FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/l) occurred in 2.3% of zoledronic acid-treated patients in a large clinical trial compared to 21% of zoledronic acid-treated patients in the Paget's disease trials.
Danish: Laboratorieundersøgelser viste forbigående calciumniveauer under den normale referenceværdi (mindre end 2,10 mmol/l) hos 2,3% af de zoledronsyre-behandlede patienter i et større klinisk studie sammenlignet med 21% af zoledronsyre-behandlede patienter i de kliniske forsøg med Pagets sygdom.
English: − Do not use Zoledronic Acid Hospira after the expiry date stated on the pack.
Danish: - Brug ikke Zoledronsyre Hospira efter den udløbsdato, der står på pakningen.
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
Danish: Intravenøst administreret zoledronsyre elimineres i en trifasisk proces: hurtig bifasisk elimination fra det systemiske kredsløb med halveringstider på t½ α 0,24 og t½β 1,87 timer efterfulgt af en lang elimineringsfase med en terminal eliminationshalveringstid på t½γ 146 timer.
English: In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Danish: I kliniske studier blev behandling med zoledronsyre først genoptaget når kreatinin-niveauet faldt inden for 10% over baselineværdien (se pkt 4.4).
English: − Sudden coldness with fainting, limpness or collapse.
Danish: - Pludselig opstået kuldefølelse med besvimelse, slaphed eller kollaps.
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: 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.
English: It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Zoledronic Acid Hospira.
Danish: Det er på nuværende tidspunkt uklart, om zoledronsyre forårsager denne uregelmæssige hjerterytme, men du skal kontakte din læge, hvis du oplever sådanne symptomer, efter du har fået Zoledronsyre Hospira.
English: It is unknown whether zoledronic acid is excreted into human milk.
Danish: Det er ukendt, om zoledronsyre udskilles i human mælk.
English: The majority of these reactions were mild to moderate and resolved within three days of the event onset.
Danish: Størstedelen af disse bivirkninger var milde til moderate og ophørte inden for tre dage efter bivirkningens opståen.
English: Pain in extremities, arthralgia, musculoskeletal pain General disorders and administration site conditions Very common:
Danish: Smerte i ekstremiteter, artralgi, muskuloskeletal smerte Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
English: Uncommon Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain
Danish: Perifert ødem, tørst, akut-fase reaktion, ikkekardielle brystsmerter
English: The onset time is 3 days post-zoledronic acid 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 zoledronsyre, og reaktionen er også refereret til ved brug af termerne ”inluenza-lignende symptomer” eller ”symptomer efter dosering”.
English: Other products containing zoledronic acid as active substance are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Danish: Andre lægemidler, der indeholder zoledronsyre som aktiv substans er tilgængelige til osteoporose indikationer og til behandling af Pagets sygdom i knoglerne.
English: In patients with renal impairment, the systemic exposure to concomitant medicinal products that are primarily excreted via the kidney may increase.
Danish: Hos patienter med nedsat nyrefunktion kan den systemiske virkning af samtidigt indgivne lægemidler, der primært udskilles via nyrerne, øges.
English: Zoledronic acid 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 anbefales ikke til patienter, der før behandlingen initieres, har svær nyreinsufficiens, som i denne population er defineret som CLcr <30 ml/min.
English: The type of adverse reactions observed in this population were similar to those previously seen in adults with advanced malignancies involving the bone (see section 4.8).
Danish: Typen af bivirkninger, der blev observeret i denne befolkningsgruppe, var sammenlignelig med tidligere observerede bivirkninger hos voksne med fremskreden malign sygdom, der involverer knoglerne (se pkt.
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, strålebehandlingeller operation af knogler, eller tumorinduceret hyperkalcæmi) hos voksne patienter med fremskredenmalign sygdom og knoglemetastaser.
English: Very Rare (may affect up to 1 in 10,000 people) Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 patienter) Sig det til lægen, hvis du får øresmerter, udflåd fra øret og/eller betændelse i øret.
English: In the single-dose dog infusion studies, 1.0 mg/kg (6 fold the recommended human therapeutic exposure based on AUC) administered over 15 minutes was well tolerated with no renal effects.
Danish: I enkelt-dosis infusions hundestudier, administreret over 15 minutter, var 1,0 mg/kg (6 gange den anbefalede humane terapeutiske eksponering baseret på AUC) fint tolereret uden nyreproblemer.
English: VIAL LABEL
Danish: POSE ETIKET
English: Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs)
Danish: Interstitiel lungesygdom (inflammation af vævet omkring luftsækkende i lungerne).
