FrancophonIA/ELRC3.0 huggingface dataset:
English: • stomach and tummy pain, indigestion, being sick, vomiting or having diarrhoea (loose bowels)
Danish: • mavesmerter, fordøjelsesbesvær, kvalme, opkastning eller diarré (løs mave)
English: (dead bone tissue) in the jaw bone)
Danish: (knoglenekrose (dødt knoglevæv))..
English: Care must be taken not to administer Bondronat concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.
Danish: Det skal omhyggeligt sikres, at Bondronat koncentrat til infusionsvæske, opløsning ikke administreres intra-arterielt eller paravenøst, da det kan forårsage vævsskade.
English: Take your tablet at least 6 hours after you last had anything to eat, drink or any other medicines or supplements except water.
Danish: Indtag Bondronat mindst 6 timer efter, at du sidst har spist, drukket eller taget nogen form for anden medicin, vitaminer og mineraler eller kosttilskud andet end vand.
English: • Bondronat is normally given by a doctor or other medical staff who have experience with the treatment of cancer
Danish: • Du får som regel Bondronat af en læge eller sygeplejerske, som har erfaring med behandling af kræft det bliver givet som infusion i en blodåre
English: If you have a raised calcium level in your blood due to a tumour then the recommended dose is a single administration of 1 vial (2 mg) or 2 vials (4 mg), depending on the severity of your illness.
Danish: Hvis du har forhøjet indhold af kalk i blodet som følge af en svulst, er den anbefalede dosis 1 hætteglas (2 mg) én gang eller 2 hætteglas (4 mg) én gang, afhængig af sværhedsgraden af din sygdom.
English: What Bondronat contains
Danish: Bondronat indeholder:
English: Paediatric population (see section 4.2 and section 5.2) The safety and efficacy of Bondronat in children and adolescents below the age of 18 years have not been established.
Danish: 4.2 og 5.2) Sikkerheden og virkningen hos børn og unge under 18 år er ikke klarlagt.
English: To convert the albumin-corrected serum calcium in mmol/l value to mg/dl, multiply by
Danish: Man konverterer albuminkorrigeret serum-calcium fra mmol/l til mg/dl ved at multiplicere med 4.
English: - Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for ibandronsyre eller over for et eller flere af hjælpestofferne anført i pkt.
English: Do not take your tablet with any drink other than water
Danish: Indtag ikke tabletten med andet end almindeligt vand
English: Talk to your doctor or pharmacist before taking Bondronat:
Danish: Kontakt lægen eller apotekspersonalet, før du tager Bondronat:
English: The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenous injection given every 3-4 weeks.
Danish: Den anbefalede dosis ved forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser er 6 mg administreret intravenøst hver 3-4. uge.
English: Prevention of skeletal events in patients with breast cancer and bone metastases with Bondronat 50 mg tablets was assessed in two randomized placebo controlled phase III trials with a duration of 96 weeks.
Danish: Forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser med Bondronat 50 mg tabletter, blev vurderet i to randomiserede, placebokontrollerede, fase III studier, som varede i 96 uger.
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: Hypersensitivity†, bronchospasm†, angioedema†, Anaphylactic reaction/shock†**
Danish: Overfølsomhed†, -bronkospasme†, angioødem †, anafylaktisk reaktion/shock
English: What you need to know before you receive Bondronat
Danish: Det skal du vide, før du begynder at få Bondronat
English: • flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, fatigue, bone pain and aching muscles and joints.
Danish: • influenzalignende symptomer herunder feber, rysten og skælven, ubehag, træthed,
English: A 15 minute infusion time has not been studied in cancer patients with a creatinine clearance of <50ml/min.
Danish: Der er ikke foretaget studier med en infusionstid på 15 minutter hos kræftpatienter med kreatininclearance < 50 ml/min.
English: Dosage: Prevention of Skeletal Events in Patients with Breast Cancer and Bone Metastases The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenously given every 3-4 weeks.
