FrancophonIA/ELRC3.0 huggingface dataset:
English: Protein binding in human plasma is approximately 87% at therapeutic concentrations, and thus interaction with other medicinal products, due to displacement is unlikely.
Danish: Proteinbindingen i humant plasma er ca. 87 % ved terapeutiske koncentrationer.Interaktioner med andre lægemidler på grund af displacering er derfor usandsynlig.
English: * Note albumin-corrected serum calcium concentrations are calculated as follows:
Danish: * Bemærk at albumin-korrigerede serum-calciumkoncentrationer beregnes på følgende måde:
English: INFORMATION IN BRAILLE bondronat 50 mg
Danish: INFORMATION I BRAILLESKRIFT bondronat 50 mg
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Bondronat in patients with concomitant risk factors.
Danish: En tandundersøgelse med forebyggende tandlægearbejde samt en individuel risikovurdering, anbefales før behandling med Bondronat hos patienter med samtidige risikofaktorer.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorsation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er opbevaringstiden og betingelserne for opbevaring før anvendelsen brugerens ansvar, og opbevaringstiden må normalt ikke være længere end 24 timer ved 2 °C - 8 °C, medmindre rekonstitueringen har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: Bondronat tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day.
Danish: Bondronat tabletter skal indtages efter faste om natten (mindst 6 timer) og før indtagelse af dagens første mad- og drikkevarer.
English: Do not take Bondronat with food or any other drinks except water as Bondronat is less effective if it is taken with food or drink (see section 3).
Danish: Brug af Bondronat sammen med mad og drikke Tag ikke Bondronat sammen med mad eller andre drikkevarer end vand, da Bondronat virker mindre effektivt, hvis det tages sammen med mad og drikke (se punkt 3).
English: However, no dosage adjustment is required when Bondronat is administered with H2-antagonists or medicinal products that increase gastric pH.
Danish: Dosisjustering er ikke nødvendig, når Bondronat administreres sammen med H2-antagonister eller lægemidler, som øger gastrisk pH.
English: - Treatment of tumour-induced hypercalcaemia with or without metastases
Danish: - til behandling af tumorinduceret hyperkalcæmi med eller uden metastaser.
English: Waymade PLC Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR United Kingdom
Danish: Waymade PLC Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR Storbritannien
English: • you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction
Danish: • du har problemer med din mund og tænder, såsom dårlig mundhygiejne, tandkødssygdom eller en planlagt tandudtrækning
English: Bondronat works by reducing the amount of calcium that is lost from your bones.
Danish: Bondronat virker ved at nedsætte den mængde kalk, som mistes fra knoglerne.
English: • you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
Danish: • du tager steroider (såsom prednisolon eller dexmethasone)
English: As no clinical data are available, dose recommendations cannot be given for patients with severe hepatic insufficiency (see section 4.2).
Danish: Da kliniske data ikke findes, kan dosis-rekommandation ikke gives for patienter med svær leverinsufficiens (se pkt.
English: Children and adolescents Bondronat should not be used in children and adolescents below the age of 18 years.
Danish: Børn og unge Bondronat må ikke anvendes til børn og unge under 18 år.
English: A repeated dose may be considered in case of insufficient response or if your illness reappears.
Danish: Gentagen dosering kan overvejes, hvis der ses utilstrækkelig effekt, eller hvis din sygdom kommer igen.
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 urinCTx-niveauet var signifikant korreleret med det primære endepunkt SMPR (Kendall-tau-b, (p<0,001)).
English: • you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
Danish: • du tidligere har været i behandling med bisphosphat (andvendes til at behandle eller forbygge knoglelidelser)
English: Bondronat contains lactose
Danish: Bondronat indeholder lactose
English: Clinical studies have not shown any evidence of deterioration in renal function with long term Bondronat therapy.
Danish: Kliniske studier har ikke vist tegn på forringelse af nyrefunktionen ved længerevarende Bondronatbehandling.
English: You can drive and use machines as it's expected that Bondronat 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 Bondronat ikke eller kun i ubetydelig grad påvirker din evne til at køre bil og betjene maskiner.
English: White to off-white film-coated tablets, of oblong shape engraved “L2” on one side and “IT” on the other side.
Danish: Hvide til råhvide filmovertrukne, aflange tabletter mærket ”L2” på den ene side og ”IT” på den anden side.
English: Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Bondronat.
