FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients being treated with Zoledronic Acid Hospira should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Danish: Patiener, der behandles med Zoledronsyre Hospira bør ikke behandles med disse produkter eller andre bisfosfanat produkter samtidigt, da den kombinerede virkning af disse stoffer er ukendte.
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, non-healing of sores or discharge during treatment with zoledronic acid.
Danish: Alle patienter bør opfordres til at opretholde en god mundhygiejne, gennemgå rutinemæssige tandeftersyn og straks rapportere eventuelle orale symptomer såsom tandmobilitet, smerter eller hævelse, vedvarende sår eller sekretion under behandling med zoledronsyre.
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 (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlæggeresultaterne af studier med referencelægemidlet indeholdende zoledronsyre i alle undergrupper af den pædiatriske population for Pagets knoglesygdom (se pkt.
English: After initiation of the zoledronic acid infusion, plasma concentrations of the active substance increased rapidly, achieving their peak at the end of the infusion period, followed by a rapid decline to < 10% of peak after 4 hours and < 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak levels.
Danish: Efter påbegyndelse af infusion med zoledronsyre, øges plasmakoncentrationen af den aktive substans hurtigt, og maksimal koncentration nås ved slutningen af infusionsperioden, efterfulgt af et hurtigt fald til < 10% af maksimalkoncentrationen efter 4 timer og < 1% af maksimalkoncentrationen efter 24 timer, med en efterfølgende forlænget periode med meget lave koncentrationer der ikke overstiger 0,1% af den maksimale koncentration.
English: The 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: Patients must be maintained well hydrated prior to and following administration of Zoledronic Acid Hospira.
Danish: Patienter skal holdes velhydrerede før og efter administration af Zoledronsyre Hospira.
English: Dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea
Danish: Ikke kendt** Dehydrering sekundært til symptomer som feber, opkastning og diarré efter behandlingen.
English: − To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Hospira concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Danish: - Når du skal tilberede en infusionsvæske indeholdende 4 mg zoledronsyre, skal du opløse Zoledronsyre Hospira koncentratet (5,0 ml) yderligere med 100 ml calciumfri eller anden infusionsvæske uden indhold af divalente kationer.
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with zoledronic acid.
Danish: Alle patienter bør opfordres til at opretholde en god mundhygiejne, gennemgå rutinemæssige tandeftersyn og straks rapportere eventuelle orale symptomer såsom tandmobilitet, smerter eller hævelse eller vedvarende sår eller sekretion under behandling med zoledronsyre.
English: This medicinal product must not be allowed to come into contact with any calcium-containing solutions.
Danish: Dette lægemiddel må ikke komme i kontakt med calcium-holdige opløsninger.
English: Before receiving Zoledronic Acid Hospira, 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: − Blurred vision, tearing of the eye, eye sensitivity to light.
Danish: - Sløret syn, tåreflåd, lysfølsomhed i øjnene.
English: Longer-term repeat administration at cumulative exposures sufficiently exceeding the maximum intended human exposure produced toxicological effects in other organs, including the gastrointestinal tract and liver, and at the site of intravenous administration.
Danish: Længerevarende gentaget administration, som gav tilstrækkelig kumulativ højere eksponering end maksimal dosis beregnet til human terapi, viste toksikologiske effekter på andre organer, inklusiv mavetarmkanalen og lever, og på det intravenøse injektionssted.
English: * Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Danish: *Dosis er beregnet ud fra forudsætning om et mål-AUC på 0,66 (mg•t/l) (CLcr = 75 ml/min).
English: This medicine contains 16 mmol (or 360 mg) sodium per dose.
Danish: Dette lægemiddel indeholder mindre end 16 mmol (eller 360 mg) natrium per dosis.
English: This resulted in exaggerated pharmacological effects considered related to the compound's inhibition of skeletal calcium mobilisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
Danish: Dette resulterede i unormalt store farmakologiske effekter, som blev vurderet til at være relateret til lægemidlets hæmning af mobiliseringen af calcium i knoglerne, hvilket resulterede i periparturient hypokalcæmi, en klasseeffekt for bisfosfonater, dystocia og afslutning af studiet før tid.
English: The adverse reactions ranked under headings of frequency, are presented in Table 7.
Danish: Bivirkningerne, der er ordnet efter hyppighed, er præsenteret i tabel 7.
English: Atypical subtrochanteric and diaphyseal femoral fractures† (bisphosphonate class adverse reaction)
Danish: Sjælden Atypiske subtrokantære og diafyseale femurfrakturer† (bifosfonat klasseeffekt)
English: Follow carefully all instructions given to you by your doctor or nurse.
Danish: Følg nøje alle instruktioner, du får af lægen eller sygeplejersken.
English: Following initiation of therapy, serum creatinine should be measured prior to each dose of Zoledronic Acid Hospira and treatment should be withheld if renal function has deteriorated.
Danish: Efter påbegyndelse af behandling bør serum-kreatinin måles før hver dosis af Zoledronsyre Hospira, og behandlingen bør tilbageholdes, hvis nyrefunktionen forværres.
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 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 fremlæggelse af resultaterne af studier med referencelægemidlet indeholdende zoledronsyre hos 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 total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race or body weight.
Danish: Total legemsclearance er 5,04 ± 2,5 l/h uafhængigt af dosis og uanset køn, alder, race og legemsvægt.
English: Aseptic techniques must be followed during the preparation of the infusion.
Danish: Der skal anvendes aseptiske teknikker under fremstilling af infusionen.
English: In the pooled results, a similar decrease in pain severity and pain interference scores relative to baseline were observed over 6 months for zoledronic acid and risedronate.
Danish: I de poolede resultater blev der for zoledronsyre og risedronat observeret lignende nedsættelse i sværhedsgraden af smerte og score for smerteinterferens relativt i forhold til baseline i løbet af 6 måneder.
English: − Zoledronic Acid Hospira must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Danish: - Zoledronsyre Hospira må kun gives af sundhedspersonale, som er trænet til at indgive bisfosfonater intravenøst, dvs. gennem en blodåre.
English: † Identified in post-marketing experience.
Danish: † Set efter markedsføring.
English: In patients with normal renal function, defined as CLcr > 60 ml/min, zoledronic acid 4 mg/100 ml solution for infusion must not be further diluted.
Danish: Hos patienter med normal nyrefunktion, defineret som CLcr >60 ml/min, må zoledronsyre 4 mg/100 ml infusionsvæske, opløsning ikke blive yderligere fortyndet.
English: For patients with normal renal function (defined as CLcr > 60 ml/min), zoledronic acid 4 mg/100 ml solution for infusion may be administered directly without any further preparation.
Danish: For patienter med normal nyrefunktion (defineret som CLcr >60 ml/min), kan zoledronsyre 4 mg/100 ml infusionsvæske, opløsning indgives direkte uden nogen yderligere forberedelse.
English: Zoledronic Acid Hospira contains the active substance zoledronic acid.
Danish: Zoledronsyre Hospira indeholder det aktive stof zoledronsyre.
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 zoledronic acid 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 zoledronsyre (se pkt.
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: Dilute before use
Danish: Skal fortyndes før brug.
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: For information on the infusion of Zoledronic Acid Hospira, see section 6.6.
Danish: For information angående infusion af Zoledronsyre Hospira se pkt.
English: Flu, upper respiratory tract infections, decreased red cell count, loss of appetite, sleeplessness, sleepiness which may include reduced alertness and awareness, tingling sensation or numbness, extreme tiredness, trembling, temporary loss of consciousness, eye infection or irritation or inflammation with pain and redness, spinning sensation, increased blood pressure, flushing, cough, shortness of breath, upset stomach, abdominal pain, constipation, dry mouth, heartburn, skin rash, excessive sweating, itching, skin reddening, neck pain, stiffness in muscles, bones and/or joints, joint swelling, muscle spasms, shoulder pain, pain in your chest muscles and rib cage, joint inflammation, muscular weakness, abnormal kidney test results, abnormal frequent urination, swelling of hands, ankles or feet, thirst, toothache, taste disturbances.
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 patienter) Influenza, øvre luftvejsinfektioner, nedsat antal røde blodlegemer, appetitløshed, søvnløshed, søvnighed, hvilket kan medføre nedsat opmærksomhed, prikkende følelse eller følelsesløshed, ekstrem træthed, rysten, midlertidig tab af bevidsthed, øjeninfektion eller irritation eller betændelse med smerter og rødme, følelse af snurren, forhøjet blodtryk, rødme, hoste, åndenød, maveproblemer, mavesmerter, forstoppelse, mundtørhed, halsbrand, hududslæt, voldsom svedtendens, kløe, rødmen af huden, smerter i nakken, stivhed i muskler, knogler og/eller led, hævede led, muskelkramper, skuldersmerter, smerter i brystmuskler og brystkasse, betændelse i led, muskelsvaghed, unormal nyrefunktionstest, hyppig vandladning, hævede hænder, ankler eller fødder, tørst, tandpine, smagsforstyrrelser.
English: Zoledronic acid treatment should be resumed at the same dose as that given prior to treatment interruption.
Danish: Zoledronsyre behandling bør genoptages med samme dosis som givet før afbrydelse af behandlingen.
English: Severe and occasionally incapacitating bone, joint and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including zoledronic acid (see section 4.8).
Danish: Alvorlig og til tider inhabiliterende knogle-, led- og/eller muskelsmerter er sjældent blevet rapporteret hos patienter behandlet med bisfosfonater, herunder zoledronsyre (se pkt.
English: The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established.
Danish: Zoledronsyres sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
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 than 24 hours at 2°C - 8°C.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -betingelser, før brug brugerens ansvar og bør normalt ikke overstige 24 timer ved 2°C - 8°C.
English: Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone.
Danish: Zoledronsyre tilhører gruppen af nitrogenholdige bisfosfonater og virker primært på knoglerne.
English: Common (may affect up to 1 in 10 people):− Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 patienter): - Hovedpine og influenzalignende symptomer som feber, træthed, svaghed, døsighed, kulderystelser samt knogle-, led- og/eller muskelsmerter.
English: Nervous system disorders Common:
Danish: Nervesystemet Almindelig:
English: - Any other medicines that contain zoledronic acid which is used to treat osteoporosis and other noncancer diseases of the bone, or any other bisphosphonate, since the combined effects of these medicines taken together with Zoledronic Acid Hospira are unknown.
Danish: - Anden medicin, der indeholder zoledronsyre, som anvendes til at behandle osteoporose eller andre sygdomme i knoglerne som ikke skyldes kræft, eller et andet bisfosfonat, da den kombinerede effekt af at tage disse lægemidler sammen med Zoledronsyre Hospira er ukendt.
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 overvåges nøje, eftersom nedsat nyrefunktion (inklusiv nyresvigt) og serum-elektrolyt (inklusive calcium, fosfor og magnesium) forstyrrelser er blevet observeret.
English: Zoledronic Acid Hospira (5 mg in 100 ml ready-to-infuse solution) is administered via an infusion line and given at a constant infusion rate.
Danish: Zoledronsyre (5 mg i 100 ml infusionsklar opløsning) administreres via en infusionsslange og ved en konstant infusionshastighed.
English: Caution is indicated when zoledronic acid 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 administreres samtidig med lægemidler, der har en signifikant indvirkning på nyrefunktionen (f.eks. aminoglykosider eller diuretika, som kan forårsage dehydrering) (se pkt.
English: The adverse reactions ranked under headings of frequency, are presented in Table 6.
Danish: Bivirkningerne, der er ordnet efter hyppighed, er præsenteret i tabel 6.
English: Zoledronic acid is not recommended in women of childbearing potential.
Danish: Zoledronsyre anbefales ikke til kvinder i den fertile alder.
English: Your doctor may ask you to undergo a dental examination before you start treatment with Zoledronic Acid Hospira.
Danish: Din læge vil måske bede dig om at få et tandeftersyn, før du starter behandling med Zoledronsyre Hospira.
English: Zoledronic Acid Hospira should be given as a single intravenous infusion in no less than 15 minutes.
Danish: Zoledronsyre Hospira skal indgives som en enkelt intravenøs infusion over minimum 15 minutter.
