natgillin/translations-raw huggingface dataset:
I et klinisk studie af de hæmodynamiske virkninger efter en enkelt oral dosis på 100 mg sildenafil hos 14 patienter med alvorlig koronararteriesygdom (CAD) (>70% stenoser i mindst 1 koronararterie) faldt det gennemsnitlige systoliske og diastoliske blodtryk i hvile med hhv. 7% og 6% sammenlignet med baseline.
In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (> 70 % stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7 % and 6 % respectively compared to baseline.
I et lille placebo-kontrolleret studie på patienter med dokumenteret tidlig aldersbetinget makulær degeneration (n=9), sildenafil (100 mg enkeltdosis) ses der ingen signifikante ændringer i udførte synsundersøgelser (synsskarphed, farveskelnen ved simuleret trafiklys, Humphrey perimeter og fotostress).
In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n = 9), sildenafil (single dose, 100 mg) demonstrated no significant changes in visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).
Revatio bør pga. manglende data ikke anvendes til gravide, medmindre det er strengt nødvendigt.
Due to lack of data, Revatio should not be used in pregnant women unless strictly necessary.
Revatio anvendes til at behandle voksne, børn og unge fra 1-17 år med for højt blodtryk i blodkarrene i lungerne (pulmonal arteriel hypertension).
Revatio 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).
PVC/aluminium blister med 300 tabletter.
PVC/Aluminium blisters of 300 tablets.
Studiepopulationen bestod af 68 (25%) mænd og 209 (75%) kvinder med en gennemsnitsalder på 49 år (alder 18-81 år) og baseline 6 minutters gangtest med en distance på mellem 100 og 450 meter inklusive (gennemsnit: 344 meter).
The study population consisted of 68 (25 %) men and 209 (75 %) women with a mean age of 49 years (range: 1881 years) and baseline 6-minute walk test distance between 100 and 450 metres inclusive (mean: 344 metres).
Resultaterne var generelt konsistente i undergrupperne i henhold til ætiologi (primær og PAH forbundet med bindevævssygdom), WHOfunktionsklasse, 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.
Hos patienter på CYP3A4-substrater og CYP3A4-substrater plus beta-blokker, var eksponeringen til sildenafil hhv. 43% og 66% højere sammenlignet med patienter, der ikke fik disse lægemidler.
The exposure to sildenafil in patients on CYP3A4 substrates and CYP3A4 substrates plus beta-blockers was 43 % and 66 % higher, respectively, compared to patients not receiving these classes of medicines.
Til voksne er den sædvanlige dosis 20 mg 3 gange dagligt (taget med 6-8 timers mellemrum med eller uden mad).
For adults, the recommended dose is 20 mg three times a day (taken 6 to 8 hours apart) taken with or without food.
Opbevaring efter rekonstituering af lægemidlet se pkt.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
- Øvrige indholdsstoffer: glucose og vand til injektionsvæsker.
- The other ingredients are glucose and water for injections.
Revatio injektionsvæske skal gives som intravenøs bolus-injektion.
Revatio solution for injection is for intravenous use as a bolus injection.
Revatio-injektionsvæske er et alternativ til patienter, der midlertidigt er ude af stand til at tage Revatio-tabletter.
Revatio solution for injection is an alternative formulation of Revatio for patients who temporarily cannot take their Revatio tablets.
Efter rekonstituering indeholder flasken 112 ml oral suspension, hvoraf de 90 ml er beregnet til brug.
Once reconstituted the bottle contains 112 ml of oral suspension, of which 90 ml is intended for dosing and administration.
De bivirkninger, der blev set i kliniske forsøg med Revatio-injektionsvæske, svarer til dem, som blev set i kliniske forsøg med Revatio-tabletter.
Side effects reported in a clinical trial with intravenous Revatio were similar to those reported in clinical trials with Revatio tablets.
Indehaveren af markedsføringstilladelsen skal sammen med de nationale myndigheder fastlægge detaljerne i et kontrolleret distributionssystem for 20 ml hætteglas Revatio 0,8 mg/ml injektionsvæske og skal implementere et nationalt program for at sikre, at alle sundhedspersoner, der vil udskrive og/eller anvende Revatio 0,8 mg/ml injektionsvæske forud for ordination får udleveret følgende:
The Marketing Authorisation Holder (MAH) shall agree the details of a controlled distribution system for the 20 ml vial of Revatio 0.8 mg/ml solution for injection with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing all healthcare professionals who intend to prescribe and/or dispense Revatio 0.8 mg/ml solution for injection are provided with the following:
Fareva Amboise Zone Industrielle 29 route des Industries 37530 Pocé-sur-Cisse Frankrig
Fareva Amboise Zone Industrielle 29 route des Industries 37530 Pocé-sur-Cisse France
Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen (efter EXP).
