natgillin/translations-raw huggingface dataset:
No pharmacokinetic data for zoledronic acid are available in patients with hypercalcaemia or in patients with hepatic insufficiency.
Nema dostupnih farmakokinetičkih podataka za zoledronatnu kiselinu u bolesnika s hiperkalcijemijom ili bolesnika s teškom insuficijencijom jetre.
Patients with TIH and evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with zoledronic acid outweighs the possible risk.
Bolesnike s hiperkalcemijom izazvanom tumorom i dokazanim pogoršanjem funkcije bubrega treba procijeniti na odgovarajući način i pritom razmotriti jesu li moguće koristi od liječenja zoledronatnom kiselinom veće od mogućih rizika.
For the treatment of Paget's disease, zoledronic acid should be prescribed only by physicians with experience in the treatment of Paget's disease of the bone.
Za liječenje Pagetove bolesti, zoledronatnu kiselinu treba propisati liječnik iskusan u liječenju Pagetove bolesti kostiju.
- If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic Acid Hospira.
- Ako se liječite radi snižavanja količine kalcija u krvi, obično ćete dobiti samo jednu infuziju
Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
Intravenski primijenjena zoledronatna kiselina eliminira se trofaznim procesom: brzi dvofazni nestanak iz sistemske cirkulacije, uz poluvijek t½α od 0,24 i t½β od 1,87 sati, nakon čega slijedi dugačka faza eliminacije s terminalnim poluvijekom eliminacije t½γ od 146 sati.
Severe and occasionally incapacitating bone, joint and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including zoledronic acid (see section 4.8).
Jaka i povremeno nepodnošljiva bol u kostima, zglobovima i/ili mišićima rijetko je prijavljena u bolesnika koji su uzimali bisfosfonate, uključujući zoledronatnu kiselinu (vidjeti dio 4.8).
Blood and lymphatic system disorders Common:
Poremećaji krvi i limfnog sustava često:
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.
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) Teške alergijske reakcije uključujući omaglicu i otežano disanje, oticanje uglavnom lica i vrata, pad krvnog tlaka, dehidraciju nakon pojave simptoma kao što su vrućica, povraćanje i proljev.
Zoledronic acid is not metabolised and is excreted unchanged via the kidney.
Zoledronatna kiselina se ne metabolizira i izlučuje se nepromijenjena putem bubrega.
• Zoledronic acid should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5).
• zoledronatnu kiselinu treba primijeniti s oprezom kada se istodobno daje s drugim lijekovima koji mogu oštetiti funkciju bubrega (vidjeti dio 4.5)
Patients who were classified as responders at the end of the 6 month core study were eligible to enter an extended follow-up period.
Bolesnici koji su na kraju šestomjesečnog osnovnog kliničkog ispitivanja bili klasificirani kao osobe koje pokazuju terapijski odgovor bili su prikladni za uključenje u produljeni period praćenja.
Your doctor, pharmacist or nurse knows how to store Zoledronic Acid Hospira properly.
Vaš liječnik, ljekarnik ili medicinska sestra znaju kako ispravno čuvati Zoledronatnu kiselinu Hospira.
The following precautions should be taken into account to minimise the risk of renal adverse reactions:
Potrebno je poduzeti sljedeće mjere opreza radi smanjenja rizika bubrežnih nuspojava:
In the single-dose dog infusion studies, 1.0 mg/kg (6 fold the recommended human therapeutic exposure based on AUC) administered over 15 minutes was well tolerated with no renal effects.
U ispitivanjima pojedinačne doze infuzijom u pasa, doza od 1,0 mg/kg (šesterostruko viša od preporučene terapijske izloženosti za ljude bazirano na AUC-u) primijenjena u trajanju od 15 minuta bila je dobro podnesena, bez učinaka na bubrege.
No interaction studies with other medicinal products have been performed with zoledronic acid.
Specifična ispitivanja interakcija između lijekova nisu provedena sa zoledronatnom kiselinom.
A subset had recurrence of symptoms when rechallenged with zoledronic acid or another bisphosphonate.
U dijela tih bolesnika simptomi su se vratili nakon ponovnog liječenja zoledronatnom kiselinom ili drugim bisfosfonatom.
Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs)
- bolest intersticija pluća (upalna bolest tkiva oko zračnih mjehurića u plućima)
In patients with mild to moderate renal impairment, reduced doses should be prepared as instructed below.
