FrancophonIA/ELRC3.0 huggingface dataset:
English: If symptoms occur, the advice of a doctor should be sought.
Danish: Kontakt en læge, hvis der forekommer symptomer.
English: Strength Pharmaceutical form Route of administration
Danish: Styrke Lægemiddelform Administration Emballage
English: Iclusig received a marketing authorisation valid throughout the EU on 1 July 2013.
Danish: Iclusig fik en markedsføringstilladelse med gyldighed i hele EU den 1. juli 2013.
English: The recommended starting dose is 45 mg once per day.
Danish: Den anbefalede startdosis er 45 mg én gang dagligt.
English: Treatment is continued for as long as the patient benefits.
Danish: Behandlingen fortsættes, så længe patienten har gavn af den.
English: Why is Iclusig authorised in the EU?
Danish: Hvorfor er Iclusig godkendt i EU?
English: Other information about Iclusig
Danish: Andre oplysninger om Iclusig
English: These diseases are rare, and Iclusig was designated an ‘orphan medicine' (a medicine used in rare diseases) on 2 February 2010.
Danish: Disse sygdomme er sjældne, og Iclusig blev udpeget som ”lægemiddel til sjældne sygdomme” den 2. februar 2010.
English: An overview of Iclusig and why it is authorised in the EU
Danish: En oversigt over Iclusig, og hvorfor det er godkendt i EU
English: What measures are being taken to ensure the safe and effective use of Iclusig?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Iclusig?
English: Further information on Iclusig can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Iclusig findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For more information about using Iclusig, see the package leaflet or contact your doctor or pharmacist.
Danish: For yderligere oplysninger om brug af Iclusig, se indlægssedlen, eller kontakt din læge eller dit apotek.
English: What is Iclusig and what is it used for?
Danish: Hvad er Iclusig, og hvad anvendes det til?
English: As for all medicines, data on the use of Iclusig are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Iclusig løbende overvåget.
English: This enzyme is found on the surface of leukaemia cells where it is involved in stimulating the cells to divide uncontrollably.
Danish: Dette enzym findes på leukæmicellernes overflade, hvor det medvirker til, at cellerne deler sig ukontrolleret.
English: The European Medicines Agency decided that Iclusig's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur afgjorde, at fordelene ved Iclusig opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Further information on the orphan designations can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (CML; ALL).
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (CML; ALL).
English: Iclusig is available as tablets (15 mg, 30 mg and 45 mg).
Danish: Iclusig leveres som tabletter i styrkerne 15 mg, 30 mg og 45 mg.
English: What are the risks associated with Iclusig?
Danish: Hvilke risici er der forbundet med Iclusig?
English: Also, the company will conduct a study in order to determine the best starting dose of Iclusig and to assess the safety and effectiveness of Iclusig following dose reduction in patients with chronic phase CML who achieve major cytogenetic response.
Danish: Virksomheden skal desuden gennemføre et studie med henblik på at fastlægge den bedste startdosis af Iclusig og vurdere sikkerheden og virkningen af Iclusig efter nedsættelse af dosis hos patienter med CML i kronisk fase, som opnår en væsentlig cytogenetisk respons.
English: The company that markets Iclusig will provide educational material for all doctors who are expected to prescribe this medicine highlighting important risks for which monitoring and dose adjustments are recommended.
Danish: Den virksomhed, der fremstiller Iclusig, skal udlevere informationsmateriale til alle læger, som forventes at ordinere dette lægemiddel, med en beskrivelse af visse alvorlige risici, for hvilke der anbefales overvågning og dosisjustering.
English: • acute lymphoblastic leukaemia (ALL) in patients who are ‘Philadelphia-chromosome positive' (Ph+).
Danish: • akut lymfoblastisk leukæmi (ALL) hos patienter, der er positive for "philadelphiakromosomet" (Ph+).
English: Ph+ means that some of the patient's genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome that leads to the development of leukaemia.
Danish: Ph+ betyder, at nogle af patientens gener har omarrangeret sig og dannet et specielt kromosom, der kaldes philadelphiakromosomet og medfører udvikling af leukæmi.
English: The most common serious side effects with Iclusig (which may affect more than 2 in 100 people) are pneumonia (infection of the lungs), pancreatitis (inflammation of the pancreas), pyrexia (fever), abdominal pain (stomach ache), myocardial infarction (heart attack), atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), peripheral arterial occlusive disease (problem with blood flow in the arteries), anaemia (low red blood cell counts), angina pectoris (pains to the chest, jaw and back due to problems with blood flow to the heart), decreased blood levels of platelets (components that help the blood to clot), febrile neutropenia (low white blood cell counts with fever), hypertension (high blood pressure), coronary artery disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle), cardiac failure (when the heart does not work as well as it should), cerebrovascular accident (stroke), sepsis (blood poisoning), cellulitis (inflammation of the deep skin tissue), acute kidney injury (kidney damage), urinary tract infection (infection of the structures that carry urine) and increased levels of lipase (an enzyme).
Danish: De hyppigste alvorlige bivirkninger med Iclusig (som kan forekomme hos mere end 2 ud af 100 personer) er pneumoni (lungebetændelse), pancreatitis (bugspytkirtelbetændelse ), pyreksi (feber), mavesmerter, myokardieinfarkt (hjerteanfald), atrieflimren (uregelmæssige hurtige sammentrækninger af hjertets forkamre), perifer arteriel okklusiv sygdom (problemer med dårlig blodgennemstrømning i arterierne), anæmi (lavt antal røde blodlegemer), angina pectoris (smerter i brystkassen, kæben og ryggen på grund af problemer med blodgennemstrømningen til hjertet), nedsat indhold af blodplader (komponenter, der hjælper blodet med at størkne), febril neutropeni (lavt antal hvide blodlegemer, ledsaget af feber), hypertension (højt blodtryk), hjertesvigt (hjertet virker ikke så godt som det skal), slagtilfælde (apopleksi), sepsis (blodforgiftning), karonararteriesygdom (hjertesvigt forårsaget af blokering af de blodkar, der forsyner hjertemusklen), cellulitis (betændelse i dybe hudvæv), akut nyreskade, urinvejsinfektion og forhøjet indhold af enzymet lipase.
English: By blocking Bcr-Abl, Iclusig helps to control the growth and spread of leukaemia cells.
Danish: Ved at blokere Bcr-Abl bidrager Iclusig til at begrænse leukæmicellernes vækst og spredning.
English: Side effects reported with Iclusig are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Iclusig vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: It is used to treat adults with the following types of leukaemia (cancer of the white blood cells):
Danish: Det anvendes til behandling af voksne patienter med følgende former for leukæmi (blodkræft, der udgår fra de hvide blodlegemer):
English: How is Iclusig used?
Danish: Hvordan anvendes Iclusig?
English: The results of the study showed that treatment with Iclusig led to clinically relevant responses in all groups of patients:
Danish: Undersøgelsen viste, at behandlingen med Iclusig havde klinisk relevant virkning hos alle grupper af patienter:
English: In the study, Iclusig was not compared with another treatment.
Danish: I studiet blev Iclusig ikke sammenlignet med nogen anden behandling.
English: If a patient develops certain severe side effects, the doctor may decide to reduce subsequent doses or delay or stop treatment.
Danish: Hvis patienten får visse svære bivirkninger, kan lægen beslutte at nedsætte dosis eller udsætte eller standse behandlingen.
English: Iclusig can only be obtained with a prescription and treatment should be started by a doctor who is experienced in the diagnosis and treatment of leukaemia.
Danish: Iclusig udleveres kun på recept, og behandlingen bør iværksættes af en læge med erfaring i diagnose og behandling af leukæmi.
English: The response to treatment was assessed by measuring the proportion of patients who had a ‘major haematological response' (when the number of white blood cells returns to normal or there is no evidence of leukaemia) or a ‘major cytogenetic response' (when the proportion of white blood cells containing the Philadelphia chromosome falls to below 35%).
Danish: Virkningen af behandlingen blev vurderet ved registrering af den andel af patienterne, der opnåede "væsentlig hæmatologisk respons" (dvs. at antallet af hvide blodlegemer bliver normalt igen, eller at der ikke er tegn på leukæmi) eller "væsentlig cytogenetisk respons" (dvs. at andelen af hvide blodlegemer med philadelphiakromosomet falder til under 35 %).
English: The risk of problems (including heart attacks and strokes) resulting from blood clots or blockages in arteries or veins could be reduced by checking for and treating contributory conditions such as high blood pressure and raised cholesterol both before and during treatment.
Danish: Risikoen for problemer (herunder hjertetilfælde og slagtilfælde) som følge af blodpropper eller blokeringer i arterierne eller venerne kunne nedbringes ved at undersøge for og behandle medvirkende tilstande, såsom højt blodtryk og forhøjet kolesterol, både før og under behandling.
English: • chronic myeloid leukaemia (CML) in its different stages known as chronic, accelerated and blast phases;
Danish: • kronisk myeloid leukæmi (CML) i stadierne kronisk fase, accelereret fase og blastfase
English: The Philadelphia-chromosome is found in some ALL patients and is present in most patients with CML.
Danish: Philadelphiakromosomet findes hos nogle patienter med ALL og hos de fleste patienter med CML.
English: Iclusig is used in patients who cannot tolerate or do not respond to dasatinib (patients with CML or ALL) or nilotinib (patients with CML), which are other cancer medicines of the same class, and for whom subsequent treatment with imatinib (a third such medicine) is not considered appropriate.
Danish: Iclusig anvendes hos patienter, der ikke tåler eller ikke reagerer på behandling med dasatinib (patienter med CML eller ALL) eller nilotinib (patienter med CML), som er andre kræftlægemidler i samme gruppe, eller patienter, som ikke er egnede til efterfølgende behandling med imatinib (et tredje sådant lægemiddel).
English: For the full list of side effects and restrictions with Iclusig, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger med Iclusig fremgår af indlægssedlen.
English: Iclusig is a cancer medicine that contains the active substance ponatinib.
Danish: Iclusig er et kræftlægemiddel, der indeholder det aktive stof ponatinib.
English: What benefits of Iclusig have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Iclusig?
English: Regarding its safety, the side effects with Iclusig were largely similar to those of other tyrosine kinase inhibitors and mostly manageable with dose reduction or dose delay.
Danish: Hvad angår sikkerheden, svarer bivirkningerne af Iclusig i det store hele til andre tyrosinkinasehæmmere og kan som regel håndteres ved nedsættelse eller udsættelse af doseringen.
English: Iclusig was shown to be an effective treatment for those patients with CML or Ph+ ALL who have limited treatment options.
Danish: CHMP bemærkede, at Iclusig var påvist at være effektivt til behandling af de patienter med CML eller Ph+ ALL, for hvem der kun findes begrænsede behandlingsmuligheder.
English: Venous thromboembolic reactions (problems due to blood clots in the veins) occurred in 6% of patients.
Danish: Venøse tromboemboliske reaktioner (problemer som følge af blodpropper i venerne) forekom hos 6 % af patienterne.
English: Arterial occlusive adverse events (clots or blockages in the arteries) occurred in 25% of patients, with serious adverse events occurring in 20% of patients.
Danish: Arterielle okklusive bivirkninger (blodpropper eller blokering i arterierne) forekom hos 25 % af patienterne, og alvorlige bivirkninger hos 20 % af patienterne.
English: It is also used in patients who have a genetic mutation called ‘T315I mutation' which makes them resistant to treatment with imatinib, dasatinib or nilotinib.
Danish: Desuden anvendes det hos patienter, der har genmutationen T315I og derfor ikke reagerer på behandling med imatinib, dasatinib eller nilotinib.
English: Iclusig has been investigated in one main study involving 449 patients with CML or Ph+ ALL and who were intolerant or resistant to treatment with dasatinib or nilotinib, or had the T315I mutation.
Danish: Iclusig er blevet undersøgt i et hovedstudie med 449 patienter, som havde CML eller Ph+ ALL og ikke tålte eller ikke reagerede på behandling med dasatinib eller nilotinib, eller som havde T315Imutationen.
English: Iclusig can lead to clots or blockages in arteries and veins and patients should have the condition of their heart and circulation considered before starting and during treatment, and be treated appropriately for any problems.
Danish: Iclusig kan medføre blodpropper eller blokeringer i arterierne og venerne, og patienternes hjerte og kredsløb skal undersøges både inden og under behandlingen, og eventuelle problemer skal behandles.
English: Ponatinib acts by blocking a tyrosine kinase called Bcr-Abl.
Danish: Ponatinib virker ved at blokere tyrosinkinasen Bcr-Abl.
English: These compounds act by blocking enzymes known as tyrosine kinases.
Danish: Disse stoffer virker ved at blokere enzymer af typen tyrosinkinase.
English: The active substance in Iclusig, ponatinib, belongs to a group of medicines called ‘tyrosine kinase inhibitors'.
Danish: Det aktive stof i Iclusig, ponatinib, tilhører lægemiddelgruppen "tyrosinkinasehæmmere".
English: Serious venous occlusive adverse events (clots or blockages in the veins) occurred in 5% of patients.
Danish: Alvorlige venøse okklusive bivirkninger (blodpropper eller blokering i venerne) forekom hos 5 % af patienterne.
English: The doctor should consider stopping treatment if the level of white cells in the blood does not return to normal within three months.
Danish: Hvis indholdet af hvide blodlegemer i blodet ikke bliver normalt igen i løbet af tre måneder, bør lægen overveje at standse behandlingen.
English: • among the patients with CML in the chronic phase, around 54% (144 out of 267) had a major cytogenetic response;
Danish: • Blandt patienterne med CML i kronisk fase opnåede ca. 54 % (144 ud af 267) væsentlig cytogenetisk respons.
English: How does Iclusig work?
Danish: Hvordan virker Iclusig?
English: • among the patients with Ph+ ALL, around 41% (13 out of 32) had a major haematological response.
Danish: • Blandt patienterne med Ph+ ALL opnåede ca. 41 % (13 ud af 32) væsentlig hæmatologisk respons.
English: • among the patients with CML in the accelerated phase, around 58% (48 out of 83) had a major haematological response;
Danish: • Blandt patienterne med CML i accelereret fase opnåede ca. 58 % (48 ud af 83) væsentlig hæmatologisk respons.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Iclusig 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 Iclusig.
English: The dose may need to be reduced or interrupted if the patient experiences certain side effects; it should be interrupted immediately if a blockage develops in an artery or vein.
Danish: Behandlingen bør afbrydes øjeblikkeligt, hvis der opstår en blokering i en arterie eller vene.
English: • among the patients with CML in the blast phase, around 31% (19 out of 62) had a major haematological response;
Danish: • Blandt patienterne med CML i blastfase opnåede ca. 31 % (19 ud af 62) væsentlig hæmatologisk respons.
English: The CVMP concluded that, based on all available data, there was no concern regarding safety or efficacy for the product.
Danish: CVMP finder på grundlag af alle foreliggende oplysninger ikke anledning til betænkelighed vedrørende produktets sikkerhed eller virkning.
English: The CVMP, therefore, recommended a variation of the Marketing Authorisation.
Danish: CVMP anbefaler godkendelse af ændringen af markedsføringstilladelsen.
English: However, it was important to ensure that the pass limits of the potency test do not drift from the original.
Danish: Det er imidlertid vigtigt at sikre, at godkendelsesgrænserne for styrkeprøven ikke flytter sig i forhold til de oprindelige.
English: BACKGROUND INFORMATION
Danish: BILAG I
English: The Marketing Authorisation(s) should be varied to reduce the variability of the serological potency test in mice by appropriate measures such as the replacement of the use of a reference vaccine in the serological potency test in mice with the use of reference serum.
Danish: Markedsføringstilladelsen (-tilladelserne) bør ændres med henblik på passende foranstaltninger til mindskelse af variabiliteten ved den serologiske styrketest i mus.
