natgillin/translations-raw huggingface dataset:
Before you receive dental treatment or undergo dental surgery, tell your dentist you are receiving treatment with Zoledronic acid Teva Generics. 
Preden vam zobozdravnik začne zdraviti zobe ali opravi stomatološko operacijo, mu povejte, da prejemate zdravilo Zoledronska kislina Teva Generics.
Tabulated list of adverse reactions Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category. 
Tabelaričen prikaz neželenih učinkov Neželeni učinki v preglednici 1 so navedeni glede na organski sitem po MedDRA klasifikaciji in glede na kategorijo pogostnosti.
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. 
Pri bolnikih s Pagetovo boleznijo so poročali o simptomih zaradi nizke koncentracije kalcija v krvi, kot so mišični krči, odrevenelost ali občutek zbadanja, posebno v predelu okrog ust.
Clinical efficacy in the treatment of post-menopausal osteoporosis (PFT) The efficacy and safety of zoledronic acid 5 mg once a year for 3 consecutive years were demonstrated in post-menopausal women (7,736 women aged 65-89 years) with either: a femoral neck bone mineral density (BMD) with a T-score ≤ -1.5 and at least two mild or one moderate existing vertebral fracture(s); or a femoral neck BMD T-score ≤ -2.5 with or without evidence of existing vertebral fracture(s). 
Klinična učinkovitost pri zdravljenju postmenopavzalne osteoporoze (PFT) Učinkovitost in varnost zoledronske kisline 5 mg na leto 3 leta zapored so dokazali pri postmenopavzalnih ženskah (7.736 ženskah, starih 65-89 let), ki so imele: bodisi vrednost T mineralne gostote kosti vratu stegnenice ≤ -1,5, pri tem pa prisotna vsaj dva manjša zloma ali en srednje hud zlom vretenca, ali pa vrednost T mineralne gostote kosti vratu stegnenice ≤ -2,5 z znaki prisotnega enega ali več zlomov vretenc ali brez njih.
The usual dose is 5 mg, given to you as one initial infusion into a vein by your doctor or nurse. 
Običajni odmerek je 5 mg in sicer vam ga da vaš zdravnik ali medicinska sestra v obliki začetne infuzije v veno.
Table 3 Between treatment comparisons of the incidence of key clinical fracture variables over 3 years 
Preglednica 3 Primerjava incidenc ključnih kliničnih zlomov med obema načinoma zdravljenja v obdobju 3 let
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription. 
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom.
In patients treated with zoledronic acid, no osteomalacia, marrow fibrosis or woven bone formation was detected. 
Pri bolnicah, ki so se zdravile z zoledronsko kislino, niso odkrili osteomalacije, fibroze kostnega mozga ali tvorbe retikularne kostnine.
What Zoledronic acid Teva Generics is and what it is used for 
Kaj je zdravilo Zoledronska kislina Teva Generics in za kaj ga uporabljamo
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. 
Deleži vseh bolnikov, pri katerih je prišlo do neželenih učinkov, so bili po prvi infuziji 44,7 %, po drugi infuziji 16,7 %, po tretji infuziji pa 10,2 %.
• Monitoring of serum creatinine should be considered in at-risk patients. 
• Pri bolnikih s povečanim tveganjem je treba razmisliti o spremljanju koncentracije kreatinina v
The most frequent finding in the repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound's pharmacological antiresorptive activity. 
Najpogostnejša ugotovitev v študijah s ponavljajočimi se odmerki je bila, da se je povečala primarna spongioza v metafizah dolgih kosti pri rastočih živalih pri skoraj vseh odmerkih.
Osteonecrosis of the jaw has multiple well documented risk factors including a diagnosis of cancer, concomitant therapies (e.g. chemotherapy, anti-angiogenic medicinal products, radiotherapy, corticosteroids) and co-morbid conditions (e.g. anaemia, coagulopathies, infection, pre-existing dental disease). 
Osteonekroza čeljusti ima številne dobro dokumentirane dejavnike tveganja, ki vključujejo diagnozo raka, sočasno zdravljenje (npr. kemoterapijo, antiangiogena zdravila, radioterapijo, kortikosteroide) in sočasna bolezenska stanja (npr. anemijo,
The efficacy of one infusion of 5 mg zoledronic acid versus daily doses of 30 mg risedronate for 2 months was demonstrated in two 6-month comparative trials. 
Ena infuzija 5 mg zoledronske kisline se je izkazala za bolj učinkovito kot odmerek 30 mg risedronata na dan v 2 mesecih v dveh 6-mesečnih primerjalnih preskusih.
