FrancophonIA/ELRC3.0 huggingface dataset:
English: Healthcare professionals are advised not to dispose of unused Zoledronic acid medac via the domestic sewage system.
Danish: Sundhedspersonalet rådes til ikke at smide ubrugt Zoledronsyre medac i afløbet.
English: The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the zoledronic acid-treated group versus 49.6% in the placebo group (p=0.003).
Danish: Andelen af patienter med mindst én SRE (eksklusiv hyperkalcæmi) var 29,8 % i den zoledronsyrebehandlede gruppe sammenlignet med 49,6 % i placebogruppen (p=0,003).
English: • To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Danish: • Når du skal tilberede en infusionsopløsning, der indeholder 4 mg zoledronsyre, skal du fortynde koncentratet (5,0 ml) yderligere med 100 ml infusionsvæske som er calciumfri eller fri for andre divalente kationer.
English: Muscle spasms, osteonecrosis of the jaw Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Danish: Muskelspasmer, osteonekrose af kæben Osteonekrose af øregangen (klasse-bivirkning for bisfosfonater) og andre anatomiske steder, inklusive femur og hofte
English: • The solution containing Zoledronic acid medac is given as a single 15-minute intravenous infusion.
Danish: • Opløsningen med Zoledronsyre medac gives som en enkelt intravenøs infusion over 15 minutter.
English: - 4.1 ml for 3.3 mg dose
Danish: 4,1 ml til 3,3 mg dosis
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as Zoledronic acid medac (see section 4.4).
Danish: Tilfælde af osteonekrose i kæben er blevet rapporteret, overvejende hos cancerpatienter i behandling med lægemidler, der hæmmer knogleresorption, såsom Zoledronsyre medac (se pkt.
English: Zoledronic acid is contraindicated in breast-feeding women (see section 4.3).
Danish: Zoledronsyre er kontraindiceret til ammende kvinder (se pkt.
English: Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients treated with zoledronic acid.
Danish: Nedsat indhold af calcium i blodet (hypokalcæmi), som kan medføre muskelkramper, tør hud, en brændende følelse, er indberettet for patienter i behandling med Zoledronsyre medac.
English: What Zoledronic acid medac contains - The active substance is zoledronic acid.
Danish: Zoledronsyre medac indeholder - Aktivt stof: zoledronsyre.
English: The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Danish: Følgende er de vigtige identificerede risici med zoledronsyre for de godkendte indikationer: Nedsat nyrefunktion, osteonekrose af kæberne, akut fasereaktion, hypokalcæmi, atrieflimren, anafylaksi, interstitiel lungesygdom.
English: • Do not use Zoledronic acid medac after the expiry date stated on the vial and carton after EXP.
Danish: • Brug ikke Zoledronsyre medac efter den udløbsdato, der står på hætteglasset og kartonen efter Exp.
English: Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer): - Overfølsomhedsreaktioner.
English: Furthermore, there is evidence of an association between hypocalcaemia and secondary neurological events reported in these cases including convulsions, hypoaesthesia and tetany (see section 4.4).
Danish: Desuden er der en påviselig association mellem hypokalcæmi og de sekundære neurologiske bivirkninger, der er rapporteret i disse tilfælde, herunder kramper, hypæstesi og tetani (se pkt.
English: *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min).
Danish: *Dosis er beregnet ud fra ønsket AUC på 0,66 (mg•t/l) (CLcr = 75 ml/min).
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic acid medac or after stopping treatment.
Danish: Fortæl det straks til din læge eller tandlæge, hvis du får sådanne symptomer under behandling med Zoledronsyre medac, eller efter behandlingen stoppes.
English: Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
Danish: Det bør overvejes at seponere bisfosfonat hos patienter med mistanke om atypisk femurfraktur, indtil der foreligger en evaluering af patienten, baseret på en individuel vurdering af fordele og risici.
English: • Zoledronic acid medac 4 mg/100 ml solution for infusion can be used immediately without further preparation for patients with normal renal function.
Danish: • Zoledronsyre medac 4 mg/100 ml infusionsvæske, opløsning, kan anvendes straks uden yderligere tilberedning til patienter med normal nyrefunktion.
English: Zoledronic acid medac contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially ‘sodium-free'.
Danish: Zoledronsyre medac indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: Pruritus, rash (including erythematous and macular rash), increased sweating
Danish: Pruritus, udslæt (inklusive erytematøst og makuløst udslæt), øget svedtendens
English: Zoledronic acid treatment should be resumed at the same dose as that prior to treatment interruption.
Danish: Behandling med zoledronsyre bør genoptages med den samme dosis som før afbrydelse af behandlingen.
English: 1 Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well-established safety profile of zoledronic acid (see section 4.8)
Danish: 1Bivirkninger med hyppigheder <5 % blev vurderet medicinsk, og det blev vist, at de er i overensstemmelse med den veletablerede sikkerhedsprofil for zoledronsyre (se pkt.
English: The following adverse reactions, listed in Table 2, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Danish: De følgende bivirkninger, der er opført i Tabel 2, er samlet fra kliniske studier og post-marketing rapporter efter fortrinsvis kronisk behandling med 4 mg zoledronsyre:
English: - Other medicines that also contain zoledronic acid and are used to treat osteoporosis and other non-cancer diseases of the bone, or any other bisphosphonate, since the combined effects of these medicines taken together with Zoledronic acid medac are unknown.
Danish: - Anden medicin, der også indeholder zoledronsyre og bruges til at behandle knogleskørhed og andre sygdomme i knoglerne, der ikke er kræft, eller andre bisfosfonater, da den kombinerede virkning af at tage disse lægemidler sammen med Zoledronsyre medac er ukendt.
English: Zoledronic acid 4 mg reduced the risk of SREs by 41% in a multiple event analysis (risk ratio=0.59, p=0.019) compared with placebo.
Danish: Zoledronsyre 4 mg reducerede risikoen for SRE med 41 % i en analyse med multiple hændelser (risikoforhold=0,59, p=0,019) sammenlignet med placebo.
English: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Danish: Svimmelhed, paræstesier, dysgeusi, hypæstesi, hyperæstesi, tremor, somnolens
English: Other medicines and Zoledronic acid medac Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Zoledronsyre medac Fortæl altid lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: • Do not use Zoledronic acid medac after the expiry date stated on the bottle and carton after
Danish: • Brug ikke Zoledronsyre medac efter den udløbsdato, der står på flasken og kartonen efter Exp.
English: After first opening, Zoledronic acid medac solution for infusion should preferably be used immediately.
Danish: Efter åbning bør Zoledronsyre medac infusionsvæske, opløsning fortrinsvis bruges straks.
English: The dose must be given as a single intravenous infusion over no less than 15 minutes.
Danish: Dosis skal administreres som en enkelt intravenøs infusion over minimum 15 minutter.
English: In clinical trials performed in patients with tumour-induced hypercalcaemia (TIH), the overall safety profile amongst all three treatment groups (zoledronic acid 4 and 8 mg and pamidronate 90 mg) was similar in types and severity.
Danish: I kliniske studier udført hos patienter med tumorinduceret hyperkalcæmi (TIH), var den samlede sikkerhedsprofil mellem de tre behandlingsgrupper (zoledronsyre 4 og 8 mg og pamidronat 90 mg) sammenlignelige i art og alvorlighed.
English: Patients who have received doses higher than those recommended (see section 4.2) should be carefully monitored, since renal function impairment (including renal failure) and serum electrolyte (including calcium, phosphorus and magnesium) abnormalities have been observed.
Danish: 4.2), bør derfor overvåges nøje, eftersom nedsat nyrefunktion (inklusive nyresvigt) og serum-elektrolyt-forstyrrelser (inklusive calcium, fosfor og magnesium) er blevet observeret.
English: Chemical and physical in-use stability has been demonstrated for glass bottles, polyethylene, polyvinylchloride and polypropylene infusion lines and infusion bags (prefilled with sodium chloride 9 mg/ml (0.9 %) solution for injection or 5 % w/v glucose solution) for 96 hours at 2-8°C and 25°C.
Danish: Kemisk og fysisk stabilitet under brug er blevet påvist for glasflasker, infusionsslanger og -poser af polyethylen, polyvinylchlorid og polypropylen (fyldt med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, eller 5 % w/v glucoseopløsning) i 96 timer ved 2-8 °C og 25 °C.
English: The results demonstrated that zoledronic acid 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Danish: Resultaterne viste, at zoledronsyre 4 mg havde sammenlignelig virkning med 90 mg pamidronat til forebyggelse af skeletrelaterede hændelser (SRE'er).
English: - High blood pressure, shortness of breath, dizziness, sleep disturbances, taste disturbances,
Danish: - Forhøjet blodtryk, åndenød, svimmelhed, søvnforstyrrelser, smagsforstyrrelser, rysten,
English: Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic acid medac or after stopping treatment.
Danish: Fortæl det straks til din læge, hvis du oplever symptomer så som nyopstået ømhed, smerte eller stivhed, eller en forværring af disse symptomer, mens du er i behandling med Zoledronsyre medac eller efter endt behandling.
English: Zoledronic acid medac 4mg/100ml solution for infusion medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Danish: Zoledronsyre medac 4 mg/100 ml infusionsvæske, opløsning medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: Upon initiation of treatment in patients with bone metastases with mild to moderate renal impairment, lower doses of zoledronic acid are recommended.
Danish: Ved påbegyndelse af behandling til patienter med knoglemetastaser og let til moderat nedsat nyrefunktion bør der anvendes lavere doser af zoledronsyre.
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders
Danish: Tabel 7: Bivirkninger observeret hos pædiatriske patienter med svær osteogenesis imperfecta1 Nervesystemet
English: The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients.
Danish: Skævheden, som blev observeret i studiet, er ikke observeret i andre studier med zoledronsyre, ej heller i studier med zoledronsyre 4 mg hver 3.-4. uge hos onkologiske patienter.
English: Population analysis showed that for a patient with creatinine clearance of 20 ml/min (severe renal impairment), or 50 ml/min (moderate impairment), the corresponding predicted clearance of zoledronic acid would be 37 % or 72%, respectively, of that of a patient showing creatinine clearance of 84 ml/min.
Danish: Populationsanalyser viste, at for en patient med en kreatininclearance på 20 ml/min (svært nedsat nyrefunktion) eller på 50 ml/min (moderat nedsat funktion), skulle den tilsvarende forventede clearance af zoledronsyre være henholdsvis 37 % eller 72 % af clearance hos en patient med en kreatininclearance på 84 ml/min.
English: Zoledronic acid treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Danish: Behandling med zoledronsyre til TIH-patienter, som også har svært nedsat nyrefunktion, bør kun overvejes efter vurdering af risici og fordele ved behandlingen.
English: Very rare (may affect up to 1 in 10,000 people): - As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia.
Danish: Meget sjælden (forekommer hos op til 1 ud af 10.000 patienter): - Som følge af lave calcium-værdier: kramper, følelsesløshed og tetani (sekundære symptomer på hypokalcæmi).
English: Zoledronic acid shows no appreciable binding to plasma proteins and does not inhibit human P450 enzymes in vitro (see section 5.2), but no formal clinical interaction studies have been performed.
Danish: Zoledronsyre udviser ingen mærkbar binding til plasmaproteiner og hæmmer ikke de humane P450enzymer in vitro (se pkt.
English: In a pooled analysis of safety data from zoledronic acid registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
Danish: I en samlet analyse af sikkerhedsdata fra zoledronsyre-registreringsstudier vedrørende forebyggelse af knogle-relaterede hændelser hos patienter med fremskred maligniteter, der involverer knoglerne, var hyppigheden af bivirkninger med relation til nedsat nyrefunktion, og som formodes at være relateret til zoledronsyre, følgende: 3,2 % ved myelomatose, 3,1 % ved prostatacancer, 4,3 % ved brystcancer og 3,2 % ved lunge- og andre faste tumorer.
English: Adverse reactions, such as dizziness and somnolence, may have influence on the ability to drive or use machines, therefore caution should be exercised with the use of zoledronic acid along with driving and operating of machinery.
Danish: Bivirkninger såsom svimmelhed og somnolens kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Each vial contains 5 ml of concentrate.
Danish: Et hætteglas indeholder 5 ml koncentrat.
English: The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months.
Danish: Ved beslutning om at behandle patienter med knoglemetastaser til forebyggelse af skeletrelaterede hændelser bør det tages i betragtning, at behandlingens effekt først indtræder efter 2-3 måneder.
English: One bottle contains 4 mg zoledronic acid.
Danish: En flaske indeholder 4 mg zoledronsyre.
English: For patients with normal renal function (defined as CLcr > 60 ml/min), zoledronic acid 4 mg/100 ml solution for infusion may be administered directly without any further preparation.
Danish: For patienter med normal nyrefunktion (defineret som CLcr >60 ml/min) kan zoledronsyre 4 mg/100 ml infusionsvæske, opløsning, administreres direkte uden nogen yderligere forberedelse.
English: Landeggerstrasse 7 A-2491 Neufeld/Leitha Austria medac
Danish: 2491 Neufeld/Leitha Østrig medac
English: • From a microbiological point of view, the solution for infusion should be used immediately, after first opening.
Danish: • Ud fra et mikrobiologisk synspunkt skal infusionsvæske, opløsning, anvendes straks efter første anbrud.
English: What you need to know before you are given Zoledronic acid medac
Danish: Det skal du vide, før du får Zoledronsyre medac
English: Zoledronic acid should only be resumed when serum creatinine returns to within 10 % of baseline.
Danish: Zoledronsyre medac bør kun genoptages, når serum-kreatinin igen er inden for 10 % af baseline.
English: You should not be given Zoledronic acid medac if you are pregnant.
Danish: Du bør ikke få Zoledronsyre medac, hvis du er gravid.
English: Placebo Zoledronic acid 4 mg
Danish: Placebo Zoledronsyre 4 mg
English: Zoledronic acid medac contains sodium
Danish: Zoledronsyre medac indeholder natrium
English: Dyspnoea, cough, bronchoconstriction Interstitial lung disease
Danish: Dyspnø, hoste, bronkokonstriktion
English: The most frequent finding in repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound's pharmacological antiresorptive activity.
Danish: Det mest almindelige resultat ved studier med gentagen administration var øget primær spongiosa i rørknoglernes metafyser hos voksende dyr ved næsten alle doser.
English: There is preponderance of specific location (head of femur, humerus and medial condyle of femur) due to local anatomical features.
Danish: På grund af lokale anatomiske forhold er der overægt af en specifik lokalisering (toppen af femur, humerus og medial kondyl af femur).
English: The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Danish: Hyppigheden af atrieflimren som alvorlig uønsket hændelse var 1,3 % (51 ud af 3.862) og 0,6 % (22 ud af 3.852) hos patienter som fik henholdsvis zoledronsyre 5 mg og placebo.
English: In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5 % (96 out of 3,862) and 1.9 % (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Danish: I et 3-års, randomiseret, dobbeltblindet, kontrolleret studie, som evaluerede virkning og sikkerhed af zoledronsyre 5 mg én gang årligt versus placebo ved behandling af postmenopausal osteoporose (PMO), var den generelle forekomst af atrieflimren 2,5 % (96 ud af 3.862) og 1,9 % (75 ud af 3.852) hos patienter, som fik henholdsvis zoledronsyre 5 mg og placebo.
English: 1 bottle of 100 ml.
Danish: 1 flaske med 100 ml.
English: Acute phase reaction
Danish: Akut fase reaktion, smerte
English: Bone pain, myalgia, arthralgia, generalised pain
Danish: Knoglesmerter, myalgi, artralgi, generaliserede smerter
English: In patients with normal renal function, defined as CLcr > 60 ml/min, zoledronic acid 4 mg/100 ml solution for infusion must not be further diluted.
Danish: Hos patienter med normal nyrefunktion, defineret som CLcr >60 ml/min, må zoledronsyre 4 mg/100 ml infusionsvæske, opløsning, ikke blive yderligere fortyndet.
English: 1 Adverse events occurring with frequencies < 5 % were medically assessed and it was shown that these cases are consistent with the well-established safety profile of zoledronic acid (see section 4.8)
Danish: Hypofosfatæmi Bivirkninger med hyppigheder <5 % blev vurderet medicinsk, og det blev vist, at de er i overensstemmelse med den veletablerede sikkerhedsprofil for zoledronsyre (se pkt.
English: The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33 % of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 cancer patients studied.
Danish: Den renale clearance af zoledronsyre korrelerer tydeligt med kreatininclearance, idet den renale clearance er ansvarlig for 75 ±33 % af kreatininclearance, hvilket viser et gennemsnit på 84 ±29 ml/min (varierende fra 22 til 143 ml/min) hos de 64 undersøgte cancerpatienter.
English: 1 bottle of 100 ml
Danish: 1 flaske med 100 ml
English: The multiple event analysis revealed a significant risk reduction of 16% in patients treated with zoledronic acid 4 mg in comparison with patients receiving pamidronate.
Danish: Analysen af multiple hændelser afslørede en signifikant risikoreduktion på 16 % hos patienter behandlet med zoledronsyre 4 mg sammenlignet med patienter behandlet med pamidronat.
English: Remove the following amount of Zoledronic acid medac solution for infusion (ml)
Danish: Udtag følgende mængde af Zoledronsyre medac infusionsvæske, opløsning (ml)
English: • From a microbiological point of view, the diluted solution for infusion should be used immediately.
Danish: • Ud fra et mikrobiologisk synspunkt skal den fortyndede infusionsvæske, opløsning, anvendes straks.
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended.
Danish: Faktorer, der kan øge risikoen for nedsat nyrefunktion, omfatter dehydrering, allerede eksisterende nedsat nyrefunktion, flere behandlingscyklusser med zoledronsyre eller andre bisfosfonater, samt brug af andre nefrotoksiske lægemidler eller brug af en kortere infusionstid end anbefalet på nuværende tidspunkt.
English: Prior to administration, 5 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (sodium chloride 9 mg/ml (0.9%) solution or 5% w/v glucose solution).
Danish: Før administration skal 5 ml koncentrat fra et hætteglas eller det volumen af udtaget koncentrat, som påkræves, fortyndes yderligere med 100 ml calciumfri infusionsvæske (natriumchlorid 9 mg/ml (0,9 %) opløsning, eller 5 % w/v glucoseopløsning).
English: It is given as a single 15-minute intravenous infusion in a separate infusion line.
Danish: Det administreres ved en enkelt intravenøs infusion over 15 minutter i en separat infusionsslange.
English: Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid.
Danish: Der er rapporteret forværring af nyrefunktion, progression til nyresvigt samt dialyse hos patienter efter indledende dosis eller enkeltdosis af 4 mg zoledronsyre.
English: Zoledronic acid 4 mg
Danish: Zoledronsyre 4 mg
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
Danish: Osteonekrose af kæberne (Osteonecrosis of the jaw, ONJ) er blevet rapporteret med hyppigheden ikke almindelig i kliniske studier og efter markedsføring hos patienter, som modtog zoledronsyre.
English: • Studies with glass bottles, several types of infusion bags and infusion lines made from polyvinylchloride, polyethylene and polypropylene (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution) showed no incompatibility with zoledronic acid.
Danish: • Studier med glasflasker samt flere typer af infusionsposer og infusionsslanger fremstillet af polyvinylklorid, polyethylen og polypropylen (fyldt med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, eller 5 % w/v glucoseopløsning), viste ingen uforligelighed med Zoledronsyre.
English: This adverse drug reaction consists of a constellation of symptoms that includes fever, myalgia, headache, extremity pain, nausea, vomiting, diarrhoea, arthralgia and arthritis with subsequent joint swelling.
Danish: Denne bivirkning består af en række symptomer, der omfatter feber, myalgi, hovedpine, smerter i arme og ben, kvalme, opkastning, diarré, artralgi og artritis med efterfølgende hævede led.