natgillin/translations-raw huggingface dataset:
In patients with normal renal function, defined as CLcr > 60 ml/min, zoledronic acid 4 mg/100 ml solution for infusion must not be further diluted.
U bolesnika s normalnom funkcijom bubrega, koja se definira kao CLcr > 60 ml/min, zoledronatna kiselina 4 mg/100 ml otopina za infuziju ne smije se dodatno razrijediti.
Acquired Fanconi syndrome General disorders and administration site conditions Common:
stečeni Fanconijev sindrom Opći poremećaji i reakcije na mjestu primjene često:
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), the majority of whom received a 4 mg dose every 3-4 weeks, but it has been observed in patients after a single administration.
Oštećenje bubrega je opaženo nakon primjene zoledronatne kiseline, osobito u bolesnika s prijašnjom disfunkcijom bubrega ili dodatnim faktorima rizika (npr. poodmakla dob, onkološki bolesnici na kemoterapiji, istodobna primjena nefrotoksičnih lijekova, istodobna diuretska terapija, teška dehidracija), od kojih je većina primala dozu od 4 mg svaka 3-4 tjedna, no opaženo je i u bolesnika nakon jednokratne primjene.
What you need to know before you are given Zoledronic Acid Hospira
Što morate znati prije nego počnete primjenjivati Zoledronatnu kiselinu Hospira
Fracture adverse events of long bones in the lower extremities were reported in approximately 24% (femur) and 14% (tibia) of zoledronic acid-treated patients vs 12% and 5% of pamidronate-treated patients with severe osteogenesis imperfecta, regardless of disease type and causality but overall incidence of fractures was comparable for the zoledronic acid and pamidronate-treated patients: 43% (32/74) vs 41% (31/76).
Nuspojava prijeloma dugih kostiju donjih ekstremiteta bila je prijavljena u približno 24% (bedrena kost) i 14% (goljenična kost) bolesnika liječenih zoledronatnom kiselinom naspram 12% odnosno 5% u bolesnika s teškim oblikom osteogenesis imperfecta liječenih pamidronatom, bez obzira na tip bolesti i uzrok, no ukupna incidencija prijeloma bila je slična u bolesnika liječenih zoledronatnom kiselinom i onih liječenih pamidronatom: 43% (32/74) naspram 41% (31/76).
Zoledronic Acid Hospira must not be allowed to come into contact with any calcium-containing solutions.
Zoledronatna kiselina Hospira ne smije doći u kontakt s otopinama koje sadrže kalcij.
Temporary interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Kad je moguće, treba uzeti u obzir privremeni prekid liječenja zoledronatnom kiselinom dok se stanje ne popravi i pripadajući čimbenici rizika ublaže.
Instructions for preparing reduced doses of Zoledronic Acid Hospira
Upute za pripremu sniženih doza Zoledronatne kiseline Hospira
6 ml, type I clear glass vial or 5 ml plastic vial, stoppered with a fluoropolymer-coated halo-butyl closure and sealed with an aluminium seal and flip-off top.
I od 6 ml ili plastična bočica od 5 ml, zatvorene halobutilnim čepom obloženim flourpolimerom, aluminijskim prstenom i ˝flip-off˝ poklopcem.
The majority of these reactions were mild to moderate and resolved within three days of the event onset.
Te nuspojave su većinom bile blage do umjerene, a povukle su se unutar tri dana od pojave.
If you experience any of the above side effects, you should contact your doctor immediately.
Ako imate bilo koji od gore navedenih nuspojava, odmah se obratite svom liječniku.
The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established.
Sigurnost i djelotvornost zoledronatne kiseline u djece i adolescenata ispod 18 godina nisu ustanovljene.
The administration of doses up to 48 mg of zoledronic acid in error has been reported.
Prijavljena je primjena doza zoledronatne kiseline do 48 mg zbog pogreške.
Psychiatric disorders Uncommon: Anxiety, sleep disturbance Rare:
anksioznost, poremećaj spavanja rijetko:
Investigations Very common:
Pretrage vrlo često:
Zoledronic Acid Hospira should be given as a single intravenous infusion in no less than 15 minutes.
