FrancophonIA/ELRC3.0 huggingface dataset:
English: • Transient increase in serum creatinine may be greater in patients with underlying impaired renal function.
Danish: • Forbigående øgning i serumkreatinin kan være højere hos patienter med underliggende
English: Zoledronic acid Teva Generics works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.
Danish: Zoledronsyre Teva Generics virker ved at normalisere remodelleringsprocessen, sikre dannelse af normalt knoglevæv og dermed genoprette knoglestyrken.
English: Your doctor, pharmacist or nurse knows how to store Zoledronic acid Teva Generics properly.
Danish: Lægen, apoteket eller sygeplejersken ved, hvordan Zoledronsyre Teva Generics skal opbevares korrekt.
English: Uncommon Insomnia
Danish: Ikke almindelig Søvnløshed
English: Bone biopsies were obtained from the iliac crest 1 year after the third annual dose in 152 post-menopausal patients with osteoporosis treated with zoledronic acid (N=82) or placebo (N=70).
Danish: Der blev udført biopsier fra crista iliaca 1 år efter den tredje årlige dose på 152 postmenopausale patienter med osteoporose behandlet med zoledronsyre (N=82) eller placebo (N=70).
English: The incidence of delayed hip fracture healing was comparable between zoledronic acid (34 [3.2%]) and placebo (29 [2.7%]).
Danish: Incidensen af forsinket heling af hoftefrakturer var sammenlignelig mellem zoledronsyre (34 [3,2 %]) og placebo (29 [2,7 %]).
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 t½α 0,24 og t½β 1,87 timer efterfulgt af en lang elimineringsfase med en terminal eliminationshalveringstid på t½γ 146 timer.
English: Any clinical fracture (1)
Danish: Alle kliniske frakturer (1)
English: At 24 months a similar significant increase of 3.6% in total hip BMD was observed for patients treated with zoledronic acid as compared to the effects observed in post-menopausal women in the HORIZON-PFT study.
Danish: Ved 24 måneder blev der observeret en signifikant øgning på 3,6 % i BMD over hele hoften hos patienter, som blev behandlet med zoledronsyre, svarende til effekten observeret hos postmenopausale kvinder i HORIZON-PFT studiet.
English: Tetracycline label was detectable in all but one of 82 biopsies obtained from patients on zoledronic acid.
Danish: Tetracyklinmarkering kunne påvises i alle, undtagen en, af de 82 biopsier fra patienter på zoledronsyre.
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: Zoledronic acid Teva Generics may also cause other side effects Very common (may affect more than 1 in 10 people) Fever
Danish: Zoledronsyre Teva Generics kan også give andre bivirkninger Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter) Feber.
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: Ask your doctor, pharmacist or nurse for advice before taking this medicine.
Danish: Spørg din læge, farmaceuten eller sundhedspersonalet til råds, før du tager dette lægemiddel.
English: Zoledronic acid Teva Generics is also used in patients who have recently broken their hip in a minor trauma such as a fall and therefore are at risk of subsequent bone breaks.
Danish: Zoledronsyre Teva Generics bruges også til patienter, der for nylig har brækket deres hofte ved et mindre uheld, fx ved fald, og som derfor har risiko for yderligere knoglebrud.
English: Not known (frequency cannot be estimated from the available data) Pain in the mouth, teeth and jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data) Smerter i mund, tænder og kæbe, hævelse eller sår inden i munden, følelsesløshed eller en følelse af tunghed i kæben, eller løsnen af en tand.
English: Table 3 Between treatment comparisons of the incidence of key clinical fracture variables over 3 years
Danish: Tabel 3 Sammenligninger mellem behandlinger af incidensen af vigtige kliniske frakturvariabler over 3 år
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: 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: Treatment of osteoporosis
Danish: Behandling af osteoporose
English: Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy
Danish: Behandling af osteoporose i forbindelse med længerevarende systemisk glukokortikoidbehandling
English: For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Danish: For patienter, som udvikler osteonekrose i kæberne under behandling med bisfosfonater, kan tandoperationer forværre disse forhold.
English: Your doctor will advise you and decide how long you should be treated with Zoledronic acid Teva Generics.
Danish: Din læge vil vejlede dig og beslutte, hvor længe du skal behandles med Zoledronsyre Teva Generics.
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 4.8).
Danish: På grund af zoledronsyres hurtige effekt på kongleomsætningen kan der udvikles forbigående hypokalcæmi, til tider symptomatisk og almindeligvis maksimal inden for de første 10 dage efter infusion af zoledronsyre (se pkt.
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 mean 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: 85% of patients were bisphosphonate-naïve.
Danish: 85 % af patienterne blev behandlet med bisfosfonat for første gang.
English: In case you recently broke your hip, it is recommended that Zoledronic acid Teva Generics is administered two or more weeks after your hip repair surgery.
Danish: Hvis du for nylig har brækket din hofte, anbefales det at Zoledronsyre Teva Generics gives to eller flere uger efter din hofteoperation.
English: Zoledronic acid Teva Generics with food and drink Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Zoledronic acid Teva Generics, as directed by your doctor.
Danish: Brug af Zoledronsyre Teva Generics sammen med mad og drikke Sørg for at drikke tilstrækkelig væske (mindst 1 eller 2 glas) før og efter behandling med Zoledronsyre Teva Generics, som din læge har fortalt dig.
English: Atrial fibrillation Uncommon Palpitations
Danish: Atrieflimren Ikke almindelig Palpitationer
English: In both women and men, Zoledronic acid Teva Generics strengthens the bone and therefore makes it less likely to break.
Danish: Hos både mænd og kvinder styrker Zoledronsyre Teva Generics knoglerne og mindsker derfor risikoen for brud.
English: Therefore, interactions resulting from displacement of highly proteinbound drugs are unlikely.
Danish: Af denne grund er interaktioner med stærkt proteinbundede stoffer på grund af fortrængning usandsynlig.
English: The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 patients studied.
Danish: Den renale clearance af zoledronsyre korrelerer tydeligt med kreatininclearance, idet den renale clearance udgjorde 75±33 % af kreatininclearance, hvilket viste en median på 84±29 ml/min (varierende fra 22 til 143 ml/min) hos de 64 undersøgte patienter.
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: The usual dose is 5 mg given as one infusion per year into a vein by your doctor or nurse.
Danish: Den sædvanlige dosis er 5 mg, der gives som én infusion pr. år i en vene af din læge eller sygeplejerske.
English: Placebo (N = 1,062) event rate
Danish: Placebo (N=1.062) hændelsesrate (%)
English: Vitamin D levels were not routinely measured but a loading dose of vitamin D (50,000 to 125,000 IU orally or via the intramuscular route) was given to the majority of patients 2 weeks prior to infusion.
Danish: Dvitamin niveauerne blev ikke målt rutinemæssigt, men en støddosis D-vitamin (50.000 til 125.000 IE oralt eller intramuskulært) blev givet til flertallet af patienterne 2 uger før infusionen.
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 kreatininclearance (målt årligt før dosering) og incidensen af nyresvigt og nedsat nyrefunktion sammenlignelig for zoledronsyre- og placebobehandlings-gruppen over tre år.
English: Zoledronic acid significantly reduced the mean days of limited activity and the days of bed rest due to back pain by 17.9 days and 11.3 days respectively compared to placebo and significantly reduced the mean days of limited activity and the days of bed rest due to fractures by 2.9 days and 0.5 days respectively compared to placebo (all p<0.01).
Danish: Zoledronsyre reducerede signifikant det gennemsnitlige antal dage med begrænset aktivitet og antal dage med sengeleje på grund af rygsmerter med henholdsvis 17,9 dage og 11,3 dage sammenlignet med placebo og reducerede signifikant det gennemsnitlige antal dage med begrænset aktivitet og dage med sengeleje på grund af frakturer med henholdsvis 2,9 dage og 0,5 dage sammenlignet med placebo (alle p<0,01).
English: The incidence of clinical fractures, including vertebral, non-vertebral and hip fractures, was evaluated in 2,127 men and women aged 50-95 years (mean age 74.5 years) with a recent (within 90 days) low-trauma hip fracture who were followed for an average of 2 years on study medication.
Danish: Incidensen af kliniske frakturer, herunder vertebrale og non-vertebrale frakturer samt hoftefrakturer, blev bedømt i 2.127 mænd og kvinder i alderen 50-59 år (gennemsnitsalder 74,5 år) med en nylig (inden for 90 dage) lavenergi-hoftefraktur, som blev fulgt i gennemsnitligt 2 år på studiemedicin.
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 Teva Generics.
Danish: Din læge kan råde dig til at tage et tilskud af calcium og D-vitamin (fx tabletter) i mindst de første ti dage, efter du har fået Zoledronsyre Teva Generics.
English: • A single dose of Zoledronic acid Teva Generics should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2).
Danish: • En enkelt dosis Zoledronsyre Teva Generics bør ikke overstige 5 mg, og infusionsvarigheden bør være mindst 15 minutter (se pkt.
English: For osteoporosis, Zoledronic acid Teva Generics works for one year.
Danish: For osteoporose virker Zoledronsyre Teva Generics i 1 år.
