FrancophonIA/ELRC3.0 huggingface dataset:
English: Together with the comprehensive risk communication and the educational material consisting of a new DHPC, prescribers' checklists and patient alert cards, it can be reasonably assumed that such prominent restrictions of use will accordingly raise the awareness of both physicians and patients for a cautious exposure to this medicinal product.
Danish: Som yderligere risikominimeringsforanstaltning skal der udleveres oplysningsmateriale til de ordinerende læger for at sikre, at kun egnede patienter behandles med lægemidlet.
English: In order to address the concern that cardiovascular risk may increase considerably over time in the predominantly elderly target population, the MAH proposed regular assessment of the patients' cardiovascular risk.
Danish: Patientens risiko for at udvikle kardiovaskulær sygdom bør vurderes før påbegyndelse af behandlingen og derefter regelmæssigt, i almindelighed hver 6.-12. måned.
English: Strontium ranelate is associated with a number of serious adverse events including serious cardiac disorders, thromboembolic events, serious skin reactions, disturbances in consciousness, seizures, hepatitis and blood cytopenic disorders.
Danish: • Protelos/Osseor bør seponeres ved opståen af iskæmisk hjertesygdom, perifer arteriel sygdom eller cerebrovaskulær sygdom og ved ukontrolleret hypertension.
English: However, the retrospective subgroup analyses performed by the MAH support the conclusion that the risks for vascular complications seemed to be reduced to a neutral level by the exclusion of patients with identified increased cardiovascular risk while anti-fracture efficacy seems to be preserved, even in the subset of patients with severe osteoporosis.
Danish: CHMP nåede frem til sine konklusioner efter at have bemærket, at Protelos/Osseor udviste forebyggende virkning, også hos patienter med høj risiko for knoglebrud.
English: • The Committee concluded, in view of the available data, that given the number of identified serious risks, for which there are considerable doubts that they can be adequately mitigated during long-term treatment, in the context of the modest benefit shown in terms of fracture prevention, the benefit-risk balance of Protelos and Osseor is not favourable.
Danish: På baggrund af de iagttagne fordele ved forebyggelse af knogleskørhed hos patienter med høj risiko konkluderede udvalget, at Protelos/Osseor fortsat bør være
English: • The Committee also considered that there are serious concerns on whether the contraindications and warnings implemented to mitigate cardiac and thromboembolic risks could be achievable in clinical practice, considering that Protelos and Osseor are intended for long-term treatment of a population of elderly patients whose cardiovascular status may deteriorate over time.
Danish: • Protelos/Osseor vil kun blive udskrevet til forebyggelse af knoglebrud hos kvinder efter overgangsalderen og mænd med svær knogleskørhed og høj risiko for knoglebrud, når det ikke er muligt at anvende andre godkendte lægemidler mod knogleskørhed.
English: Regardless of the definition of severity of osteoporosis used, the estimates of cardiac and thromboembolic risks change in the restricted population (excluding those with contraindications) when compared to the whole PMO population dataset.
Danish: Den endelige anbefaling fra EMA for anvendelse af Protelos/Osseor var baseret på analyse af poolede data fra randomiserede undersøgelser hos ca. 7 500 postmenopausale kvinder med osteoporose.
English: The postmenopausal osteoporotic (PMO) population for strontium ranelate comprises data from 7 randomised studies: 2 phase II studies CL2-004 (Meunier, 2002; NP07869) and CL2-005 (Reginster 2002; NP08511) and 5 phase III studies CL3-009 (Meunier, 2004; NP08338/NP22819), CL3-010 (Reginster 2005; NP08340/NP22824), CL3-013 (Hwang 2008; NP22514), CL3-015 (Liu 2009; NP25026), CL3-017 (NP24357).
Danish: Tlf. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
English: In addition, other relevant changes have been implemented in the product information of strontium ranelate, strengthening the contraindications and warnings as well as restricting the indication for strontium ranelate to patients at high risk of fracture for whom treatment with other medicinal products is not possible due to, for example, contraindications or intolerance.
Danish: Det Europæiske Lægemiddelagentur har foretaget en gennemgang af Protelos/Osseor og anbefalet yderligere begrænsninger for anvendelsen hos patienter, der ikke kan behandles med andre godkendte lægemidler mod knogleskørhed.