U bolesnika s blagim do umjerenim oštećenjem bubrega potrebno je pripremiti smanjene doze prema niže navedenim uputama.
What Zoledronic Acid Hospira looks like and contents of the pack Zoledronic Acid Hospira is a clear and colourless solution.
Kako Zoledronatna kiselina Hospira izgleda i sadržaj pakiranja Zoledronatna kiselina Hospira je bistra i bezbojna otopina.
There was a transient increase in serum creatinine observed within 10 days in 1.8% of zoledronic acid-treated patients versus 0.8% of placebo-treated patients.
Opaženo je prolazno povećanje kreatinina u serumu unutar 10 dana u 1,8% bolesnika liječenih zoledronatnom kiselinom naspram 0,8% bolesnika koji su primali placebo.
In some instances, the hypocalcaemia may be life-threatening (see section 4.8).
U nekim slučajevima hipokalcemija je bila životnougrožavajuća (vidjeti dio 4.8).
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 medicinal product 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.
Mala opažena povećanja AUC (0-24hr) vrijednosti za oko 30% do 40% u slučaju blagog do umjerenog oštećenja bubrega naspram bolesnika s normalnom funkcijom bubrega te pomanjkanje akumulacije lijeka pri višekratnim dozama bez obzira na bubrežnu funkciju, navode na zaključak da nije potrebno prilagođavati dozu zoledronatne kiseline u slučaju blagog (Clcr = 50-80 ml/min) i umjerenog oštećenja bubrega s klirensom kreatinina do 35 ml/min.
Administration of 0.001 mg/kg/day subcutaneously in rats and 0.005 mg/kg intravenously once every 2-3 days in dogs for up to 52 weeks was also well tolerated.
Doza od 0,001 mg/kg na dan primijenjena supkutano u štakora i doza od 0,005 mg/kg primijenjena intravenski u pasa jednom svaka 2-3 dana do najviše 52 tjedna također su se dobro podnosile.
Zoledronic acid shows no appreciable binding to plasma proteins and does not inhibit human P450 enzymes in vitro (see section 5.2), but no formal clinical interaction studies have been performed.
Zoledronatna kiselina se ne veže u nekoj zamjetnoj mjeri za proteine plazme i ne inhibira ljudske enzime P450 in vitro (vidjeti dio 5.2), ali nisu provedena formalna klinička ispitivanja interakcija.
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.
Jednokratnim i višekratnim 5-minutnim i 15-minutnim infuzijama 2, 4, 8 i 16 mg zoledronatne kiseline u 64 bolesnika dobiveni su sljedeći farmakokinetički podaci za koje se utvrdilo da ne ovise o dozi.
Dystocia was observed at the lowest dose (0.01 mg/kg body weight) tested in rats.
Distocija je bila opažena pri najnižoj dozi (0,01 mg/kg tjelesne težine) ispitanoj u štakora.
The infusion time must not be less than 15 minutes.
Vrijeme inuzije ne smije biti kraće od 15 minuta.
Hypocalcaemia has been reported in patients treated with zoledronic acid.
Hipokalcemija je prijavljena u bolesnika koji su liječeni zoledronatnom kiselinom.
- Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
- Prevencija koštanih događaja (patološki prijelomi, spinalna kompresija, zračenje ili kirurški zahvat na kosti ili hiperkalcijemija izazvana tumorom) u odraslih bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kost.
Zoledronic acid 4 mg significantly reduced the proportion of patients experiencing at least one skeletal related event (SRE), delayed the median time to first SRE by > 5 months, and reduced the annual incidence of events per patient - skeletal morbidity rate.
Zoledronatna kiselina u dozi od 4 mg značajno je smanjila udio bolesnika s najmanje jednim koštanim događajem, produljila medijan vremena do prvog koštanog događaja za > 5 mjeseci i smanjila godišnju incidenciju događaja po bolesniku - stopu koštanog pobola.
Very rare:
uveitis vrlo rijetko:
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.
Ukupan postotak bolesnika koji su imali nuspojave nakon prve, druge i treće infuzije iznosio je 44,7%, 16,7% i 10,2%.
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.
Bolesnicima treba savjetovati da tijekom liječenja bisfosfonatima prijave svaku bol u bedru, kuku ili preponama, a svakog bolesnika s takvim simptomima treba pregledati na nepotpuni prijelom bedrene kosti.
Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound medicinal products are therefore unlikely.
Zoledronatna kiselina se ne veže u nekoj zamjetnoj mjeri za proteine plazme (približno 43-55% vezanja), stoga nisu vjerojatne interakcije zbog preraspodjele lijeka koji se veže za proteine u znatnoj mjeri.
Increases in serum creatinine also occur in some patients with chronic administration of zoledronic acid at recommended doses for prevention of skeletal related events, although less frequently.
U nekih bolesnika dolazi do povišenja kreatinina u serumu i kod kronične primjene zoledronatne kiseline u dozama koje se preporučuju za prevenciju koštanih događaja, iako manje učestalo.
Your doctor may recommend a dental examination before you start treatment with Zoledronic Acid Hospira - if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid Hospira and inform your doctor about your dental treatment.
Vaš liječnik može preporučiti pregled kod zubara prije nego počnete liječenje Zoledronatnom kiselinom Hospira - ako se liječite kod zubara ili trebate ići na zubarski kirurški zahvat, obavijestite svog zubara da se liječite Zoledronatnom kiselinom Hospira i obavijestite svog liječnika o Vašem liječenju kod zubara.
In an in vitro study, zoledronic acid showed low affinity for the cellular components of human blood, with a mean blood to plasma concentration ratio of 0.59 in a concentration range of 30 ng/ml to 5000 ng/ml.
U in vitro ispitivanju, zoledronatna kiselina je pokazala niski afinitet za ljudske krvne stanice, uz srednju vrijednost omjera koncentracije krvi prema plazmi od 0,59 za raspon koncentracije od 30 ng/ml do 5000 ng/ml.
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in Paget's disease of the bone (see section 4.2 for information on paediatric use).
Europska agencija za lijekove ukinula je obvezu podnošenja rezultata ispitivanja referentnog lijeka koji sadrži zoledronatnu kiselinu u svim podskupinama pedijatrijske populacije u Pagetovoj bolesti kosti (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
An extension study was conducted in order to examine the long-term general and renal safety of once yearly or twice yearly zoledronic acid over the 12-month extension treatment period in children who had completed one year of treatment with either zoledronic acid or pamidronate in the core study.
Produžetak ispitivanja proveo se da bi se ispitala dugotrajna opća sigurnost zoledronatne kiseline i njezina sigurnost za bubrege kod primjene jednom ili dvaput godišnje tijekom 12-mjesečnog produžetka razdoblja liječenja u djece koja su dovršila godinu dana liječenja zoledronatnom kiselinom ili pamidronatom u glavnom ispitivanju.
Following initiation of therapy, serum creatinine should be measured prior to each dose of Zoledronic Acid Hospira and treatment should be withheld if renal function has deteriorated.
Nakon početka terapije kreatinin u serumu treba mjeriti prije svake doze zoledronatne kiseline, a liječenje treba obustaviti ako se funkcija bubrega pogorša.
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic Acid Hospira.
Ako već imate hipokalcemiju, ona se mora korigirati prije uvođenja prve doze Zoledronatne kiseline Hospira.
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.
U ispitivanjima s intravenskom bolus injekcijom, doze koje su se dobro podnosile su se smanjivale s povećanjem trajanja ispitivanja: dozu od 0,2 i 0,02 mg/kg dnevno dobro su podnosili štakori, odnosno psi tijekom 4 tjedna, no nakon 52 tjedna primjene štakori su podnosili dozu od samo 0,01 mg/kg, a psi od samo 0,005 mg/kg.
Zoledronic acid 4 mg was also studied in a double-blind, randomised, placebo-controlled trial in 228 patients with documented bone metastases from breast cancer to evaluate the effect of 4 mg zoledronic acid on the skeletal related event (SRE) rate ratio, calculated as the total number of SRE events (excluding hypercalcaemia and adjusted for prior fracture), divided by the total risk period.
Zoledronatna kiselina od 4 mg također se ispitivala u dvostruko slijepom, randomiziranom, placebom kontroliranom ispitivanju u 228 bolesnika s potvrđenim koštanim metastazama raka dojke da bi se procijenio učinak 4 mg zoledronatne kiseline na omjer stope koštanih događaja izračunatog kao ukupni broj koštanih događaja (bez hiperkalcemije i prilagođen s obzirom na prethodne prijelome) podijeljen s ukupnim rizičnim razdobljem.
