FrancophonIA/ELRC3.0 huggingface dataset:
English: • swollen legs or feet
Croatian: • natečene noge ili stopala
English: Maximum observed plasma concentrations were reached within 0.5 to 2 hours (median 1 hour) in the fasted state and absolute bioavailability was about 0.6%.
Croatian: Maksimalne zabilježene koncentracije u plazmi postignute su u vremenu od 0,5 do 2 sata (medijan vremena 1 sat) nakon uzimanja lijeka natašte, a apsolutna bioraspoloživost je iznosila oko 0,6%.
English: Water may be taken at any time during the course of Iasibon treatment (see section 4.5).
Croatian: Obična voda se smije uzimati bilo kada za vrijeme trajanja liječenja lijekom Iasibon (vidjeti dio 4.5).
English: The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50%) and the remainder is eliminated unchanged by the kidney.
Croatian: Apsorbirana frakcija ibandronatne kiseline se iz cirkulacije uklanja putem koštane apsorpcije (procjenjeno na 40-50%), a ostatak se nepromijenjen izlučuje putem bubrega.
English: Creatinine Clearance (ml/min)
Croatian: Klirens kreatinina (ml/min)
English: • changes in blood test results such as Gamma GT or creatinine
Croatian: • promjene u laboratorijskim nalazima poput gama-GT ili kreatinina
English: In humans, the apparent terminal volume of distribution is at least 90 l and the amount of dose reaching the bone is estimated to be 40-50% of the circulating dose.
Croatian: U ljudi prividni terminalni volumen raspodjele iznosi najmanje 90 l, a procjenjuje se da količina doze koja dospijeva do kostiju iznosi oko 40% do 50% cirkulirajuće doze.
English: What Iasibon contains
Croatian: Što Iasibon sadrži
English: This is because Iasibon can affect the way some other medicines work.
Croatian: To je zato što Iasibon može utjecati na djelovanje drugih lijekova.
English: • Do not use this medicine if you notice that the solution is not clear or contains particles.
Croatian: • Ovaj lijek se ne smije upotrijebiti ako primijetite da otopina nije bistra ili sadrži čestice.
English: • a condition affecting the blood vessels in your brain called ‘cerebrovascular disorder' (stroke or brain bleeding)
Croatian: • stanje koje pogađa krvne žile mozga zvano “cerebrovaskularni poremećaj” (moždani udar ili krvarenje u mozgu)
English: • itching or tingling skin around your mouth
Croatian: • svrbež ili trnci kože oko usta
English: In particular, tell your doctor or pharmacist if you are receiving a type of antibiotic injection called ‘aminoglycoside' such as gentamicin.
Croatian: Posebno, obavijestite svog liječnika ili ljekarnika ako primate injekcije antibiotika iz skupine aminoglikozida, poput gentamicina.
English: Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Iasibon tablets.
Croatian: Lijekove i nadomjesne pripravke (uključujući kalcij) također bi trebalo izbjegavati prije uzimanja tableta lijeka Iasibon.
English: After initial systemic exposure, ibandronic acid rapidly binds to bone or is excreted into urine.
Croatian: Nakon početne sistemske ekspozicije, ibandronatna kiselina se brzo veže za kost ili se izlučuje u urin.
English: Therefore, with such products, including food, intake must be delayed at least 30 minutes following oral administration.
Croatian: Stoga uzimanje takvih proizvoda, uključujući hranu, mora biti odgođeno najmanje 30 minuta nakon peroralnog uzimanja lijeka.
English: A limited number of patients (50 patients) have received a second infusion for hypercalcaemia.
Croatian: Ograničeni broj bolesnika (50 bolesnika) primio je drugu infuziju za hiperkalcijemiju.
English: H2-antagonists or other medicinal products that increase gastric pH.
Croatian: H2-antagonisti ili drugi lijekovi koji povećavaju pH u želucu
English: Iasibon is usually administered in a hospital setting.
