FrancophonIA/ELRC3.0 huggingface dataset:
English: - Other medicines that also contain zoledronic acid and which are used to treat osteoporosis and other non-cancer diseases of the bone, or any other bisphosphonate, since the combined effects of these medicines taken together with Zoledronic acid Mylan are unknown.
Croatian: - Druge lijekove koji također sadrže zoledronatnu kiselinu i koriste se za liječenje osteoporoze i drugih bolesti kostiju koje nisu uzrokovane rakom ili bilo koji drugi bisfosfonat, budući da kombinirani učinci ovih lijekova kad se uzimaju zajedno sa Zoledronatnom kiselinom Mylan nisu poznati - Antiangiogene lijekove (primjenjuju se za liječenje raka), budući da je kombinacija ovih lijekova sa zoledronatnom kiselinom povezana s povećanim rizikom od osteonekroze čeljusti.
English: 15 ml colourless type I glass vial with a bromobutyl rubber stopper and an aluminium crimp cap with plastic flip-off component.
Croatian: Bezbojna staklena (tip 1) bočica od 15 ml s čepom od brombutilne gume, aluminijskim prstenom i plastičnim "flip-off" zatvaračem.
English: Do not mix Zoledronic acid Mylan concentrate with calcium-containing or other divalent cation-containing solutions such as lactated Ringer's solution.
Croatian: Nemojte miješati koncentrat Zoledronatne kiseline Mylan s otopinama koje sadrže kalcij ili druge dvovalentne katione kao što je otopina Ringerovog laktata.
English: Intravenous use after dilution.
Croatian: Za primjenu u venu nakon razrjeđivanja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica s 5 ml koncentrata sadrži 4 mg zoledronatne kiseline (u obliku hidrata).
English: - To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the concentrate (5 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Croatian: Da biste pripremili otopinu za infuziju koja sadrži 4 mg zoledronatne kiseline, dodatno razrijedite koncentrat (5 ml) sa 100 ml otopine za infuziju koja ne sadrži kalcij niti druge dvovalentne katione.
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: Stopa fibrilacije atrija kao ozbiljnog štetnog događaja bila je 1,3% (51 od 3862) kod bolesnica koje su primale zoledronatnu kiselinu u dozi od 5 mg i 0,6% (22 od 3852) bolesnica koje su primale placebo.
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: 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 Mylan.
Croatian: Tijekom liječenja Zoledronatnom kiselinom Mylan 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.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
English: Rare (may affect up to 1 in 1,000 people): - As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Croatian: Rijetko (može se javiti u do 1 na 1000 osoba): - Kao posljedica niskih razina kalcija: nepravilni otkucaji srca (srčana artimija, uslijed hipokalcemije).
English: After dilution: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C-8°C and at 25°C after dilution in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution (minimal concentration: 3 mg/100 ml; maximal concentration: 4 mg/100 ml).
Croatian: Nakon razrjeđivanja: Kemijska i fizikalna stabilnost u primjeni dokazana je tijekom 48 sati na temperaturi od 2°C do 8°C i na 25°C nakon razrjeđivanja u 100 ml 0,9 %-tne (9 mg/ml) otopine natrijevog klorida za injekciju ili 5% -tne m/V otopine glukoze (minimalna koncentracija: 3 mg/100 ml; maksimalna koncentracija: 4 mg/100 ml).
English: 82.6% (p=0.005)* 88.4% (p=0.002)*
Croatian: (p = 0,002)*
English: 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.
Croatian: Pogoršanje funkcije bubrega, koje napreduje do zatajenja bubrega i dijalize, zabilježeno je u bolesnika nakon početne doze ili jednokratne doze 4 mg zoledronatne kiseline.
English: Pam 90 mg zoledronic acid 4 mg
Croatian: Pamidronat 90 mg zoledronatna kiselina 4 mg
English: Your doctor will carry out blood tests before you start treatment with Zoledronic acid Mylan and will check your response to treatment at regular intervals.
Croatian: Prije nego što počnete primati Zoledronatnu kiselinu Mylan, liječnik će Vam napraviti krvne pretrage i u redovitim vremenskim razmacima provjeravati Vaš odgovor na liječenje.
English: No dose adjustment is necessary in TIH patients with serum creatinine < 400 μmol/l or < 4.5 mg/dl (see section 4.4).
Croatian: Nije potrebna prilagodba doze u bolesnika s hiperkalcemijom izazvanom tumorom i vrijednostima kreatinina u serumu < 400 μmol/l ili < 4,5 mg/dl (vidjeti dio 4.4).
English: - if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic acid Mylan and inform your doctor about your dental treatment.
Croatian: Vaš liječnik može preporučiti pregled kod zubara prije nego počnete liječenje Zoledronatnom kiselinom Mylan. - ako se liječite kod zubara ili trebate ići na zubarski kirurški zahvat, obavijestite svog zubara da se liječite Zoledronatnom kiselinom Mylan i obavijestite svog liječnika o Vašem liječenju kod zubara.
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C-8°C and at 25°C after dilution in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution (minimal concentration: 3 mg/100 ml; maximal concentration: 4 mg/100 ml).
Croatian: - Kemijska i fizikalna stabilnost u primjeni dokazana je tijekom 48 sati na temperaturi od 2°C do 8°C i na 25°C nakon razrjeđivanja u 100 ml otopine natrijevog klorida za injekcije od 9 mg/ml (0,9%) ili 5% -tne m/V otopine glukoze (minimalna koncentracija: 3 mg/100 ml; maksimalna koncentracija: 4 mg/100 ml).
English: Special precautions for disposal and other handling 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 for injection or 5% w/v glucose solution).
Croatian: 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 (otopina natrijevog klorida za injekciju od 9 mg/ml (0,9%) ili 5%-tna m/V otopina glukoze).
English: EU/1/12/786/003
Croatian: EU/1/12/786/003 10 bočica
English: EU/1/12/786/002
Croatian: EU/1/12/786/002 4 bočice
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 5 ml.
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 1 bočica od 5 ml
English: Zoledronic acid Mylan must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Croatian: Zoledronatnu kiselinu Mylan bolesnicima smiju propisivati i primjenjivati samo liječnici s iskustvom u intravenskoj primjeni bisfosfonata.
English: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy)
Croatian: Tablica 2: Rezultati djelotvornosti (bolesnici s karcinomom prostate koji primaju hormonsku terapiju) Bilo koji koštani događaj (+ hiperkalcemija izazvana tumorom)
English: Sodium citrate Sodium hydroxide Hydrochloric acid Water for injections
Croatian: 6.1 Popis pomoćnih tvari natrijev citrat natrijev hidroksid kloridna kiselina voda za injekcije
English: - if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which zoledronic acid belongs), or any of the other ingredients of this medicine (listed in section 6).
Croatian: Zoledronatna kiselina) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Zoledronic acid 4 mg (N=86) 45.3% (p=0.104)
Croatian: Zoledronatna kiselina 4 mg (N = 86)
English: The concentrate is supplied in a clear and colourless glass vial with a rubber stopper and a plastic flip-off cap. One vial contains 5 ml of concentrate.
Croatian: Koncentrat se isporučuje u prozirnoj i bezbojnoj staklenoj bočici sa gumenim čepom i plastičnim "flip-off" zatvaračem.
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: Ovaj lijek ne smije se miješati s kalcijem ili drugim otopinama za infuziju koje sadrže dvovalentne katione kao što je otopina Ringerovog laktata, te se mora primijeniti kao zasebna intravenska otopina putem zasebne infuzijske linije.
English: You must not be given Zoledronic acid Mylan: - if you are breast-feeding.
Croatian: Ne smijete dobiti Zoledronatnu kiselinu Mylan - ako dojite.
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 grčenja mišića, suhe kože, osjećaja pečenja.
English: The withdrawn amount of concentrate must be further diluted in 100 ml of sterile sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Croatian: Izvučenu količinu koncentrata treba dodatno razrijediti u 100 ml sterilne otopine za injekciju 9 mg/ml (0,9%) natrijevog klorida ili 5%-tne m/V otopine glukoze.
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 (može se javiti u do 1 na 10 osoba): - Glavobolja i sindrom sličan gripi koji se sastoji od vrućice, umora, slabosti, omamljenosti,
English: Zoledronic acid Mylan 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.
Croatian: Koncentrat Zoledronatne kiseline Mylan 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 putem zasebnog infuzijskog sustava.
English: - High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation,
Croatian: - Nizak krvni tlak - Bol u prsištu - Kožne reakcije (crvenilo i oticanje) na mjestu primjene infuzije, osip, svrbež - 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 -
English: Warnings and precautions Talk to your doctor before you are given Zoledronic acid Mylan: - if you have or have had a kidney problem.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego primite Zoledronatnu kiselinu Mylan, ako: - imate ili ste imali tegobe s bubrezima - osjećate ili ste osjećali bol, oticanje ili utrnulost čeljusti, težinu u čeljusti ili klimanje zuba.
English: Mean changes from baseline in BPI scores.
Croatian: Srednja vrijednost promjene u BPI od početne vrijednosti
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 > 400 μmol/l ili > 4,5 mg/dl bili su isključeni iz kliničkih ispitivanja.
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 (CLcr).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/001-004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/786/001-004
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING (INCLUDING BLUE BOX) LABEL FOR MULTIPACK OF 4 VIALS (4 PACKS OF 1) WRAPPED IN TRANSPARENT FOIL
Croatian: OZNAKA ZA VIŠESTRUKO PAKIRANJE OD 4 BOČICE (4 PAKIRANJA PO 1 BOČICA) UMOTANO U PROZIRNU FOLIJU
English: Zoledronic acid Mylan contains sodium
Croatian: Zoledronatna kiselina Mylan sadrži natrij
English: - Studies with polyolefin bags (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution), showed no incompatibility with Zoledronic acid Mylan.
Croatian: - Ispitivanja sa poliolefinskim vrećicama (napunjenima otopinom za injekciju natrijevog klorida od 9 mg/ml (0,9%) ili 5% m/V otopinom glukoze) pokazala su da nema inkompatibilnosti sa zoledronatnom kiselinom Mylan.
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 se liječili zoledronatnom kiselinom.
English: How to prepare and administer Zoledronic acid Mylan
Croatian: Kako pripremiti i primijeniti Zoledronatnu kiselinu Mylan
English: In the clinical trials, renal deterioration was defined as follows: - For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 μmol/l), an increase of
Croatian: U kliničkim je ispitivanjima pogoršanje funkcije bubrega bilo definirano na sljedeći način: - povišenje vrijednosti kreatinina za 0,5 mg/dl ili 44 μmol/l, u bolesnika s normalnom početnom vrijednošću kreatinina u serumu (< 1,4 mg/dl ili < 124 μmol/l), - povišenje vrijednosti kreatinina za 1,0 mg/dl ili 88 μmol/l, u bolesnika s poremećenom početnom vrijednošću kreatinina (> 1,4 mg/dl ili > 124 μmol/l).
English: Studies with polyolefin bags (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution), showed no incompatibility with Zoledronic acid Mylan.
Croatian: Ispitivanja s poliolefinskim vrećicama (napunjenima 0,9%-tnom (9 mg/ml ) otopinom natrijevog klorida za injekcije ili 5% -tnom m/V otopinom glukoze) nisu pokazala inkompatibilnosti sa Zoledronatnom kiselinom Mylan.
English: The hydration status of patients must be assessed prior to and following administration of Zoledronic acid Mylan to ensure that they are adequately hydrated.
Croatian: Prije i poslije primjene Zoledronatne kiseline Mylan mora se provjeriti status hidracije bolesnika kako bi se osiguralo da su primjereno hidrirani.
English: Proportion of patients with SREs (%) p-value
Croatian: Udio bolesnika s koštanim događajem (%) p-vrijednost Medijan vremena do koštanog događaja (dani)
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 Mylan or after stopping treatment.
Croatian: Odmah obavijestite svog liječnika ako za vrijeme liječenja Zometom ili nakon prestanka liječenja dobijete simptome kao što su novonastali ili pogoršani bolovi ili ukočenost.
English: You must not be given Zoledronic acid Mylan if you are breast-feeding.
Croatian: Ne smijete dobivati Zoledronatnu kiselinu Mylan ako dojite.
English: To avoid potential incompatibilities, Zoledronic acid Mylan concentrate is to be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Croatian: Kako bi se izbjegle potencijalne inkompatibilnosti, koncentrat Zoledronatne kiseline Mylan mora se razrijediti 0,9 %-tnom (9 mg/ml) otopinom natrijevog klorida za injekcije ili 5% -tnom m/V otopinom glukoze.
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 neurološki štetni događaji (koji uključuju konvulzije, hipoesteziju i tetaniju).
English: Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Croatian: Zoledronatna kiselina Mylan 4 mg/5 ml koncentrat za otopinu za infuziju zoledronatna kiselina
English: Hypocalcaemia
Croatian: hipokalcemija
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 m/V otopina glukoze.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/786/001 1 bočica
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients)
Croatian: Tablica 4: Rezultati djelotvornosti (u bolesnika s karcinomom dojke i multiplim mijelomom) Bilo koji koštani događaj (+ hiperkalcemija izazvana tumorom)
English: The following properties have been demonstrated in preclinical studies: - 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 - In vitro: Inhibicija proliferacije osteoblasta, izravno citostatsko i proapoptotsko djelovanje na tumorske stanice, sinergistički citostatski učinak s drugim antitumorskim lijekovima,
English: Contraindications
Croatian: 4.3 Kontraindikacije
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg zoledronic acid (as monohydrate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 4 mg zoledronatne kiseline (u obliku hidrata).
English: In clinical trials with zoledronic acid, patients with serum creatinine > 265 μmol/l or > 3.0 mg/dl were excluded.
Croatian: Bolesnici s vrijednošću kreatinina u serumu > 265 μmol/l ili > 3,0 mg/dl bili su isključeni iz kliničkih ispitivanja sa zoledronatnom kiselinom.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Zoledronatna kiselina Mylan 4 mg/5 ml koncentrat za otopinu za infuziju zoledronatna kiselina
English: 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.
Croatian: Ova nuspojava sastoji se od skupine simptoma koja uključuje vrućicu, mialgiju, glavobolju, bol u ekstremitetima, mučninu, povraćanje, proljev, artralgiju i artritis s posljedičnim oticanjem zglobova Vrijeme nastupa je ≤ 3 dana nakon infuzije zoledronatne kiseline, a reakcija se još zove “sindrom nalik gripi” ili simptomi “nakon doziranja”.
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion
Croatian: NAZIV LIJEKA Zoledronatna kiselina Mylan 4 mg/5 ml koncentrat za otopinu za infuziju
English: How to store Zoledronic acid Mylan
Croatian: Kako primjenjivati Zoledronatnu kiselinu Mylan
English: - Do not use Zoledronic acid Mylan after the expiry date stated on the vial and carton after EXP. - The unopened vial does not require any specific storage conditions.
Croatian: - Zoledronatna kiselina Mylan se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake„Rok valjanosti“.
English: How Zoledronic acid Mylan is used
Croatian: Koliko se Zoledronatne kiseline Mylan daje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING (WITHOUT BLUE BOX) BOX OF 1 VIAL AS PART OF A MULTIPACK COMPRISING 4 VIALS
Croatian: KUTIJA S 1 BOČICOM KAO DIO VIŠESTRUKOG PAKIRANJA KOJE SADRŽI 4 BOČICE
English: 1 vial of 5 ml 4 vials of 5 ml 10 vials of 5 ml
Croatian: 4 bočice od 5 ml
English: - Sudden coldness with fainting, limpness or collapse.
Croatian: - Iznenadan osjećaj hladnoće s nesvjesticom, posrtanjem ili kolapsom - Otežano disanje uz piskanje u plućima ili kašljanje - Koprivnjača.
English: How much Zoledronic acid Mylan is given - The usual single dose given is 4 mg zoledronic acid.
Croatian: - Obično se daje jednokratna doza od 4 mg Zoledronatne kiseline.
English: Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe hypocalcaemia.
Croatian: Kao posljedica teške hipokalcemije zabilježeni su nepravilni srčani otkucaji (srčane aritmije), napadaji, grčevi i trzaji (tetanija).
English: Hypocalcaemia has been reported in patients treated with zoledronic acid.
Croatian: U bolesnika liječenih zoledronatnom kiselinom zabilježeni su slučajevi hipokalcemije.
English: In most cases no specific treatment is required and the symptoms disappear after a short time (couple of hours or days).
Croatian: zimice i bolova u kostima, zglobovima i/ili mišićima; u većini slučajeva nije potrebno posebno liječenje, i simptomi nestaju nakon kratkog vremena (nekoliko sati ili dana) - Reakcije probavnog sustava, kao što su mučnina i povraćanje, kao i gubitak apetita - Konjunktivitis - Smanjeni broj crvenih krvnih stanica (anemija).
English: You should not be given Zoledronic acid Mylan if you are pregnant.
Croatian: Ako ste trudni, ne smijete primati Zoledronatnu kiselinu Mylan.
English: What Zoledronic acid Mylan contains - The active substance is zoledronic acid.
Croatian: - Djelatna tvar je zoledronatna kiselina.
English: Blister (OPA/Alu /PVC-Alu) 10 x 1 tablets (unit dose)
Croatian: Blister (OPA/Alu /PVCAlu)
English: Oral use
Croatian: Jačina
English: No data are currently available for ages younger than 2 years.
Croatian: Trenutno nema podataka za djecu mlađu od 2 godine.
English: The temperature must not exceed 37°C.
Croatian: Temperatura ne smije premašiti 37°C.
English: The frequency of the type of event is not known (cannot be estimated from available data).
Croatian: Učestalost ove vrste događaja nije poznata (ne može se procijeniti iz dostupnih podataka).
English: Of these, 2 were children aged 2 and 5 years and 2 were adolescents of 16 years.
Croatian: Od njih su dva bolesnika bila u dobi od 2 i 5 godina, a dva su bili adolescenti od 16 godina.
English: Component 1
Croatian: Komponenta 1
English: Jerusalem 9777605, Israel
Croatian: Jerusalem 9777605, Izrael
English: However, for some procedures (e.g., liver traumata) larger volumes may be required.
Croatian: Međutim, za neke postupke (primjerice kod traume jetre) mogu biti potrebni veći volumeni.