English: • The Committee took note of a number of risks associated to strontium ranelate, namely serious cardiac disorders (including myocardial infarction), thromboembolic events (including VTE), serious skin reactions (including DRESS syndrome, Stevens-Johnson syndrome and toxic epidermal necrolysis), disturbances in consciousness, seizures, hepatitis and blood cytopenic disorders.
Danish: • Du skal ikke bruge Protelos/Osseor, hvis du har eller har haft hjerte-karproblemer såsom slagtilfælde, hjerteanfald eller nedsat blodgennemstrømning i arterierne.
English: However the CHMP took the view that assessment of cardiovascular risk is a primary task for practising physicians, mainly relying on accessible information (such as family and patient history, smoking status, body mass index, waist circumference, blood pressure) and commonly investigated laboratory values (such as blood glucose and lipids).
Danish: Disse patienter skal desuden regelmæssigt vurderes af lægen, og behandlingen standses, hvis der opstår hjerte-karproblemer såsom ukontrolleret forhøjet blodtryk eller hjertekrampe.
English: Avoiding vertebral fractures is an important treatment goal as they are associated with high morbidity and mortality, substantially impact on the quality of life and are known to predict future fractures.
Danish: Protelos/Osseor (strontiumranelat) er godkendt i EU til behandling af svær knogleskørhed hos kvinder efter overgangsalderen med høj risiko for knoglebrud med henblik på at forebygge brud på rygsøjlen og hofterne.
English: • The CHMP took into account the PRAC recommendation and all the information provided by the MAH in writing and at an oral explanation.
Danish: PRAC's anbefalinger blev overgivet til Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
English: • The Committee considered that the exclusion of patients with contraindications relating to cardiovascular and thromboembolic risks impacted on the statistical significance of the observed increased risks.
Danish: • Patienter, der på nuværende tidspunkt er i behandling med Protelos/Osseor, bør gennemgås i fornødent omfang.
English: Study CLE-12911-021, for example, was an observational international prospective cohort survey (non-interventional) performed in seven EU countries with the main objective to follow-up during 3 years a cohort of post-menopausal women treated with strontium ranelate with a special focus on all potential safety concerns.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom en behandlingsmulighed for patienter, der ikke tidligere har haft hjertekarsygdom og ikke kan få andre lægemidler.
English: Data submitted as part of the routine benefit-risk assessment within a periodic safety update report (PSUR), covering the period from 22 September 2011 to 21 September 2012, was assessed by the PRAC and raised concerns regarding cardiovascular safety beyond the already recognised risk for venous thromboembolism.
Danish: Disse endelige anbefalinger fra agenturets Udvalg for Lægemidler til Mennesker (CHMP) følger efter, at Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC) indledningsvis tilrådede suspendering af lægemidlet på grund af dets hjerte-kar-risiko.
English: The recommended starting dose depends on the patient's height and weight.
Danish: Den anbefalede startdosis afhænger af patientens højde og vægt.
English: Patients with moderately or severely impaired liver function should be treated with lower doses.
Danish: Patienter med moderat eller svært nedsat leverfunktion skal behandles med lavere doser.
English: It blocks the proteasome, which is a system within the cells that breaks down proteins when they are no longer needed.
Danish: Det blokerer proteasomet, som er cellernes system til at nedbryde proteiner, der ikke længere er brug for.
English: When the proteins in the cancer cells, such as the proteins that control the growth of the cells, are not broken down, the cells are affected and they eventually die.
Danish: Når proteinerne i kræftcellerne, såsom de proteiner, der regulerer cellevækst, ikke nedbrydes, påvirkes cellerne, hvorefter de til sidst dør.
English: If a patient develops severe side effects after a treatment cycle, the treatment must be suspended, delayed or the dose adjusted.
Danish: Hvis patienten udvikler alvorlige bivirkninger efter et behandlingsforløb, skal behandlingen afbrydes eller udskydes, eller dosen justeres.
English: Further information on Bortezomib Fresenius Kabi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
Danish: Yderligere information om Bortezomib Fresenius Kabi findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Velcade, and do not need to be repeated for Bortezomib Fresenius Kabi.
Danish: Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Velcade, og de behøver ikke at blive gentaget for Bortezomib Fresenius Kabi.
English: When given into a vein, the solution is given as a three- to five-second injection through a catheter (a thin sterile tube).
Danish: Når opløsningen gives i en blodåre, sker det ved en injektion over tre til fem sekunder gennem et kateter (en tynd, steril slange).
English: For more information on generic medicines, see the question-andanswer document here.
Danish: Der kan indhentes yderligere oplysninger om generiske lægemidler i dokumentet med spørgsmål og svar her.
English: This means that Bortezomib Fresenius Kabi contains the same active substance, bortezomib, and works in the same way as a ‘reference medicine' already authorised in the EU called Velcade.
Danish: Det betyder, at Bortezomib Fresenius Kabi indeholder det samme aktive stof, bortezomib, og virker på samme måde som et "referencelægemiddel", der allerede er godkendt i EU, og som hedder Velcade.
English: Doses of Bortezomib Fresenius Kabi are given intermittently, with rest periods in between doses, in treatment cycles of three to six weeks depending on whether Bortezomib Fresenius Kabi is given alone or in combination with other medicines.
Danish: Bortezomib Fresenius Kabi-doser gives uden faste intervaller, med hvileperioder mellem doserne, i behandlingsforløb på tre til seks uger, afhængigt af om Bortezomib Fresenius Kabi gives alene eller i kombination med andre lægemidler.
English: Additionally, when Bortezomib Fresenius Kabi is given under the skin, the active substance in both products, which have the same composition, is expected to be absorbed in the same way.
Danish: Når Bortezomib Fresenius Kabi indgives under huden, forventes det aktive stof i begge produkter, som har samme sammensætning, desuden at blive optaget på samme måde.
English: There was no need for ‘bioequivalence' studies to investigate whether Bortezomib Fresenius Kabi 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 Bortezomib Fresenius Kabi optages identisk med referencelægemidlet for at give det samme niveau af det aktive stof i blodet.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Bortezomib Fresenius Kabi has been shown to be comparable to Velcade.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Bortezomib Fresenius Kabi kan sammenlignes med Velcade.
English: Side effects reported with Bortezomib Fresenius Kabi are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Bortezomib Fresenius Kabi vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: The company that markets Bortezomib Fresenius Kabi will ensure that healthcare professionals receive educational material explaining how to calculate the dose and how to prepare and administer the medicine.
Danish: Virksomheden, der markedsfører Bortezomib Fresenius Kabi, sørger for, at sundhedspersonale modtager oplysningsmateriale om dosisberegning og om, hvordan lægemidlet forberedes og indgives.
English: The active substance in Bortezomib Fresenius Kabi, bortezomib, is a proteasome inhibitor.
Danish: Det aktive stof i Bortezomib Fresenius Kabi, bortezomib, er en proteasomhæmmer.
English: Bortezomib Fresenius Kabi is a medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Danish: Bortezomib Fresenius Kabi er et lægemiddel, der anvendes til behandling af myelomatose, som er blodkræft, hos følgende patientgrupper:
English: • previously untreated adults who cannot have high-dose chemotherapy with a blood stem-cell transplant.
Danish: • tidligere ubehandlede voksne, som ikke kan få højdosiskemoterapi med blodstamcelletransplantation.
English: What measures are being taken to ensure the safe and effective use of Bortezomib Fresenius Kabi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Bortezomib Fresenius Kabi?
English: Because Bortezomib Fresenius Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Bortezomib Fresenius Kabi er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: For more information about using Bortezomib Fresenius Kabi, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Bortezomib Fresenius Kabi, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Therefore, the Agency's view was that, as for Velcade, the benefits of Bortezomib Fresenius Kabi outweigh the identified risks and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Bortezomib Fresenius Kabi opvejer de identificerede risici som for Velcade, og at det kan godkendes til anvendelse i EU.
English: As for every medicine, the company provided studies on the quality of Bortezomib Fresenius Kabi.
Danish: Som for alle lægemidler fremlagde virksomheden studier af kvaliteten af Bortezomib Fresenius Kabi.
English: Bortezomib Fresenius Kabi is a ‘generic medicine'.
Danish: Bortezomib Fresenius Kabi er et "generisk lægemiddel".
English: Bortezomib Fresenius Kabi is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation.
