FrancophonIA/ELRC3.0 huggingface dataset:
English: Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Danish: Zoledronsyre var ikke mutagen i de udførte mutagenicitetsprøver, og undersøgelse af cancerogenicitet kunne ikke påvise cancerogent potentiale.
English: if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zometa 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 Zometa tilhører) eller et af de øvrige indholdsstoffer i Zometa (angivet i punkt 6).
English: Zoledronic acid shows no appreciable binding to plasma proteins and does not inhibit human P450 enzymes in vitro (see section 5.2), but no formal clinical interaction studies have been performed.
Danish: Zoledronsyre udviser ingen mærkbar binding til plasmaproteiner og hæmmer ikke de humane P450-enzymer in vitro (se afsnit 5.2), men der er ikke udført nogen formelle kliniske interaktionsstudier.
English: Low counts of white blood cells and blood platelets.
Danish: - Lavt antal hvide blodceller og blodplader.
English: Shake the vial gently to dissolve the powder.
Danish: Omryst hætteglasset forsigtigt for at opløse pulveret.
English: A dental examination with appropriate preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with bisphosphonates in patients with concomitant risk factors.
Danish: Et tandeftersyn med passende forebyggende tandbehandling og en individuel benefit/risk-vurdering anbefales inden behandling med bisfosfonater hos patienter med samtidige risikofaktorer.
English: Median time to onset of the first SRE was not reached in the zoledronic acid-treated arm at the end of the study and was significantly prolonged compared to placebo (p=0.007).
Danish: Median tiden for fremkomst af den første SRE blev ikke nået i den zoledronsyrebehandlede studiearm ved slutningen af studiet og var signifikant forlænget sammenlignet med placebo (p=0,007).
English: Anxiety, sleep disturbance
Danish: Angst, søvnforstyrrelser
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 Zometa 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 forsiktighed når Zometa anvendes i forbindelse med bilkørsel og betjening af maskiner.
English: Fewer zoledronic acid 4 mg patients suffered pathological fractures.
Danish: Færre zoledronsyre 4 mg-patienter oplevede patologiske frakturer.
English: In addition to being a potent inhibitor of bone resorption, zoledronic acid also possesses several antitumour 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: The active substance in Zometa is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Danish: Det aktive stof i Zometa er zoledronsyre, der tilhører en gruppe af stoffer kaldet bisfosfonater.
English: Caution is indicated when Zometa is used with other potentially nephrotoxic medicinal products.
Danish: Der bør udvises forsigtighed når Zometa anvendes sammen med andre potentielt nefrotoksiske lægemidler.
English: Your doctor will carry out blood tests before you start treatment with Zometa and will check your response to treatment at regular intervals.
Danish: Lægen vil tage en blodprøve, inden du begynder behandling med Zometa, og vil med regelmæssige mellemrum kontrollere, hvordan du reagerer på behandlingen.
English: The following risk factors should be considered when evaluating an individual's risk of developing ONJ: - Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
Danish: Følgende risikofaktorer skal tages i betragtning, når risikoen for at udvikle osteonekrose af kæberne skal vurderes hos den enkelte patient: - Bisfosfonatets potens (øget risiko ved højpotente stoffer), administrationsvej (øget risiko ved parenteral administration) og kumuleret dosis af bisfosfonater.
English: While the risk is reduced with a dose of 4 mg zoledronic acid administered over 15 minutes, deterioration in renal function may still occur.
Danish: Selvom risikoen reduceres ved administration af 4 mg zoledronsyre over 15 minutter, kan der stadig opstå forværring af nyrefunktionen.
English: Use immediately after first opening.
Danish: Skal anvendes straks efter åbning.
English: Zometa treatment should be resumed at the same dose as that given prior to treatment interruption.
Danish: Zometa behandling bør genoptages med samme dosis som givet før afbrydelse af behandlingen.
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 Zometa.
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 Zometa.
