FrancophonIA/ELRC3.0 huggingface dataset:
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: U bolesnika s normalnom funkcijom bubrega, koja se definira kao klirens kreatinina veći od 60 ml/min, zoledronatna kiselina 4 mg/100 ml otopina za infuziju ne smije se dodatno razrijediti.
English: After first opening, Zometa solution for infusion should preferably be used immediately.
Croatian: Nakon prvog otvaranja, Zometa otopinu za infuziju trebalo bi po mogućnosti odmah upotrijebiti.
English: The administration of doses up to 48 mg of zoledronic acid in error has been reported.
Croatian: Zabilježena je primjena doza zoledronatne kiseline do 48 mg zbog pogreške.
English: Zometa is contraindicated in breast-feeding women (see section 4.3).
Croatian: Zometa je kontraindicirana tijekom dojenja (vidjeti dio 4.3).
English: One vial with 5 ml concentrate for solution for infusion Four vials with 5 ml concentrate for solution for infusion
Croatian: Jedna bočica s 5 ml koncentrata za otopinu za infuziju Četiri bočice s 5 ml koncentrata za otopinu za infuziju
English: The results demonstrated that zoledronic acid 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Croatian: Rezultati su pokazali podjednaku djelotvornost zoledronatne kiseline u dozi od 4 mg i 90 mg pamidronata u sprječavanju koštanih događaja.
English: Patients treated with Zometa should be given the package leaflet and the patient reminder card.
Croatian: Bolesnicima koji se liječe Zometom potrebno je dati Uputu o lijeku i karticupodsjetnik za bolesnika.
English: From a microbiological point of view, the solution for infusion should be used immediately, after first opening.
Croatian: S mikrobiološkog stajališta, otopina za infuziju se nakon prvog otvaranja treba primijeniti odmah.
English: In a second study including solid tumours other than breast or prostate cancer, zoledronic acid 4 mg significantly reduced the proportion of patients with an SRE, delayed the median time to first SRE by > 2 months, and reduced the skeletal morbidity rate.
Croatian: U drugom ispitivanju u bolesnika sa solidnim tumorima, izuzev tumora dojke i prostate, zoledronatna kiselina u dozi od 4 mg značajno je smanjila udio bolesnika s koštanim događajima, produljila medijan vremena do prvog koštanog događaja za više od 2 mjeseca i smanjila stopu koštanog pobola.
English: Zometa must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Croatian: Zometu bolesnicima smiju propisivati i primjenjivati samo liječnici s iskustvom u intravenskoj primjeni bisfosfonata.
English: The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Croatian: Otopina koja sadrži zoledronatnu kiselinu primjenjuje se kao jednokratna intravenska infuzija u trajanju od 15 minuta putem zasebne infuzijske linije.
English: To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table 1 below.
Croatian: Da biste pripremili snižene doze za bolesnike s početnim klirensom kreatinina ≤60 ml/min, poslužite se tablicom 1 niže.
English: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoaesthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Croatian: Zabilježene su srčane aritmije i neurološki štetni događaji (koji uključuju konvulzije, hipoesteziju i tetaniju) kao posljedica teške hipokalcemije.
English: How to store Zometa
Croatian: Kako čuvati Zometu
English: One ampoule of solvent 5 ml Four vials 4 mg Four ampoules of solvent 5 ml
Croatian: Jedna bočica s 4 mg Jedna ampula s 5 ml otapala Četiri bočice s 4 mg Četiri ampule s 5 ml otapala
English: Patients must be assessed prior to administration of Zometa to ensure that they are adequately hydrated.
Croatian: Bolesnici moraju biti pregledani prije primjene Zomete kako bi se potvrdilo da su ogovarajuće hidrirani.
English: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
Croatian: Vrućica, gripi nalik sindrom (uključujući umor, tresavicu, malaksalost i crvenilo uz osjećaj vrućine)
English: After reconstitution and dilution: From a microbiological point of view, the reconstituted and diluted solution for infusion should be used immediately.
Croatian: Nakon rekonstitucije i razrjeđivanja: S mikrobiološkog stajališta, rekonstituirana i razrijeđena otopina za infuziju treba se primijeniti odmah.
English: Zometa is supplied as unit packs containing 1 or 4 vials and 1 or 4 ampoules, respectively, and as multi-packs containing 10 (10x 1+1) vials and ampoules.
Croatian: Zometa se isporučuje u jediničnim pakiranjima koja sadrže 1 ili 4 bočice i 1 ili 4 ampule i u višestrukim pakiranjima koja sadrže 10 (10x 1+1) bočica i ampula.
English: Table 2 Efficacy results (prostate cancer patients receiving hormonal therapy)
Croatian: Tablica 2 Rezultati djelotvornosti (bolesnici s karcinomom prostate koji primaju hormonsku terapiju)
English: Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zometa 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: 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: You must not be given Zometa if you are breast-feeding.
