FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (may affect up to 1 in 10 people): • feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/food pipe)
Croatian: Često (mogu se javiti kod manje od 1 na 10 osoba): • mučnina, žgaravica i nelagoda pri gutanju (upala jednjaka)
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 je smanjena za otprilike 90% kada se ibandronatna kiselina primjenjuje uz standardni doručak, u usporedbi s bioraspoloživosti opaženom u ispitanika koji su je primijenili natašte.
English: There is no evidence for clinically relevant interethnic differences between Asians and Caucasians in ibandronic acid disposition.
Croatian: Nema dokaza klinički značajnih međuetničkih razlika između azijata i bijelaca u izloženosti ibandronatnoj kiselini.
English: Relative risk reduction of clinical vertebral fracture
Croatian: Smanjenje relativnog rizika za kliničke prijelome kralježaka
English: Ibandronic acid leads to progressive net gains in bone mass and a decreased incidence of fractures through the reduction of elevated bone turnover towards premenopausal levels in postmenopausal women.
Croatian: U postmenopauzalnih žena ibandronatna kiselina dovodi do progresivnog neto povećanja koštane mase i smanjuje incidenciju prijeloma smanjujući povećanu koštanu pregradnju na premenopauzalne vrijednosti.
English: Tel: +39 02 89 17 98 1
Croatian: Teva Italia S.r.l. Tel: +39 02 89 17 98 1
English: Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Croatian: Ibandronatna kiselina Teva ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na blister pakovanju i kutiji iza oznake „EXP“ ili „Rok valjanosti“.
English: Ocular inflammation*†
Croatian: Upala oka*†*
English: Ibandronic acid 150 mg once monthly (N=291)
Croatian: Ibandronatna kiselina 150 mg jedanput mjesečno (n=291)
English: Secondary efficacy endpoints
Croatian: Sekundarne mjere ishoda djelotvornosti
English: METHOD AND ROUTE OF ADMINISTRATION Do not suck, chew or crush the tablets.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Ne otapajte u ustima, ne žvačite i ne drobite tablete.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovog lijeka obratite se svom liječniku ili ljekarniku.
English: Tablet coating:
Croatian: Ovojnica tablete:
English: Subjects with severe renal failure (CLcr less than 30 ml/min) receiving daily oral administration of 10 mg ibandronic acid for 21 days, had 2-3 fold higher plasma concentrations than subjects with normal renal function and total clearance of ibandronic acid was 44 ml/min.
Croatian: Ispitanici s teškim zatajenjem bubrega (CLcr manji od 30 ml/min) koji su peroralno uzimali 10 mg ibandronatne kiseline svakodnevno u razdoblju od 21 dan, imali su 2 do 3 puta više koncentracije u plazmi od ispitanika s normalnom funkcijom bubrega, dok je ukupni klirens ibandronatne kiseline iznosio 44 ml/min.
English: Therefore, it is recommended that the tablets should be taken after an overnight fast (at least 6 hours) and fasting should continue for at least 30 minutes after the dose has been taken (see section 4.2).
Croatian: Stoga se uzimanje tableta preporučuje natašte, nakon noćnog gladovanja (barem 6 sati), a hrana se ne smije uzimati još barem 30 minuta nakon uzimanja doze (vidjeti dio 4.2).
English: Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
Croatian: U bolesnika kod kojih se sumnja na atipičan prijelom bedrene kosti treba razmotriti obustavljanje liječenja bisfosfonatima nakon procjene stanja bolesnika i na temelju ocjene omjera koristi i rizika za svakoga pojedinog bolesnika.
English: Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia
Croatian: Nepravilnosti jednjaka koje dovode do zastoja u pražnjenju jednjaka kao što su strikture ili ahalazija.
English: How to take Ibandronic Acid Teva).
Croatian: Kako uzimati ibandronatnu kiselinu Teva).
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: At one year, 83.5 % (p= 0.006) of patients receiving ibandronic acid 150 mg once monthly and 73.9 % of patients receiving ibandronic acid 2.5 mg daily were identified as responders (defined as a decrease ≥50% from baseline).
Croatian: Nakon jedne godine odgovorilo je 83,5% (p= 0,006) bolesnika koji su primali ibandronatnu kiselinu 150 mg jedanput mjesečno odnosno 73,9% bolesnika koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno (definirano kao smanjenje od ≥50% od početne vrijednosti).
English: Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Croatian: Nuspojave ibandronatne kiseline opažene u ispitivanjima reproduktivne toksičnosti u štakora jednake su očekivanima za bisfosfonate kao skupinu lijekova.
English: Among these patients, the incidence of upper gastrointestinal events in the patients treated with ibandronic acid 150 mg once monthly was similar to that in patients treated with ibandronic acid 2.5 mg daily.
Croatian: Među ovim bolesnicima, incidencija nuspojava u obliku poremećaja gornjeg dijela gastrointestinalnog trakta u bolesnika koji su primali ibandronatnu kiselinu 150 mg jedanput mjesečno bila je slična onoj u bolesnika koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno.
English: You may have early signs of a possible unusual fracture of the thigh bone.
Croatian: To mogu biti rani znakovi mogućeg neubičajenog prijeloma bedrene kosti.
English: Adequate intake of calcium and vitamin D is important in all patients.
Croatian: Za sve je bolesnike važno da uzimaju odgovarajuće količine kalcija i vitamina D.
English: Calcium supplements, antacids and some oral medicinal products containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Ibandronic Acid Teva.
Croatian: Nadomjesci kalcija, antacidi i neki peroralni lijekovi koji sadrže multivalentne katione (kao što su aluminij, magnezij i željezo) mogu utjecati na apsorpciju Ibandronatne kiseline Teva.
English: Renal clearance of ibandronic acid in patients with various degrees of renal impairment is linearly related to creatinine clearance.
Croatian: Bubrežni klirens ibandronatne kiseline u bolesnika s različitim stupnjevima oštećenja funkcije bubrega linearno je povezan s klirensom kreatinina.
English: Month 2
Croatian: Mjesec 1 Mjesec 2 Mjesec 3
English: Therefore, it is recommended that the tablets should be taken after an overnight fast (minimum 6 hours) and fasting should continue for at least 30 minutes after the dose has been taken (see section 4.2).
Croatian: Stoga se uzimanje tableta preporučuje natašte, nakon noćnog gladovanja (barem 6 sati), a hrana se ne smije uzimati najmanje još sljedećih 30 minuta nakon uzimanja doze (vidjeti dio 4.2).
English: Haemorrhage, duodenal ulcer, gastritis, dysphagia, dry mouth
Croatian: Krvarenje, vrijed na dvanaesniku, gastritis, disfagija, suha usta
English: At one year (primary analysis), 91.3 % (p=0.005) of patients receiving ibandronic acid 150 mg once monthly had a lumbar spine BMD increase above or equal to baseline (BMD responders), compared with 84.0 % of patients receiving ibandronic acid 2.5 mg daily.
Croatian: Nakon jedne godine (primarna analiza) u 91,3% (p=0,005) bolesnika koji su primali ibandronatnu kiselinu 150 mg jedanput mjesečno došlo je do povećanja BMD lumbalne kralježnice više ili jednako početnoj vrijednosti (BMD responderi) u usporedbi s 84% bolesnika koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno.
English: It contains the active substance ibandronic acid.
Croatian: Sadrži djelatnu tvar ibandronatnu kiselinu.
English: Ibandronic acid 150 mg once monthly (N=320)
Croatian: Ibandronatna kiselina 150 mg jedanput mjesečno (n=320)
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Ibandronic Acid Teva in patients with concomitant risk factors.
Croatian: U bolesnika s istodobno prisutnim faktorima rizika preporučuje se prije liječenja lijekom Ibandronatna kiselina Teva provesti pregled zuba i preventivne stomatološke zahvate te ocijeniti omjer koristi i rizika za svakog pojedinog bolesnika.
English: Children and adolescents Ibandronic Acid Teva should not be used in children and adolescents below the age of 18 years.
Croatian: Djeca i adolescenti Ibandronatna kiselina Teva ne se smije davati djeci i adolescentima mlađima od 18 godina.
English: Back pain
Croatian: Bol u leđima
English: Children and adolescents Do not give Ibandronic Acid Teva to children or adolescents below 18 years.
Croatian: Djeca i adolescenti Ibandronatnu kiselinu Teva nemojte davati djeci i adolecentima mlađim od 18 godina.
English: If you forget to take Ibandronic Acid Teva - If you forget to take your tablet on the morning of your chosen day, do not take a tablet later in the day.
Croatian: Ako zaboravite uzeti tabletu ujutro na odabrani dan, nemojte je uzimati kasnije toga istog dana.
English: No specific information is available on the treatment of overdose with Ibandronic Acid Teva.
Croatian: Nisu dostupne specifične informacije o liječenju u slučaju predoziranja Ibandronatnom kiselinom Teva.
English: The following risk factors should be considered when evaluating a patient's risk of developing ONJ: - Potency of the medicinal product that inhibit bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy.
Croatian: Pri ocjenjivanju bolesnikova rizika za razvoj osteonekroze čeljusti potrebno je razmotriti sljedeće faktore rizika: - potentnost lijeka koji inhibira koštanu resorpciju (veći rizik kod primjene visoko potentnih spojeva), put primjene (veći rizik kod parenteralne primjene) i kumulativnu dozu inhibitora koštane resorpcije - rak, popratna stanja (npr. anemija, koagulopatije, infekcija), pušenje - istodobno primijenjene terapije: kortikosteroidi, kemoterapija, inhibitori angiogeneze,
English: Do not take a double dose to make up for a forgotten dose.
Croatian: Ako ste zaboravili uzeti Ibandronatnu kiselinu Teva Nemojte uzeti dvostruku dozu da biste nadoknadili dozu koju ste propustili.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Ibandronic Acid Teva 50 mg: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Ibandronatna kiselina Teva 50 mg: lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: However, oral overdosage may result in upper gastrointestinal events, such as upset stomach, heartburn, oesophagitis, gastritis or ulcer.
Croatian: Predoziranje peroralnim putem može rezultirati poremećajima gornjeg dijela gastrointestinalnog trakta, primjerice iritacijom želuca, žgaravicom, ezofagitisom, gastritisom ili vrijedom.
English: Ibandronic acid 2.5 mg daily
Croatian: Ibandronatna kiselina 2,5 mg jedanput dnevno
English: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 007
Croatian: Österreich ratiopharm Arzneimittel Vertriebs-GmbH
English: Headache Dizziness
Croatian: Upala oka
English: No specific information is available on the treatment of overdosage with Ibandronic Acid Teva.
Croatian: Nisu dostupne specifične informacije o liječenju u slučajevima predoziranja Ibandronatnom kiselinom Teva.
English: Since acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration (see section 4.4).
Croatian: Acetilsalicilatna kiselina i nesteroidni protuupalni lijekovi Budući da se acetilsalicilatna kiselina, nesteroidni protuupalni lijekovi i bisfosfonati povezuju s gastrointestinalnom iritacijom, potreban je oprez pri njihovoj istodobnoj primjeni (vidjeti dio 4.4).
English: Hypocalcaemi a*
Croatian: Hipokalcijemija*
English: Paediatric population (see section 4.2 and section 5.2) Ibandronic acid was not studied in the paediatric population, therefore no efficacy or safety data are available for this patient population.
Croatian: Ibandronatna kiselina nije ispitivana na pedijatrijskoj populaciji, stoga nisu dostupni podaci o djelotvornosti i sigurnosti primjene u ovoj skupini bolesnika.
English: When a more stringent criterion is considered, which combines both lumbar spine and total hip BMD, 83.9 % (p<0.001) and 65.7 % of patients receiving ibandronic acid 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders at one year.
Croatian: Prema strožem kriteriju, gdje se uzima u obzir BMD lumbalne kralježnice i cijelog kuka, nakon jedne godine odgovorilo je 83,9% (p<0,001) bolesnika koji su primali ibandronatnu kiselinu 150 mg jedanput mjesečno odnosno 65,7% bolesnika koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno.
English: At two years, 87.1 % (p<0.001) and 70.5 %,of patients met this criterion in the 150 mg monthly and 2.5 mg daily arms respectively.
Croatian: Nakon dvije godine taj je kriterij zadovoljilo 87,1% (p<0,001) bolesnika u skupini 150 mg jedanput mjesečno odnosno 70,5% bolesnika u skupini 2,5 mg jedanput dnevno.
English: Since Nonsteroidal Anti-Inflammatory medicinal products and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Croatian: Budući da su nesteroidni protuupalni lijekovi povezani s gastrointestinalnom iritacijom, potreban je oprez pri istodobnom peroralnom liječenju.
English: White, biconvex, capsule-shaped film-coated tablets, engraved “50” on one side and plain on the other.
Croatian: Bijele, bikonveksne, filmom obložene tablete, oblika kapsule s utisnutom oznakom „50“ na jednoj strani i bez oznake na drugoj strani.
English: BMD - mean change relative to baseline lumbar spine at year 3 BMD - mean change relative to baseline total hip at year 3
Croatian: BMD - srednja promjena u odnosu na početne vrijednosti za lumbalnu kralježnicu nakon 3 godine
English: Ibandronic Acid Teva comes in blisters (PVC/Aclar/PVC - Aluminium) in cartons of 1 or 3 tablets.
Croatian: Ibandronatna kiselina Teva dostupna je u pakovanju od 1 ili 3 tablete u PVC/Aclar/PVC //aluminij blisteru, u kutiji.
English: Patients with renal impairment
Croatian: Bolesnici s oštećenjem bubrega
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva
English: There are no data on the effects of ibandronic acid in humans.
Croatian: Nema saznanja o djelovanju ibandronatne kiseline u ljudi.
English: Do not chew, suck or crush the tablet.
Croatian: Nemojte žvakati, otapati u ustima niti drobiti tabletu.
English: Do not suck, chew or crush the tablet.
Croatian: Ne otapajte u ustima, ne žvačite i ne drobite tabletu.
English: Fatigue
Croatian: Svrbež
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines: - supplements containing calcium, magnesium, iron or aluminium - acetylsalicylic acid and non-steroidal anti-inflammatory medicines called “NSAIDs”, such as ibuprofen or naproxen.
Croatian: Posebno, obavijestite svog liječnika ili ljekarnika ukoliko uzimate neke od sljedećih lijekova: - nadomjesne pripravke kalcija, magnezija, željeza ili aluminija
English: Special populations Renal impairment
Croatian: Posebne populacije Oštećenje funkcije jetre
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/642/003 1 film-coated tablet EU/1/10/642/004 3 film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/10/642/003 1 filmom obložena tableta
English: Uncommon (may affect less than 1 in 100 people):
Croatian: Manje često (mogu se javiti u manje od 1 na 100 osoba):
English: România Teva Pharmaceuticals S.R.L
Croatian: Malta Teva Pharmaceuticals Ireland, L-Irlanda
English: Very rare (may affect up to 1 in 10,000 people):
Croatian: Vrlo rijetko (mogu se javiti u manje od 1 na 10 000 osoba):
English: After intravenous administration of 0.5 mg, total, renal, and non-renal clearances decreased by 67 %, 77 % and 50 %, respectively, in subjects with severe renal failure but there was no reduction in tolerability associated with the increase in exposure.
Croatian: Nakon intravenske primjene 0,5 mg u bolesnika sa teškim oštećenjem funkcije bubrega, ukupni, bubrežni i nebubrežni klirens smanjili su se za 67%, 77% odnosno 50%.
English: For total hip BMD, 90.0 % (p<0.001) of patients receiving ibandronic acid 150 mg once monthly and 76.7 % of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline at one year.
Croatian: Što se tiče vrijednosti BMD kuka, nakon jedne godine je u 90% (p<0,001) bolesnika koji su primali ibandronatnu kiselinu 150 mg jedanput mjesečno, odnosno 76,7% bolesnika koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno, došlo je do povećanja BMD cijelog kuka više ili jednako početnoj vrijednosti.
English: The usual dose of Ibandronic Acid Teva is one tablet once a month.
Croatian: Uobičajena doza je jedna tableta Ibandronatne kiseline Teva mjesečno.
English: How to take Ibandronic Acid Teva
Croatian: Kako uzimati Ibandronatnu kiselinu Teva
English: - Take your Ibandronic Acid Teva tablet after you first get up for the day, and before you have anything to eat or drink (on an empty stomach)
Croatian: - Tabletu Ibandronatne kiseline Teva uzmite nakon ustajanja ujutro, te prije nego pojedete ili popijete nešto (na prazan želudac) - Progutajte tabletu s punom čašom obične vode (najmanje 180 ml).
English: Since acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Croatian: Acetilsalicilatna kiselina i nesteroidni protuupalni lijekovi Budući da se acetilsalicilatna kiselina, nesteroidni protuupalni lijekovi i bisfosfonati povezuju s gastrointestinalnom iritacijom, potreban je oprez pri njihovoj istodobnoj primjeni.
English: Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 150 mg ibandronatne kiseline (u obliku natrijevog hidrata).
English: EU/1/10/642/003 1 film-coated tablet in PVC/Aclar/PVC - Aluminium blister in cardboard boxes EU/1/10/642/004 3 film-coated tablets in PVC/Aclar/PVC - Aluminium blisters in cardboard boxes
Croatian: EU/1/10/642/003 1 filmom obložena tableta u PVC/Aclar/PVC//aluminij blisteru, kutiji
English: The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration.
Croatian: Nakon peroralne primjene apsorpcija ibandronatne kiseline u gornjem dijelu probavne cijevi je brza.
English: If you take more Ibandronic Acid Teva than you should If you take too many tablets talk to a doctor or go to hospital straight away.
Croatian: Ako uzmete previše tableta, obratite se svom liječniku ili odmah idite u bolnicu.
English: Due to the limited clinical experience, ibandronic acid is not recommended in patients with severe renal impairment (see sections 4.2 and 4.4).