English: Hypocalcaemia has been reported in patients treated with zoledronic acid.
Danish: Hypokalcæmi er blevet rapporteret hos patienter i behandling med zoledronsyre.
English: Dystocia was observed at the lowest dose (0.01 mg/kg body weight) tested in rats.
Danish: Dystoki blev observeret ved den laveste dosis (0,01 mg/kg kropsvægt), der blev afprøvet i rotter.
English: Zoledronic acid is not systemically metabolised and does not affect human cytochrome P450 enzymes in vitro (see section 5.2).
Danish: Zoledronsyre metaboliseres ikke systemisk og påvirker ikke de humane cytokrom P450 enzymer in vitro (se pkt.
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 bør overvejes ved evaluering af en patients risiko for at udvikle ONJ: - Styrken af bisfosfonat (højere risiko for højpotente forbindelser), administrationsvej (højere risiko for parenteral administration) og kumulative doser af bisfosfonater.
English: It comes in 100 ml plastic bags as a readyto-use solution for infusion.
Danish: Den leveres i 100 ml plastikpose som en infusionsvæske klar til brug.
English: − Zoledronic Acid Hospira must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein (also referred to as ‘IV' administration).
Danish: - Zoledronsyre Hospira må kun gives af sundhedspersonale, som er trænet til at indgive bisfosfonater intravenøst, dvs. gennem en blodåre (også kaldt IV administration).
English: − Low level of magnesium and potassium in the blood.
Danish: - Lavt indhold af magnesium og kalium i blodet.
English: This will help to prevent dehydration.
Danish: Det vil hjælpe dig med at undgå væsketab.
English: Your doctor, nurse or pharmacist knows how to store Zoledronic Acid Hospira properly (see section
Danish: Lægen, sygeplejersken og apoteket ved, hvordan Zoledronsyre Hospira skal opbevares korrekt (se pkt.
English: In a pooled analysis of safety data from trials for the use of zoledronic acid 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 zoldronsyre-registreringsstudier vedrørende forebyggelse af knogle-relaterede hændelser hos patienter med fremskreden malign sygdom, der involverer knoglerne, var frekvensen af bivirkninger med relation til nedsat nyrefunktion, og som formodes at være relateret til zoledronsyre, følgende: 3,2% ved multipelt myelom, 3,1% ved prostatacancer, 4,3% ved brystcancer og 3,2% ved lunge- og andre solide tumorer.
English: − Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Danish: - Der er i meget sjældne tilfælde set osteonekrose af andre knogler end kæben, særligt af hoften eller låret.
English: Zoledronic acid has been associated with reports of renal dysfunction.
Danish: Zoledronsyre har været forbundet med rapporter om nedsat nyrefunktion.
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta Nervous system disorders
Danish: Tabel 6: Bivirkninger observeret hos pædiatriske patienter med svær osteogenesis imperfecta Nervesystemet
English: - Zoledronic Acid Hospira 4 mg/100 ml solution for infusion can be used immediately without further preparation for patients with normal renal function.
Danish: - Zoledronsyre Hospira 4 mg/100 ml infusionsvæske, opløsning kan anvendes straks uden yderligere tilberedning til patienter med normal nyrefunktion.
English: It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Zoledronic Acid Hospira, as directed by your healthcare provider.
Danish: Det er vigtigt, at du drikker mindst 2 glas væske (fx vand), inden for et par timer før behandling med Zoledronsyre Hospira, som anvist af sundhedspersonalet.
English: Other medicines and Zoledronic Acid Hospira Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin og Zoledronsyre Hospira Fortæl det altid til lægen, apotekspersonalet eller til din sygeplejerske, hvis du bruger anden medicin eller har brugt det for nylig.
English: Renal impairment has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal dysfunction or additional risk factors (e.g. advanced age, oncology patients with chemotherapy, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, severe dehydration), the majority of whom received a 4 mg dose every 3-4 weeks, but it has been observed in patients after a single administration.
Danish: Nedsat nyrefunktion er set efter administration af zoledronsyre, specielt hos patienter med eksisterende nyreproblemer eller yderligere risikofaktorer (f.eks. ældre patienter, cancerpatienter i kemoterapibehandling, samtidig behandling med nefrotoksiske lægemidler, samtidig behandling med diuretika, svær dehydrering), hvoraf de fleste modtog en dosis på 4 mg hver 3.-4. uge, men det er set hos patienter efter en enkelt administration.
English: For atrial fibrillation serious adverse events the pooled incidences were 1.3% for zoledronic acid and 0.8% for placebo.
Danish: For alvorlige bivirkninger af atrieflimren var den samlede incidens 1,3% for zoledronsyre og 0,8% for placebo.
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 øresmerter, udflåd fra øret og/eller betændelse i øret.
English: − The solution containing zoledronic acid must not be further diluted or mixed with other infusion solutions.
Danish: Opløsningen indeholdende zoledronsyre må ikke fortyndes yderligere eller blandes med andre infusionsopløsninger.
English: Zoledronic acid 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 til TIH-patienter, som også har svær nyreinsufficiens, bør kun overvejes efter vurdering af risici og fordele ved behandlingen.
English: Like all medicines, Zoledronic Acid Hospira can cause side effects, although not everybody gets them.
Danish: Zoledronsyre Hospira kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The chance of experiencing these side effects decreases with subsequent doses of Zoledronic Acid Hospira.
Danish: Risikoen for at få disse bivirkninger aftager ved de efterfølgende doser Zoledronsyre Hospira.
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal produktet anvendes straks.
English: - if you have had some or all of the parathyroid glands in your neck surgically removed.
Danish: - hvis du har fået fjernet en eller flere af biskjoldbruskkirtlerne på halsen ved en operation.
English: Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Hospira and will check your response to treatment at regular intervals.
Danish: Lægen vil tage blodprøver, inden du begynder behandling med Zoledronsyre Hospira, og vil med regelmæssige mellemrum kontrollere, hvordan du reagerer på behandlingen.
English: Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with zoledronic acid (see section 4.3).
Danish: Præ-eksisterende hypokalcæmi skal behandles med tilstrækkelig indgivelse af calcium og Dvitamin, før behandling med zoledronsyre initieres (se pkt.
English: Zoledronic Acid Hospira must not be mixed or given intravenously with any other medicinal products.
Danish: Zoledronsyre Hospira må ikke blandes eller gives intravenøst sammen med andre lægemidler.
English: Zoledronic Acid Hospira must not be allowed to come into contact with any calcium-containing solutions.
Danish: Zoledronsyre Hospira må ikke komme i kontakt med calciumholdige opløsninger.
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid and other bisphosphonates as well as use of other nephrotoxic medicinal products.
Danish: Faktorer, der kan øge potentialet for nedsættelse af nyrefunktionen, inkluderer dehydrering, allerede eksisterende nyreinsufficiens, adskillige cyklus af zoledronsyre og andre bisfosfonater så vel som brug af andre nefrotoksiske lægemidler.
English: No dose adjustment is necessary in patients with creatinine clearance 35 ml/min.
Danish: Dosisjustering er ikke nødvendig til patienter med kreatinin clearance ≥ 35 ml/min.
English: Kidney disorders (e.g. decreased urine output) may occur.
Danish: Nyreproblemer (fx nedsat mængde urin) kan forekomme.
English: Instructions for preparing reduced doses of Zoledronic Acid Hospira
Danish: Instruktion i fremstilling af reducerede doser Zoledronsyre Hospira
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: The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients.
Danish: Skævheden som blev observeret i studiet er ikke observeret i andre studier med zoledronsyre, ej heller i studier med zoledronsyre 4 mg hver 3-4 uge i onkologiske patienter.
English: Remove the volume of Zoledronic Acid Hospira solution indicated from the bag prior to administration.
Danish: Udtag mængden af Zoledronsyre Hospira, som angivet på posen, før administration.
English: The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Danish: Behandlingens start eller en ny behandling bør udskydes hos patienter med uhelede sår i det bløde væv i munden.
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Zoledronic Acid Hospira in patients with concomitant risk factors.
Danish: Et tandeftersyn med forebyggende tandbehandling og en individuel benefit/risk-vurdering anbefales inden behandling med Zoledronsyre Hospira hos patienter med samtidige risikofaktorer.
English: 6 ml, type I clear glass vial or 5 ml plastic vial, stoppered with a fluoropolymer-coated halo-butyl closure and sealed with an aluminium seal and flip-off top.
Danish: 6 ml, type I, klart hætteglas eller 5 ml plastik hætteglas, med en fluorpolymer-belagt halobutyl prop og med aluminiumsforsegling og flip-off låg.
English: Patients must be appropriately hydrated prior to administration of Zoledronic Acid Hospira.
Danish: Patienter skal være passende hydreret før administration af Zoledronsyre Hospira.
English: The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth, except in medical emergency situations.