Zoledronic acid was well tolerated when administered subcutaneously to rats and intravenously to dogs at doses up to 0.02 mg/kg daily for 4 weeks.
Zoledronatna kiselina dobro se podnosila kad se primjenjivala supkutano štakorima i intravenski psima u dozama do 0,02 mg/kg dnevno tijekom 4 tjedna.
This medicinal product must not be allowed to come into contact with any calcium-containing solutions.
Ovaj lijek ne smije doći u kontakt s otopinama koje sadrže kalcij.
Not known**
Prijelomi*
Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles
Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles
The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Ukupni klirens iz tijela je 5,04±2,5 l/h, neovisan o dozi i na njega ne utječu spol, dob, rasa i tjelesna težina.
Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Za bolesnike s teškom insuficijencijom bubrega dostupni su samo ograničeni farmakokinetički podaci (klirens kreatinina < 30 ml/min).
- Zoledronic Acid Hospira 4 mg/100 ml solution for infusion can be used immediately without further preparation for patients with normal renal function.
- Zoledronatna kiselina Hospira 4 mg/100 ml otopina za infuziju može se upotrijebiti odmah bez dodatne pripreme za bolesnike s normalnom funkcijom bubrega.
In clinical trials in osteoporosis, the change in creatinine clearance (measured annually prior to dosing) and the incidence of renal failure and impairment was comparable for both the zoledronic acid and placebo treatment groups over three years.
U kliničkim ispitivanjima osteoporoze, promjena klirensa kreatinina (mjerenog godišnje prije doziranja) i incidencija zatajenja i oštećenja bubrega bile su usporedive u skupini liječenoj zoledronatnom kiselinom i skupini koja je primala placebo tijekom tri godine.
Zoledronic acid is not systemically metabolised and does not affect human cytochrome P450 enzymes in vitro (see section 5.2).
Zoledronatna kiselina se ne metabolizira sistemski niti utječe na ljudski citokrom enzim P450 in vitro (vidjeti dio 5.2).
The highest non-lethal single intravenous dose was 10 mg/kg body weight in mice and 0.6 mg/kg in rats.
Najviša jednokratna intravenska doza bez letalnog učinka iznosila je 10 mg/kg tjelesne težine u miševa i 0,6 mg/kg u štakora.
− Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
- uočeno je da se također vrlo rijetko pojavila i na drugim kostima osim čeljusti, naročito na kuku ili bedrima.
The recommended dose in hypercalcaemia (albumin-corrected serum calcium ≥ 12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
Preporučena doza kod hiperkalcijemije (serumski kalcij korigiran za albumin ≥ 12,0 mg/dl ili 3,0 mmol/l) je jednokratna doza od 4 mg zoledronatne kiseline.
The onset time is 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Vrijeme nastupa je ≤ 3 dana nakon infuzije zoledronatne kiseline, a reakcije se još zovu “simptomi nalik gripi” ili “simptomi nakon doziranja”.
This adverse drug reaction consists of a constellation of symptoms that includes fever, myalgia, headache, extremity pain, nausea, vomiting, diarrhoea, arthralgia and arthritis with subsequent joint swelling.
Ova nuspojava sastoji se od konstelacije simptoma koji uključuju vrućicu, mialgiju, glavobolju, bol u ekstremitetima, mučninu, povraćanje, proljev, artralgiju i artritis s posljedičnim oticanjem zglobova.
Upon initiation of treatment in patients with bone metastases with mild to moderate renal impairment, lower doses of zoledronic acid are recommended.
Nakon početka liječenja bolesnika s koštanim metastazama i blagim do umjerenim oštećenjem bubrega preporučuju se niže doze zoledronatne kiseline.
The first randomised, double-blind, placebo-controlled study compared zoledronic acid 4 mg to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Prvo randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje uspoređivalo je zoledronatnu kiselinu u dozi od 4 mg s placebom u prevenciji koštanih događaja u bolesnika s rakom prostate.
In clinical trials performed in patients with tumour-induced hypercalcaemia (TIH), the overall safety profile amongst all three treatment groups (zoledronic acid 4 and 8 mg and pamidronate 90 mg) was similar in types and severity.
U kliničkim ispitivanjima provedenima u bolesnika s hiperkalcijemijom izazvanom tumorom, cjelokupni sigurnosni profil bio je sličan po vrsti i težini u sve tri liječene skupine (zoledronatna kiselina u dozi od 4 mg i 8 mg i pamidronat u dozi od 90 mg).
The frequencies for each of these identified risks are shown in Table 1.
Učestalosti svakog pojedinog utvrđenog rizika navedene su u Tablici 1.
Longer-term repeat administration at doses bracketing the highest intended human therapeutic dose of zoledronic acid produced toxicological effects in other organs, including the gastrointestinal tract, liver, spleen and lungs, and at intravenous injection sites.
Dugotrajna ponovna primjena doza koje se približavaju najvišoj terapijskoj dozi zoledronatne kiseline za ljude proizvela je toksikološke učinke u drugim organima, uključujući gastrointestinalni trakt, jetru, slezenu i pluća te promjene na mjestu primjene intravenske injekcije.
The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients.
Opažena neravnoteža u ovom ispitivanju nije bila opažena u drugim ispitivanjima zoledronatne kiseline, uključujući ispitivanja zoledronatne kiseline u dozi od 4 mg primijenjene svaka 3-4 tjedna u onkoloških bolesnika.
The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the zoledronic acid -treated group versus 49.6% in the placebo group (p=0.003).
Udio bolesnika s barem jednim koštanim događajem (isključujući hiperkalcemiju) bio je 29,8% u skupini liječenoj zoledronatnom kiselinom naspram 49,6% u placebo skupini (p=0,003).
The chance of experiencing these side effects decreases with subsequent doses of Zoledronic Acid Hospira.
Izgledi za pojavu ovih nuspojava smanjuju se sa sljedećim dozama Zoledronatne kiseline Hospira.
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
Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika i normalno ne smiju biti dulji od 24 sata pri 2
Pharmacodynamic effects
Farmakodinamički učinci:
Zoledronic acid 4 mg (N=86)
10. dan zoledronatna kiselina 4 mg (n=86)
Zoledronic acid is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
Zoledronatna kiselina je kontraindicirana u bolesnika s klirensom kreatinina < 35 ml/min (vidjeti dijelove 4.3 i 4.4).
Patients must be assessed prior to administration of zoledronic acid to ensure that they are adequately hydrated.
Bolesnici moraju biti pregledani prije primjene zoledronatne kiseline kako bi se potvrdilo da su odgovarajuće hidrirani.
In the clinical programme patients aged 1 to < 3 years received 0.025 mg/kg zoledronic acid (up to a maximum single dose of 0.35 mg) every 3 months and patients aged 3 to 17 years received 0.05 mg/kg zoledronic acid (up to a maximum single dose of 0.83 mg) every 3 months.
Bolesnici uključeni u klinički program u dobi od 1 do < 3 godine primali su 0,025 mg/kg zoledronatne kiseline (do najviše jednokratne doze od 0,35 mg) svaka 3 mjeseca, a bolesnici u dobi od 3 do 17 godina primali su 0,05 mg/kg zoledronatne kiseline (do najviše jednokratne doze od 0,83 mg) svaka 3 mjeseca.
If any of these apply to you, tell your doctor straight away.
Ako se bilo što od navednog odnosi na vas, odmah se obratite svom liječniku.
The recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone is 4 mg zoledronic acid every 3 to 4 weeks.
Preporučena doza za prevenciju koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti je 4 mg zoledronatne kiseline svaka 3 do 4 tjedna.
The effects of intravenous zoledronic acid in the treatment of paediatric patients (age 1 to 17 years) with severe osteogenesis imperfecta (types I, III and IV) were compared to intravenous pamidronate in one international, multicentre, randomised, open-label study with 74 and 76 patients in each treatment group, respectively.
Učinci intravenski primijenjene zoledronatne kiseline u liječenju pedijatrijskih bolesnika (u dobi od 1 do 17 godina) s teškim oblikom osteogenesis imperfecta (tipovi I, III i IV) usporedili su se s učincima intravenski primijenjenog pamidronata u jednom međunarodnom, multicentričnom, randomiziranom ispitivanju otvorenog tipa u svakoj liječenoj skupini, jednoj sa 74 i drugoj sa 76 bolesnika.
Day 10
4. dan