FrancophonIA/ELRC3.0 huggingface dataset:
English: 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:
Danish: 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:
English: Fareva Amboise Zone Industrielle 29 route des Industries 37530 Pocé-sur-Cisse France
Danish: Fareva Amboise Zone Industrielle 29 route des Industries 37530 Pocé-sur-Cisse Frankrig
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen (efter EXP).
English: Vaso-occlusive crises in patients with sickle cell anaemia Sildenafil should not be used in patients with pulmonary hypertension secondary to sickle cell anaemia.
Danish: Vaso-okklusiv krise hos patienter med seglcelleanæmi Sildenafil må ikke anvendes til patienter med pulmonal hypertension sekundært til seglcelleanæmi.
English: If you experience sudden decrease or loss of vision, stop taking Revatio and contact your doctor immediately (see also section 4).
Danish: Hvis De oplever pludseligt nedsat syn eller synstab, skal De stoppe med at tage Revatio og straks kontakte Deres læge (se også afsnit 4).
English: There was one serious adverse reaction in a subject with severe ischaemic cardiomyopathy who experienced ventricular fibrillation and death 6 days post study.
Danish: Der blev set 1 alvorlig bivirkning hos en patient med svær iskæmisk kardiomyopati, som fik ventrikelflimren og døde 6 dage efter indgift af studiemedicinen.
English: 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.
Danish: 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.
English: Contains glucose and water for injections.
Danish: Indeholder glucose og vand til injektionsvæsker
English: 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.
Danish: I pivotalstudiet blev i alt 207 patienter behandlet med Revatio, og status for patienternes langtidsoverlevelse blev vurderet i mindst 3 år.
English: The estimated difference between the medium sildenafil dose and placebo was 11.33 % (95 % CI: 1.72 to 20.94) (see Table 2).
Danish: Den estimerede forskel mellem den gennemsnitslige sildenafildosis og placebo var 11,33% (95% CI: 1,72-20,94) (se tabel 2).
English: 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 %].
Danish: 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%).
English: Limited data suggest that the abrupt discontinuation of oral Revatio is not associated with rebound worsening of pulmonary arterial hypertension.
Danish: 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.
English: What Revatio looks like and contents of the pack Revatio film-coated tablets are white and round in shape.
Danish: Revatio filmovertrukne tabletter er hvide og runde.
English: The mean absolute oral bioavailability is 41 % (range 25-63 %).
Danish: Den gennemsnitlige absolutte orale biotilgængelighed er 41% (25-63%).
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
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: Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.
Danish: Indehaver af markedsføringstilladelsen: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgien.
English: • 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.
Danish: - 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.
English: Revatio with food and drink You should not drink grapefruit juice while you are being treated with Revatio.
Danish: De må ikke drikke grapefrugtjuice, mens De er i behandling med Revatio.
English: The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted as addon therapy, and neither was arginine supplementation.
Danish: Brugen af prostacyclin, prostacyclin analoger og endothelinreceptorantagonister som tillægsbehandling samt arginin-tilskud var ikke tilladt.
English: Excipient(s) with known effect Each tablet also contains 0.7 mg of lactose.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver tablet indeholder også 0,7 mg lactose.
English: 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).
Danish: 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).
English: While the bottle is upright, on a flat surface, insert the tip of the oral dosing syringe into the adaptor (figure 7).
Danish: Stil flasken lodret på en plan overflade og indsæt spidsen af doseringssprøjten i adaptoren (Figur 7).
English: The usual dose is 10 mg (corresponding to 12.5 ml) three times a day.
Danish: Almindeligvis gives en dosis på 10 mg (svarende til 12,5 ml) 3 gange dagligt.
English: 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.
Danish: 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.
English: 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.
Danish: 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 %.
English: IMMEDIATE PACKAGING/BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT PRIMÆR EMBALLAGE/BLISTER
English: 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.
Danish: 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.
English: PVC/Aluminium blisters of 90 tablets.
Danish: PVC/aluminium blister med 90 tabletter.
English: - 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
Danish: - 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,
English: One 125 ml amber glass bottle (with a polypropylene screw cap) contains 32.27 g of powder for oral suspension.
Danish: 125 ml mørkfarvet glasflaske (med skruelåg af polypropylen) indeholder 32,27 g pulver til oral suspension.
English: In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 96 %, 91 % and 82 %, respectively.
Danish: I denne population var Kaplan-Meier-estimater for 1, 2 og 3 års overlevelse hhv. 96 %, 91 % og 82 %.
English: Revatio 10 mg/ml powder for oral suspension
Danish: Revatio 10 mg/ml pulver til oral suspension
English: 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).
Danish: 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.
English: 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.
Danish: 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.
