FrancophonIA/ELRC3.0 huggingface dataset:
English: As there has been some data showing an increased risk of heart attack with Osseor, the decision to prescribe Osseor should take into account the patient's individual heart risk.
Danish: Da der er nogle data, som viser, at der er en forhøjet risiko for hjerteanfald forbundet med Osseor, bør der tages højde for den enkelte patients risiko for hjerteproblemer, inden der træffes beslutning om at ordinere Osseor.
English: Osseor has also been compared with placebo in a main study involving 261 male patients at increased risk of having a broken bone.
Danish: Osseor blev også sammenlignet med placebo i en hovedundersøgelse af 261 mandlige patienter med forhøjet risiko for knoglebrud.
English: Osteoporosis is also observed in men due to gradual bone loss with ageing.
Danish: Osteoporose forekommer også hos mænd på grund af gradvis tab af knoglemasse med alderen.
English: In the first study, this was based on the number of patients who, over three years, developed a new break in the spine, and in the second study, it was based on the number of patients who had a new break due to osteoporosis at any site other than the spine.
Danish: I den første undersøgelse blev dette bedømt på, hvor stort et antal patienter, der i løbet af tre år fik et nyt brud på rygsøjlen, og i den anden undersøgelse på, hvor mange patienter, der fik et nyt knoglebrud på grund af osteoporose ethvert andet sted end på rygsøjlen.
English: What is Osseor?
Danish: Hvad er Osseor?
English: • cerebrovascular disease (diseases affecting the blood vessels in the brain, such as stroke).
Danish: • cerebrovaskulære sygdomme (sygdomme, der påvirker blodforsyningen til hjernen, såsom slagtilfælde).
English: The active substance in Osseor, strontium ranelate, acts on the bone structure.
Danish: Det aktive stof i Osseor, strontiumranelat, indvirker på knoglernes struktur.
English: Osseor is used to treat severe osteoporosis (a disease that makes bones fragile) in post-menopausal women and men who have a high risk of fracture and cannot be treated with other medicines approved for osteoporosis.
Danish: Osseor anvendes til behandling af svær osteoporose (knogleskørhed) hos kvinder efter overgangsalderen og mænd, som har forhøjet risiko for brud og ikke kan behandles med andre lægemidler til behandling af osteoporose.
English: In both studies, Osseor was compared with placebo (a dummy treatment) and the main measure of effectiveness was the reduction in the risk of a new bone break with Osseor.
Danish: I begge undersøgelser blev Osseor sammenlignet med placebo (en virkningsløs behandling), og virkningen blev hovedsagelig bedømt på risikoen for et nyt knoglebrud med Osseor.
English: In postmenopausal women, Osseor reduces the risk of vertebral and hip fractures.
Danish: Hos kvinder efter overgangsalderen mindsker Osseor risikoen for knoglebrud i rygsøjlen og hoften.
English: Exactly how strontium works in osteoporosis is not fully understood, but it is known to stimulate bone formation and reduce bone breakdown.
Danish: Strontiums virkningsmekanisme kendes ikke helt, men det fremmer knogledannelsen og mindsker knoglenedbrydningen.
English: Once in the gut, strontium ranelate releases strontium, which is absorbed into the bone.
Danish: I tarmen frigiver strontiumranelat strontium, der optages i knoglerne.
English: What is Osseor used for?
Danish: Hvad anvendes Osseor til?
English: For the full list of all side effects reported with Osseor, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Osseor fremgår af indlægssedlen.
English: How has Osseor been studied?
Danish: Hvordan blev Osseor undersøgt?
English: What benefit has Osseor shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Osseor?
English: In the study in male patients, the bone density in the lower part of the spine increased by 7% after one year of treatment in patients taking Osseor, compared with an increase of 1.7% in patients taking placebo.
Danish: Undersøgelsen af mandlige patienter viste, at hos de patienter, der tog Osseor, blev knogletætheden i den nederste del af rygsøjlen forøget med 7 % efter et års behandling.
English: EPAR summary for the public strontium ranelate
Danish: EPAR - sammendrag for offentligheden
English: How is Osseor used?
Danish: Hvordan anvendes Osseor?
English: How does Osseor work?
Danish: Hvordan virker Osseor?
English: MA (EU) number (Invented) name
Danish: MF (EU)-nummer (Særnavn)navn Styrke
English: Member state
Danish: Medlemss tat
English: Active substance + Strength
Danish: Lægemidlets navn i kortform Aktivt stof og styrke
English: Germany Symbiopharm Gmbh
Danish: Tyskland Symbiopharm GmbH
English: Austria Symbiopharm Gmbh
Danish: Østrig Symbiopharm GmbH
English: Hungary Symbiopharm Gmbh
Danish: Ungarn Symbiopharm GmbH
English: Marketing Authorisation Holder Short name of the Medicinal Product
Danish: Indehaver af markedsføringstilladelse
English: The frequency of such re-activation appears to be low.
Danish: Forekomsten af reaktivering ser ud til at være lav.
English: More information on these medicines can be found on EMA's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere oplysninger om disse lægemidler findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The review of direct-acting antivirals for the treatment of hepatitis C was initiated on 17 March 2016 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Danish: Gennemgangen af direkte virkende antivirale lægemidler til behandling af hepatitis C blev indledt den 17. marts 2016 på anmodning af Europa-Kommissionen i medfør af artikel 20 i forordning (EF) nr. 726/2004.
English: You may also receive treatment for hepatitis B.
Danish: Du kan også få behandling for hepatitis B.
English: 2 Around 30 cases of hepatitis B re-activation have been reported to date among the many thousands of patients treated.
Danish: 2 Omkring 30 tilfælde af hepatitis B-reaktivering er blevet indberettet til dato blandt de mange tusinder af behandlede patienter.
English: Re-activation of hepatitis B may cause serious liver problems.
Danish: Reaktivering af hepatitis B kan forårsage alvorlige leverproblemer.
English: The CHMP's opinion was passed to the European Commission, which issued a legally binding decision valid throughout the EU.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som vedtog en retligt bindende beslutning med gyldighed i hele EU.
English: On 14 April 2016 the scope of the review was extended to include the risk of liver cancer, in addition to the potential risk of hepatitis B re-activation.
Danish: Den 14. april 2016 blev gennemgangen udvidet til også at omfatte risikoen for leverkræft ud over risikoen for hepatitis B-reaktivering.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 23/2/2017.
Danish: CHMP's udtalelse blev fremsendt til Europa-Kommissionen, som traf en endelig juridisk bindende beslutning med gyldighed i alle EU-medlemsstater den 23. februar 2017.
English: The review of direct-acting antivirals was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: Gennemgangen af direkte virkende antivirale lægemidler blev foretaget af EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC).
English: Further studies needed to assess risk of liver cancer with these medicines
Danish: Der er behov for yderligere undersøgelser for at vurdere risikoen for leverkræft ved brug af disse lægemidler
English: Direct-acting antivirals work by blocking the action of proteins which are essential for making new hepatitis C viruses.
Danish: Direkte virkende antivirale lægemidler virker ved at blokere aktiviteten af proteiner, der er afgørende for dannelsen af nye hepatitis C-vira.
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Danish: Gennemgangen blev foretaget af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC), der har ansvaret for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som fremsatte et sæt anbefalinger.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 February 2017 EMA/141732/2017
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23.
English: The PRAC recommendation to include a warning in the prescribing information about hepatitis B reactivation and how to minimise it was endorsed by EMA's Committee for Medicinal Products for Human Use (CHMP).
Danish: PRAC's anbefaling om at indføje en advarsel om hepatitis B-reaktivering i ordinationsoplysningerne og anvisninger i, hvordan man kan minimere risikoen, blev støttet af EMA's Udvalg for Lægemidler til Mennesker (CHMP).
English: Companies marketing these medicines have been asked to perform a prospective study to assess the risk of recurrence of previously treated hepatocellular carcinoma, and a prospective cohort study in patients with cirrhosis to assess the incidence and type of de novo hepatocellular carcinoma.
Danish: De virksomheder, der markedsfører disse lægemidler, er blevet bedt om at gennemføre en prospektiv undersøgelse med henblik på at vurdere risikoen for recidiv af tidligere behandlet hepatocellulært karcinom og en prospektiv kohorteundersøgelse af patienter med cirrose for at vurdere forekomsten og typen af de novo-hepatocellulært karcinom.
English: • If you have both hepatitis B and C virus infections, your doctor will monitor you closely during and after treatment with direct-acting antivirals.
Danish: • Hvis du både har hepatitis B- og hepatitis C, vil din læge overvåge dig nøje under og efter behandlingen med direkte virkende antivirale lægemidler.
English: In addition to data on hepatitis B re-activation, EMA also reviewed data suggesting that patients treated with direct-acting antivirals who have previously been treated for liver cancer could be at risk of their cancer returning early.
