FrancophonIA/ELRC3.0 huggingface dataset:
English: Toxic effects, e.g signs of renal damage, were observed in dogs only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: Hos hunde blev der kun iagttaget toksiske virkninger, f.eks. tegn på renal skade, ved eksponering, som anses for i tilstrækkelig grad at overstige maksimal eksponering for mennesker, og disse derfor kun er af ringe relevans for klinisk brug.
English: Physicians should be alert to any signs or symptoms signaling a possible oesophageal reaction and patients should be instructed to discontinue Ibandronic Acid Teva 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 Ibandronsyre Teva-behandlingen og kontakte lægen, hvis de udvikler dysfagi, odynofagi, retrosternal smerte eller ny eller forværret halsbrand.
English: Table 2 Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Danish: Tabel 2 Effektresultater (brystkræftpatienter med metastaserende knoglesygdom)
English: However, 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 dog hurtigt og når 10 % af peakværdien indenfor 3 og 8 timer efter henholdsvis intravenøs og peroral administration.
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: Patienten skal informeres om at rapportere enhver lår-, hofte- eller lyskesmerte under bisphosphonatbehandlingen, og alle patienter, som fremviser disse symptomer, skal evalueres for en ufuldstændig femurfraktur.
English: The following risk factors should be considered when evaluating a patient's risk of developing ONJ: - Potency of the medicinal product that inhibit bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy.
Danish: Følgende risikofaktorer bør overvejes ved vurdering af en patients risiko for at udvikle knoglenekrose i kæben: - styrken af lægemidlet, der hæmmer knogleresorption (højere risiko for højpotente stoffer),
English: NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Teva B.V.
English: No evidence of direct foetal toxicity or teratogenic effects was observed for ibandronic acid in intravenously or orally treated rats and rabbits.
Danish: Der fandtes ikke tegn på direkte føtal toksisk eller teratogen effekt af ibandronsyre hos peroralt eller intravenøst behandlede rotter og kaniner.
English: Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Danish: Kontakt straks din læge og tandlæge, hvis du oplever problemer med din mund eller tænder såsom løse tænder, smerter eller hævelser eller hvis dine sår væsker og/eller ikke heler, da dette kan være tegn på knoglenekrose i kæben.
English: Table 4: Results from 3 years fracture study MF 4411 (%, 95 % CI) for patients with lumbar spine BMD T-score below -2.5 at baseline
Danish: Tabel 4: Resultater fra 3-års frakturundersøgelse (MF 4411) (%, 95 % Konfidensinterval) for patienter med lumbal columna BMD T-score under -2,5 ved baseline
English: If you develop these symptoms, stop taking Ibandronic Acid Teva and tell your doctor straight away (see sections 3 and 4).
Danish: Hvis du udvikler disse symptomer, skal du stoppe med at tage Ibandronsyre Teva og straks kontakte din læge (se punkt 3 og 4).
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonate, ATC Code: M05BA06
Danish: Farmakoterapeutisk klassifikation: Midler til behandling af knoglesygdomme, bisphosphonater, ATCkode: M05BA06
English: The safety of oral treatment with ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo-controlled clinical studies, with the large majority of patients coming from the pivotal three year fracture study (MF
Danish: Sikkerheden af oral behandling med ibandronsyre 2,5 mg daglig er undersøgt hos 1251 patienter, som indgik i 4 placebokontrollerede kliniske studier; hovedparten af disse patienter var fra det pivotale treårs frakturstudie (MF 4411).
English: Ibandronic Acid Teva may help lower the chances of breaking bones (fractures).
Danish: Ibandronsyre Teva kan hjælpe til at formindske risikoen for knoglebrud (frakturer).
English: In reproductive studies in rats by the intravenous route, ibandronic acid decreased sperm counts at doses of 0.3 and 1 mg/kg/day and decreased fertility in males at 1 mg/kg/day and in females at 1.2 mg/kg/day.
Danish: I reproduktionsstudier hos rotter nedsatte ibandronsyre sædkvaliteten ved intravenøs indgift af 0,3 og 1 mg/kg/døgn og fertiliteten hos hanner ved 1 mg/kg/døgn og hos hunner ved 1,2 mg/kg/døgn.
English: No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal or greater than 30 ml/min.
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat nyreinsufficiens, hvor kreatininclearance er lig med eller over 30 ml/min.
English: • Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes).
Danish: • Du skal indtage indtage tabletten i oprejst stilling (siddende eller stående) og forblive oprejst i den næste time (60 minutter) efter, at du har taget din tablet.
English: • It helps to prevent your bones from breaking (fractures).
Danish: • Det hjælper med at forebygge knoglebrud
English: Some people need to be especially careful while they're taking Ibandronic Acid Teva.
Danish: Visse personer skal være særlig forsigtige når de tager Ibandronsyre Teva.
English: - If you forgot to take your tablet on your chosen day and your next scheduled dose is more than 7 days away…
Danish: • Hvis du har glemt at tage din tablet på din planlagte dag og din næste planlagte dosis skal tages efter mere end 7 dage.
English: Note down the date you take your tablet.
Danish: Skriv datoen for indtagelsen af tabletten ned.
English: • inflammation of the duodenum (first section of the bowel) causing stomach pain
Danish: • betændelse i tolvfingertarmen (den første del af tarmen), hvilket giver mavesmerter.
English: Ibandronic Acid Teva is prescribed to you to treat postmenopausal osteoporosis because you have an increased risk of fractures.
Danish: Ibandronsyre Teva er ordineret til dig til behandling af osteoporose (knogleskørhed) efter menopausen (overgangsalderen), fordi du har en øget risiko for knoglebrud.
English: The usual dose of Ibandronic Acid Teva is one tablet each day.
Danish: Den sædvanlige dosis Ibandronsyre Teva er én tablet dagligt.
English: Influenza-like illness includes events reported as acute phase reaction or symptoms including myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, or bone pain.
Danish: Influenzalignende sygdom inkluderer hændelser rapporteret som akut fasereaktion eller symptomer inkluderende myalgi, artralgi, feber, kulderystelser, træthed, kvalme, appetitløshed eller knoglesmerter.
English: • flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and aching muscles and joints.
Danish: • influenzalignende symptomer herunder feber, rysten og skælven, ubehag, knoglesmerter samt smerter i muskler og led.
English: No specific information is available on the treatment of overdosage with Ibandronic Acid Teva.
Danish: Der er ingen tilgængelig specifik information vedrørende behandling af overdosering med Ibandronsyre Teva.
English: In studies in rats using the intravenous route, ibandronic acid decreased fertility at high daily doses (see section 5.3).
Danish: I studier på rotter hvor intravenøs indgift blev anvendt, nedsatte ibandronsyre fertiliteten ved høje daglige doser (se pkt.
English: Medicinal product-Food Interactions
Danish: Lægemiddel-fødeinteraktioner
English: Table 2: Mean relative change from baseline of lumbar spine, total hip, femoral neck and trochanter BMD after one year (primary analysis) and two years of treatment (Per-Protocol Population) in study BM 16549.
Danish: Tabel 2: Den gennemsnitlige relative ændring fra baseline for lumbal-, hofte-, lårbenshals- og trochanter BMD efter etårs (primær analyse) og toårs behandling (pr. protokol population) i studie BM
English: METHOD AND ROUTE OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: However, no dosage adjustment is required when Ibandronic Acid Teva is administered with H2-antagonists or medicinal products that increase gastric pH.
Danish: Dosisjustering er ikke nødvendig, når Ibandronsyre Teva administreres sammen med H2-antagonister eller andre lægemidler, som øger gastrisk pH.
English: Therefore, patients should not take other oral medicinal products for at least 6 hours before taking Ibandronic Acid Teva and for 1 hour following intake of Ibandronic Acid Teva.
Danish: Patienten bør derfor ikke indtage andre orale lægemidler i mindst 6 timer inden indtagelse af Ibandronsyre Teva, samt i 1 time efter indtagelsen af Ibandronsyre Teva.
