FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Tadalafil Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Tadalafil Mylan er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, antages det at have de samme fordele og risici som referencelægemidlet.
English: Tadalafil Mylan can also be used in men to treat the signs and symptoms of benign prostatic hyperplasia (enlarged prostate gland that is not cancerous), which involve problems with the flow of urine.
Danish: Tadalafil Mylan kan desuden anvendes hos mænd til behandling af tegn og symptomer på godartet forstørret blærehalskirtel (benign prostatahyperplasi), som giver problemer med vandladningen.
English: What are the benefits and risks of Tadalafil Mylan?
Danish: Hvilke fordele og risici er der forbundet med Tadalafil Mylan?
English: It is not intended to provide practical advice on how to use Tadalafil Mylan.
Danish: Det er ikke en praktisk vejledning i, hvordan Tadalafil Mylan bør anvendes.
English: For treating men with benign prostatic hyperplasia, or men with both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day.
Danish: Til behandling af mænd med godartet blærehalskirtelforstørrelse eller med både godartet blærehalskirtelforstørrelse og rejsningsproblemer er den anbefalede dosis 5 mg én gang dagligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tadalafil Mylan has been shown to have comparable quality and to be bioequivalent to Cialis.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) fandt, at Tadalafil Mylan i overensstemmelse med EUkravene er påvist at have en kvalitet svarende til Cialis og at være bioækvivalent med dette.
English: What is Tadalafil Mylan and what is it used for?
Danish: Hvad er Tadalafil Mylan, og hvad anvendes det til?
English: The active substance of Tadalafil Mylan, tadalafil, belongs to a group of medicines called 'phosphodiesterase type 5 (PDE5) inhibitors'.
Danish: Det aktive stof i Tadalafil Mylan, tadalafil, tilhører lægemiddelgruppen fosfodiesterase 5-hæmmere (PDE-5-hæmmere).
English: Other information about Tadalafil Mylan
Danish: Andre oplysninger om Tadalafil Mylan
English: This may reduce the problems with the flow of urine which are symptoms of benign prostatic hyperplasia.
Danish: Dette kan nedsætte problemerne med vandladning, som er symptomer på godartet forstørrelse af blærehalskirtlen.
English: Because Tadalafil Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Cialis.
Danish: Da Tadalafil Mylan er et generisk lægemiddel, er der udelukkende udført undersøgelser til at fastlægge, at det er bioækvivalent med referencelægemidlet, Cialis.
English: By blocking the breakdown of cGMP, Tadalafil Mylan restores erectile function.
Danish: Ved at blokere nedbrydningen af cGMP genopretter Tadalafil Mylan evnen til at få rejsning.
English: For practical information about using Tadalafil Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Tadalafil Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Tadalafil Mylan approved?
Danish: Hvorfor er Tadalafil Mylan blevet godkendt?
English: It is a ‘generic medicine'.
Danish: Tadalafil Mylan er et “generisk lægemiddel”.
English: The Committee recommended that Tadalafil Mylan be approved for use in the EU.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse i EU for Tadalafil Mylan.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection.
Danish: Det får muskelvævet i svulmelegemerne (corpora cavernosa) i penis til at afslappes, hvorved blodtilførslen til svulmelegemerne øges, så der frembringes rejsning.
English: How is Tadalafil Mylan used?
Danish: Hvordan anvendes Tadalafil Mylan ?
English: How has Tadalafil Mylan been studied?
Danish: Hvordan blev Tadalafil Mylan undersøgt?
English: How does Tadalafil Mylan work?
Danish: Hvordan virker Tadalafil Mylan ?
English: Not known: frequency cannot be estimated from the available data
Danish: Ikke kendt: hyppigheden kan ikke vurderes ud fra tilgængelige data
English: Use in adults, including elderly patients
Danish: Anvendelse til voksne, inklusive ældre patienter
English: Date of first authorisation: 20 February 2014 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 20. februar 2014 Dato for seneste fornyelse:
English: • Only use one bottle at a time.
Danish: • Brug kun én flaske ad gangen.
English: Unilateral treatment can result in permanent heterochromia.
Danish: Unilateral behandling kan resultere i permanent heterokromi.
English: The recommended dose is
Danish: Den anbefalede dosis er:
English: This change may be permanent.
Danish: Denne farveændring kan være permanent.
English: SE = Standard Error; CI = Confidence Interval;
Danish: SE = Standardfejl; CI = Konfidensinterval;
English: • Tilt your head or your child's head gently back.
