FrancophonIA/ELRC3.0 huggingface dataset:
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 midler, der har været på markedet siden 1950'erne.
English: Olazax olanzapine
Danish: Olazax olanzapin
English: This is a summary of the European public assessment report (EPAR) for Olazax.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Olazax.
English: The European Commission granted a marketing authorisation valid throughout the EU for Olazax on 11 December 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Olazax den 11. december 2009.
English: It is available as tablets (5, 7.5 10, 15 and 20 mg).
Danish: Det fås som tabletter (5 mg, 7,5 mg, 10 mg, 15 mg og 20 mg).
English: The full EPAR for Olazax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Olanzapin Glenmark findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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 symptomer, der blandt andet består i 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 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 Olazax.
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 Olazax skal anvendes.
English: This means that Olazax is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zyprexa.
Danish: Det betyder, at Olazax 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 in bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Danish: Da disse neurotransmittere spiller en aktiv rolle ved skizofreni og ved bipolar sygdom, medvirker olanzapin til at normalisere hjerneaktiviteten, så sygdomssymptomerne mindskes.
English: Olazax is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Danish: Olazax anvendes endvidere til at behandle moderate til svære maniske episoder (ekstremt højt humør) hos voksne.
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: The recommended starting dose of Olazax 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: Other information about Olazax
Danish: Andre oplysninger om Olazax
English: Olazax is used to treat adults with schizophrenia.
Danish: Olazax anvendes til behandling af voksne med skizofreni.
English: What are the benefits and risks of Olazax shown during the studies?
Danish: Hvilken fordel og risiko viser undersøgelserne, at der er ved Olazax?
English: Olazax is a ‘generic medicine'.
Danish: Olazax er et »generisk lægemiddel«.
English: Olazax is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Danish: Olazax er også effektivt i fastholdelsen af den kliniske bedring ved fortsat behandling af patienter, der har reageret på den indledende behandling.
English: The CHMP concluded that, in accordance with EU requirements, Olazax 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 Olazax er af sammenlignelig kvalitet og er bioækvivalent med Zyprexa.
English: The active substance in Olazax, olanzapine, is an antipsychotic medicine.
Danish: Det aktive stof i Olazax, olanzapin, er et antipsykotisk lægemiddel.
English: The dose is adjusted according to how well the patient responds to and tolerates the treatment.
Danish: Dosis justeres alt efter, hvordan medicinen virker, og hvor godt den tåles af patienten.
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 with alternating periods of high mood and depression) who have responded to an initial course of treatment.
Danish: Det kan endvidere anvendes til at forhindre tilbagevenden af sådanne episoder ved bipolar sygdom (en psykisk lidelse, hvor patienten svinger mellem højt humør og depression) hos voksne, der har reageret på den indledende behandling.
English: Olazax is a medicine containing the active substance olanzapine.
Danish: Olazax er et lægemiddel, som indeholder det aktive stof olanzapin.
English: The Committee recommended that Olazax be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Olazax.
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 som for Zyprexa.
English: Because Olazax 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.
Danish: Da Olazax er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: For more information about treatment with Olazax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.This summary was last updated in 07-2014.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Olazax, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Because Olazax is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Zyprexa.
Danish: Da Olazax er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Zyprexa.
English: Why has Olazax been approved?
Danish: Hvorfor blev Olazax godkendt?
English: What is Olazax?
Danish: Hvad er Olazax?
English: How has Olazax been studied?
Danish: Hvordan blev Olazax undersøgt?
English: What is Olazax used for?
Danish: Hvad anvendes Olazax til?
English: How is Olazax used?
Danish: Hvordan anvendes Olazax?
English: How does Olazax work?
Danish: Hvordan virker Olazax?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Teva on 20 April 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Capecitabine Teva den 20. april 2012.
English: The full EPAR for Capecitabine Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Capecitabine Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is available as tablets (150 and 500 mg).
Danish: Det fås som tabletter (150 og 500 mg).
English: Capecitabine Teva is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight).
Danish: Capecitabine Teva tages to gange dagligt i doser mellem 625 og 1 250 mg pr. kvadratmeter legemsoverflade (beregnet ved anvendelse af patientens højde og vægt).
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 Capecitabine 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 anvendelsesbetingelserne for Capecitabine Teva.
English: The doctor will calculate the number of 150 and 500 mg tablets the patient needs to take.
Danish: Lægen beregner det antal tabletter på 150 mg og 500 mg, som patienten skal tage.
English: Capecitabine Teva tablets should be swallowed with water within the 30 minutes after a meal.
Danish: Capecitabine Teva-tabletterne sluges hele med vand inden for 30 minutter efter et måltid.
English: This is a summary of the European public assessment report (EPAR) for Capecitabine Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Capecitabine Teva.
English: For more information about treatment with Capecitabine 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 Capecitabine Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: As a result, it inhibits the growth of tumour cells and eventually kills them.
Danish: Derved hæmmes væksten af kræftcellerne, der til sidst dør.
English: Full details are available in the summary of product characteristics (also part of the EPAR).
Danish: De fuldstændige oplysninger herom fremgår af produktresuméet (også er en del af EPAR).
English: This means that Capecitabine Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Xeloda.
Danish: Det betyder, at Capecitabine Teva er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union, og som hedder Xeloda.
English: What are the benefits and risks of Capecitabine Teva?
Danish: Hvilke fordele og risici er der forbundet med Capecitabine Teva?
English: The CHMP concluded that, in accordance with EU requirements, Capecitabine Teva has been shown to have comparable quality and to be bioequivalent to Xeloda.
Danish: CHMP konkluderede, at Capecitabine Teva i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Xeloda.
English: Other information about Capecitabine Teva
Danish: Andre oplysninger om Capecitabine Teva
English: EPAR summary for the public capecitabine
Danish: EPAR sammendrag for offentligheden capecitabin
English: Capecitabine Teva is used with or without other anticancer medicines;
Danish: Capecitabine Teva anvendes med eller uden andre lægemidler mod kræft,
English: Because Capecitabine Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Xeloda.
Danish: Da Capecitabine Teva er et generisk lægemiddel, har patientundersøgelserne været begrænset til tests for at påvise, at det er bioækvivalent med referencelægemidlet, Xeloda.
English: Capecitabine Teva is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Danish: Capecitabine Teva kan anvendes med eller uden andre midler mod kræft til patienter, der er opereret for tyktarmskræft i ‘stadium III' eller ‘Dukes' stadium C',
English: Capecitabine Teva should only be prescribed by a doctor who is qualified in the use of anticancer medicines.
Danish: Capecitabine Teva må kun ordineres af en læge, som er specialiseret i brug af lægemidler mod kræft.
English: The Committee recommended that Capecitabine Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af en markedsføringstilladelse for Capecitabine Teva.
English: The active substance in Capecitabine Teva, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Danish: Det aktive stof i Capecitabine Teva, capecitabin, er et cytotoksisk lægemiddel (et lægemiddel, som dræber celler, der deler sig såsom kræftceller) og tilhører gruppen af ‘antimetabolitter' (stofskiftehæmmere).
English: Capecitabine Teva is a medicine that contains the active substance capecitabine.
Danish: Capecitabine Teva er et lægemiddel, der indeholder det aktive stof capecitabin.
English: Because Capecitabine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Capecitabine Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Capecitabine Teva is a ‘generic medicine'.
Danish: Capecitabine Teva er et ‘generisk lægemiddel'.
English: Capecitabine Teva is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Danish: Capecitabine Teva anvendes sammen med andre lægemidler mod kræft, herunder et platinholdigt kræftmiddel såsom cisplatin,
English: Capecitabine Teva is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Danish: Capecitabine Teva anvendes her sammen med docetaxel (et andet lægemiddel mod kræft) efter svigt af antracykliner (en anden form for lægemiddel mod kræft).
English: Why has Capecitabine Teva been approved?
Danish: Hvorfor blev Capecitabine Teva godkendt?
English: How has Capecitabine Teva been studied?
Danish: Hvordan blev Capecitabine Teva undersøgt?
English: What is Capecitabine Teva?
Danish: Hvad er Capecitabine Teva?
English: Capecitabine Teva is an anticancer medicine.
