FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common (may affect more than 1 in 10 people): • Low level of phosphate in the blood.
Danish: Meget almindelig (forekommer hos flere end 1 ud af 10 patienter): - Lavt fosfatindhold i blodet.
English: The active substance in Zoledronic Acid Accord is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Danish: Det aktive stof i Zoledronsyre Accord er zoledronsyre, der tilhører en gruppe af stoffer kaldet bisfosfonater.
English: • Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with Zoledronic Acid Accord.
Danish: Undersøgelser med forskellige typer af infusionsslanger fremstillet af polyvinylklorid, polyethylen og polypropylen viste ingen uforligelighed med Zoledronsyre Accord.
English: For instructions on the dilution of zoledronic acid before administration, see section 6.6.
Danish: For instruktioner om fortynding af zoledronsyre før administration, se pkt.
English: Packs containing 1, 4 or 10 vials.
Danish: Pakninger indeholdende henholdsvis 1, 4 eller 10 hætteglas.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -betingelser før brug brugerens ansvar og bør normalt ikke overstige 24 timer ved 2 °C til 8 °C, medmindre fortynding er sket under kontrollerede og validerede antiseptiske forhold.
English: Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Danish: Der er kun begrænsede farmakokinetiske data vedrørende patienter med svær nyreinsufficiens (kreatinineclearance < 30 ml/min).
English: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating zoledronic acid therapy.
Danish: Standard hyperkalcæmirelaterede metabolske parametre som serumniveauer af calcium, fosfat og magnesium, bør monitoreres grundigt efter påbegyndt behandling med zoledronsyre.
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 Accord along with driving and operating of machinery.
Danish: Bivirkninger såsom svimmelhed og døsighed kan påvirke evnen til at føre motorkøretøj eller betjene maskiner, der skal derfor iagttages forsigtighed, når Zoledronsyre Accord anvendes i forbindelse med bilkørsel og betjening af maskiner.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere information om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: After initiating the infusion of zoledronic acid, the plasma concentrations of zoledronic acid rapidly increased, achieving their peak at the end of the infusion period, followed by a rapid decline to < 10% of peak after 4 hours and < 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak prior to the second infusion of zoledronic acid on day 28.
Danish: Efter påbegyndelse af infusion med zoledronsyre, øges plasmakoncentrationen af zoledronsyre hurtigt, og maksimal koncentration nås ved slutningen af infusionsperioden, efterfulgt af et hurtigt fald til <10 % af maksimalkoncentrationen efter 4 timer og < 1 % af maksimalkoncentrationen efter 24 timer, med en efterfølgende forlænget periode med meget lave koncentrationer der ikke overstiger 0,1% af den maksimale koncentration inden den 2. infusion af zoledronsyre på dag 28.
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
Danish: Intravenøst indgivet zoledronsyre elimineres i en trifasisk proces: hurtig bifasisk elimination fra det systemiske kredsløb med halveringstider på t½ 0,24 og t½ 1,87 timer efterfulgt af en lang elimineringsfase med en terminal eliminationshalveringstid på t½γ 146 timer.
English: In clinical studies, zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Danish: I kliniske studier er zoledronsyre indgivet samtidig med almindeligt anvendte anticancerlægemidler, diuretika, antibiotika og analgesika uden tilsyneladende kliniske interaktioner.
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 placebo gruppen (p=0,003).
English: • if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid Accord and inform your doctor about your dental treatment.
Danish: hvis du er under tandlægebehandling eller skal have en tandoperation, bør du fortælle tandlægen, at du er i behandling med Zoledronsyre Accord og informere din læge om tandlægebehandlingen.
English: • Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
Danish: - Alvorlige overfølsomhedsreaktioner: åndenød, hævelse hovedsageligt i ansigt og hals.
English: • If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic Acid Accord.
Danish: - Hvis du er i behandling for at nedsætte calciumindholdet i blodet, vil du som regel kun få én infusion med Zoledronsyre Accord.
English: Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Danish: Behandling af voksne patienter med tumorinduceret hyperkalcæmi (TIH).
English: During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).
Danish: Efter markedsføringen er følgende bivirkninger blevet rapporteret (hyppighed sjælden): Atypiske subtrokantære og diafyseale femurfrakturer (bisfosfonat klasseeffekt).
English: Zoledronic Acid Accord contains the same active substance as found in Aclasta (zoledronic acid).
Danish: Zoledronsyre Accord indeholder den samme aktive substans som Aclasta (zoledronsyre).
English: The onset time is ≤ 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Danish: Starttidspunktet er ≤ 3 dage efter infusion med zoledronsyre, og reaktionen er også refereret til ved brug af termerne ”inluenza-lignende symptomer” eller ”symptomer efter dosering”.
English: The recommended dose in hypercalcaemia (albumin-corrected serum calcium ≥12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
Danish: Den anbefalede dosis ved hyperkalcæmi (albumin-korrigeret serumcalcium ≥12,0 mg/dl eller 3,0 mmol/l) er en enkelt dosis på 4 mg zoledronsyre.
English: Patients must be maintained well hydrated prior to and following administration of zoledronic acid.
Danish: Patienter skal holdes velhydrerede før og efter administration af zoledronsyre.
English: • The unopened vial does not require any specific storage conditions.
Danish: - Det uåbnede hætteglas kræver ingen særlige forholdsregler vedrørende opbevaringen.
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 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: 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: Healthcare professionals are advised not to dispose of unused Zoledronic Acid Accord via the domestic sewage system.
Danish: Sundhedspersonalet rådes til ikke at smide ubrugt Zoledronsyre Accord i kloaken.
English: Zoledronic Acid Accord is not recommended for use in adolescents and children below the age of 18 years.
Danish: Børn og teenagere Zoledronsyre Accord bør ikke bruges til børn og teenagere under 18 år.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate) Clear and colourless solution.
Danish: LÆGEMIDDELFORM Koncentrat til infusionsvæske, opløsning (sterilt koncentrat) Klar og farveløs opløsning.
English: When initiating treatment with zoledronic acid in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Danish: Når behandling med zoledronsyre initieres hos patienter med multipelt myelom eller knoglemetastatisk skade fra solide tumorer bør serum-kreatinin og kreatininclearence (CLcr) bestemmes.
English: Zoledronic acid treatment should be resumed at the same dose as that given prior to treatment interruption.
Danish: Behandling med zoledronsyre bør genoptages med den samme dosis som blev givet før afbrydelse af behandlingen.
English: Patients being treated with Zoledronic Acid Accord should not be treated with Aclasta or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Danish: Patienter, som behandles med Zoledronsyre Accord, bør ikke samtidig behandles med Aclasta eller andre bisfosfonater, da den kombinerede effekt af disse stoffer er ukendt.
English: Zoledronic acid 4 mg significantly reduced the proportion of patients experiencing at least one skeletal related event (SRE), delayed the median time to first SRE by > 5 months, and reduced the annual incidence of events per patient-skeletal morbidity rate.
Danish: Zoledronsyre 4 mg reducerede signifikant andelen af patienter, der oplevede mindst én skeletrelateret hændelse (SRE), forsinkede den gennemsnitlige tid til første SRE med > 5 måneder og reducerede den årlige incidens af hændelser per patient - skeletal morbiditet.
English: Hypophosphataemia 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 frekvenser < 5 % blev vurderet medicinsk, og det blev vist, at de er i overensstemmelse med den veletablerede sikkerhedsprofil for zoledronsyre (se pkt.
English: • Zoledronic Acid Accord must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Danish: - Zoledronsyre Accord må kun gives af sundhedspersonale, som er trænet til at indgive bisfosfonater intravenøst, dvs. gennem en blodåre.
English: 5-ml plastic vial made of clear, cycloolefine copolymer with chlorobutyl rubber stopper and aluminium cap with flip-off component.
Danish: 5 ml plastikhætteglas fremstillett af klar, cyclo-olefin-copolymer med chlorobutylgummiprop og aluminiumhætte med flip-off-komponent.
English: In long-term animal studies, zoledronic acid inhibits bone resorption without adversely affecting the formation, mineralization or mechanical properties of bone.
Danish: I langsigtede dyreundersøgelser inhiberer zoledronsyre knogleresorptionen uden negativ påvirkning af knogledannelse, knoglemineralisation eller knoglernes mekaniske egenskaber.
