natgillin/translations-raw huggingface dataset:
I tilfælde af klinisk signifikant hypokalcæmi kan tilstanden reverseres ved supplerende oralt calcium og/eller intravenøs infusion af calciumglukonat.
In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral calcium and/or an intravenous infusion of calcium gluconate.
Der blev observeret teratogenicitet hos rotter ved doser på 0,2 mg/kg og sås tydeligt i form af ydre og viscerale misdannelser samt misdannelser i skelettet.
Teratogenicity was observed in rats at doses 0.2 mg/kg and was manifested by external, visceral and skeletal malformations.
- Følg nøje alle de andre instruktioner, som du har fået af din læge, sygeplejerske eller farmaceut.
- Carefully follow all the other instructions given to you by your doctor, nurse or pharmacist.
Baseret på evalueringen af både kliniske studier og tilfælde post-marketing er der tilstrækkelig evidens til at understøtte en sammenhæng mellem zoledronsyre-behandling og de rapporterede tilfælde af hypokalcæmi og den sekundære udvikling af hjertearytmi.
Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between zoledronic acid therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Andre produkter, som indeholder det aktive stof zoledronsyre er tilgængelige til onkologiindikationer.
Other products containing zoledronic acid as active substance are available for oncology indications.
Alle patienter modtog tilstrækkeligt D-vitamin- og calciumtilskud i det postmenopausale osteoporosestudie, forebyggelsesstudiet af kliniske frakturer efter hoftefraktur, og studierne med Pagets sygdom (se også pkt.
All patients received adequate supplementation with vitamin D and calcium in the post-menopausal osteoporosis trial, the prevention of clinical fractures after hip fracture trial, and the Paget's disease trials (see also section 4.2).
Patienter bør få deres serum-kreatinin niveau vurderet før hver dosis af zoledronsyre.
Patients should have their serum creatinine levels assessed prior to each dose of zoledronic acid.
oC efter fortynding.
oC after dilution
Andel af patienter med SRE'er (%) p-værdi Mediantid til SRE (dage)
Proportion of patients with SREs (%) p-value Median time to SRE (days)
Forhøjet knogleomsætning er karakteristisk for Pagets sygdom af knoglerne.
Elevated bone turnover is a characteristic of Paget's disease of the bone.
Det aktive stof i Zoledronsyre Hospira er zoledronsyre, der tilhører en gruppe af stoffer kaldet bisfosfonater.
The active substance in Zoledronic Acid Hospira is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Desuden er der en påviselig association mellem hypokalcæmi og de sekundære neurologiske bivirkninger, der er rapporteret i disse tilfælde, herunder kramper, hypæstesi og tetani (se pkt.
Furthermore, there is evidence of an association between hypocalcaemia and secondary neurological events reported in these cases including; convulsions, hypoaesthesia and tetany (see section 4.4).
Frekvenserne for hver af de identificerede risici er vist i tabel 1.
The frequencies for each of these identified risks are shown in Table 1.
Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data) Alvorlige allergiske reaktioner inklusive svimmelhed og vejrtrækningsbesvær, hævelse hovedsageligt af ansigt og hals, lavt blodtryk, dehydrering sekundært til symptomer som feber, opkastning og diarré efter behandlingen.
Not known (frequency cannot be estimated from the available data) Severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the face and throat, decreased blood pressure, dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea.
- Efter åbning skal præparatet bruges straks for at undgå mikrobiel forurening.
- After opening the bag, the product should be used immediately in order to avoid microbial contamination.
- Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og posen.
- Do not use this medicine after the expiry date which is stated on the carton and bag.
I intravenøse bolusstudier faldt dosis, som var fint tolereret med stigende studievarighed: 0,2 og 0,02 mg/kg dagligt var fint tolereret i 4 uger hos henholdsvis rotter og hunde, men kun 0,01 mg/kg og 0,005 mg/kg hos henholdsvis rotter og hunde, når det indgives i 52 uger.
In the intravenous bolus studies, the doses that were well-tolerated decreased with increasing study duration: 0.2 and 0.02 mg/kg daily was well tolerated for 4 weeks in rats and dogs, respectively but only 0.01 mg/kg and 0.005 mg/kg in rats and dogs, respectively, when given for 52 weeks.
Din læge vil vejlede dig og beslutte, hvor længe du skal behandles med Zoledronsyre Hospira.
Your doctor will advise you and decide how long you should be treated with Zoledronic Acid Hospira.
