natgillin/translations-raw huggingface dataset:
At two years 78.7% (p=0.002) and 65.6% of patients were identified as responders in the 150 mg monthly and 2.5 mg daily arms respectively.
Po dveh letih je bilo odzivnih 78, 7% bolnikov (p = 0, 002), ki so prejemali 150 mg enkrat na mesec in 65, 6% bolnikov, ki so jemali 2, 5 mg enkrat na dan.
Based on the results of study BM 16549, Bondenza 150 mg once monthly is expected to be at least as effective in preventing fractures as ibandronic acid 2.5 mg daily.
Glede na rezultate študije BM 16549 pričakujemo, da je Bondenza 150 mg enkrat na mesec najmanj enako učinkovita v preprečevanju zlomov kakor ibandronska kislina 2, 5 mg enkrat na dan.
Ibandronic acid 2.5 mg daily
Ibandronska kislina 2, 5 mg enkrat na dan
In the initial three-year, randomised, double-blind, placebo-controlled, fracture study (MF 4411), a statistically significant and medically relevant decrease in the incidence of new radiographic morphometric and clinical vertebral fractures was demonstrated (table 4).
V prvotni triletni randomizirani, dvojno slepi, s placebom primerjani študiji zlomov (MF 4411) so ugotovili statistično značilno in klinično pomembno zmanjšanje incidence novih zlomov vretenc, določeno radiografsko, morfometrično ali klinično (preglednica 4).
In this study, ibandronic acid was evaluated at oral doses of 2.5 mg daily and 20 mg intermittently as an exploratory regimen.
V tej študiji so proučevali ibandronsko kislino v peroralnem odmerku 2, 5 mg na dan in 20 mg intermitentno kot raziskovalno odmerjanje.
The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at 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.
Študija je vključevala ženske, stare od 55 do 80 let, ki so bile vsaj 5 let v postmenopavzi in ki so imele MKG ledvene hrbtenice 2 do 5 SD pod povprečno vrednostjo pred menopavzo (T- vrednost) pri vsaj enem vretencu (L1- L4) ter so imele enega do štiri predhodnih zlomov vretenc.
All patients received 500 mg calcium and 400 IU vitamin D daily.
Vse bolnice so prejemale 500 mg kalcija in 400 i. e. vitamina D na dan.
Efficacy was evaluated in 2,928 patients. ibandronic acid 2.5 mg administered daily, showed a statistically significant and medically relevant reduction in the incidence of new vertebral fractures.
Dajanje 2, 5 mg ibandronske kisline na dan je povzročilo statistično značilno in klinično pomembno zmanjšanje incidence novih zlomov vretenc.
This regimen reduced the occurrence of new radiographic vertebral fractures by 62% (p=0.0001) over the three year duration of the study.
Ta shema je v triletni študiji zmanjšala pojavnost novih zlomov vretenc, določeno radiografsko, za 62% (p = 0, 0001).
A relative risk reduction of 61% was observed after 2 years (p=0.0006).
Zmanjšanje relativnega tveganja za 61% so opazili po 2 letih (p = 0, 0006).
No statistically significant difference was attained after 1 year of treatment (p=0.056).
Po 1 letu zdravljenja niso opazili statistično značilne razlike (p = 0, 056).
The incidence of clinical vertebral fractures was also significantly reduced by 49% (p=0.011).
Incidenca kliničnih zlomov vretenc je bila značilno zmanjšana za 49% (p = 0, 011).
The strong effect on vertebral fractures was furthermore reflected by a statistically significant reduction of height loss compared to placebo (p < 0.0001).
Močan vpliv na zlome vretenc se je kazal tudi s statistično značilno manjšo izgubo telesne višine v primerjavi s placebom (p < 0, 0001).
Table 4:
10 Preglednica 4.
Results from 3 years fracture study MF 4411 (%, 95% CI)
Rezultati 3- letne študije zlomov MF 4411 (%, 95 -% interval zaupanja).
Relative Risk Reduction New morphometric vertebral fractures
ibandronska kislina 2, 5 mg enkrat na dan (n = 977)
Placebo (N=974)
Zmanjšanje relativnega tveganja za nove zlome vretenc (določeno morfometrično)
Relative risk reduction of clinical vertebral fracture
Incidenca kliničnih zlomov vretenc
49% (14.03, 69.49)
2, 75% (1, 61; 3, 89)
Incidence of clinical vertebral fracture BMD – mean change relative to baseline lumbar spine at year 3
MKG – povprečna sprememba glede na izhodiščno vrednost za ledveno hrbtenico po 3 letih
-0.69% (-1.0, -0.4)
– 0, 69% (– 1, 0; – 0, 4)
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.
Učinek zdravljenja z ibandronsko kislino so nadalje proučevali v analizi podskupine bolnikov, katerih T- vrednost MKG ledvene hrbtenice je bila na začetku zdravljenja pod – 2, 5.
10 Table 5:
Preglednica 5.
Results from 3 years fracture study MF 4411 (%, 95% CI) for patients with lumbar spine BMD T-score below – 2.5 at baseline
Rezultati 3- letne študije zlomov MF 4411 (%, 95 -% interval zaupanja) za bolnike, ki so imeli na začetku zdravljenja T- vrednost MKG ledvene hrbtenice pod – 2, 5.
ibandronic acid 2.5 mg daily (N=575) 59% (34.5, 74.3)
ibandronska kislina 2, 5 mg enkrat na dan (n = 575)
Incidence of new morphometric vertebral fractures
Zmanjšanje relativnega tveganja za nove zlome vretenc (določeno morfometrično)
12.54% (9.53, 15.55)
59% (34, 5; 74, 3)
5.36% (3.31, 7.41)
Incidenca novih zlomov vretenc (določeno morfometrično)
Relative risk reduction of clinical vertebral fracture
12, 54% (9, 53; 15, 55)
50% (9.49, 71.91)
5, 36% (3, 31; 7, 41)
Incidence of clinical vertebral fracture
Zmanjšanje relativnega tveganja za klinične zlome vretenc
3.57% (1.89, 5.24)
50% (9, 49; 71, 91)
BMD – mean change relative to baseline lumbar spine at year 3
Incidenca novih zlomov vretenc MKG – povprečna sprememba glede na izhodiščno vrednost za ledveno hrbtenico po 3 letih
1.13% (0.6, 1.7)
6, 97% (4, 67; 9, 27) 1, 13% (0, 6; 1, 7)
7.01% (6.5, 7.6)
3, 57% (1, 89; 5, 24) 7, 01% (6, 5; 7, 6)
-0.70% (-1.1, -0.2)
– 0, 70% (– 1, 1; – 0, 2)
In the overall patient population of the study MF4411, no reduction was observed for non-vertebral fractures, however daily ibandronate appeared to be effective in a high-risk subpopulation (femoral neck BMD T-score < -3.0), where a non-vertebral fracture risk reduction of 69% was observed.
V celotni populaciji bolnikov v študiji MF4411 niso opazili zmanjšanja nevretenčnih zlomov, ugotovili pa so, da je bil ibandronat enkrat na dan učinkovit pri podskupini bolnikov z visokim tveganjem (T- vrednost MKG stegneničnega vratu pod – 3, 0), kjer se je tveganje za nevretenčne zlome zmanjšalo za 69%.
Daily treatment with 2.5 mg resulted in progressive increases in BMD at vertebral and nonvertebral sites of the skeleton.
Zdravljenje z 2, 5 mg na dan je povzročilo progresivno zvečanje MKG vretenc in nevretenčnih delov skeleta.
Three-year lumbar spine BMD increase compared to placebo was 5.3% and 6.5% compared to baseline.
11 Porast MKG ledvene hrbtenice je po 3 letih v primerjavi s placebom znašal 5, 3%, v primerjavi z izhodiščno vrednostjo pa 6, 5%.
