FrancophonIA/ELRC3.0 huggingface dataset:
English: Pregabalin Zentiva 25 mg hard capsules Pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Zentiva 25 mg hårde kapsler Pregabalin
English: What Pregabalin Zentiva looks like and contents of the pack
Danish: Hvordan Pregabalin Zentiva ser ud og indhold i pakning 25 mg hårde kapsler
English: Flesh opaque cap and Flesh opaque body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “200”, containing almost white powder.
Danish: Hudfarvet, uigennemsigtig top og hudfarvet, uigennemsigtig bund, cirka 19,4 mm lange, hårde gelatinekapsler med prægning ”200”, indeholder næsten hvidt pulver.
English: Pregabalin Zentiva 150 mg hard capsules Capsule cap and body Black iron oxide (E172) Titanium dioxide (E171) Gelatin
Danish: Pregabalin Zentiva 150 mg hårde kapsler Kapseltop og -bund - Sort jernoxid (E172) - Titandioxid (E171) - Gelatine
English: Pregabalin Zentiva 200 mg hard capsules Capsule cap and body Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin
Danish: Pregabalin Zentiva 200 mg hårde kapsler Kapseltop og -bund - Rød jernoxid (E172) - Gul jernoxid (E172) - Titandioxid (E171) - Gelatine
English: Pregabalin Zentiva 300 mg hard capsules Pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Zentiva 300 mg hårde kapsler Pregabalin
English: Pregabalin Zentiva 50 mg hard capsules Capsule cap and body Black iron oxide (E172) Titanium dioxide (E171) Gelatin
Danish: Pregabalin Zentiva 50 mg hårde kapsler Kapseltop og -bund - Sort jernoxid (E172) - Titandioxid (E171) - Gelatine
English: Pregabalin Zentiva 50 mg hard capsules Pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Zentiva 50 mg hårde kapsler Pregabalin
English: Pregabalin Zentiva 150 mg
Danish: INFORMATION I BRAILLE-SKRIFT Pregabalin Zentiva 150 mg
English: • Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal.
Danish: rysten, talevanskeligheder, snurrende fornemmelse, følelsesløshed, sløvhed, søvnlignende sløvhedstilstand, søvnforstyrrelser, træthed, følelse af at være unormal.
English: Pregabalin Zentiva 100 mg hard capsules Capsule cap and body Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin.
Danish: Pregabalin Zentiva 100 mg hårde kapsler Kapseltop og -bund - Rød jernoxid (E172) - Gul jernoxid (E172) - Titandioxid (E171) - Gelatine
English: Pregabalin Zentiva 50 mg
Danish: INFORMATION I BRAILLE-SKRIFT Pregabalin Zentiva 50 mg
English: Pregabalin Zentiva 225 mg hard capsules Capsule cap
Danish: 225 mg hårde kapsler
English: Each hard capsule contains 225 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 225 mg pregabalin.
English: Each hard capsule contains 75 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 75 mg pregabalin.
English: Pregabalin Zentiva 75 mg hard capsules Capsule cap
Danish: 75 mg hårde kapsler
English: The physician information should contain the following key messages:
Danish: Lægeinformationen skal indeholde information om følgende hovedbudskaber:
English: • Physician information
Danish: • Lægeinformation
English: • The possibility to include patients in the registry study to facilitate the collection of long term efficacy and safety data;
Danish: • Muligheden for at inkludere patienter i registerstudiet for at facilitere indsamlingen af data vedrørende langtidseffekt og sikkerhed;
English: • The identified or potential risk of immunogenicity that might lead to immune-mediated symptoms;
Danish: • Den identificerede eller potentielle risiko for immunogenicitet, som kan medføre immunmedierede symptomer;
English: • The need for Health Care Professionals to perform an annual clinical assessment of patients regarding a potential increased risk for the development of malignancies;
Danish: • Nødvendigheden af at sundhedspersonale udfører en årlig klinisk evaluering af patienter med hensyn til en potentiel øget risiko for udvikling af maligniteter;
English: • The proper patient management as regards the interaction with vaccination;
Danish: • Den korrekte patientbehandling med hensyn til interaktion ved vaccination;
English: • The need to instruct patients on proper techniques for self-administration when the patient is willing and capable to do so, and guidance for Health Care Professionals on how to report administration errors;
Danish: • Nødvendigheden af at instruere patienterne i den korrekte teknik til selv-administration, når patienten er villig til og har mulighed for at gøre dette, samt vejledning til sundhedspersonale i rapportering af administrationsfejl;
English: • The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Ilaris;
Danish: • Risikoen for alvorlige infektioner, herunder opportunistiske bakterie-, virus- og svampeinfektioner hos patienter, som behandles med Ilaris;
English: • The role and use of patient alert card.
Danish: • Patientkortets formål og anvendelse.
English: • The need to measure neutrophil counts prior to initiating treatment, after 1 to 2 months and periodically thereafter while receiving Ilaris as treatment with Ilaris should not be initiated in patients with neutropenia;
Danish: • Nødvendigheden af at måle neutrofiltal før initiering af behandlingen, efter 1 til 2 måneder og periodisk herefter, så længe patienten er i behandling med Ilaris, da behandling med Ilaris ikke må initieres hos patienter med neutropeni;
English: • The need to monitor patients for changes in their lipid profiles;
Danish: • Nødvendigheden af at monitorere ændringer i patientens lipidprofiler;
English: • The unknown safety of Ilaris in pregnant and lactating women, thus the need for physicians to discuss this risk with patients if they become or plan to become pregnant;
Danish: • Den ukendte sikkerhed af Ilaris hos gravide og ammende kvinder, og nødvendigheden af, at lægen diskuterer risici med patienter, der bliver gravide eller planlægger at blive gravide;
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandende skal sikre, at alle betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet beskrevet nedenfor er implementeret:
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET SOM SKAL IMPLEMENTERES AF MEDLEMSLANDENDE
English: • Educational material
Danish: • Informationsmateriale
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES AF MEDLEMSSTATERNE
English: The Member States must ensure that all conditions with regard to the safe and effective use of the medicinal products described below are implemented:
Danish: Medlemsstaterne skal sikre, at alle betingelser med hensyn til en sikker og effektiv anvendelse af de beskrevne lægemidler bliver implementeret:
English: The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal aftale indholdet i et informationsprogram med de relevante nationale myndigheder og skal derefter implementere programmet nationalt for at sikre, at læger, før de ordinerer lægemidlet, modtager en informationspakke, der er målrettet mod sundhedspersonale, og som har følgende indhold:
English: Provision of dosing calculator to simplify the calculation of the correct dose and guide in correct reconstitution and administration.
Danish: Tilvejebringelse af en doseringsberegner, der kan gøre beregningen af den korrekte dosis simplere og hjælpe til at sikre korrekt rekonstitution og administration.
English: Advice on when further investigations and a bone marrow biopsy might be appropriate.
Danish: Henstilling om, hvornår yderligere undersøgelser samt knoglemarvsbiopsi kan blive nødvendige.
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Danish: • Produktresumé (SPC) samt indlægsseddel og etikettering.
English: If use of romiplostim is deemed necessary, platelet count should be closely monitored to minimise the risk of thromboembolic complications.
Danish: Hvis brug af romiplostim skønnes nødvendig, skal trombocyttallet overvåges nøje for at minimere risikoen for tromboemboliske komplikationer.
English: Data from clinical trials in MDS on the incidence of blast cell increases and progression to AML.
Danish: Data fra kliniske undersøgelser om MDS vedrørende incidensen af blastcelle-stigninger og progression til AML.
English: Background information on reticulin in the bone marrow.
Danish: Baggrundsinformation om retikulin i knoglemarven.
English: Romiplostim should not be used in patients with moderate to severe hepatic impairment unless the expected benefit outweighs the identified risk of portal venous thrombosis.
Danish: Romiplostim må ikke anvendes til patienter med moderat til svært nedsat leverfunktion medmindre den forventede fordel opvejer den påviste risiko for portal venetrombose.
English: • Obligations of the health care professional in relation to the prescribing of romiplostim and the need to provide comprehensive advice on risk-benefit to patients.
Danish: • Sundhedspersonalets pligter i forbindelse med ordination af romiplostim og nødvendigheden af grundig patientvejledning angående forholdet mellem risici og fordele.
