FrancophonIA/ELRC3.0 huggingface dataset:
English: A double-blind, placebo-controlled exercise stress trial evaluated 144 patients with erectile dysfunction and chronic stable angina who regularly received anti-anginal medicinal products (except nitrates).
Danish: I et dobbeltblindet, placebokontrolleret motionsstressstudie, hvori 144 patienter med erektil dysfunsktion og kronisk stabil angina tog deres sædvanlige medicin mod angina pectoris (undtaget nitrater), blev der ikke set kliniske relevante forskelle i tiden indtil angina blev en begrænsende faktor for sildenafil sammenlignet med placebo.
English: EU/1/09/595/011 [1 film-coated tablet] EU/1/09/595/012 [2 film-coated tablets] EU/1/09/595/013 [4 film-coated tablets] EU/1/09/595/014 [8 film-coated tablets] EU/1/09/595/015 [12 film-coated tablets] EU/1/09/595/018 [24 film-coated tablets]
Danish: EU/1/09/595/011 [1 filmovertrukken tablet] EU/1/09/595/012 [2 filmovertrukne tabletter] EU/1/09/595/013 [4 filmovertrukne tabletter] EU/1/09/595/014 [8 filmovertrukne tabletter] EU/1/09/595/015 [12 filmovertrukne tabletter] EU/1/09/595/018 [24 filmovertrukne tabletter]
English: - The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone K29-32,
Danish: Hver tablet indeholder 100 mg sildenafil (som citrat) - Øvrige indholdsstoffer: lactosemonohydrate, mikrokrystallinsk cellulose, povidon K29-32,
English: Sildenafil Actavis is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Danish: Sildenafil Actavis er kontraindiceret til patienter, som på grund af non-arteritis anterior iskæmisk opticus-neuropati (NAION) har nedsættelse af synet på det ene øje.
English: Sildenafil Actavis 50 mg film-coated tablets EU/1/09/595/006
Danish: Sildenafil Actavis 50 mg filmovertrukne tabletter EU/1/09/595/006
English: Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil (as citrate).
Danish: Hver tablet indeholder 25 mg, 50 mg eller 100 mg sildenafil (som citrat) - Aktivt stof: sildenafil.
English: Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
Danish: Samtidig indgift af HIV-proteasehæmmeren saquinavir, en CYP3A4-hæmmer, ved steady state (1200 mg 3 gange dagligt) med sildenafil (100 mg enkeltdosis) resulterede i en stigning af sildenafils Cmax på 140% og en stigning i sildenafils plasma AUC på 210%.
English: - If you experience sudden decrease or loss of vision, stop taking Sildenafil Actavis and contact your doctor immediately.
Danish: - hvis du oplever pludselig nedsættelse af synet eller tab af synet, skal du stoppe med at tage
English: 220 Hafnarfjörður Iceland
Danish: 220 Hafnarfjordur
English: Sildenafil Actavis 100 mg film-coated tablets PVC-PVDC/Aluminium blisters in cartons of 1, 2, 4, 8, 12 or 24 tablets.
Danish: Sildenafil Actavis 100 mg filmovertrukne tabletter PVC-PVDC/aluminium blister i kartoner med 1, 2, 4, 8, 12 eller 24 tabletter.
English: Reykjavíkurvegi 78 IS-220 Hafnarfjörður Iceland
Danish: Reykjavikurvegi 78 IS-220 Hafnarfjördur Iceland
English: Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of sildenafil.
Danish: Efter markedsføringen er der i forbindelse med brugen af sildenafil rappoteret alvorlige kardiovaskulære hændelser, herunder myokardieinfarkt, ustabil angina pectoris, pludselig hjertedød, ventrikulær arytmi, cerebrovaskulær blødning, transitorisk cerebral iskæmi, hypertension og hypotension.
English: EU/1/09/595/001 [1 film-coated tablet] EU/1/09/595/002 [2 film-coated tablets] EU/1/09/595/003 [4 film-coated tablets] EU/1/09/595/004 [8 film-coated tablets] EU/1/09/595/005 [12 film-coated tablets] EU/1/09/595/016 [24 film-coated tablets]
Danish: EU/1/09/595/001 [1 filmovertrukken tablet] EU/1/09/595/002 [2 filmovertrukne tabletter] EU/1/09/595/003 [4 filmovertrukne tabletter] EU/1/09/595/004 [8 filmovertrukne tabletter] EU/1/09/595/005 [12 filmovertrukne tabletter] EU/1/09/595/016 [24 filmovertrukne tabletter]
English: EU/1/09/595/006 [1 film-coated tablet] EU/1/09/595/007 [2 film-coated tablets] EU/1/09/595/008 [4 film-coated tablets] EU/1/09/595/009 [8 film-coated tablets] EU/1/09/595/010 [12 film-coated tablets] EU/1/09/595/017 [24 film-coated tablets]
Danish: EU/1/09/595/006 [1 filmovertrukken tablet] EU/1/09/595/007 [2 filmovertrukne tabletter] EU/1/09/595/008 [4 filmovertrukne tabletter] EU/1/09/595/009 [8 filmovertrukne tabletter] EU/1/09/595/010 [12 filmovertrukne tabletter] EU/1/09/595/017 [24 filmovertrukne tabletter]
English: Sildenafil Actavis 50 mg film-coated tablets PVC-PVDC/Aluminium blisters in cartons of 1, 2, 4, 8, 12 or 24 tablets.
Danish: Sildenafil Actavis 50 mg filmovertrukne tabletter PVC-PVDC/aluminium blister i kartoner med 1, 2, 4, 8, 12 eller 24 tabletter.
English: What Sildenafil Actavis is and what it is used for What you need to know before you take Sildenafil Actavis How to take Sildenafil Actavis Possible side effects
Danish: Det skal du vide, før du begynder at tage Sildenafil Actavis Sådan skal du tage Sildenafil Actavis Bivirkninger
English: Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated.
Danish: 5.1) er det vist, at sildenafil potenserer nitraters hypotensive effekt, hvorfor indgift sammen med nitrogenoxiddonorere (som amylnitrit) eller enhver form for nitrater er kontraindiceret.
English: Cerebrovascular accident, Transient ischaemic attack, Seizure,*
Danish: Cerebrovaskulær hændelse, transitorisk iskæmisk attak, krampeanfald*, tilbagevendende krampeanfald*, synkope
English: Consistent with its known effects on the nitric oxide/cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).
Danish: 5.1) har sildenafil vist sig at forstærke den hypotensive effekt af nitrater, og samtidig anvendelse af nitrogenoxiddonorer eller nitrater i en hvilken som helst form er derfor kontraindiceret (se pkt.
English: In addition, initiation of sildenafil at a dose of 25 mg should be considered (see sections 4.4 and 4.5).
Danish: Derudover bør initiering af sildenafil i en dosis på 25 mg overvejes (se pkt.
English: In order for Sildenafil Actavis to be effective, sexual stimulation is required.
Danish: Seksuel stimulation er nødvendig for at Sildenafil Actavis kan virke.
English: Somnolence, Hypoaesthesia
Danish: Hovedpine Svimmelhed Søvnighed, hypæstesi
English: NAME OF THE MEDICINAL PRODUCT Sildenafil Actavis 25 mg film-coated tablets Sildenafil Actavis 50 mg film-coated tablets Sildenafil Actavis 100 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Sildenafil Actavis 25 mg filmovertrukne tabletter Sildenafil Actavis 50 mg filmovertrukne tabletter Sildenafil Actavis 100 mg filmovertrukne tabletter
English: If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking Sildenafil Actavis.
Danish: Kontakt lægen, før du tager Sildenafil Actavis, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter, så som lactose.
English: 6.5 Nature and contents of container Sildenafil Actavis 25 mg film-coated tablets PVC-PVDC/Aluminium blisters in cartons of 1, 2, 4, 8, 12 or 24 tablets.
Danish: 6.5 Emballagetype og pakningsstørrelser Sildenafil Actavis 25 mg filmovertrukne tabletter PVC-PVDC/aluminium blister i kartoner med 1, 2, 4, 8,12 eller 24 tabletter.
English: What you need to know before you take Sildenafil Actavis Do not take Sildenafil Actavis - If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section
Danish: - hvis du er allergisk over for sildenafil eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Actavis Logo
English: INFORMATION IN BRAILLE Sildenafil Actavis 25 mg
Danish: INFORMATION I BRAILLE-SKRIFT Sildenafil Actavis 25 mg
English: INFORMATION IN BRAILLE Sildenafil Actavis 100 mg
Danish: INFORMATION I BRAILLE-SKRIFT Sildenafil Actavis 100 mg
English: Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction, ATC Code: G04BE03.
Danish: Farmakoterapeutisk gruppe: Urogenitalsystem og kønshormoner: Systemiske midler til erektil dysfunktion.
English: Teл: +359 24899585
Danish: България Актавис ЕАД Teл: +359 24899585
English: INFORMATION IN BRAILLE Sildenafil Actavis 50 mg
Danish: INFORMATION I BRAILLE-SKRIFT Sildenafil Actavis 50 mg
English: Uncommon (³ 1/1000 and
Danish: (³ 1/1.000 og
English: For oral use.
