FrancophonIA/ELRC3.0 huggingface dataset:
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 in postmenopausal 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: Oral supplementation with vitamin D has no effect on strontium exposure.
Danish: Perorale tilskud af D-vitamin påvirker ikke eksponeringen for strontium.
English: Table 2: Incidence of patients with hip fracture and relative risk reduction in patients with BMD ≤ -2.4 SD (NHANES III) and age ≥ 74 years
Danish: Tabel 2: Incidens af patienter med hoftefraktur og relativ risikoreduktion hos patienter med BMD ≤-2,4 SD (NHANES
English: • Patient alert card
Danish: • Patientsikkerhedskort
English: • OSSEOR 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: • OSSEOR 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: Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
Danish: Yderligere symptomer, som man skal være opmærksom på, er sår i munden, svælget eller næsen eller på kønsorganerne samt øjenbetændelse (røde og hævede øjne).
English: The clinical consequence of osteoporosis is fractures.
Danish: Klinisk medfører osteoporose frakturer.
English: Your doctor may advise you to take calcium and vitamin D supplements in addition to OSSEOR.
Danish: Lægen vil måske anbefale, at De ud over OSSEOR får kalk- og D-vitamintilskud.
English: Paper/polyethylene/aluminium/polyethylene sachets.
Danish: 6.5 Emballagetype og pakningsstørrelser Breve af papir/polyethylen/aluminium/polyethylen.
English: • OSSEOR 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: • OSSEOR 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: OTHER Read the package leaflet before use
Danish: ANDET Læs indlægssedlen inden brug.
English: 84 sachets
Danish: 84 breve
English: - in adult men, 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: - hos voksne mænd, 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: TROPOS involved 5,091 postmenopausal women with osteoporosis (low femoral neck BMD and prevalent fracture in more than half of them) and a mean age of 77 years.
Danish: TROPOS omfattede 5.091 postmenopausale kvinder med osteoporose (lavt BMD i collum femoris og udbredt forekomst af frakturer hos over halvdelen) og en gennemsnitsalder på 77 år.
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with strontium ranelate after careful consideration (see sections 4.3 and 4.8).
Danish: Patienter med signifikante risikofaktorer for kardiovaskulære hændelser (f.eks. hypertension, hyperlipidæmi, diabetes mellitus, rygning) bør kun behandles med strontiumranelat efter omhyggelig overvejelse (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 2 g of strontium ranelate.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et brev indeholder 2 g strontiumranelat.
English: What OSSEOR contains - The active substance is strontium ranelate.
Danish: OSSEOR indeholder: - Aktivt stof: strontiumranelat.
English: The data on skeletal strontium ranelate accumulation in longer term exposure is limited.
Danish: Data for akkumulation af strontiumranelat i knogler efter langvarig behandling er begrænsede.
English: Chronic oral administration of strontium ranelate at high doses in rodents induced bone and tooth abnormalities, mainly consisting of spontaneous fractures and delayed mineralisation that were reversible after cessation of treatment.
Danish: Kronisk oral indgivelse af strontiumranelat i høje doser til gnavere medførte knogle- og tandanomalier, som især bestod af spontane brud og forhalet mineralisering ; virkningerne var reversible efter endt behandling.
English: 100 sachets
Danish: 100 breve
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION OSSEOR 2 g granules for oral suspension.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) OSSEOR 2 g granulat til oral suspension.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Sachet
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Breve
English: - if you are immobilised permanently or for some time such as being wheel-chair bound, or confined to bed or if you are to undergo an operation or recovering from an operation.
Danish: - hvis De er immobil, dvs. Deres bevægelighed er nedsat permanent eller i nogen tid, og De fx er bundet til en kørestol eller sengeliggende, eller hvis De skal opereres eller er ved at komme Dem efter en operation.
English: DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
Danish: DRESS viser sig i første omgang som influenzalignende symptomer og udslæt i ansigtet, hvorefter der opstår et udbredt udslæt og høj feber, unormal leverfunktion (ses i blodprøver), et forhøjet antal af en bestemt type hvide blodlegemer (eosinofili) samt forstørrede lymfekirtler.
