FrancophonIA/ELRC3.0 huggingface dataset:
English: The company informed the CHMP that there are currently no ongoing clinical trials with Milnacipran Pierre Fabre Médicament/Impulsor in Europe for fibromyalgia.
Danish: Virksomheden informerede CHMP om, at der ikke er nogen igangværende kliniske undersøgelser af Milnacipran Pierre Fabre Médicament/Impulsor i Europa anvendt til behandling af fibromyalgi.
English: The active substance in Milnacipran Pierre Fabre Médicament/Impulsor, milnacipran, is a ‘serotoninnoradrenaline re-uptake inhibitor'.
Danish: Det aktive stof i Milnacipran Pierre Fabre Médicament/Impulsor, milnacipran, er en "serotoninnoradrenalin genoptagelseshæmmer".
English: What is Milnacipran Pierre Fabre Médicament/Impulsor?
Danish: Hvad er Milnacipran Pierre Fabre Médicament/Impulsor?
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Milnacipran Pierre Fabre Médicament/Impulsor?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Milnacipran Pierre Fabre Médicament/Impulsor eller i programmer for anvendelse af Milnacipran Pierre Fabre Médicament/Impulsor med særlig udleveringstilladelse?
English: What was Milnacipran Pierre Fabre Médicament/Impulsor expected to be used for?
Danish: Hvad forventedes Milnacipran Pierre Fabre Médicament/Impulsor anvendt til?
English: Hence, the CHMP recommended that Milnacipran Pierre Fabre Médicament/Impulsor be refused marketing authorisation.
Danish: CHMP anbefalede derfor at give afslag på ansøgningen om markedsføringstilladelse for Milnacipran Pierre Fabre Médicament/Impulsor.
English: How was Milnacipran Pierre Fabre Médicament/Impulsor expected to work?
Danish: Hvordan forventedes Milnacipran Pierre Fabre Médicament/Impulsor at virke?
English: The response rate in these patients was about 52%.
Danish: Responsraten i disse patienter var cirka 52%.
English: However, such reports have been infrequent.
Danish: Sådanne rapporter har dog været sjældent forekommende.
English: Unopened bottle: 3 years.
Danish: Uåbnet flaske: 3 år.
English: The following response rates were observed:
Danish: Følgende responsrater blev observeret:
English: Your doctor will monitor this and take any necessary measures.
Danish: Din læge vil kontrollere dette og tage alle de nødvendige forholdsregler.
English: Adults and older people
Danish: Voksne og ældre
English: • At the request of the European Medicines Agency,
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur
English: Time on study (weeks)
Danish: Tid i studiet (uger)
English: Not to be sold separately.
Danish: Må ikke sælges enkeltvis.
English: Please open here
Danish: Åbnes her
English: Any SRE (+TIH)
Danish: Enhver SRE (+TIH)
English: Patients aged 65 years and over
Danish: Patienter i alderen 65 år og derover
English: In most cases no specific treatment is required and the symptoms disappear after a short time (couple of hours or days).
Danish: De fleste tilfælde har ikke krævet speciel behandling, og symptomerne er forsvundet efter kort tid (nogle timer eller dage).
English: Use the entire contents.
Danish: Brug hele indeholdet.
English: You should therefore be careful when driving, using machinery or performing other tasks that need full attention.
Danish: Vær derfor særlig opmærksom når du kører bil, betjener maskiner eller udfører andre opgaver, der kræver din fulde opmærksomhed.
English: Do not use Zometa after the expiry date stated on the pack.
Danish: Brug ikke Zometa efter den udløbsdato, der står på pakningen.
English: Follow carefully all instructions given to you by your doctor.
Danish: Følg nøje alle instruktioner, som du har fået af din læge.
English: The most common ones are usually mild and will probably disappear after a short time.
Danish: De mest almindelige bivirkninger er normalt milde og vil sandsynligvis forsvinde efter kort tid.
English: Mutagenicity and carcinogenic potential
Danish: Mutagenicitet og cancerogent potentiale
English: In some instances the hypocalcaemia may be life-threatening.
Danish: I nogle tilfælde kan hypokalcæmien være livstruende.
English: Zometa should not be used during pregnancy.
Danish: Zometa bør ikke anvendes under graviditet.
English: Children and adolescents Zometa is not recommended for use in adolescents and children below the age of 18 years.
Danish: Børn og unge Zometa bør ikke bruges til børn og teenagere under 18 år.
English: It is used:
Danish: Det bruges til:
English: If you are given more Zometa than you should be If you have received doses higher than those recommended, you must be carefully monitored by your doctor.
Danish: Hvis du har fået mere Zometa, end du skulle have haft Hvis du har fået højere doser end dem, der er anbefalet, skal du nøje overvåges af din læge.
English: Median time to normocalcaemia was 4 days.
Danish: Mediantid til normo kalcæmi var 4 dage.
English: There were no statistically significant differences between the two zoledronic acid doses.
Danish: Der var ingen statistisk signifikante forskelle mellem de to zoledronsyredoser.
English: The time to onset of symptoms varied from one day to several months after starting treatment.
Danish: Tidsrummet til forekomst af symptomer varierede fra én dag til flere måneder efter behandlingsstart.
English: In particular there was no clear evidence of efficacy on incidence of fracture or on pain.
Danish: Der sås i særdeleshed ikke noget klart bevis for effekt på hyppigheden af fraktur eller på smerte.
English: Zometa can be given to people aged 65 years and over.
Danish: Zometa kan gives til patienter i alderen 65 år og derover.
English: NA Not Applicable
Danish: NA Ikke relevant (Not Applicable)
English: Risk reduction of suffering from multiple events** (%)
Danish: Reduktion i risiko for gentagne hændelser**
English: • To reduce the amount of calcium in the blood in adult patients where it is too high due to the presence of a tumour.
Danish: • At nedsætte mængden af calcium i blodet hos voksne, hvor det er for højt som følge af tilstedeværelsen af en tumor.
English: Attention should also be paid to the possibility of hypomagnesaemia developing during treatment.
Danish: Opmærksomheden henledes endvidere på muligheden for udvikling af hypomagnesiæmi under behandlingen.
English: Clinical experience with acute overdose of Zometa is limited.
Danish: Klinisk erfaring med akut overdosis af Zometa er begrænset.
English: Proportion of patients with SREs (%) p-value
Danish: Andel af patienter med SRE'er (%) p-værdi
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Osteonecrosis of other anatomical sites
Danish: Osteonekrose af andre anatomiske steder
English: There have been very rare cases of drowsiness and sleepiness with the use of Zometa.
Danish: Der har været meget sjældne tilfælde af døsighed og søvnighed ved brug af Zometa.
English: Baseline creatinine clearance (ml/min)
Danish: Baseline kreatinin clearance (ml/min)
English: The mechanism behind the increased incidence of atrial fibrillation in this single clinical trial is unknown.
Danish: Mekanismen bag den øgede forekomst af atrieflimren i dette ene kliniske studie er ukendt.
English: There are no adequate data on the use of zoledronic acid in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af zoledronsyre til gravide kvinder.
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Danish: Total legemsclearance er 5,04±2,5 l/h uafhængigt af dosis og uanset køn, alder, race og legemsvægt.
English: As only limited clinical data are available in patients with severe hepatic insufficiency, no specific recommendations can be given for this patient population.
Danish: Da der kun eksisterer begrænsede kliniske data for patienter med kraftigt nedsat leverfunktion, kan der ikke gives nogen specifikke anbefalinger for denne patientgruppe.
English: Low blood pressure.
Danish: - Lavt blodtryk.
English: Treatment of TIH
Danish: Behandling af TIH
English: Any unused solution should be discarded.
Danish: Al ubrugt opløsning bør kasseres.
English: Tell your doctor if you are or think that you may be pregnant.
Danish: Fortæl lægen, hvis du er gravid eller tror, du er det.
English: Age, body weight, gender and creatinine clearance appear to have no effect on zoledronic acid systemic exposure.
Danish: Alder, vægt, køn og kreatininclearance synes ikke at have nogen effekt på systemisk eksponering af zoledronsyre.
English: Patients were evenly distributed between zoledronic acid-treated and placebo groups.
Danish: Patienterne var lige fordelt mellem den zoledronsyrebehandlede og placebo grupperne.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Danish: Farmakoterapeutisk klassifikation: Midler til behandling af knoglesygdomme, bisfosfonater, ATCkode: M05BA08
English: The treatment effects were less pronounced in patients with blastic lesions.
Danish: Behandlingseffekten var mindre udtalt hos patienter med blastiske læsioner.
English: * 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
Danish: * Inkluderer vertebrale og non-vertebrale frakturer ** Indeholder alle skeletrelaterede hændelser, det totale antal samt tid til hver hændelse under undersøgelsen.
English: Patients received either 4 mg zoledronic acid or placebo every four weeks for one year.
Danish: Patienterne fik enten 4 mg zoledronsyre eller placebo hver fjerde uge i et år.
English: It is not known whether zoledronic acid is excreted into human milk.
Danish: Det er ukendt, om zoledronsyre udskilles i human mælk.
