FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Yttriga?
Danish: Hvad er Yttriga?
English: More information on the restrictions on the use of medicines radiolabelled with Yttriga will be found in their package leaflets.
Danish: Yderligere oplysninger om begrænsninger for anvendelsen af lægemidler, der er radiomærket med Yttriga, fremgår af indlægssedlen.
English: What benefit has Yttriga shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Yttriga?
English: Yttriga is used to label medicines that have been specially developed for use with yttrium (90Y) chloride.
Danish: Yttriga anvendes til at mærke lægemidler, der er specielt udviklet til anvendelse sammen med yttrium (90Y)-chlorid.
English: Yttriga is a radioactive liquid that contains the active substance yttrium (90Y) chloride.
Danish: Yttriga er en radioaktiv væske, der indeholder det aktive stof yttrium (90Y)-chlorid.
English: The side effects seen with treatment involving Yttriga will therefore depend largely on the medicine being labelled and will be described in that medicine's package leaflet.
Danish: Bivirkningerne ved en behandling, som omfatter Yttriga, afhænger derfor i høj grad af det anvendte lægemiddel, der radiomærkes, og vil være beskrevet i indlægssedlen for det pågældende lægemiddel.
English: Radiolabelling is a technique where a substance is labelled (tagged) with a radioactive compound.
Danish: Radiomærkning er en teknik, hvor et stof mærkes med et radioaktivt præparat.
English: The active substance in Yttriga, yttrium (90Y) chloride, is a radioactive compound that emits a type of radiation known as beta radiation.
Danish: Det aktive stof i Yttriga, yttrium (90Y)-chlorid, er et radioaktivt stof, der udsender en type stråling kaldet betastråling.
English: What is Yttriga used for?
Danish: Hvad anvendes Yttriga til?
English: The radiolabelled medicine is then given to the patient according to the instructions in that medicine's summary of product characteristics (SmPC).
Danish: Det radiomærkede lægemiddel gives herefter til patienten i overensstemmelse med anvisningerne i indlægssedlen.
English: The effect of Yttriga depends on the nature of the medicine that is radiolabelled with it. An example of its use is the treatment of some type of tumours, where the radiolabelled medicine carries the radioactivity to the site of a tumour to destroy the tumour cells.
Danish: Et eksempel på dets anvendelse er behandling af visse typer tumorer, hvor det radiomærkede lægemiddel bærer radioaktiviteten frem til det sted, hvor tumoren befinder sig, for at tilintetgøre tumorcellerne.
English: How has Yttriga been studied?
Danish: Hvordan blev Yttriga undersøgt?
English: How is Yttriga used?
Danish: Hvordan anvendes Yttriga?
English: Yttriga yttrium (90Y) chloride
Danish: Y)-chlorid
English: How does Yttriga work?
Danish: Hvordan virker Yttriga?
English: • Importance of regularly monitoring cardiovascular risk.
Danish: • Vigtigheden af regelmæssig monitorering af kardiovaskulær risiko.
English: PROTELOS has been studied in clinical trials involving nearly 8,000 participants.
Danish: PROTELOS er undersøgt i kliniske studier med næsten 8.000 deltagere.
English: Your doctor will tell you how long you should continue to take PROTELOS.
Danish: Deres læge vil oplyse Dem om, hvor længe De skal fortsætte med at tage PROTELOS.
English: In each Member State where PROTELOS is marketed, the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
Danish: I hvert medlemsland, hvor PROTELOS er markedsført, skal indehaveren af markedsføringstilladelsen (MAH) aftale det endelige undervisningsprogram med den relevante nationale sundhedsmyndighed.
English: If tests are positive for one or both alleles, PROTELOS should not be started.
Danish: Hvis resultaterne er positive for en eller begge alleler, bør PROTELOS ikke initieres.
English: Your doctor will not prescribe PROTELOS for you if you are at particular risk.
Danish: Deres læge vil ikke ordinere PROTELOS, hvis De har særlig risiko for dette.
English: Paper/polyethylene/aluminium/polyethylene sachets.
Danish: Breve af papir/polyethylen/aluminium/polyethylen.
English: Children and adolescents PROTELOS is not intended for use in children and adolescents (below the age of 18).
Danish: Børn og unge PROTELOS er ikke beregnet til børn og unge (under 18 år).
English: Table 1: Incidence of patients with vertebral fracture and relative risk reduction
Danish: Tabel 1: Incidens af patienter med vertebralfrakturer og relativ risikoreduktion
English: When treating patients over 80 years at risk of VTE, the need for continued treatment with PROTELOS should be re-evaluated.
Danish: Ved behandling af patienter over 80 år med risiko for VTE bør behovet for fortsat behandling med PROTELOS revurderes.
English: Your doctor will evaluate the conditions of your heart and blood vessels regularly, generally every 6 to 12 months for as long you are taking PROTELOS.
Danish: Deres læge vil regelmæssigt undersøge Deres hjerte og blodårer, normalt hver 6. til 12. måned, så længe, De tager PROTELOS.
English: INFORMATION IN BRAILLE PROTELOS 2 g
Danish: INFORMATION I BRAILLESKRIFT PROTELOS 2 g
English: Due to the relatively slow absorption of strontium, food and calcium intake should be avoided both before and after administration of PROTELOS.
Danish: På grund af den relativt langsomme absorption af strontium bør indtagelse af føde og calcium undgås såvel før som efter administration af PROTELOS.
English: Adverse reactionsare listed below using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Bivirkninger er angivet nedenfor i henhold til følgende konvention: meget almindelig (≥ 1/10), almindelig (≥1/100 til <1/10 ), ikke almindelig (≥ 1/1.000 til <1/100), sjælden (≥ 1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If you have stopped treatment due to hypersensitivity reactions, do not take PROTELOS again.
Danish: Hvis De har stoppet behandlingen på grund af overfølsomhedsreaktioner, må De aldrig tage PROTELOS igen.
English: Your doctor should be able to advise if a blood test is necessary before taking PROTELOS.
Danish: Deres læge vil kunne rådgive Dem, om det er nødvendigt at tage en blodprøve før en behandling med PROTELOS.
English: PROTELOS is supplied in boxes of 7, 14, 28, 56, 84 or 100 sachets.
Danish: PROTELOS udleveres i æsker med 7, 14, 28, 56, 84 eller 100 breve.
English: If you need to have blood or urine tests to check your level of calcium, you should tell the laboratory that you are taking PROTELOS as it may interfere with some testing methods.
Danish: Hvis De skal have taget blod- eller urinprøver for at kontrollere Deres koncentration af calcium, skal De fortælle på laboratoriet, at De tager PROTELOS, da det kan påvirke nogle undersøgelsesmetoder.
English: • The initiation of treatment with PROTELOS should be based on an assessment of the individual patient's overall risk.
Danish: • Initiering af PROTELOS-behandling bør baseres på en vurdering af den enkelte patients samlede risiko.
English: Statistically significant increases in BMD were observed as early as 6 months following initiation of PROTELOS treatment versus placebo.
Danish: Statistisk signifikante stigninger i BMD blev observeret allerede 6 måneder efter initiering af PROTELOS-behandling versus placebo.
English: PROTELOS also decreased the number of patients with a body height loss of at least 1 cm as compared to placebo.
Danish: PROTELOS reducerede også antallet af patienter med legemshøjde nedsat med mindst 1 cm sammenlignet med placebo.
English: • The contraindications to the treatment with PROTELOS.
Danish: • Kontraindikationerne ved PROTELOS-behandlingen.
English: - reduces bone resorption by decreasing osteoclast differentiation and resorbing activity.
Danish: - reducerer knogleresorption ved at nedsætte osteoklastdifferentiering og resorptionsaktivitet.
English: If the following happens to you, stop using PROTELOS and talk to your doctor immediately:
Danish: Hvis De oplever følgende skal De stoppe med at tage PROTELOS og øjeblikkelig tale med Deres læge:
English: Physico-chemical data suggest excretion of Strontium ranelate in human milk.
Danish: Fysisk-kemiske data indikerer, at strontiumranelat udskilles i human mælk.
English: This should be taken into account when interpreting BMD changes during treatment with PROTELOS.
Danish: Der bør tages højde for dette ved udlægning af ændringer i knoglernes mineraltæthed under behandling med PROTELOS.
English: Quality of life assessment on the QUALIOST specific scale as well as the General Health perception score of the SF-36 general scale indicated benefit of PROTELOS, compared with placebo.
Danish: Vurdering af livskvalitet ifølge QUALIOST-skalaen samt generel helbredsstatus vurderet ud fra den generelle SF-36-skala tydede på fordele ved PROTELOS sammenlignet med placebo.
English: It is therefore preferable to take antacids at least two hours after PROTELOS.
Danish: Antacida skal derfor fortrinsvis tages mindst to timer efter PROTELOS.
English: What you need to know before you take PROTELOS
Danish: Det skal De vide, før De begynder at tage PROTELOS
English: If you take more sachets of PROTELOS than recommended by your doctor, tell your doctor or pharmacist.
