natgillin/translations-raw huggingface dataset:
No symptomatic cases of hypocalcaemia were observed.
Nisu opaženi simptomatski slučajevi hipokalcijemije.
It is important that you follow this advice carefully so that the level of calcium in your blood does not become too low in the period after the infusion.
Važno je da se pažljivo pridržavate tog savjeta kako razina kalcija u krvi ne bi postala preniska u razdoblju nakon primjene infuzije.
The frequency of hypocalcaemia was much lower following subsequent infusions.
Učestalost hipokalcijemije bila je znatno niža nakon daljnjih infuzija.
Class effects:
Učinci klase:
2100 Gödöllő
2100 Gödöllő Mađarska
A summary of results is presented in Table 3.
Sažetak rezultata prikazan je u Tablici 3.
Zoledronic acid Teva Generics may work for longer than one year, and your doctor will let you know if you need to be treated again.
Zoledronatna kiselina Teva Generics može djelovati duže od godinu dana, a liječnik će Vam reći ako se trebate ponovo liječiti.
• When to seek attention from the health care provider
• Kada zatražiti pomoć zdravstvenog djelatnika
Limited data on re-treatment of Paget's disease are available (see section 5.1).
Dostupni su samo ograničeni podaci o ponovnom liječenje Pagetove bolesti (vidjeti dio 5.1).
This is especially important in patients who take diuretics (“water pills”) and in elderly patients.
To je osobito važno u bolesnika koji uzimaju diuretike („tablete za mokrenje“) i u starijih bolesnika.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za sve infromacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje u promet gotovog lijeka:
• Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non smoking and healthy diet
• Potreba za primjerenim nadomještanjem kalcija i vitamina D, primjerenom fizičkom aktivnošću, nepušenjem i zdravom prehranom
Table 1 Infections and infestations
Tablica 1. Infekcije i infestacije
Poor healing of these fractures has also been reported.
Također je zabilježeno slabo zacjeljivanje tih prijeloma.
EXP After opening: 24 hours at 2°C - 8°C
Nakon otvaranja: 24 sata na 2°C - 8°C
** Based on post-marketing reports.
** Temeljeno na izvješćima poslije stavljanja u promet.
No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.
Dozu nije potrebno prilagođavati jer su bioraspoloživost, distribucija i eliminacija bili slični u starijih bolesnika i mlađih ispitanika.
In the HORIZON-RFT study 508 men were randomised into the study and 185 patients had BMD assessed at 24 months.
U ispitivanju HORIZON-RFT randomizirano je 508 muškaraca i u 185 bolesnika BMD je bio procijenjen nakon 24 mjeseca.
Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Zoledronatna kiselina bila je proučavana u štakora zbog potencijalnih štetnih učinaka na plodnost roditeljske i F1 generacije.
At the menopause, a woman's ovaries stop producing the female hormone oestrogen, which helps keep bones healthy.
U menopauzi ženski jajnici prestaju stvarati ženski hormon estrogen koji pomaže u održavanju zdravih kostiju.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Unutar svake skupine učestalosti, nuspojave su poredane prema padajućoj ozbiljnosti.
- if you have hypocalcaemia (this means that the levels of calcium in your blood are too low).
- ako imate hipokalcijemiju (što znači da imate prenisku razinu kalcija u krvi).
The physician educational material should contain the following key elements:
Edukativni materijali za liječnika trebaju sadržavati sljedeće ključne elemente:
These could be signs of bone damage in the jaw (osteonecrosis).
To bi mogli biti znakovi oštećenja kostiju u čeljusti (osteonekroze).
Hypocalcaemia* Uncommon Anorexia, decreased appetite
Hipokalcijemija * Manje često Anoreksija, smanjen apetit
The majority of patients continued to receive glucocorticoids for the one year duration of the trial.
Većina bolesnika nastavila je primati glukokortikoide tijekom godine dana trajanja ispitivanja.
The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race or body weight.
Ukupni klirens iz organizma je 5,04 ± 2,5 l/sat, neovisno o dozi i bez obzira na spol, dob, rasu i tjelesnu težinu.
At least one new vertebral fracture (0-1 year) At least one new vertebral fracture (0-2 year) At least one new vertebral fracture (0-3 year) ** p <0.0001
Najmanje jedan novi vertebralni prijelom (0-1 godina) Najmanje jedan novi vertebralni prijelom (0-2 godine) Najmanje jedan novi vertebralni prijelom (0-3 godine) ** p <0,0001
Osteoporosis could also occur in men and women because of the long term use of steroids, which can affect the strength of bones.
Osteoporoza se također može pojaviti u muškaraca i žena zbog dugotrajnog korištenja steroida koji utječu na čvrstoću kostiju.
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.
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 bubrege (npr. aminoglikozidi) ili ako uzimate diuretike (“tablete za mokrenje”) koji mogu uzrokovati dehidraciju.
Side effects related to the first infusion are very common (occurring in more than 30% of patients) but are less common following subsequent infusions.
Nuspojave povezane s prvom infuzijom su vrlo česte (javljaju se u više od 30% bolesnika), ali su znatno rjeđe nakon daljnjih infuzija.
Many of these patients had signs of local infection including osteomyelitis, and the majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Mnogi od tih bolesnika imali su znakove lokalne infekcije uključujući osteomijelitis, a većina izvješća odnosi se na bolesnike s rakom nakon vađenja zubi ili drugih stomatoloških operacija.
If you feel dizzy while taking Zoledronic acid Teva Generics, do not drive or use machines until you feel better.
Ako osjećate omaglicu dok uzimate Zoledronatnu kiselinu Teva Generics, nemojte upravljati vozilima ili strojevima dok se ne budete osjećali bolje.
Pharmachemie B.V. Swensweg 5
Pharmachemie B.V. sweg 5
Repeat dosing did not lead to further reduction of bone turnover markers.
Ponovljeno doziranje nije dovelo do dodatnog smanjenja markera koštane pregradnje.
Many patients with osteoporosis have no symptoms but they are still at risk of breaking bones because osteoporosis has made their bones weaker.
Mnogi bolesnici s osteoporozom nemaju simptome, ali su svejedno izloženi riziku od loma kostiju jer je osteoporoza oslabila njihove kosti.
Histomorphometric analysis showed a 63% reduction in bone turnover.
Histomorfometrijska analiza pokazala je smanjenje koštane pregradnje od 63%.
It is normal that old bone is removed and is replaced with new bone material.
Normalno je da se stara kost razgrađuje i da se obnavlja novim koštanim tkivom.
Thus these results precluded determining a definitive effect of zoledronic acid on fertility in humans.
Stoga su ti rezultati spriječili utvrđivanje definitivnog učinka zoledronatne kiseline na plodnost u ljudi.
The symptoms are usually mild to moderate and go away within three days.
Simptomi su obično blagi do umjereno teški i nestaju unutar tri dana.
Not known** Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects)
Nije poznato** Osteonekroza čeljusti (vidjeti dijelove 4.4 i 4.8 Učinci klase)
Physicians should consider clinical monitoring for these patients.
Liječnici moraju procijeniti potrebu za kliničkim praćenjem u tih bolesnika.
- if you have severe kidney problems.
- ako imate teških problema s bubrezima.
These results were consistent with biochemical marker evidence of normalisation of bone turnover.
Ti su rezultati bili u skladu s biokemijskim markerima koji su pokazali normalizaciju koštane pregradnje.
Placebo (N = 1,062) event rate
Placebo (N=1062) stopa događaja
This is especially important for the elderly and for patients receiving diuretic therapy.
To je osobito važno za starije osobe i bolesnike koji primaju diuretsku terapiju.
The primary efficacy variable was the incidence of clinical fractures over the duration of the study.
Primarna varijabla djelotvornosti bila je incidencija kliničkih prijeloma tijekom trajanja ispitivanja.
Uncommon (may affect up to 1 in 100 people) Skin reactions such as redness.
Manje često (mogu se javiti u do 1 na 100 osoba) Kožne reakcije poput crvenila.
The patient information pack should be provided and contain the following key messages:
Potrebno je napraviti informativni paket za bolesnika u kojem će biti navedene sljedeće ključne poruke:
During this entire time period bone turnover markers were within the pre-menopausal range at the end of each year.
Tijekom čitavog razdoblja markeri koštane pregradnje bili su unutar premenopauzalnog raspona na kraju svake godine.
Patients should be informed about symptoms of hypocalcaemia and receive adequate clinical monitoring during the period of risk.
Bolesnike je potrebno obavijestiti o simptomima hipokalcijemije te ih tijekom razdoblja rizika odgovarajuće klinički pratiti.
If you experience any of the above side effects, you should contact your doctor immediately.
Ako primijetite bilo koju od navedenih nuspojava, odmah se obratite svom liječniku.
As with other bisphosphonates, the retention time of zoledronic acid in bones is very long.
Kao i u slučaju ostalih bisfosfonata, vrijeme zadržavanja zoledronatne kiseline u kostima je vrlo dugo.
Gödöllő 2100
Gödöllő 2100 Mađarska
Effect on all clinical fractures
Učinak na sve kliničke prijelome
These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Ti poprečni ili kratki kosi prijelomi mogu nastati bilo gdje na bedrenoj kosti, od neposredno ispod malog trohantera do neposredno iznad suprakondilarnog dijela.
• Monitoring of serum creatinine should be considered in at-risk patients.
• Praćenje kreatinina u serumu potrebno je uzeti u obzir u bolesnika s rizikom.
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.
INFORMATION FOR THE HEALTHCARE PROFESSIONAL
INFORMACIJE ZA ZDRAVSTVENE DJELATNIKE
• Transient increase in serum creatinine may be greater in patients with underlying impaired renal function.
• Prolazni porast kreatinina u serumu može biti veći u bolesnika koji imaju predležeću oštećenu funkciju bubrega.
Other disturbances of mineral metabolism must also be effectively treated (e.g. diminished parathyroid reserve, intestinal calcium malabsorption).
Ostali poremećaji metabolizma minerala također se moraju učinkovito liječiti (npr. smanjenje zalihe paratireoidnih žlijezda, intestinalna malapsorpcija kalcija).
Following the menopause bone loss occurs, bones become weaker and break more easily.
Nakon menopauze dolazi do gubitka kosti, kosti postaju slabije i lakše se lome.
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.
Povećanje vremena infuzije sa 5 na 15 minuta uzrokovalo je 30% smanjenje koncentracije zoledronatne kiseline na kraju infuzije, ali nije imalo učinka na površinu ispod krivulje plazmatske koncentracije u odnosu na vrijeme.
While on treatment, these patients should avoid invasive dental procedures if possible.
Ako je moguće, ovi bolesnici moraju izbjegavati invazivne stomatološke zahvate tijekom liječenja.
The study was not designed to measure significant differences in hip fracture, but a trend was seen towards reduction in new hip fractures.
Ispitivanje nije bilo osmišljeno tako da mjeri značajne razlike prijeloma kuka, ali je zapažen trend smanjenja novih prijeloma kuka.
There was no accumulation of the active substance in plasma after multiple doses given every 28 days.
Nije bilo nakupljanja zoledronatne kiseline u plazmi nakon višestrukih doza lijeka davanih svakih 28 dana.
The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of zoledronic acid on an individual patient basis, particularly after 5 or more years of use.
Potrebu za nastavkom liječenja potrebno je ponovno procijeniti periodički na osnovi odnosa koristi i potencijalnih rizika zoledronatne kiseline u svakog pojedinačnog bolesnika, a posebno nakon 5 ili više godina primjene.
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 znakova oštećenog remodeliranja kosti kao i bez dokaza o mineralizacijskim defektima.
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 prije navedenim t½ vrijednostima) vjerojatno predstavljaju brz koštani unos i izlučivanje putem bubrega.
Swelling, redness, pain and itching to the eyes or eye sensitivity to light.
Oticanje, crvenilo, bol i svrbež očiju ili osjetljivost očiju na svjetlost.
Paget's disease
Pagetova bolest
Any clinical fracture (1)
Bilo koji klinički prijelom (1)
Effect on bone mineral density (BMD)
Učinci na mineralnu gustoću kosti (BMD)
Decreased circulating levels of sex hormones, mainly oestrogens converted from androgens, also play a role in the more gradual bone loss observed in men.
Sniženje razine spolnih hormona u cirkulaciji, prvenstveno estrogena koji su nastali od androgena, također ima ulogu u postupnijem gubitku kosti zamijećenom u muškaraca.
This uptake into bone is common for all bisphosphonates and is presumably a consequence of the structural analogy to pyrophosphate.
Taj je unos u koštano tkivo zajednički za sve bisfosfonate i vjerojatno je posljedica strukturalne analogije s pirofosfatima.
All cause mortality was 10% (101 patients) in the zoledronic acid-treated group compared to 13% (141 patients) in the placebo group.
Smrtnost zbog svih uzroka bila je 10% (101 bolesnik) u skupini liječenih zoledronatnom kiselinom u usporedbi s 13% (141 bolesnik) u placebo skupini.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
U bolesnika koji razviju osteonekrozu čeljusti tijekom liječenja bisfosfonatima, stomatološka operacija mogla bi pogoršati stanje.
It is an inhibitor of osteoclast-mediated bone resorption.
Ona je inhibitor osteoklastične resorpcije kosti.
You must not be given Zoledronic acid Teva Generics if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Zoledronatnu kiselinu Teva Generics ne smijete primati ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete.
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 Teva Generics.
Liječnik Vam može savjetovati da uzimate nadomjestke kalcija i vitamina D (na primjer tablete) najmanje prvih deset dana nakon primjene Zoledronatne kiseline Teva Generics.
Teratogenicity was observed in rats at doses ≥ 0.2 mg/kg and was manifested by external, visceral and skeletal malformations.
Teratogenost je zapažena u štakora pri dozama od ≥ 0,2 mg/kg, a izražavala se vanjskim i visceralnim malformacijama te malformacijama skeleta.
- if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6).
- ako ste alergični na zoledronatnu kiselinu, druge bisfosfonate ili na bilo koju pomoćnu tvar ovog lijeka (navedeni u dijelu 6).
Zoledronic acid significantly decreased the incidence of one or more new vertebral fractures over three years and as early as the one year timepoint (see Table 2).
Zoledronatna kiselina značajno je smanjila incidenciju jednog ili više novih vertebralnih prijeloma tijekom tri godine i najranije već tijekom prve godine (vidjeti Tablicu 2).
The most frequent finding in the repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound's pharmacological antiresorptive activity.
Najčešći nalaz u ispitivanjima s ponovljenim dozama bio je povećano primarno spongiozno tkivo u metafizama dugih kostiju kod životinja u razvoju i to pri gotovo svim dozama, odnosno nalaz koji je odražavao farmakološko antiresorpcijsko djelovanje kemijskog spoja.
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 predoziranja koje dovodi do klinički značajne hipokalcijemije, obrat se može postići oralnom primjenom kalcija u obliku dodatka prehrani i/ili intravenskom infuzijom kalcijevog glukonata.
• Contraindication in pregnancy and in breast-feeding women
• Kontraindikacija u trudnica i u dojilja
It is currently unclear whether Zoledronic acid Teva Generics causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Zoledronic acid Teva Generics.
Trenutačno nije jasno uzrokuje li Zoledronatna kiselina Teva Generics te nepravilne otkucaje srca, ali morate se javiti liječniku ako osjetite takve simptome nakon što primite Zoledronatnu kiselinu Teva Generics.
Swelling and/or pain at the infusion site may occur.
Može doći do oticanja i/ili boli na mjestu primjene infuzije.
Very common Fever Common
Vrlo često Vrućica Često
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 završetka produljenog razdoblja praćenja zbog potrebe za ponovnim liječenjem Pagetove bolesti nakon početne doze bilo je duže u slučaju zoledronatne kiseline (7,7 godina) nego risedronata (5,1 godina).
Five of the 6 patients had SAP within the normal range at month 6 (Last Observation Carried Forward, LOCF).
Pet od 6 bolesnika imalo je SAP s normalnim rasponom nakon 6 mjeseci (uz posljednje zapažanje prenijeto dalje, engl.
Treatment of osteoporosis
Liječenje osteoporoze
For the treatment of Paget's disease, zoledronic acid should be prescribed only by physicians with experience in the treatment of Paget's disease of the bone.
Za liječenje Pagetove bolesti, zoledronatnu kiselinu smiju propisivati samo liječnici koji imaju iskustva u liječenju Pagetove bolesti kosti.
It comes in a clear plastic bottle.
Lijek je dostupan u prozirnim plastičnim bočicama.
Zoledronic acid Teva Generics is not recommended for anyone under 18 years of age.
Zoledronatna kiselina Teva Generics ne preporuča se osobama mlađima od 18 godina.
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% od primijenjene doze nađeno je u mokraći, dok je ostatak uglavnom ostao vezan na koštano tkivo.
Other medicines and Zoledronic acid Teva Generics Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Drugi lijekovi i Zoledronatna kiselina Teva Generics Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate ili ste nedavno uzeli ili biste mogli uzeti primijeniti bilo koje druge lijekove.
Your doctor will advise you and decide how long you should be treated with Zoledronic acid Teva Generics.
On će Vam dati savjet i odlučiti koliko dugo biste se trebali liječiti Zoledronatnom kiselinom Teva Generics.
Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
Obratite se svom liječniku ako osjetite bol, slabost ili nelagodu u bedru, kuku ili preponama jer to mogu biti rani znakovi mogućeg prijeloma bedrene kosti.
The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established.
Nisu utvrđene sigurnost i djelotvornost zoledronatne kiseline u djece i adolescenata ispod 18 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 od 5 mg zoledronatne kiseline u odnosu na dnevne doze od 30 mg risedronata za 2 mjeseca bila je pokazana u dva šestomjesečna usporedna ispitivanja.
Ninety-five percent of the patients received their infusion two or more weeks after the hip fracture repair and the median timing of infusion was approximately six weeks after the hip fracture repair.
Devedesetpet posto bolesnika je primilo svoju infuziju dva ili više tjedana nakon oporavka prijeloma kuka, a medijan vremena infuzije bio je približno šest tjedana nakon oporavka prijeloma kuka.
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 kako je opisno u daljnjem tekstu.
Thereafter bone markers stabilised within the pre-menopausal range.
Nakon toga su se koštani markeri stabilizirali unutar premenopauzalnog raspona.
Single and multiple 5 and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients yielded the following pharmacokinetic data, which were found to be dose independent.
Jednostruke i višestruke infuzije od 2, 4, 8 i 16 mg zoledronatne kiseline u trajanju od 5 i 15 minuta primijenjene u 64 bolesnika s koštanim metastazama dale su sljedeće farmakokinetičke podatke za koje je ustanovljeno da nisu ovisni o dozi.
Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Zoledronatna kiselina se u provedenim ispitivanjima mutagenosti nije pokazala mutagenom, dok ispitivanje karcinogenosti nije dalo nikakve dokaze o karcinogenom potencijalu.
It is important to take calcium and vitamin D supplements (for example tablets) as directed by your doctor.
Važno je uzimati nadomjestke kalcija i vitamina D (na primjer tablete) prema uputama liječnika.
Cyclic Olefin Polymer (COP) plastic bottle, fitted with a chlorobutyl/butyl rubber stopper and aluminium cap fitted with violet plastic flip off disc.
Plastična bočica od cikloolefinskog polimera (COP) s klorobutil/butilnim gumenim čepom i aluminijskom kapicom s ljubičastim plastičnim flip off diskom.
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 4.8).
Zbog brzog nastupa učinka zoledronatne kiseline na pregradnju kosti, može se razviti prolazna hipokalcijemija, koja je katkada simptomatska, a obično je najjača unutar prvih 10 dana nakon infuzije zoledronatne kiseline (vidjeti dio 4.8).
Zoledronic acid Teva Generics works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.
Zoledronatna kiselina Teva Generics djeluje tako što vraća proces preoblikovanja kosti u normalu osiguravajući stvaranje normalne kosti, čime kosti postaju snažnije.