Danish: Forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser Den anbefalede dosis ved forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser er 6 mg intravenøs injektion hver 3-4 uge.
English: Albumin-corrected serum calcium (mmol/l)
Danish: Albuminkorrigeret serum-calcium (mmol/l)
English: What you need to know before you take Bondronat
Danish: Det skal du vide, før du begynder at tage Bondronat
English: EU/1/96/012/012: 5 vials
Danish: EU/1/96/012/012: 5 hætteglas
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/009: 28film-coated tablets EU/1/96/012/010: 84 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/96/012/009: 28 filmovertrukne tabletter
English: Do not receive Bondronat: if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in section 6 if you have, or have ever had low levels of calcium in your blood
Danish: • hvis du er allergisk over for ibandronsyre eller et af de øvrige indholdsstoffer i Bondronat (angivet i punkt 6) hvis du har problemer med spiserøret, såsom indsnævring eller synkebesvær hvis du ikke kan stå eller sidde oprejst i mindst én time (60 minutter) ad gangen hvis du har eller nogensinde har haft lavt kalkindhold i blodet
English: Atnahs Pharma Netherlands B.V. Strawinskylaan 3127
Danish: Strawinskylaan 3127
English: Keep taking Bondronat for as long as your doctor tells you.
Danish: Det er vigtigt, at du anvender Bondronat så længe, din læge har ordineret det. Bondronat kan kun afhjælpe din tilstand så længe, du fortsætter med at anvende det.
English: The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis for the jaw, and ocular inflammation (see paragraph “description of selected adverse reactions” and section 4.4).
Danish: De alvorligste bivirkninger indrapporteret er anafylaktisk reaktion/shock, atypiske femurfrakturer, knoglenekrose i kæben og inflammation i øjet (se afsnit ”Beskrivelse af udvalgte bivirkninger” og pkt.
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administratio ns-stedet
English: = serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)] To convert the albumin-corrected serum calcium in mmol/l value to mg/dl, multiply by
Danish: Albuminkorrigeret serum-calcium (mg/dl) = Serum-calcium (mg/dl) + 0,8 x [4-albumin (g/dl)] Man konverterer albuminkorrigeret serum-calcium fra mmol/l til mg/dl ved at multiplicere med 4.
English: NAME OF THE MEDICINAL PRODUCT Bondronat 50 mg film-coated tablets ibandronic acid
Danish: LÆGEMIDLETS NAVN Bondronat 50 mg filmovertrukne tabletter ibandronsyre
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) a dosage adjustment to one 50 mg film-coated tablet every second day is recommended (see section 5.2).
Danish: For patienter med moderat nedsat nyrefunktion (kreatininclearance ≥ 30 og < 50 ml/min) anbefales en dosisjustering til én 50 mg filmovertrukken tablet hver anden dag (se pkt.
English: What Bondronat looks like and contents of the pack The film-coated tablets are of oblong shape and white to off-white in colour, engraved L2/IT.
Danish: De filmovertrukne tabletter er aflange og hvide til råhvide mærket L2/IT.
English: ONJ can also occur after stopping treatment.
Danish: Knoglenekrose i kæben kan også forekomme efter behandlingen med Bondronat er stoppet.
English: Cellulose, microcrystalline Crospovidone Stearic acid
Danish: Mikrokrystallinsk cellulose Crospovidon
English: Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate)
Danish: Hver filmovertrukken tablet indeholder 50 mg ibandronsyre (som natriummonohydrat)
English: Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration (see section 4.4).
Danish: Da acetylsalicylsyre, NSAID-præparater og bisphosphonater er forbundet med gastrointestinal irritation, bør der udvises forsigtighed, hvis acetylsalicylsyre eller et NSAID-præparat administreres sammen med Bondronat (se pkt.
English: It is recommended that the product once diluted be used immediately (see point 5 of this leaflet ‘How to store Bondronat').
Danish: Det anbefales at opløsningen anvendes straks efter fortynding (se pkt.
English: Bone resorption due to malignant disease is characterised by excessive bone resorption that is not balanced with appropriate bone formation.
Danish: Knogleresorptionen ved malign sygdom karakteriseres ved en udtalt knogleresorption, som ikke modsvares af en tilsvarende knogleformation.
English: EU/1/96/012/013: 10 vials
Danish: EU/1/96/012/013: 10 hætteglas
English: Albumin-corrected Serum calcium (mg/dl)
Danish: Albuminkorrigeret serumcalcium (mg/dl)
English: No dosage adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat nyrefunktion (CLcr ≥ 50 og < 80 ml/min).
English: Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Danish: Da acetylsalicylsyre, NSAID-præparater og bisphosphonater er forbundet med gastrointestinal irritation, bør der udvises forsigtighed, hvis acetylsalicylsyre eller et NSAID-præparat administreres sammen med Bondronat.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 50 mg ibandronsyre (som natriummonohydrat).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Bondronat Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Talk to your doctor, pharmacist or nurse before receiving Bondronat:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du får Bondronat:
English: If you are not sure, talk to your doctor or pharmacist before taking Bondronat.
Danish: Hvis du er i tvivl, så kontakt lægen eller apotekspersonalet, inden du tager Bondronat.
English: • Keep this medicine out of the sight and reach of children
Danish: • Opbevar lægemidlet utilgængeligt for børn
English: Your doctor may do regular blood tests while you are receiving Bondronat.
Danish: Lægen kan vælge at tage regelmæssige blodprøver, mens du er i behandling med Bondronat, for at undersøge, om du får den rigtige mængde medicin.
English: If you are not sure, talk to your doctor or pharmacist before having Bondronat.
Danish: Hvis du er i tvivl, så kontakt lægen eller apotekspersonalet, før du får Bondronat.
English: • It helps to prevent your bones from breaking (fractures) • It also helps to prevent other bone problems that may need surgery or radiotherapy
Danish: Det hjælper med at forebygge andre knogleproblemer, som kan kræve operation eller strålebehandling
English: • stomach problems such as ‘gastroenteritis” or ‘gastritis'
Danish: • maveproblemer, såsom mave-tarmkatar eller mavekatar
English: Additional risk minimisation measures The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Danish: Indehaveren af markedsføringstilladelsen skal sikre at patient huskekort vedrørende knoglenekrose i kæben er implementeret..
English: Bondronat is supplied as packs containing 1, 5 and 10 vials (6 ml type I glass vialwith a bromobutyl rubber stopper).
Danish: Bondronat leveres i pakninger med 1, 5 og 10 hætteglas (6 ml hætteglas af type I glas med en brombutyl-gummiprop).
English: • Do not throw away any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden
English: Bondronat is supplied as packs containing 1 vial (2 ml type I glass vial with a bromobutyl rubber stopper).
Danish: Bondronat findes i pakninger indeholdende 1 hætteglas (2 ml hætteglas af glas type I med en brombutyl-gummiprop).
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller på apoteketspersonalet, hvis der er noget, du er i tvivl om.
English: For patients with mild renal impairment (CLcr ≥50 and <80 mL/min) no dosage adjustment is necessary.
Danish: Hos patienter med let nedsat nyrefunktion (CLcr ≥ 50 og < 80 ml/min) er justering af dosis ikke nødvendig.
English: Excipients with known effect Bondronat is essentially sodium free.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Bondronat er stort set uden natrium.
English: Gastroenteritis, gastritis, mouth ulceration, dysphagia, cheilitis
Danish: Gastroenteritis, gastritis, sår i munden, dysfagi, cheilitis
English: Hypocalcaemia
Danish: Hypofosfatæm
English: Bondronat 2 mg concentrate for solution for infusion ibandronic acid
Danish: Bondronat 2 mg koncentrat til infusionsvæske, opløsning ibandronsyre
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/011: 1 vial
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/96/012/011: 1 hætteglas
English: How to receive Bondronat
Danish: Sådan får du Bondronat
English: Bondronat contains the active substance ibandronic acid.
Danish: Bondronat indeholder det aktive stof ibandronsyre, som tilhører en gruppe af lægemidler kaldet bisphosphonater.
English: If you have moderate kidney problems, your doctor may reduce your dose to one tablet every other day.
Danish: Hvis du lider af nyreproblemer, kan din læge vælge at nedsætte dosis til én tablet hver anden dag (i tilfælde af moderat nyresygdom) eller til én tablet om ugen (i tilfælde af alvorlig nyresygdom).
English: = serum calcium (mmol/l) - [0.02 x albumin (g/l)] + Or
Danish: = Serum-calcium (mmol/l) - [0,02 x albumin (g/l)] Eller
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
Danish: Knoglenekrose i kæben†** Knoglenekrose i den ydre øregang (klasseeffekt for bisphosphonat
English: Bondronat 6 mg concentrate for solution for infusion ibandronic acid
Danish: Bondronat 6 mg koncentrat til infusionsvæske, opløsning ibandronsyre
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 Et hætteglas med 2 ml koncentrat til infusionsvæske, opløsning indeholder 2 mg ibandronsyre (som natriummonohydrat).
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving Bondronat for oncology indications (see section 4.8).
Danish: Knoglenekrose i kæben er blevet rapporteret meget sjældent efter markedsføring hos patienter ved behandling med Bondronat for osteoporose (se pkt.
English: In patients with moderate hypercalcaemia (albumin-corrected serum calcium <3 mmol/l or <12 mg/dl) 2 mg is an effective dose.
Danish: Hos patienter med moderat hyperkalcæmi (albuminkorrigeret serum-calcium < 3 mmol/l eller < 12 mg/dl) er 2 mg en effektiv dosis.
English: A statistically significant improvement in bone pain score was shown for Bondronat 50 mg compared to placebo.
Danish: Bondronat 50 mg viste i sammenligning med placebo en statistisk signifikant forbedring i knoglesmertescore.
English: A statistically significant improvement in bone pain score was shown for intravenous Bondronat 6 mg compared to placebo.
Danish: Intravenøs Bondronat 6 mg viste i sammenligning med placebo en statistisk signifikant forbedring i knoglesmertescore.
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 (stigning af serum albuminkorrigeret serum-calcium 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: NAME OF THE MEDICINAL PRODUCT Bondronat 2 mg concentrate for solution for infusion.
Danish: LÆGEMIDLETS NAVN Bondronat 2 mg koncentrat til infusionsvæske, opløsning.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et hætteglas med 6 ml koncentrat til infusionsvæske, opløsning indeholder 6 mg ibandronsyre (som natriummonohydrat).
English: Bisphosphonates act by inhibiting osteoclast activity, although the precise mechanism is still not clear.
Danish: Bisphosphonater virker ved at hæmme osteoklast-aktiviteten.
English: How to take Bondronat
Danish: Sådan skal du tage Bondronat
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bondronat 2 mg concentrate for solution for infusion ibandronic acid
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Bondronat 2 mg koncentrat til infusionsvæske, opløsning ibandronsyre i.v.
English: • if you have or ever had low calcium in your blood Do not take this medicine if any of the above apply to you.
Danish: • hvis du har eller nogensinde har haft lavt kalkindhold i blodet
English: The median time to relapse (re-increase of serum albumin corrected serum calcium above 3 mmol/l) was 18-19 days for the 2 mg and 4 mg doses.
Danish: Mediantiden for tilbagefald (tilbagevendende stigning af serum albuminkorrigeret serum-calcium 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: - Water is the only drink that should be taken with Bondronat.
Danish: - Bondronat må kun indtages sammen med vand.
English: Cases of ONJ have been reported in the post marketing setting for ibandronic acid.
Danish: Tilfælde af knoglenekrose i kæben er blevet rapporteret efter markedsføring hos patienter i behandling med ibandronsyre.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/96/012/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/009
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/96/012/009
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bondronat 6 mg concentrate for solution for infusion ibandronic acid
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Bondronat 6 mg koncentrat til infusionsvæske, opløsning ibandronsyre i.v.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/011
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/96/012/011
English: Patients treated with Bondronat should be given the package leaflet and the patient reminder card.
Danish: Indlægsseddel og huskekort bør udleveres til patienter i behandling med Bondronat.
English: Method and route of administration Bondronat concentrate for solution for infusion should be administered as an intravenous infusion.
Danish: Dosering og indgivelsesmåde Bondronat koncentrat til infusionsvæske, opløsning skal gives som en intravenøs infusion.
English: One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate)
Danish: Et hætteglas med 6 ml koncentrat til infusionsvæske, opløsning indeholder 6 mg ibandronsyre (som natriummonohydrat)
English: One vial with 2 ml of a concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate)
Danish: Et hætteglas med 2 ml koncentrat til infusionsvæske, opløsning indeholder 2 mg ibandronsyre (som natriummonohydrat)
English: Prevention of skeletal events in patients with breast cancer and bone metastases with Bondronat 6 mg administered intravenously was assessed in one randomized placebo controlled phase III trial with a duration of 96 weeks.
Danish: Behandlingen med Bondronat 6 mg administreret intravenøst ved forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser blev vurderet i et randomiseret, placebokontrolleret fase III-studie, som varede i 96 uger.
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: The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, and ocular inflammation (see paragraph “Description of selected adverse reactions” and section 4.4).Treatment was most frequently associated with a decrease in serum calcium to below normal range (hypocalcaemia), followed by dyspepsia.
Danish: De alvorligste bivirkninger indrapporteret er anafylaktisk reaktion/shock, atypiske femurfrakturer, knoglenekrose i kæben, gastrointestinal irritation og inflammation i øjet (se afsnit ”Beskrivelse af udvalgte bivirkninger” og pkt.
English: Mon Tue Wed Thu Fri Sat Sun
Danish: Man Tir Ons Tor Fre Lør Søn
English: Table 2 Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease) All Skeletal Related Events (SREs) Placebo n=158
Danish: Alle skeletrelaterede hændelser (SREs) Placebo n=158
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 2 mg of ibandronic acid (as sodium monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 2 mg ibandronsyre (som natriummonohydrat).
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 svær hyperkalcæmi (albuminkorrigeret serum-calcium*  3 mmol/l eller  12 mg/dl) vil 4 mg være en passende enkelt-dosis.
English: Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with IV ibandronic acid.
Danish: Der er rapporteret anafylaktisk reaktion/shock, inklusive dødelige tilfælde, hos patienter behandlet med i.v.
English: Bondronat concentrate for solution for infusion should be administered as an intravenous infusion.
Danish: Bondronat koncentrat til infusionsvæske, opløsning skal efter fortynding gives som en intravenøs infusion.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 6 mg of ibandronic acid (as sodium monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 6 mg ibandronsyre (som natriummonohydrat).
English: • It helps to prevent other bone problems that may need surgery or radiotherapy Bondronat can also be prescribed if you have a raised calcium level in your blood due to a tumour.
Danish: Bondronat kan også blive ordineret, hvis du har forhøjet indhold af kalk i blodet som følge af en svulst.
English: Further, as protein binding of ibandronic acid is approximately 87%
Danish: Proteinbindingen i humant plasma er ca. 87 % ved terapeutiske koncentrationer.
English: If you take too many tablets talk to a doctor or go to hospital straight away.
Danish: Tal straks med en læge eller tag på skadestuen med det samme, hvis du har indtaget for mange tabletter.