FrancophonIA/ELRC3.0 huggingface dataset:
English: If you take more {Invented Name} than you should If you have taken too much {Invented Name}, or if someone else accidentally takes your tablets, contact a doctor or hospital for advice immediately.
Danish: Kontakt straks læge eller skadestue, hvis du har taget flere {X}-tabletter, eller hvis en anden ved et uheld tager dine tabletter.
English: N Number of events1
Danish: Antal hændelser1
English: In the adjuvant setting a sequential treatment schedule (letrozole 2 years followed by tamoxifen 3 years) could also be considered depending on the patient`s safety profile (see sections 4.2, 4.8 and 5.1).
Danish: Ved adjuverende behandling kan et sekventielt behandlingsprogram også overvejes (letrozol i 2 år efterfulgt af tamoxifen i 3 år) afhængigt af patientens sikkerhedsprofil (se pkt.
English: Tamoxifen>{Invented Name}
Danish: Tamoxifen->{X}
English: 1 Log rank test, stratified by randomisation option and use of chemotherapy (yes/no) 2 DFS events: loco-regional recurrence, distant metastasis, invasive contralateral breast cancer,
Danish: 1 Log-rank-test, stratificeret i forhold til strata ved randomisering og brug af kemoterapi (ja/nej) 2 Hændelser ved sygdomsfri overlevelse: lokoregionalt tilbagefald, fjernmetastaser, invasiv kontralateral brystcancer, sekundær (ikke-bryst) primær malignitet, død uanset årsag uden cancer i anamnesen.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke kan tåle visse sukkerarter.
English: Continue taking {Invented Name} every day for as long as your doctor tells you.
Danish: Fortsæt med at tage {X} hver dag i så lang tid, som din læge siger, du skal tage det. Du kan have brug for at tage det i måneder eller i år.
English: Breast pain
Danish: Vaginalblødning
English: Statistically significant differences were observed in favour of letrozole 2.5 mg compared to megestrol acetate in overall objective tumour response rate (24% vs 16%, P=0.04), and in time to treatment failure (P=0.04).
Danish: Der blev observeret statistisk signifikante forskelle til fordel for letrozol 2,5 mg sammenlignet med megestrolacetat i den samlede objektive tumorresponsrate (24% versus 16%,
English: If any of these conditions apply to you, tell your doctor.
Danish: Hvis noget af dette passer på dig, skal du fortælle det til din læge.
English: How to take {Invented Name}
Danish: SÅDAN SKAL DU TAGE {X}
English: First-line treatment
Danish: Første-linje-behandling
English: Insufficient data are available in cases of renal insufficiency with creatinine clearance lower than 10 ml/min (see sections 4.4 and 5.2).
Danish: Ved kreatininclearance mindre end 10 ml/min er data utilstrækkelige (se pkt.
English: Hazard ratio (HR) (95% CI for HR) P
Danish: Relativ risiko (RR) (95% KI for RR) p
English: Time to distant metastasis (secondary)
Danish: Tid til fjernmetastaser (sekundær) Total overlevelse (sekundær) - antal døde
English: HR (95% CI)2
Danish: RR (95% KI)2 p-værdi
English: {Invented Name} monotherapy
Danish: {X} monoterapi
English: In the adjuvant setting a sequential treatment schedule (letrozole 2 years followed by tamoxifen 3 years) could also be considered (see sections 4.4 and 5.1).
Danish: Ved adjuverende behandling kan det også overvejes at anvende et sekventielt behandlingsprogram (letrozol i 2 år efterfulgt af tamoxifen i 3 år) (se pkt.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally]
Danish: 6.2 Uforligeligheder [Udfyldes nationalt]
English: If you have any questions about how long to keep taking {Invented Name}, talk to your doctor.
Danish: Spørg lægen, hvis du har spørgsmål om, hvor længe du skal blive ved med at tage {X}.
English: Urinary tract infection Neoplasms, benign, malignant and unspecified (including cysts and polyps) Uncommon:
Danish: Infektioner og parasitære sygdomme Ikke almindelig Urinvejsinfektion Benigne, maligne og uspecificerede tumorer (inkl.
English: Check with your doctor or pharmacist if you are not sure.
Danish: - Spørg lægen eller apoteketspersonalet, hvis der er mere, du vil vide.
English: Tumour pain1 Blood and the lymphatic system disorders Uncommon:
Danish: Blod og lymfesystem Ikke almindelig Leukopeni Immunsystemet Ikke kendt
English: 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container [To be completed nationally] 6.6 Special precautions for disposal [To be completed nationally]
Danish: 6.4 Særlige opbevaringsforhold [Udfyldes nationalt]
English: Hormone antagonist and related agents: aromatase inhibitor, ATC code: L02BG04.
Danish: ATC-kode: L02BG04.
English: Within 2 weeks after administration of 2.5 mg 14C
Danish: Inden for to uger efter administration af 2,5 mg 14C-mærket letrozol til raske postmenopausale frivillige forsøgspersoner blev
English: Do not stop taking {Invented Name} unless your doctor tells you to. See also the section above “How long to take {Invented Name}”.
Danish: Se også afsnittet ”Hvor længe skal du tage {X}”.
English: Disease-free survival
Danish: Censoreret analyse af sygdomsfri overlevelse3
English: Hepatitis Skin and subcutaneous tissue disorders Very common:
Danish: Hud og subkutane væv Meget almindelig Øget svedtendens Almindelig
English: Psychiatric disorders Common:
Danish: Oversigt over indlægssedlen:
English: BIG 1-98 was a multicentre, double-blind study in which over 8,000 postmenopausal women with hormone receptor-positive early breast cancer were randomised to one of the following treatments:
Danish: BIG 1-98 var et multicenter, dobbeltblindet studie, hvor mere end 8.000 postmenopausale kvinder med hormonreceptor-positiv tidlig brystcancer blev randomiseret til en af følgende behandlinger: A. tamoxifen i 5 år; B. {X} i 5 år; C. tamoxifen i 2 år efterfulgt af {X} i 3 år; D. {X} i 2 år efterfulgt af tamoxifen i 3 år.
English: [Letrozole →]Tamoxifen 1460
Danish: [Letrozol →]Tamoxifen
English: Arthritis Renal and urinary disorders Uncommon:
Danish: Ikke almindelig Artritis Nyrer og urinveje
English: Hair loss
Danish: Knoglebrud
English: Headache
Danish: Hedeture
English: What you need to know befor you take {Invented Name}
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE {X}
English: HR = Hazard ratio; CI = Confidence Interval
Danish: KI = konfidensinterval
English: Dizziness
Danish: Letrozol
English: Pruritus, urticaria
Danish: Lever og galdeveje
English: Eye disorders such as blurred vision, eye irritation
Danish: Ikke almindelig Grå stær, øjenirritation, sløret syn Hjerte
English: Cardiac adverse reactions
Danish: Hjerterelaterede bivirkninger
English: Vaginal discharge or dryness
Danish: Vaskulære sygdomme
English: Nervous disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, somnolence, insomnia
Danish: Disse bivirkninger forekommer hos mellem 1 og 10 ud af 1.000 patienter: - Nervøse lidelser såsom ængstelse, nervøsitet, irritabilitet, døsighed, problemer med at huske,
English: Eye disorders Uncommon
Danish: Mave-tarmkanalen Almindelig
English: Other medicines and {Invented Name}
Danish: Brug af anden medicin sammen med {X}
English: Other side effects are uncommon.
Danish: Ikke almindelige bivirkninger.
English: Difficulty breathing, chest pain, fainting, rapid heart rate, bluish skin discoloration, or sudden arm, leg or foot pain (signs that a blood clot may have formed).
Danish: - Hævelse af arme, hænder, fødder eller ankler (vand i kroppen) - Nedtrykthed (depression) - Vægtøgning - Hårtab - Forhøjet blodtryk - Mavesmerter - Tør hud - Vaginalblødning
English: Vascular disorders Very common:
Danish: Meget almindelig Hedeture
English: Letrozole
Danish: PRODUKTRESUME
English: DFS events: loco-regional recurrence, distant metastasis, invasive contralateral breast cancer, second
Danish: 2 Hændelser ved sygdomsfri overlevelse : lokoregionalt tilbagefald, fjernmetastaser, invasiv kontralateral brystcancer, sekundær (ikke bryst) primær cancer, død uanset årsag uden cancer i anamnesen.
English: Not known:
Danish: som ikke er nævnt her.
English: HR1
Danish: N
English: Dry mouth, stomatitis1 Hepatobiliary disorders Uncommon:
Danish: cyster og polypper) Ikke almindelig Tumorsmerter1
English: Insufficient data are available for patients with severe hepatic impairment.
Danish: Ved svært nedsat leverfunktion er data utilstrækkelige.
English: Ritemvia received a marketing authorisation valid throughout the EU on 13 July 2017.
Danish: Ritemvia fik en markedsføringstilladelse med gyldighed i hele EU den 13. juli 2017.
English: The full EPAR for Ritemvia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ritemvia
Danish: Den fuldstændige EPAR for Ritemvia findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/ritemvia.
English: Other information about Ritemvia
Danish: Andre oplysninger om Ritemvia
English: Patients with GPA, MPA or pemphigus vulgaris must also not receive Ritemvia if they have severe heart problems.
Danish: Patienter med GPA, MPA eller pemfigus vulgaris må heller ikke få Ritemvia, hvis de har svære hjerteproblemer.
English: What measures are being taken to ensure the safe and effective use of Ritemvia?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ritemvia?
English: This means that Ritemvia is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Ritemvia i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: ‘Autoimmune' means that the disease is caused by the immune system (the body's natural defences) attacking the body's own cells.
Danish: at sygdommen opstår ved, at immunsystemet (kroppens naturlige forsvar) angriber kroppens egne celler.
English: As for all medicines, data on the use of Ritemvia are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Ritemvia løbende overvåget.
English: An overview of Ritemvia and why it is authorised in the EU
Danish: En oversigt over Ritemvia, og hvorfor det er godkendt i EU
English: Ritemvia should be given under the close supervision of an experienced healthcare professional and in a place where facilities for resuscitating patients are immediately available.
Danish: Ritemvia bør gives under tæt overvågning af en erfaren sundhedsperson på et sted, hvor genoplivningsudstyr er umiddelbart tilgængeligt.
English: Why is Ritemvia authorised in the EU?
Danish: Hvorfor er Ritemvia godkendt i EU?
English: Patients are also to receive an alert card, which they are to carry at all times, instructing them to contact their doctor immediately if they have any of the listed symptoms of infection.
Danish: Patienterne vil desuden få udleveret et patientkort, som de altid skal have på sig, med instruktioner om straks at kontakte lægen, hvis de får nogen af de nævnte symptomer på infektion.
English: In this study improvement was seen in 96% of cases (67 of 70 patients) with Ritemvia and 90% (63 of 70 patients) with Rituxan.
Danish: I dette studie sås der en forbedring i 96 % af tilfældene (hos 67 ud af 70 patienter) med Ritemvia og i 90 % af tilfældene (hos 63 ud af 70 patienter) med Rituxan.
English: In GPA and MPA, destroying the B cells lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.
Danish: Ved GPA og MPA fører ødelæggelsen af B-cellerne til nedsat dannelse af antistoffer, der menes at spille en vigtig rolle ved at angribe blodkarrene og forårsage inflammation.
English: What is Ritemvia and what is it used for?
Danish: Hvad er Ritemvia, og hvad anvendes det til?
English: Side effects reported with Ritemvia are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Ritemvia vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Ritemvia can only be obtained with a prescription.
Danish: Ritemvia fås kun på recept.
English: Ritemvia must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients.
Danish: Ritemvia må ikke anvendes hos personer, der er overfølsomme (allergiske) over for rituximab, museproteiner eller et af de øvrige indholdsstoffer.
English: Ritemvia contains the active substance rituximab.
Danish: Ritemvia indeholder det aktive stof rituximab.
English: The reference medicine for Ritemvia is MabThera.
Danish: Referencelægemidlet for Ritemvia er MabThera.
English: For more information about using Ritemvia, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Ritemvia, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Doctors prescribing Ritemvia for cancer will be provided with educational material reminding them of the need to use the medicine only by infusion into a vein.
Danish: Læger, der ordinerer Ritemvia mod kræft, vil få udleveret undervisningsmateriale, der minder dem om nødvendigheden af kun at anvende lægemidlet ved infusion i en vene.
English: The study showed that Ritemvia and MabThera had comparable effects on arthritis symptoms: after 24 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Ritemvia and 73% (43 of 59 patients) with MabThera.
Danish: Det fremgik af studiet, at Ritemvia og MabThera havde en sammenlignelig virkning på gigtsymptomer: Andelen af patienter, som opnåede en forbedring på 20 % i symptomscoren (kaldet ACR20) efter 24 uger, var 74 % (114 ud af 155 patienter) med Ritemvia og 73 % (43 ud af 59 patienter) med MabThera.
English: The safety of Ritemvia has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine MabThera.
Danish: Sikkerheden ved Ritemvia er blevet vurderet, og på grundlag af alle de gennemførte studier anses bivirkningerne ved lægemidlet for at være sammenlignelige med bivirkningerne ved referencelægemidlet MabThera.
English: What are the risks associated with Ritemvia?
Danish: Hvilke risici er der forbundet med Ritemvia?
English: Further evidence came from supportive studies including one involving 121 patients with advanced follicular lymphoma, where adding Ritemvia to chemotherapy medicines was at least as effective as adding Rituxan, the US version of MabThera.
Danish: Der var yderligere evidens fra underbyggende studier, herunder et, som omfattede 121 patienter med fremskredent follikulært lymfom, hvor det var mindst lige så effektivt at tilføje Ritemvia til kemoterapi som at tilføje Rituxan, den amerikanske version af MabThera.
English: Because Ritemvia is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Ritemvia.
Danish: Da Ritemvia er et biosimilært lægemiddel, behøver alle de studier af rituximabs virkning og sikkerhed, der er udført for MabThera, ikke at blive gentaget for Ritemvia.
English: It is available as a concentrate for making a solution that must be given by infusion (drip) into a vein.
Danish: Det findes som et koncentrat til fremstilling af en opløsning, der skal indgives ved infusion (drop) i en vene.
English: In addition, Ritemvia has been compared with MabThera given into a vein in a main study involving 372 patients with active rheumatoid arthritis (an inflammatory disease).
Danish: Desuden er Ritemvia blevet sammenlignet med MabThera indgivet i en vene i et hovedstudie, der omfattede 372 patienter med aktiv rheumatoid artritis (en inflammatorisk sygdom).
English: Ritemvia is a ‘biosimilar medicine'.
Danish: Ritemvia er et "biosimilært" lægemiddel.
English: Ritemvia is a medicine used in adults to treat the following blood cancers and inflammatory conditions:
Danish: Ritemvia er et lægemiddel, der anvendes til behandling af voksne med følgende former for blodkræft og betændelsesbetingede (inflammatoriske) sygdomme:
English: The company that markets Ritemvia will provide doctors and patients using the medicine for noncancer conditions with educational material including information on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML.
Danish: Virksomheden, der markedsfører Ritemvia, vil udlevere undervisningsmateriale til læger og patienter, som anvender lægemidlet til andre sygdomme end kræft, herunder information om, at lægemidlet skal gives på et sted, hvor der er genoplivningsudstyr tilgængeligt, og om risikoen for infektion, herunder PML.
English: In addition, a study comparing Ritemvia to MabThera in patients with rheumatoid arthritis (which can support its use in other inflammatory disorders such as GPA and MPA) showed that both medicines are similarly effective, and a supportive study in follicular lymphoma showed effectiveness in cancer.
Danish: Endvidere fremgik det af et studie, hvor Ritemvia blev sammenlignet med MabThera hos patienter med rheumatoid artritis (som kan underbygge dets anvendelse ved andre inflammatoriske sygdomme som GPA og MPA), at begge lægemidler er lige effektive, og et underbyggende studie af patienter med follikulært lymfom viste effektivitet ved kræft.
English: All these data were considered sufficient to conclude that Ritemvia will behave in the same way as MabThera in terms of its effectiveness and safety in its authorised uses.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Ritemvia vil have de samme egenskaber som MabThera, hvad angår sikkerhed og virkning, ved de godkendte anvendelser.
English: Studies have also shown that giving Ritemvia produces similar levels of the active substance in the body to giving MabThera.
Danish: Studier har også vist, at indgivelse af Ritemvia frembringer samme mængde af det aktive stof i kroppen som indgivelse af MabThera.
English: Therefore, the Agency's view was that, as for MabThera, the benefits of Ritemvia outweigh the identified risks and it can be authorised for use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Ritemvia opvejer de identificerede risici som for MabThera, og at det kan godkendes til anvendelse i EU.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ritemvia has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Ritemvias og MabTheras struktur, renhed og biologiske aktivitet svarer til hinanden, og at de fordeles i kroppen på samme måde.
English: Laboratory studies comparing Ritemvia with MabThera have shown that the active substance in Ritemvia is highly similar to that in MabThera in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, hvor Ritemvia er sammenlignet med MabThera, har vist, at Ritemvias aktive stof er meget lig MabTheras, hvad angår struktur, renhed og biologisk aktivitet.
English: How is Ritemvia used?
Danish: Hvordan anvendes Ritemvia?
English: How does Ritemvia work?
Danish: Hvordan virker Ritemvia?
English: What benefits of Ritemvia have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Ritemvia?
English: For the full list of side effects of Ritemvia, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Ritemvia fremgår af indlægssedlen.
English: Depending on the condition it is used to treat, Ritemvia may be given with chemotherapy (other cancer medicines) or medicines used for inflammatory disorders (corticosteroids).
Danish: Alt efter hvilken sygdom Ritemvia anvendes mod, kan det gives sammen med kemoterapi (andre kræftlægemidler) eller lægemidler mod inflammatoriske sygdomme (binyrebarkhormon).
English: When rituximab attaches to CD20, it causes the death of B cells, which helps in lymphoma and CLL, where B cells have become cancerous.
Danish: Dette hjælper ved lymfom og CLL, hvor B-celler er blevet til kræftceller.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ritemvia have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ritemvia.
English: The active substance in Ritemvia, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B cells (types of white blood cells).
Danish: Det er fremstillet, så det genkender og binder sig til proteinet CD20, der findes på overfladen af B-celler (typer af hvide blodlegemer).
English: Strength Pharmaceutical form Route of administration Packaging Package size EU/1/09/536/001 Topotecan Actavis 1 mg l t o r
Danish: Emballage Pakningsstørrelse t r
English: Date of first authorisation: 03rd October 2011 Date of latest renewal: 22nd July 2016
Danish: Dato for første markedsføringstilladelse: 3. oktober 2011 Dato for seneste fornyelse: 22. juli 2016
English: Levetiracetam Accord must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Danish: Levetiracetam Accord skal tages to gange dagligt, én gang om morgenen og én gang om aftenen, på omtrent samme tidspunkt hver dag.
English: You may take Levetiracetam Accord with or without food.
Danish: De kan tage Levetiracetam Accord med eller uden mad.
English: current epidemiological studies (on about 100 children) do not suggest an increased risk of neurodevelopmental disorders or delays.
Danish: De nuværende epidemiologiske undersøgelser (med ca. 100 børn) tyder imidlertid ikke på øget risiko for neuroudviklingsmæssige forstyrrelser eller forsinkelser.
English: The major metabolic pathway (24 % of the dose) is an enzymatic hydrolysis of the acetamide group.
Danish: Den vigtigste metaboliseringsvej (24 % af dosis) er enzymatisk hydrolyse af acetamid -gruppen.
English: In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study.
Danish: Herudover har 101 spædbørn under 12 måneder været eksponeret i et post-marketingsikkerhedsstudie.
English: - Do not stop your treatment without your doctor's advice as this could increase your seizures.
Danish: • Stop ikke behandlingen uden lægens anbefaling, da dette kan øge antallet af anfald.
English: This effect was pronounced for the younger infants, and subsided as age increased, to become negligible around 4 years of age.
Danish: Denne effekt var udtalt for de yngste spædbørn og aftog med stigende alder for til sidst at forsvinde omkring 4-års-alderen.
English: If you forget to take Levetiracetam Accord Contact your doctor if you have missed one or more doses.
Danish: Hvis De har glemt at tage Levetiracetam Accord Kontakt lægen, hvis De har glemt en eller flere doser.
English: Therefore, the interaction of Levetiracetam with other substances, or vice versa, is unlikely.
Danish: Derfor er interaktion mellem Levetiracetam og andre lægemidler eller vice versa ikke sandsynlig.
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Danish: Bivirkningerne er præsenteret i rækkefølge efter faldende alvorlighed, og deres hyppighed er defineret på følgende måde: 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) og meget sjælden (<1/10.000).
English: This includes, any possible side effects not listed in this leaflet.
Danish: Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.