natgillin/translations-raw huggingface dataset:
Ved erfaring efter markedsføring er der rapporteret om alvorlige og lejlighedsvis invaliderende knogle, led-, og/eller muskelsmerter hos patienter i behandling med zoledronsyre. 
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking zoledronic acid.
I betragtning af zoledronsyres potentielle indflydelse på nyrefunktionen, manglende omfattende kliniske sikkerhedsdata hos patienter med alvorlig nedsat nyrefunktion (i kliniske studier defineret som serumkreatinin 400 mol/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 zoledronsyre ikke anbefales til patienter med alvorlig nedsat nyrefunktion. 
In view of the potential impact of zoledronic acid 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 zoledronic acid is not recommended in patients with severe renal impairment.
Inden for 3 dage efter indgivelse af zoledronsyre, er en akut fasereaktion almindeligvis blevet indrapporteret med symptomer som knoglesmerter, feber, træthed, artralgi, myalgi, stivhed og artritis med efterfølgende hævede led; disse symptomer aftager som regel inden for få dage (se beskrivelse af udvalgte bivirkninger). 
Within three days after zoledronic acid administration, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Baseret på evalueringen af både kliniske studier og tilfælde post-marketing er der tilstrækkelig evidens til at understøtte en sammenhæng mellem behandling med zoledronsyre og de rapporterede tilfælde af hypokalcæmi og den sekundære udvikling af hjertearytmi. 
Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between zoledronic acid therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
- Lavt indhold af magnesium og kalium i blodet. 
• Low level of magnesium and potassium in the blood.
Zoledronsyre anbefales ikke til patienter, der før behandlingen initieres, har svær nyreinsufficiens, som i denne population er defineret som CLcr < 30 ml/min. 
Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
- Anden medicin, der også indeholder zoledronsyre og bruges til at behandle knogleskørhed og andre ikke-kræft sygdomme i knoglerne, eller andre bisfosfonater, da den kombinerede effekt af at tage disse lægemidler sammen med Zoledronsyre Accord er ukendt. 
• Other medicines that also contain zoledronic acid and are used to treat osteoporosis and other non-cancer diseases of the bone, or any other bisphosphonate, since the combined effects of these medicines taken together with Zoledronic Acid Accord are unknown.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX
I det kliniske program fik patienter i alderen 1 til < 3 år 0,025 mg/kg zoledronsyre (i en maksimal engangsdosis på op til 0,35 mg) hver 3. måned, og patienter i alderen 3 til 17 år fik 0,05 mg/kg zoledronsyre (i en maksimal engangsdosis på op til 0,83 mg) hver 3. måned. 
In the clinical programme patients aged 1 to < 3 years received 0.025 mg/kg zoledronic acid (up to a maximum single dose of 0.35 mg) every 3 months and patients aged 3 to 17 years received 0.05 mg/kg zoledronic acid (up to a maximum single dose of 0.83 mg) every 3 months.
- Følg nøje alle de andre instruktioner, som du har fået af din læge, på apoteket eller af sundhedspersonalet. 
• Carefully follow all the other instructions given to you by your doctor, pharmacist or nurse.
- Smertefuld rødme og/eller hævelse af øjet. 
• Painful redness and/or swelling of the eye.
Da der ikke eksisterer data om forligeligheden af Zoledronsyre Accord med andre intravenøst indgivne stoffer, må Zoledronsyre Accord ikke blandes med andre lægemidler eller stoffer og bør altid indgives gennem en separat infusionsslange 
• Since no data are available on the compatibility of Zoledronic Acid Accord with other intravenously administered substances, Zoledronic Acid Accord must not be mixed with other medications/substances and should always be given through a separate infusion line.
- Anti-angiogenetisk medicin (brugt til behandling af kræft), da kombination af dette og Zoledronsyre Accord har været forbundet med en øget risiko for osteonekrose i kæberne. 
• Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
Følgende risikofaktorer skal tages i betragtning, når risikoen for at udvikle osteonekrose af kæberne skal vurderes hos den enkelte patient: 
The following risk factors should be considered when evaluating an individual's risk of developing ONJ:
Øvrige indholdsstoffer: mannitol, natriumcitrat, vand til injektionsvæsker. 
• The other ingredients are: mannitol, sodium citrate, water for injections.
Populationsanalyser viste, at for en patient med en kreatinineclearance på 20 ml/min (svær nyreinsufficiens) eller på 50 ml/min (moderat insufficiens), skulle den tilsvarende beregnede clearance af zoledronsyre være henholdsvis 37 % eller 72 % af clearance hos en patient med en kreatinineclearance på 84 ml/min. 
Population analysis showed that for a patient with creatinine clearance of 20 ml/min (severe renal impairment), or 50 ml/min (moderate impairment), the corresponding predicted clearance of zoledronic acid would be 37% or 72%, respectively, of that of a patient showing creatinine clearance of 84 ml/min.
Hvis du har hypokalcæmi, skal den korrigeres, inden du får den første dosis af Zoledronsyre Accord. 
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic Acid Accord.
DATO FOR ÆNDRING AF TEKSTEN Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu 
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
- Kraftige knogle-, led- og/eller muskelsmerter, lejlighedsvis invaliderende. 
• Severe bone, joint and/or muscle pain, occasionally incapacitating.
Din læge vil måske bede dig om at få et tandeftersyn, før du starter behandling med Zoledronsyre Accord. 
Your doctor may recommend a dental examination before you start treatment with Zoledronic Acid Accord.
Der skal udvises forsigtighed, når Zoledronsyre Accord gives sammen med lægemidler, der vides at forårsage hypokalcæmi, da de kan have en synergistisk effekt, resulterende i svær hypokalcæmi (se pkt 4.5). 
Caution is advised when Zolendronc Acid Accord is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Nedsat indhold af calcium i blodet (hypokalcæmi), som kan medføre muskelkramper, tør hud, en brændende følelse, er indberettet for patienter i behandling med Zoledronsyre Accord. 
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 Accord.
Smerte i ekstremiteter, artralgi, muskuloskeletal smerte 
Pain in extremities, arthralgia, musculoskeletal pain
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). 
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).
- Usædvanlige brud på lårbensknoglen, primært hos patienter i langtidsbehandling for osteoporose kan forekomme i sjældne tilfælde. 
• Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med referencelægemidlet 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. 
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).
Zoledronsyre bør kun genoptages, når serum-kreatinin igen er inden for 10 
Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline.
Opbevaringsbetingelser for den rekonstituerede infusionsvæske, se pkt. 
For storage conditions of the reconstituted solution for infusion, see section 6.3.
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): 
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):
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/834/001 
MARKETING AUTHORISATION NUMBERS EU/1/13/834/001
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. 
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.
hvis du har eller har haft smerte, hævelse eller fornemmelse af følelsesløshed i kæben, følelsen af tyngde i kæben eller af løse tænder. 
• 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.
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. 
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.
Patienternes hydreringsstatus skal vurderes før og efter indgivelsen af Zoledronsyre Accord for at sikre, de er tilstrækkeligt hydrerede. 
The hydration status of patients must be assessed prior to and following administration of Zoledronic Acid Accord to ensure that they are adequately hydrated.
Fortæl det straks til din læge eller tandlæge, hvis du får sådanne symptomer, mens du er i behandling med Zoledronsyre Accord eller efter behandlingsophør. 
Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic Acid Accord or after stopping treatment.
LISTE OVER HJÆLPESTOFFER Hjælpestoffer: mannitol (E421), natriumcitrat og vand til injektionsvæske. 
Excipients: mannitol (E421), sodium citrate and water for injections.
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 
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
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). 
• 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
Sløret syn, tåreflåd, lysfølsomhed i øjnene. 
• Blurred vision, tearing of the eye, eye sensitivity to light.
Cancer, følgesygdomme (fx anæmi, koagulationslidelse, infektion), rygning. 
Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Analysen vedrørende gentagne hændelser afslørede en signifikant risikoreduktion på 16 % hos patienter behandlet med zoledronsyre 4 mg sammenlignet med patienter behandlet med pamidronat. 
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.
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. 
Other medicines and Zoledronic Acid Accord Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLASSETS ETIKET 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
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. 
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%).
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. 
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.
Pludselig opstået kuldefølelse med besvimelse, slaphed eller kollaps. 
• Sudden coldness with fainting, limpness or collapse.
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.
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.
Hos patienter med let til moderat nedsat nyrefunktion anbefales nedsatte doser af zoledronsyre (se afsnittet ”Dosering” ovenfor samt pkt. 
In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
Serumcalcium bør måles og hypokalcæmi korrigeres, inden behandling med Zoledronsyre Accord påbegyndes. 
Serum calcium should be measured and hypocalcaemia must be corrected before initiating Zoledronic Acid Accord therapy.
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. 
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.
Aktivt stof: zoledronsyre. 
• The active substance is zoledronic acid.
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. 
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.
- Der er i meget sjældne tilfælde set osteonekrose af andre knogler end kæben, særligt af hoften eller låret. 
• Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
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. 
• 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.
- Uregelmæssig hjerterytme (atrieflimren) er set hos patienter, der fik zoledronsyre for postmenopausal osteoporose. 
• Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Zoledronsyre Accord må kun udskrives og administreres til patienter af sundhedspersonale med erfaring i administration af intravenøse bisfosfonater. 
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.
4.2), 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 (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.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 5 ml 
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
- Sig det til lægen, hvis du får øresmerter, udflåd fra øret og/eller betændelse i øret. 
• Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Du bør ikke få Zoledronsyre Accord, hvis du er gravid. 
You should not be given Zoledronic Acid Accord if you are pregnant.
Hjertearytmi og neurologiske bivirkninger (herunder kramper, hypæstesi og tetani) er blevet rapporteret sekundært til tilfælde af alvorlig hypokalcæmi. 
Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoasthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Skeletal morbiditets rate p-værdi 
p-value Skeletal morbidity rate p-value
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. 
• 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.
Tabel 4: Effektresultater (patienter med brystcancer eller multipelt myelom) 
Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
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). 
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).
Sjælden (forekommer hos op til 1 ud af 1.000 patienter): 
Rare (may affect up to 1 in 1,000 people):
- Forhøjet blodtryk, åndenød, svimmelhed, angst, søvnforstyrrelser, smagsforstyrrelser, rysten, følelsesløshed eller prikkende fornemmelse i hænder eller fødder, diarré, forstoppelse, mavesmerter, mundtørhed. 
• High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea constipation,
EU/1/13/834/001- 1 hætteglas EU/1/13/834/002- 4 hætteglas EU/1/13/834/003- 10 hætteglas 
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
I kliniske forsøg med zoledronsyre blev patienter med serum-kreatinin > 265 mol/l eller > 3,0 mg/dl ekskluderet. 
In clinical trials with zoledronic acid, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded.
Opløsningen indeholdende zoledronsyre indgives ved en enkelt intravenøs infusion over 15 minutter i en separat infusionsslange. 
• The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Anvendes straks efter fortynding. 
EXP Use immediately after dilution.
Tabel 3: Effektresultater (solide tumorer udover bryst- og prostatacancer) 
Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Voksne og ældre 
Children and adolescents
anvendelse efter fortynding 
use after dilution
Tandsygdom i anamnesen, dårlig mundhygiejne, parodontal sygdom, invasiv tandbehandling (fx tandudtrækninger) og dårligt tilpassede tandproteser. 
History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures (e.g. tooth extractions) and poorly fitting dentures
Det er ikke nødvendigt at dosisjustere patienter med TIH og serum-kreatinin < 400 μmol/l eller < 4,5 mg/dl (se afsnit 4.4). 
No dose adjustment is necessary in TIH patients with serum creatinine < 400 µmol/l or < 4.5 mg/dl (see section 4.4).