FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Zoledronic acid Mylan.
Danish: Alle patienter bør opfordres til at opretholde en god mundhygiejne, gennemgå rutinemæssige tandeftersyn og straks rapportere eventuelle orale symptomer såsom tandmobilitet, smerter eller hævelse eller vedvarende sår eller sekretion under behandling med Zoledronsyre Mylan.
English: Additional information on handling of Zoledronic acid Mylan, including guidance on preparation of reduced doses, is provided in section 4.2.
Danish: Yderligere information om håndtering af Zoledronsyre Mylan, inklusive vejledning om forberedelse af nedsatte doser er angivet i pkt.
English: The following adverse reactions, listed in Table 1, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Danish: De følgende bivirkninger, opført i Tabel 1, er samlet fra kliniske studier og post-marketing rapporter efter fortrinsvis kronisk behandling med 4 mg zoledronsyre:
English: Zoledronic acid Mylan contains the same active substance as found in medicinal products indicated for treatment of osteoporosis and Paget´s disease of the bone.
Danish: Zoledronsyre Mylan indeholder den samme aktive substans som i lægemidler, der er indiceret til behandling af osteoporose og Pagets knoglesygdom.
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-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis den 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 foregået under kontrollerede og godkendte aseptiske forhold.
English: • Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1
Danish: • Overfølsomhed over for det aktive stof, andre bisfosfonater eller over for et eller flere af hjælpestofferne anført i pkt 6.1.
English: Hypocalcaemia is an important identified risk with zoledronic acid in the approved indications.
Danish: Hypokalcæmi er en vigtig, identificeret risiko ved Zoledronsyre Mylan ved de godkendte indikationer.
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 hypercalcæmirelaterede metabolske parametre som serumniveauer af calcium, fosfat og magnesium, bør monitoreres grundigt efter påbegyndt behandling med zoledronsyre.
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 Mylan 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 Mylan og informere din læge om tandlægebehandlingen.
English: Your doctor will carry out blood tests before you start treatment with Zoledronic acid Mylan and will check your response to treatment at regular intervals.
Danish: Lægen vil tage en blodprøve, inden du begynder behandling med Zoledronsyre Mylan, og vil med regelmæssige mellemrum kontrollere, hvordan du reagerer på behandlingen.
English: The active substance in Zoledronic acid Mylan is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Danish: Det aktive stof i Zoledronsyre Mylan er zoledronsyre, der tilhører en gruppe af stoffer kaldet bisfosfonater.
English: - For single use only.
Danish: Kun til engangsbrug.
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 (eksklusive hyperkalcæmi) var 29,8% i den zoledronsyrebehandlede gruppe sammenlignet med 49,6% i placebo gruppen (p=0,003).
English: How often you will be given Zoledronic acid Mylan - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic acid Mylan every three to four weeks.
Danish: Hvor ofte skal du have Zoledronsyre Mylan - Hvis du er i forebyggende behandling for knoglekomplikationer pga. knoglemetastaser, vil du få en infusion af Zoledronsyre Mylan hver tredje til fjerde uge.
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 t ½ 0,24 og t ½ 1,87 timer efterfulgt af en lang elimineringsfase med en terminal eliminationshalveringstid på t ½ 146 timer.
English: Zoledronic acid treatment should be resumed at the same dose as that given prior to treatment interruption.
Danish: Zoledronsyre-behandling bør genoptages med samme dosis som givet før afbrydelse af behandlingen.
English: The majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Danish: Størstedelen af rapporterne refererer til cancerpatienter, som har fået trukket en tand ud eller har fået foretaget andre tandoperationer.
English: The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06-0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Danish: Sikkerhedsmargenerne i forbindelse med renal påvirkning var smalle i langvarige dyrestudier med gentaget parenteral indgift, men det kumulative niveau af ingen uønskede hændelser (NOAELs) ved studier med enkeltdoser (1,6 mg/kg) og flere doser på op til en måned (0,06-0,6 mg/kg/dag) tydede ikke på renal påvirkning ved doser svarende til eller højere end den højeste dosis beregnet til human terapi.
English: The primary endpoint of the study was the percent change from baseline in lumbar spine bone mineral density (BMD) after 12 months of treatment.
Danish: Undersøgelsens primære endepunkt var den procentvise ændring i knoglemineraltætheden (BMD) i lænderygsøjlen efter 12 måneders behandling.
English: - if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
Danish: - hvis du har eller har haft smerter, hævelse eller fornemmelse af følelsesløshed i kæben, følelsen af tyngde i kæben eller af løse tænder.
English: Patients being treated with Zoledronic acid Mylan should not be treated with such medicinal products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Danish: Patienter, som behandles med Zoledronsyre Mylan, bør ikke samtidig behandles med sådanne lægemidler eller andre bisfosfonater, da den kombinerede effekt af disse stoffer er ukendt.
English: Zoledronic acid Mylan must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Danish: Zoledronsyre Mylan må kun udskrives og administreres til patienter af sundhedspersonale med erfaring i administration af intravenøse bisfosfonater.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Yderligere oplysninger om findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: (e.g. tooth extractions) and poorly fitting dentures.
Danish: (f.eks. tandudtrækninger) og dårligt tilpassede tandproteser.
English: For instructions on the dilution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om rekonstituering og fortynding af lægemidlet før administration, se pkt.
English: The following conventional classification is used: 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: Følgende konventionelle klassifikation er anvendt: 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: - 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 (til behandling af kræft), da kombination af dette og zoledronsyre har været forbundet med en øget risiko for osteonekrose i kæberne.
English: - In vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer medicinal products, anti-adhesion/invasion activity.
Danish: - In vivo: Hæmning af osteoblastdannelse, direkte cytostatisk og pro-apoptotisk aktivitet på tumorceller, synergistisk cytostatisk effekt med andre anti-cancer lægemidler, anti-adhæsion-/invasionsaktivitet.
English: - Low level of magnesium and potassium in the blood.
Danish: Lavt indhold af magnesium og kalium i blodet.
English: In long-term animal studies, zoledronic acid inhibits bone resorption without adversely affecting the formation, mineralisation or mechanical properties of bone.
Danish: I længerevarende dyrestudier inhiberer zoledronsyre knogleresorptionen uden negativ påvirkning af knogledannelse, knoglemineralisation eller knoglernes mekaniske egenskaber.
English: - Other medicines that also contain zoledronic acid and which 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 Mylan 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 Mylan er ukendt.
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 baseline (serumkreatinin clearance < 30 ml/min), kan zoledronsyre ikke anbefales til patienter med alvorlig nedsat nyrefunktion.
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Danish: Osteonekrose af øregangen (klassebivirkning for bisfosfonater) og andre anatomiske steder, inklusive femur og hofte
English: Acute renal failure, haematuria, proteinuria Acquired Fanconi syndrome
Danish: Akut nyresvigt, hæmaturi, proteinuri Erhvervet Fanconis syndrom
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: 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 Mylan along with driving and operating of machinery.
Danish: Bivirkninger såsom svimmelhed og døsighed kan påvirke evnen til at føre motorkøretøj og betjene maskiner, der skal derfor udvises forsigtighed når zoledronsyre anvendes i forbindelse med bilkørsel og betjening af maskiner.
English: - Since no data are available on the compatibility of Zoledronic acid Mylan with other intravenously administered substances, Zoledronic acid Mylan must not be mixed with other medicinal products/substances and should always be given through a separate infusion line.
Danish: Da der ikke eksisterer data om forligeligheden af Zoledronsyre Mylan med andre intravenøst indgivne stoffer, må Zoledronsyre Mylan ikke blandes med andre lægemidler eller stoffer og bør altid indgives gennem en separat infusionsslange.
English: 1 vial of 5 ml 4 vials of 5 ml 10 vials of 5 ml
Danish: 1 hætteglas á 5 ml 4 hætteglas á 5 ml 10 hætteglas á 5 ml
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Danish: Total legemsclearance er 5,04±2,5 l/t uafhængigt af dosis og uanset køn,
English: It is used: - To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
Danish: Det bruges til: - At forebygge knoglekomplikationer, f.eks. knoglebrud hos voksne patienter med knoglemetastaser (spredning af kræft fra den primære kræftknude til knoglerne).
English: - Zoledronic acid Mylan must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Danish: - Zoledronsyre Mylan må kun gives af sundhedspersonale, som er trænet til at indgive bisfosfonater intravenøst, dvs. gennem en blodåre.
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 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: Date of latest renewal: 24.05.2017
Danish: Dato for første markedsføringstilladelse: 23.08.2012 Dato for seneste fornyelse: 24.05.2017
English: - Severe bone, joint and/or muscle pain, occasionally incapacitating.
Danish: Kraftige knogle-, led- og/eller muskelsmerter, lejlighedsvis invaliderende.
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 dobbeltblindet, randomiseret, placebokontrolleret studie i 228 patienter med dokumenterede knoglemetastaser fra brystkræft, for at evaluere effekten af 4 mg zoledronsyre på skeletrelaterede hændelser (SRE) forekomst-ratio beregnet som det totale antal af SRE hændelser (eksklusive hyperkalcæmi og justeret for tidligere frakturer) delt med den totale risikoperiode.
English: If you are given more Zoledronic acid Mylan than you should be If you have received doses higher than those recommended, you must be carefully monitored by your doctor.
Danish: Hvis du har fået højere doser end dem, der er anbefalet, skal du nøje overvåges af din læge.
English: Instructions for preparing reduced doses of Zoledronic acid Mylan: Withdraw the appropriate volume of the liquid concentrate, as follows: - 4.4 ml for 3.5 mg dose
Danish: Instruktion for tilberedning af reducerede doser af Zoledronsyre Mylan: Udtag det passende volumen af det flydende koncentrat efter følgende: 4,4 ml til 3,5 mg dosis
English: The hydration status of patients must be assessed prior to and following administration of Zoledronic acid Mylan to ensure that they are adequately hydrated.
Danish: Patienternes hydreringsstatus skal vurderes før og efter indgivelsen af Zoledronsyre Mylan for at sikre, at de er tilstrækkeligt hydrerede.
English: Your doctor may recommend a dental examination before you start treatment with Zoledronic acid Mylan.
Danish: Din læge vil måske bede dig om at få et tandeftersyn, før du starter behandling med Zoledronsyre Mylan.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, dvs. den er i det væsentligste natriumfri.
English: Warnings and precautions Talk to your doctor before you are given Zoledronic acid Mylan: - if you have or have had a kidney problem.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du begynder at få Zoledronsyre Mylan: - hvis du har eller har haft en nyrelidelse.
English: Zoledronic acid Mylan is supplied as packs containing 1, 4 or 10 vials or as multipacks comprising 4 packs, each containing 1 vial.
Danish: Zoledronsyre Mylan fås i pakninger med 1, 4 eller 10 hætteglas eller som multipakninger med 4 pakninger, der hver indeholder 1 hætteglas.
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 seponeres, hvis nyrefunktionen forværres.
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 i onkologiske patienter.
English: How much Zoledronic acid Mylan is given - The usual single dose given is 4 mg zoledronic acid.
Danish: Hvor meget Zoledronsyre Mylan skal du have - Den normale enkeltdosis er 4 mg zoledronsyre.
English: Very rare (may affect up to 1 in 10,000 people): - Fainting due to low blood pressure.
Danish: Meget sjælden (forekommer hos op til 1 ud af 10.000 patienter): Besvimelse på grund af lavt blodtryk.
English: - From a microbiological point of view, the diluted solution for infusion should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning til infusion anvendes.
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 (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 kreatininclearance på 84 ml/min.
English: - Blurred vision, tearing of the eye, eye sensitivity to light.
Danish: Sløret syn, tåreflåd, lysfølsomhed i øjnene.
English: Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of a condition called osteonecrosis of the jaw.
Danish: Kontakt straks din læge eller tandlæge, hvis du får nogle problemer med din mund eller tænder, som f.eks. tab af tænder, smerte eller hævelse, eller manglende sårheling eller pus fra såret, da dette kan være tegn på en tilstand kaldet osteonekrose i kæben.
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: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på den fremstillere, der er ansvarlige for batchfrigivelse
English: In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Danish: I kliniske studier blev behandling med zoledronsyre først genoptaget når kreatinin-niveauet faldt inden for 10% over baselineværdien (se pkt.
English: Instructions for preparing reduced doses of Zoledronic acid Mylan
Danish: Instruktion i fremstilling af reducerede doser Zoledronsyre Mylan
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of zoledronic acid.
Danish: Hvis du har hypokalcæmi, skal den korrigeres, inden du får den første dosis af zoledronsyre.
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 Zoledronsyre Mylan-behandling og de rapporterede tilfælde af hypokalcæmi og den sekundære udvikling af hjertearytmi.
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: - Weight increase.
Danish: Øget svedtendens.
English: 15 ml colourless type I glass vial with a bromobutyl rubber stopper and an aluminium crimp cap with plastic flip-off component.
Danish: 15 ml farveløs type I hætteglas med bromobutylgummiprop og aluminium hætte med en aftagelig plastikkomponent.
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: Frekvensen af atrieflimren som alvorlig utilsigtigt 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: Zoledronic acid Mylan is not recommended for use in adolescents and children below the age of 18 years.
Danish: Børn og unge Zoledronsyre Mylan bør ikke anvendes til børn og unge under 18 år.
English: Multipack: 4 vials (4 packs of 1)
Danish: Multipakning: 4 hætteglas (4 pakninger af 1)