FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2: Mean relative change from baseline of lumbar spine, total hip, femoral neck and trochanter BMD after one year (primary analysis) and two years of treatment (Per-Protocol Population) in study BM 16550.
Danish: Gennemsnitlig relativ ændring i BMD fra baseline af lumbal columna, total hofte, lårbenshals og trochanter efter et års (primær analyse) og to års behandling (per protokol population) i studie BM 16550
English: Ibandronic acid intravenous injection decreased levels of serum C-telopeptide of the alpha chain of Type I collagen (CTX) within 3 - 7 days of starting treatment and decreased levels of osteocalcin within 3 months.
Danish: Intravenøse injektioner med ibandronsyre nedsatte koncentrationen af serum-C-telopeptid af alfakæden af type I kollagen (CTX) indenfor 3-7 dage efter påbegyndelsen af behandlingen og af osteocalcin indenfor 3 måneder.
English: Ibandronic acid Accord can also be prescribed if you have a raised calcium level in your blood due to a tumour.
Danish: Ibandronsyre Accord kan også blive ordineret, hvis du har forhøjet indhold af calcium i blodet som følge af en svulst.
English: Hypersensitivity†, bronchospasm†, angioedema† anaphylactic reaction/shock†
Danish: Overfølsomhed†, bronkospasme †, angioødem†, anafylaktisk reaktion/shock
English: In a study in 130 patients with metastatic breast cancer the safety of ibandronic acid infused over 1 hour or 15 minutes was compared.
Danish: I en klinisk undersøgelse med 130 patienter med metastatisk brystkræft blev sikkerheden af ibandronsyre sammenlignet ved infusion over 1 time i forhold til infusion over 15 minutter.
English: The overall proportion of patients who experienced an adverse reaction was 26.0 % and 28.6 % for ibandronic acid 3 mg injection every 3 months after one year and two years, respectively.
Danish: Det totale antal patienter, som havde en bivirkning, var 26,0% og 28,6% for ibandronsyre 3mg som injektion hver 3. måned efter henholdsvis et og to år.
English: Phlebitis/ thrombophlebitis
Danish: Flebitis/tromboflebitis
English: It is supplied as packs containing 1, 5 or 10 vials.
Danish: Det leveres i pakninger af 1, 5 eller 10 hætteglas.
English: • if you have kidney problems.
Danish: • hvis du har problemer med nyrerne
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Danish: LÆGEMIDDELFORM Koncentrat til infusionsvæske, opløsning (sterilt koncentrat).
English: radiotherapy to bone for treatment of fractures/impending fractures surgery to bone for treatment of fractures vertebral fractures non-vertebral fractures.
Danish: knoglestrålebehandling for behandling af frakturer/truende frakturer knoglekirurgi for behandling af frakturer vertebrale frakturer non-vertebrale frakturer
English: Due to the limited data available, ibandronic acid should not be used in all patients with end-stage renal disease.
Danish: På grund af den begrænsede kliniske erfaring, bør ibandronsyre ikke anvendes til alle patienter med terminal nyresygdom.
English: Colourless, clear solution.
Danish: En farveløs, klar opløsning.
English: • a condition affecting the blood vessels in your brain called ‘“cerebrovascular disorder”' (stroke or brain bleeding)
Danish: • en tilstand som påvirker blodkarrerne i din hjerne kaldet cerebrovaskulær forstyrrelse
English: Clinical studies in hypercalcaemia of malignancy demonstrated that the inhibitory effect of ibandronic acid on tumour-induced osteolysis, and specifically on tumour-induced hypercalcaemia, is characterised by a decrease in serum calcium and urinary calcium excretion.
Danish: Kliniske studier ved malign hyperkalcæmi har vist, at ibandronsyres hæmmende virkning på tumorinduceret osteolyse og specifikt på tumorinduceret hyperkalcæmi er karakteriseret ved nedsættelse af serum-calcium og urin calcium udskillelsen.