Danish: Oral anvendelse
English: Sildenafil Actavis 50 mg film-coated tablets are blue elliptical, biconvex, 13.0 x 6.5 mm and marked “SL50” on one side.
Danish: Sildenafil Actavis 50 mg filmovertrukne tabletter er blå, ellipseformede, bikonvekse, 13,0 x 6,5 mm og mærket med ”SL50” på den ene side.
English: Sildenafil Actavis 100 mg film-coated tablets are blue elliptical, biconvex, 17.0 x 8.5 mm and marked “SL100” on one side.
Danish: Sildenafil Actavis 100 mg filmovertrukne tabletter er blå ellipseformede, bikonveks, 17,0 x 8,5 mm og mærket ”SL100” på den ene side.
English: Marketing Authorisation Holder Actavis Group PTC ehf.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Actavis Group PTC ehf.
English: Sildenafil Actavis 25 mg film-coated tablets are blue elliptical, biconvex, 10.0 x 5.0 mm and marked “SL25” on one side.
Danish: Sildenafil Actavis 25 mg filmovertrukne tabletter er blå, ellipseformede, bikonvekse, 10,0 x 5,0 mm og mærket med ”SL25” på den ene side.
English: The major circulating metabolite results from N-demethylation of sildenafil.
Danish: N-demethylering af sildenafil.
English: Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or liver problems.
Danish: Sig det til lægen, hvis du har nyre- eller leverproblemer.
English: Sildenafil Actavis 25 mg film-coated tablets
Danish: Sildenafil Actavis 25 mg filmovertrukne tabletter
English: Each tablet contains 25 mg of sildenafil (as citrate).
Danish: Hver tablet indeholder 25 mg sildenafil (som citrat) - Aktivt stof: sildenafil.
English: To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start Sildenafil Actavis.
Danish: Du bør være på en regelmæssig daglig dosis af alfablokkere, før du tager Sildenafil Actavis, for at nedsætte sandsynligheden for at disse symptomer kan opstå.
English: Sildenafil Actavis 50 mg tablets Each tablet contains 124.76 mg lactose (as monohydrate).
Danish: Sildenafil Actavis 25 mg filmovertrukne tabletter Hver tablet indeholder 62,38 mg lactose (som monohydrat) Sildenafil Actavis 50 mg filmovertrukne tabletter Hver tablet indeholder 124,76 mg lactose (som monohydrat) Sildenafil Actavis 100 mg filmovertrukne tabletter Hver tablet indeholder 249,52 mg lactose (som monohydrat) Alle hjælpestoffer er anført under pkt.
English: Each tablet contains 50 mg of sildenafil (as citrate).
Danish: Hver tablet indeholder 50 mg sildenafil (som citrat) - Aktivt stof: sildenafil.
English: Sildenafil Actavis 50 mg film-coated tablets
Danish: Sildenafil Actavis 50 mg filmovertrukne tabletter
English: PUREN Pharma GmbH & Co. KG Tel: +49 895589090
Danish: KG Tel: +49 895589090
English: Each tablet contains sildenafil citrate equivalent to 25, 50 or 100 mg of sildenafil.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder sildenafilcitrat svarende til 25, 50 og 100 mg sildenafil Hjælpestof, som behandleren skal være opmærksom på:
English: With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).
Danish: bør en startdosis på 25 mg overvejes til patienter i samtidig behandling med andre CYP3A4-hæmmere (se pkt.
English: Τηλ: +357 22583333
Danish: A. Potamitis Medicare Ltd Τηλ: +357 22583333
English: Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder sildenafilcitrat svarende til 100 mg sildenafil
English: Sildenafil Actavis is a treatment for adult men with erectile dysfunction, sometimes known as impotence.
Danish: Sildenafil Actavis er til behandling af voksne mænd med erektil dysfunktion, også kendt som impotens, hvilket er manglende evne til at opnå og/eller opretholde tilstrækkelig erektion til at gennemføre tilfredstilllende seksuel aktivitet.
