FrancophonIA/ELRC3.0 huggingface dataset:
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: EXP Shelf life after dilution: See leaflet.
Danish: EXP Holdbarhed efter fortynding: Se indlægsseddel.
English: Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
Danish: Ikke almindelig (kan påvirke op til 1 ud af 100 patienter): - Overfølsomhedsreaktioner.
English: Zoledronic acid Actavis contains sodium
Danish: Zoledronsyre Actavis indeholder natrium
English: - if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
Danish: − hvis du har eller har haft smerte, hævelse eller fornemmelse af følelsesløshed i kæben,
English: Clinical studies in tumour-induced hypercalcaemia (TIH) demonstrated that the effect of zoledronic acid is characterised by decreases in serum calcium and urinary calcium excretion.
Danish: Resultater fra kliniske undersøgelser vedrørende behandling af TIH Kliniske studier af tumorinduceret hypercalcæmi (TIH) viser, at effekten af zoledronsyre er karakteriseret ved fald i serumcalcium og urinudskillelse af calcium.
English: - The active substance is zoledronic acid.
Danish: − Aktivt stof: Zoledronsyre.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, hvis du bruger anden medicin, har brugt det eller tror du har brugt det for nylig.
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: - For storage conditions of Zoledronic acid Actavis after dilution, see “Shelf life after dilution”
Danish: Opvearingsbetingelser for Zoledronsyre Actavis efter fortynding, se ”Holdbarhed efter fortynding” ovenfor.
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 Actavis 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 Actavis eller efter endt behandling.
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid 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 potentialet for nedsættelse af nyrefunktionen, inkluderer dehydrering, allerede eksisterende nyreinsufficiens, flere behandlingscyklusser af zoledronsyre eller andre bisfosfonater så vel som brug af andre nefrotoksiske lægemidler eller brug af en kortere infusionstid end anbefalet på nuværende tidspunkt.
English: Muscle spasms, osteonecrosis of the jaw Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Danish: Muskelspasmer, osteonekrose af kæberne Osteonekrose af øregangen (klasse-bivirkning for bisfosfonater) og andre anatomiske steder, inklusive femur og hofte.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) .
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé, pkt.
English: The hydration status of patients must be assessed prior to and following administration of Zoledronic acid Actavis to ensure that they are adequately hydrated.
Danish: Patienternes hydreringsstatus skal vurderes før og efter indgivelsen af Zoledronsyre Actavis for at sikre, at de er tilstrækkeligt hydrerede.
English: You should not be given Zoledronic acid Actavis:
Danish: Du må ikke få Zoledronsyre Actavis:
English: Zoledronic acid 4 mg was also studied in a double-blind, randomised, placebo-controlled trial in 228 patients with documented bone metastases from breast cancer to evaluate the effect of 4 mg zoledronic acid on the skeletal related event (SRE) rate ratio, calculated as the total number of SRE
Danish: Zoledronsyre 4 mg blev også undersøgt i et dobbeltblindt, randomiseret, placebokontrolleret studie i 228 patienter med dokumenterede knoglemetastaser fra brystkræft, for at evaluere effekten af 4 mg zoledronsyre på skeletrelaterede hændelser (SRE) forekomsts-ratio beregnet som det totale antal af SRE hændelser (eksklusiv hypercalcæmi og justeret for tidligere frakturer) delt med den totale risikoperiode.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR VIALS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKER TIL HÆTTEGLAS
English: The results demonstrated that 4 mg zoledronic acid showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Danish: Resultaterne viste, at 4 mg zoledronsyre havde sammenlignelig effekt med 90 mg pamidronat til forebyggelse af skeletrelaterede hændelser (SRE).
English: - Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) - Flu-like symptoms including arthritis and joint swelling.
Danish: - Interstitiel lungesygdom (inflammation i vævet omkring lungernes alveoler) - Influenza-lignende symptomer herunder gigt (artritis) og hævede led.
English: - To prepare an infusion solution containing 4 mg Zoledronic acid Actavis, further dilute the Zoledronic acid Actavis 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 Actavis, skal du opløse Zoledronsyre Actavis koncentratet (5,0 ml) yderligere med 100 ml calciumfri eller anden infusionsvæske uden indhold af divalente kationer.
English: In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients that were given zoledronic acid as indicated in sections 4.1 and 4.2.
Danish: Ved erfaring efter markedsføring er der rapporteret om alvorlige og lejlighedsvis invaliderende knogle-, led-, og/eller muskelsmerter hos patienter, der modtog zoledronsyre efter anvisningerne under pkt.
English: Very rare (may affect up to 1 in 10,000 people): - As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Danish: Meget sjælden (forekommer hos op til 1 ud af 10.000 patienter): - Som en konsekvens af lave calcium-værdier: anfald, følelsesløshed og tetani (sekundære symptomer på hypokalcæmi).
English: You should not be given Zoledronic acid Actavis if you are pregnant.
Danish: Du bør ikke få Zoledronsyre Actavis, hvis du er gravid.
English: In clinical studies, zoledronic acid, used as indicated in sections 4.1 and 4.2, has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Danish: 4.1 og 4.2, indgivet samtidig med almindeligt anvendte anticancerlægemidler, diuretika, antibiotika og analgesika uden tilsyneladende kliniske interaktioner.
English: One vial contains 5 ml of solution.
Danish: Et hætteglas indeholder 5 ml opløsning.
English: Patients treated with Zoledronic acid Actavis should be given the package leaflet and the patient reminder card.
Danish: Patienter i behandling med Zoledronsyre Actavis bør få udleveret indlægssedlen og patienthuskekortet.
English: Uncommon (may affect up to 1 in 100 people): - Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Danish: Ikke almindelig (kan påvirke op til 1 ud af 100 patienter): - Smerter i munden, tænder og/eller kæberne, hævelse eller ikke helende sår inde i munden eller,
English: Contents of the pack and other information What Zoledronic acid Actavis contains
Danish: Pakningstørrelser og yderligere oplysninger Zoledronsyre Actavis indeholder
English: What you need to know before you are given Zoledronic acid Actavis
Danish: Det skal du vide, før du får Zoledronsyre Actavis
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
Danish: Osteonekrose af kæberne (ONK) er blevet rapporteret med frekvensen ”ikke almindelig” i kliniske forsøg og efter markedsføring hos patienter behandlet med zoledronsyre.
English: 1Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid as indicated in sections 4.1 and 4.2 (see section 4.8)
Danish: 1Bivirkninger med frekvenser < 5% blev vurderet medicinsk, og det blev vist, at de er i overensstemmelse med den veletablerede sikkerhedsprofil for zoledronsyre som indikeret under pkt.
English: In clinical trials with zoledronic acid, patients with serum creatinine > 265 micromol/l or > 3.0 mg/dl were excluded.
Danish: I kliniske forsøg med zoledronsyre blev patienter med serum-kreatinin > 265 mikromol/l eller > 3,0 mg/dl ekskluderet.
English: Prior to administration, 5 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution or 5% w/v glucose solution).
Danish: Før administration skal 5 ml koncentrat fra et hætteglas eller det påkrævede udtagende volumen af koncentratet fortyndes yderligere med 100 ml calciumfri infusionsvæske (0,9% w/v natriumklorideller 5% w/v glukoseopløsning).
English: This adverse drug reaction consists of a constellation of symptoms that includes fever, myalgia, headache, extremity pain, nausea, vomiting, diarrhoea, arthralgia and arthritis with subsequent joint swelling.
Danish: Denne bivirkning består af en række symptomer der inkluderer feber, myalgi, hovedpine, smerter i arme og ben, kvalme, opkastning, diarré, artralgi og artritis med efterfølgende hævede led .
