FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of Zoledronic acid Teva Pharma in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.
Danish: Anvendelse af Zoledronsyre Teva Pharma til patienter med svært nedsat nyrefunktion (kreatininclearance < 35 ml/min) er kontraindiceret grundet en øget risiko for nyresvigt hos denne population.
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 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: For the treatment of Paget's disease, Zoledronic acid Teva Pharma should be prescribed only by physicians with experience in the treatment of Paget's disease of the bone.
Danish: Til behandling af Pagets sygdom bør Zoledronsyre Teva Pharma kun ordineres af læger med erfaring i behandlingen af Pagets sygdom af knoglerne.
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: Cyklisk olefin-polymer (COP) plastikflaske (cykloolefinik polymer) lukket med chlorbutylgummiprop og et aluminium fliplåg med violet flip-off plastskive.
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Zoledronic acid Teva Pharma in patients with concomitant risk factors.
Danish: Et tandeftersyn med forebyggende tandbehandling og en individuel benefit/risk-vurdering anbefales inden behandling med Zoledronsyre Teva Pharma hos patienter med samtidige risikofaktorer.
English: You must not be given Zoledronic acid Teva Pharma 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 Pharma, hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 August 2012
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 16. august 2012 Dato for seneste fornyelse:
English: In both women and men, Zoledronic acid Teva Pharma strengthens the bone and therefore makes it less likely to break.
Danish: Hos både mænd og kvinder styrker Zoledronsyre Teva Pharma knoglerne og mindsker derfor risikoen for brud.
English: - 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
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
English: o Need for adequate calcium and vitamin D supplementation, appropriate physical activity,
Danish: • Behovet for tilstrækkeligt indtag af calcium- og Vitamin D-tilskud, passende fysisk aktivitet,
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Danish: For opbevaringsbetingelser for lægemidlet efter åbning, se pkt.
English: Measurement of serum calcium before infusion of Zoledronic acid Teva Pharma is recommended for patients with Paget´s disease.
Danish: Måling af serum calcium inden infusion med Zoledronsyre Teva Pharma er anbefalet hos patienter med Pagets sygdom.
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: Re-treatment consists of an additional intravenous infusion of 5 mg Zoledronic acid Teva Pharma after an interval of one year or longer from initial treatment in patients who have relapsed.
Danish: Efterbehandling gives som en ekstra intravenøs infusion af 5 mg Zoledronsyre Teva Pharma efter et interval på 1 år eller længere fra den første behandling til patienter, som har tilbagefald.
English: You may eat normally on the day you are treated with Zoledronic acid Teva Pharma.
Danish: Du kan spise normalt den dag, du får behandling med Zoledronsyre Teva Pharma.
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 Teva Pharma (see section 4.8).
Danish: På grund af zoledronsyres hurtige effekt på knogleomsætningen kan der udvikles forbigående hypokalcæmi, til tider symptomatisk og almindeligvis maksimal inden for de første 10 dage efter infusion af Zoledronsyre Teva Pharma (se pkt.
English: • Zoledronic acid Teva Pharma should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5).
Danish: • Zoledronsyre Teva Pharma bør anvendes med forsigtighed, når det anvendes samtidigt med andre lægemidler, som kan påvirke nyrefunktionen (se pkt.
English: Therefore, interactions resulting from displacement of highly protein-bound drugs are unlikely.
Danish: Af denne grund er interaktioner med stærkt proteinbundede stoffer på grund af fortrængning usandsynlig.
English: Zoledronic acid Teva Pharma 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 Pharma må ikke blandes eller gives intravenøst med andre lægemidler og skal gives gennem en separat infusionsslange med en konstant infusionshastighed.
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) lowtrauma hip fracture who were followed for an average of 2 years on study treatment.
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 studiebehandling.
English: If you are under dental treatment or are due to undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Zoledronic acid Teva Pharma.
Danish: Hvis du er i gang med tandbehandling eller skal gennemgå kæbekirurgi (fx en tandudtrækning), skal du fortælle din læge om din tandbehandling, og fortælle din tandlæge, at du er i behandling med Zoledronsyre Teva Pharma.
English: For osteoporosis, Zoledronic acid Teva Pharma works for one year.
Danish: For osteoporose virker Zoledronsyre Teva Pharma i 1 år.
English: In the trial for the prevention of clinical fractures following a recent hip fracture, vitamin D levels were not routinely measured but the majority of patients received a loading dose of vitamin D prior to zoledronic acid administration (see section 4.2).
Danish: I forebyggelsesstudiet for kliniske frakturer efter en nylig hoftefraktur blev D-vitamin niveauet ikke målt rutinemæssigt, men flertallet af patienter modtog en støddosis D-vitamin forud for administrationen af zolidronsyre (se pkt.
English: oesophagitis, toothache, gastritis#
Danish: øsofagit, tandpine, gastrit#
English: The recommended dose is a single intravenous infusion of 5 mg Zoledronic acid Teva Pharma.
Danish: Den anbefalede dosis er en enkelt intravenøs infusion af 5 mg Zoledronsyre Teva Pharma.
English: Talk to your doctor, pharmacist or nurse before you are given Zoledronic acid Teva Pharma: - if you are being treated with any medicine containing zoledronic acid, which is also the active substance of Zoledronic acid Teva Pharma (zoledronic acid is used in adult patients with certain types of cancer to prevent bone complications or to reduce the amount of calcium).
Danish: Før du får Zoledronsyre Teva Pharma, skal du fortælle det til lægen, apoteket eller sundhedspersonalet: - hvis du er i behandling med anden medicin, der også indeholder zoledronsyre, der er det samme aktive stof i Zoledronsyre Teva Pharma (zoledronsyre bruges til voksne patienter med visse kræftformer for at forebygge knoglekomplikationer eller for at nedsætte mængden af calcium).
English: Your doctor, pharmacist or nurse knows how to store Zoledronic acid Teva Pharma properly.
Danish: Lægen, apoteket eller sygeplejersken ved, hvordan Zoledronsyre Teva Pharma skal opbevares korrekt.
English: Patients must be appropriately hydrated prior to administration of Zoledronic acid Teva Pharma.
Danish: Patienter skal være passende hydreret før administration af Zoledronsyre Teva Pharma.
English: The hip fracture event rate was 1.44% for zoledronic acidtreated patients compared to 2.49% for placebo-treated patients.
Danish: Hændelsesraten for hoftefrakturer var 1,44 % for patienter behandlet med zoledronsyre sammenlignet med 2,49 % for patienter behandlet med placebo.
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 sundhedspersonalet.
English: In case you recently broke your hip, it is recommended that Zoledronic acid Teva Pharma is administered two or more weeks after your hip repair surgery.
Danish: Hvis du for nylig har brækket din hofte, anbefales det at zoledronsyre gives i to eller flere uger efter din hofteoperation.
English: • Contraindication in pregnancy and in breast-feeding women
Danish: • Kontraindikationer hos gravide og ammende kvinder
English: Hypocalcaemia* Uncommon Decreased appetite
Danish: Ikke almindelig Nedsat appetit
English: Your doctor will advise you and decide how long you should be treated with Zoledronic acid Teva Pharma.
Danish: Din læge vil vejlede dig og beslutte, hvor længe du skal behandles med Zoledronsyre Teva Pharma.
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: • 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 fraktur, inklusive personer med en nylig lavenergi-hoftefraktur.
English: Zoledronic acid Teva Pharma 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 Pharma 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: 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 Pharma.
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 Pharma.
English: It comes in a polyolefin/styreneethylene-butylene (SEB) foil bag with a foil over pouch.
Danish: Den leveres i en foliepose af polyolefin/styrenethylen-butylen (SEB) i en folieyderpose.
English: • Need to infuse Zoledronic acid Teva Pharma slowly over a period of no less than 15 minutes
Danish: • Nødvendigheden af at infusere Zoledronsyre Teva Pharma langsomt over en periode på mindst
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid 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 referenceproduktet indeholdende zoledronsyre 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: Zoledronic acid Teva Pharma is supplied in multipacks of 5 (5 x 1) or 10 (10 x 1) bags .
Danish: Zoledronsyre Teva Pharma leveres i multipakninger bestående af 5 (5 x 1) eller 10 (10 x 1) poser.
English: This will help prevent dehydration.
Danish: Det vil hjælpe dig med at undgå væsketab.
English: Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given Zoledronic acid Teva Pharma.
Danish: Følg nøje alle lægens, farmaceutens eller sundhedspersonalets instruktioner, før du anvender Zoledronsyre Teva Pharma.
English: Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with Zoledronic acid Teva Pharma (see section 4.3).
Danish: Eksisterende hypokalcæmi skal behandles med tilstrækkelig indgivelse af calcium og D-vitamin, før behandling med Zoledronsyre Teva Pharma initieres (se pkt.
English: Before receiving Zoledronic acid Teva Pharma 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
Danish: Før du får Zoledron Teva Pharma-behandling, skal du fortælle din læge, farmaceut eller sundhedspersonale, hvis - du har nogle problemer med din mund eller tænder, som fx dårlig mundhygiejne,
English: Caution is indicated when Zoledronic acid Teva Pharma is administered in conjunction with medicinal products that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration) (see section 4.4).
Danish: Forsigtighed tilrådes når Zoledronsyre Teva Pharma administreres samtidig med lægemidler, der har en signifikant indvirkning på nyrefunktionen (fx aminoglykosider eller diuretika, som kan forårsage dehydrering) (se pkt.
English: The rate of atrial fibrillation serious adverse events was increased in patients receiving zoledronic acid (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 zoledronsyre (1,3 %) (51 ud af 3.862) sammenlignet med patienter som modtog placebo (0,6 %) (22 ud af 3.852).
