natgillin/translations-raw huggingface dataset:
Andel af patienter med SRE'er (%) p-værdi 
Proportion of patients with SREs (%) p-value
Det er på nuværende tidspunkt uklart, om zoledronsyre forårsager uregelmæssig hjerterytme, men du skal sige det til din læge, hvis du oplever sådanne symptomer efter, at du har fået zoledronsyre. 
It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received zoledronic acid.
I løbet af de første 24 timer findes 39±16% af den indgivne dosis i urinen, hvorimod den resterende mængde primært er bundet til knoglevævet. 
Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
Osteonekrose af andre anatomiske steder 
Osteonecrosis of other anatomical sites
Der har været meget sjældne tilfælde af døsighed og søvnighed ved brug af Zometa. 
There have been very rare cases of drowsiness and sleepiness with the use of Zometa.
Baseline kreatinin clearance (ml/min) 
Baseline creatinine clearance (ml/min)
Mekanismen bag den øgede forekomst af atrieflimren i dette ene kliniske studie er ukendt. 
The mechanism behind the increased incidence of atrial fibrillation in this single clinical trial is unknown.
Der er utilstrækkelige data fra anvendelse af zoledronsyre til gravide kvinder. 
There are no adequate data on the use of zoledronic acid in pregnant women.
Total legemsclearance er 5,04±2,5 l/h uafhængigt af dosis og uanset køn, alder, race og legemsvægt. 
The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Da der kun eksisterer begrænsede kliniske data for patienter med kraftigt nedsat leverfunktion, kan der ikke gives nogen specifikke anbefalinger for denne patientgruppe. 
As only limited clinical data are available in patients with severe hepatic insufficiency, no specific recommendations can be given for this patient population.
- Lavt blodtryk. 
Low blood pressure.
Behandling af TIH 
Treatment of TIH
Al ubrugt opløsning bør kasseres. 
Any unused solution should be discarded.
Fortæl lægen, hvis du er gravid eller tror, du er det. 
Tell your doctor if you are or think that you may be pregnant.
Alder, vægt, køn og kreatininclearance synes ikke at have nogen effekt på systemisk eksponering af zoledronsyre. 
Age, body weight, gender and creatinine clearance appear to have no effect on zoledronic acid systemic exposure.
Patienterne var lige fordelt mellem den zoledronsyrebehandlede og placebo grupperne. 
Patients were evenly distributed between zoledronic acid-treated and placebo groups.
Farmakoterapeutisk klassifikation: Midler til behandling af knoglesygdomme, bisfosfonater, ATCkode: M05BA08 
Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Behandlingseffekten var mindre udtalt hos patienter med blastiske læsioner. 
The treatment effects were less pronounced in patients with blastic lesions.
* Inkluderer vertebrale og non-vertebrale frakturer ** Indeholder alle skeletrelaterede hændelser, det totale antal samt tid til hver hændelse under undersøgelsen. 
* Includes vertebral and non-vertebral fractures ** Accounts for all skeletal events, the total number as well as time to each event during the trial NR Not Reached
Patienterne fik enten 4 mg zoledronsyre eller placebo hver fjerde uge i et år. 
Patients received either 4 mg zoledronic acid or placebo every four weeks for one year.
Det er ukendt, om zoledronsyre udskilles i human mælk. 
It is not known whether zoledronic acid is excreted into human milk.
Selv om der ikke blev observeret teratogenicitet eller føtal toksicitet hos kaniner, blev der observeret maternal toksicitet. 
Although no teratogenicity or foetotoxicity was observed in the rabbit, maternal toxicity was found.
Frakturer* 
Fractures*
Mange af disse patienter har også modtaget kemoterapi og kortikosteroider og viste tegn på lokal infektion inklusive osteomyelitis. 
Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Zometa bør kun genoptages, når serum-kreatinin igen er inden for 10% af baseline. 
Zometa should only be resumed when serum creatinine returns to within 10% of baseline.
Hvis opløsningen ikke bruges straks, skal den opbevares i køleskab ved 2 °C - 8 °C. 
If the solution is not used immediately, it should be stored in a refrigerator at 2°C - 8°C.
- Lavt niveau af calcium i blodet. 
Low level of calcium in the blood.
Der sås ingen akkumulering af zoledronsyre i plasma efter gentagne doser administreret hver 28. dag. 
There was no accumulation of zoledronic acid in plasma after multiple doses given every 28 days.
Hypokalcæmi er en vigtig, identificeret risiko ved Zometa ved de godkendte indikationer. 
Hypocalcaemia is an important identified risk with Zometa in the approved indications.
Figur 1 Gennemsnitlige ændringer fra baseline i BPI scoringer. 
Figure 1 Mean changes from baseline in BPI scores.
INFORMATION TIL SUNDHEDSPERSONALET 
INFORMATION FOR THE HEALTHCARE PROFESSIONAL
Forøgelse af infusionstiden fra 5 til 15 minutter forårsagede en 30% nedgang i zoledronsyre koncentrationen ved afslutningen af infusionen, men havde ingen effekt på areal under plasma koncentration mod tid kurven. 
Increasing the infusion time from 5 to 15 minutes caused a 30% decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve.
De fleste patienter havde symptomlindring efter afslutning af behandling. 
Most patients had relief of symptoms after stopping treatment.
- En nyresygdom, der hedder Fanconis syndrom (vil normalt blive fastslået af din læge med nogle bestemte urinprøver). 
A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Subkronisk og kronisk toksicitet 
Subchronic and chronic toxicity
Dato for første markedsføringstilladelse: 20.03.2001 Dato for seneste fornyelse: 20.03.2006 
Date of first authorisation: 20.03.2001 Date of latest renewal: 20.03.2006
CLcr beregnes ud fra serum-kreatinin ved brug af Cockeroft-Gault formlen. 
CLcr is calculated from serum creatinine using the Cockcroft-Gault formula.
Akut fase reaktion, smerte 
Acute phase reaction, pain
Kvinder i den fertile alder skal tilrådes at undgå at blive gravide. 
Women of child-bearing potential should be advised to avoid becoming pregnant.
Interpatient variabilitet med hensyn til farmakokinetiske parametre for zoledronsyre var højt, som det er set med andre bisfosfonater. 
The interpatient variability in pharmacokinetic parameters for zoledronic acid was high, as seen with other bisphosphonates.
Statistisk signifikante forskelle er markeret (*p<0,05) for sammenligning mellem behandlinger (4 mg zoledronsyre vs. placebo) 
Statistically significant differences are marked (*p<0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
1 flaske, 100 ml 
1 bottle, 100 ml
De estimerede behandlingseffekter på BMD var ens, men studiedesignet var ikke stærkt nok til at etablere en non-inferiør effekt for zoledronsyre. 
Estimated treatment effects on BMD were similar, but the trial design was not sufficiently robust to establish non-inferior efficacy for zoledronic acid.
Overhydrering bør undgås hos patienter med risiko for hjertesvigt. 
Overhydration should be avoided in patients at risk of cardiac failure.
Idet disse patienter kun blev efterbehandlet med en dosis på 8 mg, er der ingen tilgængelige data som sammenligner med en dosis på 4 mg zoledronsyre. 
Since those patients were retreated with the 8 mg dose only, there are no data available allowing comparison with the 4 mg zoledronic acid dose.
Der er intet, der tyder på, at der kræves særlige forholdsregler. 
There is no evidence to suggest that any extra precautions are needed.
Tumorer kan accelerere den normale knogleomsætning på en sådan måde, at afgivelsen af calcium fra knoglerne forøges. 
Tumours can accelerate normal bone change in such a way that the release of calcium from bone is increased.
Behandlingens start eller en ny behandling bør udskydes hos patienter med uhelede sår i det bløde væv i munden, undtaget i akutte medicinsk tilfælde. 
The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth, except in medical emergency situations.
Dato for første markedsføringstilladelse: 24.03.2003 Dato for seneste fornyelse: 20.03.2006 
Date of first authorisation: 24.03.2003 Date of latest renewal: 20.03.2006
Hvor meget Zometa skal du have - Den normale enkeltdosis er 4 mg. - Hvis du har problemer med nyrerne, vil lægen give dig en lavere dosis afhængig af sværhedsgraden af dine nyreproblemer. 
How much Zometa is given - The usual single dose given is 4 mg. - If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
Lægen, apotekspersonalet eller sundhedspersonalet ved, hvordan Zometa skal opbevares korrekt (se afsnit 6). 
Your doctor, pharmacist or nurse knows how to store Zometa properly (see section 6).
Patienter, der fik zoledronsyre 4 mg, indberettede mindre stigning i smerter end patienter, der fik placebo, og forskellen nåede signfikansniveauet ved måned 3, 9, 21 og 24. 
Patients receiving zoledronic acid 4 mg reported less increase in pain than those receiving placebo, and the difference reached significance at months 3, 9, 21 and 24.
Disse resultater forhindrede bestemmelsen af zoledronsyres definitive effekt på fertiliteten hos mennesker. 
Thus these results precluded determining a definitive effect of zoledronic acid on fertility in humans.
Fortolkning af risikoen for fraktur er vanskeliggjort af det faktum, at fraktur er en almindelig hændelse hos patienter med svær osteogenesis imperfecta som et led i sygdomsprocessen. 
Interpretation of the risk of fracture is confounded by the fact that fractures are common events in patients with severe osteogenesis imperfecta as part of the disease process.
Hvis hypokalcæmi, hypofosfatæmi eller hypomagnesiæmi forekommer kan supplement behandling være nødvendigt i kort tid. 
If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, short-term supplemental therapy may be necessary.
Hvidt til råhvidt pulver og klar, farveløs solvens. 
White to off-white powder and clear, colourless solvent.
- Lavt antal røde blodceller (anæmi). 
Low level of red blood cells (anaemia).
Fra knoglevævet afgives den meget langsomt tilbage til det systemiske kredsløb og elimineres gennem nyrerne. 
From the bone tissue it is released very slowly back into the systemic circulation and eliminated via the kidney.
SRE forekomsten (hændelser/person-år) var 0,628 for zoledronsyre og 1,096 for placebo. 
The SRE rate (events/person year) was 0.628 for zoledronic acid and 1.096 for placebo.
- Hvis du er i behandling for at nedsætte calciumindholdet i blodet, vil du som regel kun få én infusion med Zometa. 
- If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zometa.
Spørg din læge til råds, før du tager nogen form for medicin, mens du er gravid, eller hvis du ammer. 
Ask your doctor for advice before taking any medicine while you are pregnant or breast-feeding.
Zoledronsyres sikkerhed og virkning hos børn i alderen 1 år til 17 år er ikke klarlagt. 
The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established.
Mediantid til SRE (dage) 
Median time to SRE (days)
Mulige risikofaktorer for osteonekrose af øregangen inkluderer steroider og kemoterapi og/eller lokale risikofaktorer som infektioner eller traumer. 
Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Ubehandlede hyperkalcæmiske patienter har generelt nogen grad af nedsat nyrefunktion, hvorfor omhyggelig monitorering af nyrefunktionen bør overvejes. 
Untreated hypercalcaemia patients generally have some degree of renal function impairment, therefore careful renal function monitoring should be considered.
Indgivelse af doser op til 48 mg af zoledronsyre er fejlagtigt blevet rapporteret. 
The administration of doses up to 48 mg of zoledronic acid in error has been reported.
Midlertidig afbrydelse af zoledronsyrebehandling bør overvejes, indtil tilstanden er afhjulpet og bidragende risikofaktorer er mindsket så vidt muligt. 
Temporary interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Undersøgelser med forskellige typer af infusionsslanger fremstillet af polyvinylklorid, polyethylen og polypropylen viste ingen uforligelighed med Zometa. 
Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with Zometa.
Det er en inhibitor af osteoklastisk knogleresorption. 
It is an inhibitor of osteoclastic bone resorption.
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.
Bisfosfonaters selektive virkning på knogler er baseret på deres høje affinitet for mineraliseret knogle, men den præcise molekylære mekanisme, der fører til inhibition af osteoklastaktiviteten, er stadig ukendt. 
The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone, but the precise molecular mechanism leading to the inhibition of osteoclastic activity is still unclear.
- Thalidomid (medicin brugt til at behandle en bestemt type blodkræft, der involverer knoglerne) eller anden medicin, der kan skade nyrerne. 
- Thalidomide (a medicine used to treat a certain type of blood cancer involving the bone) or any other medicines which may harm your kidneys.
Hos patienter med multipelt myelom kan risikoen for nedsat nyrefunktion øges, når Zometa anvendes i kombination med thalidomid. 
In multiple myeloma patients, the risk of renal dysfunction may be increased when Zometa is used in combination with thalidomide.
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.
Hvis dit calciumniveau falder for meget, skal du måske have ekstra calcium tilført som infusion. 
If your level of calcium falls too low, you may have to be given supplemental calcium by infusion.
Hvor ofte skal du have Zometa - Hvis du er i forebyggende behandling for knoglekomplikationer pga. knoglemetastaser, vil du få en infusion af Zometa hver tredje til fjerde uge. 
How often Zometa is given - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zometa every three to four weeks.
hvis du er under tandlægebehandling eller skal have en tandoperation, bør du fortælle tandlægen, at du er i behandling med Zometa og informere din læge om tandlægebehandlingen. 
if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zometa and inform your doctor about your dental treatment.
Dystoci blev observeret ved den laveste dosis (0,01 mg/kg kropsvægt) testet i rotter. 
Dystocia was observed at the lowest dose (0.01 mg/kg bodyweight) tested in the rat.
For patienter med behov for tandoperationer er der ikke nogen tilgængelige data, der viser, om stop af behandlingen med bisfosfonater reducerer risikoen for osteonekrose af kæben. 
For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Smerte scoringen for zoledronsyre var konsekvent under baseline og smertereduktionen var ledsaget af en tendens til nedsat smertestillende score. 
The pain score for zoledronic acid was consistently below baseline and pain reduction was accompanied by a trend in reduced analgesics score.
Zoledronsyre var ikke mutagen i de udførte mutagenicitetsprøver, og undersøgelse af cancerogenicitet kunne ikke påvise cancerogent potentiale. 
Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
hvis du er allergisk over for zoledronsyre, et andet bisfosfonat (den gruppe af stoffer, som Zometa tilhører) eller et af de øvrige indholdsstoffer i Zometa (angivet i punkt 6). 
if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zometa belongs), or any of the other ingredients of this medicine (listed in section 6).
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.
- Lavt antal hvide blodceller og blodplader. 
Low counts of white blood cells and blood platelets.
Omryst hætteglasset forsigtigt for at opløse pulveret. 
Shake the vial gently to dissolve the powder.
Et tandeftersyn med passende forebyggende tandbehandling og en individuel benefit/risk-vurdering anbefales inden behandling med bisfosfonater hos patienter med samtidige risikofaktorer. 
A dental examination with appropriate preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with bisphosphonates in patients with concomitant risk factors.
Median tiden for fremkomst af den første SRE blev ikke nået i den zoledronsyrebehandlede studiearm ved slutningen af studiet og var signifikant forlænget sammenlignet med placebo (p=0,007). 
Median time to onset of the first SRE was not reached in the zoledronic acid-treated arm at the end of the study and was significantly prolonged compared to placebo (p=0.007).
Angst, søvnforstyrrelser 
Anxiety, sleep disturbance
Bivirkninger såsom svimmelhed og døsighed kan påvirke evnen til at føre motorkøretøj eller betjene maskiner, der skal derfor iagttages forsiktighed når Zometa anvendes i forbindelse med bilkørsel og betjening af maskiner. 
Adverse reactions, such as dizziness and somnolence, may have influence on the ability to drive or use machines, therefore caution should be exercised with the use of Zometa along with driving and operating of machinery.
Færre zoledronsyre 4 mg-patienter oplevede patologiske frakturer. 
Fewer zoledronic acid 4 mg patients suffered pathological fractures.
Ud over at være en potent hæmmer af knogleresorption, har zolendronsyre også adskillige anti-tumor egenskaber der kan bidrage til den samlede effekt i behandling af metastaserende knoglesygdom. 
In addition to being a potent inhibitor of bone resorption, zoledronic acid also possesses several antitumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease.
Det aktive stof i Zometa er zoledronsyre, der tilhører en gruppe af stoffer kaldet bisfosfonater. 
The active substance in Zometa is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Der bør udvises forsigtighed når Zometa anvendes sammen med andre potentielt nefrotoksiske lægemidler. 
Caution is indicated when Zometa is used with other potentially nephrotoxic medicinal products.
Lægen vil tage en blodprøve, inden du begynder behandling med Zometa, og vil med regelmæssige mellemrum kontrollere, hvordan du reagerer på behandlingen. 
Your doctor will carry out blood tests before you start treatment with Zometa and will check your response to treatment at regular intervals.
Følgende risikofaktorer skal tages i betragtning, når risikoen for at udvikle osteonekrose af kæberne skal vurderes hos den enkelte patient: - Bisfosfonatets potens (øget risiko ved højpotente stoffer), administrationsvej (øget risiko ved parenteral administration) og kumuleret dosis af bisfosfonater. 
The following risk factors should be considered when evaluating an individual's risk of developing ONJ: - Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
Selvom risikoen reduceres ved administration af 4 mg zoledronsyre over 15 minutter, kan der stadig opstå forværring af nyrefunktionen. 
While the risk is reduced with a dose of 4 mg zoledronic acid administered over 15 minutes, deterioration in renal function may still occur.
Skal anvendes straks efter åbning. 
Use immediately after first opening.
Zometa behandling bør genoptages med samme dosis som givet før afbrydelse af behandlingen. 
Zometa treatment should be resumed at the same dose as that given prior to treatment interruption.
Alle patienter bør opfordres til at opretholde en god mundhygiejne, gennemgå rutinemæssige tandeftersyn og straks rapportere eventuelle orale symptomer såsom tandmobilitet, smerter eller hævelse eller vedvarende sår eller sekretion under behandling med Zometa. 
All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Zometa.
Aseptiske teknikker skal anvendes under tilberedning af infusionen. 
Aseptic techniques must be followed during the preparation of the infusion.
Den højeste ikke-letale intravenøse enkeltdosis var 10 mg/kg legemsvægt hos mus og 0,6 mg/kg hos rotter. 
The highest non-lethal single intravenous dose was 10 mg/kg bodyweight in mice and 0.6 mg/kg in rats.
Begrænsede farmakokinetiske data hos børn med svær osteogenesis imperfecta indikerer, at zoledronsyres farmakokinetik hos børn i alderen 3 til 17 år er sammenlignelig med voksnes ved samme mg/kg dosisniveau. 
Limited pharmacokinetic data in children with severe osteogenesis imperfecta suggest that zoledronic acid pharmacokinetics in children aged 3 to 17 years are similar to those in adults at a similar mg/kg dose level.
Meget almindelig (forekommer hos flere end 1 ud af 10 patienter): - Lavt fosfatindhold i blodet. 
Very common (may affect more than 1 in 10 people): Low level of phosphate in the blood.
Behandlingsperioden var 12 måneder forudgået af en 4-9-ugers screeningsperiode, hvor der blev givet tilskud af calcium og D-vitamin i mindst 2 uger. 
The study treatment period was 12 months preceded by a 4- to 9-week screening period during which vitamin D and elemental calcium supplements were taken for at least 2 weeks.
Zometa indeholder 
What Zometa contains
Der eksisterer ingen farmakokinetiske data for zoledronsyre til patienter med hyperkalcæmi eller patienter med leverinsufficiens. 
No pharmacokinetic data for zoledronic acid are available in patients with hypercalcaemia or in patients with hepatic insufficiency.
Zometa indeholder den samme aktive substans som Aclasta (zoledronsyre). 
Zometa contains the same active substance as found in Aclasta (zoledronic acid).
Der er kun begrænsede farmakokinetiske data vedrørende patienter med svær nyreinsufficiens (kreatinineclearance <30 ml/min). 
Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
- Alvorlige overfølsomhedsreaktioner: åndenød, hævelse hovedsageligt i ansigt og hals. 
Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.