natgillin/translations-raw huggingface dataset:
I en pooled analyse af sikkerhedsdata fra zoledronsyre-registreringsstudier vedrørende forebyggelse af skelet-relaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser, var frekvensen af bivirkninger med relation til nedsat nyrefunktions og som formodes at være relateret til zoledronsyre, følgende: multipelt myeloma (3,2%), prostatacancer (3,1%), brystcancer (4,3%), lungecancer og andre solide tumorer (3,2%). 
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%).
Sløret syn, sklerit og orbital inflammation Uveitis 
Blurred vision, scleritis and orbital inflammation Uveitis
Meget sjælden (kan påvirke på til 1 ud af 10.000 patienter): - Besvimelse på grund af lavt blodtryk. 
Very rare (may affect up to 1 in 10,000 people): - Fainting due to low blood pressure.
Hvis du har hypokalcæmi, skal den korrigeres, inden du får den første dosis af Zoledronsyre Actavis. 
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid Actavis.
Din læge vil måske bede dig om at få et tandeftersyn, før du starter behandling med Zoledronsyre Actavis. 
Your doctor may recommend a dental examination before you start treatment with Zoledronic acid Actavis.
• Overfølsomhed over for det aktive stof, andre bisfosfonater eller over for et eller flere af hjælpestofferne angivet i pkt. 
• Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1
Der tilrådes forsigtighed, når Zoledronsyre Actavis 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. 
Caution is advised when Zoledronic acid Actavis 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.
Nedsat indhold af calcium i blodet (hypokalcæmi), som kan medføre muskelkramper, tør hud, en brændende følelse, er indberettet for patienter i behandling med Zoledronsyre Actavis. 
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.
- Forebyggelse af skeletrelaterede hændelser (patologiske frakturer, spinal kompression, strålebehandling eller operation af knogler, eller tumorinduceret hypercalcæmi) hos voksne patienter med fremskreden malign sygdom og knoglemetastaser. 
- 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.
Instruktion for tilberedning af reducerede doser af Zoledronsyre Actavis: Udtag det passende volumen af det flydende koncentrat efter følgende: 4,4 ml til 3,5 mg dosis 
Instructions for preparing reduced doses of Zoledronic acid Actavis: Withdraw the appropriate volume of the liquid concentrate, as follows: 4.4 ml for 3.5 mg dose
Analysen vedrørende gentagne hændelser afslørede en signifikant risikoreduktion på 16 % hos patienter behandlet med 4 mg zoledronsyre sammenlignet med patienter behandlet med pamidronat. 
The multiple event analysis revealed a significant risk reduction of 16% in patients treated with 4 mg zoledronic acid in comparison with patients receiving pamidronate.
I et tredje fase III randomiseret, dobbeltblindt studie blev 4 mg zoledronsyre eller 90 mg pamidronat administreret hver 3. til 4. uge sammenlignet hos patienter med multiple myelomer eller brystkræft og mindst én knoglelæsion. 
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.
Zoledronsyre Actavis leveres som et klart og farveløst koncentrat til infusionsvæske, opløsning (sterilt koncentrat), i et plastik hætteglas. 
Zoledronic acid Actavis is supplied as a clear and colourless concentrate for solution for infusion (sterile concentrate) in a plastic vial.
- Sig det til lægen, hvis du får øret og/eller betændelse i øret. 
- Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Fortæl det straks til din læge eller tandlæge, hvis du får sådanne symptomer, mens du er i behandling med Zoledronsyre Actavis eller efter behandlingsophør. 
Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic acid Actavis or after stopping treatment.
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. 
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.
EXP Holdbarhed efter fortynding: Se indlægsseddel. 
EXP Shelf life after dilution: See leaflet.
Ikke almindelig (kan påvirke op til 1 ud af 100 patienter): - Overfølsomhedsreaktioner. 
Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
Zoledronsyre Actavis indeholder natrium 
Zoledronic acid Actavis contains sodium
− hvis du har eller har haft smerte, hævelse eller fornemmelse af følelsesløshed i kæben, 
- 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.
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. 
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.
− Aktivt stof: Zoledronsyre. 
- The active substance is zoledronic acid.
Fortæl det altid til lægen, hvis du bruger anden medicin, har brugt det eller tror du har brugt det for nylig. 
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Zoledronsyre var teratogen hos rotter i subkutane doser på ≥ 0,2 mg/kg. 
Zoledronic acid was teratogenic in the rat at subcutaneous doses ≥ 0.2 mg/kg.
Opvearingsbetingelser for Zoledronsyre Actavis efter fortynding, se ”Holdbarhed efter fortynding” ovenfor. 
- For storage conditions of Zoledronic acid Actavis after dilution, see “Shelf life after dilution”
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. 
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.
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. 
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.
Muskelspasmer, osteonekrose af kæberne Osteonekrose af øregangen (klasse-bivirkning for bisfosfonater) og andre anatomiske steder, inklusive femur og hofte. 
Muscle spasms, osteonecrosis of the jaw Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé, pkt. 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) .
Patienternes hydreringsstatus skal vurderes før og efter indgivelsen af Zoledronsyre Actavis for at sikre, at de er tilstrækkeligt hydrerede. 
The hydration status of patients must be assessed prior to and following administration of Zoledronic acid Actavis to ensure that they are adequately hydrated.
Du må ikke få Zoledronsyre Actavis: 
You should not be given Zoledronic acid Actavis:
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. 
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
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKER TIL HÆTTEGLAS 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR VIALS
Resultaterne viste, at 4 mg zoledronsyre havde sammenlignelig effekt med 90 mg pamidronat til forebyggelse af skeletrelaterede hændelser (SRE). 
The results demonstrated that 4 mg zoledronic acid showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
- Interstitiel lungesygdom (inflammation i vævet omkring lungernes alveoler) - Influenza-lignende symptomer herunder gigt (artritis) og hævede led. 
- Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) - Flu-like symptoms including arthritis and joint swelling.
− 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. 
- 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.
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. 
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.
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). 
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).
Du bør ikke få Zoledronsyre Actavis, hvis du er gravid. 
You should not be given Zoledronic acid Actavis if you are pregnant.
4.1 og 4.2, indgivet samtidig med almindeligt anvendte anticancerlægemidler, diuretika, antibiotika og analgesika uden tilsyneladende kliniske interaktioner. 
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.
Et hætteglas indeholder 5 ml opløsning. 
One vial contains 5 ml of solution.
Patienter i behandling med Zoledronsyre Actavis bør få udleveret indlægssedlen og patienthuskekortet. 
Patients treated with Zoledronic acid Actavis should be given the package leaflet and the patient reminder card.
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, 
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.
Pakningstørrelser og yderligere oplysninger Zoledronsyre Actavis indeholder 
Contents of the pack and other information What Zoledronic acid Actavis contains
Det skal du vide, før du får Zoledronsyre Actavis 
What you need to know before you are given Zoledronic acid Actavis
Osteonekrose af kæberne (ONK) er blevet rapporteret med frekvensen ”ikke almindelig” i kliniske forsøg og efter markedsføring hos patienter behandlet med zoledronsyre. 
Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
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. 
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)
I kliniske forsøg med zoledronsyre blev patienter med serum-kreatinin > 265 mikromol/l eller > 3,0 mg/dl ekskluderet. 
In clinical trials with zoledronic acid, patients with serum creatinine > 265 micromol/l or > 3.0 mg/dl were excluded.
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). 
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).
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 . 
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.
Asteni, perifere ødemer, reaktioner ved injektionsstedet (inklusive smerter, irritation, hævelse, induration), brystsmerter, vægtøgning, anafylaktisk reaktion/shock, urticaria 
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
− Brug ikke Zoledronsyre Actavis efter den udløbsdato, der står på hætteglasset og pakningen, efter EXP. 
- 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.
Sjælden (kan påvirke op til 1 ud 1000 patienter): - Som en konsekvens af lave calcium-værdier: uregelmæssig hjerterytme (hjertearytmi; 
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).
Sjælden (kan påvirke op til 1 ud 1000 patienter): - Langsom hjerterytme. 
Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
− Opløsningen indeholdende zoledronsyre indgives ved en enkelt intravenøs infusion over 15 minutter i en seperat infusionsslange. 
- The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
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. 
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.
− hvis du ammer. 
- if you are breast-feeding.
Det er ikke nødvendigt at dosisjustere patienter med TIH og serum-kreatinin < 400 mikromol/l eller < 4,5 mg/dl (se afsnit 4.4). 
No dose adjustment is necessary in TIH patients with serum creatinine < 400 micromol/l or < 4.5 mg/dl (see section 4.4).
Den udtagne mængde af koncentratet skal fortyndes yderligere i 100 ml sterilt 0,9% w/v natriumklorid- eller 5% w/v glukoseopløsning. 
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.
Der er rapporteret forværring af nyrefunktion, progression til nyresvigt samt dialyse hos patienter efter initial dosis eller enkeltdosis af 4 mg zoledronsyre (se pkt. 
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).
Almindelig (kan påvirke op til 1 ud af 10 patienter): - Hovedpine og influenzalignende symptomer som feber, træthed, svaghed, døsighed, 
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.
- 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. 
- 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.
Når behandling med Zoledronsyre Actavis initieres hos patienter med multiple myelom eller knoglemetastatisk skade fra solide tumorer bør serum-kreatinin og kreatininclearence (CLcr) bestemmes. 
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.
Anbefalet dosis af Zoledronsyre Actavis* 
Zoledronic acid Actavis recommended dose*
Koncentrat til infusionsvæske, opløsning 1 x 5 ml hætteglas 
Concentrate for solution for infusion 1 x 5 ml vial
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. 
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.
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. 
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.
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. 
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).
Zoledronsyre Actavis 4 mg/5 ml sterilt koncentrat zoledronsyre 
Zoledronic acid Actavis 4 mg/5 ml sterile concentrate zoledronic acid
Tabel 2: Effektresultater (patienter med prostatacancer i hormonbehandling) Enhver SRE (+TIH) 
Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy)
Brug af anden medicin sammen med Zoledronsyre Actavis 
Other medicines and Zoledronic acid Actavis
I kliniske forsøg blev patienter med serum-kreatinin > 400 mikromol/l eller > 4,5 mg/dl ekskluderet. 
In the clinical studies, patients with serum creatinine > 400 micromol/l or > 4.5 mg/dl were excluded.
Der er andre lægemidler tilgængelige til osteoporose-indikationer og behandling af Pagets knoglesygdom, som indeholder zoledronsyre som det aktive indholdsstof. 
Other products containing zoledronic acid as active substances are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Indlægsseddel: Information til brugeren Zoledronsyre Actavis 4 mg/5 ml koncentrat til infusionsvæske, opløsning zoledronsyre 
Package leaflet: Information for the user Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ} Andre informationskilder 
This leaflet was last revised in {month YYYY}.
4.1 og 4.2, er blevet forbundet med rapporter om nedsat nyrefunktion. 
Zoledronic acid, used as indicated in sections 4.1 and 4.2, has been associated with reports of renal dysfunction.
Mens du er i behandling med Zoledronsyre Actavis, skal du holde en god mundhygiejne (inkl. 
While being treated with Zoledronic acid Actavis, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Du må ikke få Zoledronsyre Actavis, hvis du ammer. 
You must not be given Zoledronic acid Actavis if you are breast-feeding.
(< 1,4 mg/dl eller < 124 mikromol/l). 
1.0 mg/dl or 88 micromol/l.
55,6% (p = 0,021)* 83,3% (p = 0,010)* 86,7% (p = 0,015)* 
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.
4.1 og 4.2), og reaktionen er også refereret til ved brug af termerne ”influenza-lignende symptomer” eller ”symptomer efter dosering”. 
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.
10 x 5 ml hætteglas 
10 x 5 ml vials
For at undgå eventuelle uforligeligheder skal der som infusionsvæske til fortynding enten bruges 0,9% w/v natriumchlorid- eller 5% w/v glucoseopløsning. 
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.
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 
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
Svimmelhed, paræstesier, dysgeusi, hypæstesi, hyperæstesi, tremor, somnolens Kramper, hypæstesi og tetani (sekundært til hypokalcæmi) 
Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence