FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the risk of partner transfer, patients hoping to achieve conception should either avoid using Fortacin, or, if it is essential to achieve penetration, should wash the glans penis as thoroughly as possible 5 minutes after applying the spray but prior to intercourse (see section 4.6).
Danish: Patienter, der ønsker konception, bør på grund af risikoen for overførsel til partneren enten undgå at bruge Fortacin eller, hvis det er essentielt at opnå penetration, vaske glans penis så grundigt som muligt 5 minutter efter påføring at sprayen, men før samleje (se pkt.
English: Male volunteers had maximum plasma concentrations of lidocaine which were less than 4% of toxic levels, and prilocaine which were less than 0.4% of toxic levels, after repeat dosing.
Danish: Efter gentagen dosering var den maksimale plasmakoncentration af lidocain hos de mandlige forsøgspersoner under 4 % af det toksiske niveau, og for prilocain under 0,4 % at det toksiske niveau.
English: • pain in the vagina
Danish: • smerter i skeden
English: Common: (may affect up to 1 in 10 people)
Danish: Almindelig: (forekommer hos indtil 1 ud af 10 behandlede):
English: • vaginal thrush (Candida) infection
Danish: • trøske i skeden (infektion med Candida)
English: • There is also a risk of a disorder reducing the amount of oxygen in the blood
Danish: • der er også risiko for nedsat iltindhold i blodet (methæmoglobinæmi).
English: • other local anaesthetics
Danish: • andre lokalbedøvende midler
English: Package leaflet: Information for the user Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution lidocaine/prilocaine
Danish: Indlægsseddel: Information til brugeren Fortacin, kutanspray, opløsning, 150 mg/ml + 50 mg/ml lidocain/prilocain
English: Therefore, patients hoping to achieve conception should either avoid using Fortacin, or, if this medicine is essential to achieve penetration, should wash the penis as thoroughly as possible five minutes after Fortacin has been applied, but prior to intercourse.
Danish: Patienter, der ønsker graviditet, bør derfor enten undgå Fortacin eller - hvis penetration er vigtig for dem - vaske hovedet af penis så grundigt som muligt fem minutter efter påføring af Fortacin, men før samleje.
English: Deterioriation was observed when Fortacin was used with polyurethane-based female and male condoms (see section 4.4).
Danish: Der blev konstateret nedsat styrke af polyuretanbaserede femidomer og kondomer ved anvendelse sammen med Fortacin (se pkt.
English: If some medicine accidentally gets into your eyes or your partner's eyes, rinse them immediately with cold water or saline solution and cover them gently until any effects, such as numbness, wear off. Be aware that normal protective mechanisms, such as blinking, or sensation of a foreign body in the eye, may not occur until the numbness has worn off.
Danish: Hvis du eller din partner ved en fejltagelse får lægemiddel i øjnene, skal øjnene straks skylles med koldt vand eller saltvand og forsigtigt holdes tildækket, indtil eventuelle virkninger såsom følelsesløshed er gået over.
English: A residual volume of fluid that is not usable will remain in the container after all doses have been administered.
Danish: Efter at alle doser er administreret, vil beholderen stadig indeholde en restmængde væske, der ikke kan bruges.
English: Each actuation delivers 50 microlitres which contains 7.5 mg lidocaine and 2.5 mg prilocaine.
Danish: - Hver spray giver 50 mikroliter, som indeholder 7,5 mg lidocain og 2,5 mg prilocain.
English: • reduced feeling in and around the penis
Danish: • nedsat følsomhed i og omkring penis
English: Cutaneous spray, solution Colourless to light yellow solution
Danish: Kutanspray, opløsning Farveløs til bleggul opløsning
English: • discomfort or itching in the vulva and vagina
Danish: • ubehag eller kløe i de ydre kønsdele og skeden
English: Patients on anti-arrhythmic medicinal products class III (e.g. amiodarone) should be treated with caution.
Danish: Forsigtighed bør udvises ved samtidig behandling med antiarytmika af klasse III (f.eks. amiodaron).
English: Anaemia related conditions
Danish: Anæmirelaterede sygdomme
English: Patients or their partner with a known history of sensitivity to local anaesthetics of the amide type.
Danish: Kendt tidligere overfølsomhed over for lokalanæstetika af amidtypen hos patienten eller dennes partner.
English: • feeling of burning in and around the penis
Danish: • brænden i og omkring penis
English: Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution lidocaine/prilocaine
Danish: Fortacin, kutanspray, opløsning, 150 mg/ml + 50 mg/ml lidocain/prilocain
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige (forekommer hos indtil 1 ud af 10 behandlede):
English: The metabolism of lidocaine and prilocaine results in the formation of 2,6-xylidine and o-toluidine, respectively, amongst other metabolites.
Danish: 2,6-xylidin og o-toluidin foruden andre metabolitter.
English: Fortacin is indicated for the treatment of lifelong premature ejaculation in adult men.
Danish: Fortacin anvendes til behandling af voksne mænd, der varigt lider af for tidlig sædafgang.
English: A higher rate of erectile dysfunction and male genital hypoaesthesia may be experienced when using Fortacin with male condoms.
Danish: Brug af Fortacin sammen med kondom kan øge forekomsten af erektil dysfunktion og genital hypæstesi hos manden.
English: - Each ml of solution contains 150 mg lidocaine and 50 mg prilocaine - Each spray delivers 50 microlitres which contains 7.5 mg lidocaine and 2.5 mg prilocaine.
Danish: Hver ml opløsning indeholder 150 mg lidocain og 50 mg prilocain Hver aktivering afgiver 50 mikroliter, som indeholder 7,5 mg lidocain og 2,5 mg prilocain.
English: Before initial use, briefly shake the spray container and then prime the pump mechanism by spraying the valve three times into the air.
Danish: Inden beholderen anvendes første gang, skal du omryste den kortvarigt og derefter gøres pumpemekanismen klar til brug, ved at aktivere ventilen, så den sprayer ud i luften tre gange.
English: Before each subsequent use, it should be briefly shaken and then the spray container should be re-primed by spraying it once.
Danish: Før hver efterfølgende anvendelse skal spraybeholderen omrystes kortvarigt og derefter gøres pumpemekanismen klar til brug, ved at der sprayes én gang.
English: How to use Fortacin
Danish: Sådan skal du bruge Fortacin
English: Talk to your doctor or pharmacist before using Fortacin - if you, or your sexual partner, have been diagnosed with a genetic disease or other condition affecting your red blood cells (glucose-6-phosphate deficiency, anaemia or methaemoglobinaemia); - if you have a history of medicine sensitivities, especially if you are not certain which medicine causes sensitivity; - if you suffer from severe liver problems.
Danish: der berører de røde blodlegemer (glukose-6-fosfat-mangel, anæmi eller methæmoglobinæmi) - hvis du tidligere har været overfølsom over for lægemidler, navnlig hvis du ikke er sikker på,
English: Each container of 6.5 ml delivers a minimum of 20 doses.
Danish: Hver 6,5 ml beholder indeholder mindst 20 doser.
English: Each container of 5 ml delivers a minimum of 12 doses.
Danish: Hver 5 ml beholder indeholder mindst 12 doser.
English: Frequency Adverse Reactions
Danish: Hyppighed Bivirkning
English: - Each spray container of 5 ml delivers a minimum of 12 doses.
Danish: - Hver 5 ml spraybeholder indeholder mindst 12 doser.
English: - Each spray container of 6.5 ml delivers a minimum of 20 doses.
Danish: - Hver 6,5 ml spraybeholder indeholder mindst 20 doser.
English: Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution
Danish: Fortacin, kutanspray, opløsning, 150 mg/ml + 50 mg/ml
English: Adverse drug reactions in male glans-penis-treated subjects System Organ Class
Danish: Bivirkninger hos mænd behandlet på glans penis
English: What Fortacin looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Before initial use, the spray container should be briefly shaken and then primed by spraying it into the air three times.
Danish: Før første gangs anvendelse af beholderen skal denne omrystes kortvarigt og derefter gøres pumpemekanismen klar til brug, ved at der sprayes tre gange ud i luften.
English: One third of the glans penis should be covered with each actuation.
Danish: Ved hver aktivering påføres sprayen på en tredjedel af glans penis.
