FrancophonIA/ELRC3.0 huggingface dataset:
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 hypercalcæmi (albuminkorrigeret serumcalcium ≥ 12,0 mg/dl eller 3,0 mmol/l) er en enkelt dosis på 4 mg zoledronsyre.
English: 5 ml concentrate in a plastic vial made of clear, colourless oleofinic polymer closed with fluoropolymer-coated bromobutyl rubber stopper and aluminium cap with plastic flip-off component.
Danish: 5 ml koncentrat i et plastik hætteglas lavet af klart, farveløst olefinsk polymer lukket med fluorpolymer-coated brombutyl gummiprop og aluminiumslåg med en aftagelig plastik komponent.
English: Your doctor will carry out blood tests before you start treatment with Zoledronic acid Actavis and will check your response to treatment at regular intervals.
Danish: Lægen vil tage en blodprøve, inden du begynder behandling med Zoledronsyre Actavis, og vil med regelmæssige mellemrum kontrollere, hvordan du reagerer på behandlingen.
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½ α 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 ½β 1,87 timer efterfulgt af en lang elimineringsfase med en terminal eliminationshalveringstid på t ½γ 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: 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 (kan påvirke 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: 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: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zoledronic acid Actavis therapy.
Danish: Standard hypercalcæmirelaterede metabolske parametre som serumniveauer af calcium, fosfat og magnesium, bør monitoreres grundigt efter påbegyndt behandling med Zoledronsyre Actavis.
English: Patients should have their serum creatinine levels assessed prior to each dose of Zoledronic acid Actavis.
Danish: Patienter bør få deres serum-kreatinin niveau vurderet før hver dosis af Zoledronsyre Actavis.
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 hypercalcæmi) var 29,8 % i den zoledronsyrebehandlede gruppe sammenlignet med 49,6 % i placebo gruppen (p=0,003).
English: Additional information on handling of Zoledronic acid Actavis, including guidance on preparation of reduced doses, is provided in section 4.2.
Danish: Yderligere information om håndtering af Zoledronsyre Actavis, inklusiv vejledning om forberedelse af nedsatte doser er angivet i pkt.
English: Zoledronic acid Actavis treatment should be resumed at the same dose as that given prior to treatment interruption.
Danish: Zoledronsyre Actavis behandling bør genoptages med samme dosis som givet før afbrydelse af behandlingen.
English: Caution is indicated when Zoledronic acid Actavis is used with other potentially nephrotoxic medicinal products.
Danish: Der bør udvises forsigtighed når Zoledronsyre Actavis anvendes sammen med andre potentielt nefrotoksiske lægemidler.
English: - if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zoledronic acid Actavis belongs), or any of the other ingredients of this medicine (listed in section 6).
Danish: − hvis du er overfølsom (allergisk) over for zoledronsyre, et andet bisfosfonat (den gruppe af stoffer, som Zoledronsyre Actavis tilhører) eller et af de øvrige indholdsstoffer i denne medicin (se pkt.
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 vitro: Hæmning af osteoblastdannelse, direkte cytostatisk og pro-apoptotisk aktivitet på tumorceller, synergistisk cytostatisk effekt med andre anti-cancermidler, anti-adhæsion/invasionsaktivitet.
English: Proportion of patients with SREs p-value
Danish: Andel af patienter med SRE'er (%) p-værdi
English: This condition is known as tumour-induced hypercalcaemia (TIH).
Danish: Denne tilstand kaldes tumorinduceret hypercalcæmi (TIH).
English: Zoledronic acid Actavis is not recommended for use in adolescents and children below the age of 18 years.
Danish: Zoledronsyre Actavis bør ikke bruges til børn og unge under 18 år.
English: - The other ingredients are: mannitol, sodium citrate and water for injections.
Danish: − Øvrige indholdsstoffer: Mannitol, natriumcitrat og vand til injektionsvæsker.
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders
Danish: Tabel 6: Bivirkninger observeret hos pædiatriske patienter med svær osteogenesis imperfecta1
English: Zoledronic acid Actavis must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Danish: Zoledronsyre Actavis må kun udskrives og administreres til patienter af sundhedspersonale med erfaring i administration af intravenøse bisfosfonater.
English: Healthcare professionals are advised not to dispose of unused Zoledronic acid Actavis via the domestic sewage system.
Danish: Sundhedspersonalet rådes til ikke at smide ubrugt Zoledronsyre Actavis i kloakken.
English: Following initiation of therapy, serum creatinine should be measured prior to each dose of Zoledronic acid Actavis and treatment should be withheld if renal function has deteriorated.
Danish: Efter påbegyndelse af behandling bør serum-kreatinin måles før hver dosis af Zoledronsyre Actavis, og behandlingen bør tilbageholdes, hvis nyrefunktionen forværres.
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 hypocalcæmi, en klasseeffekt for bisfosfonater, dystoci og afslutning af forsøget før tid.
English: Zoledronic acid Actavis should not be used during pregnancy.
Danish: Zoledronsyre Actavis bør ikke anvendes under graviditet.
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients)
Danish: Tabel 4: Effektresultater (patienter med brystcancer eller multiple myelomer)
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: Patients must be maintained well hydrated prior to and following administration of Zoledronic acid Actavis.
Danish: Patienter skal holdes velhydrerede før og efter administration af Zoledronsyre Actavis.
English: In clinical trials performed in patients with tumour-induced hypercalcaemia (TIH), the overall safety profile amongst all three treatment groups (zoledronic acid 4 and 8 mg and pamidronate 90 mg) was similar in types and severity.
Danish: I kliniske undersøgelser udført i patienter med tumorinduceret hypercalcæmi (TIH), var den overordnede sikkerhedsprofil mellem de tre behandlingsgrupper (zoledronsyre 4 og 8 mg og pamidronat 90 mg) lignende i art og alvorlighed.
English: Patients being treated with Zoledronic acid Actavis should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Danish: Patienter, som behandles med Zoledronsyre Actavis, bør ikke samtidig behandles med sådanne lægemidler eller andre bisfosfonater, da den kombinerede effekt af disse stoffer er ukendt.
English: Very common (may affect more than 1 in 10 people): - Low level of phosphate in the blood.
Danish: Meget almindelig (kan påvirke mere end 1 ud af 10 patienter): - Lavt fosfatindhold i blodet.
English: - Since no data are available on the compatibility of Zoledronic acid Actavis with other intravenously administered substances, Zoledronic acid Actavis 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 forligelighed af Zoledronsyre Actavis med andre intravenøst indgivne stoffer, må Zoledronsyre Actavis ikke blandes med andre lægemidler eller stoffer og bør altid indgives gennem en separat infusionsslange.
English: Zoledronic acid Actavis 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 Actavis til TIH-patienter, som også har svær nyreinsufficiens, bør kun overvejes efter vurdering af risici og fordele ved behandlingen.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal 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 fremlæggelse af resultaterne af studier med zoledronsyre hos alle undergrupper af den pædiatriske population ved behandlingen af tumorinduceret hypercalcæmi (TIH) og forebyggelse af skeletrelaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser (se pkt 4,2 for information om pædiatrisk anvendelse).
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 micromol/l or ≥ 4.5 mg/dl for patients with TIH and ≥ 265 micromol/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 Actavis 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 mikromol/l eller ≥ 4,5 mg/dl hos patienter med TIH, og ≥ 265 mikromol/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 Actavis ikke anbefales til patienter med alvorlig nedsat nyrefunktion.
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 Actavis har været forbundet med en øget risiko for osteonekrose i kæberne.
English: - Zoledronic acid Actavis must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Danish: - Zoledronsyre Actavis må kun gives af sundhedspersonale, som er trænet til at indgive bisfosfonater intravenøst, dvs. gennem en blodåre.
English: - Blurred vision, tearing of the eye, eye sensitivity to light.
Danish: − Sløret syn, tåreflåd, lysfølsomhed i øjnene.
English: It is not known whether zoledronic acid is excreted into human milk.
Danish: Det er ikke kendt, om zoledronsyre bliver udskildt med modermælken.
English: (e.g. tooth extractions) and poorly fitting dentures
Danish: (fx tandudtrækninger)og dårligt tilpassede tandproteser.
English: Zoledronic acid Actavis 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 Actavis anbefales ikke til patienter, der før behandlingen initieres, har svær nyreinsufficiens, som i denne population er defineret som CLcr < 30 ml/min.
English: Patients with TIH and evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with Zoledronic acid Actavis outweighs the possible risk.
Danish: Patienter med TIH og verificeret forværret nyrefunktion bør evalueres på relevant vis, og det bør overvejes om den potentielle gavn af behandling med Zoledronsyre Actavis opvejer de mulige ricisi.
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer)
Danish: Tabel 3: Effektresultater (solide tumorer udover bryst- og prostatacancer)
English: Contains mannitol, sodium citrate and water for injections.
Danish: Indeholder mannitol, natriumcitrat og vand til injektionsvæsker.
English: Zoledronic acid Actavis is contraindicated in breast-feeding women (see section 4.3).
Danish: Zoledronsyre Actavis er kontraindikeret hos kvinder, der ammer (se pkt 4.3).
English: - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic acid Actavis every three to four weeks.
Danish: - Hvis du er i forebyggende behandling for knoglekomplikationer pga. knoglemetastaser, vil du få en infusion af Zoledronsyre Actavis hver tredje til fjerde uge.
English: Warnings and precautions Talk to your doctor before you are given Zoledronic acid Actavis:
Danish: Advarsler og forsigtighedsregler Kontakt lægen før du begynder at få Zoledronsyre Actavis,:
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (23) mg per dosis, dvs. den er hovedsagelig ”natriumfri”.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mikromol natrium (23 mg) per dosis, dvs. det er hovedsageligt ”natriumfrit”.
English: 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Danish: 4,0 mg zoledronsyre 3,5 mg* zoledronsyre 3,3 mg* zoledronsyre 3,0 mg* zoledronsyre *Dosis er beregnet ud fra forudsætning om et mål-AUC på 0,66 (mg•t/l) (CLcr = 75 ml/min).
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er ordnet under overskrifter om hyppighed, den hyppigste først, ved brug af de følgende konventionelle regler: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, the following Zoledronic acid Actavis dose is recommended (see also section 4.4):
Danish: Til patienter med knoglemetastaser, der før behandlingen initieres, har mild til moderat nyreinsufficiens, som i denne population er defineret som CLcr 30-60 ml/min, anbefales følgende dosis af Zoledronsyre Actavis (se også afsnit 4.4):
English: Hypomagnesaemia, hypokalaemia
Danish: Hypomagnesæmi, hypokaliæmi
English: In patients who show evidence of renal deterioration during treatment, Zoledronic acid Actavis should be withheld.
Danish: Hos patienter, der har påvist forværret nyrefunktion under behandling, bør Zoledronsyre Actavis tilbageholdes.
English: - Other medicines that contain zoledronic acid which are used to treat osteoporosis and other noncancer diseases of the bone, or any other bisphosphonate, since the combined effects of these medicines taken together with Zoledronic acid Actavis are unknown.
Danish: - Anden medicin, der indeholder zoledronsyre, som 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 Actavis er ukendt.
English: In a pooled analysis of safety data from zoledronic acid registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
Danish: I en pooled analyse af sikkerhedsdata fra zoledronsyre-registreringsstudier vedrørende forebyggelse af skelet-relaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser, var frekvensen af bivirkninger med relation til nedsat nyrefunktions og som formodes at være relateret til zoledronsyre, følgende: multipelt myeloma (3,2%), prostatacancer (3,1%), brystcancer (4,3%), lungecancer og andre solide tumorer (3,2%).
English: Blurred vision, scleritis and orbital inflammation Uveitis
Danish: Sløret syn, sklerit og orbital inflammation Uveitis
English: Very rare (may affect up to 1 in 10,000 people): - Fainting due to low blood pressure.
Danish: Meget sjælden (kan påvirke på til 1 ud af 10.000 patienter): - Besvimelse på grund af lavt blodtryk.
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid Actavis.
Danish: Hvis du har hypokalcæmi, skal den korrigeres, inden du får den første dosis af Zoledronsyre Actavis.
English: Your doctor may recommend a dental examination before you start treatment with Zoledronic acid Actavis.
Danish: Din læge vil måske bede dig om at få et tandeftersyn, før du starter behandling med Zoledronsyre Actavis.
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 angivet i pkt.
English: Caution is advised when Zoledronic acid Actavis is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Danish: Der tilrådes forsigtighed, når Zoledronsyre Actavis indgives sammen med anti-angiogene lægemidler, da der er set en øget hyppighed af osteonekrose af kæberne hos patienter i samtidig behandling med disse lægemidler.
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.
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 Actavis.
English: - Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Danish: - Forebyggelse af skeletrelaterede hændelser (patologiske frakturer, spinal kompression, strålebehandling eller operation af knogler, eller tumorinduceret hypercalcæmi) hos voksne patienter med fremskreden malign sygdom og knoglemetastaser.
English: Instructions for preparing reduced doses of Zoledronic acid Actavis: 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 Actavis: Udtag det passende volumen af det flydende koncentrat efter følgende: 4,4 ml til 3,5 mg dosis
English: The multiple event analysis revealed a significant risk reduction of 16% in patients treated with 4 mg zoledronic acid in comparison with patients receiving pamidronate.
Danish: Analysen vedrørende gentagne hændelser afslørede en signifikant risikoreduktion på 16 % hos patienter behandlet med 4 mg zoledronsyre sammenlignet med patienter behandlet med pamidronat.
English: In a third phase III randomised, double-blind trial, 4 mg zoledronic acid or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
Danish: I et tredje fase III randomiseret, dobbeltblindt studie blev 4 mg zoledronsyre eller 90 mg pamidronat administreret hver 3. til 4. uge sammenlignet hos patienter med multiple myelomer eller brystkræft og mindst én knoglelæsion.
English: Zoledronic acid Actavis is supplied as a clear and colourless concentrate for solution for infusion (sterile concentrate) in a plastic vial.
Danish: Zoledronsyre Actavis leveres som et klart og farveløst koncentrat til infusionsvæske, opløsning (sterilt koncentrat), i et plastik hætteglas.
English: - Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Danish: - Sig det til lægen, hvis du får øret og/eller betændelse i øret.
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic acid Actavis or after stopping treatment.
Danish: Fortæl det straks til din læge eller tandlæge, hvis du får sådanne symptomer, mens du er i behandling med Zoledronsyre Actavis eller efter behandlingsophør.