FrancophonIA/ELRC3.0 huggingface dataset:
English: The TAC was 113 g/day at baseline in the Selincro group (n=148) and 108 g/day at baseline in the placebo group (n=155).
Danish: Det daglige totale alkoholforbrug var 113 g dagligt ved baseline i Selincro gruppen (n=148) og 108 g dagligt ved baseline i placebogruppen (n=155).
English: In a study in patients diagnosed with pathological gambling, doses of nalmefene up to 90 mg/day for 16 weeks were investigated.
Danish: Nalmefendoser på op til 90 mg dagligt i 16 uger blev undersøgt i et studie med patienter, der var blevet diagnosticeret med ludomani.
English: How to take Selincro
Danish: Sådan skal du tage Selincro
English: For the patients who continued in the study and provided efficacy data at 1 year, the TAC was 24 g/day in the Selincro group (n=78) and 47 g/day in the placebo group (n=29).
Danish: For de patienter, som fortsatte i undersøgelsen og gav effektdata efter 1 år, var det daglige totale alkoholforbrug 24 g dagligt i Selincro gruppen (n=78) og 47 g dagligt i placebogruppen (n=29).
English: Comorbidity
Danish: Co-morbiditet
English: Muscle spasms
Danish: • Muskelsmerte
English: What Selincro contains
Danish: Selincro indeholder:
English: For the patients who continued in the study and provided efficacy data at Month 6, the TAC was 40 g/day in the Selincro-group (n=85) and 57 g/day in the placebo group (n=114).
Danish: For de patienter, som fortsatte i undersøgelsen og gav effektdata ved Måned 6, var det daglige totale alkoholforbrug 40 g dagligt i Selincro gruppen (n=85) og 57 g dagligt i placebogruppen (n=114).
English: What Selincro is and what it is used for What you need to know before you take Selincro How to take Selincro
Danish: Det skal du vide, før du begynder at tage Selincro Sådan skal du tage Selincro Bivirkninger
English: For the patients who continued in the study and provided efficacy data at 1 year, the number of HDDs was 5 days/month in the Selincro group (n=78) and 10 days/month in the placebo group (n= 29).
Danish: For de patienter, som fortsatte i undersøgelsen og gav effektdata efter 1 år, var der i Selincro gruppen (n=78) 5 dage om måneden med stort alkoholforbrug og 10 dage om måneden i placebogruppen (n=29).
English: For the patients who continued in the study and provided efficacy data at Month 6, the TAC was 44 g/day in the Selincro group (n=103) and 52 g/day in the placebo group (n=111).
Danish: For de patienter, som fortsatte i undersøgelsen og gav effektdata ved Måned 6, var det daglige totale alkoholforbrug 44 g dagligt i Selincro gruppen (n=103) og 52 g dagligt i placebogruppen (n=111).
English: This study comprised a total of 665 patients.
Danish: Denne undersøgelse omfattede i alt 665 patienter, hvoraf 52% af patienterne havde et stort eller meget stort alkoholforbrug ved baseline.
English: For HDDs there were 23 days/month at baseline in the Selincro group (n=148) and 22 days/month at baseline in the placebo group (n=155).
Danish: I Selincro gruppen (n=148) var der 23 dage pr. måned med stort alkoholforbrug ved baseline, og i placebogruppen (n=155) var der 22 dage pr. måned ved baseline.
English: For HDDs there were 23 days/month at baseline in the Selincro group (n=171) and 23 days/month at baseline in the placebo group (n=167).
Danish: I Selincro gruppen (n=171) var der 23 dage pr. måned med stort alkoholforbrug ved baseline, og i placebogruppen (n=167) var der 23 dage pr. måned ved baseline.
English: The side effects reported with Selincro were mainly mild or moderate, occurred at the beginning of treatment and lasted for a few hours to a few days.
Danish: De bivirkninger, der blev indberettet for Selincro, var for det meste milde eller moderate.
English: For the patients who continued in the study and provided efficacy data at Month 6, the number of HDDs was 10 days/month in the Selincro group (n=103) and 12 days/month in the placebo group (n=111).
Danish: For de patienter, som fortsatte i undersøgelsen og gav effektdata ved Måned 6, var der i Selincro gruppen (n=103) 10 dage om måneden med stort alkoholforbrug og 12 dage om måneden i placebogruppen (n=111).
English: For the patients who continued in the study and provided efficacy data at Month 6, the number of HDDs was 9 days/month in the Selincro group (n=85) and 14 days/month in the placebo group (n=114).
Danish: For de patienter, som fortsatte i undersøgelsen og gav effektdata ved Måned 6, var der i Selincro gruppen (n=85) 9 dage om måneden med stort alkoholforbrug og 14 dage om måneden i placebogruppen (n=114).
English: From distribution, metabolism, and excretion data, it appears that nalmefene has a high hepatic extraction ratio.
Danish: Det kunne tyde på, at nalmefen har en høj udskillelsesratio via leveren at dømme ud fra distributions-, metabolisme- og udskillelsesdata.
English: Common (may affect up to 1 in 10 people) - loss of appetite - difficulty sleeping, confusion, feeling restless, reduced sex drive - drowsiness, body twitches, feeling less alert, peculiar sensation in the skin like pins and needles,
Danish: • Døsighed, sitren i kroppen, nedsat opmærksomhed, underlig fornemmelse i huden - f.eks.
English: For HDDs there were 19 days/month at baseline in the Selincro-group (n=141) and19 days/month at baseline in the placebo group (n=42).
Danish: I Selincro gruppen (n=141) var der 19 dage pr. måned med stort alkoholforbrug ved baseline, og i placebogruppen (n=42) var der 19 dage pr.
English: At the next visit, Selincro may be initiated in patients who continued to have a high DRL (see section 5.1) over this two-week period, in conjunction with psychosocial intervention focused on treatment adherence and reducing alcohol consumption.
Danish: 5.1) i løbet af de to uger, sammen med psykosocial intervention, der fokuserer på at fremme overholdelsen af behandlingen og på at reducere alkoholforbruget.
English: Name and address of the manufacturers responsible for batch release H. Lundbeck A/S
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse
English: reduced sense of touch - racing heart, a sensation of a rapid, forceful, or irregular beating of the heart - vomiting, dry mouth, diarrhoea - excessive sweating - muscle spasms - feeling of exhaustion, weakness, discomfort or uneasiness, feeling strange - weight loss
Danish: • Galoperende hjerte, en følelse af hurtige, kraftige eller uregelmæssige hjerteslag
English: You may experience acute opioid withdrawal symptoms (such as feeling sick, vomiting, shakiness, sweating and anxiety) - if you experience, or suspect you are experiencing opioid withdrawal symptoms - if your liver or kidney function is poor - if you are experiencing or have recently experienced several alcohol withdrawal symptoms
Danish: Du kan opleve akut opioidabstinenssymptomer (såsom kvalme, opkastning, rystelser, svedtendens og angst).
English: Fatigue Asthenia
Danish: • Kvalme
English: Somnolence Tremor
Danish: Tremor
English: Erythema
Danish: • Kløen
English: Hepatic impairment
Danish: • Hovedpine
English: This prevents the cancer cells from dividing and they eventually die.
Danish: Dette forhindrer kræftcellerne i at dele sig, så de til sidst dør.
English: The full EPAR for Topotecan Hospira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Topotecan Hospira findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This means that Topotecan Hospira is similar to a ‘reference medicine' already authorised in the European Union (EU).
Danish: Det betyder, at Topotecan Hospira er identisk med et »referencelægemiddel«, som allerede er godkendt i Den Europæiske Union (EU).
English: This document is a summary of the European Public Assessment Report (EPAR) for Topotecan Hospira.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Topotecan Hospira.
English: The European Commission granted a marketing authorisation valid throughout the EU for Topotecan Hospira on 10 June 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Topotecan Hospira den 10. juni 2010.
English: For lung cancer, Topotecan Hospira is given every day for five days with a three-week interval between the start of each course.
Danish: Ved behandling af lungekræft gives Topotecan Hospira hver dag i fem dage med et interval på tre uger mellem starten på hvert forløb.
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 Topotecan Hospira.
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 Topotecan Hospira skal anvendes.
English: For more information about treatment with Topotecan Hospira, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Topotecan Hospira, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: When the enzyme is blocked, the DNA strands break.
Danish: Når enzymet blokeres, opstår der brud på dna-strengene.
English: Treatment with Topotecan Hospira should only be given under the supervision of a doctor experienced in the use of chemotherapy.
Danish: Behandlingen med Topotecan Hospira bør kun gives under tilsyn af en læge med erfaring i anvendelse af kemoterapi.
English: It blocks an enzyme called topoisomerase I, which is involved in the division of DNA.
Danish: Det blokerer et enzym kaldet topoisomerase I, der medvirker ved delingen af dna.
English: The patient's blood levels of white blood cells, platelets and haemoglobin should be checked before treatment, to ensure that they are above set minimum levels.
Danish: Inden behandlingen bør indholdet af hvide blodlegemer, blodplader og hæmoglobin i patientens blod kontrolleres for at sikre, at det ligger over det fastlagte minimumsniveau.
English: The CHMP concluded that, in accordance with EU requirements, Topotecan Hospira has been shown to be comparable to Hycamtin.
Danish: CHMP konkluderede, at Topotecan Hospira i overensstemmelse med EU's krav har vist sig at være sammenligneligt med Hycamtin.
English: It is also used together with cisplatin (another anticancer medicine) to treat women with cervical cancer (cancer of the cervix), when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix).
Danish: Det anvendes desuden sammen med cisplatin (et andet lægemiddel mod kræft) til behandling af kvinder med livmoderhalskræft, hvis kræften er vendt tilbage efter strålebehandling, og når sygdommen er fremskreden (stadium IVB: kræften har bredt sig fra livmoderhalsen til andre dele af kroppen).
English: No additional studies were needed as Topotecan Hospira is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Danish: Der var ikke behov for supplerende undersøgelser, da Topotecan Hospira indgives ved infusion og indeholder det samme aktive stof som referencelægemidlet Hycamtin.
English: The dose of Topotecan Hospira to be used depends on the type of cancer that it is being used to treat and the patient's weight and height.
Danish: Den nødvendige dosis Topotecan Hospira afhænger af den pågældende kræfttype og patientens højde og vægt.
English: Because Topotecan Hospira produces the same levels of the active substance in the body as the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Danish: Da Topotecan Hospira danner de samme mængder af det aktive stof i kroppen som referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Topotecan Hospira also affects non-cancer cells, which causes side effects.
Danish: Topotecan Hospira påvirker også andre celler end kræftcellerne, hvilket medfører bivirkninger.
English: The active substance in Topotecan Hospira, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Danish: Det aktive stof i Topotecan Hospira, topotecan, er et lægemiddel mod kræft, der tilhører gruppen af »topoisomerasehæmmere«.
English: Topotecan Hospira is a ‘hybrid medicine'.
Danish: Topotecan Hospira er et »hybridt lægemiddel«.
English: For full details, see the Summary of Product Characteristics (also part of the EPAR).
Danish: De nærmere oplysninger fremgår af produktresuméet (også en del af denne EPAR).
English: What are the benefit and risk of Topotecan Hospira?
Danish: Hvilken fordel og risiko er der forbundet med Topotecan Hospira?
English: The Committee recommended that Topotecan Hospira be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Topotecan Hospira.
English: Topotecan Hospira is a concentrate that is made up into a solution for infusion (drip into a vein).
Danish: Topotecan Hospira er et koncentrat, der blandes til en opløsning til infusion (dråbetilførsel i en vene).
English: The reference medicine Hycamtin is available as a powder to be made up into a solution for infusion and not as a concentrate.
Danish: Referencelægemidlet Hycamtin fås som pulver til infusionsvæske, opløsning, og ikke som koncentrat.
English: When used with cisplatin in cervical cancer, Topotecan Hospira is given on days 1, 2 and 3 (with cisplatin given on day 1).
Danish: Når Topotecan Hospira anvendes sammen med cisplatin til behandling af livmoderhalskræft, indgives det som en infusion på dag 1, 2 og 3 (cisplatin gives på dag 1).
English: Topotecan Hospira is used on its own to treat small cell lung cancer, when the cancer has relapsed (come back).
Danish: Topotecan Hospira anvendes som enebehandling til patienter med tilbagefald af småcellet lungekræft (hvor kræften er vendt tilbage).
English: Other information about Topotecan Hospira:
Danish: Andre oplysninger om Topotecan Hospira
English: Why has Topotecan Hospira been approved?
Danish: Hvorfor blev Topotecan Hospira godkendt?
English: The doses may need to be adjusted or other medicines given to the patients, when the level of white blood cells remains particularly low.
Danish: Hvis antallet af hvide blodlegemer bliver ved med at være særdeles lavt, kan det være nødvendigt at justere dosis af dette lægemiddel eller give patienten andre lægemidler.
English: What is Topotecan Hospira?
Danish: Hvad er Topotecan Hospira?
English: How has Topotecan Hospira been studied?
Danish: Hvordan blev Topotecan Hospira undersøgt?
English: What is Topotecan Hospira used for?
Danish: Hvad anvendes Topotecan Hospira til?
English: How is Topotecan Hospira used?
Danish: Hvordan anvendes Topotecan Hospira?
English: How does Topotecan Hospira work?
Danish: Hvordan virker Topotecan Hospira?
English: Further information on Kanjinti can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Kanjinti findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Kanjinti is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Kanjinti i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: An overview of Kanjinti and why it is authorised in the EU
Danish: En oversigt over Kanjinti og hvorfor det er godkendt i EU
English: As for all medicines, data on the use of Kanjinti are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Kanjinti løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Kanjinti?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kanjinti?
English: After treatment of up to a year, 48% of those given Kanjinti (172 of 358) and 41% of those given the reference medicine Herceptin (137 of 338) had no invasive cancer cells in the breasts or surrounding lymph nodes.
Danish: Efter behandling i op til et år havde 48 % af de patienter, der fik Kanjinti (172 ud af 358), og 41 % af de patienter, der fik referencelægemidlet Herceptin (137 ud af 338), ingen invasive kræftceller i brysterne eller de omgivende lymfeknuder.
English: The dose depends on the patient's body weight, on the condition being treated and on whether Kanjinti is given every week or every 3 weeks.
Danish: Dosis afhænger af patientens legemsvægt, den tilstand, der skal behandles, og om Kanjinti gives hver uge eller hver tredje uge.
English: Other information about Kanjinti
Danish: Andre oplysninger om Kanjinti
English: In addition, one study involving 696 patients with early breast cancer that overexpressed HER2 showed that Kanjinti was effective in treating the condition.
Danish: Endvidere viste et studie, der omfattede 696 patienter med tidlige stadier af brystkræft og overudtryk af HER2, at Kanjinti var effektivt til at behandle tilstanden.
English: Side effects reported with Kanjinti are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Kanjinti vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: For more information about using Kanjinti, see the package leaflet or contact a doctor or pharmacist.
Danish: For mere information om brug af Kanjinti, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What is Kanjinti and what is it used for?
Danish: Hvad er Kanjinti, og hvad anvendes det til?
English: The most common or serious side effects with Kanjinti are heart problems, reactions related to the Kanjinti infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.
Danish: De hyppigste eller alvorligste bivirkninger ved Kanjinti er hjerteproblemer, reaktioner i forbindelse med Kanjinti-infusionen, nedsat antal blodlegemer (navnlig hvide blodlegemer), infektioner og lungeproblemer.
English: Why is Kanjinti authorised in the EU?
Danish: Hvorfor blev Kanjinti godkendt i EU?
English: Kanjinti is a cancer medicine used to treat the following conditions:
Danish: Kanjinti er et lægemiddel mod kræft, der anvendes til behandling af følgende tilstande:
English: In the light of all the data provided the difference was not assessed to be relevant and it was concluded that Kanjinti would behave in the same way as Herceptin in its approved indications.
Danish: I lyset af de samlede data vurderedes det, at forskellen ikke var relevant, og det blev konkluderet, at Kanjinti vil have samme virkning som Herceptin i de godkendte indikationer.
English: Kanjinti can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines.
Danish: Kanjinti udleveres kun efter recept, og behandlingen skal iværksættes af en læge med erfaring i brug af kræftlægemidler.
English: By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells.
Danish: Ved at binde sig til HER2 aktiverer trastuzumab immunsystemets celler, som derefter dræber tumorcellerne.
English: The reference medicine for Kanjinti is Herceptin.
Danish: Referencelægemidlet for Kanjinti er Herceptin.
English: Because Kanjinti is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Kanjinti.
Danish: Da Kanjinti er et biosimilært lægemiddel, behøver de undersøgelser af trastuzumabs virkning og sikkerhed, der er udført for Herceptin, ikke at blive gentaget for Kanjinti.
English: Kanjinti contains the active substance trastuzumab.
Danish: Kanjinti indeholder det aktive stof trastuzumab.
English: It is also used in combination with other cancer medicines: with paclitaxel or docetaxel, or with another class of medicines called aromatase inhibitors;
Danish: Det anvendes også i kombination med andre kræftlægemidler (paclitaxel eller docetaxel) eller sammen med en anden lægemiddelklasse, der kaldes aromatasehæmmere
English: The active substance in Kanjinti, trastuzumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the HER2 protein.
Danish: Det aktive stof i Kanjinti, trastuzumab, er et monoklonalt antistof (en type protein), der er designet til at genkende og binde sig til HER2-proteinet.
English: For early breast cancer, treatment is given for a year or until the disease comes back, and for metastatic breast or gastric cancer, treatment is continued for as long as it remains effective.
Danish: Til behandling af tidlige stadier af brystkræft gives lægemidlet i et år, eller indtil sygdommen kommer tilbage, og til behandling af metastatisk brystkræft eller mavekræft fortsættes behandlingen, så længe den er effektiv.
English: What are the risks associated with Kanjinti?
Danish: Hvilke risici er der forbundet med Kanjinti?
English: Kanjinti must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients.
Danish: Kanjinti må ikke anvendes hos personer, der er overfølsomme (allergiske) over for trastuzumab, museproteiner eller et af de øvrige indholdsstoffer.
English: It is given by infusion (drip) into a vein over 90 minutes every week or every 3 weeks for breast cancer, and every 3 weeks for gastric cancer.
Danish: Det gives som en 90-minutters infusion (drop) i en blodåre hver eller hver tredje uge til behandling af brystkræft og hver tredje uge til behandling af mavekræft.
English: Kanjinti can only be used when the cancer ‘overexpresses HER2': this means that the cancer produces a protein called HER2 in large quantities on the cancer cells.
Danish: Kanjinti må kun anvendes, hvis kræften har såkaldt "overudtryk af HER2", dvs. hvis der på overfladen af kræftcellerne dannes store mængder af proteinet HER2.
English: Kanjinti is a ‘biosimilar medicine'.
Danish: Kanjinti er et "biosimilært lægemiddel".
English: • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
Danish: • tidlige stadier af brystkræft (når kræften har spredt sig inde i brystet eller til kirtlerne under armen, men ikke til andre dele af kroppen) efter operation, kemoterapi (lægemidler til behandling af kræft) og strålebehandling.
English: For cancers that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Kanjinti is used before surgery in combination with chemotherapy and then again after surgery on its own;
Danish: Ved tumorer, som er lokalt fremskredne (herunder inflammatoriske tumorer), eller som er mere end 2 cm brede, anvendes Kanjinti før operation i kombination med kemoterapi og igen efter operation som enkeltstofbehandling
English: Studies have also shown that giving Kanjinti produces similar levels of the active substance in the body to giving Herceptin.
Danish: Studier har også vist, at indgivelse af Kanjinti giver samme niveau af det aktive stof i kroppen som indgivelse af Herceptin.
English: Laboratory studies comparing Kanjinti with Herceptin have shown that the active substance in Kanjinti is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, der sammenligner Kanjinti med Herceptin, har vist, at det aktive stof i Kanjinti i vid udstrækning svarer til det aktive stof i Herceptin, hvad angår struktur, renhed og biologisk aktivitet.