FrancophonIA/ELRC3.0 huggingface dataset:
English: The number of SREs was also significantly reduced with ibandronic acid 6 mg and there was a 40% reduction in the risk of a SRE over placebo (relative risk 0.6, p = 0.003).
Croatian: Broj SRE bio je također znatno smanjen uz ibandronatnu kiselinu 6 mg, sa 40% smanjenim rizikom od pojave SRE u usporedbi s placebom (relativni rizik 0,6; p = 0,003).
English: It is supplied as packs containing 1, 5 or 10 vials.
Croatian: Dostupno u pakiranjima od 1, 5 ili 10 bočica.
English: The range of observed apparent half-lives is broad, the apparent terminal half-life is generally in the range of 10 - 72 hours.
Croatian: Raspon prividnog poluvijeka je širok, a prividni terminalni poluvijek u načelu ima raspon od 10 do 72 sata.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Croatian: Uvjete čuvanja razrijeđenog lijeka vidjeti u dijelu 6.3
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to ibandronic acid administration.
Croatian: Tijekom liječenja, invazivne stomatološke zahvate treba izvoditi tek nakon pažljivog razmatranja i izbjegavati ih neposredno blizu primjene ibandronatne kiseline.
English: Three-year lumbar spine BMD increase compared to placebo was 5.3 % and 6.5 % compared to baseline.
Croatian: Nakon tri godine uočeno je povećanje BMD lumbalne kralježnice u usporedbi s placebom od 5,3% i 6,5% naspram početnih vrijednosti.
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05BA06
Croatian: Farmakoterapijska skupina: Pripravci za liječenje bolesti kostiju, bisfosfonati, ATK oznaka: M05BA06
English: Caution is to be taken in patients with known hypersensitivity to other bisphosphonates.
Croatian: Oprez je potreban u bolesnika s poznatom preosjetljivošću na druge bisfosfonate.
English: There is no evidence that ibandronic acid is metabolized in animals or humans.
Croatian: Nema dokaza da se ibandronatna kiselina metabolizira u životinja ili ljudi.
English: • low calcium or phosphate levels in your blood
Croatian: • smanjena razina kalcija i fosfata u krvi
English: After 5 years of receiving Ibandronic acid Accord, please consult with your doctor whether you should continue to receive Ibandronic acid Accord.
Croatian: Nakon 5 godina primjene lijeka Ibandronic acid Accord posavjetujte se sa savojim liječnikom o tome trebate li ga nastaviti primati.
English: Due to the limited data available, ibandronic acid should not be used in all patients with end-stage renal disease.
Croatian: Zbog dostupnih ograničenih podataka ibandronatnu kiselinu ne bi trebalo primjenjivati u bolesnika s terminalnom bolešću bubrega.
English: Both daily, intermittent (with a dose-free interval of 9 - 10 weeks per quarter) oral doses as well as intravenous doses of ibandronic acid in postmenopausal women produced biochemical changes indicative of dose-dependent inhibition of bone resorption.
Croatian: Dnevne kao i intermitentne peroralne doze (uz intervale od 9 do 10 tjedana po tromjesečju bez doze) kao i intravenske doze ibandronatne kiseline u žena u postmenopauzi proizvele su biokemijske promjene koje ukazuju na inhibiciju razgradnje kosti ovisnu o dozi.
English: In clinical pharmacology trial WP18551, after a single dose intravenous administration of 6 mg (15 minutes infusion), mean AUC0-24 increased by 14% and 86%, respectively, in subjects with mild (mean estimated CLcr=68.1 ml/min) and moderate (mean estimated CLcr= 41.2 ml/min) renal impairment compared to healthy volunteers (mean estimated CLcr=120 ml/min).
Croatian: U kliničkom farmakološkom ispitivanju WP18551, nakon intravenske primjene jedne doze od 6 mg (15-minutna infuzija) prosječni AUC0-24 se povećao za 14% u ispitanika s blagim (srednja procijenjena vrijednost CLcr = 68,1 ml/min) odnosno za 86% u ispitanika s umjerenim (srednja procijenjena vrijednost CLcr = 41,2 ml/min) oštećenjem bubrega u odnosu na zdrave dobrovoljce (srednja procijenjena vrijednost CLcr = 120 ml/min).
English: Ibandronic acid 6 mg n=154
Croatian: Ibandronatna kiselina 6 mg n=154
English: The deterioration in Quality of Life was significantly less in ibandronic acid treated patients compared with placebo.
Croatian: Pogoršanje kvalitete života bilo je znatno manje u bolesnika liječenih ibandronatnom kiselinom nego u bolesnika koji su primali placebo.
English: The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at the lumbar spine of -2 to -5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
Croatian: U ispitivanju su bile uključene žene od 55 do 80 godina koje su bile u postmenopauzi najmanje pet godina i u kojih je BMD lumbalne kralježnice iznosio od -2 do -5 SD manje od premenopauzalne srednje vrijednosti (T vrijednost) na barem jednom kralješku [L1-L4], a koje su imale od jednog do četiri postojeća prijeloma kralježaka.
English: The pharmacokinetics of ibandronic acid in patients with end-stage renal disease was only assessed in a small number of patients managed by haemodialysis, therefore, the pharmacokinetics of ibandronic acid in the patients not undergoing haemodialysis is unknown.
Croatian: Farmakokinetika ibandronatne kiseline u bolesnika s terminalnom bolešću bubrega bila je određena samo u malog broja bolesnika na hemodijalizi, a farmakokinetika ibandronatne kiseline u bolesnika koji nisu na hemodijalizi nije poznata.
English: BMD - mean change relative to baseline lumbar spine at year 3
Croatian: BMD - srednja promjena u odnosu na početne vrijednosti za lumbalnu kralježnicu nakon 3 godine
English: Protein binding in human plasma is approximately 87% at therapeutic concentrations, and thus interaction with other medicinal products, due to displacement is unlikely.
Croatian: Pri terapijskim koncentracijama vezanje za proteine plazme u ljudi iznosi otprilike 87% i stoga interakcija s drugim lijekovima zbog istiskivanja nije vjerojatna.
English: You may have early signs of severe jaw problems (necrosis
Croatian: To mogu biti rani znakovi teških problema s čeljusti (nekroza
English: Pharmaco-therapeutic group: Medicinal products for treatment of bone diseases, bisphosphonate, ATC Code: M05BA06.
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje bolesti kostiju, bisfosfonati, ATK oznaka: M05BA06.
English: You may have early signs of a possible unusual fracture of the thigh bone.
Croatian: To mogu biti rani znakovi mogućeg neuobičajenog prijeloma bedrene kosti
English: Some patients need to be especially careful when using Ibandronic acid Accord.
Croatian: Neki bolesnici trebaju biti osobito oprezni kod primjene lijeka Ibandronic acid Accord.
English: Protein binding in human plasma is approximately 85 % - 87 % (determined in vitro at therapeutic ibandronic acid concentrations), and thus there is a low potential for interaction with other medicinal products due to displacement.
Croatian: Vezanje na proteine plazme iznosi otprilike 85% do 87 % (određeno in vitro pri terapijskim koncentracijama lijeka) i stoga je mala vjerojatnost interakcije s drugim lijekovima zbog istiskivanja.
English: In humans, the efficacy of both daily and intermittent administration with a dose-free interval of 9 - 10 weeks of ibandronic acid was confirmed in a clinical trial (MF 4411), in which ibandronic acid demonstrated anti-fracture efficacy.
Croatian: U ljudi je djelotvornost dnevne i intermitentne primjene s intervalom od 9 do 10 tjedana bez primanja doze ibandronatne kiseline potvrđena kliničkim ispitivanjem (MF 4411) u kojemu je ibandronatna kiselina pokazala djelotvornost u sprečavanju prijeloma.
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 poluvijekova širok je te ovisi o dozi i osjetljivosti metode, no prividni terminalni poluvijek u načelu ima raspon od 10 do 60 sati.
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 distribucije iznosi najmanje 90 l, dok se količina doze koja dospijeva do kosti procjenjuje na 40-50% cirkulirajuće doze.
English: North Harrow Middlesex HA1 4HF United Kingdom
Croatian: North Harrow Middlesex HA1 4HF Ujedinjeno Kraljevstvo
English: Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation.
Croatian: Ibandronatna kiselina eliminira se isključivo bubrežnom ekskrecijom i ne prolazi biotransformaciju.
English: Biochemical markers of bone turnover (such as urinary CTX and serum Osteocalcin) showed the expected pattern of suppression to premenopausal levels and reached maximum suppression within a period of 3 - 6 months of using 2.5 mg ibandronic acid daily.
Croatian: Biokemijski biljezi koštane pregradnje (kao što je CTX u urinu i serumski osteokalcin) pokazali su očekivani obrazac snižavanja do premenopauzalnih razina te su dosegnuli najviše sniženje tijekom 3 do 6 mjeseci primjenom 2,5 mg ibandronatne kiseline dnevno.
English: A clinically meaningful reduction of 50 % of biochemical markers of bone resorption was observed as early as one month after starting treatment with ibandronic acid 2.5 mg.
Croatian: Klinički značajno smanjenje biokemijskih biljega koštane resorpcije od 50% primijećeno je već mjesec dana nakon početka liječenja ibandronatnom kiselinom u dozi od 2,5 mg.
English: No data are available (see section 5.1 and section 5.2).
Croatian: Nema podataka o primjeni u djece (vidjeti dio 5.1 i dio 5.2).
English: The histological analysis of bone biopsies after two and three years of treatment of postmenopausal women with doses of oral ibandronic acid 2.5 mg daily and intermittent intravenous doses of up to 1 mg every 3 months showed bone of normal quality and no indication of a mineralisation defect.
Croatian: Histološka analiza biopsije kosti nakon dvije i tri godine liječenja žena u postmenopauzi dnevnim oralnim dozama ibandronatne kiseline od 2,5 mg i intermitentnim intravenskim dozama do 1 mg svaka tri mjeseca pokazala je da je kost normalne kvalitete i bez znakova poremećaja mineralizacije.
English: Temporary interruption of ibandronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Croatian: Kad je moguće, treba uzeti u obzir privremeni prekid liječenja ibandronatnom kiselinom dok se stanje ne popravi i pripadajući čimbenici rizika ublaže.
English: • pain or injury at the injection site
Croatian: • bol ili ozljeda na mjestu injekcije
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 Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions
Croatian: Potrebno je razmotriti sljedeće faktore rizika prilikom procjene rizika od pojave osteonekroze čeljusti u bolesnika: potentnost lijeka koji inibira resorpciju kostiju (rizik je veći za jako potentne spojeve), put primjene (rizik je veći za parenteralnu primjenu) i kumulativna doza terapije za resorpciju kostiju rak, komorbidna zdravstvena stanja (npr. anemija, koagulopatije, infekcija), pušenje istovremene terapije: kortikosteroidi, kemoterapija, inhibitori angiogeneze, radioterapija glave i vrata loša zubna higijena, parodontne bolesti, loše podešene proteze, bolesti zuba u anamnezi, invazivni zubarski zahvati, npr. vađenje zuba
English: The overall proportion of patients who experienced an adverse reaction was 26.0 % and 28.6 % for ibandronic acid 3 mg injection every 3 months after one year and two years, respectively.
Croatian: Ukupan udio bolesnika koji su imali nuspojave iznosio je 26,0% i 28,6% za injekciju ibandronatne kiseline od 3 mg primijenjenu svaka tri mjeseca nakon jedne, odnosno dvije godine.
English: • pain in your muscles, joints, or back
Croatian: • bol u mišićima, zglobovima ili leđima
English: Furthermore, ibandronic acid 3 mg injection every 3 months was proven superior to oral ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p<0.001, and at two years, p<0.001.
Croatian: Nadalje, injekcija ibandronatne kiseline od 3 mg svaka tri mjeseca dokazano je učinkovitija od peroralno primijenjene ibandronatne kiseline od 2,5 mg jedanput dnevno u povećanju BMD lumbalne kralježnice u prospektivno planiranoj analizi nakon jedne godine (p<0,001) i nakon dvije godine (p<0,001).
English: Clinical studies in hypercalcaemia of malignancy demonstrated that the inhibitory effect of ibandronic acid on tumour-induced osteolysis, and specifically on tumour-induced hypercalcaemia, is characterised by a decrease in serum calcium and urinary calcium excretion.
Croatian: Klinička ispitivanja hiperkalcijemije povezane sa zloćudnim bolestima pokazala su da je inhibitorni učinak ibandronatne kiseline na osteolizu uzrokovanu tumorom, a osobito hiperkalcijemiju uzrokovanu tumorom, karakteriziran smanjenjem kalcija u serumu i izlučivanjem kalcija urinom.
English: Cerebrovascular disorder, nerve root lesion, amnesia, migraine, neuralgia, hypertonia, hyperaestesia, paraesthesia circumoral, parosmia
Croatian: cerebrovaskularni poremećaji, lezija korijena živaca, amnezija, migrena, neuralgija, hipertonija, hiperestezija, cirkumoralna parestezija,
English: • mouth ulcers, swollen lips (‘“cheilitis”'), oral thrush
Croatian: • vrijed usta, natečene usne (“heilitis”), oralna kandidijaza
English: It does not interfere with osteoclast recruitment.
Croatian: Ne interferiraju s aktivacijom osteoklasta.
English: Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic acid.
Croatian: Slučajevi ozbiljnih, ponekad smrtonosnih alergijskih reakcija, prijavljeni su u bolesnika koji su intravenski liječeni ibandronatnom kiselinom.
English: In subjects with severe renal impairment (mean estimated CLcr=21.2 ml/min), doseadjusted mean AUC0-24h was increased by 110% compared to healthy volunteers.
Croatian: Kod bolesnika s teškim oštećenjem bubrega (srednja procijenjena vrijednost CLcr = 21,2 ml/min), srednja vrijednost AUC0-24h prilagođena dozi, je bila povećana za 110% u odnosu na zdrave dobrovoljce.
English: Accord Healthcare Ltd. Sage House 319 Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom
Croatian: Sage House 319 Pinner Road North Harrow, Middlesex HA1 4HF Ujedinjeno Kraljevstvo
English: Infusion Volume 1 and Time2
Croatian: Volumen infuzije1 i vrijeme2
English: Based on knowledge of this class of compounds, intravenous overdosage may result in hypocalcaemia, hypophosphataemia, and hypomagnesaemia, which can cause paraesthesia.
Croatian: Na temelju poznavanja ove skupine spojeva, intravensko predoziranje može izazvati hipokalcijemiju, hipofosfatemiju i hipomagnezijemiju, što može uzrokovati paresteziju.
English: • feeling thirsty, sore throat, changes in taste
Croatian: • žeđ, grlobolja, promjene okusa
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 renalnog izlučivanja ne obuhvaća ni poznate kisele niti bazne transportne sustave uključene u izlučivanje drugih djelatnih tvari.
English: There are no data on the use of ibandronic acid in patients less than 18 years old.
Croatian: Ne postoje podaci o primjeni ibandronatne kiseline u bolesnika mlađih od 18 godina.
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 prijelomi mogući su bilo gdje na bedrenoj kosti, odmah ispod maloga trohantera pa sve do iznad suprakondilarnog područja.
English: The treatment effect of ibandronic acid was further assessed in an analysis of the subpopulation of patients who, at baseline, had a lumbar spine BMD T-score below -2.5 (table 4).
Croatian: Učinak liječenja ibandronatne kiseline dodatno je procijenjen analizom populacijske podskupine bolesnika čija je početna T-vrijednost BMD lumbalne kralježnice bila manja od -2,5 (Tablica 4).
English: Pharmacokinetics of ibandronic acid are similar in men and women.
Croatian: Farmakokinetička svojstva ibandronatne kiseline slična su u žena i muškaraca.
English: Pre-filled syringes made of colourless glass, the grey plunger rubber stopper and tip cap, containing 3 ml of solution for injection.
Croatian: Napunjena štrcaljka napravljena od bezbojnog stakla, sa sivim gumenim čepom klipa i zatvaračem vrha sadrži 3 ml otopine za injekciju.
English: After that, go back to getting the injections every 3 months from the date of the most recent injection.
Croatian: Nakon toga vratite se režimu primanja injekcije svaka tri mjeseca, brojeći od datuma posljednje primljene injekcije.
English: The recommended dose of Ibandronic acid Accord for the intravenous injection is 3 mg (1 pre-filled syringe) once every 3 months.
Croatian: Preporučena doza lijeka Ibandronic acid Accord za intravensku injekciju iznosi 3 mg (1 napunjena štrcaljka) jedanput svaka tri mjeseca.
English: The solution is irritant, therefore strict adherence to the intravenous route of administration is important.
Croatian: Otopina je nadražujuća pa je potrebno strogo se pridržavati isključivo intravenskog puta primjene.
English: Ibandronic acid Accord can also be prescribed if you have a raised calcium level in your blood due to a tumour.
Croatian: Ibandronic acid Accord će Vam biti propisan i ukoliko imate povišenu razinu kalcija u krvi uzrokovanu tumorom.
English: Data from this study demonstrated a significant advantage for intravenous ibandronic acid 6 mg over placebo in the reduction in SREs measured by the time-adjusted SMPR (p=0.004).
Croatian: Podaci prikupljeni tijekom ovog ispitivanja pokazali su znatnu prednost ibandronatne kiseline 6 mg dane intravenski, u odnosu na placebo u pogledu smanjivanja SRE, mjereno vremenski prilagođenim SMPR-om (p=0,004).
English: Bioavailability and pharmacokinetics of ibandronic acid are similar in both men and women.
Croatian: Bioraspoloživost i farmakokinetika ibandronatne kiseline su slični u žena i muškaraca.
English: Based on knowledge of this class of compounds, intravenous overdosage may result in hypocalcaemia, hypophosphataemia, and hypomagnesaemia.
Croatian: Na temelju poznavanja ove skupine spojeva, intravensko predoziranje može uzrokovati hipokalcijemiju, hipofosfatemiju i hipomagnezijemiju.
English: = serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)]
Croatian: = kalcij u serumu (mg/dl) + 0,8 x [4 - albumin (g/dl)]
English: In severe cases intravenous infusion of appropriate doses of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, may be needed.
Croatian: U teškim slučajevima može biti potrebna intravenska infuzija odgovarajućih doza kalcijeva glukonata, kalijeva ili natrijeva fosfata te magnezijeva sulfata.
English: Table 1 lists adverse drug reactions from the pivotal phase III studies (Treatment of tumour induced hypercalcaemia: 311 patients treated with ibandronic acid 2 mg or 4 mg; Prevention of skeletal events in patients with breast cancer and bone metastases: 152 patients treated with ibandronic acid 6 mg), and from post-marketing experience.
Croatian: U tablici 1 navedene su nuspojave lijeka iz faze III pivotalnih kliničkih ispitivanja (Liječenje hiperkalcijemije nastale zbog tumora: 311 bolesnika liječeno ibandronatnom kiselinom od 2 mg ili 4 mg; Sprječavanje koštanih događaja u bolesnika s rakom dojke i koštanim metastazama: 152 bolesnika liječena ibandronatnom kiselinom od 6 mg i iz iskustava nakon stavljanja lijeka na tržište.
English: You should also take calcium and vitamin-D supplements, as recommended by your doctor.
Croatian: Za vrijeme liječenja neophodno je uzimati preparate s kalcijem i vitaminom D koje Vam je preporučio liječnik.
English: Ibandronic acid Accord is available in packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.
Croatian: Lijek Ibandronic acid Accord je dostupan u pakiranju od 1 napunjene štrcaljke i 1 injekcijske igle ili 4 napunjene štrcaljke i 4 injekcijske igle.
English: The safety and efficacy of ibandronic acid in children and adolescents below the age of 18 years have not been established.
Croatian: Sigurnost i djelotvornost ibandronatne kiseline u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: Subjects with severe renal impairment (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: The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Croatian: Nositelj odobrenja osigurat će provedbu kartice s podsjetnicima za pacijente u vezi s osteonekrozom čeljusti.
English: Mutagenicity/Carcinogenicity
Croatian: Mutagenost/karcinogenost
English: Table 1: Adverse reactions occurring in postmenopausal women receiving ibandronic acid 3 mg injection every 3 months or ibandronic acid 2.5 mg daily in the phase III studies BM16550 and MF 4411, and in post-marketing experience.
Croatian: Tablica 1: Nuspojave koje se pojavljuju u žena u postmenopauzi koje primaju injekcije ibandronatne kiseline od 3 mg svaka 3 mjeseca ili 2,5 mg ibandronatne kiseline jedanput dnevno u ispitivanjima faze III BM 16550 i MF 4411 i nakon stavljanja lijeka na tržište.
English: Infusion Volume 1 and Time 2
Croatian: Volumen infuzije 2
English: It is supplied as packs containing 1 vial with 2 ml of concentrate.
Croatian: Isporučuje se u pakiranju od 1 bočice s 2 ml koncentrata.
English: Also, some other medicines can affect the way Ibandronic acid Accord works.
Croatian: Također, drugi lijekovi mogu utjecati na djelovanje Ibandronic acid Accorda.
English: In addition, 64.8 % of patients receiving 3 mg every 3 months injection were identified as responders (defined as a decrease ≥ 50 % from baseline), compared with 64.9 % of patients receiving 2.5 mg daily orally.
Croatian: Osim toga, na liječenje je odgovorilo 64,8% bolesnika koji su primali injekciju od 3 mg svaka tri mjeseca (definirano kao smanjenje od ≥50% od početne vrijednosti), u usporedbi s 64,9% bolesnika koji su peroralno primali dozu od 2,5 mg jedanput dnevno.
English: 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.
Croatian: U reproduktivnim ispitivanjima peroralne primjene na štakorima, djelovanje na plodnost obuhvaćalo je povećane preimplantacijske gubitke pri dozama od 1 mg/kg na dan i višim.
English: Existing hypocalcaemia must be corrected before starting ibandronic acid injection therapy.
Croatian: Postojeća hipokalcijemija se mora korigirati prije početka terapije injekcijama ibandronatne kiseline.
English: This is because Ibandronic acid Accord can affect the way some other medicines work.
Croatian: Ibandronic acid Accord može utjecati na djelovanje drugih lijekova.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 mg/2 ml
Croatian: 5. SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2 mg/2 ml