FrancophonIA/ELRC3.0 huggingface dataset:
English: In subjects with severe renal impairment (mean estimated CLcr = 21.2 mL/min), dose-adjusted 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: This is because Iasibon can affect the way some other medicines work.
Danish: Dette skyldes at Iasibon kan påvirke den måde anden medicin virker på, ligesom anden medicin kan påvirke den måde, hvorpå Iasibon virker.
English: If you forget to take Iasibon
Danish: Hvis De har glemt at tage Iasibon
English: Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (277 patients) or 50 mg Ibandronate (287 patients).
Danish: Kvindelige patienter med brystkræft og radiologisk verificerede knoglemetastaser blev randomiseret til placebo (277 patienter) eller 50 mg ibandronsyre (287 patienter).
English: Analgesic use *
Danish: Analgetika forbrug*
English: Tests for genotoxicity revealed no evidence of genetic activity for ibandronic acid.
Danish: Studier for genotoksicitet viste ingen tegn på genetisk aktivitet af ibandronsyre.
English: Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4).
Danish: Diagnose for cancer, kemoterapi, strålebehandling, kortikosteroider og dårlig mundhygiejne er også anset for risikofaktorer (se pkt.
English: Iasibon is indicated in adults for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Danish: Iasibon er indiceret til voksne til forebyggelse af knoglerelaterede hændelser (patologiske frakturer, knoglekomplikationer, som kræver strålebehandling eller operation) hos patienter med brystkræft og knoglemetastaser.
English: It is not known whether ibandronic acid is excreted in human milk.
Danish: Det vides ikke om ibandronsyre udskilles i human mælk.
English: Bioavailability is reduced by about 90% when ibandronic acid is administered with a standard breakfast in comparison with bioavailability seen in fasted subjects.
Danish: Biotilgængeligheden reduceres med ca. 90 %, når ibandronsyre indtages sammen med et almindeligt morgenmåltid i forhold til biotilgængeligheden hos fastende personer.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt.
English: • changes in your blood cells (‘anaemia')
Danish: • ændringer i blodcellerne (blodmangel)
English: • sleep problems, feeling anxious, emotional instability, or mood swings
Danish: • søvnproblemer, angst, følelsesmæssig ustabilitet eller humørsvingninger
English: Treatment was most frequently associated with a decrease in serum calcium to below normal range (hypocalcaemia), followed by dyspepsia.
Danish: 4.4).Behandlingen var hyppigst forbundet med et fald i serum-calcium til under normalområdet (hypokalcæmi), derefter kom dyspepsi.
English: In studies in rats using the intravenous route, ibandronic acid decreased fertility at high daily doses (see section 5.3).
Danish: I rottestudier hvor intravenøs indgift blev anvendt, nedsatte ibandronsyre fertiliteten ved høje daglige doser (se pkt.
English: Less frequently, decrease in serum calcium below normal range (hypocalcaemia) is reported.
Danish: Mindre hyppigt er der rapporteret et fald iserum-calcium til under normalområdet (hypokalcæmi).
English: The liver has no significant role in the clearance of ibandronic acid since it is not metabolized but is cleared by renal excretion and by uptake into bone.
Danish: Leveren spiller ikke nogen væsentlig rolle ved udskillelsen af ibandronsyre, som ikke metaboliseres, men udskilles gennem nyrerne, samt ved optagelse i knoglerne.
English: ≥50 CLcr <80 6 mg (6 ml of concentrate for solution for infusion)
Danish: ≥ 50 CLcr < 80 6 mg (6 ml koncentrat til infusionsvæske)
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 anbefalede 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: • flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, fatigue, bone pain and aching muscles and joints.
Danish: • influenzalignende symptomer herunder feber, rysten og skælven, ubehag, træthed, knoglesmerter samt smerter i muskler og led.
English: Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (158 patients) or 6 mg Ibandronate (154 patients).
Danish: Kvindelige patienter med brystkræft og radiologisk verificerede knoglemetastaser blev randomiseret til placebo (158 patienter) eller 6 mg ibandronsyre (154 patienter).
English: Anaemia, blood dyscrasia
Danish: Anæmi, bloddyskrasi
English: • Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements
Danish: • Tag Deres tablet så snart De står op om morgenen, før De spiser noget, drikker noget eller tager nogen form for medicin, vitaminer og mineraler eller kosttilskud.
English: For oral use.
Danish: AdministrationTil oral anvendelse.
English: The results from this trial are summarised below.
Danish: Resultaterne fra dette studie er beskrevet i det følgende.
English: A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
Danish: En tandundersøgelse med passende forebyggende tandlægearbejde bør overvejes hos patienter med samtidige risikofaktorer (som f.eks. kræft, kemoterapi, strålebehandling, kortikosteroider, dårlig oral hygiejne) før behandling med bisphosphonater.