Do not use this medicine after the expiry date which is stated on the carton after EXP.
Vaso-okklusiv krise hos patienter med seglcelleanæmi Sildenafil må ikke anvendes til patienter med pulmonal hypertension sekundært til seglcelleanæmi.
Vaso-occlusive crises in patients with sickle cell anaemia Sildenafil should not be used in patients with pulmonary hypertension secondary to sickle cell anaemia.
Hvis De oplever pludseligt nedsat syn eller synstab, skal De stoppe med at tage Revatio og straks kontakte Deres læge (se også afsnit 4).
If you experience sudden decrease or loss of vision, stop taking Revatio and contact your doctor immediately (see also section 4).
Der blev set 1 alvorlig bivirkning hos en patient med svær iskæmisk kardiomyopati, som fik ventrikelflimren og døde 6 dage efter indgift af studiemedicinen.
There was one serious adverse reaction in a subject with severe ischaemic cardiomyopathy who experienced ventricular fibrillation and death 6 days post study.
Ud af de 94 forsøgspersoner, som rapporterede en alvorlig bivirking, var 14/55 (25,5%) forsøgspersoner i lavdosis-gruppen, 35/74 (47%) i middeldosis-gruppen og 45/100 (45%) i højdosisgruppen.
Of the 94 subjects reporting a serious adverse event, 14/55 (25.5%) subjects were in the low dose group, 35/74 (47.3%) in the medium dose group, and 45/100 (45%) in the high dose group.
Indeholder glucose og vand til injektionsvæsker
Contains glucose and water for injections.
I pivotalstudiet blev i alt 207 patienter behandlet med Revatio, og status for patienternes langtidsoverlevelse blev vurderet i mindst 3 år.
A total of 207 patients were treated with Revatio in the pivotal study, and their long term survival status was assessed for a minimum of 3 years.
Den estimerede forskel mellem den gennemsnitslige sildenafildosis og placebo var 11,33% (95% CI: 1,72-20,94) (se tabel 2).
The estimated difference between the medium sildenafil dose and placebo was 11.33 % (95 % CI: 1.72 to 20.94) (see Table 2).
Forsøgspersonerne (38% drenge og 62% piger) havde en legemsvægt ≥8 kg, primær pulmonal hypertension (PPH) (33%) eller PAH sekundært til kongenit hjertesygdom (systemisk-pulmonal shunt 37%, kirurgisk intervention 30%).
Subjects (38 % male and 62 % female) had a body weight  8 kg, and had primary pulmonary hypertension (PPH) [33 %], or PAH secondary to congenital heart disease [systemic-to-pulmonary shunt 37 %, surgical repair 30 %].
Data fra et begrænset antal antyder, at en pludselig afbrydelse af oral Revatio-behandling ikke er forbundet med et forværret tilbagefald af pulmonal arteriel hypertension.
Limited data suggest that the abrupt discontinuation of oral Revatio is not associated with rebound worsening of pulmonary arterial hypertension.
Revatio filmovertrukne tabletter er hvide og runde.
What Revatio looks like and contents of the pack Revatio film-coated tablets are white and round in shape.
Den gennemsnitlige absolutte orale biotilgængelighed er 41% (25-63%).
The mean absolute oral bioavailability is 41 % (range 25-63 %).
- har mistet store mængder væske (dehydrering), dette kan ske, hvis De sveder meget, eller hvis
- 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.
Hos patienter med primær PAH var behandlingseffekten 31,1 m sammenlignet med 7,7 m hos patienter med PAH associeret med bindevævssygdom.
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.
Indehaver af markedsføringstilladelsen: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgien.
Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.
- medicin, der indeholder erythromycin, clarithromycin, telithromycin (antibiotika til at behandle visse typer bakterieinfektioner), saquinavir (mod hiv) eller nefazodon (mod depression), da dosis måske skal justeres.
• Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as your dose may need to be adjusted.
De må ikke drikke grapefrugtjuice, mens De er i behandling med Revatio.
Revatio with food and drink You should not drink grapefruit juice while you are being treated with Revatio.
Brugen af prostacyclin, prostacyclin analoger og endothelinreceptorantagonister som tillægsbehandling samt arginin-tilskud var ikke tilladt.
The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted as addon therapy, and neither was arginine supplementation.
Hjælpestoffer, som behandleren skal være opmærksom på Hver tablet indeholder også 0,7 mg lactose.
Excipient(s) with known effect Each tablet also contains 0.7 mg of lactose.
Hos raske ældre frivillige forsøgspersoner (65 år og derover) ses en reduceret clearance af sildenafil, som medfører ca. 90% højere plasmakoncentration af sildenafil og den aktive N-desmethylmetabolit, sammenlignet med yngre frivillige forsøgspersoner (18-45 år).
Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90 % higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Stil flasken lodret på en plan overflade og indsæt spidsen af doseringssprøjten i adaptoren (Figur 7).
While the bottle is upright, on a flat surface, insert the tip of the oral dosing syringe into the adaptor (figure 7).
Almindeligvis gives en dosis på 10 mg (svarende til 12,5 ml) 3 gange dagligt.
The usual dose is 10 mg (corresponding to 12.5 ml) three times a day.
175 patienter (63%) inkluderes med diagnosen primær pulmonal hypertension, 84 (30%) med diagnosen PAH forbundet med bindevævssygdom og 18 (7%) af patienterne med diagnosen PAH efterfulgt kirurgisk intervention af medført hjertelidelser.
175 patients (63 %) included were diagnosed with primary pulmonary hypertension, 84 (30 %) were diagnosed with PAH associated with connective tissue disease and 18 (7 %) of the patients were diagnosed with PAH following surgical repair of congenital heart lesions.
Ved baseline var overlevelse for patienter i WHOfunktionsklasse II efter 1, 2 og 3 år hhv. 99 %, 91 % og 84 %, og for patienter i WHO-funktionsklasse III hhv. 94 %, 90 % og 81 %.
Survival in patients of WHO functional class II at baseline at 1, 2 and 3 years was 99 %, 91 %, and 84 % respectively, and for patients of WHO functional class III at baseline was 94 %, 90 %, and 81 %, respectively.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT PRIMÆR EMBALLAGE/BLISTER
IMMEDIATE PACKAGING/BLISTER
Revatio injektionsvæske bør kun gives til patienter, der allerede er i oral Revatio-behandling, som erstatning for oral Revatio i tilfælde af, at de midlertidigt er ude af stand til at anvende oral Revatiobehandling.
Revatio solution for injection should be administered to patients already prescribed oral Revatio as a replacement for oral administration under conditions where they are temporarily unable to take oral Revatio therapy.
PVC/aluminium blister med 90 tabletter.
PVC/Aluminium blisters of 90 tablets.
- Øvrige indholdsstoffer: Pulver til oral suspension: Sorbitol, vandfri citronsyre, sucralose, natriumcitrat, xanthangummi, titandioxid (E171), natriumbenzoat (E211), kolloid vandfri silica; Druesmag: maltodextrin, druesaft koncentrat, akaciegummi, ananasjuice koncentrat, vandfri citronsyre, naturlige smagsstoffer,
- The other ingredients are: Powder for oral suspension: sorbitol, citric acid anhydrous, sucralose, sodium citrate, xanthan gum, titanium dioxide (E171), sodium benzoate (E211), silica, colloidal anhydrous; Grape flavour: maltodextrin, grape juice concentrate, gum acacia, pineapple juice concentrate, citric acid anhydrous, natural flavouring
125 ml mørkfarvet glasflaske (med skruelåg af polypropylen) indeholder 32,27 g pulver til oral suspension.
One 125 ml amber glass bottle (with a polypropylene screw cap) contains 32.27 g of powder for oral suspension.
I denne population var Kaplan-Meier-estimater for 1, 2 og 3 års overlevelse hhv. 96 %, 91 % og 82 %.
In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 96 %, 91 % and 82 %, respectively.
Revatio 10 mg/ml pulver til oral suspension
Revatio 10 mg/ml powder for oral suspension
Samtidig administration af PDE5-hæmmere, inklusive sildenafil, med guanylatcyklase-stimulatorer, som f.eks. riociguat, er kontraindikeret, da det kan føre til symptomatisk hypotension (se pkt.
The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).
Den gennemsnitlige ændring fra baseline i blodtryk (i siddende stilling) var størst efter 1 time, -9,1 mmHg (SD ± 12,5) og -3,0 mmHg (SD ± 4,9) for hhv. systolisk og diastolisk blodtryk.
The mean changes from baseline in sitting blood pressure were greatest at 1 hour, -9.1 mmHg (SD ± 12.5) and -3.0 (SD ± 4.9) mmHg for systolic and diastolic pressure respectively.
Adaptoren gør, at der er muligt, at fylde doseringssprøjten fra flasken.
The adaptor is provided so that you can fill the oral dosing syringe with medicine from the bottle.
De må ikke få Revatio
You should not be given Revatio:
Sikkerhed og virkning af doser større end 12,5 ml 3 gange dagligt er ikke klarlagt.
Safety and effectiveness of doses higher than 12.5 ml (10 mg) TID have not been established.
Kemisk og fysisk forligelighed er vist for følgende injektions-/infusionsvæsker:
Chemical and physical compatibility has been demonstrated with the following diluents:
Data fra et begrænset antal antyder, at en pludselig afbrydelse af Revatio-behandlingen ikke er forbundet med et forværret tilbagefald af pulmonal arteriel hypertension.
Limited data suggest that the abrupt discontinuation of Revatio is not associated with rebound worsening of pulmonary arterial hypertension.
Hvis den ikke er blandet, skal De blande den efter anvisningerne nedenfor.
If the powder is not reconstituted, you should reconstitute the oral suspension by following the instructions below.
Der skal altid tilføjes 90 ml (3 x 30 ml) vand i alt, uanset hvilken dosis der skal tages (figur 3).
You should always add a total of 90 ml (3 x 30 ml) of water irrespective of the dose you are taking (figure 3).
Fremstiller Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, Frankrig.
Manufacturer Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.
Patienterne blev randomiseret til 1 af 4 behandlingsgrupper: Placebo, sildenafil 20 mg, sildenafil 40 mg eller sildenafil 80 mg 3 gange dagligt.
Patients were randomised to one of four treatment groups: placebo, sildenafil 20 mg, sildenafil 40 mg or sildenafil 80 mg, three times a day.
Sikkerhed og effekt af sildenafil ved samtidig anvendelse af andre lægemidler til pulmonal arteriel hypertension (f.eks ambrisentan, iloprost) er ikke undersøgt i kontrollerede kliniske studier.
The efficacy and safety of sildenafil co-administered with other treatments for pulmonary arterial hypertension (eg, ambrisentan, iloprost) has not been studied in controlled clinical trials.
For sildenafil/epoprostenol-behandlede patienter var den samlede hyppighed for ophør med behandling pga. bivirkninger 5,2% sammenlignet med 10,7% hos de placebo/epoprostenol-behandlede patienter.
The overall frequency of discontinuations in sildenafil/epoprostenol treated patients due to adverse events was 5.2 % compared to 10.7 % in the placebo/epoprostenol treated patients.
Denne type medicin bruges ofte til lindring af angina pectoris eller “brystsmerter” (se afsnit 2 Før De tager Revatio).
These medicines are often given for relief of angina pectoris or “chest pain” (see section 2.
I dette studie var 63 af 234 (27%) af patienterne <7 år (sildenafil lavdosis=2, middeldosis=17, højdosis=28, placebo=16), og 171 af 234 (73%) af patienterne var >7 år (sildenafil lavdosis=40, middeldosis=37, højdosis=49, placebo=44 se nedenfor).
In this trial, 63 of 234 (27 %) patients were < 7 years old (sildenafil low dose = 2; medium dose = 17; high dose = 28; placebo = 16) and 171 of 234 (73 %) patients were 7 years or older (sildenafil low dose = 40; medium dose = 38; and high dose = 49; placebo = 44).
Effekt og sikkerhed hos voksne patienter med PAH (ved samtidig administration af bosentan) Et randomiseret dobbelt-blindt, placebo-kontrolleret studie blev udført hos 103 klinisk stabile patienter med PAH (WHO FC II og III), som havde fået behandling med bosentan i mindst 3 måneder.
Efficacy and safety in adult patients with PAH (when used in combination with bosentan) A randomized, double-blind, placebo controlled study was conducted in 103 clinically stable subjects with PAH (WHO FC II and III) who were on bosentan therapy for a minimum of three months.
I denne population var Kaplan-Meier-estimater for 1-, 2- og 3-års overlevelse hhv. 92%, 81% og 74%.
In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 92 %, 81 % and 74 %, respectively.
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.
Bemærk: Udløbsdatoen er 30 dage efter rekonstitution.
Note: Expires 30 days after reconstitution.
Ved steady-state er plasmakoncentrationen of N-desmethylmetabolitten ca. 16% sammenlignet med 61% for intravenøst hhv. oralt administreret sildenafil.
At steady state plasma concentrations of N-desmethyl metabolite are approximately 16 % versus 61 % those of sildenafil after IV and oral dosing, respectively.
