FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to administration, 5.0 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose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: Prije primjene, 5,0 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: Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone.
Croatian: Zoledronatna kiselina pripada skupini bisfosfonata koji sadrže dušik i djeluje prvenstveno na kost.
English: After dilution: From a microbiological point of view, the diluted solution for infusion should be used immediately.
Croatian: Nakon razrjeđivanja: s mikrobiološkog stajališta, razrijeđenu otopinu za infuziju treba odmah primijeniti.
English: Zoledronic acid must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Croatian: Zoledronatnu kiselinu Hospira bolesnicima smiju propisivati i primjenjivati samo zdravstveni radnici s iskustvom u intravenskoj primjeni bisfosfonata.
English: This resulted in exaggerated pharmacological effects considered to be related to the compound's inhibition of skeletal calcium metabolisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
Croatian: Rezultati su pokazali pojačane farmakološke učinke za koje se smatra da su povezani s inhibicijom metabolizma kalcija u kostima koju ta tvar izaziva s posljedičnom hipokalcemijom u vrijeme parturicije, što je učinak svojstven skupini bisfosfonata, s distocijom i ranim prekidom ispitivanja.
English: Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic Acid Hospira.
Croatian: Vaš liječnik bi trebao napraviti pretrage krvi radi provjere bubrežne funkcije (razine kreatinina) prije svake doze Zoledronatne kiseline Hospira.
English: In the HORIZON - Pivotal Fracture Trial [PFT] (see section 5.1), 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 and placebo, respectively.
Croatian: U HORIZON-Pivotal Fracture Trial [PFT] ispitivanju (vidjeti dio 5.1) ukupna incidencija atrijske fibrilacije iznosila je 2,5% (96 od 3862) i 1,9% (75 od 3852) u bolesnika koji su primali zoledronatnu kiselinu, odnosno placebo.
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 u bolesnika s klirensom kreatinina od 20 ml/min (teško oštećenje bubrega) bio 37%, odnosno u bolesnika s klirensom kreatinina od 50 ml/min (umjereno oštećenje) 72% onoga kakav postoji u bolesnika s klirensom kreatinina od 84 ml/min.
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 (see section 4.4).
Croatian: Propadanje funkcije bubrega koje napreduje do zatajenja bubrega i dijalize, prijavljeno je u bolesnika i nakon početne jednokratne doze zoledronatne kiseline od 4 mg (vidjeti dio 4.4).
English: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, Interstitial lung disease.
Croatian: oštećenje bubrega, osteonekroza čeljusti, reakcija akutne faze, hipokalcijemija, fibrilacija atrija, anafilaksija, intersticijska bolest pluća.
English: Uncommon: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Croatian: omaglica, parestezija, disgeuzija, hipoestezija, hiperestezija, tremor, somnolencija vrlo rijetko:
English: Flu, upper respiratory tract infections, decreased red cell count, loss of appetite, sleeplessness, sleepiness which may include reduced alertness and awareness, tingling sensation or numbness, extreme tiredness, trembling, temporary loss of consciousness, eye infection or irritation or inflammation with pain and redness, spinning sensation, increased blood pressure, flushing, cough, shortness of breath, upset stomach, abdominal pain, constipation, dry mouth, heartburn, skin rash, excessive sweating, itching, skin reddening, neck pain, stiffness in muscles, bones and/or joints, joint swelling, muscle spasms, shoulder pain, pain in your chest muscles and rib cage, joint inflammation, muscular weakness, abnormal kidney test results, abnormal frequent urination, swelling of hands, ankles or feet, thirst, toothache, taste disturbances.
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba): gripa, infekcije gornjih dišnih puteva, snžen broj crvenih krvnih stanica, gubitak apetita, nesanica, pospanost koja može uključivati smanjenu pažnju i svijest, trnci ili ukočenost, krajnji umor, drhtanje, privremeni gubitak svijesti, infekcije oka ili iritacija ili upala uz bol i crvenilo, osjećaj vrtnje, povišeni krvni tlak, navale vrućine, kašalj, nedostatak zraka, nelagoda u trbuhu, bol u trbuhu, zatvor, suhoća usta, žgaravica, kožni osip, pojačano znojenje, svrbež, crvenilo kože, bol u vratu, krutost mišića, kostiju i/ili zglobova, oticanje zgloba, grčevi mišića, bol u ramenu, bol u Vašim prsnim mišićima i rebrima, upala zgloba, mišićna slabost, odstupanja u rezultatima bubrežnih testova, neuobičajeno često mokrenje, oticanje dlanova, gležnjeva ili stopala, žeđ, zubobolja, poremećaji okusa.
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving zoledronic acid for osteoporosis.
Croatian: Nuspojava koja se zove osteonekroza čeljusti (ONČ) (oštećenje čeljusne kosti) zabilježena je nakon stavljanja lijek u promet u bolesnika koji su primali zoledronatnu kiselinu za osteoporozu.
English: Adequate calcium and vitamin D intake are recommended in association with zoledronic acid administration.
Croatian: Preporuča se adekvatan unos kalcija i vitamina D s primjenom zoledronatne kiseline.
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic Acid Hospira or after stopping treatment.
Croatian: Obavijestite svog liječnika i stomatologa odmah ako imate takve simptome tijekom ili nakon liječenja Zoledronatnom kiselinom Hospira.
English: How Zoledronic Acid Hospira is given - Zoledronic Acid Hospira 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: Kako se daje Zoledronatna kiselina Hospira - Zoledronatna kiselina Hospira se daje u venu kao infuzija u trajanju od najmanje 15 minuta i mora se primijeniti kao jednokratna intravenska otopina kroz zasebnu infuzijsku liniju.
English: Patients should have their serum creatinine levels assessed prior to each dose of zoledronic acid.
Croatian: Bolesnicima treba provjeriti razinu kreatinina u serumu prije primjene svake doze zoledronatne kiseline.
English: For storage conditions of the diluted solution for infusion, see section 6.3.
Croatian: Uvjete čuvanja razrijeđene otopine za infuziju vidjeti u dijelu 6.3.
English: The interpatient variability in pharmacokinetic parameters for zoledronic acid was high, as seen with other bisphosphonates.
Croatian: Farmakokinetički parametri zoledronatne kiseline, viđenih i kod drugih bisfosfonata, uvelike se razlikuju između pojedinih bolesnika.
English: Table 1: Preparation of reduced doses of Zoledronic Acid Hospira 4 mg/100 ml solution for infusion
Croatian: Tablica 1: Priprema sniženih doza Zoledronatne kiseline Hospira 4 mg/100 ml otopine za infuziju
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 jednom randomiziranom, dvostruko slijepom, kontroliranom ispitivanju u trajanju od 3 godine u kojem se ocjenjivala djelotvornost i sigurnost zoledronatne kiseline u dozi od 5 mg jednom godišnje naspram placeba u liječenju osteoporoze u postmenopauzi, ukupna incidencija fibrilacije atrija bila je 2,5% (96 od 3862) u bolesnica koje su primale zoledronatnu kiselinu u dozi od 5 mg, odnosno 1,9% (75 od 3852) u onih koje su primale placebo.
English: Zoledronic Acid Hospira is not recommended for use in adolescents and children below the age of 18 years.
Croatian: Ne preporučuje se primjena Zoledronatne kiseline Hospira u adolescenata i djece mlađe od 18 godina.
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 ( 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
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: Osteonecrosis of the jaw 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: Aseptic techniques must be followed during preparation of the infusion.
Croatian: Tijekom pripreme infuzije moraju se koristiti aseptičke tehnike.
English: − The bag does not require any specific storage conditions.
Croatian: - Vrećica ne zahtijeva posebne uvjete čuvanja.
English: Skeletal morbidity rate p-value
Croatian: p-vrijednost stopa koštanog pobola
English: Zoledronic acid is not recommended in women of childbearing potential.
Croatian: Zoledronatna kiselina se ne proporučuje ženama u reproduktivnoj dobi.
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, non-healing of sores or discharge during treatment with zoledronic acid.
Croatian: Tijekom liječenja zoledronatnom kiselinom 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: 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 bubrega zoledronatnom kiselinom dolazi u obzir tek nakon procjene rizika i koristi od liječenja.
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) naspram placeba.
English: Uncommon (may affect up to 1 in 100 people):− 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.
Croatian: Manje često (može se javiti u do 1 na 100 osoba): - bol u ustima, zubima i/ili čeljusti, oticanje ili ranice u ustima ili čeljusti koje ne cijele, iscjedak, utrnulost ili osjećaj težine u čeljusti, klimanje zuba.
English: - Do not use this medicine after the expiry date which is stated on the carton.
Croatian: - Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji.
English: Your doctor may ask you to undergo a dental examination before you start treatment with Zoledronic Acid Hospira.
Croatian: Vaš liječnik Vas može zatražiti da napravite detaljan pregled zuba prije početka liječenja Zoledronatnom kiselinom Hospira.
English: 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.
Croatian: Trenutno nije jasno uzrokuje li zoledronatna kiselina taj nepravilan srčani ritam, no ako osjetite takve simptome nakon što ste primili zoledronatnu kiselinu, morate to prijaviti liječniku.
English: − Zoledronic Acid Hospira must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein (also referred to as ‘IV' administration).
Croatian: - Zoledronatnu kiselinu Hospira smije davati samo zdravstveni radnici iskusni u primjeni bisfosfonata intravenskim putem, tj. u venu (također poznato i kao i.v. primjena).
English: In patients with mild to moderate renal impairment, reduced Zoledronic Acid Hospira doses are recommended (see section “Posology” above and section 4.4).
Croatian: U bolesnika s blagim do umjerenim oštećenjem bubrega preporučuju se snižene doze Zoledronatne kiseline Hospira (vidjeti dio “Doziranje” gore i dio 4.4).
English: Zoledronic acid is eliminated by renal excretion.
Croatian: Zoledronatna kiselina se eliminira izlučivanjem putem bubrega.
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), rare ( 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
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: There was no accumulation of the active substance in plasma after multiple doses given every 28 days.
Croatian: Nakon primjene višestrukih doza svakih 28 dana nije došlo do akumulacije djelatne tvari u plazmi.
English: Very rare Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Croatian: osteonekroza vanjskog slušnog kanala (nuspojava razreda bisfosfonata) i drugih anatomskih mjesta uključujući bedrenu kost i kuk
English: − Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Croatian: Često (može se javiti u do 1 na 10 osoba): - teško oštećenje bubrega (obično će ga utvrditi liječnik pomoću određenih specifičnih krvnih pretraga).
English: 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.
Croatian: Bubrežni klirens zoledronatne kiseline uspoređen je s klirensom kreatinina, s time da je bubrežni klirens predstavljao 75 ± 33% klirensa kreatinina što je pokazalo srednju vrijednost od 84 ± 29 ml/min (raspon od 22 do 143 ml/min) u 64 ispitivana bolesnika.
English: To avoid potential incompatibilities, Zoledronic Acid Hospira 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, Zoledronatna kiselina Hospira se mora razrijediti s otopinom za injekciju natrijevog klorida od 9 mg/ml (0,9%) ili 5% m/V otopinom glukoze.
English: It also contains mannitol, sodium citrate, water for injections and sodium chloride.
Croatian: Također sadrži manitol, natrijev citrat, vodu za injekcije i natrijev klorid.
English: How to prepare and administer Zoledronic Acid Hospira
Croatian: Kako pripremiti i primijeniti Zoledronatnu kiselinu Hospira
English: Before stopping Zoledronic Acid Hospira therapy If you are considering stopping Zoledronic Acid Hospira treatment, please go to your next appointment and discuss this with your doctor.
Croatian: Ako razmišljate o prekidu liječenja Zoledronatnom kiselinom Hospira, molimo da dođete na sljedeći termin i raspravite odluku s Vašim liječnikom.
English: In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
Croatian: U bolesnika s blagim do umjerenim oštećenjem bubrega preporučuju se snižene doze zoledronatne kiseline (vidjeti dio “Doziranje” gore i dio 4.4).
English: The rate of atrial fibrillation serious adverse events was increased in patients receiving zoledronic acid (1.3%) (51 out of 3,862) compared with patients receiving placebo (0.6%) (22 out of 3,852).
Croatian: Stopa ozbiljnih štetnih događaja fibrilacije atrija bila je veća u bolesnika koji su primali zoledronatnu kiselinu (1,3%) (51 od 3862), naspram bolesnika koji su primali placebo (0,6%) (22 od 3852).
English: Mannitol, sodium citrate and water for injections.
Croatian: manitol, natrijev citrat i voda za injekcije.
English: Fewer zoledronic acid 4 mg patients suffered pathological fractures.
Croatian: Manji broj bolesnika koji su primali zoledronatnu kiselinu u dozi od 4 mg imao je patološke prijelome.
English: Zoledronic Acid Hospira must not be mixed or given intravenously with any other medicinal product and must be given through a separate infusion line at a constant infusion rate.
Croatian: Zoledronatna kiselina Hospira ne smije se miješati ili dati intravenski s drugim lijekovima te se mora primijeniti putem zasebne infuzijske linije s uz konstantnu brzinu infuzije.
English: Patients were evenly distributed between zoledronic acid -treated and placebo groups.
Croatian: Bolesnici su bili podjednako raspodijeljeni u skupinu koja je primala zoledronatnu kiselinu i skupinu koja je primala placebo.
English: 4 CLINICAL PARTICULARS
Croatian: KLINIČKI PODACI
English: † Identified in post-marketing experience.
Croatian: † Primijećeno nakon stavljanja lijeka u promet.
English: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
Croatian: Uz terapiju bisfosfonatima prijavljeni su atipični suptrohanterni i dijafizni prijelomi bedrene kosti, prvenstveno u bolesnika koji su dugotrajno bili liječeni zbog osteoporoze.
English: Frequency categories are defined using the following convention: very common ( 1/10); common ( 1/100 to <1/10); uncommon ( 1/1,000 to <1/100); rare ( 1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti su definirane prema sljedećoj konvenciji: 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: Zoledronic Acid Hospira is contraindicated during pregnancy (see section 4.3).
Croatian: Zoledronatna kiselina Hospira je kontraindicirana tijekom dojenja (vidjeti dio 4.3).
English: Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for the treatment of postmenopausal osteoporosis.
Croatian: Nepravilan srčani ritam (fibrilacija atrija) primijećen je u bolesnika koji su primali zoledronatnu kiselinu zbog liječenja osteoporoze u postmenopauzi.
English: Zoledronic Acid Hospira contains sodium
Croatian: Zoledronatna kiselina Hospira sadrži natrij
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 0,9%-tne otopine za injekciju natrijevog klorida ili 5%-tne otopine glukoze.
English: Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Hospira and will check your response to treatment at regular intervals.
Croatian: Prije nego što počnete liječenje Zoledronatnom kiselinom Hospira, liječnik će Vam napraviti krvne pretrage i u redovitim vremenskim razmacima provjeravati Vaš odgovor na liječenje.
English: Headache, dizziness, sickness, vomiting, diarrhoea, pain in the muscles, pain in the bones and/or joints, pain in the back, arms or legs, flu-like symptoms (e.g. tiredness, chills, joint and muscle pain), chills, feeling of tiredness and lack of interest, weakness, pain, feeling unwell, swelling and/or pain at the infusion site.
Croatian: Često (mogu se javiti u do 1 na 10 osoba): glavobolja, omaglica, mučnina, povraćanje, proljev, bol u mišićima, bol u kostima i/ili zglobovima, bol u leđima, rukama ili nogama, simptomi nalik gripi (npr. umor, zimica, bol u zglobovima ili mišićma), zimica, osjećaj umora, gubitak interesa, slabost, bol, loše osjećanje, oticanje i/ili bol na mjestu infuzije.
English: Table 5: Proportion of complete responders by day in the combined TIH studies Day 4
Croatian: Tablica 5: Udio ispitanika s potpunim odgovorom prema danima u kombiniranim ispitivanjima liječenja hiperkalcijemije izazvane tumorom
English: Patients being treated with Zoledronic Acid Hospira should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Croatian: Bolesnici koji se liječe Zoledronatnom kiselinom Hospira ne smiju se liječiti sličnim lijekovima ili drugim bisfosfonatima istodobno, budući da kombinirani učinci tih lijekova nisu poznati.
English: What Zoledronic Acid Hospira 5 mg/100 ml solution for infusion contains - The active substance is zoledronic acid.
Croatian: Što Zoledronatna kiselina Hospira 5 mg/100 ml otopina za infuziju sadrži - Djelatna tvar je zoledronatna kiselina.
English: Clinical trial results in the prevention of skeletal related events in patients with advanced malignancies involving bone
Croatian: Rezultati kliničkih ispitivanja u prevenciji koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kost
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: The adverse reactions ranked under headings of frequency, are presented in Table 7.
Croatian: Nuspojave navedene prema učestalosti prikazane su u tablici 7.
English: Zoledronic Acid Hospira must not be mixed with other infusion solutions and should be administered as a single intravenous solution in a separate infusion line.
Croatian: Zoledronatna kiselina Hospira ne smije se miješati s drugim otopinama za infuziju i treba se primijeniti kao jednokratna intravenska otopina kroz posebnu infuzijsku liniju.
English: Table 6: Proportion of complete responders by day in the combined TIH studies Day 4
Croatian: Tablica 6: Udio ispitanika s potpunim odgovorom prema danima u kombiniranim ispitivanjima liječenja hiperkalcijemije izazvane tumorom
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as zoledronic acid (see section 4.4).
Croatian: Slučajevi osteonekroze čeljusti su prijavljeni, uglavnom u onkoloških bolesnika liječenih lijekovima koji inhibiraju resorpciju kosti, kao što je zoledronatna kiselina (vidjeti dio 4.4).