FrancophonIA/ELRC3.0 huggingface dataset:
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Ibandronic Acid Teva on an individual patient basis, particularly after 5 or more years of use.
Danish: Behovet for fortsat behandling skal revurderes regelmæssigt, baseret på fordele og mulige risici af Ibandronsyre Teva for den enkelte patient, især efter anvendelse i 5 år eller mere.
English: The difference between the apparent total and renal clearances is considered to reflect the uptake by bone.
Danish: Forskellen mellem den tilsyneladende totale og renale clearance afspejler formentlig optagelsen i knoglerne.
English: The anti-fracture effect was consistent over the duration of the study.
Danish: Antifraktureffekten var konsistent gennem hele undersøgelsen.
English: The incidence of clinical vertebral fractures was also significantly reduced by 49 % (p=0.011).
Danish: Hyppigheden af kliniske vertebrale frakturer blev desuden signifikant reduceret med 49 % (p=0,011).
English: H2-antagonists or other medicinal products that increase gastric pH.
Danish: H2-antagonister og andre lægemidler, der øger gastrisk pH.
English: Total clearance of ibandronic acid is low with average values in the range 84-160 ml/min.
Danish: Den totale clearance af ibandronsyre er lav med middelværdier i området 84-160 ml/min.
English: This helps to stop your bones from getting weaker.
Danish: Det modvirker, at dine knogler bliver svagere.
English: The primary pharmacological effects of ibandronic acid on bone are not directly related to actual plasma concentrations, as demonstrated by various studies in animals and humans.
Danish: Den primære farmakologiske effekt af ibandronsyre på knogler er ikke direkte relateret til de aktuelle plasmakoncentrationer, hvilket er påvist i flere studier på dyr og mennesker.
English: These symptoms are typically in association with the first dose, generally of short duration, mild or moderate in intensity, and usually resolve during continuing treatment without requiring remedial measures (see paragraph “Influenza like illness”).
Danish: Disse symptomer ses typisk i forbindelse med den første dosis, er almindeligvis kortvarige, er af let eller moderat intensitet og forsvinder normalt under fortsat behandling uden afhjælpende foranstaltninger (se afsnittet ”Influenzalignende sygdom”).
English: Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa.
Danish: Oralt administrerede bisphosphonater kan forårsage lokal irritation af den øvre gastrointestinale slimhinde.
English: Atypical fractures of the femur
Danish: Atypiske frakturer på femur
English: As with other bisphosphonates, the kidney was identified to be the primary target organ of systemic toxicity.
Danish: Som for andre bisphosphonater, blev nyrerne identificeret som det primære målorgan for den systemiske toksicitet.
English: The most frequently reported adverse reactions are arthralgia and influenza-like symptoms.
Danish: De hyppigst indberettede bivirkninger er artralgi og influenzalignende symptomer.
English: This regimen reduced the occurrence of new radiographic vertebral fractures by 62 % (p=0.0001) over the three year duration of the study.
Danish: Dette regimen reducerede forekomsten af nye røntgenverificerede vertebrale frakturer med 62 % (p=0,0001) gennem den 3-årige undersøgelsesperiode.
English: If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled.
Danish: Hvis næste planlagte dosis skal tages inden 7 dage, skal patienterne vente, indtil de skal tage næste planlagte dosis og derefter fortsætte med at tage en tablet om måneden som oprindeligt planlagt.
English: Total hip BMD
Danish: Total hofte BMD
English: • Swallow the tablet whole.
Danish: • Synk tablettten hel.
English: Treatment was most frequently associated with a decrease in serum calcium to below normal range (hypocalcaemia), followed by dyspepsia.
Danish: Behandlingen var hyppigst forbundet med et fald i serum-calcium til under normalområdet (hypokalcæmi), derefter kom dyspepsi.
English: Pharmacokinetics in special populations
Danish: Farmakokinetik hos særlige populationer
English: These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture.
Danish: Disse frakturer forekommer efter minimalt eller intet traume, men nogle patienter får lår- eller lyskesmerter, ofte med tilhørende billedmæssige karakteristika af stressfrakturer, uger til måneder før den komplette femurfraktur viser sig.
English: Fasting should be continued for at least 30 minutes after taking the tablet.
Danish: Fasten skal fortsættes mindst 30 minutter efter tabletindtagelsen.
English: As the values calculated are largely a function of the duration of study, the dose used, and assay sensitivity, the true terminal half-life is likely to be substantially longer, in common with other bisphosphonates.
Danish: Da de beregnede værdier for det meste er en funktion af studiets varighed, den anvendte dosis og analysens følsomhed, er den sande terminale halveringstid sandsynligvis væsentlig højere ligesom hos andre bisphosphonater.
English: • if you cannot stand or sit upright for at least one hour (60 minutes) at a time
Danish: • hvis du ikke kan stå eller sidde oprejst i mindst én time (60 minutter) ad gangen
English: The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration.
Danish: Absorptionen af ibandronsyre i den øvre gastrointestinalkanal er hurtig efter oral administration.
English: SRE relative risk p=0.003
Danish: SRE relativ risiko p=0,003
English: The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Danish: Start af behandling eller opstart af et nyt behandlingsforløb bør udskydes hos patienter der har uhelede, åbne og sår i mundens bløde væv.
English: Once monthly tablet.
Danish: Én tablet om måneden.
English: Biochemical markers of bone turnover (such as urinary CTX and serum Osteocalcin) showed the expected pattern of suppression to premenopausal levels and reached maximum suppression within a period of 3-6 months.
Danish: Biokemiske markører for knogleomsætning (som f.eks. urin CTX og serum osteocalcin) viste det forventede suppressionsmønster til præmenopausale værdier og maksimal suppression opnåedes indenfor 3-6 måneder.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Ibandronic Acid Teva may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they will not be able to see or feel a difference.
Danish: Ibandronsyre Teva kan ophæve knogletab ved at forhindre yderligere tab af knoglevæv og ved at øge knoglemassen hos de fleste kvinder, som tager det, selvom de ikke vil kunne se eller føle en forskel.
English: The extent of absorption is impaired when taken together with food or beverages (other than water).
Danish: Absorptionen nedsættes ved samtidig indtagelse af føde eller drikkevarer (andet end vand).
English: 2031 GA Haarlem The Netherlands
Danish: 2031 GA Haarlem Holland
English: - Swallow your tablet whole, - do not chew it, crush it or let it dissolve in your mouth.
Danish: • Synk tabletten hel - lad være med at tygge den, knuse den eller opløse den i munden.
English: A tabular summary of the secondary efficacy results is presented in Table 3.
Danish: En oversigt over de sekundære effektresultater fremgår af tabel 3.
English: • if you have or ever had low calcium in your blood.
Danish: • hvis du har, eller har haft, et lavt indhold af kalk i blodet.
English: With no further dosing, there is a loss of suppression of biochemical markers of bone resorption.
Danish: Efter ingen yderligere behandling er der et tab af suppression af de biokemiske markører for knogleresorption.
English: Marketing Authorisation Holder: Teva B.V.
Danish: Indehaver af markedsføringstilladelsen: Teva B.V.
English: - After you've waited for an hour, you can have your first food and drink of the day.
Danish: • Efter du har ventet én time, kan du indtage dagens første måltid eller drikkevarer.
English: In growing rats, there was no evidence of impaired mineralization even at doses greater than 5,000 times the dose required for osteoporosis treatment.
Danish: I studier med rotter i vækst fandtes der ikke tegn på nedsat mineralisering, selv ved doser som var 5.000 gange højere end dosis til osteoporosebehandling.
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: Femoral neck BMD 1.7 [1.3, 2.1] Trochanter BMD
Danish: Lårbenshals BMD 1,7 [1,3, 2,1]
English: Most cases did not lead to cessation of therapy.
Danish: I de fleste tilfælde medførte bivirkningerne ikke ophør af behandlingen.
English: After initial systemic exposure, ibandronic acid rapidly binds to bone or is excreted into urine.
Danish: Efter initial systemisk eksponering bindes ibandronsyre hurtigt til knogler eller udskilles med urinen.
English: In the overall patient population of the study MF 4411, no reduction was observed for non-vertebral fractures, however daily ibandronic acid appeared to be effective in a high-risk subpopulation (femoral neck BMD T-score < -3.0), where a non-vertebral fracture risk reduction of 69 % was observed.
Danish: I den samlede patientpopulation i studie MF 4411 sås ingen reduktion af non-vertebrale frakturer, selvom dagligt indtag af ibandronsyre tilsyneladende havde effekt i en højrisikoundergruppe (lårbenshalsen BMD T-score < -3,0), hvor en risikoreduktion på 69 % blev observeret.
English: At doses that were considerably higher than the pharmacologically effective doses, ibandronic acid did not have any effect on bone mineralisation.
Danish: Ved doser som var betydeligt større end de farmakologisk effektive doser, havde ibandronsyre ingen effekt på mineraliseringen af knoglerne.
English: Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Danish: Mulige risikofaktorer for knoglenekrose e i den ydre øregang omfatter brug af steroider og kemoterapi og/eller lokale risikofaktorer såsom infektion eller traumer.
English: 3 film-coated tablets pack Month 1
Danish: 3 filmovertruke tabletpakninger Måned 1
English: Method of administration For oral use.
Danish: Indgivelsesmåde: Til oral anvendelse.
English: Table 1 Adverse Drug Reactions Reported for Oral Administration of Ibandronic Acid
Danish: Tabel 1 Bivirkninger rapporteret for oral administration af ibandronsyre
English: Patients should pay particular attention to and be able to comply with the dosing instructions (see section 4.2).
Danish: Patienter skal være særligt opmærksomme på og være i stand til at følge doseringsvejledningen (se pkt.
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 bisphosphonater administreres sammen med aminoglycosider, idet begge lægemidler kan bevirke nedsættelse af calciumniveauerne i længere perioder.
English: - a type of antibiotic injection called “aminoglycoside” such as gentamicin.
Danish: • injektioner af en type antibiotika, der kaldes ”aminoglykosider” såsom gentamicin.
English: Once you've eaten, it's OK to lie down if you wish, and to take any other medication you need.
Danish: Efter du har spist, er det i orden at ligge ned eller indtage anden medicin.
English: Do not take your tablet with water with a high concentration of calcium, fruit juice or any other drinks.
Danish: Indtag ikke tabletten sammen med vand med et højt kalkindhold, frugtjuice eller andre drikkevarer end vand.
English: After intravenous administration of 0.5 mg, total, renal, and non-renal clearances decreased by 67 %, 77 % and 50 %, respectively, in subjects with severe renal failure but there was no reduction in tolerability associated with the increase in exposure.
Danish: Efter intravenøs administration af 0,5 mg faldt den totale, renale og ikke-renale clearance hos patienter med svær nyrefunktionsnedsættelse med henholdsvis 67 %, 77 % og 50 %, men der fandtes ikke nedsat tolerabilitet i forbindelse med den øgede eksponering.
English: Following the third and fourth dose, the median maximum inhibition 6 days post dose was 74 % with reduction to a median inhibition of 56 % seen 28 days following the fourth dose.
Danish: Efter tredje og fjerde dosis var den mediane maksimale hæmning 6 dage efter indtagelsen 74 % med et fald til en median hæmning på 56 % 28 dage efter indtagelsen af fjerde dosis.
English: Paraesthesia, dysgeusia (taste perversion)
Danish: Paræstesi, dysgeusi (smagsforstyrrelser)
English: Reproductive toxicity:
Danish: Reproduktionstoksicitet:
English: Bisphosphonates act by inhibiting osteoclast activity, although the precise mechanism is still not clear.
Danish: Bisphosphonater virker ved at hæmme osteoklast-aktiviteten, men virkningsmekanismen er endnu ikke fuldt ud klarlagt.
English: Month 2
Danish: Måned 2
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Ibandronic Acid Teva in patients with concomitant risk factors.
Danish: En tandundersøgelse med forebyggende tandlægearbejde samt en individuel risikovurdering, anbefales før behandling med Ibandronsyre Teva hos patienter med samtidige risikofaktorer.
English: (see sections 5.1 and 5.2).
Danish: 5.1 og 5.2).
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: 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 væsentlig øgning af frie plasmakoncentrationer.
English: Do not make yourself vomit, and do not lie down - this could cause Ibandronic Acid Teva to irritate your oesophagus.
Danish: Fremkald ikke opkastning, og læg dig ikke ned - dette kan medføre, at Ibandronsyre Teva irriterer spiserøret.
English: The treatment effect of ibandronic acid was further assessed in an analysis of the subpopulation of patients who at baseline had a lumbar spine BMD T-score below -2.5.
Danish: Effekten af behandlingen med ibandronsyre blev yderligere vurderet i en analyse af subpopulationen af patienter, som ved baseline havde en lumbal columna BMD T-score under -2,5.
English: In this study, ibandronic acid was evaluated at oral doses of 2.5 mg daily and 20 mg intermittently as an exploratory regimen.
Danish: I denne undersøgelse blev ibandronsyre undersøgt ved doser på 2,5 mg daglig og 20 mg intermitterende som et eksploratorisk regime.
English: Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (277 patients) or 50 mg ibandronic acid (287 patients).
Danish: Kvindelige patienter med brystkræft og radiologisk verificerede knoglemetastaser blev randomiseret til placebo (277 patienter) eller 50 mg ibandronsyre (287 patienter).
English: • dry mouth, strange taste in your mouth or difficulty swallowing
Danish: • mundtørhed, mærkelig smag i munden eller synkebesvær
English: There was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats at an extrapolated exposure of at least 35 times above human exposure.
Danish: Der fandtes ikke tegn på direkte føtal toksisk eller teratogen effekt af ibandronsyre hos oralt behandlede rotter og kaniner, og der var ikke uønskede hændelser på F1-afkommet hos rotter ved en ekstrapoleret eksponering, som var mindst 35 gange over den humane eksponering.
English: At the menopause, a woman's ovaries stop producing the female hormone, oestrogen, which helps to keep her skeleton healthy.
Danish: I forbindelse med menopausen ophører kvinders æggestokke med at producere det kvindelige hormon, østrogen, som hjælper med at vedligeholde knoglerne.
English: In table 1 a complete list of known adverse reactions is presented.
Danish: Tabel 1 viser en komplet lsite over kendte bivirkninger.
English: This reduction in urinary CTx levels was significantly correlated with the primary efficacy endpoint SMPR (Kendall-tau-b (p<0.001)).
Danish: Reduktionen i urin CTx niveauet var signifikant korreleret med det primære endepunkt SMPR (Kendall-tau-b, (p<0,001)).
English: In humans, the efficacy of both daily and intermittent administration with a dose-free interval of 9-10 weeks of ibandronic acid was confirmed in a clinical trial (MF 4411), in which ibandronic acid demonstrated anti-fracture efficacy.
Danish: Hos mennesker blev effekten af både daglig og intermitterende administration med et dosisfri interval på 9-10 uger af ibandronsyre bekræftet i et klinisk studie (MF 4411), hvori ibandronsyre viste antifraktur-effekt.
English: Ibandronic Acid Teva therapy should only be initiated by physicians experienced in the treatment of cancer.
Danish: Behandling med Ibandronsyre Teva bør kun initieres af læger med erfaring med behandling af cancer.
English: ** Median change from baseline to last assessment
Danish: * Middelændring fra baseline til sidste evaluering ** Median ændring fra baseline til sidste evaluering
English: Studies in lactating rats have demonstrated the presence of low levels of ibandronic acid in the milk following intravenous administration.
Danish: Studier med diegivende rotter har vist tilstedeværelse af små mængder ibandronsyre i mælken efter intravenøs administration.
English: The pharmacokinetics of ibandronic acid in these patients is unknown, and ibandronic acid should not be used under these circumstances.
Danish: Farmakokinetikken for ibandronsyre er ukendt for disse patienter, og ibandronsyre bør ikke anvendes under disse omstændigheder.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}
English: Decreased renal calcium excretion may be accompanied by a fall in serum phosphate levels not requiring therapeutic measures.
Danish: Nedsat renal calcium-udskillelse kan efterfølges af et fald i serum-phosphat, men dette kræver ikke terapeutiske forholdsregler.
English: Three-year lumbar spine BMD increase compared to placebo was 5.3 % and 6.5 % compared to baseline.
Danish: Der fandtes efter 3 år en lumbal BMD-stigning på 5,3 % i forhold til placebo og på 6,5 % i forhold til baseline.
English: UAB "Sicor Biotech" filiāle Latvijā
Danish: Eesti UAB "Sicor Biotech" Eesti filiaal
English: - The tablets should be swallowed whole with a full glass of water (180 to 240 ml) while the patient is standing or sitting in an upright position.
Danish: - Tabletterne skal synkes hele med et helt glas vand (180 til 240 ml), mens patienten står op eller sidder i oprejst stilling.
English: Increases at the hip compared to baseline were 2.8 % at the femoral neck, 3.4 % at the total hip, and 5.5 % at the trochanter.
Danish: Stigningen i BMD i hoften i forhold til baseline var 2,8 % i lårbenshalsen, 3,4 % i hele hoften og 5,5 % i trochanter.
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 nogle af symptomerne bliver generende eller varer mere end et par dage
English: It's important to keep taking Ibandronic Acid Teva every month, as long as your doctor prescribes it for you.
Danish: Det er vigtigt, at du anvender Ibandronsyre Teva hver måned, så længe lægen ordinerer det.
English: The strong effect on vertebral fractures was furthermore reflected by a statistically significant reduction of height loss compared to placebo (p<0.0001).
Danish: Den udtalte effekt på vertebrale frakturer viste sig desuden ved en statistisk signifikant reduktion i højdetab sammenlignet med placebo (p<0,0001).
English: The deterioration in Quality of Life and WHO performance status was significantly less in ibandronic acid treated patients compared with placebo.
Danish: Forringelsen i livskvalitet og WHO-performance status var signifikant mindre for ibandronsyre-behandlede patienter i forhold til placebo.
English: Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation.
Danish: Ibandronsyre elimineres udelukkende ved renal ekskretion og gennemgår ikke biotransformation.
English: H2 blockers or proton pump inhibitors
Danish: H2-antagonister eller protonpumpehæmmere
English: Aminoglycosides
Danish: Aminoglykosider
English: While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Danish: Mens du er i behandling bør du opretholde en god mundhygiejne (herunder regelmæssig tandbørstning) og få foretaget rutinemæssig tandeftersyn.
English: There was also a 38% reduction in the risk of developing an SRE for ibandronic acid 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 ibandronsyre i forhold til placebo (relativ risiko 0,62, p=0,003).
English: They are designed to help your Ibandronic Acid Teva tablet reach your stomach quickly, so it's less likely to cause irritation.
Danish: De er lavet med henblik på, at Ibandronsyre Tevatabletten hurtigt når frem til maven, så der er mindst mulig sandsynlighed for at forårsage irritation.
English: The pain reduction was consistently below baseline throughout the entire study and accompanied by a significantly reduced use of analgesics compared to placebo.
Danish: Smertereduktionen var permanent under baseline gennem hele undersøgelsen og blev ledsaget af et signifikant reduceret forbrug af analgetika.
English: The range of observed apparent half-lives is broad and dependent on dose and assay sensitivity, but the apparent terminal half-life is generally in the range of 10-60 hours.
Danish: Måleområdet for de tilsyneladende halveringstider er bredt og afhænger af dosis og målefølsomhed, men den tilsyneladende terminale halveringstid er generelt i området 10-60 timer.
English: In the initial three-year, randomised, double-blind, placebo-controlled, fracture study (MF 4411), a statistically significant and medically relevant decrease in the incidence of new radiographic morphometric and clinical vertebral fractures was demonstrated (table 3).
Danish: I det første treårs randomiserede, dobbeltblinde, placebokontrollerede frakturstudie (MF 4411) påvistes et statistisk signifikant og medicinsk relevant fald i hyppigheden af nye røntgenmorfometriske og kliniske vertebrale frakturer (tabel 3).
English: The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at lumbar spine of 2 to 5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
Danish: Undersøgelsen omfattede kvinder i alderen 55 til 80 år, som var mindst 5 år postmenopausale, havde et BMD på 2 til 5 SD under den præmenopausale middelværdi (T-score) i mindst én ryghvirvel [L1-L4], og som havde haft 1-4 tidligere vertebrale frakturer.