FrancophonIA/ELRC3.0 huggingface dataset:
English: Other things that can increase the risk of fractures include: - not enough calcium and vitamin D in the diet - smoking, or drinking too much alcohol - not enough walking or other weight-bearing exercise - a family history of osteoporosis
Danish: Andre forhold som kan øge risikoen for knoglebrud er: - for lidt kalk og vitamin D i kosten - rygning eller for meget alkohol - ikke nok gåture eller anden vægtbærende aktivitet - osteoporose i familien
English: After one year (primary analysis) the median relative change from baseline was -76 % for Bondenza 150 mg once monthly and -67 % for ibandronic acid 2.5 mg daily.
Danish: Efter et år (primær analyse) var de mediane, relative ændringer fra baseline -76 % for gruppen, som fik Bondenza 150 mg én gang om måneden og -67 % for gruppen, som fik ibandronsyre 2,5 mg daglig.
English: Bondenza 3 mg injection every 3 months (N=334)
Danish: Bondenza 3 mg injektion hver 3. måned (N=334)
English: Gender Pharmacokinetics of ibandronic acid are similar in men and women.
Danish: Køn Farmakokinetikken for ibandronsyre er ens hos mænd og kvinder.
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 frakturstudiet MF 4411 (%, 95 % konfidensinterval) for patienter med lumbal columna BMD T-score under -2,5 ved baseline
English: At one year, 83.5 % (p= 0.006) of patients receiving Bondenza 150 mg once monthly and 73.9 % of patients receiving ibandronic acid 2.5 mg daily were identified as responders (defined as a decrease ≥50 % from baseline).
Danish: Efter et år var 83,5 % (p=0,006) af patienterne, som fik Bondenza 150 mg én gang om måneden og 73,9 % af patienterne, som fik ibandronsyre 2,5 mg daglig, identificeret som respondenter (defineret som et fald ≥ 50 % fra baseline).
English: .Table 1: Adverse reactions occurring in postmenopausal women receiving Bondenza 3 mg injection every 3 months or ibandronic acid 2.5 mg daily in the phase III studies BM16550 and MF 4411, and in post-marketing experience.
Danish: Tabel 1: Bivirkninger hos postmenopausale kvinder, som fik Bondenza 3 mg som injektion hver 3. måned eller ibandronsyre 2,5 mg daglig i fase III studierne BM16550 og MF4411, samt bivirkninger set efter markedsføring.
English: However, based on a knowledge of this class of compounds, oral overdose may result in upper gastrointestinal adverse reactions (such as upset stomach, dyspepsia, oesophagitis, gastritis, or ulcer) or hypocalcaemia.
Danish: Baseret på erfaringer fra lignende præparater inden for samme klasse vides det dog, at overdosering kan forårsage øvre gastrointestinale bivirkninger (som f.eks. mavebesvær, dyspepsi, oesophagitis, gastritis eller mavesår) eller hypokalcæmi.
English: There is no relevant use of Bondenza in children below 18 years, and Bondenza was not studied in this population.
Danish: Anvendelse af Bondenza er ikke relevant hos børn under 18 år, og der er ingen erfaring med behandling af denne population (se pkt.
English: In humans, the efficacy of both daily and intermittent administration with a dose-free interval of 9-10 weeks of ibandronic acid was confirmed in a clinical trial (MF 4411), in which ibandronic acid demonstrated anti-fracture efficacy.
Danish: Hos mennesker blev effekten af både daglig og intermitterende administration af ibandronsyre med et dosisfrit interval på 9-10 uger bekræftet i et klinisk studie (MF 4411).
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 et-års (primær analyse) og to-års behandling (per-protokol population) i studie BM 16549
English: • stomach pain (such as gastritis) or tummy pain, , indigestion, nausea, having diarrhoea (loose bowels) or constipation
Danish: • mavesmerter (så som mavekatar eller mave-tarmkatar), fordøjelsesbesvær, kvalme, diarré (løs mave) eller forstoppelse.
English: Bondenza 3 mg solution for injection in pre-filled syringes is a clear colourless solution.
Danish: Bondenza 3 mg injektionsvæske, opløsning i fyldte injektionssprøjter er en klar, farveløs opløsning.
English: In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of Bondenza 150 mg once monthly and ibandronic acid 2.5 mg daily was similar.
Danish: I et to-års studie hos postmenopausale kvinder med osteoporose (BM 16549) var sikkerheden af Bondenza 150 mg én gang om måneden den samme som for ibandronsyre 2,5 mg daglig.
English: NAME OF THE MEDICINAL PRODUCT Bondenza 150 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Bondenza 150 mg filmovertrukne tabletter.
English: Bondenza is available in packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.
Danish: Bondenza kan fås i pakninger indeholdende 1 fyldt injektionssprøjte og 1 injektionskanyle eller 4 fyldte injektionssprøjter og 4 injektionskanyler.
English: Among these patients, the incidence of upper gastrointestinal events in the patients treated with Bondenza 150 mg once monthly was similar to that in patients treated with ibandronic acid 2.5 mg daily.
Danish: Incidensen af øvre gastrointestinale hændelser var den samme hos patienter, som blev behandlet med 150 mg Bondenza én gang om måneden, som hos patienter, som blev behandlet med 2,5 mg ibandronsyre daglig.
English: Due to limited clinical experience, Bondenza is not recommended for patients with a creatinine clearance below 30 ml/min (see section 5.2).
Danish: På grund af begrænset klinisk erfaring anbefales Bondenza ikke til patienter med kreatinin-clearance lavere end 30 ml/min (se pkt 5.2).
English: At two years, 87.1 % (p<0.001) and 70.5 %,of patients met this criterion in the 150 mg monthly and 2.5 mg daily arms respectively.
Danish: Efter to år mødte 87,1 % (p<0,001) og 70,5 % af patienterne dette kriterie i armene for henholdsvis 150 mg én gang om måneden og 2,5 mg daglig.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere informationer om Bondenza er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: When a more stringent criterion is considered, which combines both lumbar spine and total hip BMD, 83.9 % (p<0.001) and 65.7 % of patients receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders at one year.
Danish: Hvis der blev anvendt et mere stringent kriterie, ved kombination af lumbal BMD og hofte BMD, var 83,9 % (p<0,001) og 65,7 % af patienterne, som henholdsvis fik Bondenza 150 mg én gang om måneden eller ibandronsyre 2,5 mg daglig, respondenter efter et år.
English: After 2 years of treatment, 85.6 % of patients receiving 3 mg injections and 77.0 % of patient receiving 2.5 mg oral therapy had increased or maintained total hip BMD (p=0.004).
Danish: Efter 2-års behandling havde 85,6 % af patienterne, som fik injektion med 3 mg og 77,0 % af patienterne, som fik 2,5 mg oralt, øget eller fastholdt hofte BMD (p=0,004).
English: If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose absorption), talk to your doctor before taking this medicine.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler eller kan fordøje visse sukkerarter (f.eks. hvis du har galaktoseintolerans, Lapp laktasemangel eller har problemer med glukose-galaktose optagelse).
English: At two years, 93.5 % (p=0.004) and 86.4 % of patients receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders.
Danish: Efter to år var 93,5 % (p=0,004) og 86,4 % af de patienter, som fik henholdsvis Bondenza 150 mg én gang om måneden eller ibandronsyre 2,5 mg daglig, respondenter.
English: Other disturbances of bone and mineral metabolism should also be effectively treated before starting Bondenza injection therapy.
Danish: Andre forstyrrelser i knogle - og mineralmetabolismen skal ligeledes behandles effektivt før behandlingen med Bondenza-injektioner påbegyndes.
English: Bondenza was not studied in the paediatric population, therefore no efficacy or safety data are available for this patient population
Danish: Der foreligger derfor ingen data om sikkerhed og virkning hos denne patientgruppe.
English: Acetylsalicylic acid and NSAIDs In a two-year study in postmenopausal women with osteoporosis (BM 16549), the incidence of upper gastrointestinal events in patients concomitantly taking acetylsalicylic acid or NSAIDs was similar in patients taking ibandronic acid 2.5 mg daily or 150 mg once monthly after one and two years.
Danish: I et to-års studie hos postmenopausale kvinder med osteoporose (BM 16549) var incidensen af øvre gastrointestinale hændelser hos patienter, som samtidig tog acetylsalicylsyre eller NSAIDs, den samme hos patienter, som tog ibandronsyre 2,5 mg daglig eller 150 mg én gang om måneden efter et og to år.
English: Bondenza 3 mg intravenous injection, administered every 3 months, was shown to be at least as effective as oral ibandronic acid 2.5 mg daily in a 2-year, randomised, double-blind, multicentre, noninferiority study (BM16550) of postmenopausal women (1386 women aged 55 - 80) with osteoporosis (lumbar spine BMD T-score below -2.5 SD at baseline).
Danish: I et 2-års, randomiseret, dobbeltblindet, non-inferiority, multicenterstudie (BM 16550) var intravenøs injektion af Bondenza 3 mg hver 3. måned mindst ligeså effektivt som oral ibandronsyre 2,5 mg daglig hos postmenopausale kvinder (1.386 kvinder i alderen 55-80 år) med osteoporose (lumbal BMD T-score under - 2,5 SD ved baseline).
English: If you're breast feeding, you may need to stop in order to take Bondenza.
Danish: Hvis du skal tage Bondenza, bør du holde op med at amme.
English: What Bondenza contains - The active substance is ibandronic acid.
Danish: Bondenza indeholder: - Det aktive stof er ibandronsyre.
English: Most cases did not lead to cessation of therapy.
Danish: I de fleste tilfælde medførte bivirkningerne ikke seponering.
English: One tablet contains 150 mg of ibandronic acid (as sodium monohydrate).
Danish: Hver tablet indeholder 150 mg ibandronsyre (som natriummonohydrat).
English: Furthermore, Bondenza 150 mg once monthly was proven superior to ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p=0.002, and at two years, p<0.001.
Danish: Desuden blev det i en prospektiv planlagt analyse vist, at Bondenza 150 mg én gang om måneden var bedre end ibandronsyre 2,5 mg daglig mht. stigning i lumbal BMD efter et år p=0,002 og efter to år p<0,001.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/266/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/03/266/003
English: At one year (primary analysis), 91.3 % (p=0.005) of patients receiving Bondenza 150 mg once monthly had a lumbar spine BMD increase above or equal to baseline (BMD responders), compared with 84.0 % of patients receiving ibandronic acid 2.5 mg daily.
Danish: Efter et år (primær analyse) havde 91,3 % (p=0,005) af de patienter, som fik Bondenza 150 mg én gang om måneden, en stigning i lumbal BMD over eller lig baseline (BMD-respondenter), sammenlignet med 84,0 % af de patienter, som fik ibandronsyre 2,5 mg daglig.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 150 mg ibandronsyre (som natriummonohydrat).
English: - Take your Bondenza tablet after you first get up for the day, and before you have anything to eat or drink (on an empty stomach) - Swallow your tablet with a full glass of water (at least 180 ml).
Danish: - Indtag Bondenza tabletten før du har fået noget at spise eller drikke (dvs. på tom mave)
English: Protein binding in human plasma is approximately 85 % - 87 % (determined in vitro at therapeutic ibandronic acid concentrations), and thus there is a low potential for interaction with other medicinal products due to displacement.
Danish: Proteinbindingen i humant plasma er ca. 8587 % (bestemt in vitro ved terapeutiske ibandronsyrekoncentrationer).
English: Table 1: Adverse reactions occurring in postmenopausal women receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily in the phase III studies BM16549 and MF4411 and in postmarketing experience.
Danish: Bivirkninger hos postmenopausale kvinder, som fik Bondenza 150 mg én gang månedlig eller ibandronsyre 2,5 mg daglig i fase III studierne BM16549 og MF4411, samt bivirkninger set efter markedsføring.
English: - The other ingredients are: tablet core: lactose monohydrate, povidone, cellulose microcrystalline, crospovidone, stearic acid purified, silica colloidal anhydrous tablet coat: hypromellose, titanium dioxide (E 171), talc, macrogol 6000
Danish: Tabletovertræk: hypromellose, titandioxid (E171), talcum, makrogol 6000 Udseende og pakningsstørrelser
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 Bondenza resulterede i en tiltagende øgning af BMD både vertebralt og non-vertebralt.
English: BMD - mean change relative to baseline lumbar spine at year 3 BMD - mean change relative to baseline total hip at year 3
Danish: Lumbal BMD - gennemsnitlig ændring i forhold til baseline - lumbal columna - efter 3 år Hofte BMD - gennemsnitlig ændring i forhold til baseline - total hofteefter 3 år
English: Bondenza can treat osteoporosis only for as long as you keep receiving the treatment, even though you will not be able to see or feel a difference.
Danish: For at få det bedste udbytte af behandlingen er det vigtigt, at du fortsætter med at få injektionerne hver 3. måned, så længe lægen ordinerer det. Bondenza kan kun behandle osteoporose så længe du fortsætter med behandlingen, også selv om du ikke kan se eller mærke forskel.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/266/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/03/266/005
English: For lumbar spine BMD, 92.1 % of patients receiving 3 mg injection every 3 months increased or maintained their BMD after 1 year of treatment (i.e. were responders) compared with 84.9 % of patients receiving oral 2.5 mg daily (p=0.002).
Danish: Efter et-års behandling havde 92,1 % af patienterne, som fik en 3 mg injektion hver 3. måned øget eller fastholdt den lumbale columna BMD (dvs. de var respondenter), sammenlignet med 84,9 % af patienterne som fik 2,5 mg dagligt oralt (p=0,002).
English: What Bondenza looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Bondenza can treat osteoporosis only as long as you keep taking it.
Danish: Det er vigtigt, at du anvender Bondenza hver måned, så længe lægen ordinerer det. Bondenza kan kun behandle osteoporose så længe du fortsætter med at tage det.
English: Based on the results of study BM 16550, Bondenza 3 mg intravenous injection, administered every 3 months is expected to be at least as effective in preventing fractures as the oral regimen of ibandronic acid 2.5 mg daily.
Danish: Baseret på resultaterne fra studie BM 16550 forventes intravenøs injektion med Bondenza 3 mg hver 3. måned at være mindst ligeså effektivt som ibandronsyre 2,5 mg oralt daglig med hensyn til at forebygge frakturer.
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 (MF4411).
Danish: Sikkerheden af oral behandling med ibandronsyre 2,5 mg daglig er undersøgt hos 1251 patienter, som indgik i 4 placebo-kontrollerede kliniske studier.
English: For total hip BMD, 90.0 % (p<0.001) of patients receiving Bondenza 150 mg once monthly and 76.7 % of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline at one year.
Danish: For hofte BMD havde 90,0 % (p<0,001) af de patienter, som fik 150 mg én gang om måneden og 76,7 % af patienterne, som fik ibandronsyre 2,5 mg daglig, stigninger i hofte BMD over eller lig baseline efter et år.
English: Planning when to take Bondenza with peel-off stickers for your personal calendar What Bondenza is and what it is used for What you need to know before you take Bondenza How to take Bondenza
Danish: Oversigt over indlægssedlen 1 Virkning og anvendelse Det skal du vide, før du begynder at få Bondenza Sådan får du Bondenza
English: NAME OF THE MEDICINAL PRODUCT Bondenza 150 mg film-coated tablets Ibandronic acid
Danish: LÆGEMIDLETS NAVN Bondenza 150 mg filmovertrukne tabletter Ibandronsyre
English: Furthermore, Bondenza 3 mg injection every 3 months was proven superior to oral ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p<0.001, and at two years, p<0.001.
Danish: Desuden blev det i en prospektiv planlagt analyse vist, at injektion med Bondenza 3 mg hver 3. måned var bedre end oral ibandronsyre 2,5 mg daglig efter et år (p<0,001) og efter to år (p<0,001).
English: - Water is the only drink that should be taken with Bondenza.
Danish: - Bondenza må kun indtages sammen med vand.
English: This includes: - eating a balanced diet rich in calcium and vitamin D - walking or other weight-bearing exercise - not smoking and not drinking too much alcohol
Danish: Dette inkluderer: - at spise en varieret kost med et stort indhold af kalk og vitamin D - at gå ture eller udøve anden vægtbærende aktivitet - at undgå rygning og for meget alkohol.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelig (kan forekomme hos 1 ud af 100 behandlede)
English: - The active substance is ibandronic acid.
Danish: - Det aktive stof er ibandronsyre.
English: Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Danish: Bivirkningerne af ibandronsyre hos rotter i reproduktionstoksicitets-studierne var de samme som for øvrige bisphosphonater.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23.02.2004
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Bondenza til dig personligt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/266/005 1 pre-filled syringe EU/1/03/266/006 4 pre-filled syringes
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/03/266/005 1 fyldt injektionssprøjte EU/1/03/266/006 4 fyldte injektionssprøjter
English: Bondenza 3 mg solution for injection ibandronic acid
Danish: Bondenza 3 mg injektionsvæske, opløsning ibandronsyre
English: ibandronic acid 2.5 mg daily (N=294)
Danish: ibandronsyre 2,5 mg daglig (N=294)
English: Bondenza 150 mg once monthly was shown to be at least as effective as ibandronic acid 2.5 mg daily at increasing BMD in a two year, double-blind, multicentre study (BM 16549) of postmenopausal women with osteoporosis (lumbar spine BMD T score below -2.5 SD at baseline).
Danish: I et to-års, dobbeltblindt multicenterstudie (BM 16549) var Bondenza 150 mg én gang om måneden mindst ligeså effektivt som ibandronsyre 2,5 mg daglig til at øge BMD hos postmenopausale kvinder med osteoporose (lumbal BMD T score under -2,5 SD ved baseline).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder 150 mg ibandronsyre (som natriummonohydrat).
English: - Acetylsalicylic acid and other non-steroidal anti-inflammatory medicines (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine.
Danish: ibuprofen, diclofenacnatrium og naproxen) kan virke irriterende på maven og tarmen.
English: ibandronic acid 2.5 mg daily (N=977)
Danish: Ibandronsyre 2,5 mg daglig (N=977)
English: One pre-filled syringe contains 3 mg of ibandronic acid in 3 ml of solution (as sodium monohydrate).
Danish: En fyldt injektionssprøjte indeholder 3 mg ibandronsyre i 3 ml opløsning (som natriummonohydrat).
English: Rare (may affect up to 1 in 1000 people): • hives
Danish: Sjælden (kan forekomme hos 1 ud af 1.000 behandlede) • nældefeber
English: This includes: - eating a balanced diet rich in calcium and vitamin D - walking or any other weight-bearing exercise - not smoking; and not drinking too much alcohol
Danish: Dette inkludererer: - at spise en varieret kost med et stort indhold af kalk og vitamin D - at gå ture eller udøve anden vægtbærende aktivitet - at undgå rygning og for meget alkohol.
English: - Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1 - Hypocalcaemia
Danish: - Overfølsomhed over for ibandronsyre eller over for et eller flere af hjælpestofferne anført i pkt.
English: Sodium acetate trihydrate
Danish: Acetylsalicylsyre og NSAID
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bondenza 3 mg solution for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ Bondenza 3 mg injektionsvæske, opløsning Ibandronsyre
English: Due to limited clinical experience, Bondenza injection is not recommended for patients with a serum creatinine above 200 μmol/l (2.3 mg/dl) or with a creatinine clearance below 30 ml/min (see section 4.2 and section 5.2).
Danish: På grund af manglende klinisk erfaring kan Bondenza injektion ikke anbefales til patienter med serumkreatinin over 200 μmol/l (2,3 mg/dl) eller med kreatininclearance (målt eller estimeret) under 30 ml/min (se pkt.
English: • heartburn, discomfort in swallowing, stomach or tummy pain (may be due to an inflammation of the stomach), indigestion, nausea, having diarrhoea (loose bowels)
Danish: • halsbrand, ubehag ved synkning, mavesmerter (kan skyldes irritaion/betændelse i maven),
English: Do not suck, chew or crush tablets Read the package leaflet before use Once monthly tablet Oral use
Danish: Læs indlægssedlen inden brug Én tablet om måneden
English: Total hip BMD
Danish: Hofte BMD
English: Tablet core
Danish: Lumbal columna
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1
Danish: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Tyskland
English: How to take Bondenza
Danish: Sådan skal du tage Bondenza
English: NAME OF THE MEDICINAL PRODUCT Bondenza 3 mg solution for injection Ibandronic acid
Danish: LÆGEMIDLETS NAVN Bondenza 3 mg injektionsvæske, opløsning Ibandronsyre
English: How to receive Bondenza
Danish: Sådan får du Bondenza
English: Cellulose, microcrystalline Crospovidone Stearic acid
Danish: Mikrokrystallinsk cellulose
English: Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Bondenza Fortæl altid lægen eller på apoteket, hvis du tager anden medicin eller har gjort det for nylig.
English: ibandronic acid 2.5 mg daily
Danish: Ibandronsyre 2,5 mg daglig
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning
English: At two years 93.4 % (p<0.001) of patients receiving Bondenza 150 mg once monthly and 78.4 %, of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline.
Danish: Efter to år havde 93,4 % (p<0,001) af patienterne, som fik henholdsvis Bondenza 150 mg én gang om måneden og 78,4 % af patienterne, som fik ibandronsyre 2,5 mg daglig, stigninger i hofte BMD over eller lig baseline.
English: NAME OF THE MEDICINAL PRODUCT Bondenza 3 mg solution for injection
Danish: LÆGEMIDLETS NAVN Bondenza 3 mg injektionsvæske, opløsning
English: H2 blockers or proton pump inhibitors
Danish: H2-receptorantagonister eller syrepumpehæmmere