FrancophonIA/ELRC3.0 huggingface dataset:
English: Comparable efficacy of the gel formulation to the tablet formulation was shown for dogs in a clinical trial.
Danish: I en sammenlignende klinisk undersøgelse hos hunde havde Ibaflin som gel samme virkning som tabletterne.
English: Strength Pharmaceutical Form
Danish: Intramuskulær anvendelse
English: Treatment should be continued long-term.
Danish: Behandlingen bør forløbe over lang tid.
English: These effects are usually mild or moderate and do not last.
Danish: Disse virkninger er normalt milde og moderate og varer ikke ved.
English: At the start of the study patients in both groups had an average score of 10.
Danish: I starten af undersøgelsen havde patienterne i begge grupper et midlertidigt målingsresultat på 10.
English: This is a summary of the European public assessment report (EPAR) for Cystadrops.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cystadrops.
English: The score ranges from 0 to 28, with 0 corresponding to no crystals.
Danish: Målingsværdierne går fra 0 til 28, hvor 0 svarer til ingen krystaller.
English: Regarding safety, although side effects related to the eye are very common, they are usually manageable.
Danish: Hvad angår sikkerhed optræder der ofte bivirkninger i relation til øjet, men de er normalt håndterbare.
English: The doctor may decrease the dose progressively to 1 drop a day depending on the results of eye examinations.
Danish: Lægen kan nedsætte dosis progressivt til 1 daglig dråbe, afhængigt af resultaterne af øjenundersøgelserne.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cystadrops'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 Cystadrops opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Because the number of patients with cystinosis is low, the disease is considered ‘rare', and Cystadrops was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 November 2008.
Danish: Da antallet af patienter med cystinose er lavt, betragtes sygdommen som "sjælden", og Cystadrops blev udpeget som "lægemiddel til sjældne sygdomme" den 7. november 2008.
English: The medicine also improved other symptoms of cystinosis such as photophobia.
Danish: Lægemidlet har også forbedret andre symptomer på cystinose såsom fotofobi.
English: Cystadrops contains the active substance mercaptamine (also known as cysteamine).
Danish: Cystadrops indeholder det aktive stof mercaptamin (også kendt som cysteamin).
English: The most common side effects with Cystadrops (which may affect more than 1 in 10 people) are related to the eye and include pain, itching and irritation in the eye, increased lacrimation (watering eyes), blurred vision and ocular hyperaemia (red eye).
Danish: De hyppigste bivirkninger ved Cystadrops (som kan forekomme hos mere end 1 ud af 10 personer) vedrører øjet og omfatter smerter, kløe og irritation i øjet, øget tåreproduktion, slørret syn og okulær hyperæmi (røde øjne).
English: What measures are being taken to ensure the safe and effective use of Cystadrops?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cystadrops?
English: Treatment with Cystadrops also led to reductions in photophobia (eye discomfort in bright light).
Danish: Behandling med Cystadrops førte også til reduktioner i fotofobi (ubehag i øjnene ved stærkt lys)
English: The full EPAR for Cystadrops can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Cystadrops findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Cystadrops
Danish: Andre oplysninger om Cystadrops
English: The recommended dose is 1 drop in each eye 4 times a day during waking hours.
Danish: Den anbefalede dosis er en dråbe i hvert øje 4 gange dagligt i patientens vågenperiode.
English: What is Cystadrops and what is it used for?
Danish: Hvad er Cystadrops, og hvad anvendes det til?
English: Cystadrops mercaptamine
Danish: Cystadrops mercaptamin
English: The active substance in Cystadrops, mercaptamine, reacts with cystine to dissolve it and to form substances that can be removed from the cells.
Danish: Det aktive stof i Cystadrops, mercaptamin, reagerer med og opløser cystin og danner stoffer, der kan fjernes fra cellerne.
English: It is not intended to provide practical advice on how to use Cystadrops.
Danish: Det er ikke en praktisk vejledning i, hvordan Cystadrops bør anvendes.
English: For more information about treatment with Cystadrops, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cystadrops, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Cystadrops can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Cystadrops findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: Cystinosis is an inherited disease where a natural substance called cystine builds up in the body forming damaging crystals, particularly in the kidneys and cornea (the transparent layer in front of the eye).
Danish: Cystinose er en arvelig sygdom, hvor et naturligt stof kaldet cystin hober sig op i kroppen, hvilket forårsager, at der dannes skadelige krystaller i nyrerne og hornhinden (den gennemsigtige hinde, der dækker det forreste af øjet).
English: Cystadrops can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in the management of cystinosis.
Danish: Cystadrops udleveres kun efter recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af cystinose.
English: Why is Cystadrops approved?
Danish: Hvorfor blev Cystadrops godkendt?