Danish: Behandlingens start eller en ny behandling bør udskydes hos patienter med uhelede sår i det bløde væv i munden, undtaget i akutte medicinske tilfælde.
English: Population analysis showed that for a patient with creatinine clearance of 20 ml/min (severe renal impairment), or 50 ml/min (moderate impairment), the corresponding predicted clearance of zoledronic acid would be 37% or 72%, respectively, of that of a patient showing creatinine clearance of 84 ml/min.
Danish: Populationsanalyser viste, at for en patient med en kreatinin clearance på 20 ml/min (svær nyreinsufficiens) eller på 50 ml/min (moderat insufficiens), skulle den tilsvarende beregnede clearance af zoledronsyre være henholdsvis 37% eller 72% af clearance hos en patient med en kreatinin clearance på 84 ml/min.
English: A subset had recurrence of symptoms when rechallenged with zoledronic acid or another bisphosphonate.
Danish: Nogle havde tilbagevendende symptomer ved gentagen behandling med zoledronsyre eller med andre bisfosfonater.
English: While on treatment, invasive dental procedures should be performed with caution and avoided in close proximity to zoledronic acid treatment.
Danish: Under behandling bør invasiv tandbehandling udføres med forsigtighed og undgås tæt på zoledronsyrebehandling.
English: In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Danish: I et 3-års, randomiseret, dobbeltblindet, kontrolleret studie, som evaluerede effekt og sikkerhed af zoledronsyre 5 mg én gang årligt versus placebo ved behandling af postmenopausal osteoporose (PMO), var den generelle forekomst af atrieflimren 2,5% (96 ud af 3.862) og 1,9% (75 ud af 3.852) hos patienter, som fik henholdsvis zoledronsyre 5 mg og placebo.
English: − if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
Danish: - hvis du har eller har haft smerte, hævelse eller fornemmelse af følelsesløshed i kæben, følelsen af tyngde i kæben eller af løse tænder.
English: − Since no data are available on the compatibility of Zoledronic Acid Hospira with other intravenously administered substances, Zoledronic Acid Hospira must not be mixed with other medicinal products/substances and should always be given through a separate infusion line.
Danish: Da der ikke foreligger data om foreneligheden af Zoledronsyre Hospira med andre intravenøst indgivne stoffer, må Zoledronsyre Hospira ikke blandes med andre lægemidler/stoffer og bør altid gives igennem en separat infusionsslange.
English: Your doctor will inform you regarding the symptoms associated with hypocalcaemia.
Danish: Din læge vil fortælle dig om de symptomer, som forbindes med hypokalcæmi (for lavt indhold af calcium i blodet).
English: Single and multiple 5 and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients yielded the following pharmacokinetic data, which were found to be dose independent.
Danish: Enkeltinfusioner og gentagne infusioner over 5 og 15 minutter af 2, 4, 8 og 16 mg zoledronsyre til 64 patienter gav nedenstående farmakokinetiske data, som viste sig at være uafhængige af dosis.
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended.
Danish: Faktorer, der kan øge risikoen for nedsat nyrefunktion, inkluderer dehydrering, allerede eksisterende nyreinsufficiens, flere behandlingscyklusser af zoledronsyre eller andre bisfosfonater så vel som brug af andre nefrotoksiske lægemidler eller brug af en kortere infusionstid end anbefalet på nuværende tidspunkt.
English: It is an inhibitor of osteoclast-mediated bone resorption.
Danish: Det er en inhibitor af osteoklastisk medieret knogleresorption.
English: It is used: To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
Danish: Det bruges til: - At forebygge knoglekomplikationer, f.eks. knoglebrud, hos voksne patienter med knoglemetastaser (spredning af kræft fra den primære kræftknude til knoglerne).
English: You should not be given Zoledronic Acid Hospira if you are pregnant.
Danish: Du bør ikke få Zoledronsyre Hospira, hvis du er gravid.
English: Each pack contains one bag which contains 4 mg of zoledronic acid.
Danish: Hver pakning indeholder 1 pose som indeholder 4 mg zoledronsyre.
English: Serum calcium should be measured and hypocalcaemia must be corrected before initiating zoledronic acid therapy.
Danish: Serumcalcium bør måles og hypokalcæmi korrigeres, inden zoledronsyre-behandling påbegyndes.
English: The following adverse reactions, listed in Table 2, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Danish: De følgende bivirkninger, opført i tabel 2, er samlet fra kliniske forsøg og post-marketing rapporter efter fortrinsvis kronisk behandling med 4 mg zoledronsyre: