FrancophonIA/ELRC3.0 huggingface dataset:
English: • Monitoring of serum creatinine should be considered in at-risk patients.
Danish: • Monitorering af serumkreatinin bør overvejes hos risikopatienter.
English: - The unopened bottle does not require any special storage conditions.
Danish: - Den uåbnede flaske kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: During this entire time period bone turnover markers were within the pre-menopausal range at the end of each year.
Danish: I hele denne periode lå knogleomsætningsmarkørerne inden for det præmenopausale interval ved udgangen af hvert år.
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette gælder også mulig bivirkninger, som ikke er medtaget i denne indlægsseddel.
English: Histomorphometric analysis showed a 63% reduction in bone turnover.
Danish: Den histomorfometriske analyse viste en 63 % reduktion i knogleomsætningen.
English: In the HORIZON-RFT study 508 men were randomised into the study and 185 patients had BMD assessed at 24 months.
Danish: I HORIZON-RTF studiet blev 508 mænd randomiseret og 185 patienter fik BMD bedømt ved 24 måneder.
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race or body weight.
Danish: Total legemsclearance er 5,04±2,5 l/time uafhængigt af dosis og uanset køn, alder, race og legemsvægt.
English: - Do not use this medicine if you notice any discolouration or particles in the solution.
Danish: - Brug ikke dette lægemiddel, hvis du bemærker misfarvning eller partikler i opløsningen.
English: The optimal duration of bisphosphonate treatment for osteoporosis has not been established.
Danish: Den optimale varighed af bisfosfonatbehandling af osteoporose er ikke fastlagt.
English: Zoledronic acid Teva Generics may work for longer than one year, and your doctor will let you know if you need to be treated again.
Danish: Zoledronsyre Teva Generics kan virke i mere end et år, og din læge vil fortælle dig, om du skal behandles igen.
English: The medicinal product must not be mixed or given intravenously with any other medicinal products.
Danish: Lægemidlet må ikke blandes eller gives intravenøst sammen med andre lægemidler.
English: • in adult men at increased risk of fracture.
Danish: • hos voksne mænd med øget risiko for fraktur.
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of zoledronic acid on an individual patient basis, particularly after 5 or more years of use.
Danish: Behovet for fortsat behandling skal revurderes regelmæssigt, baseret på fordele og mulige risici af zoledronsyre for den enkelte patient, især efter anvendelse i 5 år eller mere.
English: Osteoporosis could also occur in men and women because of the long term use of steroids, which can affect the strength of bones.
Danish: Osteoporose kan også opstå hos mænd og kvinder på grund af langtidsbrug af steroider, som kan påvirke styrken af knoglerne.
English: Many of the reported cases have been associated with dental procedures such as tooth extraction.
Danish: Mange af de rapporterede tilfælde har været i forbindelse med tandoperationer, så som udtrækning af en tand.
English: • Physician educational material
Danish: • Lægeundervisningsmateriale
English: The inter- and intra-subject variation for plasma clearance of zoledronic acid was shown to be 36% and 34%, respectively.
Danish: Inter- og intraindividuel variation i zoledronsyreclearance i plasma er vist at være henholdsvis 36 % og 34 %.
English: The study was not designed to measure significant differences in hip fracture, but a trend was seen towards reduction in new hip fractures.
Danish: Studiet var ikke designet til at måle signifikante forskelle i hoftefraktur, men der ses en tendens mod reduktion i nye hoftefrakturer.
English: The clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Danish: Den behandlende læges kliniske bedømmelse bør bestemme behandlingsplanen for den enkelte patient baseret på en individuel benefit/risk-vurdering.
English: Any unused solution should be discarded.
Danish: Ubrugt opløsning skal kasseres.
English: Not all pack size may be marketed.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: At least one new vertebral fracture (0-1 year) At least one new vertebral fracture (0-2 year) At least one new vertebral fracture (0-3 year) ** p <0.0001
Danish: Mindst en ny vertebral fraktur (0-1 år) Mindst en ny vertebral fraktur (0-2 år) Mindst en ny vertebral fraktur (0-3 år) ** p <0,0001
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Danish: Farmakoterapeutisk klassifikation: Lægemidler til behandling af knoglesygdomme, bisfosfonater, ATC-kode: M05BA08
English: Hypocalcaemia* Uncommon Anorexia, decreased appetite
Danish: Hypokalcæmi* Ikke almindelig Anoreksi, nedsat appetit
English: In the three-year osteoporosis study standing height was measured annually using a stadiometer.
Danish: I det treårige osteoporosestudie blev den stående højde målt årligt med et stadiometer.
English: - if you have hypocalcaemia (this means that the levels of calcium in your blood are too low).
Danish: - hvis du har hypokalcæmi (dvs. du har for lavt indhold af calcium i blodet).
English: Many patients with osteoporosis have no symptoms but they are still at risk of breaking bones because osteoporosis has made their bones weaker.
Danish: Mange patienter med osteoporose har ingen symptomer, men de har stadig risiko for knoglebrud, fordi osteoporosen har svækket knoglerne.
English: Other products containing zoledronic acid as active substances are available for oncology indications.
Danish: Andre produkter, der indeholder zoledronsyre som aktivt stof, fås til onkologiindikationer.
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 tid kurven.
English: Clinical efficacy in men
Danish: Klinisk effekt hos mænd
English: It is unknown whether zoledronic acid is excreted into human milk.
Danish: Det vides ikke, om zoledronsyre udskilles i human mælk.
English: Repeat dosing did not lead to further reduction of bone turnover markers.
Danish: Gentagen dosering førte ikke til yderligere reduktion af knogleomsætningsmarkørerne.
English: These could be signs of bone damage in the jaw (osteonecrosis).
Danish: Dette kan være tegn på knogleskade i kæben (osteonekrose).
English: Class effects)
Danish: Klasseeffekter)
English: Summary of vertebral fracture efficacy at 12, 24 and 36 months
Danish: Tabel 2 Resumé af effekt på vertebrale frakturer ved 12, 24 og 36 måneder
English: Table 2
Danish: Tabel 1
English: The majority of patients continued to receive glucocorticoids for the one year duration of the trial.
Danish: Hovedparten af patienterne fortsatte med at få glukokortikoider i det år, studiet varede.
English: Aseptic techniques must be followed during preparation of the infusion.
Danish: Aseptiske arbejdsmetoder skal følges ved tilberedelse af infusionen.
English: If you feel dizzy while taking Zoledronic acid Teva Generics, do not drive or use machines until you feel better.
Danish: Hvis du føler dig svimmel, mens du tager Zoledronsyre Teva Generics, må du ikke køre bil eller betjene maskiner, før du har det bedre.
English: EXP After opening: 24 hours at 2°C - 8°C
Danish: EXP: Efter åbning: 24 timer ved 2°C - 8°C.
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 oral calcium og/eller intravenøs infusion af calciumglukonat.
English: Many of these patients had signs of local infection including osteomyelitis, and the majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Danish: Mange af disse patienter viste tegn på lokal infektion inklusive osteomyelitis, og størstedelen af rapporterne refererer til cancerpatienter, som har fået trukket en tand ud eller har fået foretaget andre tandoperationer.
English: Only clear solution free from particles and discoloration should be used.
Danish: Kun en klar opløsning, fri for partikler og misfarvning må benyttes.
English: Adverse reactions, such as dizziness, may affect the ability to drive or use machines, though no studies on this effect with zoledronic acid have been performed.
Danish: Bivirkninger, såsom svimmelhed, kan påvirke evnen til at føre motorkøretøj eller betjene maskiner; der er dog ikke foretaget undersøgelser af denne virkning med zoledronsyre.
English: Concomitant osteoporosis therapy included: calcitonin, raloxifene, tamoxifen, hormone replacement therapy, tibolone; but excluded other bisphosphonates.
Danish: Samtidig osteoporosebehandling omfattede: calcitonin, raloxifen, tamoxifen, hormonsubstitutionsbehandling, tibolon, men udelukkede andre bisfosfonater.
English: If you missed a dose of Zoledronic acid Teva Generics Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Danish: Hvis du har glemt en dosis Zoledronsyre Teva Generics Kontakt din læge eller dit hospital så hurtigt som muligt for at få en ny tid.
English: The pack sizes of 5 and 10 bottles are only available in multipacks.
Danish: Pakningsstørrelserne bestående af 5 og 10 flasker leveres kun i multipakninger.
English: Decreased circulating levels of sex hormones, mainly oestrogens converted from androgens, also play a role in the more gradual bone loss observed in men.
Danish: Nedsat niveau af cirkulerende kønshormoner, især østrogener omdannet fra androgener spiller også en rolle i det mere gradvise knogletab, der ses hos mænd.
English: Not known** 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: It is currently unclear whether Zoledronic acid Teva Generics causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Zoledronic acid Teva Generics.
Danish: Det er på nuværende tidspunkt uklart, om Zoledronsyre Teva Generics forårsager denne uregelmæssige hjerterytme, men du skal kontakte din læge, hvis du oplever sådanne symptomer, efter du har fået Zoledronsyre Teva Generics.
English: For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Danish: For patienter med behov for tandoperationer er der ingen tilgængelige data, der viser, om stop af behandling med bisfosfonater reducerer risikoen for osteonekrose i kæben.
English: • 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/benerfit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Clinical vertebral fracture (2)
Danish: Klinisk vertebral fraktur (2)
English: Before you receive treatment with Zoledronic acid Teva Generics, tell your doctor if you have (or have had) pain, swelling or numbness in your gums, jaw or both, if your jaw feels heavy, or if you have lost a tooth.
Danish: Før du bliver behandlet med Zoledronsyre Teva Generics, skal du fortælle din læge, hvis du har (eller har haft) smerte, hævelse eller følelsesløshed i dine gummer, din kæbe eller begge steder, hvis din kæbe føles tung, eller hvis du har mistet en tand.
English: Frequency categories are defined 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
Danish: Frekvenserne er defineret ved brug af følgende konvention: 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: Patients were stratified with respect to duration of glucocorticoid use prior to randomisation (≤ 3 months versus > 3 months).
Danish: Patienterne blev inddelt i forhold til varigheden af deres glukokortikoidbehandling før randomisering (≤ 3 måneder versus > 3 måneder).
English: In another study in men (study CZOL446M2308) an annual infusion of zoledronic acid was non-inferior to weekly alendronate for the percentage change in lumbar spine BMD at month 24 relative to baseline.
Danish: I et andet studie, som omfattede mænd, (studie CZOL446M2308) var en årlig infusion af zoledronsyre non-inferiør i forhold til ugentlig alendronat for den procentuelle ændring i lænderyg-BMD ved måned 24 i forhold til baseline.
English: The overall percentage of patients who experienced adverse reactions were 44.7%, 16.7% and 10.2% after the first, second and third infusion, respectively.
Danish: Den overordnede procentdel af patienter, som oplevede bivirkninger, var henholdsvis 44,7 %, 16,7 % og 10,2 % efter første, anden og tredje infusion.
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 Teva Generics.
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 Teva Generics.
English: The primary efficacy variable was the incidence of clinical fractures over the duration of the study.
Danish: Den primære effektvariabel var incidensen af kliniske frakturer i løbet af studiet.
English: Women who were evaluated for the incidence of vertebral fractures did not receive concomitant osteoporosis therapy, which was allowed for women contributing to the hip and all clinical fracture evaluations.
Danish: Kvinder, som blev evalueret for incidens af vertebrale frakturer, modtog ikke samtidig osteoporosebehandling, hvilket var tilladt for kvinder, som bidrog til evalueringerne af hoftefrakturer og alle kliniske frakturer.
English: Class effects:
Danish: Klasseeffekter:
English: Uncommon Vertigo
Danish: Ikke almindelig Vertigo
English: For the treatment of post-menopausal osteoporosis, osteoporosis in men and the treatment of osteoporosis associated with long-term systemic glucocorticoid therapy, the recommended dose is a single intravenous infusion of 5 mg zoledronic acid administered once a year.
Danish: Til behandling af postmenopausal osteoporose, osteoporose hos mænd og behandling af osteoporose i forbindelse med længerevarende systemisk glukokortikoidbehandling er den anbefalede dosis en enkelt intravenøs infusion af 5 mg zoledronsyre administreret en gang om året.
English: There was no progressive reduction of bone turnover markers with repeated annual dosing.
Danish: Der var ingen progressiv reduktion af knogleomsætningsmarkørerne ved gentagen årlig dosering.
English: Other disturbances of mineral metabolism must also be effectively treated (e.g. diminished parathyroid reserve, intestinal calcium malabsorption).
Danish: Andre forstyrrelser af mineralmetabolismen skal ligeledes behandles effektivt (fx hypoparathyroidisme, intestinal calciummalabsorption).
English: The study was not powered to show a reduction in clinical fractures compared to risedronate.
Danish: Studiet havde ikke styrke til at vise reduktion i kliniske frakturer sammenlignet med risedronat.
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Danish: For opbevaringsbetingelser efter åbning af lægemidlet, se pkt.
English: Thereafter bone markers stabilised within the pre-menopausal range.
Danish: Derefter stabiliseredes knoglemarkørerne inden for det præmenopausale interval.
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: Zoledronic acid demonstrated a consistent effect over 3 years, resulting in a 41% reduction in the risk of hip fractures (95% CI, 17% to 58%).
Danish: Zoledronsyre viste en konsistent effekt over 3 år på 41 % reduktion i risikoen for hoftefrakturer (95 % CI, 17 % til 58 %).
English: Bone specific alkaline phosphatase (BSAP), serum N-terminal propeptide of type I collagen (P1NP) and serum beta-C-telopeptides (b-CTx) were evaluated in subsets ranging from 517 to 1,246 patients at periodic intervals throughout the study.
