FrancophonIA/ELRC3.0 huggingface dataset:
English: Emdocam is a ‘generic' medicine which means that Emdocam is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam).
Danish: Emdocam er et "generisk lægemiddel", hvilket betyder, at Emdocam svarer til et "referenceveterinærlægemiddel", som allerede er godkendt i EU (Metacam).
English: Emdocam was considered to be bioequivalent with the reference medicine.
Danish: Emdocam blev anset for at være bioækvivalent med referencelægemidlet.
English: In cattle it is used together with appropriate antibiotics, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways) and to treat acute mastitis (inflammation of the udder).
Danish: Hos kvæg anvendes det sammen med passende antibiotikabehandling for at reducere kliniske symptomer på akut respiratorisk infektion (infektion i lunger og luftveje) og for at behandle akut mastitis (yverbetændelse).
English: Consequently, Emdocam's benefit is taken as being the same as that of the reference medicine.
Danish: Derfor anses fordelene ved Emdocam for at være de samme som fordelene ved referencelægemidlet.
English: Why has Emdocam been approved?
Danish: Hvorfor blev Emdocam godkendt?
English: Emdocam is ‘bioequivalent' to the reference medicine which means that it is equivalent to Metacam in the way it is absorbed and used by the body.
Danish: Emdocam er "bioækvivalent" med referencelægemidlet, hvilket betyder, at det optages og udnyttes i kroppen på samme måde som Metacam.
English: What is Emdocam?
Danish: Hvad er Emdocam?
English: Emdocam is used in horses to relieve colic (abdominal pain) and the inflammation and pain in musculo-skeletal disorders.
Danish: Emdocam anvendes hos heste til lindring af kolik (mavesmerter) samt betændelse og smerter i forbindelse med lidelser i bevægeapparatet.
English: Emdocam is given in cattle as a single injection of 0.5 mg per kg body weight under the skin or into a vein.
Danish: Emdocam gives hos kalve som en enkelt injektion af 0,5 mg pr. kg kropsvægt under huden eller i en vene.
English: What is Emdocam used for?
Danish: Hvad anvendes Emdocam til?
English: It is given as a single injection of 0.4 mg per kg body weight into a muscle.
Danish: Det gives som en enkelt injektion i en muskel af 0,4 mg pr. kg kropsvægt.
English: Emdocam is given as a single injection of 0.6 mg per kg body weight into the horse's vein.
Danish: Emdocam gives som en enkelt injektion af 0,6 mg pr. kg kropsvægt i en af hestens vener.
English: The CVMP considered that, in accordance with European Union requirements, Emdocam is bioequivalent to Metacam.
Danish: CVMP var af den opfattelse, at Emdocam er bioækvivalent med Metacam, i overensstemmelse med EU's krav.
English: How has Emdocam been studied?
Danish: Hvordan blev Emdocam undersøgt?
English: What benefit has Emdocam shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Emdocam?
English: How does Emdocam work?
Danish: Hvordan virker Emdocam?
English: It is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Danish: Det kaldes et "atypisk" antipsykotisk lægemiddel, fordi det adskiller sig fra de ældre antipsykotiske lægemidler, der har været på markedet siden 1950'erne.
English: The dose is adjusted depending on how well the patient responds to and tolerates the treatment.
Danish: Dosis justeres afhængigt af, hvor god patientens respons er, og hvor godt patienten tåler behandlingen.
English: The full EPAR for Olanzapine Cipla can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Olanzapine Cipla findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Previously known as Olanzapine Neopharma.
Danish: Tidligere kendt som Olanzapine Neopharma.
English: This is a summary of the European public assessment report (EPAR) for Olanzapine Cipla.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Olanzapine Cipla.
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 sindssygdom med en række symptomer, herunder 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: 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 de to neurotransmittere 5-hydroxytryptamin (også kaldet serotonin) og dopamin.
English: The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Neopharma on 14 November 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vasovist den 14. november 2007.
English: The recommended starting dose of Olanzapine Cipla 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: Den anbefalede startdosis af Olanzapine Cipla afhænger af, hvilken sygdom der behandles: 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: Patients over 65 years of age and patients who have problems with their liver or kidneys may need a lower starting dose of 5 mg per day.
Danish: Patienter over 65 år og patienter, som har problemer med deres lever eller nyrer, skal muligvis
English: For more information about treatment with Olanzapine Cipla, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Olanzapine Cipla, 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 Cipla.
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,
English: This means that Olanzapine Cipla is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zyprexa.
Danish: Det betyder, at Olanzapine Cipla er identisk med et ”referencelægemiddel”, som allerede er godkendt i Den Europæiske Union (EU), og som hedder Zyprexa.
