FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare: icterus, cholestatic icterus.
Danish: Sjælden: Gulsot, chlolestatisk ikterus.
English: If creatinine clearance is ≤ 30 ml/minute/1.73 m2 or the serum creatinine concentration is
Danish: Hvis kreatininclearance er < 30 ml/minut/1,73 m2 eller kreatininkoncentrationen > 175 µmol/l, er maksimal daglig intravenøs dosis 400 mg.
English: Hypersensitivity reactions and allergic reactions occurred in some cases after the first administration of ciprofloxacin.
Danish: Overfølsomhedsreaktioner og allergiske reaktioner forekommer i nogle tilfælde efter den første behandling med ciprofloxacin, sker det skal lægen straks konsulteres.
English: distorted sensation of taste, dizziness, headache, difficulty in sleeping (insomnia), restlessness (agitation), confusion
Danish: ændret smagsoplevelse, svimmelhed, hovedpine, søvnløshed (insomnia), uro (agitation), forfjamskelse.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for infusion
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Infusionsvæske, opløsning
English: 2 mg/ml Solution for infusion Intravenous use 200 mg/100 ml, 400 mg/200 ml
Danish: 200 mg/100 ml, 400 mg/200 ml
English: You should consult your doctor if you are pregnant or wish to become pregnant.
Danish: Du skal informere din læge hvis du er gravid eller planlægger at blive det. Rådfør dig med din læge eller apoteket, før du tager noget medicin.
English: 6.6 Special precautions for disposal and other handling
Danish: 6.6 Instruktioner vedrørende håndtering og destruktion
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Du bør informere din læge, hvis du anvender anden medicin eller har gjort det for nylig.
English: reduced taste, altered sensation (paraesthesia), shaking (tremor), spasms/ convulsions (seizures), severe headache (migraine)
Danish: tab af smagsevne, ændret følsomhed (paræstesier), rysten (tremor), spasmer/konvulsioner (kramperanfald)
English: Uncommon: increase in eosinophilic cells (eosinophilia), reduction in white blood cells (leucopenia)
Danish: stigning af antallet af eosinofila celler (eosinofili), fald i antallet af hvide blodlegemer (leucopeni), hvilket øger muligheden for infektioner
English: GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BEGRUNDELSE FOR ÆNDRINGEN AF PRODUKTRESUMÉET (PRODUKTRESUMÉERNE), ETIKETTERINGEN OG INDLÆGSSEDLEN Ud fra følgende betragtninger:
English: Ear and inner ear disorders Rare:
Danish: Øre og balanceorgan Sjældne:
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Se Annex I - udfyldes nationalt]
English: Mixing with other solutions: see sections 6.2 and 6.6.
Danish: 6.2 og 6.6.
English: The usual dose in adults is 200-400 mg of ciprofloxacin twice daily.
Danish: Sædvanlig dosis til voksne er 200 - 400 mg to gange daglig.
English: Therefore, the use of ciprofloxacin in children is generally not recommended, except for cystic fibrosis patients (see section 4.1).
Danish: Der er utilstrækkelige data tilgængelige om anvendelsen af ciprofloxacin til børn og unge, hvorfor anvendelsen generelt ikke anbefales hertil, undtagen til patienter med cystisk fibrose (jf. pkt.
English: Barcelona,SpainTel-No.: 0034 93 225 6580Fax.No.
Danish: Tel-No.: 0034 93 225 6580 Fax.No.
English: Ciprofloxacin Kabi and associated names (See Annex I) 100 mg/50 ml, solution for infusion Ciprofloxacin Kabi and associated names (See Annex I) 200 mg/100 ml, solution for infusion Ciprofloxacin Kabi and associated names (See Annex I) 400 mg/200 ml, solution for infusion [See Annex I - To be completed nationally]
Danish: Ciprofloxacin Kabi navn og tilhørende navne (Se bilag I) 100 mg/50 ml, infusionsvæske, opløsning Ciprofloxacin Kabi navn og tilhørende navne (Se bilag I) 200 mg/100 ml, infusionsvæske, opløsning Ciprofloxacin Kabi navn og tilhørende navne (Se bilag I) 400 mg/200 ml, infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
English: Therefore, the serum creatinine concentration must be checked regularly (twice per week) in these patients.
Danish: Som følge af samtidig indgift af ciprofloxacin og ciclosporin har der i enkeltstående tilfælde været observeret en forbigående øgning af serumkreatinin, hvorfor serumkreatinin skal checkes regelmæssigt (2 gange om ugen) hos disse patienter.
English: Enterobacter aerogenes
Danish: Enterobacter aerogenes Enterobacter spp.
English: Strength Pharmaceutical Form
Danish: FARMAKOLOGISKE EGENSKABER
English: Ciprofloxacin Kabi 200 mg/100 ml solution for infusion: pack sizes: 1, 5, 10, 20, 30 or 40 bags.
Danish: Ciprofloxacin Kabi 200 mg/100 ml infusionsvæske, opløsning: pakningsstørrelser: 1, 5, 10, 20, 30 or 40 poser.
English: Ciprofloxacin Kabi 400 mg/200 ml solution for infusion: pack sizes: 1, 5, 10, 20, 30 or 40 bags.]
Danish: Ciprofloxacin Kabi 400 mg/200 ml infusion, opløsning: pakningsstørrelser: 1, 5, 10, 20, 30 or 40 poser.
English: The applicant/MAH should discuss both the 100 mg twice daily (bid) dose and the 200 - 400 mg bid dose from a safety and efficacy point of view.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen skulle redegøre for sikkerheden og virkningen af doseringen 100 mg to gange dagligt og 200-400 mg to gange dagligt.
English: Cardiac disorders:
Danish: Kardielle forstyrrelser
English: inflammation of blood vessels (vasculitis) characterised by: small spots caused by bleeding in the skin (petechiae), bloody blisters (haemorrhagic bullae), skin nodes (papules), formation of eschar (dead tissue that sheds (sloughs-off) from healthy skin)
Danish: betændelse i blodkar (vaskulit), som kendetegnes ved: mindre udslæt forårsaget af blødning i huden (petekier), blodige blistre (hæmorrhagisk bullae),
English: Very rare: vasculitis (petechiae, hemorrhagic bullae, papules, crust formation).
Danish: Meget sjælden: Vaskulitis (punktformede blodudtrækninger, hæmoragisk bulløs, papula, skorpedannelse).
English: The adult dosage is 200 - 400 mg ciprofloxacin twice daily.
Danish: Voksne: 200-400 mg 2 gange daglig.
English: However the published data presented demonstrated the safety and efficacy of high-dose ciprofloxacin (daily dose of 1200 mg IV [or 1500 mg peroral]) with or without an option to oral switch, in various serious and life threatening infections.
Danish: De forelagte publicerede data godtgjorde imidlertid sikkerheden og virkningen af den høje dosering af ciprofloxacin (1200 mg dagligt i.v.
English: HOW TO USE CIPROFLOXACIN KABI
Danish: HVORDAN DU ANVENDER CIPROFLOXACIN KABI
English: muscular pain (myalgia), joint disorder (swollen joints)
Danish: muskelsmerter (myalgi), ledforstyrelser (hævede led)
English: It is contained in a clear flexible polyolefine bag with aluminium overpouch containing 200 ml solution.
Danish: Den er fyldt på en klar fleksibel polyolefin pose med en aluminiumoverpose indeholdende 200 ml opløsning.
English: [Ciprofloxacin Kabi 100 mg/50 ml solution for infusion: pack sizes: 1, 5, 10, 20, 30 or 40 bags.
Danish: Ciprofloxacin Kabi 100 mg/50 ml infusionsvæske, opløsning: pakningsstørrelser: 1, 5, 10, 20, 30 eller 40 poser.
English: Acinetobacter baumannii
Danish: Acinetobacter baumannii Campylobacter spp.
English: General disorders and administration site conditions Uncommon: general sensation of weakness, fatigue (asthenia), irritation or pain at the injection site Rare:
Danish: generel følelse af svaghed, træthed (astheni), irritation eller smerte på indstikstedet.
English: It is contained in a clear flexible polyolefine bag with aluminium overpouch containing 50 ml solution.
Danish: Den er fyldt på en klar fleksibel polyolefin pose med en aluminiumoverpose indeholdende 50 ml opløsning.
English: What Ciprofloxacin Kabi contains
Danish: Hvad indeholder Ciprofloxacin Kabi
English: increased blood sugar level (hyperglycaemia) Mental (psychiatric) disorders Rare:
Danish: forhøjet blodsukkerværdi (hyperglykæmi)
English: fungal infection in the gastrointestinal system (gastrointestinal moniliasis), pancreas inflammation (pancreatitis)
Danish: svampeinfektion i mave/tarmkanalen (gastrointestinal moniliasis), betændelse i bugspytkirtlen (pankreatit) Lever- og galde lidelser Sjældne:
English: You should consult your doctor if you are breast-feeding your child.
Danish: Du skal rådføre dig med din læge før du anvender Ciprofloxacin Kabi, hvis du ammer dit barn.
English: Each bag of 50 ml contains 100 mg of ciprofloxacin.
