FrancophonIA/ELRC3.0 huggingface dataset:
English: In a second study including solid tumours other than breast or prostate cancer, zoledronic acid 4 mg significantly reduced the proportion of patients with an SRE, delayed the median time to first SRE by > 2 months, and reduced the skeletal morbidity rate.
Danish: I et andet studie inkluderende andre solide tumorer end bryst- eller prostatacancer, reducerede zoledronsyre 4 mg signifikant andelen af patienter med SRE'er, forsinkede gennemsnitstiden til første SRE med >2 måneder og reducerede den skeletale morbiditets rate.
English: Sudden coldness with fainting, limpness or collapse.
Danish: Pludselig opstået kuldefølelse med besvimelse, slaphed eller kollaps.
English: During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Danish: Patienten skal informeres om at rapportere enhver lår-, hofte- eller lyskesmerte under bisfosfonatbehandlingen, og alle patienter, som fremviser disse symptomer, skal evalueres for en ufuldstændig femurfraktur.
English: The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Danish: Frekvensen af atrieflimren som alvorlig utilsigtigt hændelse var 1,3 % (51 ud af 3.862) og 0,6 % (22 ud af 3.852) hos patienter som fik henholdsvis zoledronsyre 5 mg og placebo.
English: Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Danish: - Usædvanlige brud på lårbensknoglen, primært hos patienter i langtidsbehandling for osteoporose kan forekomme i sjældne tilfælde.
English: Solvent for Zometa Water for injections 5 ml
Danish: Solvens til Zometa Vand til injektionsvæske 5 ml
English: Severe bone, joint and/or muscle pain, occasionally incapacitating.
Danish: - Kraftige knogle-, led- og/eller muskelsmerter, lejlighedsvis invaliderende.
English: Clear and colourless solution
Danish: Klar og farveløs opløsning
English: It also contains mannitol and sodium citrate.
Danish: Indeholder også mannitol og natriumcitrat.
English: Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet (se pkt.
English: Zometa is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Danish: Zometa anbefales ikke til patienter, der før behandlingen initieres, har svær nyreinsufficiens, som i denne population er defineret som CLcr <30 ml/min.
English: Zometa 4 mg/100 ml solution for infusion can be used immediately without further preparation for patients with normal renal function.
Danish: Zometa 4 mg/100 ml infusionsvæske, opløsning kan anvendes straks uden yderligere tilberedning til patienter med normal nyrefunktion.
English: Additional information on handling of Zometa, including guidance on the preparation of reduced doses using the Zometa ready-to-use bottle, is provided in section 4.2.
Danish: Yderligere information om håndtering af Zometa, inklusive vejledning om forberedelse af nedsatte doser ved brug af flasken med Zometa, der er klar til brug, er angivet i pkt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med zoledronsyre i alle undergrupper af den pædiatriske population ved behandling af tumorinduceret hyperkalcæmi (TIH) og forebyggelse af skeletrelaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser (se pkt.
English: The frequencies for each of these identified risks are shown in Table 2.
Danish: Frekvenserne for hver af de identificerede risici er vist i Tabel 2.
English: - Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Danish: - Forebyggelse af skeletrelaterede hændelser (patologiske frakturer, spinal kompression, strålebehandling eller operation af knogler, eller tumorinduceret hyperkalcæmi) hos voksne patienter med fremskreden malign sygdom og knoglemetastaser.
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zometa or after stopping treatment.
Danish: Fortæl det straks til din læge eller tandlæge, hvis du får sådanne symptomer, mens du er i behandling med Zometa eller efter behandlingsophør.
English: Confusion.
Danish: - Forvirring.
English: In clinical trials 69 patients who relapsed or were refractory to initial treatment (zoledronic acid 4 mg, 8 mg or pamidronate 90 mg) were retreated with 8 mg zoledronic acid.
Danish: I kliniske undersøgelser blev 69 patienter, som fik recidiv eller som var uimodtagelig for den indledende behandling (zoledronsyre 4 mg, 8 mg eller pamidronat 90 mg), efterbehandlet med 8 mg zoledronsyre.
English: Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
Danish: Kontakt lægen, hvis du får smerter, svaghed eller ubehag i låret, hoften eller lysken, idet det kan være tidlige tegn på et muligt brud på lårbensknoglen.
English: • To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
Danish: • At forebygge knoglekomplikationer, fx knoglebrud, hos voksne patienter med knoglemetastaser (spredning af kræft fra den primære kræftknude til knoglerne).
English: Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Danish: - Der er i meget sjældne tilfælde set osteonekrose af andre knogler end kæben, særligt af hoften eller låret.
English: Multipack (4x1 bottle)
Danish: Multipakning (4x1 flaske)
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 cancer patients studied.
Danish: Den renale clearance af zoledronsyre korrelerer tydeligt med kreatininclearance, idet den renale clearance er ansvarlig for 7533% af kreatininclearance, hvilket viser en median på 8429 ml/min (varierende fra 22 til 143 ml/min) hos de 64 undersøgte cancerpatienter.
English: - Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Danish: - Cancer, følgesygdomme (fx anæmi, koagulationslidelse, infektion), rygning.
English: Multipack (5x1 bottle)
Danish: Multipakning (5x1 flaske)
English: The multiple event analysis revealed a significant risk reduction of 16% in patients treated with zoledronic acid 4 mg in comparison with patients receiving pamidronate.
Danish: Analysen vedrørende gentagne hændelser afslørede en signifikant risikoreduktion på 16% hos patienter behandlet med zoledronsyre 4 mg sammenlignet med patienter behandlet med pamidronat.
English: Very rare:
Danish: Meget sjælden
English: One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
Danish: En ml koncentrat indeholder 0,8 mg zoledronsyre (som monohydrat).
English: • Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof, andre bisfosfonater eller over for et eller flere af hjælpestofferne anført i pkt.
English: Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
Danish: Det bør overvejes at seponere bisfosfonat hos patienter med mistanke om atypisk femurfraktur, indtil der foreligger en evaluering af patienten, baseret på en individuel benefit/risk-vurdering.
English: Caution is advised when bisphosphonates are administered with aminoglycosides, calcitonin or loop diuretics, since these agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required (see section 4.4).
Danish: Der tilrådes forsigtighed, når bisfosfonater indgives sammen med aminoglykosider, calcitonin eller loop-diuretika, da disse stoffer kan have en additiv effekt og give et lavere serumcalciumniveau i længere perioder end påkrævet (se pkt 4.4).
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as Zometa (see section 4.4).
Danish: Tilfælde af osteonekrose i kæberne er blevet rapporteret, overvejende hos cancerpatienter i behandling med lægemidler, der hæmmer knogleresorption, såsom Zometa (se pkt.
English: Patients treated with Zometa should be given the package leaflet and the patient reminder card.
Danish: Patienter i behandling med Zometa bør få udleveret indlægssedlen og patienthuskekortet.
English: One ampoule of solvent 5 ml
Danish: En ampul med solvens 5 ml
English: Patients whose blood calcium levels are not too high will also be prescribed calcium and vitamin D supplements to be taken each day.
Danish: Patienter, som ikke har for højt calciumindhold i blodet, vil få ordineret dagligt tilskud af calcium og D-vitamin.
English: In a third phase III randomised, double-blind trial, zoledronic acid 4 mg or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
Danish: I et tredje fase III randomiseret, dobbeltblindt studie blev zoledronsyre 4 mg eller pamidronat 90 mg administreret hver 3. til 4. uge sammenlignet hos patienter med multipelt myelom eller brystkræft og mindst én knoglelæsion.
English: Zoledronic acid was teratogenic in the rat at subcutaneous doses  0.2 mg/kg.
Danish: Zoledronsyre var teratogen hos rotter i subkutane doser på 0,2 mg/kg.
English: Remove the following amount of Zometa solution for infusion (ml)
Danish: Udtag følgende mængde af Zometa infusionsvæske, opløsning (ml)
English: Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Danish: - Sig det til lægen, hvis du får øresmerter, udflåd fra øret og/eller betændelse i øret.
English: In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Danish: I et 3-års, randomiseret, dobbeltblindet, kontrolleret studie, som evaluerede effekt og sikkerhed af zolendronsyre 5 mg én gang årligt versus placebo ved behandling af postmenopausal osteoporose (PMO), var den generelle forekomst af atrieflimren 2,5 % (96 ud af 3.862) og 1,9 % (75 ud af 3.852) hos patienter, som fik henholdsvis zoledronsyre 5 mg og placebo.
English: The solvent ampoule contains water for injections.
Danish: Solvensampullen indeholder vand til injektionsvæske.
English: Hypomagnesaemia, hypokalaemia
Danish: Hypomagnesiæmi, hypokaliæmi
English: In a pooled analysis of safety data from Zometa registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to Zometa (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
Danish: I en pooled analyse af sikkerhedsdata fra Zometa-registreringsstudier vedrørende forebyggelse af knogle-relaterede hændelser hos patienter med fremskreden malign sygdom, der involverer knoglerne, var frekvensen af bivirkninger med relation til nedsat nyrefunktion, og som formodes at være relateret til Zometa, følgende: 3,2% ved multipelt myelom, 3,1% ved prostatacancer, 4,3% ved brystcancer og 3,2% ved lunge- og andre solide tumorer.