Hjælpestoffer, som behandleren skal være opmærksom på: 1 ml oral suspension indeholder 250 mg sorbitol.
Excipient(s) with known effect Each ml of oral suspension contains 250 mg sorbitol.
Revatio injektionsvæske anvendes til behandling af voksne patienter (≥ 18 år) med pulmonal arteriel hypertension klassificeret som WHO-funktionsklasse II og III, og som er i oral Revatio-behandling, men som midlertidigt er ude af stand til at modtage oral behandling, men ellers er klinisk og hæmodynamisk stabile.
Revatio solution for injection is for the treatment of adult patients (≥ 18 years) with pulmonary arterial hypertension who are currently prescribed oral Revatio and who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable.
Hvis De har glemt at tage Revatio
If you forget to take Revatio
Citronsyre, vandfri Sucralose
Citric acid anhydrous Sucralose
PDE5-hæmmere, så som Revatio, har vist sig at øge den blodtrykssænkende virkning af denne medicin.
PDE5 inhibitors, such as Revatio have been shown to increase the hypotensive effects of this medicine.
Revatio er kontraindiceret hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C) (se pkt.
Revatio is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).
Lægemidlet må kun udleveres efter recept (Se bilag I: Produktresumé, se pkt.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Tilføj i alt 90 ml vand (3 x 30 ml) og følg vejledning nøje i indlægssedlen, og sørg for at omryste flasken grundigt efter tilsætning af de 60 ml og de resterende 30 ml.Fjern låget igen og isæt flaskeadaptoren i flaskehalsen.
Add a total of 90 ml of water (3 x 30 ml) strictly following the package leaflet, ensuring the bottle is shaken vigorously after adding 60 ml and the remaining 30 ml.
Sildenafil er en svag hæmmer af cytokrom P450 (CYP)-isoformer 1A2, 2C9, 2C19, 2D6, 2E1 og 3A4 (IC50 >150 µM).
Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 M).
5 % glucose/0,45 % natriumchlorid-injektions-/infusionsvæske 5 % glucose/Ringer-lactat infusionsvæske 5 % glucose/20 mmol kaliumchlorid-injektions-/infusionsvæske
5 % glucose solution sodium chloride 9 mg/ml (0.9 %) solution Lactated Ringer's solution 5 % glucose/0.45 % sodium chloride solution 5 % glucose/lactated Ringer's solution 5 % glucose/20 mEq potassium chloride solution
Pulver: Må ikke opbevares ved temperaturer over 30
Powder: Do not store above 30°C.
Hos raske forsøgspersoner er plasmakoncentrationen af N-desmethylmetabolitten efter intravenøs indgift signifikant lavere end efter oral indgift.
In healthy volunteers, the plasma levels of the N-desmethyl metabolite following intravenous dosing are significantly lower than those observed following oral dosing.
Dosisjustering til 10 mg 2 gange dagligt bør overvejes efter omhyggelig risk/benefit-vurdering, og kun hvis behandlingen ikke er veltolereret.
A downward dose adjustment to 10 mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated.
Det Europæiske Lægemiddelagentur har udsat kravet om fremlæggelse af resultaterne af studier med Revatio til nyfødte med pulmonal arteriel hypertension (se pkt.
The European Medicines Agency has deferred the obligation to submit the results of studies with Revatio in newborns with pulmonary arterial hypertension (see section 4.2 for information on paediatric use).
Dette koncentrationsinterval dækker stigningen i sildenafils eksponering set i specielt designede lægemiddelinteraktionsstudier med CYP3A4-hæmmere (undtagen med de mest potente af CYP3A4-hæmmerne som f.eks. ketoconazol, itraconazol, ritonavir).
This concentration range covers the increase in sildenafil exposure observed in specifically designed drug interaction studies with CYP3A4 inhibitors (except with the most potent of the CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir).
Enkeltdoser af antacida (magnesiumhydroxid/aluminiumhydroxid) påvirker ikke den orale biotilgængelighed af sildenafil.
Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the oral bioavailability of sildenafil.
De mest almindeligt rapporterede bivirkninger (større eller lig med 10%) for Revatio sammenlignet med placebo er hovedpine, ansigtsrødme, dyspepsi, diarré og smerter i ekstremiteterne.
The most commonly reported adverse reactions that occurred (greater or equal to 10 %) on Revatio compared to placebo were headache, flushing, dyspepsia, diarrhoea and pain in extremity.
Pædiatrisk population Revatios sikkerhed og virkning hos børn under 1 år er ikke klarlagt.
The safety and efficacy of Revatio in children below 1 year of age has not been established.