Danish: Ud over data om hepatitis B-reaktivering gennemgik EMA også data, der indikerer, at patienter, der behandles med direkte virkende antivirale lægemidler, og som tidligere er blevet behandlet for leverkræft, kan have en risiko for, at et eventuelt tilbagefald af kræften fremskyndes.
English: These measures aim to minimise the risk of hepatitis B re-activation with direct-acting antivirals.
Danish: Disse foranstaltninger har til formål at minimere risikoen for hepatitis B-reaktivering ved behandling med direkte virkende antivirale lægemidler.
English: • You will be tested for hepatitis B before starting treatment with direct-acting antivirals to check if you might be at risk of hepatitis B reactivation.
Danish: • Du vil blive testet for hepatitis B før påbegyndelse af behandlingen med direkte virkende antivirale lægemidler for at tjekke, om du har risiko for reaktivering af hepatitis B.
English: On 15 December 2016, the European Medicines Agency (EMA) confirmed its recommendation to screen all patients for hepatitis B before starting treatment with direct-acting antivirals for hepatitis C; patients infected with both hepatitis B and C viruses must be monitored and managed according to current clinical guidelines.
Danish: EMA bekræftede den 15. december 2016 sin anbefaling om at screene alle patienter for hepatitis B inden påbegyndelse af behandling med direkte virkende antivirale lægemidler mod hepatitis C; patienter, der er smittet med både hepatitis B og hepatitis C, skal overvåges og behandles i overensstemmelse med gældende kliniske retningslinjer.
English: The CHMP agreed that companies should carry out a study to evaluate the risk of liver cancer returning with direct-acting antivirals.
Danish: CHMP konkluderede, at lægemiddelvirksomhederne skal gennemføre en undersøgelse af risikoen for tilbagefald af leverkræft ved behandling med direkte virkende antivirale lægemidler.
English: • Direct-acting antiviral medicines (including Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax) are effective treatments for long-term hepatitis C that can be used without interferons (medicines known to have troublesome side effects).
Danish: • Direkte virkende antivirale lægemidler (herunder Daklinza, Exviera, Harvoni, Olysio, Sovaldi og Viekirax) er effektive behandlinger for langvarig hepatitis C, som kan anvendes uden interferoner (lægemidler, der kan have generende bivirkninger).
English: • Therapeutic guidelines recommend that, in patients with advanced fibrosis and cirrhosis, surveillance for hepatocellular carcinoma should continue even after sustained viral response has been achieved.
Danish: • De terapeutiske retningslinjer anbefaler, at overvågningen for hepatocellulært karcinom bør fortsætte hos patienter med fremskreden fibrose og cirrose, selv efter at der er opnået vedvarende viralt respons.
English: In this context, further research is also needed on the risk of new liver cancers in patients with chronic hepatitis C and cirrhosis (liver scarring) that are treated with directacting antivirals.
Danish: I denne forbindelse er der også behov for yderligere forskning i risikoen for ny leverkræft hos patienter med kronisk hepatitis C og cirrose (ardannelse på leveren), der er i behandling med direkte virkende antivirale lægemidler.
English: Direct-acting antivirals (marketed in the EU as Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax)1 are important medicines for treating chronic (long term) hepatitis C, a disease of the liver caused by hepatitis C virus.
Danish: Direkte virkende antivirale midler (der markedsføres i EU som Daklinza, Exviera, Harvoni, Olysio, Sovaldi og Viekirax)1 er vigtige lægemidler til behandling af kronisk (langvarig) hepatitis C, der er en leversygdom forårsaget af hepatitis C-virus.
English: • Further studies are needed to evaluate the risk of recurring or newly diagnosed hepatocellular carcinoma in patients treated with direct-acting antivirals.
Danish: • Der er behov for yderligere undersøgelser af risikoen for recidiv eller ny-diagnosticering af hepatocellulært karcinom hos patienter i behandling med direkte virkende antivirale lægemidler.
English: The review covered the following direct-acting antivirals for treating chronic hepatitis C: Daklinza (daclatasvir), Exviera (dasabuvir), Harvoni (sofosbuvir / ledipasvir), Olysio (simeprevir), Sovaldi
Danish: Gennemgangen omfattede følgende direkte virkende antivirale lægemidler til behandling af kronisk hepatitis C: Daklinza (daclatasvir), Exviera (dasabuvir), Harvoni (sofosbuvir/ledipasvir), Olysio (simeprevir), Sovaldi (sofosbuvir) og Viekirax (ombitasvir/paritaprevir/ritonavir).
English: • If you also have hepatitis B virus infection, direct-acting antivirals for hepatitis C may cause the hepatitis B infection to become active again.
Danish: • Hvis du også har hepatitis B, kan direkte virkende antivirale lægemidler mod hepatitis C få hepatitis B til at blive aktiv igen.
English: • All patients should be screened for hepatitis B before starting treatment with direct-acting antivirals for hepatitis C; patients co-infected with hepatitis B and C must then be monitored and managed according to current clinical guidelines.
Danish: • Alle patienter bør screenes for hepatitis B før påbegyndelse af behandling med direkte virkende antivirale lægemidler mod hepatitis C; patienter, der er smittet med både hepatitis B og hepatitis C, skal overvåges og behandles i overensstemmelse med gældende kliniske retningslinjer.
English: It looked into cases2 of returning signs and symptoms of previously inactive hepatitis B infection (re-activation) when patients were treated with direct-acting antivirals for hepatitis C.
Danish: Udvalget undersøgte en række sager2 om tilbagevenden af tegn og symptomer på tidligere inaktiv hepatitis B-infektion (reaktivering), hvor patienter var blevet behandlet med direkte virkende antivirale lægemidler mod hepatitis C.
English: Since the start of this review, two other direct-acting antivirals, Epclusa (sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir), have been authorised in the EU.
Danish: Efter påbegyndelsen af denne gennemgang er to andre direkte virkende antivirale midler blevet godkendt i EU (Epclusa (sofosbuvir/velpatasvir) og Zepatier (elbasvir/grazoprevir)).
English: • Cases of hepatitis B re-activation (with severe consequences) have been reported in patients coinfected with hepatitis B and C viruses treated with direct-acting antivirals.
Danish: • Der er indberettet tilfælde af hepatitis B-reaktivering (med svære konsekvenser) hos patienter, der har både hepatitis B og hepatitis C, og som bliver behandlet med direkte virkende antivirale lægemidler.
English: The hepatitis B re-activation is thought to be the consequence of the rapid treatment-induced reduction in hepatitis C virus (as co-infection is known to suppress the hepatitis B virus) and the lack of activity of direct-acting antivirals against hepatitis B virus.
Danish: Hepatitis B-reaktivering menes at være en konsekvens af den hurtige behandlingsfremkaldte reduktion af hepatitis C-virus (idet samtidig infektion undertrykker hepatitis B-virus) og manglende aktivitet af direkte virkende antivirale lægemidler mod hepatitis B-virus.
English: Speak to your doctor if you have any question or concern regarding your treatment.
Danish: • Fortæl det til lægen, hvis du har eller tidligere har haft hepatitis B. Kontakt lægen, hvis du har spørgsmål til din behandling eller er i tvivl om noget.
English: • Hepatitis B re-activation is thought to be caused by the rapid treatment-induced reduction in hepatitis C virus (as co-infection is known to suppress the hepatitis B virus) and the lack of antihepatitis B activity of direct-acting antivirals.
Danish: • Hepatitis B-reaktivering menes at skyldes den hurtige behandlingsinducerede reduktion af hepatitis C-virus (idet samtidig infektion undertrykker hepatitis B-virus) og manglende aktivitet af direkte virkende antivirale lægemidler mod hepatitis B.
English: Description and strength
Danish: Beskrivelse og styrke
English: 31 March 2016 EMA/174254/2016
Danish: Den 31. marts 2016 EMA/174254/2016
English: Measures to avoid medication errors with Exjade
Danish: Foranstaltninger til undgåelse af medicineringsfejl med Exjade
English: More information on Exjade, including its indications in full, can be found on the Agency's website: ema.europa.eu/Findmedicine/Human medicines/European public assessment reports.
Danish: Yderligere oplysninger om Exjade, herunder alle dets anvendelser, findes på agenturets websted: ema.europa.eu/Findmedicine/Human medicines/European public assessment reports.
English: It has important information about your treatment and how to take the medicine.
Danish: Den indeholder vigtige oplysninger om din behandling og om, hvordan du skal tage lægemidlet.
English: • Your doctor will have worked out the dose of Exjade you need.
Danish: • Din læge vil have beregnet, hvilken dosis af Exjade, du behøver.
English: • The summary of product characteristics and the educational materials on the use of Exjade should be followed because they give important information on its use.
Danish: • Produktresuméet og oplysningsmaterialet, om anvendelsen af Exjade bør følges, da de indeholder vigtige oplysninger om dets anvendelse.
English: Dispersible tablets (to be discontinued)
Danish: Dispergible tabletter (vil udgå)
English: • The following table describes the differences between the two formulations: Film-coated tablets
Danish: • Følgende tabel beskriver forskellene mellem de to formuleringer: Filmovertrukne tabletter
English: The doctor will tell you how much of the new tablet you need to take.
Danish: Lægen vil fortælle dig, hvor meget du skal have af de nye tabletter.
English: • Read the package leaflet and other information you have been given with your tablets.
Danish: • Læs indlægssedlen og anden information, som du har fået sammen med dine tabletter.
English: How to take tablets
Danish: Hvordan tabletterne skal indtages
English: This helps to correct iron overload and prevent the extra iron from damaging organs such as the heart and liver.
Danish: Dette medvirker til at korrigere overbelastning med jern og forhindrer det overskydende jern i at beskadige organer såsom hjerte og lever.
English: The dose depends on your weight, the amount of iron in your blood, how well your liver and kidneys work and the amount of blood transfusions you receive.
Danish: Dosis afhænger af din vægt, jernindholdet i dit blod, hvor godt din lever og dine nyrer og virker, og hvor mange blodtransfusioner, du får.
English: The two types of tablets can be easily distinguished by their shape, and the design of the outer cartons and blisters.
Danish: De to tablettyper kan let skelnes på deres form og på udformningen af den ydre karton og blisterkortet.
English: Exjade contains the active substance deferasirox which is an ‘iron chelator'.
Danish: Exjade indeholder det aktive stof deferasirox som et "jernkelaterende" stof.
English: 10-40 mg/kg daily, rounded to the nearest whole tablet size
Danish: 10-40 mg/kg dagligt, oprundet til nærmeste hele tabletstørrelse
English: The education material will advise that the doses for the two types of Exjade tablets are different.
Danish: Oplysningsmaterialet vil forklare, at doserne for de to typer af Exjade tabletter er forskellige.
English: Once daily, must be taken on an empty stomach, at least 30 minutes before food
Danish: Én gang dagligt, skal tages på tom mave mindst 30 minutter før et måltid
English: • To avoid errors, prescriptions for Exjade must specify the type of formulation (dispersible tablets or film-coated tablets), the prescribed dose in mg/kg/day, and the calculated dose per day with the strength of film-coated or dispersible tablets.
Danish: • For at undgå fejl skal ordinationer på Exjade angive formuleringens art (dispergible tabletter eller filmovertrukne tabletter), den ordinerede dosis i mg/kg/dag og den beregnede dosis per dag med styrken af filmovertrukne tabletter eller dispergible tabletter.
English: Does not contain lactose
Danish: Indeholder ikke lactose
English: This means that it attaches to iron in the body to form a ‘chelate' that can be excreted by the body, mainly in the stool.
Danish: Det betyder, at det bindes til jern i kroppen og derved danner et "kelat", som kroppen kan udskille, hovedsagelig i afføringen.
English: Excipient: lactose
Danish: Hjælpestof: lactose
English: Swallowed whole with some water or crushed and sprinkled on soft food (e.g. yogurt or apple sauce)
Danish: Synkes hele med vand, eller knuses og drysses på bløde madvarer (f.eks. yoghurt eller æblesauce)
English: Round, white tablets containing 125 mg, 250 mg and 500 mg (all white)
Danish: Runde, hvide tabletter indeholdende 125 mg, 250 mg og 500 mg (alle hvide)
English: • Bioavailability of film-coated tablets is higher than of the dispersible tablets and the strength of film-coated tablets is correspondingly lower.
Danish: • Biotilgængeligheden af de filmovertrukne tabletter er højere end af dispergible tabletter, og styrken af de filmovertrukne tabletter er tilsvarende lavere.
English: Film-coated tablets containing 90, 180 and 360 mg are equivalent to dispersible tablets containing 125, 250 and 500 mg, respectively.
Danish: Filmovertrukne tabletter indeholdende 90, 180 og 360 mg svarer til dispergible tabletter indeholdende hhv. 125, 250 og 500 mg.
English: If you are switching from dispersible tablets to the new film-coated tablets, you will need a smaller dose.
Danish: Hvis du skifter fra smeltetabletter til de nye filmovertrukne tabletter, behøver du en mindre dosis.
English: Educational material to raise awareness of dose variation between different types of tablets
Danish: Oplysningsmateriale, der gør opmærksom på forskellen i dosis mellem forskellige typer tabletter
English: Dose range (adults and children) 7-28 mg/kg daily, rounded to the nearest whole tablet size
Danish: Dosisinterval (voksne og børn) 7-28 mg/kg dagligt, oprundet til nærmeste hele tabletstørrelse