FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Et tandeftersyn med passende forebyggende tandbehandling og en individuel benefit-risk-vurdering anbefales før behandling med bisfosfonater hos patienter med flere samtidige risikofaktorer.
English: The management plan for patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ.
Danish: Behandlingsplanen for patienter, der udvikler ONJ, bør udfærdiges i tæt samarbejde mellem den behandlende læge og en tandlæge eller en kæbekirurg med erfaring i ONJ.
English: The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Danish: CHMP anbefaler, at betingelserne for markedsføringstilladelsen ændres.
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 seponering af behandlingen med bisfosfonater reducerer risikoen for osteonekrose af kæberne.
English: 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.
Danish: Starttidspunktet er ≤3 dage efter infusion med zoledronsyre, og reaktionen er også refereret til ved brug af termerne ”influenza-lignende symptomer” eller ”symptomer efter dosering”.
English: The pain score for zoledronic acid was consistently below baseline and pain reduction was accompanied by a trend in reduced analgesics score.
Danish: Smertescoringen for zoledronsyre var konsekvent under baseline og smertereduktionen var ledsaget af en tendens til nedsat smertestillende score.
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 1-17 år er ikke klarlagt.
English: 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).
Danish: Mediantiden 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).
English: 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.
Danish: Behandlingsperioden i studiet var 12 måneder forudgået af en 4-9-ugers screeningsperiode, hvor der blev givet tilskud af calcium og D-vitamin i mindst 2 uger.
English: There are no site specific risk factors for osteonecrosis apart from additional oral risk factors for osteonecrosis of the jaw.
Danish: Der findes ingen sted-specifikke risiko faktorer for osteonekrose ud over øgede orale risiko faktorer for osteonekrose af kæben.
English: Patients should have their serum creatinine levels assessed prior to each dose of zoledronic acid.
Danish: Patienter bør få deres serum-kreatinin-niveau vurderet før hver dosis af zoledronsyre.
English: 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.
Danish: Begrænsede farmakokinetiske data hos børn med svær osteogenesis imperfecta indikerer, at zoledronsyres farmakokinetik hos børn i alderen 3-17 år er sammenlignelig med voksnes ved samme mg/kg dosisniveau.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for zoledronic acid (indicated for cancer and fractures), the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for zoledronsyre (indiceret til cancer og frakturer) er CHMP nået frem til følgende videnskabelige konklusioner:
English: Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Danish: Pamidronat 90 mg (N = 99) 33,3 % * p-værdier sammenlignet med pamidronat.
English: How much Zoledronic acid medac 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 Zoledronsyre medac skal du have - Den normale enkeltdosis er 4 mg. - Hvis du har problemer med nyrerne, vil lægen give dig en lavere dosis afhængigt af sværhedsgraden af dine nyreproblemer.
English: Caution is indicated when zoledronic acid is used with other potentially nephrotoxic medicinal products.
Danish: Der bør udvises forsigtighed, når zoledronsyre anvendes sammen med andre potentielt nefrotoksiske lægemidler.
English: 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.
Danish: Der blev udført et forlænget studie 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 gennemført et års behandling med enten zoledronsyre eller pamidronat i hovedstudiet.
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to zoledronic acid administration.
Danish: Under behandling bør der kun udføres invasiv tandbehandling efter en nøje overvejelse, og de bør undgås tæt på administrationen af zoledronsyre.
English: - Sleepiness.
Danish: - Søvnighed.
English: 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.
Danish: Den nedsatte dosis til patienter med nedsat nyrefunktion forventes at give samme AUC, som er set hos patienter med kreatininclearence på 75 ml/min.
English: Common (may affect up to 1 in 10 people): - Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer): - Svært nedsat nyrefunktion (vil normalt blive afgjort af din læge ved hjælp af en speciel type blodprøver).
English: The primary endpoint of the study was the percent change from baseline in lumbar spine bone mineral density (BMD) after 12 months of treatment.
Danish: Undersøgelsens primære endepunkt var den procentuelle ændring i knoglemineralsk densitet (BMD) i lænderygsøjlen efter 12 måneders behandling.
English: 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.
