FrancophonIA/ELRC3.0 huggingface dataset:
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: Bonviva 150 mg film-coated tablets Ibandronic acid
Croatian: Bonviva 150 mg filmom obložene tablete ibandronatna kiselina
English: • If you have any further questions, ask your doctor or pharmacist.
Croatian: • Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku
English: Bonviva 150 mg once monthly (N=291)
Croatian: Bonviva 150 mg jedanput mjesečno (n=291)
English: The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, ocular inflammation, (see paragraph “Description of selected adverse reactions” and section 4.4).
Croatian: Najozbiljnije prijavljene nuspojave su anafilaktička reakcija/šok, atipični prijelomi bedrene kosti, osteonekroza čeljusti, gastrointestinalna iritacija i upala oka (vidjeti odlomak „Opis odabranih nuspojava“ i dio 4.4).
English: Bonviva 3 mg injection every 3 months (N=365)
Croatian: Injekcija lijeka Bonviva 3 mg svaka 3 mjeseca (N=334)
English: A clinically meaningful reduction of 50 % of biochemical markers of bone resorption was observed as early as one month after start of 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: Bonviva solution for injection must not be mixed with calcium-containing solutions or other intravenously administered medicinal products.
Croatian: Bonviva otopina za injekciju ne smije se miješati s otopinama koje sadrže kalcij kao ni s drugim lijekovima za intravensku primjenu.
English: Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14 % and 18 % of patients used histamine (H2) blockers or proton pump inhibitors after one and two years, respectively.
Croatian: Blokatori H2 receptora ili inhibitori protonske pumpe 14% od više od 1500 bolesnika uključenih u ispitivanje BM 16549 u kojem su se uspoređivali mjesečni i dnevni režimi doziranja ibandronatne kiseline nakon jedne godine koristilo je histaminske (H2) blokatore ili inhibitore protonske pumpe, odnosno 18% nakon dvije godine.
English: Bonviva 3 mg solution for injection in pre-filled syringe like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Croatian: Bonviva 3 mg otopina za injekciju u napunjenoj štrcaljki može, poput ostalih bisfosfonata koji se primjenjuju intravenski, izazvati prolazno smanjenje vrijednosti kalcija u serumu.
English: Furthermore, Bonviva 150 mg once monthly was proven superior to ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p=0.002, and at two years, p<0.001.
Croatian: Nadalje, Bonviva 150 mg jedanput mjesečno dokazano je bolja od ibandronatne kiseline 2,5 mg jedanput dnevno u povećavanju BMD lumbalne kralježnice u prospektivno planiranoj analizi nakon jedne godine, p=0,002, i nakon dvije godine, p<0,001.
English: NAME OF THE MEDICINAL PRODUCT Bonviva 150 mg film-coated tablets
Croatian: NAZIV LIJEKA Bonviva 150 mg filmom obložene tablete
English: *See further information below †Identified in post-marketing experience.
Croatian: *Za daljnje informacije vidjeti nastavak teksta † Zabilježeno nakon stavljanja lijeka na tržište
English: The overall proportion of patients who experienced an adverse reaction, was 22.7 % and 25.0 % for Bonviva 150 mg once monthly after one and two years, respectively.
Croatian: Sveukupni udio bolesnika koji su imali nuspojave, iznosio je 22,7% odnosno 25% za lijek Bonviva 150 mg jedanput mjesečno nakon jedne odnosno dvije godine.
English: • If you have certain problems with your gullet/food pipe (oesophagus) such as narrowing or difficulty swallowing.
Croatian: • ako imate probleme s jednjakom/cijevi koja povezuje usta sa želucem (ezofagusom), kao što su suženje ili teškoće prilikom gutanja
English: 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.
Croatian: Na temelju poznavanja ove skupine spojeva, predoziranje peroralnim putem može rezultirati nuspojavama gornjeg dijela gastrointestinalnog trakta (primjerice iritacijom želuca, dispepsijom, ezofagitisom, gastritisom ili ulkusom) ili hipokalcijemijom.
English: Based on the results of study BM 16549, Bonviva 150 mg once monthly is expected to be at least as effective in preventing fractures as ibandronic acid 2.5 mg daily.
Croatian: Na temelju rezultata studije BM 16549 očekuje se da će Bonviva 150 mg jedanput mjesečno biti barem jednako djelotvorna u sprječavanju prijeloma kao ibandronatna kiselina 2,5 mg jedanput dnevno.
English: Do not use Bonviva this medicine after the expiry date which is stated on the carton and on the syringe after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i štrcaljki iza oznake „Rok valjanosti“ ili „EXP“.
English: No specific information is available on the treatment of overdose with Bonviva.
Croatian: Nisu dostupne specifične informacije o liječenju u slučajevima predoziranja lijekom Bonviva.