English: ≥30 CLcr <50 4 mg (4 ml of concentrate for solution for infusion)
Danish: ≥ 30 CLcr < 50 4 mg (4 ml koncentrat til infusionsvæske)
English: There was a marked depression of urinary markers of bone resorption (pyridinoline and deoxypyridinoline) in patients treated with Ibandronate 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: Contains 0.86 mg lactose (as lactose monohydrate).
Danish: 1 tablet indeholder 0.86 mg lactose (som lactosemonohydrat).
English: Lung oedema, stridor
Danish: Lungeødem, stridor
English: The number of SREs was also significantly reduced with Ibandronate 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: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 ampoule
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1 ampul
English: Table 1 Adverse Drug Reactions Reported for Oral Administration of Ibandronate
Danish: Tabel 1 Bivirkninger rapporteret for oral administration af ibandronsyre
English: • skin problems
Danish: • hudproblemer
English: Clinically relevant hypocalcaemia (very low serum calcium levels) should be corrected by intravenous administration of calcium gluconate.
Danish: Klinisk relevant hypokalcæmi (meget lav calciumkoncentration i blodet) skal korrigeres med en intravenøs administration af calciumgluconat.
English: • a high level of alkaline phosphatase in your blood
Danish: • høj koncentration af alkalisk fosfatase i blodet
English: In the prevention of skeletal events in patients with breast cancer and bone metastases, treatment is most frequently associated with asthenia followed by rise in body temperature and headache.
Danish: Som forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser er behandlingen oftest forbundet med asteni efterfulgt af stigning i kropstemperatur og hovedpine.
English: Common (may affect up to 1 in 10 people): • feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/ food pipe)
Danish: Almindelig (kan forekomme hos 1 ud af 10 behandlede) kvalme, halsbrand eller ubehag ved at synke (betændelse i spiserøret)
English: The inhibition of endogenous bone resorption has also been documented by 45Ca kinetic studies and by the release of radioactive tetracycline previously incorporated into the skeleton.
Danish: Hæmning af endogen knogleresorption er dokumenteret ved 45 Ca kinetikstudier og ved frigivelse af radioaktivt tetracyklin, indbygget i skelettet.
English: • your body temperature getting too low (‘hypothermia')
Danish: • nedsat kropstemperatur (hypotermi)
English: After reconstitution: Store at 2°C - 8°C (in a refrigerator).
Danish: Efter rekonstituering: Opbevares ved 2-8 °C (i køleskab).
English: Frequency of administration
Danish: Anvendelseshyppighed
English: For treatment of tumour induced hypercalcaemia, Iasibon concentrate for solution for infusion is generally given as a single infusion.
Danish: Til behandling af tumorinduceret hyperkalcæmi skal Iasibon koncentrat til infusionsvæske, opløsning generelt gives som en enkelt infusion.
English: Ibandronate 6 mg n=154
Danish: Ibandronsyre 6 mg n=154
English: For these patients and dosages, the median time to achieve normocalcaemia was 4 to 7 days.
Danish: Mediantiden for opnåelse af normokalcæmi var 4-7 dage for disse patienter og disse doser.
English: (see section 5.1 and section 5.2).
Danish: 5.1 og 5.2).
English: On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that Iasibon 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 Iasibon ikke eller kun i ubetydelig grad at påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not suck, chew or crush tablets Read the package leaflet before use Oral use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Tabletterne må ikke tygges, suttes eller knuses Læs indlægssedlen inden brug.
English: • if you have, or have ever had low levels of calcium in your blood.
Danish: - hvis du har eller nogen sinde har haft lavt kalkindhold i blodet.
English: • This medicine has been prescribed for you only.
Danish: Lægen har ordineret dette lægemiddel til Dem personligt.
English: Patients with known hypersensitivity to other bisphosphonates Caution is to be taken in patients with known hypersensitivity to other bisphosphonates.
Danish: Patienter med kendt overfølsomhed over for andre bisphosphonater Forsigtighed skal udvises hos patienter med kendt overfølsomhed over for andre bisphosphonater.
English: You may have early signs of severe jaw problems (necrosis
Danish: Du kan have tidlige tegn på alvorlige problemer med kæben (nekrose (dødt knoglevæv) i kæbeknoglen).
English: For patients with severe renal impairment (CLcr <30 mL/min) the recommended dose is one 50 mg film-coated tablet once weekly.
Danish: For patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) er den anbefalede dosis én 50 mg filmovertrukken tablet én gang ugentligt.
English: Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: I de prækliniske studier blev der kun set effekter efter doser, der i væsentlig grad overstiger den maksimale humane eksponering, hvilket indikerer ubetydelig relevans mhp.
English: Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis), has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates.
