FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/771/001-006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/771/001-006
English: - Confusion.
Danish: - Forvirring.
English: After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and 25°C.
Danish: Efter fortynding: Kemisk og fysisk stabilitet er blevet påvist at være op til 24 timer ved 2-8 °C og 25 °C.
English: EU/1/12/771/001 1 plastic vial EU/1/12/771/002 4 plastic vials EU/1/12/771/003 10 plastic vials EU/1/12/771/004 1 glass vial EU/1/12/771/005 4 glass vials EU/1/12/771/006 10 glass vials
Danish: EU/1/12/771/001 1 plastik hætteglas EU/1/12/771/002 4 plastik hætteglas EU/1/12/771/003 10 plastik hætteglas EU/1/12/771/004 1 hætteglas EU/1/12/771/005 4 hætteglas EU/1/12/771/006 10 hætteglas
English: METHOD OF ADMINISTRATION Dilute before use.
Danish: ADMINISTRATIONSMETODE Fortyndes før anvendelse.
English: If you are given more Zoledronic Acid Teva 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 mere Zoledronsyre Teva, end du skulle have haft Hvis du har fået højere doser end dem, der er anbefalet, skal du nøje overvåges af din læge.
English: Attention should also be paid to the possibility of hypomagnesaemia developing during treatment.
Danish: Opmærksomheden henledes endvidere på muligheden for udvikling af hypomagnesæmi under behandlingen.
English: Table 5: Proportion of complete responders by day in the combined TIH studies Day 4
Danish: Tabel 5: Andel af patienter med fuldt respons pr. dag i de kombinerede TIH-studier
English: − A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Danish: - En nyresygdom, der hedder Fanconis syndrom (vil normalt blive fastslået af din læge med nogle bestemte urinprøver).
English: Please see below for maximum in-use storage time.
Danish: Se nedenfor for maksimal opbevaringstid før anvendelse.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -betingelser før brug brugerens ansvar.
English: Zoledronic Acid Teva can be given to people aged 65 years and over.
Danish: Zoledronsyre Teva kan gives til patienter i alderen 65 år og derover.
English: EXP Use immediately after dilution.
Danish: EXP Anvendes straks efter fortynding.
English: - Low level of calcium in the blood.
Danish: - Lavt niveau af calcium i blodet.
English: After dilution, it is preferable to use the diluted medicine immediately.
Danish: Efter fortynding er det bedst at anvendende det fortyndede lægemiddel straks.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 August 2012
Danish: Dato for første markedsføringstilladelse: 16. august 2012
English: - The total time between dilution, storage in the refrigerator and end of administration must not exceed 24 hours.
Danish: − Den samlede tid mellem rekonstituering, opbevaring i køleskab og indgiftens afslutning må ikke overskride 24 timer.
English: Other medicinal products containing zoledronic acid as active substances are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Danish: Andre lægemidler, der indeholder zoledronsyre som aktiv substans, er tilgængelige til osteoporoseindikationer og behandling af Pagets sygdom af knoglerne.
English: If a lower dose of zoledronic acid 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 zoledronsyre, skal der først udtages en passende mindre volumen som angivet nedenfor og derefter fortynde yderligere med 100 ml infusionsopløsning.
English: There have been very rare cases of drowsiness and sleepiness with the use of zoledronic acid.
Danish: Der har været meget sjældne tilfælde af døsighed og søvnighed ved brug af Zoledronsyre Teva.
English: - Low level of red blood cells (anaemia).
Danish: - Lavt antal røde blodceller (anæmi).
English: Hypocalcaemia is an important identified risk with Zoledronic Acid Teva in the approved indications.
Danish: Hypokalcæmi er en vigtig, identificeret risiko ved Zoledronsyre Teva ved de godkendte indikationer.
English: Zoledronic Acid Teva should only be resumed when serum creatinine returns to within 10% of baseline.
Danish: Zoledronsyre Teva bør kun genoptages, når serum-kreatinin igen er inden for 10% af baseline.
English: The pain score for zoledronic acid was consistently below baseline and pain reduction was accompanied by a trend in reduced analgesics score.
Danish: Smerte-scoringen for zoledronsyre var konsekvent under baseline og smertereduktionen var ledsaget af en tendens til nedsat smertestillende score.
English: - If you are being treated to reduce the amount of calcium in your blood, you will normally only be given a single infusion of Zoledronic Acid Teva.
Danish: - Hvis du er i behandling for at nedsætte calciumindholdet i blodet, vil du som regel kun få én enkelt infusion med Zoledronsyre Teva.
English: - Low counts of white blood cells and blood platelets.
Danish: - Lavt antal hvide blodceller og blodplader.
English: 1Adverse 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: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1.
Danish: Tabel 6: Bivirkninger observeret hos pædiatriske patienter med svær osteogenesis imperfecta1
English: In the event of hypocalcaemia, calcium gluconate infusions should be administered as clinically indicated.
Danish: I tilfælde af hypocalkæmi bør calciumglukonat-infusioner administreres, hvis det er klinisk indikeret.
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: Pack sizes of 1, 4 or 10 vials.
Danish: Pakninger indeholdende 1, 4 eller 10 hætteglas.
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 Teva 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 Teva og informere din læge om tandlægebehandlingen.
English: In addition to being a potent inhibitor of bone resorption, zoledronic acid also possesses several anti-tumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease.
Danish: Ud over at være en potent hæmmer af knogleresorption, har zolendronsyre også adskillige anti-tumor egenskaber der kan bidrage til den samlede effekt i behandling af metastaserende knoglesygdom.
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 Teva.
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 Teva.
English: Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Danish: Pamidronat 90 mg (N = 99) 33,3% * p-værdier sammenlignet med pamidronat.
English: Additional information on handling on Zoledronic Acid Teva, including guidance on preparation of reduced doses, is provided in section 4.2.
Danish: Yderligere information om håndtering af Zoledronsyre Teva, inklusive vejledning om forberedelse af nedsatte doser er angivet i pkt.
English: The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established.
Danish: Zoledronsyres sikkerhed og virkning hos børn i alderen 1 år til17 år er ikke klarlagt.
English: The total time between dilution, storage in a refrigerator at 2°C - 8°C and end of administration must not exceed 24 hours.
Danish: Det samlede tidsrum mellem fortynding, opbevaring i køleskab ved 2 °C til 8 °C og indgiftens afslutning må ikke overstige 24 timer.
English: Each plastic or clear glass vial contains 5 ml of a clear, colourless concentrate.
Danish: Et plastik- eller gennemsigtigt glashætteglas indeholder 5 ml af en klar, farveløs koncentrat.
English: How much Zoledronic Acid Teva is given - The usual single dose given is 4 mg. - If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
Danish: Hvis du har fået for meget Zoledronsyre Teva - Den normale enkeltdosis er 4 mg. - Hvis du har problemer med nyrerne, vil lægen give dig en lavere dosis afhængig af sværhedsgraden af dine nyreproblemer.
English: - if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which zoledronic acid belongs), or any of the other ingredients of this medicine (listed in section 6).
Danish: − hvis du er allergisk over for zoledronsyre, et andet bisfosfonat (den gruppe af stoffer, som Zoledronsyre Teva tilhører) eller et af de øvrige indholdsstoffer i Zoledronsyre Teva (angivet i punkt 6).
English: Caution is indicated when Zoledronic Acid Teva is used with other potentially nephrotoxic medicinal products.
Danish: Der bør udvises forsigtighed når Zoledronsyre Teva anvendes sammen med andre potentielt nefrotoksiske lægemidler.
English: - Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with zoledronic acid.
Danish: − Undersøgelser med forskellige typer af infusionsslanger fremstillet af polyvinylklorid, polyethylen og polypropylen viste ingen uforligelighed med Zoledronsyre Teva.
English: Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Teva and will check your response to treatment at regular intervals.
Danish: Lægen vil tage en blodprøve, inden du begynder behandling med Zoledronsyre Teva, og vil med regelmæssige mellemrum kontrollere, hvordan du reagerer på behandlingen.
English: How often Zoledronic Acid Teva is given - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic Acid Teva every three to four weeks.
Danish: Hvor ofte skal du have Zoledronsyre Teva - Hvis du er i forebyggende behandling for knoglekomplikationer pga. knoglemetastaser, vil du få en infusion af Zoledronsyre Teva hver tredje til fjerde uge.
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when Zoledronic Acid Teva is used in combination with thalidomide.
Danish: Hos patienter med multipelt myelom kan risikoen for nedsat nyrefunktion øges når Zoledronsyre Teva anvendes i kombination med thalidomid.
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 afsnit 4.4).
English: For instructions of the dilution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om rekonstitution og fortynding af lægemidlet før administration, se pkt.
English: - Sleepiness.
Danish: − Søvnighed.
English: Common (may affect up to 1 in 10 people): - Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Danish: Almindelig (forekommer hos op til 1 ud af 10 patienter): - Svært nedsat nyrefunktion (vil normalt blive afgjort af din læge ved hjælp af en speciel type blodprøver).
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 ½α 0,24 og t ½α 1,87 timer efterfulgt af en lang elimineringsfase med en terminal eliminationshalveringstid på t ½α 146 timer.
English: Zoledronic Acid Teva should not be used during pregnancy.
Danish: Zoledronsyre Teva bør ikke anvendes under graviditet.
English: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zoledronic Acid Teva therapy.
Danish: Standard hyperkalcæmirelaterede metabolske parametre som serumniveauer af calcium, fosfat og magnesium, bør monitoreres grundigt efter påbegyndt behandling med Zoledronsyre Teva.
English: The active substance in this medicine is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Danish: Det aktive stof i Zoledronsyre Teva er zoledronsyre, der tilhører en gruppe af stoffer kaldet bisfosfonater.
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 Teva 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 Teva anvendes i forbindelse med bilkørsel og betjening af maskiner.
English: Zoledronic Acid Teva must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Danish: Zoledronsyre Teva må kun udskrives og administreres til patienter af sundhedspersonale med erfaring i administration af intravenøse bisfosfonater.
English: - Since no data are available on the compatibility of zoledronic acid with other intravenously administered substances, zoledronic acid 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 med andre intravenøst indgivne stoffer, må zoledronsyre ikke blandes med andre lægemidler eller stoffer og bør altid indgives gennem en separat infusionsslange.
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: Zoledronic Acid Teva is supplied as packs containing 1, 4 or 10 vials.
Danish: Zoledronsyre Teva leveres i pakninger, som indeholder henholdsvis 1, 4 eller 10 hætteglas.
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 smerte, hævelse eller fornemmelse af følelsesløshed i kæben, følelsen af tyngde i kæben eller af løse tænder.
English: Placebo Δ Zoledronic acid 
Danish: Placebo Δ Zoledronsyre 
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 (albuminkorrigeret serumcalcium ≥12,0 mg/dl eller 3,0 mmol/l) er en enkelt dosis på 4 mg zoledronsyre.
English: Following initiation of therapy, serum creatinine should be measured prior to each dose of Zoledronic Acid Teva and treatment should be withheld if renal function has deteriorated.
Danish: Efter påbegyndelse af behandling bør serum-kreatinin måles før hver dosis af Zoledronsyre Teva, og behandlingen bør tilbageholdes, hvis nyrefunktionen forværres.
English: Patients being treated with Zoledronic acid Teva should not be treated with such medicinal products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Danish: Patienter, der bliver behandlet med Zoledronsyre Teva, bør ikke behandles samtidig med sådanne lægemidler eller andre bisphosphonater, da den kombinerede virkning er ukendt.
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-cancermidler, anti-adhæsion/invasionsaktivitet.
English: If the solution is not used immediately, storage prior to use is the responsibility of the user and should be in a refrigerator at 2°C - 8°C.
Danish: Hvis opløsningen ikke anvendes straks, er brugeren ansvarlig for, at opløsningen før brug opbevares i køleskab ved 2°C - 8°C.
English: Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier med zoledronsyre har påvist reproduktionstoksicitet (se pkt.
English: The refrigerated solution should then be equilibrated to room temperature before administration.
Danish: Den afkølede opløsning skal derefter tilpasses stuetemperatur før administration.
English: Cyclic Olefin Polymer (COP) plastic vial or clear glass vial (type I) with chlorobutyl/butyl flurotec stopper and aluminium cap with plastic flip-off cap.
Danish: Cyklisk olefin-polymer (COP) plastik hætteglas eller gennemsigtigt hætteglas (type I) med Flurotec chlorobutyl/butyl gummiprop og aluminiumslåg med plastik afrivningshætte.
English: When initiating treatment with Zoledronic Acid Teva 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 Teva initieres hos patienter med multipelt myelom eller knoglemetastatisk skade fra solide tumorer bør serum-kreatinin og kreatininclearence (CLcr) bestemmes.
English: Each vial contains 5 ml of concentrate.
Danish: Hvert hætteglas indeholder 5 ml koncentrat.
English: - Low level of magnesium and potassium in the blood.
Danish: - Lavt indhold af magnesium og kalium i blodet.
English: - Do not use Zoledronic Acid Teva after the expiry date stated on the vial and carton after EXP.
Danish: − Brug ikke Zoledronsyre Teva efter den udløbsdato, der står på hætteglasset og pakningen efter Exp.
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 Teva 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 µmol/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 Teva ikke anbefales til patienter med alvorlig nedsat nyrefunktion.
English: Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between Zoledronic Acid Teva 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 Teva -behandling og de rapporterede tilfælde af hypokalcæmi og den sekundære udvikling af hjertearytmi.
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: - Severe bone, joint and/or muscle pain, occasionally incapacitating.
Danish: - Kraftige knogle-, led- og/eller muskelsmerter, lejlighedsvis invaliderende.
English: Zoledronic Acid Teva 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 Teva til TIH-patienter, som også har svær nyreinsufficiens, bør kun overvejes efter vurdering af risici og fordele ved behandlingen.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2°C - 8°C .
Danish: Hvis det ikke bruges straks, er opbevaringstiderne og -betingelserne efter anbrud indtil anvendelse brugerens ansvar og vil normalt ikke være længere end 24 timer ved opbevaring ved 2 °C til 8 °C.
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 Teva 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 Teva er ukendt.
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to zoledronic acid administration.
Danish: Under behandling bør invasiv tandbehandling udføres med forsigtighed og undgås tæt på administration af zoledronsyre
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 en kombination af dette og Zoledronsyre Teva har været forbundet med en øget risiko for osteonekrose i kæberne.
English: Zoledronic Acid Teva 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 Teva anbefales ikke til patienter, der før behandlingen initieres, har svær nyreinsufficiens, som i denne population er defineret som CLcr <30 ml/min.
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.