English: Zoledronic Acid Accord 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 Accord til TIH-patienter, som også har svær nyreinsufficiens, bør kun overvejes efter vurdering af risici og fordele ved behandlingen.
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: Following initiation of therapy, serum creatinine should be measured prior to each dose of zoledronic acid and treatment should be withheld if renal function has deteriorated.
Danish: Efter påbegyndelse af behandling bør serum-kreatinin måles før hver dosis af zoledronsyre, og behandlingen bør tilbageholdes, hvis nyrefunktionen forværres.
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: In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking zoledronic acid.
Danish: Ved erfaring efter markedsføring er der rapporteret om alvorlige og lejlighedsvis invaliderende knogle, led-, og/eller muskelsmerter hos patienter i behandling med zoledronsyre.
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 zoledronic acid 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 zoledronsyre ikke anbefales til patienter med alvorlig nedsat nyrefunktion.
English: Within three days after zoledronic acid 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 zoledronsyre, er en akut fasereaktion almindeligvis 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: Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between zoledronic acid 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 behandling med zoledronsyre og de rapporterede tilfælde af hypokalcæmi og den sekundære udvikling af hjertearytmi.
English: • Low level of magnesium and potassium in the blood.
Danish: - Lavt indhold af magnesium og kalium i blodet.
English: Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Danish: Zoledronsyre anbefales ikke til patienter, der før behandlingen initieres, har svær nyreinsufficiens, som i denne population er defineret som CLcr < 30 ml/min.
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 Accord are unknown.
Danish: - Anden 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 Zoledronsyre Accord er ukendt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE
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: • Carefully follow all the other instructions given to you by your doctor, pharmacist or nurse.
Danish: - Følg nøje alle de andre instruktioner, som du har fået af din læge, på apoteket eller af sundhedspersonalet.
English: • Painful redness and/or swelling of the eye.
Danish: - Smertefuld rødme og/eller hævelse af øjet.
English: • Since no data are available on the compatibility of Zoledronic Acid Accord with other intravenously administered substances, Zoledronic Acid Accord must not be mixed with other medications/substances and should always be given through a separate infusion line.
Danish: Da der ikke eksisterer data om forligeligheden af Zoledronsyre Accord med andre intravenøst indgivne stoffer, må Zoledronsyre Accord ikke blandes med andre lægemidler eller stoffer og bør altid indgives gennem en separat infusionsslange
English: • Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
Danish: - Anti-angiogenetisk medicin (brugt til behandling af kræft), da kombination af dette og Zoledronsyre Accord har været forbundet med en øget risiko for osteonekrose i kæberne.
English: The following risk factors should be considered when evaluating an individual's risk of developing ONJ:
Danish: Følgende risikofaktorer skal tages i betragtning, når risikoen for at udvikle osteonekrose af kæberne skal vurderes hos den enkelte patient:
English: • The other ingredients are: mannitol, sodium citrate, water for injections.
Danish: Øvrige indholdsstoffer: mannitol, natriumcitrat, vand til injektionsvæsker.
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: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic Acid Accord.
Danish: Hvis du har hypokalcæmi, skal den korrigeres, inden du får den første dosis af Zoledronsyre Accord.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: • Severe bone, joint and/or muscle pain, occasionally incapacitating.
Danish: - Kraftige knogle-, led- og/eller muskelsmerter, lejlighedsvis invaliderende.
English: Your doctor may recommend a dental examination before you start treatment with Zoledronic Acid Accord.
Danish: Din læge vil måske bede dig om at få et tandeftersyn, før du starter behandling med Zoledronsyre Accord.
English: Caution is advised when Zolendronc Acid Accord 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 Zoledronsyre Accord 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: 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 Accord.
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 Accord.
English: Pain in extremities, arthralgia, musculoskeletal pain
Danish: Smerte i ekstremiteter, artralgi, muskuloskeletal smerte
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: • Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Danish: - Usædvanlige brud på lårbensknoglen, primært hos patienter i langtidsbehandling for osteoporose kan forekomme i sjældne tilfælde.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med referencelægemidlet i alle undergrupper af den pædiatriske population ved behandling af tumorinduceret hyperkalcæmi (TIH) og forebyggelse af skeletrelaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser (se pkt.
English: Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline.
Danish: Zoledronsyre bør kun genoptages, når serum-kreatinin igen er inden for 10