Din læge, apoteket eller sygeplejersken ved, hvordan Zoledronsyre Hospira skal opbevares korrekt.
Your doctor, pharmacist or nurse knows how to store Zoledronic Acid Hospira properly.
Zoledronsyre 8 mg (N=90)
Zoledronic acid 8 mg (N=90)
Farmakoterapeutisk klassifikation: Lægemidler til behandling af knoglesygdomme, bisfosfonater, ATC-kode: M05BA08
Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Mediantid til recidiv (fornyet stigning af albuminkorrigeret serumcalcium 2,9 mmol/l) var 30-40 dage for patienter i behandling med zoledronsyre i forhold til 17 dage for patienter i behandling med 90 mg pamidronat (p-værdier: 0,001 for 4 mg og 0,007 for 8 mg zoledronsyre).
Median time to relapse (re-increase of albumin-corrected serum calcium 2.9 mmol/l) was 30 to 40 days for patients treated with zoledronic acid versus 17 days for those treated with pamidronate 90 mg (p-values: 0.001 for 4 mg and 0.007 for 8 mg zoledronic acid).
Osteonekrose i kæben kan også opstå efter, at behandlingen er stoppet.
ONJ can also occur after stopping treatment.
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 μmol/l eller ≥4,5 mg/dl hos patienter med TIH, og ≥265 µmol/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 basislinien (serumkreatinin clearance <30 ml/min), kan zoledronsyre 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 µmol/l or 4.5 mg/dl for patients with TIH and 265 µmol/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 is not recommended in patients with severe renal impairment.
Det blev vurderet, om zoledronsyre havde potentielle bivirkninger i rotter, der påvirkede fertiliteten hos den parenterale generation og F1-generationen.
Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Den lange virkningsvarighed af zoledronsyre kan tilskrives høj bindingsaffinitet til det aktive site i farnesylpyrofosfatsyntase (FPP) og dets stærke bindingsaffinitet til knoglemineral.
The long duration of action of zoledronic acid is attributable to its high binding affinity for the active site of farnesyl pyrophosphate (FPP) synthase and its strong binding affinity to bone mineral.
I fase I doseringsundersøgelser i patienter med mild til moderat tumorindiceret hyperkalcæmi (TIH), var den afprøvede effektive dosis cirka 1,2-2,5 mg.
finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2-2.5 mg.
Behandlingsperioden var 12 måneder forudgået af en 4-9ugers screeningsperiode, hvor der blev givet tilskud af calcium og D-vitamin i mindst 2 uger.
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.
Zoledronsyre bindes ikke mærkbart til plasmaproteiner (cirka 43-55% bundet), og interaktioner med stærkt proteinbundende lægemidler på grund af fortrængning, er derfor usandsynlig.
Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound medicinal products are therefore unlikely.
I intravenøse infusionsstudier blev renal tolerabilitet overfor zoledronsyre bestemt hos rotter, som fik 0,6 mg/kg givet som 15 minutters infusion i alt seks gange med 3 dages interval (for en kumulativ dosis svarende til AUC niveau cirka 6 gange højere den humane terapeutiske eksponering), mens fem 15 minutters infusioner af 0,25 mg/kg blev administreret med 2-3 ugers interval (en kumulativ dosis svarende til 7 gange den humane terapeutiske eksponering) hos hunde var fint tolereret.
In the intravenous infusion studies, renal tolerability of zoledronic acid was established in rats when given 0.6 mg/kg as 15-minute infusions at 3-day intervals, six times in total (for a cumulative dose that corresponded to AUC levels about 6 times the human therapeutic exposure) while five 15-minute infusions of 0.25 mg/kg administered at 2-3-week intervals (a cumulative dose that corresponded to 7 times the human therapeutic exposure) were well tolerated in dogs.
Der er begrænset klinisk erfaring med akut overdosering.
Clinical experience with acute overdose is limited.
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, når sammenlignet med placebo (Figur 1).
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).
Meget almindelig (kan forekomme hos flere 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.
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.
• Zoledronsyre bør anvendes med forsigtighed, når det anvendes samtidigt med andre lægemidler, som kan påvirke nyrefunktionen (se pkt.
• Zoledronic acid should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5).
- Anti-angiogenetisk medicin (brugt til behandling af kræft), da kombination af dette og Zoledronsyre Hospira 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 Hospira has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
Aseptiske teknikker skal anvendes under tilberedning af infusionen.
Aseptic techniques must be followed during preparation of the infusion.
Ved erfaring efter markedsføring er der rapporteret om alvorlige og lejlighedsvis invaliderende knogle-, led-, og/eller muskelsmerter hos patienter i behandling med zoledronsyre.
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking zoledronic acid.
- Samtidig behandling: kortikosteroider, kemoterapi, angiogenesehæmmere, stråleterapi af hoved og nakke.
- Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck.
Frekvenserne for hver af de identificerede risici er vist i tabel 2.
The frequencies for each of these identified risks are shown in Table 2.
Zoledronsyre Hospira anbefalet dosis* 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).
Zoledronic Acid Hospira recommended dose* 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).
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%).
Zoledronsyre må kun udskrives og administreres til patienter af sundhedspersonalemed erfaring i administrationaf intravenøse bisfosfonater.
Zoledronic acid must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Lavt indhold af fosfat i blodet.
Low levels of phosphate in the blood.
Zoledronsyre 4 mg (N=86)
Zoledronic acid 4 mg (N=86)
Der er ikke udført interaktionsundersøgelser med andre lægemidler og zoledronsyre.
No interaction studies with other medicinal products have been performed with zoledronic acid.
- 4,4 ml til 3,5 mg dosis - 4,1 ml til 3,3 mg dosis - 3,8 ml til 3,0 mg dosis
- 4.4 ml for 3.5 mg dose - 4.1 ml for 3.3 mg dose - 3.8 ml for 3.0 mg dose
Det vides ikke, om zoledronsyre udskilles i human mælk.
It is not known whether zoledronic acid is excreted into human milk.
Laboratorieundersøgelser viste forbigående calciumniveauer 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.
- Brug ikke Zoledronsyre Hospira efter den udløbsdato, der står på pakningen.
− Do not use Zoledronic Acid Hospira after the expiry date stated on the pack.
Intravenøst administreret zoledronsyre elimineres i en trifasisk proces: hurtig bifasisk elimination fra det systemiske kredsløb med halveringstider på t½ α 0,24 og t½β 1,87 timer efterfulgt af en lang elimineringsfase med en terminal eliminationshalveringstid på t½γ 146 timer.
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.
I kliniske studier blev behandling med zoledronsyre først genoptaget når kreatinin-niveauet faldt inden for 10% over baselineværdien (se pkt 4.4).
In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
- Pludselig opstået kuldefølelse med besvimelse, slaphed eller kollaps.
− Sudden coldness with fainting, limpness or collapse.
Zoledronsyre 4 mg reducerede signifikant andelen af patienter, der oplevede mindst én skeletrelateret hændelse (SRE), forsinkede den gennemsnitlige tid til første SRE med > 5 måneder og reducerede den årlige incidens af hændelser per patient - skeletal morbiditet.
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.
Nedsat indhold af calcium i blodet (hypokalcæmi), som kan medføre muskelkramper, tør hud, en brændende følelse, er indberettet for patienter i behandling med zoledronsyre.
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.
Det er på nuværende tidspunkt uklart, om zoledronsyre forårsager denne uregelmæssige hjerterytme, men du skal kontakte din læge, hvis du oplever sådanne symptomer, efter du har fået Zoledronsyre Hospira.
It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Zoledronic Acid Hospira.
Det er ukendt, om zoledronsyre udskilles i human mælk.
It is unknown whether zoledronic acid is excreted into human milk.
Størstedelen af disse bivirkninger var milde til moderate og ophørte inden for tre dage efter bivirkningens opståen.
The majority of these reactions were mild to moderate and resolved within three days of the event onset.
Smerte i ekstremiteter, artralgi, muskuloskeletal smerte Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
Pain in extremities, arthralgia, musculoskeletal pain General disorders and administration site conditions Very common:
Perifert ødem, tørst, akut-fase reaktion, ikkekardielle brystsmerter
Uncommon Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain
Starttidspunktet er ≤ 3 dage efter infusion med zoledronsyre, og reaktionen er også refereret til ved brug af termerne ”inluenza-lignende symptomer” eller ”symptomer efter dosering”.
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.
Andre lægemidler, der indeholder zoledronsyre som aktiv substans er tilgængelige til osteoporose indikationer og til behandling af Pagets sygdom i knoglerne.
Other products containing zoledronic acid as active substance are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Hos patienter med nedsat nyrefunktion kan den systemiske virkning af samtidigt indgivne lægemidler, der primært udskilles via nyrerne, øges.
In patients with renal impairment, the systemic exposure to concomitant medicinal products that are primarily excreted via the kidney may increase.
Zoledronsyre anbefales ikke til patienter, der før behandlingen initieres, har svær nyreinsufficiens, som i denne population er defineret som CLcr <30 ml/min.
Zoledronic acid 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.
Typen af bivirkninger, der blev observeret i denne befolkningsgruppe, var sammenlignelig med tidligere observerede bivirkninger hos voksne med fremskreden malign sygdom, der involverer knoglerne (se pkt.
The type of adverse reactions observed in this population were similar to those previously seen in adults with advanced malignancies involving the bone (see section 4.8).
Forebyggelse af skeletrelaterede hændelser (patologiske frakturer, spinal kompression, strålebehandlingeller operation af knogler, eller tumorinduceret hyperkalcæmi) hos voksne patienter med fremskredenmalign 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.
Meget sjælden (kan forekomme hos op til 1 ud af 10.000 patienter) Sig det til lægen, hvis du får øresmerter, udflåd fra øret og/eller betændelse i øret.
Very Rare (may affect up to 1 in 10,000 people) Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
I enkelt-dosis infusions hundestudier, administreret over 15 minutter, var 1,0 mg/kg (6 gange den anbefalede humane terapeutiske eksponering baseret på AUC) fint tolereret uden nyreproblemer.
In the single-dose dog infusion studies, 1.0 mg/kg (6 fold the recommended human therapeutic exposure based on AUC) administered over 15 minutes was well tolerated with no renal effects.
POSE ETIKET
VIAL LABEL
Interstitiel lungesygdom (inflammation af vævet omkring luftsækkende i lungerne).
Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs)
Hypokalcæmi er blevet rapporteret hos patienter i behandling med zoledronsyre.
Hypocalcaemia has been reported in patients treated with zoledronic acid.
Dystoki blev observeret ved den laveste dosis (0,01 mg/kg kropsvægt), der blev afprøvet i rotter.
Dystocia was observed at the lowest dose (0.01 mg/kg body weight) tested in rats.
Zoledronsyre metaboliseres ikke systemisk og påvirker ikke de humane cytokrom P450 enzymer in vitro (se pkt.
Zoledronic acid is not systemically metabolised and does not affect human cytochrome P450 enzymes in vitro (see section 5.2).
Følgende risikofaktorer bør overvejes ved evaluering af en patients risiko for at udvikle ONJ: - Styrken af bisfosfonat (højere risiko for højpotente forbindelser), administrationsvej (højere risiko for parenteral administration) og kumulative doser af bisfosfonater.
The following risk factors should be considered when evaluating an individual's risk of developing ONJ: - Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
Den leveres i 100 ml plastikpose som en infusionsvæske klar til brug.
It comes in 100 ml plastic bags as a readyto-use solution for infusion.
- Zoledronsyre Hospira må kun gives af sundhedspersonale, som er trænet til at indgive bisfosfonater intravenøst, dvs. gennem en blodåre (også kaldt IV administration).
− Zoledronic Acid Hospira must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein (also referred to as ‘IV' administration).
- Lavt indhold af magnesium og kalium i blodet.
− Low level of magnesium and potassium in the blood.
Det vil hjælpe dig med at undgå væsketab.
This will help to prevent dehydration.
Lægen, sygeplejersken og apoteket ved, hvordan Zoledronsyre Hospira skal opbevares korrekt (se pkt.
Your doctor, nurse or pharmacist knows how to store Zoledronic Acid Hospira properly (see section
I en pooled analyse af sikkerhedsdata fra zoldronsyre-registreringsstudier vedrørende forebyggelse af knogle-relaterede hændelser hos patienter med fremskreden malign sygdom, der involverer knoglerne, var frekvensen af bivirkninger med relation til nedsat nyrefunktion, og som formodes at være relateret til zoledronsyre, følgende: 3,2% ved multipelt myelom, 3,1% ved prostatacancer, 4,3% ved brystcancer og 3,2% ved lunge- og andre solide tumorer.
In a pooled analysis of safety data from trials for the use of zoledronic acid 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%).
- Der er i meget sjældne tilfælde set osteonekrose af andre knogler end kæben, særligt af hoften eller låret.
− Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Zoledronsyre har været forbundet med rapporter om nedsat nyrefunktion.
Zoledronic acid has been associated with reports of renal dysfunction.
Tabel 6: Bivirkninger observeret hos pædiatriske patienter med svær osteogenesis imperfecta Nervesystemet
Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta Nervous system disorders