English: • Contraindication in patients with creatinine clearance < 35 ml/min
Danish: Kontraindikationer hos patienter med kreatininclearance <35 ml/min
English: Zoledronic acid Teva Pharma is supplied in packs of 1 bottle and multipacks of 5 (5 x 1) or 10 (10 x 1) bottles.
Danish: Zoledronsyre Teva Pharma leveres i pakninger bestående af 1 flaske og multipakninger bestående af 5 (5 x 1) eller 10 (10 x 1) flasker.
English: Multilayer polyolefin/styrene-ethylene-butylene (SEB) bag with SFC polypropylene infusion port closed with rubber stopper and snap cap.
Danish: Flerlagspose af polyolefin/styren-ethylen-butylen (SEB) med SFC polypropyleninfusionsport lukket med gummiprop og låg.
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: Zoledronic acid Teva Pharma is contraindicated during pregnancy (see section 4.3).
Danish: Zoledronsyre Teva Pharma er kontraindiceret under graviditet (se pkt.
English: After opening: 24 hours at 2°C - 8°C
Danish: Efter åbning: 24 timer ved 2°C-8°C.
English: You can also report side effects directly the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Excipients: Mannitol, sodium citrate and water for injections.
Danish: Hjælpestoffer: Mannitol, natriumcitrat og vand til injektionsvæsker.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodium-free.”
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. 100 ml, dvs. det er i det væsentlige natriumfrit.
English: Zoledronic acid Teva Pharma is administered via a vented infusion line and given slowly at a constant infusion rate.
Danish: Zoledronsyre Teva Pharma administreres via en separat infusionsslange og ved en langsom konstant infusionshastighed.
English: Zoledronic acid Teva Pharma must not be allowed to come into contact with any calcium-containing solutions.
Danish: Zoledronsyre Teva Pharma må ikke komme i kontakt med calciumholdige opløsninger.
English: Your doctor may ask you to undergo a dental examination before you start treatment with Zoledronic acid Teva Pharma.
Danish: Din læge vil måske bede dig om at få et tandeftersyn, før du starter behandling med Zoledronsyre Teva Pharma.
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 Teva Pharma, 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 Teva Pharma, som anvist af sundhedspersonalet.
English: Zoledronic acid (N=3,875) event rate
Danish: Zoledronsy re (N=3.875) hændelsesrate (%)
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, doubleblind, 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: Netherlands
Danish: Nederland
English: Table 4 Between treatment comparisons of the incidence of key clinical fracture variables Outcome
Danish: Tabel 4 Sammenligninger mellem behandlinger af incidensen af vigtige kliniske
English: The chance of experiencing these side effects decreases with subsequent doses of Zoledronic acid Teva Pharma.
Danish: Risikoen for at få disse bivirkninger aftager ved de efterfølgende doser Zoledronsyre Teva Pharma.
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 såretfølelsesløshed eller en følelse af tunghed i kæben, eller løsnen af en tand; dette kan være tegn på knogleskade i kæben (osteonekrose).
English: The Marketing Authorisation Holder (MAH) shall provide an educational programme targeting all physicians who are expected to prescribe/use Zoledronic acid Teva Pharma for the treatment of osteoporosis prior to the launch in Member States.
Danish: Før markedsføring i medlemsstaterne skal indehaveren af markedsføringstilladelsen (MAH) skal sørge for et uddannelsesprogram, der er udarbejdet til alle læger, der forventes at udskrive/anvende Zoledronsyre Teva Pharma til behandling af osteoporose.
English: Zoledronic acid Teva Pharma contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodium-free.”
Danish: Zoledronsyre Teva Pharma indeholder natrium Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. 100 ml, det vil sige er praktisk taget "natriumfrit".
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
English: Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic acid Teva Pharma.
Danish: Din læge bør tage en blodprøve for at kontrollere din nyrefunktion (kreatininniveau) før hver Zoledronsyre Teva Pharma-dosis.
English: In patients with a recent low-trauma hip fracture, it is recommended to give the zoledronic acid 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 Zoledronsyre Teva Pharma-infusion mindst to uger efter hoftefrakturhelingen (se pkt.
English: Your doctor should do a blood test to check your kidney function before each dose of Zoledronic acid Teva Pharma.
Danish: Din læge bør tage en blodprøve for at kontrollere din nyrefunktion før hver Zoledronsyre Teva Pharma-dosis.
English: Zoledronic acid Teva Pharma contains the active substance zoledronic acid.
Danish: Zoledronsyre Teva Pharma indeholder det aktive stof zoledronsyre.
English: Patients treated with Zoledronic acid Teva Pharma should be given the package leaflet and the patient reminder card.
Danish: Patienter i behandling med Zoledronsyre Teva Pharma bør få udleveret indlægssedlen og patienthuskekortet.