English: Zoledronic acid works by attaching itself to the bone and slowing down the rate of bone change.
Danish: Zoledronsyre virker ved at binde sig til knoglerne og nedsætte knogleomsætningshastigheden.
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of Zometa and other bisphosphonates as well as use of other nephrotoxic medicinal products.
Danish: Faktorer, der kan øge potentialet for nedsættelse af nyrefunktionen, inkluderer dehydrering, allerede eksisterende nyreinsufficiens, adskillige cyklus af Zometa og andre bisfosfonater så vel som brug af andre nefrotoksiske lægemidler.
English: Serum calcium should be measured and hypocalcaemia must be corrected before initiating Zometa therapy.
Danish: Serumcalcium bør måles og hypokalcæmi korrigeres, inden Zometa-behandling påbegyndes.
English: Powder vial:
Danish: Pulver hætteglas:
English: Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse
Danish: Hypertension, hypotension, atrieflimren, hypotension førende til synkope eller kredsløbssvigt
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer then 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis den ikke anvendes straks, er opbevaringstid og -betingelser før brug brugerens ansvar og bør normalt ikke overstige 24 timer ved 2 °C til 8 °C, medmindre fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: For instructions on the dilution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om fortynding af lægemidlet før administration, se pkt.
English: Instructions for preparing reduced doses of Zometa
Danish: Instruktion i fremstilling af reducerede doser Zometa
English: Zometa is supplied as a unit pack containing one bottle or as multipacks comprising 4 or 5 cartons, each containing 1 bottle.
Danish: Zometa leveres i en enkeltpakning, der indeholder en flaske eller som multipakninger bestående af 4 eller 5 kartoner, der hver indeholder 1 flaske.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om Zometa findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Skin and subcutaneous tissue disorders Uncommon:
Danish: Hud og subkutane væv Ikke almindelig
English: AMPOULE LABEL
Danish: AMPULENS ETIKET
English: Hyperkalaemia, hypernatraemia
Danish: Hyperkaliæmi, hypernatriæmi
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of Zometa or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended.
Danish: Faktorer, der kan øge risikoen for nedsat nyrefunktion, inkluderer dehydrering, allerede eksisterende nyreinsufficiens, flere behandlingscyklusser af Zometa eller andre bisfosfonater så vel som brug af andre nefrotoksiske lægemidler eller brug af en kortere infusionstid end anbefalet på nuværende tidspunkt.
English: This medicinal product must not be allowed to come into contact with any calcium-containing solutions and it must not be mixed or given intravenously with any other medicinal product in the same infusion line.
Danish: Dette lægemiddel må ikke komme i kontakt med nogle opløsninger indeholdende calcium, og det må ikke blandes med eller gives intravenøst med noget andet lægemiddel i samme infusionsslange.
English: Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of a condition called osteonecrosis of the jaw.
Danish: Kontakt straks din læge eller tandlæge, hvis du får nogle problemer med din mund eller tænder, som fx tab af tænder, smerte eller hævelse, eller manglende sårheling eller pus fra såret, da dette kan være tegn på en tilstand kaldet osteonekrose i kæben.
English: Stable for 24 hours at 2C - 8C after further dilution in 100 ml physiological saline or 5% w/v glucose solution.
Danish: Holdbar 24 timer ved 2°C - 8°C efter yderligere fortynding i 100 ml fysiologisk saltvand eller 5% w/v glucoseinjektions-/infusionsvæske.
English: You will be given adequate calcium and vitamin D supplements.
Danish: Du skal have tilstrækkeligt tilskud af calcium og vitamin D.
English: 100 ml solution in a transparent, colourless, plastic (cycloolefinic copolymer) bottle closed with a fluorocarbon polymer coated bromobutyl rubber stopper and an aluminum cap with a flip-off component of polypropylene.
Danish: 100 ml opløsning i en plastikflaske (cykloolefin coplymer), der er gennemsigtig og farveløs og lukket med en brombutyl-gummiprop, der er overtrukket med fluorcarbonpolymer og forsynet med et aluminiumslåg med en aftagelig komponent af polypropylen.
English: Tell your doctor about any of the following side effects as soon as possible:
Danish: Giv lægen besked så hurtigt som muligt, hvis du bemærker en eller flere af nedenstående bivirkninger:
English: Multi-packs containing 10 (10 packs of 1+1) vials and ampoules of water for injections.
Danish: Multipakninger indeholdende 10 (10 pakninger af 1+1) hætteglas og ampuller med vand til injektionsvæsker.
English: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
Danish: Der er rapporteret om atypiske subtrokantære og diafyseale femurfrakturer ved bisfosfonatbehandling, primært hos patienter i langtidsbehandling af osteoporose.
English: Day 4
Danish: 4. dag
English: Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zometa or after stopping treatment.
Danish: Fortæl det straks til din læge, hvis du oplever symptomer så som nyopstået ømhed, smerte eller stivhed, eller en forværring af disse symptomer, mens du er i behandling med Zometa eller efter endt behandling.
English: The type of adverse reactions observed in this population were similar to those previously seen in adults with advanced malignancies involving the bone (see section 4.8).
Danish: Typen af bivirkninger, der blev observeret i denne befolkningsgruppe, var sammenlignelig med tidligere observerede bivirkninger hos voksne med fremskeden malign sygdom, der involverer knoglerne (se pkt.
English: Adjusted dose (mg zoledronic acid in 100 ml)
Danish: Tilpasset dosis (mg zoledronsyre i 100 ml)
English: Each pack contains the vial with powder, together with an ampoule of 5 ml water for injections, which is used to dissolve the powder.
Danish: Hver pakning indeholder hætteglas med pulver sammen med en ampul med 5 ml vand til infusionsvæsker, som skal bruges til at opløse pulveret.
English: Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid.
Danish: Der er rapporteret forværring af nyrefunktion, progression til nyresvigt samt dialyse hos patienter efter initial dosis eller enkeltdosis af 4 mg zoledronsyre.
English: The results demonstrated that zoledronic acid 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Danish: Resultaterne viste, at zoledronsyre 4 mg havde sammenlignelig effekt med 90 mg pamidronat til forebyggelse af skeletrelaterede hændelser (SRE).
English: Clear and colourless solution.
Danish: Klar og farveløs opløsning.
English: Vial: 5-ml plastic vial made of clear, colourless cycloolefine copolymer with fluoropolymer-coated bromobutyl rubber stopper and aluminium cap with plastic flip-off component.
Danish: Hætteglas: 5 ml plastik hætteglas lavet af klart, farveløst cycloolefin copolymer med fluorpolymercoated brombutyl gummiprop og aluminiumslåg med en aftagelig plastik komponent.
English: Patients who have received doses higher than those recommended (see section 4.2) should be carefully monitored, since renal function impairment (including renal failure) and serum electrolyte (including calcium, phosphorus and magnesium) abnormalities have been observed.
Danish: 4.2), bør derfor overvåges nøje, eftersom nedsat nyrefunktion (inklusive nyresvigt) og serum-elektrolyt (inklusive calcium, fosfor og magnesium) forstyrrelser er blevet observeret.
English: Day 7
Danish: 7. dag
English: The dose must be given as a single intravenous infusion over no less than 15 minutes.
Danish: Dosis skal indgives som en enkelt intravenøs infusion over minimum 15 minutter.
English: Dissolution must be complete before the solution is withdrawn.
Danish: Pulveret skal være fuldstændigt opløst, før opløsningen anvendes.
English: Patients should be adequately supplemented with calcium and vitamin D.
Danish: Patienterne skal have tilstrækkeligt tilskud af calcium og vitamin D.
English: One ampoule of solvent 5 ml Four vials 4 mg Four ampoules of solvent 5 ml
Danish: Et hætteglas a 4 mg En ampul med solvens 5 ml Fire hætteglas a 4 mg Fire ampuller med solvens 5 ml
English: Table 1 Preparation of reduced doses of Zometa 4 mg/100 ml solution for infusion
Danish: Tabel 1 Tilberedning af nedsatte doser af Zometa 4 mg/100 ml, infusionsvæske, opløsning
English: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
Danish: Asteni, perifere ødemer, reaktioner ved injektionsstedet (inklusive smerter, irritation, hævelse, induration), brystsmerter, vægtøgning, anafylaktisk reaktion/shock, urticaria
English: The most frequent finding in repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound's pharmacological antiresorptive activity.
Danish: Det mest almindelige resultat ved studier med gentaget indgift var øget primær spongiosa i rørknoglernes metafyser hos voksende dyr ved næsten alle doser.
English: The following adverse reactions, listed in Table 1, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Danish: De følgende bivirkninger, opført i Tabel 1, er samlet fra kliniske forsøg og post-marketing rapporter efter fortrinsvis kronisk behandling med 4 mg zoledronsyre:
English: Other medicines and Zometa Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Zometa Fortæl altid lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: What you need to know before you are given Zometa
Danish: Det skal du vide, før du får Zometa
English: Table 6 Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta
Danish: Tabel 6 Bivirkninger observeret hos pædiatriske patienter med svær osteogenesis imperfecta
English: The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months.
Danish: Ved beslutning om at behandle patienter med knoglemetastaser til forebyggelse af skeletrelaterede hændelser, bør det tages i betragtning at behandlingens effekt først indtræder efter 2-3 måneder.