Danish: Knoglenekrose i kæben, normalt i forbindelse med tandudtrækning og/eller lokal infektion (herunder osteomyelitis) er rapporteret hos kræftpatienter, der får behandlingsregimer indeholdende primært intravenøst administrerede bisphosphonater.
English: And
Danish: Og
English: Iasibon concentrate for solution for infusion should be administered as an intravenous infusion over 2 hours.
Danish: Iasibon koncentrat til infusionsvæske skal administreres som intravenøs infusion over 2 timer.
English: There are no data available characterising the use of a shorter infusion time in patients with creatinine clearance below 50 ml/min.
Danish: Der er ingen tilgængelige data for kortere infusionstid hos patienter med kreatininclearance under 50 ml/min.
English: • heart and circulatory problems (including palpitations, heart attack, hypertension , high blood pressure and varicose veins)
Danish: • problemer med hjerte og kredsløb (inklusive hjertebanken, hjertetilfælde, forhøjet blodtryk og åreknuder)
English: Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Iasibon therapy.
Danish: Patienter med forstyrrelser i knogle- og mineralmetabolisme Hypokalcæmi og andre forstyrrelser i knogle- og mineralmetabolisme skal behandles effektivt før behandling med Iasibon initieres.
English: - Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases
Danish: - forebyggelse af knoglerelaterede hændelser (patologiske frakturer, knoglekomplikationer, som kræver strålebehandling eller operation) hos patienter med brystkræft og knoglemetastaser.
English: Exposure to ibandronic acid in patients with various degrees of renal impairment is related to creatinine clearance (CLcr).
Danish: Eksponering af ibandronsyre hos patienter med forskellige grader af nedsat nyrefunktion er relateret til kreatininclearance (CLcr).
English: For patients with breast cancer and bone metastases, Iasibon infusion should be administered every 3-4 weeks.
Danish: Til patienter med brystkræft og knoglemetastaser skal Iasibon infusionen gives hver 3-4 uge.
English: White round biconvex tablets
Danish: Hvide, runde, bikonvekse tabletter
English: Iasibon should not be mixed with calcium containing solutions.
Danish: Iasibon må ikke blandes med væsker, der indeholder calcium.
English: Iasibon is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called ‘bone metastases').
Danish: Iasibon er til voksne og bliver ordineret til dig, hvis De har brystkræft, som har spredt sig til Deres knogler (kaldet knoglemetastaser).
English: What Iasibon looks like and contents of the pack The film-coated tablets are white, round biconvex tablets supplied in Polyamide/Al/PVC - Aluminum foil blister.
Danish: De filmovertrukne tabletter er hvide, runde, bikonvekse tabletter leveret i polyamid/aluminium/PVCaluminium blisterpakninger.
English: Paediatric population (see section 4.2 and section 5.1) There are no data on the use of Iasibon in patients less than 18 years old.
Danish: 4.2 og 5.1) Der foreligger ingen data vedrørende brugen af Iasibon til patienter under 18 år.
English: Sleep disorder, anxiety, affection lability
Danish: Søvnforstyrrelser, angst, affektlabilitet
English: Prescribers should consult the section Patients with Renal Impairment (see section 4.2) for recommendations on dosing and administration in this patient group.
Danish: 4.2) for anbefaling af dosering og administration til denne patientgruppe.
English: Albumin-corrected Serum calcium (mg/dl)
Danish: Albuminkorrigeret serum-calcium (mg/dl)
English: Myocardial ischaemia, cardiovascular disorder, palpitations
Danish: Myokardiel iskæmi, kardiovaskulære forstyrrelser, palpitationer
English: There are no adequate data from the use of ibandronic acid in pregnant women.
Danish: Der er utilstrækkelig data fra anvendelse af ibandronsyre til gravide kvinder.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Ampoule
Danish: MINDSTEKRAV TIL OPLYSNINGER, PÅ SMÅ INDRE EMBALLAGER Ampul
English: Pyrexia, influenzalike illness**, oedema peripheral, asthenia, thirst
Danish: Pyreksi, influenzalignende sygdom** perifere ødemer, asteni, tørst
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE PAKNING
English: • Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet og på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned..
English: Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Iasibon therapy for metastatic bone disease.
Danish: Patienter med forstyrrelser i knogle- og mineralmetabolisme Hypokalcæmi og andre forstyrrelser i knogle- og mineralmetabolisme skal behandles effektivt inden påbegyndelse af Iasibon-behandling ved metastatisk knoglesygdom.
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: Ocular inflammati on†**
Danish: Inflammation i øjet †**
English: Cerebrovascular disorder, nerve root lesion , amnesia, migraine, neuralgia, hypertonia, hyperaestesia, paraesthesia circumoral, parosmia
Danish: Cerebrovaskulære forstyrrelser, nerverodslæsioner, amnesi, migræne, neuralgi, hypertoni, hyperæstesi, paræstesi omkring munden, parosmi
English: Only clear solution without particles should be used.
Danish: Der må kun anvendes en klar infusionsvæske uden partikler.
English: The deterioration in Quality of Life was significantly less in Ibandronate treated patients compared with placebo.
Danish: Forringelsen i livskvalitet var signifikant mindre for ibandronsyrebehandlede patienter i forhold til placebo.
English: Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic acid.
Danish: Der er rapporteret om tilfælde af alvorlige, nogle gange dødelige, allergiske reaktioner hos patienter, der har fået ibandronsyre intravenøst.
English: 2 mg (2 ml of concentrate for solution for infusion)
Danish: 2 mg (2 ml koncentrat til infusionsvæske)
English: After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator)
Danish: Efter fortynding er infusionsopløsningen stabil i 24 timer ved 2 °C - 8 °C (i køleskab)
English: • headache, feeling dizzy or feeling weak
Danish: • hovedpine, svimmelhed eller svaghedsfølelse
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: Subjects with severe renal impairment (CLcr ≤ 30 mL/min) receiving oral administration of 10 mg ibandronic acid daily for 21 days, had 2-3 fold higher plasma concentrations than subjects with normal renal function (CLcr ≥80 mL/min).
Danish: Patienter med svært nedsat nyrefunktion (kreatinclearance < 30 ml/min), som fik 10 mg peroral ibandronsyre dagligt i 21 dage, havde 2-3 gange højere plasmakoncentrationer end personer med normal nyrefunktion (kreatinclearance > 80 ml/min).
English: Injury, injection site pain
Danish: Skader, smerter på injektionsstedet
English: The deterioration in Quality of Life and WHO performance status was significantly less in Ibandronate treated patients compared with placebo.
Danish: Forringelsen i livskvalitet og WHO performance status var signifikant mindre for ibandronsyrebehandlede patienter i forhold til placebo.
English: Other medicines and Iasibon
Danish: Brug af anden medicin sammen med Iasibon
English: • tablet core: povidone, microcrystalline cellulose, crospovidone, maize starch pregelatinised,
Danish: • tabletkerne: povidon, mikrokrystallinsk cellulose, crospovidon, prægelatineret majsstivelse, glyceroldibehenat, kolloid vandfri silica.
English: Data from this study demonstrated a significant advantage for intravenous Ibandronate 6 mg over placebo in the reduction in SREs measured by the time-adjusted SMPR (p=0.004).
Danish: Resultaterne fra dette studie 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: For the prevention of skeletal events in patients with breast cancer and bone metastases, the Iasibon infusion is repeated at 3-4 week intervals.
Danish: Ved forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser gentages Iasibon infusionen med 3-4 ugers intervaller.
English: General disorders and administratio n site conditions
Danish: Almene symptomer og reaktioner på administratio ns-stedet
English: • feeling thirsty, sore throat, changes in taste
Danish: • tørst, ømhed i halsen, smagsforstyrrelser
English: If you experience one of the following symptoms, such as shortness of breath/difficulty breathing, tight feeling in throat, swelling of tongue, dizziness, feeling of loss of consciousness, redness or swelling of face, body rash, nausea and vomiting, you should immediately alert your doctor or nurse (see section 4).
Danish: Du skal omgående kontakte læge eller sundhedspersonale, hvis du oplever et af følgende symptomer: Åndenød/vejrtrækningsbesvær, følelse af at halsen snørrer sig sammen, hævelse af tungen, svimmelhed, følelse af at miste bevidstheden, rødme eller hævelse af ansigtet, hududslæt, kvalme og opkastning (se punkt 4).
English: The median time to relapse (return of albumin-corrected serum calcium above 3.0 mmol/l) was 18 to 26 days.
Danish: Mediantiden til recidiv (tilbagevenden af albuminkorrigeret serum-calcium til over 3 mmol/l) var 18-26 dage.
English: Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
Danish: Knoglenekrose i kæben er også rapporteret hos patienter med osteoporose, der får orale bisphosphonater.
English: Calcium containing solutions should not be mixed with Iasibon concentrate for solution for infusion.
Danish: Opløsninger indeholdende calcium må ikke blandes med Iasibon koncentrat til infusionsvæske, opløsning.
English: No evidence of direct foetal toxicity or teratogenic effects were observed for ibandronic acid in intravenously treated rats and rabbits.
Danish: Der fandtes ikke tegn på direkte føtal toksisk eller teratogen effekt af ibandronsyre hos intravenøst behandlede rotter og kaniner.
English: To convert the albumin-corrected serum calcium in mmol/l value to mg/dl, multiply by 4.
Danish: Man konverterer albuminkorrigeret serum-calcium fra mmol/l til mg/dl ved at multiplicere med 4.
English: • if you have kidney problems.
Danish: • hvis De har problemer med nyrerne.