natgillin/translations-raw huggingface dataset:
Most patients had relief of symptoms after stopping treatment.
U većine bolesnika simptomi su se povukli nakon prekida liječenja.
The frequency of hypocalcaemia was much lower following subsequent infusions.
Učestalost hipokalcemije bila je znatno niža nakon narednih infuzija.
If you feel dizzy while taking Zoledronic Acid Hospira, do not drive or use machines until you feel better.
Ako osjećate omaglicu dok uzimate Zoledronatnu kiselinu Hospira, nemojte upravljati vozilima ili raditi sa strojevima dok se ne budete osjećali bolje.
• A single dose of zoledronic acid should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2).
• jedna doza zoledronatne kiseline ne smije prijeći 5 mg, a trajanje infuzije treba biti najmanje 15 minuta (vidjeti dio 4.2).
Manufacturer Hospira UK Limited Horizon
Proizvođač Hospira UK Limited Horizon
Age, body weight, gender and creatinine clearance appear to have no effect on zoledronic acid systemic exposure.
Čini se da dob, tjelesna težina, spol i klirens kreatinina ne utječu na sistemsku izloženost zoledronatnoj kiselini.
As with other bisphosphonates, the retention time of zoledronic acid in bones is very long.
Kao i s drugim bisfosfonatima, vrijeme zadržavanja zoledronatne kiseline u kostima je vrlo dugo.
Clinical experience with acute overdose is limited.
Kliničko iskustvo s akutnim predoziranjem je ograničeno.
− Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
- teška alergijska reakcija: nedostatak zraka, oticanje koje uglavnom zahvaća lice i grlo.
Your doctor can recommend a mild pain reliever such as ibuprofen or paracetamol to reduce these side effects.
Vaš liječnik će Vam preporučiti blagi lijek protiv bolova poput ibuprofena ili paracetamola, kako bi se smanjile ove nuspojave.
Patients receiving zoledronic acid 4 mg reported less increase in pain than those receiving placebo, and the difference reached significance at months 3, 9, 21 and 24.
Bolesnici koji su primali zoledronatnu kiselinu u dozi od 4 mg prijavili su manje povećanje boli od onih koji su primali placebo, a ta je razlika bila značajna u 3., 9., 21. i 24. mjesecu.
Patients should be informed about symptoms of hypocalcaemia and receive adequate clinical monitoring during the period of risk.
Bolesnike treba informirati o simptomima hipokalcemije i klinički nadzirati tijekom perioda rizika.
Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Farmakoterapijska skupina: lijekovi za liječenje bolesti kostiju, bisfosfonati, ATK oznaka: M05BA08
Cases of severe hypocalcaemia requiring hospitalisation have been reported.
Prijavljeni su slučajevi teške hipokalcemije koji zahtijevaju hospitalizaciju.
Concentrate for solution for infusion (sterile concentrate)
Koncentrat za otopinu za infuziju (sterilni koncentrat)
The early disposition phases (α and β, with t½ values above) presumably represent rapid uptake into bone and excretion via the kidneys.
Rane faze dispozicije (α i β, s t½ vrijednostima navedenim gore) vjerojatno predstavljaju brzu apsorpciju u kost i izlučivanje putem bubrega.
Tell your doctor about any of the following serious side effects straight away:
Odmah obavijestite svog liječnika o svakoj od sljedećih ozbiljnih nuspojava:
In Paget's disease, bone remodelling is too rapid and new bone is formed in a disordered fashion, which makes it weaker than normal.
Kod Pagetove bolesti preoblikovanje kosti je prebrzo te se nova kost stvara na poremećen način, čime postaje slabija nego normalno.
The symptoms are usually mild to moderate and go away within three days.
Simptomi su obično blagi do umjereni i nestaju unutar tri dana.
ONJ can also occur after stopping treatment.
ONČ se također može javiti nakon prestanka liječenja.
Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
pamidronat 90 mg (n=99) *p-vrijednosti naspram pamidronata
This uptake into bone is common for all bisphosphonates and is presumably a consequence of the structural analogy to pyrophosphate.
Ova pohrana u kost je zajednička za sve bisfosfonate i vjerojatno je posljedica analogne strukture s pirofosfatom.
It belongs to a group of medicines called bisphosphonates and is used to treat Paget's disease of the bone in adults.
Pripada skupini lijekova koji se nazivaju bisfosfonati i koji se koriste za liječenje Pagetove bolesti kostiju u odraslih.
• Transient increase in serum creatinine may be greater in patients with underlying impaired renal function.
• prolazno povećanje serumskog kreatinina može biti veće u bolesnika s podležećim oštećenjem bubrega
** Accounts for all skeletal events, the total number as well as time to each event during the trial
** Odnosi se na sve koštane događaje, njihov ukupni broj i vrijeme do svakog pojedinog događaja tijekom ispitivanja.
Painful redness and/or swelling of the eye.
- bolno crvenilo i/ili oticanje oka.
Other disturbances of mineral metabolism must also be effectively treated (e.g. diminished parathyroid reserve, intestinal calcium malabsorption).
Druge poremećaje metabolizma minerala također treba učinkovito liječiti (npr. smanjiti paratiroidne rezerve, crijevnu malapsorpciju kalcija).
The percentage of patients who experienced adverse reactions was lower in a smaller study (19.5%, 10.4%, 10.7% after the first, second and third infusion, respectively), where prophylaxis against adverse reactions was used.
Postotak bolesnika koji su imali nuspojave bio je niži u manjoj studiji (19,5%, 10,4%, 10,7% nakon prve, druge, odnosno treće infuzije) kad je bila korištena profilaksa protiv nuspojava.
If you wear dentures you should make sure these fit properly.
Ako nosite protezu, pazite da dobro prilježe.
Stable for 24 hours at 2
Rok valjanosti: Stabilan 24 sata na 2
CLcr is calculated from serum creatinine using the Cockcroft-Gault formula.
CLcr izračunava se pomoću Cockcroft-Gaultove formule.
The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone, but the precise molecular mechanism leading to the inhibition of osteoclastic activity is still unclear.
Selektivno djelovanje bisfosfonata na kost temelji se na njihovom visokom afinitetu za mineraliziranu kost, no točan molekularni mehanizam koji dovodi do inhibicije osteoklastične aktivnosti još nije jasan.
For information on the infusion of Zoledronic Acid Hospira, see section 6.6.
Za informacije o infuziji Zoledronatne kiseline Hospira, vidjeti dio 6.6.
The mean time of ending the Extended Observation Period due to the need for Paget's re-treatment from the initial dose was longer for zoledronic acid (7.7 years) than for risedronate (5.1 years).
Srednje vrijeme od završetka produljenog perioda praćenja od početne doze, zbog potrebe za ponovnim liječenjem Pagetove bolesti, bilo je dulje za zoledronatnu kiselinu (7,7 godina) nego za risedronat (5,1 godina).
The efficacy of one infusion of 5 mg zoledronic acid versus daily doses of 30 mg risedronate for 2 months was demonstrated in two 6-month comparative trials.
Djelotvornost jedne infuzije 5 mg zoledronatne kiseline naspram dnevnih doza od 30 mg risedronata za 2 mjeseca bila je pokazana u dva 6-mjesečna usporedna ispitivanja.
If a lower dose of Zoledronic Acid Hospira is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Ako je potrebna niža doza Zoledronatne kiseline Hospira, prvo izvucite odgovarajući volumen kako je navedeno niže i potom ga dodatno razrijedite sa 100 ml otopine za infuziju.
p-value Skeletal morbidity rate p-value Risk reduction of suffering from multiple events** (%)
p-vrijednost stopa koštanog pobola p-vrijednost smanjenje rizika od višestrukih događaja** (%)
Additional information on handling of Zoledronic Acid Hospira, including guidance on preparation of reduced doses, is provided in section 4.2.
Dodatne informacije o rukovanju Zoledronatnom kiselinom Hospira, uključujući upute za pripremu sniženih doza, nalaze se u dijelu 4.2.
Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
Tijekom prvih 24 sata, 39 ± 16% primijenjene doze izlučuje se mokraćom, dok se ostatak uglavnom veže na koštano tkivo.
After 6 months, zoledronic acid showed 96% (169/176) and 89% (156/176) response and serum alkaline phosphatase (SAP) normalisation rates compared to 74% (127/171) and 58% (99/171) for risedronate (all p<0.001).
Nakon 6 mjeseci, zoledronatna kiselina je pokazala 96% (169/176) i 89% (156/176) odgovor i normalizaciju razina alkalne fosfataze u serumu naspram 74% (127/171) i 58% (99/171) za risedronat (sve p<0,001).
The usual dose is 5 mg, given to you as one single infusion into a vein by your doctor or nurse.
Uobičajena doza je 5 mg, a daje Vam je liječnik ili medicinska sestra u obliku jednokratne infuzije u venu.
It is especially important for your doctor to know all the medicines you are taking, especially if you are taking any medicines known to be harmful to your kidneys (e.g. aminoglycosides) or diuretics (“waterpills”) that may cause dehydration.
Osobito je važno da Vaš liječnik zna za sve lijekove koje uzimate, naročito ako uzimate lijekove za koje je poznato da štetno djeluju na Vaše bubrege (npr. aminoglikozidi) ili ako uzimate diuretike ("tablete za mokrenje") koji mogu uzrokovati dehidraciju.
• Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of zoledronic acid.
• bolesnici, pogotovo stariji i oni koji primaju diuretsku terapiju, trebaju biti prikladno hidrirani prije primjene zoledronatne kiseline
Low levels of phosphate in the blood.
Niske razine fosfata u krvi.
In the Paget's disease trials, symptomatic hypocalcaemia was observed in approximately 1% of patients, in all of whom it resolved.
U kliničkim ispitivanjima Pagetove bolesti opažena je simptomatska hipokalcemija u otprilike 1% bolesnika, od koje su se svi oporavili.
Confusion
konfuzija
In addition to being a potent inhibitor of bone resorption, zoledronic acid also possesses several antitumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease.
Osim što je potentni inhibitor resorpcije kosti, zoledronatna kiselina također ima nekoliko antitumorskih svojstava koja bi mogla pridonositi njezinoj sveukupnoj djelotvornosti u liječenju metastatske koštane bolesti.
Statistically significant differences are marked (*p<0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
Označene su statistički značajne razlike (*p < 0,05) između dvije terapije usporedbe (4 mg zoledronatne kiseline naspram placeba)
− Low level of calcium in the blood.
- niska razina kalcija u krvi.
Acute phase reaction, pain
reakcija akutne faze, bol
At the request of the European Medicines Agency, Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
Zoledronic Acid Hospira can be given to people aged 65 years and over.
Zoledronatna kiselina Hospira može se davati osobama u dobi od 65 ili više godina.
- After opening the bag, the product should be used immediately in order to avoid microbial contamination.
- Nakon otvaranja vrećice, lijek treba odmah primijeniti kako bi se izbjeglo mikrobiološko onečišćenje.
There was no accumulation of zoledronic acid in plasma after multiple doses given every 28 days.
Nije došlo do akumulacije zoledronatne kiseline u plazmi nakon višestrukih doza koje se primjenjuju svakih 28 dana.
If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, short-term supplemental therapy may be necessary.
Ako se razviju hipokalcemija, hipofosfatemija ili hipomagnezijemija, možda bude potrebna kratkotrajna terapija njihovim nadomjescima.
Any unused solution should be discarded.
Svu neiskorištenu otopinu treba baciti.
1 intravenous bag
1 intravenska vrećica
Bone biopsy results showed bone of normal quality with no evidence of impaired bone remodelling and no evidence of mineralisation defects.
Rezultati biopsije kosti pokazali su kost normalne kvalitete bez dokaza oštećenog remodeliranja kosti kao i bez dokaza defekata mineralizacije.
The inter- and intra-subject variation for plasma clearance of zoledronic acid was shown to be 36% and 34%, respectively.
Pokazalo se da inter- i intra-individualno variranje u klirensu zoledronatne kiseline iz plazme je 36%, odnosno 34%.
In a large clinical trial in 7,736 patients, osteonecrosis of the jaw has been reported in one patient treated with zoledronic acid and one patient treated with placebo.
U velikom kliničkom ispitivanju na 7736 bolesnika, osteonekroza čeljusti je prijavljena u jednog bolesnika liječenih zoledronatnom kiselinom i jednog bolesnika koji je primao placebo.
Bone histology was evaluated in 7 patients with Paget's disease 6 months after treatment with 5 mg zoledronic acid.
Histologija kosti procijenjena je u 7 bolesnika s Pagetovom bolešću 6 mjeseci nakon liječenja s 5 mg zoledronatne kiseline.
Incidence of individual adverse reactions following the first infusion was: fever (17.1%), myalgia (7.8%), flu-like symptoms (6.7%), arthralgia (4.8%) and headache (5.1%).
Incidencija pojedinih nuspojava nakon prve infuzije bila je: vrućica (17,1%), mialgija (7,8%), simptomi nalik gripi (6,7%), artralgija (4,8%) i glavobolja (5,1%).
Angioneurotic oedema
angioneurotski edem
oC after dilution
oC nakon razrjeđivanja.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
U bolesnika koji razviju osteonekrozu čeljusti za vrijeme terapije bisfosfonatima, stomatološki kirurški zahvat može pogoršati stanje.
Clinical efficacy in the treatment of Paget's disease of the bone
Klinička djelotvornost u liječenju Pagetove bolest kosti
- Carefully follow all the other instructions given to you by your doctor, nurse or pharmacist.
- Pažljivo slijedite sve druge upute koje su Vam dali liječnik, medicinska sestra ili ljekarnik.
Each pack contains one vial with concentrate.
Svako pakiranje sadrži jednu bočicu s koncentratom.
The long duration of action of zoledronic acid is attributable to its high binding affinity for the active site of farnesyl pyrophosphate (FPP) synthase and its strong binding affinity to bone mineral.
Dugo trajanje djelovanja zoledronatne kiseline pripisuje se njenom visokom afinitetu vezanja na aktivno mjesto farnezil pirofosfat (FPP) sintaze i njenom snažnom afinitetu vezanja na mineral kosti.
The mechanism behind the increased incidence of atrial fibrillation in this single clinical trial is unknown.
Mehanizam koji je dovodio do povećane incidencije fibrilacije atrija u tom jednom kliničkom ispitivanju je nepoznat.
− Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Obratite se liječniku ako imate bol u uhu, iscjedak iz uha i/ili infekciju uha.
Hyperkalaemia, hypernatraemia
hiperkalemija, hipernatremija
Solution for infusion 1 intravenous bag
otopina za infuziju 1 intravenska vrećica
While the risk is reduced with a dose of zoledronic acid administered over 15 minutes, deterioration in renal function may still occur.
Premda je rizik smanjen kod primjene zoledronatne kiseline primijenjene tijekom 15 minuta i dalje može nastupiti pogoršanje funkcije bubrega.
No teratological or embryo/foetal effects were observed in rabbits, although maternal toxicity was marked at 0.1 mg/kg due to decreased serum calcium levels.
U kunića nisu opaženi teratološki ili embrio/fetalni učinci, iako je toksičnost za majku bila izrazita pri dozi od 0,1 mg/kg zbog smanjenih razina kalcija u serumu.
You may eat normally on the day you are treated with Zoledronic Acid Hospira.
Možete normalno jesti na dan liječenja Zoledronatnom kiselinom Hospira.
While being treated with Zoledronic Acid Hospira, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Za vrijeme liječenja Zoledronatnom kiselinom Hospira, morate održavati dobru oralnu higijenu (uključujući redovito pranje zuba) i obavljati rutinske preglede kod zubara.
Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given Zoledronic Acid Hospira.
Pažljivo slijedite sve upute koje ste dobili od liječnika, ljekarnika ili medicinske sestre prije nego primijenite Zoledronatnu kiselinu Hospira.
The type of adverse reactions observed in this population were similar to those previously seen in adults with advanced malignancies involving the bone (see section 4.8).
Vrsta nuspojava opažena u ove populacije bila je slična onima koje su prethodno viđene u odraslih bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kost (vidjeti dio 4.8).
Your doctor may advise you to take calcium and vitamin D supplements (e.g. tablets) for at least the first ten days after being given Zoledronic Acid Hospira.
Liječnik Vam može savjetovati da uzimate kalcij i vitamin D u obliku nadomjestaka prehrani (na primjer tableta) najmanje tijekom prvih deset dana nakon primjene Zoledronatne kiseline Hospira.
The study treatment period was 12 months preceded by a 4- to 9-week screening period during which vitamin D and elemental calcium supplements were taken for at least 2 weeks.
Ispitivano liječenje trajalo je 12 mjeseci, a prethodilo mu je probirno razdoblje od 4 do 9 tjedana tijekom kojeg su bolesnici uzimali vitamin D i nadomjestke elementarnog kalcija tijekom najmanje 2 tjedna.
Re-treatment consists of an additional intravenous infusion of 5 mg zoledronic acid after an interval of one year or longer from initial treatment in patients who have relapsed.
Ponovno liječenje sastoji se od dodatne intravenske infuzije 5 mg zoledronatne kiseline nakon perioda od jedne godine ili duljem od početnog liječenja bolesnika u kojih se bolest ponovno pojavila.
- Patients with hypocalcaemia (see section 4.4).
- Bolesnici s hipokalcemijom (vidjeti dio 4.4).
The majority of the side effects, such as fever and chills, pain in the muscles or joints, and headache, occur within the first three days following the dose of Zoledronic Acid Hospira.
Većina nuspojava, poput vrućice i zimice, bolova u mišićima ili zglobovima te glavobolje javlja se unutar prva tri dana nakon primjene doze Zoledronatne kiseline Hospira.
Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Zoledronatna kiselina nije pokazala mutagenost na provedenim testovima mutagenosti, a ispitivanje kancerogenosti nije pružilo nikakav dokaz kancerogenog potencijala.
The incidence of post-dose symptoms occurring within the first three days after administration of Zoledronic Acid Hospira can be reduced with the administration of paracetamol or ibuprofen shortly following Zoledronic Acid Hospira administration.
Incidencija simptoma koji se javljaju u prva tri dana nakon primjene doze Zoledronatne kiseline Hospira mogu se smanjiti uzimanjem paracetamola ili ibuprofena nedugo nakon uzimanja Zoledronatne kiseline Hospira.
The main molecular target of zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase.
Glavni molekularni cilj zoledronatne kiseline u osteoklastu je enzim farnezil pirofosfat sintaza.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Unutar svake skupine učestalosti nuspojave su prikazane prema padajućoj ozbiljnosti.
In clinical studies, zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
U kliničkim ispitivanjima zoledronatna kiselina primjenjivala se istodobno s uobičajeno primijenjenim antitumorskim lijekovima, diureticima, antibioticima i analgeticima bez klinički vidljivih interakcija.
In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
U kliničkim je ispitivanjima liječenje zoledronatnom kiselinom nastavljeno tek kad se razina kreatinina vratila na vrijednosti unutar 10% početne vrijednosti (vidjeti dio 4.4).
− Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with zoledronic acid.
- Ispitivanja s nekoliko vrsta infuzijskih linija od polivinilklorida, polietilena i polipropilena nisu pokazala inkompatibilnost sa zoledronatnom kiselinom.
Due to the rapid onset of effect of zoledronic acid on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion of zoledronic acid (see section
Zbog brzog nastupa učinka zoledronatne kiseline na pregradnju kostiju može se razviti prolazna hipokalcemija, ponekad simptomatska, koja se može razviti i obično je najviša unutar prvih 10 dana nakon infuzije zoledronatne kiseline (vidjeti dio 4.8).
In the clinical trials, renal deterioration was defined as follows:
U kliničkim je ispitivanjima pogoršanje funkcije bubrega bilo definirano na sljedeći način:
Since zoledronic acid is not metabolised in humans and the substance was found to have little or no capacity as a direct-acting and/or irreversible metabolism-dependent inhibitor of P450 enzymes, zoledronic acid is unlikely to reduce the metabolic clearance of substances which are metabolised via the cytochrome P450 enzyme systems.
Budući da se zoledronatna kiselina ne metabolizira u ljudi, a da je utvrđeno da ima malu ili nikakvu sposobnost da, djelujući direktno i/ili kao ireverzibilni inhibitor ovisan o metabolizmu, inhibira P450 enzime, nije vjerojatno da će zoledronatna kiselina smanjiti metabolički klirens tvari koje se metaboliziraju preko enzimskog sustava citokroma P450.
The majority of these reactions occur within the first three days following zoledronic acid administration.
Većina tih nuspojava pojavila se unutar prva tri dana nakon primjene zoledronatne kiseline.
The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone.
Selektivno djelovanje bisfosfonata na kost temelji se njihovom visokom afinitetu za mineraliziranu kost.
Treatment of Paget's disease of the bone in adults.
Liječenje Pagetove bolesti kostiju u odraslih.
The majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Većina prijavljenih slučajeva odnosila se na onkološke bolesnike nakon vađenja zuba ili drugih stomatoloških operacija.
Zoledronic acid 8 mg (N=90)
zoledronatna kiselina 8 mg (n=90)
Re-treatment of Paget's disease: After initial treatment with zoledronic acid in Paget's disease, an extended remission period is observed in responding patients.
Ponovno liječenje Pagetove bolesti: Nakon početnog liječenja Pagetove bolesti zoledronatnom kiselinom, produženi period remisije opažen je u bolesnika koji su dobro reagirali na liječenje.
• Creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula before each Zoledronic Acid Hospira dose.
• potrebno je izračunati klirens kreatinina na temelju stvarne tjelesne težine pomoću CockcroftGault formule prije svake doze Zoledronatne kiseline Hospira
Increasing the infusion time from 5 to 15 minutes caused a 30% decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve.
Produljenje trajanja infuzije s 5 na 15 minuta prouzročilo je 30%-tno sniženje koncentracije zoledronatne kiseline na kraju infuzije, ali nije imalo nikakvog učinka na područje ispod krivulje koncentracije u plazmi naspram vremena mjerenja.