English: • difficulty or pain passing urine
Danish: • omtumlethed eller svimmelhed
English: Uncommon Pyrexia
Danish: Pyreksi
English: • itching in and around the penis
Danish: • kløe i og omkring penis
English: • Blurred vision
Danish: • sløret syn
English: What Fortacin is and what it is used for What you need to know before you use Fortacin How to use Fortacin
Danish: Det skal du vide, før du begynder at bruge Fortacin Sådan skal du bruge Fortacin Bivirkninger
English: They are very unlikely to happen if it is used as instructed:
Danish: Hvis Fortacin bruges som anvist, er det meget usandsynligt, at du får sådanne symptomer:
English: • redness on and around the penis
Danish: • prikken i og omkring penis
English: Posology
Danish: Dysuri
English: Uncommon Headache
Danish: Hovedpine
English: Medicinal product no longer authorised
Danish: Lægem idlet er ikke længere autoriseret
English: 3 inhalers (3 x 60 doses)
Danish: 3 inhalatorer (3 x 60 doser)
English: 1 inhaler (60 doses)
Danish: 1 inhalator (60 doser)
English: MA (EU) number Invented name Strength Pharmaceutical
Danish: MF (EU)nummer
English: The European Commission granted a marketing authorisation valid throughout the European Union for Revatio on 28 October 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Revatio den 28.oktober 2005.
English: Other information about Revatio
Danish: Andre oplysninger om Revatio
English: The full EPAR for Revatio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Revatio 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 Revatio.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Revatio.
English: The main study in children involved 235 children aged 1 to 17 years with PAH.
Danish: Hovedundersøgelse af børn omfattede 235 børn i alderen 1-17 år med PAH.
English: Revatio contains the active substance sildenafil.
Danish: Revatio indeholder det aktive stof sildenafil.
English: The CHMP concluded that Revatio provides an alternative treatment option for PAH.
Danish: CHMP konkluderede, at Revatio udgør et alternativ til behandling af PAH.
English: Why is Revatio approved?
Danish: Hvorfor blev Revatio godkendt?
English: The active substance in Revatio, sildenafil, belongs to a group of medicines called ‘phosphodiesterase type 5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Danish: Det aktive stof i Revatio, sildenafil, tilhører en gruppe af lægemidler kaldet "phosphodiesterase type 5 (PDE5)-hæmmere", hvilket betyder, at det blokerer PDE5-enzymet.
English: It is not intended to provide practical advice on how to use Revatio.
Danish: Det er ikke en praktisk vejledning i, hvordan Revatio bør anvendes.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Revatio's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Revatio opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The main study in adults involved 277 patients with PAH, most of whom had class II or class III disease.
Danish: Hovedundersøgelsen af voksne omfattede 277 patienter med PAH, hvoraf de fleste havde klasse IIeller klasse III-sygdomme.
English: What is Revatio and what is it used for?
Danish: Hvad er Revatio, og hvad anvendes det til?
English: Revatio was more effective than placebo (a dummy treatment) at improving exercise capacity in one main study in adults and another main study in children.
Danish: Revatio var mere effektivt end placebo (en virkningsløs behandling) til at forbedre den fysiske kapacitet i en hovedundersøgelse, hvori der indgik voksne, og i en anden hovedundersøgelse, hvori der indgik børn.
English: Lower doses of Revatio may be needed in patients taking some medicines that affect the way Revatio is broken down in the body.
Danish: Der kan være behov for lavere doser af Revatio til patienter, som tager lægemidler, der kan påvirke den måde, hvorpå Revatio nedbrydes i kroppen.
English: This enzyme is found in the blood vessels of the lungs.
Danish: Dette enzym findes i blodkarrene i lungerne.
English: The company that markets Revatio will agree with each European Union Member State on how the solution for injection will be distributed.
Danish: Virksomheden, der fremstiller Revatio, skal aftale med de enkelte EU-medlemsstater, hvordan injektionsvæsken skal distribueres.
English: Before treatment, adults with class II disease could walk an average of 378m in 6 minutes.
Danish: Inden behandlingen kunne voksne med klasse II- sygdom i gennemsnit gå 378m på 6 minutter.
English: What measures are being taken to ensure the safe use of Revatio?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Revatio?
English: What are the risks associated with Revatio?
Danish: Hvilke risici er der forbundet med Revatio?
English: Adults with class III disease could walk an average of 326 m at the start of the study.
Danish: Voksne med klasse III-sygdomme kunne gennemsnitligt gå 326 m, da undersøgelsen begyndte.
English: The company also presented the results of studies showing that the tablets were equivalent to the oral suspension (produced similar levels of sildenafil in the blood), and that a 10 mg injection was equivalent to a 20 mg tablet.
Danish: Virksomheden fremlagde endvidere resultaterne af undersøgelser, som viste, at tabletterne svarede til den orale suspension (producerede de samme mængder sildenafil i blodet), og at en 10 mg-injektion svarede til en 20 mg-tablet.