Increases at the hip compared to baseline were 2.8% at the femoral neck, 3.4% at the total hip, and 5.5% at the trochanter.
V primerjavi z izhodiščno vrednostjo je porast mineralne kostne gostote znašal za stegnenični vrat 2, 8%, za kolk 3, 4% in 5, 5% za trohanter.
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.
Klinično pomembno 50 -% zmanjšanje biokemičnih označevalcev kostne resorpcije so opazili že en mesec po začetku zdravljenja z 2, 5 mg ibandronske kisline.
Absorption 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.
Absorpcija Po peroralnem jemanju je absorpcija ibandronske kisline v zgornjem delu gastrontestinalnega trakta hitra, plazemske koncentracije naraščajo do peroralnega vnosa 50 mg v odvisnosti od odmerka, pri večjih vnosih pa so opazili večje poraste plazemskih koncentracij od sorazmernih z odmerkom.
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%.
Najvišje plazemske koncentracije so bile med postom dosežene v času od 0, 5 ure do 2 ur (mediana časa 1 ura), absolutna biološka uporabnost je bila okoli 0, 6 -%.
The extent of absorption is impaired when taken together with food or beverages (other than plain water).
Obseg absorpcije je pri sočasnem jemanju hrane ali pijače (druge kot navadna voda) zmanjšan.
Bioavailability is reduced by about 90% when ibandronic acid is administered with a standard breakfast in comparison with bioavailability seen in fasted subjects.
Pri sočasnem jemanju ibandronske kisline s standardnim zajtrkom se biološka uporabnost zmanjša za okoli 90% v primerjavi z biološko uporabnostjo, ki so jo opazili pri bolnikih po postu.
11 Distribution After initial systemic exposure, ibandronic acid rapidly binds to bone or is excreted into urine.
Porazdelitev Po prvotni sistemski izpostavljenosti se ibandronska kislina hitro veže v kostno tkivo ali pa se izloči skozi ledvice.
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.
Pri ljudeh znaša navidezni končni volumen porazdelitve najmanj 90 l, količina odmerka, ki doseže kosti, je ocenjena na 40 do 50% odmerka, ki je v krvnem obtoku.
Protein binding in human plasma is approximately 85% - 87% (determined in vitro at therapeutic concentrations), and thus there is a low potential for interaction with other medicinal products due to displacement.
Vezava na plazemske beljakovine pri ljudeh je približno 85 - do 87 -% (določeno in vitro pri terapevtskih koncentracijah), zato je medsebojno delovanje z drugimi zdravili zaradi izpodrivanja malo verjetno.
Metabolism There is no evidence that ibandronic acid is metabolised in animals or humans.
Presnova Ni dokazov, da bi se ibandronska kislina pri ljudeh in živalih presnavljala.
Elimination The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50% in postmenopausal women) and the remainder is eliminated unchanged by the kidney.
Izločanje Absorbiran delež ibandronske kisline se iz sistemskega krvnega obtoka v kostno tkivo odstrani z absorpcijo (ocenjeno na 40 do 50% pri ženskah v postmenopavzi), ostanek pa se izloči skozi ledvice v nespremenjeni obliki.
The range of observed apparent half-lives is broad, the apparent terminal half-life is generally in the range of 10-72 hours.
Navidezni končni razpolovni čas je v splošnem v razponu od 10 do 72 ur.
As the values calculated are largely a function of the duration of study, the dose used, and assay sensitivity, the true terminal half-life is likely to be substantially longer, in common with other bisphosphonates.
Ker so izračunane vrednosti precej odvisne od trajanja študije, uporabljenega odmerka in občutljivosti metode, je pravi končni razpolovni čas verjetno precej daljši, kar je skupno vsem bisfosfonatom.
Early plasma levels fall quickly reaching 10% of peak values within 3 and 8 hours after intravenous or oral administration respectively.
Zgodnje plazemske koncentracije hitro padejo, 10% največje vrednosti dosežejo 3 ure po intravenskem dajanju in 8 ur po peroralnem dajanju.
Total clearance of ibandronic acid is low with average values in the range 84-160 ml/ min.
Skupni očistek ibandronske kisline je majhen, povprečna vrednost znaša od 84 do 160 ml/ min.
Renal clearance (about 60 mL/ min in healthy postmenopausal females) accounts for 50-60% of total clearance and is related to creatinine clearance.
Ledvični očistek (okoli 60 ml/ min pri zdravih ženskah v postmenopavzi) znaša okoli 50 do 60% celotnega očistka in je povezan s kreatininskim očistkom.
Pharmacokinetics in special clinical situations
12 Farmakokinetika pri posebnih skupinah
Race There is no evidence for any clinically relevant inter-ethnic differences between Asians and Caucasians in ibandronic acid disposition.
Rasa Za klinično pomembne medetnične razlike v razpoložljivosti ibandronske kisline med Azijci in Kavkazijci ni dokazov.
Patients with renal impairment Renal clearance of ibandronic acid in patients with various degrees of renal impairment is linearly related to creatinine clearance.
Bolniki z ledvično okvaro Renalni očistek ibandronske kisline pri bolnikih z različnimi stopnjami ledvične okvare je v linearni odvisnosti od kreatininskega očistka.
No dose adjustment is necessary for patients with mild or moderate renal impairment (CLcr equal or greater than 30 ml/ min), as shown in study BM 16549 where the majority of patients had mild to moderate renal impairment.
Za bolnike z blago ali zmerno ledvično okvaro (očistek kreatinina (CLcr) enak ali večji kot 30 ml/ min) prilagajanje odmerkov ni potrebno, kar se je pokazalo v študiji BM 16549, kjer je večina bolnikov imela blažjo do zmerno ledvično okvaro.
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.
Celokupni očistek ibandronske kisline je bil pri teh bolnikih 44 ml/ min.
After intravenous administration of 0.5 mg, total, renal, and non-renal clearances decreased by 67%, 77% and 50%, respectively, in subjects with severe renal failure but there was no reduction in tolerability associated with the increase in exposure.
Zaradi povečane izpostavljenosti pa ni prišlo do zmanjšanja prenašanja zdravila.
Due to the limited clinical experience, Bondenza is not recommended in patients with severe renal impairment (see section 4.2 and section 4.4).
Zaradi omejenih kliničnih izkušenj jemanje Bondenze pri bolnikih s hudo okvaro ledvic ni priporočljivo (glejte poglavje 4. 2 in poglavje 4. 4).
Patients with hepatic impairment There are no pharmacokinetic data for ibandronic acid in patients who have hepatic impairment.
Bolniki z jetrno okvaro Za bolnike z jetrno okvaro za ibandronsko kislino ni farmakokinetičnih podatkov.
12 Elderly Population In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Starejši bolniki Multivariantna analiza je pokazala, da starost za vse preizkušane farmakokinetične parametre ni neodvisen dejavnik.
As renal function decreases with age this is the only factor to take into consideration (see renal impairment section).
Ker se ledvična funkcija z leti zmanjšuje, je to edini dejavnik, ki ga je treba upoštevati (glejte odstavek ledvična okvara).
Paediatric population There are no data on the use of Bondenza in these age groups.
Pediatrično bolniki O uporabi Bondenze pri tej skupini bolnikov ni podatkov.
Toxic effects, e. g signs of renal damage, were observed in dogs only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Toksične učinke, na primer znake poškodbe ledvic, so opazili pri psih samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
Mutagenicity/ Carcinogenicity:
Mutagenost/ kancerogenost:
There was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats at an extrapolated exposure of at least 35 times above human exposure.
Pri podganah in kuncih, ki so peroralno prejemali ibandronsko kislino, niso opazili neposrednih škodljivih vplivov na plod ali teratogenega delovanja.
Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Pri ekstrapolaciji izpostavljenosti, ki je 35- krat presegala izpostavljenost pri človeku, na razvoj F1 potomcev podgan niso opazili škodljivih vplivov.
Tablet core Lactose monohydrate Povidone Cellulose, microcrystalline Crospovidone Stearic acid Silica, colloidal anhydrous
Jedro tablete laktoza monohidrat povidon mikrokristalna celuloza krospovidon stearinska kislina brezvoden koloidni silicijev dioksid
Tablet coat Hypromellose Titanium dioxide E171 Talc Macrogol 6,000
Obloga tablete hipromeloza titanov dioksid E171 smukec makrogol 6000
13 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
Bondenza 150 mg film-coated tablets are supplied in blisters (PVC/ PVDC) containing 1 or 3 tablets.
Filmsko obložene tablete Bondenza 150 mg so na voljo v (PVC/ PVDC) pretisnih omotih z 1 ali 3 tabletami.
NAME OF THE MEDICINAL PRODUCT
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
Bondenza 3 mg solution for injection
DATUM ZADNJE REVIZIJE BESEDILA
2.
15 1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
IME ZDRAVILA
The concentration of ibandronic acid in the solution for injection is 1mg per ml.
Bondenza 3 mg raztopina za injiciranje
For a full list of excipients, see section 6.1.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
The recommended dose of ibandronic acid is 3 mg, administered as an intravenous injection over 15 - 30 seconds, every three months.
Odmerjanje Priporočeni odmerek ibandronske kisline je 3 mg v obliki intravenske injekcije, ki jo dajemo 15 do 30 sekund, vsake 3 mesece.
Patients must receive supplemental calcium and vitamin D (see section 4.4 and section 4.5)
Bolniki morajo prejemati dodatke kalcija in vitamina D (glejte poglavje 4. 4 in poglavje 4. 5).
Special Populations Patients with renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment where serum creatinine is equal or below 200 μ mol/ l (2.3 mg/ dl) or where creatinine clearance (measured or estimated) is equal or greater than 30 ml/ min.
Posebne skupine bolnikov Bolniki z ledvično okvaro Pri bolnikih z blago do zmerno ledvično okvaro, ki imajo serumski kreatinin enak ali manjši kot 200 µmol/ l (2, 3 mg/ dl) ali očistek kreatinina (izmerjen ali ocenjen) enak ali večji kot 30 ml/ min, prilagajanje odmerkov ni potrebno.
Bondenza injection is not recommended for use in patients who have a serum creatinine above 200 μ mol/ 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)
Uporaba Bondenze v obliki injekcije pri bolnikih s serumskim kreatininom nad 200 µmol/ l (2, 3 mg/ dl) ali s kreatininskim očistkom (izmerjenim ali ocenjenim) pod 30 ml/ min zaradi omejenih kliničnih podatkov iz študij, ki so vključevale take bolnike, ni priporočljiva (glejte poglavje 4. 4 in poglavje 5. 2).
Patients with hepatic impairment No dose adjustment is required (see section 5.2).
Bolniki z jetrno okvaro Prilagajanje odmerkov ni potrebno (glejte poglavje 5. 2).
15 Paediatric Population There is no relevant use of Bondenza in children, and Bondenza was not studied in the paediatric population.
Zdravila Bondenza pri pediatričnih bolnikih niso proučevali.
Strict adherence to the intravenous administration route is required (see section 4.4).
Zdravilo moramo dajati izključno intravensko (glejte poglavje 4. 4).
Administration failures Strict adherence to the intravenous route of administration is required.
Napake pri aplikaciji Zdravilo moramo dajati izključno intravensko.
Care must be taken not to administer Bondenza injection via intra-arterial or paravenous administration as this could lead to tissue damage.
Biti moramo previdni, da injekcije Bondenze ne damo intraarterijsko ali paravensko, ker lahko poškodujemo tkivo.
Hypocalcaemia Bondenza, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Hipokalcemija Bondenza lahko, tako kot drugi bisfosfonati, ki jih dajemo intravensko, povzroči prehodno zmanjšanje serumskih vrednosti kalcija.
Existing hypocalcaemia must be corrected before starting Bondenza injection therapy.
Obstoječo hipokalcemijo je treba popraviti pred začetkom zdravljenja z Bondenzo v obliki injekcije.
Renal impairment 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.
Ledvična okvara Bolnike, ki imajo sočasno še druge bolezni ali jemljejo zdravila z možnimi neželenimi učinki za ledvice, je treba med zdravljenjem redno spremljati v skladu z dobro zdravniško prakso.
Due to limited clinical experience, Bondenza injection is not recommended for patients with a serum creatinine above 200 μ mol/ l (2.3 mg/ dl) or with a creatinine clearance below 30 ml/ min (see section 4.2 and section 5.2).
Zaradi omejenih kliničnih izkušenj Bondenze v obliki injekcije ne priporočamo bolnikom, ki imajo serumski kreatinin nad 200 µmol/ l (2, 3 mg/ dl) ali kreatininski očistek, manjši kot 30 ml/ min (glejte poglavje 4. 2 in poglavje 5. 2).
Osteonecrosis of the jaw Osteonecrosis of the jaw, generally associated with tooth extraction and/ or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates.
Osteonekroza čeljusti Pri bolnikih z rakom, ki so prejemali zdravljenje, ki je prvenstveno vključevalo bisfosfonate, dane intravensko, so poročali o osteonekrozi čeljusti, po navadi povezani z izdrtjem zoba ali lokalno okužbo (vključno z osteomielitisom) ali obojim.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e. g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
Pri bolnikih s sočasnimi dejavniki tveganja (npr. rak, kemoterapija, radioterapija, kortikosteroidi, slaba ustna higiena) je treba pred začetkom zdravljenja z bisfosfonati razmisliti o pregledu zobovja in primernih preventivnih zobozdravstvenih posegih.
16 4.5 Interaction with other medicinal products and other forms of interaction
17 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Furthermore, plasma protein binding 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.
Vezava ibandronske kisline na beljakovine v plazmi je približno 85 - do 87 -% (določeno in vitro pri terapevtskih koncentracijah ibandronske kisline), zato obstaja majhna možnost za medsebojno delovanje z drugimi zdravili zaradi izpodrivanja.
No interaction was observed when co-administered with melphalan/ prednisolone in patients with multiple myeloma.
Pri bolnikih z multiplim mielomom, ki so sočasno jemali melfalan ali prednizolon, medsebojnega delovanja niso opazili.
The safety of oral treatment with ibandronic acid 2.5 mg once daily was evaluated in 1251 patients treated in 4 placebo-controlled clinical studies; 73% of these patients came from the pivotal three-year treatment study (MF 4411).
Varnost peroralnega zdravljenja z 2, 5 mg ibandronske kisline enkrat na dan so proučevali v 4 s placebom kontroliranih kliničnih študijah pri 1251 bolnikih; 73% teh bolnikov je sodelovalo v ključni triletni študiji (MF 4411).
The overall safety profile of ibandronic acid 2.5 mg daily in all these studies was similar to that of placebo.
Celoten varnostni profil ibandronske kisline 2, 5 mg, dane enkrat na dan, je bil v vseh teh študijah podoben kakor pri placebu.
The overall proportion of patients who experienced an adverse reaction, i. e. adverse event with a possible or probable relationship to trial medicinal product, in the pivotal treatment study (MF 4411) was 19.8% for ibandronic acid and 17.9% for placebo.
Celoten delež bolnikov, pri katerih se je pojavil neželeni učinek, to je neželeni dogodek z možno ali verjetno povezavo z zdravilom v preskušanju, je v ključni študiji zdravljenja (MF 4411) za ibandronsko kislino znašal 19, 8%, za placebo pa 17, 9%.