natgillin/translations-raw huggingface dataset:
Tabel 1: Serumbaktericidt antistofrespons én måned efter Menveo-vaccination hos forsøgspersoner i alderen 2-5 år og 6-10 år 
Table 1: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 2-5 years and 6-10 years
135 og Y forblev konstant fra 21 måneder til 5 år efter vaccination i Menveo-gruppen og reduceredes en smule over tid mod serogruppe A (tabel 6). 
The percentages of subjects with hSBA ≥ 1:8 remained constant against serogroups C, W-135, and Y from 21 months to 5 years postvaccination in the Menveo group and decreased slightly over time against serogroup A (Table 6).
Blandt patienter med risiko for hæmatom efter intramuskulær injektion bør risiko/benefit ved vaccinering forinden vurderes klinisk. 
The risk-benefit ratio for persons at risk of haematoma following intramuscular injection must be evaluated by health care professionals.
Der blev observeret antistofpersistens mod serogrupperne C, W-135 og Y, hvor procentdelen af forsøgspersoner i aldersgrupperne 2-5 år og 6-10 år med hSBA ≥ 1:8 var henholdsvis 32 % og 56 % mod serogruppe C, 74 % og 80 % mod serogruppe W-135, og 48 % og 53 % mod serogruppe Y. GMT'erne var henholdsvis 6,5 og 12 for serogruppe C, 19 og 26 for serogruppe W-135 og 8,13 og 10 for serogruppe Y. For serogruppe A havde henholdsvis 14 % og 22 % af forsøgsdeltagerne i aldersgrupperne 2-5 år og 6-10 år hSBA ≥ 1:8 (GMT'er 2,95 og 3,73). 
and Y, with the percentages of subjects with hSBA ≥ 1:8 being 32% and 56% against serogroup C in subjects 2-5 and 6-10 years of age, respectively, 74% and 80% against serogroup W-135, and 48% and 53% against serogroup Y. GMTs were respectively 6.5 and 12 for serogroup C, 19 and 26 for serogroup W-135, and 8.13 and 10 for serogroup Y. For serogroup A, 14% and 22% of subjects 2-5
Antistofpersistensen 5 år efter primær vaccination blev vurderet i studie V59P20E1, som var en forlængelse af studie V59P20. 
Persistence of immune response and booster response in children 2 to 10 years of age Antibody persistence at 5 years after primary vaccination was assessed in study V59P20E1, this was an extension of study V59P20.
I studie V59P6E1 var procentdelen af Menveo-vaccinerede med hSBA ≥ 1:8 et år efter vaccinationen stadig signifikant højere sammenlignet med ACWY-PS-vaccinerede for serogruppe C, W-135 og Y og sammenlignelig for serogruppe A. hSBA-GMT'erne for serogruppe W-135 og Y var højst for Menveo-vaccinerede. 
In study V59P6E1, at one year post vaccination, the percentage of Menveo recipients with hSBA ≥ 1:8 remained significantly higher compared with ACWY-PS recipients for serogroups C, W-135 and Y, and similar between the two study groups for serogroup A. hSBA GMTs for serogroups W-135 and Y were higher among Menveo recipients.
% forsøgspersoner med hSBA≥1:8 
Percentages of subjects with hSBA≥1:8
• Meningokokgruppe Y-oligosaccharid 
• Meningococcal group Y oligosaccharide
Ikke almindelige: svimmelhed 
Uncommon: dizziness
Hvis du vil have yderligere oplysninger om Menveo, skal du henvende dig til den lokale repræsentant: 
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Den yder ingen beskyttelse mod andre typer af meningokokbakterier, som ikke findes i vaccinen, eller andre årsager til meningitis og sepsis (blodforgiftning). 
It cannot protect against other types of meningococcal bacteria other than groups A, C, W-135 and Y, or against other causes of meningitis and sepsis (blood poisoning).
Andelen af forsøgspersoner med hSBA ≥ 1:8 var ikke-inferiør til ACWY-PS med hensyn til alle fire serogrupper og statistisk overlegen med hensyn til serogrupperne A og Y (tabel 10). 
ACWY-PS for all four serogroups and statistically superior for serogroups A and Y (Table 10).
12 måneder efter vaccination hSBA ≥ 1:8 (95 %-CI) 
12 months post-vaccination hSBA ≥1:8
Dinatriumphosphatdihydrat 
Disodium phosphate dihydrate
• Meningokokgruppe A-oligosaccharid 
• Meningococcal group A oligosaccharide
Meget almindelige: irritabilitet, utilpashed, smerter på injektionsstedet, erytem på injektionsstedet (≤ 50 mm), induration på injektionsstedet (≤ 50 mm) Almindelige: erytem på injektionsstedet (> 50 mm), induration på injektionsstedet (> 50 mm), 
Very common: irritability, malaise, injection site pain, injection site erythema (≤50 mm), injection site induration (≤50 mm)
Meningokokoligosaccharid-gruppe W-135 5 mikrogram konjugeret til Corynebacterium diphtheriae CRM197 protein 3,3-8,3 mikrogram 
Meningococcal group W-135 oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3-8.3 micrograms
Meningokokoligosaccharid-gruppe A 10 mikrogram konjugeret til Corynebacterium diphtheriae CRM197 protein 16,7-33,3 mikrogram 
Meningococcal group A oligosaccharides 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7-33.3 micrograms
Meningokokoligosaccharid-gruppe C 5 mikrogram konjugeret til Corynebacterium diphtheriae CRM197 protein 7,1-12,5 mikrogram 
Meningococcal group C oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1-12.5 micrograms
Almindelig: rødme (> 50 mm) og induration (> 50 mm) på injektionsstedet, feber ≥38 °C, kulderystelser 
Common: injection site erythema (>50mm), injection site induration (>50mm), chills, fever ≥38oC
N=94 N=64 N=64 N=59 N=59 
Y N=96 N=96 N=94 N=94 N=64 N=64 N=59 N=59
Et år efter vaccination udviste en højere andel af de Menveo-vaccinerede forsøgspersoner en hSBA ≥ 1:8 for serogrupperne C, W-135 og Y, med sammenlignelige niveauer for serogruppe A, - sammenlignet med ACWY-PS. Der blev observeret tilsvarende resultater ved sammenligning af hSBA GMT. 
At one year post vaccination in these same subjects, compared with ACWY-PS, a higher proportion of subjects vaccinated with Menveo had hSBA ≥1:8 for serogroups C, W-135, and Y, with comparable levels for serogroup A. Similar findings were observed in the comparison of hSBA GMTs.
1-5 % for serogruppe A, 13-28 % for serogruppe C, 42-64 % for serogruppe W-135 og 6-19 % for serogruppe Y. En måned efter den sidste vaccination var procentdelene af forsøgspersoner med hSBA ≥1:8 i gruppen med 2 doser og i gruppen med en enkelt dosis på tværs af de to aldersgrupper 90-95 % vs. 76-80 % for serogruppe A, 98-99 % vs. 76-87 % for serogruppe C, 99 % vs. 93-96 % for serogruppe W-135 og 96 % vs. 65-69 % for serogruppe Y. 1 måned efter vaccination var GMT'erne højere i gruppen med 2 doser end i gruppen med en enkelt dosis i begge aldersgrupper. 
Y. At 1 month post last vaccination, the percentages of subjects with hSBA ≥1:8 in the 2-dose group and in the single dose group across the two age strata were: 90%-95% vs 76%-80% for serogroup A, 98%-99% vs 76%-87% for serogroup C, 99% vs 93%-96% for serogroup W-135, and 96% vs 65%69% for serogroup Y. GMTs were higher in the 2-dose group than the single dose group at 1 month after vaccination in both age strata; however, this difference was less pronounced in the older age stratum.
Ikke almindelig: kløe på injektionsstedet 
Uncommon: injection site pruritus
Meningokokoligosaccharid-gruppe Y 5 mikrogram konjugeret til Corynebacterium diphtheriae CRM197 protein 5,6-10,0 mikrogram 
Meningococcal group Y oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6-10.0 micrograms.
W135 N=96 N=96 N=95 
W-135 N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
Meget almindelige: hovedpine, kvalme, smerte på injektionsstedet, rødme på injektionsstedet (≤ 50 mm), hårdhed på injektionsstedet (≤ 50 mm), muskelsmerter, generel utilpashed Almindelige: udslæt, rødme på injektionsstedet (> 50 mm), hårdhed på injektionsstedet (> 50 mm), ledsmerter, feber ≥ 38 °C, kulderystelser 
Very common: headache, nausea, injection site pain, injection site redness (≤ 50 mm), injection site firmness (≤ 50 mm), muscle ache, generally feeling unwell
som følger: Serogruppe A: 75 % (780/1.039), serogruppe C: 80 % (735/923), serogruppe W135: 94 % (570/609) og serogruppe Y: 81 % (510/630). 
In the subset of subjects aged 11-18 years who were seronegative at baseline (hSBA < 1:4), the proportion of subjects who achieved a hSBA ≥ 1:8 after a dose of Menveo were as follows: serogroup A 75% (780/1039); serogroup C 80% (735/923); serogroup W-135 94% (570/609); serogroup Y 81% (510/630).
Opløsning 
Solution
C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET 
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
N=94 N=64 N=64 N=60 N=60 
C N=96 N=96 N=94 N=94 N=64 N=64 N=60 N=60
N=95 N=64 N=64 N=60 N=60 
CI) A N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
Udseende og pakningsstørrelser 
What Menveo looks like and contents of the pack
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.