FrancophonIA/ELRC3.0 huggingface dataset:
English: In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Azomyr led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo.
Danish: Til allergisk rhinitis førte en to ugers behandling med Azomyr 5 mg, hvis man ser på resultaterne af alle undersøgelserne taget under et, til et fald i symptomscoren på gennemsnitlig 25 til 32 % sammenlignet med et fald på 12 til 26 % hos patienter, som fik placebo.
English: Azomyr is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Danish: Azomyr anvendes til lindring af symptomer på allergisk rhinitis (betændelse i næsepassagerne, som forårsages af allergi, f.eks. høfeber eller allergi over for støvmider) eller urticaria (en hudlidelse forårsaget af allergi med symptomer, der omfatter kløe og nældefeber).
English: Why has Azomyr been approved?
Danish: Hvorfor blev Azomyr godkendt?
English: What is Azomyr?
Danish: Hvad er Azomyr?
English: It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
Danish: Det virker ved at blokere de receptorer, hvortil histamin normalt binder sig.
English: What is Azomyr used for?
Danish: Hvad anvendes Azomyr til?
English: How has Azomyr been studied?
Danish: Hvordan blev Azomyr undersøgt?
English: What benefit has Azomyr shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Azomyr?
English: How is Azomyr used?
Danish: Hvordan anvendes Azomyr?
English: How does Azomyr work?
Danish: Hvordan virker Azomyr?
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the Member States
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelform, styrker, indgivelsesvej, indehavere af markedsføringstilladelser i medlemsstaterne
English: FENOFIBRATO PENSA 160 mg comprimidos recubiertos con película EFG 160 mg Film-coated tablet Oral use
Danish: FENOFIBRATO PENSA 160 mg comprimidos recubiertos con película EFG
English: FENOFIBRATO RANBAXY 160 mg comprimidos recubiertos con película EFG 160 mg Film-coated tablet Oral use
Danish: FENOFIBRATO RANBAXY 160 mg comprimidos recubiertos con película EFG 160 mg
English: Based on best response
Danish: Baseret på bedste respons
English: The European Medicines Agency has deferred the obligation to submit the final results of this study.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge de endelige resultater af dette studie.
English: These pain improvements were maintained at all subsequent evaluations.
Danish: Disse forbedringer i smertescore blev opretholdt ved alle efterfølgende evalueringer.
English: In rare cases allergic reactions may be severe.
Danish: Allergiske reaktioner kan i sjældne tilfælde være alvorlige.
English: 1 CI = Exact Confidence Interval
Danish: 1 CI = Nøjagtigt konfidensinterval
English: Regular monitoring of calcium levels is especially important in these patients.
Danish: Regelmæssig monitorering af calciumniveauet er særligt vigtigt hos disse patienter.
English: • in patients with advanced cancer: development of another form of cancer.
Danish: • hos patienter med fremskreden cancer: udvikling af en anden cancerform.
English: 4 Class effect
Danish: 4 Klasseeffekt
English: It is especially important that you tell your doctor if you are being treated with
Danish: Det er især vigtigt, at du fortæller det til din læge, hvis du er i behandling med
English: The median time to surgery was 261 days.
Danish: Mediantiden indtil operation var 261 dage.
English: Combined advanced cancer
Danish: Kombineret fremskreden cancer
English: Increasing body weight was associated with decreases in systemic exposure, and vice versa.
Danish: Stigende legemsvægt var forbundet med reduktion i den systemiske eksponering og omvendt.
English: Overall safety profile is consistent in all approved indications for XGEVA.
Danish: Den overordnede sikkerhedsprofil er ensartet i alle godkendte indikationer for XGEVA.
English: No overall differences in safety or efficacy were observed between geriatric patients and younger patients.
Danish: Der blev ikke observeret nogen overordnede forskelle i sikkerhed eller virkning mellem geriatriske og yngre patienter.
English: It is important to try to prevent osteonecrosis of the jaw developing as it may be a painful condition that can be difficult to treat.
Danish: Det er vigtigt at forsøge at undgå, at der opstår osteonekrose i kæben, da det kan være en smertefuld tilstand, som kan være svær at behandle.
English: Efficacy results from study 4 are presented in figure 2 and table 3.
Danish: Effektresultater fra studie 4 er vist i figur 2 og tabel 3.
English: It is important to tell your doctor if you are pregnant, think you may be pregnant, or plan to get pregnant.
Danish: Det er vigtigt at fortælle det til din læge, hvis du er gravid; mener, at du kan være gravid eller planlægger at blive gravid.
English: Pack sizes of one, three or four.
Danish: Pakningsstørrelser med 1, 3 eller 4.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på etiketten og æsken.
English: Effect on pain
Danish: Virkning på smerter
English: The overall incidence of clinically significant hypocalcaemia was 9%.
Danish: Den overordnede forekomst af klinisk signifikant hypokalcæmi var 9%.
English: All 20 patients (100%) with histology assessments responded.
Danish: Alle 20 patienter (100%) med histologiske vurderinger havde respons.
English: - if you are allergic to denosumab or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for denosumab eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Between weeks 9 and 49, median trough levels varied by less than 9%.
Danish: Mellem uge 9 og uge 49 vekslede median-minimumsniveauerne med under 9%.
English: The median duration of response was not estimable (four patients experienced disease progressions following an objective response).
Danish: Medianvarigheden af respons kunne ikke estimeres (fire patienter havde sygdomsprogression efter en objektiv respons).
English: Musculoskeletal pain leading to discontinuation of study treatment was uncommon.
Danish: Musculoskeletale smerter, som førte til seponering af studiebehandlingen, var ikke almindeligt.
English: An investigator assessment reported that all 18 adolescent patients had a best response of stable disease or better (complete response in 2 patients, partial response in 8 patients, and stable disease in 8 patients).
Danish: I en investigatorvurdering blev det rapporteret, at alle 18 unge patienter havde en bedste respons i form af stabil sygdom eller bedre (komplet respons hos 2 patienter, delvis respons hos 8 patienter og stabil sygdom hos 8 patienter).
English: A no observed adverse effect level for reproductive effects was not established.
Danish: Der blev ikke fastlagt et niveau for ingen observeret reproduktionsmæssig virkning.
English: Events have occurred during treatment and up to 9 months after treatment was discontinued (see section 4.4).
Danish: Der er forekommet hændelser under behandlingen og op til 9 måneder efter seponering af behandlingen (se pkt.
English: Upon enrolment of 305 patients in studies 5 and 6 a retrospective independent review of radiographic imaging data was performed.
Danish: Ved inklusionen af 305 patienter i studie 5 og 6 blev der udført en retrospektiv, uafhængig gennemgang af de røntgendiagnostiske data.
English: Number of patients with an objective response
Danish: Antal patienter med objektiv respons
English: Each pack contains one, three or four single use vials.
Danish: Hver pakning indeholder 1, 3 eller 4 engangshætteglas.
English: Date of latest renewal: 4 April 2016
Danish: Dato for første markedsføringstilladelse: 13. juli 2011 Dato for seneste fornyelse: 4. april 2016
English: • another medicine containing denosumab
Danish: • et andet lægemiddel, der indeholder denosumab
English: 1 See section Description of selected adverse reactions 2 See section Other special populations 3 See section 4.4
Danish: 1 Se afsnittet Beskrivelse af udvalgte bivirkninger 2 Se afsnittet Andre specielle populationer 3 Se pkt.
English: One hundred and ninety had at least 1 evaluable time point response and were included in the analysis (table 4).
Danish: 190 havde mindst 1 evaluerbar respons ved de planlagte tidspunkter og blev inkluderet i analysen (tabel 4).
English: Do not use XGEVA:
Danish: Brug ikke XGEVA:
English: The non-linearity is likely due to a saturable target-mediated elimination pathway of importance at low concentrations.
Danish: Nonlineariteten skyldes sandsynligvis en saturabel, målmedieret elimineringsvej ved lave koncentrationer.
English: • The entire contents of the vial should be injected.
Danish: • Hele indholdet af hætteglasset skal injiceres.
English: NR 33.2
Danish: IN 33,2
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 eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan de hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Clinical characteristics of these cases were similar between treatment groups.
Danish: De kliniske karakteristika for disse tilfælde var ens i behandlingsgrupperne.
English: Standard tests to investigate the genotoxicity potential of denosumab have not been evaluated, since such tests are not relevant for this molecule.
Danish: Standardtest til undersøgelse af denosumabs genotoksiske potentiale er ikke blevet evalueret, da sådanne test ikke er relevante for dette molekyle.
English: There was no evidence of maternal harm prior to labour; adverse maternal effects occurred infrequently during labour.
Danish: Der var ingen tegn på maternel skade inden fødslen; i sjældne tilfælde optrådte der uønskede virkninger hos moderen under fødslen.
English: XGEVA has no or negligible influence on the ability to drive and use machines.
Danish: XGEVA påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: - Your doctor will give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with XGEVA.
Danish: - Din læge vil udlevere et patientkort til dig, der indeholder vigtige sikkerhedsoplysninger, du skal være opmærksom på inden og under din behandling med XGEVA.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (inklusive cyster og polypper)
English: 25ºC) before injecting and inject slowly.
Danish: 25°C) inden injektion, og injektionsvæsken bør injiceres langsomt.
English: Response criteria included elimination of giant cells based on histopathology or lack of progression by radiography.
Danish: Kriterierne for respons omfattede eliminering af kæmpeceller baseret på histopatologi eller manglende progression observeret på røntgen.
English: Patients with giant cell tumour of bone should be evaluated at regular intervals to determine whether they continue to benefit from treatment.
Danish: Patienter med kæmpecelletumorer i knogle skal undersøges med regelmæssige intervaller for at finde ud af, hvorvidt de fortsat har fordel af behandlingen.
English: • low phosphate levels in the blood (hypophosphataemia),
Danish: • lave fosfatniveauer i blodet (hypofosfatæmi),
English: Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids.
Danish: Metabolisme og elimination forventes at følge de immunoglobulin udskillelsesveje, hvilket fører til nedbrydning til små peptider og de enkelte aminosyrer.
English: Patients should be monitored for radiological signs of malignancy, new radiolucency or osteolysis.
Danish: Patienterne skal monitoreres radiologisk for tegn på malignitet, ny radiolucens eller osteolyse.
English: The median time to response was 3.1 months (95% CI: 2.89, 3.65).
Danish: Mediantiden indtil respons var 3,1 måneder (95% CI: 2,89; 3,65).
English: The alterations were not considered clinically-relevant, since pharmacodynamic effects based on bone turnover markers were consistent across a wide range of body weight.
Danish: Ændringerne blev ikke anset for at være klinisk signifikante, da de farmakodynamiske virkninger baseret på markører for knogleomsætning var konsekvente på tværs af et bredt interval af legemsvægt.
English: XGEVA has not been tested in pregnant women.
Danish: XGEVA er ikke blevet testet på gravide kvinder.
English: This study did not control for prognostic factors and anti-neoplastic treatments.
Danish: Der blev i dette studie ikke kontrolleret for prognostiske faktorer og antineoplastiske behandlinger.
English: If you are being treated for giant cell tumour of bone, you will receive an additional dose 1 week and 2 weeks after the first dose.
Danish: Hvis du er i behandling for en kæmpecelletumor i knogle, vil du få yderligere en dosis henholdsvis 1 uge og 2 uger efter den første dosis.
English: N = Number of subjects randomised * = Statistically significant for superiority; ** = Statistically significant for non-inferiority
Danish: N = Antal randomiserede patienter * = Statistisk signifikant mht. superioritet; ** = Statistisk signifikant mht. noninferioritet
English: Study 2 other solid tumours** or multiple myeloma
Danish: Studie 2 andre solide tumorer** eller multipelt myelom
English: Based on these limited data, the adverse event profile appeared to be similar to adults.
Danish: På baggrund af disse begrænsede data forekom bivirkningsprofilen at være sammenlignelig med bivirkningsprofilen hos voksne.
English: Hypocalcaemia1, 2
Danish: Hypokalcæmi1, 2
English: The primary and secondary endpoints evaluated the occurrence of one or more skeletal related events (SREs).
Danish: I de primære og sekundære endpoint blev forekomsten af en eller flere knoglerelaterede hændelser (KRH'er) evalueret.
English: • Before receiving treatment, tell your doctor/nurse (healthcare professional) if you have any problems with your mouth or teeth.
Danish: • Fortæl det inden behandlingen til din læge/sygeplejersken (sundhedspersonalet), hvis du har problemer med din mund eller dine tænder.
English: Any effects of XGEVA are likely to be greater during the second and third trimesters of pregnancy since monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester.
