FrancophonIA/ELRC3.0 huggingface dataset:
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: There was a marked depression of urinary markers of bone resorption (pyridinoline and deoxypyridinoline) in patients treated with Bondronat that was statistically significant compared to placebo.
Danish: Der påvistes en tydelig nedsættelse af urinmarkørerne for knogleresorption (pyridinolin og deoxypyridinolin) hos patienterne behandlet med Bondronat, hvilket var statistisk signifikant i forhold til placebo.
English: Your doctor may do regular blood tests while you are taking Bondronat.
Danish: Din læge kan vælge at tage regelmæssige blodprøver, mens du er i behandling med Bondronat.
English: Talk to a nurse or a doctor straight away if you notice any of the following serious side effects, you may need urgent medical treatment:
Danish: Tal straks med sundhedspersonalet eller lægen, hvis du oplever nogle af følgende alvorlige bivirkninger, du kan have brug for akut lægehjælp:
English: Paediatric population (see section 4.2 and section 5.1) There are no data on the use of Bondronat in patients less than 18 years old.
Danish: 4.2 og 5.1) Der findes ingen data vedrørende brugen af Bondronat til patienter under 18 år.
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 Tabletterne må ikke tygges, suttes eller knuses Læs indlægssedlen inden brug Oral anvendelse
English: Therefore, with such products, including food, intake must be delayed at least 30 minutes following oral administration.
Danish: Indtagelse af sådanne produkter, herunder føde, må derfor først påbegyndes mindst 30 minutter efter peroral Bondronat indtagelse.
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 din tablet så snart du står op om morgenen, før du spiser noget, drikker noget eller tager nogen form for medicin, vitaminer og mineraler eller kosttilskud
English: After reconstitution: Store at 2 °C - 8 °C (in a refrigerator).
Danish: Efter rekonstituering: Opbevares ved 2 °C - 8 °C (i køleskab).
English: The number of SREs was also significantly reduced with Bondronat 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 Bondronat 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: There is no evidence for clinically relevant interethnic differences between Asians and Caucasians in ibandronic acid disposition.
Danish: Der er ikke noget der tyder på en klinisk relevant inter-etnisk forskel i tilstedeværelsen af ibandronsyre mellem asiater og kaukasere.
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 Bondronat.
Danish: I overensstemmelse med individuel klinisk vurdering anbefales det dog alligevel at kontrollere nyrefunktionen, serum-calcium, phosphat og magnesium hos patienter i Bondronatbehandling.
English: • if you have high or low blood levels of vitamin D or any other minerals
Danish: • hvis du har forhøjet eller nedsat indhold af vitamin D eller andre mineraler i blodet
English: Film-coated tablets.
Danish: Filmovertrukne tabletter.
English: • tooth problems
Danish: • tandproblemer
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 mest hyppigt forbundet med asteni efterfulgt af stigning i kropstemperatur og hovedpine.
English: There was also a 38% reduction in the risk of developing an SRE for Bondronat treated patients when compared with placebo (relative risk 0.62, p=0.003).
Danish: Der var en 38 % reduktion i risiko for udvikling af en SRE i forhold til placebo (relativ risiko 0,62, p=0,003).
English: Bondronat concentrate for solution for infusion should be administered as an intravenous infusion over 2 hours.
Danish: Bondronat koncentrat til infusionsvæske skal administreres som intravenøs infusion over 2 timer.
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 (CLcr ≤ 30 ml/min), som fik 10 mg peroral ibandronsyre dagligt i 21 dage, havde 2-3 gange højere plasmakoncentrationer end personer med normal nyrefunktion (CLcr > 80 ml/min).
English: The overall adverse event profile of ibandronic acid following the 15 minute infusion was consistent with the known safety profile over longer infusion times and no new safety concerns were identified relating to the use of a 15 minute infusion time.
Danish: Den samlede bivirkningsprofil for ibandronsyre efter 15 minutters infusion svarede til den sikkerhedsprofil, der er set ved længere infusionstider.
English: Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Bondronat therapy.
Danish: Patienter med forstyrrelser i knogle- og mineralmetabolisme Hypokalcæmi og andre forstyrrelser i knogle- og mineralmetabolisme skal behandles effektivt før behandling med Bondronat initieres.