Danish: Hver pose på 50 ml indeholder 100 mg ciprofloxacin.
English: It is contained in a clear flexible polyolefine bag with aluminium overpouch containing 100 ml solution.
Danish: Den er fyldt på en klar fleksibel polyolefin pose med en aluminiumoverpose indeholdende 100 ml opløsning..
English: Common: rash.
Danish: Almindelig: Rødmen
English: Since ciprofloxacin is associated with very rare cases of QT prolongation (see section 4.8) caution should be exercised when treating patients at risk for torsade de pointes arrhythmia.
Danish: Da ciprofloxacin er forbundet med meget sjældne tilfælde af QT- intervalforlængelse (jf. pkt.
English: liver inflammation (hepatitis), destruction of liver tissue (liver cell necrosis, very rarely resulting in life-threatening liver failure)
Danish: leverbetændelse (hepatitis), forstørrelse af leveren (levercellenekrose, resulterer i meget sjældne tilfælde af livstruende leversvigt) Lidelser i huden og blødvæv Almindelig:
English: SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: PRODUKTRESUME ETIKETTERING OG INDLÆGSSEDDEL
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for infusion contains 2 mg ciprofloxacin (as hydrogen sulphate) [Each bag with 50 ml contains 100 mg ciprofloxacin.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml infusionsvæske indeholder 2 mg ciprofloxacin (som ciprofloxacin hydrogensulphate) Hver 50 ml infusionspose indeholder 100 mg ciprofloxacin.
English: HOW TO STORE CIPROFLOXACIN KABI
Danish: HVORDAN DU OPBEVARER CIPROFLOXACIN KABI
English: With regard to the safety and use of ciprofloxacin in children, see also section 4.4 - Children and growing adolescents except for the treatment of acute pulmonary exacerbations of cystic fibrosis in children aged 5 to 17 years.
Danish: - Børn og unge i vækst bortset fra behandling af akutte pulmonære exacerbationer af cystisk fibrose hos børn i alderen 5- 17 år.
English: Psychiatric disorders:
Danish: Psykiatriske lidelser Sjældne:
English: Uncommon: eosinophilia, leukopenia.
Danish: Lidelser i blod og lymfe Ikke almindelig: Eosinofeli, leukopeni.
English: Ciprofloxacin and other fluoroquinolones may cause photosensibility.
Danish: Ciprofloxacin og andre fluoroquinoloner kan forårsage fotosensibilitet, hvorfor det under behandling med ciprofloxacin anbefales at undgå længere tids eksponering til sollys eller UV lys.
English: Hypersensitivity:
Danish: Overfølsomhed
English: Ciprofloxacin Kabi and associated names (See Annex I) 400 mg/200 ml solution for infusion [See Annex I - To be completed nationally]
Danish: Ciprofloxacin Kabi navn og tilhørende navne (Se bilag I) 400 mg/200 ml, infusionsvæske, opløsning [Se Annex I - Udfyldes nationalt]
English: Ciprofloxacin Kabi and associated names (See Annex I) 100 mg/50 ml solution for infusion [See Annex I - To be completed nationally]
Danish: Ciprofloxacin Kabi navn og tilhørende navne (Se bilag I) 100 mg/50 ml, infusionsvæske, opløsning [Se Annex I - Udfyldes nationalt]
English: Disorders of the stomach and intestine Common:
Danish: Lidelser i mave/tarmkanalen Almindelige:
English: Each bag with 100 ml contains 200 mg ciprofloxacin.
Danish: Hver pose på 100 ml indeholder 200 mg ciprofloxacin.
English: Each bag of 200 ml contains 400 mg of ciprofloxacin.
Danish: Hver pose på 200 ml indeholder 400 mg ciprofloxacin.
English: Respiratory, thoracic and mediastinal disorders:
Danish: Respiratoriske lidelser, lidelser i thorax og mediastinum Sjælden: Dyspnø, laryngal ødem.
English: Ciprofloxacin Kabi and associated names (See Annex I) 200 mg/100 ml solution for infusion [See Annex I - To be completed nationally]
Danish: Ciprofloxacin Kabi navn og tilhørende navne (Se bilag I) 200 mg/100 ml, infusionsvæske, opløsning [Se Annex I - Udfyldes nationalt]
English: General disorders and administration site conditions:
Danish: Generelle symptomer og forstyrrelser ved applikationsstedet Ikke almindelige:
English: • feeling depressed or confused after administration of Ciprofloxacin Kabi.
Danish: hvis du føler dig deprimeret eller forvirret efter at du har fået Ciprofloxacin Kabi skal du kontakte din læge med det samme.