Danish: Capecitabine Teva er et lægemiddel mod kræft.
English: What is Capecitabine Teva used for?
Danish: Hvad anvendes Capecitabine Teva til?
English: How is Capecitabine Teva used?
Danish: Hvordan anvendes Capecitabine Teva?
English: How does Capecitabine Teva work?
Danish: Hvordan virker Capecitabine Teva?
English: Steady-state is reached within one week.
Danish: Steady-state nås inden for én uge.
English: Ask your doctor for advice prior to driving or using machines.
Danish: Spørg din læge til råds, inden du kører bil eller betjener maskiner.
English: If necessary, the concomitant use of these medicinal products should be at the lowest effective dose.
Danish: Hvis det er nødvendigt, bør samtidig brug af disse lægemidler ske med den laveste effektive dosis.
English: Do not stop taking Xadago without first talking to your doctor.
Danish: Du må ikke stoppe med at tage Xadago uden først at tale med din læge.
English: Via della Chimica, 9 36100 Vicenza Italy
Danish: Via della Chimica, 9 36100 Vicenza Italien
English: Not all pack sizes may be marketed.
Danish: Ikke alle pakningsstørrelser markedsføres.
English: Plasma protein binding of safinamide is 88-90%.
Danish: Plasmaproteinbinding af safinamid er 88-90 %
English: None of these metabolites are pharmacologically active.
Danish: Ingen af disse matabolitter er farmakologisk aktive.
English: Treatment with safinamide should be started at 50 mg per day.
Danish: Behandling med safinamid bør påbegyndes med 50 mg om dagen.
English: CGI-C: patients who were much/very much improved p-value (f)
Danish: CGI-C: patienter der viser stor/meget stor forbedring p-værdi (f)
English: This daily dose may be increased to 100 mg/day on the basis of individual clinical need.
Danish: Denne daglige dosis kan øges til 100 mg/dag alt efter individuelt klinisk behov.
English: Email: info.zambonspa@zambongroup.com
Danish: E-mail: info.zambonspa@zambongroup.com
English: Responder analyses (post-hoc) (e) n(%) ON time increase ≥60 minutes p-value ≥60 minutes increase ON time and decrease in OFF time and ≥ 30% improvement UPDRS III p-value
Danish: Respondent-analyse (post-hoc) (e) n(%) ON tid øgning ≥60 minutter p-værdi ≥60 minutters øgning ON tid og fald i OFF tid og ≥30 % forbedring UPDRS III p-værdi
English: Safinamide should be taken with water.
Danish: Safinamid skal tages med vand.
English: The terminal elimination half-life of total radioactivity was approximately 80 hours.
Danish: Den terminale halveringstid af den samlede radioaktivitet var cirka 80 timer.
English: Date of first authorisation: 24 February 2015 Date of latest renewal:
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 24 februar 2015 Dato for seneste fornyelse:
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP” The expiry date refers to the last day of that month.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisteret efter ”EXP” Udløbsdatoen er den sidste dag i den nævnte måned.
English: The primary efficacy parameter was the change from baseline to endpoint in ‘ON Time without troublesome dyskinesia'.
Danish: Den primære virkningsparameter var ændringen fra udgangspunktet til endepunktet i ‘ON tid uden generende dyskinesi'.
English: Xadago is used for the treatment of Parkinson's disease in adults.
Danish: Xadago anvendes til behandling af Parkinsons sygdom hos voksne.
English: A risk for the breast-fed child cannot be excluded.
Danish: En risiko for det diende barn kan ikke udelukkes.
English: If a dose is missed the next dose should be taken at the usual time the next day.
Danish: Hvis en dosis udelades, skal næste dosis tages på sædvanlig tid den efterfølgende dag.
English: Dyskinesia occurred early in treatment, was rated “severe”, led to discontinuation in very few patients (approx. 1.5%), and did not require reduction of dose in any patient.
Danish: Dyskinesi opstod tidligt i behandlingen, blev vurderet som "alvorlig", førte til afbrydelse hos meget få patienter (ca. 1,5 %), og krævede ikke reduktion af dosis hos nogen patienter.