English: Revatio must not be taken with nitrates (medicines used to treat angina), or with medicines that could affect the way that Revatio is broken down in the body, such as ketoconazole or itraconazole (antifungal medicines) and ritonavir (used to treat HIV infection).
Danish: Revatio må ikke indtages sammen med nitrater (lægemidler, der anvendes til behandling af angina) eller lægemidler, som kan påvirke den måde, hvorpå Revatio nedbrydes i kroppen, såsom ketoconazol eller itraconazol (lægemidler til behandling af svampeinfektioner) og ritonavir (lægemiddel til behandling af hivinfektion).
English: In children aged 1 to 17 years, the recommended dose is 10 mg three times a day in children weighing less than 20 kg and 20 mg three times a day in those over 20 kg. Higher doses should not be used.
Danish: Til børn i alderen 1 til 17 år er den anbefalede dosis Revatio 10 mg tre gange dagligt til børn, som vejer under 20 kg, eller 20 mg tre gange dagligt til dem, som vejer over 20 kg. Der må ikke anvendes højere doser.
English: This leads to high blood pressure in the vessels taking blood from the heart to the lungs and reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
Danish: Det medfører et forhøjet blodtryk i de kar, der fører blodet fra hjertet til lungerne, og reducerer den mængde ilt, der kan komme ind i blodet i lungerne, hvilket vanskeliggør fysisk aktivitet.
English: Revatio must not be taken by patients who have ever had a problem with blood flow in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).
Danish: Revatio må ikke indtages af patienter, som på noget tidspunkt har haft et problem med blodtilførslen til nerven i øjet kaldet non-arteritis anterior iskæmisk opticusneuropati (NAION).
English: After 16 weeks, the maximum volume of oxygen the children used during exercise increased on average by 10.2% with Revatio compared with 0.5% with placebo.
Danish: Efter 16 uger blev den maksimale mængde ilt, der blev brugt under fysisk aktivitet, øget med 10, 2 % med Revation sammenlignet med 0,5 % med placebo.
English: Change in exercise capacity in this study was measured as the improvement in the maximum volume of oxygen used during exercise after 16 weeks of treatment, in children able to perform the exercise tests.
Danish: Ændringen i den fysiske kapacitet blev hovedsagelig målt på forbedringen af den maksimale mængde ilt, der blev brugt under fysisk aktivitet efter 16 ugers behandling, hos børn, der var i stand til at udføre de fysiske test.
English: It must not be started in patients with severe liver disease or severe hypotension (very low blood pressure), or who have recently had a stroke or heart attack, because Revatio has not been studied in these groups of patients.
Danish: Behandlingen med Revatio må ikke påbegyndes hos patienter med alvorlige leversygdomme, alvorlig hypotension (meget lavt blodtryk) eller patienter, som for nylig har haft et hjertetilfælde, da Revatio ikke er blevet undersøgt hos disse patienter.
English: In adults, Revatio is used in patients with class II (slight limitation of physical activity) or class III (marked limitation of physical activity) PAH.
Danish: Hos voksne anvendes Revatio til behandling af patienter med PAH i klasse II (lettere begrænsning af fysisk aktivitet) og III (markant begrænsning af fysisk aktivitet).
English: In adults, Revatio is taken at a dose of 20 mg three times a day.
Danish: Til voksne gives Revatio som en 20 mg-dosis tre gange dagligt.
English: Revatio can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of PAH.
Danish: Revatio udleveres kun efter recept, og behandlingen bør kun iværksættes og overvåges af en læge med erfaring i behandling af pulmonal arteriel hypertension.
English: Revatio is available as tablets (20 mg), a solution for injection (0.8 mg/ml) and a powder to be made up into an oral suspension (10 mg/ml).
Danish: Revatio fås som tabletter (20 mg), en injektionsvæske, opløsning (0,8 mg/ml), og et pulver til fremstilling af en oral suspension (10 mg/ml).
English: In patients with PAH, sildenafil widens the blood vessels of the lungs, which lowers the blood pressure and improves symptoms.
Danish: Hos patienter med PAH udvider sildenafil blodkarrene i lungerne, hvilket får blodtrykket til at falde og forbedrer symptomerne.
English: For more information about treatment with Revatio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Revatio, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Revatio is a medicine used to treat adults and children from 1 year of age with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries of the lungs).
Danish: Revatio anvendes til at behandle voksne og børn fra 1 år og opefter med pulmonal arteriel hypertension (PAH), som er unormalt højt blodtryk i lungearterierne.
English: Change in exercise capacity was measured as the improvement in the distance patients could walk in 6 minutes after 12 weeks of treatment.
Danish: Ændringen i den fysiske kapacitet blev hovedsagelig målt på forbedringen af den distance, patienterne kunne gå på 6 minutter efter 12 ugers behandling.
English: In children, the most common side effects (which may affect up to 1 patient in 10) are throat and nose infections, headache, vomiting, fever, diarrhoea, flu and nosebleeds.
Danish: Hos børn var de hyppigste bivirkninger (som kan optræde hos flere end 1 ud af 10 patienter) hals- og næseindfektioner, hovedpine, opkastning, feber, diarré, influenza og næseblødninger.
English: For the full list of all side effects reported with Revatio, see the package leaflet.
Danish: Den fuldstændige liste over samtlige bivirkninger ved Revatio fremgår af indlægssedlen.
English: What benefits of Revatio have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Revatio?
English: How does Revatio work?
Danish: Hvordan virker Revatio?
English: The solution for injection is for adults who cannot take Revatio tablets or oral suspension for a short period, but whose condition is stable.
Danish: Injektionsvæsken, opløsning, anvendes til voksne, hvis tilstand er stabil, men som i en kort periode ikke kan tage Revatio som tabletter eller som oral suspension.
English: For practical information about using Revatio, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Revatio, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: After 12 weeks, this distance had increased by 49 m more in the patients taking 20 mg Revatio than in the patients taking placebo.
Danish: Efter 12 uger var denne distance forlænget med 49 m mere hos patienter, der fik 20 mg Revatio, end hos patienter, der fik placebo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Revatio have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Revatio.
English: How is Revatio used?
Danish: Hvordan anvendes Revatio?
English: It will also ensure that doctors and pharmacists who will prescribe or dispense the solution for injection in each Member State receive information about how it should be used and how to report side effects such as low blood pressure.
Danish: Disse pakker skal indeholde oplysninger om, hvordan lægemidlet anvendes, og om hvordan man indberetter bivirkninger som for eksempel lavt blodtryk.
English: The most common side effects with Revatio in adults (which may affect more than 1 patient in 10) are headache, flushing (reddening of the skin), dyspepsia (heartburn), diarrhoea and pain in arm or leg. Side effects are similar with the solution for injection.
Danish: De hyppigste bivirkninger ved Revatio hos voksne (som kan optræde hos flere end 1 ud af 10 patienter) er hovedpine, rødme, dyspepsi (halsbrand), diarré og smerter i arme og ben.
English: This distance had increased by 45 m more in the patients taking 20 mg Revatio than in those taking placebo after 12 weeks.
Danish: Efter 12 uger var denne distance forlænget med 45 m mere hos de patienter, der fik 20 mg Revatio,end hos dem, der fik placebo.
English: In adults who cannot take the tablets or oral suspension, the solution for injection is injected into a vein by a doctor or nurse at a dose of 10 mg (12.5 ml) three times a day.
Danish: Injektionsvæsken injiceres i en vene i en dosis a 10 mg (12,5 ml) tre gange dagligt af en læge eller sygeplejerske hos voksne, som ikke kan tage tabletten eller den orale suspension.
English: PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Danish: Pulmonal arteriel hypertension er en invaliderende sygdom, hvor der sker en alvorlig forsnævring af blodkarrene i lungerne.
English: When it is blocked, a substance called ‘cyclic guanine monophosphate' (cGMP) cannot be broken down, so that it remains in the vessels where it causes relaxation and widening of the blood vessels.
Danish: Når det blokeres, kan et stof kaldet "cyklisk guanin monophosphat" (cGMP) ikke nedbrydes.
English: This product contains a genetically modified organism (GMO).
Danish: Dette produkt indeholder en genetisk modificeret organisme (GMO).
English: --1 1 dose (0.2 ml) contains:
Danish: --1 1 dosis (0,2 ml) indeholder:
English: A/Vietnam/1203/2004 (H5N1) strain (A/Vietnam/1203/2004, MEDI 0141000136) 10
Danish: A/Vietnam/1203/2004 (H5N1)-stamme (A/Vietnam/1203/2004, MEDI 0141000136) 10