FrancophonIA/ELRC3.0 huggingface dataset:
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of ibandronic acid on an individual patient basis, particularly after 5 or more years of use.
Danish: Behovet for fortsat behandling skal revurderes regelmæssigt, baseret på fordele og mulige risici af ibandronsyre for den enkelte patient, især efter anvendelse i 5 år eller mere.
English: If you inadvertently inject into the tissues around the vein, patients may experience local irritation, pain and inflammation at the injection site.
Danish: Hvis du ved et uheld kommer til at injicere i vævet omkring venen, kan patienterne få lokal irritation, smerte og inflammation på injektionsstedet.
English: • if you are allergic to any other bisphosphonates.
Danish: • hvis du er allergisk over for andre bisphosphonater
English: • not enough walking or other weight-bearing exercise
Danish: • ikke nok gåture eller anden vægtbærende aktivitet
English: • you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
Danish: får lægemidler, som kaldes kortikosteroider (for eksempel prednisolon eller dexamethason).
English: In particular, tell your doctor or pharmacist if you are receiving a type of antibiotic injection called ‘“aminoglycoside”' such as gentamicin.
Danish: Fortæl især lægen eller apotekspersonalet, hvis du får injektioner af en type antibiotika der kaldes ‘aminoglykosider' såsom gentamicin.
English: The anti-fracture effect was consistent over the duration of the study.
Danish: Antifraktur-effekten var konsistent gennem hele undersøgelsen.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2° C to 8°C unless dilution has taken place in controlled and validated aseptic condition.
Danish: Hvis det ikke anvendes omgående, er opbevaringstid og -betingelser før brugen brugerens ansvar, og opbevaringstiden bør normalt ikke overstige 24 timer ved 2 °C til 8 °C, medmindre fortyndingen har fundet sted under kontrollerede og validerede aseptiske forhold.
English: The management plan of the patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ.
Danish: Behandlingsplanen for patienter, som udvikler ONJ, skal udarbejdes i tæt samarbejde mellem den behandlende læge og en tandlæge eller tandkirurg med ekspertise inden for ONJ.
English: Manufacturer Accord Healthcare Limited Sage House
Danish: Accord Healthcare Limited Sage House
English: • you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
Danish: tidligere er blevet behandlet med bisfosfonater (anvendes til behandling eller forebyggelse af knoglelidelser).
English: This regimen reduced the occurrence of new radiographic vertebral fractures by 62 % (p=0.0001) over the three year duration of the study.
Danish: Dette regime reducerede forekomsten af nye røntgenverificerede vertebrale frakturer med 62 % (p=0,0001) gennem den 3-årige undersøgelsesperiode.
English: All Skeletal Related Events (SREs) Placebo n=158
Danish: Alle skeletrelaterede hændelser (SREs) Placebo n=158
English: From a microbiological point of view, the solution for infusion should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør infusionsvæsken anvendes omgående.
English: Talk to a nurse or a doctor straight away if you notice any of the following serious side effectsyou may need urgent medical treatment:
Danish: Tal straks med sygeplejersken eller lægen, hvis du oplever nogle af følgende alvorlige bivirkninger - du kan have brug for akut lægehjælp:
English: Administration failures
Danish: Administrationsfejl
English: The solution for injection must be administered into a vein only, and not anywhere else in the body.
Danish: Opløsningen til injektionen må kun gives i en blodåre og ikke andre steder i kroppen.
English: In growing rats, there was no evidence of impaired mineralisation even at doses greater than 5,000 times the dose required for osteoporosis treatment.
Danish: I studier med rotter i vækst, fandtes der ikke tegn på nedsat mineralisering, selv ved doser som var 5.000 gange højere end dosis til osteoporosebehandling.
English: The following risk factors should be considered when evaluating a patient's risk of developing ONJ: Potency of the medicinal product that inhibit bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy
Danish: De følgende risikofaktorer bør tages i betragtning ved vurdering af en patients risiko for at udvikle ONJ: · Styrken af det lægemiddel, som hæmmer knogleresorptionen (øget risiko ved meget potente forbindelser), administrationsvej (øget risiko ved parenteral administration) og den kumulative dosis af knogleresorptionsbehandlingen.
English: The person giving the injection should throw away any unused solution and put the used syringe and injection needle into an appropriate disposal container.
