FrancophonIA/ELRC3.0 huggingface dataset:
English: The first study involved 173 patients aged 12 years and above.
Danish: I den første undersøgelse deltog 173 patienter på over 12 år.
English: A total of 848 bleeding episodes were recorded during the study, 94% of which resolved with one or two injections of Afstyla.
Danish: Der blev i løben af undersøgelsen registreret i alt 848 blødningsepisoder, hvoraf 94 % blev afhjulpet med en eller to indsprøjtninger af Afstyla.
English: It contains the active substance lonoctocog alfa.
Danish: Det indeholder det aktive stof ionoctocog alfa.
English: Afstyla must not be used in patients with known allergy to hamster proteins.
Danish: Afstyla må ikke anvendes hos patienter, der vides at være allergiske over for hamsterproteiner.
English: Among those patients who received Afstyla to prevent bleeding, an average of 1.14 bleeding episodes per year was recorded for each patient which was lower than the 19.64 episodes per year in patients not receiving Afstyla for prevention.
Danish: Hos de patienter, der fik Afstyla til at forebygge blødning, blev der i gennemsnit registreret 1,14 blødningsepisoder årligt for hver patient, hvilket var lavere end de 19,64 episoder per år, der forekom hos patienter, som ikke fik Afstyla som forebyggelse.
English: The dose and frequency of the injections depend on whether Afstyla is used to treat or prevent bleeding, the severity of the patient's factor VIII deficiency, the extent and location of the bleeding and the patient's condition and bodyweight.
Danish: Dosis og hyppighed af indsprøjtningerne afhænger af, om Afstyla skal anvendes til at behandle eller forebygge blødning, og desuden af, hvor alvorlig patientens mangel på faktor VIII er, blødningens omfang og beliggenhed samt patientens tilstand og legemsvægt.
English: Among those patients who received Afstyla to prevent bleeding, the average number of bleeding episodes per year was 2.30 for patients receiving Afstyla three times a week, and 4.37 for those receiving Afstyla twice a week.
Danish: Blandt de patienter, der fik Afstyla til at forebygge blødning, var det gennemsnitlige antal blødningsepisoder pr. år 2,30 for dem, der fik Afstyla tre gange om ugen, og 4,37 for dem, der fik Afstyla to gange om ugen.
English: Afstyla can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Danish: Afstyla udleveres kun efter recept, og behandlingen bør finde sted under opsyn af en læge med erfaring i behandling af hæmofili.
English: For more information about treatment with Afstyla, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Afstyla, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In the 16 surgical procedures that occurred during the study, Afstyla was rated as ‘excellent' or ‘good' in preventing bleeding episodes when used two to three times a week.
Danish: Ved de 16 operative indgreb, der blev foretaget i løbet af undersøgelsen, blev Afstyla bedømt som "udmærket" eller "godt" til at forebygge blødningsepisoder, når det blev anvendt to-tre gange om ugen.
English: Afstyla has been shown to be effective at preventing and treating bleeding episodes in two main studies in patients with severe haemophilia A who were previously treated with other factor VIII products.
Danish: Afstyla er påvist at være effektivt til at behandle og forebygge blødningsepisoder i to hovedundersøgelser med deltagelse af patienter, der havde svær hæmofili A og tidligere var behandlet med andre faktor VIII-produkter.
English: There is also a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Danish: Der er desuden den risiko ved faktor VIII-lægemidler, at nogle patienter danner antistoffer (inhibitorer) mod faktor VIII, hvilket medfører, at lægemidlet ikke længere virker, så kontrollen med blødning svigter.
English: Afstyla was rated as ‘excellent' or ‘good' at treating 92% of the bleeding episodes.
Danish: Afstyla blev bedømt som "udmærket" eller "godt" ved behandling af 92 % af blødningsepisoderne.
English: Afstyla was rated as ‘excellent' or ‘good' at treating 96% of the 347 bleeding episodes recorded during the study; 96% of bleeding episodes resolved with one or two injections of Afstyla.