English: You must not be given Zoledronic acid Teva Generics 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 Teva Generics, hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: Before you receive dental treatment or undergo dental surgery, tell your dentist you are receiving treatment with Zoledronic acid Teva Generics.
Danish: Før du skal have tandbehandling eller gennemgå oral kirurgi, skal du fortælle din tandlæge, at du er i behandling med Zoledronsyre Teva Generics.
English: Efficacy was demonstrated if non-inferiority to risedronate was shown sequentially with respect to the percentage change in lumbar spine BMD at 12 months relative to baseline in the treatment and prevention subpopulations, respectively.
Danish: Effekt blev påvist, hvis non-inferioritet over for risedronat blev vist sekventielt med hensyn til den procentuelle forandring i BMD i lænderygsøjlen efter 12 måneder i forhold til basisniveau i undergrupperne for henholdsvis behandling og forebyggelse.
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: Eksisterende hypokalcæmi skal behandles med tilstrækkelig indgivelse af calcium og D-vitamin, før behandling med zoledronsyre initieres (se pkt.
English: Pharmacodynamic effects 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: During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).
Danish: Efter dette lægemiddel kom på markedet er følgende reaktioner blevet rapporteret (sjælden hyppighed): atypiske subtrokantære og diafyseale femurfrakturer (en klasseeffekt for bisfosfonater).
English: Effect on morphometric vertebral fractures
Danish: Effekt på morfometriske vertebrale frakturer
English: In patients treated with zoledronic acid, no osteomalacia, marrow fibrosis or woven bone formation was detected.
Danish: Hos patienter behandlet med zoledronsyre blev der ikke påvist nogen osteomalaci, marvfibrose eller dannelse af spongiøst knoglevæv.
English: Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound drugs are therefore unlikely.
Danish: Zoledronsyre bindes ikke mærkbart til plasmaproteiner (cirka 43-55 % bundet), og interaktioner med stærkt proteinbundende stoffer på grund af fortrængning, er derfor usandsynlig.
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, fx muskelkramper, følelsesløshed eller en snurrende fornemmelse især omkring munden blevet rapporteret.
English: At the menopause, a woman's ovaries stop producing the female hormone oestrogen, which helps keep bones healthy.
Danish: I overgangsalderen holder kvindens æggestokke op med at producere det kvindelige kønshormon østrogen, som er med til at holde knoglerne sunde og raske.
English: Patients were randomised to either zoledronic acid 5 mg single infusion or to oral risedronate 5 mg daily for one year.
Danish: Patienterne blev randomiseret til behandling med enten en enkelt infusion zoledronsyre 5 mg eller oralt risedronat 5 mg daglig i 1 år.
English: No dose adjustment is necessary in patients with creatinine clearance ≥ 35 ml/min.
Danish: Dosisjustering er ikke nødvendig til patienter med kreatininclearance ≥ 35 ml/min.
English: Zoledronic acid is contraindicated during pregnancy (see section 4.3).
Danish: Zoledronsyre er kontraindiceret under graviditet (se pkt.
English: Clinical efficacy in the treatment of osteoporosis in patients at increased risk of fracture after a recent hip fracture (RFT)
Danish: Klinisk effekt i behandlingen af osteoporose hos patienter med øget frakturrisiko efter nylig hoftefraktur (RTF)
English: Clinical efficacy in osteoporosis associated with long-term systemic glucocorticoid therapy The efficacy and safety of zoledronic acid in the treatment and prevention of osteoporosis associated with long-term systemic glucocorticoid therapy were assessed in a randomised, multicentre, double-blind, stratified, active-controlled study of 833 men and women aged 18-85 years (mean age for men 56.4 years; for women 53.5 years) treated with > 7.5 mg/day oral prednisone (or equivalent).
Danish: Klinisk effekt ved osteoporose i forbindelse med længerevarende systemisk glukokortikoidbehandling Effekten og sikkerheden af zoledronsyre ved behandling og forebyggelse af osteoporose i forbindelse med længerevarende systemisk glukokortikoidbehandling blev vurderet i et randomiseret, multicenter, dobbeltblindet, stratificeret, aktivt kontrolleret studie med 833 mænd og kvinder i alderen 18-85 år (gennemsnitsalder for mænd 56,4 år; for kvinder 53,5 år) behandlet med > 7,5 mg prednisolon (eller tilsvarende) oralt dagligt.
English: Zoledronic acid significantly increased BMD at the lumbar spine, hip, and distal radius relative to treatment with placebo at all timepoints (6, 12, 24 and 36 months).
Danish: Zoledronsyre øgede BMD signifikant ved den lumbale columna, hofte og distale radius i forhold til behandling med placebo på alle tidspunkter (6, 12, 24 og 36 måneder).