Danish: Personen, som indgiver injektionen, skal smide al ubrugt medicin ud og bortskaffe brugte sprøjter og injektionskanyler i en egnet affaldscontainer.
English: Ibandronic acid is removed from the circulation via bone absorption (estimated to be 40 - 50 % in postmenopausal women) and the remainder is eliminated unchanged by the kidney.
Danish: Ibandronsyre fjernes fra cirkulationen via knogleabsorption (estimeret til 40-50 % hos postmenopausale kvinder), og resten udskilles uændret gennem nyrerne.
English: You may be having a serious, potentially life threatening allergic reaction (see section 2).
Danish: Du kan have fået en alvorlig allergisk reaktion, som kan være livstruende (se punkt 2)
English: Both daily and intermittent (with prolonged dose-free intervals) long-term administration in rats, dogs and monkeys was associated with formation of new bone of normal quality and maintained or increased mechanical strength even at doses in the toxic range.
Danish: Både daglig og intermitterende langtidsadminstration (med forlængede dosisfri intervaller) til rotter, hunde og aber resulterede i dannelse af ny knogle med normal kvalitet og bevaret eller øget mekanisk styrke, selv ved toksiske doser.
English: Do not use this medicine if you notice that the solution is not clear or contains particles.
Danish: Du må ikke få lægemidlet, hvis du bemærker, at infusionsvæsken ikke er klar, eller hvis den indeholder partikler.
English: Clinically meaningful reductions in serum CTX levels were observed at all time points measured.
Danish: Der blev set klinisk betydende reduktioner i serum-CTX-koncentrationer på alle målte tidspunkter.
English: The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Danish: Påbegyndelse af behandling eller af nye behandlingsforløb bør udsættes hos patienter med ikkeophelede, åbne bløddelslæsioner i munden.
English: In the overall patient population of the study MF4411, no reduction was observed for non-vertebral fractures, however daily ibandronic acid appeared to be effective in a high-risk subpopulation (femoral neck BMD T-score < -3.0), where a non-vertebral fracture risk reduction of 69 % was observed.
Danish: I den samlede patientpopulation i studie MF4411 sås ingen reduktion af non-vertebrale frakturer, selvom dagligt indtag af ibandronsyre tilsyneladende havde effekt i en højrisiko-undergruppe (lårbenshals-BMD-T-score < -3,0), hvor en risikoreduktion på 69 % blev observeret.
English: If you have raised calcium level in your blood due to a tumour then the recommended dose is a single administration of 2 mg or 4 mg, depending on the severity of your illness.
Danish: Hvis du har forhøjet indhold af calcium i blodet som følge af en svulst, er den anbefalede dosis en enkel indgift af 2 mg eller 4 mg, afhængig af sværhedsgraden af din sygdom.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Accord Healthcare S.L.U.
Danish: Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen Accord Healthcare S.L.U.
English: The treatment effect of ibandronic acid was further assessed in an analysis of the subpopulation of patients who, at baseline, had a lumbar spine BMD T-score below -2.5 (table 4).
Danish: Effekten af behandlingen med ibandronsyre blev yderligere vurderet i en analyse af subpopulationen af patienter, som ved baseline havde en lumbal BMD T-score under -2,5 (tabel 4).
English: • you don't receive routine dental care or have not had a dental check up for a long time
Danish: ikke jævnligt går til tandlæge eller ikke har fået tjekket dine tænder i lang tid.
English: The injection should be given into the vein by a physician or qualified/trained health care worker.
Danish: Injektionen skal gives i en vene af en læge eller en kvalificeret sundhedsperson.
English: A tabular summary of these secondary efficacy results is presented in Table 3.
Danish: En oversigt over de sekundære effektresultater fremgår af tabel 3.
English: Most cases of adverse reactions did not lead to cessation of therapy.
Danish: De fleste tilfælde af bivirkninger førte ikke til seponering.
English: Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (158 patients) or 6 mg ibandronic acid (154 patients).
Danish: Kvindelige patienter med brystkræft og radiologisk verificerede knoglemetastaser blev randomiseret til placebo (158 patienter) eller 6 mg ibandronsyre (154 patienter).
English: Method of administration For intravenous administration.
Danish: Til intravenøs administration.
English: As renal function decreases with age, this is the only factor that should be considered (see renal impairment section).
