FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment is necessary for patients with mild or moderate renal impairment (CLcr equal or greater than 30 ml/min), as shown in study BM 16549 where the majority of patients had mild to moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig for patienter med mild eller moderat nyrefunktionsnedsættelse (CLcr lig med eller over 30 ml/min) som vist i studie BM 16549, hvor de fleste patienter havde mild til moderat nyrefunktionsnedsættelse.
English: Efficacy results are summarised in Table 2.
Danish: Effektresultaterne fremgår af tabel 2.
English: In young (fast growing) rats, the endogenous bone resorption is also inhibited, leading to increased normal bone mass compared with untreated animals.
Danish: Den endogene knogleresorption er også hæmmet hos unge (hurtigvoksende) rotter, hvilket medfører en øget normal knoglemasse sammenlignet med ubehandlede dyr.
English: The risk of severe oesophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of oesophageal irritation.
Danish: Risikoen for alvorlige bivirkninger i spiserøret synes at være større hos patienter, som ikke efterlever doseringsvejledningen og/eller forsætter behandling med orale bisphosphonater efter udvikling af symptomer, der tyder på øsofageal irritation.
English: Ibandronic acid 2.5 mg administered daily, showed a statistically significant and medically relevant reduction in the incidence of new vertebral fractures.
Danish: Ibandronsyre 2,5 mg administreret dagligt resulterede i en statistisk signifikant og medicinsk relevant reduktion i forekomsten af nye vertebrale frakturer.
English: As renal function decreases with age, this is the only factor to take into consideration (see renal impairment section).
Danish: Da nyrefunktionen falder med alderen, er dette den eneste faktor, som bør overvejes (se afsnittet vedrørende nedsat nyrefunktion).
English: Urinary concentrations of the bone resorption marker CTx (C-terminal telopeptide released from Type I collagen) were significantly reduced in the ibandronic acid group compared to placebo.
Danish: Koncentrationen af urinmarkører for knogleresorption CTx (C-terminaltelopeptid frigjort fra Type I kollagen) blev signifikant reduceret i ibandronsyre-gruppen i forhold til placebo.
English: (≥ 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: • Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Danish: • tal med din læge, hvis du har ørepine, udflåd fra øret og/eller øreinfektion.
English: Acetylsalicylic acid and NSAIDs
Danish: Acetylsalisylsyre og andre NSAIDs
English: Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1).
Danish: Behandling af osteoporose hos postmenopausale kvinder med øget risiko for frakturer (se pkt.
English: The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration and plasma concentrations increase in a dose-proportional manner up to 50 mg oral intake, with greater than dose-proportional increases seen above this dose.
Danish: Absorptionen af ibandronsyre i den øvre mave-tarmkanal er hurtig efter oral administration, og plasmakoncentrationen øges dosisafhængigt op til 50 mg oral indtagelse, mens der ses større end dosis-proportionale stigninger over denne dosis.
English: In some cases, these events did not resolve until the ibandronic acid was discontinued.
Danish: I nogle tilfælde ophørte disse hændelser ikke, før ibandronsyre blev seponeret.
English: In a Phase 1 bioequivalence study conducted in 72 postmenopausal women receiving 150 mg orally every 28 days for a total of four doses, inhibition in serum CTX following the first dose was seen as early as 24 hours post-dose (median inhibition 28 %), with median maximal inhibition (69 %) seen 6 days later.
Danish: I et fase I bioækvivalens-studie hos 72 postmenopausale kvinder, som fik 150 mg oralt hver 28. dag, i i alt 4 doser, blev der set hæmning af serum-CTX efter første dosis allerede 24 timer efter indtagelsen (median hæmning 28 %) med median maksimal hæmning (69 %) 6 dage senere.
English: The histological analysis of bone biopsies after two and three years of treatment of postmenopausal women showed bone of normal quality and no indication of a mineralization defect.
Danish: Efter 2 og 3 års behandling af postmenopausale kvinder, viste histologiske analyser af knoglebiopsier, knogler af normal kvalitet og ingen tegn på mineraliseringsdefekter.
English: Therefore dosage adjustment is not necessary in patients with hepatic impairment.
Danish: Dosisjustering er derfor ikke nødvendig hos patienter med nedsat leverfunktion.
