FrancophonIA/ELRC3.0 huggingface dataset:
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: Lumbar spine L2-L4 BMD
Danish: Lumbal columna L2-L4 BMD Hofte BMD Lårbenshals BMD Trochanter BMD
English: Hypocalcaemia and other disturbances of bone and mineral metabolism should be assessed and effectively treated before starting Ibandronic acid Accord injection therapy.
Danish: Hypokalcæmi og andre forstyrrelser af knogle- og mineralmetabolismen skal vurderes og behandles effektivt før behandlingen med Ibandronsyre Accord-injektioner påbegyndes.
English: All patients must receive adequate supplemental calcium and vitamin D.
Danish: Alle patienter skal have et tilstrækkeligt tilskud af calcium og vitamin D.
English: Other disturbances of bone and mineral metabolism should also be effectively treated before starting ibandronic acid injection therapy.
Danish: Andre forstyrrelser i knogle- og mineralmetabolismen skal ligeledes behandles effektivt, før behandlingen med ibandronsyre-injektioner påbegyndes.
English: Elderly (see section 4.2) In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Danish: I en multivariant analyse kunne alder ikke påvises som en uafhængig faktor for nogen af de undersøgte farmakokinetiske parametre.
English: It is supplied in glass vials (type I) with rubber stopper and aluminium seals with flip-off cap.
Danish: Det leveres i hætteglas (type I) med gummiprop og aluminiumforsegling, der kan vippes af.
English: Prevention of skeletal events in patients with breast cancer and bone metastases
Danish: Forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser
English: Where Ibandronic acid Accord 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 Ibandronsyre Accord administreres via en eksisterende intravenøs infusionsslange skal infusionsvæsken begrænses til enten isotonisk saltvand eller 50 mg/ml (5 %) glucoseopløsning.
English: Calcium containing solutions should not be mixed with Ibandronic acid Accord concentrate for solution for infusion.
Danish: Opløsninger indeholdende calcium må ikke blandes med Ibandronsyre Accord koncentrat til infusionsvæske, opløsning.
English: Talk to your doctor before receiving Ibandronic acid Accord:
Danish: Kontakt lægen, før du tager Ibandronsyre Accord:
English: Incidence of clinical vertebral fracture
Danish: Hyppighed af kliniske vertebrale frakturer
English: ibandronic acid 3 mg injection every 3 months (N=365)
Danish: Ibandronsyre 3 mg injektion hver 3. måned (N=365)
English: Excipient with known effect Ibandronic acid injection is essentially sodium free.
Danish: Hjælpestof med kendt virkning Ibandronsyre er stort set uden natrium.
English: Due to limited clinical experience, ibandronic acid 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 ibandronsyre 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: Furthermore, ibandronic acid 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 ibandronsyre 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: Each pre-filled syringe contains 3 ml of solution.
Danish: Hver injektionssprøjte indeholder 3 ml opløsning.
English: All patients must receive supplemental calcium and vitamin D.
Danish: Alle patienter skal have tilskud af calcium og vitamin D.
English: Prior to treatment with ibandronic acid the patient should be adequately rehydrated with 9 mg/ml (0.9%) sodium chloride solution.
Danish: Forud for behandling med ibandronsyre bør patienten være tilfredsstillende hydreret med 9 mg/ml (0,9 %) NaCl-injektionsvæske.
English: It is supplied as packs containing 1 vial with 2 ml of concentrate.
Danish: Det leveres i pakninger med 1 hætteglas med 2 ml opløsning.
English: Do not use this medicine after the expiry date which is stated on the carton and on the label after EXP.
Danish: Brug ikke få lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other active substances.
Danish: Eliminationsvejen ser ikke ud til at omfatte kendte syre- eller basetransport-systemer, som anvendes i forbindelse med udskillelsen af andre aktive substanser (se pkt.
English: In vivo, ibandronic acid prevents bone destruction experimentally induced by cessation of gonadal function, retinoids, tumours or tumour extracts.
