natgillin/translations-raw huggingface dataset:
Den leveres i multipakninger bestående af 5 eller 10 poser.
It is supplied in multipacks containing 5 or 10 bags.
Kontakt lægen, før du får Zoledronsyre Teva Generics: - hvis du er i behandling med et andet bisfosfonat, da den kombinerede effekt af disse lægemidler taget sammen med Zoledronsyre Teva Generics er ukendt.
Talk to your doctor before you are given Zoledronic acid Teva Generics: - if you are being treated with any other bisphosphonate medicine, since the combined effects of these medicines taken together with Zoledronic acid Teva Generics are unknown.
Et tandeftersyn med passende forebyggende tandbehandling bør overvejes før behandling med bisfosfonater hos patienter med flere samtidige risikofaktorer (fx cancer, kemoterapi, anti-angiogene lægemidler, kortikosteroider, dårlig mundhygiejne).
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, anti-angiogenic medicinal products, corticosteroids, poor oral hygiene).
Det er vigtigt, at du tager tilskud af calcium og D-vitamin (fx tabletter) efter lægens anvisninger.
It is important to take calcium and vitamin D supplements (for example tablets) as directed by your doctor.
Laboratorieundersøgelser viste forbigående kalciumniveauer under den normale referenceværdi (mindre end 2,10 mmol/l) hos 2,3 % af de zoledronsyre-behandlede patienter i et større klinisk studie sammenlignet med 21 % af zoledronsyre-behandlede patienter i de kliniske forsøg med Pagets sygdom.
Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/l) occurred in 2.3% of zoledronic acid-treated patients in a large clinical trial compared to 21% of zoledronic acid-treated patients in the Paget's disease trials.
Ikke kendt** Nedsat nyrefunktion.
Not known** Renal impairment.
Navn og adresse på fremstillerne, der er ansvarlige for batchfrigivelse
Name and address of the manufacturer(s) responsible for batch release
Klinisk effekt ved behandling af postmenopausal osteoporose [PFT] Virkning og sikkerhed af zoledronsyre 5 mg en gang årligt i 3 konsekutive år er påvist hos postmenopausale kvinder (7.736 kvinder i alderen 65-89 år) med enten: en knoglemineraltæthed (BMD) med en t-score for lårbenshalsen ≤ -1,5, og mindst to milde eller en moderat eksisterende vertebral(e) fraktur(er); eller en BMD T-score for lårbenshalsen ≤ -2,5 med eller uden bevis for eksisterende vertebral (e) fraktur(er).
Clinical efficacy in the treatment of post-menopausal osteoporosis (PFT) The efficacy and safety of zoledronic acid 5 mg once a year for 3 consecutive years were demonstrated in post-menopausal women (7,736 women aged 65-89 years) with either: a femoral neck bone mineral density (BMD) with a T-score ≤ -1.5 and at least two mild or one moderate existing vertebral fracture(s); or a femoral neck BMD T-score ≤ -2.5 with or without evidence of existing vertebral fracture(s).
Zoledronsyre (5 mg i 100 ml infusionsklar opløsning) administreres via en separat infusionsslange og ved en konstant infusionshastighed.
Zoledronic acid (5 mg in 100 ml ready-to-infuse solution) is administered via a vented infusion line and given at a constant infusion rate.
Den leveres i en foliepose af polyolefin/styren-ethylen-butylen (SEB) i en folieyderpose.
It comes in a polyolefin/styrene-ethylene-butylene (SEB) foil bag with a foil over pouch.
Dialysekrævende nyresvigt eller letale tilfælde er i sjældne tilfælde opstået hos patienter med underliggende nyresygdom eller med en af risikofaktorerne beskrevet ovenfor.
Renal failure requiring dialysis or with a fatal outcome has rarely occurred in patients with underlying renal impairment or with any of the risk factors described above.
Efter overgangsalderen sker der knogletab, og knoglerne bliver svagere og brækker lettere.
Following the menopause bone loss occurs, bones become weaker and break more easily.
Forsigtighed tilrådes når zoledronsyre administreres samtidig med lægemidler, der har en signifikant indvirkning på nyrefunktionen (fx aminoglykosider eller diuretika, som kan forårsage dehydrering) (se pkt.
Caution is indicated when zoledronic acid is administered in conjunction with medicinal products that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration) (see section 4.4).
Patienter med nedsat leverfunktion Dosisjustering er ikke nødvendig (se pkt.
Patients with hepatic impairment No dose adjustment is required (see section 5.2).
