FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 10: Immunogenicity of one dose of Menveo or ACWY-PS in adults aged 56-65 years, measured at one month post vaccination.
Danish: Tabel 10: Immunogenicitet af 1 dosis Menveo eller ACWY-PS hos voksne i alderen 56-65 år, målt en måned efter vaccination
English: Menveo must be prepared for administration by reconstituting the powder with the solution.
Danish: Før administration skal pulveret rekonstitueres med opløsningen.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or diphtheria toxoid (CRM197), or a life-threatening reaction after previous administration of a vaccine containing similar components (see section 4.4).
Danish: 6.1, eller difteritoksoid (CRM197), eller livstruende reaktion som følge af vaccine med indhold af lignende indholdsstoffer (se pkt.
English: hSBA GMTs (95% CI)
Danish: hSBA GMT (95 % CI)
English: In the subset of subjects aged 19-55 years who were seronegative at baseline, the proportion of subjects who achieved a hSBA ≥ 1:8 after a dose of Menveo were as follows: serogroup A 67% (582/875); serogroup C 71% (401/563); serogroup W135 82% (131/160); serogroup Y 66% (173/263).
Danish: I undergruppen af forsøgspersoner i alderen 19-55 år, der var seronegative ved baseline, var forholdet af forsøgspersoner, der opnåede en hSBA ≥ 1:8 efter 1 dosis af Menveo, som følger: Serogruppe A 67 % (582/875), serogruppe C 71 % (401/563), serogruppe W-135 82 % (131/160) og serogruppe Y 66 % (173/263).
English: The most common adverse reactions during the clinical trials generally persisted for one to two days and were not severe.
Danish: De hyppigst rapporterede bivirkninger i de kliniske studier varede normalt kun en eller to dage og var ikke alvorlige.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt vaccine samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine
Danish: Menveo pulver og opløsning til injektionsvæske, opløsning Meningokokgruppe A, C, W-135 og Y konjugeret vaccine
English: Do not use Menveo if you or your child has:
Danish: Du eller dit barn må ikke få Menveo, hvis du/dit barn
English: MenA Conjugate
Danish: MenA konjugat
English: Immunogenicity in adolescents
Danish: Immunogenicitet hos unge
English: Persistence of immune response and booster response in adolescents
Danish: Persistens af immunrespons og boosterrespons hos børn i alderen 2-10 år
English: The comparative immunogenicity of Menveo vs. ACWY-PS was evaluated in subjects aged 56-65 years, in study V59P17.
Danish: Immunogenicitet af Menveo vs. ACWY-PS blev sammenlignet hos forsøgspersoner i alderen 56-65 år,
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest ændret den Andre informationskilder
English: Table 5: Immunogenicity of one dose of Menveo or ACWY-PS in adolescents, measured at one month post vaccination
Danish: Tabel 5: Immunogenicitet efter 1 dosis Menveo eller ACWY-PS hos unge, målt en måned efter vaccination
English: In the pivotal, randomised, observer-blind study V59P20, in which participants were stratified by age (2 through 5 years and 6 through 10 years), the immunogenicity of a single dose of Menveo one month post vaccination was compared with the single dose of ACWY-D. Immunogenicity results one month after Menveo vaccination among subjects aged 2-5 years and 6-10 years are summarized below in Table 1
Danish: I det pivotale, randomiserede, observatørblindede studie V59P20, hvor personerne blev stratificeret i henhold til alder (2-5 år og 6-10 år), blev immunogeniciteten af en enkelt dosis Menveo, målt én måned efter vaccination, sammenlignet med en enkelt dosis ACWY-D.
English: N=42 N=49 N=49
Danish: N=42 N=49 N=49 N=42
English: Time point
Danish: Tidspunkt
English: In 5 years post vaccination, the percentage of Menveo recipients with hSBA ≥ 1:8 remained significantly higher compared with ACWY-PS recipients for serogroups C and Y. Higher hSBA GMTs were observed for serogroups W-135 and Y (Table 7).
Danish: 5 år efter vaccination var procentdelen af Menveo-vaccinerede med hSBA ≥ 1:8 stadig signifikant højere sammenlignet med ACWY-PS-vaccinerede for serogruppe C og Y. De højeste hSBA-GMT'er blev observeret for serogruppe W-135 og Y (Tabel 7).
English: A booster dose of Menveo was administered 5 years after primary vaccination with Menveo or ACWY-PS. At 7 days after the booster dose, 98%-100% of subjects who previously received Menveo and 73%-84% of subjects who previously received ACWY-PS achieved hSBA ≥1:8 against serogroups A, C, W-135 and Y. At one month post vaccination, the percentages of subjects with hSBA≥1:8 were 98%-100% and 84%-96%, respectively.
Danish: En Menveo-boosterdosis blev administreret 5 år efter primær vaccination med Menveo eller ACWY-PS. 7 dage efter boosterdosen opnåede 98-100 % af forsøgspersonerne, som tidligere var vaccineret med Menveo, og 73-84 % af forsøgspersonerne, som tidligere var vaccineret med ACWY-PS, hSBA ≥1:8 mod serogruppe A, C, W-135 og Y. En måned efter vaccination var procentdelen af forsøgspersoner med hSBA≥1:8 henholdsvis 98-100 % og 84-96 %.
English: N=41 N=49 N=49
Danish: N=41 N=49 N=49 N=41
English: Table 3: Persistence of immune responses 5 years after primary vaccination with Menveo, and immune responses 1 month after a booster dose among subjects aged 2 - 5 years and 6 -10 years at the time of primary vaccination
Danish: Persistens af immunresponser 5 år efter primær vaccination med Menveo og immunresponser 1 måned efter en boosterdosis hos forsøgsdeltagere, som var henholdsvis 2-5 år og 6-10 år på tidspunktet for den primære vaccination
English: Before the injection of any vaccine, the person responsible for administration must take all precautions known for the prevention of allergic or any other reactions including thorough medical history and current health status.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Før injektion af enhver vaccine skal den person, der er ansvarlig for administrationen, tage alle relevante forholdsregler med henblik på at undgå allergiske eller andre reaktioner.
English: Table 2: Immunogenicity of one dose of Menveo or ACWY-PS in subjects 2 through 10 years of age, measured at one month and twelve months post-vaccination
Danish: Tabel 2: Immunogenicitet af 1 dosis Menveo eller ACWY-PS hos forsøgspersoner i alderen 2-10 år målt én måned og 12 måneder efter vaccination
English: Table 4: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 11-18 years
Danish: Tabel 4: Serumbaktericidt antistofrespons på Menveo en måned efter vaccination af forsøgspersoner i alderen 11-18 år
English: 6-10 years hSBA ≥1:8
Danish: 6-10 år hSBA ≥ 1:8 konfidensinterval)
English: Table 9: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 19-55 years
Danish: Tabel 9: Serumbaktericidt antistofrespons på Menveo en måned efter vaccination af forsøgspersoner i alderen 19-55 år
English: At 1 year post last vaccination, the percentages of subjects with hSBA ≥1:8 after the 2-dose series and the single dose were both lower than at 1 month post-vaccination (30% after the 2-dose series, 11%20% after the single dose for serogroup A; 61%-81% and 41%-55% for serogroup C; 92%-94% and 90%-91% for serogroup W-135; 67%-75% and 57%-65% for serogroup Y).
Danish: Et år efter den sidste vaccination var procentdelene af forsøgspersoner med hSBA ≥1:8 både efter serien med 2 doser og efter den enkelte dosis lavere end 1 måned post-vaccination (30 % efter serien med 2 doser vs. 11-20 % efter den enkelte dosis for serogruppe A; 61-81 % og 41-55 % for serogruppe C; 92-94 % og 90-91 % for serogruppe W-135; 67-75 % og 57-65 % for serogruppe Y).
English: At 7 days post vaccination, 64% of subjects achieved hSBA ≥1:8 against serogroup A and 88% through 90% of subjects had bactericidal antibodies against serogroups C, W-135 and Y. At one month post vaccination, 92% through 98% of subjects had hSBA ≥1:8 against serogroups A, C, W-135 and Y. A robust immune response as measured by hSBA GMTs against all serogroups was also observed at 7 days (GMTs 34 through 70) and 28 days (GMTs 79 through 127) after a single dose vaccination.
Danish: 7 dage efter vaccination opnåede 64 % af forsøgsdeltagerne hSBA ≥1:8 mod serogruppe A, og 88-90 % af forsøgspersonerne havde baktericide antistoffer mod serogruppe C, W-135 og Y. En måned efter vaccination havde 92-98 % af forsøgspersonerne hSBA ≥1:8 mod serogruppe A, C, W-135 og Y. Et solidt immunrespons målt ved hSBA-GMT mod alle serogrupper blev også observeret 7 dage (GMT'er 34-70) og 28 dage (GMT'er 79-127) efter en enkelt vaccinedosis.
English: Table 1: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 2-5 years and 6-10 years
Danish: Tabel 1: Serumbaktericidt antistofrespons én måned efter Menveo-vaccination hos forsøgspersoner i alderen 2-5 år og 6-10 år
English: 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).
Danish: 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).
English: The risk-benefit ratio for persons at risk of haematoma following intramuscular injection must be evaluated by health care professionals.
Danish: Blandt patienter med risiko for hæmatom efter intramuskulær injektion bør risiko/benefit ved vaccinering forinden vurderes klinisk.
English: 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
Danish: 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).
English: 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.
Danish: Antistofpersistensen 5 år efter primær vaccination blev vurderet i studie V59P20E1, som var en forlængelse af studie V59P20.
English: 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.
Danish: 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.
English: Percentages of subjects with hSBA≥1:8
Danish: % forsøgspersoner med hSBA≥1:8
English: • Meningococcal group Y oligosaccharide
Danish: • Meningokokgruppe Y-oligosaccharid
English: Uncommon: dizziness
Danish: Ikke almindelige: svimmelhed
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Menveo, skal du henvende dig til den lokale repræsentant:
English: 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).
Danish: Den yder ingen beskyttelse mod andre typer af meningokokbakterier, som ikke findes i vaccinen, eller andre årsager til meningitis og sepsis (blodforgiftning).
English: ACWY-PS for all four serogroups and statistically superior for serogroups A and Y (Table 10).
Danish: 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).
English: 12 months post-vaccination hSBA ≥1:8
Danish: 12 måneder efter vaccination hSBA ≥ 1:8 (95 %-CI)
English: Disodium phosphate dihydrate
Danish: Dinatriumphosphatdihydrat
English: • Meningococcal group A oligosaccharide
Danish: • Meningokokgruppe A-oligosaccharid
English: Very common: irritability, malaise, injection site pain, injection site erythema (≤50 mm), injection site induration (≤50 mm)
Danish: 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),
English: Meningococcal group W-135 oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3-8.3 micrograms
Danish: Meningokokoligosaccharid-gruppe W-135 5 mikrogram konjugeret til Corynebacterium diphtheriae CRM197 protein 3,3-8,3 mikrogram
English: Meningococcal group A oligosaccharides 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7-33.3 micrograms
Danish: Meningokokoligosaccharid-gruppe A 10 mikrogram konjugeret til Corynebacterium diphtheriae CRM197 protein 16,7-33,3 mikrogram
English: Meningococcal group C oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1-12.5 micrograms
Danish: Meningokokoligosaccharid-gruppe C 5 mikrogram konjugeret til Corynebacterium diphtheriae CRM197 protein 7,1-12,5 mikrogram
English: Common: injection site erythema (>50mm), injection site induration (>50mm), chills, fever ≥38oC
Danish: Almindelig: rødme (> 50 mm) og induration (> 50 mm) på injektionsstedet, feber ≥38 °C, kulderystelser
English: Y N=96 N=96 N=94 N=94 N=64 N=64 N=59 N=59
Danish: N=94 N=64 N=64 N=59 N=59
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Uncommon: injection site pruritus
Danish: Ikke almindelig: kløe på injektionsstedet
English: GlaxoSmithKline BV Tel: + 31 (0)30 69 38 100 nlinfo@gsk.com
Danish: GlaxoSmithKline BV Tel: + 31 (0)30 69 38 100
English: Meningococcal group Y oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6-10.0 micrograms.
Danish: Meningokokoligosaccharid-gruppe Y 5 mikrogram konjugeret til Corynebacterium diphtheriae CRM197 protein 5,6-10,0 mikrogram
English: W-135 N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
Danish: W135 N=96 N=96 N=95
English: Very common: headache, nausea, injection site pain, injection site redness (≤ 50 mm), injection site firmness (≤ 50 mm), muscle ache, generally feeling unwell
Danish: 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
English: 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).
Danish: som følger: Serogruppe A: 75 % (780/1.039), serogruppe C: 80 % (735/923), serogruppe W135: 94 % (570/609) og serogruppe Y: 81 % (510/630).
English: Solution
Danish: Opløsning
English: 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
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: C N=96 N=96 N=94 N=94 N=64 N=64 N=60 N=60
Danish: N=94 N=64 N=64 N=60 N=60
English: CI) A N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
Danish: N=95 N=64 N=64 N=60 N=60
English: What Menveo looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Very common: injection site pain, injection site erythema (≤50 mm), injection site induration
Danish: Meget almindelige: smerte, rødme (≤ 50 mm) og induration (≤ 50 mm) på injektionsstedet, utilpashed
English: 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
Danish: Det skal du vide, før du eller dit barn får Menveo Sådan bruges Menveo
English: GlaxoSmithKline S.p.A. Tel: +39 (0)45 9218 111
Danish: Tel: +39 (0)45 9218 111
English: • 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.
Danish: 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.
English: Background information
Danish: Information til patienter
English: 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.
Danish: 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]).
English: Overall conclusion
Danish: Mere om proceduren
English: Scientific conclusions
Danish: Information til sundhedspersoner
English: 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.
Danish: • Protelos/Osseor må ikke anvendes til patienter med manifest nuværende eller tidligere iskæmisk hjertesygdom, perifer arteriel sygdom og/eller cerebrovaskulær sygdom eller ukontrolleret hypertension.
English: Overall summary of the scientific evaluation of Protelos/Osseor by the PRAC
Danish: “CHMP tilsluttede sig PRAC's samlede vurdering af risiciene ved Protelos/Osseor.
English: This is expected to better characterise the risk in the restricted population and also to assess the effectiveness of the risk minimisation measures.
Danish: Det er desuden vigtigt, at virksomheden får pålæg om at foretage yderligere undersøgelser til påvisning af effektiviteten af de nye foranstaltninger.
English: 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.
Danish: 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.
English: 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.
Danish: “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.
English: 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.
Danish: • 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.
English: Points of differences with the PRAC recommendation and scientific rationale of the CHMP position
Danish: Yderligere oplysninger om PRAC's anbefaling og baggrunden for denne gennemgang findes på agenturets websted.
English: 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.
Danish: 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.