natgillin/translations-raw huggingface dataset:
For information angående infusion af Zoledronsyre Hospira se pkt.
For information on the infusion of Zoledronic Acid Hospira, see section 6.6.
Ikke almindelige (kan forekomme hos op til 1 ud af 100 patienter) Influenza, øvre luftvejsinfektioner, nedsat antal røde blodlegemer, appetitløshed, søvnløshed, søvnighed, hvilket kan medføre nedsat opmærksomhed, prikkende følelse eller følelsesløshed, ekstrem træthed, rysten, midlertidig tab af bevidsthed, øjeninfektion eller irritation eller betændelse med smerter og rødme, følelse af snurren, forhøjet blodtryk, rødme, hoste, åndenød, maveproblemer, mavesmerter, forstoppelse, mundtørhed, halsbrand, hududslæt, voldsom svedtendens, kløe, rødmen af huden, smerter i nakken, stivhed i muskler, knogler og/eller led, hævede led, muskelkramper, skuldersmerter, smerter i brystmuskler og brystkasse, betændelse i led, muskelsvaghed, unormal nyrefunktionstest, hyppig vandladning, hævede hænder, ankler eller fødder, tørst, tandpine, smagsforstyrrelser.
Flu, upper respiratory tract infections, decreased red cell count, loss of appetite, sleeplessness, sleepiness which may include reduced alertness and awareness, tingling sensation or numbness, extreme tiredness, trembling, temporary loss of consciousness, eye infection or irritation or inflammation with pain and redness, spinning sensation, increased blood pressure, flushing, cough, shortness of breath, upset stomach, abdominal pain, constipation, dry mouth, heartburn, skin rash, excessive sweating, itching, skin reddening, neck pain, stiffness in muscles, bones and/or joints, joint swelling, muscle spasms, shoulder pain, pain in your chest muscles and rib cage, joint inflammation, muscular weakness, abnormal kidney test results, abnormal frequent urination, swelling of hands, ankles or feet, thirst, toothache, taste disturbances.
Zoledronsyre behandling bør genoptages med samme dosis som givet før afbrydelse af behandlingen.
Zoledronic acid treatment should be resumed at the same dose as that given prior to treatment interruption.
Alvorlig og til tider inhabiliterende knogle-, led- og/eller muskelsmerter er sjældent blevet rapporteret hos patienter behandlet med bisfosfonater, herunder zoledronsyre (se pkt.
Severe and occasionally incapacitating bone, joint and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including zoledronic acid (see section 4.8).
Zoledronsyres sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established.
Hvis det ikke anvendes straks, er opbevaringstid og -betingelser, før brug brugerens ansvar og bør normalt ikke overstige 24 timer ved 2°C - 8°C.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Zoledronsyre tilhører gruppen af nitrogenholdige bisfosfonater og virker primært på knoglerne.
Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone.
Almindelig (kan forekomme hos op til 1 ud af 10 patienter): - Hovedpine og influenzalignende symptomer som feber, træthed, svaghed, døsighed, kulderystelser samt knogle-, led- og/eller muskelsmerter.
Common (may affect up to 1 in 10 people):− Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Nervesystemet Almindelig:
Nervous system disorders Common:
- Anden medicin, der indeholder zoledronsyre, som anvendes til at behandle osteoporose eller andre sygdomme i knoglerne som ikke skyldes kræft, eller et andet bisfosfonat, da den kombinerede effekt af at tage disse lægemidler sammen med Zoledronsyre Hospira er ukendt.
- Any other medicines that contain zoledronic acid which is 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 Hospira are unknown.
4.2), bør overvåges nøje, eftersom nedsat nyrefunktion (inklusiv nyresvigt) og serum-elektrolyt (inklusive calcium, fosfor og magnesium) forstyrrelser er blevet observeret.
Patients who have received doses higher than those recommended (see section 4.2) should be carefully monitored, since renal function impairment (including renal failure) and serum electrolyte (including calcium, phosphorus and magnesium) abnormalities have been observed.
Zoledronsyre (5 mg i 100 ml infusionsklar opløsning) administreres via en infusionsslange og ved en konstant infusionshastighed.
Zoledronic Acid Hospira (5 mg in 100 ml ready-to-infuse solution) is administered via an infusion line and given at a constant infusion rate.
Forsigtighed tilrådes når zoledronsyre administreres samtidig med lægemidler, der har en signifikant indvirkning på nyrefunktionen (f.eks. 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).
Bivirkningerne, der er ordnet efter hyppighed, er præsenteret i tabel 6.
The adverse reactions ranked under headings of frequency, are presented in Table 6.
Zoledronsyre anbefales ikke til kvinder i den fertile alder.
Zoledronic acid is not recommended in women of childbearing potential.
