FrancophonIA/ELRC3.0 huggingface dataset:
English: For storage conditions of the reconstituted solution for infusion, see section 6.3.
Danish: Opbevaringsbetingelser for den rekonstituerede infusionsvæske, se pkt.
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, the following zoledronic acid dose is recommended (see also section 4.4):
Danish: Til patienter med knoglemetastaser, der før behandlingen initieres, har mild til moderat nyreinsufficiens, som i denne population er defineret som CLcr 30-60 ml/min, anbefales følgende dosis af zoledronsyre (se også afsnit 4.4):
English: MARKETING AUTHORISATION NUMBERS EU/1/13/834/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/834/001
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: • 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, følelsen af tyngde i kæben eller af løse tænder.
English: Caution is advised when zoledronic acid is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Danish: Der tilrådes forsigtighed, når zoledronsyre indgives sammen med anti-angiogene lægemidler, da der er set en øget hyppighed af osteonekrose af kæberne hos patienter i samtidig behandling med disse lægemidler.
English: The hydration status of patients must be assessed prior to and following administration of Zoledronic Acid Accord to ensure that they are adequately hydrated.
Danish: Patienternes hydreringsstatus skal vurderes før og efter indgivelsen af Zoledronsyre Accord for at sikre, de er tilstrækkeligt hydrerede.
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic Acid Accord or after stopping treatment.
Danish: Fortæl det straks til din læge eller tandlæge, hvis du får sådanne symptomer, mens du er i behandling med Zoledronsyre Accord eller efter behandlingsophør.
English: Excipients: mannitol (E421), sodium citrate and water for injections.
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestoffer: mannitol (E421), natriumcitrat og vand til injektionsvæske.
English: Instructions for preparing reduced doses of Zoledronic Acid Accord 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 Accord Udtag en passende volumen af det nødvendige koncentrat som følger: 4,4 ml til 3,5 mg dosis
English: • if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zoledronic Acid Accord belongs), or any of the other ingredients of this medicine
Danish: hvis du er allergisk over for zoledronsyre, et andet bisfosfonat (den gruppe af stoffer, som Zoledronsyre Accord tilhører) eller et af de øvrige indholdsstoffer i Zoledronsyre Accord (angivet i punkt 6).
English: • Blurred vision, tearing of the eye, eye sensitivity to light.
Danish: Sløret syn, tåreflåd, lysfølsomhed i øjnene.
English: Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Danish: Cancer, følgesygdomme (fx anæmi, koagulationslidelse, infektion), rygning.
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: Other medicines and Zoledronic Acid Accord Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Zoledronsyre Accord Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLASSETS ETIKET
English: In a pooled analysis of safety data from zoledronic acid 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 zoledronic acid (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 zoledronsyre-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 zoledronsyre, følgende: 3,2 % ved multipelt myelom, 3,1 % ved prostatacancer, 4,3 % ved brystcancer og 3,2 % ved lunge- og andre solide tumorer.
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 zoledronsyre 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: • Sudden coldness with fainting, limpness or collapse.
Danish: Pludselig opstået kuldefølelse med besvimelse, slaphed eller kollaps.
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: 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: In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
Danish: Hos patienter med let til moderat nedsat nyrefunktion anbefales nedsatte doser af zoledronsyre (se afsnittet ”Dosering” ovenfor samt pkt.
English: Serum calcium should be measured and hypocalcaemia must be corrected before initiating Zoledronic Acid Accord therapy.
Danish: Serumcalcium bør måles og hypokalcæmi korrigeres, inden behandling med Zoledronsyre Accord påbegyndes.
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 Accord 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 Accord eller efter endt behandling.
English: • The active substance is zoledronic acid.
Danish: Aktivt stof: zoledronsyre.
English: Zoledronic acid 4 mg (N=86) 45.3% (p=0.104) 82.6% (p=0.005)* 88.4% (p=0.002)* 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)* Pamidronat 90 mg (N = 99) 33,3 % * p-værdier sammenlignet med pamidronat.
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: • Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Danish: Det er især vigtigt, at du fortæller lægen, hvis du også får: - Aminoglykosider (en type medicin til behandling af alvorlige infektioner), calcitonin (en type medicin til behandling knogleskørhed efter menopausen og til for højt calcium), slyngediuretika (vanddrivende medicin til behandling af forhøjet blodtryk eller væskesamlinger) eller anden medicin, der sænker calcium, da kombinationen af disse stoffer og bisfosfonater kan forårsage, at blodets indhold af calcium bliver for lavt.
English: • Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Danish: - Uregelmæssig hjerterytme (atrieflimren) er set hos patienter, der fik zoledronsyre for postmenopausal osteoporose.
English: 4.2 Posology and method of administration Zoledronic Acid Accord must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Danish: Zoledronsyre Accord må kun udskrives og administreres til patienter af sundhedspersonale med erfaring i administration af intravenøse bisfosfonater.
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 (inklusiv nyresvigt) og serum-elektrolyt (inklusiv calcium, fosfor og magnesium) forstyrrelser er blevet observeret.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 5 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: You should not be given Zoledronic Acid Accord if you are pregnant.
Danish: Du bør ikke få Zoledronsyre Accord, hvis du er gravid.
English: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoasthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Danish: Hjertearytmi og neurologiske bivirkninger (herunder kramper, hypæstesi og tetani) er blevet rapporteret sekundært til tilfælde af alvorlig hypokalcæmi.
English: p-value Skeletal morbidity rate p-value
Danish: Skeletal morbiditets rate p-værdi
English: • To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Accord concentrate (5ml) 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 fortynde Zoledronsyre Accord-koncentratet (5 ml) yderligere med 100 ml infusionsvæske, som er calciumfri eller fri for andre divalente kationer.
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Danish: Tabel 4: Effektresultater (patienter med brystcancer eller multipelt myelom)
English: Baseline creatinine clearance (ml/min) Zoledronic acid recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Doses have been calculated assuming target AUC of 0.66 (mg-hr/l) (CLcr = 75 ml/min).
Danish: Anbefalet dosis af zoledronsyre* 4,0 mg zoledronsyre 3,5 mg* zoledronsyre 3,3 mg* zoledronsyre 3,0 mg* zoledronsyre *Dosis er beregnet ud fra forudsætning om et mål-AUC på 0,66 (mg-t/l) (CLcr = 75 ml/min).
English: Rare (may affect up to 1 in 1,000 people):
Danish: Sjælden (forekommer hos op til 1 ud af 1.000 patienter):
English: • High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea constipation,
Danish: - Forhøjet blodtryk, åndenød, svimmelhed, angst, søvnforstyrrelser, smagsforstyrrelser, rysten, følelsesløshed eller prikkende fornemmelse i hænder eller fødder, diarré, forstoppelse, mavesmerter, mundtørhed.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/834/001- 1vial pack EU/1/13/834/002- 4 vial pack EU/1/13/834/003- 10 vial pack
Danish: EU/1/13/834/001- 1 hætteglas EU/1/13/834/002- 4 hætteglas EU/1/13/834/003- 10 hætteglas
English: In clinical trials with zoledronic acid, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded.
Danish: I kliniske forsøg med zoledronsyre blev patienter med serum-kreatinin > 265 mol/l eller > 3,0 mg/dl ekskluderet.
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 separat infusionsslange.
English: EXP Use immediately after dilution.
Danish: Anvendes straks efter fortynding.
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Danish: Tabel 3: Effektresultater (solide tumorer udover bryst- og prostatacancer)
English: Children and adolescents
Danish: Voksne og ældre
English: use after dilution
Danish: anvendelse efter fortynding
English: History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures (e.g. tooth extractions) and poorly fitting dentures
Danish: Tandsygdom i anamnesen, dårlig mundhygiejne, parodontal sygdom, invasiv tandbehandling (fx tandudtrækninger) og dårligt tilpassede tandproteser.
English: No dose adjustment is necessary in TIH patients with serum creatinine < 400 µmol/l or < 4.5 mg/dl (see section 4.4).
Danish: Det er ikke nødvendigt at dosisjustere patienter med TIH og serum-kreatinin < 400 μmol/l eller < 4,5 mg/dl (se afsnit 4.4).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zoledronic Acid Accord 4 mg/5 ml sterile concentrate zoledronic acid
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Zoledronsyre Accord 4 mg/5 ml sterilt koncentrat zoledronsyre
English: In the clinical trials, renal deterioration was defined as follows: For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 µmol/l), an increase of 0.5 mg/dl or 44 µmol/l; For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 µmol/l), an increase of 1.0 mg/dl or 88 µmol/l.
Danish: Forværring af nyrefunktion blev i kliniske studier defineret som følger: Øgning på 0,5 mg/dl eller 44 μmol/l hos patienter med normal serum-kreatinin ved baseline (<1,4 mg/dl eller <124 μmol/l).
English: • Slow heart beat.
Danish: - Langsom hjerterytme.
English: The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at der implementeres patienthuskekort vedrørende osteonekrose af kæberne.
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: Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Danish: Analyser af gentagne hændelser viste risikoreduktion på 30,7 % i udviklingen af skeletrelaterede hændelser i zoledronsyre 4 mggruppen sammenlignet med placebo.
English: What you need to know before you are given Zoledronic Acid Accord 3.
Danish: Det skal du vide, før du begynder at bruge Zoledronsyre Accord 3.
English: Patients treated with Zoledronic Acid Accord should be given the package leaflet and the patient reminder card. Posology
Danish: Patienter i behandling med Zoledronsyre Accord bør få udleveret indlægssedlen og patienthuskekortet.
English: Zoledronic Acid Accord contains sodium
Danish: Zoledronsyre Accord indeholder natrium
English: What Zoledronic Acid Accord contains
Danish: Zoledronsyre Accord indeholder
English: Prior to administration, 5ml 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 for Injection or 5% w/v glucose solution).