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: Patients with a previous history of gastrointestinal disease including patients with peptic ulcer without recent bleeding or hospitalisation, and patients with dyspepsia or reflux controlled by medication were included in the once monthly treatment study.
Danish: Patienter med tidligere forekomst af gastrointestinale sygdomme, inklusive patienter med mavesår uden nylig blødning eller indlæggelse, og patienter med dyspepsi eller medicinsk behandlet refluks, var inkluderet i studiet, med behandling én gang om måneden.
English: Crospovidone (type A) Silica colloidal anhydrous Stearic acid
Danish: Crospovidon (type A) Silica kolloid vandfri Stearinsyre
English: Animal models confirm that ibandronic acid is a highly potent inhibitor of osteoclastic activity.
Danish: Dyremodeller bekræfter, at ibandronsyre er en højpotent hæmmer af osteoklastaktiviteten.
English: As renal function decreases with age this is the only factor to take into consideration (see renal impairment section).
Danish: Da nyrefunktionen falder med alderen, er dette den eneste faktor som bør overvejes (se afsnittet vedrørende nedsat nyrefunktion).
English: If there is concern regarding potentially high levels of calcium in the tap water (hard water), it is advised to use bottled water with a low mineral content.
Danish: Hvis der er usikkerhed omkring potentielt høje calciumkoncentrationer i postevandet (hårdt vand), anbefales det at bruge vand på flaske med et lavt mineralindhold.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf skal destrueres i henhold til lokale retningslinjer.
English: Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Ibandronic Acid Teva tablets.
Danish: Medicin og kosttilskud (herunder calcium) skal ligeledes undgås inden indtagelse af Ibandronsyre Teva-tabletter.
English: - Swallow your tablet with a full glass of water (at least 180 ml).
Danish: • Synk tabletten med et helt glas vand (mindst 180 ml).
English: Ibandronic Acid Teva works by reducing the amount of calcium that is lost from your bones.
Danish: Ibandronsyre Teva virker ved at nedsætte den mængde calcium, som mistes fra knoglerne.
English: After 5 years of using Ibandronic Acid Teva, please consult with your doctor whether you should continue to take Ibandronic Acid Teva.
Danish: Når du har anvendt Ibandronsyre Teva i 5 år, skal du spørge din læge, om du fortsat skal anvende Ibandronsyre Teva.
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 Teva.
Danish: I overensstemmelse med individuel klinisk vurdering anbefales det dog alligevel at kontrollere nyrefunktionen, serum-calcium, phosphat og magnesium hos patienter i Ibandronsyre Teva-behandling.
English: If you take more Ibandronic Acid Teva than you should If you've taken more than one tablet by mistake, drink a full glass of milk and talk to your doctor straight away.
Danish: Hvis du har taget for mange Ibandronsyre Teva filmovertrukne tabletter Hvis du ved en fejl har indtaget mere end én tablet, skal du drikke et helt glas mælk og straks kontakte lægen.
English: Ibandronic Acid Teva is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called bone “metastases”).
Danish: Ibandronsyre Teva bruges til voksne og bliver ordineret til dig, hvis du har brystkræft, som har spredt sig til dine knogler (kaldet knoglemetastaser).
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: Asthma exacerbation
Danish: Astma eksacerbation
English: The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other active substances.
Danish: Eliminationsvejen ser ikke ud til at omfatte kendte syre- eller basetransport-systemer, som anvendes i forbindelse med udskillelsen af andre aktive substanser.
English: Anaphylactic reaction/shock
Danish: Anafylaktisk reaktion/shock
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: 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 ibandronic acid 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 ibandronsyre) samt bivirkninger set efter markedsføring.
English: • severe pain in the chest, severe pain after swallowing food or drink, severe nausea, or vomiting, difficulty in swallowing.
Danish: • stærke brystsmerter, stærk smerte efter at have sunket mad eller drikke, voldsom kvalme eller opkastning, synkebevær.
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 producerede ibandronsyre 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: This is because aminoglycosides and Ibandronic Acid Teva can both lower the amount of calcium in your blood.
Danish: Aminoglykosider og Ibandronsyre Teva kan begge nedsætte mængden af calcium i dit blod.
English: In humans, the apparent terminal volume of distribution is at least 90 l and the amount of dose reaching the bone is estimated to be 40-50% of the circulating dose.
Danish: Hos mennesker er det tilsyneladende terminale fordelingsvolumen mindst 90 liter, og det estimeres, at 40-50 % af den cirkulerende dosis bindes til knoglerne.
English: Prevention of skeletal events in patients with breast cancer and bone metastases with ibandronic acid 50 mg tablets was assessed in two randomized placebo controlled phase III trials with a duration of 96 weeks.
Danish: Forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser med ibandronsyre 50 mg tabletter, blev vurderet i to randomiserede, placebokontrollerede, fase III-studier, som varede i 96 uger.
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 post-marketingrapporter om gastriske og duodenale sår i forbindelse med brug af orale bisphosphonat, i visse tilfælde alvorlige og med komplikationer.
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/risk-vurdering.
English: Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause.
Danish: Osteoporose er en udtynding og svækkelse af knoglerne, som ofte ses hos kvinder efter menopausen (overgangsalderen).
English: Influenza-like illness
Danish: Influenzalignende sygdom
English: • new pain, weakness or discomfort in your thigh, hip or groin.
Danish: • ny smerte, svækkelse eller ubehag i dine lår, hofte eller lyske.
English: Maximum observed plasma concentrations were reached within 0.5 to 2 hours (median 1 hour) in the fasted state and absolute bioavailability was about 0.6%.
Danish: Maksimal plasmakoncentration blev opnået i løbet af 0,5 til 2 timer (median 1 time) i fastetilstand, og den absolutte biotilgængelighed var ca. 0,6 %.
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 Ibandronic Acid Teva.
Danish: Irritation, betændelse eller sår i spiserøret/mavesækken ofte med symptomer, såsom stærke brystsmerter, stærke smerter efter at havt slugt mad og/eller drikke, kraftig kvalme eller opkastning kan forekomme, specielt hvis du ikke drikker et helt glas almindeligt vand og/eller du lægger dig ned inden for en time, efter du har taget Ibandronsyre Teva.
English: However, since this increase is within the normal variability of the bioavailability of ibandronic acid, no dose adjustment is considered necessary when Ibandronic Acid Teva is administered with H2-antagonists or other active substances which increase gastric pH.
Danish: Da øgningen ligger inden for den normale variabilitet for biotilgængeligheden af ibandronsyre, anses dosisjustering ikke for nødvendig, når Ibandronsyre Teva administreres sammen med H2-antagonister eller andre aktive substanser, som øger gastrisk pH.
English: Talk to your doctor or pharmacist before taking Ibandronic Acid Teva: - if you are allergic to any other bisphosphonates - if you have any swallowing or digestion problems - if you have high or low blood levels of vitamin D or any other minerals - if you have kidney problems.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Ibandronsyre Teva: - hvis du er allergisk over for andre bisphosphonater - hvis du har synkebesvær eller fordøjelsesbesvær - hvis du har forhøjet eller nedsat indhold af vitamin D eller andre mineraler i blodet - hvis du har problemer med nyrerne.
English: Ibandronic Acid Teva is less effective if it's taken with food.
Danish: Ibandronsyre Teva er mindre effektivt, når det indtages sammen med mad.
English: Early plasma levels fall quickly reaching 10 % of peak values within 3 and 8 hours after intravenous or oral administration respectively.
Danish: De tidlige plasmaværdier falder hurtigt, og når 10 % af peakværdien inden for 3 og 8 timer efter henholdsvis intravenøs og oral administration.
English: - Patients should not chew , suck or crush the tablet because of a potential for oropharyngeal ulceration.
Danish: - Patienterne må ikke tygge, sutte eller knuse tabletterne på grund af risiko for orofaryngeal ulceration.
English: Ibandronic Acid Teva 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: Ibandronsyre Teva er indiceret til voksne til forebyggelse af knoglerelaterede hændelser (patologiske frakturer, knoglekomplikationer, som kræver strålebehandling eller operation) hos patienter med brystkræft og knoglemetastaser.
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 Teva.
Danish: Alle patienter bør opfordres til at opretholde en god mundhygiejne, gennemgå rutinemæssige tandundersøgelser og straks rapportere eventuelle symptomer, såsom løse tænder, smerter eller hævelser samt sår der væsker og/eller ikke heler under behandling med Ibandronsyre Teva.
