FrancophonIA/ELRC3.0 huggingface dataset:
English: Thumb pad Green plunger rod
Danish: Trykflade Grøn stempelstang
English: Solution for injection.
Danish: Bortskaf injektionssprøjten.
English: Commonly asked questions Q. What if I see air bubbles in the pre-filled pen?
Danish: Hvad nu hvis der er luftbobler i min fyldte pen?
English: Dispose of the syringe in a sharps container or as directed by your doctor, pharmacist or nurse.
Danish: Læg injektionssprøjten i en kanyleboks, eller bortskaf den som anvist af lægen, sygeplejersken eller apotekspersonalet.
English: Abbreviations: N = number of patients in the intent-to-treat population Note: patients with missing data were counted as non-responders a p < 0.001 compared with placebo b Patients with Itch NRS >= 4 at baseline: placebo N = 374, Taltz 80 mg Q4W N = 379, Taltz 80 mg Q2W N = 391
Danish: bPatienter med Itch NRS ≥ 4 ved baseline: placebo N = 374, Taltz 80 mg Q4W N = 379, Taltz 80 mg Q2W N = 391.
English: Abbreviations: N = number of patients in the intent-to-treat population Note: patients with missing data were counted as non-responders a p < 0.001 compared with placebo b p < 0.001 compared with etanercept c Patients with Itch NRS >= 4 at baseline: placebo N = 158, Taltz 80 mg Q4W N = 313, Taltz 80 mg Q2W N = 320, Etanercept N = 312
Danish: cPatienter med Itch NRS ≥ 4 ved baseline: placebo N = 158, Taltz 80 mg Q4W N = 313, Taltz 80 mg Q2W N = 320, etanercept N = 312.
English: What Taltz is and what it is used for What you need to know before you use Taltz How to use Taltz
Danish: Det skal du vide, før du begynder at bruge Taltz Sådan skal du bruge Taltz Bivirkninger
English: Check with your doctor, nurse or pharmacist if you are not sure how to use this medicine.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: • 1 sharps container for disposal of pre-filled pen
Danish: • 1 kanyleboks til de brugte penne.
English: Dispose of the prefilled pen in a sharps container or as directed by your doctor, pharmacist or nurse.
Danish: Læg pennen i en kanyleboks, eller bortskaf den som anvist af lægen, sygeplejersken eller apotekspersonalet.
English: The solution/the syringe must not be shaken.
Danish: Injektionsvæsken/injektionssprøjten må ikke omrystes.
English: Anaphylaxish
Danish: Anafylaksih
English: If you use more Taltz than you should
Danish: Hvis du har taget for meget Taltz
English: Commonly asked questions Q. What if I see air bubbles in my syringe?
Danish: Hvad nu hvis der er luftbobler i min injektionssprøjte?
English: Taltz 80 mg solution for injection in pre-filled pen.
Danish: LÆGEMIDLETS NAVN Taltz 80 mg injektionsvæske, opløsning i fyldt pen.
English: Ask your doctor, nurse or pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: Each pre-filled syringe contains 80 mg ixekizumab in 1 ml.
Danish: Hver fyldt pen indeholder 80 mg ixekizumab i 1 ml injektionsvæske.
English: Taltz 80 mg solution for injection in pre-filled syringe ixekizumab
Danish: Taltz 80 mg injektionsvæske, opløsning i fyldt pen ixekizumab
English: Instructions for use Taltz 80 mg solution for injection in pre-filled syringe
Danish: LÆGEMIDLETS NAVN Taltz 80 mg injektionsvæske, opløsning i fyldt injektionssprøjte
English: reduction ≥ 4b
Danish: NRS på ≥ 4b
English: A. Do not touch the needle or replace the base cap.
Danish: Lad være med at røre ved nålen og sæt ikke hætten på igen.
English: BSA≥10 and sPGA≥3).
Danish: N med baseline SFQ punkt 2 Score ≥2
English: Taltz 80 mg injection ixekizumab Subcutaneous use
Danish: Taltz 80 mg injektionsvæske, opløsning i fyldt injektionssprøjte ixekizumab
English: Each pre-filled pen contains 80 mg ixekizumab in 1 ml.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver fyldt pen indeholder 80 mg ixekizumab i 1 ml.
English: EU/1/15/1085/001 EU/1/15/1085/002 EU/1/15/1085/003
Danish: EU/1/15/1085/002 2 fyldte penne
English: points at week 12 (84.6% for Taltz Q2W, 79.2% for Taltz Q4W and 16.5% for placebo) and the benefit was sustained over time up to Week 60 in patients treated with Taltz who were sPGA (0 or 1)
Danish: og 16,5% for placebo), og virkningen blev opretholdt frem til uge 60 hos patienter behandlet med Taltz, som var sPGA(0 eller 1)-responderende ved uge 12.
English: EU/1/15/1085/001 1 pre-filled pen EU/1/15/1085/002 2 pre-filled pens EU/1/15/1085/003 3 pre-filled pens
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1085/001 EU/1/15/1085/002 EU/1/15/1085/003 DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 25. april 2016
English: • 1 sharps container for disposal of syringes
Danish: • 1 kanyleboks til de brugte injektionssprøjter.
English: EU/1/15/1085/004 EU/1/15/1085/005 EU/1/15/1085/006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1085/004 EU/1/15/1085/005 EU/1/15/1085/006 DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 25. april 2016
English: - Cold sores of mouth, skin and mucous membranes (herpes simplex, mucocutaneous)
Danish: Tinea-infektion, Herpes simplex (mukokutan)c
English: • Before you use the Taltz pre-filled syringe, read and carefully follow all the step-by-step instructions.
Danish: • Før du bruger den fyldte injektionssprøjte med Taltz, skal du læse og omhyggeligt følge alle instruktionerne trin for trin. Gem brugervejledningen og brug den ved behov.
English: For both Taltz Q2W and Q4W: b p<0.01 and c p<0.001 compared with placebo.
Danish: bp<0,01 og cp<0,001 sammenlignet med placebo.
English: • Keep the syringe out of the reach and sight of children.
Danish: • Opbevar injektionssprøjten utilgængeligt for børn.
English: Strength Pharmaceutical Form Route of Administration
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Indhold Pakningsstørrelse
English: Repso leflunomide
Danish: Repso leflunomid
English: This is a summary of the European public assessment report (EPAR) for Repso.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Repso.
English: The full EPAR for Repso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Repso findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
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 Repso.
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 Repso.
English: Repso is a ‘generic medicine'.
Danish: Repso er et ‘generisk lægemiddel'.
English: Other information about Repso
Danish: Andre oplysninger om Repso:
English: This means that Repso is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
Danish: Det betyder, at Repso er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Arava.
English: It is available as tablets (white and round: 10 mg; dark beige and triangular: 20 mg).
Danish: Det fås som tabletter (hvide og runde: 10 mg, mørk beige og trekantformede: 20 mg).
English: For more information about treatment with Repso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Repso, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the benefits and risks of Repso?
Danish: Hvilken fordel og risiko er der forbundet med Repso?
English: Repso treatment starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Danish: Behandlingen med Repso indledes med en ‘initialdosis' på 100 mg en gang dagligt i tre dage efterfulgt af en vedligeholdelsesdosis.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Repso to TEVA Pharma B.V. on 14 March 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Repso til TEVA Pharma B.V.
English: The Committee recommended that Repso be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Repso.
English: The active substance in Repso, leflunomide, is an immunosuppressant.
Danish: Det aktive stof i Repso, leflunomid, er et immundæmpende stof.
English: With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.
Danish: Med færre lymfocytter er der mindre inflammation, hvilket medvirker til at dæmpe symptomerne på arthritis.
English: The CHMP concluded that, in accordance with EU requirements, Repso has been shown to have comparable quality and to be bioequivalent to Arava.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Repso er af sammenlignelig kvalitet og er bioækvivalent med Arava.
English: Repso is a medicine that contains the active substance leflunomide.
Danish: Repso er et lægemiddel, der indeholder det aktive stof leflunomid.
English: Repso is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Danish: Arava anvendes til behandling af voksne med aktiv rheumatoid arthritis (en sygdom i immunsystemet, der fremkalder inflammation i leddene) eller aktiv arthritis psoriatica (en sygdom, som fremkalder røde, afskallende pletter på huden og inflammation i leddene).
English: The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Repso, and regularly during treatment.
Danish: Lægen skal tage blodprøver for at kontrollere patientens lever, leukocyttal og trombocyttal, inden der ordineres Repso, og regelmæssigt under behandlingen.
English: Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply.
Danish: Leflunomid gør dette ved at blokere for et enzym kaldet "dihydroorotat dehydrogenase", som er nødvendigt for, at lymfocytter kan dele sig.
English: Repso treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Danish: Behandling med Repso må kun iværksættes og overvåges af en specialist med erfaring inden for behandling af patienter med rheumatoid arthritis og arthritis psoriatica.
English: Because Repso 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 Repso er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: It reduces inflammation by reducing the production of immune cells called ‘lymphocytes', which are responsible for inflammation.
Danish: Det reducerer inflammationen ved at begrænse dannelsen af immunceller kaldet ‘lymfocytter', som forårsager inflammationen.
English: Because Repso is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava.
Danish: Da Repso er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Arava.
English: Why has Repso been approved?
Danish: Hvorfor blev Repso godkendt?
English: How has Repso been studied?
Danish: Hvordan blev Repso undersøgt?
English: What is Repso used for?
Danish: Hvad anvendes Repso til?
English: What is Repso?
Danish: Hvad er Repso?
English: How is Repso used?
Danish: Hvordan anvendes Repso?
English: These studies included nearly 2,500 patients, of whom over 1,400 received valproate.
Danish: Disse undersøgelser omfattede næsten 2 500 patienter, hvoraf over 1 400 fik valproat.
English: Please follow his/her instructions, otherwise you will not fully benefit from your medicine.
Danish: Følg venligst hans/hendes anvisninger, ellers vil du ikke drage fuld fordel af din medicin.
English: There is a positive benefit-risk relation with regard to the aforementioned indication.
Danish: Benefit-risk-forholdet er positivt for ovennævnte indikation.
English: Prolonged-release formulations can be given once or twice daily.
Danish: Depotformuleringer kan gives en eller to gange daglig.
English: Post-hoc analyses were done of the large Bowden study.
Danish: Der blev foretaget post hoc-analyser af den store Bowdenundersøgelse.
English: Anticonvulsants are increasingly becoming an alternative.
Danish: Krampestillende lægemidler bliver i stadig større grad et alternativ.
English: The prolonged-release tablets should preferably be taken 1 hour before meals (on an empty stomach in the morning).
Danish: Depottabletterne skal helst tages 1 time inden måltider (på tom mave om morgenen).
English: The two recurrence prevention studies are of sufficient duration and have an active comparator as requested by European guidelines.
Danish: De to undersøgelser af forebyggelse af tilbagevenden er af tilstrækkelig varighed og har et aktivt sammenligningslægemiddel, sådan som det kræves i de europæiske retningslinjer.
English: 4.1 Therapeutic indications
Danish: 4.1 TERAPEUTISKE INDIKATIONER
English: Valproate is a well-known anti-epileptic substance.
Danish: Valproat er et velkendt antiepileptisk stof.
English: 1.1 Mania
Danish: 1.1 Mani
English: {Invented name} can be used when lithium can not be used.
Danish: {(Sær)navn} kan bruges, når lithium ikke kan bruges.
English: They should be swallowed whole or in halves, not chewed, and taken with plenty of fluid (e.g. a glass of water).
Danish: De skal synkes hele eller halve, de må ikke tygges, og de skal tages med rigelig væske (f.eks. et glas vand).
English: Patients receiving daily doses higher than 45mg/kg/day body weight should be carefully monitored.
Danish: Patienter, der får daglige doser på mere end 45 mg/kg legemsvægt, skal monitoreres nøje.
English: As only very small amounts are found, however, these do not generally present any risk to the child and weaning is not usually necessary.
Danish: Da der kun er fundet meget små mængder, udgør disse mængder sædvanligvis ingen risiko for barnet, og det er normalt ikke nødvendigt at holde op med at amme.
English: 2.2 Risk Management Plan
Danish: 2.2 Risikostyringsplan
English: 4.4 Special warnings and precautions for use
Danish: 4.4 SÆRLIGE ADVARSLER OG FORSIGTIGHEDSREGLER VEDRØRENDE BRUGEN
English: The daily dose will be determined according to age and body weight.
Danish: Den daglige dosis vil bestemmes ud fra alder og legemsvægt.
English: Method and duration of administration:
Danish: Indgivelsesmåde og -varighed:
English: Children may be allowed to grow out of the dose per kg body weight instead of making age-related dose adjustments, whereby EEG findings should not deteriorate.
Danish: Man kan lade børn vokse ud af dosis pr. kg legemsvægt i stedet for at foretage aldersrelaterede dosisjusteringer, hvorved EEGfund ikke bør forværres.
English: In adults:
Danish: Voksne:
English: {Invented name} is used in the treatment of
Danish: {(Sær)navn} bruges i behandlingen af
English: The major potentially serious safety concerns relate to liver dysfunction and pancreatitis.
Danish: De største potentielt alvorlige betænkeligheder ved sikkerheden er leverfunktionsnedsættelse og pancreatitis.
English: The duration of treatment is determined by the treating doctor.
Danish: Behandlingsvarigheden afgøres af den behandlende læge.
English: Among the mood stabilizers lithium has the longest track record and is therefore a reasonable first choice.
Danish: Blandt de humørstabiliserende lægemidler har lithium den længste resultatliste og er derfor et rimeligt førstevalg.
English: Withdrawal must take the form of a gradual dose reduction over a period of one to two years.
Danish: Seponering skal ske i form af gradvis dosisreduktion i løbet af en periode på et til to år.
English: In addition there is a considerable risk due to the narrow therapeutic window of this substance.
Danish: Hertil kommer, at der er en betydelig risiko som følge af dette stofs snævre terapeutiske indeks.
English: However, it has recently been estimated that up to 40% of the patients with bipolar disorder do not or insufficiently respond to an adequate lithium therapy.
Danish: Man anslog dog for nylig, at op til 40 % af patienterne med bipolær lidelse ikke responderer på eller responderer i utilstrækkelig grad på en passende lithiumbehandling.
English: However one study is lacking a short placebo arm, which is a deficiency and brings doubts about the validity of the results.
Danish: I den ene undersøgelse er der dog ikke medregnet en kort placeboarm, hvilket er en mangel, og det rejser tvivl om resultaternes gyldighed.
English: 1.2 Prevention of Recurrence of mood episodes
Danish: 1.2 Forebyggelse af humørsvingningsepisoders tilbagevenden
English: Antiepileptic therapy is always a long-term therapy.
Danish: Antiepileptisk behandling er altid langtidsbehandling.
English: Your doctor will determine the exact dose required on an individual basis.
Danish: Din læge vil bestemme den nøjagtige, påkrævede dosis på individuel basis.
English: You should not take this medicine if you are pregnant or a women of child-bearing age unless explicitly advised by your doctor.
Danish: Du må ikke tage denne medicin, hvis du er gravid eller er en kvinde i den fødedygtige alder, medmindre din læge udtrykkeligt har tilrådet det.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for <active substance>.
Danish: Mekanismen bag denne risiko er ikke kendt, og de forhåndenværende data udelukker ikke muligheden for en øget risiko for valproat.
English: National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Danish: De nationale kompetente myndigheder skal koordineret af referencemedlemsstaten sikre, at følgende betingelser opfyldes af indehaverne af markedsføringstilladelsen.
English: Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Danish: Patienterne bør derfor overvåges for tegn på selvmordstanker og suicidal adfærd, og passende behandling bør overvejes.
English: With respect to the formulation, there is some evidence that gastro-resistant tablets might provide some advantages in terms of safety as compared to immediate release formulation.
Danish: Med hensyn til formuleringen er der visse tegn på, at gastroresistente tabletter kan have visse sikkerhedsmæssige fordele sammenlignet med en formulering med øjeblikkelig frigivelse.
English: The safety profile of valproate is well characterised from forty years of experience in the treatment of epilepsy.
Danish: Valproats sikkerhedsprofil er velbeskrevet efter 40 års erfaring med behandling af epilepsi.