English: Klebsiella oxytoca
Danish: E. coli ESBL producine Klebsiella pneumonia Klebsiella oxytoca
English: Uncommon: pruritis, papillo-macular rash, urticaria.
Danish: Ikke almindelig: Pruritis, papillomakulært udslæt, nældefeber.
English: intravenous dose.
Danish: nedsat leverfunktion.
English: Uncommon: vomiting, digestive disorders, gassiness (flatulence), loss of appetite, abdominal pain Rare:
Danish: opkastning, fordøjelsesbesvær, luft i tarmen (flatulence), appetitløshed, mavesmerter
English: Immune system disorders:
Danish: Lidelser i immunsystemet
English: Uncommon: arthralgia (joint pain).
Danish: Ikke almindelig: Atralgi (ledsmerter).
English: You must not breast-feed your child during treatment with ciprofloxacin, due to the risk of malformation of joint cartilage and other harmful effects in the breast-fed infant.
Danish: På grund af risiko for misdannelse af ledbrusk og andre skadelige virkninger på det ammede barn, skal amningen afbrydes under behandling med ciprofloxacin.
English: There are insufficient data available with regard to the use of ciprofloxacin in children and adolescents.
Danish: Med hensyn til sikkerhed ved anvendelsen af ciprofloxacin til børn jf. pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution for infusion contains 2 mg ciprofloxacin (as hydrogen sulphate) Each bag with 200 ml contains 400 mg ciprofloxacin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml infusionsvæske indeholder 2 mg ciprofloxacin (som hydrogensulphat) Hver pose med 200 ml indeholder 400 mg ciprofloxacin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution for infusion contains 2 mg ciprofloxacin (as hydrogen sulphate) Each bag with 50 ml contains 100 mg ciprofloxacin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml infusionsvæske indeholder 2 mg ciprofloxacin (som hydrogensulphat) Hver pose med 50 ml indeholder 100 mg ciprofloxacin.
English: You should consult your doctor if one of the precautions and warnings mentioned below are or were applicable to you in the past.
Danish: Vær særlig forsigtig med at anvende Ciprofloxacin Kabi: Du bør tale med din læge, hvis nogle af advarslerne gælder dig eller tidligere har gjalt dig.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution for infusion contains 2 mg ciprofloxacin (as hydrogen sulphate) Each bag with 100 ml contains 200 mg ciprofloxacin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml infusionsvæske indeholder 2 mg ciprofloxacin (som hydrogensulphat) Hver pose med 100 ml indeholder 200 mg ciprofloxacin.
English: Breathing and chest disorders Rare:
Danish: Infektioner og infestationer Ikke almindelige:
English: Each bag of 100 ml contains 200 mg of ciprofloxacin.
Danish: Hver 100 ml infusionspose indeholder 200 mg ciprofloxacin.
English: Uncommon: asthenia (general sensation of weakness, fatigue), injection site reactions.
Danish: Generelle symptomer og forstyrrelser ved applikationssted Ikke almindelig: Asteni (generel følelse af svaghed, udmattelse), reaktioner på indstiksstedet.
English: In the majority of studies a regimen of 500 mg b.i.d.
Danish: I størstedelen af undersøgelserne anvendtes 500 mg oralt to gange dagligt.
English: Disorders of the skeletal muscles, tendons and bones Uncommon: joint pain (arthralgia) Rare:
Danish: udposninger i huden (papula), skorpedannelse (død hud, som løsnes fra frisk hud) Åndedræt og brystkasse Sjældne:
English: Pseudomonas aeruginosa
Danish: Lever- og galdevejslidelser
English: Whereas
Danish: Den
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vivanza on 4 March 2003.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vivanza den 4. marts 2003.
English: • patients who have had a stroke or a heart attack within the last six months;
Danish: • - patienter, som har haft et hjerte- eller slagtilfælde inden for de seneste seks måneder
English: The full EPAR for Vivanza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Vivanza findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Vivanza.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vivanza.
English: The main measure of effectiveness was the ability to get and maintain an erection.
Danish: Det primære effektmål var evnen til at få og opretholde en erektion.
English: Vivanza was significantly more effective than placebo for all measures in all studies.
Danish: Vivanza var betydeligt mere virkningsfuld end placebo i alle målinger i samtlige undersøgelser.
English: It must not be used when sexual activity is inadvisable, such as in men with severe heart disease.
Danish: Det må ikke anvendes, når seksuel aktivitet er frarådet, f.eks. hos mænd med alvorlige hjertesygdomme.
English: This was recorded in two questionnaires completed at home.
Danish: Resultaterne blev opnået ved hjælp af to spørgeskemaer, som deltagerne udfyldte hjemme.