English: The adaptor is provided so that you can fill the oral dosing syringe with medicine from the bottle.
Danish: Adaptoren gør, at der er muligt, at fylde doseringssprøjten fra flasken.
English: You should not be given Revatio:
Danish: De må ikke få Revatio
English: Safety and effectiveness of doses higher than 12.5 ml (10 mg) TID have not been established.
Danish: Sikkerhed og virkning af doser større end 12,5 ml 3 gange dagligt er ikke klarlagt.
English: Chemical and physical compatibility has been demonstrated with the following diluents:
Danish: Kemisk og fysisk forligelighed er vist for følgende injektions-/infusionsvæsker:
English: Limited data suggest that the abrupt discontinuation of Revatio is not associated with rebound worsening of pulmonary arterial hypertension.
Danish: Data fra et begrænset antal antyder, at en pludselig afbrydelse af Revatio-behandlingen ikke er forbundet med et forværret tilbagefald af pulmonal arteriel hypertension.
English: If the powder is not reconstituted, you should reconstitute the oral suspension by following the instructions below.
Danish: Hvis den ikke er blandet, skal De blande den efter anvisningerne nedenfor.
English: You should always add a total of 90 ml (3 x 30 ml) of water irrespective of the dose you are taking (figure 3).
Danish: Der skal altid tilføjes 90 ml (3 x 30 ml) vand i alt, uanset hvilken dosis der skal tages (figur 3).
English: Manufacturer Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.
Danish: Fremstiller Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, Frankrig.
English: Patients were randomised to one of four treatment groups: placebo, sildenafil 20 mg, sildenafil 40 mg or sildenafil 80 mg, three times a day.
Danish: Patienterne blev randomiseret til 1 af 4 behandlingsgrupper: Placebo, sildenafil 20 mg, sildenafil 40 mg eller sildenafil 80 mg 3 gange dagligt.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: These medicines are often given for relief of angina pectoris or “chest pain” (see section 2.
Danish: Denne type medicin bruges ofte til lindring af angina pectoris eller “brystsmerter” (se afsnit 2 Før De tager Revatio).
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 92 %, 81 % and 74 %, respectively.
Danish: I denne population var Kaplan-Meier-estimater for 1-, 2- og 3-års overlevelse hhv. 92%, 81% og 74%.
English: Sildenafil had no significant effect on atorvastatin exposure (AUC increased 11 %), suggesting that sildenafil does not have a clinically relevant effect on CYP3A4.
Danish: Sildenafil har ingen signifikant effekt på atorvastatins eksponering (AUC steg 11%), hvilket tyder på at sildenafil ikke har en relevant klinisk effekt på CYP3A4.
English: Note: Expires 30 days after reconstitution.
Danish: Bemærk: Udløbsdatoen er 30 dage efter rekonstitution.
English: At steady state plasma concentrations of N-desmethyl metabolite are approximately 16 % versus 61 % those of sildenafil after IV and oral dosing, respectively.
Danish: Ved steady-state er plasmakoncentrationen of N-desmethylmetabolitten ca. 16% sammenlignet med 61% for intravenøst hhv. oralt administreret sildenafil.
English: Excipient(s) with known effect Each ml of oral suspension contains 250 mg sorbitol.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: 1 ml oral suspension indeholder 250 mg sorbitol.
English: 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.
Danish: 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.
English: If you forget to take Revatio
Danish: Hvis De har glemt at tage Revatio
English: Citric acid anhydrous Sucralose
Danish: Citronsyre, vandfri Sucralose
English: PDE5 inhibitors, such as Revatio have been shown to increase the hypotensive effects of this medicine.
Danish: PDE5-hæmmere, så som Revatio, har vist sig at øge den blodtrykssænkende virkning af denne medicin.
English: Revatio is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).
Danish: Revatio er kontraindiceret hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C) (se pkt.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter recept (Se bilag I: Produktresumé, se pkt.
English: 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.
Danish: 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.
English: Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 M).
Danish: Sildenafil er en svag hæmmer af cytokrom P450 (CYP)-isoformer 1A2, 2C9, 2C19, 2D6, 2E1 og 3A4 (IC50 >150 µM).
English: 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
Danish: 5 % glucose/0,45 % natriumchlorid-injektions-/infusionsvæske 5 % glucose/Ringer-lactat infusionsvæske 5 % glucose/20 mmol kaliumchlorid-injektions-/infusionsvæske
English: Powder: Do not store above 30°C.
Danish: Pulver: Må ikke opbevares ved temperaturer over 30
English: In healthy volunteers, the plasma levels of the N-desmethyl metabolite following intravenous dosing are significantly lower than those observed following oral dosing.
Danish: Hos raske forsøgspersoner er plasmakoncentrationen af N-desmethylmetabolitten efter intravenøs indgift signifikant lavere end efter oral indgift.
English: 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.
Danish: Dosisjustering til 10 mg 2 gange dagligt bør overvejes efter omhyggelig risk/benefit-vurdering, og kun hvis behandlingen ikke er veltolereret.
English: 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).
Danish: Det Europæiske Lægemiddelagentur har udsat kravet om fremlæggelse af resultaterne af studier med Revatio til nyfødte med pulmonal arteriel hypertension (se pkt.
English: 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).
Danish: 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).
English: Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the oral bioavailability of sildenafil.
Danish: Enkeltdoser af antacida (magnesiumhydroxid/aluminiumhydroxid) påvirker ikke den orale biotilgængelighed af sildenafil.
English: 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.
Danish: De mest almindeligt rapporterede bivirkninger (større eller lig med 10%) for Revatio sammenlignet med placebo er hovedpine, ansigtsrødme, dyspepsi, diarré og smerter i ekstremiteterne.
English: The safety and efficacy of Revatio in children below 1 year of age has not been established.
Danish: Pædiatrisk population Revatios sikkerhed og virkning hos børn under 1 år er ikke klarlagt.
English: The recommended dose is 10 mg (corresponding to 12.5 ml) three times a day administered as an intravenous bolus injection (see section 6.6).
Danish: Den anbefalede dosis er 10 mg (svarende til 12,5 ml) 3 gange dagligt som intravenøs bolus-injektion (se pkt.
English: What you need to know before you are given Revatio
Danish: Det skal De vide, før De får Revatio
English: An additional 5 deaths were reported subsequently.The causes of deaths were related to PAH.
Danish: Yderligere 5 dødsfald blev efterfølgende rapporteret.
English: Put the tip of the oral dosing syringe into the mouth.
Danish: Indfør spidsen af sprøjten i munden.
English: A mean placebo-corrected treatment effect of -3.9 mmHg was observed in favour of sildenafil (95 % CI: -5.7, -2.1) (p = 0.00003).
Danish: Der blev set en gennemsnitlig placebo-korrigeret behandlingseffekt på -3,9 mmHg til fordel for sildenafil (95% CI: -5,7, -2,1) (p=0,00003).
English: Oral sildenafil had no significant effect on atorvastatin exposure (AUC increased 11 %), suggesting that sildenafil does not have a clinically relevant effect on CYP3A4.
Danish: Oralt administreret sildenafil har ingen signifikant effekt på atorvastatins eksponering (AUC steg 11%), hvilket tyder på, at sildenafil ikke har en relevant klinisk effekt på CYP3A4.
English: Mean baseline peak volume of oxygen consumed (VO2) values were comparable across the sildenafil treatment groups (17.37 to 18.03 ml/kg/min), and slightly higher for the placebo treatment group (20.02 ml/kg/min).
Danish: Det gennemsnitslige maksimale iltforbrug (VO2) ved baseline var sammenligneligt i de 3 sildenafilgrupper (17,37-18,03 ml/kg/minut) og lidt højere i placebogruppen (20,02 ml/kg/minut).
English: Most patients were WHO Functional Class II (107/277, 39 %) or III (160/277, 58 %) with a mean baseline 6 minute walking distance of 378 meters and 326 meters respectively; fewer patients were Class I (1/277, 0.4 %) or IV (9/277, 3 %) at baseline.
Danish: De fleste patienter var ved baseline klassificeret i WHO-funktionsklasse II (107/277, 39%) eller III (160/277, 58%) med en gennemsnitlig 6 minutters gangdistance på hhv. 378 meter og 326 meter ved baseline; færre patienter var i klasse I (1/277, 0,4%) eller IV (9/277, 3%) ved baseline.
English: In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh class A and B) sildenafil clearance was reduced, resulting in increases in AUC (85 %) and Cmax (47 %) compared to age-matched volunteers with no hepatic impairment.
Danish: Hos frivillige forsøgspersoner med let til moderat levercirrhose (Child-Pugh klasse A og B) reduceres sildenafils clearance, hvilket giver stigninger i AUC (85%) og Cmax (47%) sammenlignet med frivillige forsøgspersoner i samme alderskategori uden nedsat leverfunktion.
English: Revatio contains sorbitol
Danish: Revatio indeholder sorbitol
English: Before you take Revatio).
Danish: (se afsnit 2 Før De tager Revatio).
English: Solution for injection 1 vial 10 mg/12.5 ml
Danish: 1 hætteglas 10 mg/12,5 ml
English: Microcrystalline cellulose Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Magnesium stearate
Danish: Mikrokrystallinsk cellulose Calciumhydrogenphosphat (vandfrit) Croscarmellosenatrium Magnesiumstearat