FrancophonIA/ELRC3.0 huggingface dataset:
English: Bonviva 3 mg injection every 3 months (N=365)
Danish: Bonviva 3 mg injektion hver 3. måned (N=365)
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: The overall proportion of patients who experienced an adverse reaction, was 22.7 % and 25.0 % for Bonviva 150 mg once monthly after one and two years, respectively.
Danish: Andelen af patienter med bivirkninger var 22,7 % og 25,0 % for Bonviva 150 mg én gang om måneden efter henholdsvis et og to år.
English: Bonviva is only for use in postmenopausal women and must not be taken by women of childbearing potential.
Danish: Bonviva er kun til brug hos postmenopausale kvinder og må ikke anvendes af fertile kvinder.
English: Other disturbances of bone and mineral metabolism should also be effectively treated before starting Bonviva injection therapy.
Danish: Andre forstyrrelser i knogle- og mineralmetabolismen skal ligeledes behandles effektivt, før behandlingen med Bonviva-injektioner påbegyndes.
English: Bonviva is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Danish: Bonviva er kun til brug hos kvinder, der er kommet i overgangsalderen, og må ikke tages af kvinder, der stadig kan få børn.
English: In particular, products containing calcium, including milk, and other multivalent cations (such as aluminium, magnesium, iron), are likely to interfere with absorption of Bonviva, 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 Bonviva.
English: (dead bone tissue) in the jaw bone).
Danish: (knoglenekrose (dødt knoglevæv))..
English: Table 3: Results from 3 years fracture study MF 4411 (%, 95 % CI) Placebo (N=974)
Danish: Resultater fra 3-års frakturstudiet MF 4411 (%, 95 % konfidensinterval) Placebo (N=974)
English: Relative Risk Reduction New morphometric vertebral fractures
Danish: Relativ risikoreduktion Nye morfometriske vertebrale frakturer
English: Bonviva 150 mg once monthly (N=291)
Danish: Bonviva 150 mg én gang om måneden (N=291)
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Bonviva administration.
Danish: Invasive tandbehandlinger bør kun udføres efter nøje vurdering under behandling med Bonviva.
English: There is no relevant use of Bonviva in children below 18 years, and Bonviva was not studied in this population (see section 5.1 and 5.2).
Danish: Anvendelse af Bonviva er ikke relevant hos børn under 18 år, og der er ingen erfaring med behandling af denne population (se pkt.
English: What Bonviva contains
Danish: Bonviva indeholder:
English: Temporary interruption of Bonviva treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Danish: Hvis det er muligt, bør det overvejes at seponere behandlingen med Bonviva midlertidigt, indtil tilstanden forbedres og risikofaktorerne for knoglenekrose i kæben er reduceret.
English: Bonviva 3 mg solution for injection in pre-filled syringe like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Danish: Bonviva 3 mg injektionsvæske i fyldte injektionssprøjter kan, som andre intravenøst administrerede bisphosphonater, forårsage forbigående fald i værdierne for serum-calcium.
English: Do not take Bonviva
Danish: Tag ikke Bonviva:
English: Arthralgia, Myalgia, Musculoskeletal pain, Muscle cramp, Musculoskeletal stiffness
Danish: Artralgi, myalgi, muskuloskeletale smerter, muskelkramper, muskuloskeletal stivhed
English: • stomach pain (such as gastritis) or tummy pain, indigestion, nausea, having diarrhoea (loose bowels) or constipation
Danish: • mavesmerter (såsom mavekatar), fordøjelsesbesvær, kvalme, diarré (løs mave) eller forstoppelse.
English: Existing hypocalcaemia must be corrected before starting Bonviva therapy.
Danish: Eksisterende hypokalcæmi skal behandles, før behandling med Bonviva initieres.
English: Bonviva 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: Bonviva skal indtages efter faste om natten (mindst 6 timer) og 1 time før dagens første indtagelse af madog drikkevarer (andet end vand) (se pkt.
English: In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of Bonviva 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 Bonviva 150 mg én gang om måneden den samme som for ibandronsyre 2,5 mg daglig.
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: - 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: • If you have any swallowing or digestive problems.
Danish: • hvis du har synkebesvær eller problemer med fordøjelsen.
English: Bonviva is available in packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.
Danish: Bonviva kan fås i pakninger indeholdende 1 fyldt injektionssprøjte og 1 injektionskanyle eller 4 fyldte injektionssprøjter og 4 injektionskanyler.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/265/003 1 film-coated tablet EU/1/03/265/004 3 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/03/265/003 1 filmovertrukken tablet EU/1/03/265/004 3 filmovertrukne tabletter
English: Bonviva 3 mg solution for injection in pre-filled syringes is a clear colourless solution.
Danish: Bonviva 3 mg injektionsvæske, opløsning i fyldte injektionssprøjter er en klar, farveløs opløsning.
English: Bonviva 150 mg film-coated tablets Ibandronic acid
Danish: Bonviva 150 mg filmovertrukne tabletter Ibandronsyre
English: Bonviva 150 mg once monthly (N=320)
Danish: Bonviva 150 mg én gang om måneden (N=320)
English: NAME OF THE MEDICINAL PRODUCT Bonviva 150 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Bonviva 150 mg filmovertrukne tabletter.
English: One year data in study BM 16549 Two year data in study BM 16549
Danish: To-års data fra studie BM 16549
English: • persistent eye pain and inflammation (if prolonged)
Danish: • vedvarende smerte og en betændelseslignende reaktion (inflammation) i øjet (hvis langvarig).
English: Based on the results of study BM 16549, Bonviva 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 Bonviva 150 mg én gang om måneden at være mindst ligeså effektivt med hensyn til at forebygge frakturer som ibandronsyre 2,5 mg daglig.
English: After one year (primary analysis) the median relative change from baseline was -76 % for Bonviva 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 Bonviva 150 mg én gang om måneden og -67 % for gruppen, som fik ibandronsyre 2,5 mg daglig.
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: Monthly tablet
Danish: Tabletkerne
English: At one year, 83.5 % (p= 0.006) of patients receiving Bonviva 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 Bonviva 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: Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, sundhedspersonalet eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/265/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/03/265/005
English: Do not use Bonviva this medicine after the expiry date which is stated on the carton and on the syringe after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, som er angivet på den ydre pakning og på injektionssprøjten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Among these patients, the incidence of upper gastrointestinal events in the patients treated with Bonviva 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 Bonviva én gang om måneden, som hos patienter, som blev behandlet med 2,5 mg ibandronsyre daglig.
English: What Bonviva is and what it is used for What you need to know before you receive Bonviva How to receive Bonviva
Danish: Oversigt over indlægssedlen 1 Virkning og anvendelse Det skal du vide, før du begynder at få Bonviva Sådan får du Bonviva
English: Bonviva should not be used during breastfeeding.
Danish: Bonviva bør ikke anvendes under amning.
English: Film-coated tablet:
Danish: Filmovertrukne tabletter:
English: EU/1/03/265/003 EU/1/03/265/004
Danish: EU/1/03/265/004
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 1.251 patienter, som indgik i 4 placebo-kontrollerede kliniske studier.
English: Before receiving treatment, tell your doctor/nurse (health care professional) if:
Danish: Fortæl lægen/sygeplejersken før du modtager behandlingen, hvis;
English: Solution for injection in pre-filled syringe:
Danish: Injektionsvæske, opløsning i fyldt injektionssprøjte:
English: BMD - mean change relative to baseline lumbar spine at year 3 BMD - mean change relative to baseline total hip at year 3
Danish: BMD - gennemsnitlig ændring i forhold til baseline - total hofte - efter 3 år
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving Bonviva for osteoporosis (see section 4.8).
Danish: Knoglenekrose i kæben er blevet rapporteret meget sjældent efter markedsføring hos patienter ved behandling med Bonviva for osteoporose (se pkt.
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: 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: 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 Bonviva 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 Bonviva 150 mg én gang om måneden eller ibandronsyre 2,5 mg daglig, respondenter efter et år.
English: Bonviva 3 mg solution for injection in pre-filled syringe should be injected intravenously over a period of 15 - 30 seconds.
Danish: Administration af Bonviva 3 mg injektionsvæske i fyldte injektionssprøjter: Bonviva 3 mg injektionsvæske i fyldte injektionssprøjter skal injiceres intravenøst over 15-30 sekunder.
English: At two years, 93.5 % (p=0.004) and 86.4 % of patients receiving Bonviva 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 Bonviva 150 mg én gang om måneden eller ibandronsyre 2,5 mg daglig, respondenter.
English: What you need to know before you receive Bonviva
Danish: Det skal du vide, før du begynder at få Bonviva
English: 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: Due to limited clinical experience, Bonviva 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 Bonviva ikke til patienter med kreatinin-clearance lavere end 30 ml/min (se pkt.
English: Please see the Summary of Product Characteristics for more information.
Danish: INFORMATION TIL SUNDHEDSPERSONALET Se produktresuméet vedrørende yderligere oplysninger.
English: Bonviva was not studied in the paediatric population, therefore no efficacy or safety data are available for this patient population.
Danish: Bonviva er ikke undersøgt i den pædiatriske population.
English: Table 1: Adverse reactions occurring in postmenopausal women receiving Bonviva 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: Bivirkninger hos postmenopausale kvinder, som fik Bonviva 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: Continuing to receive Bonviva
Danish: Fortsat indtagelse af Bonviva
English: Bonviva 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 Bonviva 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 Tscore under - 2,5 SD ved baseline).
