FrancophonIA/ELRC3.0 huggingface dataset:
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Enviage, skal du henvende dig til den lokale repræsentant:
English: Elderly patients (over 65 years) No adjustment of the initial dose is required for elderly patients.
Danish: Der kræves ingen justering af initialdosen for ældre patienter.
English: NAME OF THE MEDICINAL PRODUCT Enviage 300 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Enviage 300 mg filmovertrukne tabletter
English: In diabetic hypertensive patients, Enviage monotherapy was safe and effective.
Danish: Hos hypertensive patienter med diabetes var monoterapi med
English: If you forget to take Enviage
Danish: Det skal du vide, før du begynder at tage Enviage
English: Not applicable.
Danish: Der er ikke
English: These include potassium sparing diuretics, potassium supplements.
Danish: Dette gælder også kaliumbesparende - furosemid, medicin, der tilhører gruppen af diuretika.
English: Treatment with Enviage resulted in an overall incidence of adverse reactions similar to placebo up to 300 mg.
Danish: Behandling med Enviage udviste en samlet incidens af bivirkninger svarende til placebo for behandling med op til 300 mg. Bivirkningerne var generelt milde og forbigående og det har kun sjældent været nødvendigt at seponere behandlingen.
English: Angioedema
Danish: Amning
English: EU/1/07/406/011-020
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/07/406/011-020
English: No adjustment of the initial dose is required for patients with mild to severe hepatic impairment (see section 5.2).
Danish: Der kræves ingen justering af initialdosen for patienter med mildt til stærkt nedsat leverfunktion (se
English: It is very important that you take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects.
Danish: Mange føler sig helt rask Det er meget vigtigt, at du tager medicinen nøjagtigt efter lægens anvisninger, hvis du vil opnå det fø
English: What Enviage looks like and contents of the pack Enviage 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.
Danish: Enviage 150 mg filmovertrukne tabletter er lyse pink, udadbuede, runde tabletter, præget med ”IL” på den ene side og ”NVR” på den anden side.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Danish: tig (pharmacovigilance er risikominimerings) milepæl er nået.
English: Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of Enviage.
Danish: Du skal sørge for at finde ud af, hvordan du reagerer på Enviage, før du kører bil, betjener maskiner eller udfører andre
English: What Enviage looks like and contents of the pack Enviage 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “IU” on one side and “NVR” on the other side.
Danish: Enviage 300 mg filmovertrukne tabletter er lyserøde, udadbuede, ovale tabletter, præget med ”IU” på den ene side og ”NVR” på den anden side.
English: Caution should be exercised in hypertensive patients with severe renal impairment due to the lack of safety information for Enviage.
Danish: På grund af de manglende sikkerhedsoplysninger for Enviage skal der udvises forsigtighed overfor patienter med svært nedsat
English: Enviage in combination with the angiotensin receptor antagonist valsartan showed an additive antihypertensive effect in the study specifically designed to investigate the effect of the combination therapy.
Danish: itiv kt i et studie specifikt designet til at undersøge effekten af ombinationsterapien.
English: България
Danish: Ireland
English: Skin and subcutaneous tissue disorders
Danish: Udseende og pakningsstørrelser
English: Silica, colloidal anhydrous
Danish: ), tidligere dialyse, nefrotisk syndrom eller renovaskulær hypertension.
English: In the event that any signs of renal failure occur, aliskiren should be promptly discontinued.
Danish: Hvis der opstår tegn på nyresvigt, skal
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: - Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som
English: Novartis Pharma Servic Tel: +386 1 300 75 77
Danish: Tel: +386 1 300 75 77
English: Talc
Danish: Horsham
English: --1 Inactivated Coxiella burnetii, strain Nine Mile: ≥72 QF Units*/ml.
Danish: --1Inaktiveret Coxiella burnetii, stamme Nine Mile: ≥72 QF enheder*/ml.
English: * QF (Q fever) Unit: relative potency of phase I antigen measured by ELISA in comparison with a reference item.
Danish: *QF (Q-feber) enhed: relativ styrke af fase-I antigen målt ved ELISA i forhold til en referenceværdi.
English: The average duration of response to treatment was 17.5 months.
Danish: I gennemsnit varede responset på behandlingen 17,5 måneder.
English: Imbruvica received a marketing authorisation valid throughout the EU on 21 October 2014.
Danish: Imbruvica fik en markedsføringstilladelse med gyldighed i hele EU den 21. oktober 2014.