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 bipolær lidelse, hjælper olanzapin med til at normalisere hjernevirksomheden, hvilket mindsker symptomerne på disse
English: The CHMP concluded that, in accordance with EU requirements, Olanzapine Cipla has been shown to have comparable quality and to be bioequivalent to Zyprexa.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Olanzapine Cipla er af sammenlignelig kvalitet og er bioækvivalent med Zyprexa.
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 endvidere anvendes til at forebygge tilbagefald af sådanne episoder ved bipolar sygdom (en psykisk lidelse, der forårsager skiftende perioder med henholdsvis højt humør og depression) hos voksne, der har responderet på det første behandlingsforløb.
English: Olanzapine Cipla is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Danish: Olanzapine Cipla anvendes også til behandling af moderate til svære maniske episoder (ekstremt højt humør) hos voksne.
English: Olanzapine Cipla is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Danish: Olanzapine Cipla er også effektivt til at fastholde den kliniske bedring ved fortsat behandling af patienter, der har vist initial behandlingsrespons.
English: The active substance in Olanzapine Cipla, olanzapine, is an antipsychotic medicine.
Danish: Det aktive stof i Olanzapine Cipla , olanzapin, er et antipsykotisk lægemiddel.
English: Olanzapine Cipla is used to treat adults with schizophrenia.
Danish: Olanzapine Cipla anvendes til behandling af voksne med skizofreni.
English: What are the benefits and risks of Olanzapine Cipla?
Danish: Hvilken fordel og risiko er der forbundet med Olanzapine Cipla?
English: Therefore, the CHMP's view was that, as for Zyprexa, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici ligesom for Zyprexa.
English: Olanzapine Cipla is a medicine that contains the active substance olanzapine.
Danish: Olanzapine Cipla er et lægemiddel, som indeholder det aktive stof olanzapin.
English: Olanzapine Cipla is a ‘generic medicine'.
Danish: Olanzapine Cipla er et ‘generisk lægemiddel'.
English: Because Olanzapine Cipla is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Danish: Da Olanzapine Cipla er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The name of the medicine was changed to Olanzapine Cipla on 16 May 2013.
Danish: Lægemidlets navn blev ændret til Olanzapine Cipla den
English: For more information on generic medicines, see the question-and-answer document here.
Danish: Der kan indhentes yderligere oplysninger om generiske lægemidler i dokumentet med
English: How is Olanzapine Cipla used?
Danish: Hvordan anvendes Olanzapine Cipla?
English: Because Olanzapine Cipla is a generic medicine, studies in patients have been limited to tests to demonstrate that it is bioequivalent to the reference medicine, Zyprexa.
Danish: Da Olanzapine Cipla er et generisk lægemiddel, har patientundersøgelserne været begrænset til test for at påvise, at det er bioækvivalent med referencelægemidlet Zyprexa To lægemidler er bioækvivalente, når de danner den samme mængde af det aktive stof i kroppen.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: Det gældende produktresumé og den gældende etikettering og indlægsseddel er de endelige versioner, der er opnået under koordinationsgruppeproceduren.
English: The full EPAR for Ongentys can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ongentys 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 Ongentys.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ongentys.
English: Ongentys must not be used in:
Danish: Ongentys må ikke anvendes til:
English: Both studies were extended for one additional year and confirmed the benefits of Ongentys when used long-term.
Danish: Begge undersøgelser blev forlænget i et yderligere år og bekræftede fordelene ved Ongentys, når det benyttes på langt sigt.
English: Among these, dyskinesia (difficulty controlling movement) may affect around 2 in 10 people.
Danish: Blandt disse kan dyskinesi (ukontrollerbare bevægelser) forekomme hos op til 2 ud af 10 personer.
English: In both studies, patients had on average off periods of about 6 to 7 hours at the start of the study.
Danish: I begge undersøgelser havde patienterne gennemsnitligt "off-perioder" på cirka 6-7 timer ved starten af undersøgelsen.
English: The benefits of Ongentys in Parkinson's disease were investigated in two main studies.
Danish: Fordelene ved Ongentys ved Parkinsons sygdom blev undersøgt i to hovedundersøgelser.
English: Fluctuations happen when the effects of the medication wear off and symptoms re-emerge before the next dose is due.
Danish: Fluktuationer forekommer, når lægemidlets virkning aftager, og symptomerne vender tilbage, inden den næste dosis skal tages.
English: What measures are being taken to ensure the safe and effective use of Ongentys?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ongentys?