Danish: Afstyla blev bedømt som "udmærket" eller "godt" til behandling af 96 % af de 347 blødningsepisoder, der blev registreret i løbet af undersøgelsen; 96 % af blødningsepisoderne blev afhjulpet med en eller to indsprøjtninger af Afstyla.
English: For the full list of all side effects and restrictions, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Afstyla fremgår af indlægssedlen.
English: Afstyla is available as a powder and solvent used to make a solution for injection.
Danish: Afstyla fås som pulver og solvens, som bruges til at fremstille en injektionsvæske, opløsning.
English: What benefits of Afstyla have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Afstyla?
English: For practical information about using Afstyla, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Afstyla, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Afstyla is a medicine used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of a clotting protein called factor VIII).
Danish: Afstyla er et lægemiddel til behandling og forebyggelse af blødning ved hæmofili A (en arvelig blødningsforstyrrelse, der skyldes mangel på proteinet faktor VIII, som medvirker ved blodets størkning).
English: How does Afstyla work?
Danish: Hvordan virker Afstyla?
English: How is Afstyla used?
Danish: Hvordan anvendes Afstyla?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Afstyla 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 Afstyla.
English: Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Danish: Patienter med hæmofili A mangler faktor VIII, der er et protein, som behøves til blodets normale størkning.
English: 10 March 2011
Danish: 10. marts 2011
English: What is Tienam?
Danish: Hvad er Tienam?
English: The European Commission issued a decision on this opinion on 10 March 2011.
Danish: Europa-Kommissionen traf en afgørelse på grundlag af denne udtalelse den 10. marts 2011.
English: The CHMP agreed on the following indications:
Danish: CHMP vedtog følgende indikationer:
English: As a result, the antibiotic stays in the body and can work for longer.
Danish: Som et resultat heraf bliver antibiotikummet i kroppen og kan virke i længere tid.
English: It can also be used in patients whose immune system is weakened when they have a fever.
Danish: Det kan ligeledes anvendes hos patienter, hvis immunsystem er svækket, når de har feber.
English: Why was Tienam reviewed?
Danish: Hvorfor blev Tienam vurderet igen?
English: concerned Member States could not agree on the indications and on the recommendation for children under three years of age.
Danish: Den berørte medlemsstat var ikke enig i indikationerne og i anbefalingen for børn under tre år.
English: During a decentralised procedure, the application submitted by the company is assessed by one Member State (the ‘reference Member State', in this instance the Netherlands), with a view of granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States').
Danish: Under en decentral procedure bliver den ansøgning, som virksomheden har indsendt, bedømt af en medlemsstat ("referencemedlemsstaten", i dette tilfælde Nederlandene) med henblik på at udstede en markedsføringstilladelse, som gælder i dette land og i andre medlemsstater (de "berørte medlemsstater").
English: The Committee also recommended harmonised wordings in other areas such as contra-indications, warnings and side effects.
Danish: Udvalget anbefalede også en harmoniseret ordlyd på andre punkter såsom kontraindikationer, advarsler og bivirkninger.
English: The CHMP also removed the use of Tienam in the prevention of infections.
Danish: CHMP fjernede også anvendelsen af Tienam til forebyggelse af infektioner.
English: A company applied in the Netherlands for a generic version of Tienam in a decentralised procedure involving 16 Member States.
Danish: En virksomhed havde i Nederlandene ansøgt om en generisk version af Tienam i en decentral procedure, der omfattede 16 medlemsstater.
English: • treatment of bacteraemia (bacteria in the blood) that is associated with or suspected to be associated with the infections listed above.
Danish: • behandling af bakteriæmi (bakterier i blodet), som er forbundet med eller formodes at være forbundet med de infektioner, der er nævnt ovenfor.
English: For children, the CHMP recommended a harmonised dosage in children over one year of age, and made no dosage recommendations for children under one year of age because of a lack of data for this age group.
Danish: For børns vedkommende anbefalede CHMP en harmoniseret dosis til børn over et år, og CHMP gav ingen doseringsanbefalinger for børn under et år, eftersom der mangler data for denne aldersgruppe.