Croatian: Ne smijete dobivati Zometu ako dojite.
English: The interpatient variability in pharmacokinetic parameters for zoledronic acid was high, as seen with other bisphosphonates.
Croatian: Farmakokinetički parametri zoledronatne kiseline, kao i drugih bisfosfonata, uvelike se razlikuju između pojedinih bolesnika.
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.
English: Table 3 Efficacy results (prostate cancer patients receiving hormonal therapy)
Croatian: Tablica 3 Rezultati djelotvornosti (bolesnici s karcinomom prostate koji primaju hormonsku terapiju)
English: How often Zometa is given - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zometa every three to four weeks.
Croatian: - Ako se liječite radi sprječavanja koštanih komplikacija izazvanih metastazama, dobivat ćete jednu infuziju Zomete svaka tri do četiri tjedna.
English: Hypophosphataemia
Croatian: Hipofosfatemija
English: What Zometa looks like and contents of the pack Zometa is supplied as a powder in a vial.
Croatian: Kako Zometa izgleda i sadržaj pakiranja Zometa se isporučuje u obliku praška u bočici.
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, reduced Zometa doses are recommended (see also section 4.4).
Croatian: U bolesnika s metastazama u kostima koji prije početka liječenja imaju blago do umjereno oštećenje funkcije bubrega, definirano u ove populacije kao klirens kreatinina od 30 do 60 ml/min, preporučuje se smanjena doza Zomete (vidjeti također dio 4.4).
English: Placebo zoledronic acid 4 mg
Croatian: Placebo zoledronatna kiselina 4 mg
English: White to off-white powder and clear, colourless solvent.
Croatian: Prašak i otapalo za otopinu za infuziju Bijeli do bjelkasti prašak i bistro, bezbojno otapalo.
English: The other ingredients are mannitol, sodium citrate.
Croatian: Drugi sastojci su manitol, natrijev citrat.
English: As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Croatian: Kao posljedica niskih razina kalcija: napadaji, utrnulost i tetanija (uslijed hipokalcemije).
English: One vial contains 4 mg of zoledronic acid.
Croatian: Jedna bočica sadrži 4 mg zoledronatne kiseline.
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 zabilježeni su atipični suptrohanterni prijelomi i prijelomi dijafize bedrene kosti, prvenstveno u bolesnika koji su dugotrajno uzimali terapiju zbog osteoporoze.
English: Pancytopenia
Croatian: Pancitopenija
English: Powder and solvent for solution for infusion
Croatian: Prašak i otapalo za otopinu za infuziju
English: It also contains mannitol, sodium citrate and water for injections.
Croatian: Također sadrži manitol, natrijev citrat i vodu za injekcije.
English: This condition is known as tumour-induced hypercalcaemia (TIH).
Croatian: To se stanje zove hiperkalcemija izazvana tumorom.
English: FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS INTERMEDIATE PACK (WITHOUT BLUE BOX)
Croatian: KUTIJA ZA 1 BOČICU I 1 AMPULU KAO MEĐUPAKIRANJE (BEZ PLAVOG OKVIRA)
English: Zometa is supplied as unit packs containing 1 or 4 vials and as multi-packs containing 10 (10x1) vials.
Croatian: Zometa se isporučuje u jediničnim pakiranjima koja sadrže 1 ili 4 bočice i u višestrukim pakiranjima koja sadrže 10 (10x1) bočica.
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 zoledronatne kiseline.
English: What Zometa looks like and contents of the pack Zometa is supplied as a liquid concentrate in a vial.
Croatian: Kako Zometa izgleda i sadržaj pakiranja Zometa se isporučuje kao tekući koncentrat u bočici.
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 (0.9% w/v sodium chloride solution or 5% w/v glucose solution).
Croatian: Prije primjene, 5,0 ml koncentrata iz jedne bočice ili izvučen potrebni volumen koncentrata mora se dodatno razrijediti sa 100 ml infuzijske otopine koja ne sadrži kalcij (0,9% m/V otopina natrijevog klorida ili 5% m/V otopina glukoze).
English: Table 3 Efficacy results (solid tumours other than breast or prostate cancer)
Croatian: Tablica 3 Rezultati djelotvornosti (solidni tumori osim karcinoma dojke i prostate)
English: Table 4 Efficacy results (solid tumours other than breast or prostate cancer)
Croatian: Tablica 4 Rezultati djelotvornosti (solidni tumori osim karcinoma dojke i prostate)
English: Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with Zometa 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 Zometom 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: Tell your doctor if you are or think that you may be pregnant.
Croatian: Ako ste trudni ili mislite da biste mogli biti trudni, obavijestite svog liječnika.
English: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zometa therapy.
