natgillin/translations-raw huggingface dataset:
Der erikke udført kliniske studierg til at vise, at de to formuleringer har sammenlignelig effekt.
No clinical studies have been performed to demonstrate that these formulations have comparable efficacy
Hvis De glemmer at tage Revatio, så tag en dosis, så snart De kommer i tanke om det, og fortsæt så med at tage Deres medicin til den sædvanlige tid.
If you forget to take Revatio, take a dose as soon as you remember, then continue to take your medicine at the usual times.
Revatio kan give svimmelhed og kan påvirke synet.
Revatio can cause dizziness and can affect vision.
• Information om pharmacovigilance-monitoringsprogrammet vedrørende den potentielle risiko for klinisk relevant hypotension og relaterede problemer, der sættes i værk ved brug af DCF.
- Information about the Pharmacovigilance Monitoring Programme regarding the potential risk of clinically relevant hypotension and related problems to be put into place with the use of the DCF.
Revatio gives som en indsprøjtning i en blodåre (vene) og vil altid blive givet af en læge eller en sygeplejerske.
Revatio is given as an intravenous injection and will always be given to you by a doctor or a nurse.
Lægen skal informere patienter, der glemmer at tage Revatio, om at tage dosis hurtigst muligt og derefter fortsætte med at tage den normale dosis.
Physicians should advise patients who forget to take Revatio to take a dose as soon as possible and then continue with the normal dose.
Tabletterne er mærket “PFIZER” på den ene side og “RVT 20” på den anden side.
The tablets are marked with “PFIZER” on one side and “RVT 20” on the other.
• Kopi af produktresumé (SPC)
- Copy of the Summary of Product Characteristics (SPC)
Tilsvarende havde 191 af de 229 forsøgspersoner (83%), som havde fået sildenafil, enten holdt eller forbedret deres WHO-funktionsklasse ved vurdering efter 1 år.
Similarly 191 of 229 subjects (83 %) who had received sildenafil had either maintained or improved their WHO Functional Class at 1 year assessment.
Disse resultater kan anvendes for andre populationer og indgivelsesformer.
These results are relevant to other populations and routes of administration.
Da Revatio gives under tæt overvågning, er det ikke sandsynligt, at en dosis vil blive glemt.
As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
6.6 for instruktion vedrørende anvendelse.
See section 6.6 for instructions of use.
• Information til sundhedspersonale
- Information for healthcare professionals
Revatio injektionsvæske anbefales ikke til børn under 18 år pga. utilstrækkelig dokumentation for sikkerhed og virkning.
Revatio solution for injection is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
Rengøring og opbevaring af sprøjten:
Cleaning and storing the syringe:
Patienter med venstre ventrikulær uddrivningsfraktion <45% eller venstre ventrikulær forkortningsfraktion <0,2% blev ikke undersøgt.
Patients with left ventricular ejection fraction < 45 % or left ventricular shortening fraction < 0.2 were not studied.
Som følge af aldersforskelle i plasmaproteinbindingen er den tilsvarende stigning i plasmakoncentration af fri sildenafil ca. 40%.
Due to agedifferences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately 40 %.
Gennemsnitlig pulmonalt systolisk blodtryk faldt med 9%.
Mean pulmonary systolic blood pressure decreased by 9 %.
Malta Vivian Corporation Ltd.
Vivian Corporation Ltd.
95% Konfidensinterval
Estimated difference 95% confidence interval
Pulver til oral suspension: Sorbitol
Powder for oral suspension: Sorbitol
Revatio bør ikke gives til børn under 1 år.
Children Revatio should not be given to children below 1 year of age.
I tilfælde af klinisk forværring på trods af Revatio-behandling, bør alternative behandlingsmuligheder overvejes.
In case of clinical deterioration in spite of Revatio treatment, alternative therapies should be considered.
- tager medicin for impotens (erektil dysfunktion).
- take medicines for erectile dysfunction.