Danish: Indtagelse af medicin, som reducerer mængden af mavesyre, såsom cimetidin og ranitidin, kan give let forøget effekt af Bondronat.
English: Dosage: Treatment of Tumour-induced Hypercalcaemia Bondronat is usually administered in a hospital setting.
Danish: Dosering: Behandling af tumor-induceret hyperkalcæmi Bondronat administreres sædvanligvis på et hospital.
English: Acetic acid (99%)
Danish: Eddikesyre (99 %)
English: • Do not use this medicine after the expiry date which is stated on the folding box and on the label after EXP.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet og på pakningen efter
English: Bondronat contains less than 1 mmol sodium (23 mg) per vial, i.e. ‘essentially sodium free'.
Danish: Bondronat indeholder mindre end 1 mmol (23 mg) natrium pr. hætteglas, dvs. den er i det væsentlige natriumfri.
English: BATCH NUMBER Batch
Danish: FREMSTILLERENSBATCHNUMMER Batch
English: Pharmaco-therapeutic group: Medicinal products for treatment of bone diseases, bisphosphonate, ATC Code: M05BA06.
Danish: Farmakoterapeutisk klassifikation: Midler til behandling af knoglesygdomme, bisphosphonater, ATCkode: M05BA06.
English: Bondronat 50 mg film coated tablets are supplied in blisters (aluminium) containing 7 tablets, which are presented as packs containing 28 or 84 tablets.
Danish: Bondronat 50 mg filmovertrukne tabletter leveres i blisterpakninger (aluminium) indeholdende 7 tabletter i pakninger med 28 eller 84 tabletter.
English: This is because Bondronat can affect the way some other medicines work.
Danish: Dette skyldes at Bondronat kan påvirke den måde anden medicin virker på, ligesom anden medicin kan påvirke den måde, hvorpå Bondronat virker.
English: Contains 88.1 mg lactose (as lactose monohydrate).
Danish: 1 tablet indeholder 88,1 mg lactose (som lactosemonohydrat).
English: The highest dose used in clinical trials was 6 mg but this dose does not add any further benefit in terms of efficacy.
Danish: Den højeste dosis anvendt i kliniske studier var 6 mg, men den dosis øger ikke virkningen.
English: The secretory pathway of renal elimination does not appear to include known acidic or basic transport systems involved in the excretion of other active substances.
Danish: Eliminationsvejen gennem nyrerne ser ikke ud til at omfatte kendte syre - eller basetransportsystemer, som anvendes i forbindelse med udskillelsen af andre aktive substanser.
English: • tablet coat: hypromellose, titanium dioxide (E 171), talc, macrogol 6,000
Danish: • Tabletovertræk: hypromellose, titandioxid (E171), talcum, macrogol 6.000
English: Ocular inflammation†**
Danish: Inflammation i øjet †**
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 Bondronat.
Danish: Der kan forekomme irritation, inflammation (betændelseslignende tilstand) eller sårdannelse i spiserøret, ofte med symptomer som stærk smerte i brystet, stærk smerte efter at have sunket mad og/eller drikke, voldsom kvalme eller opkastning, især hvis du ikke drikker et helt glas almindeligt vand, og/eller hvis du ligger ned inden for én time efter, du har taget Bondronat.
English: Bioavailability was reduced by approximately 75% when Bondronat tablets were administered 2 hours after a standard meal.
Danish: Biotilgængeligheden blev reduceret med ca. 75 %, når Bondronat-tabletter blev indtaget 2 timer efter et standardmåltid.
English: Less frequently, a decrease in serum calcium below normal range (hypocalcaemia) is reported.
Danish: Mindre hyppigt er der rapporteret et fald i serum-calcium til under normalområdet (hypokalcæmi).
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: The pain reduction was consistently below baseline throughout the entire study and accompanied by a significantly reduced use of analgesics.
Danish: Smerteniveauet var permanent under baseline gennem hele studiet og blev ledsaget af et signifikant reduceret forbrug af analgetika.
English: On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that Bondronat 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 Bondronat ikke eller kun i ubetydelig grad at påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Before receiving treatment, tell your doctor/nurse (health care professional) if:
Danish: Før du modtager behandlingen, fortæl din læge eller sygeplejerske, hvis:
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 væsentlig øgning af frie plasmakoncentrationer.
English: Caution is advised when bisphosphonates are administered with aminoglycosides, since both substances can lower serum calcium levels for prolonged periods.
Danish: Forsigtighed tilrådes, når bisphosphonater gives samtidigt med aminoglykosider, da begge lægemidler kan nedsætte serum-calcium i længere perioder.
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: Frequency categories are defined using the following convention: very common (>1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
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: In a study in 130 patients with metastatic breast cancer the safety of Bondronat infused over 1 hour or 15 minutes was compared.
Danish: I et klinisk studie med 130 patienter med metastatisk brystkræft blev sikkerheden af Bondronat sammenlignet ved infusion over 1 time i forhold til infusion over 15 minutter.
English: Therefore, Bondronat should not be used during pregnancy.
Danish: Bondronat bør ikke anvendes under graviditet.
English: Urinary concentrations of the bone resorption marker CTx (C-terminal telopeptide released from Type I collagen) were significantly reduced in the Bondronat group compared to placebo.
Danish: Koncentrationen af urinmarkører for knogleresorption CTx (C-terminaltelopeptid frigjort fra Type I kollagen) blev signifikant reduceret i Bondronat-gruppen i forhold til placebo.
English: (see section 5.1 and 5.2).
Danish: 5.1 og 5.2).
English: • Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes).
Danish: • Du skal 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: Hypocalcaemia**
Danish: Hypokalcæmi**
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-marketing rapporter om gastriske og duodenale sår, i visse tilfælde alvorlige og med komplikationer, i forbindelse med brug af orale bisphosphonater.
English: Clinically relevant hypocalcaemia should be corrected by intravenous administration of calcium gluconate.
Danish: Klinisk relevant hypokalcæmi bør korrigeres ved intravenøs administration af calciumglukonat.
English: StevensJohnson Syndrome†, Erythema Multiforme†, Dermatitis Bullous†
Danish: StevensJohnsons syndrom†, erythema multiforme†, bulløs dermatitis†
English: • a type of antibiotic injection called “aminoglycoside” such as gentamicin.
Danish: • injektioner af en type antibiotika der kaldes ‘aminoglykosider' såsom gentamicin.
English: Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Bondronat 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 Bondronat gives til patienter med aktive øvre gastrointestinale problemer (f.eks. diagnosticeret Barretts øsofagitis, dysfagi, andre sygdomme i spiserøret, gastritis, duodenitis eller ulcus).
English: Acetylsalicylic acid and NSAIDs
Danish: Acetylsalicylsyre og NSAID-præparater
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: Bondronat tablets contain lactose and should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Danish: Bondronat-tabletter indeholder lactose og bør ikke administreres til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Clinical studies in the treatment of tumour-induced hypercalcaemia Clinical studies in hypercalcaemia of malignancy demonstrated that the inhibitory effect of ibandronic acid on tumour-induced osteolysis, and specifically on tumour-induced hypercalcaemia, is characterised by a decrease in serum calcium and urinary calcium excretion.
Danish: Kliniske studier ved behandling af tumorinduceret hyperkalcæmi Kliniske studier ved malign hyperkalcæmi har vist, at ibandronsyres hæmmende virkning på tumorinduceret osteolyse og specifikt på tumorinduceret hyperkalcæmi er karakteriseret ved nedsættelse af serum-calcium og urin-calcium udskillelsen.
English: Total clearance of ibandronic acid was reduced to 44 ml/min in the subjects with severe renal impairment compared with 129 mL/min in subjects with normal renal function.
Danish: Det samlede ibandronsyre clearance var reduceret til 44 ml/min hos patienter med svært nedsat nyrefunktion sammenlignet med 129 ml/min hos patienter med normal nyrefunktion.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister foil
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTERFOLIE
English: Your doctor may ask you to undergo a dental examination before starting treatment with Bondronat.
Danish: Din læge kan bede dig om at gennemgå et tandeftersyn før du starter med Bondronat-behandling.
English: Take Bondronat 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: Indtag Bondronat 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: All Skeletal Related Events (SREs) Placebo n=277
Danish: Alle knoglerelaterede hændelser (SREs) Placebo n=277
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 Bondronat.
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 Bondronat.
English: Hypromellose Titanium dioxide (E 171) Talc
Danish: Tabletovertræk: Hypromellose Titandioxid (E171) Talcum
English: LIST OF EXCIPIENTS The tablets also contain lactose monohydrate.
Danish: LISTE OVER HJÆLPESTOFFER Tabletterne indeholder også lactosemonohydrat.
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale yderpakning for at beskytte mod fugt
English: • If you have heart problems and the doctor recommended to limit your daily fluid intake
Danish: • hvis du har problemer med hjerte og din læge anbefaler, at du begrænser din daglige væskeindtagelse
English: Do not take Bondronat:
Danish: Du må ikke få Bondronat:
English: If you stop taking Bondronat
Danish: Hvis du holder op med at tage Bondronat
English: • if you have heart problems and the doctor recommended to limit your daily fluid intake
Danish: • hvis du har problemer med hjerte, og din læge anbefaler, at du begrænser din daglige væskeindtagelse
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: • heart and circulatory problems (including palpitations, heart attack, hypertension (high blood pressure) and varicose veins)
Danish: • problemer med hjerte og kredsløb (inklusive hjertebanken, hjertetilfælde, forhøjet blodtryk og åreknuder)
English: Physicians should be alert to any signs or symptoms signaling a possible oesophageal reaction and patients should be instructed to discontinue Bondronat 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 Bondronat-behandlingen og kontakte læge, hvis de udvikler dysfagi, odynofagi, retrosternal smerte eller nyopstået eller forværret halsbrand.
English: Appropriate medical support and monitoring measures should be readily available when Bondronat intravenous injection is administered.
Danish: Passende nødhjælpsforanstaltninger skal være let tilgængelige, når intravenøs injektion med Bondronat administreres.
English: ≥50 CLcr<80 6 mg (6 ml of concentrate for solution for infusion)
Danish: ≥ 50 CLcr < 80 6 mg (6 ml koncentrat til infusionsvæske)
English: In particular, tell your doctor or pharmacist if you are receiving a type of antibiotic injection called ‘aminoglycoside' such as gentamicin.
Danish: Fortæl især lægen eller apotekspersonalet, hvis du får injektioner af en type antibiotika der kaldes ‘aminoglykosider' såsom gentamicin.
English: Receiving this medicine
Danish: Når du får denne medicin
English: The recommended dose is one 50 mg film-coated tablet daily.
Danish: Dosering Den anbefalede dosis er én 50 mg filmovertrukken tablet dagligt.
English: Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (277 patients) or 50 mg Bondronat (287 patients).
Danish: Kvindelige patienter med brystkræft og radiologisk verificerede knoglemetastaser blev randomiseret til placebo (277 patienter) eller 50 mg Bondronat (287 patienter).
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 Bondronat (angivet i punkt 6)
English: Studies in lactating rats have demonstrated the presence of low levels of ibandronic acid in the milk following intravenous administration.
Danish: Studier på diende rotter har vist tilstedeværelse af små mængder ibandronsyre i mælken efter intravenøs administration.
English: Talk to your doctor first if you want to drive, use machines or tools.
Danish: Tal med din læge først, hvis du vil køre bil eller arbejde med maskiner.
English: If you forget to take Bondronat
Danish: Hvis du har glemt at tage Bondronat
English: Table 1 Adverse Reactions Reported for Intravenous Administration of Bondronat System Organ
Danish: Tabel 1 Bivirkninger som er rapporteret efter intravenøst administreret Bondronat Systemorganklasse
English: Pyrexia, influenza-like illness**, oedema peripheral, asthenia, thirst
Danish: Pyreksi, influenzalignende sygdom** perifere ødemer, asteni, tørst
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Filmovertrukne tabletter
English: Up to now there is no experience of acute poisoning with Bondronat concentrate for solution for infusion.
Danish: Indtil nu foreligger der ingen erfaringer med akut forgiftning med Bondronat koncentrat til infusionsvæske, opløsning.
English: This is because NSAIDs, and Bondronat can both irritate your stomach and gut
Danish: Det er fordi NSAIDer og Bondronat begge kan irritere din mave-tarmkanal
English: Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (158 patients) or 6 mg Bondronat (154 patients).
Danish: Kvindelige patienter med brystkræft og radiologisk verificerede knoglemetastaser blev randomiseret til placebo (158 patienter) eller 6 mg Bondronat (154 patienter).
English: The safety and efficacy of Bondronat in children and adolescents below the age of 18 years have not been established.
Danish: Sikkerheden og virkningen af Bondronat hos børn og unge under 18 år er ikke klarlagt.