English: Although no teratogenicity or foetotoxicity was observed in the rabbit, maternal toxicity was found.
Danish: Selv om der ikke blev observeret teratogenicitet eller føtal toksicitet hos kaniner, blev der observeret maternal toksicitet.
English: Fractures*
Danish: Frakturer*
English: Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Danish: Mange af disse patienter har også modtaget kemoterapi og kortikosteroider og viste tegn på lokal infektion inklusive osteomyelitis.
English: Zometa should only be resumed when serum creatinine returns to within 10% of baseline.
Danish: Zometa bør kun genoptages, når serum-kreatinin igen er inden for 10% af baseline.
English: If the solution is not used immediately, it should be stored in a refrigerator at 2°C - 8°C.
Danish: Hvis opløsningen ikke bruges straks, skal den opbevares i køleskab ved 2 °C - 8 °C.
English: Low level of calcium in the blood.
Danish: - Lavt niveau af calcium i blodet.
English: There was no accumulation of zoledronic acid in plasma after multiple doses given every 28 days.
Danish: Der sås ingen akkumulering af zoledronsyre i plasma efter gentagne doser administreret hver 28. dag.
English: Hypocalcaemia is an important identified risk with Zometa in the approved indications.
Danish: Hypokalcæmi er en vigtig, identificeret risiko ved Zometa ved de godkendte indikationer.
English: Figure 1 Mean changes from baseline in BPI scores.
Danish: Figur 1 Gennemsnitlige ændringer fra baseline i BPI scoringer.
English: INFORMATION FOR THE HEALTHCARE PROFESSIONAL
Danish: INFORMATION TIL SUNDHEDSPERSONALET
English: 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.
Danish: 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.
English: Most patients had relief of symptoms after stopping treatment.
Danish: De fleste patienter havde symptomlindring efter afslutning af behandling.
English: A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Danish: - En nyresygdom, der hedder Fanconis syndrom (vil normalt blive fastslået af din læge med nogle bestemte urinprøver).
English: Subchronic and chronic toxicity
Danish: Subkronisk og kronisk toksicitet
English: Date of first authorisation: 20.03.2001 Date of latest renewal: 20.03.2006
Danish: Dato for første markedsføringstilladelse: 20.03.2001 Dato for seneste fornyelse: 20.03.2006
English: CLcr is calculated from serum creatinine using the Cockcroft-Gault formula.
Danish: CLcr beregnes ud fra serum-kreatinin ved brug af Cockeroft-Gault formlen.
English: Acute phase reaction, pain
Danish: Akut fase reaktion, smerte
English: Women of child-bearing potential should be advised to avoid becoming pregnant.
Danish: Kvinder i den fertile alder skal tilrådes at undgå at blive gravide.
English: The interpatient variability in pharmacokinetic parameters for zoledronic acid was high, as seen with other bisphosphonates.
Danish: Interpatient variabilitet med hensyn til farmakokinetiske parametre for zoledronsyre var højt, som det er set med andre bisfosfonater.
English: Statistically significant differences are marked (*p<0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
Danish: Statistisk signifikante forskelle er markeret (*p<0,05) for sammenligning mellem behandlinger (4 mg zoledronsyre vs. placebo)
English: 1 bottle, 100 ml
Danish: 1 flaske, 100 ml
English: Estimated treatment effects on BMD were similar, but the trial design was not sufficiently robust to establish non-inferior efficacy for zoledronic acid.
Danish: De estimerede behandlingseffekter på BMD var ens, men studiedesignet var ikke stærkt nok til at etablere en non-inferiør effekt for zoledronsyre.
English: Overhydration should be avoided in patients at risk of cardiac failure.
Danish: Overhydrering bør undgås hos patienter med risiko for hjertesvigt.
English: 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.
Danish: 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.
English: There is no evidence to suggest that any extra precautions are needed.
Danish: Der er intet, der tyder på, at der kræves særlige forholdsregler.
English: Tumours can accelerate normal bone change in such a way that the release of calcium from bone is increased.
Danish: Tumorer kan accelerere den normale knogleomsætning på en sådan måde, at afgivelsen af calcium fra knoglerne forøges.
English: 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.
Danish: Behandlingens start eller en ny behandling bør udskydes hos patienter med uhelede sår i det bløde væv i munden, undtaget i akutte medicinsk tilfælde.
English: Date of first authorisation: 24.03.2003 Date of latest renewal: 20.03.2006
Danish: Dato for første markedsføringstilladelse: 24.03.2003 Dato for seneste fornyelse: 20.03.2006
English: 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.
Danish: 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.
English: Your doctor, pharmacist or nurse knows how to store Zometa properly (see section 6).
Danish: Lægen, apotekspersonalet eller sundhedspersonalet ved, hvordan Zometa skal opbevares korrekt (se afsnit 6).
English: 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.
Danish: 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.
English: Thus these results precluded determining a definitive effect of zoledronic acid on fertility in humans.
Danish: Disse resultater forhindrede bestemmelsen af zoledronsyres definitive effekt på fertiliteten hos mennesker.
English: 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.
Danish: 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.
English: If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, short-term supplemental therapy may be necessary.
Danish: Hvis hypokalcæmi, hypofosfatæmi eller hypomagnesiæmi forekommer kan supplement behandling være nødvendigt i kort tid.
English: White to off-white powder and clear, colourless solvent.
Danish: Hvidt til råhvidt pulver og klar, farveløs solvens.
English: Low level of red blood cells (anaemia).
Danish: - Lavt antal røde blodceller (anæmi).
English: From the bone tissue it is released very slowly back into the systemic circulation and eliminated via the kidney.
Danish: Fra knoglevævet afgives den meget langsomt tilbage til det systemiske kredsløb og elimineres gennem nyrerne.
English: The SRE rate (events/person year) was 0.628 for zoledronic acid and 1.096 for placebo.
Danish: SRE forekomsten (hændelser/person-år) var 0,628 for zoledronsyre og 1,096 for placebo.
English: - If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zometa.
Danish: - Hvis du er i behandling for at nedsætte calciumindholdet i blodet, vil du som regel kun få én infusion med Zometa.
English: Ask your doctor for advice before taking any medicine while you are pregnant or breast-feeding.
Danish: Spørg din læge til råds, før du tager nogen form for medicin, mens du er gravid, eller hvis du ammer.
English: The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established.
Danish: Zoledronsyres sikkerhed og virkning hos børn i alderen 1 år til 17 år er ikke klarlagt.
English: Median time to SRE (days)
Danish: Mediantid til SRE (dage)
English: 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.
Danish: Mulige risikofaktorer for osteonekrose af øregangen inkluderer steroider og kemoterapi og/eller lokale risikofaktorer som infektioner eller traumer.
English: Untreated hypercalcaemia patients generally have some degree of renal function impairment, therefore careful renal function monitoring should be considered.
Danish: Ubehandlede hyperkalcæmiske patienter har generelt nogen grad af nedsat nyrefunktion, hvorfor omhyggelig monitorering af nyrefunktionen bør overvejes.
English: The administration of doses up to 48 mg of zoledronic acid in error has been reported.
Danish: Indgivelse af doser op til 48 mg af zoledronsyre er fejlagtigt blevet rapporteret.
English: Temporary interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Danish: Midlertidig afbrydelse af zoledronsyrebehandling bør overvejes, indtil tilstanden er afhjulpet og bidragende risikofaktorer er mindsket så vidt muligt.
English: Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with Zometa.
Danish: Undersøgelser med forskellige typer af infusionsslanger fremstillet af polyvinylklorid, polyethylen og polypropylen viste ingen uforligelighed med Zometa.
English: It is an inhibitor of osteoclastic bone resorption.
Danish: Det er en inhibitor af osteoklastisk knogleresorption.
English: Patients should have their serum creatinine levels assessed prior to each dose of Zometa.
Danish: Patienter bør få deres serum-kreatinin niveau vurderet før hver dosis af Zometa.
English: 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.
Danish: 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.
English: - Thalidomide (a medicine used to treat a certain type of blood cancer involving the bone) or any other medicines which may harm your kidneys.
Danish: - Thalidomid (medicin brugt til at behandle en bestemt type blodkræft, der involverer knoglerne) eller anden medicin, der kan skade nyrerne.
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when Zometa is used in combination with thalidomide.
Danish: Hos patienter med multipelt myelom kan risikoen for nedsat nyrefunktion øges, når Zometa anvendes i kombination med thalidomid.
English: 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.
Danish: 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.
English: If your level of calcium falls too low, you may have to be given supplemental calcium by infusion.
Danish: Hvis dit calciumniveau falder for meget, skal du måske have ekstra calcium tilført som infusion.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Dystocia was observed at the lowest dose (0.01 mg/kg bodyweight) tested in the rat.
Danish: Dystoci blev observeret ved den laveste dosis (0,01 mg/kg kropsvægt) testet i rotter.
English: 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.
Danish: 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.
English: The pain score for zoledronic acid was consistently below baseline and pain reduction was accompanied by a trend in reduced analgesics score.
Danish: Smerte scoringen for zoledronsyre var konsekvent under baseline og smertereduktionen var ledsaget af en tendens til nedsat smertestillende score.