Danish: Da nyrefunktionen falder med alderen, er dette den eneste faktor som bør overvejes (se afsnittet vedrørende nedsat nyrefunktion).
English: • changes in blood test results such as Gamma GT or creatinine
Danish: • ændringer i blodprøver, såsom gamma-glutamyltransferase eller kreatinin
English: Caution is advised when bisphosphonates are administered with aminoglycosides, since both substances can lower serum calcium levels for prolonged periods.
Danish: Forsigtighed tilrådes, når der gives bisphosphonater sammen med aminoglykosider, da begge lægemidler kan nedsætte serum-calcium i længere perioder.
English: After intravenous administration of 0.5 mg of ibandronic acid, total, renal, and non-renal clearances decreased by 67 %, 77 % and 50 %, respectively, in subjects with severe renal failure, but there was no reduction in tolerability associated with the increase in exposure.
Danish: Efter intravenøs administration af 0,5 mg ibandronsyre faldt den totale, renale og ikke-renale clearance hos patienter med svær nyrefunktionsnedsættelse, med henholdsvis 67 %, 77 % og 50 %, men der fandtes ikke nedsat tolerabilitet i forbindelse med den øgede eksponering.
English: For intravenous use only.
Danish: Kun til intravenøs brug
English: Ibandronic acid is indicated in adults for
Danish: Ibandronsyre er indiceret til voksne til:
English: • If you have heart problems and the doctor recommended to limit your daily fluid intake.
Danish: • Hvis du har problemer med hjerte, og din læge anbefaler, at du begrænser din daglige væskeindtagelse.
English: Further, as protein binding of ibandronic acid is approximately 87% at therapeutic concentrations, hypoproteinaemia in severe liver disease is unlikely to lead to clinically significant increases in free plasma concentration.
Danish: Da proteinbindingen for ibandronsyre desuden er ca. 87% ved terapeutiske koncentrationer, er det ikke sandsynligt at hypoproteinæmi ved svær leversygdom medfører væsentlig øgning af frie plasmakoncentrationer.
English: Two year data in study BM 16550
Danish: Et-års data fra studie BM 16550 To-års data fra studie BM 16550
English: While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Danish: Mens du er i behandling, skal du opretholde en god mundhygiejne (herunder børste tænder regelmæssigt) og gå regelmæssigt til tandlæge.
English: Temporary interruption of ibandronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Danish: Det bør overvejes at afbryde behandlingen med ibandronsyre midlertidigt, indtil tilstanden forsvinder, og de bidragende risikofaktorer om muligt er minimeret.
English: Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause.
Danish: Osteoporose er en udtynding og svækkelse af knoglerne, som ofte ses hos kvinder efter menopausen.
English: • if you have heart problems and the doctor recommended to limit your daily fluid intake
Danish: • hvis du har problemer med hjertet, og din læge anbefaler, at du begrænser din daglige væskeindtagelse
English: Ibandronic acid Accord may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won't be able to see or feel a difference.
Danish: Ibandronsyre Accord kan ophæve knogletab ved at forhindre yderligere tab af knoglevæv og ved at øge knoglemassen hos kvinder, som tager det, selvom de ikke vil kunne se eller føle en forskel.
English: The following points should be strictly adhered to regarding the use and disposal of syringes and other medicinal sharps:
Danish: Følgende punkter omhandlende brug og destruktion af sprøjter og medicinske nåle skal følges nøje:
English: Dosage: Treatment of Tumour-induced hypercalcaemia Ibandronic acid Accord is usually administered in a hospital setting.
Danish: Dosering: Behandling af tumor-induceret hyperkalcæmi Ibandronsyre Accord administreres sædvanligvis på et hospital.
English: • walking or other weight-bearing exercise
Danish: • at gå ture eller udøve anden vægtbærende aktivitet
English: After 5 years of receiving Ibandronic acid Accord, please consult with your doctor whether you should continue to receive Ibandronic acid Accord.
Danish: Når du har fået Ibandronsyre Accord i 5 år, skal du spørge din læge, om du fortsat skal have Ibandronsyre Accord.
English: • You should take calcium and vitamin-D supplements while receiving Ibandronic acid Accord.
Danish: • Du skal tage et tilskud af kalk og vitamin D, mens du får Ibandronsyre Accord.
English: Prescribers should consult the section Patients with Renal Impairment below for recommendations on dosing and administration in this patient group.
Danish: Behandlende læger henvises til afsnittet ”Patienter med nedsat nyrefunktion” for anbefaling af dosering og administration i denne patientgruppe.
English: Adequate intake of calcium and vitamin D is important in all patients.
Danish: Adækvat indtagelse af calcium og vitamin D er vigtigt til alle patienter.
English: In this study, ibandronic acid was evaluated at oral doses of 2.5 mg daily and 20 mg intermittently as an exploratory regimen.
Danish: I dette studie blev ibandronsyre undersøgt ved doser på 2,5 mg daglig og 20 mg intermitterende som et eksploratorisk regime.
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with ibandronic acid in patients with concomitant risk factors.
Danish: Undersøgelse af tænderne sammen med forebyggende tandbehandling og en individuel vurdering af fordele og risici anbefales før behandling med ibandronsyre hos patienter med samtidige risikofaktorer.
English: • tooth problems.
Danish: • tandproblemer.
English: Three-year lumbar spine BMD increase compared to placebo was 5.3 % and 6.5 % compared to baseline.
Danish: Der fandtes efter 3 år en lumbal BMD stigning på 5,3 % i forhold til placebo og på 6,5 % i forhold til baseline.
English: Ibandronic acid Accord is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called ‘bone metastases').
Danish: Ibandronsyre Accord er til voksne og bliver ordineret til dig, hvis du har brystkræft, som har spredt sig til dine knogler (kaldet knoglemetastaser).
English: In the initial three-year, randomised, double-blind, placebo-controlled, fracture study (MF 4411), a statistically significant and medically relevant decrease in the incidence of new radiographic morphometric and clinical vertebral fractures was demonstrated (table 3).
Danish: I det første tre-års, randomiserede, dobbeltblindede, placebokontrollerede frakturstudie (MF 4411) påvistes et statistisk signifikant og medicinsk relevant fald i hyppigheden af nye røntgenmorfometriske og kliniske vertebrale frakturer (tabel 3).
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to ibandronic acid administration.
Danish: Under behandlingen bør invasive tandbehandlinger kun gennemføres efter nøje overvejelse og bør undgås tæt på tidspunktet for administration af ibandronsyre.
English: In most cases no specific treatment was required and the symptoms subsided after a couple of hours/days.
Danish: De fleste tilfælde krævedes ingen specifik behandling og symptomerne forsvandt efter et par timer/dage
English: A clinically meaningful reduction of 50 % of biochemical markers of bone resorption was observed as early as one month after starting treatment with ibandronic acid 2.5 mg.
Danish: En klinisk relevant reduktion på 50 % i biokemiske markører for knogleresorption blev observeret allerede en måned efter start på behandling med ibandronsyre 2,5 mg.
English: • Ibandronic acid Accord is normally given by a doctor or other medical staff who have experience with the treatment of cancer.
Danish: • Du får som regel Ibandronsyre Accord af en læge eller sygeplejerske, som har erfaring med behandling af kræft
English: Increases at the hip compared to baseline were 2.8 % at the femoral neck, 3.4 % at the total hip, and 5.5 % at the trochanter.
Danish: Stigningen i hofte BMD i forhold til baseline var 2,8 % i lårbenshalsen, 3,4 % i hele hoften og 5,5 % i trochanter.
English: These symptoms are typically in association with the first dose, generally of short duration, mild or moderate in intensity, and usually resolve during continuing treatment without requiring remedial measures (please see paragraph “Influenza like illness”).
Danish: Disse symptomer ses typisk i forbindelse med den første dosis, er almindeligvis kortvarige, er af let eller moderat intensitet og forsvinder normalt under fortsat behandling uden afhjælpende foranstaltninger (se afsnittet ”Influenzalignende sygdom”).
English: Do not receive Ibandronic acid Accord if you are pregnant, planning to get pregnant or if you are breast-feeding.
Danish: Du må ikke få Ibandronic Acid Accord, hvis du er gravid eller planlægger at blive gravid, eller hvis du ammer.
English: Biochemical markers of bone turnover (such as urinary CTX and serum Osteocalcin) showed the expected pattern of suppression to premenopausal levels and reached maximum suppression within a period of 3 - 6 months of using 2.5 mg ibandronic acid daily.
Danish: Biokemiske markører for knogleomsætning (som f.eks urin-CTX og serum-osteocalcin) viste det forventede suppressionsmønster til præmenopausale værdier og maksimal suppression opnåedes indenfor 3-6 måneder ved anvendelse af 2,5 mg ibandronsyre daglig.
English: The deterioration in Quality of Life was significantly less in ibandronic acid treated patients compared with placebo.
Danish: Forringelsen i livskvalitet var signifikant mindre for ibandronsyre-behandlede patienter i forhold til placebo.
English: Ibandronic acid Accord works by reducing the amount of calcium that is lost from your bones.
Danish: Ibandronsyre Accord virker ved at nedsætte den mængde calcium, som mistes fra knoglerne.
English: In severe cases intravenous infusion of appropriate doses of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, may be needed.
Danish: I svære tilfælde kan det blive nødvendigt med intravenøs infusion af passende doser calciumglukonat, kalium eller natriumphosphat og magnesiumsulfat.
English: If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with ibandronic acid.
Danish: Hvis du i øjeblikket får tandbehandling eller skal have en tandoperation (for eksempel have en tand trukket ud), skal du informere lægen om tandbehandlingen og fortælle din tandlæge, at du er i behandling med ibandronsyre.
English: The number of SREs was also significantly reduced with ibandronic acid 6 mg and there was a 40% reduction in the risk of a SRE over placebo (relative risk 0.6, p = 0.003).
Danish: Antallet af SREs var desuden signifikant reduceret ved ibandronsyre 6 mg ligesom der var en 40 % reduktion i risiko for en SRE i forhold til placebo (relativ risiko 0,6, p=0,003).
English: The incidence of clinical vertebral fractures was also significantly reduced by 49 % after 3 years (p=0.011).
Danish: Hyppigheden af kliniske vertebrale frakturer blev desuden signifikant reduceret med 49 % (p=0,011).
English: The most frequently reported adverse reactions are arthralgia and influenza-like symptoms.
Danish: De oftest indberettede bivirkninger er artralgi og influenzalignende symptomer.
English: Intravenous use, for infusion after dilution.
Danish: Til intravenøs infusion efter fortynding.
English: Strict adherence to the intravenous administration route is required (see section 4.4).
Danish: Proceduren for intravenøs administration skal nøje overholdes (se pkt.
English: The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at the lumbar spine of -2 to -5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
Danish: Undersøgelsen omfattede kvinder i alderen 55 til 80 år, som var mindst 5 år postmenopausale, havde lumbal BMD på -2 til -5 SD under den præmenopausale middelværdi (T-score) i mindst én ryghvirvel [L1-L4], og som havde haft 1-4 tidligere vertebrale frakturer.
English: There are no data on the use of ibandronic acid in patients less than 18 years old.
Danish: Der foreligger ingen data vedrørende brugen af ibandronsyre til patienter under 18 år.
English: Plasma concentrations of ibandronic acid increase in a dose-proportional manner after intravenous administration of 0.5 mg to 6 mg.
Danish: Plasmakoncentrationen af ibandronsyre øges dosisproportionalt efter intravenøs administration af 0,56 mg.
English: Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1).
Danish: Behandling af osteoporose hos postmenopausale kvinder, med øget risiko for frakturer (se pkt.
English: In addition, 64.8 % of patients receiving 3 mg every 3 months injection were identified as responders (defined as a decrease ≥ 50 % from baseline), compared with 64.9 % of patients receiving 2.5 mg daily orally.
Danish: Desuden var 64,8 % af patienterne, som fik injektion med 3 mg hver 3. måned, respondenter (defineret som et fald på ≥50 % fra baseline), sammenlignet med 64,9 % af patienterne som fik 2,5 mg daglig oralt.
English: This is because aminoglycosides and Ibandronic acid Accord can both lower the amount of calcium in your blood.
Danish: Aminoglykosider og Ibandronsyre Accord kan begge nedsætte mængden af calcium i dit blod.
English: If you have breast cancer that has spread to your bones, then the recommended dose is 6 mg every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
Danish: Hvis du lider af brystkræft, som har spredt sig til dine knogler, er den anbefalede dosis 6 mg hver 3.-4. uge, givet som infusion i en blodåre i løbet af mindst 15 minutter.