FrancophonIA/ELRC3.0 huggingface dataset:
English: Absorption Not applicable
Danish: Absorption Ikke relevant
English: Missed dose:
Danish: Glemte doser:
English: System Organ Class Common
Danish: Systemorganklasse Almindelig
English: However, since this increase is within the normal variability of the bioavailability of ibandronic acid, no dose adjustment is considered necessary when Bondenza is administered with H2antagonists or other active substances which increase gastric pH.
Danish: Da øgningen ligger inden for den normale variabilitet for biotilgængeligheden af ibandronsyre, anses dosisjustering ikke for nødvendig, når Bondenza administreres sammen med H2-antagonister eller andre aktive substanser, som øger gastrisk pH.
English: Patients with cardiac impairment Overhydration should be avoided in patients at risk of cardiac failure.
Danish: Patienter med nedsat hjertefunktion Overhydrering skal undgås hos patienter med risiko for hjertesvigt.
English: Bondenza should not be used during pregnancy.
Danish: Bondenza bør ikke anvendes ved graviditet.
English: Bondenza may help lower the chances of breaking bones (fractures).
Danish: Bondenza kan formindske risikoen for knoglebrud (frakturer).
English: The tablets are supplied in blisters containing 1 or 3 tablets.
Danish: Tabletter findes i blisterpakninger indeholdende 1 og 3 tabletter.
English: INFORMATION IN BRAILLE Bondenza 150 mg
Danish: INFORMATION I BRAILLESKRIFT Bondenza 150 mg
English: - If you have any disturbance of mineral metabolism (such as vitamin D deficiency)
Danish: - Hvis du har problemer med mineralmetabolismen (f.eks. vitamin D mangel).
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at det lægemiddelovervågningssystem, som er beskrevet i modul 1.8.1 i markedsføringstilladelsen, er på plads og fungerer før og under markedsføringen af lægemidlet.
English: You can drive and use machines as it's expected that Bondenza 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 Bondenza ikke eller kun i ubetydelig grad påvirker din evne til at køre bil og betjene maskiner.
English: So be especially careful if you take painkillers or anti-inflammatories while you're taking Bondenza.
Danish: Du skal derfor være særlig forsigtig, hvis du tager smertestillende eller antiinflammatorisk medicin samtidig med, du tager Bondenza.
English: Marketing Authorisation Holder Roche Registration Limited 6 Falcon Way
Danish: Indehaver af markedsføringstilladelsen Roche Registration Limited 6 Falcon Way
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: - Take your Bondenza tablet at least 6 hours after you last had anything to eat or drink except water.
Danish: - Indtag Bondenza tabletten mindst 6 timer efter, at du sidst har spist eller drukket, bortset fra vand.
English: Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Danish: På grund af risikoen for øsofageal irritation, bør opkastning ikke induceres, og patienten skal forblive i oprejst stilling.
English: For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Danish: For de patienter, der udvikler knoglenekrose i kæben, under behandling med bisphosphonater, kan tandkirurgi forværre tilstanden.
English: Therefore, patients should not take other oral medicinal products for at least 6 hours before taking Bondenza and for 1 hour following intake of Bondenza.
Danish: Patienten bør derfor ikke indtage andre orale lægemidler i mindst 6 timer inden indtagelse af Bondenza, samt i 1 time efter indtagelsen af Bondenza.
English: - Patients should not lie down for 1 hour after taking Bondenza.
Danish: - Patienten må ikke ligge ned før 1 time efter indtagelse af Bondenza.
English: Talk to your doctor before receiving Bondenza: - If you have or have ever had kidney problems, kidney failure or have needed dialysis, or if you have any other disease that may affect your kidneys
Danish: Kontakt lægen før du tager Bondenza: - Hvis du har eller har haft problemer med nyrerne, nyresvigt eller haft behov for dialyse, eller hvis du har andre sygdomme, som kan påvirke dine nyrer
English: NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration Ltd.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Roche Registration Ltd.
English: Studies in rats have shown some reproductive toxicity (see section 5.3).
Danish: Studier med rotter har vist en vis reproduktionstoksisitet (se pkt 5.3).
English: Contains 162.75 mg lactose monohydrate (equivalent to 154.6 mg anhydrous lactose).
Danish: Indeholder 162,75 mg lactosemonohydrat (ækvivalent med 154,6 mg vandfri lactose).
English: In the overall patient population of the study MF4411, 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 MF4411 sås ingen reduktion af non-vertebrale frakturer, selvom dagligt indtag af ibandronsyre tilsyneladende havde effekt i en højrisiko-undergruppe (lårbenshals-BMD-T-score < -3,0), hvor en risikoreduktion på 69 % blev observeret.
English: Do not take your tablet with l 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: Bondenza 150 mg film-coated tablets are supplied in blisters (PVC/PVDC, sealed with aluminium foil) containing 1 or 3 tablets.
Danish: Bondenza 150 mg filmovertrukne tabletter leveres i blisterpakninger (PVC/PVDC, forseglet med aluminiumsfolie) indeholdende 1 eller 3 tabletter.
English: Mean relative changes from baseline % [95% CI]
Danish: Gennemsnitlige relative ændringer fra baseline, % [95% konfidensinterval]
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05BA06
Danish: Farmakoterapeutisk klassifikation: Midler til behandling af knoglesygdomme, bisphosphonater, ATCkode: M05BA06
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3 mg/3 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 3 mg/3 ml
English: Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4).
Danish: Kræftdiagnose, kemoterapi, strålebehandling, kortikosteroider og dårlig mundhygiejne er også anset som risikofaktorer (se pkt 4.4).
English: Month 1 __/__/__ 3 film-coated tablets Month 2 __/__/__ 3 film-coated tablets Month 3 __/__/__ 3 film-coated tablets Note down the date you take your tablet
Danish: Måned 1 _/_/_ 3 filmovertrukne tabletter Måned 2 _/_/_ 3 filmovertrukne tabletter Måned 3 _/_/_ 3 filmovertrukne tabletter
English: Biotransformation There is no evidence that ibandronic acid is metabolised in animals or humans.
Danish: Biotransformation Der er ikke tegn på, at ibandronsyre metaboliseres i dyr eller mennesker.
English: Both bioavailability and BMD gains are reduced when food or beverage is taken less than 60 minutes after ibandronic acid is ingested.
Danish: Både biotilgængelighed og BMD stigninger reduceres, når føde eller drikkevarer indtages mindre end 60 minutter efter indtagelse af ibandronsyre.
English: General disorders and administration site conditions *See further information below †Identified in post-marketing experience.
Danish: Almene symptomer og reaktioner på administrations stedet * Se yderligere information nedenfor † Identificeret ved erfaring efter markedsføring
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 Bondenza.
Danish: Der kan forekomme irritation, inflammation (betændelse) 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 Bondenza.
English: - Supplements containing calcium, magnesium, iron or aluminium, as they could possibly influence the effects of Bondenza.
Danish: - Kostilskud, som indeholder kalk, magnesium, jern eller aluminium, idet de muligvis kan påvirke virkningen af Bondenza.
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 (please see paragraph “Influenza like illness”).
Danish: Disse symptomer ses typisk i forbindelse med den første dosis, er oftest kortvarige, lette eller moderate og forsvinder normalt under fortsat behandling uden afhjælpende foranstaltninger (se afsnittet ”Influenzalignende sygdom”).
English: After swallowing your monthly Bondenza tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.
Danish: Efter indtagelse af din månedlige Bondenza tablet skal du vente 1 time, inden du tager anden medicin, herunder tabletter eller anden form for medicin mod dårlig fordøjelse, kalktilskud eller vitaminer.
English: No indication of carcinogenic potential was observed.
Danish: Der fandtes ingen tegn på karcinogen effekt.
English: On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that Bondenza 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 Bondenza ikke eller kun i ubetydelig grad at påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: If you forget to take Bondenza
Danish: Hvis du har glemt at tage Bondenza
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 én tablet om måneden som oprindeligt planlagt.
English: Two year data in study BM 16550
Danish: To-års data fra studie BM 16549
English: Some people need to be especially careful while they're taking Bondenza.
Danish: Visse personer skal være særlig forsigtige når de tager Bondenza.
English: - If you have, or had in the past low blood calcium.
Danish: - hvis du har, eller har haft et lavt indhold af kalk i blodet.
English: Do not take Bondenza if you're pregnant or breast feeding.
Danish: Tag ikke Bondenza hvis du er gravid eller ammer.
English: This information is intended for healthcare professionals only:
Danish: Denne information er kun beregnet for sundhedspersonalet.
English: Bondenza is essentially sodium free.
Danish: Bondenza er stort set uden natrium
English: Talk to your doctor before taking Bondenza: - If you have any disturbances of mineral metabolism (such as vitamin D deficiency).
Danish: Kontakt lægen, før du tager Bondenza: - hvis du har problemer med mineralmetabolismen (f.eks. vitamin D mangel).
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Danish: Indehaveren af markedsføringstilladelsen skal udføre de lægemiddelovervågningsaktiviteter, som er beskrevet i lægemiddelovervågningsplanen (ifølge aftalen i RMP, modul 1.8.2. i markedsføringstilladelsen), og enhver efterfølgende opdatering af RMP, som er godkendt af Udvalget for Lægemidler til Mennesker (CHMP).
English: Do not take your tablet at bedtime or before you get up for the day.
Danish: Indtag ikke tabletten ved sengetid eller før du er stået op.
English: Oral bioavailability of ibandronic acid is generally reduced in the presence of food.
Danish: Den orale biotilgængelighed for ibandronsyre er generelt nedsat ved tilstedeværelse af føde.
English: In table 1 an overview of adverse reactions is presented.
Danish: Tabel 1 viser en oversigt over bivirkninger.
English: Bondenza belongs to a group of medicines called bisphosphonates.
Danish: Bondenza tilhører en medicingruppe, som kaldes bisphosphonater.
English: Bondenza contains less than 1 mmol sodium (23 mg) per dose (3 ml), i.e. essentially “sodiumfree”.
Danish: Bondenza indeholder mindre end 1 mmol (23 mg) natrium pr. dosis (3 ml), d.v.s. den er i det væsentlige natriumfri.
English: Therefore dose adjustment is not necessary in patients with hepatic impairment.
Danish: Dosisjustering er derfor ikke nødvendig hos patienter med nedsat leverfunktion.
English: The most frequently reported adverse reactions were arthralgia and influenza-like symptoms.
Danish: De hyppigst indberettede bivirkninger var artralgi og influenzalignende symptomer.
English: Bondenza, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Danish: Bondenza kan, ligesom andre intravenøst administrerede bisphosphonater, forårsage et forbigående fald i værdierne for serum calcium.
English: - If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Bondenza.
Danish: - Hvis du får tandbehandling eller tandoperation, skal du fortælle din tandlæge, at du er i behandling med Bondenza.
English: Renal clearance (about 60 mL/min in healthy postmenopausal females) accounts for 50-60 % of total clearance and is related to creatinine clearance.
Danish: Den renale clearance (ca. 60 ml/min hos raske postmenopausale kvinder) udgør 50-60 % af den totale clearance og er relateret til kreatininclearance.
English: - Take one Bondenza 150 mg tablet once a month.
Danish: - Tag én Bondenza 150 mg tablet én gang om måneden.
English: Bondenza intravenous injection decreased levels of serum C-telopeptide of the alpha chain of Type I collagen (CTX) within 3 - 7 days of starting treatment and decreased levels of osteocalcin within 3 months.
Danish: Intravenøse injektioner med Bondenza nedsatte koncentrationen af serum-C-telopeptid af alfakæden af type I kollagen (CTX) indenfor 3-7 dage efter påbegyndelsen af behandlingen og af osteocalcin indenfor 3 måneder.
English: Once you've taken your tablet, put a tick in the box on the sticker.
Danish: Så snart du har indtaget din tablet, krydser du af i feltet på huskesedlen.
English: - Tablets should be swallowed whole with a glass of water (180 to 240 ml) while the patient is sitting or standing in an upright position.
Danish: - Tabletterne skal synkes hele med et glas vand (180 til 240 ml), mens patienten sidder ned eller står op. Vand med en høj calciumkoncentration må ikke anvendes.
English: No specific information is available on the treatment of overdosage with Bondenza.
Danish: Der er ingen tilgængelig specifik information vedrørende behandling af overdosering med Bondenza.
English: Milk or antacids should be given to bind Bondenza, and any adverse reactions treated symptomatically.
Danish: Der bør indtages mælk eller antacida med henblik på at binde Bondenza, og bivirkninger behandles symptomatisk.
English: Bondenza 3 mg injection every 3 months
Danish: Bondenza 3 mg injektion hver 3 måned
English: In healthy male volunteers and postmenopausal women, intravenous administration of ranitidine caused an increase in ibandronic acid bioavailability of about 20 %, probably as a result of reduced gastric acidity.
Danish: Hos raske mandlige forsøgspersoner og hos postmenopausale kvinder medførte intravenøs administration af ranitidin en ca. 20 % øgning i biotilgængeligheden af ibandronsyre, formentlig som et resultat af den reducerede gastriske surhedsgrad.
English: Calcium supplements, antacids and some oral medicinal products containing multivalent cations Calcium supplements, antacids and some oral medicinal products containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Bondenza.
Danish: Calciumtilskud, antacida og visse orale lægemidler indeholdende multivalente kationer Calciumtilskud, antacida samt visse orale lægemidler indeholdende multivalente kationer (som f.eks. aluminium, magnesium, jern), vil sandsynligvis påvirke absorptionen af Bondenza.
English: Do not receive Bondenza - if you have, or had in the past, low blood calcium.
Danish: Du må ikke få Bondenza: - hvis du har, eller har haft et lavt indhold af kalk i blodet.
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: The recommended dose of Bondenza for the intravenous injection is 3 mg (1 pre-filled syringe) once every 3 months.
Danish: Den anbefalede dosis af Bondenza til intravenøs injektion er 3 mg (1 fyldt injektionssprøjte) én gang hver 3. måned.
English: Paediatric population (see section 4.2 and section 5.1) There are no data on the use of Bondenza in these age groups.
Danish: 4.2 og 5.1) Der foreligger ingen data vedrørende brugen af Bondenza til disse aldersgrupper.
English: Care must be taken not to administer Bondenza injection via intra-arterial or paravenous administration as this could lead to tissue damage.
Danish: Der skal udvises forsigtighed for ikke at give Bondenza-injektionerne intraarterielt eller paravenøst, da det kan medføre vævsskader.
English: Physicians should be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue Bondenza 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 Bondenza-behandlingen og kontakte læge, hvis de udvikler dysfagi, odynofagi, retrosternal smerte eller nyopstået eller forværret halsbrand.
English: A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
Danish: En tandundersøgelse med passende forebyggende tandlægearbejde bør overvejes hos patienter med samtidige risikofaktorer (som kræft, kemoterapi, strålebehandling, kortikosteroider, dårlig mundhygiejne) før behandling med bisphosphonater.
English: Bondenza tablets are white to off white, of oblong shape and marked “BNVA” on one side, and “150” on the other side.
Danish: Bondenza tabletter er hvide til råhvide, aflange og mærket med ”BNVA” på den ene side og ”150” på den anden side.
English: Elderly population (>65 years) No dose adjustment is required (see section 5.2).
Danish: Ældre population (> 65 år) Dosisjustering er ikke nødvendig (se pkt.
English: The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration and plasma concentrations increase in a dose-proportional manner up to 50 mg oral intake, with greater than dose-proportional increases seen above this dose.
Danish: Absorptionen af ibandronsyre i den øvre mavetarmkanal er hurtig efter oral administration og plasmakoncentrationen øges dosisafhængigt op til 50 mg oral indtagelse, mens der ses større end dosis-proportionale stigninger over denne dosis.
English: Pre-filled syringes (5 ml) made of colourless type I glass, the grey rubber plunger stopper and tip cap are made of fluororesin-laminated butyl rubber, containing 3 ml of solution for injection.
Danish: Forfyldte injektionssprøjter (5 ml) lavet af farveløst type I glas, den grå gummistempelstopper og gummiproppen er lavet af fluoresinlamineret butylgummi, indeholder 3 ml opløsning til injektion.
English: Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Bondenza 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 Bondenza gives til patienter med aktive øvre gastrointestinale problemer (f.eks. diagnosticeret Barretts øsofagitis, dysfagi, andre sygdomme i spiserøret, gastritis, duodenitis eller ulcus).
English: Bondenza 3 mg solution for injection in pre-filled syringe must not be mixed with calcium-containing solutions (such as Ringer-Lactate solution, calcium heparin) or other intravenously administered medicinal products.
Danish: Bondenza 3 mg injektionsvæske i fyldte injektionssprøjter må ikke blandes med opløsninger som indeholder calcium (som f.eks Ringer-Laktat opløsning, calcium heparin) eller andre intravenøst administrerede lægemidler.
English: You may develop low levels of calcium, phosphorus or magnesium in the blood.
Danish: Du kan få lave koncentrationer af kalk, fosfor eller magnesium i blodet.
English: The recommended dose is one 150 mg film-coated tablet once a month.
Danish: Den anbefalede dosis er én 150 mg filmovertrukken tablet én gang om måneden.
English: The safety profile of Bondenza is derived from controlled clinical trials and post-marketing experience .
Danish: Bondenzas sikkerhedsprofil stammer fra kontrollerede kliniske forsøg og bivirkninger set efter markedsføring.
English: No dose adjustment is necessary for patients with mild or moderate renal impairment (CLcr equal or greater than 30 ml/min), as shown in study BM 16549 where the majority of patients had mild to moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig for patienter med mild eller moderat nyrefunktionsnedsættelse (CLcr ≥ 30 ml/min), som vist i studie BM 16459, hvor de fleste patienter havde mild til moderat nyrefunktionsnedsættelse.
English: Therefore, patients should fast overnight (at least 6 hours) before taking Bondenza and continue fasting for 1 hour following intake of Bondenza (see section 4.2).
Danish: Patienterne skal derfor faste natten over (mindst 6 timer) inden indtagelse af Bondenza og fortsætte med at faste 1 time efter indtagelsen af Bondenza (se pkt.
English: There are no adequate data from the use of ibandronic acid in pregnant women.
Danish: Der er ikke tilstrækkelig erfaring med anvendelse af ibandronsyre til gravide.
English: Bioavailability is reduced by about 90 % when ibandronic acid is administered with a standard breakfast in comparison with bioavailability seen in fasted subjects.
Danish: Biotilgængeligheden reduceres med ca. 90 %, når ibandronsyre indtages sammen med et almindeligt morgenmåltid i forhold til biotilgængeligheden hos personer i fastetilstand.
English: Bondenza 150 mg once monthly
Danish: Bondenza 150 mg én gang om måneden