natgillin/translations-raw huggingface dataset:
It is given as a single 15-minute intravenous infusion in a separate infusion line.
Primjenjuje se kao jednokratna 15-minutna intravenska infuzija kroz zasebnu infuzijsku liniju.
Teratogenicity was observed in rats at doses 0.2 mg/kg and was manifested by external, visceral and skeletal malformations.
Teratogenost je opažena u štakora pri dozama ≥ 0,2 mg/kg, a izražavala se vanjskim i visceralnim malformacijama te malformacijama skeleta.
Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily.
Bolesnicima također treba davati oralni nadomjestak kalcija od 500 mg i 400 IU vitamina
Six patients who achieved therapeutic response 6 months after treatment with zoledronic acid and later experienced disease relapse during the extended follow-up period were re-treated with zoledronic acid after a mean time of 6.5 years from initial treatment to re-treatment.
Šest bolesnika koji su postigli terapijski odgovor 6 mjeseci nakon liječenja zoledronatnom kiselinom, a koji su kasnije doživjeli relaps bolesti tijekom produljenog perioda praćenja, ponovno su liječeni zoledronatnom kiselinom, a srednje vrijeme od početnog liječenja do ponovnog liječenja bilo je 6,5 godina.
From the bone tissue it is released very slowly back into the systemic circulation and eliminated via the kidney.
Iz koštanog tkiva se otpušta vrlo sporo natrag u sistemsku cirkulaciju i eliminira putem bubrega.
The recommended dose is a single intravenous infusion of 5 mg zoledronic acid.
Preporučena doza je jednokratna intravenska infuzija 5 mg zoledronatne kiseline.
In a large clinical trial, local reactions at the infusion site, such as redness, swelling and/or pain, were reported (0.7%) following the administration of zoledronic acid.
U velikom kliničkom ispitivanju prijavljene su lokalne reakcije na mjestu primjene infuzije (0,7%), kao što su crvenilo, oticanje i/ili bol, nakon primjene zoledronatne kiseline.
Zoledronic Acid Hospira, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Zoledronatnu kiselinu Hospira, dodatno razrijeđenu u 100 ml (vidjeti dio 6.6), treba primijeniti kao jednokratnu intravensku infuziju u trajanju od najmanje 15 minuta.
Other products containing zoledronic acid as active substance are available for oncology indications.
Ostali lijekovi koji sadrže zoledronatnu kiselinu kao djelatnu tvar dostupni su za onkološke indikacije.
In patients with Paget's disease, symptoms due to low blood calcium, such as muscle spasms, or numbness, or a tingling sensation especially in the area around the mouth have been reported.
U bolesnika s Pagetovom bolešću prijavljeni su simptomi uzrokovani niskom razinom kalcija u krvi, kao što su grčevi mišića ili utrnutost ili trnci, osobito u području oko usta.
Your doctor will advise you and decide how long you should be treated with Zoledronic Acid Hospira.
Liječnik će Vam dati savjet i odlučiti koliko dugo biste se trebali liječiti Zoledronatnom kiselinom Hospira.
Healthcare professionals are advised not to dispose of unused Zoledronic Acid Hospira via the domestic sewage system.
Zdravstvenim radnicima se savjetuje da ne bacaju neiskorištenu Zoledronatnu kiselinu Hospira u otpadne vode.
The following are the important identified risks with zoledronic acid in the approved indications:
Utvrđeni su sljedeći važni rizici primjene zoledronatne kiseline u odobrenim indikacijama:
Very common (may affect more than 1 in 10 people):− Low level of phosphate in the blood.
Vrlo često (može se javiti u do 1 na 10 osoba): - niska razina fosfata u krvi.
In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral calcium and/or an intravenous infusion of calcium gluconate.
U slučaju da predoziranje dovodi do klinički značajne hipokalcemije, suprotni učinak se može postići nadomještanjem oralnog kalcija i/ili intravenskom infuzijom kalcijevog glukonata.
− Keep Zoledronic Acid Hospira out of the reach and sight of children.
- Zoledronatnu kiselinu Hospira čuvajte izvan pogleda i dohvata djece.
Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Moguće nuspojave zoledronatne kiseline na plodnost ispitane su na roditeljskoj i F1 generaciji štakora.
Arthritis and joint swelling as a symptom of acute phase reaction
artritis i oticanje zglobova kao simptomi reakcije akutne faze
It comes in 100 ml plastic bags as a readyto-use solution for infusion.
Isporučuje se u plastičnim vrećicama od 100 ml kao otopina za infuziju spremna za uporabu.
- Pregnancy and breast-feeding (see section 4.6).
- Trudnoća i dojenje (vidjeti dio 4.6).
CARTON FOR 1 BAG AS UNIT PACK
KUTIJA ZA 1 VREĆICU KAO JEDINIČNO PAKIRANJE
Zoledronic acid has been associated with renal impairment manifested as deterioration in renal function (i.e. increased serum creatinine) and in rare cases acute renal failure.
Zoledronatna kiselina je bila povezana s oštećenjem bubrega koje se očitovalo kao slabljenje bubrežne funkcije (npr. povišeni kreatinin u serumu) i u rijetkim slučajevima kao akutno zatajenje bubrega.
Zoledronic acid should not be used during pregnancy.
Zoledronatna kiselina ne smije se primjenjivati tijekom trudnoće.
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 kliničkih i postmarketinških ispitivanja, postoji dovoljno dokaza koji podupiru povezanost liječenja zoledronatnom kiselinom i prijavljenih slučajeva hipokalcemije i posljedičnog razvoja srčane aritmije.
− The diluted Zoledronic Acid Hospira infusion solution should be used immediately in order to avoid microbial contamination.
- Razrijeđena otopina za infuziju Zoledronatne kiseline Hospira mora se primjeniti odmah da bi se izbjeglo mikrobno zagađenje.
These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture.
Prijelomi nastaju nakon minimalne traume ili bez ikakve traume, pri čemu neki bolesnici osjete bol u bedru ili preponama, a na radiološkim slikama često su prisutni znakovi stresnog prijeloma tjednima ili mjesecima prije nego što nastane potpuni prijelom bedrene kosti.
In multiple myeloma patients, the risk of renal dysfunction may be increased when zoledronic acid is used in combination with thalidomide.
U bolesnika s multiplim mijelomom, rizik od poremećaja funkcije bubrega može biti povećan kad se primjenjuje zoledronatna kiselina u kombinaciji s talidomidom.
Of the 153 zoledronic acid-treated patients and 115 risedronate-treated patients who entered an extended observation study, after a median duration of follow-up of 3.8 years from time of dosing, the proportion of patients ending the Extended Observation Period due to the need for re-treatment (clinical judgment) was higher for risedronate (48 patients, or 41.7%) compared with zoledronic acid (11 patients, or 7.2%).
Od 153 bolesnika liječenih zoledronatnom kiselinom i 115 bolesnika liječenih risedronatom, koji su ušli u produljenu studiju praćenja, nakon medijana trajanja praćenja od 3,8 godina, računato od vremena doziranja, stopa bolesnika koji su završili produljeni period praćenja zbog potrebe za ponovnim liječenjem (klinička procjena) bila je veća za risedronat (48 bolesnika ili 41,7%) naspram zoledronatne kiseline (11 bolesnika ili 7,2%).
− For single use only.
Samo za jednokratnu primjenu.
Patients who have received doses higher than those recommended (see section 4.2) should be carefully monitored, since renal function impairment (including renal failure) and serum electrolyte (including calcium, phosphorus and magnesium) abnormalities have been observed.
Bolesnike koji su primili više doze od preporučenih (vidjeti dio 4.2) treba pažljivo pratiti budući da su primijećena oštećenja bubrega (uključujući zatajenje bubrega) i poremećaji serumskih elektrolita (uključujući kalcij, fosfor i magnezij).
The incidence of these reactions decreased markedly with subsequent annual doses of zoledronic acid.
Incidencija tih nuspojava značajno se smanjila s narednim godišnjim dozama zoledronatne kiseline.
Median time to onset of the first SRE was not reached in the zoledronic acid -treated arm at the end of the study and was significantly prolonged compared to placebo (p=0.007).
Medijan vremena do nastupa prvog koštanog događaja nije dosegnut u skupini liječenoj zoledronatnom kiselinom do kraja ispitivanja i bio je značajno dulji naspram placeba (p=0,007).
Pharmacokinetic/pharmacodynamic relationships
Odnos farmakokinetika/farmakodinamika
Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia)
konvulzije, hipoestezija i tetanija (zbog hipokalcemije)
- 4.4 ml for 3.5 mg dose - 4.1 ml for 3.3 mg dose - 3.8 ml for 3.0 mg dose
- 4,4 ml za dozu od 3,5 mg - 4,1 ml za dozu od 3,3 mg - 3,8 ml za dozu od 3,0 mg
Adverse reactions, such as dizziness and somnolence, may have influence on the ability to drive or use machines, therefore caution should be exercised with the use of zoledronic acid along with driving and operating of machinery.
Nuspojave poput omaglice i somnolencije mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima te je stoga potreban oprez kad se tijekom primjene zoledronatne kiseline upravlja vozilima i radi sa strojevima.
Elevated bone turnover is a characteristic of Paget's disease of the bone.
Povećana pregradnja kosti je osobina Pagetove bolesti kostiju.
Other medicines and Zoledronic Acid Hospira Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Drugi lijekovi i Zoledronatna kiselina Hospira Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Nuspojave u tablici 1 su navedene prema klasifikaciji organskih sustava prema MedDRA-i i učestalosti.
Episcleritis
episkleritis
Furthermore, there is evidence of an association between hypocalcaemia and secondary neurological events reported in these cases including; convulsions, hypoaesthesia and tetany (see section 4.4).
Nadalje, postoji dokaz povezanosti hipokalcemije i posljedičnih neuroloških događaja uključujući konvulzije, hipoesteziju i tetaniju (vidjeti dio 4.4).
What Zoledronic Acid Hospira looks like and contents of the pack Zoledronic Acid Hospira is supplied as a liquid concentrate (referred to as a ‘concentrate for solution for infusion' or ‘sterile concentrate') in a vial.
Kako Zoledronatna kiselina Hospira izgleda i sadržaj pakiranja Zoledronatna kiselina Hospira je tekući koncentrat (koji se naziva "koncentrat za otopinu za infuziju" ili "sterilni koncentrat") u bočici.
The mechanism behind the increased incidence of atrial fibrillation is unknown.
Nije poznat mehanizam u pozadini povećane incidencije fibrilacije atrija.
Clinical experience with acute overdose of zoledronic acid is limited.
Kliničko iskustvo s akutnim predoziranjem zoledronatnom kiselinom je ograničeno.
Zoledronic Acid Hospira works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.
Zoledronatna kiselina djeluje tako što vraća proces preoblikovanja kosti u normalu, osiguravajući stvaranje normalne kosti, čime kosti postaju snažnije.
Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with Zoledronic Acid Hospira.
Dodatno, bilo je sporadičnih prijava osteonekroze drugih anatomskih mjesta, uključujući kuk i bedrenu kost, koje su bile prijavljene pretežno u odraslih bolesnika oboljelih od raka liječenih Zoledronatnom kiselinom Hospira.
Within three days after zoledronic acid administration, 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).
Unutar tri dana nakon primjene zoledronatne kiseline često je prijavljena 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 unutar nekoliko dana (vidjeti opis odabranih nuspojava).
Untreated hypercalcaemia patients generally have some degree of renal function impairment, therefore careful renal function monitoring should be considered.
Bolesnici s neliječenom hiperkalcijemijom najčešće imaju neki stupanj oštećenja funkcije bubrega pa je stoga potrebno razmotriti pažljivo praćenje funkcije bubrega.
These could be signs of bone damage in the jaw (osteonecrosis).
To mogu biti znakovi oštećenja kosti u čeljusti (osteonekroze).
It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Zoledronic Acid Hospira, as directed by your healthcare provider.
Važno je za Vas da pijete barem 2 čaše tekućine (npr. vode), unutra nekoliko sati prije primanja Zoledronatne kiseline Hospira, prema uputama svog zdravstvenog radnika.
- Zoledronic Acid Hospira is ready for use.
- Zoledronatna kiselina Hospira je spremna za primjenu.
Zoledronic Acid Hospira is not recommended for anyone under 18 years of age.
Zoledronatna kiselina Hospira ne preporučuje se osobama mlađim od 18 godina.
Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/l) occurred in 2.3% of zoledronic acid-treated patients in a large clinical trial compared to 21% of zoledronic acid-treated patients in the Paget's disease trials.
Na temelju laboratorijske procjene, prolazne asimptomatske razine kalcija ispod normalnog referentnog raspona (manje od 2,10 mmol/1) javile su se u 2,3% bolesnika liječenih zoledronatnom kiselinom u velikom kliničkom ispitivanju, naspram 21% bolesnika liječenih zoledronatnom kiselinom u kliničkim ispitivanjima Pagetove bolesti.
Before receiving Zoledronic Acid Hospira, tell your doctor, pharmacist or nurse if - you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction; - you do not receive routine dental care or have not had a dental check-up for a long time; - you are a smoker (as this may increase the risk of dental problems); - you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders); - you are taking medicines called corticosteroids (such as prednisolone or dexamethasone) - you have cancer.
Prije liječenja Zoledronatnom kiselinom Hospira, recite svom liječniku, ljekarniku ili medicinskoj sestri ako: - imate problema s ustima ili zubima poput loše oralne higijene, bolesti desni ili kirurških zahvata zuba - ne primate rutinsku stomatološku skrb ili niste dugo bili na pregledu kod zubara - ste pušač (to može povećati rizik razvoja stomatoloških problema) - ste prethodno liječeni s bisfosfonatima (koji se primjenjuju za liječenje ili sprječavanje poremećaja kosti) - uzimate lijekove koji se zovu kortikosteroidi (poput prednizolona ili deksametazona) - imate rak.
In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between zoledronic acid (2.6%) and placebo (2.1%).
U ispitivanjima osteoporoze (PFT, HORIZON-Recurrent Fracture Trial [RFT]) objedinjena incidencija fibrilacije atrija bila je usporediva kod zoledronatne kiseline (2,6%) i placeba (2, 1%).
Caution is indicated when zoledronic acid is used with other potentially nephrotoxic medicinal products.
Oprez je indiciran kad se zoledronatna kiselina primjenjuje s drugim potencijalno nefrotoksičnim lijekovima.
Adverse reactions, such as dizziness, may affect the ability to drive or use machines.
Nuspojava kao što je omaglica može utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
p-value Median time to SRE (days)
p-vrijednost medijan vremena do koštanog događaja (dani)
Zoledronic acid has been associated with reports of renal dysfunction.
Zoledronatna kiselina povezuje se s prijavama disfunkcije bubrega.
In paediatric patients with severe osteogenesis imperfecta, zoledronic acid seems to be associated with more pronounced risks for acute phase reaction, hypocalcaemia and unexplained tachycardia, in comparison to pamidronate, but this difference declined after subsequent infusions.
Čini se da je u pedijatrijskih bolesnika s teškim oblikom osteogenesis imperfecta zoledronatna kiselina povezana s izraženijim rizikom od reakcije akutne faze, hipokalcemije i neobjašnjene tahikardije u odnosu na pamidronat, ali ta se razlika smanjila nakon narednih infuzija.
The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established.
Sigurnost i djelotvornost primjene zoledronatne kiseline u djece u dobi od 1 do 17 godina nije ustanovljena.
Longer-term repeat administration at cumulative exposures sufficiently exceeding the maximum intended human exposure produced toxicological effects in other organs, including the gastrointestinal tract and liver, and at the site of intravenous administration.
Dugotrajna ponovljena primjena pri kumulativnim izloženostima koje su dovoljno prekoračivale najvišu planiranu izloženost u ljudi, izazvala je toksikološke učinke na druge organe, uključujući gastrointestinalni trakt i jetru, kao i na mjestu intravenske primjene.
Common C-reactive protein increased Uncommon Blood calcium decreased Observed in patients taking concomitant glucocorticosteroids.
Pretrage često povišeni C-reaktivni protein manje često sniženi kalcij u krvi # Opaženo u bolesnika koji istodobno uzimaju glukokortikosteroide.
All patients received adequate supplementation with vitamin D and calcium in the post-menopausal osteoporosis trial, the prevention of clinical fractures after hip fracture trial, and the Paget's disease trials (see also section 4.2).
Svi su bolesnici primili odgovarajuće nadomjestke vitamina D i kalcija u ispitivanju osteoporoze u postmenopauzi, prevenciji kliničkih prijeloma nakon ispitivanja prijeloma kuka te ispitivanjima Pagetove bolesti (vidjeti također dio 4.2).
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.
Kad se počinje liječenje zoledronatnom kiselinom u bolesnika s multiplim mijelomom ili metastatskim koštanim lezijama solidnih tumora, potrebno je odrediti vrijednosti kreatinina u serumu i klirens kreatinina (CLcr).
The reduced doses for patients with renal impairment are expected to achieve the same AUC as that seen in patients with creatinine clearance of 75 ml/min.
Očekuje se da će snižene doze u bolesnika s oštećenjem bubrega postići isti AUC kakav se opaža u bolesnika s klirensom kreatinina od 75 ml/min.
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 naspram 90 mg pamidronata, u unaprijed planiranoj analizi kombinirali su se rezultati dva ključna multicentrična ispitivanja u bolesnika s hiperkalcijemijom izazvanom tumorom.
Measurement of serum calcium before infusion of zoledronic acid is recommended for patients with Paget´s disease.
Preporuča se mjerenje serumskog kalcija prije infuzije zoledronatne kiseline u bolesnika s Pagetovom bolesti.
− if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
- ako imate ili ste imali bol, oticanje ili utrnulost čeljusti, težinu u čeljusti ili klimanje zuba.
Therefore, interactions resulting from displacement of highly protein-bound medicinal products are unlikely.
Zbog toga, interakcije nastale istiskivanjem lijekova, koji su u velikoj mjeri vezani na proteine, nisu vjerojatne.
In the intravenous infusion studies, renal tolerability of zoledronic acid was established in rats when given 0.6 mg/kg as 15-minute infusions at 3-day intervals, six times in total (for a cumulative dose that corresponded to AUC levels about 6 times the human therapeutic exposure) while five 15-minute infusions of 0.25 mg/kg administered at 2-3-week intervals (a cumulative dose that corresponded to 7 times the human therapeutic exposure) were well tolerated in dogs.
U ispitivanjima s intravenskom infuzijom, bubrežna podnošljivost zoledronatne kiseline utvrđena je u štakora kada su dobivali 0,6 mg/kg u obliku 15-minutne infuzije u intervalima od 3 dana, ukupno šest puta (čime se dobila kumulativna doza koja je odgovarala AUC razinama koje su bile otprilike 6 puta veće od terapijske izloženosti za ljude), dok su psi dobro podnosili pet 15-minutnih infuzija u dozi od 0,25 mg/kg primijenjenih u intervalima od 2-3 tjedna (kumulativna doza je odgovarala 7 puta većoj terapijskoj izloženosti za ljude).
Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and binding is concentration independent.
Zoledronatna kiselina se ne veže u velikoj mjeri na proteine plazme (veže se oko 43-55%), a vezanje ne ovisi o koncentraciji.
Your doctor, nurse or pharmacist knows how to store Zoledronic Acid Hospira properly (see section
Vaš liječnik, medicinska sestra ili ljekarnik znaju kako ispravno čuvati Zoledronatnu kiselinu Hospira (vidjeti dio 6).
Other products containing zoledronic acid as active substance are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Dostupni su drugi lijekovi koji sadrže zoledronatnu kiselinu kao djelatnu tvar indiciranu kod osteoporoze i za liječenje Pagetove bolesti kostiju.
Median time to relapse (re-increase of albumin-corrected serum calcium 2.9 mmol/l) was 30 to 40 days for patients treated with zoledronic acid versus 17 days for those treated with pamidronate 90 mg (p-values: 0.001 for 4 mg and 0.007 for 8 mg zoledronic acid).
Medijan vremena do relapsa (ponovnog povišenja kalcija u serumu korigiranog za albumin ≥ 2,9 mmol/l) iznosio je 30 do 40 dana u bolesnika liječenih zoledronatnom kiselinom naspram 17 dana u onih liječenih pamidronatom u dozi od 90 mg (pvrijednosti: 0,001 za 4 mg i 0,007 za 8 mg zoledronatne kiseline).
Five of the 6 patients had SAP within the normal range at month 6 (Late Observation Carried Forward, LOCF).
Pet od 6 bolesnika imalo je razinu alkalne fosfataze u serumu unutar normalnih granica nakon 6 mjeseci (kasni period praćenja).
Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid (see section 4.8)
Štetni događaji koji nastaju s učestalošću < 5% bili su medicinski procijenjeni i pokazalo se da su ti slučajevi u skladu s dobro utvrđenim sigurnosnim profilom zoledronatne kiseline (vidjeti dio 4.8).
In clinical trials in osteoporosis, approximately 0.2% of patients had notable declines of serum calcium levels (less than 1.87 mmol/l) following zoledronic acid administration.
Otprilike 0,2% bolesnika u kliničkom ispitivanju osteoporoze imalo je značajan pad razine kalcija u serumu (manje od 1,87 mmol/1) nakon primjene zoledronatne kiseline.
In patients with renal impairment, the systemic exposure to concomitant medicinal products that are primarily excreted via the kidney may increase.
U bolesnika s oštećenjem bubrega, sistemska izloženost lijekovima koji se prvenstveno izlučuju putem bubrega, može se povećati.
Hypocalcaemia is an important identified risk with zoledronic acid in the approved indications.
Hipokalcemija je važan identificirani rizik u primjeni zoledronatne kiseline u odobrenim indikacijama.