FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinical data are available regarding adverse events in breast-fed infants, but amounts ingested would not be expected to cause any adverse effects.
Danish: Der findes ingen tilgængelige kliniske data vedrørende bivirkninger hos ammede spædbørn, men de indtagne mængder forventes ikke at forårsage bivirkninger.
English: Physicians should advise patients what to do in the event of postural hypotensive symptoms.
Danish: Lægen bør informere patienten om, hvad han/hun skal gøre i tilfælde af ortostatiske hypotensive symptomer.
English: Sildenafil had no effect on saquinavir pharmacokinetics.
Danish: Sildenafil har ingen virkning på saquinavirs farmakokinetik.
English: Efficacy in adult patients with PAH (when used in combination with epoprostenol)
Danish: Effekt hos voksne patienter med PAH (ved anvendelse sammen med epoprostenol)
English: These were the only factors with a statistically significant impact on sildenafil pharmacokinetics in patients with pulmonary arterial hypertension.
Danish: Disse var de eneste faktorer med statistisk signifikant indvirkning på sildenafils farmakokinetik hos patienter med pulmonal arteriel hypertension.
English: Both findings suggest a lower clearance and/or a higher oral bioavailability of sildenafil in patients with pulmonary arterial hypertension compared to healthy volunteers.
Danish: 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.
English: - 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).
Danish: 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).
English: Data from one lactating woman indicate that sildenafil and its active metabolite N-desmethylsildenafil are excreted into breast milk at very low levels.
Danish: Data fra en enkelt ammende kvinde indikerer, at sildenafil og dets aktive metabolit N-desmethylsildenafil udskilles i meget små mængder i human mælk.
English: Sildenafil (or placebo) was added to patients' background therapy which could have included a combination of anticoagulation, digoxin, calcium channel blockers, diuretics or oxygen.
Danish: Sildenafil (eller placebo) blev adderet patienternes standardbehandling, som kunne omfatte en kombination af antikoagulantia, digoxin, calciumkanalblokkere, diuretika eller oxygen.
English: Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation.
Danish: Sildenafil øger derfor cGMP i de pulmonale vaskulære glatte muskelceller, med deraf følgende afslapning.
English: Nervous system disorders Very common headache
Danish: Nervesystemet Meget almindelig hovedpine
English: The safety and efficacy of sildenafil in children below 1 year of age has not been established.
Danish: Pædiatrisk population Sildenafil sikkerhed og virkning hos børn under 1 år er ikke klarlagt.
English: 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.
Danish: 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.
English: No interactions were observed between sildenafil (100 mg single dose) and acenocoumarol.
Danish: Der ses ingen interaktioner mellem sildenafil (100 mg enkeltdosis) og acenocoumarol.
English: The PAH patients included those with Primary Pulmonary Arterial Hypertension (212/267, 79%) and PAH associated with connective tissue disease (55/267, 21%).
Danish: PAH-patienterne inkluderede dem med primær pulmonal arteriel hypertension (212/267, 79%) og PAH associeret med bindevævssygdom (55/267, 21%).
English: - if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV).
Danish: hvis De tager medicin til behandling af svampeinfektioner som f.eks. ketoconazol eller itraconazol eller medicin som indeholder ritonavir (mod hiv).
English: 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.
Danish: I alt 134 patienter blev behandlet med sildenafil i det indledende studie, og deres langtidsoverlevelse blev vurderet i minimum 3 år.
English: Due to the nitrate component it has the potential to have serious interaction with sildenafil (see section 4.3).
Danish: På grund af nitratkomponenten kan det muligvis give alvorlig interaktion med sildenafil (se pkt.
English: 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.
Danish: Dosisjustering til 20 mg 2 gange dagligt bør overvejes efter omhyggelig risk/benefit-vurdering, og kun hvis behandlingen ikke er veltolereret.
English: Veno-occlusive disease
Danish: Veneokklusiv sygdom
English: Secondary endpoints included haemodynamic monitoring, symptom assessment, WHO functional class, change in background treatment, and quality of life measurements.
Danish: Sekundære endepunkter inkluderede hæmodynamisk monitorering, symptomvurdering, WHOfunktionsklasse, ændring i baggrundsbehandling og måling af livskvalitet.
English: 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.
Danish: 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.
English: Initial dose adjustments are not required in patients with hepatic impairment (Child-Pugh class A and B).