• Informationskort med følgende hovedbudskaber: o Nødvendigheden af inden hver behandling med Zoledronsyre Teva Generics at beregne kreatininclearance på basis af den faktiske legemsvægt ved at bruge o Kontraindiceret til patienter med kreatininclearance < 35 ml/min o Kontraindikationer hos gravide og ammende kvinder grundet potentiel teratogenicitet o Nødvendigheden af at sikre passende hydrering af patienten specielt ældre patienter o Nødvendigheden af at infusere Zoledronsyre Teva Generics langsomt over en periode o Tilstrækkelig calcium- og Vitamin D-optag er anbefalet i forbindelse med o Nødvendigheden af passende fysisk aktivitet, rygestop og sund diæt
• Reminder card with the following key messages: o Need to calculate creatinine clearance based on actual body weight using the CockcroftGault formula before each treatment with Zoledronic acid Teva Generics o Contraindication in patients with creatinine clearance < 35 ml/min o Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity o Need to ensure appropriate hydration of the patient especially those at an advanced age and those receiving diuretic therapy o Need to infuse Zoledronic acid Teva Generics slowly over a period of no less than 15 minutes o Once-yearly dosing regime o Adequate calcium and vitamin D intake are recommended in association with zoledronic acid administration o Need for appropriate physical activity, non-smoking and healthy diet
Osteonekrose af kæberne er blevet rapporteret hos patienter behandlet med zoledronsyre.
Osteonecrosis of the jaw has been reported in patients treated with zoledronic acid.
Klinisk effekt ved behandling af Pagets sygdom af knoglerne Zoledronsyre blev undersøgt hos mænd og kvinder i alderen over 30 år med primært mild til moderat Pagets sygdom af knoglerne (gennemsnitlig serum alkalisk fosfatase niveau på 2,6-3,0 gange den øvre grænseværdi for det normale aldersspecifikke referenceområde ved inklusion i studiet) bekræftet ved radiografisk påvisning.
Clinical efficacy in the treatment of Paget's disease of the bone Zoledronic acid was studied in male and female patients aged above 30 years with primarily mild to moderate Paget's disease of the bone (median serum alkaline phosphatase level 2.6-3.0 times the upper limit of the age-specific normal reference range at the time of study entry) confirmed by radiographic evidence.
Der sås en forbigående stigning i serumkreatinin inden for 10 dage hos 1,8 % af patienterne behandlet med zoledronsyre mod 0,8 % hos patienterne behandlet med placebo.
There was a transient increase in serum creatinine observed within 10 days in 1.8% of zoledronic acid-treated patients versus 0.8% of placebo-treated patients.
I osteoporoseforsøget (PFT, HORIZON - Tilbagevendende Fraktur Studie [RFT] var den samlede incidens for atrieflimren sammenlignelig for zoledronsyre (2,6 %) og placebo (2,1 %).
In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between zoledronic acid (2.6%) and placebo (2.1%).
• Behovet for tilstrækkeligt indtag af calcium- og Vitamin D-tilskud, passende fysisk aktivitet,
• Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non smoking and healthy diet
For alvorlige bivirkninger af atrieflimren var den samlede incidens 1,3 % for zoledronsyre og 0,8 % for placebo.
For atrial fibrillation serious adverse events the pooled incidences were 1.3% for zoledronic acid and 0.8% for placebo.
Det er vigtigt, at du drikker mindst 2 glas væske (fx vand), inden for et par timer før behandling med Zoledronsyre Teva Generics, som anvist af sundhedspersonalet.
It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Zoledronic acid Teva Generics, as directed by your healthcare provider.
MikroCT-analysen (μCT) påviste øget trabekulær knoglevolumen og bevarelse af trabekulær knoglearkitektur hos patienter behandlet med zoledronsyre sammenlignet med placebo.
Microcomputed tomography (μCT) analysis demonstrated increased trabecular bone volume and preservation of trabecular bone architecture in patients treated with zoledronic acid compared to placebo.
Zoledronsyre Teva Generics må ikke komme i kontakt med calciumholdige opløsninger.
Zoledronic acid Teva Generics must not be allowed to come into contact with any calcium-containing solutions.
Zoledronsyre Teva Generics har ingen eller kun ubetydelig indvirkning på evnen til at køre bil og betjene maskiner.
Zoledronic acid Teva Generics has no or negligible influence on the ability to drive and use machines.
Der er mange veldokumenterede risikofaktorer for osteonekrose i kæberne inklusive cancer-diagnose, samtidige behandlinger (fx kemoterapi, anti-angiogene lægemidler, strålebehandling, kortikosteroider) og følgesygdomme (fx anæmi, koagulationslidelse, infektion, præ-eksisterende tandsygdomme).
Osteonecrosis of the jaw has multiple well documented risk factors including a diagnosis of cancer, concomitant therapies (e.g. chemotherapy, anti-angiogenic medicinal products, radiotherapy, corticosteroids) and co-morbid conditions (e.g. anaemia, coagulopathies, infection, pre-existing dental disease).
Patienter skal være passende hydreret før administration af Zoledronsyre Teva Generics.
Patients must be appropriately hydrated prior to administration of zoledronic acid.
Tabel 4 Sammenligninger mellem behandlinger af incidensen af vigtige kliniske
Table 4 Between treatment comparisons of the incidence of key clinical fracture variables
Incidensen af post-dosis-symptomer, der opstår inden for de første tre dage efter administration af Zoledronsyre Teva Generics, kan reduceres ved at administrere paracetamol eller ibuprofen kort efter administration af Zoledronsyre Teva Generics.
The incidence of post-dose symptoms occuring within the first three days after administration of Zoledronic acid Teva Generics can be reduced with the administration of paracetamol or ibuprofen shortly following Zoledronic acid Teva Generics administration
Kemisk og fysisk stabilitet er påvist i 24 timer ved 2-8°C og 25°C.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C and 25ºC.
Din læge bør tage en blodprøve for at kontrollere din nyrefunktion (kreatininniveau) før hver Zoledronsyre Teva Generics-dosis.
Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic acid Teva Generics.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med zoledronsyre i alle undergrupper af den pædiatriske population for Pagets knoglesygdom, osteoporose hos mænd og post-menopausale kvinder med øget risiko for fraktur, og forebyggelse af kliniske frakturer efter hoftefraktur hos mænd og kvinder (se pkt.
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 Paget's disease of the bone, osteoporosis in post-menopausal women at an increased risk of fracture, osteoporosis in men at increased risk of fracture and prevention of clinical fractures after a hip fracture in men and women (see section 4.2 for information on paediatric use).
Nedsat nyrefunktion er set efter administration af zoledronsyre, specielt hos patienter med eksisterende nyreproblemer eller yderligere risikofaktorer (fx ældre patienter, cancerpatienter i kemoterapibehandling, samtidig behandling med nefrotoksiske lægemidler, samtidig behandling med diuretika, svær dehydrering), hvoraf de fleste modtog en dosis på 4 mg hver 3.-4. uge, men det er set hos patienter efter en enkelt administration.
Renal impairment has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal dysfunction or additional risk factors (e.g. advanced age, oncology patients with chemotherapy, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, severe dehydration), with the majority of them receiving a 4 mg dose every 3-4 weeks, but it has been observed in patients after a single administration.
Brug af anden medicin sammen med Zoledronsyre Teva Generics Fortæl altid lægen, farmaceuten eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
Other medicines and Zoledronic acid Teva Generics Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
• Yderligere risikominimeringsforanstaltninger Indehaveren af markedsføringstilladelsen (MAH) skal sikre at uddannelsesprogrammet, der er udarbejdet for de godkendte indikationer − behandling af osteoporose hos postmenopausale kvinder og mænd med øget risiko for knoglebrud, inklusive personer med en nylig lavenergi-hoftefraktur og behandling af osteoporose i forbindelse med længerevarende systemisk glukokortikoidbehandling hos postmenopausale kvinder og mænd med øget risiko for fraktur − opdateres.
The Marketing Authorisation Holder (MAH) shall ensure that the educational programme implemented for the authorised indications of treatment of osteoporosis in post-menopausal women and in men at increased risk of fracture, including those with a recent low-trauma hip fracture, and treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture is updated.
Incidensen af post-dosis-symptomer, der opstår inden for de første tre dage efter administration af zoledronsyre, kan reduceres ved at administrere paracetamol eller ibuprofen kort efter administration af zoledronsyre.
The incidence of post-dose symptoms occuring within the first three days after administration of zoledronic acid can be reduced with the administration of paracetamol or ibuprofen shortly following zoledronic acid administration.
• Før hver zoledronsyre-dosis bør kreatininclearance beregnes på basis af den faktiske legemsvægt ved at bruge Cockcroft-Gault formlen.
• Creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula before each zoledronic acid dose.
I sjældne tilfælde er osteonekrose (primært i kæberne) blevet rapporteret overvejende hos cancerpatienter, der er i behandling med bisfosfonater, herunder zoledronsyre.
Uncommonly, cases of osteonecrosis (primarily of the jaw) have been reported, predominantly in cancer patients treated with bisphosphonates, including zoledronic acid.
Patienter på 75 år og derover, der blev behandlet med zoledronsyre, reducerede risikoen med 60 % for vertebral fraktur sammenlignet med placebo patienter (p<0,0001).
Zoledronic acid-treated patients aged 75 years and older exhibited a 60% reduction in the risk of vertebral fractures compared to placebo patients (p<0.0001).
Risikoen for at få disse bivirkninger aftager ved de efterfølgende doser Zoledronsyre Teva Generics.
The chance of experiencing these side effects decreases with subsequent doses of Zoledronic acid Teva Generics.
Din læge bør tage en blodprøve for at kontrollere din nyrefunktion før hver Zoledronsyre Teva Generics-dosis.
Your doctor should do a blood test to check your kidney function before each dose of Zoledronic acid Teva Generics.
Ikke almindelig Anæmi
Uncommon Anaemia
Den leveres i pakningsstørrelser med 1, 5 eller 10. Pakningsstørrelserne med 5 og 10 leveres kun i multipakninger med 5 eller 10 pakker, der hver indeholder 1 flaske.
The pack sizes of 5 and 10 are only available as multipacks comprising of 5 or 10 packs, each containing 1 bottle.
Infusionsvæske, opløsning Multipakning: 5 poser x 100 ml Multipakning: 10 poser x 100 ml
Solution for infusion multipack: 5 bags x 100 ml multipack: 10 bags x 100 ml
Patienter, der behandles med zoledronsyre, bør ikke behandles med sådanne produkter eller andre bisfosfonater samtidig, da den kombinerede effekt af disse lægemidler er ukendt.
Patients being treated with zoledronic acid should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Du må ikke få Zoledronsyre Teva Generics: - hvis du er allergisk over for zoledronsyre, andre bisfosfonater eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
- if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6).
Zoledronsyregruppen viste ca. 2,5 mm mindre højdetab sammenlignet med placebo (95 % CI: 1,6 mm, 3,5 mm) [p<0,0001].
The zoledronic acid group revealed approximately 2.5 mm less height loss compared to placebo (95% CI: 1.6 mm, 3.5 mm) [p<0.0001].
Hver pose indeholder 100 ml opløsning.
Each bag contains 100 ml of solution.
Hændelsesraten for hoftefrakturer var 1,44 % for patienter behandlet med Zoledronsyre sammenlignet med 2,49 % for patienter behandlet med placebo.
The hip fracture event rate was 1.44% for zoledronic acid-treated patients compared to 2.49% for placebo-treated patients.
• Patienter, specielt ældre patienter og patienter i behandling med diuretika, bør være passende hydreret forud for behandling med Zoledronsyre Teva Generics.
• Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of Zoledronic acid Teva Generics.
Zoledronsyre Teva Generics leveres i multipakninger bestående af 5 eller 10 poser.
Zoledronic acid Teva Generics is supplied in multipacks containing 5 or 10 bags.
B-CTx var signifikant reduceret med 61 % under baselineniveau ved 12 måneder, og det blev opretholdt med 55 % under baseline ved 36 måneder.
B-CTx was significantly reduced by 61% below baseline levels at 12 months and was sustained at 55% below baseline levels at 36 months.
Behandling med en årlig zoledronsyre-dosis på 5 mg reducerede BSAP signifikant med 30 % i forhold til baseline ved 12 måneder, hvilket blev opretholdt med 28 % under baselineniveau ved 36 måneder.
Treatment with a 5 mg annual dose of zoledronic acid significantly reduced BSAP by 30% relative to baseline at 12 months which was sustained at 28% below baseline levels at 36 months.
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE POSE
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BAG
Hos patienter med nylig lavenergi-hoftefraktur anbefales det at administrere zoledronsyre-infusion i mindst to uger efter hoftefrakturhelingen (se pkt.
In patients with a recent low-trauma hip fracture, it is recommended to give the zoledronic acid infusion at least two weeks after hip fracture repair (see section 5.1).
P1NP var signifikant reduceret med 61 % under baselineniveau ved 12 måneder, og dette blev opretholdt med 52 % under baseline ved 36 måneder.
P1NP was significantly reduced by 61% below baseline levels at 12 months and was sustained at 52% below baseline levels at 36 months.
Kvinder i den fertile alder Zoledronsyre anbefales ikke til kvinder i den fertile alder.
Women of childbearing potential Zoledronic acid is not recommended in women of childbearing potential.
- Brug ikke lægemidlet efter den udløbsdato, der står på æsken og flaskens etiket efter udløbsdatoen.
- Do not use this medicine after the expiry date which is stated on the bottle and carton label after EXP.
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKENS ETIKET
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Zoledronsyre Teva Generics indeholder det aktive stof zoledronsyre.
Zoledronic acid Teva Generics contains the active substance zoledronic acid.
Patienter, der behandles med Zoledronsyre Teva Generics, bør ikke behandles med sådanne produkter eller andre bisfosfonater samtidig, da den kombinerede effekt af disse lægemidler er ukendt.
Patients being treated with Zoledronic acid Teva Generics should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Anvendelse af Zoledronsyre Teva Generics til patienter med svært nedsat nyrefunktion (kreatininclearance < 35 ml/min) er kontraindiceret grundet en øget risiko for nyresvigt hos denne population.
The use of Zoledronic acid Teva Generics in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.
Knoglehistologi
Bone histology
Anvendelse af zoledronsyre til patienter med svært nedsat nyrefunktion (kreatininclearance < 35 ml/min) er kontraindiceret grundet en øget risiko for nyresvigt hos denne population.
The use of zoledronic acid in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.
Yderligere tilrådes det kraftigt hos patienter med Pagets sygdom at sikre et tilstrækkeligt calciumtilskud svarende til mindst 500 mg calcium to gange daglig i mindst 10 dage efter administration af zoledronsyre (se pkt.
In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following zoledronic acid administration (see section 4.2).
• Væsentlige tegn og symptomer på alvorlige bivirkninger • Hvornår det er nødvendigt at opsøge sundhedspersonale
• Key signs and symptoms of serious adverse events
Multipakning: 5 flasker x 100 ml Multipakning: 10 flasker x 100 ml
PHARMACEUTICAL FORM AND CONTENTS Solution for infusion multipack: 5 bottles x 100 ml multipack: 10 bottles x 100 ml
Hjælpestoffer: mannitol, natriumcitrat og vand til injektionsvæsker.
LIST OF EXCIPIENTS Excipients: Mannitol, sodium citrate and water for injections.
• Zoledronsyre Teva Generics bør anvendes med forsigtighed, når det anvendes samtidigt med andre lægemidler, som kan påvirke nyrefunktionen (se pkt.
• Zoledronic acid Teva Generics should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5).
Hver flaske indeholder 100 ml opløsning.
Each bottle contains 100 ml of solution.
Behandling med zoledronsyre resulterede i 5,4 % stigning i BMD på hele hoften og 4,3 % ved lårbenshalsen over 24 måneder sammenlignet med placebo.
Treatment with zoledronic acid resulted in an increase in BMD of 5.4% at the total hip and 4.3% at the femoral neck over 24 months as compared to placebo.
Behandling med zoledronsyre resulterede i en øgning af BMD med 6,7 % ved den lumbale columna, 6,0 % ved total hofte, 5,1 % ved lårbenshals og 3,2 % ved den distale radius over 3 år sammenlignet med placebo.
Treatment with zoledronic acid resulted in a 6.7% increase in BMD at the lumbar spine, 6.0% at the total hip, 5.1% at the femoral neck, and 3.2% at the distal radius over 3 years as compared to placebo.
Ikke almindelig Letargi, paræstesi, somnolens (søvnlignende bevidsthedssvækkelse), tremor, synkope, dysgeusi
Uncommon Lethargy, paraesthesia, somnolence, tremor, syncope, dysgeusia
Hævelse omkring øjnene, røde øjne, øjensmerter og øjenkløe eller lysfølsomme øjne.
Swelling, redness, pain and itching to the eyes or eye sensitivity to light.
Ikke almindelige (kan forekomme hos op til 1 ud af 100 patienter) Hudreaktioner som fx rødme.
Uncommon (may affect up to 1 in 100 people) Skin reactions such as redness.
Alle kvinder modtog 1.000 til 1.500 mg usammensat calcium og 400 til 1.200 IU D-vitamintilskud dagligt.
All women received 1,000 to 1,500 mg elemental calcium and 400 to 1,200 IU of vitamin D supplements daily.