FrancophonIA/ELRC3.0 huggingface dataset:
English: These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Danish: Disse transverse eller korte, skrå frakturer kan forekomme et hvilket som helst sted langs lårbenet fra lige under trochanter minor til lige over den suprakondulære brede del af lårbenet.
English: Π.T.Χατζηγεωργίου εταιρεία Ltd CY-3042 Λεμεσός, Γιλντίζ 31 Τηλ: 00357 25372425
Danish: Π.T.Χατζηγεeωργίου εταιρεία Ltd CY-3042 Λεμεσός, Γιλντίζ 31 Τηλ: 00357 25372425
English: Ask your doctor or pharmacist for advice before taking this medicine.
Danish: Spørg din læge eller apotekspersonalet til råds, før du tager denne medicin.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 July 2011
Danish: Dato for første markedsføringstilladelse: 26. juli 2011
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 glas postevand (180 til 240 ml), med patienten i siddende eller oprejst stilling.
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, Bisphosphonates, ATC Code: M05BA06.
Danish: Farmakoterapeutisk klassifikation: Lægemidler til behandling af knoglesygdomme, bifosfonat, ATC-kode: M05BA06.
English: The serum calcium level may fall to hypocalcaemic values.
Danish: Serum-calcium kan falde til hypokalkæmiske værdier.
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 sår i mundens bløde væv.
English: This includes any possible side effects not listed in this leaflet.
Danish: Det omfatter evt. bivirkninger, som ikke er nævnt her.
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 orofaryngal ulceration.
English: Do not take Ibandronic acid Sandoz if you are pregnant, planning to get pregnant or if you are breastfeeding.
Danish: Tag ikke Ibandronsyre Sandoz, hvis du er gravid, har planer om at blive gravid eller ammer.
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 bekymring med hensyn til potentielle høje calciumniveauer i postevandet (hårdt vand) så tilrådes det at drikke flaskevand med lavt mineralindhold.
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.
Danish: Ikke desto mindre anbefales det, i henhold til den kliniske vurdering af den individuelle patient, at nyrefunktion, serum-calcium, fosfat og magnesium skal monitoreres hos patienter, der behandles med ibandronsyre.
English: Multiple events were therefore, counted only once in any given 12 week period for the purposes of the analysis.
Danish: Multiple hændelser blev derfor kun talt én gang til analyseformålet.
English: 6, Dervenakion EL-15351 Pallini Attiki Greece
Danish: 6, Dervenakion EL-15351 Pallini Attiki Grækenland
English: The usual dose of Ibandronic acid Sandoz is one tablet each day.
Danish: Den sædvanlige dosis af Ibandronsyre Sandoz er én tablet hver dag.
English: As with other bisphosphonates, the kidney was identified to be the primary target organ of systemic toxicity.
Danish: Som for andre bifosfonater, blev nyrerne identificeret som det primære målorgan for den systemiske toksicitet.
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 god mundhygiejne (herunder regelmæssig tandbørstning) og få foretaget rutinemæssige tandeftersyn.
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 opstår efter minimalt eller intet traume, og visse patienter oplever smerter i lår eller lyske, der ofte forbindes med radiologiske tegn på stressfrakturer, uger eller måneder før der opstår en hel femurfraktur.
English: In some cases, these events did not resolve until the ibandronic acid was discontinued.
Danish: I visse tilfælde kunne disse hændelser ikke afhjælpes, før ibandronsyren blev seponeret.
English: It is important that you take Ibandronic acid Sandoz at the right time and in the right way.
Danish: Det er vigtigt, at du tager Ibandronsyre Sandoz på rette tidspunkt og på rette måde.
English: LIST OF EXCIPIENTS The tablets also contain lactose.
Danish: LISTE OVER HJÆLPESTOFFER Tabletterne indeholder også lactose.
English: Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture.
Danish: Frakturer er ofte bilaterale; den kontralaterale femur bør derfor undersøges hos bifosfonatbehandlede patienter, der har pådraget sig en fraktur i femurskaftet.
English: Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa.
Danish: Oralt administrerede bifosfonater kan forårsage lokal irritation af den øvre gastrointestinale slimhinde.
English: Patients should receive supplemental calcium and/or vitamin D if dietary intake is inadequate.
Danish: Patienterne bør have et calcium- og/eller vitamin-D-tilskud, hvis disse ikke indtages tilstrækkeligt gennem føden.
English: Otherwise, some of the medicine could leak back into your food pipe/gullet (oesophagus).
Danish: Ellers kan noget af medicinen lække tilbage i dit spiserør (øsofagus).
English: • if you have problems with your food pipe/gullet (oesophagus) such as narrowing or difficulty swallowing
Danish: • hvis du har problemer med dit/din spiserør/hals (øsofagus) såsom forsnævring eller vanskeligheder ved at synke
English: Table 1 Adverse Drug Reactions Reported for Oral Administration of Ibandronic acid System Organ
Danish: Tabel 1 Bivirkninger, der blev rapporteret for oral administration af ibandronsyre System organklasse
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 postevand).
English: Paraesthesia, dysgeusia (taste perversion)
Danish: Paræstesi, dysgeusi (smagsforstyrrelse)
English: If you are taking a tablet each day, skip the missed dose completely.
Danish: Hvis du tager en tablet hver dag, skal du springe den manglende dosis helt over.
English: • if you have kidney problems
Danish: • hvis du har nyreproblemer
English: If you have severe kidney problems, your doctor may reduce your dose to one tablet each week.
Danish: Hvis du har alvorlige nyreproblemer, kan din læge reducere din dosis til én tablet om ugen.
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 behandlede patienter i forhold til placebo (relativ risiko 0,62, p=0,003).
English: - radiotherapy to bone for treatment of fractures/impending fractures - surgery to bone for treatment of fractures - vertebral fractures - non-vertebral fractures
Danish: - knoglestrålebehandling for behandling af frakturer/truende frakturer - knoglekirurgi for behandling af frakturer - vertebrale frakturer - ikke-vertebrale frakturer
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 og før dit første måltid, drikkevarer, anden medicin eller kosttilskud.
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 dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece
Danish: Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Grækenland
English: Titanium dioxide
Danish: Hypromellose Titandioxid
English: If you have moderate kidney problems, your doctor may reduce your dose to one tablet every other day.
Danish: Hvis du har moderate nyreproblemer, kan din læge reducere din dosis til én tablet hver anden dag.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Danish: Yderligere information om dette lægemiddel kan findes på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu
English: Bisphosphonates act by inhibiting osteoclast activity, although the precise mechanism is still not clear.
Danish: Bifosfonater virker ved at hæmme osteoklastaktiviteten, men virkningsmekanismen er endnu ikke fuldt ud klarlagt.
English: Bioavailability was reduced by approximately 75% when ibandronic acid tablets were administered 2 hours after a standard meal.
Danish: Biotilgængeligheden blev reduceret med ca. 75 %, når ibandronsyre-tabletter blev indtaget 2 timer efter et standardmåltid.
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 af antallet af implantationssteder, forstyrrelser af den normale fødsel (dystoki), en øgning af viskerale variationer (nyre pelvis ureter syndrom) og tandabnormaliteter på F1 afkommet hos rotter.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not suck, chew or crush tablets.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Tabletterne må ikke tygges, suttes eller knuses.
English: However, no dosage adjustment is required when ibandronic acid is administered with H2-antagonists or medicinal products that increase gastric pH.
Danish: Dosisjustering er ikke nødvendig, når ibandronsyre administreres sammen med H2-antagonister eller lægemidler, som øger gastrisk pH.
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Ibandronic acid Sandoz in patients with concomitant risk factors.
Danish: En tandundersøgelse med forebyggende tandlægearbejde samt en individuel risikovurdering, anbefales før behandling med Ibandronsyre Sandoz hos patienter med samtidige risikofaktorer.
English: Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Ibandronic acid Sandoz tablets.
Danish: Produkter, som indeholder calcium og andre multivalente kationer (som f.eks. aluminium, magnesium, jern), herunder mælk og føde, vil sandsynligvis påvirke absorptionen af Ibandronsyre Sandoz tabletter.
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, indbygget i skelettet.
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 terapeutisk forholdsregler.
English: ONJ can also occur after stopping treatment.
Danish: Knoglenekrose i kæben kan også forekomme efter behandling er stoppet.
English: This is because it can cause irritation, inflammation or ulcers in your food pipe/gullet (oesophagus).
Danish: Det er fordi, det kan forårsage irritation, inflammation eller sår i dit/din spiserør/hals (øsofagus).
English: Hypersensitivity†, bronchospasm†, angioedema†, Anaphylactic reaction/shock†**
Danish: Overfølsomhed†, bronkospasme†, angioødem†, anafylaktisk reaktion/chok†**
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 Sandoz.
Danish: Der kan forekomme irritation, inflammation og sårdannelse i halsen/spiserøret (øsofagus), ofte med symptomer af alvorlige mavesmerter, alvorlige smerter efter synkning af føde- og/eller drikkevarer, alvorlig kvalme eller opkastning, især hvis du ikke drikker et helt glas vand og/eller hvis du ligger dig ned inden for 1 time efter, at du har taget Ibandronsyre Sandoz.
English: Ibandronic acid Sandoz tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day.
Danish: Ibandronsyre Sandoz tabletter skal indtages efter natlig faste (mindst 6 timer) og før indtagelse af madeller drikkevarer.
English: Children and adolescents Ibandronic acid Sandoz should not be used in children and adolescents below the age of 18 years.
Danish: Børn og unge Ibandronsyre Sandoz bør ikke anvendes til børn og unge under 18 år.
English: Ibandronic acid Sandoz 50 mg film-coated tablets are supplied in Polyamide/Al/PVC - Aluminium foil blister with 3, 6, 9, 28 or 84 tablets, packaged in a cardboard box.
Danish: Ibandronsyre Sandoz 50 mg filmovertrukne tabletter leveres i polyamid/aluminium/PVC - aluminium blisterpakninger med 3, 6, 9, 28 eller 84 tabletter pakket i papæske.
English: DK-2300 København S Danmörk/Danmark/Tanska info.sandoz-dk@sandoz.com Tlf: +45 6395 1000
Danish: DK-2300 København S Danmark/Danmörk/Tanska info.sandoz-dk@sandoz.com Tlf: +45 6395 1000
English: Ibandronic acid Sandoz therapy should only be initiated by physicians experienced in the treatment of cancer.
Danish: Behandling med Ibandronsyre Sandoz bør kun initieres af læger med erfaring i behandling af cancer.
English: Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Ibandronic acid Sandoz therapy.
Danish: Patienter med forstyrrelser i knogle- og mineralstofskifte Hypokalkæmi og andre forstyrrelser i knogle- og mineralstofskiftet bør behandles effektivt før behandling med Ibandronsyre Sandoz initieres.
English: Hypocalcaemia**
Danish: Hypokalkæmi**
English: No specific information is available on the treatment of overdosage with ibandronic acid.
Danish: Der er ingen tilgængelig specifik information vedrørende behandling af overdosering med ibandronsyre.
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: 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: Seponering af bifosfonatbehandlingen hos patienter, der mistænkes for at have en atypisk femurfraktur, skal overvejes, afhængig af patientens evaluering baseret på en individuel vurdering af risici/fordele.
English: The other ingredients are: - tablet core: povidone, microcrystalline cellulose, crospovidone, maize starch pregelatinised,
Danish: Øvrige indholdsstoffer: - tabletkerne: povidon, mikrokrystallinsk cellulose, crospovidon, prægelatineret majsstivelse,
English: - Patients should not lie down for 60 minutes after taking Ibandronic acid Sandoz.
Danish: - Patienter må ikke ligge ned i op til 60 minutter efter indtagelse af Ibandronsyre Sandoz.