Croatian: Ibandronatna kiselina se ne preporučuje bolesnicima s teškim oštećenjem funkcije bubrega zbog ograničenih kliničkih iskustava (vidjeti dijelove 4.2 i dio 4.4).
English: Patients should receive supplemental calcium and/or vitamin D if dietary intake is inadequate.
Croatian: Ako unos prehranom nije dovoljan, bolesnici trebaju uzimati dodatke kalcija i/ili vitamina D.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg ibandronic acid (as sodium monohydrate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 50 mg ibandronatne kiseline (u obliku natrijevog hidrata).
English: They include a decreased number of implantation sites, interference with natural delivery (dystocia), an increase in visceral variations (renal pelvis ureter syndrome) and teeth abnormalities in F1 offspring in rats.
Croatian: Nuspojave ibandronatne kiseline opažene u ispitivanjima reproduktivne toksičnosti u štakora bile su očekivane za ovu skupinu lijekova (bisfosfonati) i uključivale su smanjeni broj mjesta implantacije, poremećaj prirodnog poroda (distocija), povećanje visceralnih varijacija (sindrom bubrega, zdjelice i mokraćovoda) te abnormalnosti zubi u F1 potomstvu štakora.
English: At two years 93.4 % (p<0.001) of patients receiving ibandronic acid 150 mg once monthly and 78.4 %, of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline.
Croatian: Nakon dvije godine je u 93,4% (p<0,001) bolesnika koji su primali ibandronatnu kiselinu 150 mg jedanput mjesečno odnosno 78,4% bolesnika koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno došlo do povećanja BMD cijelog kuka više ili jednako početnoj razini.
English: • dizziness
Croatian: • koprivnjača
English: Therefore, Ibandronic Acid Teva should not be used during pregnancy.
Croatian: Stoga se Ibandronatna kiselina Teva ne smije koristiti u trudnoći.
English: Ibandronic Acid Teva comes in blisters (PVC/Aclar/PVC - Aluminium) in cartons of 28 or 84 tablets.
Croatian: Ibandronatna kiselina Teva dostupna je u pakovanju od 28 tableta ili 84 tablete u PVC/Aclar/PVC //aluminij blisteru, u kutiji.
English: WHO performance score *
Croatian: Opće stanje prema WHO *
English: How to store Ibandronic Acid Teva
Croatian: Kako čuvati Ibandronatnu kiselinu Teva
English: • Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Croatian: To mogu biti rani znakovi teških problema čeljusne kosti (nekroze, tj. odumiranja koštanog tkiva). obratite se liječniku ako imate bol u uhu, iscjedak iz uha i/ili infekciju uha.
English: Ibandronic Acid Teva contains the active substance ibandronic acid.
Croatian: Ibandronatna kiselina Teva sadrži djelatnu tvar ibandronatnu kiselinu.
English: 3 film-coated tablets
Croatian: Pakovanje od 3 filmom obložene tablete
English: Total clearance of ibandronic acid was reduced to 44 ml/min in the subjects with severe renal impairment compared with 129 mL/min in subjects with normal renal function.No dosage adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Croatian: Ukupni klirens ibandronatne kiseline bio je smanjen na 44 ml/min u bolesnika s teškim oštećenjima bubrega, u usporedbi sa 129 ml/min kod osoba s normalnom funkcijom bubrega.
English: Teva Nederland B.V. Tel: +31 800 0228 400
Croatian: Tel: +31 800 0228 400
English: Relative Risk Reduction New morphometric vertebral fractures Incidence of new morphometric vertebral fractures
Croatian: Smanjenje relativnog rizika Novi prijelomi kralježaka, utvrđeni morfometrički
English: White, biconvex, capsule-shaped film-coated tablets, engraved “I150” on one side and plain on the other.
Croatian: Bijele bikonveksne, filmom obložene tablete oblika kapsule s utisnutom oznakom „1150“ na jednoj strani i bez oznake na drugoj strani.
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post-marketing setting in patients receiving Ibandronic Acid Teva for oncology indications (see section 4.8).
Croatian: U bolesnika koji su nakon njegova stavljanja u promet primali Ibandronatnu kiselinu Teva za onkološke indikacije, vrlo je rijetko prijavljena osteonekroza čeljusti (vidjeti dio 4.8).
English: You may have a severe inflammation of your gullet/food pipe, possibly with sores or constriction of the gullet/food pipe
Croatian: Možda imate jaku upalu jednjaka/cijevi koja povezuje usta sa želucem, možda s ranama i suženjem jednjaka/cijevi koja povezuje usta sa želucem
English: Ibandronic acid 2.5 mg daily (N=318)
Croatian: Ibandronatna kiselina 2,5 mg jedanput dnevno (n=318)