English: Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects)
Danish: 4.4 og 4.8 klasseeffekter)
English: Following initiation of therapy, serum creatinine should be measured prior to each dose of zoledronic acid and treatment should be withheld if renal function has deteriorated.
Danish: Efter påbegyndelse af behandling bør serum-kreatinin måles før hver dosis zoledronsyre, og behandlingen bør tilbageholdes, hvis nyrefunktionen forværres.
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: Pam 90 mg zoledronic acid
Danish: Pam 90 mg Zoledronsyre 4 mg
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, f.eks. knoglebrud, hos voksne patienter med knoglemetastaser (spredning af kræft fra den primære kræftknude til knoglerne).
English: Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic Acid Hospira 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 Zoledronsyre Hospira eller efter endt behandling.
English: − Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
Danish: - Mave-tarm-symptomer såsom kvalme og opkastning samt appetitløshed.
English: After dilution: From a microbiological point of view, the diluted solution for infusion should be used immediately.
Danish: Efter opløsning: Ud fra et mikrobiologisk synspunkt skal den fortyndede opløsning til infusion anvendes straks.
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 Zoledronic Acid Hospira 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 Zoledronsyre Hospira (se pkt.
English: Table 7: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta Nervous system disorders
Danish: Tabel 7: Bivirkninger observeret hos pædiatriske patienter med svær osteogenesis imperfecta Nervesystemet Almindelig:
English: The use of Zoledronic Acid Hospira 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 Hospira til patienter med svært nedsat nyrefunktion (kreatinin clearance < 35 ml/min) er kontraindiceret grundet en øget risiko for nyresvigt hos denne population.
English: - Pregnancy and breast-feeding (see section 4.6).
Danish: - Graviditet og amning (se pkt.
English: Zoledronic Acid Hospira treatment should be resumed at the same dose as that given prior to treatment interruption.
Danish: Behandling med Zoledronsyre Hospira bør genoptages med den samme dosis som blev givet før afbrydelse af behandlingen.
English: Solution for infusion 1 intravenous bag
Danish: Infusionsvæske, opløsning 1 intravenøs pose
English: − if you are allergic (hypersensitive) to zoledronic acid, another bisphosphonate (the group of substances to which zoledronic acid belongs), or any of the other ingredients of Zoledronic Acid Hospira (listed in section 6).
Danish: - hvis du er allergisk over for zoledronsyre, et andet bisfosfonat (den gruppe af stoffer, som zoledronsyre tilhører) eller et af de øvrige indholdsstoffer i Zoledronsyre Hospira (angivet i pkt.
English: Zoledronic Acid Hospira must not be mixed or given intravenously with any other medicinal product and must be given through a separate infusion line at a constant infusion rate.
Danish: Zoledronsyre Hospira må ikke blandes eller gives intravenøst med andre lægemidler og skal gives gennem en separat infusionsslange med en konstant infusionshastighed.
English: Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic Acid Hospira.
Danish: Din læge bør tage en blodprøve for at kontrollere din nyrefunktion (kreatininniveau) før hver dosis Zoledronsyre Hospira.
English: The hydration status of patients must be assessed prior to and following administration of zoledronic acid to ensure that they are adequately hydrated.
Danish: Patienternes hydreringsstatus skal vurderes før og efter indgivelsen af zoledronsyre for at sikre, at de er tilstrækkeligt hydrerede.
English: Zoledronic Acid Recommended Dose* 4.0 mg zoledronic acid
Danish: Anbefalet dosis zoledronsyre* 4,0 mg zoledronsyre
English: The use of zoledronic acid 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 til patienter med svært nedsat nyrefunktion (kreatinin clearance < 35 ml/min) er kontraindiceret grundet en øget risiko for nyresvigt hos denne population.
English: Adjusted dose (mg zoledronic acid) *
Danish: Tilpasset dosis (mg zoledronsyre) *
English: The most frequent finding in the 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: Zoledronic Acid
Danish: Zoledronsyre
English: Your doctor should do a blood test to check your kidney function before each dose of Zoledronic Acid Hospira.
Danish: Din læge bør tage en blodprøve for at kontrollere din nyrefunktion før hver dosis Zoledronsyre Hospira.