FrancophonIA/ELRC3.0 huggingface dataset:
English: It belongs to a group of medicines called bisphosphonates and is used to treat Paget's disease of the bone in adults.
Danish: Det tilhører en gruppe af stoffer, kaldet bisfosfonater, og anvendes til behandling af Pagets sygdom i knoglerne hos voksne.
English: - If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic Acid Hospira.
Danish: - Hvis du er i behandling for at nedsætte calciumindholdet i blodet, vil du som regel kun få én infusion med Zoledronsyre Hospira.
English: Hypocalcaemia is an important identified risk with zoledronic acid in the approved indications.
Danish: Hypokalcæmi er en vigtig, identificeret risiko ved zoledronsyre ved de godkendte indikationer.
English: − Low level of calcium in the blood.
Danish: - Lavt niveau af calcium i blodet.
English: Measurement of serum calcium before infusion of zoledronic acid is recommended for patients with Paget´s disease.
Danish: Måling af serum calcium inden infusion med zoledronsyre er anbefalet hos patienter med Pagets sygdom.
English: The percentage of patients who experienced adverse reactions was lower in a smaller study (19.5%, 10.4%, 10.7% after the first, second and third infusion, respectively), where prophylaxis against adverse reactions was used.
Danish: Procentdelen af patienter, som oplevede bivirkninger, var lavere i et mindre studie (19,5%, 10,4%, 10,7% efter henholdsvis den første, anden og tredje infusion), hvor profylakse mod bivirkninger blev anvendt.
English: The majority of the side effects, such as fever and chills, pain in the muscles or joints, and headache, occur within the first three days following the dose of Zoledronic Acid Hospira.
Danish: Størstedelen af bivirkningerne, såsom feber og kulderystelser, smerter i muskler eller led og hovedpine, opstår inden for de første tre dage efter en dosis Zoledronsyre Hospira.
English: Increases in serum creatinine also occur in some patients with chronic administration of zoledronic acid at recommended doses for prevention of skeletal related events, although less frequently.
Danish: Der er hos nogle patienter også set stigninger i serum-kreatinin ved kronisk administration af zoledronsyre i anbefalede doser til forebyggelse af skeletrelaterede hændelser, selvom dette er mindre hyppigt.
English: If you are given more Zoledronic Acid Hospira 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 for meget Zoledronsyre Hospira Hvis du har fået højere doser end dem, der er anbefalet, skal du nøje overvåges af din læge.
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when zoledronic acid is used in combination with thalidomide.
Danish: Hos patienter med multipelt myelom kan risikoen for nedsat nyrefunktion øges, når zoledronsyre anvendes i kombination med thalidomid.
English: Your doctor may advise you to take calcium and vitamin D supplements (e.g. tablets) for at least the first ten days after being given Zoledronic Acid Hospira.
Danish: Din læge kan råde dig til at tage et tilskud af calcium og D-vitamin (f.eks. tabletter) i mindst de første ti dage, efter du har fået Zoledronsyre Hospira.
English: • Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of zoledronic acid.
Danish: • Patienter, specielt ældre patienter og patienter i behandling med diuretika, bør være passende hydreret forud for behandling med zoledronsyre.
English: You must not be given Zoledronic Acid Hospira if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Danish: Du må ikke få Zoledronsyre Hospira, hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: Zoledronic acid should not be used during pregnancy.
Danish: Zoledronsyre bør ikke anvendes under graviditet.
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 zoledronsyre også adskillige anti-tumor egenskaber der kan bidrage til den samlede effekt i behandling af metastaserende knoglesygdom.
English: The recommended dose is a single intravenous infusion of 5 mg zoledronic acid.
Danish: Den anbefalede dosis er en enkelt intravenøs infusion af 5 mg zoledronsyre.
English: There was no accumulation of the active substance in plasma after multiple doses given every 28 days.
Danish: Der var ingen akkumulering af den aktive substans i plasma efter gentagne doser administreret hver 28. dag.
English: Bone histology was evaluated in 7 patients with Paget's disease 6 months after treatment with 5 mg zoledronic acid.
Danish: Knoglehistologi blev evalueret hos 7 patienter med Pagets sygdom 6 måneder efter behandling med 5 mg zoledronsyre.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle mistænkte bivirkninger via det nationale rapporteringssystem anført i Appendiks V .
English: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating zoledronic acid therapy.
Danish: Standard hyperkalcæmirelaterede metaboliske parametre som serumniveauer af calcium, fosfat og magnesium, bør monitoreres grundigt efter påbegyndt behandling med zoledronsyre.
English: Instructions for preparing reduced doses of Zoledronic Acid Hospira: 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 Hospira: Udtag det passende volumen af det flydende koncentrat efter følgende: - 4,4 ml til 3,5 mg dosis
English: The following properties have been demonstrated in preclinical studies:
Danish: Følgende egenskaber er vist i prækliniske undersøgelser:
English: In a large clinical trial, local reactions at the infusion site, such as redness, swelling and/or pain, were reported (0.7%) following the administration of zoledronic acid.
Danish: I et større klinisk studie blev der rapporteret lokale reaktioner som rødme, hævelse og/eller smerter på infusionsstedet (0,7%) efter administration af zoledronsyre.
English: Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Danish: (N=99) *p-værdier sammenlignet med pamidronat.
English: After 6 months, zoledronic acid showed 96% (169/176) and 89% (156/176) response and serum alkaline phosphatase (SAP) normalisation rates compared to 74% (127/171) and 58% (99/171) for risedronate (all p<0.001).
Danish: Efter 6 måneder viste zoledronsyre respons hos 96% (169/176) og en serum alkalisk fosfatase (SAP) normaliseringsrate hos 89% (156/176) sammenlignet med 74% (127/171) og 58% (99/171) for risedronat (alle p < 0,001).
English: The reduced doses for patients with renal impairment are expected to achieve the same AUC as that seen in patients with creatinine clearance of 75 ml/min.
Danish: Den nedsatte dosis til patienter med nyreinsufficiens forventes at give samme AUC, som er set hos patienter med kreatinin clearance på 75 ml/min.
English: The administration of doses up to 48 mg of zoledronic acid in error has been reported.
Danish: Fejlagtig indgivelse af doser op til 48 mg af zoledronsyre er blevet rapporteret.
English: Re-treatment of Paget's disease: After initial treatment with zoledronic acid in Paget's disease, an extended remission period is observed in responding patients.
Danish: Efterbehandling af Pagets sygdom: Efter den første behandling med zoledronsyre ved Pagets sygdom er der observeret en længerevarende periode med remission hos responderende patienter.
English: Re-treatment consists of an additional intravenous infusion of 5 mg zoledronic acid after an interval of one year or longer from initial treatment in patients who have relapsed.
Danish: Efterbehandling gives som en ekstra intravenøs infusion af 5 mg zoledronsyre efter et interval på 1 år eller længere fra den første behandling til patienter, som har tilbagefald.
English: The mechanism behind the increased incidence of atrial fibrillation is unknown.
Danish: Mekanismen bag den øgede forekomst af atrieflimren er ukendt.
English: Additional information on handling of Zoledronic Acid Hospira, including guidance on preparation of reduced doses, is provided in section 4.2.
Danish: Yderligere information om håndtering af Zoledronsyre Hospira, inklusiv vejledning om forberedelse af nedsatte doser er angivet i pkt.
English: Caution is indicated when zoledronic acid is used with other potentially nephrotoxic medicinal products.
Danish: Der bør udvises forsigtighed når zoledronsyre anvendes sammen med andre potentielt nefrotoksiske lægemidler.
English: Zoledronic acid has been associated with renal impairment manifested as deterioration in renal function (i.e. increased serum creatinine) and in rare cases acute renal failure.
Danish: Zoledronsyre er associeret med nedsat nyrefunktion manifesteret som en forringelse af nyrefunktionen (dvs. øget serumkreatinin) og i sjældne tilfælde akut nyresvigt.
English: Due to the rapid onset of effect of zoledronic acid on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion of zoledronic acid (see section
Danish: På grund af zoledronsyres hurtige effekt på knogleomsætningen kan der udvikles forbigående hypokalcæmi, til tider symptomatisk og almindeligvis maksimal inden for de første 10 dage efter infusion af zoledronsyre (se pkt.
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: In clinical studies, zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Danish: I kliniske studier er zoledronsyre indgivet samtidig med almindeligt anvendte anticancerlægemidler, diuretika, antibiotika og analgetika uden tilsyneladende kliniske interaktioner.
English: Since zoledronic acid is not metabolised in humans and the substance was found to have little or no capacity as a direct-acting and/or irreversible metabolism-dependent inhibitor of P450 enzymes, zoledronic acid is unlikely to reduce the metabolic clearance of substances which are metabolised via the cytochrome P450 enzyme systems.
Danish: Siden zoledronsyre ikke metaboliseres i mennesker, og da stoffet havde lille eller ingen effekt som en direkte virkende og/eller irreversibel metabolismeafhængig hæmmer af P450 enzymer, er det usandsynligt, at zoledronsyre reducerer den metaboliske udskillelse af stoffer, som metaboliseres af cytokrom P450 enzymsystemet.
English: − The diluted Zoledronic Acid Hospira infusion solution should be used immediately in order to avoid microbial contamination.
Danish: - Den fortyndede Zoledronsyre Hospira infusionsvæske bør anvendes straks for at undgå mikrobiologisk kontaminering.
English: - Thalidomide (a medicine used to treat a certain type of blood cancer involving the bone) or any other medicines which may harm your kidneys.
Danish: - Thalidomid (medicin brugt til at behandle en bestemt type blodkræft, der involverer knoglerne) eller anden medicin, der kan skade dine nyrer.
English: - Zoledronic Acid Hospira is ready for use.
Danish: - Zoledronsyre Hospira er klar til brug.
English: Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture.
Danish: Frakturerne er ofte bilaterale; derfor bør den kontralaterale femur undersøges hos patienter, som behandles med bisfosfonater, og som har pådraget sig en fraktur af lårbensskaftet.
English: When initiating treatment with zoledronic acid 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 initieres hos patienter med multipelt myelom eller knoglemetastatisk skade fra solide tumorer bør serum-kreatinin og kreatinin clearance (CLcr) bestemmes.
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: In patients with Paget's disease, symptoms due to low blood calcium, such as muscle spasms, or numbness, or a tingling sensation especially in the area around the mouth have been reported.
Danish: Hos patienter med Pagets sygdom er symptomer på grund af lavt calciumindhold i blodet, f.eks. muskelkramper, følelsesløshed eller en snurrende fornemmelse især omkring munden blevet rapporteret.
English: Special populations (see section 4.2)
Danish: Specielle populationer (se pkt.
English: The infusion time must not be less than 15 minutes.
Danish: Infusionstiden må ikke være mindre end 15 minutter.
English: Increasing the infusion time from 5 to 15 minutes caused a 30% decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve.
Danish: Forøgelse af infusionstiden fra 5 til 15 minutter forårsagede en 30 % nedgang i zoledronsyrekoncentrationen ved afslutningen af infusionen, men havde ingen effekt på arealet under plasmakoncentration versus tidskurven.
English: In a large clinical trial in 7,736 patients, osteonecrosis of the jaw has been reported in one patient treated with zoledronic acid and one patient treated with placebo.
Danish: I et større klinisk studie med 7.736 patienter er der rapporteret om osteonekrose i kæberne hos en patient behandlet med zoledronsyre og en patient behandlet med placebo.
English: The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone.
Danish: De selektive virkninger af bisfosfonater på knogler er baseret på deres høje affinitet til mineraliseret knogle.
English: If you feel dizzy while taking Zoledronic Acid Hospira, do not drive or use machines until you feel better.
Danish: Hvis du føler dig svimmel, mens du tage r, må du ikke køre bil eller betjene maskiner, før du har det bedre.
English: Zoledronic Acid Hospira works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.
Danish: Zoledronsyre Hospira virker ved at normalisere remodelleringsprocessen, sikre dannelse af normalt knoglevæv og dermed genoprette knoglestyrken.
English: This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment.
Danish: Grunden er, at du måske kan udvikle serum-elektrolyt afvigelser (f.eks. unormale niveauer af calcium, fosfor og magnesium) og/eller ændringer i nyrefunktionen, inkl.
English: For the treatment of Paget's disease, zoledronic acid should be prescribed only by physicians with experience in the treatment of Paget's disease of the bone.
Danish: Til behandling af Pagets sygdom bør zoledronsyre kun ordineres af læger med erfaring i behandlingen af Pagets sygdom af knoglerne.
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 clinical trials, renal deterioration was defined as follows:
Danish: Forværring af nyrefunktion blev i kliniske studier defineret som følger:
English: How often Zoledronic Acid Hospira 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 Hospira every three to four weeks.
Danish: Hvor ofte skal du have Zoledronsyre Hospira - Hvis du er i forebyggende behandling for knoglekomplikationer pga. knoglemetastaser, vil du få en infusion af Zoledronsyre Hospira hver tredje til fjerde uge.
English: CARTON FOR 1 BAG AS UNIT PACK
Danish: KARTON TIL 1 POSE SOM ENKELTPAKNING
English: The efficacy of one infusion of 5 mg zoledronic acid versus daily doses of 30 mg risedronate for 2 months was demonstrated in two 6-month comparative trials.
Danish: Effekten af én infusion på 5 mg zoledronsyre versus daglige doser på 30 mg risedronat i 2 måneder blev vist i to sammenligningsstudier med en varighed på 6 måneder.
English: This is especially important for the elderly and for patients receiving diuretic therapy.
Danish: Dette gælder specielt for ældre patienter og for patienter, som er i behandling med diuretika.
English: Incidence of individual adverse reactions following the first infusion was: fever (17.1%), myalgia (7.8%), flu-like symptoms (6.7%), arthralgia (4.8%) and headache (5.1%).
Danish: Incidensen af individuelle bivirkninger efter første infusion var: Feber (17,1%), muskelsmerter (7,8%), influenzalignende symptomer (6,7%), ledsmerter (4,8%) og hovedpine (5,1%).
English: It is especially important for your doctor to know all the medicines you are taking, especially if you are taking any medicines known to be harmful to your kidneys (e.g. aminoglycosides) or diuretics (“waterpills”) that may cause dehydration.
Danish: Det er især vigtigt, at lægen har kendskab til al den medicin du bruger, specielt hvis du bruger anden medicin, som man ved, kan skade nyrerne (f.eks. aminoglykosider) eller diuretika (”vanddrivende midler”), der kan forårsage dehydrering.
English: Before stopping Zoledronic Acid Hospira therapy If you are considering stopping Zoledronic Acid Hospira treatment, please go to your next appointment and discuss this with your doctor.
Danish: Før Zoledronsyre Hospira behandlingen stoppes Hvis du overvejer at stoppe Zoledronsyre Hospira behandlingen, bedes du gå til din næste tid og drøfte det med lægen.
English: Therefore, interactions resulting from displacement of highly protein-bound medicinal products are unlikely.
Danish: Af denne grund er interaktioner med stærkt proteinbundede lægemidler på grund af fortrængning usandsynlig.
English: In clinical trials in osteoporosis, approximately 0.2% of patients had notable declines of serum calcium levels (less than 1.87 mmol/l) following zoledronic acid administration.
Danish: I kliniske studier om osteoporose havde omkring 0,2% af patienterne et betydeligt fald i serumcalciumniveauet (mindre end 1,87 mmol/l) efter administration af zoledronsyre.
English: Of the 153 zoledronic acid-treated patients and 115 risedronate-treated patients who entered an extended observation study, after a median duration of follow-up of 3.8 years from time of dosing, the proportion of patients ending the Extended Observation Period due to the need for re-treatment (clinical judgment) was higher for risedronate (48 patients, or 41.7%) compared with zoledronic acid (11 patients, or 7.2%).
Danish: Af de 153 patienter behandlet med zoledronsyre og 115 patienter behandlet med risedronat, som deltog i et udvidet observationsstudie, var andelen af patienter, som afsluttede den udvidede observationsperiode (efter en gennemsnitlig opfølgningsvarighed på 3,8 år efter dosering) pga. behov for efterbehandling (klinisk bedømmelse), højere for risedronat (48 patienter eller 41,7%) end for zoledronsyre (11 patienter eller 7,2%).
English: Clinical experience with acute overdose of zoledronic acid is limited.
Danish: Klinisk erfaring med akut overdosis af zoledronsyre er begrænset.
English: Treatment of Paget's disease of the bone in adults.
Danish: Behandling af Pagets sygdom af knoglerne hos voksne.
English: Six patients who achieved therapeutic response 6 months after treatment with zoledronic acid and later experienced disease relapse during the extended follow-up period were re-treated with zoledronic acid after a mean time of 6.5 years from initial treatment to re-treatment.
Danish: Seks patienter, som opnåede terapeutisk respons 6 måneder efter behandling med zoledronsyre, og som senere fik sygdomstilbagefald i den udvidede opfølgningsperiode, blev efterbehandlet med zoledronsyre gennemsnitligt 6,5 år efter første behandling.
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 vitro: Hæmning af osteoblastdannelse, direkte cytostatisk og pro-apoptotisk aktivitet på tumorceller, synergistisk cytostatisk effekt med andre anti-cancermidler, anti-adhæsion/invasionsaktivitet.
English: Adverse reactions, such as dizziness, may affect the ability to drive or use machines.
Danish: Bivirkninger, såsom svimmelhed, kan påvirke evnen til at føre motorkøretøj eller betjene maskine.
English: Concentrate for solution for infusion (sterile concentrate)
Danish: Koncentrat til infusionsvæske, opløsning (sterilt koncentrat)
English: Each pack contains one vial with concentrate.
Danish: Hver pakning indeholder et hætteglas med koncentrat.
English: In the trial for the prevention of clinical fractures following a recent hip fracture, vitamin D levels were not routinely measured but the majority of patients received a loading dose of vitamin D prior to zoledronic acid administration (see section 4.2).
Danish: I forebyggelsesstudiet for kliniske frakturer efter en nylig hoftefraktur blev D-vitamin niveauet ikke målt rutinemæssigt, men flertallet af patienter modtog en støddosis D-vitamin forud for administrationen af zoledronsyre (se pkt.
English: The usual dose is 5 mg, given to you as one single infusion into a vein by your doctor or nurse.
Danish: Den sædvanlige dosis er 5 mg, som indgives af din læge eller sygeplejerske som en infusion i en vene.
English: At the request of the European Medicines Agency, Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Limited data on re-treatment of Paget's disease are available (see section 5.1).
Danish: Der er begrænsede tilgængelige data om efterbehandling af Pagets sygdom (se pkt.
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: - Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Danish: - Behandlingaf voksne patienter med tumorinducerethyperkalcæmi (TIH).
English: Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and binding is concentration independent.
Danish: Zoledronsyre bindes ikke mærkbart til plasmaproteiner (cirka 43-55% bundet), og bindingen er uafhængig af koncentrationen.
English: The incidence of these reactions decreased markedly with subsequent annual doses of zoledronic acid.
Danish: Incidensen af disse bivirkninger faldt markant ved de efterfølgende årlige doser zoledronsyre.
English: You may eat normally on the day you are treated with Zoledronic Acid Hospira.
Danish: Du kan spise normalt den dag, du får behandling med Zoledronsyre Hospira.