Zoledronatnu kiselinu Hospira treba primijeniti kao jednokratnu intravensku infuziju u trajanju od najmanje 15 minuta.
This medicine contains 16 mmol (or 360 mg) sodium per dose.
Ovaj lijek sadrži 16 mmol natrija (360 mg) po dozi.
- Do not use this medicine after the expiry date which is stated on the carton and bag.
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i vrećici.
For atrial fibrillation serious adverse events the pooled incidences were 1.3% for zoledronic acid and 0.8% for placebo.
Objedinjena incidencija ozbiljnih štetnih događaja fibrilacije atrija bila je 1,3% za zoledronatnu kiselinu i 0,8% za placebo.
Caution is indicated when zoledronic acid is administered in conjunction with medicinal products that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration) (see section 4.4).
Potreban je oprez kada se zoledronatna kiselina primjenjuje zajedno s lijekovima koji mogu značajno utjecati na funkciju bubrega (npr. aminoglikozidi ili diuretici koji mogu uzrokovati dehidraciju) (vidjeti dio 4.4).
In patients who show evidence of renal deterioration during treatment, zoledronic acid should be withheld.
U bolesnika u kojih se pojave znakovi pogoršanja funkcije bubrega tijekom liječenja, treba prekinuti primjenu zoledronatne kiseline.
* Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
* Doze su izračunate za ciljnu AUC od 0,66 (mg•hr/l) (CLcr = 75 ml/min).
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 the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja referentnog lijeka koji sadrži zoledronatnu kiselinu u svim podskupinama pedijatrijske populacije u liječenju hiperkalcijemije izazvane tumorom i prevenciji događaja povezanih s koštanim sustavom u bolesnika s uznapredovalom zloćudnom bolešću koja zahvaća kosti (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table 1 below.
Za pripremu sniženih doza za bolesnike s početnim CLcr ≤ 60 ml/min, vidjeti Tablicu 1 niže.
Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Zoledronatna kiselina se ne preporučuje za bolesnike koje prije početka terapije imaju teško oštećenje bubrega koje se za ovu populaciju definira kao klirens kreatinina < 30 ml/min.
The pain score for zoledronic acid was consistently below baseline and pain reduction was accompanied by a trend in reduced analgesics score.
Rezultat na ljestvici bola za zoledronatnu kiselinu bio je dosljedno ispod početne razine, a smanjenje boli bilo je praćeno trendom smanjenja bodova za analgetike.
In view of the potential impact of zoledronic acid on renal function, the lack of clinical safety data in patients with severe renal impairment (in clinical trials defined as serum creatinine 400 µmol/l or 4.5 mg/dl for patients with TIH and 265 µmol/l or 3.0 mg/dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/min), the use of zoledronic acid is not recommended in patients with severe renal impairment.
S obzirom na mogući utjecaj zoledronatne kiseline na funkciju bubrega, nedostatak kliničkih podataka o sigurnosti u bolesnika s teškim oštećenjem bubrega (u kliničkim ispitivanjima definiranim kao kreatinin u serumu ≥ 400 μmol/l ili ≥ 4,5 mg/dl u bolesnika s hiperkalcijemijom izazvanom tumorom odnosno ≥ 265 μmol/l ili ≥ 3,0 mg/dl u bolesnika s rakom i koštanim metastazama) na početku liječenja i ograničene farmakokinetičke podatke u bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) na početku liječenja, ne preporučuje se primjena zoledronatne kiseline u bolesnika s teškim oštećenjem bubrega.
− To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Hospira concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Da bi pripremili otopinu za infuziju koja sadrži 4 mg zoledronatne kiseline, dodatno razrijedite koncentrat Zoledronatne kiseline Hospira (5,0 ml) sa 100 ml otopine za infuziju koja ne sadrži kalcij niti druge dvovalentne katione.
Zoledronic acid treatment should be resumed at the same dose as that given prior to treatment interruption.
Liječenje zoledronatnom kiselinom treba nastaviti istom dozom koja se primjenjivala prije prekida liječenja.
Caution is advised when Zoledronic Acid Hospira is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Preporuča se oprez kad se zoledronatna kiselina primjenjuje s antiangiogenim lijekovima jer je primijećena povećana incidencija osteonekroze čeljusti u bolesnika koji su istodobno liječeni ovim lijekovima.
The use of Zoledronic Acid Hospira in children and adolescents has not been studied.
Primjena Zoledronatne kiseline Hospira u djece i adolescenata nije ispitivana.
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).
Uz to, u bolesnika s Pagetovom bolesti, strogo se preporuča osigurati adekvatnu nadoknadu kalcija od najmanje 500 mg elementarnog kalcija dvaput dnevno tijekom najmanje 10 dana nakon primjene zoledronatne kiseline (vidjeti dio 4.2).
Nervous system disorders Common:
Poremećaji živčanog sustava često:
In Phase I dose finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2-2.5 mg.
U ispitivanjima faze I, određivanja doze u bolesnika s blagom do umjerenom hiperkalcijemijom izazvanom tumorom, djelotvorne ispitivane doze bile su u rasponu od približno 1,2 do 2,5 mg.
Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid.
Pogoršanje funkcije bubrega koje napreduje do zatajenja bubrega i dijalize, prijavljeno je u bolesnika nakon početne doze ili jednokratne doze od 4 mg zoledronatne kiseline.
It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Zoledronic Acid Hospira.
Trenutačno je nejasno uzrokuje li zoledronatna kiselina nepravilan srčani ritam, ali trebate to prijaviti svom liječniku ako primijetite takve simptome nakon uzimanja Zoledronatne kiseline Hospira.
Zoledronic Acid Hospira must not be mixed or given intravenously with any other medicinal products.
Zoledronatna kiselina Hospira se ne smije miješati niti davati intravenski s bilo kojim drugim lijekom.
− Since no data are available on the compatibility of Zoledronic Acid Hospira with other intravenously administered substances, Zoledronic Acid Hospira must not be mixed with other medicinal products/substances and should always be given through a separate infusion line.
- Budući da nema dostupnih podataka o kompatibilnosti Zoledronatne kiseline Hospira s drugim tvarima za intravensku primjenu, Zoledronatna kiselina Hospira ne smije se miješati s drugim lijekovima/tvarima i uvijek se mora primjenjivati kroz zasebnu infuzijsku liniju.
Concentrate for solution for infusion 4 mg/5 ml
koncentrat za otopinu za infuziju 4 mg/5 ml
Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline.
S primjenom zoledronatne kiseline smije se nastaviti tek kad se kreatinin u serumu vrati na vrijednosti unutar 10% početne vrijednosti.
- Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
- Liječenje odraslih bolesnika s hiperkalcijemijom izazvanom tumorom.
Hypophosphataemia
hipofosfatemija
Blood creatinine and blood urea increased, hypocalcaemia Uncommon: Hypomagnesaemia, hypokalaemia Rare:
povišeni kreatinin i urea u krvi, hipokalcemija manje često:
The SRE rate (events/person year) was 0.628 for zoledronic acid and 1.096 for placebo.
Stopa koštanih događaja (događaja po osobi/godini) iznosila je 0,628 u skupini koja je primala zoledronatnu kiselinu i 1,096 u placebo skupini.
The frequencies for each of these identified risks are shown in Table 2.
Učestalosti svakog pojedinog utvrđenog rizika navedene su u Tablici 2.
Uncommon: Thrombocytopenia, leukopenia Rare:
trombocitopenija, leukopenija rijetko:
Do not mix Zoledronic Acid Hospira concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Nemojte miješati koncentrat Zoledronatne kiseline Hospira s otopinama koje sadrže kalcij ili druge dvovalentne katione kao što je otopina Ringerovog laktata.
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.
Ako se ne upotrijebi odmah, vrijeme i uvjeti čuvanja prije upotrebe su odgovornost korisnika i ne bi trebali biti dulji od 24 sata na 2°8° C.
There was faster normalisation of corrected serum calcium at day 4 for 8 mg zoledronic acid and at day 7 for 4 mg and 8 mg zoledronic acid.
Bila je brža normalizacija korigiranog kalcija u serumu 4. dana kod doze zoledronatne kiseline od 8 mg i 7. dana kod doze zoledronatne kiseline od 4 i 8 mg.