Danish: Hvis De tager flere breve PROTELOS end Deres læge har anbefalet, skal De oplyse det til Deres læge eller apotek.
English: PROTELOS, which contains the substance strontium ranelate, belongs to a group of medicines used to treat bone diseases.
Danish: PROTELOS, der indeholder stoffet strontiumranelat, hører til en gruppe lægemidler til behandling af knoglesygdomme.
English: It is recommended that you take PROTELOS in-between meals, preferably at bedtime at least two hours after food, milk or milk products or calcium supplements.
Danish: Det anbefales, at De tager PROTELOS mellem måltiderne, helst ved sengetid og mindst to timer efter indtagelse af mad, mælk eller mælkeprodukter eller kalktilskud.
English: PROTELOS contains aspartame, a source of phenylalanine, which may be harmful for people with phenylketonuria.
Danish: PROTELOS indeholder aspartam, en kilde til phenylalanin, som kan være skadeligt for patienter med fenylketonuri (PKU, Føllings sygdom).
English: • PROTELOS should only be used with caution in: o Patients with significant risk factors for cardiovascular events such as hypertension, hyperlipidaemia, diabetes mellitus or smoking.
Danish: • PROTELOS skal anvendes med forsigtighed til: o Patienter med signifikante risikofaktorer for kardiovaskulære hændelser såsom hypertension, hyperlipidæmi, diabetes mellitus eller rygning.
English: It is important that you continue taking PROTELOS for as long as your doctor prescribes the medicine.
Danish: Det er vigtigt, at De bliver ved med at tage PROTELOS i den periode, lægen har fastlagt.
English: During PROTELOS treatment, these cardiovascular risks should be monitored on a regular basis generally every 6 to 12 months.
Danish: Under PROTELOS-behandlingen bør disse kardiovaskulære risici monitoreres med regelmæssige intervaller sædvanligvis hver 6. til 12. måned.
English: The safety and efficacy of PROTELOS in children aged below 18 years have not been established.
Danish: PROTELOS' sikkerhed og virkning hos børn i alderen under 18 år er ikke klarlagt.
English: Available data indicate that these factors account for approximately 50% of the measured change in BMD over 3 years of treatment with PROTELOS 2 g/day.
Danish: De aktuelle data tyder på, at disse faktorer tegner sig for ca. 50 % af den målte ændring i mineraltætheden i løbet af de 3 års behandling med 2 g PROTELOS daglig.
English: and TROPOS enrolled 1,556 patients over 80 years at inclusion (23.1% of the study population).
Danish: Tilsammen rekrutterede SOTI og TROPOS 1.556 patienter, der var over 80 år ved inklusion (23,1 % af studiepopulationen).
English: You may lie down immediately after taking PROTELOS if you wish.
Danish: De må gerne lægge Dem ned umiddelbart efter indtagelse af PROTELOS.
English: However, when this dosing regimen is impractical due to the recommended administration of PROTELOS at bedtime, concomitant intake remains acceptable.
Danish: Hvis et sådant behandlingsregime ikke er praktisk muligt på grund af den anbefalede indgivelse af PROTELOS ved sengetid, vil samtidig indgivelse dog være acceptabelt.
English: The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, PROTELOS should be administered in-between meals.
Danish: Absorptionen af strontiumranelat nedsættes af føde, mælk og mælkeprodukter, og PROTELOS bør derfor tages mellem måltiderne.
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where PROTELOS is marketed, all physicians who are expected to prescribe PROTELOS are provided with the following educational package:
Danish: Efter diskussion og aftale med den relevante nationale sundhedsmyndighed i hvert medlemsland, hvor PROTELOS er markedsført, skal MAH sikre, at nedenstående undervisningspakke leveres til alle læger, som forventes at ordinere PROTELOS:
English: The highest risk for occurrence of SJS or TEN is within the first weeks of treatment and usually around 3-6 weeks for DRESS.
Danish: Risikoen for SJS eller TEN er størst de første uger af behandlingen og for DRESS efter ca. 3-6 uger.
English: If PROTELOS is used inadvertently during pregnancy, treatment must be stopped.
Danish: Hvis PROTELOS ved en fejltagelse anvendes under graviditet, skal det seponeres.
English: EXP If not used immediately after reconstitution, the preparation should be consumed within 24 hours.
Danish: Hvis tilberedningen ikke anvendes umiddelbart efter rekonstitution skal den drikkes inden for 24 timer.
English: PROTELOS works by reducing bone breakdown and stimulating rebuilding of bone and therefore reduces the risk of fracture.
Danish: PROTELOS virker ved at nedsætte nedbrydningen af knogler og stimulere genopbygningen af knoglemasse, hvorved risikoen for frakturer nedsættes.
English: The anti-fracture studies program of PROTELOS was made up of two placebo-controlled phase III studies: SOTI study and TROPOS study.
Danish: PROTELOS-studieprogrammet til undersøgelse af virkningen mod frakturer omfattede to placebokontrollerede fase III-studier: SOTI og TROPOS.
English: Efficacy of PROTELOS to reduce the risk of new vertebral fracture was confirmed in the TROPOS study, including for osteoporotic patients without fragility fracture at baseline.
Danish: Effekten af PROTELOS til nedsættelse af risikoen for nye vertebralfrakturer blev bekræftet i TROPOS-studiet, også for osteoporosepatienter uden frakturer på grund af knogleskørhed ved baseline.
English: PROTELOS reduced the relative risk of new vertebral fracture by 41% over 3 years in the SOTI study (table 1).
Danish: PROTELOS nedsatte den relative risiko for nye vertebralfrakturer med 41 % i løbet af 3 år i SOTI (Tabel 1).
English: In phase III studies, which demonstrated the anti-fracture efficacy of PROTELOS treatment, measured mean BMD increased from baseline with PROTELOS by approximately 4% per year at the lumbar spine and 2% per year at the femoral neck, reaching 13% to 15% and 5% to 6% respectively after 3 years, depending on the study.
Danish: I fase III-studier, som påviste PROTELOS-behandlingens virkning mod frakturer, steg den målte BMD fra baseline med PROTELOS med ca. 4 % om året ved columna lumbalis og 2 % om året ved collum femoris og nåede efter 3 år op på henholdsvis 13-15 % og 5-6 % afhængigt af studiet.
English: The European Medicines Agency has waived the obligation to submit the results of studies with PROTELOS in all subsets of the paediatric population in osteoporosis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med PROTELOS i alle undergrupper af den pædiatriske population med osteoporose (se pkt.
English: Do not take PROTELOS: - if you are allergic to strontium ranelate or any of the other ingredients of PROTELOS (listed in section 6).
Danish: Tag ikke PROTELOS - hvis De er allergisk over for strontiumranelat eller et af de øvrige indholdsstoffer i PROTELOS
English: In this group, over 3 years of treatment, PROTELOS reduced the risk of hip fracture by 36% relative to the placebo group (table 2).
Danish: Hos denne gruppe reducerede 3 års behandling med PROTELOS risikoen for hoftefraktur med 36 % set i forhold til placebogruppen (Tabel 2).
English: As a precautionary measure, PROTELOS treatment should be suspended during treatment with oral tetracycline or quinolone antibiotics.
Danish: Som forsigtighedsregel bør behandling med PROTELOS indstilles under peroral antibiotikabehandling med tetracyclin og quinolon.
English: If you are taking medicines containing calcium, you should leave at least 2 hours before you take PROTELOS.
Danish: Hvis De tager medicin, der indeholder kalk, skal der gå mindst 2 timer, før De tager PROTELOS.
English: In a pooled analysis of randomised placebo-controlled studies in post-menopausal osteoporotic patients , the most common adverse reactions consisted of nausea and diarrhoea, which were generally reported at the beginning of treatment with no noticeable difference between groups afterwards.
Danish: I en poolet analyse af randomiserede, placebokontrollerede studier af postmenopausale, osteoporotiske patienter, var de mest almindelige bivirkninger kvalme og diarré, som især opstod ved behandlingens start og uden nogen bemærkelsesværdig forskel mellem de to grupper bagefter.
English: What PROTELOS contains - The active substance is strontium ranelate.
Danish: PROTELOS indeholder: - Aktivt stof: strontiumranelat.
English: In vitro, strontium ranelate: - increases bone formation in bone tissue culture as well as osteoblast precursor replication and collagen synthesis in bone cell culture.
Danish: Det er påvist in vitro, at strontiumranelat: - øger knogledannelsen i knoglevævskultur samt replikation af osteoblast-prækursorer og kollagen syntese i knoglecellekultur.
English: Where possible, screening for HLA-A*33:03 and HLA-B*58:01 alleles could be considered before starting treatment with PROTELOS in patients of Han Chinese origin.
Danish: Når det er muligt, kan en screening for HLA-A*33:03 og HLAB*58:01 alleler overvejes før initiering af en behandling med PROTELOS hos patienter af hankinesisk oprindelse.
English: Do not take calcium supplements at bedtime, at the same time as PROTELOS.
Danish: De må ikke tage kalktilskud ved sengetid samtidig med PROTELOS.
English: PROTELOS should not be used during breast-feeding.
Danish: PROTELOS må ikke anvendes under amning.
English: During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must immediately stop taking PROTELOS and seek medical advice (see section 4).
Danish: Hvis De får en allergisk reaktion under behandlingen (såsom hævelser i ansigt, tunge eller hals, besvær med at trække vejret eller synke, hududslæt), skal De omgående stoppe med at tage PROTELOS og søge lægehjælp (se punkt 4).
English: It is recommended that you take PROTELOS at bedtime, preferably at least 2 hours after dinner.
Danish: Det anbefales at tage PROTELOS ved sengetid og helst mindst 2 timer efter aftensmåltidet.
English: The outcome of DRESS is favorable in most cases upon discontinuation of PROTELOS and after initiation of corticosteroid therapy when necessary.
Danish: I de fleste tilfælde af DRESS restitueres patienten efter seponering af PROTELOS og om nødvendigt efter initiering af behandling med kortikosteroider.
English: Driving and using machines: Protelos is unlikely to affect your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at PROTELOS påvirker Deres evne til at køre bil eller arbejde med maskiner.
English: PROTELOS is a medicine used to treat severe osteoporosis: - in postmenopausal women, - in adult men, at high risk of fracture, for whom other alternative treatments are not possible.
Danish: PROTELOS er et lægemiddel til behandling af alvorlig knogleskørhed (osteoporose): - hos kvinder, når de er holdt op med at menstruere, - hos voksne mænd, med øget risiko for brud, hvor alternative behandlinger ikke er mulige.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: De kan finde yderligere oplysninger om PROTELOS på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Over 12 months, a statistically significant increase in mean lumbar spine BMD, main efficacy criteria (E (SE) = 5.32% (0.75); 95%CI = [3.86 ; 6.79]; p<0,001), similar to that observed in the pivotal antifracture phase III studies carried-out inpostmenopausal women, was observed.
Danish: I løbet af 12 måneder blev der observeret en statistisk signifikant stigning i gennemsnitlig lumbal BMD, det vigtigste effektkriterium (E (SE) = 5,32 % (0,75); 95 % CI = [3,86; 6,79]; p<0,001), svarende til observationen i det pivotale fase III-antifrakturstudie, der blev udført hos postmenopausale kvinder.
English: If you forget to take PROTELOS:
Danish: Hvis De har glemt at tage PROTELOS
English: Do not take PROTELOS during pregnancy or when you are breastfeeding.
Danish: De må ikke tage PROTELOS, hvis De er gravid, eller hvis De ammer.
English: Reduction in production of blood cells in the bone marrow.
Danish: Sjælden: Nedsat produktion af røde blodlegemer i knoglemarven.
English: If the patient has developed SJS, TEN or DRESS with the use of PROTELOS, PROTELOS must not be re-started.
Danish: Hvis patienten har udviklet SJS, TEN eller DRESS ved behandling med PROTELOS, må behandling med PROTELOS ikke genoptages på et senere tidspunkt.
English: Manufacturer(s) Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy
Danish: Les Laboratoires Servier Industrie 905, route de Saran F-45520 Gidy
English: If you stop taking PROTELOS:
Danish: Hvis De holder op med at tage PROTELOS
English: • PROTELOS is contraindicated and must not be used in patients with : o Established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Danish: • PROTELOS er kontraindiceret til og må ikke anvendes hos patienter med: o Anamnese med påvist nuværende eller tidligere iskæmisk hjertesygdom, perifer arteriel sygdom og/eller cerebrovaskulær sygdom.
English: • PROTELOS is only indicated for use in patients with severe osteoporosis at high risk of fracture, 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 er kun indiceret til anvendelse hos patienter med svær osteoporose med høj risiko for frakturer, hvor andre lægemidler godkendt til behandling af osteoporose ikke er en mulighed, fx på grund af kontraindikationer eller intolerance.
English: Your doctor may advise you to take calcium and vitamin D supplements in addition to PROTELOS.
Danish: Lægen vil måske anbefale, at De ud over PROTELOS får kalk- og D-vitamintilskud.
English: Treatment should be stopped if the patient develops ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or if hypertension is uncontrolled (see section 4.3).
Danish: Behandlingen bør seponeres, hvis patienten udvikler iskæmisk hjertesygdom, perifer arteriel sygdom eller cerebrovaskulær sygdom, eller hvis hypertension ikke kan kontrolleres (se pkt.