FrancophonIA/ELRC3.0 huggingface dataset:
English: • Reminder card with the following key messages: o Need to calculate creatinine clearance based on actual body weight using the Cockcroft-Gault formula before each treatment with Aclasta o Contraindication in patients with creatinine clearance < 35 ml/min o Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity o Need to ensure appropriate hydration of the patient especially those at an advanced age and those receiving diuretic therapy o Need to infuse Aclasta slowly over a period of no less than 15 minutes o Once-yearly dosing regime o Adequate calcium and vitamin D intake are recommended in association with Aclasta administration o Need for appropriate physical activity, non-smoking and healthy diet
Danish: • Informationskort med følgende hovedbudskaber: o Nødvendigheden af inden hver behandling med Aclasta at beregne kreatininclearance på basis af den faktiske legemsvægt ved at bruge Cockcroft-Gault formlen o Kontraindiceret til patienter med kreatininclearance < 35 ml/min o Kontraindikationer hos gravide og ammende kvinder grundet potentiel teratogenicitet o Nødvendigheden af at sikre passende hydrering af patienten specielt ældre patienter og patienter i diuretisk behandling o Nødvendigheden af at infusere Aclasta langsomt over en periode på mindst 15 minutter o Doseringsregime én gang årligt o Tilstrækkelig calcium- og Vitamin D-optag er anbefalet i forbindelse med Aclastaadministration o Nødvendigheden af passende fysisk aktivitet, rygestop og sund diæt
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 Aclasta 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 Aclasta (se pkt.
English: In patients treated with Aclasta, no osteomalacia, marrow fibrosis or woven bone formation was detected.
Danish: Hos patienter behandlet med Aclasta blev der ikke påvist nogen osteomalaci, marvfibrose eller dannelse af spongiøst knoglevæv.
English: Table 4 Between treatment comparisons of the incidence of key clinical fracture variables
Danish: Tabel 4 Sammenligninger mellem behandlinger af incidensen af vigtige kliniske frakturvariabler
English: Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound medicinal products are therefore unlikely.
Danish: Zoledronsyre bindes ikke mærkbart til plasmaproteiner (cirka 43-55 % bundet), og interaktioner med stærkt proteinbundende lægemidler på grund af fortrængning, er derfor usandsynlig.
English: - Aclasta 5 mg solution for infusion is ready for use.
Danish: - Aclasta 5 mg infusionsvæske, opløsning er klar til brug.
English: Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Aclasta.
Danish: Din læge bør tage en blodprøve for at kontrollere din nyrefunktion (kreatininniveau) før hver Aclastadosis.
English: Aclasta is administered via a vented infusion line and given slowly at a constant infusion rate.
Danish: Aclasta administreres via en separat infusionsslange og ved en langsom konstant infusionshastighed.
English: Aclasta-treated patients aged 75 years and older exhibited a 60% reduction in the risk of vertebral fractures compared to placebo patients (p<0.0001).
Danish: Patienter på 75 år og derover, der blev behandlet med Aclasta, reducerede risikoen med 60 % for vertebral fraktur sammenlignet med placebo patienter (p<0,0001).
English: Multipack
Danish: Multipakning
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml vial of Aclasta, i.e. essentially “sodium free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per 100 ml Aclasta (1 hætteglas), dvs. det er i det væsentlige natriumfrit.
English: The hip fracture event rate was 1.44% for Aclasta-treated patients compared to 2.49% for placebo-treated patients.
Danish: Hændelsesraten for hoftefrakturer var 1,44 % for patienter behandlet med Aclasta sammenlignet med 2,49 % for patienter behandlet med placebo.
English: Your doctor should do a blood test to check your kidney function before each dose of Aclasta.
Danish: Din læge bør tage en blodprøve for at kontrollere din nyrefunktion før hver Aclastadosis.
English: 1 bottle of 100 ml Component of a multipack.
Danish: 1 flaske indeholder 100 ml Del af multipakning.
English: The Aclasta group revealed approximately 2.5 mm less height loss compared to placebo (95% CI: 1.6 mm, 3.5 mm) [p<0.0001].