In a pooled analysis of safety data from trials for the use of zoledronic acid for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
U analizi objedinjenih podataka o sigurnosti iz ispitivanja primjene zoledronatne kiseline za prevenciju koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti, sumnjalo se da je učestalost štetnih događaja oštećenja bubrega povezanih sa zoledronatnom kiselinom (nuspojave) bila sljedeća: multipli mijelom (3,2%), rak prostate (3,1%), rak dojke (4,3%), rak plućni i drugi solidni tumori (3,2%).
- The unopened bag does not require any special storage conditions.
- Neotvorena vrećica ne zahtijeva posebne uvjete čuvanja.
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 Class effects)
Prijavljeni su rijetki slučajevi zatajenja bubrega koji iziskuju dijalizu i rijetki slučajevi sa smrtnim ishodom u bolesnika s postojećom disfunkcijom bubrega ili drugim faktorima rizika kao što su: poodmakla dob, istodobna primjena nefrotoksičnih lijekova, istodobna primjena diuretske terapije ili dehidracija u razdoblju nakon infuzije (vidjeti dijelove 4.4 i 4.8 učinci skupine).
- Severe renal impairment with creatinine clearance < 35 ml/min (see section 4.4).
- Teško oštećenje bubrega s klirensom kreatinina < 35 ml/min (vidjeti dio 4.4).
Flu-like symptoms including arthritis and joint swelling.
- simptomi nalik gripi, uključujući artritis i oticanje zglobova.
•Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1.
• Preosjetljivost na djelatnu tvar, druge bisfosfonate ili neku od pomoćnih tvari navedenih u dijelu 6.1.
The multiple event analysis revealed a significant risk reduction of 16% in patients treated with zoledronic acid 4 mg in comparison with patients receiving pamidronate.
Analiza višestrukih događaja pokazala je značajno smanjenje rizika za 16% u bolesnika liječenih zoledronatnom kiselinom u dozi od 4 mg naspram bolesnika koji su primali pamidronat.
After initiation of the zoledronic acid infusion, plasma concentrations of the active substance increased rapidly, achieving their peak at the end of the infusion period, followed by a rapid decline to < 10% of peak after 4 hours and < 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak levels.
Nakon uvođenja infuzije zoledronatne kiseline, koncentracije djelatne tvari u plazmi brzo su se povećavale, pri čemu su vršnu vrijednost postigle na kraju perioda infuzije, nakon čega je slijedio brzi pad na < 10% vršne vrijednosti nakon 4 sata, zatim na < 1% vršne vrijednosti nakon 24 sata, s produljenim periodom vrlo niskih koncentracija koje nisu prelazile 0,1% vršnih razina.
Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoaesthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Aritmije srca i neurološke nuspojave (uključujući konvulzije, hipoesteziju i tetaniju) prijavljeni su kao posljedica hipokalcemije.
Adjusted dose (mg zoledronic acid) *
Prilagođena doza (mg zoledronatne kiseline)*
Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Ispitivanja utjecaja zoledronatne kiseline na reproduktivnost životinja pokazala su da postoji reproduktivna toksičnost (vidjeti dio 5.3).
Hypersensitivity reactions including rare cases of bronchoconstriction, urticaria and angioedema, and very rare cases of anaphylactic reaction/shock
Poremećaji imunološkog sustava nepoznato** reakcija preosjetljivosti, uključujući rijetke slučajeve bronhokonstrikcije, urtikarije, angioedem i vrlo rijetko anafilaktičku reakciju/šok
What Zoledronic Acid Hospira is and what it is used for
Što je Zoledronatna kiselina Hospira i za što se koristi
The active substance in Zoledronic Acid Hospira is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Djelatna tvar u Zoledronatnoj kiselini Hospira je zoledronatna kiselina, koja pripada skupini tvari koje se zovu bisfosfonati.
The use of Zoledronic Acid Hospira in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.
Primjena Zoledronatne kiseline Hospira u bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 35 ml/min) je kontraindicirana zbog povećanog rizika od zatajenja bubrega u ovoj populaciji.
You will be given adequate calcium and vitamin D supplements.
Dobit ćete odgovarajuće nadomjestke kalcija i vitamina D.
After initiating the infusion of zoledronic acid, the plasma concentrations of zoledronic acid rapidly increased, achieving their peak at the end of the infusion period, followed by a rapid decline to < 10% of peak after 4 hours and < 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak prior to the second infusion of zoledronic acid on day 28.
Nakon početka infuzije zoledronatne kiseline, koncentracija zoledronatne kiseline u plazmi brzo se povisila i postigla vršnu vrijednost na kraju razdoblja infuzije, nakon čega je uslijedilo brzo sniženje na < 10% vršne vrijednosti nakon 4 sata te < 1% vršne vrijednosti nakon 24 sata, s narednim produljenim razdobljem vrlo niskih koncentracija koje nisu prelazile 0,1% vršne vrijednosti prije druge infuzije zoledronatne kiseline 28. dana.
In a third phase III randomised, double-blind trial, zoledronic acid 4 mg or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
U randomiziranom, dvostruko slijepom ispitivanju faze III uspoređivala se zoledronatna kiselina u dozi od 4 mg s pamidronatom u dozi od 90 mg svaka 3 do 4 tjedna u bolesnika s multiplim mijelomom ili rakom dojke i najmanje jednom koštanom lezijom.
Solution for infusion 4 mg/100 ml
otopina za infuziju 4 mg/100 ml
For patients with normal renal function (defined as CLcr > 60 ml/min), zoledronic acid 4 mg/100 ml solution for infusion may be administered directly without any further preparation.
U bolesnika s normalnom funkcijom bubrega (definiranom kao CLcr > 60 ml/min) zoledronatna kiselina 4 mg/100 ml otopina za infuziju može se primijeniti izravno bez ikakvog dodatnog razrjeđivanja.
The following adverse reactions, listed in Table 1, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Sljedeće nuspojave, navedene u Tablici 1, prikupljene su iz kliničkih ispitivanja i prijava nakon stavljanja lijeka u promet, uglavnom kod kroničnog liječenja s 4 mg zoledronatne kiseline:
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06-0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Dugotrajna ispitivanja ponovljenih parenteralnih doza u životinja pokazala su uzak raspon sigurnosti s obzirom na učinke na bubrege, ali najviša kumulativna doza koja ne uzrokuje oštećenje (NOAEL) u ispitivanjima jednostruke doze (1,6 mg/kg) i višestrukih doza u trajanju do jednog mjeseca (0,060,6 mg/kg/dan) nije imala učinke na bubrege pri dozama jednakima ili višima od najviše terapijske doze za ljude.
Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
Obratite se liječniku ako osjetite bol, slabost ili nelagodu u Vašem bedru, kuku ili preponama, jer to može biti rani znak mogućeg prijeloma bedrene kosti.
Renal impairment has been observed in patients after a single administration, renal failure requiring dialysis or with a fatal outcome has rarely occurred in patients with underlying renal impairment or with any of the risk factors described above.
Zatajenje bubrega koje zahtijeva dijalizu ili koje je imalo smrtni ishod u rijetkim slučajevima se pojavilo u bolesnika s podležećim oštećenjem bubrega ili s bilo kojim gore opisanim faktorima rizika.
The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race or body weight.
Ukupan tjelesni klirens je 5,04 ± 2,5 1/h, neovisno o dozi te na njega ne utječe spol, dob, rasa ili tjelesna težina.
Remove the volume of Zoledronic Acid Hospira solution indicated from the bag prior to administration.
Izvucite navedeni volumen Zoledronatne kiseline Hospira iz vreće prije primjene.
Placebo Zoledronic Acid
Placebo Zoledronatna kiselina
Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid and other bisphosphonates as well as use of other nephrotoxic medicinal products.
Faktori koji mogu povećati mogućnost pogoršanja funkcije bubrega uključuju dehidraciju, prethodno postojeće oštećenje bubrega, višestruke cikluse liječenja zoledronatnom kiselinom i drugim bisfosfonatima kao i primjenu drugih nefrotoksičnih lijekova.
Table 7: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta Nervous system disorders
Tablica 7: Nuspojave opažene u pedijatrijskih bolesnika s teškim oblikom osteogenesis imperfecta Poremećaji živčanog sustava često: