FrancophonIA/ELRC3.0 huggingface dataset:
English: The rationale for enzyme replacement therapy is to restore a level of enzymatic activity sufficient to clear the accumulating substrate in the organ tissues; thereby, preventing, stabilizing or reversing the progressive decline in function of these organs before irreversible damage has occurred.
Slovenian: Mehanizem delovanja Temeljno vodilo encimske nadomestne terapije je ponovna vzpostavitev takšne encimske aktivnosti, ki bo zadoščala za očiščenje nakopičenega substrata v tkivih organov in na ta način preprečevala,
English: lacrimation increased eye pruritus, ocular hyperaemia
Slovenian: Očesne bolezni povečano solzenje očesni pruritus, očesna hiperemija
English: Slowly, withdraw 7.0 ml (equal to 35 mg) of the reconstituted solution from each vial up to the total volume required for the patient dose.
Slovenian: Počasi izvlecite 7,0 ml (kar ustreza 35 mg) rekonstituirane raztopine iz vsake viale do celotne količine, ki je potrebna za bolnikov odmerek.
English: Use of Fabrazyme during breastfeeding is not recommended.
Slovenian: Uporaba zdravila Fabrazyme v času dojenja ni priporočljiva.
English: However, the effect of Fabrazyme treatment on the kidney function was limited in some patients with advanced renal disease.
Slovenian: Fabrazyme na delovanje ledvic pri nekaterih bolnikih z napredovalo boleznijo ledvic omejen.
English: Baseline CL was 77 ml/min with a Vss of 2.6 l; half-life was 55 min. After IgG seroconversion, CL decreased to 35 ml/min, Vss increased to 5.4 l, and half-life increased to 240 min.
Slovenian: Osnovni CL je bil 77 ml/min z Vss 2,6 l; razpolovni čas je bil 55 min.
English: • lethargy
Slovenian: • urtikarija
English: - The need to seek urgent treatment in the event of failure to gain venous access or if there is a lack of efficacy - The need to keep a diary to document each treatment received at home and to bring it at each visit
Slovenian: - navodilo za iskanje nujne zdravniške pomoči v primeru vsakega neželenega učinka med infundiranjem, - potrebo po nujnem zdravljenju v primeru neuspešne uporabe venskega dostopa ali neučinkovanja zdravila,
English: The 2 female patients had little or no GL-3 accumulation in the superficial skin vascular endothelium at baseline, making this conclusion applicable in male patients only.
Slovenian: Obe bolnici ženskega spola sta kopičili GL-3 v žilnem endoteliju vrhnje plasti kože v osnovi le v majhni meri ali sploh ne, kar pomeni, da so bili zaključki uporabni le za bolnike moškega spola.
English: Patients experiencing mild or moderate infusion-associated reactions when treated with agalsidase beta during clinical trials have continued therapy after a reduction in the infusion rate (~0.15 mg/min; 10 mg/hr) and/or pre-treatment with antihistamines, paracetamol, ibuprofen and/or corticosteroids.
Slovenian: (~0,15 mg/min; 10 mg/uro) in/ali predhodnem zdravljenju z antihistaminiki, paracetamolom, ibuprofenom in/ali kortikosteroidi.
English: No dose adjustment is necessary for patients with renal insufficiency.
Slovenian: Pri bolnikih z ledvično insuficienco ni potrebna prilagoditev odmerka.
English: • musculoskeletal stiffness
Slovenian: • zategnjenost mišic
English: • throat pain
Slovenian: • trebušne bolečine
English: • lower blood oxygen levels • serious inflammation of the vessels
Slovenian: • nižje ravni kisika v krvi
English: After reconstitution with 1.1 ml water for injections, each vial of Fabrazyme contains 5 mg/ml of agalsidase beta.
Slovenian: Po rekonstituciji s 1,1 ml vode za injekcije vsebuje vsaka viala zdravila Fabrazyme 5 mg/ml agalzidaze beta.
English: Do not use the solution if foreign particles are observed or if the solution is discoloured.
Slovenian: Raztopine ne uporabljajte, če v njej opazite tujke ali če je spremenila barvo.
English: The reconstituted solution cannot be stored and should be promptly diluted; only the diluted solution can be held for up to 24 hours at 2ºC -8ºC.
Slovenian: Rekonstituirane raztopine ne shranjujte, ampak jo takoj razredčite; le razredčeno raztopino lahko shranjujete do 24 ur pri
English: • decreased blood pressure • hot flush
Slovenian: • znižan krvni tlak
English: Agalsidase beta is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Slovenian: Agalzidaza beta je beljakovina in pričakujemo, da se presnovno razgradi s hidrolizo peptidov, zato ni pričakovati, da bi okvarjeno jetrno delovanje klinično pomembno vplivalo na farmakokinetiko agalzidaze beta.
English: - That it is the responsibility of the prescribing physician to determine which patients may be suitable for home or self-administration of Fabrazyme.
Slovenian: - Da je odgovornost zdravnika, ki predpiše zdravilo Fabrazyme, da presodi, kateri bolniki so primerni za dajanje zdravila na domu ali za samo dajanje.
English: • feeling hot
Slovenian: • pekoč občutek
English: Gastrointestinal Disorders nausea, vomiting abdominal pain, abdominal pain upper, abdominal discomfort, stomach discomfort, hypoaesthesia oral, diarrhoea dyspepsia, dysphagia --
Slovenian: Bolezni prebavil navzea, bruhanje trebušne bolečine, bolečine v zgornjem trebušnem predelu, neugodje v trebuhu, neugodje v želodcu, oralna hipestezija, diareja disepsija, disfagija
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Each vial of Fabrazyme contains a nominal value of 35 mg of agalsidase beta.
Slovenian: Fabrazyme 35 mg prašek za koncentrat za raztopino za infundiranje Vsaka viala zdravila Fabrazyme vsebuje nominalno vrednost 35 mg agalzidaze beta.
English: Reconstitute each vial of Fabrazyme 5 mg with 1.1 ml water for injections.
Slovenian: Vsako vialo zdravila Fabrazyme 5 mg rekonstituirajte s 1,1 ml vode za injekcije.
English: Uncommon (may affect up to 1 in 100 people): • tremor
Slovenian: Občasni (se lahko pojavijo pri največ 1 bolniku od 100 bolnikov):
English: ANNEX II A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: Reconstitute each vial of Fabrazyme 35 mg with 7.2 ml water for injections.
Slovenian: Vsako vialo zdravila Fabrazyme 35 mg rekonstituirajte s 7,2 ml vode za injekcije.
English: Vascular disorders flushing, hypertension, pallor, hypotension, hot flush peripheral coldness --
Slovenian: hipotenzija, vročično zardevanje periferna hladnost
English: • increased blood pressure • joint pain
Slovenian: • zvišan krvni tlak
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion
Slovenian: Fabrazyme 35 mg prašek za koncentrat za raztopino za infundiranje Fabrazyme 5 mg prašek za koncentrat za raztopino za infundiranje
English: Fabrazyme 5 mg powder for concentrate for solution for infusion Each vial of Fabrazyme contains a nominal value of 5 mg of agalsidase beta.
Slovenian: Fabrazyme 5 mg prašek za koncentrat za raztopino za infundiranje Vsaka viala zdravila Fabrazyme vsebuje nominalno vrednost 5 mg agalzidaze beta.
English: • tinnitus
Slovenian: • tinitus
English: Marketing Authorisation Holder and Manufacturer Marketing authorisation holder
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Reconstitute each vial of Fabrazyme 35 mg with 7.2 ml water for injections.
Slovenian: Fabrazyme 35 mg prašek za koncentrat za raztopino za infundiranje Vsako vialo zdravila Fabrazyme 35 mg rekonstituirajte s 7,2 ml vode za injekcije.
English: • itching eyes
Slovenian: • pekoče oči
English: Renal elimination of agalsidase beta is considered to be a minor pathway for clearance.
Slovenian: Ledvično izločanje velja za manj pomembno pot izločanja agalzidaze beta.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Fabrazyme Vsebina pakiranja in dodatne informacije
English: Fabrazyme 5 mg powder for concentrate for solution for infusion Reconstitute each vial of Fabrazyme 5 mg with 1.1 ml water for injections.
Slovenian: Fabrazyme 5 mg prašek za koncentrat za raztopino za infundiranje Vsako vialo zdravila Fabrazyme 5 mg rekonstituirajte s 1,1 ml vode za injekcije.
English: Musculoskeletal and connective tissue disorders pain in extremity, myalgia, back pain, muscle spasms, arthralgia, muscle tightness, musculoskeletal stiffness musculoskeletal pain --
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva bolečine v udih, mialgija, bolečine v hrbtu, mišični krči,
English: • ear pain
Slovenian: • obrazni edem
English: • abnormal tear secretion • rash
Slovenian: • nenormalno izločanje solz • izpuščaj
English: • increased heart beat
Slovenian: • pospešen srčni utrip
English: • low heart rate
Slovenian: • počasno bitje srca
English: The reconstituted solution cannot be stored and should be promptly diluted; only the diluted solution can be held for up to 24 hours at 2°C-8°C.
Slovenian: ampak jo takoj razredčite; le razredčeno raztopino lahko shranjujete do 24 ur pri temperaturi
English: How to store Fabrazyme
Slovenian: Shranjevanje zdravila Fabrazyme
English: Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate.
Slovenian: Pomožne snovi: manitol natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat.
English: Agalsidase beta clearance was not influenced by weight in this population.
Slovenian: V tej populaciji telesna masa ni imela vpliva na očistek agalzidaze beta.
English: Talk to your doctor or pharmacist before using Fabrazyme.
Slovenian: Pred začetkom uporabe zdravila Fabrazyme se posvetujte z zdravnikom.
English: Sanofi S.p.A. Tel: +39 02 39394275
Slovenian: Tel: +39 02 39394275
English: Following treatment with 1 mg/kg every other week for 24 weeks, a dose regimen of 0.3 mg/kg every 2 weeks for 18 months was able to maintain the clearance of cellular GL-3 in the capillary endothelium of the kidney, other kidney cell types and skin (superficial skin capillary endothelium) in the majority of patients.
Slovenian: 18 mesecev, vzdrževati očistek celičnega GL-3 v kapilarnem endoteliju ledvic, drugih vrstah ledvičnih celic in koži (površinski kapilarni endotelij kože) pri večini bolnikov.
English: Another double-blind, placebo-controlled study of 82 patients was performed to determine whether Fabrazyme would reduce the rate of occurrence of renal, cardiac, or cerebrovascular disease or death.
Slovenian: Da bi ugotovili, ali Fabrazyme zmanjšuje stopnjo pogostnosti ledvičnih, srčnih ali cerebrovaskularnih bolezni ali smrti, so opravili še eno dvojno slepo s placebom nadzorovano študijo na 82 bolnikih.
English: In an additional 5-year open-label paediatric study, 31 male patients aged 5 to 18 years were randomized prior to the onset of clinical symptoms involving major organs and treated with two lower dose regimens of agalsidase beta, 0.5 mg/kg every 2 weeks or 1.0 mg/kg every 4 weeks.
Slovenian: randomizirali pred pojavom kliničnih simptomov, ki so zajeli pomembne organe, in so jih zdravili z dvema manjšima odmerkoma agalzidaze beta: 0,5 mg/kg vsaka 2 tedna ali 1,0 mg/kg vsake 4 tedne.
English: Subsequent infusions may need to occur in a clinical setting.
Slovenian: Bolnik mora nadaljnje infuzije prejeti v bolnišnici.
English: • burning sensation
Slovenian: • oteženo požiranje
English: • musculoskeletal pain
Slovenian: • mišični krči
English: • urticaria
Slovenian: • bolehnost
English: The effect of Fabrazyme treatment on the kidneys may be limited in patients with advanced renal disease.
Slovenian: Bolniki z napredovalo ledvično boleznijo Pri bolnikih z napredovalo ledvično boleznijo bo morda učinek zdravljenja z zdravilom Fabrazyme na ledvicah omejen.
English: Infusion of Fabrazyme at home may be considered for patients who are tolerating their infusions well.
Slovenian: Pri bolnikih, ki dobro prenašajo infuzije zdravila Fabrazyme, je mogoče infundiranje na domu.
English: 5 vials of powder for concentrate for solution for infusion.
Slovenian: 5 vial praška za koncentrat za raztopino za infundiranje.
English: Anaphylactoid reactions have been reported in the postmarketing setting.
Slovenian: V času trženja zdravila so poročali o anafilaktičnih reakcijah.
English: 10 vials of powder for concentrate for solution for infusion.
Slovenian: 10 vial praška za koncentrat za raztopino za infundiranje.
English: Fabrazyme 35 mg powder for concentrate for solution for infusion agalsidase beta
Slovenian: Fabrazyme 35 mg prašek za koncentrat za raztopino za infundiranje agalzidaza beta
English: 1 vial of powder for concentrate for solution for infusion.
Slovenian: 1 viala praška za koncentrat za raztopino za infundiranje.
English: Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat
English: • muscle tightness
Slovenian: • mišično-skeletna togost
English: • runny nose
Slovenian: • zamašenost nosu
English: Fabrazyme 5 mg powder for concentrate for solution for infusion agalsidase beta
Slovenian: Fabrazyme 5 mg prašek za koncentrat za raztopino za infundiranje agalzidaza beta
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 35 mg is supplied in clear Type I glass 20 ml vials.
Slovenian: Fabrazyme 35 mg prašek za koncentrat za raztopino za infundiranje Zdravilo Fabrazyme 35 mg se dobavlja v prozornih 20 ml vialah iz stekla tipa I. Zaporka sestoji iz zamaška iz silikonizirane butilne gume in aluminijastega pokrovčka s plastično odmično kapico.
English: In one open-label paediatric study, sixteen patients with Fabry disease (8-16 years old; 14 males, 2 females) had been treated for one year at 1.0 mg/kg every 2 weeks.
Slovenian: let; 14 moških, 2 ženski) s Fabryjevo boleznijo z odmerkom 1,0 mg/kg vsaka 2 tedna.
English: • redness
Slovenian: • sopenje
English: Fabry disease
Slovenian: Ušesne bolezni,
English: Fabrazyme 5 mg powder for concentrate for solution for infusion Fabrazyme 5 mg is supplied in clear Type I glass 5 ml vials.
Slovenian: Fabrazyme 5 mg prašek za koncentrat za raztopino za infundiranje Zdravilo Fabrazyme 5 mg se dobavlja v prozornih 5 ml vialah iz stekla tipa I. Zaporka sestoji iz zamaška iz silikonizirane butilne gume in aluminijastega pokrovčka s plastično odmično kapico.
English: • red rash
Slovenian: • rdeč izpuščaj
English: Respiratory, thoracic and mediastinal disorders dyspnoea, nasal congestion, throat tightness, wheezing, cough, dyspnoea exacerbated bronchospasm, pharyngolaryngeal pain, rhinnorhoea, tachypnoea, upper respiratory tract congestion hypoxia
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja, zamašenost nosu, stiskanje v grlu, sopenje, kašljanje, poslabšana dispneja bronhospazem,
English: Manufacturer
Slovenian: Uporaba
English: - The treating physician will be responsible for determining which patients may be suitable for home or self-administration of Fabrazyme and for arranging for treatment at home and training the patient and/or caregiver in the appropriate skills necessary for this.
Slovenian: - Lečeči zdravnik je odgovoren, da presodi, ali je bolnik primeren za zdravljenje z uporabo zdravila Fabrazyme na domu ali samodajanje.
English: The net effect of these changes after seroconversion was an increase in exposure of 2- to 3-fold based on AUC and Cmax.
Slovenian: Po serokonverziji IgG je CL padel na 35 ml/min, Vss je zrastel na 5,4 l, razpolovni čas se je povečal na 240 min. Neto učinek teh sprememb po serokonverziji je bil 2 do 3 krat večji po izpostavljenosti glede na AUC in Cmax.
English: Posology
Slovenian: Redčenje
English: Patients with advanced renal disease
Slovenian: Bolniki s protitelesi proti r-hαGAL
English: - Necessary skills have to be acquired by non-healthcare professionals before Fabrazyme may be safely and effectively administered at home. - Their prescribing physician will provide training on the following elements: - That it is essential to follow strictly the prescribed dose and infusion rate - Method of preparation and administration of Fabrazyme - Instructions in handling possible adverse events - Instruction to seek emergency treatment by healthcare professionals in the event of any adverse reactions during an infusion
Slovenian: - postopek priprave in dajanja zdravila Fabrazyme, - navodilo za obravnavo možnih neželenih dogodkov,
English: Nervous system disorders headache, paraesthesia dizziness, somnolence, hypoaesthesia, burning sensation, lethargy, syncope hyperaesthesia, tremor
Slovenian: hipestezija, pekoč občutek, letargija,
English: • stomach discomfort
Slovenian: • neugodje v trebuhu
English: The powder for concentrate for solution for infusion has to be reconstituted with water for injections, diluted with 0.9% sodium chloride intravenous solution and then administered by intravenous infusion.
Slovenian: Navodila za uporabo - rekonstitucija, redčenje in uporaba Prašek za koncentrat za raztopino za injiciranje rekonstituirajte z vodo za injekcije, razredčite z 0,9 %
English: The level of support required for home infusion will be discussed and agreed by the patient and/or caregiver with the prescribing physician.
Slovenian: Bolnik oz. negovalec se z zdravnikom pogovorita in dogovorita o zahtevah za infundiranje na domu.
English: • malaise
Slovenian: • utrujenost
English: In another study with 30 paediatric patients with available pharmacokinetics data, aged 5 to 18 years, treated with two lower dose regimens of 0.5 mg/kg every 2 weeks and 1.0 mg/kg every 4 weeks, mean CL was 4.6 and 2.3 ml/min/kg, respectively, mean Vss was 0.27 and 0.22 l/kg, respectively, and mean elimination half-life was 88 and 107 minutes, respectively.
Slovenian: Povprečni CL je bil pri prvih 4,6 in pri drugih 2,3 ml/min/kg, povprečni Vss pri prvih 0,27 in pri drugih 0,22 l/kg, povprečni eliminacijski razpolovni čas pa pri prvih 88 in pri drugih 107 minut.
English: The educational material for patients should include information on the following key elements: - The prescribing physician may decide that Fabrazyme may be administered at home.
Slovenian: Izobraževalno gradivo mora obsegati naslednje: • priročnik o infundiranju na domu za zdravstveno osebje,
English: • pain
Slovenian: • bledica
English: Skin and subcutaneous tissue disorders pruritus, urticaria, rash, erythema, pruritus generalized, angioneurotic oedema, swelling face, rash maculo-papular livedo reticularis, rash erythematous, rash pruritic, skin discolouration, skin discomfort leukocytoclastic vasculitis
Slovenian: zatekanje obraza, makulopapulozni izpuščaj livedo reticularis, eritematozni izpuščaj, pruritični izpuščaj,
English: • influenza-like illness
Slovenian: • gripi podobna bolezen • edem
English: • nasal congestion
Slovenian: • vročično zardevanje
English: • infusion site pain
Slovenian: • bolečina na mestu infundiranja
English: The educational programme contains the following:
Slovenian: Izobraževalni program vsebuje naslednje:
English: The duration of the trial was one year.
Slovenian: Študija je trajala eno leto.
English: - if you are unable to take daily calcium supplements.
Slovenian: - če ne morete vsak dan jemati nadomestkov kalcija.
English: Both cases resolved.
Slovenian: Oba sta okrevala.
English: The infusion will take at least 15 minutes.
Slovenian: Infuzija bo trajala vsaj 15 minut.
English: Clinical efficacy in men
Slovenian: Klinična učinkovitost pri moških
English: (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: - if you have hypocalcaemia (this means that the levels of calcium in your blood are too low).