English: Further information on Imbruvica can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/imbruvica .
Danish: Yderligere information om Imbruvica findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/imbruvica.
English: The side effects of the medicine were considered acceptable.
Danish: Bivirkningerne ved lægemidlet anses for at være acceptable.
English: Imbruvica is available as capsules (140 mg) and tablets (140, 280, 420 and 560 mg).
Danish: Imbruvica fås som kapsler (140 mg) og tabletter (140, 280, 420 og 560 mg).
English: Other information about Imbruvica
Danish: Andre oplysninger om Imbruvica
English: As for all medicines, data on the use of Imbruvica are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Imbruvica løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Imbruvica?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Imbruvica?
English: Treatment with Imbruvica should continue for as long as the disease improves or remains stable and the side effects are tolerable.
Danish: Behandlingen med Imbruvica bør fortsættes, så længe sygdommen bedres eller holder sig stabil, og bivirkningerne er tålelige.
English: The European Medicines Agency decided that Imbruvica's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Imbruvica opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What is Imbruvica and what is it used for?
Danish: Hvad er Imbruvica, og hvad anvendes det til?
English: Side effects reported with Imbruvica are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Imbruvica vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: An overview of Imbruvica and why it is authorised in the EU
Danish: En oversigt over Imbruvica, og hvorfor det er godkendt i EU
English: Imbruvica can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in using cancer medicines.
Danish: Imbruvica fås kun på recept, og behandlingen skal iværksættes og overvåges af en læge med erfaring i brug af kræftmedicin.
English: Response to treatment was measured as a reduction in the blood levels of the protein IgM, which is present in high levels in patients with Waldenström's disease.
Danish: Responset på behandlingen blev målt som reduktionen i blodets indhold af proteinet IgM, der findes i store mængder i blodet hos patienter med Waldenströms sygdom.
English: Imbruvica is a medicine for treating adult patients with the following blood cancers:
Danish: Imbruvica er et lægemiddel, der anvendes til behandling af voksne patienter med følgende typer blodkræft:
English: Chronic lymphocytic leukaemia
Danish: Kronisk lymfatisk leukæmi
English: Imbruvica contains the active substance ibrutinib.
Danish: Imbruvica indeholder det aktive stof ibrutinib.
English: Why is Imbruvica authorised in the EU?
Danish: Hvorfor er Imbruvica godkendt i EU?
English: These diseases are rare, and Imbruvica was designated an ‘orphan medicine' (a medicine used in rare diseases) for chronic lymphocytic leukaemia on 26 April 2012, mantle cell lymphoma on 12 March 2013 and Waldenström's macroglobulinaemia on 29 April 2014.
Danish: Disse sygdomme er sjældne, og Imbruvica blev udpeget som "lægemiddel til sjældne sygdomme" til behandling af kronisk lymfatisk leukæmi den 26. april 2012, mantelcellelymfom den 12. marts 2013 og Waldenströms makroglobulinæmi den 29. april 2014.
English: In addition Imbruvica was shown to be effective in patients with Waldenström's macroglobulinaemia..
Danish: Derudover er det påvist, at Imbruvica er effektivt hos patienter med Waldenströms makroglobulinæmi.
English: The average time before patients died or the disease got worse was 15 months with Imbruvica versus 6 months with temsirolimus.
Danish: Den gennemsnitlige tid, inden patienterne døde eller sygdommen forværredes, var 15 måneder ved behandling med Imbruvica, sammenholdt med 6 måneder ved behandling med temsirolimus.
English: If the patient is taking other medicines that may interact with Imbruvica, or gets severe side effects, the dose may be lowered or treatment interrupted.
Danish: Ved behandling med andre lægemidler, der kan vekselvirke med Imbruvica, eller ved svære bivirkninger kan dosis sættes ned, eller behandlingen afbrydes.
English: The most common side effects with Imbruvica (which may affect more than 1 in 5 people) are diarrhoea, neutropenia (low levels of neutrophils, a type of white blood cell), pain in muscles and bones, haemorrhage (bleeding), bruising, rash, feeling sick and thrombocytopenia (low blood platelet counts).
Danish: De hyppigste bivirkninger ved Imbruvica (som kan forekomme hos 1 ud af 5 personer) er diarré, neutropeni (lavt antal neutrofiler, en type hvide blodlegemer), smerter i muskler og knogler, blødning, blå mærker, udslæt, kvalme og trombocytopeni (lavt antal blodplader).
