natgillin/translations-raw huggingface dataset:
CrCl bregnes ud fra serum- kreatinin ved brug af Cockeroft- Gault formlen.
CrCl is calculated from serum creatinine using the Cockcroft-Gault formula.
Zometa anbefales ikke til patienter, der før behandlingen initieres, har svær nyreinsufficiens, som i denne population er defineret som CrCl < 30 ml/ min.
Zometa is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CrCl < 30 ml/ min.
I kliniske forsøg med Zometa blev patienter med serum- kreatinin > 265 μmol/ l eller > 3, 0 mg/ dl ekskluderet.
In clinical trials with Zometa, patients with serum creatinine > 265 µmol/ l or > 3.0 mg/ dl were excluded.
Til patienter med knoglemetastaser, der før behandlingen initieres, har mild til moderat nyreinsufficiens, som i denne population er defineret som CrCl 30– 60 ml/ min, anbefales følgende dosis af Zometa (se også afsnit 4. 4):
In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CrCl 30– 60 ml/ min, the following Zometa dose is recommended (see also section 4.4):
Baseline kreatinin clearance (ml/ min) > 60
Clearance (ml/ min) > 60
dosis af Zometa * 4, 0 mg
Zometa Recommended Dose* 4.0 mg
50– 60 40– 49 30– 39
50– 60 40– 49 30– 39
* Dosis er beregnet ud fra forudsætning om et mål- AUC på 0, 66 (mg• t/ l) (CrCl=75 ml/ min).
*Doses have been calculated assuming target AUC of 0.66 (mg• hr/ l) (CrCl=75 ml/ min).
Den nedsatte dosis til patienter med nyreinsufficiens forventes at give samme AUC, som er set hos patienter med kreatinin clearence på 75 ml/ min.
The reduced doses for patients with renal impairment are expected to achieve the same AUC as that seen in patients with creatinine clearance of 75 ml/ min.
Efter påbegyndelse af behandling bør serum- kreatinin måles før hver dosis af Zometa, og behandlingen bør tilbageholdes, hvis nyrefunktionen forværres.
Following initiation of therapy, serum creatinine should be measured prior to each dose of Zometa and treatment should be withheld if renal function has deteriorated.
- Øgning på 0, 5 mg/ dl eller 44 μmol/ l hos patienter med normal serum- kreatinin ved baseline
0.5 mg/ dl or 44 µmol/ l;
(< 1, 4 mg/ dl eller < 124 μmol/ l).
- For patients with an abnormal baseline creatinine (> 1.4 mg/ dl or > 124 µmol/ l), an increase of
- Øgning på 1, 0 mg/ dl eller 88 μmol/ l hos patienter med abnorm kreatinin ved baseline
1.0 mg/ dl or 88 µmol/ l.
I kliniske studier blev behandling med Zometa først genoptaget når kreatinin- niveauet faldt inden for 10% over baselineværdien (se afsnit 4. 4).
In the clinical studies, Zometa treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Behandling med Zometa bør genoptages med den samme dosis som før afbrydelse af behandlingen.
Zometa treatment should be resumed at the same dose as that prior to treatment interruption.
Instruktion i fremstilling af reducerede doser Zometa Udtag en passende volumen af den rekonstituerede opløsning (4 mg/ 5 ml):
Instructions for preparing reduced doses of Zometa Withdraw an appropriate volume of the reconstituted solution (4 mg/ 5 ml) as needed:
- 4, 4 ml til 3, 5 mg dosis
- 4.4 ml for 3.5 mg dose
- 4, 1 ml til 3, 3 mg dosis
- 4.1 ml for 3.3 mg dose
- 3, 8 ml til 3, 0 mg dosis
- 3.8 ml for 3.0 mg dose
For information om rekonstituering og fortynding af Zometa henvises til afsnit 6. 6.
For information on the reconstitution and dilution of Zometa, see section 6.6.
Den udtagne mængde af den rekonstituerede opløsning skal fortyndes i 100 ml sterilt 0, 9% w/ v natriumklorid - eller 5% w/ v glukoseopløsning.
The withdrawn amount of reconstituted solution must be diluted in 100 ml of sterile 0.9% w/ v sodium chloride solution or 5% w/ v glucose solution.
Anvendelse af Zometa til pædiatriske patienter er ikke undersøgt.
The use of Zometa in paediatric patients has not been studied.
Zometa bør ikke anvendes til denne patientgruppe, før yderligere data er tilgængelige.
Zometa should not be used in that patient population until further data becomes available.
Zometa pulver til infusionsvæske, opløsning, er kontraindiceret til kvinder der ammer og patienter med klinisk signifikant overfølsomhed over for zoledronsyre, andre bisfosfonater eller over for et eller flere af hjælpestofferne i Zometa.
Zometa powder for solution for infusion is contraindicated in breast-feeding women and in patients with clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or any of the excipients in the formulation of Zometa.
Generelt Før indgift af Zometa skal patienterne vurderes med henblik på at sikre, de er vel hydrerede.
General Patients must be assessed prior to administration of Zometa to ensure that they are adequately hydrated.
Standard hypercalcæmirelaterede metabolske parametre som serumniveauer af calcium, fosfat og magnesium, bør monitoreres grundigt efter påbegyndt behandling med Zometa.
Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zometa therapy.
Hvis hypocalcæmi, hypofosfatæmi eller hypomagnesæmi forekommer kan supplement behandling være nødvendigt i kort tid.
If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, short-term supplemental therapy may be necessary.
Sikkerhed og effekt af Zometa er ikke fastsat hos pædiatriske patienter.
The safety and efficacy of Zometa in paediatric patients have not been established.
Nyreinsufficiens TIH- patienter med verificeret forværret nyrefunktion bør evalueres på relevant vis, og det bør overvejes om den potentielle gavn af behandling opvejer de mulige ricisi.
Renal insufficiency Patients with TIH with evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with Zometa outweighs the possible risk.
Ved beslutning om at behandle patienter med knoglemetastaser til forebyggelse af skeletrelaterede hændelser, bør det tages i betragtning at behandlingens effekt først indtræder efter 2– 3 måneder.
The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2– 3 months.
Som andre bisfosfonater, har Zometa været forbundet med rapporter om nedsat nyrefunktion.
As with other bisphosphonates, Zometa has been associated with reports of renal dysfunction.
Faktorer, der kan øge potentialet for nedsættelse af nyrefunktionen, inkluderer dehydrering, allerede eksisterende nyreinsufficiens, adskillige cyklus af Zometa og andre bisfosfonater så vel som brug af andre nefrotoksiske stoffer.
Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of Zometa and other bisphosphonates as well as use of other nephrotoxic drugs.
Selvom risikoen reduceres ved administration af Zometa 4 mg over 15 minutter, kan der stadig opstå forværring af nyrefunktionen.
While the risk is reduced with a dose of Zometa 4 mg administered over 15 minutes, deterioration in renal function may still occur.
Der er rapporteret forværring af nyrefunktion, progression til nyresvigt samt dialyse hos patienter efter initial dosis eller enkeltdosis af Zometa.
Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of Zometa.
Der er hos nogen patienter også set stigninger i serum- kreatinin ved kronisk administration af Zometa i anbefalede doser til forebyggelse af skeletrelaterede hændelser, selvom dette er mindre hyppigt.
Increases in serum creatinine also occur in some patients with chronic administration of Zometa at recommended doses for prevention of skeletal related events, although less frequently.
Patienter bør få deres serum- kreatinin niveau vurderet før hver dosis af Zometa.
Patients should have their serum creatinine levels assessed prior to each dose of Zometa.
Ved initiering af behandling til patienter med knoglemetastaser og mild til moderat nyreinsufficiens anbefales nedsatte doser af Zometa.
Upon initiation of treatment in patients with bone metastases with mild to moderate renal impairment, lower doses of Zometa are recommended.
Zometa bør kun genoptages, når serum- kreatinin igen er inden for 10% af baseline (se afsnit 4. 2).
Zometa should only be resumed when serum creatinine returns to within 10% of baseline (see section 4.2).
I betragtning af bisfosfonaters, inklusiv Zometas, potentielle indflydelse på nyrefunktionen, manglende omfattende kliniske sikkerhedsdata hos patienter med alvorlig nedsat nyrefunktion (i kliniske studier defineret som serumkreatinin ≥400 μmol/ l eller ≥4, 5 mg/ dl hos patienter med TIH, og ≥265 µmol/ l eller ≥3, 0 mg/ dl hos patienter med henholdsvis cancer og knoglemetastaser) i forhold til deres baseline værdi og kun begrænsede farmakokinetiske data hos patienter med svært nedsat nyrefunktion ved baselinien (serumkreatinin clearance < 30 ml/ min), kan Zometa ikke anbefales til patienter med alvorlig nedsat nyrefunktion.
In view of the potential impact of bisphosphonates, including Zometa, on renal function, the lack of clinical safety data in patients with severe renal impairment (in clinical trials defined as serum creatinine ≥ 400 µmol/ l or ≥ 4.5 mg/ dl for patients with TIH and ≥ 265 µmol/ l or ≥ 3.0 mg/ dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/ min), the use of Zometa is not recommended in patients with severe renal impairment.
4 Leverinsufficiens Da der kun eksisterer begrænsede kliniske data for patienter med kraftigt nedsat leverfunktion, kan der ikke gives nogen specifikke anbefalinger for denne patientgruppe.
Hepatic insufficiency As only limited clinical data are available in patients with severe hepatic insufficiency, no specific recommendations can be given for this patient population.
Osteonekrose af kæberne Osteonekrose af kæberne er blevet rapporteret hos patienter, overvejende patienter med cancer, som modtog behandling med bisfosfonater, herunder Zometa.
4 Osteonecrosis of the jaw Osteonecrosis of the jaw has been reported in patients, predominantly those with cancer, receiving treatment with bisphosphonates, including Zometa.
Mange viste tegn på lokal infektion inklusiv osteomyelitis.
Many had signs of local infection including osteomyelitis.
Klinisk bedømmelse af den behandlende læge bør vejlede behandlingsplanen for den enkelte patient baseret på individuel fordel/ risiko vurdering.
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/ risk assessment.
Muskel - og knoglesmerter Ved erfaring efter markedsføring er der rapporteret om alvorlige og lejlighedsvis invaliderende knogle -, led -, og/ eller muskelsmerter hos patienter i bisfosfonatbehandling.
Musculoskeletal pain In post-marketing experience, severe and occasionally incapacitating bone, joint, and/ or muscle pain have been reported in patients taking bisphosphonates.
Denne gruppe lægemidler inkluderer Zometa (zoledronsyre).
This category of drugs includes Zometa (zoledronic acid).
Nogle havde tilbagevendende symptomer ved gentagen behandling med samme lægemiddel eller med andre bisfosfonater.
A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate.
Zoledronsyre udviser ingen mærkbar binding til plasmaproteiner og hæmmer ikke de humane P450- enzymer in vitro (se afsnit 5. 2), men der er ikke udført nogen formelle kliniske interaktionsstudier.
Zoledronic acid shows no appreciable binding to plasma proteins and does not inhibit human P450 enzymes in vitro (see section 5.2), but no formal clinical interaction studies have been performed.
Der tilrådes forsigtighed, når bisfosfonater indgives sammen med aminoglykosider, da begge stoffer kan have en additiv effekt og give et lavere serumcalciumniveau i længere perioder end påkrævet.
Caution is advised when bisphosphonates are administered with aminoglycosides, since both agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required.
Der bør udvises forsigtighed når Zometa anvendes sammen med andre potentielt nefrotoksiske lægemidler.
Caution is indicated when Zometa is used with other potentially nephrotoxic drugs.
Hos patienter med multiple myelomer kan risikoen for nedsat nyrefunktion øges når intravenøse bisfosfonater anvendes i kombination med thalidomid.
In multiple myeloma patients, the risk of renal dysfunction may be increased when intravenous bisphosphonates are used in combination with thalidomide.
Reproduktionsstudier hos dyr med zoledronsyre har påvist reproduktionstoksicitet (se afsnit 5. 3).
Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Det er ikke kendt om zoledronsyre bliver udskildt med modermælken.
It is not known whether zoledronic acid is excreted into human milk.
Zometa er kontraindikeret hos kvinder der ammer (se afsnit 4. 3).
Zometa is contraindicated in breast-feeding women (see section 4.3).
Frekvensen af bivirkninger ved Zometa 4 mg er primært baseret på dataindsamlinger fra kronisk behandling.
Frequencies of adverse reactions for Zometa 4 mg are mainly based on data collection from chronic treatment.
Bivirkningerne ved Zometa ligner de bivirkninger der er observeret ved andre bisfosfonater og kan forventes at forekomme hos ca.
Adverse reactions to Zometa are similar to those reported for other bisphosphonates and can be expected to occur in approximately one third of patients.
1/ 3 af patienterne.
Intravenous administration has been most
9% af patienterne, inkluderende knoglesmerter (9, 1%), feber (7, 2%), træthed (4, 1%) og kulderystelser (2, 9%).
5 commonly associated with a flu-like syndrome in about 9% of patients, including bone pain (9.1%), fever (7.2%), fatigue (4.1%) and rigors (2.9%).
3%.
Occasionally cases of arthralgia and myalgia in approximately 3% have been reported.
Der findes ingen informationer om disse bivirkninger er reversible.
No information is available on the reversibility of these adverse effects.
20% af patienterne), som er asymptomatisk og ikke kræver behandling.
Frequently, the reduction in renal calcium excretion is accompanied by a fall in serum phosphate levels (in approximately 20% of patients), which is asymptomatic not requiring treatment.
3% af patienterne.
The serum calcium may fall to asymptomatic hypocalcaemic levels in approximately 3% of patients.
Der er observeret tilfælde af gastrointestinale reaktioner som kvalme (5, 8%) og opkastning (2, 6%) efter intravenøs infusion af Zometa.
Gastrointestinal reactions, such as nausea (5.8%) and vomiting (2.6%) have been reported following intravenous infusion of Zometa.
Der er i få tilfælde også observeret lokale reaktioner på infusionsstedet som rødme eller hævelse og/ eller smerter hos færre end 1% af patienterne.
Occasionally local reactions at the infusion site such as redness or swelling and/ or pain were also observed in less than 1% of the patients.
Der er indberettet anoreksi hos 1, 5% af patienterne behandlet med Zometa 4 mg.
Anorexia was reported in 1.5% of patients treated with Zometa 4 mg.
Der blev iagttaget få tilfælde af udslæt eller kløe (under 1%).
Few cases of rash or pruritus have been observed (below 1%).
1%.
As with other bisphosphonates, cases of conjunctivitis in approximately 1% have been reported.
Der er rapporteret nogle tilfælde af nedsat nyrefunktion (2, 3%); ætiologien synes dog i mange tilfælde at være multifaktoriel.
There have been some reports of impaired renal function (2.3%), although the aetiology appears to be multifactorial in many cases.
Der er, på baggrund af poolede analyser af placebo- kontrollerede studier, rapporteret svær anæmi (Hgb < 8, 0 g/ dl) hos 5, 2% af patienterne der fik Zometa 4 mg versus 4, 2% der fik placebo.
Based on pooled analysis of placebo controlled studies, severe anaemia (Hb < 8.0 g/ dl) was reported in 5.2% of patients receiving Zometa 4 mg versus 4.2% on placebo.
De følgende bivirkninger, opført i Tabel 1, er samlet fra kliniske forsøg efter fortrinsvis kronisk behandling med zoledronsyre:
The following adverse drug reactions, listed in Table 1, have been accumulated from clinical studies following predominantly chronic treatment with zoledronic acid:
Bivirkningerne er ordnet under overskrifter om hyppighed, den hyppigste først, ved brug af de følgende konventionelle regler: meget almindelig (≥1/ 10), almindelig (≥1/ 100, < 1/ 10), ualmindelig (≥1/ 1. 000, < 1/ 100), sjælden (≥1/ 10. 000, < 1/ 1. 000), meget sjælden (< 1/ 10. 000), inklusiv isolerede rapporter.
Very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1,000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1,000), very rare (< 1/ 10,000), including isolated reports.
6 Sygdomme i blod - og lymfesystem
6 Blood and lymphatic system disorders
Anæmi Thrombocytopeni, leukopeni Pancytopeni
Anaemia Thrombocytopenia, leukopenia Pancytopenia
Hovedpine Svimmelhed, paræstesier, smagsforstyrrelser, hypoaesthesi, hyperaesthesi, tremor
Headache Dizziness, paraesthesia, taste disturbance, hypoaesthesia, hyperaesthesia, tremor
Psykiske lidelser Øjensygdomme
Psychiatric disorders Eye disorders
Konjunktivitis Sløret syn Uveitis, episcleritis
Conjunctivitis Blurred vision Uveitis, episcleritis
Kvalme, opkastning, anoreksi Diarré, obstipation, abdominalsmerter, dyspepsi, stomatitis, mundtørhed
Nausea, vomiting, anorexia Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
Pruritus, udslæt (inklusiv erythematøst og makuløst udslæt), øget svedtendens
Pruritus, rash (including erythematous and macular rash), increased sweating
Sygdomme i bevægapparatet, bindevæv og knogler
Musculoskeletal, connective tissue and bone disorders
Muskelkramper
Muscle cramps
Hjerte- kar sygdomme Sygdomme i nyre og
Cardiovascular disorders Renal and urinary
Sjælden: urinveje Almindelig:
Rare: disorders Common:
Hypertension, hypotension Bradykardi Nedsat nyrefunktion Akut nyresvigt, hæmaturi, proteinuri
Hypertension, hypotension Bradycardia Renal impairment Acute renal failure, haematuria, proteinuria
Forstyrrelser i immunsystemet Almene lidelser og
Immune system disorders General disorders
Sjælden: reaktioner på indgivelsesstedet Almindelig
Rare: and administration site conditions Common:
Hypersensitivitets reaktioner Angioneurotisk ødem Feber, influenzalignende syndrom (inkluderende træthed, kulderystelser, utilpashed og hedeture)
Hypersensitivity reaction Angioneurotic oedema Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
Asteni, perifere ødemer, reaktioner ved injektionsstedet (inklusiv smerter, irritation, hævelse, induration), brystsmerter, vægtøgning
Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase
Afvigelser ved laboratorieanalyser
Laboratory abnormalities
Hypofosfatæmi Øgninger i serumkreatinin og serumurea, hypocalcæmi
Hypophosphataemia Blood creatinine and blood urea increased, hypocalcaemia
Hypomagnesæmi, hypokaliæmi Hyperkaliæmi, hypernatriæmi
Hypomagnesaemia, hypokalaemia Hyperkalaemia, hypernatraemia
I et 3- års, randomiseret, dobbeltblindt, kontrolleret studie, som evaluerede effekt og sikkerhed af zolendronsyre 5 mg én gang årligt versus placebo ved behandling af postmenopausal osteoporose (PMO), var den generelle forekomst af atrieflimren 2, 5% (96 ud af 3. 862) og 1, 9% (75 ud af 3. 852)
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.
Frekvensen af atrieflimren som alvorlig utilsigtigt hændelse var 1, 3% (51 ud af 3. 862) og 0, 6% (22 ud af 3. 852) hos patienter som fik henholdsvis zoledronsyre 5 mg og placebo.
The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Skævheden som blev observeret i studiet er ikke observeret i andre studier med zoledronsyre, ej heller i studier med Zometa (zoledronsyre) 4 mg hver 3- 4 uge i onkologiske patienter.
The imbalance observed in this trial has not been observed in 7 other trials with zoledronic acid, including those with Zometa (zoledronic acid) 4 mg every 3-4 weeks in oncology patients.
Mekanismen bag den øgede forekomst af atrieflimren i dette ene kliniske studier er ukendt.
The mechanism behind the increased incidence of atrial fibrillation in this single clinical trial is unknown.
Post- marketing erfaring Følgende bivirkninger er blevet rapporteret under brug af Zometa efter godkendelsen.
Post-marketing experience The following adverse reactions have been reported during post-approval use of Zometa.
Tilfælde af osteonekrose (primært i kæberne) er blevet rapporteret, overvejende hos cancerpatienter i behandling med bisfosfonater, herunder Zometa.
Cases of osteonecrosis (primarily of the jaws) have been reported, predominantly in cancer patients treated with bisphosphonates, including Zometa.
Mange af disse patienter viste tegn på lokal infektion inklusiv osteomyelitis, og størstedelen af rapporterne referer til cancerpatienter, som har fået trukket en tand ud eller har fået foretaget andre tandoperationer.
Many of these patients had signs of local infection including osteomyelitis, and the majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Der er mange dokumenterede risikofaktorer for osteonekrose i kæberne inklusiv cancer- diagnose, samtidige behandlinger (f. eks. kemoterapi, strålebehandling, kortikosteroider) og følgesygdomme (f. eks. anæmi, koagulationslidelse, infektion, præ- eksisterende orale sygdomme).
Osteonecrosis of the jaws has multiple documented risk factors including a diagnosis of cancer, concomitant therapies (e. g. chemotherapy, radiotherapy, corticosteroids) and co-morbid conditions (e. g. anaemia, coagulopathies, infection, pre-existing oral disease).
Selvom årsagen ikke er blevet bestemt, er det klogt at undgå tandoperationer, fordi helbredelsen kan blive forlænget (se afsnit 4. 4).
Although causality has not been determined, it is prudent to avoid dental surgery as recovery may be prolonged (see section 4.4).
I meget sjældne tilfælde er følgende hændelser blevet rapporteret: hypotension førende til synkope eller kredsløbskollaps, primært hos patienter med underliggende risikofaktorer, atrieflimren, somnolens, bronkokonstriktion, anafylaktisk reaktion/ shock og urticaria.
In very rare cases, the following events have been reported: hypotension leading to syncope or circulatory collapse, primarily in patients with underlying risk factors, atrial fibrillation, somnolence, bronchoconstriction, anaphylactic reaction/ shock, and urticaria.
Eftersom disse rapporter er fra en population af usikker størrelse og er påvirket af andre faktorer er det vanskeligt at vurdere kausaliteten og estimere frekvensen af hændelser.
Because these reports are from a population of uncertain size and are subject to confounding factors, it is difficult to assess causality and to estimate event incidence rates.
Patienter, som har fået højere doser end de anbefalede, bør derfor overvåges nøje, eftersom nedsat nyrefunktion (inklusiv nyresvigt) og serum- elektrolyt (inklusiv calcium, fosfor og magnesium) forstyrrelser er blevet observeret.
Patients who have received doses higher than those recommended should be carefully monitored, since renal function impairment (including renal failure) and serum electrolyte (including calcium, phosphorus and magnesium) abnormalities have been observed.
I tilfælde af hypocalcæmi bør calciumglukonat- infusioner administreres, hvis det er klinisk indikeret.
In the event of hypocalcaemia, calcium gluconate infusions should be administered as clinically indicated.