English: Secondary to the pharmacological effects of strontium ranelate, slight decreases in calcium and parathyroid hormone (PTH) serum concentrations, increases in blood phosphorus concentrations and in total alkaline phosphatase activity were observed, with no observed clinical consequences.
Danish: Ud over den farmakologiske virkning af strontiumranelat sås mindre fald i serumkoncentrationen af calcium og parathyroideahormon, stigninger i serumphosphor og i total alkalisk fosfatase, mens der ikke observeredes kliniske følger.
English: SOTI involved 1,649 postmenopausal women with established osteoporosis (low lumbar BMD and prevalent vertebral fracture) and a mean age of 70 years.
Danish: SOTI omfattede 1.649 postmenopausale kvinder med påvist osteoporose (lavt BMD i columna lumbalis og udbredt forekomst af vertebralfrakturer) og en gennemsnitsalder på 70 år.
English: Developmental toxicity studies in rats and rabbits resulted in bone and tooth abnormalities (e.g. bent long bones and wavy ribs) in the offspring.
Danish: Studier i udviklingstoksicitet hos rotter og kaniner viste misdannelser i knogler og tænder (fx bøjede lange knogler og bølgede ribben) hos afkommet.
English: Overall incidence rates for adverse reactions with strontium ranelate did not differ from placebo and adverse reactions were usually mild and transient.
Danish: Der var ingen forskel mellem den generelle incidens af bivirkninger med strontiumranelat og placebo, og bivirkningerne var sædvanligvis milde og forbigående.
English: The decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4).
Danish: Beslutningen om at ordinere strontiumranelat bør baseres på en vurdering af den enkelte patients samlede risiko (se pkt.
English: Cardiac ischaemic events
Danish: Kardielle iskæmiske hændelser
English: Established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Danish: Anamnese med påvist nuværende eller tidligere iskæmisk hjertesygdom, perifer arteriesygdom og/eller cerebrovaskulær sygdom.
English: - if you have established ischaemic heart disease, or cerebrovascular disease, e.g. you have been diagnosed with a heart attack, stroke, or transient ischaemic attack (temporary reduction of blood flow to the brain; also known as “mini-stroke”), angina, or blockages of blood vessels to the heart or brain.
Danish: - hvis De har fået påvist hjerte-karsygdom med nedsat ilttilførsel til hjertet, eller problemer med blodtilførslen til hjernen, fx hvis De har fået diagnosticeret hjertetilfælde, slagtilfælde eller forbigående blodprop i hjernen (midlertidig nedsættelse af blodtilførsel til hjernen, også kendt som ”et lille slagtilfælde”) hjertekramper (angina), eller blokering af en blodåre til hjertet eller hjernen.
English: If you take it by accident during pregnancy or breastfeeding, stop taking it straight away and talk to your doctor.
Danish: Hvis De er gravid eller ammer og får medicinen ved en fejltagelse, skal De straks holde op med at tage det og tale med lægen.
English: OSSEOR can interact with milk and milk products, so it is important that you mix OSSEOR only with water to be sure it works properly.
Danish: Derfor er det vigtigt kun at blande OSSEOR med vand for at sikre, at det virker korrekt.
English: No dosage adjustment is therefore required in patients with mild-to-moderate renal impairment.
Danish: Dosisjustering er derfor ikke nødvendig hos patienter med let til moderat nyrefunktionsnedsættelse.
English: In the event of substantial overdose, vomiting may be considered to remove unabsorbed active substance.
Danish: I tilfælde af en større overdosis bør det overvejes at få patienten til at kaste op for at fjerne ikkeabsorberet lægemiddel.
English: The frequency of possible side effects listed below is defined using the following convention: very common: may affect more than 1 in 10 people common: may affect 1 in 10 people uncommon: mayaffect 1 in 100 people rare: mayaffect up to 1 in 1,000 people very rare: may affect up to 1 in 10,000 people not known: frequency cannot be estimated from the available data
Danish: Meget almindelig: kan forekomme hos flere end 1 ud af 10 behandlede Almindelig: kan forekomme hos mellem 1 og 10 ud af 100 behandlede Ikke almindelig: kan forekomme hos mellem 1 og 10 ud af 1.000 behandlede Sjælden: kan forekomme hos mellem 1 og 10 ud af 10.000 behandlede Meget sjælden: kan forekomme hos mellem 1 ud af 10.000 behandlede Ikke kendt: kan ikke vurderes ud fra forhåndenværende data.
