FrancophonIA/ELRC3.0 huggingface dataset:
English: − Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with zoledronic acid.
Danish: - Undersøgelser med flere typer af infusionsslanger fremstillet af polyvinylklorid, polyethylen og polypropylen viste ingen uforligelighed med zoledronsyre.
English: Healthcare professionals are advised not to dispose of unused Zoledronic Acid Hospira via the domestic sewage system.
Danish: Sundhedspersonalet rådes til ikke at smide ubrugt Zoledronsyre Hospira i kloakken.
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 Dag 4
English: 100 ml polypropylene bags with a polypropylene twist-off port fitted with a cap, with a polyester/polypropylene overwrap
Danish: 100 ml polypropylen pose med en polypropylen twist-off port med hætte og forsynet med en polyester/polypropylen yderpose.
English: Bone biopsy results showed bone of normal quality with no evidence of impaired bone remodelling and no evidence of mineralisation defects.
Danish: Resultater af knoglebiopsi viste knogler af normal kvalitet og ingen nedsat remodellering af knoglerne og ingen mineraliseringsdefekter.
English: Hypersensitivity reactions including rare cases of bronchoconstriction, urticaria and angioedema, and very rare cases of anaphylactic reaction/shock
Danish: Ikke kendt** Hypersensitivitetsreaktioner inklusive sjældne tilfælde af bronkokonstriktion, urticaria og angioødem og meget sjældne tilfælde af anafylaktisk reaktion/shock
English: Painful redness and/or swelling of the eye.
Danish: Smertefuld rødmen og/eller hævelse af øjet.
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 carcinogenicitet kunne ikke påvise carcinogent potentiale.
English: The mean time of ending the Extended Observation Period due to the need for Paget's re-treatment from the initial dose was longer for zoledronic acid (7.7 years) than for risedronate (5.1 years).
Danish: Ved Pagets sygdom var gennemsnitstiden fra den første dosis til afslutning af den udvidede observationsperiode pga. behov for efterbehandling længere for zoledronsyre (7,7 år) end for risedronat (5,1 år).
English: In clinical trials in osteoporosis, the change in creatinine clearance (measured annually prior to dosing) and the incidence of renal failure and impairment was comparable for both the zoledronic acid and placebo treatment groups over three years.
Danish: I kliniske studier om osteoporose var ændringen i kreatinin clearance (målt årligt før dosering) og incidensen af nyresvigt og nedsat nyrefunktion sammenlignelig for zoledronsyre- og placebobehandlings-gruppen over tre år.
English: Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given Zoledronic Acid Hospira.
Danish: Følg nøje alle lægens, farmaceutens eller sygeplejerskens instruktioner, før du anvender Zoledronsyre Hospira.
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 along with driving and operating of machinery.
Danish: Bivirkninger såsom svimmelhed og somnolens kan påvirke evnen til at føre motorkøretøj eller betjene maskiner, der skal derfor udvises forsigtighed når zoledronsyre anvendes i forbindelse med bilkørsel og betjening af maskiner.
English: Acquired Fanconi syndrome General disorders and administration site conditions Common:
Danish: Erhvervet Fanconis syndrom Almene symptomer og reaktioner på administrationsstedet Almindelig:
English: Table 6: Proportion of complete responders by day in the combined TIH studies Day 4
Danish: Tabel 6: Andel af patienter med fuldt respons pr. dag i de kombinerede TIH-studier Dag 4
English: The main molecular target of zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase.
Danish: Zoledronsyres primære molekylære mål i osteoklasterne er enzymet farnesylpyrofosfatsyntase.
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal tages i betragtning hvis patienten er på kontrolleret natrium-diæt.
English: - In vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
Danish: - In vivo: Hæmning af osteoklastisk knogleresorption, hvilket ændrer knoglemarvens mikromiljø og mindsker bidraget til tumorcellevæksten, den anti-angiogenetiske aktivitet og anti-smerte aktiviteten.
English: In patients who show evidence of renal deterioration during treatment, zoledronic acid should be withheld.
Danish: Hos patienter, der har påvist forværret nyrefunktion under behandling, bør zoledronsyre tilbageholdes.
English: Talk to your doctor before you are given Zoledronic Acid Hospira: - if you are being treated with any medicine containing zoledronic acid, which is also the active substance of Zoledronic Acid Hospira (zoledronic acid is used in adult patients with certain types of cancer to prevent bone complications or to reduce the amount of calcium).
Danish: Kontakt lægen før du får Zoledronsyre Hospira: - hvis du er i behandling med anden medicin, der også indeholder zoledronsyre, der er det samme aktive stof i Zoledronsyre Hospira (zoledronsyre bruges til voksne patienter med visse kræftformer for at forebygge knoglekomplikationer eller for at nedsætte mængden af calcium).
English: Clinical efficacy in the treatment of Paget's disease of the bone
Danish: Klinisk effekt ved behandling af Pagets sygdom af knoglerne
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 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 opvejer de mulige ricisi.
English: Zoledronic acid was studied in male and female patients aged above 30 years with primarily mild to moderate Paget's disease of the bone (median serum alkaline phosphatase level 2.6-3.0 times the upper limit of the age-specific normal reference range at the time of study entry) confirmed by radiographic evidence.
Danish: Zoledronsyre blev undersøgt hos mænd og kvinder i alderen over 30 år med primært mild til moderat Pagets sygdom af knoglerne (gennemsnitlig serum alkalisk fosfatase niveau på 2,6-3,0 gange den øvre grænseværdi for det normale aldersspecifikke referenceområde ved inklusion i studiet) bekræftet ved radiografisk påvisning.
English: The highest non-lethal single intravenous dose was 10 mg/kg body weight 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: − Severe bone, joint and/or muscle pain, occasionally incapacitating.
Danish: - Kraftige knogle-, led- og/eller muskelsmerter, lejlighedsvis invaliderende.
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 af 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: 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: 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 (kreatinin clearance <30 ml/min).
English: In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral calcium and/or an intravenous infusion of calcium gluconate.
Danish: I tilfælde af klinisk signifikant hypokalcæmi kan tilstanden reverseres ved supplerende oralt calcium og/eller intravenøs infusion af calciumglukonat.
English: Teratogenicity was observed in rats at doses 0.2 mg/kg and was manifested by external, visceral and skeletal malformations.
Danish: Der blev observeret teratogenicitet hos rotter ved doser på 0,2 mg/kg og sås tydeligt i form af ydre og viscerale misdannelser samt misdannelser i skelettet.
English: - Carefully follow all the other instructions given to you by your doctor, nurse or pharmacist.
Danish: - Følg nøje alle de andre instruktioner, som du har fået af din læge, sygeplejerske eller farmaceut.
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-behandling og de rapporterede tilfælde af hypokalcæmi og den sekundære udvikling af hjertearytmi.
English: Other products containing zoledronic acid as active substance are available for oncology indications.
Danish: Andre produkter, som indeholder det aktive stof zoledronsyre er tilgængelige til onkologiindikationer.
English: All patients received adequate supplementation with vitamin D and calcium in the post-menopausal osteoporosis trial, the prevention of clinical fractures after hip fracture trial, and the Paget's disease trials (see also section 4.2).
Danish: Alle patienter modtog tilstrækkeligt D-vitamin- og calciumtilskud i det postmenopausale osteoporosestudie, forebyggelsesstudiet af kliniske frakturer efter hoftefraktur, og studierne med Pagets sygdom (se også pkt.
English: Patients should have their serum creatinine levels assessed prior to each dose of zoledronic acid.
Danish: Patienter bør få deres serum-kreatinin niveau vurderet før hver dosis af zoledronsyre.
English: oC after dilution
Danish: oC efter fortynding.
English: Proportion of patients with SREs (%) p-value Median time to SRE (days)
Danish: Andel af patienter med SRE'er (%) p-værdi Mediantid til SRE (dage)
English: Elevated bone turnover is a characteristic of Paget's disease of the bone.
Danish: Forhøjet knogleomsætning er karakteristisk for Pagets sygdom af knoglerne.
English: The active substance in Zoledronic Acid Hospira is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Danish: Det aktive stof i Zoledronsyre Hospira er zoledronsyre, der tilhører en gruppe af stoffer kaldet bisfosfonater.
English: Furthermore, there is evidence of an association between hypocalcaemia and secondary neurological events reported in these cases including; convulsions, hypoaesthesia and tetany (see section 4.4).
Danish: Desuden er der en påviselig association mellem hypokalcæmi og de sekundære neurologiske bivirkninger, der er rapporteret i disse tilfælde, herunder kramper, hypæstesi og tetani (se pkt.
English: The frequencies for each of these identified risks are shown in Table 1.
Danish: Frekvenserne for hver af de identificerede risici er vist i tabel 1.
English: Not known (frequency cannot be estimated from the available data) Severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the face and throat, decreased blood pressure, dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea.
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data) Alvorlige allergiske reaktioner inklusive svimmelhed og vejrtrækningsbesvær, hævelse hovedsageligt af ansigt og hals, lavt blodtryk, dehydrering sekundært til symptomer som feber, opkastning og diarré efter behandlingen.
English: - After opening the bag, the product should be used immediately in order to avoid microbial contamination.
Danish: - Efter åbning skal præparatet bruges straks for at undgå mikrobiel forurening.
English: - Do not use this medicine after the expiry date which is stated on the carton and bag.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og posen.
English: In the intravenous bolus studies, the doses that were well-tolerated decreased with increasing study duration: 0.2 and 0.02 mg/kg daily was well tolerated for 4 weeks in rats and dogs, respectively but only 0.01 mg/kg and 0.005 mg/kg in rats and dogs, respectively, when given for 52 weeks.
Danish: I intravenøse bolusstudier faldt dosis, som var fint tolereret med stigende studievarighed: 0,2 og 0,02 mg/kg dagligt var fint tolereret i 4 uger hos henholdsvis rotter og hunde, men kun 0,01 mg/kg og 0,005 mg/kg hos henholdsvis rotter og hunde, når det indgives i 52 uger.
English: Your doctor will advise you and decide how long you should be treated with Zoledronic Acid Hospira.
Danish: Din læge vil vejlede dig og beslutte, hvor længe du skal behandles med Zoledronsyre Hospira.
English: Your doctor, pharmacist or nurse knows how to store Zoledronic Acid Hospira properly.
Danish: Din læge, apoteket eller sygeplejersken ved, hvordan Zoledronsyre Hospira skal opbevares korrekt.
English: Zoledronic acid 8 mg (N=90)
Danish: Zoledronsyre 8 mg (N=90)
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Danish: Farmakoterapeutisk klassifikation: Lægemidler til behandling af knoglesygdomme, bisfosfonater, ATC-kode: M05BA08
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: ONJ can also occur after stopping treatment.
Danish: Osteonekrose i kæben kan også opstå efter, at behandlingen er stoppet.
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 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 basislinien (serumkreatinin clearance <30 ml/min), kan zoledronsyre ikke anbefales til patienter med alvorlig nedsat nyrefunktion.
English: Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Danish: Det blev vurderet, om zoledronsyre havde potentielle bivirkninger i rotter, der påvirkede fertiliteten hos den parenterale generation og F1-generationen.
English: The long duration of action of zoledronic acid is attributable to its high binding affinity for the active site of farnesyl pyrophosphate (FPP) synthase and its strong binding affinity to bone mineral.
Danish: Den lange virkningsvarighed af zoledronsyre kan tilskrives høj bindingsaffinitet til det aktive site i farnesylpyrofosfatsyntase (FPP) og dets stærke bindingsaffinitet til knoglemineral.
English: 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: 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 4-9ugers screeningsperiode, hvor der blev givet tilskud af calcium og D-vitamin i mindst 2 uger.
English: Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound medicinal products are therefore unlikely.
Danish: Zoledronsyre bindes ikke mærkbart til plasmaproteiner (cirka 43-55% bundet), og interaktioner med stærkt proteinbundende lægemidler på grund af fortrængning, er derfor usandsynlig.
English: In the intravenous infusion studies, renal tolerability of zoledronic acid was established in rats when given 0.6 mg/kg as 15-minute infusions at 3-day intervals, six times in total (for a cumulative dose that corresponded to AUC levels about 6 times the human therapeutic exposure) while five 15-minute infusions of 0.25 mg/kg administered at 2-3-week intervals (a cumulative dose that corresponded to 7 times the human therapeutic exposure) were well tolerated in dogs.
Danish: I intravenøse infusionsstudier blev renal tolerabilitet overfor zoledronsyre bestemt hos rotter, som fik 0,6 mg/kg givet som 15 minutters infusion i alt seks gange med 3 dages interval (for en kumulativ dosis svarende til AUC niveau cirka 6 gange højere den humane terapeutiske eksponering), mens fem 15 minutters infusioner af 0,25 mg/kg blev administreret med 2-3 ugers interval (en kumulativ dosis svarende til 7 gange den humane terapeutiske eksponering) hos hunde var fint tolereret.
English: Clinical experience with acute overdose is limited.
Danish: Der er begrænset klinisk erfaring med akut overdosering.
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: Very common (may affect more than 1 in 10 people):− Low level of phosphate in the blood.
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 patienter): - Lavt fosfatindhold i blodet.
English: There was a transient increase in serum creatinine observed within 10 days in 1.8% of zoledronic acid-treated patients versus 0.8% of placebo-treated patients.
Danish: Der sås en forbigående stigning i serumkreatinin inden for 10 dage hos 1,8% af patienterne behandlet med zoledronsyre mod 0,8 % hos patienterne behandlet med placebo.
English: • Zoledronic acid should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5).
Danish: • Zoledronsyre bør anvendes med forsigtighed, når det anvendes samtidigt med andre lægemidler, som kan påvirke nyrefunktionen (se pkt.
English: - Anti-angiogenic medicines (used to treat cancer), since the combination of these with Zoledronic Acid Hospira 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 Hospira har været forbundet med en øget risiko for osteonekrose i kæberne.
English: Aseptic techniques must be followed during preparation of the infusion.
Danish: Aseptiske teknikker skal anvendes under tilberedning af infusionen.
English: In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking zoledronic acid.
Danish: Ved erfaring efter markedsføring er der rapporteret om alvorlige og lejlighedsvis invaliderende knogle-, led-, og/eller muskelsmerter hos patienter i behandling med zoledronsyre.
English: - Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck.
Danish: - Samtidig behandling: kortikosteroider, kemoterapi, angiogenesehæmmere, stråleterapi af hoved og nakke.
English: The frequencies for each of these identified risks are shown in Table 2.
Danish: Frekvenserne for hver af de identificerede risici er vist i tabel 2.
English: Zoledronic Acid Hospira recommended dose* 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: Zoledronsyre Hospira anbefalet dosis* 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: In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between zoledronic acid (2.6%) and placebo (2.1%).
Danish: I osteoporoseforsøget (PFT, HORIZON - Tilbagevendende Fraktur Studie [RFT] var den samlede incidens for atrieflimren sammenlignelig for zoledronsyre (2,6%) og placebo (2,1%).
English: Zoledronic acid must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Danish: Zoledronsyre må kun udskrives og administreres til patienter af sundhedspersonalemed erfaring i administrationaf intravenøse bisfosfonater.
English: Low levels of phosphate in the blood.
Danish: Lavt indhold af fosfat i blodet.
English: Zoledronic acid 4 mg (N=86)
Danish: Zoledronsyre 4 mg (N=86)
English: No interaction studies with other medicinal products have been performed with zoledronic acid.
Danish: Der er ikke udført interaktionsundersøgelser med andre lægemidler og zoledronsyre.
English: - 4.4 ml for 3.5 mg dose - 4.1 ml for 3.3 mg dose - 3.8 ml for 3.0 mg dose
Danish: - 4,4 ml til 3,5 mg dosis - 4,1 ml til 3,3 mg dosis - 3,8 ml til 3,0 mg dosis
English: It is not known whether zoledronic acid is excreted into human milk.
Danish: Det vides ikke, om zoledronsyre udskilles i human mælk.