
In order to minimise the potential for developing postural hypotension, patients should be haemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment.
Hvis De har glemt at tage Granpidam 
If you forget to take Granpidam
I to placebo-kontrollerede studier er bivirkningerne generelt milde til moderate. 
In the two placebo-controlled studies adverse events were generally mild to moderate in severity.
Øre og labyrint Almindelig vertigo 
Ear and labyrinth disorders Common vertigo
Forbedringer blev set i kardielt indeks i alle tre behandlingsgrupper sammenlignet med placebo, hhv. 10%, 4% og 15% for lav-, middel- og højdosis-grupperne. 
Improvements were observed with cardiac index with all three sildenafil groups over placebo, 10%, 4% and 15% for the low, medium and high dose groups respectively.
Plasmahalveringstiden for sildenafil blev estimeret til 4,2-4,4 timer i området 10-70 kg legemsvægt og viste ikke forskelle af klinisk relevans. 
Sildenafil plasma concentration half-life values were estimated to range from 4.2 to 4.4 hours for a range of 10 to 70 kg of body weight and did not show any differences that would appear as clinically relevant.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 20 mg sildenafil (som citrat). 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Resultaterne var generelt konsistente i undergrupperne i henhold til ætiologi (primær og PAH forbundet med bindevævssygdom), WHO-funktionsklasse, køn, race, undersøgelsessted, middel PAP og PVRI. 
Results were generally consistent in subgroups according to aetiology (primary and connective tissue disease-associated PAH), WHO functional class, gender, race, location, mean PAP and PVRI.
Behandling med sildenafil forlængede tiden indtil klinisk forværring af PAH signifikant sammenlignet med placebo (p=0,0074). 
Treatment with sildenafil significantly delayed the time to clinical worsening of PAH compared to placebo (p = 0.0074).
Hududslæt og pludselig hørenedsættelse eller døvhed og for lavt blodtryk er også set (hyppighed er ukendt, kan ikke vurderes ud fra tilgængelige data). 
Skin rash and sudden decrease or loss of hearing and decreased blood pressure have also been reported at an unknown frequency (frequency cannot be estimated from the available data).
Data fra et begrænset antal antyder, at en pludselig afbrydelse af sildenafil -behandlingen ikke er forbundet med et forværret tilbagefald af pulmonal arteriel hypertension. 
Limited data suggest that the abrupt discontinuation of sildenafil is not associated with rebound worsening of pulmonary arterial hypertension.
Forsøgspersoner, der fik aktiv behandling med sildenafil, fortsatte med det samme behandlingsregime, hvorimod forsøgspersonerne i placebogruppen i det kortvarige studie blev randomiseret til behandling med sildenafil. 
Subjects on active sildenafil therapy continued on the same treatment regimen, while those in the placebo group in the short-term study were randomly reassigned to sildenafil treatment.
De fleste af disse bivirkninger var af let til moderat sværhedsgrad. 
Most of these adverse reactions were considered mild to moderate in severity.
Granpidam må kun anvendes under graviditet, hvis det er strengt nødvendigt. 
Granpidam should not be used during pregnancy unless strictly necessary.
Det tilsvarende fald i det diastoliske blodtryk i liggende stilling var 7 mmHg. 
The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg.
Der ses ingen signifikante interaktioner, når sildenafil (50 mg) anvendes sammen med tolbutamid (250 mg) eller warfarin (40 mg), som begge metaboliseres af CYP2C9. 
No significant interactions were shown when sildenafil (50 mg) was co-administered with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9.
Især har sildenafil mere end 4.000 gange større selektivitet for PDE5 end for PDE3, den cAMP-specifikke fosfodiesteraseisoform, som er involveret i kontrollen af hjertets kontraktilitet. 
In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.
Hvis priapisme ikke behandles med det samme, kan det resultere i beskadigelse af penisvæv og permanent impotens (se pkt. 
If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result (see section 4.8).
Sildenafil, bør anvendes med forsigtighed hos patienter med anatomisk deformitet af penis (som f.eks. vinkling, kavernøs fibrose eller Peyronies sygdom), eller hos patienter med lidelser, som kan prædisponere til priapisme (som f.eks. seglcelleanæmi, multipelt myelom eller leukæmi). 
Sildenafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Denne metabolit har en fosfodiesteraseselektivitetsprofil svarende til sildenafil og en in vitro styrke over for PDE5 på ca. 50% af moderstoffet. 
This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% that of the parent drug.
Effekt hos voksne patienter med pulmonalarteriel hypertension (PAH) 
Efficacy in adult patients with pulmonary arterial hypertension (PAH)