FrancophonIA/ELRC3.0 huggingface dataset:
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 OSSEOR, 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 OSSEOR sammenlignet med placebo.
English: Italia I.F.B.
Danish: I.F.B.
English: Date of latest renewal: 21/09/2009
Danish: Dato for første markedsføringstilladelse: 21/09/2004 Dato for seneste fornyelse: 21/09/2009
English: Due to the nature of the treated disease, strontium ranelate is intended for long-term use.
Danish: På grund af den sygdom, der behandles, er strontiumranelat beregnet til langtidsbehandling.
English: 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: De mest almindelige bivirkninger var kvalme og diaré, som især opstod ved behandlingens start og uden nogen bemærkelsesværdig forskel mellem de to grupper bagefter.
English: Administration of milk or antacids may be helpful to reduce the absorption of the active substance.
Danish: Administration af mælk eller antacida kan medvirke til at nedsætte absorption af det aktive stof.
English: This is especially common in women after the menopause.
Danish: Dette sker især hos kvinder, når de er holdt op med at få menstruation.
English: Available data indicate that these factors account for approximately 50% of the measured change in BMD over 3 years of treatment with OSSEOR 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 OSSEOR daglig.
English: About osteoporosis
Danish: Om osteoporose
English: During OSSEOR treatment, these cardiovascular risks should be monitored on a regular basis generally every 6 to 12 months.
Danish: Under OSSEOR-behandlingen bør disse kardiovaskulære risici monitoreres med regelmæssige intervaller sædvanligvis hver 6. til 12. måned.
English: The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, OSSEOR should be administered in-between meals.
Danish: Absorptionen af strontiumranelat nedsættes af føde, mælk og mælkeprodukter, og OSSEOR bør derfor tages mellem måltiderne.
English: It is recommended that you take OSSEOR 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 OSSEOR mellem måltiderne, helst ved sengetid og mindst to timer efter indtagelse af mad, mælk eller mælkeprodukter eller kalktilskud.
English: This should be taken into account when interpreting BMD changes during treatment with OSSEOR.
Danish: Der bør tages højde for dette ved udlægning af ændringer i knoglernes mineraltæthed under behandling med OSSEOR.
English: Talk to your doctor if any effects become troublesome or persist.
Danish: Tal med lægen, hvis en bivirkning bliver generende eller varer ved.
English: In addition to their treatment (2 g/day strontium ranelate or placebo), the patients received adapted calcium and vitamin D supplements throughout both studies.
Danish: Ud over studiebehandling (strontiumranelat 2 g daglig eller placebo) fik patienterne i begge studier tilpassede calcium- og D-vitamintilskud.
English: - if you have severe kidney disease
Danish: - hvis De lider af en alvorlig nyresygdom.
English: Food, milk and derivative products, and medicinal products containing calcium may reduce the bioavailability of strontium ranelate by approximately 60-70%.
Danish: Føde, mælk og mælkeprodukter samt lægemidler, der indeholder calcium, kan nedsætte strontiumranelats biotilgængelighed med ca. 60-70 %.
English: OSSEOR works by reducing bone breakdown and stimulating rebuilding of bone and therefore reduces the risk of fracture.
Danish: OSSEOR virker ved at nedsætte nedbrydningen af knogler og stimulere genopbygningen af knoglemasse, hvorved risikoen for frakturer nedsættes.
English: However, when this dosing regimen is impractical due to the recommended administration of OSSEOR at bedtime, concomitant intake remains acceptable.
Danish: Hvis et sådant behandlingsregime ikke er praktisk muligt på grund af den anbefalede indgivelse af OSSEOR ved sengetid, vil samtidig indgivelse dog være acceptabelt.
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where OSSEOR is marketed, all physicians who are expected to prescribe OSSEOR are provided with the following educational package:
Danish: Efter diskussion og aftale med den relevante nationale sundhedsmyndighed i hvert medlemsland, hvor OSSEOR er markedsført, skal MAH sikre, at nedenstående undervisningspakke leveres til alle læger, som forventes at ordinere OSSEOR:
English: If OSSEOR is used inadvertently during pregnancy, treatment must be stopped.
Danish: Hvis OSSEOR ved en fejltagelse anvendes under graviditet, skal det seponeres.
English: It is therefore preferable to take antacids at least two hours after OSSEOR.
Danish: Antacida skal derfor fortrinsvis tages mindst to timer efter OSSEOR.
English: Signs of a blood clot include painful swelling in your leg, sudden chest pain or difficulty breathing.
Danish: Tegn på blodpropper kan være smertefulde hævelser i benet, pludselige smerter i brystkassen eller vejrtrækningsbesvær.
English: Strontium has a volume of distribution of about 1 l/kg.
Danish: Fordelingsvolumen er ca. 1 l/kg.
English: Heart attack may occur commonly in patients at high risk for heart disease.
Danish: Hjertetilfælde kan forekomme med hyppigheden almindelig hos patienter med øget risiko for hjertesygdom.
English: No interaction was observed with oral supplementation of vitamin D.
Danish: Der er ikke konstateret interaktion med perorale D-vitamintilskud.
English: Empty the granules from the sachet into a glass;
Danish: Tøm granulatet i brevet over i et glas.
English: Nausea, diarrhoea, headache, skin irritation, memory troubles, fainting fit.
Danish: Kvalme, diarré, hovedpine, hudirritation, hukommelsesproblemer, besvimelsesanfald.
English: In accordance with good medical practice, periodic assessment of renal function is recommended in patients with chronic renal impairment.
Danish: I henhold til god klinisk praksis anbefales regelmæssig vurdering af nyrefunktionen hos patienter med kronisk nedsat nyrefunktion.
English: Single administration of doses up to 11 g in healthy young male volunteers did not cause any particular symptoms.
Danish: Enkeltdoser på op til 11 g hos normalpersoner af hankøn udløste ingen særlige symptomer.
English: An in vivo clinical interaction study showed that the administration of aluminium and magnesium hydroxides either two hours before or together with strontium ranelate caused a slight decrease in the absorption of strontium ranelate (20-25% AUC decrease), while absorption was almost unaffected when the antacid was given two hours after strontium ranelate.
Danish: Et klinisk interaktionsstudie udført in vivo viste, at administration af aluminium- og magnesiumhydroxid enten to timer før eller sammen med strontiumranelat gav en mindre nedsættelse i strontiumranelats absorption (AUC faldt med 20-25 %), mens absorptionen var næsten upåvirket, når antacida blev givet to timer efter strontiumranelat.
English: The pharmacokinetics of strontium and ranelic acid have been assessed in healthy young men and healthy postmenopausal women, as well as during long-term exposure in men with osteoporosis and postmenopausal osteoporotic women including elderly women.
Danish: Farmakokinetikken for strontium og ranelinsyre er vurderet hos raske unge mænd og raske postmenopausale kvinder samt under langvarig eksponering af mænd med osteoporose og postmenopausale kvinder med osteoporose, herunder også ældre.
English: Strontium ranelate has no or negligible influence on the ability to drive and use machines.
Danish: Strontiumranelat påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Do not take OSSEOR during pregnancy or when you are breastfeeding.
Danish: De må ikke tage OSSEOR, hvis De er gravid, eller hvis De ammer.
English: A number of risk factors are associated with postmenopausal osteoporosis including low bone mass, low bone mineral density, early menopause, a history of smoking and a family history of osteoporosis.
Danish: En række risikofaktorer sættes i forbindelse med postmenopausal osteoporose, herunder lav knoglemasse, lav knoglemineraltæthed, tidlig menopause, tidligere rygning samt osteoporose i familien.
English: Once reconstituted in water, the suspension is stable for 24 hours.
Danish: Efter rekonstitution i vand er suspensionen holdbar i 24 timer.
English: Efficacy of OSSEOR 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 OSSEOR til nedsættelse af risikoen for nye vertebralfrakturer blev bekræftet i TROPOSstudiet, også for osteoporosepatienter uden frakturer på grund af knogleskørhed ved baseline.
English: If you take too many sachets of OSSEOR, tell your doctor or pharmacist.
Danish: Hvis De tager for mange breve OSSEOR, skal De oplyse det til Deres læge eller apotek.
English: Do not take calcium supplements at bedtime, at the same time as OSSEOR.
Danish: De må ikke tage kalktilskud ved sengetid samtidig med OSSEOR.
English: The treatment should only be started by a doctor with experience of treating osteoporosis.
Danish: Behandlingen bør kun indledes af en læge, der har erfaring med behandling af osteoporose.
English: Excipient OSSEOR contains a source of phenylalanine, which may be harmful for people with phenylketonuria.
Danish: OSSEOR indeholder en kilde til phenylalanin, som kan være skadeligt for patienter med fenylketonuri (PKU, Føllings sygdom).
English: You may lie down immediately after taking OSSEOR if you wish.
Danish: De må gerne lægge ned Dem umiddelbart efter indtagelse af OSSEOR.
English: The absolute bioavailability of strontium is about 25% (range 19-27%) after an oral dose of 2 g strontium ranelate.
Danish: For strontium er absolut biotilgængelighed ca. 25 % (interval 19-27 %) efter en peroral dosis på 2 g strontiumranelat.
English: Long-term safety has been evaluated in postmenopausal women with osteoporosis treated for up to 60 months with strontium ranelate 2 g/day (n=3,352) or placebo (n=3,317) in phase III studies.
Danish: Langtidssikkerheden er evalueret hos postmenopausale kvinder med osteoporose, der blev behandlet i op til 60 måneder med 2 g strontiumranelat daglig (n = 3.352) eller placebo (n = 3.317) i fase III-studier.
English: Therefore, administration of OSSEOR and such products should be separated by at least two hours (see section 5.2).
Danish: Der bør derfor gå mindst to timer mellem administration af OSSEOR og denne type produkter (se pkt.
English: Due to its high polarity, the absorption, distribution and binding to plasma proteins of ranelic acid are low.
Danish: På grund af høj polaritet udviser ranelinsyre lav absorption, fordeling og plasmaproteinbinding.
English: Recovery could be slow and recurrences of the syndrome have been reported in some cases after discontinuation of corticosteroid therapy.
Danish: Bedring kan indtræffe langsomt, og i nogle tilfælde er der set recidiv efter seponering af kortikosteroidbehandlingen.
English: Food, milk and milk products reduce the absorption of strontium ranelate.
Danish: Mad, mælk og mælkeprodukter nedsætter optagelsen af strontiumranelat.
English: The anti-fracture studies program of OSSEOR was made up of two placebo-controlled phase III studies: SOTI study and TROPOS study.
Danish: OSSEOR-studieprogrammet til undersøgelse af virkningen mod frakturer omfattede to placebokontrollerede fase III-studier: SOTI og TROPOS.
English: The European Medicines Agency has waived the obligation to submit the results of studies with OSSEOR 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 OSSEOR i alle undergrupper af den pædiatriske population med osteoporose (se pkt.
English: Osteoporosis-therapy is usually required for a long period.
Danish: Det er sædvanligvis nødvendigt med langtidsbehandling for osteoporose.
English: In phase III studies, which demonstrated the anti-fracture efficacy of OSSEOR treatment, measured mean BMD increased from baseline with OSSEOR 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 OSSEOR-behandlingens virkning mod frakturer, steg den målte BMD fra baseline med OSSEOR 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: OSSEOR reduced the relative risk of new vertebral fracture by 41% over 3 years in the SOTI study (table 1).
Danish: OSSEOR nedsatte den relative risiko for nye vertebralfrakturer med 41 % i løbet af 3 år i SOTI (Tabel 1).
English: Take the granules contained in the sachets as a suspension in a glass of water (see instructions below).
Danish: Granulatet i brevene skal opslæmmes i et glas vand (se vejledningen nedenfor).
English: Intake of strontium ranelate with calcium or food reduces the bioavailability of strontium by approximately 60-70%, compared with administration 3 hours after a meal.
Danish: Når strontiumranelat indtages sammen med calcium eller føde, reduceres dets biotilgængelighed med ca. 60-70 % sammenlignet med administration 3 timer efter et måltid.
English: In phase III studies, 85% of the patients had a creatinine clearance between 30 and 70 ml/min and 6% below 30 ml/min at inclusion, and the mean creatinine clearance was about 50 ml/min.
Danish: I fase III-studie lå kreatininclearance hos 85 % af patienterne i intervallet 30-70 ml/min, og hos 6 % var den under 30 ml/min ved inklusion, og middelkreatininclearance var ca. 50 ml/min.
English: OSSEOR is a non-hormonal medicine used to treat severe osteoporosis: - in postmenopausal women, - in men, at high risk of fracture, for whom other alternative treatments are not possible.
Danish: OSSEOR er et ikke-hormonelt lægemiddel til behandling af alvorlig knogleskørhed (osteoporose): - hos kvinder, når de er holdt op med at menstruere, - hos mænd, med øget risiko for brud, hvor alternative behandlinger ikke er mulige.
English: The binding of strontium to human plasma proteins is low (25%) and strontium has a high affinity for bone tissue.
Danish: Strontium binder kun i ringe grad til humant plasmaprotein (25 %), men med høj affinitet til knoglevæv.
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; - reduces bone resorption by decreasing osteoclast differentiation and resorbing activity.
Danish: Det er påvist in vitro, at strontiumranelat: - øger knogledannelsen i knoglevævskultur samt replikation af osteoblast-prækursorer og kollagensyntese i knoglecellekultur - reducerer knogleresorption ved at nedsætte osteoklastdifferentiering og resorptionsaktivitet.
English: As a precautionary measure, OSSEOR treatment should be suspended during treatment with oral tetracycline or quinolone antibiotics.
Danish: Som forsigtighedsregel bør behandling med OSSEOR indstilles under peroral antibiotikabehandling med tetracyclin og quinolon.
English: What you need to know before you take osseor Do not take OSSEOR: - if you are allergic to strontium ranelate or any of the other ingredients of OSSEOR (listed in section 6).
Danish: Tag ikke OSSEOR - hvis De er allergisk over for strontiumranelat eller et af de øvrige indholdsstoffer i OSSEOR (angivet i punkt 6).
English: In bone tissue of treated animals and humans, strontium is mainly adsorbed onto the crystal surface and only slightly substitutes for calcium in the apatite crystal of newly formed bone.
Danish: I knoglevæv fra behandlede dyr og mennesker absorberes strontium hovedsagelig på krystaloverfladen og substituerer kun i ringe grad calcium i apatitkrystal i nydannet knogle.
English: PHARMACEUTICAL FORM Granules for oral suspension Yellow granules
Danish: LÆGEMIDDELFORM Granulat til oral suspension Gult granulat
English: Strontium excretion occurs via the kidneys and the gastrointestinal tract.
Danish: Strontium udskilles via nyrerne og gastrointestinalkanalen.
English: The highest risk of occurrence of serious skin reactions is within the first weeks of treatment for Stevens-Johnson syndrome and toxic epidermal necrolysis and usually around 3-6 weeks for DRESS.
Danish: Der er størst risiko for at udvikle alvorlige hudreaktioner de første uger af behandlingen, hvad angår Stevens-Johnsons syndrom og toksisk epidermal nekrolyse, mens DRESS sædvanligvis opstår efter ca. 3-6 uger.
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 OSSEOR and seek medical advice.
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 OSSEOR og søge lægehjælp.
English: • The treatment should be either discontinued or stopped in the following situations: o If the patient develops ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or if hypertension is uncontrolled, the treatment should be stopped.
Danish: • Behandlingen bør enten afbrydes eller stoppes i følgende situationer: o Hvis patienten udvikler iskæmisk hjertesygdom, perifer arteriel sygdom, cerebrovaskulær sygdom, eller hvis hypertension ikke kan kontrolleres, skal behandlingen stoppes.
English: Therefore, in medical practice, inductively coupled plasma atomic emission spectrometry or atomic absorption spectrometry methods should be used to ensure an accurate assessment of blood and urinary calcium concentrations.
Danish: I lægelig praksis bør der derfor anvendes en metode baseret på atomemissionsspektrometri med induktivt koblet plasma (ICP-AES) eller atomabsorptionsspektrofotometri for at sikre en nøjagtig vurdering af calciumkoncentrationerne i blod og urin.
English: - If you are taking medicines containing calcium, you should leave at least 2 hours before you take OSSEOR.
Danish: - Hvis De tager medicin, der indeholder kalk, skal der gå mindst 2 timer, før De tager OSSEOR.
English: In phase III studies, as compared to placebo, biochemical markers of bone formation (bone-specific alkaline phosphatase and C-terminal propeptide of type I procollagen) increased and those of bone resorption (serum C-telopeptide and urinary N-telopeptide cross links) decreased from the third month of treatment up to 3 years.
