natgillin/translations-raw huggingface dataset:
6.5 Nature and contents of container multilayer polyolefin/styrene-ethylene-butylene (SEB) bag with SFC polypropylene infusion port closed with rubber stopper and snap cap.
Večplastna, vreča iz poliolefin/stiren-etilen-butilena (SEB) z SFC propilenskim nastavkom za infundiranje, zaprtim z gumijastim zamaškom in snemno zaporko.
Zoledronic acid Teva Generics contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodium-free.”
Zdravilo Zoledronska kislina Teva Generics vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 ml, kar v bistvu pomeni »brez natrija«.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/912/004
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/912/004
Zoledronic acid is contraindicated during breast-feeding (see section 4.3).
Uporaba zoledronske kisline v času dojenja je kontraindicirana (glejte poglavje 4.3).
All participants received 1,000 mg elemental calcium plus 400 to 1,000 IU vitamin D supplementation per day.
Vsi bolniki so prejemali dodatke 1.000 mg elementarnega kalcija in 400 do 1.000 i.e. vitamina D na dan.
Small observed increases in AUC(0-24hr), by about 30% to 40% in mild to moderate renal impairment, compared to a patient with normal renal function, and lack of accumulation of drug with multiple doses irrespective of renal function, suggest that dose adjustments of zoledronic acid in mild (Clcr = 50-80 ml/min) and moderate renal impairment down to a creatinine clearance of 35 ml/min are not necessary.
Majhno zvečanje AUC(0-24hr) za okrog 30 do 40 %, ki so ga opazili pri bolnikih z blago do zmerno ledvično okvaro v primerjavi z bolniki z normalnim ledvičnim delovanjem, in odsotnost kopičenja zdravila ob večkratnih odmerkih, ne glede na ledvično delovanje,
PHARMACEUTICAL FORM AND CONTENTS Solution for infusion multipack: 5 bottles x 100 ml multipack: 10 bottles x 100 ml
raztopina za infundiranje skupno pakiranje: 5 plastenk x 100 ml skupno pakiranje: 10 plastenk x 100 ml intravenska uporaba
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.
Subkronična in kronična toksičnost V študijah z intravenskim infundiranjem so dokazali ledvično prenosljivost za zoledronsko kislino pri podganah, ki so jim dajali odmerek 0,6 mg/kg v 15-minutnih infuzijah v 3-dnevnih presledkih (kumulativni odmerek je ustrezal ravnem AUC, ki so bile približno 6-krat večje od terapevtske izpostavljenosti pri človeku).
This resulted in exaggerated pharmacological effects considered related to the compound's inhibition of skeletal calcium mobilisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
To je v obdobju okrog poroda povzročalo hipokalciemijo (kar je značilno za celo skupino difosfonatov), distocijo in predčasno prekinitev študije.
Zoledronic acid Teva Generics contains the active substance zoledronic acid.
Zdravilo Zoledronska kislina Teva Generics vsebuje zdravilno učinkovino zoledronsko kislino.
MARKETING AUTHORISATION HOLDER Teva B.V.
Imetnik dovoljenja za promet z zdravilom Teva B.V.
• Key signs and symptoms of serious adverse events
• ključne znake in simptome resnih neželenih dogodkov, • navodila o tem, kdaj je treba poiskati zdravniško pomoč.
4.1 Therapeutic indications
4.1 Terapevtske indikacije Zdravljenje osteoporoze
It comes in a polyolefin/styrene-ethylene-butylene (SEB) foil bag with a foil over pouch.
Pakirana je v 100 ml večplastno, vrečo iz poliolefin/stiren-etilen-butilena (SEB) obdano s folijsko vrečo.
Treatment with zoledronic acid resulted in an increase in BMD of 5.4% at the total hip and 4.3% at the femoral neck over 24 months as compared to placebo.
Zdravljenje z zoledronsko kislino je po 24 mesecih v primerjavi s placebom povzročilo povečanje mineralne gostote kosti celotnega kolka za 5,4 % in vratu stegnenice za 4,3 %.
P1NP was significantly reduced by 61% below baseline levels at 12 months and was sustained at 52% below baseline levels at 36 months.
Vrednosti N-končnega propeptida kolagena tipa I so se po 12 mesecih statistično značilno znižale za 61 % od izhodiščnih vrednosti, znižanje se je po 36 mesecih ohranilo na vrednosti 52 % pod izhodiščnimi vrednostmi.
Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic acid Teva Generics.
Zdravnik mora pred vsakim odmerkom zdravila Zoledronska kislina Teva Generics opraviti krvne preiskave, da preveri delovanje vaših ledvic (raven kreatinina).
Approximately 42% of patients had a femoral neck BMD T-score below -2.5 and approximately 45% of the patients had a femoral neck BMD T-score above -2.5. zoledronic acid was administered once a year, until at least 211 patients in the study population had confirmed clinical fractures.
Približno 42 % bolnikov je imelo vrednost T mineralne gostote kosti vratu stegnenice pod -2,5 in približno 45 % bolnikov je imelo vrednost T mineralne gostote kosti vratu stegnenice nad -2,5.
For information on the infusion of zoledronic acid, see section 6.6.
Za informacije o infundiranju zoledronske kisline glejte poglavje 6.6. 4.3 Kontraindikacije
The incidence of fractures was 8 for zoledronic acid-treated patients versus 7 for risedronate-treated patients (p=0.8055).
skupini z zoledronsko kislino je bila incidenca zlomov 8 v primerjavi z incidenco 7 v skupini z risedronatom (p=0,8055).
The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 patients studied.
Ledvični očistek je znašal 75 ± 33 % očistka kreatinina, ki je pri 64 proučevanih bolnikih pokazal srednjo vrednost
Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C and 25ºC.
Kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi 2 °C - 8 °C in 25 °C.
The pack sizes of 5 and 10 are only available as multipacks comprising of 5 or 10 packs, each containing 1 bottle.
Na voljo je v pakiranjih po 1, 5 in 10 plastenk.V pakiranjih po 5 in 10 plastenk je vsaka plastenka posebej pakirana v zunanjo ovojnino
The Marketing Authorisation Holder (MAH) shall ensure that the educational programme implemented for the authorised indications of treatment of osteoporosis in post-menopausal women and in men at increased risk of fracture, including those with a recent low-trauma hip fracture, and treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture is updated.
• Dodatni ukrepi za zmanjševanje tveganj Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo izobraževalni program, ki ga je izvajal za odobrene indikacije zdravljenja osteoporoze pri postmenopavzalnih ženskah in pri moških s povečanim tveganjem za zlome, vključno s tistimi z nedavnim zlomom kolka po lažji poškodbi,
Description of selected adverse reactions
Opis izbranih neželenih učinkov Učinki po skupinah:
You must not be given Zoledronic acid Teva Generics if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, ne smete dobiti zdravila
Adequate calcium and vitamin D intake are recommended in association with zoledronic acid administration.
Skupaj z dajanjem zoledronske kisline se priporoča zadostno uživanje kalcija in vitamina D.
The percentage of patients who experienced adverse reactions was lower in a smaller study (19.5%, 10.4%, 10.7% after the first, second and third infusion, respectively), where prophylaxis against adverse reactions was used.
V manjši študiji, v kateri so uporabljali profilakso proti neželenim učinkom, so bili deleži vseh bolnikov, pri katerih je prišlo do neželenih učinkov, nižji, in sicer po prvi infuziji 19,5 %, po drugi infuziji 10,4 %, po tretji infuziji pa 10,7 %.
Patients must be appropriately hydrated prior to administration of zoledronic acid.
Preden bolniki dobijo zoledronsko kislino, morajo biti primerno hidrirani.
• Patient information pack
• Komplet podatkov o zdravilu za bolnika
Renal impairment has been observed in patients after a single administration.
Po prejemu enkratnega odmerka so pri bolnikih opazili okvaro ledvic.
In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following zoledronic acid administration (see section 4.2).
Skupaj z dajanjem zoledronske kisline je priporočeno zadostno uživanje kalcija in vitamina D. Poleg tega je zelo priporočljivo bolnikom s Pagetovo boleznijo zagotoviti zadostno dodajanje kalcija, ki ustreza vsaj 500 mg elementarnega kalcija, dvakrat na dan vsaj 10 dni po uporabi zoledronske kisline (glejte poglavje 4.2).
Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8
Bolezni sečil občasni zvišana vrednost kreatinina v krvi, polakisurija, proteinurija neznana** okvara ledvic; pri bolnikih s predhodno ledvično disfunkcijo ali z drugimi dejavniki tveganja, kot so višja starost bolnika, sočasna uporaba nefrotoksičnih zdravil, diuretičnega zdravljenja ali dehidracija v času po infuziji, so poročali o redkih primerih odpovedi ledvic, pri kateri je potrebna dializa, in redkih primerih s smrtnim izidom (glejte poglavji 4.4 in 4.8 odstavek Učinki po skupinah)
• A single dose of Zoledronic acid Teva Generics should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2).
• Posamezen odmerek zoledronske kisline ne sme presegati 5 mg, infuzija pa mora trajati najmanj
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 to 8°C.
Če ni uporabljeno takoj, je za čas shranjevanja zdravila med uporabo in pogoje shranjevanja pred uporabo odgovoren uporabnik sam. Čas shranjevanja naj praviloma ne presega 24 ur pri temperaturi od 2 do 8 °C.
Psychiatric disorders
Psihiatrične motnje nespečnost
Women who were evaluated for the incidence of vertebral fractures did not receive concomitant osteoporosis therapy, which was allowed for women contributing to the hip and all clinical fracture evaluations.
Ženske, ki so jih pregledovali glede zlomov vretenc, niso sočasno prejemale zdravil za zdravljenje osteoporoze,
Zoledronic acid Teva Generics is supplied in multipacks containing 5 or 10 bags.
Zdravilo Zoledronska kislina Teva Generics je na voljo v skupnem pakiranju po 5 ali 10 vreč.
How to store Zoledronic acid Teva Generics
Kako se daje zdravilo Zoledronska kislina Teva Generics
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.
Če ni uporabljeno takoj, je za čas shranjevanja zdravila med uporabo in pogoje shranjevanja pred uporabo odgovoren uporabnik sam. Čas shranjevanja naj praviloma ne presega 24 ur pri temperaturi od 2 °C do 8 °C.
Each ml of solution contains 0.05 mg zoledronic acid (as monohydrate).
En ml raztopine vsebuje 0,05 mg zoledronske kisline (v obliki monohidrata).
Treatment with a 5 mg annual dose of zoledronic acid significantly reduced BSAP by 30% relative to baseline at 12 months which was sustained at 28% below baseline levels at
Zdravljenje z odmerkom zoledronske kisline 5 mg na leto je statistično značilno znižalo vrednosti kostno specifične alkalne fosfataze po 12 mesecih za 30 % glede na izhodišče.
Relative risk reduction in fracture incidence % (CI)
relativno znižanje tveganja za zlome % (IZ)
Absolute reduction in fracture incidence % (CI)
absolutno znižanje deleža zlomov % (IZ)
Each bag contains 100 ml of solution.
Ena vreča vsebuje 100 ml raztopine.
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml; i.e. essentially “sodiumfree.”
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 ml, kar v bistvu pomeni “brez natrija.”
Vitamin D levels were not routinely measured but a loading dose of vitamin D (50,000 to 125,000 IU orally or via the intramuscular route) was given to the majority of patients 2 weeks prior to infusion.
Zoledronsko kislino so prejemali enkrat na leto, dokler ni vsaj pri 211 bolnikih v študiji prišlo do dokazanega kliničnega zloma. Koncentracij vitamina D niso merili rutinsko, vendar je večina bolnikov 2 tedna pred infuzijo prejela večji začetni odmerek vitamina D (50.000 do 125.000
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (without blue box)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (brez »blue box« podatkov)
Uncommon Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain Not known** Dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea
utrujenost, astenija, bolečine, splošno slabo počutje, reakcija na mestu injiciranja periferni edemi, žeja, reakcija akutne faze vnetja, nekardiogena bolečina v prsnem košu neznana** dehidracija zaradi simptomov po odmerjanju, kot so zvišana telesna temperatura, bruhanje in driska
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (with blue box)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA SKUPNO PAKIRANJE (z »blue box« podatki)
Non-vertebral fracture (1) *p-value <0.001, **p-value <0.0001 (1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures
(1) brez zlomov prstov rok in nog ter zlomov na področju obraza (2) vključno s kliničnimi zlomi prsnih in ledvenih vretenc
C-reactive protein increased Uncommon Blood calcium decreased
Preiskave zvišana vrednost C-reaktivnega proteina znižana vrednost kalcija v krvi pri bolnikih, ki so sočasno jemali glukokortikoide.
- Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
- Kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi 2 °C - 8 °C in 25 °C.
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodiumfree.”
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 ml vialo, kar v bistvu pomeni “brez natrija”.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj, dispneja
Atrial fibrillation Uncommon Palpitations
Srčne bolezni atrijska fibrilacija palpitacije
Relative reduction in fracture incidence % (CI)
relativno znižanje odstotka zlomov % (IZ)
- After opening the bottle, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
- Po odprtju plastenke: kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi 2 °C - 8 °C in 25 °C.
Mechanism of action
Taki ukrepi
- Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients, listed in section 6.1.
- Preobčutljivost na zdravilno učinkovino, katerega od difosfonatov ali katero koli pomožno snov,
Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness Atypical subtrochanteric and diaphyseal femoral fractures† (bisphosphonate class adverse reaction)
Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija, artralgija, bolečine v kosteh, bolečine v hrbtu, bolečine v okončinah bolečina v vratu, mišičnoskeletna okorelost, otekanje sklepov, mišični spazmi, bolečine v rami, mišičnoskeletna bolečina v prsnem košu, mišičnoskeletna bolečina, okorelost sklepov, artritis, šibkost mišic atipični subtrohanterni zlomi stegnenice in zlomi diafize stegnenice† (za difosfonate značilen neželeni učinek)
Other medicines and Zoledronic acid Teva Generics Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika, farmacevta ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
- Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. - The unopened bottle does not require any special storage conditions.
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan
Nausea, vomiting, diarrhoea Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth, oesophagitis, toothache, gastritis#
gastroezofagealna refluksna bolezen, obstipacija, suha usta, vnetje požiralnika, zobobol, gastritis#
The increases in BMD were significantly greater in the zoledronic acid-treated group at the lumbar spine and femoral neck at 12 months compared to risedronate (all p<0.03).
Učinek na mineralno gostoto kosti (bone mineral density - BMD) Po 12 mesecih je bilo povečanje mineralne gostote kosti ledvene hrbtenice in vratu stegnenice statistično značilno večje v skupini bolnikov, ki so prejemali zoledronsko kislino, v primerjavi s tistimi, ki so prejemali risedronat (vse vrednosti p <0,03).
It comes in a clear plastic bottle.
Pakirana v prozornih plastenkah.
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Generics 5 mg solution for infusion in bags
IME ZDRAVILA Zoledronska kislina Teva Generics 5 mg raztopina za infundiranje v plastenkah
Uncommon Lethargy, paraesthesia, somnolence, tremor, syncope, dysgeusia
Bolezni živčevja glavobol, omotičnost letargija, parestezija, somnolenca, tremor, sinkopa, motnje okušanja
1 bag of 100 ml
raztopina za infundiranje ena plastenka s 100 ml
Each bottle contains 100 ml of solution
Ena vreča vsebuje 100 ml raztopine
Táncsics Mihály út 82.,
TEVA Pharmaceutical Works Private Limited Company Táncsics Mihály út 82
Each bottle contains 100 ml of solution.
Ena plastenka vsebuje 100 ml raztopine.
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic acid Teva Generics for the treatment of postmenopausal osteoporosis.
Pri bolnicah, ki so prejemale zdravilo Zoledronska kislina Teva Generics zaradi postmenopavzalne osteoporoze, so poročali o nepravilnem bitja srca (atrijski fibrilaciji).
• Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of zoledronic acid.
• Pred odmerjanjem zoledronske kisline morajo biti bolniki, zlasti starejši in tisti, ki jemljejo
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, anti-angiogenic medicinal products, corticosteroids, poor oral hygiene).
Pri bolnikih s spremljajočimi dejavniki tveganja (na primer rak, kemoterapija, antiangiogena zdravila, kortikosteroidi, slaba ustna higiena) je treba pred začetkom zdravljenja z difosfonati razmisliti o zobozdravniškem pregledu z ustreznimi preventivnimi zobozdravstvenimi ukrepi.
Your doctor should do a blood test to check your kidney function before each dose of Zoledronic acid Teva Generics.
Zdravnik mora pred vsakim odmerjanjem zdravila Zoledronska kislina Teva Generics s krvnimi preiskavami pregledati delovanje vaših ledvic.
Not known** Renal impairment.
Bolezni imunskega sistema pogostnost neznana**
One bottle contains 5 mg zoledronic acid (as monohydrate).
Ena plastenka s 100 ml raztopine vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
Teva Gyógyszergyár Zrt
Atipičen zlom stegnenice
• Zoledronic acid Teva Generics should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5).
• Pri sočasni uporabi zoledronske kisline z drugimi zdravili, ki lahko vplivajo na delovanje ledvic,
Not known (frequency cannot be estimated from the available data) Pain in the mouth, teeth and jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Bolečine v ustih, zobeh in čeljusti, oteklina ali ranice v ustni votlini, odrevenelost ali občutek pritiska v čeljusti ali majanje zoba - to so lahko znaki odmiranja kosti v čeljusti (osteonekroze).
- Do not use this medicine after the expiry date which is stated on the bag and carton after EXP.
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vreči in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Zoledronic acid (N = 1,065) event rate (%)
Izid zoledronska kislina (N=3.875) delež dogodkov placebo (N=3.861) delež dogodkov absolutno znižanje deleža zlomov % (IZ)
Effect on all clinical fractures
Primerjava incidenc ključnih kliničnih zlomov med obema načinoma
How to prepare and administer Zoledronic acid Teva Generics
Druga zdravila in zdravilo Zoledronska kislina Teva Generics
In the subpopulation of patients receiving glucocorticoids for more than 3 months prior to randomisation, zoledronic acid increased lumbar spine BMD by 4.06% versus 2.71% for risedronate (mean difference: 1.36% ; p<0.001).
V podskupini bolnikov, ki so prejemali glukokortikoide več kot 3 mesece pred randomizacijo, je zoledronska kislina povečala mineralno gostoto kosti ledvene hrbtenice za 4,06 % v primerjavi z 2,71 % pri uporabi risedronata (z razliko povprečij: 1,36 %; p < 0,001).
In the subpopulation of patients receiving glucocorticoids for more than 3 months prior to randomisation, zoledronic acid increased lumbar spine BMD by 4.06% versus 2.71% for risedronate (mean difference: 1.36%; p<0.001).
V podskupini bolnikov, ki so prejemali glukokortikoide več kot 3 mesece pred randomizacijo, je zoledronska kislina povečala mineralno gostoto kosti ledvene hrbtenice za 4,06 % v primerjavi z 2,71 % pri uporabi risedronata (z razliko povprečij: 1,36 %; p <0,001).
Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Neželene učinke zoledronske kisline na plodnost generacije staršev in prve generacije potomcev so ocenjevali na podganah.
(CI)
V
In the subpopulation of patients that had received glucocorticoids for 3 months or less prior to randomisation, zoledronic acid increased lumbar spine BMD by 2.60% versus 0.64% for risedronate (mean difference: 1.96% ; p<0.001).
V podskupini bolnikov, ki so prejemali glukokortikoide 3 mesece ali manj pred randomizacijo, je zoledronska kislina povečalo mineralno gostoto kosti ledvene hrbtenice za 2,60 % v primerjavi z 0,64 % pri uporabi risedronata (z razliko povprečij: 1,96 %; p < 0,001).
In the subpopulation of patients that had received glucocorticoids for 3 months or less prior to randomisation, zoledronic acid increased lumbar spine BMD by 2.60% versus 0.64% for risedronate (mean difference: 1.96%; p<0.001).
V podskupini bolnikov, ki so prejemali glukokortikoide 3 mesece ali manj pred randomizacijo, je zoledronska kislina povečala mineralno gostoto kosti ledvene hrbtenice za 2,60 % v primerjavi z 0,64 % pri uporabi risedronata (z razliko povprečij: 1,96 %; p <0,001).
Effect on hip fractures
Označevalci pregradnje kosti
At 24 months a similar significant increase of 3.6% in total hip BMD was observed for patients treated with zoledronic acid as compared to the effects observed in post-menopausal women in the HORIZON-PFT study.
Po 24 mesecih so pri bolnikih, ki so prejemali zoledronsko kislino, opažali pomembno 3,6-odstotno povečanje mineralne gostote kosti celotnega kolka, kar je podobno učinkom,