Danish: • Læn hovedet eller dit barns hoved forsigtigt tilbage.
English: Continue with the next dose as planned.
Danish: Tag næste dosis som planlagt.
English: This is especially important in women who are pregnant or are attempting to become pregnant.
Danish: Det gælder især kvinder, som er gravide eller kvinder, som forsøger at blive gravide.
English: Optimal effect is obtained if the dose is administered in the evening.
Danish: Optimal effekt opnås, hvis dosis administreres om aftenen.
English: The following side effects have been observed with IZBA:
Danish: Følgende bivirkninger er observeret med IZBA:
English: • Travoprost may be absorbed through the skin.
Danish: • Travoprost kan optages gennem huden.
English: Do not use this medicine after the expiry date which is stated on the bottle and the box after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på flasken og kartonen efter ”EXP”.
English: Package leaflet : Information for the user
Danish: Indlægsseddel: Information til brugeren
English: (picture 3).
Danish: (billede 2).
English: This helps to stop IZBA getting into the rest of the body.
Danish: Det forhindrer, at IZBA kommer ud i resten af kroppen.
English: Travoprost is an ester prodrug.
Danish: Travopost er et ester prodrug.
English: The effects of this medicine in pregnant women are not known.
Danish: Hvordan dette lægemiddel påvirker gravide kvinder er ikke kendt.
English: Not known vertigo, tinnitus
Danish: Ikke kendt vertigo, tinnitus
English: No data are available for children less than 2 months old.
Danish: Der foreligger ingen data for børn under 2 måneder.
English: Therefore, no need for dose adjustment at the lower concentration of active ingredient is anticipated.
Danish: Derfor forventes der ikke at være behov for dosisjustering ved den lavere koncentration af det aktive indholdsstof.
English: Mean difference is travoprost - timolol.
Danish: Gennemsnitsforskellen er travoprost - timolol.
English: The change in iris colour occurs slowly and may not be noticeable for months to years.
Danish: Ændring af irisfarven sker langsomt, og den vil først ses efter måneder eller år.
English: • If you use drops in both eyes, repeat the steps for the other eye.
Danish: • Hvis du skal dryppe begge øjne, så gentag processen i det andet øje.
English: If any of the medicinal product comes into contact with the skin, it should be washed off straight away.
Danish: Hvis noget af medicinen kommer i kontakt med huden, skal det vaskes af med det samme.
English: Before treatment is instituted, patients must be informed of the possibility of a permanent change in eye colour.
Danish: Før behandling påbegyndes, skal patienterne informeres om, at denne farveændring i øjet muligvis er permanent.
English: The effect on IOP was seen after the second week of treatment and was consistently maintained throughout the 12 week period of study for all age groups.
Danish: Virkningen på IOP sås efter anden behandlingsuge, og den blev konsekvent opretholdt gennem alle studiets 12 uger for samtlige aldersgrupper.
English: Women who are pregnant or attempting to become pregnant should exercise appropriate precautions to avoid direct exposure to the contents of the bottle.
Danish: Kvinder, som er gravide, eller som forsøger at blive gravide, skal træffe passende forholdsregler for at undgå direkte berøring af flaskens indhold.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene til fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD-listen), som fastsat i artikel 107c, stk.7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Both side effects were observed with a higher incidence in children and adolescents compared to adults.
Danish: Begge bivirkninger blev set med en højere hyppighed hos børn og unge sammenlignet med voksne.
English: Mean Difference a
Danish: Gennemsnitsforskel a
English: The patient should remove the protective overwrap immediately prior to initial use.
Danish: Patienten skal fjerne beskyttelsesfolien umiddelbart før anvendelse første gang.
English: You may find that your vision is blurred for a time just after you use IZBA.
Danish: Du kan opleve, at dit syn bliver midlertidigt sløret lige efter, at du har brugt IZBA.
English: A topical overdose is not likely to occur or to be associated with toxicity.
Danish: En topikal overdosis er usandsynlig og vil i givet fald sandsynligvis ikke være associeret med toksicitet.
English: Hence, despite the very small amounts of travoprost used by patients in eye drops, a risk to the environment cannot be excluded.
Danish: Selvom patienter bruger meget små mængder af travoprost i øjendråber, kan man derfor ikke udelukke en risiko for miljøet.
English: The safety and efficacy of travoprost have not been established in this age group.
Danish: Sikkerhed og virkning af travoprost er ikke klarlagt for denne aldersgruppe.
English: Do not use IZBA if you are pregnant.
Danish: Brug ikke IZBA, hvis du er gravid.
English: No long-term safety data are available in the paediatric population.
Danish: Der foreligger ingen data om den langsigtede sikkerhed hos den pædiatriske population.
English: It could infect the drops.
Danish: Det kan forurene dråberne.
English: Reduction of the intraocular pressure in man starts about 2 hours after administration and maximum effect is reached after 12 hours.
Danish: Nedsættelse af det intraokulære tryk hos mennesker begynder cirka 2 timer efter administration, og den maksimale effekt opnås efter 12 timer.
English: Do not use IZBA:
Danish: Brug ikke IZBA:
English: The mean percent reductions in IOP from baseline to each study visit and assessment time point ranged from 28.4% to 30.7%.
Danish: Mean procentreduktionen i IOP fra baseline til hvert enkelt forsøgsbesøg og evalueringstidspunkt varierede fra 28,4% til 30,7%.
English: Ask your doctor for advice if this applies to you.
Danish: Spørg din læge, hvis dette er aktuelt for dig.
English: If you or your child use more IZBA than you should Rinse all the medicine out with warm water.
Danish: Hvis du eller dit barn har brugt for meget IZBA Skyl al lægemidlet ud med varmt vand.
English: No dosage adjustment is necessary in these patients.
Danish: Ingen dosisjustering er nødvendig for disse patienter.
English: IZBA should only be used as an eye drop.
Danish: IZBA må kun bruges som øjendråber.
English: The long-term effects on the melanocytes and any consequences thereof are currently unknown.
Danish: Langtidseffekten på melanocytterne og konsekvenserne heraf er endnu ukendt.
English: Travoprost is considered a persistent, bioaccumulative and toxic (PBT) substance.
Danish: Travoprost anses for at være et persistent, bioakkumulerende og toksisk (PBT) stof.
English: The short-term safety profiles in the different paediatric subsets were also similar (see section 5.1).
Danish: Korttidssikkerhedsprofilerne i de forskellige pædiatriske undergrupper var også sammenlignelig (se pkt.
English: Read all of this leaflet carefully before you start using this medicine because it contains information important for you - Keep this leaflet.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: Significant lowering of intraocular pressure can be maintained for periods exceeding 24 hours with a single dose.
Danish: Signifikant sænkning af det intraokulære tryk kan opretholdes i perioder på over 24 timer med en enkelt dosis.
English: Patients must be instructed to remove contact lenses prior to application of IZBA and wait 15 minutes after instillation of the dose before reinsertion.
Danish: Patienterne skal instrueres om at fjerne kontaktlinserne før applikation af IZBA og vente 15 minutter efter instillation af dosis, før linserne sættes på igen.
English: IZBA may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes.
Danish: IZBA kan gradvist ændre øjenfarven ved at øge antallet af melanosomer (pigmentgranula) i melanocytterne.
English: Patients received either travoprost 0.004% once daily or timolol 0.5% (or 0.25% for subjects younger than 3 years old) twice daily.
Danish: Patienterne fik enten travoprost 0,004% én gang dagligt eller timolol 0,5% (eller 0,25% til patienter under 3 år) to gange dagligt.
English: IZBA should therefore be used with caution in patients with active intraocular inflammation.
Danish: IZBA bør derfor anvendes med forsigtighed hos patienter med aktiv intraokulær inflammation.
English: • Close the bottle cap firmly immediately after use.
Danish: • Luk flasken omhyggeligt straks efter brug.
English: Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may become more brownish.
Danish: Det typiske billede er, at den brune pigmentering rundt om pupillen spredes koncentrisk mod periferien af det berørte øje, men hele iris eller dele af den kan blive mere brunligt.
English: After discontinuation of therapy, no further increase in brown iris pigment has been observed.
Danish: Efter seponering af behandlingen er der ikke observeret nogen yderligere forøgelse af den brune pigmentering.
English: In the unlikely event of coming in contact with a substantial portion of the contents of the bottle, thoroughly cleanse the exposed area immediately.
Danish: I det usandsynlige tilfælde, at en betydelig del af flaskens indhold kommer i kontakt med huden, skal det eksponerede område straks skylles.
English: In a similar 3-month study in adult patients, these events occurred at an incidence of 11.4% and 0%, respectively.
Danish: I et tilsvarende 3 måneders studie hos voksne patienter forekom disse bivirkninger med en hyppighed på henholdsvis 11,4% og 0%.
English: If a dose is missed, treatment should be continued with the next dose as planned.
Danish: Hvis en dosis springes over, skal behandlingen genoptages med næste dosis i henhold til planen.
English: Polyquaternium-1
Danish: Polyquaternium-1 (polyquaternium-1)
English: It is absorbed through the cornea where the isopropyl ester is hydrolysed to the active free acid.
Danish: Det absorberes via cornea, hvor isopropylesteren hydrolyseres til den aktive frie syre.
English: • Hold the bottle, pointing down, between your thumb and fingers.
Danish: • Hold flasken med bunden i vejret mellem din tommelfinger og de andre fingre.
English: • IZBA may gradually change the colour of your iris (the coloured part of your eye).
Danish: • IZBA kan gradvist ændre din irisfarve (den farvede del af dine øjne).
English: IZBA has not been specifically studied in a clinical trial involving paediatric subjects.
Danish: IZBA er ikke undersøgt specifikt i et klinisk forsøg, der omfattede pædiatriske patienter.
English: Reproduction toxicity studies have been undertaken in rat, mice and rabbit by systemic route.
Danish: Reproduktions-toksicitetsstudier er blevet udført på rotter, mus og kaniner ved systemisk administration.
English: Pack sizes: 1 or 3 bottles.
Danish: Pakningsstørrelse: 1 eller 3 flasker.
English: IZBA may gradually change eyelashes in the treated eye(s); these changes were observed in about half of the patients in clinical trials and include: increased length, thickness, pigmentation, and/or number of lashes.
Danish: IZBA kan gradvist ændre øjenvipperne på de(t) behandlede øje/ne; disse forandringer er observeret hos cirka halvdelen af patienterne i de kliniske forsøg og omfatter: Øget længde, tykkelse, pigmentering, og/eller antal af øjenvipper.
English: IZBA is used to reduce high pressure in the eye in adults, adolescents and children from 3 years old onward.
Danish: IZBA anvendes til at sænke forhøjet tryk i øjet hos voksne, unge og børn fra 3 år og derover.
English: IZBA has no or negligible influence on the ability to drive and use machines.
Danish: IZBA påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The change in eye colour has predominantly been seen in patients with mixed coloured irides, i.e., blue-brown, grey-brown, yellow-brown and green-brown; however, it has also been observed in patients with brown eyes.
Danish: Ændringen i øjenfarve har været dominerende hos patienter med blandet øjenfarve, f.eks. blå-brun, grå-brun, gul-brun og grøn-brun, men er også blevet observeret hos patienter med brune øjne.
English: • Immediately before using a bottle for the first time, tear open the overwrap pouch, take the bottle out (picture 1) and write the date of opening on the carton in the space provided.
Danish: • Umiddelbart før du bruger flasken første gang, skal du fjerne beskyttelsesfolien og tage flasken ud (billede 1), samt skrive åbningsdatoen, hvor der er gjort plads til det på etiketten.
English: Low levels of radioactivity were measured in amniotic fluid and foetal tissues of pregnant rats administered
Danish: Lave niveauer af radioaktivitet blev målt i amnionvæske og føtalt væv fra gravide rotter, som havde fået indgivet
English: One drop in the affected eye or eyes, once a day in the evening.
Danish: 1 dråbe i det/de pågældende øje/øjne, én gang dagligt - om aftenen.
English: Talk to your doctor or pharmacist before using IZBA.
Danish: Kontakt lægen eller apotekspersonalet, før du bruger IZBA.
English: Mannitol (E421)
Danish: Mannitol (E421) (mannitolum)
English: Metabolism is the major route of elimination of both travoprost and the active free acid.
Danish: Metabolisme er den dominerede eliminationsvej for både travoprost og den aktive frie syre.
English: The mean reduction from baseline in IOP ranged from 7.1 to 8.2 mmHg as summarised in Table 3.
Danish: Mean reduktionen fra baseline i IOP varierede fra 7,1 til 8,2 mmHg, som anført i Tabel 3.
English: Increased palpebral fissure observed in monkeys were not seen in rabbits or in the clinical trials with travoprost products and is considered to be species specific.
Danish: Den øgede forekomst af palpebral fissur, som blev observeret hos aber, blev ikke observeret hos kaniner eller i kliniske forsøg med travoprost-produkter, og anses for at være artsspecifik.
English: You must throw away the bottle 4 weeks after you first opened it, to prevent infections, and use a new bottle.
Danish: Flasken skal smides ud 4 uger efter, at den er åbnet første gang, for at forhindre, at du får en øjeninfektion.
English: • After using IZBA, keep the eyelid closed, apply gentle pressure by pressing a finger into the corner of the eye, by the nose (picture 4) for at least 1 minute.
Danish: • Efter at have dryppet med IZBA, skal øjenlåget holdes lukket, og du trykke en finger mod øjenkrogen ind mod næsen (billede 4) i mindst 1 minut.
English: EXP Discard 4 weeks after first opening
Danish: EXP Kasseres 4 uger efter åbning.
English: It should be noted that travoprost is considered a PBT substance (see section 5.3).
Danish: Det bør bemærkes at travoprost anses for at være et PBT-stof (se pkt.
English: There are no data on the effects of travoprost on human fertility.
Danish: Der er ingen eller utilstrækkelige data vedrørende travoprosts virkning på human fertilitet.
English: The most frequent adverse reactions reported in the paediatric population were ocular hyperaemia (16.9%) and growth of eyelashes (6.5%).
Danish: De hyppigste indberettede bivirkninger hos den pædiatriske population var okulær hyperæmi (16,9%) og vækst af øjenvipper (6,5%).
English: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines.
Danish: Midlertidigt sløret syn eller andre synsforstyrrelser kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Topical ocular administration of travoprost to monkeys at concentrations of up to 0.012% to the right eye, twice daily for one year resulted in no systemic toxicity.
Danish: Topisk okulær administration af travoprost til aber i koncentrationer op til 0,012% i højre øje 2 gange dagligt i et år resulterede ikke i nogen systemisk toksicitet.
English: Not known asthma aggravated, epistaxis
Danish: Ikke kendt forværret astma, epistaxis
English: IOP reductions for this group were based on only 6 patients in the timolol group and 9 patients in the travoprost group where 4 patients in the travoprost group versus 0 patients in the timolol group had no relevant mean IOP reduction at Week 12.
Danish: IOP-reduktionerne for denne gruppe var baseret på kun 6 patienter i timolol-gruppen og 9 patienter i travoprost-gruppen, hvor 4 patienter i travoprost-gruppen og 0 patienter i timololgruppen ikke havde nogen relevant gennemsnitlig reduktion i IOP ved uge 12.
English: It is unknown whether travoprost from eye drops is excreted in human breast milk.
Danish: Det er ukendt, om travoprost i øjendråber udskilles i human mælk.
English: Aqueous humour concentrations declined with a half-life of approximately 1.5 hours.
Danish: Koncentrationen i kammervandet falder med en halveringstid på cirka 1,5 timer.
English: IZBA may get into your milk.
Danish: IZBA kan gå over i modermælken.
English: This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
Danish: Det kan reducere den systemiske absorption af lægemidler givet i øjet og resultere i færre systemiske bivirkninger.
English: If IZBA is swallowed, consult your doctor or pharmacist immediately.
Danish: Hvis IZBA bliver slugt, så kontakt straks din læge eller apoteket.
English: If you or your child are using other eye preparations such as eye drop or eye ointment, wait for at least 5 minutes between putting in IZBA and the other eye preparations.
Danish: Hvis du eller dit barn bruger andre øjenlægemidler, herunder øjendråber eller øjensalver, skal der gå mindst 5 minutter mellem brug af IZBA og de andre øjenlægemidler.
English: Not known depression, anxiety, insomnia
Danish: Ikke kendt depression, angst, insomni
English: 95% CI *One subject had missing data at 8 AM at Week 6; one had missing data at 4 PM at Month 3.
Danish: 95% CI *En forsøgsperson havde manglende data for kl. 8.00 for uge 6.
English: Women of childbearing potential/contraception
Danish: Kvinder i den fødedygtige alder/prævention
English: Animal studies have shown excretion of travoprost and metabolites in breast milk.
Danish: Dyrestudier har vist, at travoprost og metabolitter udskilles i mælk.
English: Prostaglandins and prostaglandin analogues are biologically active materials that may be absorbed through the skin.
Danish: Prostaglandiner og prostaglandinanaloger er biologisk aktive stoffer, som kan absorberes gennem huden.