English: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria Arthritis and joint swelling as a symptom of acute phase reaction
Danish: Asteni, perifere ødemer, reaktioner ved injektionsstedet (inklusive smerter, irritation, hævelse, induration), brystsmerter, vægtøgning, anafylaktisk reaktion/shock, urticaria
English: - Do not use Zoledronic acid Actavis after the expiry date stated on the vial and carton after EXP. - This medicinal product does not require any specific storage conditions.
Danish: − Brug ikke Zoledronsyre Actavis efter den udløbsdato, der står på hætteglasset og pakningen, efter EXP.
English: Rare (may affect up to 1 in 1,000 people): - As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Danish: Sjælden (kan påvirke op til 1 ud 1000 patienter): - Som en konsekvens af lave calcium-værdier: uregelmæssig hjerterytme (hjertearytmi;
English: Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Danish: Sjælden (kan påvirke op til 1 ud 1000 patienter): - Langsom hjerterytme.
English: - The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Danish: − Opløsningen indeholdende zoledronsyre indgives ved en enkelt intravenøs infusion over 15 minutter i en seperat infusionsslange.
English: After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and at 25°C after dilution in 100 ml 0.9% w/v sodium chloride solution or 100 ml 5% w/v glucose.
Danish: Efter fortynding: Den kemiske og fysiske stabilitet under brug er undersøgt i 24 timer ved 2°C - 8°C og ved 25°C efter fortynding i 100 ml 0,9% w/v natriumkloridopløsning eller 100 ml 5% w/v glukoseopløsning.
English: - if you are breast-feeding.
Danish: − hvis du ammer.
English: No dose adjustment is necessary in TIH patients with serum creatinine < 400 micromol/l or < 4.5 mg/dl (see section 4.4).
Danish: Det er ikke nødvendigt at dosisjustere patienter med TIH og serum-kreatinin < 400 mikromol/l eller < 4,5 mg/dl (se afsnit 4.4).
English: The withdrawn amount of concentrate must be further diluted in 100 ml of sterile 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Danish: Den udtagne mængde af koncentratet skal fortyndes yderligere i 100 ml sterilt 0,9% w/v natriumklorid- eller 5% w/v glukoseopløsning.
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 (see section 4.4).
Danish: Der er rapporteret forværring af nyrefunktion, progression til nyresvigt samt dialyse hos patienter efter initial dosis eller enkeltdosis af 4 mg zoledronsyre (se pkt.
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 påvirke op til 1 ud af 10 patienter): - Hovedpine og influenzalignende symptomer som feber, træthed, svaghed, døsighed,
English: - Shelf life after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and at 25°C after dilution in 100 ml 0.9% w/v sodium chloride solution or 100 ml 5% w/v glucose.
Danish: - Holdbarhed efter fortynding: Den kemiske og fysiske stabilitet under brug er undersøgt i 24 timer ved 2°C - 8°C og ved 25°C efter fortynding i 100 ml 0,9% w/v natriumkloridopløsning eller 100 ml 5% w/v glukoseopløsning.
English: Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with Zoledronic acid Actavis in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Danish: Når behandling med Zoledronsyre Actavis initieres hos patienter med multiple myelom eller knoglemetastatisk skade fra solide tumorer bør serum-kreatinin og kreatininclearence (CLcr) bestemmes.
English: Zoledronic acid Actavis recommended dose*
Danish: Anbefalet dosis af Zoledronsyre Actavis*
English: Concentrate for solution for infusion 1 x 5 ml vial
Danish: Koncentrat til infusionsvæske, opløsning 1 x 5 ml hætteglas
English: Zoledronic acid Actavis must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Danish: Zoledronsyre Actavis koncentrat må ikke blandes med calcium eller anden divalent kationholdig infusionsopløsning såsom Ringer-lactatopløsning, og bør indgives som en enkelt intravenøs opløsning i en separat infusionsslange.