English: This medicine should not be used during pregnancy and in women of child-bearing potential unless clearly necessary (i.e. in situations where other treatments are ineffective or not tolerated).
Danish: Dette lægemiddel bør ikke anvendes under graviditet eller af kvinder i den fertile alder, medmindre det er klart nødvendigt (dvs. i situationer, hvor andre behandlinger ikke er effektive eller ikke tolereres).
English: Based on the submitted data it cannot be concluded, that efficacy of valproate in the claimed indication is dependent on chemical form or formulation.
Danish: På baggrund af de fremsendte data kan det ikke konkluderes, at valproats virkning til den indikation, der ansøges om, afhænger af den kemiske form eller formulering.
English: Generally, in the treatment of seizures no dose reduction or withdrawal of the medicine should be attempted until the patient has been free of seizures for at least two to three years.
Danish: Ved behandling af krampeanfald bør dosisreduktion eller seponering af medicinen generelt ikke forsøges, før patienten har været anfaldsfri i mindst to til tre år.
English: A teratogenic risk associated with the use of valproate in pregnant women, including the potential for delayed intellectual development has been identified following in utero exposure to valproate.
Danish: En teratogen risiko forbundet med brugen af valproat hos gravide kvinder, herunder en risiko for forsinket intellektuel udvikling, er blevet observeret efter in utero-eksponering for valproat.
English: The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose which produces the desired clinical effect.
Danish: Dosis skal øges så hurtigt som muligt for at opnå den laveste terapeutiske dosis, som giver den ønskede kliniske effekt.
English: Experience with long-term use of Valproinsäure-ratiopharm chrono is limited, particularly in children under 6 years of age.
Danish: Erfaring med langtidsanvendelse af [HANDELSNAVN] er begrænset, især hos børn under 6 år.
English: - acute mania and for the prevention of recurrence in patients with bipolar disorder - Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive.
Danish: - akut mani, og til forebyggelse af recidiv hos patienter med bipolær sygdom - Mani, hvor du kan føle dig eksalteret, opstemt, ophidset, entusiastisk eller hyperaktiv.
English: Concerning recurrence prevention of mood episodes, evidence of efficacy of valproate is mainly based on two double-blind studies with a maintenance period of 52 weeks and 20 months duration, respectively (Bowden et al., 2000 and Calabrese et al., 2005).
Danish: Hvad angår forebyggelse af humørsvingningsepisoders tilbagevenden, er dokumentationen for valproats virkning hovedsagelig baseret på to dobbeltblindede undersøgelser med en vedligeholdelsesperiode af henholdsvis 52 ugers og 20 måneders varighed (Bowden et al., 2000 og Calabrese et al., 2005).
English: In case of gastrointestinal side-effects due to treatment, the prolonged-release tablets should be taken during or after a meal.
Danish: I tilfælde af gastrointestinale bivirkninger pga. behandlingen skal depottabletterne tages i løbet af eller efter et måltid.
English: Although the pathogenesis of bipolar disorder is unclear, it is known that mood stabilizers, such as valproate, can prevent its recurrence.
Danish: Selv om der ikke er klarhed over bipolær lidelses patogenese, ved man, at humørstabiliserende lægemidler såsom valproat kan forebygge en tilbagevenden af denne.
English: In addition, valproate has been used as the reference comparator treatment in many Phase III studies of atypical antipsychotic drugs in the treatment and prevention of mania.
Danish: Hertil kommer, at valproat er blevet anvendt som referencesammenligningsbehandling i mange fase III-undersøgelser af atypiske antipsykotiske lægemidler til behandling og forebyggelse af mani.
English: As such, this represents one of the largest bodies of clinical trial data relating to the pharmacotherapy of bipolar disorder.
Danish: Som sådan udgør dette en af de største mængder af kliniske undersøgelsesdata om farmakoterapi i forbindelse med bipolær lidelse.
English: Chemical forms and formulations of valproate
Danish: Kemiske former og formuleringer af valproat
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
Danish: Selvmordstanker og suicidal adfærd er rapporteret hos patienter i behandling med antiepileptika ved flere forskellige indikationer.
English: Ratiopharm Nederland B.V. Florapark 4
Danish: Nederlandene ratiopharm Nederland bv Florapark 4