English: EU/1/10/642/002 84 film-coated tablets
Danish: EU/1/10/642/002 84 filmovertrukne tabletter
English: • low calcium levels in your blood
Danish: • lavt indhold af kalk i blodet
English: So be especially careful if you take painkillers or anti-inflammatories while you're taking Ibandronic Acid Teva.
Danish: Du skal derfor være særlig forsigtig, hvis du tager smertestillende eller antiinflammatorisk medicin samtidig med, du tager Ibandronsyre Teva.
English: Special populations Renal impairment
Danish: Specielle populationer Nedsat nyrefunktion
English: Pooled data from these studies demonstrated a significant advantage for ibandronic acid 50 mg p.o. over placebo in the reduction in SREs measured by the SMPR (p=0.041).
Danish: Sammenfattende resultater fra disse undersøgelser viste en signifikant fordel for ibandronsyre 50 mg p.o. frem for placebo, til reduktion af SREs målt ved den tidsjusterede SMPR (p=0,041).
English: Adverse reactions such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some cases severe and requiring hospitalisation, 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: Table 3 Secondary Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Danish: Tabel 3 Sekundære effektresultater (brystkræftpatienter med metastaserende knoglesygdom)
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
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 Teva therapy.
Danish: Hypokalcæmi og andre forstyrrelser i knogle og mineralmetabolisme bør behandles effektivt før behandling med Ibandronsyre Teva initieres.
English: Their selective action on bone tissue is based on the high affinity of bisphosphonates for bone mineral.
Danish: Den selektive virkning på knoglevævet er baseret på bisphosphonaters høje affinitet til knoglemineraler.
English: One year data in study BM 16549 Two year data in study BM
Danish: Etårs data (i studie BM 16549)
English: Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% and 18% of patients used histamine (H2) blockers or proton pump inhibitors after one and two years, respectively.
Danish: Hos over 1500 patienter, som indgik i studie BM 16549, der sammenlignede månedlig behandling med ibandronsyre med daglig behandling, anvendte 14 % og 18 % histamin (H2)-blokkere eller syrepumpehæmmere efter henholdsvis et og to år.
English: Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Ibandronic Acid Teva.
Danish: Indtagelse af medicin, som reducerer mængden af mavesyre, såsom cimetidin og ranitidin, kan give let forøget effekt af Ibandronsyre Teva.
English: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
Danish: Der er rapporteret om atypiske subtrochantære og diafyseale femurfrakturer ved bisphosphonatbehandling, primært hos patienter i langtidsbehandling af osteoporose.
English: On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that Ibandronic Acid Teva has no or negligible influence on the ability to drive and use machines.
Danish: På baggrund af den farmakodynamiske og farmakokinetiske profil og de rapporterede bivirkninger forventes Ibandronsyre Teva ikke eller kun i ubetydelig grad at påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: StevensJohnson syndrome†, erythema multiforme†, dermatitis bullous†
Danish: StevensJohnsons syndrom†, erythema multiforme †, bulløs dermatitis†
English: Stevens-Johnson syndrome†, Erythema multiforme†, Dermatitis bullous†
Danish: Stevens-Johnsons syndrom†, erythema multiforme†, bulløs dermatitis†
English: Milk or antacids should be given to bind Ibandronic Acid Teva.
Danish: Der bør indtages mælk eller antacida med henblik på at binde Ibandronsyre Teva.
English: If you are not sure, talk to your doctor or pharmacist before taking Ibandronic Acid Teva.
Danish: Hvis du er i tvivl, så kontakt lægen eller apotekspersonalet, inden du tager Ibandronsyre Teva.
English: The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50% in postmenopausal women) and the remainder is eliminated unchanged by the kidney.
Danish: Den absorberede del af ibandronsyre elimineres fra cirkulationen via knogleabsorption (estimeret til 40-50 % hos postmenopausale kvinder), og den resterende del udskilles uændret via nyrerne.
English: The range of observed apparent half-lives is broad, the apparent terminal half-life is generally in the range of 10-72 hours.
Danish: Den tilsyneladende terminale halveringstid er generelt i området 10-72 timer.
English: Ocular inflammation*†
Danish: Inflammation i øjet*†
English: The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50%) and the remainder is eliminated unchanged by the kidney.
Danish: Den absorberede del af ibandronsyre elimineres fra cirkulationen via knogleresorption (estimeret til 40-50 %) og den resterende del udskilles uændret gennem nyrerne.
English: Take Ibandronic Acid Teva with 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 Ibandronsyre Teva 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: This is because NSAIDs and Ibandronic Acid Teva can both irritate your stomach and gut
Danish: Det er fordi NSAIDer og Ibandronsyre Teva begge kan irritere din mave-tarmkanal
English: Ibandronic acid selectively inhibits osteoclast activity, reducing bone resorption and thereby reducing skeletal complications of the malignant disease.
Danish: Ibandronsyre hæmmer selektivt osteoklastaktiviteten, reducerer knogleresorptionen og mindsker herved skeletkomplikationerne ved den maligne sygdom.
English: Month 1 __/__/__
Danish: Måned 1 __/__/__
English: Tests for genotoxicity revealed no evidence of genetic activity for ibandronic acid.
Danish: Undersøgelser for genotoksicitet viste ingen tegn på genetisk aktivitet af ibandronsyre.
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 et nedsat antal implantationssteder, forstyrrelser af den normale fødsel (dystocia), en øgning af viscerale forandringer (nyre-pelvis-ureter-syndrom) og tandabnormaliteter på F1-afkommet hos rotter.
English: Daily treatment with 2.5 mg resulted in progressive increases in BMD at vertebral and nonvertebral sites of the skeleton.
Danish: Daglig behandling med 2,5 mg resulterede i en tiltagende øgning af BMD både vertebralt og nonvertebralt.
English: Your doctor may do regular blood tests while you are taking Ibandronic Acid Teva.
Danish: Din læge kan vælge at tage regelmæssige blodprøver, mens du er i behandling med Ibandronsyre Teva.
English: They include a decreased number of implantation sites, interference with natural delivery (dystocia), and an increase in visceral variations (renal pelvis ureter syndrome).
Danish: De omfatter en nedsættelse af antallet af implantationssteder, forstyrrelser af den normale fødsel (dystocia) og en øgning af viscerale forandringer (nyre-pelvis-ureter-syndrom).
English: • Take your tablet with a full glass of water only (about 200 mL).
Danish: • Tag din Ibandronsyre Teva-tablet udelukkende med et helt glas vand (ca. 200 ml).
English: You can drive and use machines as it's expected that Ibandronic Acid Teva has no or negligible effect on your ability to drive and use machines.
Danish: Du kan køre bil og betjene maskiner, da det forventes, at Ibandronsyre Teva ikke eller i ubetydelig grad påvirker din evne til at køre bil og betjene maskiner.
English: There are no adequate data from the use of ibandronic acid in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af ibandronsyre hos gravide kvinder.
English: • itching, swelling of your face, lips, tongue and throat, with difficulty breathing.
Danish: • kløe, hævelse af ansigt, læber, tunge og hals, med vejrtrækningsproblemer.
English: Based on the results of study BM 16549, ibandronic acid 150 mg once monthly is expected to be at least as effective in preventing fractures as ibandronic acid 2.5 mg daily.
Danish: På grundlag af resultaterne fra studie BM 16549 forventes ibandronsyre 150 mg én gang om måneden at være mindst ligeså effektivt med hensyn til at forebygge frakturer som ibandronsyre 2,5 mg daglig.
English: In healthy male volunteers and postmenopausal women, intravenous ranitidine caused an increase in ibandronic acid bioavailability of about 20% (which is within the normal variability of the bioavailability of ibandronic acid), probably as a result of reduced gastric acidity.
Danish: Hos raske, mandlige forsøgspersoner og hos postmenopausale kvinder, bevirkede intravenøs ranitidin en ca. 20 % øgning i biotilgængeligheden af ibandronsyre (som ligger inden for den normale variabilitet for biotilgængeligheden af ibandronsyre), formentlig som et resultat af den reducerede gastriske surhedsgrad.
English: The other ingredients are:
Danish: Dette inkluderer:
English: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Danish: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Storbritannien
English: No dose adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat nyrefunktion (CLcr ≥ 50 og < 80 ml/min).
English: Renal clearance of ibandronic acid in patients with various degrees of renal impairment is linearly related to creatinine clearance.
Danish: Den renale clearance for ibandronsyre hos patienter med forskellige grader af nedsat nyrefunktion er lineært relateret til kreatininclearance.
English: Table 1: Adverse reactions occurring in postmenopausal women receiving ibandronic acid 150 mg once monthly or ibandronic acid 2.5 mg daily in the phase III studies BM 16549 and MF 4411 and in post-marketing experience.
Danish: Tabel 1: Bivirkninger hos postmenopausale kvinder, som fik ibandronsyre 150 mg én gang månedlig eller ibandronsyre 2,5 mg daglig i fase III-studierne BM 16549 og MF 4411 samt bivirkninger set efter markedsføring.
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: Ask your doctor or pharmacist for advice before taking this medicine.
Danish: Tal med din læge eller apotekspersonalet før du tager dette lægemiddel.
English: Angioedema, Face oedema, Urticaria
Danish: Angioødem, ansigtsødem, urticaria
English: • if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in section 6
Danish: • hvis du er allergisk over for ibandronsyre eller et af de øvrige indholdsstoffer i dette lægemiddel
English: It contains the active substance ibandronic acid.
Danish: Det indeholder det aktive stof ibandronsyre.
English: There is no relevant use of Ibandronic Acid Teva in children below 18 years, and Ibandronic Acid Teva was not studied in this population (see section 5.1 and section 5.2).
Danish: Anvendelse af Ibandronsyre Teva er ikke relevant hos børn under 18 år, og Ibandronsyre Teva er ikke undersøgt hos denne population (se pkt.
English: Do not take your tablet with any drink other than water.
Danish: • Tag ikke tabletten med andet end almindeligt vand.
English: There are no pharmacokinetic data for ibandronic acid in patients who have hepatic impairment.
Danish: Der er ingen farmakokinetiske data for ibandronsyre hos patienter med nedsat leverfunktion.
English: In case a dose is missed, patients should be instructed to take one Ibandronic Acid Teva 150 mg tablet the morning after the tablet is remembered, unless the time to the next scheduled dose is within 7 days.
Danish: Hvis patienterne opdager, at de har glemt at tage en Ibandronsyre Teva-tablet 150 mg, skal de tage den næste morgen forudsat, at der er mindst 7 dage til næste dosis.
English: The overall proportion of patients who experienced an adverse reaction, was 22.7 % and 25.0 % for ibandronic acid 150 mg once monthly after one and two years, respectively.
Danish: Andelen af patienter med bivirkninger var 22,7 % og 25,0 % for ibandronsyre 150 mg én gang om måneden efter henholdsvis et og to år.
English: Ibandronic acid belongs to the bisphosphonate group of compounds which act specifically on bone.
Danish: Ibandronsyre hører til bisphosphonatgruppen af forbindelser, som virker specifikt på knoglerne.
English: Therefore, it is recommended that the tablets should be taken after an overnight fast (at least 6 hours) and fasting should continue for at least 30 minutes after the dose has been taken (see section 4.2).
Danish: Det anbefales derfor, at tabletterne indtages efter natlig faste (mindst 6 timer), og at fasten fortsættes mindst 30 minutter efter tabletindtagelsen (se pkt.
English: Clinical studies have not shown any evidence of deterioration in renal function with long term ibandronic acid therapy.
Danish: Kliniske studier har ikke vist tegn på forringelse af nyrefunktionen ved længerevarende ibandronsyrebehandling.
English: Ibandronic Acid Teva is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Danish: Ibandronsyre Teva er kun til brug hos kvinder, der er kommet i overgangsalderen, og må ikke tages af kvinder, der stadig kan få børn.
English: Atypical subtrochanteric and diaphyseal femoral fractures†
Danish: Atypiske subtrochantære og diafyseale femurfrakturer †