FrancophonIA/ELRC3.0 huggingface dataset:
English: The plasma protein binding is low, with the unbound fraction ranging from 60% at 2 ng/ml to 77% at 2000 ng/ml of zoledronic acid.
Danish: Plasmaproteinbindingen er lav med den ubundne fraktion varierende fra 60 % ved 2 ng/ml til 77 % ved 2.000 ng zoledronsyre/ml.
English: The effects of intravenous zoledronic acid in the treatment of paediatric patients (age 1 to 17 years) with severe osteogenesis imperfecta (types I, III and IV) were compared to intravenous pamidronate in one international, multicentre, randomised, open-label study with 74 and 76 patients in each treatment group, respectively.
Danish: Virkningen af zoledronsyre givet intravenøst til pædiatriske patienter (i alderen 1 til 17 år) med svær osteogenesis imperfecta (type I, III og IV) blev sammenlignet med intravenøst administreret pamidronat i en international, multicenter, randomiseret, åben undersøgelse med henholdsvis 74 og 76 patienter i hver behandlingsgruppe.
English: The management plan for patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ.
Danish: Planen for patienter, der udvikler osteonekrose, bør laves i tæt samarbejde mellem den behandlende læge og en tandlæge eller oral kirurg med ekspertise i osteonekrose.
English: In an in vitro study, zoledronic acid showed low affinity for the cellular components of human blood, with a mean blood to plasma concentration ratio of 0.59 in a concentration range of 30 ng/ml to 5000 ng/ml.
Danish: I et in vitro studie udviste zoledronsyre lav affinitet for cellekomponenterne i humant blod med en gennemsnitlig blod/plasma-koncentrationsratio på 0,59 i koncentrationsområdet fra 30 ng/ml til 5.000 ng/ml.
English: Single and multiple 5- and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients with bone metastases yielded the following pharmacokinetic data, which were found to be dose independent.
Danish: Enkeltinfusioner og gentagne infusioner over 5 og 15 minutter af 2, 4, 8 og 16 mg zoledronsyre til 64 patienter med knoglemetastaser gav nedenstående farmakokinetiske data, som viste sig at være uafhængige af dosis.
English: - Aclasta (a medicine that also contains zoledronic acid and is 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 Zometa are unknown.
Danish: - Aclasta (medicin, der også indeholder zoledronsyre og bruges til at behandle knogleskørhed og andre ikke-kræft sygdomme i knoglerne), eller andre bisfosfonater, da den kombinerede effekt af at tage disse lægemidler sammen med Zometa er ukendt.
English: This condition is known as tumour-induced hypercalcaemia (TIH).
Danish: Denne tilstand kaldes tumorinduceret hyperkalcæmi (TIH).
English: Use immediately after reconstitution and dilution.
Danish: Anvendes straks efter rekonstitution og opløsning.
English: These could be signs of bone damage in the jaw (osteonecrosis).
Danish: Disse symptomer kan være tegn på skade i kæbeknoglerne (osteonekrose).
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zometa.
Danish: Hvis du har hypokalcæmi, skal den korrigeres, inden du får den første dosis af Zometa.
English: Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have a higher risk of developing osteonecrosis of the jaw.
Danish: Patienter, der er i kemoterapi og/eller strålebehandling, som er i steroidbehandling, som skal have en tandoperation, som ikke går til regelmæssige tandeftersyn, som har sygdomme i tandkødet, som er rygere eller som tidligere har været i behandling med bisfosfonater (bruges til at forebygge knoglesygdomme) kan have en højere risiko for at udvikle osteonekrose i kæberne.
English: Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Danish: Zoledronsyres potentielle uønskede virkninger på fertiliteten blev vurderet i rotter hos forældre og F1 generationen.
English: The solution containing zoledronic acid must not be further diluted or mixed with other infusion solutions.
Danish: Opløsningen indeholdende zoledronsyre må ikke fortyndes yderligere eller blandes med andre infusionsopløsninger.
English: Skeletal morbidity rate p-value
Danish: Skeletal morbiditet p-værdi
English: In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking Zometa.
Danish: Ved erfaring efter markedsføring er der rapporteret om alvorlige og lejlighedsvis invaliderende knogle-, led-, og/eller muskelsmerter hos patienter i behandling med Zometa.
English: - In vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer drugs, anti-adhesion/invasion activity.
Danish: - In vivo: Hæmning af osteoblastdannelse, direkte cytostatisk og pro-apoptotisk aktivitet på tumorceller, synergistisk cytostatisk effekt med andre anti-cancermidler, anti-adhæsion/invasionsaktivitet.
English: The diluted Zometa infusion solution should be used immediately in order to avoid microbial contamination.
Danish: Den fortyndede Zometa infusionsvæske bør anvendes straks for at undgå mikrobiologisk kontaminering.
English: In view of the potential impact of zoledronic acid on renal function, the lack of clinical safety data in patients with severe renal impairment (in clinical trials defined as serum creatinine ≥ 400 µmol/l or ≥ 4.5 mg/dl for patients with TIH and ≥ 265 µmol/l or ≥ 3.0 mg/dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/min), the use of Zometa is not recommended in patients with severe renal impairment.
Danish: I betragtning af zoledronsyres potentielle indflydelse på nyrefunktionen, manglende omfattende kliniske sikkerhedsdata hos patienter med alvorlig nedsat nyrefunktion (i kliniske studier defineret som serumkreatinin 400 mol/l eller 4,5 mg/dl hos patienter med TIH, og ≥265 µmol/l eller ≥3,0 mg/dl hos patienter med henholdsvis cancer og knoglemetastaser) i forhold til deres baseline værdi og kun begrænsede farmakokinetiske data hos patienter med svært nedsat nyrefunktion ved baselinien (serumkreatinin clearance <30 ml/min), kan Zometa ikke anbefales til patienter med alvorlig nedsat nyrefunktion.
English: Blurred vision, tearing of the eye, eye sensitivity to light.
Danish: Sløret syn, tåreflåd, lysfølsomhed i øjnene.
English: In paediatric patients with severe osteogenesis imperfecta, zoledronic acid seems to be associated with more pronounced risks for acute phase reaction, hypocalcaemia and unexplained tachycardia, in comparison to pamidronate, but this difference declined after subsequent infusions.
Danish: Hos pædiatriske patienter med svær osteogenesis imperfecta menes zoledronsyre, ved sammenligning med pamidronat, at være forbundet med mere udbredte risici for akut fase reaktion, hypokalcæmi og uforklarlig takykardi, men forskellen aftog ved efterfølgende infusioner.
English: Zoledronic acid does not inhibit human P450 enzymes in vitro, shows no biotransformation and in animal studies < 3% of the administered dose was recovered in the faeces, suggesting no relevant role of liver function in the pharmacokinetics of zoledronic acid.
Danish: Zoledronsyre inhiberer ikke humane P450-enzymer in vitro og udviser ingen biotransformation, og i dyreforsøg blev <3% af den indgivne dosis fundet i fæces, hvilket antyder, at leverfunktionen ikke spiller en væsentlig rolle for zoledronsyres farmakokinetiske egenskaber.
English: In patients with mild to moderate renal impairment, reduced doses should be prepared as instructed below.
Danish: Patienter med mild til moderat nedsat nyrefunktion skal have nedsatte doser, der tilberedes som beskrevet nedenfor.
English: Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between Zometa therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Danish: Baseret på evalueringen af både kliniske studier og tilfælde post-marketing er der tilstrækkelig evidens til at understøtte en sammenhæng mellem Zometa-behandling og de rapporterede tilfælde af hypokalcæmi og den sekundære udvikling af hjertearytmi.
English: Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily.
Danish: Patienterne bør også tage oralt calciumtilskud på 500 mg samt 400 IE D-vitamin daglig.
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 undersøgelser udført i patienter med tumorinduceret hyperkalcæmi (TIH), var den overordnede sikkerhedsprofil mellem de tre behandlingsgrupper (zoledronsyre 4 og 8 mg og pamidronat 90 mg) lignende i art og alvorlighed.
English: Zoledronic acid is not metabolised and is excreted unchanged via the kidney.
Danish: Zoledronsyre metaboliseres ikke og udskilles i uændret form gennem nyrerne.
English: During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphopsphonate class adverse reaction).
Danish: Efter markedsføringen er følgende bivirkninger blevet rapporteret (hyppighed sjælden): Atypiske subtrokantære og diafyseale femurfrakturer (bisfosfonat klasseeffekt).
English: Zometa must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Danish: - Zometa må kun gives af sundhedspersonale, som er trænet til at indgive bisfosfonater intravenøst, dvs. gennem en blodåre.
English: Each pack contains the vial with concentrate.
Danish: Hver pakning indeholder hætteglas med koncentrat.
English: One bottle contains 100 ml solution.
Danish: En flaske indeholder 100 ml opløsning.
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: The first randomised, double-blind, placebo-controlled study compared zoledronic acid 4 mg to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Danish: Det første randomiserede, dobbeltblinde placebo-kontrollerede studie sammenlignede zoledronsyre 4 mg med placebo med henblik på forebyggelse af skeletrelaterede hændelser (SRE'er) hos patienter med prostatacancer.
English: Blurred vision, scleritis and orbital inflammation
Danish: Sløret syn, sklerit og orbital inflammation
English: The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with Zometa (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 Zometa (zoledronsyre) 4 mg hver 3-4 uge i onkologiske patienter.
English: For intravenous use only
Danish: Kun til intravenøs anvendelse
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Danish: Osteonekrose af øregangen (klasse-bivirkning for bisfosfonater) og andre anatomiske steder, inklusive femur og hofte
English: Nausea, vomiting, decreased appetite
Danish: Kvalme, opkastning, nedsat appetit
English: Table 5 Proportion of complete responders by day in the combined TIH studies
Danish: Tabel 5 Andel af patienter med fuldt respons pr. dag i de kombinerede TIH-studier
English: Zoledronic acid 4 mg was also studied in a double-blind, randomised, placebo-controlled trial in 228 patients with documented bone metastases from breast cancer to evaluate the effect of 4 mg zoledronic acid on the skeletal related event (SRE) rate ratio, calculated as the total number of SRE events (excluding hypercalcaemia and adjusted for prior fracture), divided by the total risk period.
Danish: Zoledronsyre 4 mg blev også undersøgt i et dobbeltblindt, randomiseret, placebokontrolleret studie i 228 patienter med dokumenterede knoglemetastaser fra brystkræft, for at evaluere effekten af 4 mg zoledronsyre på skeletrelaterede hændelser (SRE) forekomsts-ratio beregnet som det totale antal af SRE hændelser (eksklusiv hyperkalcæmi og justeret for tidligere frakturer) delt med den totale risikoperiode.
English: Vomiting, nausea
Danish: Opkastning, kvalme
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 initiering af behandling til patienter med knoglemetastaser og mild til moderat nyreinsufficiens anbefales nedsatte doser af zoledronsyre.
English: Within three days after Zometa administration, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Danish: Inden for 3 dage efter indgivelse af Zometa er en akut fasereaktion blevet indrapporteret med symptomer som knoglesmerter, feber, træthed, artralgi, myalgi, stivhed og artritis med efterfølgende hævede led; disse symptomer aftager som regel inden for få dage (se beskrivelse af udvalgte bivirkninger).
English: The refrigerated solution should then be equilibrated to room temperature prior to administration.
Danish: Den afkølede opløsning skal derefter tilpasses stuetemperatur før administration.
English: Zometa 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 Zometa til TIH-patienter, som også har svær nyreinsufficiens, bør kun overvejes efter vurdering af risici og fordele ved behandlingen.
English: Longer-term repeat administration at doses bracketing the highest intended human therapeutic dose of zoledronic acid produced toxicological effects in other organs, including the gastrointestinal tract, liver, spleen and lungs, and at intravenous injection sites.
Danish: Længerevarende gentaget indgift af doser svarende til den højeste dosis af zoledronsyre beregnet til human terapi havde toksikologiske virkninger på andre organer, herunder mavetarmkanal, lever, milt og lunger, og på intravenøse injektionssteder.
English: The reduced doses for patients with renal impairment are expected to achieve the same AUC as that seen in patients with creatinine clearance of 75 ml/min.
Danish: Den nedsatte dosis til patienter med nyreinsufficiens forventes at give samme AUC, som er set hos patienter med kreatininclearence på 75 ml/min.
English: The recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone is 4 mg zoledronic acid every 3 to 4 weeks.
Danish: Anbefalet dosis til forebyggelse af skeletrelaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser er 4 mg zoledronsyre hver 3. til 4. uge.
English: This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment.
Danish: Grunden er, at du måske kan udvikle serum-elektrolyt afvigelser (fx unormale niveauer af calcium, fosfor og magnesium) og/eller ændringer i nyrefunktionen, inkl.
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: A subset had recurrence of symptoms when rechallenged with Zometa or another bisphosphonate.
Danish: Nogle havde tilbagevendende symptomer ved gentagen behandling med Zometa eller med andre bisfosfonater.
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 kreatinineclearance på 20 ml/min (svær nyreinsufficiens) eller på 50 ml/min (moderat insufficiens), skulle den tilsvarende beregnede clearance af zoledronsyre være henholdsvis 37% eller 72% af clearance hos en patient med en kreatinineclearance på 84 ml/min.
English: The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.
Danish: Muligheden for osteonekrose af øregangen skal overvejes hos patienter, der får behandling med bisfosfonater, og som udviser øresymptomer, herunder kroniske øreinfektioner.
English: In the clinical programme patients aged 1 to < 3 years received 0.025 mg/kg zoledronic acid (up to a maximum single dose of 0.35 mg) every 3 months and patients aged 3 to 17 years received 0.05 mg/kg zoledronic acid (up to a maximum single dose of 0.83 mg) every 3 months.
Danish: I det kliniske program fik patienter i alderen 1 til <3 år 0,025 mg/kg zoledronsyre (i en maksimal engangsdosis på op til 0,35 mg) hver 3. måned, og patienter i alderen 3 til 17 år fik 0,05 mg/kg zoledronsyre (i en maksimal engangsdosis på op til 0,83 mg) hver 3. måned.
English: Zoledronic acid was well tolerated when administered subcutaneously to rats and intravenously to dogs at doses up to 0.02 mg/kg daily for 4 weeks.
Danish: Zoledronsyre blev fint tolereret, når den blev indgivet subkutant til rotter og intravenøst til hunde i doser indtil 0,02 mg/kg dagligt i 4 uger.
English: Manufacturer Novartis Pharma GmbH Roonstrasse 25
Danish: Fremstiller Novartis Pharma GmbH Roonstrasse 25
English: The unopened bottle does not require any special storage conditions.
Danish: Den uåbnede flaske kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Table 6 Proportion of complete responders by day in the combined TIH studies
Danish: Tabel 6 Andel af patienter med fuldt respons pr. dag i de kombinerede TIH-studier
English: Multi-packs containing 4 (4x 1) or 5 (5x 1) bottles.
Danish: Multipakninger indeholdende 4 (4x1) eller 5 (5x1) flasker.
English: If a lower dose of Zometa is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Danish: Hvis der kræves en nedsat dosis af Zometa, skal der først udtages en passende mindre volumen som angivet nedenfor og derefter fortynde yderligere med 100 ml infusionsopløsning.
English: Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia)
Danish: Bradykardi, hjertearytmi (sekundært til hypokalcæmi)
English: For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Danish: For patienter, som udvikler osteonekrose af kæberne under behandling med bisfosfonater, kan tandoperationer forværre disse forhold.
English: Additional information on handling of Zometa, including guidance on preparation of reduced doses, is provided in section 4.2.
Danish: Yderligere information om håndtering af Zometa, inklusive vejledning om forberedelse af nedsatte doser er angivet i pkt.
English: The frequencies for each of these identified risks are shown in Table 1.
Danish: Frekvenserne for hver af de identificerede risici er vist i Tabel 1.
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 synes der at være en association mellem hypokalcæmi og de sekundære neurologiske bivirkninger, der er rapporteret i disse tilfælde, herunder kramper, hypæstesi og tetani (se pkt.
English: Arthritis and joint swelling as a symptom of acute phase reaction
Danish: Artritis og hævede led som symptomer på en akut fasereaktion
English: Zoledronic acid belongs to the class of bisphosphonates and acts primarily on bone.
Danish: Zoledronsyre tilhører gruppen af bisfosfonater og virker primært på knoglerne.
English: The following properties have been demonstrated in preclinical studies: - In vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
Danish: Følgende egenskaber er vist i prækliniske undersøgelser: - In vivo: Hæmning af osteoklastisk knogleresorption, hvilket ændrer knoglemarvens mikromiljø og mindsker bidraget til tumorcellevæksten, den anti-angiogenetiske aktivitet og anti-smerte aktiviteten.
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er ordnet under overskrifter om hyppighed, den hyppigste først, ved brug af de følgende konventionelle regler: Meget almindelig (1/10), almindelig (1/100 til <1/10), ikke almindelig (1/1.000 til <1/100), sjælden (1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Powder vial: 6 ml colourless glass vial, hydrolytic glass type I (Ph.
Danish: Pulver hætteglas: 6 ml farveløst hætteglas af glas, hydrolytisk type I glas (Ph.Eur.)
English: Caution is advised when Zometa is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Danish: Der skal udvises forsigtighed, når Zometa gives sammen med lægemidler, der vides at forårsage hypokalcæmi, da de kan have en synergistisk effekt, resulterende i svær hypokalcæmi (se pkt 4.5).
English: Median time to relapse (re-increase of albumin-corrected serum calcium  2.9 mmol/l) was 30 to 40 days for patients treated with zoledronic acid versus 17 days for those treated with pamidronate 90 mg (p-values: 0.001 for 4 mg and 0.007 for 8 mg zoledronic acid).
Danish: Mediantid til recidiv (fornyet stigning af albuminkorrigeret serumcalcium 2,9 mmol/l) var 30-40 dage for patienter i behandling med zoledronsyre i forhold til 17 dage for patienter i behandling med 90 mg pamidronat (p-værdier: 0,001 for 4 mg og 0,007 for 8 mg zoledronsyre).
English: Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Danish: - Uregelmæssig hjerterytme (atrieflimren) er set hos patienter, der fik zoledronsyre for postmenopausal osteoporose.
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 Zometa.
Danish: Nedsat indhold af calcium i blodet (hypokalcæmi), som kan medføre muskelkramper, tør hud, en brændende følelse, er indberettet for patienter i behandling med Zometa.
English: Patients with TIH and evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with Zometa outweighs the possible risk.
Danish: Patienter med TIH og verificeret forværret nyrefunktion bør evalueres på relevant vis, og det bør overvejes om den potentielle gavn af behandling opvejer de mulige ricisi.