natgillin/translations-raw huggingface dataset:
Meget almindelige: smerte, rødme (≤ 50 mm) og induration (≤ 50 mm) på injektionsstedet, utilpashed
Very common: injection site pain, injection site erythema (≤50 mm), injection site induration
Det skal du vide, før du eller dit barn får Menveo Sådan bruges Menveo
What Menveo is and what it is used for What you need to know before you or your child are given Menveo How to use Menveo
Gennemgangen af Protelos/Osseor blev indledt i maj 2013 på anmodning af Europa-Kommissionen i medfør af artikel 20 i forordning (EF) nr. 726/2004.
• The Committee considered Protelos and Osseor (strontium ranelate) in the procedure under Article 20 of Regulation (EC) No 726/2004, initiated by the European Commission.
Information til patienter
Background information
Resultaterne viste øget risiko for myokardieinfarkt med Protelos/Osseor i forhold til placebo (1,7 % mod 1,1 %) med en relativ risiko på 1,6 (95 % SI [1,07; 2,38]) samt øget risiko for venøse tromboemboliske hændelser - 1,9 % mod 1,3 % med en relativ risiko på 1,5 (95 % SI [1,04; 2,19]).
The relative risk reduction of proximal femur and hip area fractures with strontium ranelate over 3 years (FAS population from TROPOS) was not statistically significant compared with placebo: 15% (RR=0.85, 95% CI [0.61; 1.19], p=0.333) and 21% (RR=0.79, 95% CI [0.59; 1.06], p=0.112), respectively.
Mere om proceduren
Overall conclusion
Information til sundhedspersoner
Scientific conclusions
• Protelos/Osseor må ikke anvendes til patienter med manifest nuværende eller tidligere iskæmisk hjertesygdom, perifer arteriel sygdom og/eller cerebrovaskulær sygdom eller ukontrolleret hypertension.
In order to assess the impact of the restrictions introduced in the product information, namely the restriction to patients with severe osteoporosis and patients without the contraindications (current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism; temporary or permanent immobilisation due to e.g. post-surgical recovery or prolonged bed rest; established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease, or uncontrolled hypertension), post-hoc subgroup analyses of the existing clinical trial data were performed.
“CHMP tilsluttede sig PRAC's samlede vurdering af risiciene ved Protelos/Osseor.
Overall summary of the scientific evaluation of Protelos/Osseor by the PRAC
Det er desuden vigtigt, at virksomheden får pålæg om at foretage yderligere undersøgelser til påvisning af effektiviteten af de nye foranstaltninger.
This is expected to better characterise the risk in the restricted population and also to assess the effectiveness of the risk minimisation measures.
Ved fastlæggelsen af, hvordan Protelos/Osseor bør anvendes, tog CHMP hensyn til PRAC's analyse af dets fordele og risici samt råd fra eksperter i knogleskørhed om, at der er en gruppe patienter, som kan have fordel af lægemidlet.
In line with the concerns expressed by the PRAC, the CHMP concluded that the benefit/risk balance of strontium ranelate needed to be re-evaluated and measures taken in order to minimize those risks so that the benefit in a newly defined target patient population could outweigh the risks.
“PRAC har under hele proceduren arbejdet tæt sammen med CHMP, og skønt vi vedgår, at anbefalingerne fra de to udvalg af forskellige, ligger vores opfattelse af forholdet mellem fordele og risiko for lægemidlet tæt op ad hinanden, og vi har samme syn på vigtigheden af effektiv overvågning af hjerte-kar-risikoen”, sagde June Raine, formand for PRAC.
The CHMP, having considered the PRAC recommendation dated January 2014 and the totality of the information provided by the MAH, is of the opinion that the benefit-risk balance of strontium ranelate remains positive in the restricted population, taking into account the agreed risk minimisation measures, including changes to the product information and additional pharmacovigilance activities.
• Protelos/Osseor bør kun anvendes til behandling af svær osteoporose hos postmenopausale kvinder og mænd med høj frakturrisiko, når der på grund af f.eks. kontraindikationer eller intolerans ikke kan anvendes andre lægemidler, der er godkendt til behandling af osteoporose.
Strontium ranelate has a different mechanism of action from other available products; this might be a valuable alternative, particularly in long-term treatment of osteoporosis and for patients for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.
Yderligere oplysninger om PRAC's anbefaling og baggrunden for denne gennemgang findes på agenturets websted.
Points of differences with the PRAC recommendation and scientific rationale of the CHMP position
CHMP fandt, at hjerte-kar-risikoen hos patienter i behandling med Protelos/Osseor kan imødegås ved at begrænse anvendelsen til patienter, der er uden tidligere hjerte-karproblemer og ikke kan få andre godkendte lægemidler til behandling af knogleskørhed.