Danish: Initial dosisjustering er ikke nødvendig hos patienter med nedsat leverfunktion (Child-Pugh klasse A og B).
English: These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers.
Danish: Disse yderligere blodtryksfald var af samme størrelsesorden, som når sildenafil blev givet alene til raske frivillige forsøgspersoner.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of fertility (see section 5.3).
Danish: Prækliniske data tyder ikke på særlig risiko for mennesker baseret på konventionelle fertilitetsstudier (se pkt.
English: If you stop taking Granpidam
Danish: Hvis De holder op med at tage Granpidam
English: Patients should not take a double dose to compensate for the missed dose.
Danish: Patienterne må ikke tage dobbelt dosis for at kompensere for den glemte dosis.
English: 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.
Danish: 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.
English: In order to minimise the potential for developing postural hypotension, patients should be haemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment.
Danish: For at mindske risikoen for udvikling af ortostatisk hypotension, bør patienterne være hæmodynamisk stabile på alfa-blokker-behandling, førend sildenafilbehandling initieres.
English: If you forget to take Granpidam
Danish: Hvis De har glemt at tage Granpidam
English: In the two placebo-controlled studies adverse events were generally mild to moderate in severity.
Danish: I to placebo-kontrollerede studier er bivirkningerne generelt milde til moderate.
English: Ear and labyrinth disorders Common vertigo
Danish: Øre og labyrint Almindelig vertigo
English: 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.
Danish: Forbedringer blev set i kardielt indeks i alle tre behandlingsgrupper sammenlignet med placebo, hhv. 10%, 4% og 15% for lav-, middel- og højdosis-grupperne.
English: 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.
Danish: Plasmahalveringstiden for sildenafil blev estimeret til 4,2-4,4 timer i området 10-70 kg legemsvægt og viste ikke forskelle af klinisk relevans.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 20 mg sildenafil (som citrat).
English: 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.
Danish: 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.
English: Treatment with sildenafil significantly delayed the time to clinical worsening of PAH compared to placebo (p = 0.0074).
Danish: Behandling med sildenafil forlængede tiden indtil klinisk forværring af PAH signifikant sammenlignet med placebo (p=0,0074).
English: 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).
Danish: Hududslæt og pludselig hørenedsættelse eller døvhed og for lavt blodtryk er også set (hyppighed er ukendt, kan ikke vurderes ud fra tilgængelige data).
English: Limited data suggest that the abrupt discontinuation of sildenafil is not associated with rebound worsening of pulmonary arterial hypertension.
Danish: Data fra et begrænset antal antyder, at en pludselig afbrydelse af sildenafil -behandlingen ikke er forbundet med et forværret tilbagefald af pulmonal arteriel hypertension.
English: 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.
Danish: 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.
English: Most of these adverse reactions were considered mild to moderate in severity.
Danish: De fleste af disse bivirkninger var af let til moderat sværhedsgrad.
English: Granpidam should not be used during pregnancy unless strictly necessary.
Danish: Granpidam må kun anvendes under graviditet, hvis det er strengt nødvendigt.
English: The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg.
Danish: Det tilsvarende fald i det diastoliske blodtryk i liggende stilling var 7 mmHg.
English: 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.
Danish: Der ses ingen signifikante interaktioner, når sildenafil (50 mg) anvendes sammen med tolbutamid (250 mg) eller warfarin (40 mg), som begge metaboliseres af CYP2C9.
English: 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.
Danish: 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.
English: If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result (see section 4.8).
Danish: Hvis priapisme ikke behandles med det samme, kan det resultere i beskadigelse af penisvæv og permanent impotens (se pkt.
English: 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).
Danish: 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).
English: This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% that of the parent drug.
Danish: Denne metabolit har en fosfodiesteraseselektivitetsprofil svarende til sildenafil og en in vitro styrke over for PDE5 på ca. 50% af moderstoffet.
English: Efficacy in adult patients with pulmonary arterial hypertension (PAH)
Danish: Effekt hos voksne patienter med pulmonalarteriel hypertension (PAH)
English: Of those sildenafil treated subjects developmentally able to perform the CPET 59/114 subjects (52%) had not shown any deterioration in Peak VO2 from start of sildenafil.
Danish: Af de forsøgspersoner, der havde fået sildenafil, og som udviklingsmæssigt var i stand til at udføre CPET-testen, havde 59/114 (52%) forsøgspersoner ikke vist forværring i maksimal VO2 fra initieringen af sildenafilbehandlingen.
English: In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased.
Danish: I enkeltdosisstudier på frivillige forsøgspersoner med doser op til 800 mg er bivirkningerne de samme, som ses efter lavere doser, men hyppighed og sværhedsgrad er øget.
English: Granpidam is used to treat adults and children and adolescents from 1 to 17 years old with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).
Danish: Granpidam anvendes til at behandle voksne, børn og unge fra 1-17 år med for højt blodtryk i blodkarrene i lungerne (pulmonal arteriel hypertension).
English: The 20 mg tablet should not be used in cases where 10 mg TID should be administered in younger patients.
Danish: Tabletten med 20 mg bør ikke anvendes i de tilfælde, hvor der administreres 10 mg 3 gange dagligt hos yngre patienter.
English: In a clinical study events of vaso-occlusive crises requiring hospitalisation were reported more commonly by patients receiving sildenafil than those receiving placebo leading to the premature termination of this study.
Danish: I et klinisk studie blev tilfælde af vaso-okklusiv krise, der krævede indlæggelse, set hyppigere hos patienter, der fik sildenafil, end hos patienter, der fik placebo, hvilket førte til, at studiet blev afsluttet før tid.
English: Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known).
Danish: Vedvarende og til tider smertefulde erektion er set hos mænd efter indtagelse af sildenafil (hyppighed er ukendt).
English: The proportion of subjects receiving supportive medicinal products at baseline (anticoagulants, digoxin, calcium channel blockers, diuretics and/or oxygen) was similar in the combined sildenafil treatment group (47.7%) and the placebo treatment group (41.7%).
Danish: Andelen af forsøgspersoner, der fik anden medicin ved baseline (antikoagulantia, digoxin, calciumblokkere, diuretika og/eller oxygen) var sammenlignelig i den kombinerede sildenafil-gruppe (47,7%) og placebogruppen (41,7%).
English: In pulmonary arterial hypertension patients, there may be a potential for increased risk of bleeding when sildenafil is initiated in patients already using a Vitamin K antagonist, particularly in patients with pulmonary arterial hypertension secondary to connective tissue disease.
Danish: Hos patienter med pulmonal arteriel hypertension kan der være en potential øget risiko for blødning, når sildenafil initieres hos patienter, der allerede anvender en vitamin-K-antagonist, især hos patienter med pulmonal arteriel hypertension sekundært til bindevævssygdom.
English: Estimates based on ANCOVA with adjustments for the covariates baseline peak VO2, etiology and weight group
Danish: Estimater er baseret på ANCOVA og korrigeret for covariat baseline maksimal VO2, ætiologi og vægtgruppe.
English: What you need to know before you take Granpidam
Danish: Det skal De vide, før De begynder at tage Granpidam
English: Concomitant use with other PDE5 inhibitors
Danish: Samtidig anvendelse med andre PDE5-hæmmere
English: If the clinical situation deteriorates, therapies that are recommended at the severe stage of the disease (e.g. epoprostenol) should be considered (see section 4.2).
Danish: Hvis det kliniske billede forværres, bør behandling, der er anbefalet i en mere alvorlig fase af sygdommen, overvejes (f.eks. epoprosterol) (se pkt.
English: The primary objective of the study was to assess the efficacy of 16 weeks of chronic treatment with oral sildenafil in paediatric subjects to improve exercise capacity as measured by the Cardiopulmonary Exercise Test (CPET) in subjects who were developmentally able to perform the test, n = 115).
Danish: Det primære formål var at vurdere virkningen af 16-ugers kronisk behandling med oral sildenafil hos pædiatriske forsøgspersoner for at forbedre fysisk funktionsniveau bestemt ved Cardiopulmonary Exercise Test (CPET) hos forsøgspersoner, der udviklingsmæssigt var i stand til at udføre testen (n=115).
English: Time to clinical worsening was a secondary endpoint as defined as the time from randomisation to the first occurrence of a clinical worsening event (death, lung transplantation, initiation of bosentan therapy, or clinical deterioration requiring a change in epoprostenol therapy).
Danish: Et sekundært endepunkt var tid indtil klinisk forværring og var defineret som tiden fra randomisering til første forekomst af symptom på klinisk forværring (død, lungetransplantation, opstart af bosentan- behandling eller klinisk forværring, der krævede ændring i epoprostenol-behandling).
English: Other pharmaceutical forms are available for administration to patients ≤20 kg and other younger patients who are not able to swallow tablets.
Danish: Andre lægemiddelformer er tilgængelige til administration til patienter ≤20 og andre yngre patienter, som ikke kan synke tabletter.
English: A total of 234 subjects aged 1 to 17 years were treated in a randomized, double-blind, multi-centre, placebo controlled parallel group, dose ranging study.
Danish: I alt 234 forsøgspersoner i alderen 1-17 år blev behandlet i et randomiseret, dobbelt-blindt, multicenter, placebokontrolleret klinisk studie med parallelle grupper.
English: Sildenafil is a potent and selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5), the enzyme that is responsible for degradation of cGMP.
Danish: Sildenafil er en potent og selektiv hæmmer af cyklisk guanosinmonophosphat (cGMP)- specifik fosfodiesterase type 5 (PDE5), enzymet der er ansvarlig for nedbrydningen af cGMP.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: - This medicine has been prescribed for you only.
Danish: Lægen har ordineret dette lægemiddel til Dem personligt.
English: Of the 234 paediatric subjects treated in the short-term, placebo-controlled study, 220 subjects entered the long-term extension study.
Danish: Af de 234 pædiatriske patienter, der blev behandlet i det kortvarige, placebokontrollerede studie, gik 220 forsøgspersoner videre til det langvarige forlængelsesstudie.
English: Pack size of 300 tablets in a carton.
Danish: Pakningsstørrelse: 300 tabletter i en karton.
English: The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina.
Danish: Den formodede mekanisme bag denne ændring i farveskelnen er relateret til hæmningen af PDE6, som er involveret i lystransduktionskaskaden af retina.
English: There was a statistically significant benefit of sildenafil compared to placebo in 6-minute walk distance.
Danish: Der var et statistisk signifikant benefit ved sildenafil sammenlignet med placebo ved en 6 minutters gangdistance.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: The safety of sildenafil has not been studied in patients with known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases) and therefore its use is not recommended.
Danish: Sikkerheden af sildenafil er ikke undersøgt hos patienter med kendte arvelige degenerative sygdomme i retina, som retinitis pigmentosa (et mindretal af disse patienter har arvelige sygdomme i retinas fosfodiesteraser), og dets anvendelse kan derfor ikke anbefales.
English: For patients with primary PAH, the treatment effect was 31.1 metres compared to 7.7 metres for patients with PAH associated with connective tissue disease.
Danish: Hos patienter med primær PAH var behandlingseffekten 31,1 m sammenlignet med 7,7 m hos patienter med PAH associeret med bindevævssygdom .
English: Do not take Granpidam - if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section
Danish: Tag ikke Granpidam hvis De er allergisk over for sildenafil eller et af de øvrige indholdsstoffer i Granpidam (angivet i afsnit 6).
English: - have low blood pressure at rest. - lose a large amount of body fluids (dehydration) which can occur when you sweat a lot or do not drink enough liquids.
Danish: har mistet store mængder væske (dehydrering), dette kan ske, hvis De sveder meget, eller hvis De ikke drikker nok væske.
English: Prolonged and sometimes painful erections have been reported in men after taking sildenafil.
Danish: Vedvarende og nogle gange smertefulde erektioner er set hos mænd efter indtagelse af sildenafil.
English: Granpidam 20 mg film-coated tablets are also provided in PVC/Alu perforated unit dose blister packs containing 15x1, 90x1 and 300x1 tablets.
Danish: Granpidam 20 mg filmovertrukne tabletter er også i PVC / Alu perforeret enhed dosis blisterpakninger indeholdende 15x1, 90x1 og 300x1 tabletter.
English: Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro.
Danish: Studier med humane blodplader tyder på, at sildenafil kan forstærke den antikoagulerende effekt af natriumnitroprussid in vitro.
English: At the recommended dose of 20 mg three times a day no reductions in systolic or diastolic pressure were seen.
Danish: Ved den anbefalede dosis på 20 mg 3 gange dagligt ses ingen reduktion i det systoliske eller diastoliske tryk.
English: Sildenafil causes mild and transient decreases in systemic blood pressure which, in the majority of cases, do not translate into clinical effects.
Danish: Sildenafil giver let og forbigående fald i det systemiske blodtryk, som i de fleste tilfælde ikke kan opfattes som klinisk relevant.