English: Patients with concomitant diseases, or who use medicinal products which have potential for undesirable effects on the kidney, should be reviewed regularly in line with good medical practice during treatment.
Croatian: Bolesnike s pratećim bolestima ili one koji uzimaju lijekove koji mogu imati štetne učinke na bubrege potrebno je tijekom liječenja redovito kontrolirati u skladu s načelima dobre medicinske prakse.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use For intravenous use only
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku Isključivo za primjenu u venu
English: EU/1/03/265/003 EU/1/03/265/004
Croatian: EU/1/03/265/004
English: Bonviva 150 mg once monthly (N=320)
Croatian: Bonviva 150 mg jedanput mjesečno (n=320)
English: Bonviva 3 mg injection every 3 months
Croatian: Injekcija lijeka Bonviva 3 mg svaka 3 mjeseca
English: How to take Bonviva).
Croatian: Kako uzimati lijek Bonviva)
English: What you need to know before you receive Bonviva
Croatian: Što morate znati prije nego počnete primati lijek Bonviva
English: Due to limited clinical experience, Bonviva is not recommended for patients with a creatinine clearance below 30 ml/min (see section 5.2).
Croatian: Zbog ograničenog kliničkog iskustva, Bonviva se ne preporučuje u bolesnika čiji je klirens kreatinina ispod 30 ml/min (vidjeti dio 5.2).
English: Table 1: Adverse reactions occurring in postmenopausal women receiving Bonviva 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 Bonviva 3mg injekcije 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: They are designed to help your Bonviva tablet reach your stomach quickly, so it's less likely to cause irritation.
Croatian: One Vam pomažu u pravilnom uzimanju Bonviva tableta i njihovu brzom dolasku u želudac čime je smanjena mogućnost pojave nadražaja.
English: • heartburn, discomfort in swallowing, stomach or tummy pain (may be due to an inflammation of the stomach), indigestion, nausea, having diarrhoea (loose bowels)
Croatian: • žgaravica, nelagoda pri gutanju, bol u trbuhu (može biti posljedica upale želuca), probavne smetnje, mučnina, proljev (osjetljiva crijeva)
English: One year data in study BM 16550 Two year data in study BM 16550
Croatian: Podaci iz ispitivanja BM 16550 nakon dvije godine
English: One year data in study BM 16549 Two year data in study BM 16549
Croatian: Podaci iz ispitivanja BM 16549 nakon dvije godine
English: • muscle cramps, stiffness of your joints and limbs
Croatian: • grčevi mišića, ukočenost zglobova ili udova
English: What you need to know before you take Bonviva
Croatian: Što morate znati prije nego počnete uzimati lijek Bonviva
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
Croatian: osteonekroza čeljusti *†, osteonekroza vanjskog slušnog kanala (nuspojava skupine bisfosfonata) †
English: After one year (primary analysis) the median relative change from baseline was -76 % for Bonviva 150 mg once monthly and -67 % for ibandronic acid 2.5 mg daily.
Croatian: Nakon jedne godine (primarna analiza) medijan relativne vrijednosti promjene u odnosu na početne vrijednosti iznosio je -76% za lijek Bonviva 150 mg jedanput mjesečno odnosno -67% za ibandronatnu kiselinu 2,5 mg jedanput dnevno.
English: 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 4411).
Croatian: 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).
English: • walking or other weight-bearing exercise
Croatian: • šetnje i druge fizičke aktivnosti
English: Pharmacokinetics in special clinical situations
Croatian: Farmakokinetika posebnih skupina
English: Bonviva 3 mg solution for injection in pre-filled syringes is a clear colourless solution.
Croatian: Bonviva 3 mg otopina za injekciju u napunjenoj štrcaljki bistra je i bezbojna otopina.
English: Existing hypocalcaemia must be corrected before starting Bonviva injection therapy.
Croatian: Postojeća hipokalcijemija se mora korigirati prije početka liječenja injekcijama lijeka Bonviva
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: Trochanter BMD
Croatian: BMD trohantera
English: Furthermore, Bonviva 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 lijeka Bonviva 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: Bonviva 3 mg solution for injection ibandronic acid
Croatian: Bonviva 3 mg otopina za injekciju ibandronatna kiselina
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: Table 1: Adverse reactions occurring in postmenopausal women receiving Bonviva 150 mg once monthly or ibandronic acid 2.5 mg daily in the phase III studies BM16549 and MF4411 and in postmarketing experience.
Croatian: Tablica 1: Nuspojave koje se pojavljuju u žena u postmenopauzi koje primaju Bonviva 150 mg tablete 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
English: Lumbar spine L2-L4 BMD 3.9 [3.4, 4.3]
Croatian: BMD lumbalne kralježnice (L2-L4)
English: Bonviva may also do so.