Danish: Ibandronsyre forhindrer in-vivo knogledestruktion eksperimentelt fremkaldt af ophørt gonadefunktion, retinoider, tumorer eller tumorekstrakter.
English: Incidence of new morphometric vertebral fractures
Danish: Hyppighed af nye morfometriske vertebrale frakturer
English: Appropriate medical support and monitoring measures should be readily available when ibandronic acid intravenous injection is administered.
Danish: Passende nødhjælpsforanstaltninger skal være let tilgængelige, når intravenøs injektion med ibandronsyre administreres.
English: Each ml of solution contains 1 mg ibandronic acid.
Danish: Hver ml opløsning indeholder 1 mg ibandronsyre.
English: Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease , invasive dental procedures e.g. tooth extractions
Danish: · Dårlig mundhygiejne, parodontal sygdom, dårligt tilpassede tandproteser, tidligere tandsygdom, invasive tandbehandlinger, f.eks. tandudtrækninger.
English: Hypocalcaemia*
Danish: Hypokalcæmi**
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 2,5mg oralt, øget eller fastholdt hofte BMD (p=0,004).
English: It does not interfere with osteoclast recruitment.
Danish: Ibandronsyre påvirker ikke osteoklast rekrutteringen.
English: For patients with mild renal impairment (CLcr ≥50 and <80 ml/min) no dosage adjustment is necessary.
Danish: For patienter med let nedsat nyrefunktion (kreatininclearance ≥ 50 og < 80 ml/min) kræves ingen dosisjustering.
English: Care must be taken not to administer ibandronic acid injection via intra-arterial or paravenous administration as this could lead to tissue damage.
Danish: Der skal udvises forsigtighed for ikke at give ibandronsyre-injektionerne intraarterielt eller paravenøst, da det kan medføre vævsskader.
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 3mg injektion hver 3. måned øget eller fastholdt den lumbale columna BMD (dvs. de var respondenter), sammenlignet med 84,9% af patienterne som fik 2,5mg dagligt oralt (p=0,002).
English: ibandronic acid 2.5 mg daily (N=575)
Danish: Ibandronsyre 2,5 mg daglig (N=575)
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: Relative risk reduction New morphometric vertebral fractures
Danish: Relativ risikoreduktion Nye morfometriske vertebrale frakturer
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 3mg, og 84,7% af patienterne, som fik oral behandling med 2,5mg, øget eller fastholdt den lumbale BMD (p=0,001).
English: • fluid build up and swelling (‘“lymphoedema”')
Danish: • ophobning af væske og hævelse (lymfeødem)
English: Ibandronic acid 2.5 mg daily tablets
Danish: Ibandronsyre tabletter, 2,5 mg daglig
English: In order to avoid potential incompatibilities, Ibandronic acid Accord concentrate for solution for infusion should only be mixed with isotonic sodium chloride solution or with 5% dextrose solution.
Danish: For at undgå potentielle uforligeligheder, skal Ibandronsyre Accord koncentrat til infusionsvæske, opløsning kun blandes med isotonisk natriumchlorid eller med 5 % glucoseinfusionsvæske.
English: 5 vials (6 mg/6 ml) 10 vials (6 mg/6 ml)
Danish: Koncentrat til infusionsvæske, opløsning 1 hætteglas (6 mg/6 ml) 5 hætteglas (6 mg/6 ml) 10 hætteglas (6 mg/6 ml)
English: Administration of Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe should be injected intravenously over a period of 15 - 30 seconds.
Danish: Ibandronsyre Accord 3 mg injektionsvæske, opløsning, i fyldte injektionssprøjter skal injiceres intravenøst over 15-30 sekunder.
English: 4 mg (4 ml of concentrate for solution for infusion)
Danish: 4 mg (4 ml koncentrat til infusionsvæske, opløsning)
English: • Keep this container out of the reach of children.
Danish: • Opbevar kanyleboksen utilgængeligt for børn
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving ibandronic acid for oncology indications (see section 4.8).
Danish: Osteonekrose i kæben (ONJ) er efter markedsføringen rapporteret med frekvensen meget sjælden hos patienter behandlet med ibandronsyre for onkologiske indikationer (se pkt.
English: 2 mg 4 mg 6 mg For these patients and dosages, the median time to achieve normocalcaemia was 4 to 7 days.
Danish: Mediantiden for opnåelse af normokalcæmi var 4-7 dage for disse patienter og disse doser.
English: Ibandronic acid 3 mg injection every 3 months Bone mineral density (BMD)
Danish: Ibandronsyre 3mg injektion hver 3. måned Knoglemineraltæthed (BMD)
English: What Ibandronic acid Accord looks like and contents of the pack Ibandronic acid Accord is a concentrate for solution for infusion (sterile concentrate).
Danish: Udseende og pakningstørrelser Ibandronsyre Accord er et koncentrat til oplsøning (sterilt koncentrat).
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 snører sig sammen, hævelse af tungen, svimmelhed, følelse af at miste bevidstheden, rødme eller hævelse af ansigtet, hududslæt, kvalme og opkastning (se punkt 4).
English: To avoid potential incompatibilities Ibandronic acid concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution.
Danish: For at undgå potentielle uforligeligheder bør ibandronsyre koncentrat til infusionsvæske, opløsning kun fortyndes med isotonisk natriumchlorid-infusionsvæske eller 5 % glucose-infusionsvæske.
English: • Treatment of tumour-induced hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 2 hours.
Danish: • Behandling af tumorinduceret hyperkalcæmi - tilsættes til 500 ml isotonisk natriumchloridinfusionsvæske eller 500 ml 5 % glucoseinfusionsvæske og infunderes over 2 timer
English: Ibandronic acid should not be used during pregnancy.
Danish: Ibandronsyre bør ikke anvendes ved graviditet.
English: Table 3: Results from 3 years fracture study MF 4411 (%, 95 % CI)
Danish: Resultater fra 3-års frakturstudiet MF 4411 (%, 95 % konfidensinterval) Placebo (N=974)
English: Other adverse reactions to ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Danish: Andre bivirkninger af ibandronsyre hos rotter i reproduktionstoksicitets-studierne var de samme som for øvrige bisphosphonater.
English: Angioedema, Facial swelling/oedema, Urticaria
Danish: Angioødem, ansigtsødem/hævelse, urticaria
English: Due to the limited clinical experience, ibandronic acid is not recommended in patients with severe renal impairment (see section 4.2 and section 4.4).
Danish: På grund af begrænsede erfaringer, kan ibandronsyre ikke anbefales til patienter med svært nedsat nyrefunktion (se pkt.
English: 6 ml, glass vial (type I) with ethylene tetrafluoroethylene rubber stopper and aluminium seals with pink flip-off cap.
Danish: 6 ml hætteglas (type I glas) med ethylentetrafluoroethylengummiprop og lyserød aluminiumforsegling, der kan vippes af.
English: Arthralgia, Myalgia, Musculoskeletal pain, Back pain
Danish: Artralgi, myalgi, muskuloskeletale smerter, rygsmerter
English: Concentrate for solution for infusion 1 vial (6 mg/6 ml)
Danish: Koncentrat til infusionsvæske, opløsning 1 hætteglas (2 mg/2 ml)
English: Cases of ONJ have been reported in the post marketing setting for ibandronic acid.
Danish: Tilfælde af ONJ i forbindelse med brug af ibandronsyre er blevet rapporteret efter markedsføringen.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. ‘essentially sodium free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. hætteglas, d.v.s. den er i det væsentlige natriumfri.
English: What you need to know before you receive Ibandronic acid Accord 3.
Danish: Det skal du vide, før du begynder at få Ibandronsyre Accord 3.
English: The solution is irritant, therefore strict adherence to the intravenous route of administration is important.
Danish: Det er derfor vigtigt nøje at overholde proceduren for intravenøs administration.
English: • inflammation of a vein
Danish: • betændelse i en blodåre
English: Following treatment discontinuation, there is a reversion to the pathological pre-treatment rates of elevated bone resorption associated with postmenopausal osteoporosis.
Danish: Ved postmenopausal osteoporose ses ved behandlingsophør, en tilbagevenden til de patologiske niveauer for knogleresorption, svarende til niveauet før behandling.
English: 6 mg (6 ml of concentrate for solution for infusion)
Danish: 6 mg (6 ml koncentrat til infusionsvæske, opløsning)
English: 319, Pinner Road North Harrow Middlesex HA1 4HF United Kingdom
Danish: North Harrow, Middlesex HA1 4HF Storbritannien
English: 2 mg (2 ml of concentrate for solution for infusion)
Danish: 2 mg (2 ml koncentrat til infusionsvæske, opløsning)
English: Ibandronic acid concentrate for solution for infusion should not be mixed with calcium containing solutions.
Danish: Ibandronsyre koncentrat til infusionsvæske, opløsning må ikke blandes med væsker indeholdende calcium.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease an adjustment in the dose is recommended (see section 4.2).
Danish: Hos patienter med moderat nedsat nyrefunktion (CLcr ≥ 30 og < 50 ml/min) eller svært nedsat nyrefunktion (CLcr < 30 ml/min), som behandles for at forebygge knoglerelaterede hændelser i forbindelse med brystkræft og knoglemetastaser, anbefales dosisjustering (se pkt.
English: Excipients with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially sodium free.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, dvs. ‘i princippet fri for natrium'.
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion One vial with 2 ml of a concentrate for solution for infusion contains 2 mg ibandronic acid (as 2.25 mg ibandronate sodium monohydrate).
Danish: Ibandronsyre Accord 2 mg koncentrat til infusionsvæske, opløsning Et hætteglas med 2 ml koncentrat til infusionsvæske, opløsning indeholder 2 mg ibandronsyre (som2,25 mg ibandronatnatriummonohydrat).
English: Uncommon (may affect less than 1 in 100 people)
Danish: Ikke almindelig (kan forekomme hos færre end 1 ud af 100 behandlede):
English: EU/1/12/798/002 EU/1/12/798/003 EU/1/12/798/004
Danish: EU/1/12/798/001 EU/1/12/798/002 EU/1/12/798/003 EU/1/12/798/004
English: It contains the active substance ibandronic acid.
Danish: Det aktive indholdsstof er ibandronsyre.
English: How to use Ibandronic acid Accord 4.
Danish: Sådan skal du bruge Ibandronsyre Accord 4.
English: • a heart rhythm problem called ‘“bundle branch block”'
Danish: • hjerteproblem kaldet grenblok
English: 6 ml, glass vial (type I) with ethylene tetrafluoroethylene rubber stopper and aluminium seals with lavender flip-off cap.
Danish: 6 ml hætteglas (type I glas) med ethylentetrafluoroethylengummiprop og lavendelfarvet aluminiumforsegling, der kan vippes af.
English: Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck
Danish: · Samtidige behandlinger: kortikosteroider, kemoterapi, angiogenesehæmmere, strålebehandling af hoved og hals.
English: EU/1/12/798/005 1 pre-filled syringe EU/1/12/798/006 4 pre-filled syringe
Danish: EU/1/12/798/005 1 fyldt injektionssprøjte EU/1/12/798/006 4 fyldte injektionssprøjter
English: Patients treated with ibandronic acid should be given the package leaflet and the patient reminder card. Ibandronic acid therapy should only be initiated by physicians experienced in the treatment of cancer.
Danish: Behandling med ibandronsyre bør kun initieres af læger med erfaring med behandling af kræft.
English: Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Danish: forebyggelse af knoglerelaterede hændelser (patologiske frakturer, knoglekomplikationer, som kræver strålebehandling eller operation) hos patienter med brystkræft og knoglemetastaser behandling af tumorinduceret hyperkalcæmi med eller uden metastaser 4.2 Dosering og indgivelsesmåde
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 hætteglas med 2 ml koncentrat til infusionsvæske, opløsning indeholder 2 mg ibandronsyre (som natriummonohydrat).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En fyldt injektionssprøjte med 3 ml opløsning, indeholder 3 mg ibandronsyre (som natriummonohydrat).
English: Injection site reactions, Asthenia
Danish: Reaktioner på injektionsstedet, asteni
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER FYLDT INJEKTIONSSPRØJTE
English: ibandronic acid 2.5 mg daily (N=377)
Danish: Ibandronsyre 2,5 mg daglig (N=977)
English: Very rare (may affect up to 1 in 10000 people):
Danish: Meget sjælden (kan forekomme hos 1 ud af 10.000 behandlede):
English: • mouth ulcers, swollen lips (‘“cheilitis”'), oral thrush
Danish: • mundsår, hævede læber (læbebetændelse), trøske
English: Rare (may affect up to 1 in 1000 people): • hives
Danish: Sjælden (kan forekomme hos 1 og 1000 behandlede): • nældefeber
English: Hypophosphataemia
Danish: Hypofosfatæm i
English: The median time to relapse (return of albumin-corrected serum calcium to levels above 3 mmol/l) was 18-19 days for the 2 mg and 4 mg doses.
Danish: Mediantiden for tilbagefald (at albuminkorrigeret serum-calcium igen steg til over 3 mmol/l) var 18-19 dage for doserne 2 mg og 4 mg. Mediantiden for tilbagefald var 26 dage med en dosis på 6 mg.
English: What Ibandronic acid Accord contains
Danish: Ibandronsyre Accord indeholder:
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving ibandronic acid for osteoporosis.
Danish: Der er efter markedsføringen af lægemidlet i sjældne tilfælde indberettet en bivirkning, som kaldes osteonekrose i kæben (ONJ: beskadigelse af knoglen i kæben) hos patienter, der fik ibandronsyre på grund af osteoporose.
English: How to receive Ibandronic acid Accord 4.
Danish: Sådan får du Ibandronsyre Accord 4.
English: In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or ≥12 mg/dl) 4 mg will be an adequate single dosage.
Danish: Hos de fleste patienter med alvorlig hyperkalcæmi (albuminkorrigeret serum-calcium* ≥3 mmol/l eller  12 mg/dl), vil 4 mg være passende som enkeltdosis.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ibandronic acid Accord 6 mg sterile concentrate ibandronic acid
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Ibandronsyre Accord 6 mg sterilt koncentrat ibandronsyre i.v.
English: Ibandronic acid Accord 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. Ibandronsyre Accord kan kun behandle osteoporose så længe du fortsætter med behandlingen, også selv om du ikke kan se eller mærke forskel.
English: Patients must receive supplemental calcium and vitamin D (see section 4.4 and section 4.5).
Danish: Patienten skal have et calcium- og vitamin D-tilskud (se pkt.
English: Each vial contains 6 mg of ibandronic acid (as sodium monohydrate).
Danish: Hvert hætteglas indeholder 6 mg ibandronsyre (som natriummonohydrat).
English: Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting ibandronic acid therapy for metastatic bone disease.
Danish: Patienter med forstyrrelser i knogle- og mineralmetabolisme Hypokalcæmi og andre forstyrrelser i knogle- og mineralmetabolisme skal effektivt behandles inden påbegyndelse af ibandronsyre-behandling ved metastatisk knoglesygdom.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ibandronic acid Accord 2 mg sterile concentrate ibandronic acid
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Ibandronsyre Accord 2 mg sterilt koncentrat ibandronsyre i.v.
English: What you need to know before you receive Ibandronic acid Accord
Danish: Det skal du vide, før du begynder at få Ibandronsyre Accord
English: Care must be taken not to administer ibandronic acid concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.
Danish: Det skal omhyggeligt sikres, at Ibandronsyre Accord koncentrat til infusionsvæske, opløsning, ikke administreres intra-arterielt eller paravenøst, da det kan forårsage vævsskade.
English: Continuing to receive Ibandronic acid Accord
Danish: Når du fortsat får Ibandronsyre Accord