English: At one year (primary analysis), 91.3 % (p=0.005) of patients receiving Bonviva 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 Bonviva 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: Table 1: Adverse reactions occurring in postmenopausal women receiving Bonviva 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 Bonviva 150 mg én gang månedlig eller ibandronsyre 2,5 mg daglig i fase III studierne BM16549 og MF4411, samt bivirkninger set efter markedsføring.
English: Oesophagitis, Gastritis, Gastro oesophageal reflux disease, Dyspepsia, Diarrhoea, Abdominal pain, Nausea
Danish: Mave-tarm-kanalen Øsofagitis, gastritis, gastroøsofageal reflukssygdom, dyspepsi, diarré, mavesmerter, kvalme
English: Furthermore, Bonviva 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 Bonviva 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: ONJ can also occur after stopping treatment.
Danish: Knoglenekrose i kæben kan også forekomme efter behandlingen med Bonviva er stoppet.
English: 1 pre-filled syringe + 1 injection needle 4 pre-filled syringes + 4 injection needles
Danish: 4 fyldte injektionssprøjter + 4 kanyler
English: After 2 years of treatment, 92.8 % of patients receiving 3 mg injections and 84.7 % of patient receiving 2.5 mg oral therapy had increased or maintained lumbar spine BMD (p=0.001).
Danish: Efter 2-års behandling havde 92,8 % af patienterne, som fik injektion med 3 mg, og 84,7 % af patienterne, som fik oral behandling med 2,5 mg, øget eller fastholdt den lumbale BMD (p=0,001).
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
Danish: Knoglenekrose i kæben*† Knoglenekrose i den ydre øregang (klasseeffekt for bisphosphonat)†
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 Bonviva resulterede i en tiltagende øgning af BMD både vertebralt og non-vertebralt.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V.*
English: However, since this increase is within the normal variability of the bioavailability of ibandronic acid, no dose adjustment is considered necessary when Bonviva 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
English: NAME OF THE MEDICINAL PRODUCT Bonviva 150 mg film-coated tablets Ibandronic acid
Danish: LÆGEMIDLETS NAVN Bonviva 150 mg filmovertrukne tabletter Ibandronsyre
English: For total hip BMD, 90.0 % (p<0.001) of patients receiving Bonviva 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: What you need to know before you take Bonviva
Danish: Det skal du vide, før du begynder at tage Bonviva
English: Bonviva 3 mg solution for injection ibandronic acid
Danish: Bonviva 3 mg injektionsvæske, opløsning ibandronsyre
English: Furthermore, Bonviva 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 Bonviva 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: Based on the results of study BM 16550, Bonviva 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 Bonviva 3 mg hver 3. måned at være mindst ligeså effektivt som ibandronsyre 2,5 mg oralt daglig med hensyn til at forebygge frakturer.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/265/005 1 pre-filled syringe EU/1/03/265/006 4 pre-filled syringes
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/03/265/005 1 fyldt injektionssprøjte EU/1/03/265/006 4 fyldte injektionssprøjter
English: Patients with concomitant diseases, or who use medicinal products which have potential for undesirable effects on the kidney, should be reviewed regularly in line with good medical practice during treatment.
Danish: I henhold til god klinisk praksis, bør patienter med sygdomme eller patienter som tager anden medicin, der kan påvirke nyrefunktionen, regelmæssigt kontrolleres under behandlingen.
English: Bonviva 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. Bonviva kan kun behandle osteoporose så længe du fortsætter med behandlingen, også selv om du ikke kan se eller mærke forskel.
English: Trochanter BMD
Danish: BMD
English: • Acetylsalicylic acid and other non-steroidal anti-inflammatory medicines (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine.
Danish: • Acetylsalicylsyre og andre nonsteroide antiinflammatoriske lægemidler (NSAIDer) (inkl.
English: • smoking, or drinking too much alcohol
Danish: • rygning eller for meget alkohol
English: Due to limited clinical experience, Bonviva 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 Bonviva 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: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bonviva 3 mg solution for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ Bonviva 3 mg injektionsvæske, opløsning Ibandronsyre
English: Bonviva 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 Bonviva 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: • 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 irritation/betændelse i maven),
English: - Water is the only drink that should be taken with Bonviva.
Danish: - Bonviva må kun indtages sammen med vand.
English: Do not receive Bonviva
Danish: Du må ikke få Bonviva:
English: Patients treated with Bonviva should be given the package leaflet and the patient reminder card.
Danish: Indlægsseddel og huskekort bør udleveres til patienter i behandling med Bonviva.
English: • This medicine has been prescribed for you only.
Danish: • Lægen har ordineret Bonviva til dig personligt.
English: NAME OF THE MEDICINAL PRODUCT Bonviva 3 mg solution for injection Ibandronic acid
Danish: LÆGEMIDLETS NAVN Bonviva 3 mg injektionsvæske, opløsning Ibandronsyre