natgillin/translations-raw huggingface dataset:
Bivirkningerne er ordnet under overskrifter om hyppighed, den hyppigste først, ved brug af de følgende konventionelle regler: 
Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention:
Kemisk og fysisk brugsstabilitet er demonstreret i 36 timer ved 2-8 °C. 
Chemical and physical in-use stability has been demonstrated for 36 hours at 2 - 8 °C.
Tabel 5: Andel af patienter med fuldt respons pr. dag i de kombinerede TIH-studier 
Table 5: Proportion of complete responders by day in the combined TIH studies
Erhvervet Fanconis syndrom 
Acquired Fanconi syndrome
Zoledronsyre Accord kan gives til patienter i alderen 65 år og derover. 
Zoledronic Acid Accord can be given to people aged 65 years and over.
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.
Hvis du har fået mere Zoledronsyre Accord, end du skulle have haft Hvis du har fået højere doser end dem, der er anbefalet, skal du nøje overvåges af din læge. 
If you are given more Zoledronic Acid Accord than you should be If you have received doses higher than those recommended, you must be carefully monitored by your doctor.
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.
Efter fortynding: Ud fra et mikrobiologisk synspunkt skal lægemidlet anvendes straks. 
After dilution: From a microbiological point of view, the product should be used immediately.
• Periodiske, opdaterede sikkerhedsindberetninger (PSUR) 
• Periodic safety update reports
- Hvis du har problemer med nyrerne, vil lægen give dig en lavere dosis afhængig af sværhedsgraden af dine nyreproblemer. 
• If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
Du eller din pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel. 
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende 
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
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.
* 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
Bisfosfonatets potens (øget risiko ved højpotente stoffer), administrationsvej (øget risiko ved parenteral administration) og kumuleret dosis af bisfosfonater. 
Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
Der har været meget sjældne tilfælde af døsighed og søvnighed ved brug af Zoledronsyre Accord. 
There have been very rare cases of drowsiness and sleepiness with the use of Zoledronic Acid Accord.
- 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).
Figur 1: Gennemsnitlige ændringer fra baseline i BPI scoringer. 
Mean changes from baseline in BPI scores.
- Lavt antal røde blodceller (anæmi). 
• Low level of red blood cells (anaemia).
Hvis den ikke anvendes straks, er opbevaringstid og -betingelser før brug brugerens ansvar og bør normalt ikke overstige 24 timer ved 2 °C-8 °C. 
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C.
- Lavt blodtryk. 
• Low blood pressure.
- 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.
- Lavt niveau af calcium i blodet. 
• Low level of calcium in the blood.
- Forvirring. 
• Confusion.
NA - Ikke relevant (Not Applicable) 
NA-Not Applicable
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.
Tabel 6: Bivirkninger observeret hos pædiatriske patienter med svær osteogenesis imperfecta1 
Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1
Lægen, apotekspersonalet eller sundhedspersonalet ved, hvordan Zoledronsyre Accord skal opbevares korrekt (se afsnit 6). 
Your doctor, pharmacist or nurse knows how to store Zoledronic Acid Accord properly (see section 6).
- Lavt antal hvide blodceller og blodplader. 
• Low counts of white blood cells and blood platelets.
319, Pinner Road North Harrow, Middlesex HA1 4HF Storbritannien 
319, Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom
Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, hvilket vil sige, at det praktisk talt er natriumfrit. 
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Dato for første markedsføringstilladelse: 16.01.2014 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16.01.2014
Nyreinsufficiens TIH: 
Renal impairment TIH:
Ud over at være en potent hæmmer af knogleresorption, har zoledronsyre 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 anti-tumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease.
- Brug ikke Zoledronsyre Accord efter den udløbsdato, der står på pakningen. 
• Do not use Zoledronic Acid Accord after the expiry date stated on the pack.
Hvis der kræves en nedsat dosis af Zoledronsyre Accord, skal der først udtages en passende volumen som beskrevet nedenfor, som derefter skal fortyndes yderligere med 100 ml infusionsopløsning. 
If a lower dose of Zoledronic Acid Accord is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Zoledronsyre Accord leveres i pakninger, som indeholder 1, 4 eller 10 hætteglas. 
Zoledronic Acid Accord is supplied as packs containing 1, 4 or 10 vials.
- Den fortyndede Zoledronsyre Accord infusionsvæske bør anvendes straks for at undgå mikrobiologisk kontaminering. 
The diluted Zoledronic Acid Accord infusion solution should be used immediately in order to avoid microbial contamination.
Yderligere information om håndtering af Zoledronsyre Accord, inklusive vejledning om forberedelse af nedsatte doser er angivet i pkt. 
Additional information on handling of Zoledronic Acid Accord, including guidance on preparation of reduced doses, is provided in section 4.2.
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.
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.
I kliniske studier blev behandling med zoledronsyre først genoptaget når kreatinin-niveauet faldt inden for 10 % over baselineværdien (se afsnit 4.4). 
In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Der er hos nogen patienter også set stigninger i serum-kreatinin ved kronisk administration af zoledronsyre 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 zoledronic acid at recommended doses for prevention of skeletal related events, although less frequently.
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 Zoledronsyre Accord. 
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 Zoledronic Acid Accord.
Ud fra et mikrobiologisk synspunkt skal den fortyndede opløsning til infusion anvendes straks. 
From a microbiological point of view, the diluted solution for infusion should be used immediately.
Lægen vil tage en blodprøve, inden du begynder behandling med Zoledronsyre Accord, og vil med regelmæssige mellemrum kontrollere, hvordan du reagerer på behandlingen. 
Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Accord and will check your response to treatment at regular intervals.
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.
Det aktive stof i Zoledronsyre Accord er zoledronsyre, der tilhører en gruppe af stoffer kaldet bisfosfonater. 
The active substance in Zoledronic Acid Accord is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Undersøgelser med forskellige typer af infusionsslanger fremstillet af polyvinylklorid, polyethylen og polypropylen viste ingen uforligelighed med Zoledronsyre Accord. 
• Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with Zoledronic Acid Accord.
For instruktioner om fortynding af zoledronsyre før administration, se pkt. 
For instructions on the dilution of zoledronic acid before administration, see section 6.6.
Pakninger indeholdende henholdsvis 1, 4 eller 10 hætteglas. 
Packs containing 1, 4 or 10 vials.
Hvis det ikke anvendes straks, er opbevaringstid og -betingelser før brug brugerens ansvar og bør normalt ikke overstige 24 timer ved 2 °C til 8 °C, medmindre fortynding er sket under kontrollerede og validerede antiseptiske forhold. 
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
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).
Standard hyperkalcæmirelaterede metabolske parametre som serumniveauer af calcium, fosfat og magnesium, bør monitoreres grundigt efter påbegyndt behandling med zoledronsyre. 
Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating zoledronic acid therapy.
Bivirkninger såsom svimmelhed og døsighed kan påvirke evnen til at føre motorkøretøj eller betjene maskiner, der skal derfor iagttages forsigtighed, når Zoledronsyre Accord 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 Zoledronic Acid Accord along with driving and operating of machinery.
Du kan finde yderligere information om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu 
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Efter påbegyndelse af infusion med zoledronsyre, øges plasmakoncentrationen af zoledronsyre hurtigt, og maksimal koncentration nås ved slutningen af infusionsperioden, efterfulgt af et hurtigt fald til <10 % af maksimalkoncentrationen efter 4 timer og < 1 % af maksimalkoncentrationen efter 24 timer, med en efterfølgende forlænget periode med meget lave koncentrationer der ikke overstiger 0,1% af den maksimale koncentration inden den 2. infusion af zoledronsyre på dag 28. 
After initiating the infusion of zoledronic acid, the plasma concentrations of zoledronic acid rapidly increased, achieving their peak at the end of the infusion period, followed by a rapid decline to < 10% of peak after 4 hours and < 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak prior to the second infusion of zoledronic acid on day 28.
Intravenøst indgivet zoledronsyre elimineres i en trifasisk proces: hurtig bifasisk elimination fra det systemiske kredsløb med halveringstider på t½ 0,24 og t½ 1,87 timer efterfulgt af en lang elimineringsfase med en terminal eliminationshalveringstid på t½γ 146 timer. 
Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
I kliniske studier er zoledronsyre indgivet samtidig med almindeligt anvendte anticancerlægemidler, diuretika, antibiotika og analgesika uden tilsyneladende kliniske interaktioner. 
In clinical studies, zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Andelen af patienter med mindst én SRE (eksklusiv hyperkalcæmi) var 29,8 % i den zoledronsyrebehandlede gruppe sammenlignet med 49,6 % i placebo gruppen (p=0,003). 
The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the zoledronic acid-treated group versus 49.6% in the placebo group (p=0.003).
hvis du er under tandlægebehandling eller skal have en tandoperation, bør du fortælle tandlægen, at du er i behandling med Zoledronsyre Accord 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 Zoledronic Acid Accord and inform your doctor about your dental treatment.
- Alvorlige overfølsomhedsreaktioner: åndenød, hævelse hovedsageligt i ansigt og hals. 
• Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
- Hvis du er i behandling for at nedsætte calciumindholdet i blodet, vil du som regel kun få én infusion med Zoledronsyre Accord. 
• If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic Acid Accord.
Behandling af voksne patienter med tumorinduceret hyperkalcæmi (TIH). 
Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Efter markedsføringen er følgende bivirkninger blevet rapporteret (hyppighed sjælden): Atypiske subtrokantære og diafyseale femurfrakturer (bisfosfonat klasseeffekt). 
During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).
Zoledronsyre Accord indeholder den samme aktive substans som Aclasta (zoledronsyre). 
Zoledronic Acid Accord contains the same active substance as found in Aclasta (zoledronic acid).
Starttidspunktet er ≤ 3 dage efter infusion med zoledronsyre, og reaktionen er også refereret til ved brug af termerne ”inluenza-lignende symptomer” eller ”symptomer efter dosering”. 
The onset time is ≤ 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Den anbefalede dosis ved hyperkalcæmi (albumin-korrigeret serumcalcium ≥12,0 mg/dl eller 3,0 mmol/l) er en enkelt dosis på 4 mg zoledronsyre. 
The recommended dose in hypercalcaemia (albumin-corrected serum calcium ≥12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
Patienter skal holdes velhydrerede før og efter administration af zoledronsyre. 
Patients must be maintained well hydrated prior to and following administration of zoledronic acid.
- Det uåbnede hætteglas kræver ingen særlige forholdsregler vedrørende opbevaringen. 
• The unopened vial does not require any specific storage conditions.
Patienter, der er i kemoterapi og/eller strålebehandling, som er i steroidbehandling, som skal have en tandoperation, som ikke går til regelmæssige tandeftersyn, som har sygdomme i tandkødet, som er rygere eller som tidligere har været i behandling med bisfosfonater (bruges til at forebygge knoglesygdomme) kan have en højere risiko for at udvikle osteonekrose i kæberne. 
Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have higher risk of developing osteonecrosis of the jaw.
Plasmaproteinbindingen er lav med den ubundne fraktion varierende fra 60 % ved 2 ng/ml til 77 % ved 2.000 ng zoledronsyre/ml. 
The plasma protein binding is low, with the unbound fraction ranging from 60% at 2 ng/ml to 77% at 2000 ng/ml of zoledronic acid
Sundhedspersonalet rådes til ikke at smide ubrugt Zoledronsyre Accord i kloaken. 
Healthcare professionals are advised not to dispose of unused Zoledronic Acid Accord via the domestic sewage system.
Børn og teenagere Zoledronsyre Accord bør ikke bruges til børn og teenagere under 18 år. 
Zoledronic Acid Accord is not recommended for use in adolescents and children below the age of 18 years.
LÆGEMIDDELFORM Koncentrat til infusionsvæske, opløsning (sterilt koncentrat) Klar og farveløs opløsning. 
PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate) Clear and colourless solution.
Når behandling med zoledronsyre initieres hos patienter med multipelt myelom eller knoglemetastatisk skade fra solide tumorer bør serum-kreatinin og kreatininclearence (CLcr) bestemmes. 
When initiating treatment with zoledronic acid in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Behandling med zoledronsyre bør genoptages med den samme dosis som blev givet før afbrydelse af behandlingen. 
Zoledronic acid treatment should be resumed at the same dose as that given prior to treatment interruption.
Patienter, som behandles med Zoledronsyre Accord, bør ikke samtidig behandles med Aclasta eller andre bisfosfonater, da den kombinerede effekt af disse stoffer er ukendt. 
Patients being treated with Zoledronic Acid Accord should not be treated with Aclasta or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Zoledronsyre 4 mg reducerede signifikant andelen af patienter, der oplevede mindst én skeletrelateret hændelse (SRE), forsinkede den gennemsnitlige tid til første SRE med > 5 måneder og reducerede den årlige incidens af hændelser per patient - skeletal morbiditet. 
Zoledronic acid 4 mg significantly reduced the proportion of patients experiencing at least one skeletal related event (SRE), delayed the median time to first SRE by > 5 months, and reduced the annual incidence of events per patient-skeletal morbidity rate.
1Bivirkninger med frekvenser < 5 % blev vurderet medicinsk, og det blev vist, at de er i overensstemmelse med den veletablerede sikkerhedsprofil for zoledronsyre (se pkt. 
Hypophosphataemia 1 Adverse 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 (see section 4.8)
- Zoledronsyre Accord må kun gives af sundhedspersonale, som er trænet til at indgive bisfosfonater intravenøst, dvs. gennem en blodåre. 
• Zoledronic Acid Accord must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
5 ml plastikhætteglas fremstillett af klar, cyclo-olefin-copolymer med chlorobutylgummiprop og aluminiumhætte med flip-off-komponent. 
5-ml plastic vial made of clear, cycloolefine copolymer with chlorobutyl rubber stopper and aluminium cap with flip-off component.
I langsigtede dyreundersøgelser inhiberer zoledronsyre knogleresorptionen uden negativ påvirkning af knogledannelse, knoglemineralisation eller knoglernes mekaniske egenskaber. 
In long-term animal studies, zoledronic acid inhibits bone resorption without adversely affecting the formation, mineralization or mechanical properties of bone.
Behandling med Zoledronsyre Accord til TIH-patienter, som også har svær nyreinsufficiens, bør kun overvejes efter vurdering af risici og fordele ved behandlingen. 
Zoledronic Acid Accord treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Zoledronsyre inhiberer ikke humane P450-enzymer in vitro og udviser ingen biotransformation, og i dyreforsøg blev < 3 % af den indgivne dosis fundet i fæces, hvilket antyder, at leverfunktionen ikke spiller en væsentlig rolle for zoledronsyres farmakokinetiske egenskaber. 
Zoledronic acid does not inhibit human P450 enzymes in vitro, shows no biotransformation and in animal studies < 3% of the administered dose was recovered in the faeces, suggesting no relevant role of liver function in the pharmacokinetics of zoledronic acid.
Efter påbegyndelse af behandling bør serum-kreatinin måles før hver dosis af zoledronsyre, og behandlingen bør tilbageholdes, hvis nyrefunktionen forværres. 
Following initiation of therapy, serum creatinine should be measured prior to each dose of zoledronic acid and treatment should be withheld if renal function has deteriorated.
In vivo: Hæmning af osteoblastdannelse, direkte cytostatisk og pro-apoptotisk aktivitet på tumorceller, synergistisk cytostatisk effekt med andre anti-cancermidler, anti-adhæsion/invasionsaktivitet. 
In-vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer drugs, anti-adhesion/invasion activity.