Danish: Knoglespecifik basisk fosfatase (bone-specific alkaline phosphatase - BSAP), serum N-terminal propeptid af type I-collagen (P1NP) og serum beta-C-telopeptider (b-CTx) blev evalueret i subsæt fra 517 til 1.246 patienter med jævne mellemrum under hele studiet.
English: All cause mortality was 10% (101 patients) in the zoledronic acid-treated group compared to 13% (141 patients) in the placebo group.
Danish: All cause mortaliteten var 10 % (101 patienter) i gruppen behandlet med zoledronsyre sammenlignet med 13 % (141 patienter) i placebogruppen.
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: In the Paget's disease trials, symptomatic hypocalcaemia was observed in approximately 1% of patients, in all of whom it resolved.
Danish: I forsøgene med Pagets sygdom sås der hypokalcæmi hos ca. 1 % af patienterne, og det forsvandt hos alle.
English: Effect on all clinical fractures The incidence rates of key clinical fracture variables are presented in Table 4.
Danish: Effekt på alle kliniske frakturer Incidensraten af vigtige kliniske frakturvariabler er angivet i tabel 4.
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: It is prudent to avoid dental surgery as recovery may be prolonged (see section 4.4).
Danish: Det er klogt at undgå tandoperationer, fordi helbredelsen kan blive forlænget (se pkt.
English: Effect on all clinical fractures
Danish: Effekt på alle kliniske frakturer
English: It belongs to a group of medicines called bisphosphonates and is used to treat post-menopausal women and adult men with osteoporosis or osteoporosis caused by treatment with steroids, and Paget's disease of the bone in adults.
Danish: Det tilhører en gruppe af stoffer, kaldet bisfosfonater, og anvendes til behandling af post-menopausale kvinder og voksne mænd med osteoporose eller osteoporose forårsaget af behandling med steroider, og Pagets sygdom af knoglerne hos voksne.
English: The incidence of fractures was 8 for zoledronic acid-treated patients versus 7 for risedronate-treated patients (p=0.8055).
Danish: Incidensen af frakturer var 8 for zoledronsyre-behandlede patienter versus 7 for risedronatbehandlede patienter (p=0,8055).
English: You may eat normally on the day you are treated with Zoledronic acid Teva Generics.
Danish: Du kan spise normalt den dag, du får behandling med Zoledronsyre Teva Generics.
English: Before stopping Zoledronic acid Teva Generics therapy If you are considering stopping Zoledronic acid Teva Generics treatment, please go to your next appointment and discuss this with your doctor.
Danish: Før Zoledronsyre Teva Generics-behandlingen stoppes Hvis du overvejer at stoppe Zoledronsyre Teva Generics-behandlingen, bedes du gå til din næste tid og drøfte det med lægen.
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 (fx aminoglykosider) eller diuretika (”vanddrivende midler”), der kan forårsage dehydrering.
English: Ninety-five percent of the patients received their infusion two or more weeks after the hip fracture repair and the median timing of infusion was approximately six weeks after the hip fracture repair.
Danish: 95 % af patienterne modtog deres infusion to eller flere uger efter hoftefrakturen blev behandlet, og gennemsnitstidspunktet for infusion var ca. 6 uger efter hoftefrakturhelingen.
English: After initiation of the zoledronic acid infusion, plasma concentrations of the active substance increased rapidly, 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 levels.
Danish: Efter påbegyndelse af infusion med zoledronsyre, øges plasmakoncentrationen af den aktive substans 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.
English: The study was not powered to show a reduction in clinical fractures in men; the incidence of clinical fractures was 7.5% in men treated with zoledronic acid versus 8.7% for placebo.
Danish: Studiet var ikke dimensioneret til at vise en reduktion i kliniske frakturer hos mænd; incidensen af kliniske frakturer var 7,5 % hos mænd behandlet med zoledronsyre i forhold til 8,7 % for placebo.
English: Osteoporosis is a disease that involves the thinning and weakening of the bones and is common in women after the menopause, but can also occur in men.
Danish: Osteoporose er en sygdom, hvor knoglerne bliver tyndere og svagere, og det er almindeligt hos kvinder efter overgangsalderen (menopausen), men kan også forekomme hos mænd.
English: • in adult men at increased risk of fracture, including those with a recent low-trauma hip fracture.
Danish: • hos voksne mænd med øget risiko for knoglebrud, inklusive personer med en nylig lavenergi-hoftefraktur.
English: Zoledronic acid Teva Generics must not be mixed or given intravenously with any other medicinal product and must be given through a separate vented infusion line at a constant infusion rate.
Danish: Zoledronsyre Teva Generics må ikke blandes eller gives intravenøst med andre lægemidler og skal gives gennem en separat infusionsslange med en konstant infusionshastighed.