FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypomagnesaemia, hypokalaemia Hyperkalaemia, hypernatraemia
Croatian: hipofosfatemija povišeni kreatinin i urea u krvi, hipokalcemija hipomagnezemija, hipokalemija hiperkalemija, hipernatremija
English: Zoledronic acid treatment should be resumed at the same dose as that prior to treatment interruption.
Croatian: Liječenje zoledronatnom kiselinom treba nastaviti istom dozom koja se davala prije prekida liječenja.
English: 55.6 % (p=0.021)* 83.3 % (p=0.010)* 86.7 % (p=0.015)*
Croatian: 55,6% (p=0,021)* 83,3% (p=0,010)* 86,7% (p=0,015)* Pamidronat 90 mg (N=99) 33,3%
English: Common (may affect up to 1 in 10 people): - Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Croatian: Često (mogu se javiti u do 1 na 10 osoba): - glavobolja i sindrom sličan gripi koji se sastoji od vrućice, umora, slabosti, omamljenosti,
English: - Sleepiness.
Croatian: - pospanost
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/001<1 vial>
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/779/001<1 vial>
English: Prior to administration, 5 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (sodium chloride 9 mg/ml (0.9%) solution or 5% w/v glucose solution).
Croatian: 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 (9 mg/ml (0,9%) otopina natrijevog klorida ili 5% m/V otopina glukoze).
English: Other medicines and Zoledronic acid medac Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: The withdrawn amount of the concentrate must be further diluted in 100 ml of sterile sodium chloride 9 mg/ml (0.9%) solution or 5% w/v glucose solution.
Croatian: Izvučenu količinu koncentrata mora se dodatno razrijediti u 100 ml sterilne 9 mg/ml (0,9%) otopine natrijevog klorida ili 5% m/V otopine glukoze.
English: Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients treated with zoledronic acid.
Croatian: U bolesnika liječenih zoledronatnom kiselinom zabilježene su snižene razine kalcija u krvi (hipokalcemija) koje ponekad dovode do mišićnih grčeva, suhe kože i osjećaja žarenja.
English: Remove the volume of Zoledronic acid medac 4 mg/100 ml solution indicated from the bottle and replace with an equal volume of sterile sodium chloride 9 mg/ml (0.9%) solution for injection, or 5% glucose.
Croatian: Izvucite navedeni volumen Zoledronatne kiseline medac 4 mg/100 ml otopine za infuziju iz boce i zamijenite ga jednakim volumenom sterilne 9 mg/ml (0,9%) otopine za injekciju natrijevog klorida ili 5%-tne otopine glukoze.
English: The following conventional classification is used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare
Croatian: Za to se koristila sljedeća uobičajena klasifikacija: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Population analysis showed that for a patient with creatinine clearance of 20 ml/min (severe renal impairment), or 50 ml/min (moderate impairment), the corresponding predicted clearance of zoledronic acid would be 37 % or 72%, respectively, of that of a patient showing creatinine clearance of 84 ml/min.
Croatian: Populacijska analiza pokazala je da bi odgovarajući predviđeni klirens zoledronatne kiseline kod bolesnika s klirensom kreatinina od 20 ml/min (teško oštećenje funkcije bubrega) bio 37%, a kod bolesnika s klirensom kreatinina od 50 ml/min (umjereno oštećenje) 72% onoga kakav postoji kod bolesnika s klirensom kreatinina od 84 ml/min.
English: Multipack: 4 x 1 bottle of 100 ml Multipack: 10 x 1 bottle of 100 ml
Croatian: Višestruko pakiranje: 4 x 1 boca od 100 ml
English: Zoledronic acid medac 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.
Croatian: Zoledronatna kiselina medac 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.
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100),
Croatian: Nuspojave su navedene prema učestalosti prema sljedećoj konvenciji, s time da su prvo navedene najčešće nuspojave: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: 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.
Croatian: 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.
English: - if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which
Croatian: - ako ste alergični (preosjetljivi) na zoledronatnu kiselinu, drugi bisfosfonat (skupina tvari kojoj pripada Zoledronatna kiselina medac) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Zoledronic acid treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Croatian: Liječenje bolesnika s hiperkalcemijom izazvanom tumorom koji imaju i teško oštećenje funkcije bubrega zoledronatnom kiselinom dolazi u obzir tek nakon procjene rizika i koristi od liječenja.
English: What you need to know before you are given Zoledronic acid medac
Croatian: Što morate znati prije nego primite Zoledronatnu kiselinu medac Kako primjenjivati Zoledronatnu kiselinu medac
English: CARTON FOR 4 VIALS
Croatian: KUTIJA ZA 4 BOČICE
English: Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia)
Croatian: hiperestezija, tremor, somnolencija konvulzije, hipoestezija i tetanija (kao posljedica hipokalcemije)
English: You must not be given Zoledronic acid medac if you are breast-feeding.
Croatian: Ne smijete dobivati Zoledronatnu kiselinu medac ako dojite.
English: 1 x 5 ml vial
Croatian: 1 ×5 ml bočica
English: The hydration status of patients must be assessed prior to and following administration of Zoledronic acid medac to ensure that they are adequately hydrated.
Croatian: Prije i poslije primjene Zoledronatne kiseline medac mora se provjeriti status hidracije bolesnika kako bi se osiguralo da su primjereno hidrirani.
English: The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months.
Croatian: Pri donošenju odluke da se liječe bolesnici s koštanim metastazama radi sprječavanja koštanih događaja, treba uzeti u obzir da učinak liječenja nastupa nakon 2-3 mjeseca.
English: Efficacy results are provided in Table 5.
Croatian: Rezultati djelotvornosti prikazani su u tablici 5.
English: - The other ingredients are: mannitol, sodium citrate, water for injections.
Croatian: − Drugi sastojci su: manitol, natrijev citrat, voda za injekcije.
English: • Additional risk minimisation measures The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet osigurat će prilaganje kartice s podsjetnikom za bolesnika u vezi s osteonekrozom čeljusti.
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid 4 mg and other bisphosphonates as well as use of other nephrotoxic medicinal products.
Croatian: Čimbenici koji mogu povećati mogućnost pogoršanja funkcije bubrega uključuju dehidraciju, postojeće oštećenje funkcije bubrega, višestruke cikluse liječenja zoledronatnom kiselinom u dozi od 4 mg i drugim bisfosfonatima, kao i uzimanje drugih nefrotoksičnih lijekova.
English: To avoid potential incompatibilities, the infusion solution used for dilution must be either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Croatian: Da biste izbjegli moguće inkompatibilnosti, otopina za infuziju koja se koristi za razrjeđenje mora biti otopina za injekciju natrijevog klorida od 0,9 mg/ml (0,9%) ili 5%-tna w/v otopina glukoze
English: 1 x5ml vial.
Croatian: 1 ×5 ml bočica.
English: To avoid potential incompatibilities, Zoledronic acid medac concentrate is to be diluted with sodium chloride 9 mg/ml (0.9%) solution or 5% glucose solution.
Croatian: Kako bi se izbjegle moguće inkompatibilnosti, koncentrat Zoledronatne kiseline medac mora se razrijediti s 9 mg/ml (0,9%) otopinom natrijevog klorida ili s 5% otopinom glukoze.
English: Table 5: Efficacy results (breast cancer and multiple myeloma patients)
Croatian: Tablica 5: Rezultati djelotvornosti (u bolesnika s karcinomom dojke i multiplim mijelomom)
English: 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.
Croatian: 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
English: 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.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika i ne bi trebali biti dulji od 24 sata na temperaturi od 2°C-8°C.
English: Zoledronic acid 4 mg reduced the risk of SREs by 41 % in a multiple event analysis (risk ratio=0.59, p=0.019) compared with placebo.
Croatian: Prema analizi višestrukih događaja, zoledronatna kiselina u dozi od 4 mg smanjila je rizik od koštanog događaja za 41% (omjer rizika=0,59, p=0,019) u usporedbi s placebom.
English: Zoledronic acid 4 mg reduced the risk of SREs by 41% in a multiple event analysis (risk ratio=0.59, p=0.019) compared with placebo.
Croatian: Prema analizi višestrukih događaja, zoledronatna kiselina u dozi od 4 mg smanjila je rizik od koštanog događaja za 41% (omjer rizika =0,59, p=0,019) u usporedbi s placebom.
English: Acute renal failure, haematuria, proteinuria Acquired Fanconi syndrome
Croatian: proteinurija stečeni Fanconijev sindrom
English: What Zoledronic acid medac looks like and contents of the pack Zoledronic acid medac is supplied as solution for infusion in a 100 ml colourless glass bottle (type I) with rubber stoppers (halobutyl, fluoropolymer coated) and aluminium flip-off caps.
Croatian: Zoledronatna kiselina medac isporučuje se kao otopina za infuziju u boci od bezbojnog stakla (tipa I) s gumenim čepom (halobutilni, obložen fluoropolimerom) i aluminijskim poklopcem.
English: 4 x 5 ml vials
Croatian: 4 ×5 ml bočice
English: One vial contains 5 ml of concentrate for solution for infusion.
Croatian: 5 ml koncentrata za otopinu za infuziju.
English: • Do not use Zoledronic acid medac after the expiry date stated on the bottle and carton after
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza
English: − In vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
Croatian: U nekliničkim ispitivanjima pokazala je sljedeća svojstva: - in vivo: inhibicija osteoklastične resorpcije kosti, koja mijenja mikrookoliš koštane srži i čini je manje pogodnom za rast tumorskih stanica, antiangiogeno djelovanje i analgetsko djelovanje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING (WITHOUT BLUE BOX) CARTON FOR 1 BOTTLE AS PART OF A MULTIPACK COMPRISING 4 BOTTLES CARTON FOR 1 BOTTLE AS PART OF A MULTIPACK COMPRISING 10 BOTTLES
Croatian: KUTIJA ZA 1 BOČICU KOJA JE DIO VIŠESTRUKOG PAKIRANJA OD 4 BOČICE KUTIJA ZA 1 BOČICU KOJA JE DIO VIŠESTRUKOG PAKIRANJA OD 10 BOČICA
English: How often Zoledronic acid medac is given - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic acid medac every three to four weeks.
Croatian: - Ako se liječite radi sprječavanja koštanih komplikacija izazvanih metastazama, dobivat ćete jednu infuziju Zoledronatne kiseline medac svaka tri do četiri tjedna.
English: One bottle contains 100 ml of solution.
Croatian: Jedna boca sadrži 100 ml otopine.
English: Austria medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Croatian: A-2491 Neufeld/Leitha Austrija medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: 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.
Croatian: Lijek se ne smije miješati s infuzijskim otopinama koje sadrže kalcij ili druge dvovalentne katione kao što je Ringerova otopina s laktatom, te se treba primijeniti kao pojedinačna intravenska otopina putem zasebne infuzijske linije.
English: Multipack: 4 x 1 vial of 5 ml Multipack: 10 x 1 vial of 5 ml
Croatian: Višestruko pakiranje: 4 x 1 bočica od 5 ml
English: How Zoledronic acid medac is given - Zoledronic acid medac 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.
Croatian: - Zoledronatna kiselina medac se daje u venu kao infuzija (drip) u trajanju od najmanje 15 minuta i mora se primijeniti kao jednokratna intravenska otopina kroz zasebnu infuzijsku liniju.
English: A dental examination with appropriate preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with bisphosphonates in patients with concomitant risk factors.
Croatian: Prije početka liječenja bisfosfonatima, u bolesnika s istodobnim rizičnim faktorima, preporučuje se stomatološki pregled uz obavljanje preventivnih stomatoloških zahvata i procjena individualne koristi i rizika.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Croatian: Farmakoterapijska skupina: lijekovi za liječenje bolesti kostiju, bisfosfonati.
English: During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Croatian: kuku ili preponama i svakog bolesnika s takvim simptomima treba pregledati na nepotpuni prijelom bedrene kosti.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL ON MULTIPACKS WITH 4 VIALS WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VIŠESTRUKOM PAKIRANJU S 4 BOČICE OMOTANOM PROZIRNOM FOLIJOM (UKLJUČUJUĆI PLAVI OKVIR)
English: Vomiting, nausea Abdominal pain
Croatian: povraćanje, mučnina bolovi u trbuhu
English: 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 medac or after stopping treatment.
Croatian: Odmah obavijestite svog liječnika ako za vrijeme liječenja Zoledronatnom kiselinom medac ili nakon prestanka liječenja dobijete simptome kao što su novonastali ili pogoršani bolovi ili ukočenost.
English: Very common: Common:
Croatian: Vrlo često: Često:
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
Croatian: Osteonekroza čeljusti zabilježena je manje često u kliničkim ispitivanjima i nakon stavljanja lijeka u promet u bolesnika koji su primali zoledronatnu kiselinu.
English: - Severe bone, joint and/or muscle pain, occasionally incapacitating.
Croatian: - jaki, ponekad onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima.
English: Colourless glass bottle type I with fluoropolymer coated halobutyl rubber stopper and aluminium flipoff cap.
Croatian: I s čepom od halobutilne gume obloženim fluoropolimerom i aluminijskim „flip-off“ poklopcem.
English: Zoledronic acid medac 4mg/5ml concentrate for solution for infusion Sanochemia Pharmazeutika AG
Croatian: Zoledronatna kiselina medac 4 mg/5 ml koncentrat za otopinu za infuziju Sanochemia Pharmazeutika AG
English: Do not mix Zoledronic acid medac with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Croatian: Nemojte miješati Zoledronatnu kiselinu medac s otopinama koje sadrže kalcij ili druge dvovalentne katione kao što je otopina Ringerovog laktata.
English: Do not mix Zoledronic acid medac concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Croatian: Nemojte miješati koncentrat Zoledronatne kiseline medac s otopinama koje sadrže kalcij ili druge dvovalentne katione kao što je otopina Ringerovog laktata.
English: Zoledronic acid medac must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Croatian: 4.2 Doziranje i način primjene Zoledronatnu kiselinu medac bolesnicima smiju propisivati i primjenjivati samo liječnici s iskustvom u intravenskoj primjeni bisfosfonata.
English: Table 1: Preparation of reduced doses of Zoledronic acid medac 4 mg/100 ml solution for infusion
Croatian: Tablica 1: Priprema sniženih doza Zoledronatne kiseline medac 4 mg/100 ml otopine za infuziju Početni klirens kreatinina (ml/min)
English: Excipients: mannitol, sodium citrate, water for injections.
Croatian: Pomoćne tvari: manitol, natrijev citrat, voda za injekcije.
English: Prevention of skeletal related events in patients with advanced malignancies involving bone: 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.
Croatian: 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.
English: Plastic vial made of clear, colourless cycloolefine copolymer with Type I bromobutyl rubber stopper and sealed with aluminium polypropylene flip-off seal.
Croatian: Plastična bočica izrađena od prozirnog, bezbojnog cikloolefinskog kopolimera s čepom od brombutilne gume tipa
English: Table 6: Proportion of complete responders by day in the combined TIH studies
Croatian: Bili su primijećene sljedeće stope odgovora: Tablica 6: Udio ispitanika s potpunim odgovorom prema danima u kombiniranim ispitivanjima liječenja hiperkalcemije izazvane tumorom
English: Radiation therapy to bone
Croatian: Radioterapija kosti
English: LIST OF EXCIPIENTS Excipients: mannitol, sodium citrate, water for injections.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: manitol, natrijev citrat, voda za injekcije.
English: Package leaflet: Information for the user Zoledronic acid medac 4 mg/100 ml solution for infusion Zoledronic acid
Croatian: Uputa o lijeku: informacija za korisnika Zoledronatna kiselina medac 4 mg/100 ml otopina za infuziju zoledronatna kiselina
English: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoaesthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Croatian: Kao posljedica teške hipokalcemije zabilježene su srčane aritmije i neurološke nuspojave (uključujući konvulzije, hipoesteziju i tetaniju).
English: In patients with mild to moderate renal impairment, reduced Zoledronic acid medac 4 mg/100 ml solution for infusion doses are recommended (see section “Posology” above and section 4.4).
Croatian: Zoledronatne kiseline medac 4 mg/100 ml otopine za infuziju (vidjeti dio “Doziranje” iznad i dio 4.4).
English: Package leaflet: Information for the user Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Croatian: Uputa o lijeku: informacija za korisnika Zoledronatna kiselina medac 4 mg/5 ml koncentrat za otopinu za infuziju zoledronatna kiselina
English: In the clinical studies, patients with serum creatinine > 400 µmol/l or > 4.5 mg/dl were excluded.
Croatian: Bolesnici s vrijednostima kreatinina u serumu većima od 400 μmol/l ili 4,5 mg/dl bili su isključeni iz kliničkih ispitivanja.
English: Table 3: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
Croatian: Tablica 3: Rezultati djelotvornosti (bolesnici s karcinomom prostate koji primaju hormonsku terapiju)
English: Skeletal morbidity rate p-value
Croatian: Stopa koštanog pobola p-vrijednost Smanjenje rizika od višestrukih
English: 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.
Croatian: 60 ml/min, zoledronatna kiselina 4 mg/100 ml otopina za infuziju ne smije se dodatno razrijediti.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2).
English: Table 4: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Croatian: Tablica 4: Rezultati djelotvornosti (solidni tumori osim karcinoma dojke i prostate)
English: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
Croatian: Tablica 2: Rezultati djelotvornosti (bolesnici s karcinomom prostate koji primaju hormonsku terapiju)
English: LABEL ON MULTIPACKS WITH 4 BOTTLES WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
Croatian: NALJEPNICA NA VIŠESTRUKOM PAKIRANJU S 4 BOCE OMOTANOM PROZIRNOM FOLIJOM (UKLJUČUJUĆI PLAVI OKVIR)
English: ≥ 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.
Croatian: S obzirom na mogući utjecaj bisfosfonata, uključujući i zoledronatnu kiselinu, na funkciju bubrega, nedostatak kliničkih podataka o sigurnosti primjene u bolesnika s teškim oštećenjem funkcije bubrega (u kliničkim ispitivanjima definiranim kao kreatinin u serumu ≥ 400 μmol/l ili ≥ 4,5 mg/dl u bolesnika s hiperkalcemijom izazvanom tumorom, odnosno ≥ 265 μmol/l ili ≥ 3,0 mg/dl u bolesnika s rakom i metastazama u kostima) na početku liječenja i ograničene farmakokinetičke podatke u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min) na početku liječenja, ne preporučuje se primjena zoledronatne kiseline u bolesnika s teškim oštećenjem funkcije bubrega.