English: Cystadrops has been compared with another less concentrated mercaptamine eye drop solution in one main study involving 32 patients from 2 years of age with cystinosis.
Danish: Cystadrops er blevet sammenlignet med en mindre koncentreret mercaptamin-øjendråbeopløsning i en hovedundersøgelse, hvori der deltog 32 patienter fra 2 år med cystinose.
English: Mercaptamine eye drop solutions made up locally in pharmacies or hospitals have been used for many years for the management of eye symptoms of cystinosis.
Danish: Øjendråbeopløsninger med mercaptamin, som blandes lokalt på apoteker og hospitaler, er blevet anvendt i mange år til behandling af øjensymptomer på cystinose.
English: What are the risks associated with Cystadrops?
Danish: Hvilke risici er der forbundet med Cystadrops?
English: The main measure of effectiveness was based on the reduction in corneal cystine crystals as seen under the microscope and quantified using a score called the IVCM score.
Danish: Behandlingens virkning blev hovedsagelig bedømt på mindskelsen af krystalaflejringer i hornhinden ved mikroskopi og med kvantificering ved hjælp af en målingsværdi kaldet IVCM-score.
English: Cystadrops is an eye medicine used in patients from 2 years of age who have cystinosis.
Danish: Cystadrops er øjenmedicin, som anvendes til patienter fra 2 år med cystinose.
English: For the full list of all side effects and restrictions with Cystadrops, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger ved Cystadrops fremgår af indlægssedlen.
English: For practical information about using Cystadrops, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Cystadrops, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In addition, Cystadrops has been shown in a study to be effective at decreasing corneal cystine crystals.
Danish: Desuden har Cystadrops i en undersøgelse vist sig at være effektivt til at mindske cystinkrystaller i hornhinden.
English: Cystadrops is used to reduce the build-up of cystine crystals in the cornea.
Danish: Cystadrops anvendes til at mindske ophobningen af cystinkrystaller i hornhinden.
English: When it is applied to the eye, the amount of cystine in the cells of the cornea decreases, limiting damage to the eye.
Danish: Ved lægemidlets kontakt med øjet reduceres mængden af cystin i hornhindens celler og begrænser herved øjenbeskadigelsen.
English: Cystadrops is available as eye drops.
Danish: Cystadrops fås som øjendråber.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cystadrops have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Cystadrops.
English: How is Cystadrops used?
Danish: Hvordan anvendes Cystadrops?
English: What benefits of Cystadrops have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Cystadrops?
English: How does Cystadrops work?
Danish: Hvordan virker Cystadrops?
English: Cystadrops was shown to be more effective than the comparator at decreasing corneal cystine crystals after 3 months of treatment: in patients using Cystadrops the IVCM score decreased by 4.6 points compared with a decrease of 0.5 points in patients using the comparator.
Danish: Hos patienter, der anvendte Cystadrops, faldt IVCM-scoren med 4,6 point sammenlignet med et fald på 0,5 point hos patienter, der anvendte sammenligningslægemidlet.
English: Damage from the build-up of cystine crystals inside the cells of the cornea can cause serious vision problems.
Danish: Dannelsen af cystinkrystaller i hornhindecellerne kan beskadige øjet og forårsage alvorlige synsforstyrrelser.
English: It is available as tablets (50 and 150 mg).
Danish: Det leveres som tabletter (50 og 150 mg).
English: Ibandronic Acid Teva EMA/357446/2015
Danish: Ibandronsyre Teva EMA/357446/2015
English: The full EPAR for Ibandronic Acid Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Ibandronsyre Teva findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Patients should also take vitamin D and calcium supplements if they do not get enough from their diet.
Danish: Patienten bør desuden tage et tilskud af vitamin D og calcium, hvis kosten ikke indeholder tilstrækkeligt heraf.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ibandronic Acid Teva on 17 September 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ibandronsyre Teva den 17. september 2010.
English: This means that Ibandronic Acid Teva is similar to a ‘reference medicine' already authorised in the European Union (EU).
Danish: Det betyder, at Ibandronsyre Teva er identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU).
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 Ibandronic Acid Teva.
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 Ibandronsyre Teva skal anvendes.
English: For more information about treatment with Ibandronic Acid Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ibandronsyre Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Ibandronic Acid Teva must be taken with a full glass of plain water (but not mineral water) while standing or sitting up, and the tablets should not be chewed, sucked or crushed.
Danish: Ibandronsyre Teva skal indtages sammen med et helt glas almindeligt vand (ikke mineralvand), mens patienten står eller sidder op, og tabletterne bør ikke tygges, suttes eller knuses.
English: The tablet must always be taken after an overnight fast, one hour before any food or drink except for water.
Danish: Tabletten skal altid tages efter at have fastet hele natten, en time før indtagelse af nogen form for mad og drikke, dog undtagen vand.