English: • patients who have hypotension (low blood pressure);
Danish: • - patienter, som har hypotension (for lavt blodtryk)
English: A risk management plan has been developed to ensure that Vivanza is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Vivanza anvendes så risikofrit som muligt.
English: Because Vivanza has not been studied in the following groups of patients, they must not use the medicine:
Danish: Da Vivanza ikke er blevet undersøgt hos de nedenstående patientgrupper, må disse grupper ikke anvende lægemidlet:
English: The dose may be increased to a maximum of 20 mg or decreased to 5 mg depending on the effectiveness and side effects.
Danish: Dosis kan øges til maksimalt 20 mg eller nedsættes til 5 mg afhængig af effekt og bivirkninger.
English: What measures are being taken to ensure the safe and effective use of Vivanza?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vivanza?
English: Other information about Vivanza
Danish: Andre oplysninger om Vivanza
English: It is available as film-coated tablets (5, 10 and 20 mg) and as orodispersible tablets (10 mg).
Danish: Det fås som filmovertrukne tabletter (5, 10 og 20 mg) og som smeltetabletter (10 mg).
English: The dose may need to be adjusted in patients taking other medicines that block enzymes that break down Vivanza.
Danish: Dosen skal muligvis justeres hos patienter, som tager andre lægemidler, der blokerer de enzymer, som nedbryder Vivanza.
English: Patients with liver problems or severe kidney problems should start treatment on the 5 mg dose.
Danish: Patienter med leverproblemer eller alvorlige nyreproblemer skal påbegynde behandling med en dosis på 5 mg.
English: Two additional main studies compared orodispersible tablets with placebo in 701 men aged 21 to 84 years.
Danish: I to yderligere hovedundersøgelser blev smeltetabletterne sammenlignet med placebo hos 701 mænd i alderen 21 til 84 år.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vivanza.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Vivanza skal anvendes.
English: Vivanza is a medicine that contains the active substance vardenafil.
Danish: Vivanza er et lægemiddel, der indeholder det aktive stof vardenafil.
English: The most common side effect with Vivanza (seen in more than 1 patient in 10) is headache.
Danish: Den hyppigste bivirkning ved Vivanza (som optræder hos flere end 1 ud af 10 patienter) er hovedpine.
English: By blocking the breakdown of cGMP, Vivanza restores erectile function.
Danish: Ved at blokere nedbrydningen af cGMP genopretter Vivanza den erektile funktion.
English: • patients with unstable angina or hereditary eye problems known as ‘retinal degenerative disorders'.
Danish: • - patienter med ustabil angina eller arvelige øjenproblemer kaldet "retinale degenerative sygdomme".
English: If Vivanza is taken with a high fat meal, the onset of activity may be delayed.
Danish: Hvis Vivanza indtages samtidig med et måltid med højt fedtindhold, kan virkningens indtræden forsinkes.
English: For more information about treatment with Vivanza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vivanza, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It must also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non arteritic anterior ischemic optic neuropathy or NAION).
Danish: Det må heller ikke indtages af patienter, som på noget tidspunkt har haft nedsat syn forårsaget af et problem med blodtilførslen til nerven i øjet (non-arteritis anterior iskæmisk opticusneuropati eller NAION).
English: The CHMP decided that Vivanza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Vivanza opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Vivanza.
English: It works by blocking the phosphodiesterase enzyme which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Danish: Det virker ved at blokere fosfodiesteraseenzymet, som normalt nedbryder et stof, der kaldes cyklisk guanosinmonophosphat (cGMP).
English: Vivanza film-coated tablets have been compared with placebo (a dummy treatment) in four main studies including 2,431 men aged 20 to 83 years.
Danish: Vivanza som filmovertrukne tabletter blev sammenlignet med placebo (en virkningsløs behandling) i fire hovedundersøgelser af 2 431 mænd i alderen 20 til 83 år.
English: Vivanza is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity.
Danish: Vivanza anvendes til behandling af voksne mænd med erektil dysfunktion (undertiden kaldet impotens), hvilket er manglende evne til at opnå eller opretholde en tilstrækkelig hård penis (erektion) til at kunne gennemføre seksuel aktivitet.
English: The recommended dose of Vivanza is 10 mg, taken by mouth with or without food, about 25 to 60 minutes before sexual activity; patients should not take more than one dose a day.
Danish: Den anbefalede dosis er 10 mg, som indtages oralt sammen med eller uden fødeindtagelse, cirka 25 til 60 minutter inden seksuel aktivitet.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vivanza, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Vivanza, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The orodispersible tablets must be taken without liquid.
Danish: Smeltetabletterne skal tages uden væske.