Din læge vil måske bede dig om at få et tandeftersyn, før du starter behandling med Zoledronsyre Hospira.
Your doctor may ask you to undergo a dental examination before you start treatment with Zoledronic Acid Hospira.
Zoledronsyre Hospira skal indgives som en enkelt intravenøs infusion over minimum 15 minutter.
Zoledronic Acid Hospira should be given as a single intravenous infusion in no less than 15 minutes.
4.4 og 4.8 klasseeffekter)
Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects)
Efter påbegyndelse af behandling bør serum-kreatinin måles før hver dosis zoledronsyre, og behandlingen bør tilbageholdes, hvis nyrefunktionen forværres.
Following initiation of therapy, serum creatinine should be measured prior to each dose of zoledronic acid and treatment should be withheld if renal function has deteriorated.
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.
Pam 90 mg Zoledronsyre 4 mg
Pam 90 mg zoledronic acid
• At forebygge knoglekomplikationer, f.eks. knoglebrud, hos voksne patienter med knoglemetastaser (spredning af kræft fra den primære kræftknude til knoglerne).
• To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
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 Hospira 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 Hospira or after stopping treatment.
- Mave-tarm-symptomer såsom kvalme og opkastning samt appetitløshed.
− Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
Efter opløsning: Ud fra et mikrobiologisk synspunkt skal den fortyndede opløsning til infusion anvendes straks.
After dilution: From a microbiological point of view, the diluted solution for infusion should be used immediately.
Det tilrådes 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 Hospira (se pkt.
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 Hospira administration (see section 4.4).
Tabel 7: Bivirkninger observeret hos pædiatriske patienter med svær osteogenesis imperfecta Nervesystemet Almindelig:
Table 7: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta Nervous system disorders
Anvendelse af Zoledronsyre Hospira til patienter med svært nedsat nyrefunktion (kreatinin clearance < 35 ml/min) er kontraindiceret grundet en øget risiko for nyresvigt hos denne population.
The use of Zoledronic Acid Hospira in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.
- Graviditet og amning (se pkt.
- Pregnancy and breast-feeding (see section 4.6).
Behandling med Zoledronsyre Hospira bør genoptages med den samme dosis som blev givet før afbrydelse af behandlingen.
Zoledronic Acid Hospira treatment should be resumed at the same dose as that given prior to treatment interruption.
Infusionsvæske, opløsning 1 intravenøs pose
Solution for infusion 1 intravenous bag
- hvis du er allergisk over for zoledronsyre, et andet bisfosfonat (den gruppe af stoffer, som zoledronsyre tilhører) eller et af de øvrige indholdsstoffer i Zoledronsyre Hospira (angivet i pkt.
− if you are allergic (hypersensitive) to zoledronic acid, another bisphosphonate (the group of substances to which zoledronic acid belongs), or any of the other ingredients of Zoledronic Acid Hospira (listed in section 6).
Zoledronsyre Hospira må ikke blandes eller gives intravenøst med andre lægemidler og skal gives gennem en separat infusionsslange med en konstant infusionshastighed.
Zoledronic Acid Hospira must not be mixed or given intravenously with any other medicinal product and must be given through a separate infusion line at a constant infusion rate.
Din læge bør tage en blodprøve for at kontrollere din nyrefunktion (kreatininniveau) før hver dosis Zoledronsyre Hospira.
Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic Acid Hospira.
Patienternes hydreringsstatus skal vurderes før og efter indgivelsen af zoledronsyre for at sikre, at de er tilstrækkeligt hydrerede.
The hydration status of patients must be assessed prior to and following administration of zoledronic acid to ensure that they are adequately hydrated.
Anbefalet dosis zoledronsyre* 4,0 mg zoledronsyre
Zoledronic Acid Recommended Dose* 4.0 mg zoledronic acid
Anvendelse af zoledronsyre til patienter med svært nedsat nyrefunktion (kreatinin clearance < 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.
Tilpasset dosis (mg zoledronsyre) *
Adjusted dose (mg zoledronic acid) *
Det mest almindelige resultat ved studier med gentaget indgift var øget primær spongiosa i rørknoglernes metafyser hos voksende dyr ved næsten alle doser.
The most frequent finding in the repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound's pharmacological antiresorptive activity.
Zoledronsyre
Zoledronic Acid
Din læge bør tage en blodprøve for at kontrollere din nyrefunktion før hver dosis Zoledronsyre Hospira.
Your doctor should do a blood test to check your kidney function before each dose of Zoledronic Acid Hospira.
Frekvensen af atrieflimren som alvorlig utilsigtigt hændelse var øget hos patienter i behandling med zoledronsyre (1,3%) (51 ud af 3.862) sammenlignet med patienter som modtog placebo (0,6%) (22 ud af 3.852).
The rate of atrial fibrillation serious adverse events was increased in patients receiving zoledronic acid (1.3%) (51 out of 3,862) compared with patients receiving placebo (0.6%) (22 out of 3,852).
Zoledronsyre Hospira indeholder natrium
Zoledronic Acid Hospira contains sodium
- Svært nedsat nyrefunktion med kreatinin clearance < 35 ml/min (se pkt.
- Severe renal impairment with creatinine clearance < 35 ml/min (see section 4.4).
Svimmelhed, paræstesier, dysgeusi, hypæstesi, hyperæstesi, tremor, somnolens
Uncommon: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Det anbefales at indtage tilstrækkeligt med calcium og D-vitamin i forbindelse med administration af zoledronsyre.
Adequate calcium and vitamin D intake are recommended in association with zoledronic acid administration.
Det anbefales at indtage tilstrækkeligt med calcium og D-vitamin i forbindelse med administration af Zoledronsyre Hospira.
Adequate calcium and vitamin D intake are recommended in association with Zoledronic Acid Hospira administration.
Koncentrat til infusionsvæske, opløsning 4 mg/5 ml
Concentrate for solution for infusion 4 mg/5 ml
Der skal udvises forsigtighed, når zoledronsyre gives sammen med lægemidler, der vides at forårsage hypokalcæmi, da de kan have en synergistisk effekt, resulterende i svær hypokalcæmi (se pkt 4.5).
Caution is advised when Zoledronic acid is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Serumkreatinin øget, pollakisuri, proteinuri
Uncommon Blood creatinine increased, pollakiuria, proteinuria
Der tilrådes forsigtighed, når Zoledronsyre Hospira 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 Hospira 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.
Hvis du er i gang med tandbehandling eller skal gennemgå kæbekirurgi (fx en tandudtrækning), skal du fortælle din læge om din tandbehandling, og fortælle din tandlæge, at du er i behandling med Zoledronsyre Hospira.
If you are under dental treatment or are due to undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Zoledronic Acid Hospira.
- Opløsningen indeholdende zoledronsyre indgives ved en enkelt intravenøs infusion over 15 minutter i en separat infusionsslange.
− The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Kun en klar opløsning fri for partikler og misfarvning må benyttes.
Only clear solution free from particles and discoloration should be used.
Sløret syn, sklerit og orbital inflammation
Uncommon: Blurred vision, scleritis and orbital inflammation Rare
Søvnløshed
somnolence
Før administration skal 5,0 ml koncentrat fra et hætteglas, eller det påkrævede udtagende volumen af koncentratet fortyndes yderligere med 100 ml calciumfri infusionsvæske (natriumklorid 9 mg/ml (0,9% ) opløsning til injektion eller 5% w/v glukoseopløsning).
Prior to administration, 5.0 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution).
Ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter): - Smerter i munden, tænder og/eller kæberne, hævelse eller ikke helende sår inde i munden eller kæben, udflåd af gullig betændelse, følelsesløshed eller følelsen af tyngde i kæberne eller løsnen af en tand.
Uncommon (may affect up to 1 in 100 people):− Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw discharge, numbness or a feeling of heaviness in the jaw or loosening of a tooth.
Zoledronsyre elimineres via nyrerne.
Zoledronic acid is eliminated by renal excretion.
Dyreforsøg har påvist reproduktionstoksicitet inklusive malformationer (se pkt.
Studies in animals with zoledronic acid have shown reproductive toxicological effects including malformations (see section 5.3).
Den anbefalede dosis ved hyperkalcæmi (albuminkorrigeret serumcalcium 12,0 mg/dl eller 3,0 mmol/l)eren enkeltdosis på4 mgzoledronsyre.Nyreinsufficiens
The recommended dose in hypercalcaemia (albumin-corrected serum calcium 12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
Hypertension, hypotension, atrieflimren, hypotension førende til synkope eller kredsløbssvigt
Cardiac disorders Uncommon: Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse
Forebyggelse af skeletrelaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser:
Prevention of skeletal related events in patients with advanced malignancies involving bone:
Zoledronsyre Hospira 4 mg/5 ml sterilt koncentrat I.V.
Zoledronic Acid Hospira 4 mg/5 ml sterile concentrate IV
- Vejrtrækningsbesvær med hiven efter vejret eller hosten.
− Difficulty in breathing with wheezing or coughing.
Der tilrådes forsigtighed, når bisfosfonater indgives sammen med aminoglykosider, calcitonin eller loop-diuretika, da disse stoffer kan have en additiv effekt og give et lavere serumcalciumniveau i længere perioder end påkrævet (se pkt.4.4).
Caution is advised when bisphosphonates are administered with aminoglycosides, calcitonin or loop diuretics, since these agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required (see section 4.4).
- Hudreaktioner (rødme og hævelse) på infusionsstedet, udslæt, kløe.