English: To avoid potential incompatibilities, Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion is to be diluted with 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Danish: For at forhindre eventuelle uforligeligheder skal Zoledronsyre Actavis 4 mg/5 ml koncentrat til infusionsvæske, opløsning, fortyndes med 0,9% w/v natriumklorid- eller 5% w/v glukoseopløsning.
English: Fracture adverse events of long bones in the lower extremities were reported in approximately 24% (femur) and 14% (tibia) of zoledronic acid-treated patients vs 12% and 5% of pamidronate-treated patients with severe osteogenesis imperfecta, regardless of disease type and causality but overall incidence of fractures was comparable for the zoledronic acid and pamidronate-treated patients: 43% (32/74) vs 41% (31/76).
Danish: Bivirkninger i form af frakturer på lange knogler i de nedre ekstremiteter var rapporteret hos ca. 24% (femur) og 14% (tibia) af zoledronsyrebehandlede patienter vs. 12 % og 5% af pamidronatbehandlede patienter med svær osteogenesis imperfecta uanset sygdomstype og kausalitet.
English: Zoledronic acid Actavis 4 mg/5 ml sterile concentrate zoledronic acid
Danish: Zoledronsyre Actavis 4 mg/5 ml sterilt koncentrat zoledronsyre
English: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy)
Danish: Tabel 2: Effektresultater (patienter med prostatacancer i hormonbehandling) Enhver SRE (+TIH)
English: Other medicines and Zoledronic acid Actavis
Danish: Brug af anden medicin sammen med Zoledronsyre Actavis
English: In the clinical studies, patients with serum creatinine > 400 micromol/l or > 4.5 mg/dl were excluded.
Danish: I kliniske forsøg blev patienter med serum-kreatinin > 400 mikromol/l eller > 4,5 mg/dl ekskluderet.
English: Other products containing zoledronic acid as active substances are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Danish: Der er andre lægemidler tilgængelige til osteoporose-indikationer og behandling af Pagets knoglesygdom, som indeholder zoledronsyre som det aktive indholdsstof.
English: Package leaflet: Information for the user Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Danish: Indlægsseddel: Information til brugeren Zoledronsyre Actavis 4 mg/5 ml koncentrat til infusionsvæske, opløsning zoledronsyre
English: This leaflet was last revised in {month YYYY}.
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ} Andre informationskilder
English: Zoledronic acid, used as indicated in sections 4.1 and 4.2, has been associated with reports of renal dysfunction.
Danish: 4.1 og 4.2, er blevet forbundet med rapporter om nedsat nyrefunktion.
English: While being treated with Zoledronic acid Actavis, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Danish: Mens du er i behandling med Zoledronsyre Actavis, skal du holde en god mundhygiejne (inkl.
English: You must not be given Zoledronic acid Actavis if you are breast-feeding.
Danish: Du må ikke få Zoledronsyre Actavis, hvis du ammer.
English: 1.0 mg/dl or 88 micromol/l.
Danish: (< 1,4 mg/dl eller < 124 mikromol/l).
English: Zoledronic acid 8 mg (N=90) 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)* Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Danish: 55,6% (p = 0,021)* 83,3% (p = 0,010)* 86,7% (p = 0,015)*
English: The onset time is ≤ 3 days post-zoledronic acid infusion (used as indicated in sections 4.1 and 4.2), and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Danish: 4.1 og 4.2), og reaktionen er også refereret til ved brug af termerne ”influenza-lignende symptomer” eller ”symptomer efter dosering”.
English: 10 x 5 ml vials
Danish: 10 x 5 ml hætteglas
English: To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/v sodium chloride or 5% w/v glucose solution.
Danish: For at undgå eventuelle uforligeligheder skal der som infusionsvæske til fortynding enten bruges 0,9% w/v natriumchlorid- eller 5% w/v glucoseopløsning.