English: For the prevention of skeletal events, one 50-mg tablet is taken once a day.
Danish: Til forebyggelse af skeletrelaterede hændelser tages der en tablet a 50 mg dagligt.
English: This is a summary of the European public assessment report (EPAR) for Ibandronic Acid Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ibandronsyre Teva.
English: For treating osteoporosis, one 150-mg tablet is taken once a month.
Danish: Til behandling af osteoporose tages der en tablet a 150 mg en gang om måneden.
English: The CHMP concluded that, in accordance with EU requirements, Ibandronic Acid Teva has been shown to have comparable quality and to be bioequivalent to Bondronat and Bonviva.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Ibandronsyre Teva er af sammenlignelig kvalitet og er bioækvivalent med Bondronat og Bonviva.
English: Ibandronic Acid Teva 50 mg is used to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).
Danish: Ibandronsyre Teva 50 mg anvendes til forebyggelse af "knoglerelaterede hændelser" (knoglebrud eller knoglekomplikationer, der kræver behandling) hos patienter med brystkræft og knoglemetastaser (kræft, der har spredt sig til knoglerne).
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases and in women with osteoporosis.
Danish: Reduktionen af knogletabet bidrager til at mindske sandsynligheden for knoglebrud og medvirker derved til at forebygge knoglebrud hos kræftpatienter med knoglemetastaser og hos kvinder med osteoporose.
English: Ibandronic Acid Teva 150 mg is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures.
Danish: Ibandronsyre Teva 150 mg anvendes til behandling af osteoporose (en sygdom, som gør knoglerne skrøbelige) hos kvinder efter overgangsalderen, som har forhøjet risiko for knoglebrud.
English: Other information about Ibandronic Acid Teva:
Danish: Andre oplysninger om Ibandronsyre Teva:
English: Because Ibandronic Acid Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicines.
Danish: Da Ibandronsyre Teva er et generisk lægemiddel, har personundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlerne.
English: What are the benefits and risks of Ibandronic Acid Teva?
Danish: Hvilke fordele og risici er der forbundet med Ibandronsyre Teva?
English: The reference medicines for Ibandronic Acid Teva are Bondronat and Bonviva.
Danish: Referencelægemidlerne for Ibandronsyre Teva er Bondronat og Bonviva.
English: The active substance in Ibandronic Acid Teva, ibandronic acid, is a bisphosphonate.
Danish: Det aktive stof i Ibandronsyre Teva, ibandronsyre, er et bisphosphonat.
English: Ibandronic Acid Teva is a medicine that contains the active substance ibandronic acid.
Danish: Ibandronsyre Teva er et lægemiddel, der indeholder det aktive stof ibandronsyre.
English: Because Ibandronic Acid Teva is a generic medicine and is bioequivalent to the reference medicines, its benefits and risks are taken as being the same as the reference medicines's.
Danish: Da Ibandronsyre Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlerne, anses benefit/risk-forholdet for at være det samme som for referencelægemidlerne.
English: Ibandronic Acid Teva is a ‘generic medicine'.
Danish: Ibandronsyre Teva er et "generisk lægemiddel".
English: The Committee recommended that Ibandronic Acid Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Ibandronsyre Teva.
English: Therefore, the CHMP's view was that, as for Bondronat and Bonviva, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Bondronat og Bonviva.
English: Why has Ibandronic Acid Teva been approved?
Danish: Hvorfor blev Ibandronsyre Teva godkendt?
English: Ibandronic Acid Teva ibandronic acid
Danish: Ibandronsyre Teva ibandronsyre
English: How has Ibandronic Acid Teva been studied?
Danish: Hvordan blev Ibandronsyre Teva undersøgt?
English: What is Ibandronic Acid Teva?
Danish: Hvad er Ibandronsyre Teva?
English: What is Ibandronic Acid Teva used for?
Danish: Hvad anvendes Ibandronsyre Teva til?
English: How is Ibandronic Acid Teva used?
Danish: Hvordan anvendes Ibandronsyre Teva?
English: How does Ibandronic Acid Teva work?
Danish: Hvordan virker Ibandronsyre Teva?
English: The following studies are the most important.
Danish: Følgende studier er de vigtigste:
English: The reason for this is not known.
Danish: Årsagen hertil er ikke kendt.
English: In some cases fatalities have been observed.
Danish: I nogle tilfælde er der observeret dødsfald.
English: This was consistent with the observations in animal studies.
Danish: Dette var i overensstemmelse med observationerne i dyrestudier.
English: To be taken with food.
Danish: Skal indtages sammen med mad.
English: Take this medicine one or two times a day every day with food.
Danish: Du skal tage denne medicin en eller to gange dagligt sammen med mad.
English: In some patients additional factor VIII was given.
Danish: Hos nogle patienter blev i tillæg givet faktor VIII.