In a large clinical trial in 7,736 patients, osteonecrosis of the jaw has been reported in one patient treated with zoledronic acid and one patient treated with placebo. 
V obsežnem kliničnem preskušanju s 7.736 bolniki so o osteonekrozi čeljusti poročali pri enem bolniku, ki je prejemal zoledronsko kislino,
Microcomputed tomography (μCT) analysis demonstrated increased trabecular bone volume and preservation of trabecular bone architecture in patients treated with zoledronic acid compared to placebo. 
Analiza s pomočjo mikroračunalniške tomografije (μCT) je pokazala povečan volumen trabekularne kostnine in ohranjeno trabekularno strukturo kosti pri bolnicah, ki so se zdravile z zoledronsko kislino, v primerjavi s tistimi, ki so prejemale placebo.
The risk reduction was 51% in bisphosphonate-naïve patients and 42% in patients allowed to take concomitant osteoporosis therapy. 
Zmanjšanje tveganja je bilo 51-odstotno v skupini bolnikov, ki še niso jemali difosfonatov, in 42-odstotno pri bolnikih, ki so lahko sočasno jemali druga zdravila za zdravljenje osteoporoze.
The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established. 
Pediatrična populacija Varnost in učinkovitost zoledronske kisline pri otrocih in mladostnikih starih do 18 let nista bili dokazani.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva B.V. 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Teva B.V.
In the trial for the prevention of clinical fractures following a recent hip fracture, vitamin D levels were not routinely measured but the majority of patients received a loading dose of vitamin D prior to zoledronic acid administration (see section 4.2). 
V preskušanju preventive kliničnih zlomov po nedavnem zlomu kolka niso rutinsko merili koncentracij vitamina D, vendar je večina bolnikov pred aplikacijo zoledronske kisline prejela večji začetni odmerek vitamina D (glejte poglavje 4.2).
Identified in post-marketing experience. 
† ugotovljeno z izkušnjami v obdobju po prihodu zdravila na trg.
Six patients who achieved therapeutic response 6 months after treatment with zoledronic acid and later experienced disease relapse during the extended follow-up period were re-treated with zoledronic acid after a mean time of 6.5 years from initial treatment to re-treatment. 
Šest bolnikov, pri katerih je prišlo do terapevtskega odziva 6 mesecev po zdravljenju z zoledronsko kislino, kasneje v obdobju podaljšanega spremljanja pa do recidiva bolezni, je ponovno prejelo zoledronsko kislino, pri čemer je interval med začetnim in ponovnim zdravljenjem v povprečju znašal
What Zoledronic acid Teva Generics is and what it is used for What you need to know before you are given Zoledronic acid Teva Generics How Zoledronic acid Teva Generics is given Possible side effects 
Kaj je zdravilo Zoledronska kislina Teva Generics in za kaj ga uporabljamo Kaj morate vedeti, preden vam dajo zdravilo Zoledronska kislina Teva Generics Kako se daje zdravilo Zoledronska kislina Teva Generics
Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone. 
Mehanizem delovanja Zoledronska kislina spada v skupino difosfonatov, ki vsebujejo dušik, in deluje primarno na kost.
Any clinical fracture (1) 
katerikoli klinični zlom (1) klinični zlom vretenca (2) nevretenčni zlom (1)
- if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na zoledronsko kislino, druge difosfonate ali katero koli sestavino tega zdravila
Patients were randomised to either zoledronic acid 5 mg single infusion or to oral risedronate 5 mg daily for one year. 
Bolnike so randomizirali tako, da so prejemali bodisi zoledronsko kislino v enkratni infuziji 5 mg ali risedronat v odmerku 5 mg enkrat na dan peroralno eno leto.
- The other ingredients are mannitol, sodium citrate and water for injections. 
Druge pomožne snovi so: manitol, natrijev citrat in voda za injekcije.
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. 
Gripa, okužbe zgornjih dihal, znižano število eritrocitov, izguba apetita, nespečnost, zaspanost, ki lahko vključuje upad pozornosti in zavesti, občutek mravljinčenja ali otrplosti, izjemna utrujenost, tresenje, začasna izguba zavesti, okužba ali draženje ali vnetje očesa z bolečino in rdečino, vrtoglavica, zvišan krvni tlak, navali rdečice, kašelj, zadihanost, razdražen želodec, bolečine v trebuhu, zapeka, suha usta, zgaga, izpuščaj, čezmerno znojenje, srbenje, rdečina kože, bolečine v vratu, okorelost mišic, kosti in/ali sklepov, otekanje sklepov, mišični krči, bolečine v rami, bolečine v mišicah prsnega koša in v rebrih, vnetje sklepov, šibkost mišic, nenormalni izvidi preiskav ledvic, nenormalno pogosto uriniranje, otekanje rok, gležnjev ali stopal, žeja, zobobol, motnje okušanja.
During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction). 
V obdobju trženja so poročali po naslednjih neželenih reakcijah (redki): atipični subtrohanterni zlomi stegnenice in zlomi diafize stegnenice (za difosfonate značilen neželeni učinek).
In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral calcium and/or an intravenous infusion of calcium gluconate. 
Klinično pomembno hipokalciemijo, ki je posledica prevelikega odmerka, lahko odpravimo z dodatkom peroralnega kalcija ali intravensko infuzijo kalcijevega glukonata ali z obema.
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. 
Ponovno zdravljene Pagetove bolezni kosti pomeni dodatno intravensko infuzijo zolendronske kisline 5 mg eno leto ali več po začetnem zdravljenju bolnikov, pri katerih pride do ponovitve bolezni.
You must not be given Zoledronic acid Teva Generics: 
Zdravila Zoledronska kislina Teva Generics ne smete dobiti:
The pack sizes of 5 and 10 bottles are only available in multipacks. 
Pakiranji po 5 in 10 plastenk sta na voljo v skupnem pakiranju.
It is an inhibitor of osteoclast-mediated bone resorption. 
Je zaviralec resorpcije kosti, ki jo povzročajo osteoklasti.
Patients being treated with Zoledronic acid Teva Generics should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown. 
Bolniki, ki prejemajo zdravilo Zoledronska kislina Teva Generics, ne smejo istočasno prejemati teh zdravil ali kateri koli druge difosfonate, saj skupni učinki teh zdravil niso znani.
The clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment. 
Lečeči zdravnik naj se pri vodenju zdravljenja posameznega bolnika opira na klinično presojo na podlagi ocene individualnega razmerja med koristjo in tveganjem.
How to store Zoledronic acid Teva Generics Contents of the pack and other information 
Shranjevanje zdravila Zoledronska kislina Teva Generics Vsebina pakiranja in dodatne informacije
Zoledronic acid significantly reduced the mean days of limited activity and the days of bed rest due to back pain by 17.9 days and 11.3 days respectively compared to placebo and significantly reduced the mean days of limited activity and the days of bed rest due to fractures by 2.9 days and 0.5 days respectively compared to placebo (all p<0.01). 
Zoledronska kislina je v primerjavi s placebom statistično značilno znižala povprečno število dni z omejeno aktivnostjo za 17,9 dni v primerjavi s placebom in statistično značilno znižala povprečno število dni z omejeno aktivnostjo za 2,9 dni in število dni, v katerih je zaradi zlomov potreben počitek v postelji, za 0,5 dni (v vseh primerih p<0,01).
Uncommonly, cases of osteonecrosis (primarily of the jaw) have been reported, predominantly in cancer patients treated with bisphosphonates, including zoledronic acid. 
O osteonekrozi (večinoma čeljusti) so občasno poročali predvsem pri bolnikih z rakom, zdravljenih z difosfonati, vključno z zoledronsko kislino.
- The unopened bottle does not require any special storage conditions. 
- Neodprta plastenka: Za shranjevanje zdravila niso potrebna posebna navodila.
The rate of atrial fibrillation serious adverse events was increased in patients receiving zoledronic acid (1.3%) (51 out of 3,862) compared with patients receiving placebo (0.6%) (22 out of 3,852). 
Delež atrijske fibrilacije, ki so jo opredelili kot resen neželen dogodek, je bil pri bolnikih, ki so prejemali zoledronsko kislino, višji (1,3 %) (pri 51 od 3.862 bolnikov) v primerjavi z bolniki, ki so prejemali placebo (0,6 %) (pri 22 od 3.852 bolnikov).
In patients with a recent low-trauma hip fracture, it is recommended to give the zoledronic acid infusion at least two weeks after hip fracture repair (see section 5.1). 
Pri bolnikih z nedavnim zlomom kolka po lažji poškodbi je pripročeno dati infuzijo zoledronske kisline najmanj dva tedna po oskrbi zloma kolka (glejte poglavje 5.1).
Frequency cannot be estimated from available data. 
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
Novartis Hrvatska d.o.o. 
Hrvatska Pliva Hrvatska d.o.o
The zoledronic acid group revealed approximately 2.5 mm less height loss compared to placebo (95% CI: 1.6 mm, 3.5 mm) [p<0.0001]. 
V skupini z zoledronsko kislino je bilo zniževanje telesne višine za približno 2,5 mm manjše kot v skupini s placebom (95 % IZ: 1,6 mm, 3,5 mm) [p<0,0001].
