FrancophonIA/ELRC3.0 huggingface dataset:
English: Not known** Hypersensitivity reactions including rare cases of bronchoconstriction, urticaria and angioedema, and very rare cases of anaphylactic reaction/shock
Croatian: Nije poznato** Reakcije preosjetljivosti uključujući rijetke slučajeve bronhokonstrikcije,
English: † Identified in post-marketing experience.
Croatian: † Identificirano poslije stavljanja lijeka u promet.
English: Zoledronic acid is contraindicated during breast-feeding (see section 4.3).
Croatian: Zoledronatna kiselina je kontraindicirana tijekom dojenja (vidjeti dio 4.3).
English: P1NP was significantly reduced by 61% below baseline levels at 12 months and was sustained at 52% below baseline levels at 36 months.
Croatian: P1NP je bio značajno smanjen za 61% ispod početnih razina nakon 12 mjeseci, a to je smanjenje održano na 52% ispod početnih razina nakon 36 mjeseci.
English: 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).
Croatian: Prije liječenja bisfosfonatima u bolesnika s istovremeno prisutnim rizičnim faktorima (primjerice rak, kemoterapija, antiangiogeni lijekovi,
English: 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.
Croatian: To je dalje dovelo do peripartalne hipokalcijemije, što je poznati učinak lijekova iz skupine bisfosfonata, te zatim distocije i prijevremenog prekida ispitivanja.
English: The overall percentage of patients who experienced adverse reactions were 44.7%, 16.7% and 10.2% after the first, second and third infusion, respectively.
Croatian: Ukupan postotak bolesnika koji su imali nuspojave nakon prve, druge, odnosno treće infuzije iznosio je 44,7%, 16,7% odnosno 10,2%.
English: Re-treatment consists of an additional intravenous infusion of 5 mg zoledronic acid after an interval of one year or longer from initial treatment in patients who have relapsed.
Croatian: bolesnika s relapsom ponovno se liječenje se sastoji od primjene dodatne intravenske infuzije od 5 mg zoledronatne kiseline nakon intervala od godinu dana ili dulje nakon početnog liječenja.
English: If refrigerated, allow the refrigerated solution to reach room temperature before administration.
Croatian: Ako je otopina u bila hladnjaku, pustite da se prije primjene zagrije na sobnu temperaturu.
English: Paget's disease of the bone
Croatian: Pagetova bolest kosti
English: Uncommon Blood creatinine increased, pollakiuria, proteinuria
Croatian: Manje često Povišen kreatinin u krvi, polakizurija,
English: All participants received 1,000 to 1,500 mg of elemental calcium plus 800 to 1,200 IU of vitamin D supplementation per day.
Croatian: Svi su bolesnici dobili 1000 do 1500 mg elementarnog kalcija plus 800 do 1200 IU nadomjestka vitamina
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C and 25ºC.
Croatian: Dokazana je kemijska i fizikalna stabilnost u primjeni tijekom 24 sata na temperaturi od 2 do 8°C te na 25ºC.
English: 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.
Croatian: Nema dostupnih podataka koji bi upućivali na to bi li prestanak liječenja bisfosfonatima smanjio rizik od osteonekroze čeljusti u bolesnika kojima su potrebni stomatološki zahvati.
English: In the pooled results, a similar decrease in pain severity and pain interference scores relative to baseline were observed over 6 months for zoledronic acid and risedronate.
Croatian: Kada su rezultati bili objedinjeni, nakon 6 mjeseci zapaženo je slično sniženje u težini boli i zbrojeva interferencije boli u odnosu na početne vrijednosti za zoledronatnu kiselinu i risedronat.
English: LIST OF EXCIPIENTS Excipients: Mannitol, sodium citrate and water for injections.
Croatian: Pomoćne tvari: mannitol, natrijev citrat i voda za injekcije.
English: The inter- and intra-subject variation for plasma clearance of zoledronic acid was shown to be 36% and 34%, respectively.
Croatian: Razlika u plazmatskom klirensu zoledronatne kiseline između ispitanika iznosila je 36%, a u pojedinačnog ispitanika 34%.
English: Zoledronic acid is eliminated by renal excretion.
Croatian: Zoledronatna kiselina se eliminira putem bubrega.
English: 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.
Croatian: zatvor, suha usta, žgaravica, kožni osip, pojačano znojenje, svrbež, crvenilo kože, bol u vratu, ukočenost mišića, kostiju i/ili zglobova, oticanje zgloba, grčevi mišića, bol u ramenu, bol u prsnim mišićima i rebrima, upala zgloba, mišićna slabost, poremećene vrijednosti bubrežnih pretraga, neuobičajeno često mokrenje, oticanje šaka, gležnjeva ili stopala, žeđ, zubobolja, poremećaji okusa.
English: 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).
Croatian: Porast BMD-a lumbalne kralježnice i vrata bedrene kosti bio je nakon 12 mjeseci značajno veći u skupini liječenoj zoledronatnom kiselinom u usporedbi s onom liječenom risedronatom (za sve p<0,03).
English: Atrial fibrillation Uncommon Palpitations
Croatian: Fibrilacija atrija
English: Any clinical fracture (1) Clinical vertebral fracture
Croatian: Bilo koji klinički prijelom (1) Klinički vertebralni prijelom (2)
English: Clinical efficacy in the treatment of Paget's disease of the bone Zoledronic acid was studied in male and female patients aged above 30 years with primarily mild to moderate Paget's disease of the bone (median serum alkaline phosphatase level 2.6-3.0 times the upper limit of the age-specific normal reference range at the time of study entry) confirmed by radiographic evidence.
Croatian: Zoledronatna kiselina ispitivana je u bolesnika oba spola koji su bili stariji od 30 godina i u kojih je radiološki potvrđena primarno blaga do umjerena Pagetova bolest kosti (u vrijeme ulaska u kliničko ispitivanje medijan razine alkalne fosfataze u serumu (SAP) bio je 2,6-3,0 puta veći od gornje granice normalnog referentnog raspona specifičnog za tu dob).
English: Each bottle contains 100 ml of solution.
Croatian: Svaka bočica sadrži 100 ml otopine.
English: For information on the infusion of zoledronic acid, see section 6.6.
Croatian: Za informacije o infuziji zoledronatne kiseline, vidjeti dio 6.6. 4.3 Kontraindikacije
English: Dystocia was observed at the lowest dose (0.01 mg/kg body weight) tested in rats.
Croatian: Uz najnižu dozu (0,01 mg/kg tjelesne težine) koja je ispitivana u štakora zapažena je distocija.
English: Not known (frequency cannot be estimated from the available data) Severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the face and throat, decreased blood pressure, dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea.
Croatian: Teške alergijske reakcije uključujući omaglicu i otežano disanje, oticanje uglavnom lica i vrata, pad krvnog tlaka, dehidracija uz simptome kao što su vrućica, povraćanje i proljev nakon primjene lijeka.
English: Renal impairment has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal dysfunction or additional risk factors (e.g. advanced age, oncology patients with chemotherapy, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, severe dehydration), with the majority of them receiving a 4 mg dose every 3-4 weeks, but it has been observed in patients after a single administration.
Croatian: osobito u bolesnika s otprije ugroženom bubrežnom funkcijom ili dodatnim rizičnim faktorima (npr. poodmakla dob, onkološki bolesnici na kemoterapiji, istovremena primjena nefrotoksičnih lijekova, istovremena diuretska terapija, teška dehidracija), od kojih je većina primala dozu od 4 mg svaka 3-4
English: It comes in a polyolefin/styrene-ethylene-butylene (SEB) foil bag with a foil over pouch.
Croatian: Lijek je dostupan u vrećicama od poliolefin/stiren-etilen-butilena (SEB), koje se nalaze u vanjskoj vrećici.
English: Zoledronic acid Teva Generics with food and drink Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Zoledronic acid Teva Generics, as directed by your doctor.
Croatian: Pazite da popijete dovoljno tekućine (najmanje jednu ili dvije čaše) prije i nakon liječenja Zoledronatnom kiselinom Teava Pharma, prema uputama liječnika.
English: 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
Croatian: bol u prsištu koja nije vezana uz srce Nije poznato** Dehidracija dodatno uz simptome nakon primjene kao što su vrućica, povraćanje i proljev
English: All women received 1,000 to 1,500 mg elemental calcium and 400 to 1,200 IU of vitamin D supplements daily.
Croatian: Sve su žene primale 1000 do 1500 mg elementarnog kalcija uz dodatke prehrani s 400 do 1200 IU vitamina
English: In patients with a recent low-trauma hip fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first zoledronic acid infusion.
Croatian: U bolesnika s nedavnim prijelomom kuka nakon manje traume, preporučuje se prije prve infuzije zoledronatne kiseline dati udarnu dozu od 50 000 do 125 000 IU vitamina
English: Táncsics Mihály út 82.,
Croatian: TEVA Pharmaceutical Works Private Limited Company Táncsics Mihály út 82.,
English: Observed in patients taking concomitant glucocorticosteroids.
Croatian: Zapaženo u bolesnika koji istovremeno uzimaju glukokortikoide.
English: Women of childbearing potential Zoledronic acid is not recommended in women of childbearing potential.
Croatian: Žene reproduktivne dobi Zoledronatna kiselina ne preporučuje se ženama reproduktivne dobi.
English: • Zoledronic acid should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5).
Croatian: • Potreban je oprez kad se zoledronatna kiselina primjenjuje zajedno s drugim lijekovima koji mogu utjecati na bubrežnu funkciju (vidjeti dio 4.5).
English: - if you have had some or all of the parathyroid glands in your neck surgically removed.
Croatian: - ako ne možete svaki dan uzimati nadomjestke kalcija. - ako su Vam iz vrata operacijom uklonjene neke ili sve paratireoidne žlijezde. - ako su Vam uklonjeni dijelovi crijeva.
English: Elevated bone turnover is a characteristic of Paget's disease of the bone.
Croatian: Za Pagetovu bolest kosti karakteristična je povećana pregradnja kosti.
English: • 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).
Croatian: • Potreban je oprez kad se Zoledronatna kiselina Teva Generics primjenjuje zajedno s drugim lijekovima koji mogu utjecati na bubrežnu funkciju (vidjeti dio 4.5).
English: 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.
Croatian: Incidencija kliničkih prijeloma bila je 7,5% u muškaraca liječenih zoledronatnom kiselinom naspram 8,7% u onih koji su primali placebo.
English: (cannot be estimated from the available data).
Croatian: (<1/10 000) nije poznato (ne može se procijeniti na osnovi dostupnih podataka).
English: Bone histology
Croatian: Histologija kosti
English: - Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
Croatian: - Dokazana je kemijska i fizikalna stabilnost u primjeni tijekom 24 sata na temperaturi od 2 do 8°C te na 25ºC.
English: 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).
Croatian: U subpopulaciji bolesnika koji su primali glukokortikoide dulje od 3 mjeseca prije randomizacije zoledronatna kiselina povisila je BMD lumbalne kralježnice za 4,06% u usporedbi sa 2,71% pri primjeni risedronata (srednja vrijednost razlike: 1,36%; p<0,001).
English: - Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients listed in section 6.1.
Croatian: - Preosjetljivost na djelatnu tvar, bilo koji bisfosfonat ili bilo koju od pomoćnih tvari navedenih u dijelu 6.1. - Bolesnici s hipokalcijemijom (vidjeti dio 4.4).
English: No dose adjustment is necessary in patients with creatinine clearance ≥ 35 ml/min.
Croatian: U bolesnika s klirensom kreatinina ≥ 35 ml/min nije potrebno prilagođavati dozu.
English: Patients were randomised to either zoledronic acid 5 mg single infusion or to oral risedronate 5 mg daily for one year.
Croatian: Bolesnici su randomizirani ili u skupinu koja je primila jednokratnu infuziju zoledronatne kiseline u dozi od 5 mg ili u skupinu koja je oralno dobivala risedronat u dozi od 5 mg na dan tijekom godine dana.
English: 1 bag of 100 ml
Croatian: 1 vrećica od 100 ml
English: Zoledronic acid (N = 1,065) event rate (%)
Croatian: Zoledronatna kiselina (N=3875)
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalanog sustava za prijavu nuspojava navedenog u Dodatku V.
English: All participants received 1,000 mg elemental calcium plus 400 to 1,000 IU vitamin D supplementation per day.
Croatian: Svi su sudionici primali 1000 mg elementarnog kalcija te 400 do 1000 IU nadomjeska vitamina
English: The use of Zoledronic acid Teva Generics in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.
Croatian: Primjena zoledronatne kiseline u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 35 ml/min) kontraindicirana je zbog povećanog rizika od zatajenja bubrega u toj populaciji.
English: Uveitis, episcleritis, iritis
Croatian: ezofagitis, zubobolja, gastritis#
English: The incidence of delayed hip fracture healing was comparable between zoledronic acid (34 [3.2%]) and placebo (29 [2.7%]).
Croatian: [3,2%]) i placebo (29 [2,7%]).
English: The usual dose is 5 mg given as one infusion per year into a vein by your doctor or nurse.
Croatian: Uobičajena doza je 5 mg koja se daje u obliku infuzije u venu jednom godišnje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACKS (with blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (s plavim okvirom)
English: For atrial fibrillation serious adverse events the pooled incidences were 1.3% for zoledronic acid and 0.8% for placebo.
Croatian: Skupna incidencija ozbiljnih štetnih događaja fibrilacije atrija bila je 1,3% za zoledronatnu kiselinu i
English: Renal impairment has been observed in patients after a single administration.
Croatian: tjedna, no zapaženo je i u bolesnika nakon jednokratne primjene.
English: It is supplied in packs sizes of 1, 5 and 10.
Croatian: Dostupna su pakiranja sa 1, 5 i 10 bočica.
English: Clinical efficacy in osteoporosis associated with long-term systemic glucocorticoid therapy The efficacy and safety of zoledronic acid in the treatment and prevention of osteoporosis associated with long-term systemic glucocorticoid therapy were assessed in a randomised, multicentre, double-blind, stratified, active-controlled study of 833 men and women aged 18-85 years (mean age for men 56.4 years; for women 53.5 years) treated with > 7.5 mg/day oral prednisone (or equivalent).
Croatian: multicentričnom, dvostruko slijepom, stratificiranom ispitivanju s djelatnom kontrolom u 833 muškaraca i žena u dobi od 18 do 85 godina (srednja dob za muškarce 56,4 godine, za žene 53,5 godina) liječenih sa >7,5mg/dan oralno primijenjenog prednizona (ili ekvivalenta).
English: Class effects)
Croatian: i 4.8 Učinci klase)
English: Adequate calcium and vitamin D intake are recommended in association with zoledronic acid administration.
Croatian: Uz primjenu zoledronatne kiseline, preporučuje se odgovarajući unos kalcija i vitamina D.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodiumfree.”
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) na 100 ml, odnosno u osnovi „ne sadrži natrij“.
English: Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture.
Croatian: Prijelomi su često obostrani te se stoga u bolesnika liječenih bisfosfonatima s prijelomom trupa bedrene kosti mora pregledati i bedrena kost na drugoj nozi.
English: How to store Zoledronic acid Teva Generics
Croatian: Kako čuvati Zoledronatnu kiselinu Teva Generics
English: Each ml of solution contains 0.05 mg zoledronic acid (as monohydrate).
Croatian: Svaki ml otopine sadrži 0,05 mg zoledronatne kiseline (u obliku hidrata).
English: Clinical vertebral fracture
Croatian: Krvožilni poremećaji
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each bag contains 5 mg zoledronic acid (as monohydrate).
Croatian: KVALITATIVNI I KVANTIATIVNI SASTAV Svaka vrećica sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
English: 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.
Croatian: Oštećenje funkcije bubrega Bubrežni klirens zoledronatne kiseline uspoređen je s klirensom kreatinina, pri čemu je bubrežni klirens predstavljao 75 ± 33% kliresna kreatinina, što je pokazalo srednju vrijednost od 84 ±
English: Measurement of serum calcium before infusion of zoledronic acid is recommended for patients with Paget´s disease.
Croatian: U bolesnika s Pagetovom bolešću preporučuje se određivanje kalcija u serumu prije infuzije zoledronatne kiseline .
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle contains 5 mg zoledronic acid (as monohydrate).
Croatian: KVALITATIVNI I KVANTIATIVNI SASTAV Svaka bočica sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
English: How Zoledronic acid Teva Generics is given
Croatian: Kako se primjenjuje Zoledronatna kiselina Teva Generics
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Samo za jednokratnu uporabu.
English: Absolute reduction in fracture incidence % (CI)
Croatian: Apsolutno smanjenje incidencije prijeloma% (CI)
English: 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.
Croatian: Pažljivo slijedite sve upute koje Vam je dao liječnik, ljekarnik ili medicinska sestra prije nego počnete uzimati Zoledronatnu kiselinu Teva Generics.
English: Österreich ratiopharm Arzenimittel Vertriebs-GmbH Tel: +43 1 97007-0
Croatian: Österreich ratiopharm Arzenimittel Vertriebs-GmbH
English: - Do not use this medicine after the expiry date which is stated on the bottle and carton label after EXP.
Croatian: - Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza
English: During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Croatian: Tijekom liječenja bisfosfonatima bolesnici se moraju uputiti da prijave svaku pojavu boli u bedrima,
English: In patients with Paget's disease, symptoms due to low blood calcium, such as muscle spasms, or numbness, or a tingling sensation especially in the area around the mouth have been reported.
Croatian: U bolesnika s Pagetovom bolešću zabilježeni su simptomi uzrokovani niskom razinom kalcija u krvi,
English: Absolute reduction in fracture event rate % (CI)
Croatian: Apsolutno smanjenje stopa događaja kod prijeloma % (CI)
English: Not known** Renal impairment.
Croatian: Nije poznato** Oštećenje funkcije bubrega.
English: Osteoporosis is a disease that involves the thinning and weakening of the bones and is common in women after the menopause, but can also occur in men.
Croatian: Osteoporoza je bolest koja uključuje stanjivanje i slabljenje kostiju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (without blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (bez plavog okvira)
English: In patients with Paget's disease symptoms due to low blood calcium, such as muscle spasms, or numbness, or a tingling sensation especially in the area around the mouth have been reported.
Croatian: kao što su grčevi mišića, utrnulost ili trnci, osobito u području oko usta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/912/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/912/001
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (with blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (s plavim okvirom)
English: One bottle contains 5 mg zoledronic acid (as monohydrate).
Croatian: Jedna bočica sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
English: Mechanism of action
Croatian: stopa događaja
English: Nausea, vomiting, diarrhoea Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth, oesophagitis, toothache, gastritis#
Croatian: Manje često Dispepsija, bol u gornjem dijelu trbuha, bol u trbuhu, gastroezofagealna refluksna bolest, konstipacija, suhoća usta,
English: Zoledronic acid is not systemically metabolised and does not affect human cytochrome P450 enzymes in vitro (see section 5.2).
Croatian: Zoledronatna kiselina se sistemski ne metabolizira i ne utječe na humane enzime citokroma
English: Non-vertebral fracture (1) *p-value <0.05, **p-value <0.01 (1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures
Croatian: Vertebralni prijelom (2) Nevertebralni prijelom (1) *p-vrijednost <0,05, **p- vrijednost <0,01
English: Relative reduction in fracture incidence % (CI)
Croatian: Relativno smanjenje incidencije prijeloma % (CI)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/912/004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/912/004
English: 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.
Croatian: zbroj vrata bedrene kosti ispod -2,5 a 45% bolesnika je imalo BMD T-zbroj vrata bedrene kosti iznad -2,5.
English: The educational programme contains the following:
Croatian: Program izobrazbe sadrži sljedeće: • Edukativne materijale za liječnika