FrancophonIA/ELRC3.0 huggingface dataset:
English: Prescribers should carefully assess the mother's clinical need for sildenafil and any potential adverse effects on the breast-fed child.
Danish: Ordinerende læger bør nøje vurdere moderens kliniske behov for sildenafil samt eventuelle potentielle bivirkninger hos det ammede barn.
English: Sildenafil and its major circulating N-desmethyl metabolite are approximately 96 % bound to plasma proteins.
Danish: Sildenafil og dets væsentligste cirkulerende N-desmethylmetabolit er omtrent 96% bundet til plasmaproteiner.
English: - have a rare inherited eye disease (retinitis pigmentosa).
Danish: - har en sjælden, arvelig øjensygdom (retinitis pigmentosa).
English: A Revatio intravenous injection will be given to you instead of your Revatio tablets.
Danish: De vil få en Revatio-indsprøjtning i stedet for Deres Revatio-tabletter.
English: Children and adolescents Revatio should not be given to children and adolescents under the age of 18.
Danish: Revatio bør ikke gives til børn og unge under 18 år.
English: The mean changes in heart rate were clinically insignificant.
Danish: De gennemsnitlige ændringer i hjertefrekvens var ikke klinisk signifikante.
English: The oral suspension must be shaken vigorously for a minimum of 10 seconds before use.
Danish: Den orale suspension skal omrystes grundigt i mindst 10 sekunder før brug.
English: A total of 134 patients were treated with Revatio 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 Revatio i det indledende studie, og deres langtidsoverlevelse blev vurderet i minimum 3 år.
English: Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance < 30 ml/min).
Danish: Initial dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion, inklusiv svært nedsat nyrefunktion (kreatininclearance <30 ml/min).
English: Taking more Revatio than you should may increase the risk of known side effects.
Danish: Hvis De tager mere Revatio, end De skal, kan det øge risikoen for bivirkninger.
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: This medicinal product does not require dilution or reconstitution before use.
Danish: Dette lægemiddel skal ikke fortyndes eller rekonstitueres inden brug.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: The constituted oral suspension (a white, grape flavoured oral suspension) should be taken approximately 6 to 8 hours apart with or without food.
Danish: Den rekonstituerede orale suspension (en hvid oral suspension med druesmag) skal tages med 6-8 timers mellemrum med eller uden mad.
English: Your doctor will determine the duration of your treatment and how much Revatio intravenous injection you will receive each day and will monitor your response and condition.
Danish: Deres læge vil afgøre, hvor længe De skal behandles, og hvor meget Revatio De skal have indsprøjtet hver dag.
English: 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 %).
Danish: 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%).
English: Your doctor may reduce the dose over a few days before stopping completely.
Danish: Lægen kan nedsætte dosis over nogle få dage, førend behandlingen standses fuldstændigt.
English: White, round, biconvex film-coated tablets marked “PFIZER” on one side and “RVT 20”on the other.
Danish: Hvide, runde, bikonvekse filmovertrukne tabletter, mærket “PFIZER” på den ene side og "RVT 20” på den anden side.
English: After reconstitution, the oral suspension is stable for 30 days.
Danish: Efter rekonstituering er den orale suspension holdbar 30 dage.
English: Its use is accordingly not recommended in these patients.
Danish: Intravenøs behandling af disse patienter kan derfor ikke anbefales.
English: As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they might be affected by Revatio, 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 Revatio, inden de kører bil eller betjener maskiner.
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 kg og andre yngre patienter som ikke kan synke tabletter.
English: Eight subjects were taking bosentan and one subject was taking treprostinil in addition to bosentan and Revatio.
Danish: 8 patienter fik bosentan, og 1 patient fik treprostinil sammen med bosentan og Revatio.
English: Do not stop taking Revatio unless your doctor tells you to.
Danish: Stop ikke med at tage Revatio, medmindre det sker i samråd med lægen.
English: Revatio brings down blood pressure in the lungs by widening the blood vessels in the lungs.
Danish: Revatio nedsætter blodtrykket i lungerne ved at udvide blodkarrene i lungerne.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De får medicinen, da den indeholder vigtige oplysninger.
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: 1 press-in bottle adapter, 1 measuring cup and 1 oral dosing syringe
Danish: 1 flaskeadaptor, 1 målebæger og 1 doseringssprøjte
English: The mean postural changes in systolic and diastolic blood pressure over time were small (< 10 mmHg) and returned towards baseline beyond 2 hours.
Danish: Den gennemsnitlige posturale ændring i systolisk og diastolisk blodtryk over tid var lille (< 10 mmHg) og vendte tilbage til baseline efter 2 timer.
English: The most common adverse reactions reported across the duration of the short-term and long-term studies were generally similar to those observed in the short-term study.
Danish: De hyppigste bivirkninger, der blev rapporteret gennem det kortvarige og langvarige studie, var generelt de samme som i det kortvarige studie.
English: In a clinical study events of vaso-occlusive crises requiring hospitalisation were reported more commonly by patients receiving Revatio 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 Revatio, end hos patienter, der fik placebo, hvilket førte til, at studiet blev afsluttet før tid.
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: Reconstituted oral suspension
Danish: Oral suspension
English: Please see instructions below before using the oral suspension.
Danish: Læs vejledningen nedenfor, før De tager suspensionen.
English: The magnitude of the interaction is expected to be reduced for intravenous sildenafil, as interactions for oral sildenafil are due, at least in part, to effects on oral first pass metabolism.
Danish: Omfanget af interaktionerne forventes mindre for intravenøst administreret sildenafil, idet interaktionerne for oral sildenafil i det mindste for en dels vedkommende skyldes first-pass metabolisme.
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, WHO-funktionsklasse, ændring i baggrundsbehandling og måling af livskvalitet.
English: 90 film-coated tablets 90 x 1 film-coated tablets 300 film-coated tablets
Danish: 90 filmovertrukne tabletter 90 x 1 filmovertrukne tablet 300 filmovertrukne tabletter
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: Refer to the patient leaflet for more detailed instructions for use.
Danish: Der henvises til indlægssedlen for mere detaljeret brugsanvisning.
English: Efficacy of oral sildenafil in adult patients with PAH (when used in combination with epoprostenol)
Danish: Effekt af oralt administreret sildenafil hos voksne patienter med PAH (ved anvendelse sammen med epoprostenol)
English: A total of 10 PAH subjects enrolled and completed the study.
Danish: I alt 10 patienter blev rekrutteret og fuldførte studiet.
English: Suddenly stopping your treatment with Revatio may lead to your symptoms getting worse.
Danish: Hvis De pludseligt stopper med at tage Revatio, kan Deres symptomer blive forværret.
English: Since there are limited data for intravenous Revatio use and since pharmacokinetic models predict that 20 mg oral and 10 mg intravenous formulations will yield similar plasma exposures, the safety information for intravenous Revatio is supported by that of oral Revatio.
Danish: Da der er begrænsede data for intravenøs Revatio, og da den farmakokinetiske model forudsiger, at 20 mg oralt administreret og 10 mg intravenøst administreret Revatio vil medføre samme plasmaeksponering, understøttes sikkerhedsinformationen for intravenøs Revatio af sikkerhedsinformationen for oral Revatio.
English: - if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section
Danish: - hvis De er allergisk over for sildenafil eller et af de øvrige indholdsstoffer i Revatio (angivet i afsnit 6).
English: This medicinal product must not be mixed with other medicinal products or intravenous diluents except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler eller intravenøse opløsningsvæsker end dem, der er anført under pkt.
English: Revatio should not be used during pregnancy unless strictly necessary.
Danish: Revatio må kun anvendes under graviditet, hvis det er strengt nødvendigt.
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: 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 bosentanbehandling eller klinisk forværring, der krævede ændring i epoprostenol-behandling).
English: Any unused oral suspension should be discarded or returned to your pharmacist after this date.
Danish: Eventuelle rester af oral suspension skal bortskaffes eller returneres til apoteket efter den anførte dato.
English: • Blood thinning medicines (for example warfarin) although these did not result in any side effects.
Danish: - blodfortyndende medicin (f.eks. warfarin), selv om det ikke resulterede i bivirkninger.
English: The tablets are provided in blister packs containing 90 tablets, 90 x 1 tablets as perforated unit dose blisters and in blister packs containing 300 tablets.
Danish: Tabletterne findes i blisterpakninger med 90 tabletter, 90 x 1 tablet som perforeret enkeltdosisblister og i blisterpakninger med 300 tabletter.
English: Other medicines and Revatio
Danish: Brug af anden medicin sammen med Revatio
English: Write the date of expiry of the constituted oral suspension on the bottle label (the date of expiry of the constituted oral suspension is 30 days from the date of constitution).
Danish: Anfør udløbsdato for den rekonstituerede orale suspension på flaskens etiket (udløbsdato er 30 dage efter rekonstitution).
English: Do not take Revatio:
Danish: Tag ikke Revatio
English: It is recommended that a pharmacist constitutes Revatio oral suspension prior to its dispensing to the patient.
Danish: Det anbefales, at en farmaceut rekonstituerer Revatio oral suspension inden udlevering til patienten.
English: - if you have recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure (<90/50 mmHg).
Danish: - hvis De for nylig har haft et slagtilfælde, eller et hjerteanfald, eller hvis De har svær leversygdom eller meget lavt blodtryk (<90/50 mmHg).
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 administeres 10 mg 3 gange dagligt hos yngere patienter.
English: Reconstitution instructions:
Danish: Instruktioner for rekonstitution:
English: Once reconstituted one bottle contains 1.12 g of sildenafil (as citrate) with a final volume of 112 ml.
Danish: Efter rekonstitution indeholder 1 flaske 1,12 g sildenafil (som citrat) med et endeligt volumen på 112 ml.
English: Women of childbearing potential and contraception in males and females Due to lack of data on effects of Revatio in pregnant women, Revatio is not recommended for women of childbearing potential unless also using appropriate contraceptive measures.
Danish: Kvinder i den fertile alder og prævention hos mænd og kvinder På grund af manglende data om virkningen af Revatio hos gravide kvinder, anbefales Revatio ikke til kvinder i den fertile alder medmindre der anvendes passende prævention.
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: 23 subjects experienced clinical worsening events in the placebo group (17.6 %) compared with 8 subjects in the sildenafil group (6.0 %).
Danish: 23 personer i placebogruppen (17,6%) fik symptomer på klinisk forværring sammenlignet med 8 personer i sildenafilgruppen (6,0%).
English: The efficacy of Revatio has not been established in patients with severe pulmonary arterial hypertension (functional class IV).
Danish: Effekten af Revatio er ikke fastslået hos patienter med alvorlig pulmonal arteriel hypertension (funktionsklasse IV).
English: It was judged to be unrelated to the study medicinal product.
Danish: Denne hændelse kunne ikke sammenkædes med studiemedicinen.
English: Glucose Water for injections
Danish: Glucose Vand til injektionsvæsker
English: Pack size: 1 bottle
Danish: Pakningsstørrelse: 1 flaske
English: If the clinical situation deteriorates, therapies that are recommended at the severe stage of the disease (eg, 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: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apoteketspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: The recommended dose of 10 mg requires a volume of 12.5 ml, to be administered as an intravenous bolus injection.
Danish: Den anbefalede dosis på 10 mg svarer til et volumen på 12,5 ml, der skal gives som en intravenøs bolus-injektion.
English: Revatio contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Danish: Revatio indeholder sildenafil, der hører til en gruppe af lægemidler, som kaldes fosfodiesterase-type 5(PDE5)-hæmmere.
English: Oral suspension Store below 30°C or in refrigerator (2°C to 8°C).
Danish: Oral suspension: Opbevares ved temperaturer under 30 oC eller i køleskab (2 oC-8
English: 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.
Danish: Hvis De er gravid eller ammer, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De tager Revatio.
English: Recent history of stroke or myocardial infarction, Severe hypotension (blood pressure < 90/50 mmHg) at initiation.
Danish: Nyligt overstået slagtilfælde eller myokardieinfarkt, Svær hypotension (blodtryk <90/50 mmHg) ved initiering.
English: If you have an erection, which lasts continuously for more than 4 hours, stop taking Revatio and contact your doctor immediately (see also section 4).
Danish: Hvis De får erektion, som varer længere end 4 timer, skal De stoppe med at tage Revatio og straks kontakte Deres læge (se også afsnit 4).
English: Dose related improvements were observed with pulmonary vascular resistance index (PVRI) and mean pulmonary arterial pressure (mPAP).
Danish: Dosisrelaterede forbedringer blev observeret for pulmonary vascular resistance index (PVRI) og det gennemsnitslige pulmonale arterietryk (mPAP).
English: Remove the cap.
Danish: Fjern låget.
English: Tap the bottle to release the powder.
Danish: Bank let på flasken for at løsne pulveret.
English: If you experience any of the following side effects you should stop taking Revatio and contact a doctor immediately (see also section 2): - if you experience sudden decrease or loss of vision (frequency not known) - if you have an erection, which lasts continuously for more than 4 hours.
Danish: Hvis De oplever nogen af følgende bivirkninger, skal De stoppe med at tage Revatio og straks kontakte lægen (se også afsnit 2): - pludseligt nedsat syn eller synstab (hyppighed ukendt) - erektion, som varer uafbrudt i mere end 4 timer.
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: Due to lack of data, Revatio should not be used in pregnant women unless strictly necessary.
Danish: Revatio bør pga. manglende data ikke anvendes til gravide, medmindre det er strengt nødvendigt.
English: 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).
Danish: Revatio anvendes til at behandle voksne, børn og unge fra 1-17 år med for højt blodtryk i blodkarrene i lungerne (pulmonal arteriel hypertension).
English: PVC/Aluminium blisters of 300 tablets.
Danish: PVC/aluminium blister med 300 tabletter.
English: 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).
Danish: 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).
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), WHOfunktionsklasse, køn, race, undersøgelsessted, middel PAP og PVRI.
English: 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.
Danish: 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.
English: For adults, the recommended dose is 20 mg three times a day (taken 6 to 8 hours apart) taken with or without food.
Danish: Til voksne er den sædvanlige dosis 20 mg 3 gange dagligt (taget med 6-8 timers mellemrum med eller uden mad).
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: Opbevaring efter rekonstituering af lægemidlet se pkt.
English: - The other ingredients are glucose and water for injections.
Danish: - Øvrige indholdsstoffer: glucose og vand til injektionsvæsker.
English: Revatio solution for injection is for intravenous use as a bolus injection.
Danish: Revatio injektionsvæske skal gives som intravenøs bolus-injektion.
English: Revatio solution for injection is an alternative formulation of Revatio for patients who temporarily cannot take their Revatio tablets.
Danish: Revatio-injektionsvæske er et alternativ til patienter, der midlertidigt er ude af stand til at tage Revatio-tabletter.
English: Once reconstituted the bottle contains 112 ml of oral suspension, of which 90 ml is intended for dosing and administration.
Danish: Efter rekonstituering indeholder flasken 112 ml oral suspension, hvoraf de 90 ml er beregnet til brug.
English: Side effects reported in a clinical trial with intravenous Revatio were similar to those reported in clinical trials with Revatio tablets.
Danish: De bivirkninger, der blev set i kliniske forsøg med Revatio-injektionsvæske, svarer til dem, som blev set i kliniske forsøg med Revatio-tabletter.