natgillin/translations-raw huggingface dataset:
In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
U randomiziranom, dvostruko slijepom, kontroliranom ispitivanju u trajanju od 3 godine u kojem se ocjenjivala djelotvornost i sigurnost zoledronatne kiseline u dozi od 5 mg jedanput godišnje u usporedbi s placebom u liječenju postmenopauzalne osteoporoze (PMO), ukupna incidencija atrijske fibrilacije iznosila je 2,5% (96 od 3862) u bolesnica koje su primale zoledronatnu kiselinu u dozi od 5 mg i 1,9% (75 od 3852) u onih koje su primale placebo.
• The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
• Otopina koja sadrži zoledronatnu kiselinu daje se kao jednokratna 15-minutna intravenska infuzija u zasebnoj infuzijskoj liniji.
• Keep Zoledronic Acid Accord out of the reach and sight of children.
Zoledronatnu kiselinu Accord čuvajte izvan dohvata i pogleda djece.
• Urticaria.
• koprivnjača.
Table 5: Proportion of complete responders by day in the combined TIH studies
Tablica 5: Udio ispitanika s potpunim odgovorom prema danima u kombiniranim ispitivanjima liječenja hiperkalcemije izazvane tumorom
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Ako imate bilo kakvih dodatnih pitanja o uporabi ovog lijeka, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
• Zoledronic Acid Accord is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
• Zoledronatna kiselina Accord daje se u venu kao infuzija (drip) u trajanju od najmanje 15 minuta i mora se primijeniti kao jednokratna intravenska otopina kroz zasebnu infuzijsku liniju.
What you need to know before you are given Zoledronic Acid Accord 3.
Što morate znati prije nego primite Zoledronatnu kiselinu Accord 3.
Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
proljev, zatvor, bolovi u trbuhu, dispepsija, stomatitis, suha usta
A subset had recurrence of symptoms when rechallenged with zoledronic acid or another bisphosphonate.
U dijela tih bolesnika simptomi su se vratili nakon ponovnog izlaganja zoledronatnoj kiselini ili drugom bisfosfonatu.
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 više od 5 mjeseci i smanjila godišnju incidenciju događaja po bolesniku - stopu koštanog pobola.
In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
U bolesnika s blagim do umjerenim oštećenjem funkcije bubrega preporučuju se snižene doze zoledronatne kiseline (vidjeti dio “Doziranje” iznad i dio 4.4).
Mannitol (E421) Sodium citrate Water for injections
6.1 Popis pomoćnih tvari manitol (E421) natrijev citrat voda za injekcije
What you need to know before you are given Zoledronic Acid Accord
Što morate znati prije nego primite Zoledronatnu kiselinu Accord
Patients should have their serum creatinine levels assessed prior to each dose of zoledronic acid.
Bolesnicima treba provjeriti razinu kreatinina u serumu prije svake primjene doze zoledronatne kiseline.
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.
Pronašla se brža normalizacija korigiranog kalcija u serumu 4. dana kod doze zoledronatne kiseline u dozi od 8 mg i 7. dana kod doze zoledronatne kiseline u dozi od 4 mg i 8 mg.
What Zoledronic Acid Accord is and what it is used for 2.
Što je Zoledronatna kiselina Accord i za što se koristi 2.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po bočici, tj. zanemarive količine natrija.
In the zoledronic acid-treated group, statistically significant improvement in pain scores (using the Brief Pain Inventory, BPI) was seen at 4 weeks and at every subsequent time point during the study, when compared to placebo (Figure 1).
Brief Pain Inventory - BPI) nakon 4 tjedna i pri svakom sljedećem mjerenju tijekom ispitivanja u usporedbi s placebom (slika 1).
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.
Čimbenici koji mogu povećati mogućnost pogoršanja funkcije bubrega uključuju dehidraciju, postojeće oštećenje funkcije bubrega, višestruke cikluse liječenja zoledronatnom kiselinom i drugim bisfosfonatima, kao i uzimanje drugih nefrotoksičnih lijekova.
Hypomagnesaemia, hypokalaemia
hipomagnezemija, hipokalemija
• Flu-like symptoms including arthritis and joint swelling.
• Simptomi nalik gripi uključujući artritis i oticanje zglobova.
Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Liječenje odraslih bolesnika s hiperkalcemijom izazvanom tumorom.
Instructions for preparing reduced doses of Zoledronic Acid Accord: Withdraw the appropriate volume of the liquid concentrate, as follows: o 4.4 ml for 3.5 mg dose o 4.1 ml for 3.3 mg dose o 3.8 ml for 3.0 mg dose
Izvucite sljedeći odgovarajući volumen tekućeg koncentrata: o 4,4 ml za dozu od 3,5 mg o 4,1 ml za dozu od 3,3 mg o 3,8 ml za dozu od 3,0 mg
• High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea constipation,
• visok krvni tlak, nedostatak zraka, omaglica, tjeskoba, poremećaji spavanja, promjena osjeta okusa, drhtavica, trnci ili utrnulost šaka ili stopala, proljev, zatvor, bol u trbuhu, suha usta.
Pruritus, rash (including erythematous and macular rash), increased sweating
svrbež, osip (uključujući eritematozni i makularni osip), pojačano znojenje
Do not mix Zoledronic Acid Accord concentrate with calcium-containing or other divalent cation-containing solutions such as lactated Ringer's solution.
Nemojte miješati koncentrat Zoledronatne kiseline Accord s otopinama koje sadrže kalcij ili druge dvovalentne katione kao što je otopina Ringerovog laktata.
For storage conditions of the reconstituted solution for infusion, see section 6.3.
Uvjete čuvanja razrijeđene otopine za infuziju vidjeti u dijelu 6.3.
What Zoledronic Acid Accord is and what it is used for
Što je Zoledronatna kiselina Accord i za što se koristi
Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended.
Čimbenici koji mogu povećati mogućnost propadanja funkcije bubrega uključuju dehidraciju, postojeće oštećenje funkcije bubrega, višestruke cikluse primanja zoledronatne kiseline ili drugih bisfosfonata, kao i istovremenu primjenu nefrotoksičnih lijekova ili kraće trajanje infuzije od trenutno preporučenog.
Anaemia
anemija
All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Zoledronic Acid Accord.
Tijekom liječenja Zoledronatnom kiselinom Accord sve bolesnike se mora poticati da održavaju dobru oralnu higijenu, redovito odlaze na stomatološke kontrole i odmah prijave bilo koji oralni simptom kao što je pomičnost zuba, bol ili oticanje, ili ranice koje ne cijele ili iscjedak.
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 ogovarajuće hidrirani.
• if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
• osjećate ili ste osjećali bol, oticanje ili utrnulost čeljusti, težinu u čeljusti ili klimanje zuba.
When initiating treatment with zoledronic acid in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Kad se počinje liječenje zoledronatnom kiselinom u bolesnika s multiplim mijelomom ili solidnim tumorom koji je metastazirao u kosti, potrebno je odrediti vrijednosti kreatinina u serumu i klirens kreatinina.
MARKETING AUTHORISATION HOLDER Accord Healthcare S.L.U.
Nositelj odobrenja za stavljanje u promet gotovog lijeka Accord Healthcare S.L.U.
• The usual single dose given is 4 mg zoledronic acid.
• Obično se daje jednokratna doza od 4 mg zoledronatne kiseline.
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 cancer patients studied.
Bubrežni klirens zoledronatne kiseline korelirao je s klirensom kreatinina, s time da je bubrežni klirens predstavljao 75±33% klirensa kreatinina, koji je prosječno iznosio 84 ± 29 ml/min (raspon, od 22 do 143 ml/min) u 64 uključena onkološka bolesnika.
Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Accord and will check your response to treatment at regular intervals.
Prije nego što počnete primati Zoledronatnu kiselinu Accord, liječnik će Vam napraviti krvne pretrage i u redovitim vremenskim razmacima provjeravati Vaš odgovor na liječenje.
Patients treated with Zoledronic Acid Accord should be given the package leaflet and the patient reminder card. Posology
Bolesnicima koji se liječe Zoledronatnom kiselinom Accord potrebno je dati Uputu o lijeku i karticu-podsjetnik za bolesnika.
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 karcinomom dojke i najmanje jednom koštanom lezijom.
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.
Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
Tablica 2: Rezultati djelotvornosti (bolesnici s karcinomom prostate koji primaju hormonsku terapiju) Bilo koji koštani događaj (+ hiperkalcemija izazvana tumorom)
Risk reduction of suffering from multiple events** (%)
p-vrijednost Stopa koštanog pobola p-vrijednost Smanjenje rizika od višestrukih događaja** (%)
The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Fibrilacija atrija pojavila se kao ozbiljna nuspojava u 1,3% (51 od 3862) bolesnica koje su primale zoledronatnu kiselinu u dozi od 5 mg i 0,6% (22 od 3852) bolesnica koje su primale placebo.
Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia)
srčana aritmija (uslijed hipokalcemije)
The results demonstrated that zoledronic acid 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Rezultati su pokazali podjednaku djelotvornost zoledronatne kiseline u dozi od 4 mg i pamidronata u dozi od 90 mg u sprječavanju koštanih događaja.
Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Tablica 3: Rezultati djelotvornosti (solidni tumori osim karcinoma dojke i prostate) Bilo koji koštani događaj (+ hiperkalcemija izazvana tumorom)
Efficacy results are provided in Table 4.
Rezultati djelotvornosti prikazani su u tablici 4.
• Do not use Zoledronic Acid Accord after the expiry date stated on the pack.
Zoledronatna kiselina Accord se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju.
Instructions for preparing reduced doses of Zoledronic Acid Accord Withdraw an appropriate volume of the concentrate needed, as follows: 4.4 ml for 3.5 mg dose
Upute za pripremu sniženih doza Zoledronatne kiseline Accord Izvucite odgovarajući volumen potrebnog koncentrata na sljedeći način:
• As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
• kao posljedica niskih vrijednosti kalcija: napadaji, utrnulost i tetanija (kao posljedica hipokalcemije).
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, zabilježeno je u bolesnika nakon početne doze ili jednokratne doze zoledronatne kiseline u dozi od 4 mg.
This medicinal product must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Ovaj lijek ne smije se miješati s kalcijem ili drugim otopinama za infuziju koje sadrže dvovalentne katione, kao što je otopina Ringerovog laktata, i treba se primijeniti kao jednokratna intravenska otopina kroz zasebnu infuzijsku liniju.
Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe hypocalcaemia.
Nepravilan rad srca (srčana aritmija), napadaji, grčevi i trzanje mišića (tetanija) zabilježeni su kao posljedica teške hipokalcemije.
• Conjunctivitis.
• konjunktivitis.
N Proportion of patients with SREs p-value Median time to SRE (days)
Udio bolesnika s koštanim događajem (%) p-vrijednost Medijan vremena do koštanog događaja (dani)
Efficacy results are provided in Table 3.
Rezultati djelotvornosti prikazani su u tablici 3.
Zoledronic Acid Accord concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Koncentrat Zoledronatna kiselina Accord ne smije se miješati s kalcijem ili drugim otopinama za infuziju koje sadrže dvovalentne katione, kao što je otopina Ringerovog laktata, i treba se primijeniti kao jednokratna intravenska otopina kroz posebnu infuzijsku liniju.
Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given Zoledronic Acid Accord
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Zoledronatnu kiselinu Accord, ako:
Efficacy results are provided in Table 2.
Rezultati djelotvornosti prikazani su u tablici 2.
• Sleepiness.
• pospanost.
Nasopharyngitis
nazofaringitis
The withdrawn amount of concentrate must be further diluted in 100 ml of sterile 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Izvučena količina koncentrata mora se dodatno razrijediti u 100 ml sterilne 0,9%-tne m/V otopine za injekciju natrijevog klorida ili 5%-tne m/V otopine glukoze.
CLINICAL PARTICULARS 4.1 Therapeutic indications 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.
Sprječavanje koštanih događaja (patološki prijelomi, kompresija kralježaka, zračenje ili kirurški zahvat na kosti ili hiperkalcemija izazvana tumorom) u odraslih bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti.
To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/v sodium chloride or 5% w/v glucose solution.
Da biste izbjegli moguće inkompatibilnosti, otopina za infuziju koja se koristi za razrjeđenje mora biti 0,9%-tna m/V otopina natrijevog klorida ili 5%-tna m/V otopina glukoze.
Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
vrućica, sindrom sličan gripi (uključujući umor, tresavicu, malaksalost i crvenilo uz osjećaj vrućine)
4.2 Posology and method of administration Zoledronic Acid Accord must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Zoledronatnu kiselinu Accord bolesnicima smiju propisivati i primjenjivati samo zdravstveni djelatnici s iskustvom u intravenskoj primjeni bisfosfonata.
EXP Use immediately after dilution.
Nakon razrjeđenja odmah upotrijebiti.
To avoid potential incompatibilities, Zoledronic Acid Accord concentrate is to be diluted with 0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution.
Da bi se izbjegle moguće inkompatibilnosti, koncentrat Zoledronatne kiseline Accord treba razrijediti sa 0,9%-tnom m/V otopinom natrijevog klorida za injekciju ili sa 5%-tnom m/V otopinom glukoze.
Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Tablica 4: Rezultati djelotvornosti (u bolesnika s karcinomom dojke i multiplim mijelomom)
How to prepare and administer Zoledronic Acid Accord
Kako pripremiti i primijeniti Zoledronatnu kiselinu Accord
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate) One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica s 5 ml koncentrata sadrži 4 mg zoledronatne kiseline (u obliku hidrata).
6 PHARMACEUTICAL PARTICULARS
6. FARMACEUTSKI PODACI
Zoledronic Acid Accord treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Liječenje bolesnika s hiperkalcemijom izazvanom tumorom koji imaju i teško oštećenje funkcije bubrega Zoledronatnom kiselinom Accord dolazi u obzir tek nakon procjene rizika i koristi od liječenja.
Prevention of skeletal related events in patients with advanced malignancies involving bone:
Sprječavanje koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti:
What Zoledronic Acid Accord contains
Što Zoledronatna kiselina Accord sadrži
Very common Vomiting, nausea Common
Vrlo često: povraćanje, mučnina Često:
• Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
• bol u ustima, zubima i/ili čeljusti, oteklina ili ranice u ustima ili čeljusti koje ne cijele, iscjedak,
There have been very rare cases of drowsiness and sleepiness with the use of Zoledronic Acid Accord.
U vrlo su rijetkim slučajevima uz primjenu Zoledronatne kiseline Accord nastupile omamljenost i pospanost.
Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic Acid Accord or after stopping treatment.
Odmah obavijestite svog liječnika ako za vrijeme liječenja Zoledronatnu kiselinu Accord kiselina ili nakon prestanka liječenja dobijete simptome kao što su novonastali ili pogoršani bolovi ili ukočenost.
Bone pain, myalgia, arthralgia, generalised pain
bolovi u kostima, mialgija, artralgija, generalizirani bolovi
Zoledronic Acid Accord contains sodium
Zoledronatna kiselina Accord sadrži natrij
How to store Zoledronic Acid Accord 6.
Kako čuvati Zoledronatnu kiselinu Accord 6.
You must not be given Zoledronic Acid Accord if you are breast-feeding.
Ne smijete dobivati Zoledronatnu kiselinu Accord ako dojite.
Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the postmarketing setting in patients receiving Zoledronic Acid Accord
Osteonekroza čeljusti zabilježena je manje često u kliničkim ispitivanjima i nakon stavljanja lijeka u promet, u bolesnika koji su se liječili Zoledronatnom kiselinom Accord.
Prior to administration, 5ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution).
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Prije primjene, 5 ml koncentrata iz jedne bočice ili izvučen potreban volumen koncentrata mora se dodatno razrijediti sa 100 ml otopine za infuziju koja ne sadrži kalcij (0,9%-tna m/V otopina natrijevog klorida za injekciju ili 5%-tna m/V otopina glukoze).
How often Zoledronic Acid Accord is given
Koliko se često daje Zoledronatna kiselina Accord
Mean changes from baseline in BPI scores.
Prosječna promjena u BPI u odnosu na početnu
Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
ATK oznaka: M05BA08
Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Zoledronatna kiselina Accord 4 mg/5 ml koncentrat za otopinu za infuziju zoledronatna kiselina
• Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
• glavobolja i sindrom sličan gripi koji se sastoji od vrućice, umora, slabosti, omamljenosti,
SPECIAL STORAGE CONDITIONS
9. POSEBNE MJERE ČUVANJA
Only clear solution free from particles and discolouration should be used.
Smije se primijeniti samo bistra otopina koja ne sadrži čestice i nije promijenila boju.
NAME OF THE MEDICINAL PRODUCT Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion
NAZIV LIJEKA Zoledronatna kiselina Accord 4 mg/5 ml koncentrat za otopinu za infuziju
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.
.Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
Baseline creatinine clearance (ml/min) Zoledronic acid recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Doses have been calculated assuming target AUC of 0.66 (mg-hr/l) (CLcr = 75 ml/min).
3,0 mg* zoledronatne kiseline *Doze su izračunate uz pretpostavku da je ciljni AUC 0,66 (mg-hr/l) (klirens kreatinina = 75 ml/min).
• Confusion.
• smetenost.
The hydration status of patients must be assessed prior to and following administration of Zoledronic Acid Accord to ensure that they are adequately hydrated.
Prije i poslije primjene Zoledronatne kiseline Accord mora se provjeriti status hidracije bolesnika kako bi se osiguralo da su primjereno hidrirani.
Very common Pyrexia, fatigue Common
Vrlo često: pireksija, umor Često:
Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoasthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Kao posljedica slučajeva teške hipokalcemije zabilježene su srčane aritimije i neurološki štetni događaji (uključujući konvulzije, hipoesteziju i tetaniju).