Croatian: Iasibon se obično primjenjuje u bolničkim uvjetima.
English: This helps to stop your bones from getting weaker.
Croatian: To pomaže zaustaviti slabljenje kostiju.
English: If there is concern regarding potentially high levels of calcium in the tap water (hard water), it is advised to use bottled water with a low mineral content.
Croatian: Ako ste zabrinuti zbog moguće visoke razine kalcija u pitkoj vodi (tvrda voda), preporučuje se koristiti vodu u bočicama s niskim udjelom minerala.
English: The dose should be infused over at least 15 minutes.
Croatian: Dozu treba davati infuzijom u trajanju od barem 15 minuta.
English: Take Iasibon at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements (e.g. products containing calcium (milk), aluminium, magnesium and iron) except water.
Croatian: Uzmite Iasibon najmanje 6 sati nakon što ste posljednji puta nešto pojeli, popili ili uzeli neki drugi lijek ili nadomjesni pripravak (npr. proizvod koji sadrži kalcij (mlijeko), aluminij, magnezij ili željezo), osim vode.
English: Not known (frequency cannot be estimated from the available data) • asthma attack
Croatian: Nepoznate učestalosti (učestalost se ne može odrediti na temelju dostupnih podataka) • napadaj astme
English: • It helps to prevent your bones from breaking (fractures).
Croatian: • Pomaže spriječiti prijelome kostiju (frakture).
English: • if you have, or have ever had low levels of calcium in your blood.
Croatian: • ako imate ili ste ikada imali nisku razinu kalcija u krvi.
English: As renal function decreases with age, this is the only factor that should be considered (see renal impairment section).
Croatian: Kako se bubrežna funkcija smanjuje s godinama, to je jedini faktor koji treba uzeti u obzir (vidjeti odjeljak o oštećenju bubrega).
English: • if you are allergic to any other bisphosphonates
Croatian: • ako ste alergični na druge bisfosfonate
English: Do not chew, suck or crush the tablet.
Croatian: Ne žvačite, ne cuclajte i ne drobite tabletu.
English: If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose absorption), talk to your doctor before taking this medicine.
Croatian: Ako vam je liječnik rekao da ne podnosite ili ne možete probaviti neke šećere (npr. ako patite od nepodnošenja galaktoze, nedostatka Lapp laktaze ili imate problema s apsorpcijom glukoze i galaktoze), posavjetujte se s liječnikom prije uzimanja ovog lijeka.
English: The serum calcium level may fall to hypocalcaemic values.
Croatian: Kalcij u serumu može pasti na hipokalcijemične vrijednosti.
English: The secretory pathway of renal elimination does not appear to include known acidic or basic transport systems involved in the excretion of other active substances.
Croatian: Čini se da put izlučivanja putem bubrega ne obuhvaća poznate kisele ni bazne transportne sustave uključene u izlučivanje drugih djelatnih tvari.
English: The content of the vial is to be used as follows:
Croatian: Sadržaj bočice mora se iskoristiti na sljedeći način:
English: Iasibon tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day.
Croatian: Iasibon tablete treba uzimati natašte, nakon noćnog gladovanja (barem 6 sati) i prije uzimanja prvog jutarnjeg obroka ili pića.
English: A shorter (i.e. 15 min) infusion time should only be used for patients with normal renal function or mild renal impairment.
Croatian: Kraće (odnosno 15-minutno) vrijeme trajanja infuzije treba koristiti samo u bolesnika s normalnom funkcijom bubrega ili s blagim oštećenjem funkcije bubrega.
English: If you stop taking Iasibon
Croatian: Ako prestanete uzimati Iasibon
English: PHARMACEUTICAL FORM Film-coated tablets.
Croatian: OBLIK Filmom obložene tablete.
English: Iasibon can also be prescribed if you have a raised calcium level in your blood due to a tumour.
Croatian: Iasibon se može propisati i ako imate povišenu razinu kalcija u krvi uzrokovanu tumorom.
English: Other medicines and Iasibon
Croatian: Drugi lijekovi i Iasibon
English: In most cases no specific treatment is required and the symptoms subside after a couple of hours/days.
Croatian: U većini slučajeva nije potrebno posebno liječenje, a simptomi se povlače nakon nekoliko sati/dana.
English: The overall adverse event profile of ibandronic acid following the 15 minute infusion was consistent with the known safety profile over longer infusion times and no new safety concerns were identified relating to the use of a 15 minute infusion time.
Croatian: Ukupni profil nuspojava ibandronatne kiseline nakon 15-minutne infuzije bio je u skladu s poznatim sigurnosnim profilom lijeka primijenjenog infuzijom duljeg trajanja te nisu identificirani novi sigurnosni rizici vezano uz primjenu 15-minutnom infuzijom.
English: • supplements containing calcium, magnesium, iron or aluminium
Croatian: • nadomjesne pripravke kalcija, magnezija, željeza ili aluminija
English: Iasibon is indicated in adults for:
Croatian: 4.1 Terapijske indikacije Iasibon je indiciran u odraslih za:
English: • tooth problems.
Croatian: • problemi sa zubima.
English: • a heart rhythm problem called ‘bundle branch block'
Croatian: • problem sa srčanim ritmom zvan “blok grane”
English: • ear pain, discharge from the ear, and/or an ear infection.
Croatian: • bol u uhu, iscjedak iz uha i/ili infekciju uha.
English: Consideration should be given to the severity of the hypercalcaemia as well as the tumour type.
Croatian: U obzir treba uzeti težinu hiperkalcijemije i vrstu tumora.
English: Renal clearance (about 60 ml/min in healthy postmenopausal females) accounts for 50-60% of total clearance and is related to creatinine clearance.
Croatian: Bubrežni klirens (oko 60 ml/min u zdravih žena u postmenopauzi) je zaslužan za 50-60% ukupnog klirensa i vezan je uz klirens kreatinina.
English: Biotransformation There is no evidence that ibandronic acid is metabolized in animals or humans.
Croatian: Biotransformacija Nema dokaza da se ibandronatna kiselina metabolizira u životinja ili ljudi.
English: If you experience one of the following symptoms, such as shortness of breath/difficulty breathing, tight feeling in throat, swelling of tongue, dizziness, feeling of loss of consciousness, redness or swelling of face, body rash, nausea and vomiting, you should immediately alert your doctor or nurse (see section 4).
Croatian: Ako se pojavi neki od sljedećih simptoma: na primjer nedostatak zraka/otežano disanje, osjećaj stezanja u grlu, oticanje jezika, omaglica, osjećaj da ćete izgubiti svijest, crvenilo ili oticanje lica, osip po tijelu, mučnina i povraćanje, morate na to odmah upozoriti svog liječnika ili medicinsku sestru
English: However, no dosage adjustment is required when Iasibon is administered with H2-antagonists or medicinal products that increase gastric pH.
Croatian: No nije potrebna prilagodba doze kad se Iasibon primjenjuje s H2-antagonistima ili drugim lijekovima koji povećavaju pH u želucu.
English: This was a composite endpoint which had the following skeletal related events (SREs) as sub-components:
Croatian: To je bila ukupna mjera ishoda u sklopu koje su se pratili sljedeći događaji vezani uz kosti (SREs = engl. skeletal related events):
English: Your doctor will work out how much Iasibon you will be given depending on your illness.
Croatian: Količinu lijeka Iasibon koju primate odredit će Vaš liječnik ovisno o Vašoj bolesti.
English: • itching, swelling of your face, lips, tongue and throat, with difficulty breathing.
Croatian: • svrbež, oticanje lica, usana, jezika i grla, s otežanim disanjem.
English: Total clearance of ibandronic acid is low with average values in the range 84-160 ml/min.
Croatian: Ukupni je klirens ibandronatne kiseline nizak, s prosječnim vrijednostima u rasponu 84-160 ml/min.
English: Then you can have your first food and drink, and take any medicines or supplements (see section 3).
Croatian: Nakon toga možete uzeti hranu, piće ili druge lijekove ili nadomjesne pripravke (vidjeti dio 3.).
English: The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis.
Croatian: Većina se izvješća odnosi na oboljele od raka, ali slučajevi osteonekroze dokumentirani su i u bolesnika liječenih od osteoporoze.
English: **See further information below †Identified in postmarketing experience.
Croatian: ** Vidjeti dodatne informacije niže † Identificirano u razdoblju nakon stavljanja lijeka na tržište.
English: While on treatment, these patients should avoid invasive dental procedures if possible.
Croatian: Za vrijeme trajanja liječenja takvi bi bolesnici, ako je ikako moguće, trebali izbjegavati invazivne zubarske zahvate.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
Croatian: Grčka Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje navedene serije u promet.
English: • a skin growth called a ‘benign skin neoplasm'
Croatian: • izraslina na koži zvana “dobroćudna novotvorina kože“
English: Iasibon 50 mg film coated tablets are supplied in Polyamide/Al/PVC - Aluminum foil blister with 3, 6, 9, 28 or 84 tablets, packaged in a cardboard box.
Croatian: Iasibon 50 mg filmom obložene tablete dolaze u blisterima od poliamid/Al/PVC - aluminijske folije s 3, 6, 9, 28 ili 84 tablete, pakiranima u kartonsku kutiju.
English: In most cases a raised serum calcium level can be reduced to the normal range within 7 days.
Croatian: U većini slučajeva povišena razina kalcija u serumu može se smanjiti na normalnu razinu unutar 7
English: • It helps to prevent other bone problems that may need surgery or radiotherapy
Croatian: • Pomaže spriječiti druge poteškoće s kostima koje bi mogle zahtijevati operaciju ili radioterapiju.
English: Treatment of tumour induced hypercalcaemia is most frequently associated with a rise in body temperature.
Croatian: Liječenje hiperkalcijemije uzrokovane tumorom najčešće je povezano s povišenjem tjelesne temperature.
English: Physicians should be alert to any signs or symptoms signaling a possible oesophageal reaction and patients should be instructed to discontinue Iasibon and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
Croatian: Liječnici trebaju biti oprezni prilikom pojave bilo kojeg znaka ili simptoma koji upućuje na moguću reakciju jednjaka, a bolesnici trebaju biti upućeni da prestanu uzimati Iasibon i potraže liječničku pomoć ako se pojavi disfagija, odinofagija, bol iza prsne kosti ili žgaravica ili dođe do pogoršanja žgaravice.
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive
English: Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of water and/or if you lie down within an hour of taking Iasibon.
Croatian: Mogu se javiti iritacija, upala ili vrijed jednjaka/cijevi koja povezuje usta sa želucem (ezofagus), često sa simptomima jake boli u prsima, jake boli nakon gutanja hrane i/ili pića, jake mučnine ili povraćanja, osobito ako ne popijete punu čašu vode i/ili ako legnete unutar jednog sata nakon uzimanja lijeka Iasibon.
English: For these patients and dosages, the median time to achieve normocalcaemia was 4 to 7 days.
Croatian: Za ove bolesnike i ovo doziranje, medijan vremena do postizanja normalne razine kalcija u krvi iznosio je 4 do 7 dana.
English: • pain in your nerves, damaged nerve root
Croatian: • bol u živcima, oštećenje korijena živca
English: Take your tablet at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements except water.
Croatian: Uzmite tabletu najmanje 6 sati nakon što ste posljednji puta nešto pojeli, popili ili uzeli neki drugi lijek ili nadomjesni pripravak, osim vode.
English: The extent of absorption is impaired when taken together with food or beverages (other than water).
Croatian: Apsorpcija je smanjena ako se lijek uzima s hranom ili pićem (osim s običnom vodom).