− Skin reactions (redness and swelling) at the infusion site, rash, itching.
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 nedsatte doser af Zoledronsyre Hospira (se også pkt.
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, reduced Zoledronic Acid Hospira doses are recommended (see also section 4.4).
Dialysekrævende nyresvigt eller letale tilfælde er i sjældne tilfælde opstået hos patienter med underliggende nyresygdom eller med en af risikofaktorerne beskrevet ovenfor.
Renal impairment has been observed in patients after a single administration, 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.
Tilpasset dosis (mg zoledronsyre)
Adjusted dose (mg zoledronic acid)
- Ud fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning til infusion anvendes straks.
− From a microbiological point of view, the diluted solution for infusion should be used immediately.
- Uregelmæssig hjerterytme (atrieflimren) er set hos patienter, der fik zoledronsyre for postmenopausal osteoporose.
− Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Indehaveren af markedsføringstilladelsen skal sikre at der implementeres patienthuskekort vedrørende osteonekrose af kæberne.
The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. 100 ml Zoledronsyre Hospira, dvs. den er i det væsentlige natriumfri.
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml dose of Zoledronic Acid Hospira, i.e. essentially “sodium free”.
• Før hver dosis Zoledronsyre Hospira bør kreatinin clearance beregnes på bais 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 Hospira dose.
Hvis du har hypokalcæmi, skal den korrigeres, inden du får den første dosis af Zoledronsyre Hospira.
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic Acid Hospira.
Zoledronsyre Hospira er kontraindiceret under gravididitet (se pkt.4.3).
Zoledronic Acid Hospira is contraindicated during breast-feeding (see section 4.3).
Nakkesmerter, stivhed i bevægeapparatet, hævelse af led, muskelkramper, skuldersmerter, muskuloskeletale smerter i brystregionen, muskuloskeletale smerter, ledstivhed, artrit, muskelsvækkelse
Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness
Hos patienter med let til moderat nedsat nyrefunktion, anbefales nedsatte doser af zoledronsyre (se afsnittet ”Dosering”ovenfor samt pkt.
In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
-Posen kræver ikke særlige opbevaringsbetingelser.
− The bag does not require any specific storage conditions.
Tabel 1: Tilberedning af nedsatte doser af Zoledronsyre Hospira 4 mg/100 ml, infusionsvæske, opløsning
Table 1: Preparation of reduced doses of Zoledronic Acid Hospira 4 mg/100 ml solution for infusion
Hos patienter med let til moderat nedsat nyrefunktion, anbefales nedsatte doser af Zoledronsyre Hospira (se afsnittet ”Dosering” ovenfor samt pkt.
In patients with mild to moderate renal impairment, reduced Zoledronic Acid Hospira doses are recommended (see section “Posology” above and section 4.4).
Fortæl det straks til din læge eller tandlæge, hvis du får sådanne symptomer, mens du er i behandling med Zoledronsyre Hospira eller efter behandlingsophør.
Tell your doctor or dentist immediately if you experience such symptoms while being treated with Zoledronic Acid Hospira or after stopping treatment.
Almindelig Hypokalcæmi* Ikke almindelig
Common Hypocalcaemia* Uncommon Decreased appetite Rare
Kontakt straks din læge og tandlæge, hvis du oplever sådanne symptomer, men du er i behandling med Zoledronsyre Hospira, eller efter at behandlingen er stoppet.
Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic Acid Hospira or after stopping treatment.
Hvis du har hypokalcæmi, skal den korrigeres, inden du får den første dosis af zoledronsyre.
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid.
Dyreforsøg har påvist reproduktionstoksicitet (se pkt.
Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
- Patienter med hypokalcæmi (se pkt.
- Patients with hypocalcaemia (see section 4.4).
Indeholder også mannitol, natriumcitrat, vand til injektionsvæsker og natriumchlorid.
It also contains mannitol, sodium citrate, water for injections and sodium chloride.
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 zoledronsyre (se også pkt.
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 dose is recommended (see also section 4.4):
Patienter i behandling med Zoledronsyre Hospira bør få udleveret indlægssedlen og patienthuskekortet.
Patients treated with Zoledronic Acid Hospira should be given the package leaflet and the patient reminder card
- hvis du er under tandlægebehandling eller skal have en tandoperation, bør du fortælle tandlægen, atdu eribehandlingmed ZoledronsyreHospiraog informere din læge om tandlægebehandlingen.
- if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid Hospira and inform your doctor about your dental treatment.
Brug af Zoledronsyre Hospira sammen med mad og drikke Sørg for at drikke tilstrækkelig væske (mindst 1 eller 2 glas) før og efter behandling med Zoledronsyre Hospira, som din læge har fortalt dig.
Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Zoledronic Acid Hospira, as directed by your doctor.