English: In the clinical trials, renal deterioration was defined as follows: - For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 micromol/l), an increase of 0.5 mg/dl or 44 micromol/l; - For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 micromol/l), an increase of
Danish: Forværring af nyrefunktion blev i kliniske studier defineret som følger: - Øgning på 0,5 mg/dl eller 44 mikromol/l hos patienter med normal serum-kreatinin ved baseline
English: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Danish: Svimmelhed, paræstesier, dysgeusi, hypæstesi, hyperæstesi, tremor, somnolens Kramper, hypæstesi og tetani (sekundært til hypokalcæmi)
English: Do not mix Zoledronic acid Actavis concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Danish: Den rekonstituerede Zoledronsyre Actavis opløsning må ikke blandes med calciumholdige eller andre divalente kationholdige opløsninger som lakteret Ringers væske.
English: Actavis Italy S.p.A Via Pasteur, 10 20014 Nerviano (MI) Italy
Danish: Actavis Italy S.p.A Via Pastiur.
English: How often Zoledronic acid Actavis is given
Danish: Hvor ofte skal du have Zoledronsyre Actavis
English: How to store Zoledronic acid Actavis
Danish: Hvordan får du Zoledronsyre Actavis
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: − Spørg lægen, apoteket eller sygeplejersken, hvis der er mere, du vil vide.
English: Patients must be assessed prior to administration of Zoledronic acid Actavis to ensure that they are adequately hydrated.
Danish: Før indgift af Zoledronsyre Actavis skal patienterne vurderes med henblik på at sikre, de er vel hydrerede.
English: Within three days after zoledronic acid administration, used as indicated in sections 4.1 and 4.2, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Danish: 4.1 og 4.2, er en akut fasereaktion almindeligvis blevet indrapporteret med symptomer som knoglesmerter, feber, træthed, artralgi, myalgi, stivhed og artritis med efterfølgende hævelse af led.
English: Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Danish: Zoledronsyre Actavis 4 mg/5 ml koncentrat til infusionsvæske, opløsning rekonstitueret yderligere i 100 ml (se pkt.
English: What Zoledronic acid Actavis is and what it is used for What you need to know before you are given Zoledronic acid Actavis How Zoledronic acid Actavis is used Possible side effects
Danish: Det skal du vide, før du får Zoledronsyre Actavis Sådan bliver du behandlet med Zoledronsyre Actavis Bivirkninger
English: Concentrate for solution for infusion (sterile concentrate).
Danish: Koncentrat til infusionsvæske, opløsning (sterilt koncentrat) Klart og farveløst koncentrat til infusionsvæske, opløsning.
English: How much Zoledronic acid Actavis is given
Danish: Hvor meget Zoledronsyre Actavis skal du have
English: Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion
Danish: Zoledronsyre Actavis 4 mg/5 ml koncentrat til infusionsvæske, opløsning
English: Instructions for preparing reduced doses of Zoledronic acid Actavis Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose
Danish: Instruktion i fremstilling af reducerede doser Zoledronsyre Actavis Udtag en passende volumen af koncentratet efter følgende:
English: - Keep Zoledronic acid Actavis out of the sight and reach of children.
Danish: − Opbevar Zoledronsyre Actavis utilgængeligt for børn.
English: Blood creatinine and blood urea increased, hypocalcaemia
Danish: Øgninger i serumkreatinin og serumurea, hypocalcæmi
English: Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Danish: Zoledronsyre Actavis 4 mg/5 ml koncentrat til infusionsvæske, opløsning zoledronsyre
English: Placebo Zoledronic acid
Danish: Placebo Δ Zoledronic
English: How Zoledronic acid Actavis is given
Danish: Hvordan skal Zoledronsyre Actavis opbevares
English: The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Danish: Nedsat nyrefunktion, osteonekrose af kæberne, akut fasereaktion, hypocalcæmi, atrieflimren, anafylaksi, interstitiel lungesygdom.