Danish: Aclastagruppen viste ca. 2,5 mm mindre højdetab sammenlignet med placebo (95 % CI: 1,6 mm, 3,5 mm) [p<0,0001].
English: There was a transient increase in serum creatinine observed within 10 days in 1.8% of Aclasta-treated patients versus 0.8% of placebo-treated patients.
Danish: Der sås en forbigående stigning i serumkreatinin inden for 10 dage hos 1,8 % af patienterne behandlet med Aclasta mod 0,8 % hos patienterne behandlet med placebo.
English: Aclasta must not be allowed to come into contact with any calcium-containing solutions.
Danish: Aclasta må ikke komme i kontakt med calciumholdige opløsninger.
English: All patients were required to receive background therapy of vitamin D and calcium.
Danish: Alle patienter blev pålagt D-vitamin og calcium som baggrundsbehandling.
English: Aclasta 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: Aclasta 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: Uveitis, episcleritis, iritis Not known** Scleritis and parophthalmia
Danish: Uveit, episklerit, irit Ikke kendt** Sklerit og paroftalmi
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 sammelignet med risedronat.
English: It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Aclasta, 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 Aclasta, som anvist af sundhedspersonalet.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, farmaceuten eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: The MAH shall ensure that the educational programme implemented for the authorised indications of treatment of osteoporosis in post-menopausal women and in men at increased risk of fracture, including those with a recent low-trauma hip fracture, and treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture is updated.
Danish: MAH skal sikre at uddannelsesprogrammet, der er udarbejdet for de godkendte indikationer behandling af osteoporose hos postmenopausale kvinder og mænd med øget risiko for knoglebrud, inklusive personer med en nylig lavenergi-hoftefraktur og behandling af osteoporose i forbindelse med længerevarende systemisk glukokortikoidbehandling hos postmenopausale kvinder og mænd med øget risiko for fraktur opdateres.
English: For information on the infusion of Aclasta, see section 6.6.
Danish: For information angående infusion af Aclasta se pkt.
English: The incidence of these reactions decreased markedly with subsequent annual doses of Aclasta.
Danish: Incidensen af disse bivirkninger faldt markant ved de efterfølgende årlige doser Aclasta.
English: Incidence of individual adverse reactions following the first infusion was: pyrexia (17.1%), myalgia (7.8%), influenza-like illness (6.7%), arthralgia (4.8%) and headache (5.1%).
Danish: Incidensen af individuelle bivirkninger efter første infusion var: pyreksi (17,1 %), muskelsmerter (7,8 %), influenzalignende sygdom (6,7 %), ledsmerter (4,8 %) og hovedpine (5,1 %).
English: In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between Aclasta (2.6%) and placebo (2.1%).
Danish: I osteoporoseforsøget (PFT, HORIZON - Tilbagevendende Fraktur Studie [RFT] var den samlede incidens for atrieflimren sammenlignelig for Aclasta (2,6 %) og placebo (2,1 %).
English: Clear and colourless solution.
Danish: Klar og farveløs opløsning
English: Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given Aclasta.
Danish: Følg nøje alle lægens, farmaceutens eller sundhedspersonalets instruktioner, før du anvender Aclasta.
English: For atrial fibrillation serious adverse events the pooled incidences were 1.3% for Aclasta and 0.8% for placebo.
Danish: For alvorlige bivirkninger af atrieflimren var den samlede incidens 1,3 % for Aclasta og 0,8 % for placebo.
English: 1 bottle of 100 ml
Danish: 1 flaske indeholder 100 ml
English: Aclasta (N=3,875) event rate
Danish: Aclasta (N=3.875) hændelsesrate (%)
English: Adequate calcium and vitamin D intake are recommended in association with Aclasta administration.
Danish: Det anbefales at indtage tilstrækkeligt med calcium og D-vitamin i forbindelse med administration af Aclasta.
English: Treatment with a 5 mg annual dose of Aclasta significantly reduced BSAP by 30% relative to baseline at 12 months which was sustained at 28% below baseline levels at 36 months.