English: Substance-related radioactivity was largely excreted in urine (76%) and only to a low extent in faeces (1.5%) after 192 hours.
Danish: Substansrelateret radioaktivitet udskiltes overvejende i urinen (76 %), og kun i ringe grad i fæces (1,5 %) efter 192 timer.
English: To what extent the nondopaminergic effects contribute to the overall effect has not been established.
Danish: Det er ikke påvist i hvor høj grad den ikke-dopaminerge effekt bidrager til den overordnede effekt.
English: There is no known antidote to safinamide or any specific treatment for safinamide overdose.
Danish: Der er ingen kendt modgift mod safinamid eller nogen specifik behandling for safinamid-overdosering.
English: Studies were not stratified for co-medication, and no randomized interaction studies were performed for these medicinal products.
Danish: Studierne er ikke stratificerede for comedicinering, og ingen randomiserede interaktionsstudier er foretaget for disse lægemidler.
English: (2 years)
Danish: (2 år)
English: No time-dependency was observed.
Danish: Der blev ikke observeret nogen tidsafhængighed.
English: There are no or limited amount of data from the use of safinamide in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af safinamid hos gravide kvinder.
English: The elimination half-life of safinamide is 20-30 hours.
Danish: Eliminations halveringstiden for safinamid er 20-30 timer.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du kan indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: The pharmacodynamic effects of safinamide have not been assessed in children and adolescents.
Danish: De farmakodynamiske virkninger af safinamid er ikke blevet vurderet hos børn og unge.
English: Adverse reactions are ranked under headings of frequency using the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opdelt efter hyppighed med følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Long-term studies in animals have shown convulsions (1.6 to 12.8 times human clinical exposure, based on plasma AUC).
Danish: Langtidsstudier i dyr har vist kramper (1,6 til 12,8 gange human klinisk eksponering, baseret på plasma-AUC).
English: (24 weeks)
Danish: (24 uger)
English: Contact your doctor immediately and take the Xadago pack with you.
Danish: Kontakt straks din læge og medbring pakningen med Xadago.
English: Do not take Xadago - If you are allergic to safinamide or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Xadago - Hvis du er allergisk over for safinamid eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt.
English: The effect on ON Time was maintained at the end of the 24-month double-blind treatment period for both safinamide doses as compared to placebo.
Danish: Virkningen på ON tid fortsatte ved slutningen af den 24-måneder lange dobbeltblindede behandlingsperiode for begge safinamid-doser sammenlignet med placebo.
English: The volume of distribution (Vss) is approximately 165 L which is 2.5-fold of body volume indicating extensive extravascular distribution of safinamide.
Danish: Fordelingsvolumen (Vss) er ca. 165 l, hvilket er 2,5 gange kroppens volumen og indikerer omfattende ekstravaskulær fordeling af safinamid.
English: Absolute bioavailability is high (95%), showing that safinamide is almost completely absorbed after oral administration and first pass metabolism is negligible.
Danish: Den absolutte biotilgængelighed er høj (95 %), og viser, at safinamid næsten absorberes fuldstændigt efter oral administration og førstepasseringsmetabolisme er ubetydelig.
English: Safinamide undergoes almost complete metabolic transformation (<10% of the administered dose was found unchanged in urine).
Danish: Safinamid gennemgår næsten fuldstændig metabolisk omdannelse (<10 % af den administrerede dosis blev fundet uændret i urinen).
English: Dose (mg/day) (a)
Danish: Dosis (mg/dag) (a)
English: If an important overdose occurs, safinamide treatment should be discontinued and supportive treatment should be administered as clinically indicated.
Danish: Hvis der sker en betydelig overdosering, bør safinamid-behandlingen seponeres, og understøttende behandling bør administreres som klinisk indiceret.
English: This effect was not seen when safinamide was used as an adjunct to dopamine agonists in early stage PD patients.
Danish: Denne virkning sås ikke, når safiamid blev brugt som et supplement til dopamin-agonister hos patienter med tidligt stadium af PD.
English: The high absorption classifies safinamide as a highly permeable substance.
Danish: Den høje absorption klassificerer safinamid som en meget gennemtrængeligt substans.