English: • tablet coat: titanium dioxide (E171), lactose monohydrate, hypromellose (E464), macrogol 4000
Croatian: • ovojnica tablete: titanijev dioksid (E171), laktoza hidrat, hipromeloza (E464), makrogol 4000.
English: Date of latest renewal: 30 September 2015
Croatian: Datum posljednje obnove odobrenja: 30. rujna 2015
English: In most cases no specific treatment was required and the symptoms subsided after a couple of hours/days.
Croatian: U većini slučajeva nije bilo potrebno posebno liječenje, a simptomi su se povlačili nakon nakoliko sati/dana.
English: Stevens-Johnson Syndrome†, Erythema Multiforme†, Dermatitis Bullous†
Croatian: Stevens- Johnsonov sindrom†, multiformni eritem†, bulozni dermatitis†
English: • Stay upright (sitting or standing) position while taking your tablet and for the next hour (60 minutes).
Croatian: • Budite u uspravnom položaju (sjedeći ili stojeći) dok uzimate tabletu te još jedan sat (60
English: • pain in your bone or muscles
Croatian: • bol u kostima ili mišićima
English: 1 0.9% sodium chloride solution or 5% glucose solution 2 Administration every 3 to 4 week
Croatian: 1 0,9% otopina natrijevog klorida ili 5% otopina glukoze 2 Primjenjuje se svaka 3 do 4 tjedna
English: • If you have heart problems and the doctor recommended to limit your daily fluid intake
Croatian: ako imate problema sa srcem i liječnik Vam je preporučio da ograničite dnevni unos tekućine
English: Rash, alopecia
Croatian: ekhimoza osip, alopecija
English: Elderly population (> 65 years) No dose adjustment is required (see section 5.2).
Croatian: Starija populacija (> 65 godina) Nije potrebna prilagodba doze (vidjeti dio 5.2).
English: • After taking your tablet, wait at least 30 minutes.
Croatian: • Nakon uzimanja tablete pričekajte barem 30 minuta.
English: You may be having a serious, potentially life threatening allergic reaction (see section 2).
Croatian: Moguće je da imate ozbiljnu alergijsku reakciju koja može biti opasna po život (pogledajte dio 2.)
English: Contains 0.86 mg lactose (as lactose monohydrate).
Croatian: Sadrži 0.86 mg laktoze (u obliku laktoza hidrata).
English: LIST OF EXCIPIENTS The tablets also contain lactose.
Croatian: POPIS POMOĆNIH TVARI Tablete također sadrže laktozu.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister foil
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister
English: After a 2 hour infusion of 2, 4 and 6 mg ibandronic acid pharmacokinetic parameters are dose proportional.
Croatian: Nakon dvosatne infuzije 2, 4 i 6 mg ibandronatne kiseline farmakokinetički parametri proporcionalni su dozi.
English: In a study in 130 patients with metastatic breast cancer the safety of Ibandronate infused over 1 hour or 15 minutes was compared.
Croatian: U ispitivanju 130 bolesnika s metastatskim rakom dojke uspoređivana je sigurnost primjene ibandronata infuzijom u trajanju od 1 sata ili 15 minuta.
English: Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation.
Croatian: Ibandronatna kiselina eliminira se isključivo renalnom ekskrecijom i nije podložna nikakvom obliku biotransformacije.
English: • headache, feeling dizzy or feeling weak
Croatian: • glavobolja, omaglica ili osjećaj slabosti
English: At doses that were considerably higher than the pharmacologically effective doses, ibandronic acid did not have any effect on bone mineralisation.
Croatian: Pri dozama koje su bile znatno veće od farmakološki učinkovitih doza, ibandronatna kiselina nije imala učinka na mineralizaciju kostiju.
English: - Patients should not chew, suck or crush the tablet because of a potential for oropharyngeal ulceration.
Croatian: - Bolesnik ne smije žvakati, sisati ni zdrobiti tabletu zbog mogućeg nastanka ulceracije u ustima i ždrijelu.
English: After taking your tablet, wait at least 30 minutes.
Croatian: Kada uzmete tabletu, pričekajte barem 30 minuta.
English: Caution is advised when bisphosphonates are administered with aminoglycosides, since both substances can lower serum calcium levels for prolonged periods.
Croatian: Potreban je oprez pri primjeni bisfosfonata s aminoglikozidima budući da obje tvari mogu smanjiti razine kalcija u serumu na dulje vrijeme.
English: Diluted solutions are for single use.
Croatian: Razrijeđena otopina namijenjena je samo za jednokratnu primjenu.
English: • skin problems
Croatian: • problemi s kožom
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 i kratki kosi lomovi mogući su bilo gdje na bedrenoj kosti, odmah ispod maloga trohantera pa sve do iznad suprakondilarnog područja.
English: No data are available (see section 5.1 and 5.2).
Croatian: Nema dostupnih podataka (vidjeti dijelove 5.1 i 5.2).
English: Ibandronate 50 mg n=287
Croatian: ibandronat 50 mg n=287
English: Iasibon contains lactose.
Croatian: Iasibon sadrži laktozu.
English: In general patients with osteolytic bone metastases require lower doses than patients with the humoral type of hypercalcaemia.
Croatian: Općenito su bolesnicima s osteolitičkim koštanim metastazama potrebne manje doze nego bolesnicima s humoralnom hiperkalcijemijom.
English: If you have moderate kidney problems, your doctor may reduce your dose to one tablet every other day.
Croatian: Ako imate umjereno teške probleme s bubrezima, liječnik Vam može smanjiti dozu na jednu tabletu svaki drugi dan.
English: Talk to a nurse or doctor if any effects become troublesome or last more than a couple of days
Croatian: Obratite se medicinskoj sestri ili liječniku ako se neki od tih simptoma pojača ili traje dulje od nekoliko dana.
English: Bioavailability was reduced by approximately 75% when Iasibon tablets were administered 2 hours after a standard meal.
Croatian: Bioraspoloživost se smanjuje za otprilike 75% ako se tablete lijeka Iasibon uzimaju 2 sata nakon standardnog obroka.
English: Bioavailability is reduced by about 90% when ibandronic acid is administered with a standard breakfast in comparison with bioavailability seen in fasted subjects.
Croatian: Bioraspoloživost se smanjuje za otprilike 90% ako se ibandronatna kiselina primjenjuje uz standardni doručak, u usporedbi s bioraspoloživosti opaženom u ispitanika koji su je primijenili natašte.
English: Film-coated tablet
Croatian: Filmom obložene tablete
English: Iasibon should not be mixed with calcium containing solutions.
Croatian: Iasibon se ne smije miješati s otopinama koje sadrže kalcij.
English: • a type of antibiotic injection called “aminoglycoside” such as gentamicin.
Croatian: • injekcije antibiotika iz skupine aminoglikozida, poput gentamicina.
English: The range of observed apparent half-lives is broad and dependent on dose and assay sensitivity, but the apparent terminal half-life is generally in the range of 10-60 hours.
Croatian: Raspon opaženih prividnih poluvjekova širok je te ovisi o dozi i osjetljivosti metode, no prividni krajnji poluvijek u načelu ima raspon od 10 do 60 sati.
English: Pharmaco-therapeutic group: Medicinal products for treatment of bone diseases, bisphosphonate, ATC Code: M05BA06
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Lijekovi za liječenje bolesti kostiju, bisfosfonati, ATK oznaka: M05BA06
English: You may be having a serious, potentially life threatening allergic reaction
Croatian: Moguće je da imate ozbiljnu alergijsku reakciju koja može biti opasna po život.
English: Iasibon therapy should only be initiated by physicians experienced in the treatment of cancer.
Croatian: Liječenje lijekom Iasibon smiju započeti samo liječnici s iskustvom u liječenju raka.