English: European Medicines Agency Veterinary Medicines and Inspections
Danish: Lægemiddelform
English: London, June 2008 EMEA/532233/2007- Rev.1
Danish: Tel: +34 91 5981343 Fax: +34 91 5972434 Email: rodrigv2@fdah.com
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
Danish: Fort Dodge Animal Health SpA
English: The referral deals with the issue that in the opinion of France equivalence between the reference vaccine batch for the erysipelas batch potency test validated in the original dossier and the new reference vaccine batches was not shown for these 2 batches and that consequently the CVMP needed to consider whether to vary, withdraw or suspend the marketing authorisation.
Danish: Ved behandlingen af en type II-ansøgning om ændring af styrkeprøven i mus med henblik på overensstemmelsen med den reviderede Ph.Eur-monografi for erysipelas-vacciner blev batch 8500 godkendt som referencevaccine.
English: OPINION FOLLOWING AN ARTICLE 40 REFERRAL FOR SUVAXYN ERY
Danish: Email: lastrag@fdah.com
English: Suvaxyn Ery is indicated for the active immunisation of pigs (gilts and sows) to reduce clinical signs caused by Erysipelothrix rhusiopathiae infections, serotype 2 and serotype 1.
Danish: Rua Dr. António Loureiro Borges, nº2, ArquiparqueMiraflores, 1495-131 Algés
English: France notified the EMEA on 11 July 2006 of a Referral under Article 40 of Council Directive 2001/82/EC, as amended, in relation to Suvaxyn Ery.
Danish: De ændringer af referencevaccinen, der indgår i denne indbringelse, vedrører erstatningen af batch 8500 med 9097 og den efterfølgende erstatning af batch 9097 med 9861.
English: The usual dose is one infusion of 4 mg over at least 15 minutes.
Danish: Den normale dosis er én infusion på 4 mg over mindst 15 minutter.
English: Further information on Zoledronic Acid Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zoledronic-acid-accord.
Danish: Yderligere information vedrørende Zoledronsyre Accord findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/zoledronic-acid-accord.
English: It is not recommended for patients with severely reduced kidney function.
Danish: Det anbefales ikke til patienter med svært nedsat nyrefunktion.
English: Zoledronic Acid Accord received a marketing authorisation valid throughout the EU on 16 January
Danish: Zoledronsyre Accord fik en markedsføringstilladelse med gyldighed i hele EU den 16. januar 2014.
English: The medicine is given as an infusion (drip) into a vein.
Danish: Lægemidlet gives som infusion (drop) i en vene.
English: This reduces bone loss.
Danish: Dette nedsætter knogletabet.
English: As for all medicines, data on the use of Zoledronic Acid Accord are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Zoledronsyre Accord løbende overvåget.
English: For more information about using Zoledronic Acid Accord, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Zoledronsyre Accord, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Zoledronic Acid Accord are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Zoledronsyre Accord vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Zometa, and do not need to be repeated for Zoledronic Acid Accord.
Danish: Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Zometa, og de behøver ikke blive gentaget for Zoledronsyre Accord.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Zoledronic Acid Accord has been shown to have comparable quality and to be comparable to Zometa.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Zoledronsyre Accord er af sammenlignelig kvalitet og er bioækvivalent med Zometa.
English: This means that Zoledronic Acid Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Danish: Det betyder, at Zoledronsyre Accord indeholder samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Zometa.
English: Therefore, the Agency's view was that, as for Zometa, the benefit outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene opvejer de identificerede risici som for Zometa, og at det kan godkendes til anvendelse i EU.
English: Because Zoledronic Acid Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicines'.
Danish: Da Zoledronsyre Accord er et generisk lægemiddel, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: There was no need for ‘bioequivalence' studies to investigate whether Zoledronic Acid Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Danish: Der var ikke behov for "bioækvivalensstudier" for at undersøge, om Zoledronsyre Accord optages identisk med referencelægemidlet for at give det samme niveau af det aktive stof i blodet.
English: As for every medicine, the company provided studies on the quality of Zoledronic Acid Accord.
Danish: Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Zoledronsyre Accord.
English: Zoledronic Acid Accord can only be obtained with a prescription and must only be prescribed and given by a healthcare professional who has experience in the use of this type of medicine given into a vein.
Danish: Zoledronsyre Accord udleveres kun efter recept og må kun ordineres og gives af en sundhedsperson, der har erfaring med brugen af denne type lægemiddel, som gives i en vene.