natgillin/translations-raw huggingface dataset:
- Zoledronsyre Hospira 4 mg/100 ml infusionsvæske, opløsning kan anvendes straks uden yderligere tilberedning til patienter med normal nyrefunktion.
- Zoledronic Acid Hospira 4 mg/100 ml solution for infusion can be used immediately without further preparation for patients with normal renal function.
Det er vigtigt, at du drikker mindst 2 glas væske (fx vand), inden for et par timer før behandling med Zoledronsyre Hospira, 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 Hospira, as directed by your healthcare provider.
Brug af anden medicin og Zoledronsyre Hospira Fortæl det altid til lægen, apotekspersonalet eller til din sygeplejerske, hvis du bruger anden medicin eller har brugt det for nylig.
Other medicines and Zoledronic Acid Hospira Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Nedsat nyrefunktion er set efter administration af zoledronsyre, specielt hos patienter med eksisterende nyreproblemer eller yderligere risikofaktorer (f.eks. 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), the majority of whom received a 4 mg dose every 3-4 weeks, but it has been observed in patients after a single administration.
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.
- Sig det til lægen, hvis du får øresmerter, udflåd fra øret og/eller betændelse i øret.
− Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Opløsningen indeholdende zoledronsyre må ikke fortyndes yderligere eller blandes med andre infusionsopløsninger.
− The solution containing zoledronic acid must not be further diluted or mixed with other infusion solutions.
Behandling med zoledronsyre til TIH-patienter, som også har svær nyreinsufficiens, bør kun overvejes efter vurdering af risici og fordele ved behandlingen.
Zoledronic acid treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Zoledronsyre Hospira kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Zoledronic Acid Hospira can cause side effects, although not everybody gets them.
Risikoen for at få disse bivirkninger aftager ved de efterfølgende doser Zoledronsyre Hospira.
The chance of experiencing these side effects decreases with subsequent doses of Zoledronic Acid Hospira.
Ud fra et mikrobiologisk synspunkt skal produktet anvendes straks.
From a microbiological point of view, the product should be used immediately.
- hvis du har fået fjernet en eller flere af biskjoldbruskkirtlerne på halsen ved en operation.
- if you have had some or all of the parathyroid glands in your neck surgically removed.
Lægen vil tage blodprøver, inden du begynder behandling med Zoledronsyre Hospira, og vil med regelmæssige mellemrum kontrollere, hvordan du reagerer på behandlingen.
Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Hospira and will check your response to treatment at regular intervals.
Præ-eksisterende hypokalcæmi skal behandles med tilstrækkelig indgivelse af calcium og Dvitamin, før behandling med zoledronsyre initieres (se pkt.
Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with zoledronic acid (see section 4.3).
Zoledronsyre Hospira må ikke blandes eller gives intravenøst sammen med andre lægemidler.
Zoledronic Acid Hospira must not be mixed or given intravenously with any other medicinal products.
Zoledronsyre Hospira må ikke komme i kontakt med calciumholdige opløsninger.
Zoledronic Acid Hospira must not be allowed to come into contact with any calcium-containing solutions.
Faktorer, der kan øge potentialet for nedsættelse af nyrefunktionen, inkluderer dehydrering, allerede eksisterende nyreinsufficiens, adskillige cyklus af zoledronsyre og andre bisfosfonater så vel som brug af andre nefrotoksiske lægemidler.
Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid and other bisphosphonates as well as use of other nephrotoxic medicinal products.
Dosisjustering er ikke nødvendig til patienter med kreatinin clearance ≥ 35 ml/min.
No dose adjustment is necessary in patients with creatinine clearance 35 ml/min.
Nyreproblemer (fx nedsat mængde urin) kan forekomme.
Kidney disorders (e.g. decreased urine output) may occur.
Instruktion i fremstilling af reducerede doser Zoledronsyre Hospira
Instructions for preparing reduced doses of Zoledronic Acid Hospira
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.
Skævheden som blev observeret i studiet er ikke observeret i andre studier med zoledronsyre, ej heller i studier med zoledronsyre 4 mg hver 3-4 uge i onkologiske patienter.
The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients.
Udtag mængden af Zoledronsyre Hospira, som angivet på posen, før administration.
Remove the volume of Zoledronic Acid Hospira solution indicated from the bag prior to administration.
Behandlingens start eller en ny behandling bør udskydes hos patienter med uhelede sår i det bløde væv i munden.
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.
Et tandeftersyn med forebyggende tandbehandling og en individuel benefit/risk-vurdering anbefales inden behandling med Zoledronsyre Hospira hos patienter med samtidige risikofaktorer.
A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Zoledronic Acid Hospira in patients with concomitant risk factors.
6 ml, type I, klart hætteglas eller 5 ml plastik hætteglas, med en fluorpolymer-belagt halobutyl prop og med aluminiumsforsegling og flip-off låg.
6 ml, type I clear glass vial or 5 ml plastic vial, stoppered with a fluoropolymer-coated halo-butyl closure and sealed with an aluminium seal and flip-off top.
Patienter skal være passende hydreret før administration af Zoledronsyre Hospira.
Patients must be appropriately hydrated prior to administration of Zoledronic Acid Hospira.
Behandlingens start eller en ny behandling bør udskydes hos patienter med uhelede sår i det bløde væv i munden, undtaget i akutte medicinske tilfælde.
The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth, except in medical emergency situations.
Populationsanalyser viste, at for en patient med en kreatinin clearance på 20 ml/min (svær nyreinsufficiens) eller på 50 ml/min (moderat insufficiens), skulle den tilsvarende beregnede clearance af zoledronsyre være henholdsvis 37% eller 72% af clearance hos en patient med en kreatinin clearance på 84 ml/min.
Population analysis showed that for a patient with creatinine clearance of 20 ml/min (severe renal impairment), or 50 ml/min (moderate impairment), the corresponding predicted clearance of zoledronic acid would be 37% or 72%, respectively, of that of a patient showing creatinine clearance of 84 ml/min.
Nogle havde tilbagevendende symptomer ved gentagen behandling med zoledronsyre eller med andre bisfosfonater.
A subset had recurrence of symptoms when rechallenged with zoledronic acid or another bisphosphonate.
Under behandling bør invasiv tandbehandling udføres med forsigtighed og undgås tæt på zoledronsyrebehandling.
While on treatment, invasive dental procedures should be performed with caution and avoided in close proximity to zoledronic acid treatment.
I et 3-års, randomiseret, dobbeltblindet, kontrolleret studie, som evaluerede effekt og sikkerhed af zoledronsyre 5 mg én gang årligt versus placebo ved behandling af postmenopausal osteoporose (PMO), var den generelle forekomst af atrieflimren 2,5% (96 ud af 3.862) og 1,9% (75 ud af 3.852) hos patienter, som fik henholdsvis zoledronsyre 5 mg og placebo.
In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
- hvis du har eller har haft smerte, hævelse eller fornemmelse af følelsesløshed i kæben, følelsen af tyngde i kæben eller af løse tænder.
− 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.
Da der ikke foreligger data om foreneligheden af Zoledronsyre Hospira med andre intravenøst indgivne stoffer, må Zoledronsyre Hospira ikke blandes med andre lægemidler/stoffer og bør altid gives igennem en separat infusionsslange.
− Since no data are available on the compatibility of Zoledronic Acid Hospira with other intravenously administered substances, Zoledronic Acid Hospira must not be mixed with other medicinal products/substances and should always be given through a separate infusion line.
Din læge vil fortælle dig om de symptomer, som forbindes med hypokalcæmi (for lavt indhold af calcium i blodet).
Your doctor will inform you regarding the symptoms associated with hypocalcaemia.
Enkeltinfusioner og gentagne infusioner over 5 og 15 minutter af 2, 4, 8 og 16 mg zoledronsyre til 64 patienter gav nedenstående farmakokinetiske data, som viste sig at være uafhængige af dosis.
Single and multiple 5 and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients yielded the following pharmacokinetic data, which were found to be dose independent.
Faktorer, der kan øge risikoen for nedsat nyrefunktion, 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.
Det er en inhibitor af osteoklastisk medieret knogleresorption.
It is an inhibitor of osteoclast-mediated bone resorption.
Det bruges til: - At forebygge knoglekomplikationer, f.eks. knoglebrud, hos voksne patienter med knoglemetastaser (spredning af kræft fra den primære kræftknude til knoglerne).
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).
Du bør ikke få Zoledronsyre Hospira, hvis du er gravid.
You should not be given Zoledronic Acid Hospira if you are pregnant.
Hver pakning indeholder 1 pose som indeholder 4 mg zoledronsyre.
Each pack contains one bag which contains 4 mg of zoledronic acid.