English: Ocular inflammation†**
Danish: Øjeninflammation†**
English: Ibandronic acid belongs to the bisphosphonate group of compounds which act specifically on bone.
Danish: Ibandronsyre hører til bifosfonatgruppen af forbindelser, som virker specifikt på knoglerne.
English: - tablet coat: titanium dioxide, lactose monohydrate, hypromellose, macrogol 4000
Danish: - tabletovertræk: titandioxid, lactosemonohydrat, hypromellose, macrogol 4000.
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 undersøgelser 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: Exposure to ibandronic acid in patients with various degree of renal impairment is related to creatinine clearance (CLcr).
Danish: Eksponering af ibandronsyre hos patienter med forskellige grader af nedsat nyrefunktion er lineært relateret til kreatininclearance (CLcr).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering angives bivirkninger i rækkefølgen af faldende sværhedsgrad.
English: Ibandronic acid should not be used during lactation.
Danish: Ibandronsyre bør ikke anvendes under laktation.
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 bifosfonater Der skal udvises forsigtighed hos patienter med kendt overfølsomhed overfor bifosfonater.
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 bifosfonater.
English: Str. Livezeni nr. 7A, RO-540472 Targu-Mures Romania
Danish: Str. Livezeni nr. 7A, RO-540472 Targu-Mures Rumænien
English: Take Ibandronic acid Sandoz at least 6 hours after you 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: Tag Ibandronsyre Sandoz 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: Blood parathyroid hormone increased
Danish: Forhøjet blodparathyroideahormon
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Polyamide/Al/PVC - Aluminium foil blister
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER TRIP Polyamid/Al/PVC - Aluminiumsfolieblister
English: Ibandronic acid Sandoz tablets is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called “bone metastases”).
Danish: Ibandronsyre Sandoz-tabletterne anvendes til voksne og vil blive ordineret til dig, hvis du har brystkræft, som har spredt sig til knoglerne (kaldet knoglemetastaser).
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 Sandoz 50 mg administered orally), and from post-marketing experience.
Danish: Tabel 1 angiver bivirkninger fra 2 pivotale fase III undersøgelser (forebyggelse af knogleskader hos patienter med brystcancer og knoglemetastaser: 286 behandlet med Ibandronsyre Sandoz 50 mg oralt) og erfaringen efter markedsføringen.
English: There are no adequate data from the use of ibandronic acid in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af ibandronsyre til gravide kvinder.
English: Adequate intake of calcium and vitamin D is important in all patients.
Danish: Det er vigtigt at alle patienter har et tilstrækkeligt indtag af calcium og D-vitamin.
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 undersøgelser, som varede i 96 uger.
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 bifosfonater gives sammen med aminoglykosider, idet begge stoffer kan bevirke nedsættelse af calciumniveauet i blodet i længere perioder.
English: Studies in lactating rats have demonstrated the presence of low levels of ibandronic acid in the milk following intravenous administration.
Danish: Forsøg med diegivende rotter har vist en forekomst af små mængder ibandronsyre i mælken efter intravenøs administration.
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 bifosfonater efter udvikling af symptomer, der tyder på øsofageal irritation.
English: During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Danish: Under bifosfonatbehandling skal patienter rådes til at rapportere alle lår-, hofte- eller lyskesmerter, og alle patienter, hos hvem der opstår sådanne symptomer, skal evalueres for en ufuldstændig femurfraktur.
English: Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Ibandronic acid Sandoz tablets.
Danish: Medicin og kosttilskud (herunder calcium) skal ligeledes undgås inden indtagelse af Ibandronsyre Sandoz tabletter.
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 forsøg 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 bifosfonater.
English: If you take more Ibandronic acid Sandoz than you should If you take too many tablets talk to a doctor or go to hospital straight away.
Danish: Hvis du har taget for mange Ibandronsyre Sandoz filmovertrukne tabletter Hvis du ved en fejl har taget for mange tabletter, skal du tale med en læge eller straks tage på hospitalet.