natgillin/translations-raw huggingface dataset:
The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Utvrđeni su sljedeći važni rizici primanja zoledronatne kiseline u odobrenim indikacijama: oštećenje funkcije bubrega, osteonekroza čeljusti, reakcija akutne faze, hipokalcemija, fibrilacija atrija,
Zoledronic acid Actavis treatment should be resumed at the same dose as that given prior to treatment interruption.
Liječenje Zoledronatnom kiselinom Actavis treba nastaviti istom dozom koja se davala prije prekida liječenja.
How to store Zoledronic acid Actavis Contents of the pack and other information
Kako čuvati Zoledronatnu kiselinu Actavis Sadržaj pakiranja i druge informacije
The following risk factors should be considered when evaluating an individual's risk of developing ONJ: - Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
Sljedeće čimbenike rizika treba uzeti u obzir kada se kod pojedinca ocjenjuje rizik od razvoja osteonekroze čeljusti ( ONČ): - Potentnost bisfosfonata (veći rizik kod visoko potentnih spojeva), put primjene (veći rizik kod parenteralne primjene) i kumulativnu dozu bisfosfonata. - -Rak, komorbiditetna stanja (npr. anemija, koagulopatije, infekcija), pušenje.
For storage conditions of Zoledronic acid Actavis after dilution, see section 6.3.
Uvjete čuvanja Zoledronatne kiseline Actavis nakon razrjeđivanja vidjeti u dijelu 6.3.
Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between zoledronic acid therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Na temelju pregleda slučajeva iz kliničkih ispitivanja i nakon stavljanja lijeka u promet postoji dovoljno dokaza o povezanosti između liječenja zoledronatnom kiselinom, zabilježenih događaja hipokalcemije i razvoja srčane aritmije kao njene posljedice.
If a lower dose of Zoledronic acid Actavis is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Actavis, prvo izvucite odgovarajući volumen kako je navedeno niže, i potom ga dodatno razrijedite sa 100 ml otopine za infuziju.
Blurred vision, scleritis and orbital inflammation Uveitis
Zamagljen vid, skleritis i upala orbite Uveitis
In a pooled analysis of safety data from zoledronic acid registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
U analizi objedinjenih podataka o sigurnosti primjene zoledronatne kiseline iz registracijskih ispitivanja za sprječavanje koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti, sumnjalo se da je učestalost štetnih događaja oštećenja funkcije bubrega povezana sa zoledronatnom kiselinom (nuspojava) na sljedeći način: multipli mijelom (3,2%), rak prostate (3,1%), rak dojke (4,3%), rak pluća i drugi solidni tumori (3,2%).
Patients must be assessed prior to administration of Zoledronic acid Actavis to ensure that they are adequately hydrated.
Bolesnici moraju biti pregledani prije primjene Zoledronatne kiseline Actavis kako bi se potvrdilo da su odgovarajuće hidrirani.
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.
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.
Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Rijetko (može se javiti u do 1 na 1000 osoba): - Usporen rad srca.
What Zoledronic acid Actavis is and what it is used for What you need to know before you are given Zoledronic acid Actavis How Zoledronic acid Actavis is used Possible side effects
Što je Zoledronatna kiselina Actavis i za što se koristi Što morate znati prije nego počnete primati Zoledronatnu kiselinu Actavis Kako primjenjivati Zoledronatnu kiselinu Actavis
To assess the effects of 4 mg zoledronic acid versus pamidronate 90 mg, the results of two pivotal multicentre studies in patients with TIH were combined in a pre-planned analysis.
Da bi se procijenili učinci 4 mg zoledronatne kiseline u usporedbi sa 90 mg pamidronata, u unaprijed planiranoj analizi kombinirali su se rezultati dva glavna multicentrična ispitivanja u bolesnika s
- Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
- Liječnik će Vam savjetovati da prije svake primjene Zoledronatne kiseline Actavis popijete dovoljnu količinu vode, kako bi se spriječila dehidracija.
NR 714
ND ND 424
Zoledronic acid Actavis is contraindicated in breast-feeding women (see section 4.3).
Zoledronatna kiselina Actavis je kontraindicirana tijekom dojenja (vidjeti dio 4.3).
EXP Shelf life after dilution: See leaflet.
EXP Rok valjanosti nakon razrjeđivanja: vidjeti uputu o lijeku.
- High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation,
- Visok krvni tlak, nedostatak zraka, omaglica, tjeskoba, poremećaji spavanja, promjena osjeta okusa, drhtavica, trnci ili utrnulost šaka ili stopala, proljev, zatvor, bol u trbuhu, suha usta.
What Zoledronic acid Actavis is and what it is used for
Što je Zoledronatna kiselina Actavis i za što se koristi
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) .
Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
You should not be given Zoledronic acid Actavis:
Ne smijete primiti Zoledronatnu kiselinu Actavis:
Actavis Italy S.p.A Via Pasteur, 10 20014 Nerviano (MI) Italy
Actavis Italy S.p.A Via Pasteur, 10
Patients must be maintained well hydrated prior to and following administration of Zoledronic acid Actavis.
Bolesnici moraju biti dobro hidrirani prije i nakon primjene Zoledronatne kiseline Actavis.
Table 4: Efficacy results (breast cancer and multiple myeloma patients)
Tablica 4: Rezultati djelotvornosti (u bolesnika s rakom dojke i multiplim mijelomom)
- Zoledronic acid Actavis must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
- Zoledronatnu kiselinu Actavis smiju davati samo zdravstveni radnici iskusni u davanju bisfosfonata intravenskim putem, tj. u venu.
One vial contains 5 ml of solution.
Jedna bočica sadrži 5 ml otopine.
Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
Manje često (može se javiti u do 1 na 100 osoba): - Reakcije preosjetljivosti.
Within three days after zoledronic acid administration, used as indicated in sections 4.1 and 4.2, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
4.1 i 4.2, često je zabilježena reakcija akutne faze sa simptomima koji uključuju bol u kostima, vrućicu, umor, artralgiju, mialgiju, tresavicu i artritis s posljedičnim oticanjem zglobova; ti se simptomi obično povuku u roku od nekoliko dana (vidjeti opis odabranih nuspojava).
Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
Proljev, konstipacija, bol u trbuhu, dispepsija, stomatitis, suha usta
Pruritus, rash (including erythematous and macular rash), increased sweating
Svrbež, osip (uključujući eritematozni i makularni osip), pojačano znojenje
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).
Osteonekroza čeljusti Slučajevi osteonekroze čeljusti pretežno su zabilježeni u onkoloških bolesnika liječenih lijekovima koji inhibiraju resorpciju kosti, kao što je zoledronatna kiselina (vidjeti dio 4.4).
Zoledronic acid 4 mg was also studied in a double-blind, randomised, placebo-controlled trial in 228 patients with documented bone metastases from breast cancer to evaluate the effect of 4 mg zoledronic acid on the skeletal related event (SRE) rate ratio, calculated as the total number of SRE
Zoledronatna kiselina od 4 mg također se ispitivala u dvostruko slijepom, randomiziranom, placebom kontroliranom ispitivanju u 228 bolesnika s potvrđenim koštanim metastazama raka dojke da bi se procijenio učinak 4 mg zoledronatne kiseline na omjer stope koštanih događaja izračunatog kao ukupni broj koštanih događaja (bez hiperkalcemije i prilagođen s obzirom na prethodne prijelome) podijeljen s ukupnim rizičnim razdobljem.
- In vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer drugs, anti-adhesion/invasion activity.
- in vitro: inhibicija proliferacije osteoblasta, izravno citostatsko i proapoptotsko djelovanje na tumorske stanice, sinergistički citostatski učinak s drugim antitumorskim lijekovima,
In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
U bolesnika s blagim do umjerenim oštećenjem funkcije bubrega preporučuju se snižene doze zoledronatne kiseline (vidjeti dio „Doziranje” iznad i dio 4.4).
Risk reduction of suffering from multiple events**
p-vrijednost Stopa koštanog pobola p-vrijednost Smanjenje rizika od višestrukih događaja** (%)
Patients being treated with Zoledronic acid Actavis should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Actavis ne smiju istodobno uzimati takve lijekove ili bilo koji drugi bisfosfonat, budući da kombinirani učinci tih tvari nisu poznati.
Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended.
Čimbenici koji mogu povećati mogućnost propadanja funkcije bubrega uključuju dehidraciju, postojeće oštećenje funkcije bubrega, višestruke cikluse primanja zoledronatne kiseline ili drugih bisfosfonata, kao i istodobnu primjenu nefrotoksičnih lijekova ili kraće trajanje infuzije od trenutno preporučenog.
Concentrate for solution for infusion 1 x 5 ml vial
Koncentrat za otopinu za infuziju 1 x 5 ml bočica
In patients who show evidence of renal deterioration during treatment, Zoledronic acid Actavis should be withheld.
U bolesnika u kojih se pojave znakovi pogoršanja funkcije bubrega tijekom liječenja treba prekinuti primjenu Zoledronatne kiseline Actavis.
Patients with TIH and evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with Zoledronic acid Actavis outweighs the possible risk.
Insuficijencija bubrega Bolesnike s hiperkalcemijom izazvanom tumorom i dokazanim pogoršanjem funkcije bubrega treba procijeniti na odgovarajući način i pritom razmotriti jesu li moguće koristi od liječenja Zoledronatnom kiselinom Actavis veće od mogućih rizika.
- The active substance is zoledronic acid.
- Djelatna tvar je zoledronatna kiselina.
Zoledronic acid Actavis should only be resumed when serum creatinine returns to within 10% of baseline.
S primjenom Zoledronatne kiseline Actavis smije se nastaviti tek kad se kreatinin u serumu vrati na vrijednosti unutar 10% početne vrijednosti.
Patients should have their serum creatinine levels assessed prior to each dose of Zoledronic acid Actavis.
Bolesnicima treba provjeriti razinu kreatinina u serumu prije svake primjene doze Zoledronatne kiseline Actavis.
The first randomised, double-blind, placebo-controlled study compared zoledronic acid 4 mg to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Prvo randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje uspoređivalo je zoledronatnu kiselinu u dozi od 4 mg s placebom u sprječavanju koštanih događaja u bolesnika s rakom prostate.
In a third phase III randomised, double-blind trial, 4 mg zoledronic acid or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
U randomiziranom, dvostruko slijepom ispitivanju faze III uspoređivala su se 4 mg zoledronatne kiseline s pamidronatom u dozi od 90 mg svaka 3 do 4 tjedna u bolesnika s multiplim mijelomom ili rakom dojke i najmanje jednom koštanom lezijom.
The multiple event analysis revealed a significant risk reduction of 16% in patients treated with 4 mg zoledronic acid in comparison with patients receiving pamidronate.
Analiza višestrukih događaja pokazala je značajno smanjenje rizika za 16% u bolesnika liječenih zoledronatnom kiselinom u dozi od 4 mg u usporedbi s bolesnicima koji su primali pamidronat.
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 Actavis.
Tijekom liječenja Zoledronatnom kiselinom Actavis 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.
What Zoledronic acid Actavis looks like and contents of the pack
Kako Zoledronatna kiselina Actavis izgleda i sadržaj pakiranja
- To prepare an infusion solution containing 4 mg Zoledronic acid Actavis, further dilute the Zoledronic acid Actavis concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Da biste pripremili otopinu za infuziju koja sadrži 4 mg Zoledronatne kiseline Actavis, dodatno razrijedite koncentrat Zoledronatne kiseline Actavis (5,0 ml) sa 100 ml otopine za infuziju koja ne sadrži kalcij niti druge dvovalentne katione.
- The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
- Otopina koja sadrži zoledronatnu kiselinu primjenjuje se kao jednokratna intravenska infuzija u trajanju od 15 minuta putem zasebne infuzijske linije.
Prevention of skeletal related events in patients with advanced malignancies involving bone Adults and older people
Sprječavanje koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti Odrasli i starije osobe
The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 cancer patients studied.
Bubrežni klirens zoledronatne kiseline korelirao je s klirensom kreatinina, s time da je bubrežni klirens predstavljao 75 ± 33% klirensa kreatinina, koji je prosječno iznosio 84 ± 29 ml/min (raspon od 22 do 143 ml/min) u 64 uključena onkološka bolesnika.
- Zoledronic acid Actavis is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
- Zoledronatna kiselina Actavis daje se u venu kao infuzija (drip) u trajanju od najmanje 15 minuta i mora se primijeniti kao jednokratna intravenska otopina kroz zasebnu infuzijsku liniju.
The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Nositelj odobrenja mora osigurati uvođenje kartice s podsjetnikom za bolesnika u svezi osteonekroze čeljusti.
The effects of intravenous zoledronic acid in the treatment of paediatric patients (age 1 to 17 years) with severe osteogenesis imperfecta (types I, III and IV) were compared to intravenous pamidronate in one international, multicentre, randomised, open-label study with 74 and 76 patients in each treatment group, respectively.
do 17 godina) s teškim oblikom osteogenesis imperfecta (tipovi I, III i IV) uspoređeni su s učincima intravenski primijenjenog pamidronata u jednom međunarodnom, multicentričnom, randomiziranom ispitivanju otvorenog tipa u dvije terapijske skupine, jedne sa 74 i druge sa 76 bolesnika.
Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Omaglica, parestezija, disgeuzija, hipoestezija, hiperestezija, tremor, somnolencija Konvulzije, hipoestezija i tetanija (uslijed hipokalcemije)
Patients treated with Zoledronic acid Actavis should be given the package leaflet and the patient reminder card.
Bolesnicima koji se liječe Zoledronatnom kiselinom Actavis potrebno je dati Uputu o lijeku i karticu s podsjetnikom za bolesnika.
Other medicines and Zoledronic acid Actavis
Drugi lijekovi i Zoledronatna kiselina Actavis
The results demonstrated that 4 mg zoledronic acid showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Rezultati su pokazali podjednaku djelotvornost zoledronatne kiseline u dozi od 4 mg i 90 mg pamidronata u sprječavanju koštanih događaja.
Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Mnogi od tih bolesnika primali su i kemoterapiju i kortikosteroide i imali su znakove lokalne infekcije uključujući osteomijelitis.Većina zabilježenih slučajeva odnosila se na onkološke bolesnike nakon vađenja zuba ili drugih stomatoloških operacija.
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.
U drugom ispitivanju u bolesnika sa solidnim tumorima, izuzev raka 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.
Zoledronic acid Actavis treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Liječenje Zoledronatnom kiselinom Actavis u bolesnika s hiperkalcemijom izazvanom tumorom koji imaju i teško oštećenje funkcije bubrega dolazi u obzir tek nakon procjene rizika i koristi od liječenja.
The withdrawn amount of concentrate must be further diluted in 100 ml of sterile 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Izvučena količina koncentrata mora se dodatno razrijediti u 100 ml sterilne 0,9%-tne m/V otopine natrijevog klorida ili 5%-tne m/V otopine glukoze.
In the clinical trials, renal deterioration was defined as follows: - For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 micromol/l), an increase of 0.5 mg/dl or 44 micromol/l; - For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 micromol/l), an increase of
- povišenje vrijednosti kreatinina za 0,5 mg/dl ili 44 mikromola/l, u bolesnika s normalnom početnom vrijednošću kreatinina u serumu (< 1,4 mg/dl ili < 124 mikromola/l); - povišenje vrijednosti kreatinina za 1,0 mg/dl ili 88 mikromola/l, u bolesnika s poremećenom početnom vrijednošću kreatinina (> 1,4 mg/dl ili > 124 mikromola/l).
Dyspnoea, cough, bronchoconstriction Interstitial lung disease
Dispneja, kašalj, bronhokonstrikcija
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.
koje napreduje do zatajenja bubrega i dijalize, zabilježeno je u bolesnika nakon početne doze ili jednokratne doze od 4 mg zoledronatne kiseline.
Zoledronic acid Actavis must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Zoledronatnu kiselinu Actavis bolesnicima smiju propisivati i primjenjivati samo liječnici s iskustvom u intravenskoj primjeni bisfosfonata.
See section 4.
DODATAK III.
To avoid potential incompatibilities, Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion is to be diluted with 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Kako bi se izbjegle moguće inkompatibilnosti, Zoledronatna kiselina Actavis 4 mg/5 ml koncentrat za otopinu za infuziju mora se razrijediti sa 0,9%-tnom m/V otopinom natrijevog klorida ili sa 5%-tnom m/V otopinom glukoze.
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).
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
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 (0.9% w/v sodium chloride solution or 5% w/v glucose solution).
Prije primjene, 5 ml koncentrata iz jedne bočice ili izvučen potreban volumen koncentrata mora se dodatno razrijediti sa 100 ml otopine za infuziju koja ne sadrži kalcij (0,9%-tna m/V otopina natrijevog klorida ili 5%-tna m/V otopina glukoze).
Muscle spasms, osteonecrosis of the jaw Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Ostenekroza vanjskog slušnog kanala (nuspojava klase bifosfonatnih lijekova) i drugih anatomskih mjesta uključujući bedrenu kost i kuk
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).
Propadanje funkcije bubrega, koje napreduje do zatajenja bubrega i dijalize, zabilježeno je u bolesnika nakon početne doze ili jednokratne doze zoledronatne kiseline od 4 mg (vidjeti dio 4.4).
No dose adjustment is necessary in TIH patients with serum creatinine < 400 micromol/l or < 4.5 mg/dl (see section 4.4).
Nije potrebna prilagodba doze u bolesnika s hiperkalcemijom izazvanom tumorom i vrijednostima kreatinina u serumu < 400 mikromola/l ili < 4,5 mg/dl (vidjeti dio 4.4).
Zoledronic acid Actavis contains sodium
Zoledronatna kiselina Actavis sadrži natrij
Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
Vrućica, sindrom nalik gripi (uključujući umor, tresavicu, malaksalost i crvenilo uz osjećaj vrućine)
Your doctor will carry out blood tests before you start treatment with Zoledronic acid Actavis and will check your response to treatment at regular intervals.
Prije nego što počnete primati Zoledronatnu kiselinu Actavis, liječnik će Vam napraviti krvne pretrage i u redovitim vremenskim razmacima provjeravati Vaš odgovor na liječenje.
After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and at 25°C after dilution in 100 ml 0.9% w/v sodium chloride solution or 100 ml 5% w/v glucose.
Nakon razrjeđivanja: kemijska i fizikalna stabilnost nakon razrjeđenja u 100 ml 0,9%-tne m/V otopine natrijevog klorida ili 100 ml 5%-tne m/V otopine glukoze dokazana je za 24 sata na temperaturi od 2°C do 8°C i na 25°C.