natgillin/translations-raw huggingface dataset:
The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration and plasma concentrations increase in a dose-proportional manner up to 50 mg oral intake, with greater than dose-proportional increases seen above this dose.
Apsorpcija ibandronatne kiseline u gornjem dijelu probavne cijevi vrlo je brza nakon peroralne primjene, dok se koncentracija u plazmi povećava proporcionalno dozi sve do peroralne primjene 50 mg, a pri većim dozama zamijećeno je povećanje veće od onog proporcionalnog dozi.
Physicians should be alert to any signs or symptoms signaling a possible oesophageal reaction and patients should be instructed to discontinue Ibandronic Acid Teva and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
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 Ibandronatnu kiselinu Teva i potraže liječničku pomoć ako se pojavi disfagija, odinofagija, retrosternalna bol, žgaravica ili dođe do pogoršanja žgaravice.
- If you have any further questions, ask your doctor or pharmacist.
• Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku
Other medicines and Ibandronic Acid Teva
Drugi lijekovi i Ibandronatna kiselina Teva
• new pain, weakness or discomfort in your thigh, hip or groin.
• novonastala bol, slabost ili nelagoda u bedru, kuku ili preponama.
Pooled data from these studies demonstrated a significant advantage for ibandronic acid 50 mg p.o. over placebo in the reduction in SREs measured by the SMPR (p=0.041).
Podaci prikupljeni tijekom ovog ispitivanja pokazali su znatnu prednost ibandronatne kiseline 50 mg peroralno u odnosu na placebo u pogledu smanjivanja SRE, mjereno SMPR-om (p=0,041).
Talk to your doctor or pharmacist before taking Ibandronic Acid Teva: - if you are allergic to any other bisphosphonates - if you have any swallowing or digestion problems - if you have high or low blood levels of vitamin D or any other minerals - if you have kidney problems.
Obratite se svom liječniku ili ljekarniku prije nego primijenite Ibandronatnu kiselinu Teva: - ako ste alergični (preosjetljivi) na druge bisfosfonate - ako imate problema s gutanjem ili probavom. - ako imate visoke ili niske razine vitamina
This is because Ibandronic Acid Teva can affect the way some other medicines work.
Ibandronatna kiselina Teva može utjecati na djelovanje drugih lijekova.
Prevention of skeletal events in patients with breast cancer and bone metastases with ibandronic acid 50 mg tablets was assessed in two randomized placebo controlled phase III trials with a duration of 96 weeks.
Prevencija koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama davanjem tableta ibandronatne kiseline od 50 mg ocijenjena je u dva randomizirana, placebom kontrolirana ispitivanja faze III u trajanju od 96 tjedana.
What you need to know before you take Ibandronic Acid Teva
Što morate znati prije nego počnete uzimati Ibandronatnu kiselinu Teva
Ibandronic Acid Teva tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day.
Tablete Ibandronatne kiseline Teva treba uzimati natašte, nakon noćnog gladovanja (barem 6 sati) i prije uzimanja prvog jutarnjeg obroka ili pića.
Table 4: Results from 3 years fracture study MF 4411 (%, 95 % CI) for patients with lumbar spine BMD T-score below -2.5 at baseline
Tablica 4: Rezultati trogodišnjeg ispitivanja prijeloma iz ispitivanja MF 4411 (%, 95% CI) za bolesnike čija je početna T-vrijednost BMD lumbalne kralježnice bila manja od -2,5
The difference between the apparent total and renal clearances is considered to reflect the uptake by bone.
Smatra se da razlika između prividnog ukupnog i bubrežnog klirensa odražava apsorpciju od strane kostiju.
A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
Dokazano je smanjenje rizika od prijeloma kralježaka, a djelotvornost u smanjenju prijeloma kuka nije pokazana.
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%.
Maksimalne zabilježene koncentracije u plazmi postignute su u vremenu od 0,5 do 2 sata (medijan 1 sat) nakon uzimanja lijeka natašte, a apsolutna bioraspoloživost bila je oko 0,6%.
Table 1: Adverse reactions occurring in postmenopausal women receiving ibandronic acid 150 mg once monthly or ibandronic acid 2.5 mg daily in the phase III studies BM 16549 and MF 4411 and in post-marketing experience.
Tablica 1: Nuspojave koje se pojavljuju u žena u postmenopauzi koje primaju tablete ibandronatne kiseline 150 mg jedanput mjesečno ili 2,5 mg ibandronatne kiseline jedanput dnevno u ispitivanjima faze III BM16549 i MF4411 i u razdoblju nakon stavljanja lijeka na tržište
- Take one Ibandronic Acid Teva 150 mg tablet once a month.
- Uzimajte jednu tabletu Ibandronatne kiseline Teva 150 mg jedanput mjesečno.
There was also a 38% reduction in the risk of developing an SRE for ibandronic acid treated patients when compared with placebo (relative risk 0.62, p=0.003).
U usporedbi s placebo grupom, u bolesnika liječenih ibandronatnom kiselinom rizik od razvoja SRE bio je za 38% manji (relativni rizik 0,62; p=0,003).
Patients with renal impairment Exposure to ibandronic acid in patients with various degree of renal impairment is related to creatinine clearance (CLcr).
Izloženost ibandronatnoj kiselini u bolesnika s različitim stupnjevima oštećenja bubrega povezana je s klirensom kreatinina (CLcr).
No evidence of direct foetal toxicity or teratogenic effects was observed for ibandronic acid in intravenously or orally treated rats and rabbits.
Nije bilo dokaza izravne fetalne toksičnosti ili teratogenog učinka u štakora i zečeva kojima je ibandronatna kiselina primijenjena intravenski ili peroralno.
In healthy male volunteers and postmenopausal women, intravenous administration of ranitidine caused an increase in ibandronic acid bioavailability of about 20%, probably as a result of reduced gastric acidity.
U zdravih muških ispitanika i žena u postmenopauzi, intravenska primjena ranitidina uzrokovala je povećanje bioraspoloživosti ibandronatne kiseline za otprilike 20%, vjerojatno kao rezultat smanjene kiselosti želuca.
Patients with hepatic impairment (see section 4.2)
Bolesnici s oštećenjem jetre (vidjeti dio 4.2)
No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal or greater than 30 ml/min.
Prilagodba doze nije potrebna u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega, čiji je klirens kreatinina jednak ili veći od 30 ml/min.
Total hip BMD
BMD cijelog kuka
- Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions.
radioterapija glave i vrata - loša oralna higijena, periodontalna bolest, loše postavljena zubna proteza, zubna bolest u anamnezi, invazivni stomatološki zahvati, npr. vađenje zuba
Ibandronic acid 50 mg n=287
Ibandronatna kiselina 50 mg n=287
Ibandronic Acid Teva therapy should only be initiated by physicians experienced in the treatment of cancer.
Terapiju Ibandronatnom kiselinom Teva smiju započeti samo liječnici s iskustvom u liječenju zloćudnih bolesti.
For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) an adjustment in the dose is recommended (see section 4.2).
U bolesnika s umjerenim (CLcr ≥30 i <50 ml/min) ili teškim oštećenjem bubrega (CLcr <30 ml/min) preporučuje se prilagodba doze (vidjeti dio 4.2).
Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Ibandronic Acid Teva.
Uzimanje lijekova za smanjenje kiseline u želucu poput cimetidina i ranitidina može neznatno povećati učinak Ibandronatne kiseline Teva.
Due to limited clinical experience, Ibandronic Acid Teva is not recommended for patients with a creatinine clearance below 30 ml/min (see section 5.2).
Zbog ograničenog kliničkog iskustva, Ibandronatna kiselina Teva ne preporučuje se u bolesnika čiji je klirens kreatinina ispod 30 ml/min (vidjeti dio 5.2).
You should take one tablet the next morning after the day you remember; then, continue taking one tablet once a month on the scheduled days you've marked on your calendar.
Uzmite jednu tabletu prvo sljedeće jutro nakon što ste se sjetili da ste zaboravili uzeti propisanu dozu; zatim ponovno počnite uzimati jednu tabletu mjesečno na onaj dan u mjesecu koji ste označili u kalendaru.
Then you can have your first food and drink, and take any medicines or supplements.
Nakon toga možete uzeti svoj prvi jutarnji obrok, piće i druge lijekove ili nadomjesne pripravke.
These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Ti poprečni i kratki kosi lomovi mogući su bilo gdje na bedrenoj kosti, odmah ispod malog trohantera pa sve do iznad suprakondilarnog područja.
You should wait until the next scheduled dose is due and take it as normal; then, continue taking one tablet once a month on the scheduled days you've marked on your calendar.
Pričekajte do datuma uzimanja sljedeće doze označene u Vašem kalendaru i uzmite je kao i obično; zatim ponovno počnite uzimati jednu tabletu jednom mjesečno na onaj dan u mjesecu koji ste označili u kalendaru.
In reproductive studies in rats by the intravenous route, ibandronic acid decreased sperm counts at doses of 0.3 and 1 mg/kg/day and decreased fertility in males at 1 mg/kg/day and in females at 1.2 mg/kg/day.
U reproduktivnim ispitivanjima na štakorima koji su lijek primali intravenski, ibandronatna je kiselina smanjila broj spermija pri dozama od 0,3 i 1 mg/kg na dan te smanjila plodnost u mužjaka pri dozi od 1 mg/kg na dan, a u ženki pri dozi od 1,2 mg/kg na dan.
BMD - mean change relative to baseline total hip at year 3
BMD - srednja promjena u odnosu na početne vrijednosti za cijeli kuk nakon 3 godine
If there is a 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.
Ako postoji sumnja povezana s potencijalno visokim razinama kalcija u pitkoj vodi (tvrda voda), preporučuje se koristiti flaširanu vodu s niskim udjelom minerala.
The safety of oral treatment with ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo-controlled clinical studies, with the large majority of patients coming from the pivotal three year fracture study (MF
Sigurnost peroralne primjene ibandronatne kiseline 2,5 mg jedanput dnevno ispitana je u 1251 bolesnika u četiri placebo kontrolirana klinička ispitivanja, od kojih je većina bolesnika bila prethodno uključena u pivotalno trogodišnje kliničko ispitivanje o prijelomima (MF 4411).
You may have early signs of a possible unusual fracture of the thigh bone
To mogu biti rani znakovi mogućeg neuobičajenog prijeloma bedrene kosti
Primary efficacy endpoints
Primarne mjere ishoda djelotvornosti
Blood parathyroid hormone increased
Povećana razina paratiroidnog hormona u krvi
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.