natgillin/translations-raw huggingface dataset:
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)
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.
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.
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.
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.
Granpidam anvendes til at behandle voksne, børn og unge fra 1-17 år med for højt blodtryk i blodkarrene i lungerne (pulmonal arteriel hypertension).
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).
Tabletten med 20 mg bør ikke anvendes i de tilfælde, hvor der administreres 10 mg 3 gange dagligt hos yngre patienter.
The 20 mg tablet should not be used in cases where 10 mg TID should be administered in younger patients.
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.
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.
Vedvarende og til tider smertefulde erektion er set hos mænd efter indtagelse af sildenafil (hyppighed er ukendt).
Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known).
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%).
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%).
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.
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.
Estimater er baseret på ANCOVA og korrigeret for covariat baseline maksimal VO2, ætiologi og vægtgruppe.
Estimates based on ANCOVA with adjustments for the covariates baseline peak VO2, etiology and weight group
Det skal De vide, før De begynder at tage Granpidam
What you need to know before you take Granpidam
Samtidig anvendelse med andre PDE5-hæmmere
Concomitant use with other PDE5 inhibitors
Hvis det kliniske billede forværres, bør behandling, der er anbefalet i en mere alvorlig fase af sygdommen, overvejes (f.eks. epoprosterol) (se pkt.
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).
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).
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).
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).
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).
Andre lægemiddelformer er tilgængelige til administration til patienter ≤20 og andre yngre patienter, som ikke kan synke tabletter.
Other pharmaceutical forms are available for administration to patients ≤20 kg and other younger patients who are not able to swallow tablets.
I alt 234 forsøgspersoner i alderen 1-17 år blev behandlet i et randomiseret, dobbelt-blindt, multicenter, placebokontrolleret klinisk studie med parallelle grupper.
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.
Sildenafil er en potent og selektiv hæmmer af cyklisk guanosinmonophosphat (cGMP)- specifik fosfodiesterase type 5 (PDE5), enzymet der er ansvarlig for nedbrydningen af cGMP.
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.
De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Lægen har ordineret dette lægemiddel til Dem personligt.
- This medicine has been prescribed for you only.
Af de 234 pædiatriske patienter, der blev behandlet i det kortvarige, placebokontrollerede studie, gik 220 forsøgspersoner videre til det langvarige forlængelsesstudie.
Of the 234 paediatric subjects treated in the short-term, placebo-controlled study, 220 subjects entered the long-term extension study.
Pakningsstørrelse: 300 tabletter i en karton.
Pack size of 300 tablets in a carton.
Den formodede mekanisme bag denne ændring i farveskelnen er relateret til hæmningen af PDE6, som er involveret i lystransduktionskaskaden af retina.
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.
Der var et statistisk signifikant benefit ved sildenafil sammenlignet med placebo ved en 6 minutters gangdistance.
There was a statistically significant benefit of sildenafil compared to placebo in 6-minute walk distance.