Slovenian: - če imate hipokalciemijo (to pomeni, da je koncentracija kalcija v vaši krvi prenizka).
English: Your doctor will let you know when to return for your next dose.
Slovenian: Zdravnik vam bo povedal, kdaj boste dobili naslednji odmerek.
English: • in post-menopausal women
Slovenian: • pri postmenopavzalnih ženskah
English: It is important that you follow this advice carefully so that the level of calcium in your blood does not become too low in the period after the infusion.
Slovenian: Pomembno je, da se skrbno ravnate po tem nasvetu, da se vam vrednosti kalcija v krvi v času po infuziji ne znižajo preveč.
English: This corresponds to a 28% reduction in the risk of all cause mortality (p=0.01).
Slovenian: To ustreza 28-odstotnemu zmanjšanju tveganja za umrljivost iz kateregakoli vzroka (p=0,01).
English: Your doctor will inform you regarding the symptoms associated with hypocalcaemia.
Slovenian: Zdravnik vas bo poučil o simptomih, ki so povezani s hipokalciemijo.
English: - if you have severe kidney problems.
Slovenian: - če imate hude težave z ledvicami.
English: This process is called remodelling.
Slovenian: Ta proces se imenuje kostna pregradnja (remodeliranje).
English: - Do not throw away any medicines via wastewater (or household waste).
Slovenian: - Zdravila ne smete odvreči v odpadne vode (ali med gospodinjske odpadke).
English: - After opening the bottle, the product should be used immediately in order to avoid microbial contamination.
Slovenian: - Po odprtju plastenke, morate zdravilo porabiti takoj, da bi preprečili onesnaženje z mikroorganizmi.
English: • Physician educational material
Slovenian: • Izobraževalni material za zdravnika
English: Many of the reported cases have been associated with dental procedures such as tooth extraction.
Slovenian: V mnogih primerih, o katerih so poročali, je bila povezana z zobozdravstvenimi posegi, kot je ekstrakcija zoba.
English: Component of a multipack, can't be sold separately.
Slovenian: Del skupnega pakiranja - ne more se prodajati ločeno.
English: Side effects related to the first infusion are very common (occurring in more than 30% of patients) but are less common following subsequent infusions.
Slovenian: V povezavi s prvo infuzijo so neželeni učinki zelo pogosti (nastopijo pri več kot 30 % bolnikov), manj pogosti pa so po naslednjih infuzijah.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: V natisnjenem navodilu morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
English: Histomorphometric analysis showed a 63% reduction in bone turnover.
Slovenian: Histomorfometrična analiza je pokazala 63 % zmanjšanje pregradnje kosti.
English: Summary of vertebral fracture efficacy at 12, 24 and 36 months
Slovenian: Preglednica 2 Pregled učinkovitosti glede zlomov vretenc po 12, 24 in 36 mesecih
English: While on treatment, these patients should avoid invasive dental procedures if possible.
Slovenian: Ti bolniki se morajo med zdravljenjem, če se le da, izogibati invazivnim zobozdravstvenim posegom.
English: Swelling and/or pain at the infusion site may occur.
Slovenian: Lahko pride do otekanja in/ali bolečine na mestu infundiranja.
English: Effect on bone mineral density (BMD)
Slovenian: Učinek na mineralno gostoto kosti (bone mineral density - BMD)
English: Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
Slovenian: V prvih 24 urah se v seč izloči 39 ± 16 % danega odmerka, preostanek pa se predvsem veže v kostno tkivo.
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race or body weight.
Slovenian: 5,04 ± 2,5 l/h, je neodvisen od odmerka in nanj ne vplivajo spol, starost, rasa ali telesna masa.
English: Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Slovenian: Zoledronska kislina v opravljenih testih mutagenosti ni bila mutagena, testiranje kancerogenosti pa ni dalo nikakršnih dokazov o kancerogenem potencialu.
English: • in adult men at increased risk of fracture.
Slovenian: • pri odraslih moških pri katerih obstaja povečano tveganje za zlom.