English: ~3 to 5
Danish: ~3 til 5
English: The possibility of medicinal product interaction cannot be excluded.
Danish: Muligheden for lægemiddelinteraktion kan ikke udelukkes.
English: AUC12 or 24
Danish: AUC12 eller 24
English: There are some other medicines that can only be used under certain circumstances as described below.
Danish: Der er visse andre lægemidler, der kun må anvendes under særlige omstændigheder som beskrevet nedenfor.
English: • bad taste in the mouth
Danish: • dårlig smag i munden
English: • difficulty paying attention
Danish: • svært ved at fastholde opmærksomheden
English: Therefore, an alternative, effective and safe method of contraception should be used during treatment.
Danish: Derfor bør der anvendes en alternativ, effektiv og sikker kontraceptionsmetode under behandling.
English: If you think you are pregnant or you are planning to become pregnant, it is very important that you discuss this with your doctor.
Danish: Hvis du tror, du er gravid, eller hvis du planlægger at blive gravid, er det meget vigtigt, at du drøfter dette med din læge.
English: Appropriate doses for this combination, with respect to efficacy and safety, have not been established.
Danish: Passende doser for denne kombination med hensyn til virkning og sikkerhed er ikke blevet fastslået.
English: Symptoms of infection - inform your doctor immediately.
Danish: Symptomer på infektion - informér omgående din læge.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you or your child.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger for dig eller dit barn.
English: Therefore concomitant use is not recommended.
Danish: Samtidig brug anbefales derfor ikke.
English: Open date: __________
Danish: Anbrudsdato: __________
English: Tell your doctor as soon as possible if this applies to you.
Danish: Fortæl det til lægen hurtigst muligt, hvis dette gør sig gældende for dig.
English: ND: Not determined.
Danish: ND: Ikke fastsat.
English: Dose alterations should not be necessary.
Danish: Dosisændring skulle ikke være nødvendig.
English: Component of a multipack can't be sold separately.
Danish: En del af en multipakning, må ikke sælges separat.
English: Digoxin (heart medicine).
Danish: Digoxin (hjertemedicin).
English: • diarrhoea (may be severe)
Danish: • diarré (kan være alvorlig)
English: Effects of food on oral absorption
Danish: Virkning af føde på oral absorption
English: Other forms of this medicine may be more appropriate for children who have difficulty swallowing tablets.
Danish: Andre former af denne medicin kan være mere passende for børn, der har svært ved at sluge tabletter.
English: If you miss a dose, take the missed dose as soon as possible.
Danish: Hvis du glemmer en dosis, skal du tage den glemte dosis så hurtigt som muligt.
English: Your doctor will discuss with you the best combination of medicines for you.
Danish: Din læge vil drøfte med dig, hvilken kombination af lægemidler, der er bedst for dig.
English: Children (2 - 12 years of age) will start with a dose smaller than this and continue up to the maximum allowed for their size.
Danish: Børn (2-12 år) starter med en lavere dosis og fortsætter op til den maksimalt tilladte dosis for deres størrelse.
English: Currently, there are no data specific to this patient population and therefore specific dosage recommendations cannot be made.
Danish: Der foreligger ingen specifikke data for denne patientgruppe, og der kan derfor ikke gives konkrete anbefalinger vedrørende dosering.
English: During episodes of diarrhoea your doctor may decide that extra monitoring is needed.
Danish: I perioder med diarré kan din læge beslutte, at ekstra kontrol er nødvendig.
English: These effects are thought to represent induction of bupropion metabolism.
Danish: Disse effekter menes at repræsentere induktion af bupropion metabolisme.
English: Do not use this medicine after the expiry date on the carton or bottle label after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen eller beholderen efter ”EXP”.
English: 1 Based on parallel group comparison.
Danish: Baseret på en parallelgruppesammenligning.
English: Accumulation of other mutations in the protease gene (including at positions 20, 33, 36, 46, 54, 71, and 90) can also contribute to ritonavir resistance.
Danish: Akkumulation af andre mutationer i proteasegenet (bl.a. ved positionerne 20, 33, 36, 46, 54, 71 og 90) kan også bidrage til resistens over for ritonavir.
English: In more than a half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
Danish: I mere end halvdelen af de rapporterede tilfælde blev behandlingen med proteasehæmmere fortsat eller genoptaget, hvis behandlingen var blevet seponeret.
English: Extra monitoring is recommended when diarrhoea occurs.
Danish: Supplerende overvågning anbefales i tilfælde af diarré.
English: Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Danish: Dosisjustering af midazolam bør overvejes, specielt hvis der administreres mere end en enkeltdosis midazolam.
English: Note: ritonavir was dosed after a meal for all listed regimens.
Danish: Bemærk: ritonavir blev doseret efter et måltid for alle anførte regimer.