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.
English: The following adverse reactions have been reported during clinical studies and/or post marketing use with Strontium ranelate.Adverse reactions, defined as adverse events considered at least possibly attributable to strontium ranelate treatment in phase III studies are listed below using the following convention (frequencies versus placebo): very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000) ; not known (cannot be estimated from the available data).
Danish: Bivirkninger, defineret som uønskede hændelser, der i hvert fald muligvis skyldes behandling med strontiumranelat i fase III-studier, er angivet nedenfor i henhold til følgende konvention (hyppighed ved sammenligning med placebo): 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: Patients treated with strontium ranelate should receive vitamin D and calcium supplements if dietary intake is inadequate.
Danish: Patienter, der behandles med strontiumranelat, skal have calcium- og D-vitamintilskud, hvis de ikke får deres behov dækket via kosten.
English: At high doses, animal studies have shown reversible bone effects in the offspring of rats and rabbits treated during pregnancy (see section 5.3).
Danish: Ved store doser i dyrestudier er der forekommet reversibel knoglepåvirkning hos afkommet ved behandling af drægtige rotter og kaniner (se pkt.
English: o As soon as possible in the event of an illness or a condition leading to immobilization, the treatment should be discontinued.
Danish: o Behandlingen skal afbrydes så hurtigt som muligt, hvis der opstår sygdom eller en tilstand, der fører til immobilisation.
English: - if you have or have had problems with your blood circulation (peripheral arterial disease) or if you have had surgery on the arteries of your legs.
Danish: - hvis De har eller har haft problemer med Deres blodcirkulation (nedsat blodtilførsel til hænder, underben og fødder) eller hvis De har fået foretaget operation af arterierne i Deres ben.
English: How OSSEOR works
Danish: Sådan virker OSSEOR
English: An a-posteriori analysis was performed on a subgroup of patients from the TROPOS study of particular medical interest and at high-risk of fracture [defined by a femoral neck BMD T-score ≤3 SD (manufacturer's range corresponding to -2.4 SD using NHANES III) and an age ≥ 74 years (n=1,977, i.e. 40% of the TROPOS study population)].
Danish: Der blev udført en à posteriori-analyse af en undergruppe i TROPOS med patienter af særlig medicinsk interesse og med høj risiko for frakturer [defineret som knoglemineraltæthed med T-score i collum femoris ≤-3 SD (fremstillers interval svarede til -2,4 SD med NHANES III) og ≥ 74 år (n = 1.977, dvs. 40 % af studiepopulationen i TROPOS)].
English: LIST OF EXCIPIENTS Also contains aspartame (E 951).
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også aspartam (E951).
English: In iliac crest bone biopsies obtained after up to 60 months of treatment with strontium ranelate 2 g/day in phase III trials, no deleterious effects on bone quality or mineralisation were observed.
Danish: I biopsier fra crista iliaca taget op til 60 måneder efter behandling med 2 g strontiumranelat daglig i fase III-studier sås ingen skadelig virkning på knoglekvalitet eller -mineralisering.
English: Treatment of postmenopausal osteoporosis:
Danish: Behandling af postmenopausal osteoporose:
English: - if you have or have had a blood clot (for example, in the blood vessels in your legs or lungs).
Danish: - hvis De har eller tidligere har haft en blodprop (fx i en blodåre i ben eller lunger).
English: The efficacy of OSSEOR was demonstrated in men with osteoporosis in a 2-year, double-blind, placebo-controlled study with a main analysis after one year in 243 patients (Intention to treat population, 161 patients received strontium ranelate) at high risk of fracture (mean age 72,7 years; mean lumbar BMD T-score value of -2.6; 28% of prevalent vertebral fracture).
Danish: OSSEORs effekt hos mænd med osteoporose blev demonstreret i et 2-årigt, dobbeltblindet, placebokontrolleret studie med en hovedanalyse efter ét år hos 243 patienter (intention to treatpopulation, 161 patienter fik strontiumranelat) med høj frakturrisiko (gennemsnitsalder 72,7 år; gennemsnitlig lumbal BMD T-score på -2,6; 28 % med prævalent vertebral fraktur).
English: In phase III placebo-controlled studies, strontium ranelate treatment was associated with an increase in the annual incidence of venous thromboembolism (VTE), including pulmonary embolism (see section 4.8).
Danish: I placebokontrollerede fase III-studier blev strontiumranelat sat i forbindelse med en øget årlig incidens af venøse tromboemboliske komplikationer (VTE) inklusive lungeemboli (se pkt.
English: smoking.
Danish: rygning.
English: This results in a rebalance of bone turnover in favour of bone formation.
Danish: Herved genetableres balancen i knogleomsætningen, og knogledannelsen fremmes.
English: New vertebral fracture over the 1st year
Danish: Nye vertebralfrakturer i løbet det første år
English: In an a-posteriori analysis of patients from the pooled SOTI and TROPOS studies with baseline lumbar spine and / or femoral neck BMD in the osteopenic range and without prevalent fracture but with at least one additional risk factor for fracture (N=176), OSSEOR reduced the risk of a first vertebral fracture by 72% over 3 years (incidence of vertebral fracture 3.6% with strontium ranelate vs. 12.0% with placebo).
Danish: I en à posteriori-analyse af patienter ud fra de samlede resultater af SOTI og TROPOS med BMDværdier for columna lumbalis og/eller collum femoris ved baseline, der svarede til osteopeni, og uden udbredte frakturer, men med mindst én yderligere risikofaktor (N = 176) reducerede OSSEOR risikoen for første vertebralfraktur med 72 % i løbet af 3 år (incidens af vertebralfraktur 3,6 % med strontiumranelat versus 12,0 % med placebo).
English: In postmenopausal women, strontium ranelate reduces the risk of vertebral and hip fractures (see section
Danish: Hos postmenopausale kvinder reducerer strontiumranelat risikoen for vertebrale frakturer og hoftefrakturer (se pkt.
English: • OSSEOR 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: o Patienter med signifikante risikofaktorer for kardiovaskulære hændelser såsom hypertension, hyperlipidæmi, diabetes mellitus eller rygning.
English: In patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance), strontium clearance decreases as creatinine clearance decreases (approximately 30% decrease over the creatinine clearance range 30 to 70 ml/min) and thereby induces an increase in strontium plasma levels.
Danish: Hos patienter med let til moderat nedsættelse af nyrefunktionen (kreatininclearance 30-70 ml/min) falder clearance af strontium med kreatininclearance (med ca. 30 % ved kreatininclearance 30-70 ml/min), hvorved strontiums plasmakoncentration øges.
English: Stevens-Johnson syndrome and toxic epidermal necrolysis appear initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Danish: Stevens-Johnsons syndrom og toksisk epidermal nekrolyse ses først som rødlige prikker eller som runde pletter (ofte med blærer i midten) på kroppen.
English: If the patient has developed SJS, TEN or DRESS with the use of OSSEOR, OSSEOR must not be re-started.
Danish: Hvis patienten har udviklet SJS, TEN eller DRESS ved behandling med OSSEOR, må behandling med OSSEOR ikke genoptages på et senere tidspunkt.
English: OSSEOR 2 g granules for oral suspension Strontium ranelate
Danish: OSSEOR 2 g granulat til oral suspension Strontiumranelat
English: In particular, in intact rats, strontium ranelate increases trabecular bone mass, trabeculae number and thickness; this results in an improvement of bone strength.
Danish: Især hos intakte rotter øger strontiumranelat trabekulær knoglemasse samt antal og tykkelse af trabeculae, hvorved knoglestyrken forbedres.
English: A higher incidence, although still rare, of hypersensitivity reactions including skin rash, SJS or TEN in patients of Asian origin has been reported.
Danish: En højere incidens af overfølsomhedsreaktioner omfattende hududslæt, SJS, eller TEN er blevet rapporteret hos patienter af asiatisk oprindelse, men det er stadigt sjældent.
English: PHARMACEUTICAL FORM AND CONTENTS Granules for oral suspension.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Granulat til oral suspension.
English: As a divalent cation, strontium is not metabolised.
Danish: Strontium er en divalent kation og metaboliseres ikke.
English: Physico-chemical data suggest excretion of Strontium ranelate in human milk OSSEOR should not be used during breast-feeding
Danish: Fysisk-kemiske data indikerer, at strontiumranelat udskilles i human mælk.
English: In patients over 80 years of age at inclusion, a pooled analysis of SOTI and TROPOS studies showed that OSSEOR reduced the relative risk of experiencing new vertebral fractures by 32% over 3 years (incidence of 19.1% with strontium ranelate vs. 26.5% with placebo).
Danish: Hos patienter, der var over 80 år ved inklusion, viste en analyse af de samlede resultater fra SOTI og TROPOS, at OSSEOR nedsatte den relative risiko for at få nye vertebralfrakturer med 32 % i løbet af 3 år (incidensen var 19,1 % med strontiumranelat versus 26,5 % med placebo).
English: Psychiatric disorders Frequency unknown:a Confusional state Insomnia Nervous system disorders Common: Headache Disturbances in consciousness Memory loss Uncommon: Seizures Frequency unknown:a Paraesthesia Dizziness Vertigo Cardiac disorders Commond: Myocardial infarction Vascular disorders Common: Venous thromboembolism (VTE) Respiratory, thoracic and mediastinal disorders Frequency unknown:a Bronchial hyperreactivity Gastrointestinal disorders Common: Nausea Diarrhoea Loose stools
Danish: Psykiske forstyrrelser Hyppighed ikke kendt:a Konfusion Insomni Nervesystemet Almindelig: Hovedpine Bevidsthedsforstyrrelser Hukommelsestab Ikke almindelig: Krampeanfald Hyppighed ikke kendt:a Paræstesi Svimmelhed Vertigo Hjerte Almindeligd: Myokardieinfarkt Vaskulære sygdomme Almindelig: Venøs tromboemboli (DVT) Luftveje, thorax og mediastinum Hyppighed ikke kendt:a Bronkial hyperreaktivitet Mave-tarm-kanalen Almindelig: Kvalme Diaré Løs afføring Hyppighed ikke kendt:a Opkastning Abdominalsmerter Irritation af mundslimhinder (stomatitis og/eller mundsår) Gastroøsofageal refluks Dyspepsi
English: These included: nonsteroidal anti-inflammatory agents (including acetylsalicylic acid), anilides (such as paracetamol), H2 blockers and proton pump inhibitors, diuretics, digoxin and cardiac glycosides, organic nitrates and other vasodilators for cardiac diseases, calcium channel blockers, beta blockers, ACE inhibitors, angiotensin II antagonists, selective beta-2 adrenoceptor agonists, oral anticoagulants, platelet aggregation inhibitors, statins, fibrates and benzodiazepine derivatives.
Danish: De omfattede følgende: Nonsteroide antiinflammatoriske midler (inklusive acetylsalicylsyre), anilider (såsom paracetamol), H2-receptorantagonister og syrepumpehæmmere, diuretika, digoxin og hjerteglycosider, organiske nitrater og andre vasodilatatorer til hjertesygdom, calciumantagonister, betablokkere, ACE-hæmmere, angiotensin II-antagonister, selektive beta-2-adrenoceptoragonister, peroral antikoagulantia, trombocytfunktionshæmmende midler, statiner, fibrater og benzodiazepinderivater.
English: How to take osseor
Danish: Sådan skal De tage OSSEOR
English: The combined effects of strontium distribution in bone (see section 5.2) and increased X-ray absorption of strontium as compared to calcium, leads to an amplification of bone mineral density (BMD) measurement by dual-photon X-ray absorptiometry (DXA).
Danish: 5.2) og øget absorption af strontium sammenlignet med calcium påvist ved røntgen førte til en udvidet måling af knoglernes mineraltæthed (BMD = bone mineral density) ved DXA-skanning (DXA = dual-energy x-ray absorptiometry).
English: In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase of myocardial infarction has been observed in OSSEOR treated patients as compared to placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% CI = [1.07 ; 2.38]).
Danish: I poolede, randomiserede, placebokontrollerede studier af postmenopausale, osteoporotiske patienter, er der observeret en betydelig stigning i myokardieinfarkt hos OSSEOR-behandlede patienter sammenlignet med placebo (1,7% versus 1,1 %), med en relativ risiko på 1,6 (95% CI = [1,07 - 2,38]).