English: Aseptic techniques must be followed during the preparation of the infusion.
Danish: Aseptiske teknikker skal anvendes under tilberedning af infusionen.
English: The highest non-lethal single intravenous dose was 10 mg/kg bodyweight in mice and 0.6 mg/kg in rats.
Danish: Den højeste ikke-letale intravenøse enkeltdosis var 10 mg/kg legemsvægt hos mus og 0,6 mg/kg hos rotter.
English: Limited pharmacokinetic data in children with severe osteogenesis imperfecta suggest that zoledronic acid pharmacokinetics in children aged 3 to 17 years are similar to those in adults at a similar mg/kg dose level.
Danish: Begrænsede farmakokinetiske data hos børn med svær osteogenesis imperfecta indikerer, at zoledronsyres farmakokinetik hos børn i alderen 3 til 17 år er sammenlignelig med voksnes ved samme mg/kg dosisniveau.
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 study treatment period was 12 months preceded by a 4- to 9-week screening period during which vitamin D and elemental calcium supplements were taken for at least 2 weeks.
Danish: Behandlingsperioden var 12 måneder forudgået af en 4-9-ugers screeningsperiode, hvor der blev givet tilskud af calcium og D-vitamin i mindst 2 uger.
English: What Zometa contains
Danish: Zometa indeholder
English: No pharmacokinetic data for zoledronic acid are available in patients with hypercalcaemia or in patients with hepatic insufficiency.
Danish: Der eksisterer ingen farmakokinetiske data for zoledronsyre til patienter med hyperkalcæmi eller patienter med leverinsufficiens.
English: Zometa contains the same active substance as found in Aclasta (zoledronic acid).
Danish: Zometa indeholder den samme aktive substans som Aclasta (zoledronsyre).
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: Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
Danish: - Alvorlige overfølsomhedsreaktioner: åndenød, hævelse hovedsageligt i ansigt og hals.
English: In the zoledronic acid-treated group, statistically significant improvement in pain scores (using the Brief Pain Inventory, BPI) was seen at 4 weeks and at every subsequent time point during the study, when compared to placebo (Figure 1).
Danish: I den zoledronsyrebehandlede gruppe blev statistisk signifikante forbedringer i smerte-scoringer (ved brug af Brief Pain Inventory, BPI) set ved 4 uger og ved hver efterfølgende tidsmåling i løbet af studiet, når sammenlignet med placebo (Figur 1).
English: In the event of hypocalcaemia, calcium gluconate infusions should be administered as clinically indicated.
Danish: I tilfælde af hypokalcæmi bør calciumglukonat-infusioner administreres, hvis det er klinisk indikeret.
English: Sleepiness.
Danish: Søvnighed.
English: After opening the bottle, the product should be used immediately in order to avoid microbial contamination.
Danish: Efter åbning af flasken bør produktet anvendes straks for at undgå mikrobiologisk kontaminering.
English: The reconstituted solution is stable for 24 hours at 2°C - 8°C.
Danish: Den færdigfremstillede opløsning kan opbevares i 24 timer ved 2 °C - 8 °C.
English: An extension study was conducted in order to examine the long-term general and renal safety of once yearly or twice yearly zoledronic acid over the 12-month extension treatment period in children who had completed one year of treatment with either zoledronic acid or pamidronate in the core study.
Danish: Der blev udført en forlænget undersøgelse for at vurdere den generelle og renale langtidssikkerhed af zoledronsyre administreret en eller to gange årligt over en forlænget behandlingsperiode af 12 måneders varighed hos børn, der havde fuldendt et års behandling med enten zoledronsyre eller pamidronat i hovedstudiet.
English: Acute toxicity
Danish: Akut toksicitet
English: - Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Danish: - Behandling af voksne patienter med tumorinduceret hyperkalcæmi (TIH).
English: Zometa must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Danish: Zometa må kun udskrives og administreres til patienter af sundhedspersonale med erfaring i administration af intravenøse bisfosfonater.
English: In the clinical studies, Zometa 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 Zometa først genoptaget når kreatinin-niveauet faldt inden for 10% over baselineværdien (se afsnit 4.4).
English: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zometa therapy.
Danish: Standard hyperkalcæmirelaterede metabolske parametre som serumniveauer af calcium, fosfat og magnesium, bør monitoreres grundigt efter påbegyndt behandling med Zometa.
English: These could be signs of bone damage in the ear.
Danish: Dette kan være tegn på knoglebeskadigelse i øret.
English: In Phase I dose finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2-2.5 mg.
Danish: I fase I doseringsundersøgelser i patienter med mild til moderat tumorindiceret hyperkalcæmi (TIH), var den afprøvede effektive dosis cirka 1,2-2,5 mg.
English: Hypophosphataemia 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 Zometa (see section 4.8)
Danish: Hypofosfatæmi Bivirkninger med frekvenser <5% blev vurderet medicinsk, og det blev vist, at de er i overensstemmelse med den veletablerede sikkerhedsprofil for Zometa (se pkt.
English: The majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Danish: Størstedelen af rapporterne referer til cancerpatienter, som har fået trukket en tand ud eller har fået foretaget andre tandoperationer.
English: Following initiation of therapy, serum creatinine should be measured prior to each dose of Zometa and treatment should be withheld if renal function has deteriorated.
Danish: Efter påbegyndelse af behandling bør serum-kreatinin måles før hver dosis af Zometa, og behandlingen bør tilbageholdes, hvis nyrefunktionen forværres.
English: Only clear solution free from particles and discolouration should be used.
Danish: Der må kun anvendes en klar opløsning fri for partikler og misfarvning.
English: In clinical studies, Zometa has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Danish: I kliniske studier er Zometa indgivet samtidig med almindeligt anvendte anticancerlægemidler, diuretika, antibiotika og analgesika uden tilsyneladende kliniske interaktioner.
English: There was faster normalisation of corrected serum calcium at day 4 for 8 mg zoledronic acid and at day 7 for 4 mg and 8 mg zoledronic acid.
Danish: Der optrådte hurtigere normalisering af korrigeret serumcalcium på 4. dag for 8 mg zoledronsyre og på 7. dag for 4 mg og 8 mg zoledronsyre.
English: Instructions for preparing reduced doses of Zometa:
Danish: Instruktion for tilberedning af reducerede doser af Zometa:
English: (e.g. tooth extractions) and poorly fitting dentures.
Danish: (fx tandudtrækninger) og dårligt tilpassede tandproteser.
English: Hypocalcaemia has been reported in patients treated with Zometa.
Danish: Hypokalcæmi er blevet rapporteret hos patienter i behandling med Zometa.
English: It is especially important that you tell your doctor if you are also taking: - Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Danish: Det er især vigtigt, at du fortæller lægen, hvis du også får: - Aminoglykosider (en type medicin til behandling af alvorlige infektioner), calcitonin (en type medicin til behandling knogleskørhed efter menopausen og til for højt calcium), slyngediuretika (vanddrivende medicin til behandling af forhøjet blodtryk eller væskesamlinger) eller anden medicin, der sænker calcium, da kombinationen af disse stoffer og bisfosfonater kan forårsage, at blodets indhold af calcium bliver for lavt.
English: The onset time is ≤ 3 days post-Zometa 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 Zometa, og reaktionen er også refereret til ved brug af termerne ”inluenza-lignende symptomer” eller ”symptomer efter dosering”.
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: 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: Administration of 0.001 mg/kg/day subcutaneously in rats and 0.005 mg/kg intravenously once every 2-3 days in dogs for up to 52 weeks was also well tolerated.
Danish: Subkutan indgift af 0,001 mg/kg/dag til rotter og 0,005 mg/kg intravenøst en gang hver 2-3 dag til hunde i indtil 52 uger blev også fint tolereret.
English: Patients being treated with Zometa 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 Zometa, bør ikke samtidig behandles med Aclasta eller andre bisfosfonater, da den kombinerede effekt af disse stoffer er ukendt.
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: BPI mean change from baseline
Danish: BPI gennemsnitlig ændring fra baseline
English: Patients must be maintained well hydrated prior to and following administration of Zometa.
Danish: Patienter skal holdes velhydrerede før og efter administration af Zometa.
English: Healthcare professionals are advised not to dispose of unused Zometa via the domestic sewage system.
Danish: Sundhedspersonalet rådes til ikke at smide ubrugt Zometa i kloakken.
English: Zometa has been associated with reports of renal dysfunction.
Danish: Zometa har været forbundet med rapporter om nedsat nyrefunktion.
English: Clinical trial results in the treatment of TIH
Danish: Resultater fra kliniske undersøgelser vedrørende behandling af TIH
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½ 0.24 and t½ 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½ 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 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: Painful redness and/or swelling of the eye.
Danish: - Smertefuld rødme og/eller hævelse af øjet.
English: Cases of severe hypocalcaemia requiring hospitalisation have been reported.
Danish: Der er blevet rapporteret alvorlige, hospitalskrævende tilfælde af hypokalcæmi.
English: - Anti-angiogenic medicines (used to treat cancer), since the combination of these with Zometa 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 Zometa har været forbundet med en øget risiko for osteonekrose i kæberne.
English: In long-term animal studies, zoledronic acid inhibits bone resorption without adversely affecting the formation, mineralisation or mechanical properties of bone.
Danish: I langsigtede dyreundersøgelser inhiberer zoledronsyre knogleresorptionen uden negativ påvirkning af knogledannelse, knoglemineralisation eller knoglernes mekaniske egenskaber.
English: Your doctor may recommend a dental examination before you start treatment with Zometa.
Danish: Din læge vil måske bede dig om at få et tandeftersyn, før du starter behandling med Zometa.
English: In patients who show evidence of renal deterioration during treatment, Zometa should be withheld.
Danish: Hos patienter, der har påvist forværret nyrefunktion under behandling, bør Zometa tilbageholdes.
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: To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table 1 below.
Danish: For at tilberede nedsatte doser til patienter med baseline CLcr≤60 ml/min henvises til Tabel 1 nedenfor.
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: To assess the effects of 4 mg zoledronic acid versus pamidronate 90 mg, the results of two pivotal multicentre studies in patients with TIH were combined in a pre-planned analysis.
Danish: For at vurdere virkningerne af 4 mg zoledronsyre i forhold til 90 mg pamidronat blev resultaterne af to pivotale multicenterundersøgelser af patienter med TIH kombineret i en forud planlagt analyse.
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 procentuelle ændring i knoglemineraltætheden (BMD) i lænderygsøjlen efter 12 måneders behandling.
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 kumulativ 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: Dyspnoea, cough, bronchoconstriction
Danish: Dyspnø, hoste, bronkokonstriktion
English: Clinical studies in tumour-induced hypercalcaemia (TIH) demonstrated that the effect of zoledronic acid is characterised by decreases in serum calcium and urinary calcium excretion.
Danish: Kliniske studier af tumorinduceret hyperkalcæmi (TIH) viser, at effekten af zoledronsyre er karakteriseret ved fald i serumcalcium og urinudskillelse af calcium.
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: Low level of magnesium and potassium in the blood.
Danish: - Lavt indhold af magnesium og kalium i blodet.
English: This resulted in exaggerated pharmacological effects considered to be related to the compound's inhibition of skeletal calcium metabolisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
Danish: Dette resulterede i unormalt store farmakologiske effekter, der menes at være relateret til stoffets hæmning af knogle-calcium-metabolismen, resulterende i periparturient hypokalcæmi, en klasseeffekt for bisfosfonater, dystoci og afslutning af forsøget før tid.