However, the CHMP considered that these show a clear tendency towards neutralisation of the cardiovascular risk when the population is restricted to patients with severe osteoporosis without contraindications.
Som yderligere risikominimeringsforanstaltning skal der udleveres oplysningsmateriale til de ordinerende læger for at sikre, at kun egnede patienter behandles med lægemidlet.
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.
Patientens risiko for at udvikle kardiovaskulær sygdom bør vurderes før påbegyndelse af behandlingen og derefter regelmæssigt, i almindelighed hver 6.-12. måned.
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.
• Protelos/Osseor bør seponeres ved opståen af iskæmisk hjertesygdom, perifer arteriel sygdom eller cerebrovaskulær sygdom og ved ukontrolleret hypertension.
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.
CHMP nåede frem til sine konklusioner efter at have bemærket, at Protelos/Osseor udviste forebyggende virkning, også hos patienter med høj risiko for knoglebrud.
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.
På baggrund af de iagttagne fordele ved forebyggelse af knogleskørhed hos patienter med høj risiko konkluderede udvalget, at Protelos/Osseor fortsat bør være
• 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.
• 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.
• 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.
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.
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.
Tlf. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
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).
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.
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.
• Du skal ikke bruge Protelos/Osseor, hvis du har eller har haft hjerte-karproblemer såsom slagtilfælde, hjerteanfald eller nedsat blodgennemstrømning i arterierne.
• 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.
Disse patienter skal desuden regelmæssigt vurderes af lægen, og behandlingen standses, hvis der opstår hjerte-karproblemer såsom ukontrolleret forhøjet blodtryk eller hjertekrampe.
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).
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.
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.
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.
• The CHMP took into account the PRAC recommendation and all the information provided by the MAH in writing and at an oral explanation.
• Patienter, der på nuværende tidspunkt er i behandling med Protelos/Osseor, bør gennemgås i fornødent omfang.
• 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.
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.
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.
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.
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.
Den anbefalede startdosis afhænger af patientens højde og vægt.
The recommended starting dose depends on the patient's height and weight.
Patienter med moderat eller svært nedsat leverfunktion skal behandles med lavere doser.
Patients with moderately or severely impaired liver function should be treated with lower doses.
Det blokerer proteasomet, som er cellernes system til at nedbryde proteiner, der ikke længere er brug for.
It blocks the proteasome, which is a system within the cells that breaks down proteins when they are no longer needed.
Når proteinerne i kræftcellerne, såsom de proteiner, der regulerer cellevækst, ikke nedbrydes, påvirkes cellerne, hvorefter de til sidst dør.
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.
Hvis patienten udvikler alvorlige bivirkninger efter et behandlingsforløb, skal behandlingen afbrydes eller udskydes, eller dosen justeres.
If a patient develops severe side effects after a treatment cycle, the treatment must be suspended, delayed or the dose adjusted.
Yderligere information om Bortezomib Fresenius Kabi findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
Further information on Bortezomib Fresenius Kabi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
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.
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.
Når opløsningen gives i en blodåre, sker det ved en injektion over tre til fem sekunder gennem et kateter (en tynd, steril slange).
When given into a vein, the solution is given as a three- to five-second injection through a catheter (a thin sterile tube).
Der kan indhentes yderligere oplysninger om generiske lægemidler i dokumentet med spørgsmål og svar her.
For more information on generic medicines, see the question-andanswer document here.
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.
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.
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.
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.
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.
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.
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.
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.
Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Bortezomib Fresenius Kabi kan sammenlignes med Velcade.
The European Medicines Agency concluded that, in accordance with EU requirements, Bortezomib Fresenius Kabi has been shown to be comparable to Velcade.
De indberettede bivirkninger ved Bortezomib Fresenius Kabi vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Bortezomib Fresenius Kabi are carefully evaluated and any necessary action taken to protect patients.
Virksomheden, der markedsfører Bortezomib Fresenius Kabi, sørger for, at sundhedspersonale modtager oplysningsmateriale om dosisberegning og om, hvordan lægemidlet forberedes og indgives.
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.
Det aktive stof i Bortezomib Fresenius Kabi, bortezomib, er en proteasomhæmmer.
The active substance in Bortezomib Fresenius Kabi, bortezomib, is a proteasome inhibitor.
Bortezomib Fresenius Kabi er et lægemiddel, der anvendes til behandling af myelomatose, som er blodkræft, hos følgende patientgrupper:
Bortezomib Fresenius Kabi is a medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:
• tidligere ubehandlede voksne, som ikke kan få højdosiskemoterapi med blodstamcelletransplantation.
• previously untreated adults who cannot have high-dose chemotherapy with a blood stem-cell transplant.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Bortezomib Fresenius Kabi?