English: Sildenafil Actavis 100 mg film-coated tablets sildenafil
Danish: LÆGEMIDLETS NAVN Sildenafil Actavis 100 mg filmovertrukne tabletter sildenafil
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Danish: BILAG II A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Sildenafil Actavis 25 mg film-coated tablets sildenafil
Danish: LÆGEMIDLETS NAVN Sildenafil Actavis 25 mg filmovertrukne tabletter sildenafil
English: Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder sildenafilcitrat svarende til 25 mg sildenafil
English: Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder sildenafilcitrat svarende til 50 mg sildenafil
English: Asthenopia, Vitreous floaters, Iris disorder, Mydriasis, Halo vision, Eye oedema, Eye swelling, Eye disorder, Conjunctival hyperaemia, Eye irritation, Abnormal sensation in eye, Eyelid oedema, Scleral
Danish: Non-arteritis anterior iskæmisk opticusneuropati (NAION)*, vaskulær okklusion i retina*, blødning i retina, arteriosklerotisk retinopati, retinal sygdom, glaukom, synsfeltdefekt, diplopi, nedsat synsskarphed, myopi, astenopi, ”flyvende fluer”, sygdom i iris, mydriasis, farvet ring omkring lyskilder, øjenødem, hævede øjne, øjenlidelse, konjunktival hyperæmi, øjenirritation, unormal følelse i øjet, øjenlågsødem, tørre øjne, skleral misfarvning
English: macrogol 6000, indigo carmine aluminium lake (E132).
Danish: indigotin I (E132).
English: Sildenafil Actavis 50 mg film-coated tablets sildenafil
Danish: LÆGEMIDLETS NAVN Sildenafil Actavis 50 mg tabletter sildenafil
English: Film-coated tablet
Danish: Udseende og pakningsstørrelser Filmovertrukken tablet
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Sildenafil Actavis, skal du henvende dig til den lokale repræsentant:
English: Date of first authorisation: 28 October 2005 Date of latest renewal: 23 September 2010
Danish: Dato for første tilladelse: 28. oktober 2005 Dato for seneste fornyelse: 23. september 2010
English: Elderly (≥ 65 years)
Danish: Ældre (≥65 år)
English: • At the request of the European Medicine Agency;
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur
English: - have a severe heart problem.
Danish: - har et alvorligt hjerteproblem.
English: There are also links to other website about rare diseases and treatments.
Danish: Der er også links til andre websteder om sjældne sygdomme og om, hvordan de behandles.
English: Keep it in a clean safe place with the medicine.
Danish: Opbevares på et rent og sikkert sted sammen med medicinen.
English: The Information for healthcare professionals should contain the following key elements:
Danish: Informationen til sundhedspersonalet skal indeholde følgende:
English: No symptoms of hypotension were associated with these changes.
Danish: Der blev ikke observeret symptomer på hypotension ved disse ændringer.
English: This will force the medicine back into the bottle.
Danish: Dette vil presse medicinen tilbage i flasken.
English: - Data Capture Form (DCF) designed to facilitate reporting of events of hypotension and associated problems
Danish: • En særlig Data Capture Form (DCF), der er udformet for at lette rapportering af tilfælde af hypotension og relaterede problemer
English: Do not squirt the medicine out quickly.
Danish: Medicinen må ikke sprøjtes ud hurtigt.
English: Repeat step 3 again.
Danish: Gentag punkt 3.
English: MedDRA system organ class (V.14.0)
Danish: MedDRA-system organklasse (V14.0)
English: Pull the plunger out of the syringe and wash both parts in water.
Danish: Træk stemplet helt ud af sprøjten og vask begge dele i vand.
English: - if you are taking riociguat.
Danish: - hvis De tager riociguat.
English: No clinical studies have been performed to demonstrate that these formulations have comparable efficacy
Danish: Der erikke udført kliniske studierg til at vise, at de to formuleringer har sammenlignelig effekt.
English: If you forget to take Revatio, take a dose as soon as you remember, then continue to take your medicine at the usual times.
Danish: 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.
English: Revatio can cause dizziness and can affect vision.
Danish: Revatio kan give svimmelhed og kan påvirke synet.
English: - 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.
Danish: • Information om pharmacovigilance-monitoringsprogrammet vedrørende den potentielle risiko for klinisk relevant hypotension og relaterede problemer, der sættes i værk ved brug af DCF.
English: Revatio is given as an intravenous injection and will always be given to you by a doctor or a nurse.
Danish: Revatio gives som en indsprøjtning i en blodåre (vene) og vil altid blive givet af en læge eller en sygeplejerske.
English: Physicians should advise patients who forget to take Revatio to take a dose as soon as possible and then continue with the normal dose.
Danish: Lægen skal informere patienter, der glemmer at tage Revatio, om at tage dosis hurtigst muligt og derefter fortsætte med at tage den normale dosis.
English: The tablets are marked with “PFIZER” on one side and “RVT 20” on the other.
Danish: Tabletterne er mærket “PFIZER” på den ene side og “RVT 20” på den anden side.
English: - Copy of the Summary of Product Characteristics (SPC)
Danish: • Kopi af produktresumé (SPC)
English: Similarly 191 of 229 subjects (83 %) who had received sildenafil had either maintained or improved their WHO Functional Class at 1 year assessment.
Danish: Tilsvarende havde 191 af de 229 forsøgspersoner (83%), som havde fået sildenafil, enten holdt eller forbedret deres WHO-funktionsklasse ved vurdering efter 1 år.
English: These results are relevant to other populations and routes of administration.
Danish: Disse resultater kan anvendes for andre populationer og indgivelsesformer.
English: As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Danish: Da Revatio gives under tæt overvågning, er det ikke sandsynligt, at en dosis vil blive glemt.
English: See section 6.6 for instructions of use.
Danish: 6.6 for instruktion vedrørende anvendelse.
English: - Information for healthcare professionals
Danish: • Information til sundhedspersonale
English: Revatio solution for injection is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
Danish: Revatio injektionsvæske anbefales ikke til børn under 18 år pga. utilstrækkelig dokumentation for sikkerhed og virkning.
English: Cleaning and storing the syringe:
Danish: Rengøring og opbevaring af sprøjten:
English: Patients with left ventricular ejection fraction < 45 % or left ventricular shortening fraction < 0.2 were not studied.
Danish: Patienter med venstre ventrikulær uddrivningsfraktion <45% eller venstre ventrikulær forkortningsfraktion <0,2% blev ikke undersøgt.
English: Due to agedifferences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately 40 %.
Danish: Som følge af aldersforskelle i plasmaproteinbindingen er den tilsvarende stigning i plasmakoncentration af fri sildenafil ca. 40%.
English: Mean pulmonary systolic blood pressure decreased by 9 %.
Danish: Gennemsnitlig pulmonalt systolisk blodtryk faldt med 9%.
English: Vivian Corporation Ltd.
Danish: Malta Vivian Corporation Ltd.
English: Estimated difference 95% confidence interval
Danish: 95% Konfidensinterval
English: Powder for oral suspension: Sorbitol
Danish: Pulver til oral suspension: Sorbitol
English: Children Revatio should not be given to children below 1 year of age.
Danish: Revatio bør ikke gives til børn under 1 år.
English: In case of clinical deterioration in spite of Revatio treatment, alternative therapies should be considered.
Danish: I tilfælde af klinisk forværring på trods af Revatio-behandling, bør alternative behandlingsmuligheder overvejes.
English: - take medicines for erectile dysfunction.
Danish: - tager medicin for impotens (erektil dysfunktion).
English: Vitamin K antagonists
Danish: Vitamin-K-antagonister
English: No special requirements for disposal.
Danish: Ingen særlige forholdsregler for destruktion.
English: Revatio is for oral use only.
Danish: Revatio er kun beregnet til oral anvendelse.
English: The safety of sildenafil has not been studied in the following sub-groups of patients, and its use is therefore contraindicated:
Danish: Sikkerheden af sildenafil er ikke undersøgt hos følgende patientundergrupper, og dets anvendelse er derfor kontraindiceret:
English: 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).
Danish: Hvis medicinen er til et barn, så sørg for at barnet sidder ned eller holdes opret, før medicinen gives (Figur 9).
English: This is based on Pharmacokinetic data only (see section 5.2.
Danish: Dette er udelukkende baseret på farmakokinetiske data (se pkt.
English: After dosing, sitting and standing blood pressure and heart rate were recorded at 30, 60, 120, 180 and 360 minute post dose.
Danish: Efter indgift blev blodtrykket (i siddende og stående stilling) og hjertefrekvens målt efter 30, 60, 120, 180 og 360 minutter.
English: If large bubbles can be seen, slowly push the plunger back into the syringe.
Danish: Hvis der ses store bobler, skub da langsomt stemplet tilbage i sprøjten.
English: Remove the cap (figure 6).
Danish: Tag derefter låget af (Figur 6).
English: Revatio passes into your breast milk at very low levels and would not be expected to harm your baby.
Danish: Revatio udskilles i modermælken i meget små mængder og forventes ikke at skade barnet.
English: Revatio has moderate influence on the ability to drive and use machines.
Danish: Revatio påvirker i moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
English: 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.
Danish: Særlige hensyn i forbindelse med patienter med nyre- eller leverproblemer Fortæl lægen, hvis De har nyre- eller leverproblemer, da dosis måske skal justeres.
English: The syringe should be washed after each dose.
Danish: Sprøjten skal rengøres efter hver brug.