FrancophonIA/ELRC3.0 huggingface dataset:
English: • changes in blood test results such as Gamma GT or creatinine
Danish: • ændringer i blodprøveresultater såsom gamma-glutamyltransferase eller kreatinin
English: Mean Cmax was not increased in patients with mild renal impairment and increased by 12% in patients with moderate renal impairment.
Danish: Gennemsnits-Cmax var ikke øget hos patienter med let nedsat nyrefunktion, og den var øget med 12 % hos patienter med moderat nedsat nyrefunktion.
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 forsvandt efter et par timer/dage.
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 klinisk signifikant øgning af frie plasmakoncentrationer.
English: The highest dose used in clinical trials was 6 mg but this dose does not add any further benefit in terms of efficacy.
Danish: Den højeste dosis anvendt i kliniske studier er 6 mg, men denne dosis øger ikke virkningen.
English: • tablet coat: titanium dioxide (E171), lactose monohydrate, hypromellose (E464), macrogol 4000
Danish: • tabletovertræk: titandioxid (E171), lactosemonohydrat, hypromellose (E464), macrogol 4000
English: Dose: Treatment of tumour-induced hypercalcaemia Iasibon is usually administered in a hospital setting.
Danish: Dosering: Behandling af tumor-induceret hyperkalcæmi Iasibon administreres sædvanligvis på et hospital.
English: No data are available .
Danish: Der foreligger ingen data.
English: Pharmaco-therapeutic group: Medicinal products for treatment of bone diseases, bisphosphonate, ATC Code: M05BA06
Danish: Farmakoterapeutisk klassifikation: Midler til behandling af knoglesygdomme, bisphosphonater, ATC kode: M05BA06
English: A repeated dose may be considered in case of insufficient response or if your illness reappears.
Danish: Gentagen dosering kan overvejes, hvis der ses utilstrækkelig effekt, eller hvis Deres sygdom kommer igen.
English: Do not receive this medicine if any of the above apply to you.
Danish: Du må ikke få denne medicin, hvis noget af ovenstående passer på Dem.
English: Iasibon can also be prescribed if you have a raised calcium level in your blood due to a tumour.
Danish: Iasibon kan også blive ordineret, hvis De har forhøjet indhold af kalk i blodet, som følge af en svulst.
English: Do not lie down.
Danish: Fremkald ikke opkastning, og læg Dem ikke ned.
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: However, no dosage adjustment is required when Iasibon is administered with H2-antagonists or medicinal products that increase gastric pH.
Danish: Dosisjustering er ikke nødvendig, når Iasibon administreres sammen med H2-antagonister eller andre lægemidle som øger gastrisk pH.
English: Stevens-Johnson Syndrome†, Erythema Multiforme†, Dermatitis Bullous†
Danish: StevensJohnsons syndrom†, erythema multiforme†, bulløs dermatitis†
English: Treatment of tumour induced hypercalcaemia is most frequently associated with a rise in body temperature.
Danish: Behandling af tumorinduceret hyperkalcæmi er hyppigst forbundet med en stigning i kropstemperatur.
English: What Iasibon contains
Danish: Iasibon indeholder
English: Biotransformation There is no evidence that ibandronic acid is metabolized in animals or humans.
Danish: Biotransformation Der er ikke tegn på, at ibandronsyre metaboliseres i dyr eller mennesker.
English: • pain in your bone or muscles
Danish: • smerter i knogler eller muskler
English: After a 2 hour infusion of 2, 4 and 6 mg ibandronic acid pharmacokinetic parameters are dose proportional.
Danish: Efter 2 timers infusion med 2, 4 og 6 mg ibandronsyre ses farmakokinetiske parametre proportionale med dosis.
English: Talk to your doctor first if you want to drive, use machines or tools.
Danish: Tal med Deres læge først, hvis De vil køre bil eller arbejde med maskiner.
English: Benign skin neoplasm
Danish: Benign neoplasma i huden
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlingsk omplikationer
English: Pharmathen International S.A. Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi Greece
Danish: Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi Grækenland
English: Infection Cystitis, vaginitis, oral candidiasis
Danish: Infektion Cystitis, vaginitis, oral candidiasis
English: Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Iasibon.
Danish: Indtagelse af medicin, som reducerer mængden af mavesyre, såsom cimetidin og ranitidin, kan give let forøget effekt af Iasibon.
English: In vivo, ibandronic acid prevents experimentally-induced bone destruction caused by cessation of gonadal function, retinoids, tumours or tumour extracts.
Danish: In vivo forhindrer ibandronsyre eksperimentelt induceret knogleødelæggelse forårsaget af ophøret af den gonadale funktion, retinoider, tumorer eller tumorekstrakter.
English: Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of water and/or if you lie down within an hour of taking Iasibon.
Danish: Der kan forekomme irritation, inflammation (betændelseslignende tilstand) eller sårdannelse i spiserøret, ofte med symptomer som stærk smerte i brystet, stærk smerte efter at have sunket mad og/eller drikke, voldsom kvalme eller opkastning, især hvis du ikke drikker et helt glas almindeligt vand, og/eller hvis du ligger ned inden for én time efter, du har taget Iasibon.
English: Repeated treatment may be considered in case of recurrent hypercalcaemia or insufficient efficacy.
Danish: Gentagen behandling kan overvejes i tilfælde med gentagen hyperkalcæmi eller utilstrækkelig behandlingseffekt.
English: Periodic safety update reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR)
English: The primary endpoint of the trial was the skeletal morbidity period rate (SMPR).
Danish: Det primære endepunkt i undersøgelsen var skeletal morbidity period rate (SMPR).
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: Iasibon 50 mg film coated tablets are supplied in Polyamide/Al/PVC - Aluminum foil blister with 3, 6, 9, 28 or 84 tablets, packaged in a cardboard box.
Danish: Iasibon 50 mg filmovertrukne tabletter leveres i polyamid/aluminium/PVC - aluminium blisterpakninger med 3, 6, 9, 28 eller 84 tabletter pakket i papæske.
English: Physicians should be alert to any signs or symptoms signaling a possible oesophageal reaction and patients should be instructed to discontinue Iasibon and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
Danish: Læger skal være opmærksomme på tegn eller symptomer, som tyder på en øsofageal reaktion, og patienterne skal instrueres i at stoppe Iasibonbehandlingen og kontakte lægen, hvis de udvikler dysfagi, odynofagi, retrosternal smerte eller nyopstået eller forværret halsbrand.
English: - Hypocalcaemia - Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia - Inability to stand or sit upright for at least 60 minutes
Danish: - Hypokalcæmi - Anormaliteter i spiserøret, som forsinker tømning af spiserøret, såsom forsnævring eller akalasi - Manglende evne til at stå eller sidde oprejst i mindst 60 minutter
English: The results from these trials are summarised below.
Danish: Resultaterne fra disse undersøgelser er beskrevet i det følgende.
English: The pain reduction was consistently below baseline throughout the entire study and accompanied by a significantly reduced use of analgesics.
Danish: Smertereduktionen var permanent under baseline gennem hele studiet og blev ledsaget af et signifikant reduceret forbrug af analgetika.
English: Your doctor may do regular blood tests while you are receiving Iasibon.
Danish: Deres læge kan vælge at tage regelmæssige blodprøver, mens De er i behandling med Iasibon.
English: Receiving this medicine
Danish: Når De får denne medicin
English: Iasibon works by reducing the amount of calcium that is lost from your bones.
Danish: Iasibon virker ved at nedsætte den mængde kalk, som mistes fra knoglerne.
English: • a type of antibiotic injection called “aminoglycoside” such as gentamicin.
Danish: • injektioner af en type antibiotika, der kaldes ”aminoglykosider”, såsom gentamicin.
English: The primary endpoint of the trials was the skeletal morbidity period rate (SMPR).
Danish: Det primære slutpunkt i studie var skeletal morbidity period rate (SMPR).
English: • It helps to prevent other bone problems that may need surgery or radiotherapy
Danish: Det hjælper med at forebygge andre knogleproblemer, som kan kræve operation eller strålebehandling.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedpersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V
English: Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Iasibon is given to patients with active upper gastrointestinal problems (e.g. known Barrett's oesophagus, dysphagia, other oesophageal diseases, gastritis, duodenitis or ulcers).
Danish: På grund af den mulige irriterende effekt og risikoen for forværring af den underliggende sygdom bør der udvises forsigtighed, når Iasibon gives til patienter med aktive øvre gastrointestinale problemer (f.eks. diagnosticeret Barretts øsofagitis, dysfagi, andre sygdomme i spiserøret, gastritis, duodenitis eller ulcus).
English: No data are available.
Danish: Der foreligger ingen data..
English: Adverse experiences such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some cases severe and requiring hospitalization, rarely with bleeding or followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates.
Danish: Bivirkninger, såsom øsofagitis, øsofageale sår og øsofageale erosioner, som i visse tilfælde har været alvorlige og hospitalskrævende, sjældent med blødning eller efterfulgt af øsofageal forsnævring eller perforation, er blevet rapporteret hos patienter, som har fået orale bisphosphonater.
English: Appropriate medical support and monitoring measures should be readily available when Iasibon intravenous injection is administered.
Danish: Passende nødhjælpsforanstaltninger skal være let tilgængelige, når intravenøs injektion med Iasibon administreres.
English: Iasibon tablets contain lactose and should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Danish: Iasibon-tabletter indeholder lactose og bør ikke administreres til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications.
Danish: Medens der i de kontrollerede kliniske studier ikke blev observeret en forøget risiko, har der været postmarketing rapporter om gastriske og duodenale sår, i visse tilfælde alvorlige og med komplikationer, i forbindelse med brug af orale bisphosphonater.
English: Elderly population (> 65 years) No dose adjustment is required (see section 5.2).
Danish: Ældre population (> 65 år) Dosisjustering er ikke nødvendig (se pkt.
English: Overdose
Danish: Overdosis
English: Clinical studies in the treatment of tumour-induced hypercalcaemia 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 behandling af tumorinduceret hyperkalcæmi Kliniske undersøgelser 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: Frequency categories are defined using the following convention: very common (>1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000),very rare
Danish: Frekvenserne er defineret på følgende måde: meget almindelig (> 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: • swollen legs or feet
Danish: • hævede ben eller fødder
English: • ear pain, discharge from the ear, and/or an ear infection.
Danish: • øresmerter, udflåd fra øret og/eller betændelse i øret.
English: • If you have heart problems and the doctor recommended to limit your daily fluid intake
Danish: • hvis De har problemer med nyrerne.• hvis du har problemer med hjerte, og din læge anbefaler, at du begrænser din daglige væskeindtagelse.
English: For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Danish: For patienter, hvor dentale indgreb er påkrævet, er der ingen tilgængelige data, der antyder, om afbrydelse af bisphosphonatbehandlingen reducerer risikoen for knoglenekrose i kæben.
English: ≥12 mg/dl) 4 mg is an adequate single dosage.
Danish: ≥ 12 mg/dl), vil 4 mg være passende som enkeltdosis.
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: hos raske postmenopausale kvinder) udgør 50-60 % af den totale clearance og er relateret til kreatininclearance.
English: Urinary concentrations of the bone resorption marker CTx (C-terminal telopeptide released from Type I collagen) were significantly reduced in the Ibandronate group compared to placebo.
Danish: Koncentrationen af urinmarkører for knogleresorption CTx (C-terminaltelopeptid frigjort fra Type I kollagen) blev signifikant reduceret i ibandronsyregruppen i forhold til placebo.
English: The medicine should be administered as an infusion in your vein over two hours.
Danish: Medicinen skal gives som infusion i en blodåre i løbet af 2 timer.
English: Iasibon contains lactose.
Danish: Iasibon indeholder lactose.
English: • itching or tingling skin around your mouth
Danish: • kløe eller prikken i huden omkring munden
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 i 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: • Stay upright (sitting or standing) position while taking your tablet and for the next hour (60 minutes).
Danish: • De skal indtage tabletten i oprejst stilling (siddende eller stående) og forblive oprejst i den næste time (60 minutter) efter, at De har taget Deres tablet.
English: • fluid in your lungs
Danish: • væske i lungerne
English: There was also a 38% reduction in the risk of developing an SRE for Ibandronate 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 for ibandronsyrebehandlede patienter i forhold til placebo (relativ risiko 0,62, p=0,003).
English: Talk to a nurse or doctor if any effects become troublesome or last more than a couple of days
Danish: Tal med sundhedspersonalet eller lægen, hvis en eller flere af bivirkningerne forværres eller varer mere end et par dage
English: This is because NSAIDs and Iasibon can both irritate your stomach and gut
Danish: Det er fordi NSAIDer og Iasibon begge kan irritere Deres mave-tarmkanal
English: Prior to treatment with Iasibon the patient should be adequately rehydrated with 9 mg/ml (0.9%) sodium chloride.
Danish: Forud for behandling med Iasibon, bør patienten være tilfredsstillende hydreret med 9 mg/ml (0,9 %) natriumchlorid.
English: For this purpose the contents of the vial are to be used as follows:
Danish: Til dette formål skal hætteglassenes indhold anvendes på følgende måde:
English: The content of the vial is to be used as follows:
Danish: Hætteglassets indhold skal bruges på følgende måde:
English: Take Iasibon at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements (e.g. products containing calcium (milk), aluminium, magnesium and iron) except water.
Danish: Indtag Iasibon mindst 6 timer efter, at du sidst har spist, drukket eller taget nogen form for anden medicin, vitaminer og mineraler eller kosttilskud (f.eks. produkter, der indeholder kalk (mælk), aluminium, magnesium og jern) andet end vand.
English: Caution is advised when bisphosphonates are administered with aminoglycosides, since both substances can lower serum calcium levels for prolonged periods.
Danish: Forsigtighed bør udvises, når bisfosfonater gives sammen med aminoglykosider, idet begge lægemidler kan bevirke nedsættelse af calciumniveauet i blodet i længere perioder.
English: PHARMACEUTICAL FORM Film-coated tablets.
Danish: 3 LÆGEMIDDELFORM Filmovertrukne tabletter.
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 Iasibonindtagelse.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister foil
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERFOLIE
English: Up to now there is no experience of acute poisoning with Iasibon concentrate for solution for infusion.
Danish: Indtil nu foreligger der ingen erfaringer med akut forgiftning med Iasibon koncentrat til infusionsvæske, opløsning.
English: Clinically relevant hypocalcaemia should be corrected by intravenous administration of calcium gluconate.
Danish: Klinisk relevant hypokalcæmi bør korrigeres ved administration af intravenøs calciumgluconat.
English: In a study in 130 patients with metastatic breast cancer the safety of Ibandronate infused over 1 hour or 15 minutes was compared.
Danish: I et klinisk stuide med 130 patienter med metastatisk brystkræft blev sikkerheden af ibandronsyre sammenlignet ved infusion over 1 time i forhold til infusion over 15 minutter.
English: Clinical studies have not shown any evidence of deterioration in renal function with long term Iasibon therapy.
Danish: Kliniske studier har ikke vist tegn på forringelse af nyrefunktionen ved længerevarende Iasibonbehandling.
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 De får injektioner af en type antibiotika der kaldes ”aminoglykosider” såsom gentamicin.
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: Det kliniske farmakologiske studie 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: This medicinal product does not require any special storage conditions prior to reconstitution.After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator)
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Lægemidlet kræver ingen særlige opbevaringsbetingelser inden rekonstitution.Efter fortynding er infusionsopløsningen stabil i 24 timer ved 2 °C - 8 °C (i køleskab)
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemidde samt affald heraf bør bortskaffes i henhold til lokale retningslinjer.
English: Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
Danish: Det bør overvejes at seponere bisphosphonat hos patienter med mistanke om atypisk femurfraktur, indtil der foreligger en evaluering af patienten, baseret på en individuel benefit/riskvurdering.
English: Patients with cardiac impairment Overhydration should be avoided in patients at risk of cardiac failure.
Danish: Patienter med nedsat hjertefunktion Overhydrering skal undgås ved patienter med risiko for hjerteinsufficiens.
English: Rare hereditary problems
Danish: Sjældne arvelige sygdomme
English: • The active substance is ibandronic acid.
Danish: • Aktivt stof: ibandronsyre.
English: For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Danish: For de patienter, der udvikler knoglenekrose i kæben, mens de er i behandling med bisphosphonater, kan tandkirurgi forværre tilstanden.
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: Treatment of tumour-induced hypercalcaemia
Danish: Behandling af tumorinduceret hyperkalcæmi
English: You may be having a serious, potentially life threatening allergic reaction
Danish: Du kan have fået en alvorlig allergisk reaktion, som kan være livstruende.
English: Therefore, Iasibon should not be used during pregnancy.
Danish: Iasibon bør ikke anvendes under graviditet.
English: Studies in lactating rats have demonstrated the presence of low levels of ibandronic acid in the milk following intravenous administration.
Danish: Studier med diende rotter har vist tilstedeværelse af små mængder ibandronsyre i mælken efter intravenøs administration.
English: Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Danish: En klinisk vurdering udført af den behandlende læge bør tilpasses behandlingsplanen for hver patient baseret på en individuel vurdering af fordele og ulemper.
English: If you stop taking Iasibon
Danish: Hvis De holder op med at tage Iasibon
English: Ibandronate 50 mg n=287
Danish: Ibandronsyre 50 mg n=287