English: Both bioavailability and BMD gains are reduced when food or beverage is taken less than 60 minutes after ibandronic acid is ingested.
Danish: Både biotilgængelighed og BMD-stigninger reduceres, når føde eller drikkevarer indtages mindre end 60 minutter efter indtagelse af ibandronsyre.
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 45Ca kinetikstudier og ved frigivelse af radioaktivt tetracyklin,
English: Water may be taken at any time during the course of Ibandronic Acid Teva treatment (see section 4.5).
Danish: Vand kan indtages på ethvert tidspunkt under Ibandronsyre Teva-behandlingen (se pkt.
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: Gender Bioavailability and pharmacokinetics of ibandronic acid are similar in men and women.
Danish: Biotilgængeligheden og farmakokinetikken for ibandronsyre er ens hos mænd og kvinder.
English: Due to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Danish: På grund af risikoen for oesophageal irritation, bør opkastning ikke induceres, og patienten bør forblive i oprejst stilling.
English: - If you forgot to take your tablet on your chosen day and your next scheduled dose is only 1 to 7 days away…
Danish: • Hvis du har glemt at tage din tablet på din planlagte dag og din næste planlagte dosis skal tages efter kun 1 til 7 dage.
English: Common Uncommon Rare
Danish: Ikke almindelig Sjælden
English: Do not take Ibandronic Acid Teva if you are pregnant, planning to get pregnant or if you are breast-feeding.
Danish: Du må ikke tage Ibandronsyre Teva, hvis du er gravid eller planlægger at blive gravid, eller hvis du ammer.
English: Ibandronic acid was taken 60 minutes before the first food or drink of the day (post-dose fasting period).
Danish: Ibandronsyre blev indtaget 60 minutter før første indtagelse af mad eller drikkevarer (post-dosis fasteperiode).
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 ikke-kliniske studier blev der kun set virkninger efter eksponeringer, der i væsentlig grad overstiger den maksimale humane eksponering.
English: No indication of carcinogenic potential was observed.
Danish: Der fandtes ingen tegn på carcinogenicitet.
English: Hypersensitivity reaction
Danish: Overfølsomhedsreaktioner
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 nitrogenholdige bisphosphonater, som virker selektivt på knoglevæv og specifikt hæmmer osteoklastaktiviteten uden direkte påvirkning af knogleopbygningen.
English: Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Danish: Der er rapporteret om tilfælde af anafylaktisk reaktion/shock, inklusive dødelige tilfælde, hos patienter behandlet med intravenøs ibandronsyre.
English: The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.
Danish: Muligheden for knoglenekrose i den ydre øregang bør overvejes hos patienter, der er i behandling med bisphosphonat, og som fremstår med øresymptomer, herunder kroniske øreinfektioner.
English: Do not take Ibandronic Acid Teva with food or any other drinks except water as Ibandronic Acid Teva is less effective if it is taken with food or drink (see section 3).
Danish: Brug af Ibandronsyre Teva sammen med mad og drikke Tag ikke Ibandronsyre Teva sammen med mad eller andre drikkevarer end vand, da Ibandronsyre Teva virker mindre effektivt, hvis det tages sammen med mad og drikke (se punkt 3).
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 en sygeplejerske eller en læge, hvis du oplever nogle af følgende alvorlige bivirkninger - du kan have brug for akut lægehjælp.
English: • persistent eye pain and inflammation
Danish: • vedvarende smerte og betændelse i øjet
English: Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Ibandronic Acid Teva 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 Ibandronsyre Teva gives til patienter med aktive øvre gastrointestinale problemer (f.eks. diagnosticeret Barretts øsofagitis, dysfagi, andre sygdomme i spiserøret, gastritis, duodenitis eller ulcus).
English: Oral bioavailability of ibandronic acid is generally reduced in the presence of food.
Danish: Den orale biotilgængelighed for ibandronat er generelt nedsat ved tilstedeværelse af føde.
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: - Patients should not chew or suck the tablet, because of a potential for oropharyngeal ulceration.
Danish: Patienten må ikke tygge eller sutte tabletterne på grund af risiko for oropharyngeal ulceration.