natgillin/translations-raw huggingface dataset:
In vivo, ibandronic acid prevents experimentally-induced bone destruction caused by cessation of gonadal function, retinoids, tumours or tumour extracts. 
In vivo, ibandronatna kiselina sprječava eksperimentalno inducirano uništavanje kosti uzrokovano zaustavljanjem gonadnih funkcija, retinoidima, tumorima ili ekstraktima tumora.
ONJ can also occur after stopping treatment. 
Osteonekroza čeljusti može se razviti i nakon prestanka liječenja.
Your doctor may ask you to undergo a dental examination before starting treatment with Ibandronic Acid Teva. 
Vaš liječnik može tražiti da prije početka liječenja lijekom Ibandronatna kiselina Teva obavite stomatološki pregled.
Method of administration For oral use. 
Način primjene Za peroralnu primjenu.
Gender Bioavailability and pharmacokinetics of ibandronic acid are similar in men and women. 
Bioraspoloživost i farmakokinetička svojstva ibandronatne kiseline slični su u žena i muškaraca.
• Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements. 
- Uzmite tablete ujutro odmah nakon ustajanja, prije uzimanja prvog jutarnjeg obroka, pića, drugih lijekova ili nadomjesnih pripravaka.
Ibandronic Acid Teva is not recommended for patients with a creatinine clearance below 30 ml/min due to limited clinical experience (see sections 4.4 and 5.2). 
Ibandronatna kiselina Teva ne preporučuje se bolesnicima čiji je klirens kreatinina manji od 30 ml/min zbog ograničenog kliničkog iskustva (vidjeti dio 4.4 i 5.2).
What Ibandronic Acid Teva contains 
Što Ibandronatna kiselina Teva sadrži
In reproductive studies in rats by the oral route effects on fertility consisted of increased preimplantation losses at dose levels of 1 mg/kg/day and higher. 
U reproduktivnim ispitivanjima peroralne primjene na štakorima, djelovanje na plodnost obuhvaćalo je povećane preimplantacijske gubitke pri razinama doza od 1 mg/kg na dan i višim.
During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture. 
Tijekom liječenja bisfosfonatima, bolesnike treba uputiti da prijave bol u bedrima, kukovima ili preponama te svakog bolesnika s ovim simptomima treba pregledati ne bi li se otkrio nepotpuni lom bedrene kosti.
• severe stomach pain. 
• jaka bol u trbuhu.
Early plasma levels fall quickly reaching 10 % of peak values within 3 and 8 hours after intravenous or oral administration respectively. 
Početne vrijednosti u plazmi brzo padaju, dostižući 10% vršnih vrijednosti u vremenu od 3 do 8 sati nakon intravenske odnosno peroralne primjene.
Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1 Hypocalcaemia 
Preosjetljivost na ibandronatnu kiselinu ili neku od pomoćnih tvari navedenih u dijelu 6.1 Hipokalcijemija.
• Take your tablet with a full glass of water only (about 200 mL). 
- Uzmite tabletu Ibandronatne kiseline Teva samo uz punu čašu vode (oko 200 ml).
Studies in lactating rats have demonstrated the presence of low levels of ibandronic acid in the milk following intravenous administration. 
Ispitivanja provedena u štakora u laktaciji pokazala su niske razine ibandronatne kiseline u mlijeku nakon intravenske primjene.
Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. 
Atipične suptrohanteričke i dijafizealne frakture femura zabilježene su kod liječenja bisfosfonatima, prvenstveno u bolesnika koji su dugotrajno primali lijekove protiv osteoporoze.
• tablet coating: titanium dioxide (E 171), hypromellose, macrogol 400, polysorbate 80. 
˗ ovojnica tablete: titanijev dioksid (E171), hipromeloza, makrogol 400, polisorbat 80
** Median change from baseline to last assessment 
** Medijan vrijednosti promjene od početne vrijednosti do zadnje procjene.
• The other ingredients are: tablet core: cellulose microcrystalline, povidone K-30, crospovidone (type A), silica colloidal anhydrous, stearic acid tablet coating: titanium dioxide (E 171), hypromellose, macrogol 400, polysorbate 80. 
- Pomoćne tvari su: jezgra tablete: celuloza mikrokristalična, povidon K-30, krospovidon (vrste A), bezvodni koloidni silicijev dioksid, stearatna kiselina ovojnica tablete: titanijev dioksid (E 171), hipromeloza, makrogol 400, polisorbat 80
Azotaemia (uraemia) 
Azotemija (uremija)
Milk or antacids should be given to bind Ibandronic Acid Teva. 
Potrebno je uzeti mlijeko ili antacide kako bi se Ibandronatna kiselina Teva vezala.
Do not take Ibandronic Acid Teva if you are pregnant or breast feeding. 
Ne uzimajte Ibandronatnu kiselinu Teva ako ste trudni ili dojite.
Ibandronic Acid Teva works by reducing the amount of calcium that is lost from your bones. 
Ibandronatna kiselina Teva djeluje tako što smanjuje gubitak kalcija iz kostiju.
The management plan of the patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ. 
Plan liječenja bolesnika u kojih se razvije osteonekroza čeljusti mora izraditi nadležni liječnik u bliskoj suradnji sa stomatologom ili oralnim kirurgom s iskustvom u liječenju osteonekroze čeljusti.
The pharmacokinetics of ibandronic acid was not assessed in patients with end-stage renal disease managed by other than hemodialysis. 
Farmakokinetska svojstva ibandronatne kiseline nisu određivana u bolesnika u terminalnom stadiju bolesti bubrega koji nisu na hemodijalizi.
Renal clearance (about 60 ml/min in healthy postmenopausal females) accounts for 50-60 % of total clearance and is related to creatinine clearance. 
Bubrežni klirens (oko 60 ml/min u zdravih žena u postmenopauzi) doprinosi s 50-60% ukupnom klirensu i povezan je s klirensom kreatinina.
Month 2 __/__/__ 
Mjesec 2 __ /__ /__
Medicinal product-Food Interactions 
Interakcija lijek-hrana
- Take your Ibandronic Acid Teva tablet at least 6 hours after you last had anything to eat or drink except water. 
- Uzmite tabletu Ibandronatne kiseline Teva najmanje 6 sati nakon zadnjeg jela ili pića, osim obične vode.
Osteonecrosis of jaw†*, osteonecrosis of the external auditory canal (bisphosphona te class adverse reaction)† 
Osteonekroza čeljusti†*, osteonekroza vanjskog slušnog kanala (nuspojava skupine bisfosfonata)†
Therefore, patients should not take other oral medicinal products for at least 6 hours before taking Ibandronic Acid Teva and for 1 hour following intake of Ibandronic Acid Teva. 
Bolesnici stoga ne bi smjeli uzimati druge peroralne lijekove barem 6 sati prije niti 1 sat nakon uzimanja Ibandronatne kiseline Teva.
The liver has no significant role in the clearance of ibandronic acid which is not metabolised but is cleared by renal excretion and by uptake into bone. 
Jetra nema bitnu ulogu u klirensu ibandronatne kiseline, koja se ne metabolizira nego se uklanja putem renalne ekskrecije i unosom u kosti.
Multiple events were therefore, counted only once in any given 12 week period for the purposes of the analysis. 
Događaji koji su se ponavljali, za potrebe analize su se stoga brojali samo jedanput.
Hypocalcaemia 
Hipokalcemija
Metabolic interactions are not considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats (see section 5.2). 
Smatra se da metaboličke interakcije s lijekovima nisu vjerojatne s obzirom na to da ibandronatna kiselina ne inhibira glavne jetrene izoenzime P450 u ljudi i ne inducira jetreni P450 citokromski sustav u štakora (vidjeti dio 5.2).
How to store Ibandronic Acid Teva Content of the pack and other information 
Kako čuvati Ibandronatnu kiselinu Teva Sadržaj pakiranja i druge informacije
Drink a full glass of milk before you go. Do not make yourself sick. 
Prije nego krenete popijte punu šalicu mlijeka.
Patients with known hypersensitivity to other bisphosphonates Caution is to be taken in patients with known hypersensitivity to other bisphosphonates. 
Bolesnici s poznatom preosjetljivošću na druge bisfosfonate
- Patients should not chew , suck or crush the tablet because of a potential for oropharyngeal ulceration. 
- Bolesnik ne smije žvakati, otapati u ustima ni zdrobiti tabletu zbog mogućeg nastanka ulceracije u ustima i ždrijelu.
Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Ibandronic Acid Teva is given to patients with active upper gastrointestinal problems (e.g. known Barrett's oesophagus, dysphagia, other oesophageal diseases, gastritis, duodenitis or ulcers). 
Zbog moguće pojave ovih učinaka iritacije i mogućnosti pogoršanja osnovne bolesti, potreban je oprez kada se Ibandronatna kiselina Teva propisuje bolesnicima s problemima gornjeg dijela gastrointestinalnog trakta (npr. Barrettov jednjak, disfagija, druge bolesti jednjaka, gastritis, duodenitis ili ulkusi).
Clinical studies have not shown any evidence of deterioration in renal function with long term ibandronic acid therapy. 
U kliničkim ispitivanjima nije bilo dokaza pogoršanja bubrežne funkcije tijekom dugotrajne terapije Ibandronatnom kiselinom Teva.
There are no adequate data from the use of ibandronic acid in pregnant women. 
Nema odgovarajućih podataka o primjeni ibandronatne kiseline u trudnica.
• heartburn, discomfort in swallowing, stomach or tummy pain (may be due to an inflammation of the stomach), indigestion, nausea, having, diarrhoea (loose bowels) muscle cramps, stiffness of your joints and limbs 
• žgaravica, nelagoda pri gutanju, bol u trbuhu (može biti posljedica upale želuca), probavne smetnje, mučnina, proljev (osjetljiva crijeva)
Ibandronic Acid Teva 150 mg: Medicinal product subject to medical prescription. 
Ibandronatna kiselina Teva 150 mg: Lijek se izdaje na recept.
Analgesic use * 
Uzimanje analgetika *
It does not interfere with osteoclast recruitment. 
Ne interferira s aktivacijom osteoklasta.
Patients should receive supplemental calcium and / or vitamin D if dietary intake is inadequate (see sections 4.4 and 4.5). 
Ako unos prehranom nije dovoljan, bolesnici trebaju uzimati dodatne količine kalcija i/ili vitamina D (vidjeti dio 4.4 i 4.5).
The release of pharmaceuticals in the environment should be minimized. 
Odlaganje lijekova u okoliš treba svesti na najmanju moguću mjeru.
Incidence of new morphometric vertebral fractures Relative risk reduction of clinical vertebral fracture Incidence of clinical vertebral fracture 
Incidencija novih prijeloma kralježaka, utvrđeni morfometrički Smanjenje relativnog rizika za kliničke prijelome kralježaka
All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Ibandronic Acid Teva. 
Sve bolesnike treba potaknuti da tijekom liječenja lijekom Ibandronatna kiselina Teva održavaju dobru oralnu higijenu, redovito odlaze na kontrolne stomatološke preglede i odmah prijave sve oralne simptome poput pomicanja zuba, boli ili oticanja, rana koje ne cijele ili iscjetka.
- Patients should not chew or suck the tablet, because of a potential for oropharyngeal ulceration. 
- Bolesnici ne smiju žvakati ili otapati u ustima tablete zbog mogućeg nastanka ulceracije u ustima i ždrijelu.
Milk or antacids should be given to bind Ibandronic Acid Teva, and any adverse reactions treated symptomatically. 
Potrebno je uzeti mlijeko ili antacide kako bi se Ibandronatna kiselina Teva vezala, a nuspojave treba liječiti simptomatski.
The unabsorbed fraction of ibandronic acid is eliminated unchanged in the faeces. 
Neapsorbirani udio ibandronatne kiseline eliminira se nepromijenjen stolicom.
The liver has no significant role in the clearance of ibandronic acid since it is not metabolized but is cleared by renal excretion and by uptake into bone. 
Jetra nema bitnu ulogu u klirensu ibandronatne kiseline jer se ibandronatna kiselina ne metabolizira nego se uklanja izlučivanjem putem bubrega i apsorpcijom u kosti.
BATCH NUMBER 
Broj serije
Gastrointestinal disorders* 
Gastrointestinalne nuspojave
While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications. 
Dok u kontroliranim kliničkim ispitivanjima nije primijećen povećani rizik, nakon stavljanja lijeka u promet, prijavljeni su kod peroralne primjene bisfosfonata ulkusi želuca i dvanaesnika, od kojih su neki bili teški i s komplikacijama.
After you have taken Ibandronic Acid Teva, please wait for 1 hour before you can have your first food and further drinks. 
Nakon što uzmete Ibandronatnu kiselinu Teva, pričekajte 1 sat prije prvog obroka i daljnih pića (vidjeti dio 3.
Oesophagitis, Gastritis, Gastro oesophageal reflux disease, Dyspepsia, Diarrhoea, Abdominal pain, Nausea 
Ezofagitis, gastritis, gastroezofagealni refluks, dispepsija, proljev, bol u abdomenu, mučnina
In particular, products containing calcium, including milk and other multivalent cations (such as aluminium, magnesium, iron), are likely to interfere with absorption of Ibandronic Acid Teva, which is consistent with findings in animal studies. 
Osobito proizvodi koji sadrže kalcij i ostale multivalentne katione (kao što su aluminij, magnezij i željezo), uključujući mlijeko, često mogu utjecati na apsorpciju Ibandronatne kiseline Teva, što je u skladu s podacima iz ispitivanja provedenih u životinja.
In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of ibandronic acid 150 mg once monthly and ibandronic acid 2.5 mg daily was similar. 
Dvogodišnje ispitivanje provedeno u žena s osteoporozom u postmenopauzi (BM 16549) pokazalo je sličnu sveukupnu sigurnost primjene ibandronatne kiseline 150 mg jednom mjesečno i ibandronatne kiseline 2,5 mg jednom dnevno.
Biochemical markers of bone turn-over 
Biokemijski biljezi koštane pregradnje
Ibandronic Acid Teva is only for use in postmenopausal women and must not be taken by women of childbearing potential. 
Ibandronatna kiselina Teva je namijenjena isključivo za žene u postmenopauzi i ne smiju je uzimati žene reproduktivne dobi.
Therefore dosage adjustment is not necessary in patients with hepatic impairment. 
Stoga nije potrebna prilagodba doze u bolesnika s oštećenjem jetre.
So be especially careful if you take painkillers or anti-inflammatories while you're taking Ibandronic Acid Teva. 
Stoga budite osobito oprezni ako tijekom uzimanja Ibandronatne kiseline Teva uzimate i lijekove protiv boli ili upale.
Anaphylactic reaction/shock* 
Anafilaktička reakcija/šok*†
For these patients, there was no difference in the incidence of upper gastrointestinal adverse events with the 150 mg once monthly regimen compared to the 2.5 mg daily regimen. 
U tih bolesnika nije uočena razlika u incidenciji nuspojava vezanih uz gornji dio gastrointestinalnog trakta primjenom 150 mg jedanput mjesečno u usporedbi s primjenom 2,5 mg jedanput dnevno.
Table 1 Adverse Drug Reactions Reported for Oral Administration of Ibandronic Acid 
Tablica 1 Nuspojave prijavljene uz peroralnu primjenu Ibandronatne kiseline Organski sustav
Biotransformation There is no evidence that ibandronic acid is metabolized in animals or humans. 
Nema dokaza da se ibandronatna kiselina metabolizira u životinja ili ljudi.
In reproductive studies in rats by the oral route, ibandronic acid decreased fertility. 
U reproduktivnim ispitivanjima peroralne primjene na štakorima, ibandronatna kiselina je smanjila njihovu plodnost.
• tablet core: cellulose microcrystalline, povidone K-30, crospovidone (type A), silica colloidal anhydrous, stearic acid; 
Pomoćne tvari su: ˗ jezgra tablete: mikrokristalična celuloza, povidon K-30, krospovidon (vrste A), koloidni bezvodni silicijev dioksid, stearatna kiselina.
Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. 
Prijelomi su često bilateralni; stoga u bolesnika koji primaju bisfosfonate i koji su imali prijelom trupa bedrene kosti treba pregledati i bedrenu kost na suprotnoj nozi.
There are no pharmacokinetic data for ibandronic acid in patients who have hepatic impairment. 
Ne postoje farmakokinetički podaci za ibandronatnu kiselinu u bolesnika s oštećenjem jetre.
EU/1/10/642/002 84 film-coated tablets 
EU/1/10/642/004 3 filmom obložene tablete
However, based on a knowledge of this class of compounds, oral overdose may result in upper gastrointestinal adverse reactions (such as upset stomach, dyspepsia, oesophagitis, gastritis, or ulcer) or hypocalcaemia. 
Na temelju poznavanja ove skupine spojeva, predoziranje peroralnim putem može rezultirati nuspojavama gornjeg dijela gastrointestinalnog trakta (npr. iritacijom želuca, dispepsijom, ezofagitisom, gastritisom ili ulkusom) ili hipokalcijemijom.
If you forget to take Ibandronic Acid Teva 
Ako ste zaboravili uzeti Ibandronatnu kiselinu Teva
What Ibandronic Acid Teva looks like and contents of the pack The Ibandronic Acid Teva film-coated tablets are white, biconvex, capsule-shaped, engraved “50” on one side and plain on the other. 
Kako Ibandronatna kiselina Teva izgleda i sadržaj pakovanja Ibandronatna kiselina Teva filmom obložene tablete su bijele, bikonveksne tablete oblika kapsule s utisnutom oznakom „50“ na jednoj strani i bez oznake na drugoj strani.
NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V. 
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva B.V.
Keep taking Ibandronic Acid Teva for as long as your doctor tells you. 
Uvijek uzimajte Ibandronatnu kiselinu Teva točno onako kako Vam je rekao liječnik.
Atypical subtrochanteri c and diaphyseal femoral fractures† 
Atipične suptrohanteričke i dijafizealne frakture femura†
Ocular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid. 
Događaji povezani s upalom oka poput uveitisa, episkleritisa i skleritisa zabilježeni su uz primjenu ibandronatne kiseline.
Ibandronic acid 150 mg once monthly 
Ibandronatna kiselina 150 mg jedanput mjesečno
Therefore, patients should fast overnight (at least 6 hours) before taking Ibandronic Acid Teva and continue fasting for 1 hour following intake of Ibandronic Acid Teva (see section 4.2). 
Bolesnici bi stoga Ibandronatnu kiselinu Teva trebali uzimati nakon noćnog gladovanja (barem 6 sati) i trebali bi gladovati još 1 sat nakon uzimanja Ibandronatne kiseline Teva (vidjeti dio 4.2).
- If you have certain problems with your gullet/food pipe (oesophagus) such as narrowing or difficulty swallowing. 
- Ako imate probleme s jednjakom (cijev koja povezuje usta sa želucem), kao što su suženje ili teškoće prilikom gutanja.
They are designed to help your Ibandronic Acid Teva tablet reach your stomach quickly, so it's less likely to cause irritation. 
One Vam pomažu u pravilnom uzimanju tableta Ibandronatne kiseline Teva i njihovu brzom dolasku u želudac, čime je smanjena mogućnost pojave nadražaja.
After one year (primary analysis) the median relative change from baseline was -76 % for ibandronic acid 150 mg once monthly and -67 % for ibandronic acid 2.5 mg daily. 
Nakon jedne godine (primarna analiza) medijan relativne vrijednosti promjene u odnosu na početne vrijednosti iznosio je -76% za ibandronatnu kiselinu 150 mg jedanput mjesečno, odnosno -67% za ibandronatnu kiselinu 2,5 mg jedanput dnevno.
The safety and efficacy of Ibandronic Acid Teva in children and adolescents below the age of 18 years have not been established. 
Sigurnost i djelotvornost Ibandronatne kiseline Teva u djece i adolescenata mlađih od 18 godina nije ustanovljena.
It is not known whether ibandronic acid is excreted in human milk. 
Nije poznato izlučuje li se ibandronatna kiselina u majčino mlijeko.
• Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes). 
- Budite u uspravnom položaju (sjedeći ili stojeći) dok uzimate tabletu te još jedan sat (60 minuta) nakon uzimanja tablete.
Subjects with severe renal impairment (CLcr ≤ 30 mL/min) receiving oral administration of 10 mg ibandronic acid daily for 21 days, had 2-3 fold higher plasma concentrations than subjects with normal renal function (CLcr ≥80 mL/min). 
Bolesnici s teškim oštećenjima bubrega (CLcr ≤30 ml/min) koji su peroralno uzimali 10 mg ibandronatne kiseline svakodnevno u razdoblju od 21 dan, imali su dvostruko do trostruko više koncentracije u plazmi od osoba s normalnom funkcijom bubrega (CLcr ≥80 ml/min).
Ostravska 29/305 
Teva Czech Industries s.r.o. Ostravska 29/305
Read the package leaflet before use. 
Prije uporabe pročitati uputu o lijeku.
Common Uncommon Rare 
Manje često Rijetko Vrlo rijetko Nepozna to
Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Ibandronic Acid Teva tablets. 
Proizvodi koji sadrže kalcij i ostale multivalentne katione (kao što su aluminij, magnezij i željezo), uključujući mlijeko i hranu, mogu utjecati na apsorpciju tableta Ibandronatne kiseline Teva.
Common (may affect up to 1 in 10 people): • feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/food pipe) 
Često (mogu se javiti kod manje od 1 na 10 osoba): • mučnina, žgaravica i nelagoda pri gutanju (upala jednjaka)
Bioavailability is reduced by about 90% when ibandronic acid is administered with a standard breakfast in comparison with bioavailability seen in fasted subjects. 
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.
There is no evidence for clinically relevant interethnic differences between Asians and Caucasians in ibandronic acid disposition. 
Nema dokaza klinički značajnih međuetničkih razlika između azijata i bijelaca u izloženosti ibandronatnoj kiselini.
Relative risk reduction of clinical vertebral fracture 
Smanjenje relativnog rizika za kliničke prijelome kralježaka
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. 
U postmenopauzalnih žena ibandronatna kiselina dovodi do progresivnog neto povećanja koštane mase i smanjuje incidenciju prijeloma smanjujući povećanu koštanu pregradnju na premenopauzalne vrijednosti.
Tel: +39 02 89 17 98 1 
Teva Italia S.r.l. Tel: +39 02 89 17 98 1
Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. 
Ibandronatna kiselina Teva ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na blister pakovanju i kutiji iza oznake „EXP“ ili „Rok valjanosti“.
Ocular inflammation*† 
Upala oka*†*
Ibandronic acid 150 mg once monthly (N=291) 
Ibandronatna kiselina 150 mg jedanput mjesečno (n=291)
Secondary efficacy endpoints 
Sekundarne mjere ishoda djelotvornosti
METHOD AND ROUTE OF ADMINISTRATION Do not suck, chew or crush the tablets. 
NAČIN I PUT(EVI) PRIMJENE LIJEKA Ne otapajte u ustima, ne žvačite i ne drobite tablete.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovog lijeka obratite se svom liječniku ili ljekarniku.
Tablet coating: 
Ovojnica tablete:
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. 
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.