natgillin/translations-raw huggingface dataset:
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.
I den zoledronsyrebehandlede gruppe blev statistisk signifikante forbedringer i smerte-scoringer (ved brug af Brief Pain Inventory, BPI) set ved 4 uger og ved hver efterfølgende tidsmåling i løbet af studiet, når sammenlignet med placebo (Figur 1).
In the zoledronic acid-treated group, statistically significant improvement in pain scores (using the Brief Pain Inventory, BPI) was seen at 4 weeks and at every subsequent time point during the study, when compared to placebo (Figure 1).
I tilfælde af hypokalcæmi bør calciumglukonat-infusioner administreres, hvis det er klinisk indikeret.
In the event of hypocalcaemia, calcium gluconate infusions should be administered as clinically indicated.
Søvnighed.
Sleepiness.
Efter åbning af flasken bør produktet anvendes straks for at undgå mikrobiologisk kontaminering.
After opening the bottle, the product should be used immediately in order to avoid microbial contamination.
Den færdigfremstillede opløsning kan opbevares i 24 timer ved 2 °C - 8 °C.
The reconstituted solution is stable for 24 hours at 2°C - 8°C.
Der blev udført en forlænget undersøgelse for at vurdere den generelle og renale langtidssikkerhed af zoledronsyre administreret en eller to gange årligt over en forlænget behandlingsperiode af 12 måneders varighed hos børn, der havde fuldendt et års behandling med enten zoledronsyre eller pamidronat i hovedstudiet.
An extension study was conducted in order to examine the long-term general and renal safety of once yearly or twice yearly zoledronic acid over the 12-month extension treatment period in children who had completed one year of treatment with either zoledronic acid or pamidronate in the core study.
Akut toksicitet
Acute toxicity
- Behandling af voksne patienter med tumorinduceret hyperkalcæmi (TIH).
- Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Zometa må kun udskrives og administreres til patienter af sundhedspersonale med erfaring i administration af intravenøse bisfosfonater.
Zometa must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
I kliniske studier blev behandling med Zometa først genoptaget når kreatinin-niveauet faldt inden for 10% over baselineværdien (se afsnit 4.4).
In the clinical studies, Zometa treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Standard hyperkalcæmirelaterede metabolske parametre som serumniveauer af calcium, fosfat og magnesium, bør monitoreres grundigt efter påbegyndt behandling med Zometa.
Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zometa therapy.
Dette kan være tegn på knoglebeskadigelse i øret.
These could be signs of bone damage in the ear.
I fase I doseringsundersøgelser i patienter med mild til moderat tumorindiceret hyperkalcæmi (TIH), var den afprøvede effektive dosis cirka 1,2-2,5 mg.
In Phase I dose finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2-2.5 mg.
Hypofosfatæmi Bivirkninger med frekvenser <5% blev vurderet medicinsk, og det blev vist, at de er i overensstemmelse med den veletablerede sikkerhedsprofil for Zometa (se pkt.
Hypophosphataemia 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 Zometa (see section 4.8)
Størstedelen af rapporterne referer til cancerpatienter, som har fået trukket en tand ud eller har fået foretaget andre tandoperationer.
The majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Efter påbegyndelse af behandling bør serum-kreatinin måles før hver dosis af Zometa, og behandlingen bør tilbageholdes, hvis nyrefunktionen forværres.
Following initiation of therapy, serum creatinine should be measured prior to each dose of Zometa and treatment should be withheld if renal function has deteriorated.
Der må kun anvendes en klar opløsning fri for partikler og misfarvning.
Only clear solution free from particles and discolouration should be used.
I kliniske studier er Zometa indgivet samtidig med almindeligt anvendte anticancerlægemidler, diuretika, antibiotika og analgesika uden tilsyneladende kliniske interaktioner.
In clinical studies, Zometa has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Der optrådte hurtigere normalisering af korrigeret serumcalcium på 4. dag for 8 mg zoledronsyre og på 7. dag for 4 mg og 8 mg zoledronsyre.
There was faster normalisation of corrected serum calcium at day 4 for 8 mg zoledronic acid and at day 7 for 4 mg and 8 mg zoledronic acid.
Instruktion for tilberedning af reducerede doser af Zometa:
Instructions for preparing reduced doses of Zometa: