FrancophonIA/ELRC3.0 huggingface dataset:
English: Heart attack may occur commonly in patients at high risk for heart disease.
Croatian: Srčani udar se se može često dogoditi u bolesnika s visokim rizikom za bolesti srca.
English: Dermatitis Alopecia
Croatian: Dermatitis Alopecija
English: What OSSEOR is and what it is used for What you need to know before you take OSSEOR How to take OSSEOR
Croatian: Što je OSSEOR i za što se koristi Što morate znati prije nego počnete uzimati OSSEOR
English: Your doctor should be able to advise if a blood test is necessary before taking OSSEOR.
Croatian: Vaš liječnik može vam savjetovati da li je potrebno provesti pretrage krvi prije uzimanja OSSEOR-a.
English: If you have stopped treatment due to hypersensitivity reactions, do not take OSSEOR again
Croatian: Ukoliko ste prestali uzimati lijek zbog reakcija preosjetljivosti, nemojte ponovo uzimati OSSEOR.
English: The safety and efficacy of OSSEOR in children aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka OSSEOR u djece mlađe od 18 godina nisu još ustanovljene.
English: diabetes, smoking.
Croatian: šećernu bolest, pušenje.
English: Mean age was 75 years at inclusion and 23% of the patients enrolled were 80 to 100 years of age.
Croatian: Srednja dob bolesnica pri uključivanju u ispitivanja bila je 75 godina, a 23% uključenih bolesnica bilo je u dobi od 80 do 100 godina.
English: What you need to know before you take OSSEOR
Croatian: Što morate znati prije nego počnete uzimati OSSEOR
English: These potentially life-threatening skin rashes are often accompanied by flu-like symptoms.
Croatian: Ovi potencijalno po život opasni kožni osipi su često praćeni simptomima sličnim gripi.
English: Adverse reactions are listed below using the following convention : very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Nuspojave su navedene niže i prema učestalosti razvrstane su na sljedeći način: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000); nepoznato (učestalost se ne može procijeniti iz dostupnih podataka).
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where OSSEOR is marketed, all physicians who are expected to prescribe OSSEOR are provided with the following educational package:
Croatian: Nositelj odobrenja će osigurati da, nakon rasprave i dogovora sa nacionalnim nadležnim tijelom svake države članice gdje je OSSEOR prisutan na tržištu, svi liječnici za koje se očekuje da će propisivati OSSEOR dobiju edukacijski paket koji sadrži:
English: If you stop taking OSSEOR:
Croatian: Ako prestanete uzimati OSSEOR:
English: However, it is recommended to drink the suspension immediately after preparation (see section 3).
Croatian: Međutim, preporučuje se suspenziju popiti odmah nakon njene pripreme (pogledajte dio 3.)
English: If you need to have blood or urine tests to check your level of calcium, you should tell the laboratory that you are taking OSSEOR as it may interfere with some testing methods.
Croatian: Ako morate obaviti pretrage krvi ili mokraće kako biste provjerili razinu kalcija, obavijestite osoblje laboratorija da uzimate OSSEOR budući da on može utjecati na neke metode pretraga.
English: However, it is recommended to drink the suspension immediately after preparation (see section 4.2)
Croatian: Međutim, preporučuje se suspenziju popiti odmah nakon pripreme (vidjeti dio 4.2)
English: Cardiac ischaemic events
Croatian: Kardijalni ishemijski događaji
English: Frequency in Clinical Trials was similar in the drug and placebo group.
Croatian: Učestalost u kliničkim ispitivanjima bila je slična između skupine s lijekom i skupine s placebom.
English: * In Asian countries reported as rare # For adverse reaction not observed in clinical trials, the upper limit of the 95% confidence interval is not higher than 3/X with X representing the total sample size summed up across all relevant clinical trials and studies.
Croatian: * U azijskim državama prijavljeno kao rijetko # za nuspojave koje nisu zabilježene u kliničkim ispitivanjima, gornja granica 95% intervala pouzdanosti nije viša od 3/X gdje X predstavlja ukupni uzorak svih relevantnih kliničkih ispitivanja.
English: Discontinuation of therapy was mainly due to nausea.
Croatian: Terapija je prekidana uglavnom zbog mučnine.
English: The PASS final study report submitted by the MAH complies with their obligation to perform a PASS to evaluate risk of serious cardiac disorders as imposed during the Article 20 procedure EMA/112925/2014.
Croatian: Završno izvješće o PASS ispitivanju koje je podnio nositelj odobrenja za stavljanje lijeka u promet u skladu je s njegovom obavezom provođenja PASS ispitivanja radi procjene rizika od nastanka ozbiljnih kardioloških poremećaja, kako je zadano tijekom postupka EMA/112925/2014 vođenom prema članku 20.
English: If you develop a rash or serious skin symptoms (see section 4), stop taking OSSEOR, seek urgent advice from a doctor and tell him that you are taking this medicine.
Croatian: Ukoliko razvijete osip ili ozbiljne kožne simptome (pogledajte dio 4) prestanite uzimati OSSEOR, hitno zatražite savjet liječnika i recite mu da uzimate ovaj lijek.
English: Musculo-skeletal fraction > 3 times the upper limit of the normal range.
Croatian: Porast vrijednosti mišićno-koštane frakcije > 3 puta iznad gornje granice normalnog raspona.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Croatian: Za uvjete čuvanja nakon pripreme lijeka, vidjeti dio 6.3
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases - Other drugs affecting bone structure and mineralisation, ATC code: M05BX03.
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje bolesti kostiju - ostali lijekovi koji utječu na građu i mineralizaciju kosti, ATK oznaka: M05BX03.
English: There were no differences in the nature of adverse reactions between treatment groups regardless of whether patients were aged below or above 80 at inclusion.
Croatian: Nije bilo razlike u prirodi nuspojava između grupa bez obzira da li su bolesnici prilikom uključivanja u ispitivanje bili mlađi ili stariji od 80 godina.
English: Oral mucosal irritation (stomatitis and/or mouth ulceration)
Croatian: Iritacija usne sluznice (stomatitis i/ili ulceracija usta)
English: Additional signs may include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
Croatian: Dodatni znakovi mogu uključiti vrijed u ustima, grlu, nosu spolovilu i konjuktivitis (crvene i otečene oči).
English: If not used immediately after reconstitution, the preparation should be consumed within 24 hours.
Croatian: Ako se ne primijeni odmah nakon pripreme, pripravak se mora popiti unutar 24 sata.
English: The highest risk for occurrence of SJS or TEN is within the first weeks of treatment and usually around 3-6 weeks for DRESS
Croatian: Najveći rizik od pojave SJS ili TEN je unutar prvih tjedana liječenja, a za DRESS obično oko 3-6 tjedana.
English: If OSSEOR is used inadvertently during pregnancy, treatment must be stopped.
Croatian: Uzima li se OSSEOR nehotice u trudnoći, liječenje se mora obustaviti.
English: Blood Creatine phosphokinase (CPK) increased a
Croatian: Povišena kreatin fosfokinaza (CPK) u krvi a
English: Its plasma clearance is about 12 ml/min (CV 22%) and its renal clearance about 7 ml/min (CV 28%).
Croatian: Njegov klirens plazme je oko 12 ml/min (CV 22 %), a bubrežni klirens je oko 7 ml/min (CV 28 %).
English: However, absence of these alleles upon genotyping does not exclude that SJS/TEN can still occur.
Croatian: Međutim, negativan nalaz kod genotipizacije ovih alela ne isključuje mogućnost pojave SJS/TEN.
English: OSSEOR contains aspartame, a source of phenylalanine, which may be harmful for people with phenylketonuria.
Croatian: Pomoćna tvar OSSEOR sadržava aspartam, izvor fenilalanina, koji može biti štetan za osobe s fenilketonurijom.
English: OSSEOR, which contains the substance strontium ranelate, belongs to a group of medicines used to treat bone diseases.
Croatian: OSSEOR, koji sadrži djelatnu tvar stroncijev ranelat, pripada skupini lijekova koji se koriste za liječenje bolesti kostiju.
English: Abdominal pain Gastrointestinal pain Gastrooesophageal reflux Dyspepsia
Croatian: Bol u abdomenu Gastrointestinalna bol Gastroezofagealni refluks Dispepsija
English: Bronchial hyperreactivity
Croatian: Bronhalna hiperreaktivnost
English: • OSSEOR should only be used with caution in: o Patients with significant risk factors for cardiovascular events such as hypertension, hyperlipidaemia, diabetes mellitus or smoking.
Croatian: • OSSEOR smije se primjenjivati samo uz oprez u: o Bolesnika sa značajnim čimbenicima rizika za nastanak kardiovaskularnih događaja kao što su hipertenzija, hiperlipidemija, diabetes mellitus ili pušenje.
English: Therefore, in view of available data regarding the PASS final study report, the PRAC considered that changes to the conditions of the marketing authorization were warranted.
Croatian: Stoga, s obzirom na dostupne podatke završnog izvješća o PASS ispitivanju, PRAC smatra da su izmjene uvjeta odobrenja za stavljanje lijeka u promet opravdane.
English: With respect to clinical vertebral fractures (defined as fractures associated with back pain and/or a body height loss of at least 1 cm), the relative risk was reduced by 38%.
Croatian: S obzirom na kliničke prijelome kralješnice (definirane kao prijelome povezane s boli u leđima i/ili smanjenjem visine tijela za barem 1 cm), OSSEOR je rizik od tih prijeloma smanjio za 38 %.
English: If the following happens to you, stop using OSSEOR and talk to your doctor immediately:
Croatian: Ako Vam se dogodi bilo što od niže navedenog, prekinite sa uzimanjem OSSEOR-a i odmah razgovarajte sa svojim liječnikom:
English: Table 1: Incidence of patients with vertebral fracture and relative risk reduction Study
Croatian: Tablica 1: Incidencija prijeloma vratne kralješnice i smanjenje relativnog rizika
English: How OSSEOR works
Croatian: Kako djeluje OSSEOR
English: Treatment should be stopped if the patient develops ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or if hypertension is uncontrolled (see section 4.3).
Croatian: Liječenje se mora prekinuti ako bolesnik razvije ishemijsku bolest srca, perifernu arterijsku bolest, cerebrovaskularnu bolest ili ako ima nekontroliranu hipertenziju (vidjeti dio 4.3).
English: The treatment should only be started by a doctor with experience in treating osteoporosis.
Croatian: Liječenje treba započeti samo liječnik s iskustvom u liječenju osteoporoze.
English: A number of risk factors are associated with postmenopausal osteoporosis including low bone mass, low bone mineral density, early menopause, a history of smoking and a family history of osteoporosis.
Croatian: Brojni su čimbenici rizika povezani s pojavom osteoporoze u poslijemenopauzi, uključivši malu koštanu masu, slabu mineralnu gustoću kosti, ranu menopauzu, pušenje u anamnezi i obiteljsku povijest pojave osteoporoze.
English: EU/1/04/287/001 EU/1/04/287/002 EU/1/04/287/003 EU/1/04/287/004 EU/1/04/287/005 EU/1/04/287/006
Croatian: EU/1/04/287/003 EU/1/04/287/004 EU/1/04/287/005 EU/1/04/287/006
English: Strontium ranelate does not present a risk for the environment.
Croatian: Stroncijev ranelat ne predstavlja opasnost za okoliš.
English: ElderlyPopulation pharmacokinetic data showed no relationship between age and apparent clearance of strontium in the target population.
Croatian: Podaci o populacijskoj farmakokinetici nisu pokazali povezanost između dobi i prividnog klirensa stroncija u ciljnoj populaciji.
English: If you take more sachets of OSSEOR than recommended by your doctor, tell your doctor or pharmacist.
Croatian: Uzmete li više vrećica OSSEOR-a nego što Vam je preporučio liječnik, kažite to svome liječniku ili ljekarniku.
English: The pharmacokinetics of strontium and ranelic acid have been assessed in healthy young men and healthy postmenopausal women, as well as during longterm exposure in men with osteoporosis and postmenopausal osteoporotic women including elderly women.
Croatian: Farmakokinetika stroncija i ranelatne kiseline bile su procijenjene u zdravih mladih muškaraca i u zdravih žena u poslijemenopauzi, kao i pri dugotrajnoj izloženosti u muškaraca s osteoporozom i u žena u poslijemenopauzi s osteoporozom, uključivši starije žene.
English: OSSEOR contains aspartame (E951):
Croatian: OSSEOR sadrži aspartam (E951):
English: Therefore, administration of OSSEOR and such products should be separated by at least two hours (see sections 4.2 and 5.2).
Croatian: Stoga razmak između uzimanja OSSEOR-a i tih proizvoda mora iznositi najmanje dva sata (vidjeti dijelove 4.2 i 5.2)
English: On the basis of the scientific conclusions for the results of the study for the medicinal product mentioned above, the CHMP is of the opinion that the benefit-risk balance of this medicinal product is unchanged, subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka rezultata ispitivanja gore spomenutog lijeka, CHMP smatra da je omjer koristi i rizika gore spomenutog lijeka nepromijenjen, uz predložene izmjene informacija o lijeku.
English: If tests are positive for one or both alleles, OSSEOR should not be started.
Croatian: Ukoliko je nalaz pozitivan za jedan ili oba alela, ne smije se započeti liječenje OSSEOR-om.
English: - Once reconstituted in water, the suspension is stable for 24 hours.
Croatian: - Nakon pripreme u vodi, suspenzija je stabilna 24 sata.
English: A higher incidence, although still rare, of hypersensitivity reactions including skin rash, SJS or TEN in patients of Asian origin has been reported (see section 4.8).
Croatian: Zabilježena je veća incidencija, iako još uvijek rijetka, reakcije preosjetljivosti uključujući kožni osip, SJS ili TEN u bolesnika azijskog porijekla (vidjeti dio 4.8).
English: - in adult men, at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.
Croatian: - u odraslih muškaraca s visokim rizikom za nastanak prijeloma, kod kojih liječenje s drugim lijekovima odobrenima za liječenje osteoporoze nije moguće zbog, na primjer, kontraindikacija ili nepodnošenja.
English: These included: nonsteroidal anti-inflammatory agents (including acetylsalicylic acid), anilides (such as paracetamol), H2 blockers and proton pump inhibitors, diuretics, digoxin and cardiac glycosides, organic nitrates and other vasodilators for cardiac diseases, calcium channel blockers, beta blockers, ACE inhibitors, angiotensin II antagonists, selective beta-2 adrenoceptor agonists, oral anticoagulants, platelet aggregation inhibitors, statins, fibrates and benzodiazepine derivatives.
Croatian: Među te se lijekove ubrajaju: nesteroidni protuupalni lijekovi (uključivši acetilsalicilatnu kiselinu), anilidi (npr. paracetamol), H2-blokatori i inhibitori protonske pumpe, diuretici, digoksin i kardijalni glikozidi, organski nitrati i ostali vazodilatatori za srčane bolesti, blokatori kalcijevih kanala, beta-blokatori, ACE inhibitori, antagonisti angiotenzina II, selektivni agonisti beta-2-adrenoreceptora, peroralni antikoagulansi, inhibitori agregacije trombocita, statini, fibrati i derivati benzodiazepina.
English: Reduction in production of blood cells in the bone marrow.
Croatian: Rijetko: Smanjena proizvodnja krvnih stanica u koštanoj srži.
English: How to take OSSEOR
Croatian: Kako uzimati OSSEOR
English: Do not take OSSEOR: - if you are allergic to strontium ranelate or any of the other ingredients of OSSEOR (listed in section 6).
Croatian: Nemojte uzimati OSSEOR: - ako ste preosjetljivi (alergični) na stroncijev ranelat ili na bilo koji drugi sastojak OSSEOR-a
English: As divalent cations can form complexes with oral tetracycline (e.g. doxycycline) and quinolone antibiotics (e.g. ciprofloxacin) at the gastro-intestinal level and thereby reduce their absorption, simultaneous administration of strontium ranelate with these medicinal products is not recommended.
Croatian: Budući da dvovalentni kationi mogu stvarati komplekse s peroralno uzetim tetraciklinskim (npr. doksiciklin) i kinolonskim (npr. ciprofloksacin) antibioticima na gastrointestinalnoj razini i time smanjiti njihovu apsorpciju, ne preporučuje se istodobna primjena stroncijeva ranelata i tih lijekova.
English: During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must immediately stop taking OSSEOR and seek medical advice (see section 4).
Croatian: Ukoliko Vam se tijekom liječenja dogodi alergijska reakcija (npr. oticanje lica, jezika ili grla, poteškoće u disanju ili gutanju, kožni osip), morate odmah prekinuti uzimanje OSSEOR -a i potražiti pomoć liječnika (pogledajte dio 4).
English: Each sachet also contains 20 mg of aspartame (E951).
Croatian: Jedna vrećica sadrži i 20 mg aspartama (E951).
English: The outcome of DRESS is favorable in most cases upon discontinuation of OSSEOR and after initiation of corticosteroid therapy when necessary.
Croatian: U većini slučajeva je ishod DRESS-a povoljan nakon prestanka primjene OSSEOR-a i nakon uvođenja liječenja kortikosteroidima kada je neophodno.
English: Together, SOTI and TROPOS enrolled 1,556 patients over 80 years at inclusion (23.1% of the study population).
Croatian: U oba ispitivanja, SOTI i TROPOS, sudjelovalo je 1556 bolesnica starijih od 80 godina pri uključivanju u ispitivanju (23,1 % populacije iz ispitivanja).
English: o As soon as possible in the event of an illness or a condition leading to immobilization, the treatment should be discontinued.
Croatian: o U slučaju bolesti ili stanja koja dovodi do imobilizacije, liječenje treba što je moguće prije prekinuti.
English: DATE OF REVISION OF THE TEXT Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu
English: The following adverse reactions have been reported during clinical studies and/or post marketing use with strontium ranelate.
Croatian: Sljedeće nuspojave zabilježene su u kliničkim ispitivanjima i/ili nakon stavljanja stroncijevog ranelata u promet.
English: In patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance), strontium clearance decreases as creatinine clearance decreases (approximately 30% decrease over the creatinine clearance range 30 to 70 ml/min) and thereby induces an increase in strontium plasma levels.
Croatian: U bolesnika s blago do umjereno oštećenom funkcijom bubrega (klirens kreatinina 30-70 ml/min) klirens stroncija smanjuje se s klirensom kreatinina (oko 30 % smanjenja pri klirensu kreatinina u rasponu od 30 do 70 ml/min), zbog čega raste razina stroncija u plazmi.
English: What OSSEOR contains - The active substance is strontium ranelate.
Croatian: Što OSSEOR sadrži - Djelatna tvar je stroncijev ranelat.
English: In a pooled analysis of randomised placebo-controlled studies in post-menopausal osteoporotic patients, the most common adverse reactions consisted of nausea and diarrhoea, which were generally reported at the beginning of treatment with no noticeable difference between groups afterwards.
Croatian: U analizi zbirnih podataka iz randomiziranih placebom kontroliranih ispitivanja u bolesnica s osteoporozom u poslijemenopauzi, najčešće nuspojave bile su mučnina i proljev, a općenito su se javljale na početku terapije, te među skupinama kasnije nije bilo uočljivih razlika.
English: The combined effects of strontium distribution in bone (see section 5.2) and increased X-ray absorption of strontium as compared to calcium, leads to an amplification of bone mineral density (BMD) measurement by dual-photon X-ray absorptiometry (DXA).
Croatian: Zahvaljujući kombiniranom djelovanju raspodjele stroncija u kosti (vidjeti dio 5.2) i pojačane apsorpcije stroncija mjerene rendgenski, u usporedbi s kalcijem, povećava se mineralna gustoća kosti (BMD) mjerena dvoenergetskom apsorpciometrijom rendgenskih zraka (DXA).
English: The efficacy and safety of strontium ranelate have been established in a broad age range (up to 100 years at inclusion) of adult men and postmenopausal women with osteoporosis.
Croatian: Djelotvornost i sigurnost stroncijeva ranelata ustanovljena je u odraslih muškaraca i žena širokog dobnog raspona (do 100 godina pri uključivanju u istraživanje) s osteoporozom u poslijemenopauzi.
English: Vomiting, abdominal pain, reflux, indigestion, constipation, flatulence, difficulty in sleeping, inflammation of the liver (hepatitis), swelling in limbs, bronchial hyperreactivity (symptoms include wheezing and shortness of breath and cough), increased level of a muscle enzyme (Creatine phosphokinase), increased levels of cholesterol.
Croatian: Povraćanje, bol u trbuhu, povrat kiseline, probavne tegobe, zatvor, vjetrovi, poteškoće sa spavanjem, upala jetre (hepatitis), otekline na udovima, bronhijalna hiperreaktivnost (simptomi uključuju piskanje, nedostatak zraka i kašalj), povišena razina mišićnih enzima (kreatinin fosfokinaza), povišena razina kolesterola.
English: Take the granules contained in the sachets as a suspension in a glass containing a minimum of 30 ml (approximately one third of a standard glass) of water.
Croatian: Granule iz vrećice uzmite u obliku otopine koju pripravite u čaši koja sadrži najmanje 30 ml (otprilike jedna trećina uobičajene čaše) vode.
English: • The treatment should be either discontinued or stopped in the following situations: o If the patient develops ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or if hypertension is uncontrolled, the treatment should be stopped.
Croatian: • Liječenje se mora prekinuti ili obustaviti u sljedećim situacijama: o Ako bolesnik razvije ishemijsku bolest srca, perifernu arterijsku bolest, cerebrovaskularnu bolest ili ako ima nekontroliranu hipertenziju liječenje se mora obustaviti.
English: - in postmenopausal women,
Croatian: - u žena u poslijemenopauzi
English: Statistically significant increases in femoral neck BMD and total hip BMD (p<0,001) were observed after 12 months.
Croatian: Nakon 12 mjeseci uočeno je statistički značajno povećanje BMD-a vrata bedrene kosti i ukupnog BMD-a kuka (p<0,001).
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (see section
Croatian: Reakcija uzrokovana lijekom uz eozinofiliju i sustavne simptome (DRESS) (vidjeti dio
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: Ako imate dodatnih pitanja vezano za primjenu ovog lijeka, upitajte svog liječnika ili ljekarnika.
English: EU/1/04/287/005 84 sachets (3 packs of 28) EU/1/04/287/006 100 sachets
Croatian: EU/1/04/287/005 84 vrećica (3 pakiranja od 28 vrećica) EU/1/04/287/006 100 vrećica
English: In phase III studies, the annual incidence of venous thromboembolism (VTE) observed over 5 years was approximately 0.7%, with a relative risk of 1.4 (95% CI = [1.0 ; 2.0]) in strontium ranelate treated patients as compared to placebo (see section 4.4).
Croatian: U ispitivanjima III. faze, godišnja incidencija venske tromboembolije (VTE) zabilježena tijekom 5 godina iznosila je približno 0,7%, s relativnim rizikom od 1,4 (95% CI = [1,0 ; 2,0]) u bolesnika liječenih stroncijevim ranelatom u usporedbi s placebom (vidjeti dio 4.4).
English: Over 12 months, a statistically significant increase in mean lumbar spine BMD, main efficacy criteria (E (SE) = 5.32% (0.75); 95%CI = [3.86 ; 6.79]; p<0,001), similar to that observed in the pivotal anti-fracture phase III studies carried-out in postmenopausal women, was observed.
Croatian: Tijekom 12 mjeseci uočeno je statistički značajno povećanje srednje vrijednosti BMD-a lumbalne kralježnice, glavnog kriterija djelotvornosti (E (SE)=5,32% (0,75); 95%CI [3,86; 6,79]; p=0,001) slično rezultatima pivotalnih ispitivanja III.