English: The risk reduction was 51% in bisphosphonate-naïve patients and 42% in patients allowed to take concomitant osteoporosis therapy.
Danish: Risikoreduktionen var 51 % for patienter som ikke havde fået bisfosfonat tidligere og 42 % for patienter, som fik lov at være i samtidig osteoporosebehandling.
English: This includes e.g. Zometa or Aclasta (medicines that also contain zoledronic acid and are used to treat the same disease or osteoporosis and other non-cancer diseases of the bone).
Danish: Aclasta (lægemidler, der også indeholder zoledronsyre, og som anvendes til at behandle den samme sygdom eller knogleskørhed og anden ikke-kræftsygdom i knoglerne).
English: Zoledronic acid significantly decreased the incidence of one or more new vertebral fractures over three years and as early as the one year timepoint (see Table 2).
Danish: Zoledronsyre reducerede incidensen af en eller flere nye vertebrale frakturer signifikant over 3 år og så tidligt som ved 1 år (se tabel 2).
English: Zoledronic acid Teva Generics is supplied in packs of 1, 5 or 10 bottles.
Danish: Zoledronsyre Teva Generics leveres i pakninger bestående af 1, 5 eller 10 flasker.
English: Cyclic Olefin Polymer (COP) plastic bottle, fitted with a chlorobutyl/butyl rubber stopper and aluminium cap fitted with violet plastic flip off disc.
Danish: Plastikflaske (cykloolefinik polymer) lukket med chlorbutyl/butyl-gummiprop og et aluminium fliplåg med violet flip-off plastskive.
English: It is supplied in multipacks containing 5 or 10 bags.
Danish: Den leveres i multipakninger bestående af 5 eller 10 poser.
English: Talk to your doctor before you are given Zoledronic acid Teva Generics: - if you are being treated with any other bisphosphonate medicine, since the combined effects of these medicines taken together with Zoledronic acid Teva Generics are unknown.
Danish: Kontakt lægen, før du får Zoledronsyre Teva Generics: - hvis du er i behandling med et andet bisfosfonat, da den kombinerede effekt af disse lægemidler taget sammen med Zoledronsyre Teva Generics er ukendt.
English: A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, anti-angiogenic medicinal products, corticosteroids, poor oral hygiene).
Danish: Et tandeftersyn med passende forebyggende tandbehandling bør overvejes før behandling med bisfosfonater hos patienter med flere samtidige risikofaktorer (fx cancer, kemoterapi, anti-angiogene lægemidler, kortikosteroider, dårlig mundhygiejne).
English: Teva Santé Tél: +33 1 55 91 7800
Danish: Tél: +33 1 55 91 7800
English: It is important to take calcium and vitamin D supplements (for example tablets) as directed by your doctor.
Danish: Det er vigtigt, at du tager tilskud af calcium og D-vitamin (fx tabletter) efter lægens anvisninger.
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 kalciumniveauer 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: Not known** Renal impairment.
Danish: Ikke kendt** Nedsat nyrefunktion.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på fremstillerne, der er ansvarlige for batchfrigivelse
English: Clinical efficacy in the treatment of post-menopausal osteoporosis (PFT) The efficacy and safety of zoledronic acid 5 mg once a year for 3 consecutive years were demonstrated in post-menopausal women (7,736 women aged 65-89 years) with either: a femoral neck bone mineral density (BMD) with a T-score ≤ -1.5 and at least two mild or one moderate existing vertebral fracture(s); or a femoral neck BMD T-score ≤ -2.5 with or without evidence of existing vertebral fracture(s).
Danish: Klinisk effekt ved behandling af postmenopausal osteoporose [PFT] Virkning og sikkerhed af zoledronsyre 5 mg en gang årligt i 3 konsekutive år er påvist hos postmenopausale kvinder (7.736 kvinder i alderen 65-89 år) med enten: en knoglemineraltæthed (BMD) med en t-score for lårbenshalsen ≤ -1,5, og mindst to milde eller en moderat eksisterende vertebral(e) fraktur(er); eller en BMD T-score for lårbenshalsen ≤ -2,5 med eller uden bevis for eksisterende vertebral (e) fraktur(er).
English: Zoledronic acid (5 mg in 100 ml ready-to-infuse solution) is administered via a vented infusion line and given at a constant infusion rate.
Danish: Zoledronsyre (5 mg i 100 ml infusionsklar opløsning) administreres via en separat infusionsslange og ved en konstant infusionshastighed.
English: It comes in a polyolefin/styrene-ethylene-butylene (SEB) foil bag with a foil over pouch.
Danish: Den leveres i en foliepose af polyolefin/styren-ethylen-butylen (SEB) i en folieyderpose.