Danish: Der optrådte hurtigere normalisering af korrigeret serum-calcium på 4. dag for 8 mg zoledronsyre og på 7. dag for 4 mg og 8 mg zoledronsyre.
English: The reports of osteonecrosis at other sites with zoledronic acid suggest similarity in reporting frequency (femur>knee>humerus) as compared to the commonly affected sites of osteonecrosis based on anatomical factors.
Danish: Rapporterne om osteonekrose af andre steder med zoledronsyre antyder lighed i forekomsten af hyppighed (femur>knæ>humerus) sammenlignet med de mest almindeligt påvirkede steder af osteonekrose baseret på anatomiske faktorer.
English: On the basis of the scientific conclusions for zoledronic acid (indicated for cancer and fractures) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing zoledronic acid (indicated for cancer and fractures) is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for zoledronsyre (indiceret til cancer og frakturer) er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel, der indeholder zoledronsyre (indiceret til cancer og frakturer), forbliver uændret i forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
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: * Omfatter vertebrale og non-vertebrale frakturer ** Indeholder alle skeletrelaterede hændelser, det totale antal samt tid til hver hændelse under studiet.
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: Behandlingsstart eller start på et nyt behandlingsforløb bør udskydes hos patienter med ikke helede åbne bløddelslæsioner i munden, undtagen i medicinske nødsituationer.
English: Instructions for preparing reduced doses of zoledronic acid
Danish: Instruktion for tilberedning af reducerede doser af zoledronsyre
English: 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).
Danish: 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, sammenlignet med placebo (Figur 1).
English: - 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 medac.
Danish: - Hvis du er i behandling for at nedsætte calciumindholdet i blodet, vil du som regel kun få én infusion med Zoledronsyre medac.
English: Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Danish: Zoledronsyre var ikke mutagen i de udførte mutagenicitetsprøver, og undersøgelse af karcinogenicitet kunne ikke påvise karcinogenicitet.
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 gør det muligt at sammenligne med en dosis på 4 mg zoledronsyre.
English: ANNEX IV SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
Danish: BILAG IV VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSEN/-ERNE
English: Clinical trial results in the treatment of severe osteogenesis imperfecta in paediatric patients aged 1 to 17 years
Danish: Resultater fra kliniske studier af behandlingen for svær osteogenesis imperfecta hos pædiatriske patienter i alderen 1-17 år
English: The analysis of the individual safety reports from clinical trials, spontaneous reports and literature retrieved 62 cases of osteonecrosis of other anatomical sites in association with zoledronic acid, with the majority of events occurring in the hip/femur (46).
Danish: Ved analyse af de individuelle sikkerhedsrapporter fra kliniske forsøg, spontane rapporter og litteratur, blev der genfundet 62 tilfælde af osteonekrose i forbindelse med zoledronsyre af andre anatomiske steder, hvoraf hovedparten af disse tilfælde forekom i hoften/femur (46).
English: EXP: Read the leaflet for the shelf life of the medicinal product after first opening.
Danish: EXP: Læs indlægssedlen for opbevaringstiden for lægemidlet efter første anbrud.
English: No pharmacokinetic data for zoledronic acid are available in patients with hypercalcaemia or in patients with hepatic insufficiency.
Danish: Der eksisterer ingen farmakokinetiske data for zoledronsyre hos patienter med hyperkalcæmi eller patienter med nedsat leverfunktion.
English: Your doctor may recommend a dental examination before you start treatment with Zoledronic acid medac.
Danish: Din læge kan anbefale en tandundersøgelse, før du starter behandlingen med Zoledronsyre medac.
English: CARTON FOR 4 VIALS
Danish: KARTON TIL 4 HÆTTEGLAS
English: - Painful redness and/or swelling of the eye.
Danish: - Smertefuld rødme og/eller hævelse af øjet.
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when zoledronic acid is used in combination with thalidomide.
Danish: Hos patienter med myelomatose kan risikoen for nedsat nyrefunktion øges, når zoledronsyre anvendes i kombination med thalidomid.
English: The administration of doses up to 48 mg of zoledronic acid in error has been reported.
Danish: Administration af utilsigtede doser op til 48 mg af zoledronsyre er blevet rapporteret.
English: Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Danish: Der er kun begrænsede farmakokinetiske data vedrørende patienter med svært nedsat nyrefunktion (kreatininclearance <30 ml/min).
English: Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Danish: Zoledronsyres potentielle bivirkninger på fertiliteten blev vurderet hos rotter hos forældre- og F1generationen.
English: EXP: Read the leaflet for the shelf life of the diluted medicinal product.
Danish: EXP: Læs indlægssedlen for opbevaringstiden for det fortyndede lægemiddel.
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 virkning på arealet under plasmakoncentrations- versus tidskurven.
English: To assess the effects of 4 mg zoledronic acid versus pamidronate 90 mg, the results of two pivotal multicentre studies in patients with TIH were combined in a pre-planned analysis.
Danish: For at vurdere virkningerne af 4 mg zoledronsyre i forhold til pamidronat 90 mg blev resultaterne af to pivotale multicenterstudier af patienter med TIH kombineret i en forud planlagt analyse.
English: • The solution containing zoledronic acid must not be further diluted or mixed with other infusion solutions.
Danish: • Opløsningen med zoledronsyre må ikke fortyndes yderligere eller blandes med andre infusionsopløsninger.
English: Therefore, the product information should be updated to reflect in sections 4.4 and 4.8 of the SmPC a warning on osteonecrosis of other anatomical sites and add this adverse reaction with a frequency very rare.
Danish: 4.8 af produktresuméet blive opdateret for at afspejle en advarsel omkring osteonekrose af andre anatomiske steder og tilføje denne bivirkning med frekvensen meget sjælden.
English: After first opening: Chemical and physical in-use stability has been demonstrated for 4 days at 2 - 8°C and 25°C.
Danish: Efter første anbrud: Kemisk og fysisk stabilitet under brug er blevet påvist i 4 dage ved 2-8 °C og 25 °C
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: Your doctor will carry out blood tests before you start treatment with Zoledronic acid medac and will check your response to treatment at regular intervals.
Danish: Lægen vil tage en blodprøve, inden du begynder behandling med Zoledronsyre medac, og vil med regelmæssige mellemrum kontrollere, hvordan du reagerer på behandlingen.
English: 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.
Danish: Zoledronsyre 4 mg reducerede signifikant andelen af patienter, der oplevede mindst én skeletrelateret hændelse (SRE), forsinkede mediantiden til første SRE med >5 måneder og reducerede den årlige incidens af hændelser pr. patient - skeletal morbiditet.
English: The plasma protein binding is low, with the unbound fraction ranging from 60% at 2 ng/ml to 77% at 2,000 ng/ml of zoledronic acid.
Danish: Plasmaproteinbindingen er lav med den ubundne fraktion varierende fra 60 % ved 2 ng/ml til 77 % ved 2.000 ng zoledronsyre/ml.
English: To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table 1 below.
Danish: For at tilberede nedsatte doser til patienter med baseline CLcr ≤ 60 ml/min henvises til Tabel 1 nedenfor.
English: Temporary interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Danish: Det bør overvejes at afbryde behandlingen med zoledronsyre midlertidigt, indtil tilstanden lindres, og de bidragende risikofaktorer om muligt reduceres.
English: In clinical studies, zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Danish: I kliniske studier er zoledronsyre blevet administreret samtidig med almindeligt anvendte anticancerlægemidler, diuretika, antibiotika og analgetika uden tilsyneladende kliniske interaktioner.
English: The active substance in Zoledronic acid medac is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Danish: Det aktive stof i Zoledronsyre medac er zoledronsyre, der tilhører en gruppe af stoffer, der kaldes bisfosfonater.
English: Zoledronic acid should not be used during pregnancy.
Danish: Zoledronsyre bør ikke anvendes under graviditeten.
English: Thrombocytopenia, leukocytopenia Pancytopenia
Danish: Trombocytopeni, leukocytopeni
English: - have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
Danish: - har eller har haft smerte, hævelse eller fornemmelse af følelsesløshed i kæben, følelsen af tyngde i kæben eller af løse tænder.
English: It is used: - to prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
Danish: Det bruges til: - at forebygge knoglekomplikationer, f.eks. knoglebrud, hos voksne patienter med knoglemetastaser (spredning af kræft fra den primære kræftknude til knoglerne).
English: 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.
Danish: Intravenøst administreret zoledronsyre elimineres i en trifasisk proces: hurtig bifasisk elimination fra det systemiske kredsløb med halveringstider på t ½α 0,24 og t ½β 1,87 timer efterfulgt af en lang elimineringsfase med en terminal eliminationshalveringstid på t ½γ 146 timer.
English: Patients were evenly distributed between zoledronic acid-treated and placebo groups.
Danish: Patienterne var lige fordelt mellem grupperne med zoledronsyre og placebo.
English: Withdraw an appropriate volume of the solution needed, as follows: - 4.4 ml for 3.5 mg dose
Danish: Udtag et passende volumen af den nødvendige opløsning på følgende måde: 4,4 ml til 3,5 mg dosis
English: − In vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer medicinal products, antiadhesion/invasion activity.
Danish: - In vivo: Hæmning af osteoblastdannelse, direkte cytostatisk og pro-apoptotisk aktivitet på tumorceller, synergistisk cytostatisk virkning med andre anti-cancerlægemidler, anti-adhæsion/invasionsaktivitet.
English: How often Zoledronic acid medac is given - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic acid medac every three to four weeks.
Danish: Hvor ofte skal du have Zoledronsyre medac - Hvis du er i forebyggende behandling for knoglekomplikationer pga. knoglemetastaser, vil du få en infusion af Zoledronsyre medac hver tredje til fjerde uge.
English: In an in vitro study, zoledronic acid showed low affinity for the cellular components of human blood, with a mean blood to plasma concentration ratio of 0.59 in a concentration range of 30 ng/ml to 5,000 ng/ml.
Danish: I et in vitro studie udviste zoledronsyre lav affinitet for cellekomponenterne i humant blod med en gennemsnitlig blod/plasma-koncentrationsratio på 0,59 i koncentrationsområdet fra 30 ng/ml til 5.000 ng/ml.
English: In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking bisphosphonates, including zoledronic acid.
Danish: Ved erfaring efter markedsføring er der rapporteret om alvorlige og lejlighedsvis invaliderende knogle-, led-, og/eller muskelsmerter hos patienter i behandling med bisfosfonater, herunder zoledronsyre.
English: - Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
Danish: - Anti-angiogenisk medicin (brugt til behandling af kræft), da kombination af dette og Zoledronsyre medac har været forbundet med en øget risiko for osteonekrose i kæberne (ONJ).
English: • Additional risk minimisation measures The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Danish: • Yderligere risikominimeringsforanstaltninger Indehaveren af markedsføringstilladelsen skal sikre, at der implementeres et memokort til patienten angående osteonekrose i kæberne.
English: Zoledronic acid medac must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Danish: Zoledronsyre medac må kun ordineres og administreres til patienter af sundhedspersonale med erfaring i administration af intravenøse bisfosfonater.
English: The effects of intravenous zoledronic acid in the treatment of paediatric patients (age 1 to 17 years) with severe osteogenesis imperfecta (types I, III and IV) were compared to intravenous pamidronate in one international, multicentre, randomised, open-label study with 74 and 76 patients in each treatment group, respectively.
Danish: Virkningen af zoledronsyre givet intravenøst til behandling af pædiatriske patienter (i alderen 1-17 år) med svær osteogenesis imperfecta (type I, III og IV) blev sammenlignet med intravenøst administreret pamidronat i et internationalt, multicenter, randomiseret, open-label studie med henholdsvis 74 og 76 patienter i hver behandlingsgruppe.
English: After first opening and dilution: From a microbiological point of view the medicinal product should be used immediately.
Danish: Efter første anbrud og fortynding: Ud fra et mikrobiologisk synspunkt skal lægemidlet anvendes straks.
English: Very common (may affect more than 1 in 10 people): - Low level of phosphate in the blood.
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer): - Lavt fosfatindhold i blodet.
English: Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg med zoledronsyre har påvist reproduktionstoksicitet (se pkt.