FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with TIH and evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with Zoledronic Acid Teva outweighs the possible risk.
Danish: Patienter med TIH og verificeret forværret nyrefunktion bør evalueres på relevant vis, og det bør overvejes om den potentielle gavn af behandling med Zoledronsyre Teva opvejer de mulige ricisi.
English: Your doctor may recommend a dental examination before you start treatment with Zoledronic Acid Teva.
Danish: Din læge vil måske bede dig om at få et tandeftersyn, før du starter behandling med Zoledronsyre Teva.
English: Arthritis and joint swelling as a symptom of acute phase reaction
Danish: Artritis og hævede led som symptom på akut fasereaktion
English: Marketing Authorisation Holder Teva B.V.
Danish: Indehaver af markedsføringstilladelsen Teva B.V.
English: - Zoledronic acid must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Danish: - Zoledronsyre Teva må kun gives af sundhedspersonale, som er trænet til at indgive bisfosfonater intravenøst, dvs. gennem en blodåre.
English: 45.3% (p=0.104) 82.6% (p=0.005)* 88.4% (p=0.002)*
Danish: 82,6% (p = 0,005)* 88,4% (p = 0,002)*
English: - For single use only.
Danish: − Kun til engangsbrug.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference 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 at fremlægge resultaterne af studier med referenceproduktet indeholdende 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: In patients who show evidence of renal deterioration during treatment, Zoledronic Acid Teva should be withheld.
Danish: Hos patienter, der har påvist forværret nyrefunktion under behandling, bør Zoledronsyre Teva tilbageholdes.
English: Very rare (may affect up to 1 in 10,000 people): - Fainting due to low blood pressure.
Danish: Meget sjælden (forekommer hos op til 1 ud af 10.000 patienter): - Besvimelse på grund af lavt blodtryk.
English: Zoledronic acid 8 mg (N=90)
Danish: Zoledronsyre 8 mg (N = 90)
English: Do not use this medicine if you notice any particles or discoloration in the solution.
Danish: Du må ikke anvende lægemidlet, hvis opløsningen indeholder partikler eller er misfarvet.
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 (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: - Blurred vision, tearing of the eye, eye sensitivity to light.
Danish: − Søret syn, tåreflåd, lysfølsomhed i øjnene.
English: - Sudden coldness with fainting, limpness or collapse.
Danish: − Pludselig opstået kuldefølelse med besvimelse, slaphed eller kollaps.
English: Median time to relapse (re-increase of albumin-corrected serum calcium ≥ 2.9 mmol/l) was 30 to 40 days for patients treated with zoledronic acid versus 17 days for those treated with pamidronate 90 mg (p-values: 0.001 for 4 mg and 0.007 for 8 mg zoledronic acid).
Danish: Mediantid til recidiv (fornyet stigning af albuminkorrigeret serumcalcium ≥2,9 mmol/l) var 30-40 dage for patienter i behandling med zoledronsyre i forhold til 17 dage for patienter i behandling med 90 mg pamidronat (p-værdier: 0,001 for 4 mg og 0,007 for 8 mg zoledronsyre).
English: Hypocalcaemia has been reported in patients treated with Zoledronic Acid Teva.
Danish: Hypokalcæmi er blevet rapporteret hos patienter i behandling med Zoledronsyre Teva.
English: Caution is advised when Zoledronic Acid Teva is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Danish: Der skal udvises forsigtighed, når Zoledronsyre Teva gives sammen med lægemidler, der vides at forårsage hypokalcæmi, da de kan have en synergistisk effekt, resulterende i svær hypokalcæmi (se pkt 4.5).
English: Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients treated with Zoledronic Acid Teva.
Danish: Nedsat indhold af calcium i blodet (hypokalcæmi), som kan medføre muskelkramper, tør hud, en brændende følelse, er indberettet for patienter i behandling med Zoledronsyre Teva.
English: The other ingredients are: mannitol, sodium citrate and water for injections.
Danish: - Øvrige indholdsstoffer: mannitol, natriumcitrat, vand til injektionsvæsker.
English: Table 1 Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er ordnet under overskrifter om hyppighed, den hyppigste først, ved brug af de følgende konventionelle regler: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
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 Teva 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 Teva (se også afsnit 4.4):
English: - From a microbiological point of view, the diluted solution for infusion should be used immediately.
Danish: − Ud fra et mikrobiologisk synspunkt skal opløsningen til infusion anvendes straks efter åbning.
English: Zoledronic acid 4 mg (N=86)
Danish: Zoledronsyre 4 mg (N = 86)
English: Caution is advised when Zoledronic Acid Teva 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 Teva 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 Teva to ensure that they are adequately hydrated.
Danish: Patienternes hydreringsstatus skal vurderes før og efter indgivelsen af Zoledronsyre Teva for at sikre, de er tilstrækkeligt hydrerede.
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: Other medicines and Zoledronic Acid Teva Tell your doctorif you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Zoledronsyre Teva Fortæl altid lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: Zoledronic Acid Teva 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 Teva* 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: Studies with glass bottles, as well as several types of infusion bags and infusion lines made from polyvinylchloride, polyethylene and polypropylene (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution), showed no incompatibility.
Danish: Studier med glasflasker, såvel som med flere typer af infusionsposer og infusionsslanger lavet af polyvinylchlorid, polyethylen og polypropylen (forfyldt med 9 mg/ml (0,9%) w/v natriumklorid- eller 5% w/v glukoseopløsning) viste ingen uforligelighed.
English: Zoledronic acid has been associated with reports of renal dysfunction.
Danish: Zoledronsyre Teva har været forbundet med rapporter om nedsat nyrefunktion.
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: 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: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy)
Danish: Tabel 2: Effektresultater (patienter med prostatacancer i hormonbehandling)
English: In a third phase III randomised, double-blind trial, 4 mg zoledronic acid 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: Suomi/Finland rationpharm Oy Puh/Tel: +358 20 180 5900
Danish: Suomi/Finland ratiopharm Oy Puh/Tel: +358 20 180 5900
English: Zoledronic Acid Teva treatment should be resumed at the same dose as that given prior to treatment interruption.
Danish: Zoledronsyre Teva behandling bør genoptages med samme dosis som givet før afbrydelse af behandlingen.
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 hyperkalcæmi (TIH) viser, at effekten af zoledronsyre er karakteriseret ved fald i serumcalcium og urinudskillelse af calcium.
English: Zoledronic Acid Teva is not recommended for use in adolescents and children below the age of 18 years.
Danish: Børn og unge Zoledronsyre Teva bør ikke bruges til børn og unge under 18 år.
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: Serum calcium should be measured and hypocalcaemia must be corrected before initiating Zoledronic Acid Teva therapy.
Danish: Serumcalcium bør måles og hypokalcæmi korrigeres, inden Zoledronsyre Teva-behandling påbegyndes.
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: Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic Acid Teva 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 Teva eller efter behandlingsophør.
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: This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
Danish: Ikke almindelig (forekommer hos op til 1 ud af 100 patienter): - Overfølsomhedsreaktioner.
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 Teva 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 Teva eller efter endt behandling.
English: Instructions for preparing reduced doses of Zoledronic Acid Teva Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose - 4.1 ml for 3.3 mg dose
Danish: Instruktion i fremstilling af reducerede doser Zoledronsyre Teva Udtag en passende volumen af koncentratet efter følgende: - 4,4 ml til 3,5 mg dosis
English: What you need to know before you are given Zoledronic Acid Teva
Danish: Det skal du vide, før du får Zoledronsyre Teva
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: Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Danish: Sjælden (forekommer hos op til 1 ud af 1.000 patienter): - Langsom hjerterytme.
English: Patients treated with Zoledronic Acid Teva should be given the package leaflet and the patient reminder card.
Danish: Patienter i behandling med Zoledronsyre Teva bør få udleveret indlægssedlen og patienthuskekortet.
English: You should not be given Zoledronic Acid Teva if you are pregnant.
Danish: Du bør ikke få Zoledronsyre Teva, hvis du er gravid.
English: Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og flaskeetiketten efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
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: Diluted Solution - The readily prepared Zoledronic Acid Teva infusion solution should preferably be used immediately.
Danish: − Den færdigfremstillede Zoledronsyre Teva infusionsvæske bør anvendes straks.
English: LIST OF EXCIPIENTS Excipients: mannitol, sodium citrate and water for injections.
Danish: Hjælpestoffer: mannitol, natriumcitrat og vand til injektionsvæsker.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et hætteglas med 5 ml koncentrat indeholder 4 mg zoledronsyre (som monohydrat).
English: What Zoledronic Acid Teva contains
Danish: Zoledronsyre Teva indeholder:
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: 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: - Increased sweating.
Danish: - Øget svedtendens.
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 µmol/l eller >3,0 mg/dl ekskluderet.
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients)
Danish: Tabel 4: Effektresultater (patienter med brystcancer eller multipelt myelom) Enhver SRE (+TIH)
English: Zoledronic Acid Teva is contraindicated in breast-feeding women (see section 4.3).
Danish: Zoledronsyre Teva er kontraindikeret hos kvinder, der ammer (se pkt.
English: The active substance is zoledronic acid.
Danish: - Aktivt stof/aktive stoffer: zoledronsyre.
English: This medicinal product 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: Dette lægemiddel må ikke blandes med infusionsopløsninger, opløsninger indeholdende calcium eller andre divalente kationer så som lakteret Ringer's væske og bør administreres som en enkelt intravenøs infusion i en separat infusionsslange.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: - Skin reactions (redness and swelling) at the infusion site, rash, itching.
Danish: - Hudreaktioner (rødme og hævelse) på infusionsstedet, udslæt, kløe.
English: - Difficulty in breathing with wheezing or coughing.
Danish: − Vejrtrækningsbesvær med hiven efter vejret eller hosten.
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving Zoledronic Acid Teva.
Danish: Osteonekrose af kæberne er blevet rapporteret med frekvensen ”ikke almindelig” i kliniske forsøg og efter markedsføring hos patienter behandlet med Zoledronsyre Teva.
English: General disorders and administration site conditions Common:
Danish: Almene symptomer og reaktioner på administrationsstedet
English: Blood and lymphatic system disorders Common:
Danish: Blod og lymfesystem
English: Interstitial lung disease
Danish: - Interstitiel lungesygdom (sygdom i alveolevævet).
English: Zoledronic Acid Teva 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 Teva 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: Dyspnoea, cough, bronchoconstriction
Danish: Dyspnø, hoste, bronkokonstriktion Interstitieal lungesygdom
English: - Urticaria.
Danish: - Vægtøgning.
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,
English: How to prepare and administer Zoledronic Acid Teva - To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Teva concentrate (5 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 Teva-koncentratet (5,0 ml) yderligere med 100 ml calciumfri eller anden infusionsvæske uden indhold af divalente kationer.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”.
Danish: Zoledronsyre Teva indeholder natriumklorid (salt) Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, dvs. det er praktisk taget ”natriumfrit”.
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 (forekommer hos op til 1 ud af 10 patienter): - Hovedpine og influenzalignende symptomer som feber, træthed, svaghed, døsighed,
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: Muscle spasms, osteonecrosis of the jaw
Danish: Muskelspasmer, osteonekrose af kæberne*
English: Additional risk minimisation measures 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: You must not be given Zoledronic Acid Teva if you are breast-feeding.
Danish: Du må ikke få Zoledronsyre Teva, hvis du ammer.
English: Manufacturer Pharmachemie B.V. Swensweg 5
Danish: Fremstiller Pharmachemie B.V.
English: Skin and subcutaneous tissue disorders Uncommon:
Danish: Hud og subkutane væv
English: Furthermore, there is evidence of an association between hypocalcaemia and secondary neurological events reported in these cases including;
Danish: Desuden synes der at være en association mellem hypokalcæmi og de sekundære neurologiske bivirkninger, der er rapporteret i disse tilfælde, herunder kramper, hypæstesi og tetani (se pkt.
English: Do not throw away any medicines via wastewater (or household waste).
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
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: strålebehandling eller operation af knogler, eller tumorinduceret hyperkalcæmi) hos voksne patienter med fremskreden malign sygdom og knoglemetastaser.
English: The withdrawn amount of concentrate must be further diluted in 100 ml of sterile sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Danish: Den udtagne mængde af koncentratet skal fortyndes yderligere i 100 ml sterilt 9 mg/ml (0,9%) w/v natriumchlorid- eller 5% w/v glucoseinjektions-/infusionsvæske.
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).