Zoledronic acid Teva Generics is supplied in packs of 1, 5 or 10 bottles. 
Zdravilo Zoledronska kislina Teva Generics je na voljo v pakiranjih po 1, 5 ali 10 plastenk.
Single and multiple 5 and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients yielded the following pharmacokinetic data, which were found to be dose independent. 
Enkratne in večkratne 5-minutne in 15-minutne infuzije po 2, 4, 8 in 16 mg zoledronske kisline so pri
- if you have a kidney problem, or used to have one. 
- če imate ali ste kdaj prej imeli težave z ledvicami.
Solution for infusion multipack: 5 bags x 100 ml multipack: 10 bags x 100 ml 
raztopina za infundiranje skupno pakiranje: 5 vreč x 100 ml skupno pakiranje: 10 vreč x 100 ml intravenska uporaba
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 4.4). 
Pri bolnikih s Pagetovo boleznijo je zelo priporočeno zadostno dodajanje kalcija, ki ustreza vsaj 500 mg elementarnega kalcija, dvakrat na dan vsaj 10 dni po uporabi zoledronske kisline (glejte poglavje 4.4).
Only clear solution free from particles and discoloration should be used. 
Uporabiti smete samo bistro raztopino brez delcev in nespremenjene barve.
Zoledronic acid (5 mg in 100 ml ready-to-infuse solution) is administered via a vented infusion line and given at a constant infusion rate. 
Način uporabe intravenska uporaba Zoledronska kislina (5 mg v 100 ml raztopine, pripravljene za infuzijo) se aplicira prek infuzijskega sistema s prezračevanjem in sicer s stalno hitrostjo infundiranja.
- if you have had some or all of the parathyroid glands in your neck surgically removed. 
- če so vam deloma ali v celoti kirurško odstranili žleze obščitnice.
Zoledronic acid-treated patients aged 75 years and older exhibited a 60% reduction in the risk of vertebral fractures compared to placebo patients (p<0.0001). 
Pri bolnikih, ki so bili stari 75 let ali starejši in so prejemali zoledronsko kislino, je bilo tveganje za zlome vretenc za 60 % manjše v primerjavi z bolniki, ki so prejemali placebo (p<0,0001).
Of the 153 zoledronic acid-treated patients and 115 risedronate-treated patients who entered an extended observation study, after a mean duration of follow-up of 3.8 years from time of dosing, the proportion of patients ending the Extended Observation Period due to the need for re-treatment (clinical judgment) was higher for risedronate (48 patients, or 41.7%) compared with zoledronic acid (11 patients, or 7.2%). 
zdravljenih z risedronatom, ki so bili vključeni v študijo podaljšanega opazovanja, je bil po povprečnem trajanju spremljanja 3,8 let od časa odmerjanja delež bolnikov, ki so zaključili svoje sodelovanje v podaljšanem obdobju opazovanja, ker so potrebovali ponovno zdravljenje (po presoji zdravnika), večji v skupini bolnikov, ki so prejemali risedronat, (48 bolnikov oziroma 41,7 %) kot v skupini bolnikov, ki so prejemali zoledronsko kislino (11 bolnikov oziroma 7,2 %).
Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/l) occurred in 2.3% of zoledronic acid-treated patients in a large clinical trial compared to 21% of zoledronic acid-treated patients in the Paget's disease trials. 
Na podlagi laboratorijskih preiskav so ugotovili, da je do prehodnega asimptomatskega znižanja koncentracij kalcija pod okvir normalnih referenčnih vrednosti (pod 2,10 mmol/l) prišlo pri 2,3 % bolnikov, ki so prejemali zoledronsko kislino v obsežnem kliničnem preskušanju, v primerjavi z 21 %
For atrial fibrillation serious adverse events the pooled incidences were 1.3% for zoledronic acid and 0.8% for placebo. 
Združeni incidenci atrijske fibrilacije, ki so jo opredelili kot resen neželen dogodek, sta bili 1,3 % pri zoledronski kislini in 0,8 % pri placebu.
What Zoledronic acid Teva Generics looks like and contents of the pack Zoledronic acid Teva Generics is a clear and colourless solution for infusion. 
Izgled zdravila Zoledronska kislina Teva Generics in vsebina pakiranja Zdravilo Zoledronska kislina Teva Generics je bistra brezbarvna raztopina za infundiranje.
Zoledronic acid is contraindicated during pregnancy (see section 4.3). 
Uporaba zoledronske kisline v nosečnosti je kontraindicirana (glejte poglavje 4.3).
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. 
Zdravilo Zoledronska kislina Teva Generics skupaj s hrano in pijačo Poskrbite, da boste pred zdravljenjem z zdravilom Zoledronska kislina Teva Generics in po njem pili dovolj tekočine (vsaj en do dva kozarca), kot vam bo naročil zdravnik.
Zoledronic acid significantly increased BMD at the lumbar spine, hip, and distal radius relative to treatment with placebo at all timepoints (6, 12, 24 and 36 months). 
Učinek na mineralno gostoto kosti (bone mineral density - BMD) Zoledronska kislina je statistično značilno povečala mineralno gostoto kosti ledvene hrbtenice, kolka in distalnega dela koželjnice v primerjavi s placebom po vseh obdobjih opazovanja (po 6, 12, 24 in 36 mesecih).
Before stopping Zoledronic acid Teva Generics therapy If you are considering stopping Zoledronic acid Teva Generics treatment, please go to your next appointment and discuss this with your doctor. 
Če nameravate prenehati z zdravljenjem z zdravilom Zoledronska kislina Teva Generics, se pri naslednjem pregledu o tem pogovorite z zdravnikom.
Increasing the infusion time from 5 to 15 minutes caused a 30% decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve. 
30-odstotno znižanje koncentracije zoledronske kisline ob koncu infundiranja, ni pa vplivalo na površino pod krivuljo plazemske koncentracije v odvisnosti od časa.
In the intravenous bolus studies, the doses that were well-tolerated decreased with increasing study duration: 0.2 and 0.02 mg/kg daily was well tolerated for 4 weeks in rats and dogs, respectively but only 0.01 mg/kg and 0.005 mg/kg in rats and dogs, respectively, when given for 52 weeks. 
V študijah z intravenskimi bolusi so se odmerki, ki so jih živali dobro prenašale, zmanjševali s podaljševanjem študije: odmerek 0,2 oziroma 0,02 mg/kg na dan so podgane in psi dobro prenašali 4 tedne, medtem ko so tako podgane kot psi 52 tednov dolgo dajanje zdravila dobro prenašali le v odmerku 0,01 mg/kg oziroma 0,005 mg/kg.
The hip fracture event rate was 1.44% for zoledronic acid-treated patients compared to 2.49% for placebo-treated patients. 
Delež zlomov kolka je bil 1,44 % v skupini z zoledronsko kislino v primerjavi z 2,49 % v skupini s placebom.
Headache, dizziness, sickness, vomiting, diarrhoea, pain in the muscles, pain in the bones and/or joints, pain in the back, arms or legs, flu-like symptoms (e.g. tiredness, chills, joint and muscle pain), chills, feeling of tiredness and lack of interest, weakness, pain, feeling unwell. 
Glavobol, omotičnost, slabost, bruhanje, driska, bolečine v mišicah, bolečine v kosteh in/ali sklepih, bolečine v hrbtu, rokah ali nogah, gripi podobni simptomi (na primer utrujenost, mrazenje, bolečine v sklepih in mišicah), mrazenje, občutek utrujenosti in pomanjkanje zanimanja, šibkost, bolečine, slabo počutje.
The usual dose is 5 mg given as one infusion per year into a vein by your doctor or nurse. 
Običajni odmerek je 5 mg, in sicer vam ga da vaš zdravnik ali medicinska sestra enkrat na leto v obliki enkratne infuzije v veno.
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. 
Pri bolnikih z nedavnim zlomom kolka po lažji poškodbi je pred prvo infuzijo zoledronske kisline priporočen večji začetni odmerek vitamina D 50.000 do 125.000 i.e. peroralno ali intramuskularno.
In the HORIZON-RFT study zoledronic acid treatment significantly increased BMD at the total hip and femoral neck relative to treatment with placebo at all timepoints. 
V študiji HORIZON-RFT je zdravljenje z zoledronsko kislino ob vseh časih opazovanja pomembno povečalo mineralno gostoto kosti celotnega kolka in vratu stegnenice v primerjavi s placebom.
Cyclic Olefin Polymer (COP) plastic bottle, fitted with a chlorobutyl/butyl rubber stopper and aluminium cap fitted with violet plastic flip off disc. 
Plastenka iz cikloolefinskega polimera z zamaškom iz klorobutila/butila in pečatom iz aluminija z vijolično plastično dvižno zaporko.
LIST OF EXCIPIENTS Excipients: Mannitol, sodium citrate and water for injections. 
Pomožne snovi: manitol, natrijev citrat in voda za injekcije.
If refrigerated, allow the refrigerated solution to reach room temperature before administration. 
Če je raztopina zdravila ohlajena, pustite, da se pred uporabo segreje na sobno temperaturo.