Danish: Behandling med en årlig Aclastadosis på 5 mg reducerede BSAP signifikant med 30 % i forhold til baseline ved 12 måneder, hvilket blev opretholdt med 28 % under baselineniveau ved 36 måneder.
English: Treatment with Aclasta resulted in a 6.7% increase in BMD at the lumbar spine, 6.0% at the total hip, 5.1% at the femoral neck, and 3.2% at the distal radius over 3 years as compared to placebo.
Danish: Behandling med Aclasta resulterede i en øgning af BMD med 6,7 % ved den lumbale columna, 6,0 % ved total hofte, 5,1 % ved lårbenshals og 3,2 % ved den distale radius over 3 år sammenlignet med placebo.
English: Not known (frequency cannot be estimated from the available data) Pain in the mouth and/or jaw, swelling or non-healing sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth; these could be signs of bone damage in the jaw (osteonecrosis).
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data) Smerter i mund og/eller kæbe, hævelse eller manglende sårheling i munden eller kæben, pus fra såret, følelsesløshed eller en følelse af tunghed i kæben, eller løsnen af en tand; dette kan være tegn på knogleskade i kæben (osteonekrose).
English: No new vertebral fractures were observed in the zoledronic acid group as compared to two new fractures in the placebo group.
Danish: I gruppen behandlet med zoledronsyre blev der ikke observeret nye vertebrale frakturer sammenlignet med placebo-gruppen, hvor der blev observeret to nye frakturer.
English: Before receiving Aclasta treatment, tell your doctor, pharmacist or nurse if - you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction; - you do not receive routine dental care or have not had a dental check-up for a long time; - you are a smoker (as this may increase the risk of dental problems); - you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders); - you are taking medicines called corticosteroids (such as prednisolone or dexamethasone) - you have cancer.
Danish: tandkødslidelser, eller en planlagt tandudtrækning; - du ikke får regelmæssig tandpleje eller ikke har haft et tandeftersyn i lang tid; - du ryger (det kan øge risikoen for tandproblemer); - du tidligere er blevet behandlet med bisfosfonat (bruges til at behandle eller forebygge knoglekomplikationer); - du tager medicin kaldet kortikosteroider (fx prednisolon eller dexamethason); - du har kræft.
English: Class effects
Danish: Klasseeffekter:
English: In the pooled results, a similar decrease in pain severity and pain interference scores relative to baseline were observed over 6 months for Aclasta and risedronate.
Danish: I de poolede resultater blev der for Aclasta og risedronat observeret lignende nedsættelse i sværhedsgraden af smerte og score for smerteinterferens relativt i forhold til baseline i løbet af 6 måneder.
English: Aclasta 5 mg solution for infusion zoledronic acid
Danish: Aclasta 5 mg infusionsvæske, opløsning zoledronsyre
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), with the majority of them receiving 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 (fx 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: Other medicines and Aclasta
Danish: Brug af anden medicin sammen med Aclasta
English: • Patient reminder card on osteonecrosis of the jaw
Danish: • Patienthuskekort om osteonekrose af kæberne
English: More patients reported serious adverse events in the zoledronic acid group than in the placebo group (5 [27.8%] patients versus 1 [6.3%] patient).
Danish: I gruppen behandlet med zoledronsyre rapporterede flere patienter alvorlige bivirkninger sammenlignet med placebo-gruppen (5 [27,8 %] patienter versus 1 [6,3 %] patient).
English: Treatment with Aclasta resulted in an increase in BMD of 5.4% at the total hip and 4.3% at the femoral neck over 24 months as compared to placebo.
Danish: Behandling med Aclasta resulterede i 5,4 % stigning i BMD på hele hoften og 4,3 % ved lårbenshalsen over 24 måneder sammenlignet med placebo.
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Danish: For opbevaringsforhold efter anbrud af lægemidlet, se pkt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Aclasta in all subsets of the paediatric population in Paget's disease of the bone, osteoporosis in post-menopausal women at an increased risk of fracture, osteoporosis in men at increased risk of fracture and prevention of clinical fractures after a hip fracture in men and women (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Aclasta i alle undergrupper af den pædiatriske population for Pagets knoglesygdom, osteoporose hos mænd og post-menopausale kvinder med øget risiko for fraktur, og forebyggelse af kliniske frakturer efter hoftefraktur hos mænd og kvinder (se pkt.
English: Uncommon (may affect up to 1 in 100 people) Swelling, redness, pain and itching to the eyes or eye sensitivity to light.
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 patienter) Hævelse omkring øjnene, røde øjne, øjensmerter og øjenkløe eller lysfølsomme øjne.
English: In addition, the following documents should be included in the patient information pack:
Danish: Derudover bør informationspakken til patienten indeholde følgende dokumenter:
English: In patients with a recent low-trauma hip fracture, it is recommended to give the Aclasta infusion at least two weeks after hip fracture repair (see section 5.1).
Danish: Hos patienter med en nylig lavenergi-hoftefraktur anbefales det at administrere Aclasta-infusion mindst to uger efter hoftefrakturhelingen (se pkt.
English: Placebo (N=1,062) event rate
Danish: Placebo (N=1.062) hændelsesrate (%)
English: Placebo (N=3,861) event rate
Danish: Placebo (N=3.861) hændelsesrate (%)
English: What Aclasta contains - The active substance is zoledronic acid.
Danish: Aclasta indeholder: - Aktivt stof: zoledronsyre.
English: Hypocalcaemia*
Danish: Hypokalcæmi*
English: CARTON (WITH BLUE BOX) FOR UNIT PACK
Danish: KARTON (INKLUSIVE ”BLUE BOX”) FOR ENKELTSTYKSPAKNING
English: Aclasta (N=1,065) event rate
Danish: Aclasta (N=1.065) hændelsesrate (%)
English: • Creatinine clearance should be calculated based on actual body weight using the
Danish: • Før hver Aclastadosis bør kreatininclearance beregnes på basis af den faktiske legemsvægt ved at bruge Cockcroft-Gault formlen.
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, including zoledronic acid (see section 4.4).
Danish: Tilfælde af osteonekrose af kæberne er blevet rapporteret overvejende hos cancerpatienter, der er i behandling med lægemidler, der hæmmer knogleresorption, herunder zoledronsyre (se pkt.
English: Zoledronic acid infusion resulted in an increase in the lumbar spine BMD Z-score least square (LS) mean difference of 0.41 at month 12 relative to baseline compared to placebo (95% CI: 0.02, 0.81;
Danish: Infusion af zoledronsyre resulterede i en stigning i gennemsnitlig lændehvirvelsøjle BMD Z-score least square (LS) på 0,41 efter 12 måneder i forhold til baseline sammenlignet med placebo (95 % CI: 0,02, 0,81; 18 og 16 patienter, henholdsvis).
English: Patients treated with Aclasta should be given the package leaflet and the patient reminder card.
Danish: Patienter i behandling med Aclasta bør få udleveret indlægssedlen og patienthuskekortet.
English: In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Aclasta administration (see section 4.2).
Danish: Yderligere tilrådes det kraftigt hos patienter med Pagets sygdom, at sikre et tilstrækkeligt calciumtilskud svarende til mindst 500 mg calcium to gange daglig i mindst 10 dage efter administration af Aclasta (se pkt.
English: How to store Aclasta
Danish: Sådan får du Aclasta
English: Cases of ONJ have been reported in the post-marketing setting for Aclasta.
Danish: Tilfælde af osteonekrose af kæberne er blevet rapporteret efter markedsføring for Aclasta.
English: In patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Aclasta administration (see section 4.4).
Danish: Det tilrådes kraftigt hos patienter med Pagets sygdom at sikre et tilstrækkeligt calciumtilskud svarende til mindst 500 mg calcium to gange daglig, i mindst 10 dage efter administration af Aclasta (se pkt.
English: In the HORIZON - Pivotal Fracture Trial [PFT] (see section 5.1), 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 Aclasta and placebo, respectively.
Danish: 5.1) 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 Aclasta og placebo.
English: It comes in 100 ml plastic bottles as a ready-to-use solution for infusion.
Danish: Den leveres i plastikflasker med 100 ml infusionsvæske klar til brug.
English: The increases in BMD were significantly greater in the Aclasta-treated group at the lumbar spine and femoral neck at 12 months compared to risedronate (all p<0.03).
Danish: Stigningen i BMD var signifikant større i lænderygsøjlen og lårbenshalsen efter 12 måneder i gruppen behandlet med Aclasta sammenlignet med risedronat (alle p < 0,03).
English: Influenza-like illness, chills, fatigue, asthenia, pain, malaise, infusion site reaction
Danish: Influenzalignende sygdom, kulderystelser, træthed, asteni, smerter, utilpashed, reaktioner på infusionsstedet
English: In the subpopulation of patients receiving glucocorticoids for more than 3 months prior to randomisation, Aclasta increased lumbar spine BMD by 4.06% versus 2.71% for risedronate (mean difference: 1.36% ; p<0.001).
Danish: I undergruppen med patienter, der havde fået glukokortikoider i 3 måneder eller derunder før randomisering, øgede Aclasta lænderygsøjlens BMD med 4,06 % i forhold til 2,71 % for risedronat (middeldifference: 1,36 %; p < 0,001).
English: Atypical subtrochanteric and diaphyseal femoral fractures† (bisphosphonate class adverse reaction)
Danish: Atypiske subtrokantære og diafyseale femurfrakturer† (bisfosfonat klasseeffekt) Meget sjælden Osteonekrose af øregangen (klassebivirkning for bisfosfonater)
English: Aclasta treatment rapidly reduced the rate of bone turnover from elevated post-menopausal levels with the nadir for resorption markers observed at 7 days, and for formation markers at 12 weeks.
Danish: Laveste niveau blev nået for resorptionsmarkørene efter 7 dage og for formationsmarkørene efter 12 uger.
English: The rate of atrial fibrillation serious adverse events was increased in patients receiving Aclasta (1.3%) (51 out of 3,862) compared with patients receiving placebo (0.6%) (22 out of 3,852).
Danish: Frekvensen af atrieflimren som alvorlig utilsigtigt hændelse var øget hos patienter i behandling med Aclasta (1,3 %) (51 ud af 3.862) sammenlignet med patienter som modtog placebo (0,6 %) (22 ud af 3.852) Mekanismen bag den øgede forekomst af atrieflimren er ukendt.
English: In the subpopulation of patients that had received glucocorticoids for 3 months or less prior to randomisation, Aclasta increased lumbar spine BMD by 2.60% versus 0.64% for risedronate (mean difference: 1.96% ; p<0.001).
Danish: I undergruppen med patienter, der havde fået glukokortikoider i mindre end 3 måneder før randomisering, øgede Aclasta BMD i lænderygsøjlen med 2,60 % i forhold til 0,64 % for risedronat (middeldifference: 1,96 %; p > 0,001).
English: 15 minutes (see section 4.2).
Danish: 4.3 og 4.4).
English: All participants received 1,000 to 1,500 mg of elemental calcium plus 800 to 1,200 IU of vitamin D supplementation per day.
Danish: Alle deltagerne modtog dagligt 1.000 til 1.500 mg usammensat calcium plus 800 til 1.200 IE Dvitaminsupplement.
English: What you need to know before you are given Aclasta
Danish: Det skal du vide, før du begynder at blive behandlet med Aclasta
English: Aclasta is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
Danish: Aclasta er kontraindiceret til patienter med kreatininclearance < 35 ml/min (se pkt.
English: Clinical efficacy in osteoporosis associated with long-term systemic glucocorticoid therapy
Danish: Klinisk effekt ved osteoporose i forbindelse med længerevarende systemisk glukokortikoidbehandling
English: Justification for not including braille accepted.
Danish: Fritaget fra krav om brailleskrift.
English: In patients with a recent low-trauma hip fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first Aclasta infusion.
Danish: Det anbefales at give en støddosis D-vitamin på 50.000 til 125.000 IE oralt eller intramuskulært før den første Aclasta-infusion hos patienter med en nylig lavenergi-hoftefraktur.