English: The European Medicines Agency has completed a review of Tienam.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Tienam.
English: The medicine is available in all EU Member States under the trade name Tienam, as well under other trade names: Conet, Imipem, Primaxin, Tenacid and Zienam.
Danish: Lægemidlet fås i alle EU-medlemsstater under særnavnet Tienam og under andre særnavne: Conet, Imipem, Primaxin, Tenacid og Zienam.
English: On 18 May 2009, the Dutch medicines regulatory agency referred the matter to the CHMP in order to harmonise the marketing authorisations for Tienam in the EU.
Danish: Den 18. maj 2009 indbragte den nederlandske lægemiddelkontrolmyndighed sagen for CHMP med henblik på en harmonisering af markedsføringstilladelserne for Tienam i EU.
English: The company that markets these medicines is Merck, Sharp & Dohme.
Danish: Disse lægemidler markedsføres af virksomheden Merck, Sharp & Dohme.
English: • use for fever in neutropenic patients when infection is suspected,
Danish: • behandling af feber hos neutropene patienter, når der er mistanke om en infektion,
English: Tienam is an antibiotic used in complicated infections, generally in hospital.
Danish: Tienam er et antibiotikum, der generelt anvendes på hospitalet ved komplicerede infektioner.
English: It has been used to treat infections of the lungs, the urinary tract (structures that carry urine), the abdomen, skin and the reproductive system.
Danish: Det er blevet anvendt til at behandle infektioner i lungerne, urinvejene (de strukturer, som leder urinen), abdomen (maven), huden og forplantningssystemet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Tienam in the European Union (EU).
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for at harmonisere ordinationsoplysningerne for Tienam i Den Europæiske Union (EU).
English: When Tienam is absorbed in the body, the imipenem component kills the bacteria that are causing the infection, while the cilastatin component blocks the dehypropeptidase enzyme in the kidney that normally breaks down imipenem.
Danish: Når Tienam optages i kroppen, dræber imipenem-komponenten de bakterier, som er årsag til infektionen, mens cilastatinkomponenten blokerer det dehydropeptidaseenzym i nyrerne, der normalt nedbryder imipenem.
English: The CHMP recommended that Tienam should not be used in some indications, such as meningitis, osteomyelitis (infection of the bones) and lung infection in cystic fibrosis patients.
Danish: CHMP anbefalede, at Tienam ikke anvendes til visse indikationer såsom meningitis, osteomyelitis (knoglemarvsbetændelse) og lungeinfektion hos patienter med cystisk fibrose.
English: Tienam contains two active substances: imipenem, which is an antibiotic belonging to the carbapenem family, and cilastatin, which is a ‘dehydropeptidase inhibitor'.
Danish: Tienam indeholder to aktive stoffer: imipenem, som er et antibiotikum, der tilhører gruppen af carbapenemer, og cilastatin, som er en "dehydropeptidasehæmmer".
English: • intra- and post-partum infections,
Danish: • intra- og post-partum-infektioner,
English: The CHMP harmonised the posology (the dose and frequency of dosing) in adults.
Danish: CHMP harmoniserede doseringen (dosis og dosishyppighed) hos voksne.
English: • severe pneumonia including hospital and ventilator-associated pneumonia,
Danish: • svær pneumoni, herunder hospitalserhvervet og respiratorerhvervet pneumoni,
English: • complicated intra-abdominal infections,
Danish: • komplicerede intraabdominale infektioner,
English: • complicated skin and soft-tissue infections,
Danish: • komplicerede hud- og bløddelsinfektioner,
English: While this process was ongoing, divergences across Member States were noted in the way Tienam can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets.
Danish: I løbet af denne procedure opstod der divergenser mellem medlemsstaterne med hensyn til den måde, som Tienam kan anvendes på, hvilket fremgik af
English: MA (EU) Number (Invented) name Strength Pharmaceutical form
Danish: MF (EU)-nummer (Særnavn) navn Styrke Lægemiddelform Administration Emballage
English: Route of administration
Danish: 2 mg Filmovertrukken
English: ∗ 2.5 mg desloratadine/120 mg pseudoephedrine sulphate
Danish: * 2,5 mg desloratadin/120 mg pseudoephedrin sulfat
English: Invented name
Danish: Invented navn
English: EU (MA) Number
Danish: EU (MA) Nummer
English: -1 Cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain: 2,500 - 8,000 PFU*
Danish: -1 Celle-associeret, levende, recombinant kalkun herpesvirus (rHVT/ND), der udtrykker fusionsprotein med avirulent Newcastle disease virus stamme D26: 2,500 - 8,000 PFU*
English: Packaging Content Package size Withdrawal period
Danish: Pakning Indhold Pakningsstørrelse
English: Strength Pharmaceutical form Target species
Danish: Styrke Farmaceutisk form Dyrearter Administrationsvej
English: Route of administration
Danish: Tilbageholdelsestid
English: It is used for the treatment of the following diseases:
Danish: Det anvendes til behandling for følgende sygdomme:
English: The usual recommended dose is 50 mg once a week.
Danish: Den anbefalede normaldosis er 50 mg en gang om ugen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Benepali on 14 January 2016.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Benepali den 14. januar 2016.
English: Treatment with 50 mg twice a week can also be used during the first 12 weeks of treatment for plaque psoriasis.
Danish: Desuden kan der anvendes 50 mg to gange om ugen i de første 12 uger af behandlingen for plaquepsoriasis.
English: The patient or carer can give the injection after appropriate training.
Danish: Patienten eller omsorgsgiveren kan give indsprøjtningen efter passende instruktion.
English: The full EPAR and risk management plan summary for Benepali can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Benepali 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 Benepali.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Benepali.
English: This means that Benepali is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det betyder, at Benepali svarer til et biologisk lægemiddel (også kaldet "referencelægemidlet"), der allerede er godkendt i Den Europæiske Union (EU).
English: What measures are being taken to ensure the safe and effective use of Benepali?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Benepali?
English: Other information about Benepali
Danish: Andre oplysninger om Benepali
English: Patients developing a serious infection should stop Benepali treatment.
Danish: Patienter, der udvikler en alvorlig infektion, bør stoppe behandling med Benepali.
English: The main measure of effectiveness was the proportion of patients who achieved at least a 20% reduction in ACR scores (a measure of painful, swollen joints and other symptoms) after 24 weeks of treatment.
Danish: Det primære effektmål var andelen af patienter, der opnåede en reduktion på mindst 20 % i ACR-score (et mål for smertende, hævede led og andre symptomer) efter 24 ugers behandling.
English: Thus, all these data were considered sufficient to conclude that Benepali will behave in the same way in terms of effectiveness in adults as in children in Benepali's approved indications.
Danish: Alle disse oplysninger blev derfor anset for tilstrækkelige til at konkludere, at Benepali vil optræde på samme måde med hensyn til virkning hos voksne som hos børn i Benepalis godkendte anvendelser.
English: Therefore, the CHMP's view was that, as for Enbrel, the benefits outweighs the identified risks.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Enbrel.
English: The educational materials also include a reminder that Benepali is not for use in children and adolescents who weigh less than 62.5 kg.
Danish: Oplysningsmaterialet påminder også om, at Benepali ikke må anvendes hos børn og unge, der vejer mindre end 62,5 kg.
English: The Committee recommended that Benepali be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Benepali.
English: Benepali is not for use in children weighing less than 62.5 kg, as Benepali does not have low-dose formulations.
Danish: Benepali er ikke til brug hos børn, der vejer mindre end 62,5 kg, da der ikke findes lavdosisformuleringer af Benepali.
English: The most common side effects with Benepali are injection-site reactions (including bleeding, redness, itching, pain and swelling) and infections (including colds, and lung, bladder and skin infections).
Danish: De hyppigste bivirkninger ved Benepali er reaktioner på injektionsstedet (herunder blødning, rødme, kløe, smerter og hævelse) og infektioner (herunder forkølelse og lunge-, blære- og hudinfektioner).
English: The reference medicine for Benepali is Enbrel.
Danish: Referencelægemidlet for Benepali er Enbrel.
English: Benepali is used in patients who have not responded to or cannot receive other treatments for this disease.
Danish: Benepali anvendes hos patienter, som ikke har responderet tilstrækkeligt på eller ikke kan få andre behandlinger for denne sygdom.
English: Patients who take Benepali must be given the special alert card that summarises important safety information about the medicine so they can recognise any serious side effects and know when to seek urgent attention from their doctor.
Danish: Patienter, der tager Benepali, skal have udleveret et særligt advarselskort, der sammenfatter vigtige sikkerhedsoplysninger om lægemidlet, så de gøres opmærksomme på alvorlige bivirkninger og hvornår de skal søge akut lægehjælp.
English: Why is Benepali approved?
Danish: Hvorfor blev Benepali godkendt?
English: • certain forms of juvenile idiopathic arthritis (a rare childhood disease causing inflammation of joints) in the following groups:
Danish: • visse former for juvenil idiopatisk arthritis (en sjælden børnesygdom, der medfører inflammation i leddene) hos følgende grupper:
English: Benepali must not be used in patients who have or are at risk of sepsis (when bacteria and toxins circulate in the blood and start to damage the organs), or in patients with infections.
Danish: Benepali må ikke anvendes hos patienter, som har eller er i fare for blodforgiftning (hvor bakterier og giftstoffer i blodet begynder at beskadige organerne), eller hos patienter med infektioner.
English: What is Benepali and what is it used for?
Danish: Hvad er Benepali, og hvad anvendes det til?
English: • psoriatic arthritis in adults who have not responded adequately to other treatments;
Danish: • arthritis psoriatica hos voksne, der ikke har responderet tilstrækkeligt på andre behandlinger
English: What are the risks associated with Benepali?
Danish: Hvilke risici er der forbundet med Benepali?
English: Benepali can also be used in patients with severe rheumatoid arthritis who have not taken methotrexate before;
Danish: Benepali kan også anvendes hos patienter med svær rheumatoid arthritis, der ikke tidligere har taget methotrexat
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Benepali has a highly similar structure, purity and biological activity to Enbrel and is distributed in the body in the same way.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Benepali har en struktur, renhed og biologisk aktivitet, som i høj grad minder om Enbrel, og at det fordeles i kroppen på samme måde.
English: The company that makes Benepali will provide educational material for doctors expected to prescribe the product (to teach patients how to use the pre-filled syringe/pen correctly).
Danish: Virksomheden, der fremstiller Benepali, skal udlevere oplysningsmateriale til læger, der forventes at ordinere lægemidlet (med henblik på at instruere patienter i, hvordan de bruger den fyldte sprøjte/pen korrekt).
English: Benepali is used either in combination with methotrexate (a medicine that acts on the immune system) in adults with moderate or severe disease who have not responded adequately to other treatments, or on its own if methotrexate is not suitable for the patient.
Danish: Benepali anvendes enten i kombination med methotrexat (et lægemiddel, der virker på immunsystemet) hos voksne med moderat eller svær sygdom, som ikke har responderet tilstrækkeligt på andre behandlinger, eller alene, når methotrexat ikke er egnet for patienten.
English: Benepali is an anti-inflammatory medicine.
Danish: Benepali er et antiinflammatorisk lægemiddel.
English: It is not intended to provide practical advice on how to use Benepali.
Danish: Det er ikke en praktisk vejledning i, hvordan Benepali bør anvendes.
English: Benepali was also compared with Enbrel in one main study involving 596 adult patients with moderate to severe rheumatoid arthritis despite treatment with methotrexate.
Danish: Benepali blev desuden sammenlignet med Enbrel i én hovedundersøgelse omfattende 596 voksne patienter, der led af moderat til svær rheumatoid artritis trods behandling med methotrexat.
English: For more information about treatment with Benepali, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Benepali, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.