Serumcalcium bør måles og hypokalcæmi korrigeres, inden zoledronsyre-behandling påbegyndes.
Serum calcium should be measured and hypocalcaemia must be corrected before initiating zoledronic acid therapy.
De følgende bivirkninger, opført i tabel 2, er samlet fra kliniske forsøg og post-marketing rapporter efter fortrinsvis kronisk behandling med 4 mg zoledronsyre:
The following adverse reactions, listed in Table 2, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Patiener, der behandles med Zoledronsyre Hospira bør ikke behandles med disse produkter eller andre bisfosfanat produkter samtidigt, da den kombinerede virkning af disse stoffer er ukendte.
Patients being treated with Zoledronic Acid Hospira should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Alle patienter bør opfordres til at opretholde en god mundhygiejne, gennemgå rutinemæssige tandeftersyn og straks rapportere eventuelle orale symptomer såsom tandmobilitet, smerter eller hævelse, vedvarende sår eller sekretion under behandling med zoledronsyre.
All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, non-healing of sores or discharge during treatment with zoledronic acid.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlæggeresultaterne af studier med referencelægemidlet indeholdende zoledronsyre i alle undergrupper af den pædiatriske population for Pagets knoglesygdom (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 (see section 4.2 for information on paediatric use).
Efter påbegyndelse af infusion med zoledronsyre, øges plasmakoncentrationen af den aktive substans hurtigt, og maksimal koncentration nås ved slutningen af infusionsperioden, efterfulgt af et hurtigt fald til < 10% af maksimalkoncentrationen efter 4 timer og < 1% af maksimalkoncentrationen efter 24 timer, med en efterfølgende forlænget periode med meget lave koncentrationer der ikke overstiger 0,1% af den maksimale koncentration.
After initiation of the zoledronic acid infusion, plasma concentrations of the active substance increased rapidly, achieving their peak at the end of the infusion period, followed by a rapid decline to < 10% of peak after 4 hours and < 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak levels.
De følgende bivirkninger, opført i tabel 1, er samlet fra kliniske forsøg og post-marketing rapporter efter fortrinsvis kronisk behandling med 4 mg zoledronsyre:
The following adverse reactions, listed in Table 1, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Patienter skal holdes velhydrerede før og efter administration af Zoledronsyre Hospira.
Patients must be maintained well hydrated prior to and following administration of Zoledronic Acid Hospira.
Ikke kendt** Dehydrering sekundært til symptomer som feber, opkastning og diarré efter behandlingen.
Dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea
- Når du skal tilberede en infusionsvæske indeholdende 4 mg zoledronsyre, skal du opløse Zoledronsyre Hospira 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, further dilute the Zoledronic Acid Hospira concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Alle patienter bør opfordres til at opretholde en god mundhygiejne, gennemgå rutinemæssige tandeftersyn og straks rapportere eventuelle orale symptomer såsom tandmobilitet, smerter eller hævelse eller vedvarende sår eller sekretion under behandling med zoledronsyre.
All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with zoledronic acid.
Dette lægemiddel må ikke komme i kontakt med calcium-holdige opløsninger.
This medicinal product must not be allowed to come into contact with any calcium-containing solutions.
tandkødslidelser, eller en planlagt tandudtrækning; - du ikke får regelmæssig tandpleje eller ikke har haft et tandeftersyn i lang tid; - du ryger (det kan øge risikoen for tandproblemer); - du tidligere er blevet behandlet med bisfosfonat (bruges til at behandle eller forebygge knoglekomplikationer); - du tager medicin kaldet kortikosteroider (fx prednisolon eller dexamethason); - du har kræft.
Before receiving Zoledronic Acid Hospira, tell your doctor, pharmacist or nurse if - you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction; - you do not receive routine dental care or have not had a dental check-up for a long time; - you are a smoker (as this may increase the risk of dental problems); - you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders); - you are taking medicines called corticosteroids (such as prednisolone or dexamethasone) - you have cancer.
- Sløret syn, tåreflåd, lysfølsomhed i øjnene.
− Blurred vision, tearing of the eye, eye sensitivity to light.
Længerevarende gentaget administration, som gav tilstrækkelig kumulativ højere eksponering end maksimal dosis beregnet til human terapi, viste toksikologiske effekter på andre organer, inklusiv mavetarmkanalen og lever, og på det intravenøse injektionssted.
Longer-term repeat administration at cumulative exposures sufficiently exceeding the maximum intended human exposure produced toxicological effects in other organs, including the gastrointestinal tract and liver, and at the site of intravenous administration.
*Dosis er beregnet ud fra forudsætning om et mål-AUC på 0,66 (mg•t/l) (CLcr = 75 ml/min).
* Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Dette lægemiddel indeholder mindre end 16 mmol (eller 360 mg) natrium per dosis.
This medicine contains 16 mmol (or 360 mg) sodium per dose.
Dette resulterede i unormalt store farmakologiske effekter, som blev vurderet til at være relateret til lægemidlets hæmning af mobiliseringen af calcium i knoglerne, hvilket resulterede i periparturient hypokalcæmi, en klasseeffekt for bisfosfonater, dystocia og afslutning af studiet før tid.
This resulted in exaggerated pharmacological effects considered related to the compound's inhibition of skeletal calcium mobilisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
Bivirkningerne, der er ordnet efter hyppighed, er præsenteret i tabel 7.
The adverse reactions ranked under headings of frequency, are presented in Table 7.
Sjælden Atypiske subtrokantære og diafyseale femurfrakturer† (bifosfonat klasseeffekt)
Atypical subtrochanteric and diaphyseal femoral fractures† (bisphosphonate class adverse reaction)
Følg nøje alle instruktioner, du får af lægen eller sygeplejersken.
Follow carefully all instructions given to you by your doctor or nurse.
Efter påbegyndelse af behandling bør serum-kreatinin måles før hver dosis af Zoledronsyre Hospira, og behandlingen bør tilbageholdes, hvis nyrefunktionen forværres.
Following initiation of therapy, serum creatinine should be measured prior to each dose of Zoledronic Acid Hospira and treatment should be withheld if renal function has deteriorated.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med referencelægemidlet indeholdende zoledronsyre hos alle undergrupper af den pædiatriske population ved behandling af tumorinduceret hyperkalcæmi (TIH) og forebyggelse af skeletrelaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser (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 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).
Total legemsclearance er 5,04 ± 2,5 l/h uafhængigt af dosis og uanset køn, alder, race og legemsvægt.
The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race or body weight.
Der skal anvendes aseptiske teknikker under fremstilling af infusionen.
Aseptic techniques must be followed during the preparation of the infusion.
I de poolede resultater blev der for zoledronsyre og risedronat observeret lignende nedsættelse i sværhedsgraden af smerte og score for smerteinterferens relativt i forhold til baseline i løbet af 6 måneder.
In the pooled results, a similar decrease in pain severity and pain interference scores relative to baseline were observed over 6 months for zoledronic acid and risedronate.
- Zoledronsyre Hospira må kun gives af sundhedspersonale, som er trænet til at indgive bisfosfonater intravenøst, dvs. gennem en blodåre.
− Zoledronic Acid Hospira must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
† Set efter markedsføring.
† Identified in post-marketing experience.
Hos patienter med normal nyrefunktion, defineret som CLcr >60 ml/min, må zoledronsyre 4 mg/100 ml infusionsvæske, opløsning ikke blive yderligere fortyndet.
In patients with normal renal function, defined as CLcr > 60 ml/min, zoledronic acid 4 mg/100 ml solution for infusion must not be further diluted.
For patienter med normal nyrefunktion (defineret som CLcr >60 ml/min), kan zoledronsyre 4 mg/100 ml infusionsvæske, opløsning indgives direkte uden nogen yderligere forberedelse.
For patients with normal renal function (defined as CLcr > 60 ml/min), zoledronic acid 4 mg/100 ml solution for infusion may be administered directly without any further preparation.
Zoledronsyre Hospira indeholder det aktive stof zoledronsyre.
Zoledronic Acid Hospira contains the active substance zoledronic acid.
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).
Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data) Smerter i mund,og/eller kæbe, hævelse eller manglende sårheling i munden eller kæben, pus fra såret, følelsesløshed eller en følelse af tunghed i kæben, eller løsnen af en tand; dette kan være tegn på knogleskade i kæben (osteonekrose).
Not known (frequency cannot be estimated from the available data) Pain in the mouth and/or jaw, swelling or non-healing sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth, these could be signs of bone damage in the jaw (osteonecrosis).
Skal fortyndes før brug.
Dilute before use
- Usædvanlige brud på lårbensknoglen, primært hos patienter i langtidsbehandling for osteoporose kan forekomme i sjældne tilfælde.
− Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.