English: For more information about using Imbruvica, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Imbruvica, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: A second study in 280 such patients compared Imbruvica with another cancer medicine, temsirolimus.
Danish: I et andet studie med 280 patienter sammenlignedes Imbruvica med et andet kræftlægemiddel, temsirolimus.
English: What are the risks associated with Imbruvica?
Danish: Hvilke risici er der forbundet med Imbruvica?
English: In addition, Imbruvica was effective in patients with mantle cell lymphoma that did not respond to or had come back after previous treatment, a group of patients with poor prognosis and few other treatment options.
Danish: Desuden var Imbruvica effektivt hos patienter med mantelcellelymfom, hvis sygdom ikke havde reageret på eller var kommet igen efter tidligere behandling, en patientgruppe med dårlig prognose og kun få andre behandlingsmuligheder.
English: It does this by blocking an enzyme called Bruton's tyrosine kinase (Btk), which promotes survival of B lymphocytes and their migration to the organs where these cells normally divide.
Danish: Det virker ved at blokere et enzym kaldet Brutons tyrosinkinase (Btk), der fremmer overlevelsen af Blymfocytter og disses vandring til organerne, hvor de typisk deler sig.
English: The most serious side effects are neutropenia, pneumonia (lung infection) and thrombocytopenia.
Danish: De alvorligste bivirkninger er neutropeni, lungebetændelse og trombocytopeni.
English: For patients with mantle cell lymphoma the dose is 560 mg once a day, for patients with chronic lymphocytic leukaemia or Waldenström's macroglobulinaemia the usual dose of Imbruvica is 420 mg once a day.
Danish: Hos patienter med mantelcellelymfom er dosen 560 mg én gang dagligt, og hos patienter med kronisk lymfatisk leukæmi eller Waldenströms makroglobulinæmi er den sædvanlige dosis af Imbruvica 420 mg én gang dagligt.
English: The company that markets Imbruvica needs to provide further data on the benefits of Imbruvica in the treatment of chronic lymphocytic leukaemia from follow-up of previously treated patients.
Danish: Den virksomhed, der markedsfører Imbruvica, skal indsende yderligere oplysninger om fordelene ved Imbruvica til behandling af kronisk lymfatisk leukæmi fra opfølgningen af tidligere behandlede patienter.
English: By blocking Btk, ibrutinib decreases survival and migration of B lymphocytes, thereby delaying progression of the cancer.
Danish: Ved at blokere Btk nedsætter ibrutinib B-lymfocytternes overlevelse og vandring, så kræftsygdommens udvikling forsinkes.
English: The active substance in Imbruvica, ibrutinib, works against cancerous B lymphocytes, a type of white blood cells.
Danish: Det aktive stof i Imbruvica, ibrutinib, virker mod maligne B-lymfocytter (en type hvide blodlegemer).
English: • mantle cell lymphoma in patients whose disease does not respond to or has come back after previous treatment;
Danish: • mantelcellelymfom hos patienter, hvis sygdom ikke har reageret på tidligere behandling eller er vendt tilbage
English: • chronic lymphocytic leukaemia (CLL) in both previously treated and untreated patients;
Danish: • kronisk lymfatisk leukæmi hos både tidligere behandlede og ubehandlede patienter
English: Waldenström's macroglobulinaemia
Danish: Waldenströms makroglobulinæmi
English: How is Imbruvica used?
Danish: Hvordan anvendes Imbruvica?
English: In one main study involving 63 patients who had previously received another treatment for Waldenström's macroglobulinaemia, the disease responded to treatment with Imbruvica in 87% of patients.
Danish: I et hovedstudie med 63 patienter, der tidligere havde fået en anden behandling mod Waldenströms makroglobulinæmi, reagerede 87 % af patienterne på behandling med Imbruvica.
English: Imbruvica was shown to be effective at delaying progression of chronic lymphocytic leukaemia, both in untreated patients and in those who had received treatment previously.
Danish: Det er påvist, at Imbruvica er effektivt til at forsinke sygdomsforværring ved kronisk lymfatisk leukæmi, både hos ubehandlede og tidligere behandlede patienter.
English: In a study in 111 patients with mantle cell lymphoma that did not respond to or had come back after previous treatment, 21% of patients taking Imbruvica had complete response (i.e. disappearance of all signs of cancer) and 47% had partial response (i.e. the patient improved but some signs of the disease remained).
Danish: I et studie med 111 patienter med mantelcellelymfom, der ikke havde reageret på eller var vendt tilbage efter tidligere behandling, oplevede 21 % af de patienter, der fik Imbruvica, fuldstændigt respons (dvs. alle tegn på kræft forsvandt), og 47 % oplevede delvist respons (dvs. patienten fik det bedre, men havde stadig nogle tegn på kræftsygdommen).
English: For the full list of side effects of Imbruvica, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Imbruvica fremgår af indlægssedlen.
English: In a study in 578 patients whose disease had not responded to or had come back after previous treatment, death or signs that the cancer was progressing occurred in 19% of patients (56 of 289) who took Imbruvica together with the cancer medicines bendamustine and rituximab compared with 63% (183 of 289) in those who took bendamustine and rituximab without Imbruvica.
Danish: I et studie med 578 patienter, hvis sygdom ikke havde reageret på eller var kommet tilbage efter tidligere behandling, blev der observeret død eller tegn på sygdomsforværring hos 19 % (56 ud af 289) af de patienter, der fik Imbruvica sammen med kræftlægemidlerne bendamustin og rituximab, sammenholdt med 63 % (183 ud af 289) af de patienter, der fik bendamustin og rituximab uden Imbruvica.
English: • Waldenström's macroglobulinaemia (also known as lymphoplasmacytic lymphoma) Imbruvica can be taken alone but can also be taken with bendamustine and rituximab or with obinutuzumab in certain patients with CLL and with rituximab in patients with Waldenström's macroglobulinaemia.
Danish: Imbruvica kan tages alene, men kan også tages sammen med bendamustin og rituximab eller sammen med obinutuzumab hos visse patienter med kronisk lymfatisk leukæmi og sammen med rituximab hos patienter med Waldenströms makroglobulinæmi.
English: In a study involving 150 patients with Waldenström's macroglobulinaemia, after 26 months, death or signs that the cancer was progressing occurred in 19% of patients who took Imbruvica together with rituximab compared with 56% of patients who took only rituximab.
Danish: I et studie med 150 patienter med Waldenströms makroglobulinæmi blev der observeret død eller tegn på progression af kræften hos 19 % af de patienter, der fik Imbruvica og rituximab, sammenholdt med 56 % af de patienter, der kun fik rituximab.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imbruvica 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 Imbruvica.
English: What benefits of Imbruvica have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Imbruvica?
English: How does Imbruvica work?
Danish: Hvordan virker Imbruvica?
English: In one study in 391 patients whose disease did not respond to or had come back after previous treatment, 66% of patients receiving Imbruvica were still alive after one year with their disease not having progressed compared with around 6% of patients receiving another cancer medicine, ofatumumab.
Danish: I et studie med 391 patienter, hvis sygdom ikke havde reageret på eller var kommet tilbage efter tidligere behandling, var 66 % af de patienter, der fik Imbruvica, stadig i live efter et år uden sygdomsforværring, sammenholdt med ca. 6 % af de patienter, der fik ofatumumab (et andet kræftlægemiddel).
English: In a study in 229 previously untreated patients, after 31 months, 79% of patients treated with Imbruvica and obinutuzumab were alive with their disease not having progressed compared with 36% of patients who took chlorambucil and obinutuzumab.
Danish: I et studie med 229 tidligere ubehandlede patienter var 79 % af de patienter, der fik Imbruvica og obinutuzumab, i live uden sygdomsprogression efter 31 måneder, sammenholdt med 36 % af de patienter, der fik chlorambucil og obinutuzumab.
English: In a study involving 269 patients who had not been treated before, around 90% of patients receiving Imbruvica were still alive with their disease not having progressed after 1.5 years of treatment compared with around 52% of patients receiving a cancer medicine called chlorambucil.
Danish: I et studie med 269 patienter, der ikke var blevet behandlet tidligere, var ca. 90 % af de patienter, der fik Imbruvica, stadig i live uden sygdomsforværring efter 1½ års behandling, sammenholdt med ca. 52 % af de patienter, der fik chlorambucil (et andet kræftlægemiddel).
English: St. John's wort (a herbal remedy used for depression and anxiety) must not be used in patients treated with Imbruvica.
Danish: Under behandling med Imbruvica må patienterne ikke få prikbladet perikum (et plantelægemiddel, der anvendes mod depression og angst).
English: 27 February 2012
Danish: Den 27. februar 2012
English: The European Commission issued a decision on 27 February 2012.
Danish: Europa-Kommissionen traf en afgørelse den 27. februar 2012.
English: What are the recommendations for patients and healthcare professionals?
Danish: Hvilke anbefalinger gælder for patienter og sundhedspersonale?
English: Outcome of procedures under Article 20 of Regulation (EC) No 726/2004 and Article 107 of Directive 2001/83/EC
Danish: Resultatet af procedurerne i henhold til artikel 20 i forordning (EF) nr. 726/2004 og artikel 107 i direktiv 2001/83/EF
English: The risk appeared to be highest when doses higher than the ones approved were used.
Danish: Risikoen så ud til at være størst, når der blev anvendt højere doser end de godkendte.
English: • The maximum recommended daily dose should not be exceeded.
Danish: • Den anbefalede maksimale dosis må ikke overskrides.
English: What is somatropin?
Danish: Hvad er somatropin?
English: 1 Procedure numbers: EMEA/H/A-107/1287; EMEA/H/000607/A-20/0021; EMEA/H/C/000315/A-20/0040; and EMEA/H/C/000602/A-20/0008.
Danish: 1 Procedurernes numre: EMEA/H/A-107/1287, EMEA/H/000607/A-20/0021, EMEA/H/C/000315/A-20/0040 og EMEA/H/C/000602/A-20/0008.
English: In particular, an increased risk of mortality due to bone tumours and cardiovascular events (such as bleeding in the brain) was seen.
Danish: Navnlig var der øget dødelighed som følge af knoglesvulster og hjerte-kar-hændelser (såsom hjerneblødninger).
English: • Patients or their carers who have any questions should speak to their doctor or pharmacist.
Danish: • Hvis patienter eller deres omsorgsgivere ønsker yderligere oplysninger, bør de tale med lægen eller apotekspersonalet.
English: Why was somatropin reviewed?
Danish: Hvorfor blev somatropin vurderet igen?
English: Medicines containing somatropin are given by injection.
Danish: Lægemidler indeholdende somatropin gives ved injektion.
English: In particular, the harmonised wording will emphasise that somatropin must not be used if there is any evidence of tumour activity, and that the maximum recommended daily dose should not be exceeded.
Danish: Navnlig skal den harmoniserede ordlyd understrege, at somatropin ikke må anvendes ved tegn på tumoraktivitet, og at den anbefalede maksimale daglige dosis ikke må overskrides.
English: Somatropin is a copy of naturally occurring human growth hormone, produced by a method known as ‘recombinant DNA technology'.
Danish: Somatropin er en kopi af naturligt menneskeligt væksthormon, der fremstilles ved "rekombinant dnateknologi".
English: • Somatropin must not be used in patients with any evidence of tumour activity.
Danish: • Somatropin må ikke anvendes hos patienter med tegn på tumoraktivitet.
English: However, the Committee noted that the available data on the long-term effects of somatropin treatment are very limited.
Danish: Udvalget konstaterede dog, at der kun foreligger meget begrænsede oplysninger om langtidsvirkningerne af behandling med somatropin.
English: The CHMP concluded that the French SAGhE study had significant methodological limitations and that the results could not be considered robust.
Danish: CHMP konkluderede, at den franske SAGhE-undersøgelse havde væsentlige metodemæssige begrænsninger, og at resultaterne ikke kunne anses for fyldestgørende.
English: At the same time, the European Commission requested the CHMP to carry out the same assessment for the centrally authorised somatropin-containing medicines.
Danish: Samtidig anmodede Europa-Kommissionen CHMP om at foretage samme vurdering af centralt godkendte lægemidler indeholdende somatropin.
English: The nationally authorised medicines are Genotropin, Humatrope, Maxomat, Norditropin, Saizen and Zomacton.
Danish: De nationalt god kendte lægemidler er Genotropin, Humatrope, Maxomat, Norditropin, Saizen og Zomacton.
English: 2 The centrally authorised somatropin-containing medicines are NutropinAq, Omnitrope and Valtropin.
Danish: 2 De centralt godkendte lægemidler indeholdende somatropin er NutropinAq, Omnitrope og Valtropin.
English: • Patients and healthcare professionals are reminded that the benefits of somatropin continue to outweigh its risks in the approved indications.
Danish: • Patienter og sundhedspersonale gøres opmærksomme på, at fordelene ved somatropin fortsat overstiger de tilknyttede risici, når det anvendes til de godkendte indikationer.