Danish: 6.6 Regler for bortskaffelse og anden håndtering Før administration skal 5 ml koncentrat fra et hætteglas eller den påkrævede mængde udtagne koncentrat fortyndes yderligere med 100 ml calciumfri infusionsvæske (0,9 % w/v natriumkloridopløsning til injektionsvæske eller 5 % w/v glucoseopløsning).
English: The following properties have been demonstrated in preclinical studies: In-vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
Danish: In vivo: Hæmning af osteoklastisk knogleresorption, hvilket ændrer knoglemarvens mikromiljø og mindsker bidraget til tumorcellevæksten, den anti-angiogenetiske aktivitet og anti-smerte aktiviteten.
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the postmarketing setting in patients receiving Zoledronic Acid Accord
Danish: Osteonekrose af kæberne er blevet rapporteret med frekvensen ”ikke almindelig” i kliniske forsøg og efter markedsføring hos patienter behandlet med Zoledronsyre Accord.
English: Zoledronic Acid Accord concentrate 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 Accord-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: Very common (1/10)
Danish: Meget almindelig ( 1/10)
English: Very common ( 1/10)
Danish: Meget almindelig (1/10)
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 koncentrat skal fortyndes yderligere i 100 ml sterilt 0,9 % w/v natriumchlorid- eller 5 % w/v glucoseinjektions-/infusionsvæske.
English: • Flu-like symptoms including arthritis and joint swelling.
Danish: - Influenza-lignende symptomer herunder gigt (artitis) og hævede led.
English: Multiple event analysis showed a 36% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Danish: Analyser af gentagne hændelser viste risikoreduktion på 36 % i udviklingen af skeletrelaterede hændelser i zoledronsyre 4 mg-gruppen sammenlignet med placebo.
English: Do not mix Zoledronic Acid Accord concentrate with calcium-containing or other divalent cation-containing solutions such as lactated Ringer's solution.
Danish: Zoledronsyre Accord-koncentrat må ikke blandes med calciumholdige opløsninger eller andre opløsninger indeholdende divalente kationer som lakteret Ringers væske.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate) One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et hætteglas med 5 ml koncentrat indeholder 4 mg zoledronsyre (som monohydrat).
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: What you need to know before you are given Zoledronic Acid Accord
Danish: Det skal du vide, før du begynder at bruge Zoledronsyre Accord
English: Common ( 1/100 to < 1/10)
Danish: Almindelig ( 1/100 til < 1/10)
English: Rare ( 1/10.000 to < 1/1.000)
Danish: Sjælden ( 1/10.000 til < 1/1.000)
English: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
Danish: Tabel 2: Effektresultater (patienter med prostatacancer i hormonbehandling)
English: • Skin reactions (redness and swelling) at the infusion site, rash, itching.
Danish: - Hudreaktioner (rødme og hævelse) på infusionsstedet, udslæt, kløe.
English: While being treated with Zoledronic Acid Accord, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Danish: Mens du er i behandling med Zoledronsyre Accord, skal du holde en god mundhygiejne (inkl.
English: Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Danish: Zoledronsyre Accord 4 mg/5 ml koncentrat til infusionsvæske, opløsning zoledronsyre
English: To avoid potential incompatibilities, Zoledronic Acid Accord concentrate is to be diluted with 0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution.
Danish: For at forhindre eventuelle uforligeligheder skal Zoledronsyre Accord-koncentrat fortyndes med 0,9 % w/v natriumklorid- eller 5 % w/v glucoseinjektions-/infusionsvæske.
English: In the clinical studies, patients with serum creatinine > 400 µmol/l or > 4.5 mg/dl were excluded.
Danish: I kliniske forsøg blev patienter med serum-kreatinin > 400 μmol/l eller > 4,5 mg/dl ekskluderet.
English: • Difficulty in breathing with wheezing or coughing.
Danish: Vejrtrækningsbesvær med hiven efter vejret eller hosten.
English: • As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Danish: Sjælden (forekommer hos op til 1 ud af 1.000 patienter): - Som følge af lave calcium-værdier: uregelmæssig hjerterytme (hjertearytmi; sekundære symptomer på hypokalcæmi).
English: • Urticaria.
Danish: Nældefeber.
English: • 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 (forekommer hos op til 1 ud af 100 patienter): - Smerter i munden, tænder og/eller kæberne, hævelse eller ikke helende sår inde i munden eller kæben, udflåd af gullig betændelse, følelsesløshed eller følelsen af tyngde i kæberne eller løsnen af en tand.
English: How Zoledronic Acid Accord is used 4.
Danish: Sådan skal du bruge Zoledronsyre Accord 4.
English: Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
Danish: 4.5), stråleterapi i nakke og hoved, kortikosteroider.
English: You must not be given Zoledronic Acid Accord if you are breast-feeding.
Danish: Du må ikke få Zoledronsyre Accord, hvis du ammer.