Danish: Eventuelle virkninger af XGEVA vil sandsynligvis være forstærkede i graviditetens andet og tredje trimester, da monoklonale antistoffer transporteres gennem placenta på en lineær måde, efterhånden som graviditeten skrider frem, og den største mængde overføres i tredje trimester.
English: ONJ was confirmed in 6.9% of patients with breast cancer and prostate cancer during the extension treatment phase.
Danish: ONJ blev bekræftet hos 6,9% af patienterne med brystcancer og prostatacancer i den forlængede behandlingsfase.
English: RANKL exists as a transmembrane or soluble protein.
Danish: RANKL findes som et transmembranprotein eller et opløseligt protein.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases - other drugs affecting bone structure and mineralisation, ATC code: M05BX04
Danish: Farmakoterapeutisk klassifikation: Midler til behandling af knoglesygdomme - andre lægemidler, med virkning på knoglestruktur og mineralisering, ATC-kode: M05BX04
English: Secondary outcome measures included superiority of time to first SRE, superiority of time to first and subsequent SRE, and overall survival.
Danish: Sekundære udfaldsmål omfattede superioritet mht. tiden indtil første KRH, superioritet mht. tiden indtil første og efterfølgende KRH og samlet overlevelse.
English: Kaplan-Meier plots of time to first on-study SRE
Danish: Kaplan-Meier-plots af tiden indtil første KRH i studiet
English: Of the remaining 15 patients, 10 (67%) radiographic measurements showed no progression of the target lesion.
Danish: Af de resterende 15 patienter havde 10 patienter (67%) ingen progression af mållæsionen ved radiografisk måling.
English: Following subcutaneous administration, bioavailability was 62%.
Danish: Biotilgængeligheden efter subkutan indgift var 62%.
English: • a bisphosphonate
Danish: • et bisfosfonat
English: Consequently, osteolysis is reduced and proliferative tumour stroma is replaced with non-proliferative, differentiated, densely woven new bone.
Danish: Osteolyse reduceres således, og proliferativ tumorstroma erstattes af non-proliferativ, differentieret, tætvævet ny knoglemasse.
English: Denosumab displayed non-linear pharmacokinetics with dose over a wide dose range, but approximately dose-proportional increases in exposure for doses of 60 mg (or 1 mg/kg) and higher.
Danish: Denosumab udviste nonlineær farmakokinetik over et bredt dosisinterval, men omtrent dosisproportionelle stigninger ved eksponering for doser på 60 mg (eller 1 mg/kg) og derover.
English: Hypocalcaemia has very commonly been reported following XGEVA administration, mostly within the first 2 weeks.
Danish: Hypokalcæmi er blevet rapporteret med frekvensen meget almindelig efter administration af XGEVA, fortrinsvis inden for de første 2 uger.
English: RANKL is essential for the formation, function and survival of osteoclasts, the sole cell type responsible for bone resorption.
Danish: RANKL er essentiel for dannelsen, funktionen og overlevelsen af osteoklaster, den eneste celletype, der står for knogleresorptionen.
English: None of the adverse events was considered serious.
Danish: Ingen bivirkninger blev anset for at være alvorlige.
English: For instructions for use, handling and disposal see section 6.6.
Danish: For instruktioner om anvendelse, håndtering og bortskaffelse, se pkt.
English: INFORMATION IN BRAILLE xgeva
Danish: INFORMATION I BRAILLESKRIFT xgeva
English: 22.14 (14.26, NE)
Danish: 22,14 (14,26; IE)
English: Additional monitoring of calcium level should be considered during therapy in patients with risk factors for hypocalcaemia, or if otherwise indicated based on the clinical condition of the patient.
Danish: Yderligere monitorering af calciumniveauet bør overvejes under behandlingen hos patienter med risikofaktorer for hypokalcæmi, eller hvis det af andre grunde er indiceret på baggrund af patientens kliniske tilstand.
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to XGEVA administration.
Danish: Under behandlingen bør invasive tandbehandlinger kun gennemføres efter nøje overvejelse og undgås tæt på tidspunktet for administration af XGEVA.
English: Using a sensitive immunoassay < 1% of patients treated with denosumab for up to 3 years tested positive for non neutralising binding antibodies with no evidence of altered pharmacokinetics, toxicity, or clinical response.
Danish: Med anvendelse af et sensitivt immunoassay blev < 1% af patienter behandlet med denosumab i op til 3 år, testet positive for ikke-neutraliserende bindende antistoffer uden tegn på ændret farmakokinetik, toksicitet eller klinisk respons.
English: Osteonecrosis of the jaw can also occur after stopping treatment.
Danish: Osteonekrose i kæben kan også opstå, efter at behandlingen er afsluttet.
English: Study 2**
Danish: Studie 2**
English: XGEVA zoledronic acid
Danish: XGEVA zoledronsyre
English: The number of patients across both study arms with ISS stage I, stage II, and stage III at diagnosis were 32.4%, 38.2%, and 29.3%, respectively.
Danish: Antallet af patienter på tværs af begge studiearme med ISS-stadie I, -stadie II og -stadie III ved diagnosen var hhv. 32,4%, 38,2% og 29,3%.
English: XGEVA is a clear, colourless to slightly yellow solution.
Danish: XGEVA er en klar, farveløs til let gul opløsning.
English: Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe og systemorganklasse er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Following a 6 month period after birth, bone related changes showed recovery and there was no effect on tooth eruption.
Danish: 6 måneder efter fødslen viste de knoglerelaterede ændringer bedring, og tandfrembruddet var ikke påvirket.
English: No data are available on the effect of denosumab on human fertility.
Danish: Der foreligger ingen data vedrørende effekten af denosumab på den humane fertilitet.
English: Overall of 225 patients for whom giant cell tumours of bone surgery (excluding lung metastases only) was planned, 109 had no surgery performed and 84 underwent a less morbid procedure than planned at baseline.
Danish: Af 225 patienter, for hvem operation af kæmpecelletumorer i knogle (kun lungemetastaser blev ekskluderet) var planlagt, blev 109 ikke operereret, og 84 gennemgik en mindre morbid procedure end planlagt ved baseline.
English: No treatment-related pattern in individual cancers or cancer groupings was apparent.
Danish: Der var intet åbenlyst behandlingsrelateret mønster for de enkelte cancertyper eller -grupper.
English: • bone, joint, and/or muscle pain which is sometimes severe,
Danish: • smerter i knogler, led og/eller muskler, der sommetider kan være alvorlige,
English: • A 27 gauge needle is recommended for the administration of denosumab.
Danish: • Det anbefales at bruge en 27 gauge kanyle til indgift af denosumab.
English: Temporary interruption of XGEVA treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Danish: Midlertidig afbrydelse af behandlingen med XGEVA, indtil tilstanden svinder, og de bidragende risikofaktorer om muligt er minimeret, bør overvejes.
English: Water for injections * Acetate buffer is formed by mixing acetic acid with sodium hydroxide
Danish: Vand til injektionsvæsker * Acetatbuffer dannes ved at blande iseddike med natriumhydroxid
English: Most subjects were receiving or had received chemotherapy.
Danish: De fleste patienter fik kemoterapi eller havde fået det.
English: You should not take XGEVA together with other medicines containing denosumab or bisphosphonates.
Danish: Du bør ikke tage XGEVA sammen med andre lægemidler, der indeholder denosumab, eller bisfosfonater.
English: NR = not reached; NA = not available; HCM = hypercalcaemia of malignancy; SMR = skeletal morbidity rate; HR = Hazard Ratio; RRR = Relative Risk Reduction †Adjusted p-values are presented for Studies 1, 2 and 3 (first SRE and first and subsequent SRE endpoints); *Accounts for all skeletal events over time; only events occurring ≥ 21 days after the previous event are counted.
Danish: IN = ikke nået; IT = ikke tilgængelig; HCM = hyperkalcæmi af malignitet; KMR = knoglemorbiditetsrate; HR = hazard ratio; RRR = relativ risikoreduktion †Justerede p-værdier vises for studie 1, 2 og 3 (endpoint med første KRH og første og efterfølgende KRH'er); *Udgør alle knoglerelaterede hændelser over tid; der medregnes kun hændelser, der opstod ≥ 21 dage efter den foregående hændelse.
English: If the level of calcium in your blood is low, your doctor may decide to give you calcium supplements before you start treatment with XGEVA.
Danish: Hvis niveauet af calcium i dit blod er lavt, vil din læge muligvis beslutte at give dig tilskud af calcium, inden du starter i behandling med XGEVA.