English: For treatment of tumour induced hypercalcaemia, Bondronat concentrate for solution for infusion is generally given as a single infusion.
Danish: Til behandling af tumorinduceret hyperkalcæmi skal Bondronat koncentrat til infusionsvæske, opløsning generelt gives som en enkelt infusion.
English: Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those expected for this class of medicinal products (bisphosphonates).
Danish: Bivirkningerne af ibandronsyre hos rotter i reproduktionstoksicitets-studierne var de samme som forventet for bisphosphonatklassen.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Atnahs Pharma Netherlands B.V.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Atnahs Pharma Netherlands B.V.
English: The deterioration in Quality of Life was significantly less in Bondronat treated patients compared with placebo.
Danish: Forringelsen i livskvalitet var signifikant mindre for Bondronat-behandlede patienter i forhold til placebo.
English: Bondronat should not be mixed with calcium containing solutions.
Danish: Bondronat må ikke blandes med væsker indeholdende calcium.
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 virkninger efter doser, der i væsentlig grad overstiger den maksimale humane eksponering.
English: • tablet core: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified stearic acid, colloidal anhydrous silica
Danish: • Tabletkerne: lactosemonohydrat, povidon, mikrokrystallinsk cellulose, crospovidon, stearinsyre,
English: Studies in rats have shown reproductive toxicity (see section 5.3).
Danish: Rottestudier har påvist reproduktionstoksisitet (se pkt.
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 Bondronat.
Danish: Informer din læge, hvis du er i gang med en tandbehandling eller vil få foretaget en tandoperation (f.eks. tandudtrækning), og fortæl ligeledes din tandlæge, at du er i behandling med Bondronat.
English: • itching, swelling of your face, lips, tongue and throat with difficulty breathing.
Danish: • kløe, hævelse af ansigt, læber, tunge og hals med vejrtrækningsproblemer.
English: Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Bondronat 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 Bondronat-behandling ved metastatisk knoglesygdom.
English: Temporary interruption of Bondronat treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Danish: Hvis det er muligt, bør det overvejes at seponere behandlingen med Bondronat midlertidigt, indtil tilstanden forbedres og risikofaktorerne for knoglenekrose i kæben er reduceret.
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 i denne patientgruppe.
English: Bondronat 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: Bondronat er indiceret til voksne til forebyggelse af knoglerelaterede hændelser (patologiske frakturer, knoglekomplikationer, som kræver strålebehandling eller operation) hos patienter med brystkræft og knoglemetastaser.
English: Table 1 lists adverse drug reactions from the pivotal phase III studies (Treatment of tumour induced hypercalcaemia: 311 patients treated with Bondronat 2 mg or 4 mg; Prevention of skeletal events in patients with breast cancer and bone metastases: 152 patients treated with Bondronat 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 Bondronat 2 mg eller 4 mg; Forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser: 152 patienter behandlet med Bondronat 6 mg) samt bivirkninger set efter markedsføring.
English: Elderly population (> 65 years) No dose adjustment is required (see section 5.2).
Danish: Ældre population (> 65 år) Dosisjustering er ikke påkrævet (se pkt.
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: The deterioration in Quality of Life and WHO performance status was significantly less in Bondronat treated patients compared with placebo.
Danish: Forringelsen i livskvalitet og WHO performance status var signifikant mindre for Bondronat-behandlede patienter i forhold til placebo.
English: even if their signs of illness are the same as yours
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har
English: Since both the kidney and the liver were found to be target organs for toxicity in preclinical studies with high doses, kidney and liver function should be monitored.
Danish: Eftersom både nyrer og lever i prækliniske studier er vist at være de organer, der udsættes for toksicitet ved høje doser, bør nyre- og leverfunktionen overvåges.
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: Sodium acetate, sodium chloride, acetic acid and water for injections.
Danish: Natriumacetat, natriumchlorid, eddikesyre og vand til injektionsvæsker.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Bondronat findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: In reproductive studies in rats by the oral route, effects on fertility consisted of increased preimplantation losses at dose levels of 1 mg/kg/day and higher.
Danish: I reproduktionsstudier hos rotter var effekten på fertiliteten øget præimplantationstab ved orale doser på 1 mg/kg/døgn og derover.
English: Table 1 lists adverse reactions from 2 pivotal phase III studies (Prevention of skeletal events in patients with breast cancer and bone metastases: 286 patients treated with Bondronat 50 mg administered orally), and from post-marketing experience.
Danish: Tabel 1 viser bivirkningerne i 2 pivotale fase III-studier (forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser: 286 patienter behandlet med 50 mg oralt administreret Bondronat) samt bivirkninger set efter markedsføring.
English: Calcium containing solutions should not be mixed with Bondronat concentrate for solution for infusion.
Danish: Opløsninger indeholdende calcium må ikke blandes med Bondronat koncentrat til infusionsvæske, opløsning.
English: Bondronat should not be used during lactation.
Danish: Bondronat bør ikke anvendes i ammeperioden.
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Bondronat administration.
Danish: Invasive tandbehandlinger bør kun udføres efter nøje vurdering under behandling med Bondronat.
English: Prior to treatment with Bondronat the patient should be adequately rehydrated with 9 mg/ml (0.9%) sodium chloride.
Danish: Forud for behandling med Bondronat, bør patienten være tilfredsstillende hydreret med 9 mg/ml (0,9 %) natriumchlorid.
English: Data from this study demonstrated a significant advantage for intravenous Bondronat 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 Bondronat 6 mg frem for placebo, ved reduktion af SREs målt ved den tidsjusterede SMPR (p=0,004).
English: Then you can have your first food and drink, and take any medicines or supplements
Danish: Derefter kan du indtage dagens første mad og drikke samt tage medicin, vitaminer og mineraler eller kosttilskud
English: This is because aminoglycosides and Bondronat can both lower the amount of calcium in your blood.
Danish: Aminoglykosider og Bondronat kan begge nedsætte mængden af kalk i dit blod.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv
English: For patients with breast cancer and bone metastases, Bondronat infusion should be administered every 3-4 weeks.
Danish: Til patienter med brystkræft og knoglemetastaser skal Bondronat infusionen gives hver 3-4 uge.
English: This is because aminoglycosides and Bondronat can both lower the amount of calcium in your blood
Danish: Aminoglykosider og Bondronat kan begge nedsætte mængden af kalk i dit blod
English: Neoplasms benign, malignant and unspecified
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
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: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving Bondronat for cancer-related conditions.
Danish: En bivirkning kaldet knoglenekrose i kæben (skader på knoglen i kæben) er blevet rapporteret meget sjældent i post-marketing perioden hos patienter ved behandling med Bondronat for kæft-relateret forhold.
English: • if you have any swallowing or digestion problems
Danish: • hvis du har synkebesvær eller fordøjelsesbesvær
English: Bondronat is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called ‘bone metastases').
Danish: Bondronat er til voksne og bliver ordineret til dig, hvis du har brystkræft, som har spredt sig til dine knogler (kaldet knoglemetastaser).
English: • if you have kidney problems
Danish: • hvis du har problemer med nyrerne
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1 hætteglas
English: NAME OF THE MEDICINAL PRODUCT Bondronat 50 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN Bondronat 50 mg filmovertrukne tabletter.
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 Bondronat (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 Bondronatbehandling (se pkt.
English: Headache, dizziness, dysgeusia (taste perversion)
Danish: Hovedpine, svimmelhed, dysgeusi (smagsforstyrrelser)
English: In order to avoid potential incompatibilities, Bondronat concentrate for solution for infusion should only be mixed with isotonic sodium chloride solution or with 5% dextrose solution.
Danish: For at undgå potentielle uforligeligheder, skal Bondronat koncentrat til infusionsvæske, opløsning kun blandes med isotonisk natriumchlorid eller med 5 % glucoseinfusionsvæske.
English: If you have a 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 kalk i blodet som følge af en svulst, er den anbefalede dosis 2 mg én gang eller 4 mg én gang, afhængig af sværhedsgraden af din sygdom.
English: • Store in the original package in order to protect from moisture
Danish: • Opbevar lægemidlet i den originale yderpakning for at beskytte mod fugt
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE PAKNING
English: What Bondronat looks like and contents of the pack Bondronat is a colourless, clear solution.
Danish: Bondronat er en farveløs, klar opløsning.
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 - Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking - Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck - Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions
Danish: administrationsvej (højere risiko for parenteral administration) og kumulativ dosis af knogleresorption behandling - kræft, komorbide tilstande (f.eks. anæmi, koagulationsforstyrrelser, infektion), rygning - samtidig behandling: kortikosteroider, kemoterapi, angiogenesehæmmere, strålebehandling af hovede og hals - dårlig mundhygiejne, paradentose, dårligt passende tandproteser, tidligere tandsygdomme,
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Intravenous use, for infusion after dilution
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Læs indlægssedlen inden brug Til intravenøs infusion efter fortynding
English: In most cases no specific treatment was required and the symptoms subsided after a couple of hours/days.
Danish: I de fleste tilfælde krævedes ingen specifik behandling, og symptomerne fortog sig efter et par timer/dage.
English: Atypical subtrochanteric and diaphyseal femoral fractures†
Danish: Atypiske subtrochantære og diafyseale femurfrakturer
English: For the prevention of skeletal events in patients with breast cancer and bone metastases, the Bondronat infusion is repeated at 3-4 week intervals.
Danish: Ved forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser gentages Bondronat infusionen med 3-4 ugers intervaller.
English: If you have breast cancer that has spread to your bones, then the recommended dose is 3 vials (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 3 hætteglas (6 mg) hver 3.-4. uge, givet som infusion i en blodåre i løbet af mindst 15 minutter.
English: Bondronat 50 mg film-coated tablets ibandronic acid
Danish: Bondronat 50 mg filmovertrukne tabletter ibandronsyre
English: Table 3 Secondary Efficacy Results (Breast cancer Patients with Metastatic Bone Disease)
Danish: Tabel 3 Sekundære effektresultater (brystkræftpatienter med metastaserende knoglesygdom)
English: Pooled data from these studies demonstrated a significant advantage for Bondronat 50 mg p.o. over placebo in the reduction in SREs measured by the SMPR (p=0.041).
Danish: Sammenfattende resultater fra dette studie viste en signifikant fordel for Bondronat 50 mg p.o. frem for placebo, til reduktion af SREs målt ved den tidsjusterede SMPR (p=0,041).
English: Patients with hepatic impairment No dose adjustment is required (see section 5.2).
Danish: Patienter med nedsat leverfunktion Dosisjustering er ikke påkrævet (se pkt.
English: The median time to relapse (return of albumin-corrected serum calcium above 3.0 mmol/l) was 18 to 26 days.
Danish: Mediantiden for tilbagefald (tilbagevenden af albumin-korrigeret serum-calcium til mere end 3 mmol/l) var 18-26 dage.
English: To avoid potential incompatibilities Bondronat concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution.
Danish: For at undgå potentielle uforligeligheder bør Bondronat koncentrat til infusionsvæske, opløsning kun fortyndes med isotonisk natriumchlorid-infusionsvæske eller 5 % glucose-infusionsvæske.
English: If you have breast cancer that has spread to your bones, then the recommended dose is 1 vial (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 1 hætteglas (6 mg) hver 3.-4. uge, givet som infusion i en blodåre i løbet af mindst 15 minutter.
English: A flu-like syndrome consisting of fever, chills, bone and/or muscle ache-like pain has occurred.
Danish: En influenzalignende tilstand med feber, kuldegysninger, knogle og/eller muskelsmerter, er set.
English: • It helps to prevent your bones from breaking (fractures)
Danish: Det hjælper med at forebygge knoglebrud
English: See also dosage section above for patients with renal impairment
Danish: Se også afsnittet ovenfor vedrørende dosering af patienter med nedsat nyrefunktion
English: • The other ingredients are sodium chloride, acetic acid, sodium acetate and water for injections
Danish: • Øvrige indholdsstoffer: natriumchlorid, eddikesyre, natriumacetat og vand til injektionsvæsker