Croatian: Nakon početka terapije Zometom potrebno je pažljivo pratiti standardne metaboličke parametre hiperkalcemije, kao što su razine kalcija, fosfata i magnezija u serumu.
English: Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe hypocalcaemia.
Croatian: Nepravilni otkucaji srca (srčana aritmija), napadaji, grčevi i trzanje mišića (tetanija) zabilježeni su kao posljedice teške hipokalcemije.
English: Multi-packs containing 10 (10 packs of 1) vials.
Croatian: Višestruka pakiranja sadrže 10 (10 pakiranja po 1) bočica.
English: For instructions on the dilution of the medicinal product before administration, see section 6.6.
Croatian: Za upute o razrjeđivanju lijeka prije primjene vidjeti dio 6.6.
English: Very rare (may affect up to 1 in 10,000 people):
Croatian: Vrlo rijetko (može se javiti u do 1 na 10 000 osoba):
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: One ampoule of solvent 5 ml
Croatian: Jedna ampula s 5 ml otapala
English: Hypocalcaemia-related ADRs
Croatian: Nuspojave povezane s hipokalcemijom
English: Fewer zoledronic acid 4 mg patients suffered pathological fractures.
Croatian: Manji je broj bolesnika koji su primali zoledronatnu kiselinu u dozi od 4 mg imao patološke prijelome.
English: Unit packs containing 1 or 4 vials.
Croatian: Jedinična pakiranja sadrže 1 ili 4 bočice.
English: Immune system disorders Uncommon:
Croatian: Poremećaji imunološkog sustava Manje često:
English: Multipack comprising ten packs, each containing one vial and one ampoule of solvent 5 ml.
Croatian: Višestruko pakiranje koje se sastoji od deset pakiranja, od kojih svako sadrži po jednu bočicu i jednu ampulu s 5 ml otapala.
English: NR NR 424
Croatian: ND 714
English: Zometa 4 mg/5 ml concentrate for solution for infusion
Croatian: Zometa 4 mg/5 ml koncentrat za otopinu za infuziju
English: After first opening: From a microbiological point of view, the solution for infusion should be used immediately.
Croatian: Nakon prvog otvaranja: S mikrobiološkog stajališta, otopinu za infuziju treba odmah primijeniti.
English: Fractures*
Croatian: Prijelomi*
English: One vial 4 mg
Croatian: Jedna bočica s 4 mg
English: Zoledronic acid 8 mg (N=90) 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)* Pamidronate 90 mg (N=99) 33.3% *p-values compared to pamidronate.
Croatian: 55,6% (p=0,021)* 83,3% (p=0,010)* 86,7% (p=0,015)*
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 čimbenicima rizika, preporučuje se stomatološki pregled uz obavljanje odgovarajućih preventivnih stomatoloških zahvata i individualna procjena koristi i rizika.
English: - History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures
Croatian: - Bolest zubiju u anamnezi, lošu oralnu higijenu, periodontalnu bolest, invazivne zahvate na zubima (npr. vađenje zuba) i zubnu protezu koja loše prijanja.
English: One vial with 5 ml concentrate for solution for infusion.
Croatian: Jedna bočica s 5 ml koncentrata za otopinu za infuziju.
English: NA Not Applicable
Croatian: NP Nije primjenjivo
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: What Zometa looks like and contents of the pack Zometa is supplied as a solution in a clear, colourless plastic bottle.
Croatian: Zometa se isporučuje u obliku otopine u prozirnoj, bezbojnoj plastičnoj boci.
English: Additional risk minimisation measures The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Croatian: Nositelj odobrenja mora osigurati uvođenje kartice-podsjetnika za bolesnika u svezi osteonekroze čeljusti.
English: Further dilute the Zometa reconstituted solution (5 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Croatian: Dodatno razrijediti rekonstituiranu otopinu Zomete (5 ml) sa 100 ml otopine za infuziju koja ne sadrži kalcij niti druge dvovalentne katione.
English: FOLDING BOX - OUTER CONTAINER OF MULTIPACK (WITH BLUE BOX)
Croatian: KUTIJA - VANJSKI SPREMNIK VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: In clinical trials with Zometa, 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 Zometom.
English: Efficacy results are provided in Table 5.
Croatian: Rezultati djelotvornosti prikazani su u Tablici 5.
English: For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Croatian: Nema dostupnih podataka koji bi pokazali smanjuje li prekid liječenja bisfosfonatima rizik od osteonekroze čeljusti u bolesnika kojima je potreban stomatološki zahvat.
English: EU/1/01/176/004 1 vial EU/1/01/176/005 4 vials
Croatian: EU/1/01/176/004 1 bočica EU/1/01/176/005 4 bočice
English: Conjunctivitis
Croatian: Konjunktivitis
English: Bone pain, myalgia, arthralgia, generalised pain
Croatian: Bolovi u kostima, mialgija, artralgija, generalizirani bolovi
English: If you are given more Zometa than you should be If you have received doses higher than those recommended, you must be carefully monitored by your doctor.
Croatian: Ako ste primili više Zomete nego što ste trebali
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 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: Multiple event analysis showed a 36% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Croatian: Analiza višestrukih događaja pokazala je smanjenje rizika od nastanka koštanih događaja za 36% u skupini koja je primala zoledronatnu kiselinu u dozi od 4 mg u odnosu na placebo.
English: PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU
English: Rare (may affect up to 1 in 1,000 people):
Croatian: Rijetko (može se javiti u do 1 na 1000 osoba):
English: From a microbiological point of view, the reconstituted and diluted solution for infusion should be used immediately.
Croatian: S mikrobiološkog stajališta, rekonstituirana i razrijeđena otopina za infuziju treba se primijeniti odmah.
English: Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
Croatian: Ovisno o nalazu pregleda bolesnika u kojih postoji sumnja na atipični prijelom bedrene kosti, potrebno je razmotriti i prekid terapije bisfosfonatima na temelju procjene omjera koristi i rizika liječenja u pojedinog bolesnika.
English: Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Croatian: Analiza višestrukih događaja pokazala je smanjenje rizika od nastanka koštanih događaja za 30,7% u bolesnika koji su primali zoledronatnu kiselinu od 4 mg u usporedbi s onima koji su primali placebo.
English: In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking Zometa.
Croatian: U razdoblju nakon stavljanja lijeka u promet, u bolesnika koji su uzimali Zometu zabilježeni su jaki i ponekad onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima.
English: Ask your doctor for advice before taking any medicine while you are pregnant or breast-feeding.
Croatian: Ako ste trudni ili dojite, obratite se svom liječniku za savjet prije nego počnete uzimati bilo koji lijek.
English: Component of a multipack comprising ten packs, each containing one vial and one ampoule
Croatian: Sastavni dio višestrukog pakiranja koje se sastoji od deset pakiranja, od kojih svako sadrži po jednu bočicu i jednu ampulu
English: Zometa 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 Zometom dolazi u obzir tek nakon procjene rizika i koristi od liječenja.
English: This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment.
Croatian: Ako je doza koju ste primili viša od preporučene, morate biti pod pomnim liječničkim nadzorom, zato što može nastupiti poremećaj elektrolita u serumu (npr. abnormalne razine kalcija, fosfora i magnezija) i/ili promjena funkcije bubrega, uključujući teško oštećenje funkcije bubrega.
English: Remove the volume of Zometa 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 solution for injection.
Croatian: Izvucite navedeni volumen Zometa otopine za infuziju iz boce i zamijenite ga jednakim volumenom sterilne otopine za injekciju natrijevog klorida od 9 mg/ml (0,9%), ili 5% otopinom glukoze za injekciju.
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving Zometa.
Croatian: Osteonekroza čeljusti zabilježena je manje često u kliničkim ispitivanjima i nakon stavljanja lijeka u promet, u bolesnika koji su se liječili Zometom.
English: Zometa 4 mg/100 ml solution for infusion
Croatian: Zometa 4 mg/100 ml otopina za infuziju
English: Figure 1 Mean changes from baseline in BPI scores.
Croatian: Slika 1 Srednja vrijednost promjene rezultata na ljestvici boli (BPI) od početne vrijednosti.
English: Replace with the following volume of sterile sodium chloride 9 mg/ml (0,9%), or 5% glucose solution for injection (ml)
Croatian: Zamijenite sljedećim volumenom sterilne otopine za injekciju natrijevog klorida od 9 mg/ml (0,9%), ili 5% otopine glukoze za injekciju (ml)
English: FOLDING BOX FOR 1 VIAL AS INTERMEDIATE PACK (WITHOUT BLUE BOX)
Croatian: KUTIJA ZA 1 BOČICU KAO MEĐUPAKIRANJE (BEZ PLAVOG OKVIRA)
English: 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.
Croatian: Izvučenu količinu koncentrata treba dodatno razrijediti u 100 ml sterilne 0,9% w/v otopine natrijevog klorida ili 5% w/v otopine glukoze.
English: Zometa 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Croatian: Zometa 4 mg/5 ml koncentrat za otopinu za infuziju zoledronatna kiselina
English: 4.1 ml for 3.3 mg dose
Croatian: 4,1 ml za dozu od 3,3 mg
English: The hydration status of patients must be assessed prior to and following administration of Zometa to assure that they are adequately hydrated.
Croatian: Prije i poslije primjene Zomete mora se provjeriti status hidracije bolesnika kako bi se osiguralo da su primjereno hidrirani.
English: Table 4 Efficacy results (breast cancer and multiple myeloma patients)
Croatian: Tablica 4 Rezultati djelotvornosti (u bolesnika s karcinomom dojke i multiplim mijelomom)