Danish: Bortezomib Fresenius Kabi anvendes desuden til behandling af mantelcellelymfom, som er en anden form for blodkræft, hos ubehandlede voksne, som ikke kan få blodstamcelletransplantation.
English: The medicine can only be obtained with a prescription and treatment should only be started and given under the supervision of a doctor who has experience in the use of cancer medicines.
Danish: Bortezomib Fresenius Kabi fås kun på recept, og behandlingen bør kun indledes og gives under tilsyn af en læge med erfaring i anvendelsen af kræftlægemidler.
English: As for all medicines, data on the use of Bortezomib Fresenius Kabi are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Bortezomib Fresenius Kabi løbende overvåget.
English: Bortezomib Fresenius Kabi must not be given by other routes.
Danish: Bortezomib Fresenius Kabi må ikke gives på andre måder.
English: An overview of Bortezomib Fresenius Kabi and why it is authorised in the EU
Danish: En oversigt over Bortezomib Fresenius Kabi, og hvorfor det er godkendt i EU
English: This is because when Bortezomib Fresenius Kabi is given by injection into a vein the active substance is delivered straight into the bloodstream.
Danish: Dette skyldes, at Bortezomib Fresenius Kabi gives ved injektion i en blodåre, så det aktive stof ledes direkte ind i blodbanen.
English: Other information about Bortezomib Fresenius Kabi
Danish: Andre oplysninger om Bortezomib Fresenius Kabi
English: Bortezomib Fresenius Kabi is available in vials (3.5 mg) as a powder to be made up into a solution for injection.
Danish: Bortezomib Fresenius Kabi fås i hætteglas (3,5 mg) som et pulver til fremstilling af en injektionsvæske, opløsning.
English: Fresenius Kabi is only given by injection into a vein or under the skin.
Danish: Bortezomib Fresenius Kabi gives udelukkende ved injektion i en blodåre eller under huden.
English: What are the benefits and risks of Bortezomib Fresenius Kabi?
Danish: Hvilken fordel og risiko er der forbundet med Bortezomib Fresenius Kabi?
English: Why is Bortezomib Fresenius Kabi authorised in the EU?
Danish: Hvorfor er Bortezomib Fresenius Kabi godkendt i EU?
English: What is Bortezomib Fresenius Kabi and what is it used for?
Danish: Hvad er Bortezomib Fresenius Kabi, og hvad anvendes det til?
English: For mantle cell lymphoma, Bortezomib Fresenius Kabi is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Danish: Ved mantelcellelymfom anvendes Bortezomib Fresenius Kabi i kombination med rituximab, cyclophosphamid, doxorubicin og prednison.
English: In these patients, Bortezomib Fresenius Kabi is used in combination with melphalan and prednisone;
Danish: Hos disse patienter anvendes Bortezomib Fresenius Kabi i kombination med melphalan og prednison
English: In this group of patients, Bortezomib Fresenius Kabi is used in combination with dexamethasone, or with dexamethasone plus thalidomide;
Danish: Hos denne gruppe patienter anvendes Bortezomib Fresenius Kabi i kombination med dexamethason eller med dexamethason og thalidomid
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bortezomib Fresenius Kabi 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 Bortezomib Fresenius Kabi.
English: Bortezomib Fresenius Kabi is either used on its own in these patients or in combination with pegylated liposomal doxorubicin or dexamethasone.
Danish: Hos disse patienter anvendes Bortezomib Fresenius Kabi enten alene eller i kombination med pegyleret liposomal doxorubicin eller dexamethason.
English: How has Bortezomib Fresenius Kabi been studied?
Danish: Hvordan blev Bortezomib Fresenius Kabi undersøgt?
English: How is Bortezomib Fresenius Kabi used?
Danish: Hvordan anvendes Bortezomib Fresenius Kabi?
English: How does Bortezomib Fresenius Kabi work?
Danish: Hvordan virker Bortezomib Fresenius Kabi?
English: Your first treatment will be given to you in a hospital.
Danish: Du vil få din første behandling på et hospital.
English: If it does, the skin could be damaged.
Danish: Hvis det sker, kan huden blive beskadiget.
English: It is not known how many people are affected:
Danish: Det vides ikke, hvor mange personer der vil få disse:
English: Also your blood pressure can become too low.
Danish: Dit blodtryk kan også blive for lavt.
English: Local infection*
Danish: Lokal infektion*
English: Investigations Unknown
Danish: Undersøgelser Ikke kendt
English: This is because your doctor needs to monitor you and find the best dose for you.
Danish: Det skyldes, at lægen skal overvåge dig og finde den dosis, som er bedst egnet til dig.
English: Don't drive or use machines unless you're feeling well.
Danish: Kør ikke bil og lad være med at arbejde med maskiner, medmindre du føler dig frisk.
English: It is very important that you follow all of their instructions carefully.
Danish: Det er meget vigtigt, at du nøje følger alle instruktioner.
English: Flolan is not a conventional anticoagulant.
Danish: Flolan er ikke en konventionelt antikoagulans.
English: Tachycardia2, bradycardia3,
Danish: Takykardi2, bradykardi3
English: • You have more frequent, or longer periods of bleeding.
Danish: • Du har hyppigere eller længerevarende perioder med blødninger.
English: A risk to the breastfeeding child cannot be excluded.
Danish: En risiko for det ammede barn kan ikke udelukkes.
English: The primary efficacy endpoint for the study was improvement in the 6MWT.
Danish: Det primære effektendepunkt for studiet var forbedring af 6MWT.
English: Tell your doctor if you get these symptoms.
Danish: Kontakt lægen, hvis du får disse symptomer.
English: • for up to 12 hours at 25oC, if it has just been made up
Danish: • i op til 12 timer ved 25 °C, hvis den lige er tilberedt
English: Adverse events are listed below by system organ class and frequency.
Danish: Bivirkningerne er listet nedenfor efter organklassesystem og frekvens.
English: Following the administration of radiolabelled epoprostenol to humans, at least 16 metabolites were found, 10 of which were structurally identified.
Danish: Efter administration af radioaktivt mærket epoprostenol til mennesker blev der fundet mindst 16 metabolitter, hvoraf 10 blev identificeret strukturmæssigt.
English: The symptoms of this are:
Danish: Symptomer på det kan være:
English: Keep dry.
Danish: Opbevares tørt.
English: Flolan is indicated for:
Danish: Flolan er indiceret til:
English: The safety and efficacy of epoprostenol in children younger than 18 years have not yet been established.
Danish: Epoprostenols sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Solvent for parenteral use:
Danish: Solvens til parenteral anvendelse:
English: No long-term animal studies have been conducted to determine the carcinogenic potential of epoprostenol.
Danish: Det er ikke udført langvarige dyrestudier til at fastslå epoprostenols karcinogene potentiale.
English: Long-term continuous infusion:
Danish: Kontinuerlig langtidsinfusion:
English: The main feature of overdose is likely to be hypotension.
Danish: Det primære symptom på overdosering er sandsynligvis hypotension.
English: The procedure given below should be closely followed.
Danish: Instruktionen beskrevet nedenfor skal følges nøje.
English: It is important that the medicine does not leak out of the vein into the surrounding tissue.
Danish: Det er vigtigt, at lægemidlet ikke siver ud af blodåren og over i det omkringliggende væv.
English: They will also advise you how to stop treatment if necessary.
Danish: De vil også rådgive dig om, hvad du skal gøre, hvis du bliver nødt til at stoppe behandlingen.
English: • You feel that your heart is beating faster, or you have chest pain or shortness of breath.
Danish: • Du føler, at dit hjerte slår hurtigere, eller at du har brystsmerter eller åndenød.
English: Infusion rate formulae - examples
Danish: Infusionshastigheder - eksempler
English: If you forget to take Flolan Do not take a double dose to make up for a forgotten dose.
Danish: Hvis du har glemt at tage Flolan Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: These haemodynamic improvements appeared to persist when epoprostenol was administered for at least 36 months in an open, nonrandomized study.
Danish: Disse hæmodynamiske forbedringer så ud til at vare ved, når epoprostenol blev administreret i mindst 36 måneder i et åbent, ikkerandomiseret studie.
English: Store between 2 and 8oC for the full administration period.
Danish: Opbevares mellem 2 C og 8 C under hele administrationsperioden.
English: • You feel dizzy or feel faint, especially on standing.
Danish: • Du føler dig svimmel eller føler, at du skal besvime, især når du står oprejst.