natgillin/translations-raw huggingface dataset:
The duration of the trial was one year.
Študija je trajala eno leto.
- if you are unable to take daily calcium supplements.
- če ne morete vsak dan jemati nadomestkov kalcija.
Both cases resolved.
Oba sta okrevala.
The infusion will take at least 15 minutes.
Infuzija bo trajala vsaj 15 minut.
Clinical efficacy in men
Klinična učinkovitost pri moških
(see Annex I: Summary of Product Characteristics, section 4.2).
(glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
- if you have hypocalcaemia (this means that the levels of calcium in your blood are too low).
- če imate hipokalciemijo (to pomeni, da je koncentracija kalcija v vaši krvi prenizka).
Your doctor will let you know when to return for your next dose.
Zdravnik vam bo povedal, kdaj boste dobili naslednji odmerek.
• in post-menopausal women
• pri postmenopavzalnih ženskah
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.
Pomembno je, da se skrbno ravnate po tem nasvetu, da se vam vrednosti kalcija v krvi v času po infuziji ne znižajo preveč.
This corresponds to a 28% reduction in the risk of all cause mortality (p=0.01).
To ustreza 28-odstotnemu zmanjšanju tveganja za umrljivost iz kateregakoli vzroka (p=0,01).
Your doctor will inform you regarding the symptoms associated with hypocalcaemia.
Zdravnik vas bo poučil o simptomih, ki so povezani s hipokalciemijo.
- if you have severe kidney problems.
- če imate hude težave z ledvicami.
This process is called remodelling.
Ta proces se imenuje kostna pregradnja (remodeliranje).
- Do not throw away any medicines via wastewater (or household waste).
- Zdravila ne smete odvreči v odpadne vode (ali med gospodinjske odpadke).
- After opening the bottle, the product should be used immediately in order to avoid microbial contamination.
- Po odprtju plastenke, morate zdravilo porabiti takoj, da bi preprečili onesnaženje z mikroorganizmi.
• Physician educational material
• Izobraževalni material za zdravnika
Many of the reported cases have been associated with dental procedures such as tooth extraction.
V mnogih primerih, o katerih so poročali, je bila povezana z zobozdravstvenimi posegi, kot je ekstrakcija zoba.
Component of a multipack, can't be sold separately.
Del skupnega pakiranja - ne more se prodajati ločeno.
Side effects related to the first infusion are very common (occurring in more than 30% of patients) but are less common following subsequent infusions.
V povezavi s prvo infuzijo so neželeni učinki zelo pogosti (nastopijo pri več kot 30 % bolnikov), manj pogosti pa so po naslednjih infuzijah.
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.
V natisnjenem navodilu morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
Histomorphometric analysis showed a 63% reduction in bone turnover.
Histomorfometrična analiza je pokazala 63 % zmanjšanje pregradnje kosti.
Summary of vertebral fracture efficacy at 12, 24 and 36 months
Preglednica 2 Pregled učinkovitosti glede zlomov vretenc po 12, 24 in 36 mesecih
While on treatment, these patients should avoid invasive dental procedures if possible.
Ti bolniki se morajo med zdravljenjem, če se le da, izogibati invazivnim zobozdravstvenim posegom.
Swelling and/or pain at the infusion site may occur.
Lahko pride do otekanja in/ali bolečine na mestu infundiranja.
Effect on bone mineral density (BMD)
Učinek na mineralno gostoto kosti (bone mineral density - BMD)
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.
V prvih 24 urah se v seč izloči 39 ± 16 % danega odmerka, preostanek pa se predvsem veže v kostno tkivo.
The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race or body weight.
5,04 ± 2,5 l/h, je neodvisen od odmerka in nanj ne vplivajo spol, starost, rasa ali telesna masa.
Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Zoledronska kislina v opravljenih testih mutagenosti ni bila mutagena, testiranje kancerogenosti pa ni dalo nikakršnih dokazov o kancerogenem potencialu.
• in adult men at increased risk of fracture.
• pri odraslih moških pri katerih obstaja povečano tveganje za zlom.
In the three-year osteoporosis study standing height was measured annually using a stadiometer.
V triletni študiji osteoporoze so enkrat na leto s stadiometrom izmerili telesno višino.
It is important to take calcium and vitamin D supplements (for example tablets) as directed by your doctor.
Pomembno je, da jemljete dodatke kalcija in vitamina D (na primer v obliki tablet), kakor vam bo naročil zdravnik.
It is especially important for your doctor to know all the medicines you are taking, especially if you are taking any medicines known to be harmful to your kidneys (e.g. aminoglycosides) or diuretics (“waterpills”) that may cause dehydration.
Posebno pomembno je, da vaš zdravnik ve, katera zdravila jemljete, zlasti če jemljete zdravila, za katera je znano, da lahko škodujejo ledvicam (na primer aminoglikozide) ali diuretike ("zdravila za odvajanje vode"), ki lahko povzročajo dehidracijo.
This will help prevent dehydration.
S tem boste preprečili dehidriranost.
Osteoporosis could also occur in men and women because of the long term use of steroids, which can affect the strength of bones.
Do osteoporoze lahko pride pri moških in ženskah tudi zaradi dolgotrajne uporabe steroidov, ki lahko prizadenejo trdnost kosti.
The highest non-lethal single intravenous dose was 10 mg/kg body weight in mice and 0.6 mg/kg in rats.
Največji ne-letalen enkratni intravenski odmerek je bil 10 mg/kg telesne mase pri miših in 0,6 mg/kg pri podganah.
Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known
Kategorije pogostnosti so opredeljene z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
In the HORIZON-RFT study 508 men were randomised into the study and 185 patients had BMD assessed at 24 months.
V študijo HORIZON-RFT so naključno izbrali 508 moških in 185 bolnikom so po 24 mesecih ocenili mineralno gostoto kosti.
The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of zoledronic acid on an individual patient basis, particularly after 5 or more years of use.
Potrebo po nadaljevanju zdravljenja z zoledronsko kislino je treba periodično ponovno oceniti glede na koristi in tveganja za posameznega bolnika, še posebno po 5 letih ali več uporabe.
Adverse reactions, such as dizziness, may affect the ability to drive or use machines, though no studies on this effect with zoledronic acid have been performed.
Neželeni učinki, kot je na primer omotičnost, lahko vplivajo na sposobnost vožnje in upravljanja s stroji, vendar študij o takem vplivu zoledronske kisline niso izvedli.
The study was not designed to measure significant differences in hip fracture, but a trend was seen towards reduction in new hip fractures.
Študija ni bila načrtovana za oceno statistično značilnih razlik glede zlomov kolka, vendar so opažali trend v smeri zmanjševanja pogostosti novih zlomov kolka.
Many of these patients had signs of local infection including osteomyelitis, and the majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Številni izmed njih so imeli znake lokalne okužbe, vključno z osteomielitisom, in v večini se poročila nanašajo na bolnike z rakom po ekstraciji zoba ali pri drugih kirurških posegih na zobeh.
Repeat dosing did not lead to further reduction of bone turnover markers.
Ponovljeno odmerjanje ni povzročalo nadaljnega zniževanja vrednosti označevalcev pregradnje kosti.
For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Za bolnike, pri katerih je zobozdravstveni poseg potreben, ni na voljo nikakršnih podatkov, ki bi kazali na to, ali prekinitev difosfonatnega zdravljenja zmanjša tveganje za osteonekrozo čeljusti.
This includes e.g. Zometa or Aclasta (medicines that also contain zoledronic acid and are used to treat the same disease or osteoporosis and other non-cancer diseases of the bone).
To vključuje npr. zdravilo Zometa ali Aclasta (zdravili, ki tudi vsebujeta zoledronsko kislino in se uporabljata za zdravljenje iste bolezni ali osteoporoze in ostalih nerakavih bolezni kosti).
This is especially important in patients who take diuretics (“water pills”) and in elderly patients.
To je zlasti pomembno pri bolnikih, ki jemljejo diuretike ("zdravila za odvajanje vode"), in pri starejših bolnikih.
Days of disability
Število dni nezmožnosti
Therefore, interactions resulting from displacement of highly proteinbound drugs are unlikely.
Zato interakcije, ki se kažejo kot izrivanje zdravil pretežno vezanih na beljakovine, niso verjetne.
It is prudent to avoid dental surgery as recovery may be prolonged (see section 4.4).
Smiselno se je izogibati kirurškim posegom na zobeh, saj lahko podaljšajo čas okrevanja (glejte poglavje 4.4).
Many patients with osteoporosis have no symptoms but they are still at risk of breaking bones because osteoporosis has made their bones weaker.
Veliko bolnikov z osteoporozo ne čuti nobenih simptomov, kljub temu pa pri njih obstaja nevarnost, da si zlomijo kosti, ker so njihove kosti zaradi osteoporoze bolj krhke.
At least one new vertebral fracture (0-1 year) At least one new vertebral fracture (0-2 year) At least one new vertebral fracture (0-3 year) ** p <0.0001
vsaj en nov zlom vretenca (v prvem letu) vsaj en nov zlom vretenca (v prvih dveh letih) vsaj en nov zlom vretenca (v prvih treh letih) ** p <0,0001
At the menopause, a woman's ovaries stop producing the female hormone oestrogen, which helps keep bones healthy.
Pri ženski po menopavzi jajčniki ne tvorijo več ženskega hormona estrogena, ki pomaga ohranjati kosti zdrave.
This will help to prevent dehydration.
Pitje bo pomagalo preprečiti dehidracijo.
These results were consistent with biochemical marker evidence of normalisation of bone turnover.
Dobljeni rezultati so se skladali z dokazi biokemijskih označevalcev normalizacije pregradnje kosti.
All clinical fractures were verified based on the radiographic and/or clinical evidence.
Učinek na vse klinične zlome Vsi klinični zlomi so bili dokazani radiografsko in/ali na podlagi kliničnih znakov.
This is especially important for the elderly and for patients receiving diuretic therapy.
To je posebno pomembno za starejše in za bolnike, ki jemljejo tudi diuretike.
Before you receive treatment with Zoledronic acid Teva Generics, tell your doctor if you have (or have had) pain, swelling or numbness in your gums, jaw or both, if your jaw feels heavy, or if you have lost a tooth.
Preden začnete zdravljenje z zdravilom Zoledronska kislina Teva Generics, zdravniku povejte, če imate (ali ste imeli kdaj prej) bolečino, oteklino ali občutek odrevenelosti v dlesnih, v čeljusti ali v obojem, če čutite težo v čeljusti ali vam je izpadel zob.
EXP After opening: 24 hours at 2°C - 8°C
EXP: Po odprtju: 24 ur pri 2 °C - 8 °C.
• in adult men at increased risk of fracture, including those with a recent low-trauma hip fracture.
• pri odraslih moških s povečanim tveganjem za zlome vključno s tistimi z nedavnim zlomom kolka po lažji poškodbi.
Patients with hepatic impairment No dose adjustment is required (see section 5.2).
Bolniki z jetrno okvaro Prilagajanje odmerjanja ni potrebno (glejte poglavje 5.2).
Placebo (N = 1,062) event rate
Izid placebo (N=1.062) delež dogodkov (%)
After 6 months, zoledronic acid showed 96% (169/176) and 89% (156/176) response and serum alkaline phosphatase (SAP) normalisation rates compared to 74% (127/171) and 58% (99/171) for risedronate (all p<0.001).
Po 6 mesecih je zoledronska kislina pokazala 96-odstotno (169/176) oziroma 89-odstotno odzivnost (156/176) oziroma pogostost normalizacije vrednosti serumske alkalne fosfataze (SAP) v primerjavi s 74 % (127/171) oziroma 58 % (99/171) pri risedronatu (v vseh primerih p <0,001).
Uncommon Hypertension, flushing Not known** Hypotension (some of the patients had underlying risk factors)
Žilne bolezni hipertenzija, navali rdečice neznana** hipotenzija (pri nekaterih od teh bolnikov so bili že prej prisotni dejavniki tveganja)
The study was not powered to show a reduction in clinical fractures in men; the incidence of clinical fractures was 7.5% in men treated with zoledronic acid versus 8.7% for placebo.
S študijo ni bilo mogoče pokazati zmanjšanja obsega kliničnih zlomov pri moških; incidenca kliničnih zlomov je bila pri moških, zdravljenih z zoledronsko kislino, 7,5 % v primerjavi z 8,7 % pri uporabi placeba.
Hypocalcaemia* Uncommon Anorexia, decreased appetite
občasni anoreksija, zmanjšan apetit
It belongs to a group of medicines called bisphosphonates and is used to treat post-menopausal women and adult men with osteoporosis or osteoporosis caused by treatment with steroids, and Paget's disease of the bone in adults.
Pripada skupini zdravil, ki se imenujejo difosfonati in jih uporabljamo za zdravljenje postmenopavzalnih žensk in odraslih moških z osteoporozo ali z osteoporozo zaradi zdravljenja s steroidi in s Pagetovo boleznijo kosti pri odraslih.
Clinical efficacy in the treatment of osteoporosis in patients at increased risk of fracture after a recent hip fracture (RFT)
Klinična učinkovitost pri zdravljenju osteoporoze pri bolnikih s povečanim tveganjem za zlome po nedavnem zlomu kolka (RFT)
The medicinal product must not be mixed or given intravenously with any other medicinal products.
Tega zdravila ne smete mešati ali dajati intravensko skupaj z drugimi zdravili.
Limited data on re-treatment of Paget's disease are available (see section 5.1).
O ponovnem zdravljenju Pagetove bolezni je na voljo omejeno število podatkov (glejte poglavje 5.1).
In a large clinical trial, local reactions at the infusion site, such as redness, swelling and/or pain, were reported (0.7%) following the administration of zoledronic acid.
V obsežnem kliničnem preskušanju so poročali o lokalnih reakcijah, kot so rdečina, oteklina in/ali bolečina (0,7 %), po odmerjanju zoledronske kisline.
This leaflet was last revised in {MM/YYYY}
Navodilo je bilo nazadnje revidirano dne {MM/YYYY} Drugi viri informacij
Zoledronic acid demonstrated a consistent effect over 3 years, resulting in a 41% reduction in the risk of hip fractures (95% CI, 17% to 58%).
Učinek na zlome kolkov Zoledronska kislina je pokazala stalen učinek v obdobju 3 let, kar je omogočilo 41-odstotno znižanje tveganja za zlom kolkov (95 % IZ: 17 % do 58 %).
The primary efficacy variable was the incidence of clinical fractures over the duration of the study.
Primarna spremenljivka za oceno učinkovitosti je bila incidenca kliničnih zlomov v celotnem poteku študije.
Since zoledronic acid is not metabolised in humans and the substance was found to have little or no capacity as a direct-acting and/or irreversible metabolism-dependent inhibitor of P450 enzymes, zoledronic acid is unlikely to reduce the metabolic clearance of substances which are metabolised via the cytochrome P450 enzyme systems.
Ker človek ne presnavlja zoledronske kisline in ker so ugotovili, da ta zdravilna učinkovina v manjši meri ali pa sploh ne deluje kot neposredno delujoči in/ali ireverzibilni, od presnove odvisni, zaviralec encimov P450, ni verjetno, da bi zoledronska kislina zmanjšala presnovni očistek snovi, ki se presnavljajo prek encimskega sistema citokrom P450.
36 months.
15 minut.
What you need to know before you are given Zoledronic acid Teva Generics Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given Zoledronic acid Teva Generics.
Kaj morate vedeti, preden vam dajo zdravilo Zoledronska kislina Teva Generics Skrbno se ravnajte po vseh navodilih zdravnika, farmacevta ali medicinske sestre, preden vam dajo zdravilo Zoledronska kislina Teva Generics.
In Paget's disease, bone remodelling is too rapid and new bone is formed in a disordered fashion, which makes it weaker than normal.
Pri Pagetovi bolezni je kostna pregradnja prehitra, nova kostnina pa se tvori nepravilno, zato je šibkejša od normalne.
Due to the rapid onset of effect of zoledronic acid on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion of zoledronic acid (see section 4.8).
Zaradi hitrega začetka delovanja zoledronske kisline na pregradnjo kosti se utegne razviti prehodna hipokalciemija, ki je včasih simptomatska in ki je navadno najbolj izražena v prvih 10 dneh po infuziji zoledronske kisline (glejte poglavje 4.8).
It is unknown whether zoledronic acid is excreted into human milk.
Ni znano, ali se zoledronska kislina izloča v materino mleko pri ljudeh.
A summary of results is presented in Table 3.
Pregled izsledkov je prikazan v preglednici 3.
Your doctor will advise you and decide how long you should be treated with Zoledronic acid Teva Generics.
Zdravnik vam bo svetoval in presodil, kako dolgo bi se morali zdraviti z zdravilom Zoledronska kislina Teva Generics.
Decreased circulating levels of sex hormones, mainly oestrogens converted from androgens, also play a role in the more gradual bone loss observed in men.
Tudi znižanje koncentracij spolnih hormonov v krvnem obtoku, predvsem estrogenov, ki se pretvorijo iz androgenov, ima pomembno vlogo pri postopnejšem izgubljanju kostnine pri moških.
Swelling, redness, pain and itching to the eyes or eye sensitivity to light.
Otekanje, rdečina, bolečina in srbenje v očeh ali povečana občutljivost oči za svetlobo.
Effect on height
Učinek na telesno višino
Your doctor, pharmacist or nurse knows how to store Zoledronic acid Teva Generics properly.
Vaš zdravnik, farmacevt in medicinska sestra vedo, kako je treba zdravilo Zoledronska kislina Teva Generics pravilno shranjevati.
The incidence of delayed hip fracture healing was comparable between zoledronic acid (34 [3.2%]) and placebo (29 [2.7%]).
Incidenca zakasnitve celjenja zloma kolka je bila primerljiva med skupinama z zoledronsko kislino (34 [3,2 %]) oziroma s placebom (29 [2,7 %]).
In patients with renal impairment, the systemic exposure to concomitant medicinal products that are primarily excreted via the kidney may increase.
Pri bolnikih z okvaro ledvic lahko pride do povečane sistemske izpostavljenosti spremljajočim zdravilom, ki se izločajo predvsem preko ledvic.
Thereafter bone markers stabilised within the pre-menopausal range.
Po tem so se vrednosti kostnih označevalcev stabilizirale v premenopavzalnem okviru.
Five of the 6 patients had SAP within the normal range at month 6 (Last Observation Carried Forward, LOCF).
Pri petih od teh šestih bolnikov je bila vrednost alkalne fosfataze v serumu po 6 mesecih v okviru normalnih vrednosti (po principu zadnje izmerjene vrednosti prenesene naprej (Last Observation Carried Forward, LOCF)).
Aseptic techniques must be followed during preparation of the infusion.
Med pripravo infuzije uporabljajte aseptične tehnike.
Teratogenicity was observed in rats at doses ≥ 0.2 mg/kg and was manifested by external, visceral and skeletal malformations.
Teratogenost so ugotovili pri podganah v odmerkih ≥ 0,2 mg/kg, ki se je kazala v obliki zunanjih, visceralnih in skeletnih malformacij.
Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound drugs are therefore unlikely.
Zoledronska kislina se ne veže v veliki meri na beljakovine plazme (vezana je približno v 43-55 %), zato interakcije, ki se kažejo kot izrinjanje zdravil pretežno vezanih na beljakovine, niso verjetne.
Not known** Hypersensitivity reactions including rare cases of bronchoconstriction, urticaria and angioedema, and very rare cases of anaphylactic reaction/shock
preobčutljivostne reakcije, vključno z redkimi primeri bronhospazma, urtikarije in angioedema in z zelo redkimi primeri anafilaktične reakcije/šoka
In another study in men (study CZOL446M2308) an annual infusion of zoledronic acid was non-inferior to weekly alendronate for the percentage change in lumbar spine BMD at month 24 relative to baseline.
V drugi študiji z moškimi (študija CZOL446M2308) letna infuzija zoledronske kisline ni bila slabša od tedenske uporabe alendronata glede odstotka spremembe mineralne gostote kosti ledvene hrbtenice po 24 mesecih v primerjavi z izhodiščem.
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.
Po začetku infundiranja zoledronske kisline so se koncentracije zdravilne učinkovine v plazmi hitro zvišale, dosegle ob koncu infundiranja vrh, ki mu je sledilo hitro znižanje na <10 % najvišje dosežene vrednosti po 4 urah in na <1 % najvišje dosežene vrednosti po 24 urah, čemur je sledilo dolgotrajno obdobje zelo nizkih koncentracij, ki niso presegle 0,1 % najvišje vrednosti.
The incidence of clinical fractures, including vertebral, non-vertebral and hip fractures, was evaluated in 2,127 men and women aged 50-95 years (mean age 74.5 years) with a recent (within 90 days) low-trauma hip fracture who were followed for an average of 2 years on study medication.
Incidenco kliničnih zlomov, vključno z zlomi vretenc, nevretenčnimi zlomi in zlomi kolka, so vrednotili pri 2.127 moških in ženskah, starih 50-95 let (povprečna starost 74,5 let) z nedavnim (v okviru 90 dni) zlomom kolka po lažji poškodbi, ki so jih opazovali povprečno 2 leti med zdravljenjem s študijskim zdravilom.
In case you recently broke your hip, it is recommended that Zoledronic acid Teva Generics is administered two or more weeks after your hip repair surgery.
Če ste si pred kratkim zlomili kolk, je priporočljivo, da dobite zdravilo Zoledronska kislina Teva Generics dva ali več tednov po operativnem zdravljenju kolka.
Effect on all clinical fractures The incidence rates of key clinical fracture variables are presented in Table 4.
Učinek na vse klinične zlome Stopnje incidenc ključnih kliničnih zlomov so prikazane v preglednici 4.
Elevated bone turnover is a characteristic of Paget's disease of the bone.
Povečana pregradnja kosti je značilnost Pagetove bolezni kosti.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študij medsebojnega delovanja z drugimi zdravili niso izvedli.
In both women and men, Zoledronic acid Teva Generics strengthens the bone and therefore makes it less likely to break.
Tako pri ženskah kot pri moških zdravilo Zoledronska kislina Teva Generics okrepi kosti in tako zmanjša verjetnost zlomov.
The use of Zoledronic acid Teva Generics in children and adolescents has not been studied.
Uporabe zdravila Zoledronska kislina Teva Generics pri otrocih in mladostnikih niso proučevali.