Danish: I fase III-studier ved sammenligning med placebo steg de biokemiske markører for knogleformation (knoglespecifikt alkalisk fosfatase og C-terminalt propeptid af type I-prokollagen), og markørerne for knogleresorption (serum-C-telopeptid- og urin-N-telopeptid-tværbindinger) faldt efter 3 måneders behandling og op til 3 år.
English: In this group, over 3 years of treatment, OSSEOR reduced the risk of hip fracture by 36% relative to the placebo group (table 2).
Danish: Hos denne gruppe reducerede 3 års behandling med OSSEOR risikoen for hoftefraktur med 36 % set i forhold til placebogruppen (Tabel 2).
English: Fertility No effects were observed on males and females fertility in animal studies.
Danish: Fertilitet Der blev ikke set påvirkning af fertiliteten hos hanner eller hunner i dyrestudier.
English: The risk of vein thrombosis (blood clots in the leg or lungs) may be increased in the event of lengthy immobilisation.
Danish: Risikoen for blodpropper i ben eller lunger kan blive større ved langvarig immobilisation.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere oplysningerom dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Treatment of Osteoporosis in men:
Danish: Behandling af osteoporose hos mænd:
English: There are no data in patients to demonstrate elimination kinetics of strontium from bone off-therapy.
Danish: Der foreligger ingen data fra patienter til påvisning af strontiums eliminationskinetik fra ubehandlede knogler.
English: Absorbed ranelic acid is rapidly eliminated unchanged via the kidneys.
Danish: Efter absorption udskilles ranelinsyre hurtigt og uændret via nyrerne.
English: The highest risk for occurrence of SJS or TEN is within the first weeks of treatment and usually around 36 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: It is recommended that you take OSSEOR at bedtime, preferably at least 2 hours after dinner.
Danish: Det anbefales at tage OSSEOR ved sengetid og helst mindst 2 timer efter aftensmåltidet.
English: Driving and using machines: Osseor is unlikely to affect your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at OSSEOR påvirker Deres evne til at køre bil eller arbejde med maskiner.
English: System Organ Class (SOC) Frequency category
Danish: Systemorganklasse Hyppighed
English: Excipient with known effect: Each sachet also contains 20 mg of aspartame (E951).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hvert brev indeholder også 20 mg aspartam (E951).
English: Strontium ranelate does not modify the bone crystal characteristics.
Danish: Strontiumranelat ændrer ikke egenskaberne ved knoglekrystal.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til oral anvendelse.
English: As strontium ranelate is not metabolised, no dose adjustment is required in patients with hepatic impairment.
Danish: Da strontiumranelat ikke metaboliseres, er dosisjustering ikke nødvendig hos patienter med nedsat leverfunktion.
English: Strontium interferes with colorimetric methods for the determination of blood and urinary calcium concentrations.
Danish: Strontium påvirker kolorimetriske metoder til bestemmelse af calciumkoncentrationen i blod og urin.
English: They may advise you to drink milk or take antacids to reduce the absorption of the active ingredient.
Danish: De vil måske få anbefalet at drikke mælk eller tager syreneutraliserende medicin for at nedsætte optagelsen af det aktive stof.
English: MARKETING AUTHORISATION HOLDER LES LABORATOIRES SERVIER 50, rue Carnot
Danish: Indehaver af markedsføringstilladelsen Les Laboratoires Servier 50, rue Carnot
English: The outcome of DRESS is favorable in most cases upon discontinuation of OSSEOR and after initiation of corticosteroid therapy when necessary.
Danish: I de fleste tilfælde af DRESS restitueres patienten efter seponering af OSSEOR og om nødvendigt efter initiering af behandling med kortikosteroider.
English: Osteoporosis is defined as BMD of the spine or hip 2.5 SD or more below the mean value of a normal young population.
Danish: Osteoporose defineres som BMD i columna eller hofter med en standardiseret afvigelse (SD), der er mindst 2,5 under middelværdien hos yngre voksne.
English: There is no pharmacokinetic data in patients with hepatic impairment.
Danish: Der foreligger ingen farmakokinetiske data fra patienter med nedsat leverfunktion.