What measures are being taken to ensure the safe and effective use of Bortezomib Fresenius Kabi?
Da Bortezomib Fresenius Kabi er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Bortezomib Fresenius Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Hvis du ønsker mere information om anvendelsen af Bortezomib Fresenius Kabi, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
For more information about using Bortezomib Fresenius Kabi, see the package leaflet or contact your doctor or pharmacist.
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.
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.
Som for alle lægemidler fremlagde virksomheden studier af kvaliteten af Bortezomib Fresenius Kabi.
As for every medicine, the company provided studies on the quality of Bortezomib Fresenius Kabi.
Bortezomib Fresenius Kabi er et "generisk lægemiddel".
Bortezomib Fresenius Kabi is a ‘generic medicine'.
Bortezomib Fresenius Kabi anvendes desuden til behandling af mantelcellelymfom, som er en anden form for blodkræft, hos ubehandlede voksne, som ikke kan få blodstamcelletransplantation.
Bortezomib Fresenius Kabi is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation.
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.
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.
Som for alle lægemidler bliver data vedrørende brugen af Bortezomib Fresenius Kabi løbende overvåget.
As for all medicines, data on the use of Bortezomib Fresenius Kabi are continuously monitored.
Bortezomib Fresenius Kabi må ikke gives på andre måder.
Bortezomib Fresenius Kabi must not be given by other routes.
En oversigt over Bortezomib Fresenius Kabi, og hvorfor det er godkendt i EU
An overview of Bortezomib Fresenius Kabi and why it is authorised in the EU
Dette skyldes, at Bortezomib Fresenius Kabi gives ved injektion i en blodåre, så det aktive stof ledes direkte ind i blodbanen.
This is because when Bortezomib Fresenius Kabi is given by injection into a vein the active substance is delivered straight into the bloodstream.
Andre oplysninger om Bortezomib Fresenius Kabi
Other information about Bortezomib Fresenius Kabi
Bortezomib Fresenius Kabi fås i hætteglas (3,5 mg) som et pulver til fremstilling af en injektionsvæske, opløsning.
Bortezomib Fresenius Kabi is available in vials (3.5 mg) as a powder to be made up into a solution for injection.
Bortezomib Fresenius Kabi gives udelukkende ved injektion i en blodåre eller under huden.
Fresenius Kabi is only given by injection into a vein or under the skin.
Hvilken fordel og risiko er der forbundet med Bortezomib Fresenius Kabi?
What are the benefits and risks of Bortezomib Fresenius Kabi?
Hvorfor er Bortezomib Fresenius Kabi godkendt i EU?
Why is Bortezomib Fresenius Kabi authorised in the EU?
Hvad er Bortezomib Fresenius Kabi, og hvad anvendes det til?
What is Bortezomib Fresenius Kabi and what is it used for?
Ved mantelcellelymfom anvendes Bortezomib Fresenius Kabi i kombination med rituximab, cyclophosphamid, doxorubicin og prednison.
For mantle cell lymphoma, Bortezomib Fresenius Kabi is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Hos disse patienter anvendes Bortezomib Fresenius Kabi i kombination med melphalan og prednison
In these patients, Bortezomib Fresenius Kabi is used in combination with melphalan and prednisone;
Hos denne gruppe patienter anvendes Bortezomib Fresenius Kabi i kombination med dexamethason eller med dexamethason og thalidomid
In this group of patients, Bortezomib Fresenius Kabi is used in combination with dexamethasone, or with dexamethasone plus thalidomide;
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.
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.
Hos disse patienter anvendes Bortezomib Fresenius Kabi enten alene eller i kombination med pegyleret liposomal doxorubicin eller dexamethason.
Bortezomib Fresenius Kabi is either used on its own in these patients or in combination with pegylated liposomal doxorubicin or dexamethasone.
Hvordan blev Bortezomib Fresenius Kabi undersøgt?
How has Bortezomib Fresenius Kabi been studied?
Hvordan anvendes Bortezomib Fresenius Kabi?
How is Bortezomib Fresenius Kabi used?
Hvordan virker Bortezomib Fresenius Kabi?
How does Bortezomib Fresenius Kabi work?
Du vil få din første behandling på et hospital.
Your first treatment will be given to you in a hospital.
Hvis det sker, kan huden blive beskadiget.
If it does, the skin could be damaged.
Det vides ikke, hvor mange personer der vil få disse:
It is not known how many people are affected:
Dit blodtryk kan også blive for lavt.
Also your blood pressure can become too low.
Lokal infektion*
Local infection*
Undersøgelser Ikke kendt
Investigations Unknown
Det skyldes, at lægen skal overvåge dig og finde den dosis, som er bedst egnet til dig.
This is because your doctor needs to monitor you and find the best dose for you.