English: Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act selectively on bone tissue and specifically inhibit osteoclast activity without directly affecting bone formation.
Danish: Ibandronsyre er et højpotent bisphosphonat, tilhørende gruppen af nitrogen-holdige bisphosphonater, som virker selektivt på knoglevæv og specifikt hæmmer osteoklast-aktiviteten uden direkte påvirkning af knogleopbygningen.
English: • pain in your bone or muscles
Danish: • smerter i knogler eller musklerne
English: • your body temperature getting too low (hypothermia)
Danish: • nedsat kropstemperatur (hypotermi)
English: Early plasma levels fall quickly, reaching 10 % of the peak values within 3 and 8 hours after intravenous or oral administration, respectively.
Danish: De tidlige plasmaværdier falder hurtigt, og når 10 % af peakværdien indenfor 3 og 8 timer efter henholdsvis intravenøs og oral administration.
English: The histological analysis of bone biopsies after two and three years of treatment of postmenopausal women with doses of oral ibandronic acid 2.5 mg daily and intermittent intravenous doses of up to 1 mg every 3 months showed bone of normal quality and no indication of a mineralisation defect.
Danish: Den histologiske analyse af knoglebiopsier efter to- og tre-års behandling af postmenopausale kvinder med orale ibandronsyre -doser på 2,5mg daglig og intermitterende intravenøse doser på op til 1 mg hver 3. måned, viste knogler af normal kvalitet og ingen tegn på mineraliseringsdefekt.
English: Ibandronic acid Accord may help lower the chances of breaking bones (fractures).
Danish: Ibandronsyre Accord kan formindske risikoen for knoglebrud (frakturer).
English: Data from this study demonstrated a significant advantage for intravenous ibandronic acid 6 mg over placebo in the reduction in SREs measured by the time-adjusted SMPR (p=0.004).
Danish: Resultaterne fra denne undersøgelse viste en signifikant fordel for intravenøs ibandronsyre 6 mg frem for placebo, ved reduktion af SREs målt ved den tidsjusterede SMPR (p=0,004).
English: They include a decreased number of implantation sites, interference with natural delivery (dystocia), an increase in visceral variations (renal pelvis ureter syndrome) and teeth abnormalities in F1 offspring in rats.
Danish: De omfatter en nedsættelse af antallet af implantationssteder, forstyrrelser af den normale fødsel (dystocia), en øgning af viscerale variationer (nyre pelvis ureter syndrom) og tandabnormaliteter på F1 afkommet hos rotter.
English: Your doctor may ask you to undergo a dental examination before starting treatment with ibandronic acid.
Danish: Din læge vil muligvis bede dig om at blive undersøgt hos tandlægen, inden behandlingen med ibandronsyre påbegyndes.
English: • if you have high or low levels of vitamin D, calcium or any other minerals.
Danish: • hvis du har forhøjet eller nedsat indhold af vitamin D, kalk eller andre mineraler i blodet
English: Some patients need to be especially careful when using Ibandronic acid Accord.
Danish: Visse personer skal være særligt forsigtige, når de får Ibandronsyre Accord.
English: If a dose is missed, the injection should be administered as soon as convenient.
Danish: Hvis en dosis glemmes, skal injektionen gives så snart som muligt.
English: On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that ibandronic acid has no or negligible influence on the ability to drive and use machines.
Danish: På baggrund af den farmakodynamiske og farmakokinetiske profil og de rapporterede bivirkninger forventes ibandronsyre ikke eller kun i ubetydelig grad at påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Pyrexia,Influenz a-like illness**, oedema peripheral, asthenia, thirst
Danish: Pyreksi, influenzalignende sygdom** perifere ødemer, asteni, tørst
English: Anaphylactic reaction/shock*†
Danish: Anafylaktisk reaktion/shock*†
English: In clinical pharmacology trial WP18551, after a single dose intravenous administration of 6 mg (15 minutes infusion), mean AUC0-24 increased by 14% and 86%, respectively, in subjects with mild (mean estimated CLcr=68.1 ml/min) and moderate (mean estimated CLcr= 41.2 ml/min) renal impairment compared to healthy volunteers (mean estimated CLcr=120 ml/min).
Danish: Den kliniske farmakologiske undersøgelse WP18551 viste følgende: Efter administration af en enkelt intravenøs dosis på 6 mg (15 minutters infusion) steg gennemsnits-AUC0-24 med henholdsvis 14% og 86% hos patienter med let (estimeret gennemsnits-CLcr = 68,1 ml/min) og moderat (estimeret gennemsnits-CLcr = 41,2 ml/min) nedsat nyrefunktion sammenlignet med raske frivillige (estimeret gennemsnits-CLcr = 120 ml/min).
English: Clinical studies in patients with breast cancer and bone metastases have shown that there is a dose dependent inhibitory effect on bone osteolysis, expressed by markers of bone resorption, and a dose dependent effect on skeletal events.
Danish: Kliniske studier hos patienter med brystkræft og knoglemetastaser har vist at der er en dosisafhængig hæmmende effekt på knogleosteolysen, udtrykt ved markører for knogleresorption, og en dosisafhængig effekt på de skeletale hændelser.
English: Please see the summary of product characteristics for more information.
Danish: Se produktresuméet vedrørende yderligere oplysninger.
English: In animal models ibandronic acid produced biochemical changes indicative of dose-dependent inhibition of bone resorption, including suppression of urinary biochemical markers of bone collagen degradation (such as deoxypyridinoline, and cross-linked N-telopeptides of type I collagen (NTX)).
Danish: I dyrestudier resulterede ibandronsyre i biokemiske ændringer, som indikerer en dosisafhængig hæmning af knogleresorptionen, herunder suppression af biokemiske urinmarkører for nedbrydning af knoglekollagen (som f.eks deoxypyridinolin og kollagen type 1 krydsbundne N-telopeptider (NTX)).
English: In the dose range recommended for treatment, the following response rates with the respective confidence intervals have been shown in clinical trials for patients with baseline albumin-corrected serum calcium ≥ 3.0 mmol/l after adequate rehydration.
Danish: Inden for det rekommenderede dosisinterval har kliniske studier vist responsrater som anført i figuren med respektive konfidensintervaller for patienter, som har en udgangsværdi for albuminkorrigeret serum-calcium  3,0 mmol/l efter nødvendig rehydrering.
English: *See further information below †Identified in post-marketing experience.
Danish: * Se yderligere information nedenfor † Identificeret ved erfaring efter markedsføring Beskrivelse af udvalgte bivirkninger
English: As renal function decreases with age, renal function is the only factor to take into consideration (see renal impairment section).
Danish: Da nyrefunktionen falder med alderen, er nyrefunktionen den eneste faktor, som bør overvejes (se punktetet vedrørende nedsat nyrefunktion).
English: • Placing used sharps containers in the household waste should be avoided.
Danish: • Undgå at sætte den brugte kanyleboks sammen med husholdningsaffaldet
English: They include a decreased number of implantation sites, interference with natural delivery (dystocia), and an increase in visceral variations (renal pelvis ureter syndrome).
Danish: De omfatter en nedsættelse af implantationssteder, forstyrrelser af den normale fødsel (dystocia), og en øgning af viscerale forandringer (renal pelvis ureter syndrom).
English: Clinical studies in the treatment of tumour-induced hypercalcaemia
Danish: Kliniske studier ved behandling af tumorinduceret hyperkalcæmi
English: Ocular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid.
Danish: Okulær inflammation såsom uveitis, episcleritis og scleritis er blevet rapporteret ved brug af ibandronsyre.
English: There was a marked depression of urinary markers of bone resorption (pyridinoline and deoxypyridinoline) in patients treated with ibandronic acid that was statistically significant compared to placebo.
Danish: Der påvistes en tydelig nedsættelse af urinmarkørerne for knogleresorption (pyridinolin og deoxypyridinolin) hos patienterne behandlet med ibandronsyre, hvilket var statistisk signifikant i forhold til placebo.
English: At 12 months median relative changes from baseline were -58.6 % for the intravenous injection of 3 mg every 3 months regimen and -62.6 % for oral 2.5 mg daily regimen.
Danish: Efter 12 måneder var de mediane, relative ændringer fra baseline -58,6 % for regimet med intravenøs injektion af 3 mg hver 3. måned og -62,6 % for det orale regime med 2,5 mg daglig.
English: Thereafter, injections should be scheduled every 3 months from the date of the last injection.
Danish: Injektionerne skal derefter gives hver tredje måned regnet fra datoen for sidste injektion.
English: Table 1 lists adverse drug reactions from the pivotal phase III studies (Treatment of tumour induced hypercalcaemia: 311 patients treated with ibandronic acid 2 mg or 4 mg; Prevention of skeletal events in patients with breast cancer and bone metastases: 152 patients treated with ibandronic acid 6 mg), and from post-marketing experience.
Danish: Tabel 1 viser bivirkningerne i de pivotale fase III-studier (Behandling af tumorinduceret hyperkalcæmi: 311 patienter behandlet med ibandronsyre 2 mg eller 4 mg; forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser: 152 patienter behandlet med ibandronsyre 6 mg) samt bivirkninger set efter markedsføring.
English: If you use more Ibandronic acid Accord than you should You may develop low levels of calcium, phosphorus or magnesium in the blood.
Danish: Hvis du har brugt for meget Ibandronsyre Accord Du kan få lave koncentrationer af kalk, fosfor eller magnesium i blodet.
English: Clinically relevant reductions in serum levels of calcium, phosphorus, and magnesium should be corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, respectively.
Danish: Klinisk relevant fald i serumkoncentrationerne af calcium, phosphor og magnesium skal korrigeres med intravenøs administration af henholdsvis calciumglukonat, kalium eller natriumphosphat og magnesiumsulfat.
English: • Place all used needles and syringes into a sharps container (puncture-proof disposable container).
Danish: • Læg alle brugte kanyler og sprøjter i en kanyleboks (brudsikker engangsbeholder)
English: The secretory pathway of renal elimination does not appear to include known acidic or basic transport systems involved in the excretion of other active substances.
Danish: Eliminationsvejen gennem nyrerne ser ikke ud til at omfatte kendte syre- eller basetransport-systemer, som anvendes i forbindelse med udskillelsen af andre aktive substanser.
English: In subjects with severe renal impairment (mean estimated CLcr=21.2 ml/min), doseadjusted mean AUC0-24h was increased by 110% compared to healthy volunteers.
Danish: Hos patienter med svært nedsat nyrefunktion (estimeret gennemsnits CLcr = 21,2 ml/min) var dosisjusteret gennemsnits-AUC0-24t forøget med 110% sammenlignet med raske frivillige.
English: Ibandronic acid Accord is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Danish: Ibandronsyre Accord er kun til brug hos kvinder, der er kommet i overgangsalderen, og må ikke tages af kvinder, der stadig kan få børn.
English: Both daily, intermittent (with a dose-free interval of 9 - 10 weeks per quarter) oral doses as well as intravenous doses of ibandronic acid in postmenopausal women produced biochemical changes indicative of dose-dependent inhibition of bone resorption.
Danish: Både daglige og intermitterende (med et dosisfrit interval på 9-10 uger pr. kvartal) orale doser og intravenøse doser af ibandronsyre til postmenopausale kvinder medførte biokemiske ændringer, som tyder på dosisafhængig hæmning af knogleresorptionen.
English: The range of observed apparent half-lives is broad, the apparent terminal half-life is generally in the range of 10 - 72 hours.
Danish: Den tilsyneladende terminale halveringstid er generelt i området 10-72 timer.
English: In addition, ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and does not induce the hepatic cytochrome P450 system in rats.
Danish: Derudover hæmmer ibandronsyre ikke de vigtigste humane hepaqtiske P450-isoenzymer og inducerer ikke det hepatiske cytochrom P450-system hos rotter.
English: Based on knowledge of this class of compounds, intravenous overdosage may result in hypocalcaemia, hypophosphataemia, and hypomagnesaemia, which can cause paraesthesia.
Danish: Baseret på kendskabet til denne lægemiddelklasse kan overdosering medføre hypokalcæmi, hypophosphatæmi og hypomagnesæmi, som kan forårsage paræstesier.
English: You should also take calcium and vitamin-D supplements, as recommended by your doctor.
Danish: Du skal også tage tilskud af kalk og vitamin D efter din læges anvisning.
English: Ask your doctor or pharmacist for advice before taking this medicine.
Danish: Tal med din læge eller apotekspersonalet, før du tager dette lægemiddel.
English: Ibandronic acid, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Danish: Ibandronsyre kan, ligesom andre intravenøst administrerede bisphosphonater, forårsage et forbigående fald i værdierne for serum-calcium.
English: Table 4: Results from 3 years fracture study MF 4411 (%, 95 % CI) for patients with lumbar spine BMD T-score below -2.5 at baseline
Danish: Resultater fra 3-års frakturstudiet MF 4411 (%, 95 % konfidensinterval) for patienter med lumbal BMD T-score under -2,5 ved baseline.
English: • if you have, or had in the past, low blood calcium.
Danish: • hvis du har eller nogen sinde har haft lavt calciumindhold i blodet
English: • pain in your muscles, joints, or back
Danish: • smerter i muskler, led eller ryg
English: Missed dose
Danish: Glemte doser:
English: The recommended dose of Ibandronic acid Accord for the intravenous injection is 3 mg (1 pre-filled syringe) once every 3 months.
Danish: Den anbefalede dosis af Ibandronsyre Accord til intravenøs injektion er 3 mg (1 fyldt injektionssprøjte) én gang hver 3. måned.
English: BMD - mean change relative to baseline total hip at year 3
Danish: BMD - gennemsnitlig ændring i forhold til baseline - total hofte - efter 3 år
English: Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with ibandronic acid (see section 4.2).
Danish: I overensstemmelse med god klinisk praksis anbefales det dog alligevel at kontrollere nyrefunktionen, serum-calcium, phosphat og magnesium på den enkelte patient i ibandronsyrebehandling (se pkt.
English: Ibandronic acid Accord is prescribed to you to treat postmenopausal osteoporosis because you have an increased risk of fractures.
Danish: Ibandronsyre Accord er ordineret til dig til behandling af osteoporose (knogleskørhed) efter menopausen (overgangsalderen), fordi du har en øget risiko for knoglebrud.
English: • eating a balanced diet rich in calcium and vitamin D
Danish: • at spise en varieret kost med et stort indhold af kalk og vitamin D
English: Renal clearance (about 60 ml/min in healthy postmenopausal females) accounts for 50-60% of total clearance and is related to creatinine clearance.
Danish: Den renale clearance (ca. 60 ml/min hos raske postmenopausale kvinder) udgør 50-60% af den totale clearance og er relateret til kreatininclearance.
English: Bioavailability and pharmacokinetics of ibandronic acid are similar in both men and women.
Danish: Biotilgængeligheden og farmakokinetikken for ibandronsyre er ens hos mænd og kvinder.
English: • not enough calcium and vitamin D in the diet
Danish: • for lidt kalk og vitamin D i kosten
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with ibandronic acid.
Danish: Alle patienter skal opfordres til at opretholde god mundhygiejne og møde op til regelmæssige tandundersøgelser og til straks at indberette mundsymptomer såsom tandmobilitet, smerter eller hævelse, sår, der ikke opheler, eller sekretion under behandling med ibandronsyre.
English: Do not take Ibandronic acid Accord if you are pregnant or breast-feeding.
Danish: Tag ikke Ibandronsyre Accord, hvis du er gravid eller ammer.
English: • injury or pain at the injection site
Danish: • skader eller smerter på injektionsstedet
English: Albumin-corrected serum calcium (mg/dl)
Danish: Albuminkorrigeret serum-calcium (mg/dl)
English: You can drive and use machines as it's expected that Ibandronic acid Accord has no or negligible effect on your ability to drive and use machines.
Danish: Du kan køre bil og betjene maskiner, da det forventes, at Ibandronsyre Accord ikke eller kun i ubetydelig grad påvirker din evne til at køre bil og betjene maskiner.
English: Patients with concomitant diseases, or who use medicinal products which have potential for undesirable effects on the kidney, should be reviewed regularly in line with good medical practice during treatment.
Danish: Patienter med samtidige sygdomme eller samtidig medicin, som kan skade nyrerne, skal kontrolleres regelmæssigt under behandlingen i henhold til god medicinsk praksis.
English: Ibandronic acid 6 mg n=154
Danish: Ibandronsyre 6 mg n=154
English: The pharmacokinetics of ibandronic acid in patients with end-stage renal disease was only assessed in a small number of patients managed by haemodialysis, therefore, the pharmacokinetics of ibandronic acid in the patients not undergoing haemodialysis is unknown.
Danish: Farmakokinetikken for ibandronsyre hos patienter med terminal nyresygdom blev kun vurderet hos en lille gruppe patienter behandlet med hæmodialyse, og derfor er farmakokinetikken hos patienter, som ikke får hæmodialyse ukendt.
English: The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at et patientkort vedrørende osteonekrose i kæben implementeres.
English: Toxic effects, e.g. signs of renal damage, were observed in dogs only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to clinical use.
Danish: Hos hunde blev der kun iagttaget toksiske virkninger, f.eks. tegn på nyreskade, ved eksponeringer, som anses for at overstige den maksimale humane eksponering i væsentlig grad.
English: Influenza like illness*, Fatigue
Danish: Influenzalignende sygdom* træthed
English: This leaflet was last revised in {date}.
Danish: Denne indlægsseddel blev senest ændret den
English: Subjects with severe renal impairment (CLcr less than 30 ml/min) receiving daily oral administration of 10 mg ibandronic acid for 21 days, had 2 - 3 fold higher plasma concentrations than subjects with normal renal function and total clearance of ibandronic acid was 44 ml/min.
Danish: Patienter med svært nedsat nyrefunktion (CLcr < 30 ml/min), som fik 10 mg oral ibandronsyre dagligt i 21 dage, havde 2-3 gange højere plasmakoncentrationer end personer med normal nyrefunktion og den totale ibandronsyre clearance var 44 ml/min.
English: The primary analysis of data from study BM16550 at one year and the confirmatory analysis at 2 years demonstrated the non-inferiority of 3 mg every 3 months injection dosing regimen compared to 2.5 mg oral daily dosing regimen, in terms of mean increases in BMD at lumbar spine, total hip, femoral neck and trochanter (Table 2).
Danish: Den primære analyse af data fra studie BM 16550 efter et år og den bekræftende analyse efter 2 år dokumenterede non-inferiority af injektionsregimet med 3 mg hver 3. måned sammenlignet med 2,5 mg oralt daglig med hensyn til stigning i BMD af lumbal columna, total hofte, lårbenshals og trochanter (tabel 2).
English: • low calcium or phosphate levels in your blood
Danish: • lav calcium- eller fosfatkoncentration i blodet