English: Other information about Ongentys
Danish: Andre oplysninger om Ongentys
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ongentys's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Ongentys opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Ongentys is available as capsules (25 mg and 50 mg) to be taken by mouth.
Danish: Ongentys fås som kapsler (25 mg og 50 mg), der tages gennem munden.
English: Ongentys contains the active substance opicapone.
Danish: Ongentys indeholder det aktive stof opicapon.
English: Ongentys is used when these fluctuations cannot be treated with the standard levodopa-containing combinations alone.
Danish: Ongentys benyttes, når disse fluktuationer ikke kan behandles alene ved hjælp af standardkombinationen indeholdende levodopa.
English: Ongentys opicapone
Danish: Ongentys opicapon
English: Regarding its safety, Ongentys was considered to be comparable to other medicines of the same class.
Danish: Ongentys sikkerhed blev vurderet til at være sammenlignelig med andre lægemidler i den samme klasse.
English: This study looked at how well the treatments reduced the time when patients have more difficulty moving about, called ‘off periods'.
Danish: I denne undersøgelse blev det registreret, hvor godt behandlingerne nedsatte de perioder, hvor patienterne har vanskeligt ved at bevæge sig, de såkaldte "off-perioder".
English: What is Ongentys and what is it used for?
Danish: Hvad er Ongentys, og hvad anvendes det til?
English: The recommended dose is 50 mg, taken once a day at bedtime, at least one hour before or after levodopa combination medicines.
Danish: Den anbefalede dosis er 50 mg taget én gang dagligt ved sengetid mindst én time før eller efter lægemidler med levodopakombinationen.
English: It is not intended to provide practical advice on how to use Ongentys.
Danish: Det er ikke en praktisk vejledning i, hvordan Ongentys bør anvendes.
English: This helps to improve the symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Danish: Dette mindsker symptomerne på Parkinsons sygdom som f.eks. stivhed og langsomme bevægelser.
English: Why is Ongentys approved?
Danish: Hvorfor blev Ongentys godkendt?
English: It enhances the effects of levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth.
Danish: Det forstærker virkningen af levodopa, der er en kopi af neurotransmitteren dopamin, som kan tages gennem munden.
English: • patients with a history of neuroleptic malignant syndrome (a nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres);
Danish: • patienter med tidligere malignt neuroleptikasyndrom (en farlig nervesygdom, sædvanligvis forårsaget af antipsykotiske lægemidler) eller rhabdomyolyse (nedbrydning af muskelfibrene)
English: The active substance in Ongentys, opicapone, works to restore the levels of dopamine in the parts of the brain that control movement and coordination.
Danish: Det aktive stof i Ongentys, opicapon, genopretter indholdet af dopamin i de dele af hjernen, der styrer bevægelser og koordination.
English: For more information about treatment with Ongentys, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ongentys, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In the second study, which also looked at the reduction in off periods, Ongentys was compared with placebo in 427 patients who were taking a levodopa / DDCI combination.
Danish: I den anden undersøgelse, som også undersøgte reduktionen i "off-perioder" blev Ongentys sammenlignet med placebo hos 427 patienter, som fik en levodopa-/DDCI-kombination.
English: Ongentys was shown to be more effective than placebo and at least as effective as the comparator entacapone in reducing off periods in patients with Parkinson's disease taking levodopa combination medicines.
Danish: Det blev påvist, at Ongentys var mere effektivt end placebo og mindst lige så effektivt som komparatoren entacapon til at reducere "off-perioder" hos patienter med Parkinsons sygdom, som tager lægemidler med levodopakombinationen.
English: The most common side effects with Ongentys are disorders of the nervous system (brain and spinal cord).
Danish: De hyppigste bivirkninger ved Ongentys er symptomer fra nervesystemet (hjerne og rygmarv).
English: Ongentys is used as an add-on to levodopa / DOPA decarboxylase inhibitors (DDCI) (other medicines for Parkinson's disease) in patients who are having fluctuations in the control of their condition.
Danish: Ongentys benyttes som et supplement til levodopa/DOPA-decarboxylasehæmmere (DDCI) (andre lægemidler mod Parkinsons sygdom) hos patienter, som har fluktuationer i kontrollen af deres tilstand.
English: Ongentys is a medicine used to treat adults with Parkinson's disease, a progressive brain disorder that causes shaking and muscle stiffness, and slows movement.
Danish: Ongentys er et lægemiddel, der anvendes til behandling af voksne patienter med Parkinsons sygdom, som er en fremadskridende hjernesygdom, der medfører rysten, langsomme bevægelser og muskelstivhed.
English: In the first study, 600 patients with fluctuations were given Ongentys, entacapone (another medicine for Parkinson's disease) or placebo (a dummy treatment), in addition to their current levodopa / DDCI combination.
Danish: I den første undersøgelse fik 600 patienter med fluktuationer Ongentys, entacapon (et andet lægemiddel mod Parkinsons sygdom) eller placebo (en inaktiv behandling) som et supplement til deres aktuelle levodopa-/DDCI-kombination.
English: What are the risks associated with Ongentys?
Danish: Hvilke risici er der forbundet med Ongentys?
English: After 14-15 weeks, off periods were shortened by 119 minutes (almost 2 hours) in patients taking Ongentys 50 mg, compared with 64 minutes in patients taking placebo.
Danish: Efter 14-15 uger blev "off-perioderne" afkortet med 119 minutter (næsten 2 timer) hos patienter, der fik Ongentys 50 mg sammenlignet med 64 minutter hos patienter, der fik placebo.
English: For practical information about using Ongentys, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ongentys, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Opicapone blocks an enzyme that is involved in the breakdown of levodopa in the body called catechol-O-methyl transferase (COMT).
Danish: Opicapon blokerer et enzym kaldet catechol-O-methyltransferase (COMT), som medvirker ved nedbrydningen af levodopa i kroppen.
English: After 14-15 weeks, off periods were shortened by 117 minutes (almost 2 hours) in patients taking Ongentys 50 mg, compared with 96 minutes (about 1 and a half hour) in patients taking the comparator medicine entacapone and 56 minutes (less than 1 hour) in patients taking placebo.
Danish: Efter 14-15 uger blev "off-perioderne” afkortet med 117 minutter (næsten to timer) hos patienter, der fik Ongentys 50 mg sammenlignet med 96 minutter (cirka halvanden time) hos patienter, der fik komparatorlægemidlet entacapon og 56 minutter (under en time) hos patienter, der fik placebo.
English: They are linked to a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulty moving about.
Danish: Dette skyldes den aftagende virkning af levodopa, hvor patienten oplever pludselige skift mellem "on-perioder", hvor patienten kan bevæge sig, og "off-perioder", hvor patienten har svært ved at bevæge sig.
English: How is Ongentys used?
Danish: Hvordan anvendes Ongentys?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ongentys 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 sikker og effektiv brug af Ongentys.
English: For the full list of all side effects reported with Ongentys, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Ongentys fremgår af indlægssedlen.
English: How does Ongentys work?
Danish: Hvordan virker Ongentys?
English: What benefits of Ongentys have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ongentys?
English: • patients with tumours of the adrenal glands (small glands located on top of the kidneys) such as pheochromocytoma and paraganglioma;
Danish: • patienter med tumorer i binyrerne (små kirtler der sidder øverst oppe på nyrerne) som f.eks.
English: • patients taking medicines known as non-selective monoamine oxidase (MAO) inhibitors except when used to treat Parkinson's disease.
Danish: • patienter, der tager lægemidler kendt som non-selektive monoaminoxidasehæmmere (MAO),
English: - if you are a woman.
Danish: - hvis du er en kvinde.
English: Therefore the use of such combinations is not recommended.
Danish: Anvendelse af sådanne kombinationer anbefales derfor ikke.
English: - if you have low blood pressure.
Danish: - hvis du har lavt blodtryk.
English: However, due to high inter-subject variability, these differences were not statistically significant.
Danish: På grund af høj interpersonvariabilitet er disse forskelle imidlertid ikke statistisk signifikante.
English: It is not possible to determine whether these events are related directly to these factors or to other factors.
Danish: Det er ikke muligt at fastslå, om disse hændelser er relateret direkte til disse faktorer eller andre faktorer.
English: ● Risk Management Plan (RMP) Not applicable.
Danish: • Risikostyringsplan (RMP) Ikke relevant.
English: Children and adolescents This medicine should NOT be given to children and adolescents under the age of 18.
Danish: Børn og unge Dette lægemiddel bør IKKE gives til børn og unge under 18 år.
English: Do not use nitrates to treat your chest pain.
Danish: - Tag ikke nitrater til at behandle dine smerter i brystet.
English: Alcoholic drink can make erection difficulties worse.
Danish: Indtagelse af alkohol kan gøre erektionsvanskeligheder værre.
English: - if you are taking riociguat.
Danish: - Hvis du tager riociguat.
English: If this occurs during or after intercourse: Get in a semi-sitting position and try to relax.
Danish: Hvis dette sker under eller efter samleje: - Sæt dig op i en tilbagelænet stilling og prøv at slappe af.
English: The maximum recommended dose is 100 mg.
Danish: Den anbefalede maksimale dosis er 100 mg.