English: Advice to follow dose adjustment guidelines to avoid platelet counts above the normal range.
Danish: Henstilling om at følge retningslinjerne for dosisjustering for at undgå trombocyttal over normalområdet.
English: Antibody testing available upon request of physician, contact details for this antibody testing.
Danish: Information om, at antistof-testning er tilgængelig på lægens begæring, og kontaktinformation til sådan antistof-testning.
English: The potential for thromboembolic events in patients with chronic ITP and those known risk factors for thromboembolic events (e.g., Factor V Leiden, ATIII deficiency, antiphospholipid syndrome).
Danish: Muligheden for tromboemboliske hændelser hos patienter med kronisk ITP og de kendte risikofaktorer for tromboemboliske hændelser (f.eks., Faktor V Leiden, ATIII-deficiens, antiphospholipid syndrom).
English: The incidence of medication errors in clinical trials.
Danish: Incidensen af medicineringsfejl i kliniske undersøgelser.
English: Advice on management of patients upon cessation of romiplostim.
Danish: Vejledning angående behandling af patienterne efter seponering af romiplostim.
English: Background rates of reticulin in the bone marrow in ITP patients and the observed incidence and potential mechanism of action of reticulin deposition in response to romiplostim.
Danish: Baggrundsniveauer for retikulin i knoglemarven hos ITP-patienter samt den observerede incidens af og mulige virkningsmekanisme for retikulinaflejring som følge af behandling med romiplostim.
English: Clarification that risk-benefit for the treatment of paediatric ITP has not been established.
Danish: Tydeliggørelse af, at forholdet mellem risikoen og fordelene ved pædiatrisk ITP-behandling ikke er afklaret.
English: The implications of romiplostim-neutralising antibodies cross-reacting with endogenous thrombopoietin (TPO).
Danish: Implikationerne af romiplostim-neutraliserende antistoffers krydsreaktion med endogent trombopoietin (TPO).
English: • Posology
Danish: • Dosering.
English: Reiteration that the risk-benefit for the treatment of thrombocytopenia in non ITP patient populations has not been established.
Danish: Risikoen og fordelene ved behandling af trombocytopeni hos ikke-ITPpatientpopulationer er ikke afklaret.
English: Romiplostim may induce the progression of existing haematological malignancies and myelodysplastic syndrome (MDS).
Danish: Romiplostim kan inducere progressionen af eksisterende hæmatologiske maligniteter og myelodysplastisk syndrom (MDS), og det bør følgelig kun anvendes som angivet i kliniske undersøgelser.
English: The incidence of neutralising antibodies to romiplostim in clinical trials.
Danish: Incidensen af romiplostim-neutraliserende antistoffer i kliniske undersøgelser.
English: The incidence in clinical trials of thrombotic/thromboembolic complications.
Danish: Incidensen af trombotiske/tromboemboliske komplikationer i kliniske undersøgelser.
English: Warning that, whilst no data exists, an outcome of reticulin deposition in response to romiplostim may be bone marrow fibrosis.
Danish: Advarsel om, at retikulinaflejring som følge af behandling med romiplostim muligvis kan føre til knoglemarvsfibrose, da der ikke er datagrundlag, som udelukker dette.
English: • The documents will discuss the following identified and potential risks: The incidence in clinical trials and likelihood of reoccurrence of thrombocytopenia after cessation of treatment.
Danish: Incidensen af trombocytopeni i kliniske undersøgelser samt sandsynligheden for recidiv af trombocytopeni ved seponering af behandlingen.
English: United Kingdom Alkem Pharma GmbH
Danish: Storbritannien Alkem Pharma GmbH
English: SIA Ingen Pharma Cefuroxime Ingen Pharma
Danish: Cefuroxime Ingen Pharma
English: Marketing Authorisatio n Holder
Danish: Indehaver af markedsføri ngstilladelse
English: Active Substance
Danish: Aktivt stof Styrke Lægemiddelform Indgivelsesvej
English: Ricefan 250 mg Cefuroxime 250 mg Film-coated tablet
Danish: Ricefan 250 mg Cefuroxime 250 mg Filmovertrukken tablet
English: Ricefan 500 mg Cefuroxime 500 mg Film-coated tablet
Danish: Ricefan 500 mg Cefuroxime 500 mg Filmovertrukken tablet
English: 14 October 2016 EMA/659373/2016 EMEA/H/C/004306
Danish: 14. oktober 2016 EMA/659373/2016 EMEA/H/C/004306
English: This prevents the cancer cells from growing and dividing, while normal cells are only slightly affected.
Danish: Derved forhindres kræftcellerne i at vokse og dele sig, mens de normale celler kun påvirkes i begrænset omfang.
English: active form happens more readily in cancer cells than in normal cells.
Danish: Omdannelsen til den aktive form sker hurtigere i kræftceller end i normale celler.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because of a change in commercial strategy.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen er sket på grund af en ændring i deres handelsstrategi.
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Danish: Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, virksomheden oprindeligt havde fremlagt, og udarbejdet en liste med spørgsmål.
English: Based on the review of the data at the time of the withdrawal, the CHMP had asked the company to provide clarification on some aspects of manufacturing, storage and plans to monitor safety and effectiveness of the medicine after authorisation.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen bad CHMP virksomheden om at gøre nærmere rede for nogle aspekter med hensyn til fremstilling og opbevaring samt planer for overvågning af lægemidlets sikkerhed og virkning efter godkendelse.
English: The active substance in both medicines, pemetrexed, is changed in the body into an active form that blocks enzymes needed to make genetic material (DNA and RNA).
Danish: Det aktive stof i de to lægemidler, pemetrexed, omsættes i kroppen til en aktiv form, der blokerer de enzymer, som skal bruges til at danne genetisk materiale (dna og rna).
English: On 22 September 2016, Hospira UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pemetrexed (as ditromethamine) Hospira, for the treatment of malignant pleural mesothelioma and non-small-cell lung cancer.
Danish: Den 22. september 2016 meddelte Hospira UK Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Pemetrexed Hospira (som ditromethamin) til behandling af kræft i lungehinderne (malignt pleuramesoteliom) og ikke-småcellet lungekræft.
English: This means that it was intended to be similar to a ‘reference medicine' already authorised in the European Union called Alimta.
Danish: Det betyder, at det var hensigten, at Pemetrexed Hospira (som ditromethamin) skulle være identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union, og som hedder Alimta.
English: Because Pemetrexed (as ditromethamine) Hospira was developed as a generic medicine, the company presented the results of studies to show the quality of the medicine.
Danish: Da Pemetrexed Hospira (som ditromethamin) blev udviklet som et generisk lægemiddel, fremlagde virksomheden resultaterne af undersøgelser for at påvise lægemidlets kvalitet.
English: No further studies were carried out because Pemetrexed (as ditromethamine) Hospira is a generic medicine that is given by infusion into a vein and contains the same active substance as the reference medicine, Alimta.
Danish: Der er ikke gennemført yderligere undersøgelser, da Pemetrexed Hospira (som ditromethamin), der gives ved infusion i en blodåre, er et generisk lægemiddel, som indeholder det samme aktive stof som referencelægemidlet Alimta.
English: The CHMP thought that the company could have addressed these questions and was of the provisional opinion that Pemetrexed (as ditromethamine) Hospira could have been approved for the treatment of malignant pleural mesothelioma and nonsmall-cell lung cancer.
Danish: CHMP mente, at virksomheden kunne have afhjulpet disse betænkeligheder, og var af den foreløbige opfattelse, at Pemetrexed Hospira (som ditromethamin) kunne være blevet godkendt til behandling af kræft i lungehinderne (malignt pleuramesoteliom) og ikke-småcellet lungekræft.
English: Pemetrexed (as ditromethamine) Hospira was expected to be used to treat two types of lung cancer: malignant pleural mesothelioma (a cancer of the lining of the lungs usually caused by exposure to asbestos) and advanced non-small-cell lung cancer of the kind known as ‘non-squamous'.
Danish: Pemetrexed Hospira (som ditromethamin) skulle anvendes til behandling af to typer lungekræft: kræft i lungehinderne (malignt pleuramesoteliom), som typisk skyldes eksponering for asbest, og fremskreden ikke-småcellet lungekræft af typen ikke-pladecellekræft.
English: Pemetrexed (as ditromethamine) Hospira is a cancer medicine that contains the active substance pemetrexed.
Danish: Pemetrexed Hospira (som ditromethamin) er et kræftlægemiddel, der indeholder det aktive stof pemetrexed.
English: It was to be available as a powder to be made up into a solution for infusion (drip) into a vein.
Danish: Det skulle markedsføres som et pulver, der fortyndes til en opløsning, som gives som infusion (drop) i en blodåre.
English: Pemetrexed (as ditromethamine) Hospira was developed as a ‘generic medicine'.
Danish: Pemetrexed Hospira (som ditromethamin) blev udviklet som et "generisk lægemiddel".
English: Pemetrexed (as ditromethamine) Hospira is expected to work in the same way as the reference medicine, Alimta.
Danish: Pemetrexed Hospira (som ditromethamin) forventes at virke på samme måde som referencelægemidlet Alimta.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for this product.
Danish: Virksomheden har til CHMP oplyst, at der aktuelt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse af Pemetrexed Hospira (som ditromethamin) med særlig udleveringstilladelse.
English: What is Pemetrexed (as ditromethamine) Hospira?
Danish: Hvad er Pemetrexed Hospira (som ditromethamin)?
English: What was Pemetrexed (as ditromethamine) Hospira expected to be used for?
Danish: Hvad forventedes Pemetrexed Hospira (som ditromethamin) anvendt til?
English: How does Pemetrexed (as ditromethamine) Hospira work?
Danish: Hvordan virker Pemetrexed Hospira (som ditromethamin)?
English: Further information on Enurev Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Enurev Breezhaler findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency also noted that the fact that the medicine is used once a day may help patients to adhere to their treatment.
Danish: Agenturet bemærkede endvidere, at det, at lægemidlet tages en gang dagligt, kan gøre det lettere for patienterne at overholde behandlingen.
English: Enurev Breezhaler received a marketing authorisation valid throughout the EU on 28 September 2012.
Danish: Enurev Breezhaler fik markedsføringstilladelse med gyldighed i hele EU den 28. september 2012.
English: the main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Danish: undersøgelser blev virkningen hovedsageligt målt på forbedringen af patienternes forcerede ekspirationsvolumen (FEV1, den maksimale luftmængde, en person kan udånde på et sekund).
English: After 12 weeks of treatment, Enurev Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.
Danish: Efter 12 måneders behandling havde Enurev Breezhaler øget FEV1 med 97 ml mere end placebo i den første undersøgelse, og med 108 ml mere i den anden undersøgelse.
English: Patients should not use more than one capsule in a day.
Danish: Patienterne bør højst anvende en kapsel dagligt.
English: What measures are being taken to ensure the safe and effective use of Enurev Breezhaler?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Enurev Breezhaler?
English: Enurev Breezhaler (glycopyrronium bromide) EMA/326865/2018
Danish: Enurev Breezhaler (glycopyrroniumbromid) EMA/326865/2018
English: The most common side effects with Enurev Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting).
Danish: De hyppigste bivirkninger ved Enurev Breezhaler (som optræder hos mere end 1 ud af 100 patienter) er tørhed i munden, nasopharyngitis (betændelse i næse og hals), søvnløshed, muskel- og knoglesmerter og gastroenteritis (diarré og opkast).
English: For more information about using Enurev Breezhaler, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om brugen af Enurev Breezhaler, kan du læse indlægssedlen eller kontakte lægen eller apoteket.
English: As for all medicines, data on the use of Enurev Breezhaler are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Enurev Breezhaler løbende overvåget.
English: This means that it widens the airways by blocking muscarinic receptors (targets) in muscle cells in the lungs.
Danish: Det betyder, at det udvider luftvejene ved at blokere de muskarine receptorer (mål) i muskelceller og lungerne.
English: In addition, there were no major safety concerns with Enurev Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines.
Danish: Desuden var der ingen væsentlige sikkerhedsproblemer forbundet med Enurev Breezhaler, hvis bivirkninger svarer til dem, der er forbundet med andre muskarine receptorantagonistlægemidler.