FrancophonIA/ELRC3.0 huggingface dataset:
English: It is an inhibitor of osteoclastic bone resorption.
Croatian: Ona je inhibitor osteoklastične resorpcije kosti.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Croatian: Farmakoterapijska skupina: lijekovi za liječenje bolesti kostiju, bisfosfonati, ATK oznaka: M05BA08
English: As only limited clinical data are available in patients with severe hepatic insufficiency, no specific recommendations can be given for this patient population.
Croatian: Budući da su za bolesnike s teškom insuficijencijom jetre dostupni samo ograničeni klinički podaci, ne mogu se dati posebne preporuke za ovu populaciju bolesnika.
English: Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
Croatian: Liječnik će Vam savjetovati da prije svakog liječenja popijete dovoljnu količinu vode, kako bi se spriječila dehidracija.
English: Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Croatian: Mnogi od tih bolesnika primali su i kemoterapiju i kortikosteroide i imali su znakove lokalne infekcije uključujući osteomijelitis.
English: Zometa should not be used during pregnancy.
Croatian: Zometa se ne smije primjenjivati tijekom trudnoće.
English: Attention should also be paid to the possibility of hypomagnesaemia developing during treatment.
Croatian: Potrebno je obratiti pozornost i na mogućnost razvoja hipomagnezemije tijekom liječenja.
English: There were no statistically significant differences between the two zoledronic acid doses.
Croatian: Nije bilo statistički značajnih razlika između dvije doze zoledronatne kiseline.
English: The time to onset of symptoms varied from one day to several months after starting treatment.
Croatian: Vrijeme do početka simptoma kretalo se u rasponu od jednog dana do nekoliko mjeseci nakon početka liječenja.
English: Subchronic and chronic toxicity
Croatian: Subkronična i kronična toksičnost
English: Blurred vision, tearing of the eye, eye sensitivity to light.
Croatian: Zamagljen vid, suzenje oka, osjetljivost očiju na svjetlost.
English: There was no accumulation of zoledronic acid in plasma after multiple doses given every 28 days.
Croatian: Nije došlo do nakupljanja zoledronatne kiseline u plazmi nakon višestrukih doza koje se daju svakih 28 dana.
English: Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
Croatian: Teška alergijska reakcija: nedostatak zraka, oteklina koja uglavnom zahvaća lice i grlo.
English: Low level of calcium in the blood.
Croatian: Niska razina kalcija u krvi.
English: Since those patients were retreated with the 8 mg dose only, there are no data available allowing comparison with the 4 mg zoledronic acid dose.
Croatian: Budući da su ti bolesnici bili ponovno liječeni samo dozom od 8 mg, nema dostupnih podataka koji bi omogućili usporedbu s dozom od 4 mg zoledronatne kiseline.
English: Caution is indicated when Zometa is used with other potentially nephrotoxic medicinal products.
Croatian: Potreban je oprez kad se Zometa koristi s drugim potencijalno nefrotoksičnim lijekovima.
English: Cases of severe hypocalcaemia requiring hospitalisation have been reported.
Croatian: Bilo je zabilježenih slučajeva teške hipokalcemije koja je zahtijevala hospitalizaciju.
English: Low counts of white blood cells and blood platelets.
Croatian: Nizak broj bijelih krvnih stanica i krvnih pločica.
English: Patients whose blood calcium levels are not too high will also be prescribed calcium and vitamin D supplements to be taken each day.
Croatian: Bolesnicima čije razine kalcija u krvi nisu previsoke također će biti propisani nadomjesci kalcija i vitamina D koje moraju uzimati svaki dan.
English: Baseline creatinine clearance (ml/min)
Croatian: Početni klirens kreatinina (ml/min)
English: - If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zometa.
Croatian: - Ako se liječite radi snižavanja količine kalcija u krvi, obično ćete dobiti samo jednu infuziju
English: CLcr is calculated from serum creatinine using the Cockcroft-Gault formula.
Croatian: Klirens kreatinina izračunava se pomoću Cockcroft-Gaultove formule.
English: Women of child-bearing potential should be advised to avoid becoming pregnant.
Croatian: Ženama reproduktivne dobi potrebno je savjetovati da izbjegavaju trudnoću.
English: Although no teratogenicity or foetotoxicity was observed in the rabbit, maternal toxicity was found.
Croatian: Iako u kunića nije bila primijećena ni teratogenost niti fetotoksičnost, pronašla se toksičnost za majku.
English: In some instances, the hypocalcaemia may be life-threatening (see section 4.8).
Croatian: U nekim slučajevima hipokalcemija može biti opasna po život (vidjeti dio 4.8).
English: Acute toxicity
Croatian: Akutna toksičnost
English: The mechanism behind the increased incidence of atrial fibrillation in this single clinical trial is unknown.
Croatian: Mehanizam koji je dovodio do povećane incidencije fibrilacije atrija u tom jednom kliničkom ispitivanju nije poznat.
English: If the solution is not used immediately, it should be stored in a refrigerator at 2°C - 8°C.
Croatian: Ako se otopina ne upotrijebi odmah, treba je čuvati u hladnjaku na temperaturi od 2°C do 8°C.
English: Low blood pressure.
Croatian: Nizak krvni tlak.
English: In some instances the hypocalcaemia may be life-threatening.
Croatian: U nekim slučajevima hipokalcemija može biti opasna po život.
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zometa.
Croatian: Ako već imate hipokalcemiju, ona se mora korigirati prije uvođenja prve doze Zomete.
English: What Zometa is and what it is used for What you need to know before you are given Zometa How Zometa is used
Croatian: Što je Zometa i za što se koristi Što morate znati prije nego počnete uzimati Zometu
English: Anxiety, sleep disturbance
Croatian: Anksioznost, poremećaj spavanja
English: 1 bottle, 100 ml
Croatian: 1 boca, 100 ml
English: Clinical experience with acute overdose of Zometa is limited.
Croatian: Kliničko iskustvo s akutnim predoziranjem Zometom je ograničeno.
English: if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zometa belongs), or any of the other ingredients of this medicine (listed in section 6).
Croatian: ako ste alergični na zoledronatnu kiselinu, drugi bisfosfonat (skupina tvari kojoj pripada Zometa) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: NR NR 424 307
Croatian: ND ND 424 307
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Croatian: Ukupni klirens iz tijela iznosi 5,04±2,5 l/h, ne ovisi o dozi i na njega ne utječu spol, dob, rasa ni tjelesna težina.
English: Nausea, vomiting, decreased appetite
Croatian: Mučnina, povraćanje, smanjeni apetit
English: Low level of red blood cells (anaemia).
Croatian: Smanjeni broj crvenih krvnih stanica (anemija).
English: Most patients had relief of symptoms after stopping treatment.
Croatian: U većine bolesnika simptomi su se povukli nakon prestanka liječenja.
English: The most frequent finding in 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.
Croatian: Najčešći nalaz u ispitivanjima ponovljene doze bio je povećana primarna spongioza u metafizama dugih kostiju životinja u razvoju kod gotovo svih doza, što je odraz farmakološkog antiresorptivnog djelovanja spoja.
English: Patients received either 4 mg zoledronic acid or placebo every four weeks for one year.
Croatian: Bolesnici su primali 4 mg zoledronatne kiseline ili placebo svaka četiri tjedna tijekom jedne godine.
English: The treatment effects were less pronounced in patients with blastic lesions.
Croatian: Učinci liječenja bili su manje izraženi u bolesnika s blastičkim lezijama.
English: Age, body weight, gender and creatinine clearance appear to have no effect on zoledronic acid systemic exposure.
Croatian: Čini se da dob, tjelesna težina, spol i klirens kreatinina ne utječu na sustavnu izloženost zoledronatnoj kiselini.
English: • To reduce the amount of calcium in the blood in adult patients where it is too high due to the presence of a tumour.
Croatian: • smanjenje količine kalcija u krvi u odraslih bolesnika kad je količina kalcija prevelika zbog prisutnosti tumora.
English: Arthritis and joint swelling as a symptom of acute phase reaction
Croatian: Artritis i oticanje zglobova kao simptomi reakcije akutne faze
English: INFORMATION FOR THE HEALTHCARE PROFESSIONAL
Croatian: INFORMACIJA ZA ZDRAVSTVENOG
English: Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Croatian: Zoledronatna kiselina nije pokazala mutageno djelovanje na provedenim testovima mutagenosti, a ispitivanje kancerogenosti nije pružilo nikakav dokaz kancerogenog potencijala.
English: 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.
Croatian: Selektivno djelovanje bisfosfonata na kost temelji se njihovom velikom afinitetu za mineraliziranu kost, no točan molekularni mehanizam koji dovodi do inhibicije osteoklastične aktivnosti još nije jasan.
English: 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.
Croatian: Bolesnici koji su primali zoledronatnu kiselinu u dozi od 4 mg prijavili su manje povećanje bola od onih koji su primali placebo, a ta je razlika bila značajna u 3., 9., 21. i 24. mjesecu.
English: Tell your doctor about any of the following side effects as soon as possible:
Croatian: Obavijestite svog liječnika čim prije o svakoj sljedećoj nuspojavi:
English: Healthcare professionals are advised not to dispose of unused Zometa via the domestic sewage system.
Croatian: Zdravstvenim djelatnicima se savjetuje da ne uklanjaju neiskorištenu Zometu putem kanalizacije.
English: Do not use Zometa after the expiry date stated on the pack.
Croatian: Zometa se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju.
English: Shake the vial gently to dissolve the powder.
Croatian: Lagano protresite bočicu kako biste otopili prašak.
English: What you need to know before you are given Zometa
Croatian: Što morate znati prije nego počnete uzimati Zometu
English: 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.
Croatian: Osim što je jaki inhibitor resorpcije kosti, zoledronatna kiselina također ima nekoliko antitumorskih svojstava koja bi mogla pridonositi njezinoj cjelokupnoj djelotvornosti u liječenju metastatske koštane bolesti.
English: Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Croatian: Obratite se liječniku ako imate bol u uhu, iscjedak iz uha i/ili infekciju uha.
English: Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with Zometa.
Croatian: Ispitivanja s nekoliko vrsta infuzijskih linija napravljenih od polivinilklorida, polietilena i polipropilena pokazala su da nema inkompatibilnosti sa Zometom.
English: Acute phase reaction, pain
Croatian: Reakcija akutne faze, bol
English: These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Croatian: Ti poprečni ili kratki kosi prijelomi mogu nastati bilo gdje duž bedrene kosti, od mjesta neposredno ispod malog trohantera do neposredno iznad suprakondilarne zone.
English: Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja zoledronatne kiseline na životinjama pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: 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.
Croatian: 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 površinu ispod krivulje koncentracije u plazmi u vremenu mjerenja.
English: Acute phase reaction
Croatian: Reakcija akutne faze
English: It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received zoledronic acid.
Croatian: Trenutno nije jasno uzrokuje li zoledronatna kiselina taj nepravilan srčani ritam, no ako osjetite takve simptome nakon što primite zoledronatnu kiselinu, morate to prijaviti liječniku.
English: Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs).
Croatian: Intersticijska bolest pluća (upala tkiva oko vrećica zraka u plućima).
English: - Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
Croatian: - Istodobnu terapiju: kemoterapiju, inhibitore angiogeneze (vidjeti dio 4.5), radioterapiju vrata i glave, kortikosteroide.
English: 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.
Croatian: 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.
English: Clinical trial results in the treatment of severe osteogenesis imperfecta in paediatric patients aged 1 to 17 years
Croatian: Rezultati kliničkih ispitivanja u liječenju teškog oblika osteogenesis imperfecta u pedijatrijskih bolesnika u dobi od 1 do 17 godina
English: Poor healing of these fractures has also been reported.
Croatian: Zabilježeno je i slabo cijeljenje takvih prijeloma.
English: if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zometa and inform your doctor about your dental treatment.
Croatian: ako se liječite kod zubara ili trebate ići na zubarski kirurški zahvat, obavijestite svog zubara da se liječite Zometom i obavijestite svog liječnika o Vašem liječenju kod zubara.
English: Weight increase.
Croatian: Povećanje tjelesne težine.
English: Painful redness and/or swelling of the eye.
Croatian: Bolno crvenilo i/ili oticanje oka.
English: 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.
Croatian: Tijekom prva 24 sata, 39±16% primijenjene doze otkrije se u mokraći, dok se preostali dio u načelu veže za koštano tkivo.
English: Tell your doctor about any of the following serious side effects straight away:
Croatian: Odmah obavijestite svog liječnika o svakoj sljedećoj ozbiljnoj nuspojavi:
English: - Carefully follow all the other instructions given to you by your doctor, pharmacist or nurse.
Croatian: - Pažljivo slijedite sve druge upute koje su Vam dali liječnik, medicinska sestra ili ljekarnik.
English: 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).
Croatian: Nadalje, postoje dokazi povezanosti između hipokalcemije i sekundarnih neuroloških događaja zabilježenih u tim slučajevima koji uključuju: konvulzije, hipoesteziju i tetaniju (vidjeti dio 4.4).
English: Estimated treatment effects on BMD were similar, but the trial design was not sufficiently robust to establish non-inferior efficacy for zoledronic acid.
Croatian: Liječenje je imalo približno slične učinke na BMD, ali ustroj ispitivanja nije bio dovoljno robustan da bi se mogla utvrditi neinferiorna djelotvornost zoledronatne kiseline.
English: Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
Croatian: Reakcije probavnog sustava, kao što su mučnina i povraćanje, kao i gubitak apetita.
English: Dissolution must be complete before the solution is withdrawn.
Croatian: Otapanje mora biti dovršeno prije nego što se izvuče otopina.
English: How to prepare and administer Zometa
Croatian: Kako pripremiti i primijeniti Zometu
English: While being treated with Zometa, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Croatian: Za vrijeme liječenja Zometom, morate održavati dobru oralnu higijenu (uključujući redovito pranje zuba) i obavljati rutinske preglede kod zubara.
English: 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 Zometa along with driving and operating of machinery.
Croatian: Nuspojave poput omaglice i pospanosti mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima te je stoga potreban oprez kad se tijekom primanja Zomete upravlja vozilima i radi sa strojevima.
English: *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Croatian: * Doze su izračunate uz pretpostavku da je ciljni AUC 0,66 (mg•h/l) (klirens kreatinina = 75 ml/min).
English: Statistically significant differences are marked (*p<0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
Croatian: Označene su statistički značajne razlike (*p < 0,05) između dva liječenja (4 mg zoledronatne kiseline nasuprot placebu)
English: Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have a higher risk of developing osteonecrosis of the jaw.
Croatian: Bolesnici kod kojih je u tijeku kemoterapija i/ili radioterapija, koji uzimaju steroide, koji idu na kirurški zahvat zuba, koji ne obavljaju rutinske preglede kod zubara, koji imaju bolest desni, koji su pušači, ili koji su se prije liječili bisfosfonatima (u svrhu liječenja ili prevencije poremećaja kostiju) mogu imati veći rizik razvoja osteonekroze čeljusti.
English: For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Croatian: Kod bolesnika koji razviju osteonekrozu čeljusti za vrijeme terapije bisfosfonatima, stomatološki kirurški zahvat može pogoršati stanje.
English: Limited pharmacokinetic data in children with severe osteogenesis imperfecta suggest that zoledronic acid pharmacokinetics in children aged 3 to 17 years are similar to those in adults at a similar mg/kg dose level.
Croatian: Ograničeni farmakokinetički podaci u djece s teškim oblikom osteogenesis imperfecta ukazuju na to da je farmakokinetika zoledronatne kiseline u djece u dobi od 3 do 17 godina slična onoj u odraslih pri sličnoj razini doze u mg/kg.
English: If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, short-term supplemental therapy may be necessary.
Croatian: Ako se razviju hipokalcemija, hipofosfatemija ili hipomagnezemija, možda bude potrebna kratkotrajna terapija njihovim nadomjescima.
English: A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Croatian: Poremećaj rada bubrega koji se zove Fanconijev sindrom (kojeg inače može odrediti Vaš liječnik pomoću određenih testova urina).
English: Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Croatian: Uočeno je da se osteonekroza također vrlo rijetko pojavila i na drugim kostima osim čeljusti, naročito na kuku ili bedrima.
English: In the clinical studies, Zometa treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Croatian: U kliničkim je ispitivanjima liječenje Zometom nastavljeno tek kad se kreatinin vratio na vrijednosti unutar 10% početne vrijednosti (vidjeti dio 4.4).
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to zoledronic acid administration.
Croatian: Tijekom liječenja, invazivne stomatološke zahvate treba izvoditi tek nakon pažljivog razmatranja i izbjegavati ih neposredno blizu primjene zoledronatne kiseline.
English: 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.
Croatian: Bolesnike koji su primili više doze od preporučenih (vidjeti dio 4.2) treba pažljivo pratiti, budući da su primijećena oštećenja funkcije bubrega (uključujući zatajenje bubrega) i poremećaji serumskih elektrolita (uključujući kalcij, fosfor i magnezij).
English: Slow heart beat.
Croatian: Usporen rad srca.
English: Overhydration should be avoided in patients at risk of cardiac failure.
Croatian: Treba izbjeći pretjeranu hidraciju bolesnika s rizikom od srčanog zatajenja.
English: 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.
Croatian: 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 nadomjeske elementarnog kalcija tijekom najmanje 2 tjedna.
English: In long-term animal studies, zoledronic acid inhibits bone resorption without adversely affecting the formation, mineralisation or mechanical properties of bone.
Croatian: U dugotrajnim ispitivanjima na životinjama, zoledronatna kiselina inhibirala je resorpciju kosti bez štetnog djelovanja na stvaranje, mineralizaciju ili mehanička svojstva kosti.
English: There are no adequate data on the use of zoledronic acid in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni zoledronatne kiseline u trudnica.
English: Zometa contains the same active substance as found in Aclasta (zoledronic acid).
Croatian: Zometa sadrži istu djelatnu tvar koja se nalazi u Aclasti (zoledronatna kiselina).
English: 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).
Croatian: Vrsta nuspojava primijećena u ove populacije bila je slična onima koje su prethodno bile primijećene u odraslih bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kost (vidjeti dio 4.8).
English: These could be signs of bone damage in the jaw (osteonecrosis).
Croatian: To mogu biti znakovi oštećenja čeljusne kosti (osteonekroza).
English: Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse
Croatian: Hipertenzija, hipotenzija, fibrilacija atrija, hipotenzija s posljedičnom sinkopom ili cirkulacijskim kolapsom