Vitamin-K-antagonister
Vitamin K antagonists
Ingen særlige forholdsregler for destruktion.
No special requirements for disposal.
Revatio er kun beregnet til oral anvendelse.
Revatio is for oral use only.
Sikkerheden af sildenafil er ikke undersøgt hos følgende patientundergrupper, og dets anvendelse er derfor kontraindiceret:
The safety of sildenafil has not been studied in the following sub-groups of patients, and its use is therefore contraindicated:
Hvis medicinen er til et barn, så sørg for at barnet sidder ned eller holdes opret, før medicinen gives (Figur 9).
If the medicine is to be given to a child, make sure the child is sitting, or is held, upright before giving the medicine (figure 9).
Dette er udelukkende baseret på farmakokinetiske data (se pkt.
This is based on Pharmacokinetic data only (see section 5.2.
Efter indgift blev blodtrykket (i siddende og stående stilling) og hjertefrekvens målt efter 30, 60, 120, 180 og 360 minutter.
After dosing, sitting and standing blood pressure and heart rate were recorded at 30, 60, 120, 180 and 360 minute post dose.
Hvis der ses store bobler, skub da langsomt stemplet tilbage i sprøjten.
If large bubbles can be seen, slowly push the plunger back into the syringe.
Tag derefter låget af (Figur 6).
Remove the cap (figure 6).
Revatio udskilles i modermælken i meget små mængder og forventes ikke at skade barnet.
Revatio passes into your breast milk at very low levels and would not be expected to harm your baby.
Revatio påvirker i moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
Revatio has moderate influence on the ability to drive and use machines.
Særlige hensyn i forbindelse med patienter med nyre- eller leverproblemer Fortæl lægen, hvis De har nyre- eller leverproblemer, da dosis måske skal justeres.
Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.
Sprøjten skal rengøres efter hver brug.
The syringe should be washed after each dose.
Ordinerende læger bør nøje vurdere moderens kliniske behov for sildenafil samt eventuelle potentielle bivirkninger hos det ammede barn.
Prescribers should carefully assess the mother's clinical need for sildenafil and any potential adverse effects on the breast-fed child.
Sildenafil og dets væsentligste cirkulerende N-desmethylmetabolit er omtrent 96% bundet til plasmaproteiner.
Sildenafil and its major circulating N-desmethyl metabolite are approximately 96 % bound to plasma proteins.
- har en sjælden, arvelig øjensygdom (retinitis pigmentosa).
- have a rare inherited eye disease (retinitis pigmentosa).
De vil få en Revatio-indsprøjtning i stedet for Deres Revatio-tabletter.
A Revatio intravenous injection will be given to you instead of your Revatio tablets.
Revatio bør ikke gives til børn og unge under 18 år.
Children and adolescents Revatio should not be given to children and adolescents under the age of 18.
De gennemsnitlige ændringer i hjertefrekvens var ikke klinisk signifikante.
The mean changes in heart rate were clinically insignificant.
Den orale suspension skal omrystes grundigt i mindst 10 sekunder før brug.
The oral suspension must be shaken vigorously for a minimum of 10 seconds before use.
I alt 134 patienter blev behandlet med Revatio i det indledende studie, og deres langtidsoverlevelse blev vurderet i minimum 3 år.
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.
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).
Hvis De tager mere Revatio, end De skal, kan det øge risikoen for bivirkninger.
Taking more Revatio than you should may increase the risk of known side effects.
- 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).
Dette lægemiddel skal ikke fortyndes eller rekonstitueres inden brug.
This medicinal product does not require dilution or reconstitution before use.
Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Den rekonstituerede orale suspension (en hvid oral suspension med druesmag) skal tages med 6-8 timers mellemrum med eller uden mad.
The constituted oral suspension (a white, grape flavoured oral suspension) should be taken approximately 6 to 8 hours apart with or without food.
Deres læge vil afgøre, hvor længe De skal behandles, og hvor meget Revatio De skal have indsprøjtet hver dag.
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.
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 %).
Lægen kan nedsætte dosis over nogle få dage, førend behandlingen standses fuldstændigt.
Your doctor may reduce the dose over a few days before stopping completely.
Hvide, runde, bikonvekse filmovertrukne tabletter, mærket “PFIZER” på den ene side og "RVT 20” på den anden side.
White, round, biconvex film-coated tablets marked “PFIZER” on one side and “RVT 20”on the other.
Efter rekonstituering er den orale suspension holdbar 30 dage.
After reconstitution, the oral suspension is stable for 30 days.
Intravenøs behandling af disse patienter kan derfor ikke anbefales.
Its use is accordingly not recommended in these patients.
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.
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.
Andre lægemiddelformer er tilgængelige til administration til patienter ≤20 kg 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.
8 patienter fik bosentan, og 1 patient fik treprostinil sammen med bosentan og Revatio.
Eight subjects were taking bosentan and one subject was taking treprostinil in addition to bosentan and Revatio.
Stop ikke med at tage Revatio, medmindre det sker i samråd med lægen.
Do not stop taking Revatio unless your doctor tells you to.
Revatio nedsætter blodtrykket i lungerne ved at udvide blodkarrene i lungerne.
Revatio brings down blood pressure in the lungs by widening the blood vessels in the lungs.
Læs denne indlægsseddel grundigt, inden De får medicinen, da den indeholder vigtige oplysninger.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
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.
1 flaskeadaptor, 1 målebæger og 1 doseringssprøjte
1 press-in bottle adapter, 1 measuring cup and 1 oral dosing syringe
Den gennemsnitlige posturale ændring i systolisk og diastolisk blodtryk over tid var lille (< 10 mmHg) og vendte tilbage til baseline efter 2 timer.
The mean postural changes in systolic and diastolic blood pressure over time were small (< 10 mmHg) and returned towards baseline beyond 2 hours.
De hyppigste bivirkninger, der blev rapporteret gennem det kortvarige og langvarige studie, var generelt de samme som i det kortvarige studie.
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.
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.
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.
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 %).
Oral suspension
Reconstituted oral suspension
Læs vejledningen nedenfor, før De tager suspensionen.
Please see instructions below before using the oral suspension.
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.
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.
Sekundære endepunkter inkluderede hæmodynamisk monitorering, symptomvurdering, WHO-funktionsklasse, 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.
90 filmovertrukne tabletter 90 x 1 filmovertrukne tablet 300 filmovertrukne tabletter
90 film-coated tablets 90 x 1 film-coated tablets 300 film-coated tablets
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.
Der henvises til indlægssedlen for mere detaljeret brugsanvisning.
Refer to the patient leaflet for more detailed instructions for use.
Effekt af oralt administreret sildenafil hos voksne patienter med PAH (ved anvendelse sammen med epoprostenol)
Efficacy of oral sildenafil in adult patients with PAH (when used in combination with epoprostenol)
I alt 10 patienter blev rekrutteret og fuldførte studiet.
A total of 10 PAH subjects enrolled and completed the study.
Hvis De pludseligt stopper med at tage Revatio, kan Deres symptomer blive forværret.
Suddenly stopping your treatment with Revatio may lead to your symptoms getting worse.
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.
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.
- hvis De er allergisk over for sildenafil eller et af de øvrige indholdsstoffer i Revatio (angivet i afsnit 6).
- if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section
Dette lægemiddel må ikke blandes med andre lægemidler eller intravenøse opløsningsvæsker end dem, der er anført under pkt.
This medicinal product must not be mixed with other medicinal products or intravenous diluents except those mentioned in section 6.6.
Revatio må kun anvendes under graviditet, hvis det er strengt nødvendigt.
Revatio should not be used during pregnancy unless strictly necessary.
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 %).
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).
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).
Eventuelle rester af oral suspension skal bortskaffes eller returneres til apoteket efter den anførte dato.
Any unused oral suspension should be discarded or returned to your pharmacist after this date.
- blodfortyndende medicin (f.eks. warfarin), selv om det ikke resulterede i bivirkninger.
• Blood thinning medicines (for example warfarin) although these did not result in any side effects.
Tabletterne findes i blisterpakninger med 90 tabletter, 90 x 1 tablet som perforeret enkeltdosisblister og i blisterpakninger med 300 tabletter.
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.
Brug af anden medicin sammen med Revatio
Other medicines and Revatio
Anfør udløbsdato for den rekonstituerede orale suspension på flaskens etiket (udløbsdato er 30 dage efter rekonstitution).
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).
Tag ikke Revatio
Do not take Revatio:
Det anbefales, at en farmaceut rekonstituerer Revatio oral suspension inden udlevering til patienten.
It is recommended that a pharmacist constitutes Revatio oral suspension prior to its dispensing to the patient.
- hvis De for nylig har haft et slagtilfælde, eller et hjerteanfald, eller hvis De har svær leversygdom eller meget lavt blodtryk (<90/50 mmHg).
- 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).
Tabletten med 20 mg bør ikke anvendes i de tilfælde, hvor der administeres 10 mg 3 gange dagligt hos yngere patienter.
The 20 mg tablet should not be used in cases where 10 mg TID should be administered in younger patients.
Instruktioner for rekonstitution:
Reconstitution instructions:
Efter rekonstitution indeholder 1 flaske 1,12 g sildenafil (som citrat) med et endeligt volumen på 112 ml.
Once reconstituted one bottle contains 1.12 g of sildenafil (as citrate) with a final volume of 112 ml.
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.
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.
- 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).
23 personer i placebogruppen (17,6%) fik symptomer på klinisk forværring sammenlignet med 8 personer i sildenafilgruppen (6,0%).
23 subjects experienced clinical worsening events in the placebo group (17.6 %) compared with 8 subjects in the sildenafil group (6.0 %).
Effekten af Revatio er ikke fastslået hos patienter med alvorlig pulmonal arteriel hypertension (funktionsklasse IV).
The efficacy of Revatio has not been established in patients with severe pulmonary arterial hypertension (functional class IV).
Denne hændelse kunne ikke sammenkædes med studiemedicinen.
It was judged to be unrelated to the study medicinal product.
Glucose Vand til injektionsvæsker
Glucose Water for injections
Pakningsstørrelse: 1 flaske
Pack size: 1 bottle
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 (eg, epoprostenol) should be considered (see section 4.2).
Fortæl altid lægen eller apoteketspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Den anbefalede dosis på 10 mg svarer til et volumen på 12,5 ml, der skal gives som en intravenøs bolus-injektion.
The recommended dose of 10 mg requires a volume of 12.5 ml, to be administered as an intravenous bolus injection.
Revatio indeholder sildenafil, der hører til en gruppe af lægemidler, som kaldes fosfodiesterase-type 5(PDE5)-hæmmere.
Revatio contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Oral suspension: Opbevares ved temperaturer under 30 oC eller i køleskab (2 oC-8
Oral suspension Store below 30°C or in refrigerator (2°C to 8°C).
Hvis De er gravid eller ammer, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De tager Revatio.
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.
Nyligt overstået slagtilfælde eller myokardieinfarkt, Svær hypotension (blodtryk <90/50 mmHg) ved initiering.
Recent history of stroke or myocardial infarction, Severe hypotension (blood pressure < 90/50 mmHg) at initiation.
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).
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).
Dosisrelaterede forbedringer blev observeret for pulmonary vascular resistance index (PVRI) og det gennemsnitslige pulmonale arterietryk (mPAP).
Dose related improvements were observed with pulmonary vascular resistance index (PVRI) and mean pulmonary arterial pressure (mPAP).
Fjern låget.
Remove the cap.
Bank let på flasken for at løsne pulveret.
Tap the bottle to release the powder.
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.
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.