FrancophonIA/ELRC3.0 huggingface dataset:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use For intravenous use only
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Læs indlægssedlen inden brug Kun til intravenøs brug
English: • muscle cramps, stiffness of your joints and limbs
Danish: • muskelkramper, stivhed i dine led og lemmer
English: Talk to a nurse or doctor if any effects become troublesome or last more than a couple of days
Danish: Tal med sundhedspersonalet eller lægen, hvis nogle af symptomerne bliver generende eller varer mere end et par dage.
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid Bondenza nøjagtigt efter lægens anvisning.
English: Bondenza is prescribed to you to treat postmenopausal osteoporosis because you have an increased risk of fractures.
Danish: Bondenza er ordineret til dig til behandling af osteoporose (knogleskørhed) efter menopausen (overgangsalderen), fordi du har en øget risiko for knoglebrud.
English: In addition, 64.8 % of patients receiving 3 mg every 3 months injection were identified as responders (defined as a decrease ≥50 % from baseline), compared with 64.9 % of patients receiving 2.5 mg daily orally.
Danish: Desuden var 64,8 % af patienterne som fik injektion med 3 mg hver 3. måned, respondenter (defineret som et fald på ≥50 % fra baseline), sammenlignet med 64,9 % af patienterne som fik 2,5 mg daglig oralt.
English: Do not inject Bondenza yourself.
Danish: Injicer ikke Bondenza selv.
English: Bondenza 3 mg solution for injection in pre-filled syringe should be injected intravenously over a period of 15 - 30 seconds.
Danish: Bondenza 3 mg injektionsvæske i fyldte injektionssprøjter skal injiceres intravenøst over 15 - 30 sekunder.
English: Medicinal product-Food Interaction
Danish: Lægemiddel-fødevareinteraktion
English: Bondenza 150 mg once monthly (N=291)
Danish: Bondenza 150 mg én gang om måneden (N=291)
English: Gender Bioavailability and pharmacokinetics of ibandronic acid are similar in men and women.
Danish: Køn Biotilgængeligheden og farmakokinetikken for ibandronsyre er ens hos mænd og kvinder.
English: - If you have any swallowing or digestive problems.
Danish: - hvis du har synkebesvær eller problemer med fordøjelsen.
English: The usual dose of Bondenza is one tablet once a month.
Danish: Den sædvanlige dosis Bondenza er 1 tablet én gang om måneden.
English: The histological analysis of bone biopsies after two and three years of treatment of postmenopausal women with doses of oral ibandronic acid 2.5 mg daily and intermittent intravenous doses of up to 1 mg every 3 months showed bone of normal quality and no indication of a mineralisation defect.
Danish: Den histologiske analyse af knoglebiopsier efter to- og tre-års behandling af postmenopausale kvinder med orale ibandronsyre -doser på 2,5 mg daglig og intermitterende intravenøse doser på op til 1 mg hver 3. måned, viste knogler af normal kvalitet og ingen tegn på mineraliseringsdefekt.
English: In animal models ibandronic acid produced biochemical changes indicative of dose-dependent inhibition of bone resorption, including suppression of urinary biochemical markers of bone collagen degradation (such as deoxypyridinoline, and cross-linked N-telopeptides of type I collagen (NTX)).
Danish: I dyrestudier resulterede ibandronsyre biokemiske ændringer, som indikerer en dosisafhængig hæmning af knogleresorptionen, herunder suppression af biokemiske urinmarkører for nedbrydning af knoglekollagen (som f.eks. deoxypyridinolin og kollagen type 1 krydsbundne N-telopeptider (NTX)).
English: Hypocalcaemia and other disturbances of bone and mineral metabolism should be assessed and effectively treated before starting Bondenza injection therapy.
Danish: Hypokalcæmi og andre forstyrrelser af knogle- og mineralmetabolismen skal vurderes og behandles effektivt før behandlingen med Bondenza-injektioner påbegyndes.
English: Biochemical markers of bone turnover (such as urinary CTX and serum Osteocalcin) showed the expected pattern of suppression to premenopausal levels and reached maximum suppression within a period of 3-6 months.
Danish: Biokemiske markører for knogleomsætning (som f.eks. urin-CTX og serum-osteocalcin) viste det forventede suppressionsmønster til præmenopausale værdier og maksimal suppression opnåedes indenfor 3-6 måneder.
English: PEEL-OFF STICKERS FOR YOUR PERSONAL CALENDAR Monthly tablet
Danish: AFTAGELIGE KLISTERMÆRKER TIL DIN PERSONLIGE KALENDER Månedlig tablet Månedlig tablet Månedlig tablet Bondenza
English: An expected decrease in bone turnover, normal quality of bone and absence of defects in mineralization were also seen after two years of treatment with Bondenza 3 mg injection.
Danish: Der blev også set et forventet fald i knogleomsætning, normal knoglekvalitet og fravær af mineraliseringsdefekt efter 2-års behandling med i.v.
English: There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before the first food of the day.
Danish: Der er ingen relevant nedsættelse af biotilgængeligheden, når Bondenza indtages 60 minutter før dagens første måltid.
English: The concentration of ibandronic acid in the solution for injection is 1mg per ml.
Danish: Koncentrationen af ibandronsyre i injektionsvæske, opløsning er 1 mg pr. ml.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere informationer om Bondenza findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Please see the Summary of Product Characteristics for more information.
Danish: Se produktresuméet vedrørende yderligere oplysninger.
English: Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
Danish: Knoglenekrose i kæben er normalt forbundet med tandudtrækning og / eller lokal infektion (herunder osteomyelitis).
English: Appropriate medical support and monitoring measures should be readily available when Bondenza intravenous injection is administered.
Danish: Passende nødhjælpsforanstaltninger skal være let tilgængelige, når intravenøs injektion med Bonviva administreres.
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: What you need to know before you receive Bondenza
Danish: Det skal du vide, før du begynder at få Bondenza
English: Date of latest renewal: 20.02.2009
Danish: Dato for første markedsføringstilladelse: 23. februar 2004 Dato for seneste fornyelse: 20. februar 2009
English: How to take Bondenza).
Danish: Sådan skal du tage Bondenza).
English: - If you have certain problems with your gullet/food pipe (oesophagus) such as narrowing or difficulty swallowing.
Danish: - hvis du har visse problemer med spiserøret, såsom indsnævring eller synkebesvær.
English: Where Bondenza is administered via an existing intravenous infusion line, the intravenous infusate should be restricted to either isotonic saline or 50 mg/ml (5 %) glucose solution.
Danish: Hvis Bondenza administreres via en eksisterende intravenøs infusionsslange skal infusionsvæsken begrænses til enten isotonisk saltvand eller 50 mg/ml (5 %) glucoseopløsning.
English: Continuing to receive Bondenza
Danish: Fortsat indtagelse af Bondenza
English: A clinically meaningful reduction of 50 % of biochemical markers of bone resorption was observed as early as one month after start of treatment with ibandronic acid 2.5 mg.
Danish: En klinisk relevant reduktion på 50 % i biokemiske markører for knogleresorption blev observeret allerede en måned efter start på behandling med ibandronsyre 2,5 mg.
English: Ask your doctor or pharmacist for advice before taking this medicine.
Danish: Tal med din læge eller apoteket før du tager dette lægemiddel.
English: Cases of serious, sometimes fatal, allergic reaction have been reported in patients treated with intravenous ibandronic acid.
Danish: Der er rapporteret om tilfælde af alvorlige, nogle gange dødelige, allergiske reaktioner hos patienter, der har fået ibandronsyre intravenøst.
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: One year data in study BM 16549 Two year data in study BM 16549
Danish: Et-års data fra studie BM 16550 To-års data fra studie BM 16550
English: - Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1 - Hypocalcaemia - Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia - Inability to stand or sit upright for at least 60 minutes
Danish: 6.1 - Hypokalcæmi - Anormaliteter i spiserøret, som forsinker tømning af spiserøret, såsom forsnævring eller akalasi - Manglende evne til at stå eller sidde oprejst i mindst 60 minutter
English: The overall proportion of patients who experienced an adverse reaction was 26.0 % and 28.6 % for Bondenza 3 mg injection every 3 months after one year and two years, respectively.
Danish: Det totale antal patienter, som havde en bivirkning, var 26,0 % og 28,6 % for Bondenza 3 mg injektion hver 3. måned efter henholdsvis et og to år.
English: Sodium chloride
Danish: Natriumchlorid Iseddikesyre
English: Pharmacokinetics in special clinical situations
Danish: Farmakokinetik hos særlige populationer
English: Do not take Bondenza - If you are allergic to ibandronic acid, or any of the other ingredients of this medicine listed in section 6).
Danish: Tag ikke Bondenza: - hvis du er allergisk over for ibandronsyre eller et af de øvrige indholdsstoffer i Bondenza
English: White to off white film-coated tablets, of oblong shape marked “BNVA” on one side, and “150” on the other side.
Danish: Hvide til råhvide, aflange, filmovertrukne tabletter mærket ”BNVA” på den ene side og ”150” på den anden side.
English: Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates.
Danish: Knoglenekrose i kæben, normalt i forbindelse med tandudtrækning og /eller lokal infektion (herunder osteomyelitis), er rapporteret blandt kræftpatienter, der får behandlingsregimer inkluderende primært intravenøst administrerede bisphosphonater.
English: - You should take calcium and vitamin-D supplements while receiving Bondenza.
Danish: - Du skal tage et tilskud af kalk og vitamin D, mens du får Bondenza.
English: The liver has no significant role in the clearance of ibandronic acid which is not metabolised but is cleared by renal excretion and by uptake into bone.
Danish: Leveren spiller ikke nogen væsentlig rolle ved udskillelsen af ibandronsyre, som ikke metaboliseres, men udskilles via nyrerne, samt optages i knoglerne.
English: Do not use this medicine after the expiry date which is stated on the carton and on the syringe after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, som er angivet på den ydre pakning og på injektionsprøjten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Also contains sodium chloride, glacial acetic acid, sodium acetate trihydrate, water for injections.
Danish: Indeholder også natriumchlorid, iseddikesyre, natriumacetattrihydrat, vand til injektionsvæsker.
English: Bondenza solution for injection must not be mixed with calcium-containing solutions or other intravenously administered medicinal products.
Danish: Bondenza-injektionsvæske, opløsning må ikke blandes med calciumholdige opløsninger eller andre intravenøst administrerede lægemidler.
English: What Bondenza contains
Danish: Bondenza indeholder:
English: • severe pain in the chest, severe pain after swallowing food or drink, severe nausea, or vomiting, difficulty in swallowing.
Danish: • stærk smerte efter at have sunket mad eller drikke, voldsom kvalme eller opkastning, synkebevær.
English: Most cases of adverse reactions did not lead to cessation of therapy
Danish: De fleste tilfælde af bivirkninger førte ikke til seponering.
English: In case a dose is missed, patients should be instructed to take one Bondenza 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 Bondenza-tablet 150 mg, skal de tage den næste morgen forudsat, at der er mindst 7 dage til næste dosis.
English: 1 film-coated tablet
Danish: 1 filmovertrukken tablet
English: The overall proportion of patients who experienced an adverse reaction, was 22.7 % and 25.0 % for Bondenza 150 mg once monthly after one and two years, respectively.
Danish: Andelen af patienter med bivirkninger var 22,7 % og 25,0 % for Bondenza 150 mg én gang om måneden efter henholdsvis et og to år.
English: Incidence of new morphometric vertebral fractures Relative risk reduction of clinical vertebral fracture Incidence of clinical vertebral fracture
Danish: Relativ risikoreduktion Nye morfometriske vertebrale frakturer Hyppighed af nye morfometriske vertebrale frakturer Relativ risikoreduktion af kliniske vertebrale frakturer Hyppighed af kliniske vertebrale frakturer
English: What you need to know before you take Bondenza
Danish: Det skal du vide, før du begynder at tage Bondenza
English: Bondenza 3 mg solution for injection in pre-filled syringe like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Danish: Bondenza 3 mg injektionsvæske i fyldte injektionssprøjter kan, som andre intravenøst administrerede bisphosphonater, forårsage forbigående fald i værdierne for serum-calcium.
English: Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
Danish: Knoglenekrose i kæben er også rapporteret blandt patienter med osteoporose, der får orale bisphosphonater.
English: General disorders and administration site conditions reactions, Asthenia
Danish: Almene symptomer og reaktioner på administrationsstedet injektionsstedet,
English: Administration of Bondenza 3 mg solution for injection in pre-filled syringe:
Danish: Administration af Bondenza 3 mg injektionsvæske i fyldte injektionssprøjter:
English: Each prefilled syringe contains 3 ml of solution.
Danish: Hver injektionssprøjte indeholder 3 ml opløsning.
English: - The other ingredients are sodium chloride, acetic acid, sodium acetate trihydrate and water for injections.
Danish: - De øvrige indholdsstoffer er natriumchlorid, eddikesyre, natriumacetattrihydrat og vand til injektionsvæsker.
English: Based on knowledge of this class of compounds, intravenous overdosage may result in hypocalcaemia, hypophosphataemia, and hypomagnesaemia, which can cause paraesthesia.
Danish: Baseret på kendskabet til denne lægemiddelklasse kan overdosering medføre hypokalcæmi , hypophosphatæmi og hypomagnesæmi, som kan forårsage paræstesier.
English: In a Phase 1 bioequivalence study conducted in 72 postmenopausal women receiving 150 mg orally every 28 days for a total of four doses, inhibition in serum CTX following the first dose was seen as early as 24 hours post-dose (median inhibition 28 %), with median maximal inhibition (69 %) seen
Danish: I et fase I bioækvivalens-studie hos 72 postmenopausale kvinder, som fik 150 mg oralt hver 28. dag, i alt 4 doser, blev der set hæmning af serum-CTX efter første dosis allerede 24 timer efter indtagelsen
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
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: Af de mere end 1.500 patienter, som indgik i studie BM 16549, der sammenlignede månedlig behandling med ibandronsyre med daglig behandling, anvendte 14 % og 18 % H2-receptorantagonister eller syrepumpehæmmere efter henholdsvis et og to år.
English: In particular, products containing calcium, including milk, and other multivalent cations (such as aluminium, magnesium, iron), are likely to interfere with absorption of Bondenza, which is consistent with findings in animal studies.
Danish: Specielt produkter indeholdende calcium, herunder mælk og andre multivalente kationer (som f.eks. aluminium, magnesium, jern) vil sandsynligvis påvirke absorptionen af Bondenza.
English: If you experience one of the following symptoms, such as shortness of breath/difficulty breathing, tight feeling in throat, swelling of tongue, dizziness, feeling of loss of consciousness, redness or swelling of face, body rash, nausea and vomiting, you should immediately alert your doctor or nurse (see section 4).
Danish: Du skal omgående kontakte læge eller sundhedspersonale, hvis du oplever et af følgende symptomer: Åndenød/vejrtrækningsbesvær, følelse af at halsen snørrer sig sammen, hævelse af tungen, svimmelhed, følelse af at miste bevidstheden, rødme eller hævelse af ansigtet, hududslæt, kvalme og opkastning (se punkt 4)..
English: Existing hypocalcaemia must be corrected before starting Bondenza therapy.
Danish: Eksisterende hypokalcæmi skal behandles, før behandling med Bondenza initieres.
English: If you are breast-feeding, you will need to stop breast-feeding in order to receive Bondenza.
Danish: Hvis du ammer, skal du stoppe med amningen for at kunne få Bondenza.
English: The proportion of patients who increased or maintained their BMD at one year at both lumbar spine and total hip was 76.2 % in the 3 mg injection every 3 months arm and 67.2 % in the 2.5 mg daily orally arm (p=0.007).
Danish: Efter et år var andelen af patienter som øgede eller fastholdt deres BMD for både lumbal og hofte, 76,2 % i behandlingsarmen med 3 mg injektion hver 3. måned og 67,2 % i armen med 2,5 mg daglig oralt (p=0,007).
English: You may have a severe inflammation of your gullet/food pipe, possibly with sores or constriction of the gullet/food pipe
Danish: Du kan have en alvorlig betændelse i spiserøret muligvis med sår, eller forsnævringer i spiserøret.
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 16550.
Danish: Tabel 2: Gennemsnitlig relativ ændring i BMD fra baseline af lumbal columna, total hofte, lårbenshals og trochanter efter et års (primær analyse) og to års behandling (per protokol population) i studie BM 16550
English: Table 3: Results from 3 years fracture study MF 4411 (%, 95 % CI) Placebo (N=974)
Danish: Tabel 3: Resultater fra 3-års frakturstudiet MF 4411 (%, 95 % konfidensinterval) Placebo (N=974)
English: Packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.
Danish: Pakninger indeholdende 1 forfyldt sprøjte og 1 injektionskanyler eller 4 forfyldte sprøjter og 4 injektionskanyler.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Danish: Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Subjects with severe renal impairment (CLcr less than 30 ml/min) receiving daily oral administration of 10 mg ibandronic acid for 21 days, had 2 - 3 fold higher plasma concentrations than subjects with normal renal function and total clearance of ibandronic acid was 44 ml/min.
Danish: Patienter med svært nedsat nyrefunktion (CLcr < 30 ml/min) som fik 10 mg oral ibandronsyre dagligt i 21 dage, havde 2-3 gange højere plasmakoncentrationer end personer med normal nyrefunktion og den totale ibandronsyre clearance var 44 ml/min.
English: Protein binding in human plasma is approximately 85 % - 87 % (determined in vitro at therapeutic concentrations), and thus there is a low potential for interaction with other medicinal products due to displacement.
Danish: Proteinbindingen i humant plasma er ca. 85-87 % (bestemt in vitro ved terapeutiske koncentrationer).
English: Water for injections
Danish: Natriumacetattrihydrat Vand til injektionsvæsker
English: Patients should receive supplemental calcium and / or vitamin D if dietary intake is inadequate (see section 4.4 and section 4.5).
Danish: Patienten bør have et calcium- og/eller vitamin D-tilskud, hvis der ikke indtages nok gennem kosten (se pkt.
English: Bondenza 3 mg injection every 3 months (N=365)
Danish: Bondenza 3 mg injektion hver 3. måned (N=365)
English: 1 pre-filled syringe + 1 injection needle 4 pre-filled syringes + 4 injection needles
Danish: 1 fyldt injektionssprøjte + 1 kanyle 4 fyldte injektionssprøjter + 4 kanyler
English: Based on the results of study BM 16549, Bondenza 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 Bondenza 150 mg én gang om måneden at være mindst ligeså effektivt med hensyn til at forebygge frakturer som ibandronsyre 2,5 mg daglig.
English: Bondenza should not be used during breastfeeding.
Danish: Bondenza bør ikke anvendes under amning.
English: For total hip BMD, 82.3 % of patients receiving 3 mg injection every 3 months were responders at one year, compared with 75.1 % of patients receiving 2.5 mg daily orally (p=0.02).
Danish: Med hensyn til hofte BMD var 82,3 % af patienterne, som fik en 3 mg injektion hver 3. måned, respondenter efter et år sammenlignet med 75,1 % af patienterne som fik 2,5 mg dagligt oralt (p=0,02).
English: Instead, consult your calendar and find out when your next scheduled dose is:
Danish: Kig i stedet i din kalender og find ud af hvornår din næste planlagte dosis skal indtages: Hvis din næste planlagte dosis skal tages efter kun 1 til 7 dage.
English: Bondenza should be taken after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day (see section 4.5) or any other oral medicinal products or supplementation (including calcium).
Danish: Bondenza skal indtages efter faste om natten (mindst 6 timer) og 1 time før dagens første indtagelse af mad- og drikkevarer (andet end vand) (se pkt.
English: The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at lumbar spine of 2 to 5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
Danish: Undersøgelsen omfattede kvinder i alderen 55 til 80 år, som var mindst 5 år postmenopausale, havde et lumbal BMD på 2 til 5 SD under den præmenopausale middelværdi (Tscore) i mindst én ryghvirvel [L1-L4], og som havde haft 1-4 tidligere vertebrale frakturer.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/266/003 1 film-coated tablet EU/1/03/266/004 3 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/03/266/003 1 filmovertrukken tablet EU/1/03/266/004 3 filmovertrukne tabletter
English: INFORMATION IN BRAILLE [Justification for not including Braille accepted]
Danish: INFORMATION I BRAILLESKRIFT Fritaget fra krav om brailleskrift
English: Bondenza 150 mg film-coated tablets Ibandronic acid
Danish: Bondenza 150 mg filmovertrukne tabletter Ibandronsyre