Croatian: Bonviva može dovesti do jednake reakcije.
English: Do not receive Bonviva
Croatian: Nemojte primiti lijek Bonviva
English: Bonviva is not recommended for patients with a creatinine clearance below 30 ml/min due to limited clinical experience (see section 4.4 and section 5.2).
Croatian: Bonviva se ne preporučuje bolesnicima čiji je klirens kreatinina manji od 30 ml/min zbog ograničenog kliničkog iskustva (vidjeti dio 4.4 i 5.2).
English: At one year, 83.5 % (p= 0.006) of patients receiving Bonviva 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 lijek Bonviva 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: Bonviva is only for use in postmenopausal women and must not be taken by women of childbearing potential.
Croatian: Bonviva je namijenjena isključivo za žene u postmenopauzi i ne smiju je uzimati žene reproduktivne dobi.
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving Bonviva for osteoporosis.
Croatian: U bolesnika koji su primali lijek Bonviva za liječenje osteoporoze nakon njegova stavljanja na tržište, vrlo je rijetko prijavljena nuspojava koja se zove osteonekroza čeljusti (oštećenje kosti u čeljusti).
English: One tablet contains 150 mg of ibandronic acid (as sodium monohydrate).
Croatian: Jedna tableta sadrži 150 mg ibandronatne kiseline (u obliku natrijevog hidrata).
English: Bonviva should not be used during breastfeeding.
Croatian: Bonviva se ne smije koristiti za vrijeme dojenja.
English: • stomach pain (such as gastritis) or tummy pain, indigestion, nausea, having diarrhoea (loose bowels) or constipation
Croatian: • bol u želucu (poput gastritisa) ili bol u trbuhu, probavne smetnje, mučnina, proljev (osjetljiva crijeva) ili zatvor
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 150 mg ibandronatne kiseline (u obliku natrijevog hidrata).
English: Influenza-like illness includes events reported as acute phase reaction or symptoms including myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, or bone pain.
Croatian: Bolest slična gripi uključuje događaje prijavljene kao reakcija akutne faze ili simptome koji uključuju bol u mišićima, bol u zglobovima, vrućicu, zimicu, umor, mučninu, gubitak teka ili bol u kostima.
English: Bonviva injection is not recommended for use in patients who have a serum creatinine above 200 μmol/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies including such patients (see section 4.4 and section 5.2).
Croatian: Bonviva injekcija ne preporučuje se za primjenu u bolesnika u kojih je kreatinin u serumu veći od 200 μmol/l (2,3 mg/dl) ili u kojih je klirens kreatinina (mjeren ili procijenjen) manji od 30 ml/min jer su dostupni ograničeni klinički podaci dobiveni u ispitivanjima takvih bolesnika (vidjeti dijelove 4.4 i
English: Patients with hepatic impairment No dose adjustment is required (see section 5.2).
Croatian: Nije potrebna prilagodba doze (vidjeti dio 5.2).
English: Due to limited clinical experience, Bonviva injection is not recommended for patients with a serum creatinine above 200 μmol/l (2.3 mg/dl) or with a creatinine clearance below 30 ml/min (see section 4.2 and section 5.2).
Croatian: Zbog ograničenih kliničkih iskustava injekcija lijeka Bonviva ne preporučuje se bolesnicima čija je razina kreatinina u serumu veća od 200 μmol/l (2,3 mg/dl) ili je klirens kreatinina manji od 30 ml/min (vidjeti dijelove 4.2 i 5.2).
English: At one year (primary analysis), 91.3 % (p=0.005) of patients receiving Bonviva 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 lijek Bonviva 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: In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of Bonviva 150 mg once monthly and ibandronic acid 2.5 mg daily was similar.
Croatian: Dvogodišnje ispitivanje provedeno u žena s osteoporozom u postmenopauzi (BM 16549) pokazalo je sličnu sveukupnu sigurnost primjene lijeka Bonviva150 mg jednom mjesečno i ibandronatne kiseline 2,5 mg jednom dnevno.
English: Do not suck, chew or crush tablets Read the package leaflet before use Once monthly tablet Oral use
Croatian: Prije uporabe pročitajte uputu o lijeku Jedna tableta mjesečno Za primjenu kroz usta
English: Titanium dioxide (E 171)
Croatian: Ovojnica tablete hipromeloza titanijev dioksid (E 171) talk makrogol 6000
English: You may develop low levels of calcium, phosphorus or magnesium in the blood.
Croatian: Ako primijenite više lijeka Bonviva nego što ste trebali Može se smanjiti razina kalcija, fosfora ili magnezija u krvi.
English: There are no data on the effects of ibandronic acid from humans.
Croatian: Nema saznanja o djelovanju ibandronatne kiseline u ljudi.
English: The dose of Bonviva is one tablet once a month.
Croatian: Doza koju trebate uzimati je jedna tableta Bonviva mjesečno.
English: In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of Bonviva 3 mg every 3 months and oral ibandronic acid 2.5 mg daily were shown to be similar.
Croatian: Dvogodišnje pivotalno ispitivanje provedeno u žena s osteoporozom u postmenopauzi (BM 16550) pokazalo je sličnu sveukupnu sigurnost primjene intravenske injekcije lijeka Bonviva 3 mg svaka tri mjeseca i peroralno primijenjene ibandronatne kiseline 2,5 mg jedanput dnevno.
English: Adverse reactions such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some cases severe and requiring hospitalisation, rarely with bleeding or followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates.
Croatian: U bolesnika koji peroralno uzimaju bisfosfonate prijavljene su nuspojave kao što su ezofagitis, ulkusi jednjaka i erozije jednjaka, koji su u nekim slučajevima bili teški i zahtijevali su bolničko liječenje, rijetko s krvarenjem ili praćeni strikturom jednjaka ili perforacijom.
English: Among these patients, the incidence of upper gastrointestinal events in the patients treated with Bonviva 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 lijek Bonviva 150 mg jedanput mjesečno bila je slična onoj u bolesnika koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno.
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Bonviva in patients with concomitant risk factors.
Croatian: U bolesnika s istodobno prisutnim faktorima rizika preporučuje se prije liječenja lijekom Bonviva provesti pregled zuba i preventivne stomatološke zahvate te ocijeniti omjer koristi i rizika za svakog pojedinog bolesnika.
English: Do not take Bonviva
Croatian: Nemojte uzimati lijek Bonviva
English: Based on the results of study BM 16550, Bonviva 3 mg intravenous injection, administered every 3 months is expected to be at least as effective in preventing fractures as the oral regimen of ibandronic acid 2.5 mg daily.
Croatian: Na temelju rezultata ispitivanja BM 16550 procjenjuje se da će intravenska injekcija lijeka Bonviva od 3 mg koja se daje svaka tri mjeseca biti barem jednako djelotvorna u sprječavanju prijeloma kao peroralna doza ibandronatne kiseline od 2,5 mg koja se uzima jedanput dnevno.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/265/003 1 film-coated tablet EU/1/03/265/004 3 film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/265/003 1 filmom obložena tableta
English: Continuing to take Bonviva
Croatian: Nastavljanje uzimanja lijeka Bonviva
English: NAME OF THE MEDICINAL PRODUCT Bonviva 3 mg solution for injection
Croatian: NAZIV LIJEKA Bonviva 3 mg otopina za injekciju
English: Oesophagitis, Gastritis, Gastro oesophageal reflux disease, Dyspepsia, Diarrhoea, Abdominal pain, Nausea
Croatian: gastritis, dispepsija, proljev, bol u abdomenu, mučnina, opstipacija
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 Bonviva 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 lijek Bonviva 150 mg jedanput mjesečno odnosno 65,7% bolesnika koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno.
English: Administration of Bonviva 3 mg solution for injection in pre-filled syringe:
Croatian: Primjena Bonviva 3 mg otopine za injekciju u napunjenoj štrcaljki:
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablets
Croatian: OBLIK I SADRŽAJ Filmom obložene tablete 1 filmom obložena tableta 3 filmom obložene tablete
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving Bonviva for osteoporosis (see section 4.8).
Croatian: U bolesnika koji su nakon njegova stavljanja u promet primali lijek Bonviva za liječenje osteoporoze, vrlo je rijetko prijavljena osteonekroza čeljusti (vidjeti dio 4.8).
English: Patients should receive supplemental calcium and / or vitamin D if dietary intake is inadequate (see section 4.4 and section 4.5).
Croatian: Ako unos prehranom nije dovoljan, bolesnici trebaju uzimati dodatne količine kalcija i/ili vitamina D (vidjeti dio 4.4 i 4.5).
English: Appropriate medical support and monitoring measures should be readily available when Bonviva intravenous injection is administered.
Croatian: Prilikom primjene intravenske injekcije lijeka Bonviva moraju biti dostupne odgovarajuća medicinska podrška i mjere nadzora.
English: One pre-filled syringe contains 3 mg of ibandronic acid in 3 ml of solution (as sodium monohydrate).
Croatian: Jedna napunjena štrcaljka sadrži 3 mg ibandronatne kiseline u 3 ml otopine (u obliku natrijevog hidrata).
English: For total hip BMD, 90.0 % (p<0.001) of patients receiving Bonviva 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 lijek Bonviva 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.