natgillin/translations-raw huggingface dataset:
- In vitro: 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.
Andel af patienter med SRE'er (%) p-værdi
Proportion of patients with SREs p-value
Denne tilstand kaldes tumorinduceret hypercalcæmi (TIH).
This condition is known as tumour-induced hypercalcaemia (TIH).
Zoledronsyre Actavis bør ikke bruges til børn og unge under 18 år.
Zoledronic acid Actavis is not recommended for use in adolescents and children below the age of 18 years.
− Øvrige indholdsstoffer: Mannitol, natriumcitrat og vand til injektionsvæsker.
- The other ingredients are: mannitol, sodium citrate and water for injections.
Tabel 6: Bivirkninger observeret hos pædiatriske patienter med svær osteogenesis imperfecta1
Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders
Zoledronsyre Actavis må kun udskrives og administreres til patienter af sundhedspersonale med erfaring i administration af intravenøse bisfosfonater.
Zoledronic acid Actavis must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Sundhedspersonalet rådes til ikke at smide ubrugt Zoledronsyre Actavis i kloakken.
Healthcare professionals are advised not to dispose of unused Zoledronic acid Actavis via the domestic sewage system.
Efter påbegyndelse af behandling bør serum-kreatinin måles før hver dosis af Zoledronsyre Actavis, og behandlingen bør tilbageholdes, hvis nyrefunktionen forværres.
Following initiation of therapy, serum creatinine should be measured prior to each dose of Zoledronic acid Actavis and treatment should be withheld if renal function has deteriorated.
Dette resulterede i unormalt store farmakologiske effekter, der menes at være relateret til stoffets hæmning af knogle-calcium-metabolismen, resulterende i periparturient hypocalcæmi, en klasseeffekt for bisfosfonater, dystoci og afslutning af forsøget før tid.
This resulted in exaggerated pharmacological effects considered to be related to the compound's inhibition of skeletal calcium metabolisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
Zoledronsyre Actavis bør ikke anvendes under graviditet.
Zoledronic acid Actavis should not be used during pregnancy.
Tabel 4: Effektresultater (patienter med brystcancer eller multiple myelomer)
Table 4: Efficacy results (breast cancer and multiple myeloma patients)
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.
Patienter skal holdes velhydrerede før og efter administration af Zoledronsyre Actavis.
Patients must be maintained well hydrated prior to and following administration of Zoledronic acid Actavis.
I kliniske undersøgelser udført i patienter med tumorinduceret hypercalcæmi (TIH), var den overordnede sikkerhedsprofil mellem de tre behandlingsgrupper (zoledronsyre 4 og 8 mg og pamidronat 90 mg) lignende i art og alvorlighed.
In clinical trials performed in patients with tumour-induced hypercalcaemia (TIH), the overall safety profile amongst all three treatment groups (zoledronic acid 4 and 8 mg and pamidronate 90 mg) was similar in types and severity.
Patienter, som behandles med Zoledronsyre Actavis, bør ikke samtidig behandles med sådanne lægemidler eller andre bisfosfonater, da den kombinerede effekt af disse stoffer er ukendt.
Patients being treated with Zoledronic acid Actavis should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Meget almindelig (kan påvirke mere 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.
− Da der ikke eksisterer data om forligelighed af Zoledronsyre Actavis med andre intravenøst indgivne stoffer, må Zoledronsyre Actavis ikke blandes med andre lægemidler eller stoffer og bør altid indgives gennem en separat infusionsslange.
- Since no data are available on the compatibility of Zoledronic acid Actavis with other intravenously administered substances, Zoledronic acid Actavis must not be mixed with other medications/substances and should always be given through a separate infusion line.
Behandling med Zoledronsyre Actavis til TIH-patienter, som også har svær nyreinsufficiens, bør kun overvejes efter vurdering af risici og fordele ved behandlingen.
Zoledronic acid Actavis treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med zoledronsyre hos alle undergrupper af den pædiatriske population ved behandlingen af tumorinduceret hypercalcæmi (TIH) og forebyggelse af skeletrelaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser (se pkt 4,2 for information om pædiatrisk anvendelse).
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
I betragtning af zoledronsyres potentielle indflydelse på nyrefunktionen, manglende omfattende kliniske sikkerhedsdata hos patienter med alvorlig nedsat nyrefunktion (i kliniske studier defineret som serumkreatinin ≥ 400 mikromol/l eller ≥ 4,5 mg/dl hos patienter med TIH, og ≥ 265 mikromol/l eller ≥ 3,0 mg/dl hos patienter med henholdsvis cancer og knoglemetastaser) i forhold til deres baseline værdi og kun begrænsede farmakokinetiske data hos patienter med svært nedsat nyrefunktion ved baselinien (serumkreatinin clearance < 30 ml/min), kan Zoledronsyre Actavis ikke anbefales til patienter med alvorlig nedsat nyrefunktion.
In view of the potential impact of zoledronic acid on renal function, the lack of clinical safety data in patients with severe renal impairment (in clinical trials defined as serum creatinine ≥ 400 micromol/l or ≥ 4.5 mg/dl for patients with TIH and ≥ 265 micromol/l or ≥ 3.0 mg/dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/min), the use of Zoledronic acid Actavis is not recommended in patients with severe renal impairment.
- Anti-angiogenetisk medicin (brugt til behandling af kræft), da kombination af dette og Zoledronsyre Actavis har været forbundet med en øget risiko for osteonekrose i kæberne.
- 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).
- Zoledronsyre Actavis må kun gives af sundhedspersonale, som er trænet til at indgive bisfosfonater intravenøst, dvs. gennem en blodåre.
- Zoledronic acid Actavis must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
− Sløret syn, tåreflåd, lysfølsomhed i øjnene.
- Blurred vision, tearing of the eye, eye sensitivity to light.
Det er ikke kendt, om zoledronsyre bliver udskildt med modermælken.
It is not known whether zoledronic acid is excreted into human milk.
(fx tandudtrækninger)og dårligt tilpassede tandproteser.
(e.g. tooth extractions) and poorly fitting dentures
Zoledronsyre Actavis anbefales ikke til patienter, der før behandlingen initieres, har svær nyreinsufficiens, som i denne population er defineret som CLcr < 30 ml/min.
Zoledronic acid Actavis is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Patienter med TIH og verificeret forværret nyrefunktion bør evalueres på relevant vis, og det bør overvejes om den potentielle gavn af behandling med Zoledronsyre Actavis opvejer de mulige ricisi.
Patients with TIH and evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with Zoledronic acid Actavis outweighs the possible risk.
Tabel 3: Effektresultater (solide tumorer udover bryst- og prostatacancer)
Table 3: Efficacy results (solid tumours other than breast or prostate cancer)
Indeholder mannitol, natriumcitrat og vand til injektionsvæsker.
Contains mannitol, sodium citrate and water for injections.
Zoledronsyre Actavis er kontraindikeret hos kvinder, der ammer (se pkt 4.3).
Zoledronic acid Actavis is contraindicated in breast-feeding women (see section 4.3).
- Hvis du er i forebyggende behandling for knoglekomplikationer pga. knoglemetastaser, vil du få en infusion af Zoledronsyre Actavis hver tredje til fjerde uge.
- If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic acid Actavis every three to four weeks.
Advarsler og forsigtighedsregler Kontakt lægen før du begynder at få Zoledronsyre Actavis,:
Warnings and precautions Talk to your doctor before you are given Zoledronic acid Actavis:
Denne medicin indeholder mindre end 1 mmol natrium (23) mg per dosis, dvs. den er hovedsagelig ”natriumfri”.
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.
Dette lægemiddel indeholder mindre end 1 mikromol natrium (23 mg) per dosis, dvs. det er hovedsageligt ”natriumfrit”.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.
4,0 mg zoledronsyre 3,5 mg* zoledronsyre 3,3 mg* zoledronsyre 3,0 mg* zoledronsyre *Dosis er beregnet ud fra forudsætning om et mål-AUC på 0,66 (mg•t/l) (CLcr = 75 ml/min).
4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Bivirkningerne er ordnet under overskrifter om hyppighed, den hyppigste først, ved brug af de følgende konventionelle regler: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Til patienter med knoglemetastaser, der før behandlingen initieres, har mild til moderat nyreinsufficiens, som i denne population er defineret som CLcr 30-60 ml/min, anbefales følgende dosis af Zoledronsyre Actavis (se også afsnit 4.4):
In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, the following Zoledronic acid Actavis dose is recommended (see also section 4.4):
Hypomagnesæmi, hypokaliæmi
Hypomagnesaemia, hypokalaemia
Hos patienter, der har påvist forværret nyrefunktion under behandling, bør Zoledronsyre Actavis tilbageholdes.
In patients who show evidence of renal deterioration during treatment, Zoledronic acid Actavis should be withheld.
- Anden medicin, der indeholder zoledronsyre, som bruges til at behandle knogleskørhed og andre ikke-kræft sygdomme i knoglerne, eller andre bisfosfonater, da den kombinerede effekt af at tage disse lægemidler sammen med Zoledronsyre Actavis er ukendt.
- Other medicines that contain zoledronic acid which are used to treat osteoporosis and other noncancer diseases of the bone, or any other bisphosphonate, since the combined effects of these medicines taken together with Zoledronic acid Actavis are unknown.
I en pooled analyse af sikkerhedsdata fra zoledronsyre-registreringsstudier vedrørende forebyggelse af skelet-relaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser, var frekvensen af bivirkninger med relation til nedsat nyrefunktions og som formodes at være relateret til zoledronsyre, følgende: multipelt myeloma (3,2%), prostatacancer (3,1%), brystcancer (4,3%), lungecancer og andre solide tumorer (3,2%).
In a pooled analysis of safety data from zoledronic acid registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
Sløret syn, sklerit og orbital inflammation Uveitis
Blurred vision, scleritis and orbital inflammation Uveitis
Meget sjælden (kan påvirke på til 1 ud af 10.000 patienter): - Besvimelse på grund af lavt blodtryk.
Very rare (may affect up to 1 in 10,000 people): - Fainting due to low blood pressure.
Hvis du har hypokalcæmi, skal den korrigeres, inden du får den første dosis af Zoledronsyre Actavis.
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid Actavis.
Din læge vil måske bede dig om at få et tandeftersyn, før du starter behandling med Zoledronsyre Actavis.
Your doctor may recommend a dental examination before you start treatment with Zoledronic acid Actavis.
• Overfølsomhed over for det aktive stof, andre bisfosfonater eller over for et eller flere af hjælpestofferne angivet i pkt.
• Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1
Der tilrådes forsigtighed, når Zoledronsyre Actavis indgives sammen med anti-angiogene lægemidler, da der er set en øget hyppighed af osteonekrose af kæberne hos patienter i samtidig behandling med disse lægemidler.
Caution is advised when Zoledronic acid Actavis is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Nedsat indhold af calcium i blodet (hypokalcæmi), som kan medføre muskelkramper, tør hud, en brændende følelse, er indberettet for patienter i behandling med Zoledronsyre Actavis.
Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients treated with zoledronic acid.
- Forebyggelse af skeletrelaterede hændelser (patologiske frakturer, spinal kompression, strålebehandling eller operation af knogler, eller tumorinduceret hypercalcæmi) hos voksne patienter med fremskreden malign sygdom og knoglemetastaser.
- Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Instruktion for tilberedning af reducerede doser af Zoledronsyre Actavis: Udtag det passende volumen af det flydende koncentrat efter følgende: 4,4 ml til 3,5 mg dosis
Instructions for preparing reduced doses of Zoledronic acid Actavis: Withdraw the appropriate volume of the liquid concentrate, as follows: 4.4 ml for 3.5 mg dose
Analysen vedrørende gentagne hændelser afslørede en signifikant risikoreduktion på 16 % hos patienter behandlet med 4 mg zoledronsyre sammenlignet med patienter behandlet med pamidronat.
The multiple event analysis revealed a significant risk reduction of 16% in patients treated with 4 mg zoledronic acid in comparison with patients receiving pamidronate.
I et tredje fase III randomiseret, dobbeltblindt studie blev 4 mg zoledronsyre eller 90 mg pamidronat administreret hver 3. til 4. uge sammenlignet hos patienter med multiple myelomer eller brystkræft og mindst én knoglelæsion.
In a third phase III randomised, double-blind trial, 4 mg zoledronic acid or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
Zoledronsyre Actavis leveres som et klart og farveløst koncentrat til infusionsvæske, opløsning (sterilt koncentrat), i et plastik hætteglas.
Zoledronic acid Actavis is supplied as a clear and colourless concentrate for solution for infusion (sterile concentrate) in a plastic vial.
- Sig det til lægen, hvis du får øret og/eller betændelse i øret.
- Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Fortæl det straks til din læge eller tandlæge, hvis du får sådanne symptomer, mens du er i behandling med Zoledronsyre Actavis eller efter behandlingsophør.
Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic acid Actavis or after stopping treatment.
Den renale clearance af zoledronsyre korrelerer tydeligt med kreatininclearance, idet den renale clearance er ansvarlig for 75 ± 33% af kreatininclearance, hvilket viser en median på 84 ± 29 ml/min (varierende fra 22 til 143 ml/min) hos de 64 undersøgte cancerpatienter.
The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 cancer patients studied.
EXP Holdbarhed efter fortynding: Se indlægsseddel.
EXP Shelf life after dilution: See leaflet.
Ikke almindelig (kan påvirke op til 1 ud af 100 patienter): - Overfølsomhedsreaktioner.
Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
Zoledronsyre Actavis indeholder natrium
Zoledronic acid Actavis contains sodium
− hvis du har eller har haft smerte, hævelse eller fornemmelse af følelsesløshed i kæben,
- if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
Resultater fra kliniske undersøgelser vedrørende behandling af TIH Kliniske studier af tumorinduceret hypercalcæmi (TIH) viser, at effekten af zoledronsyre er karakteriseret ved fald i serumcalcium og urinudskillelse af calcium.
Clinical studies in tumour-induced hypercalcaemia (TIH) demonstrated that the effect of zoledronic acid is characterised by decreases in serum calcium and urinary calcium excretion.
− Aktivt stof: Zoledronsyre.
- The active substance is zoledronic acid.
Fortæl det altid til lægen, hvis du bruger anden medicin, har brugt det eller tror du har brugt det for nylig.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Zoledronsyre var teratogen hos rotter i subkutane doser på ≥ 0,2 mg/kg.
Zoledronic acid was teratogenic in the rat at subcutaneous doses ≥ 0.2 mg/kg.
Opvearingsbetingelser for Zoledronsyre Actavis efter fortynding, se ”Holdbarhed efter fortynding” ovenfor.
- For storage conditions of Zoledronic acid Actavis after dilution, see “Shelf life after dilution”
Fortæl det straks til din læge, hvis du oplever symptomer så som nyopstået ømhed, smerte eller stivhed, eller en forværring af disse symptomer, mens du er i behandling med Zoledronsyre Actavis eller efter endt behandling.
Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic acid Actavis or after stopping treatment.
Faktorer, der kan øge potentialet for nedsættelse af nyrefunktionen, inkluderer dehydrering, allerede eksisterende nyreinsufficiens, flere behandlingscyklusser af zoledronsyre eller andre bisfosfonater så vel som brug af andre nefrotoksiske lægemidler eller brug af en kortere infusionstid end anbefalet på nuværende tidspunkt.
Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended.
Muskelspasmer, osteonekrose af kæberne Osteonekrose af øregangen (klasse-bivirkning for bisfosfonater) og andre anatomiske steder, inklusive femur og hofte.
Muscle spasms, osteonecrosis of the jaw Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé, pkt.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) .
Patienternes hydreringsstatus skal vurderes før og efter indgivelsen af Zoledronsyre Actavis for at sikre, at de er tilstrækkeligt hydrerede.
The hydration status of patients must be assessed prior to and following administration of Zoledronic acid Actavis to ensure that they are adequately hydrated.
Du må ikke få Zoledronsyre Actavis:
You should not be given Zoledronic acid Actavis:
Zoledronsyre 4 mg blev også undersøgt i et dobbeltblindt, randomiseret, placebokontrolleret studie i 228 patienter med dokumenterede knoglemetastaser fra brystkræft, for at evaluere effekten af 4 mg zoledronsyre på skeletrelaterede hændelser (SRE) forekomsts-ratio beregnet som det totale antal af SRE hændelser (eksklusiv hypercalcæmi og justeret for tidligere frakturer) delt med den totale risikoperiode.
Zoledronic acid 4 mg was also studied in a double-blind, randomised, placebo-controlled trial in 228 patients with documented bone metastases from breast cancer to evaluate the effect of 4 mg zoledronic acid on the skeletal related event (SRE) rate ratio, calculated as the total number of SRE
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKER TIL HÆTTEGLAS
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR VIALS
Resultaterne viste, at 4 mg zoledronsyre havde sammenlignelig effekt med 90 mg pamidronat til forebyggelse af skeletrelaterede hændelser (SRE).
The results demonstrated that 4 mg zoledronic acid showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
- Interstitiel lungesygdom (inflammation i vævet omkring lungernes alveoler) - Influenza-lignende symptomer herunder gigt (artritis) og hævede led.
- Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) - Flu-like symptoms including arthritis and joint swelling.
− Når du skal tilberede en infusionsvæske indeholdende 4 mg Zoledronsyre Actavis, skal du opløse Zoledronsyre Actavis koncentratet (5,0 ml) yderligere med 100 ml calciumfri eller anden infusionsvæske uden indhold af divalente kationer.
- To prepare an infusion solution containing 4 mg Zoledronic acid Actavis, further dilute the Zoledronic acid Actavis concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Ved erfaring efter markedsføring er der rapporteret om alvorlige og lejlighedsvis invaliderende knogle-, led-, og/eller muskelsmerter hos patienter, der modtog zoledronsyre efter anvisningerne under pkt.
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients that were given zoledronic acid as indicated in sections 4.1 and 4.2.