FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Olanzapine Teva on 12 December 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Olanzapin Teva den 12. december 2007.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine.
Danish: Det menes, at den gavnlige virkning af olanzapin skyldes, at det blokerer receptorerne for neurotransmitternes 5-hydroxytryptamin (også kaldet serotonin) og dopamin.
English: Since these neurotransmitters are involved in schizophrenia and bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Danish: Da disse neurotransmittere er medvirkende til skizofreni og bipolar sygdom, hjælper olanzapin med til at normalisere hjernevirksomheden, hvilket mindsker symptomerne på disse sygdomme.
English: Schizophrenia is a mental illness that has a number of symptoms including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Danish: Skizofreni er en psykisk sygdom, hvis symptomer blandt andet er desorganiseret tankegang og tale, hallucinationer (opfattelsen af at høre eller se ting, som ikke er der), mistænksomhed og vrangforestillinger (forestillinger, der er ude af trit med virkeligheden).
English: The orodispersible tablets, which can be used as an alternative to the tablets, are taken by being placed on the tongue, where they disintegrate quickly in the saliva, or by mixing them in water before swallowing.
Danish: Smeltetabletterne, der kan anvendes som et alternativ til tabletterne, tages ved, at de lægges under tungen, hvor de hurtigt opløses af spyttet, eller ved at man opløser dem i vand, før de tages.
English: For more information about treatment with Olanzapine 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 Olanzapin Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
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 Olanzapine 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 Olanzapin Teva skal anvendes.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Danish: Derved afbrydes de signaler, som hjernecellerne sender til hinanden ved hjælp af "neurotransmittere", dvs. kemiske stoffer, som nervecellerne kommunikerer med indbyrdes.
English: It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness causing alternating periods of high mood and depression) who have responded to an initial course of treatment.
Danish: Det kan også anvendes til at forebygge recidiverende episoder (når symptomerne vender tilbage) hos voksne med bipolar sygdom (en psykisk lidelse, hvor patienten svinger mellem højt humør og depression), som har vist initial behandlingsrespons.
English: Olanzapine Teva is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Danish: Olanzapin Teva anvendes ligeledes til at behandle moderate til svære maniske episoder (ekstremt højt humør) hos voksne.
English: The recommended starting dose of Olanzapine Teva depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Danish: Der anvendes 10 mg om dagen til skizofreni og forebyggelse af maniske episoder og 15 mg om dagen til behandling af maniske episoder, medmindre det anvendes sammen med andre lægemidler.
English: This means that Olanzapine Teva is similar to ‘reference medicines' already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotab.
Danish: Det betyder, at Olanzapin Teva er identisk med ‘referencelægemidler', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Zyprexa og Zyprexa Velotab.
English: Olanzapine Teva is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Danish: Olanzapin Teva er også effektivt i fastholdelsen af den kliniske bedring ved fortsat behandling af patienter, der har vist initial behandlingsrespons.
English: Olanzapine Teva is used to treat adults with schizophrenia.
Danish: Olanzapin Teva anvendes til behandling af voksne med skizofreni.
English: Olanzapine Teva olanzapine
Danish: Olanzapin Teva olanzapin
English: The active substance in Olanzapine Teva, olanzapine, is an antipsychotic medicine.
Danish: Det aktive stof i Olanzapin Teva, olanzapin, er et antipsykotisk lægemiddel.
English: Olanzapine Teva is a medicine containing the active substance olanzapine.
Danish: Olanzapin Teva er et lægemiddel, som indeholder det aktive stof olanzapin.
English: Because Olanzapine Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicines.
Danish: Da Olanzapin Teva er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet.
English: Other information about Olanzapine Teva
Danish: Andre oplysninger om Olanzapin Teva:
English: What are the benefits and risks of Olanzapine Teva?
Danish: Hvilken fordel og risiko er der forbundet med Olanzapin Teva?
English: Olanzapine Teva is a ‘generic medicine'.
Danish: Olanzapin Teva er et ‘generisk lægemiddel'.
English: Because Olanzapine Teva is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as those of the reference medicines.
Danish: Da Olanzapin Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlerne, anses benefit/risk-forholdet for at være det samme som for referencelægemidlerne.
English: The CHMP concluded that, in accordance with EU requirements, Olanzapine Teva has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Olanzapin Teva i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Zyprexa og Zyprexa Velotab.
English: The Committee recommended that Olanzapine Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Olanzapin Teva.
English: Therefore, the CHMP's view was that, as for Zyprexa and Zyprexa Velotab, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Zyprexa og Zyprexa Velotab.
English: Why has Olanzapine Teva been approved?
Danish: Hvorfor er Olanzapin Teva blevet godkendt?
English: What is Olanzapine Teva?
Danish: Hvad er Olanzapin Teva?
English: How has Olanzapine Teva been studied?
Danish: Hvordan er Olanzapin Teva blevet undersøgt?
English: What is Olanzapine Teva used for?
Danish: Hvad anvendes Olanzapin Teva til?
English: How is Olanzapine Teva used?
Danish: Hvordan anvendes Olanzapin Teva?
English: How does Olanzapine Teva work?
Danish: Hvordan virker Olanzapin Teva?
English: The marketing authorisation holder of SoliCol D3 shall provide evidence that the manufacturing process complies with the requirements of Commission Directive 2003/94/EC laying down the principles and guidelines of Good Manufacturing Practice (GMP) as provided for in Article 8(3) of Directive 2001/83/EC.
Danish: For at kunne ophæve suspenderingen af SoliCol D3 skal de kompetente myndigheder sikre, at nedenstående betingelser er opfyldt af indehaveren/indehaverne af markedsføringstilladelsen: Indehaveren af markedsføringstilladelsen for SoliCol D3 skal dokumentere, at fremstillingsprocessen opfylder kravene i Kommissionens direktiv 2003/94/EF om principper og retningslinjer for god fremstillingspraksis som foreskrevet i artikel 8, stk. 3, i direktiv 2001/83/EF.
English: Conditions for lifting the suspension of the marketing authorisation(s)
Danish: Betingelser for ophævelse af suspenderingen af markedsføringstilladelsen/tilladelserne
English: Annex III Conditions for lifting the suspension of the marketing authorisation(s)
Danish: Bilag III Betingelser for ophævelse af suspenderingen af markedsføringstilladelsen/-tilladelserne
English: The full EPAR for Erelzi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Erelzi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Over 70% of those given Erelzi (186 of 264 patients) and roughly 72% of those given Enbrel (191 of 267) had at least 75% reduction in their symptom score after 12 weeks of treatment, which was the main measure of effectiveness.
Danish: Over 70 % af dem, der fik Erelzi (186 af 264 patienter) og ca. 72 % af dem, der fik Enbrel (191 af 267), fik reduceret deres symptomscore med mindst 75 % efter 12 ugers behandling, hvilket var det væsentligste effektmål.
English: This is a summary of the European public assessment report (EPAR) for Erelzi.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Erelzi.
English: In children, the dose will depend on body weight.
Danish: Hos børn afhænger dosis af legemsvægten.
English: In adults, the usual recommended dose is 25 mg twice a week or 50 mg once a week.
Danish: Den anbefalede dosis til voksne er normalt 25 mg to gange ugentligt eller 50 mg én gang ugentligt.
English: This means that Erelzi 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 Erelzi meget nøje svarer til et biologisk lægemiddel ("referencelægemidlet"), som allerede er godkendt i Den Europæiske Union (EU).
English: Erelzi was also shown to be as effective as Enbrel in one main study involving 531 adults with plaque psoriasis.
Danish: Erelzi er desuden påvist at være lige så effektivt som Enbrel i én hovedundersøgelse med 531 voksne med plaque psoriasis.
English: Erelzi is mostly used when these conditions are severe or moderately severe, or when other treatments have not worked well enough or cannot be used.
Danish: Erelzi anvendes hovedsagelig, når disse sygdomme er svære til moderat svære, eller når andre behandlinger ikke har virket godt nok eller ikke kan anvendes.
English: Other information about Erelzi
Danish: Andre oplysninger om Erelzi
English: What measures are being taken to ensure the safe and effective use of Erelzi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Erelzi?
English: The educational materials also include a reminder that Erelzi is not for use in children and adolescents who weigh less than 62.5 kg.
Danish: Informationsmaterialet skal også indeholde en påmindelse om, at Erelzi ikke er til brug hos børn og unge, der vejer under 62,5 kg.
English: The Committee recommended that Erelzi be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Erelzi.
English: What is Erelzi and what is it used for?
Danish: Hvad er Erelzi, og hvad anvendes det til?
English: The reference medicine for Erelzi is Enbrel.
Danish: Referencelægemidlet for Erelzi er Enbrel.
English: Treatment with 50 mg twice a week can also be used during the first 12 weeks of treatment for plaque psoriasis.
Danish: Til behandling af plaque psoriasis kan der også gives 50 mg to gange om ugen i de første 12 uger af behandlingen.
English: It is not intended to provide practical advice on how to use Erelzi.
Danish: Det er ikke en praktisk vejledning i, hvordan Erelzi bør anvendes.
English: Because Erelzi is a biosimilar medicine, the studies on effectiveness and safety of etanercept carried out with Enbrel do not all need to be repeated for Erelzi.
Danish: Da Erelzi er et biosimilært lægemiddel, behøver de undersøgelser af virkning og sikkerhed af etanercept, der er udført for Enbrel, ikke gentages for Erelzi.
English: Why is Erelzi approved?
Danish: Hvorfor blev Erelzi godkendt?
English: Patients developing a serious infection should stop Erelzi treatment.
Danish: Patienter, der får en alvorlig infektion, skal stoppe med at tage Erelzi.
English: The most common side effects with etanercept (seen in more than 1 patient in 10) 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 med etanercept (som forekommer hos mere end 1 ud af 10 patienter) er reaktioner på injektionsstedet (herunder blødning, rødme, kløe, smerte og hævelse) og infektioner (herunder forkølelse og lunge-, blære- og hudinfektioner).
English: Therefore, the CHMP's view was that, as for Enbrel, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Enbrel.
English: Erelzi 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 active infections.
Danish: Erelzi må ikke anvendes hos patienter, der har risiko for blodforgiftning (sepsis, hvor bakterier og giftstoffer cirkulerer i blodet og begynder at beskadige organerne) eller hos patienter med aktive infektioner.
English: What are the risks associated with Erelzi?
Danish: Hvilke risici er der forbundet med Erelzi?
English: The injection is given under the skin and the patient or their carer can give the injection if they have been trained appropriately.
Danish: Injektionen gives under huden, og injektionen kan gives af patienten eller dennes omsorgsgiver efter tilstrækkelig oplæring.
English: The company that markets Erelzi will provide educational material for doctors expected to prescribe the product to teach patients how to use the pre-filled pen correctly and a special alert card for patients so they can recognise serious side effects and know when to seek urgent attention from their doctor.
Danish: Virksomheden, der markedsfører Erelzi, vil udlevere informationsmateriale til læger, der forventes at ordinere produktet, med henblik på, at de kan instruere patienterne i, hvordan man bruger den fyldte pen korrekt, og et særligt advarselskort til patienterne, der sætter dem i stand til at genkende alvorlige bivirkninger og vide, hvornår de skal søge akut lægehjælp.
English: For more information on biosimilar medicines, see here.
Danish: Yderligere oplysninger om biosimilære lægemidler findes her.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Erelzi has been shown to have a comparable quality, safety and effectiveness to Enbrel.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Erelzi og Enbrels kvalitet, sikkerhed og virkning svarer til hinanden.
English: Erelzi is not for use in children who need doses other than 25 or 50 mg (e.g. those weighing less than 62.5 kg), because it is only available in these doses; an alternative product should be used in such children.
Danish: Erelzi er ikke til brug hos børn, der behøver andre doser end 25 eller 50 mg (f.eks. dem, der vejer under 62,5 kg), da det kun fås i disse doser.
English: Treatment is started and supervised by specialised doctors with experience in diagnosing and treating the diseases Erelzi is used for.
Danish: Behandlingen påbegyndes og overvåges af speciallæger med erfaring i diagnosticering og behandling af de sygdomme, som Erelzi anvendes til.
English: Erelzi is an anti-inflammatory medicine for treating the following diseases:
Danish: Erelzi er et betændelseshæmmende lægemiddel til behandling af følgende sygdomme:
English: This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Erelzi is used to treat.
Danish: Dette stof er en medvirkende årsag til betændelse og findes i høje koncentrationer hos patienter med de sygdomme, som Erelzi anvendes til.
English: Laboratory studies comparing Erelzi with Enbrel have shown that the active substance in Erelzi is highly similar to that in Enbrel in terms of structure, purity and biological activity.
Danish: Laboratorieundersøgelser, der sammenligner Erelzi med Enbrel, har vist, at det aktive stof i Erelzi i meget høj grad svarer til det aktive stof i Enbrel hvad angår struktur, renhed og biologisk aktivitet.
English: The active substance in Erelzi, etanercept, is a protein that has been designed to block the activity of a substance called tumour necrosis factor alpha (TNF).
Danish: Det aktive stof i Erelzi, etanercept, er et protein, der er udformet, så det blokerer aktiviteten af stoffet tumornekrosefaktor alfa (TNF).
English: By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
Danish: Ved at blokere TNF reducerer dette aktive stof betændelsen og de andre symptomer på sygdommene.
English: Studies were carried out to show that Erelzi produces similar levels of the active substance in the body to Enbrel.
Danish: Der er udført undersøgelser, der viser, at Erelzi frembringer samme mængde aktivt stof i kroppen som Enbrel.
English: For more information about treatment with Erelzi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Erelzi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For detailed information on the use of Erelzi in all conditions, see the summary of product characteristics (also part of the EPAR).
Danish: Nærmere oplysninger om anvendelsen af Erelzi til alle sygdomme fremgår af produktresuméet (også en del af denne EPAR).
English: • plaque psoriasis (a disease causing red, scaly patches on the skin) in adults and children;
Danish: • plaque psoriasis (en sygdom, der giver røde, skællende pletter på huden) hos voksne og børn
English: How is Erelzi used?
Danish: Hvordan anvendes Erelzi?
English: What benefits of Erelzi have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Erelzi?
English: For practical information about using Erelzi, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Erelzi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: • axial spondyloarthritis (a chronic inflammatory disease of the spine) in adults when there are no abnormalities seen on x-ray.
Danish: • kronisk betændelsestilstand i rygsøjlen (aksial spondyloarthritis) hos voksne, hvor der intet unormalt ses på røntgen.
English: • rheumatoid arthritis (a disease causing inflammation of the joints) in adults, used with another medicine, methotrexate, or alone;
Danish: • leddegigt (rheumatoid arthritis) hos voksne, anvendt enten sammen med et andet lægemiddel,
English: Erelzi is available as prefilled syringes and pens containing a solution for injection.
Danish: Erelzi fås som fyldte sprøjter og penne, der indeholder en injektionsvæske, opløsning.
English: • certain forms of juvenile idiopathic arthritis (diseases causing inflammation in the joints, with first appearance in childhood or adolescence);
Danish: • visse former af gigtsygdomme, der optræder første gang, når man er barn eller ung (juvenil idiopatisk arthritis)
English: • psoriatic arthritis (psoriasis with inflammation of the joints) in adults and adolescents;
Danish: • psoriasisgigt (psoriatisk arthritis) hos voksne og unge
English: For the full list of all side effects reported with Erelzi, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Erelzi fremgår af indlægssedlen.
English: How does Erelzi work?
Danish: Hvordan virker Erelzi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Erelzi have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Erelzi.
English: Erelzi contains the active substance etanercept and is a ‘biosimilar medicine'.
Danish: Erelzi er et "biosimilært" lægemiddel.
English: • ankylosing spondylitis (a disease causing inflammation of the joints of the spine) in adults;
Danish: • Bechterews sygdom (ankyloserende spondylitis), der medfører betændelse og smerter i leddene i rygsøjlen hos voksne
English: This summary was last updated in October 2016.
Danish: Dette sammendrag blev sidst ajourført i oktober 2016.
English: This effect increases with higher doses and/or repeated treatments.
Danish: Denne effekt øges ved stigende doser og/eller gentagne behandlinger.
English: The full EPAR for VarroMed can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for VarroMed findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: VarroMed is irritating to the skin and eyes.
Danish: VarroMed virker irriterende på hud og øjne.
English: Heavily contaminated clothes should be changed immediately and washed before re-use.
Danish: Stærkt forurenet tøj skal skiftes snarest muligt og vaskes, før det bruges igen.
English: This is a summary of the European public assessment report (EPAR) for VarroMed.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for VarroMed.
English: People must not eat, drink or smoke while using the medicine.
Danish: Der må ikke spises, drikkes eller ryges under brugen af dette veterinærlægemiddel.
English: The withdrawal period is the time required after administration of a medicine before honey may be used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter administration af et lægemiddel, før honningen kan anvendes til menneskeligt konsum.
English: The European Commission granted a marketing authorisation valid throughout the EU for VarroMed on 2 February 2017.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for VarroMed den 02/02/2017.
English: In each location 20 test groups were compared to 12 control groups treated with flumethrin (another medicine effective against parasites).
Danish: Hvert sted blev 20 testgrupper sammenlignet med 12 kontrolgrupper, der blev behandlet med flumethrin (et andet virksomt lægemiddel mod parasitter).
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that VarroMed's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved VarroMed opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.