FrancophonIA/ELRC3.0 huggingface dataset:
English: Hrvatska {Ime} <{Adresa} {Poštanski broj} {grad}> Tel: +{Telefonski broj} <{e-mail}> Ireland {Name} <{Address} IRL - {Town} {Code for Dublin}> Tel: +{Telephone number} <{e-mail}> România {Nume} <{Adresă} {Oraş} {Cod poştal} - RO> Tel: +{Număr de telefon} <{e-mail}> Slovenija {Ime} <{Naslov} SI-0000 {Mesto}> Tel: +{telefonska številka} <{e-mail}>
Croatian: Hrvatska {Naziv} <{Adresa} {Poštanski broj} {grad}> Tel: + {Telefonski broj} <{e-mail}> Ireland {Name} <{Address} IRL - {Town} {Code for Dublin}> Tel: + {Telephone number} <{e-mail}> România {Nume} <{Adresă} {Oraş} {Cod poştal} - RO> Tel: + {Număr de telefon} <{e-mail}> Slovenija {Ime} <{Naslov} SI-0000 {Mesto}> Tel: + {telefonska številka} <{e-mail}>
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR <THE CONDITIONAL MARKETING AUTHORISATION> <THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES>
Croatian: POSEBNE OBVEZE ZA PROVEDBE MJERA NAKON DAVANJA ODOBRENJA KOD <UVJETNOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET> <ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA>
English: <For storage conditions after <reconstitution> <dilution> <first opening> of the medicinal product, see section 6.3.>
Croatian: <razrjeđivanja> <prvog otvaranja> lijeka vidjeti u dijelu 6.3.>
English: <Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).>
Croatian: <Lijek se izdaje na poseban i ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).>
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu<, and on the website of {name of Member State Agency (link)}>.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu<, kao i na internetskoj stranici {naziv nadležnog tijela države članice (poveznica)}>.
English: Do not <take> <use> X
Croatian: Nemojte <uzimati> <primjenjivati> X
English: DOSIMETRY>
Croatian: <11. DOZIMETRIJA>
English: <Medicinal product subject to special medical prescription.>
Croatian: <Lijek se izdaje na poseban recept.>
English: <Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).>
Croatian: <Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).>
English: <{X} is contraindicated in children aged {x to y} <years> <months> [or any other relevant subsets, e.g. weight, pubertal age, gender] <for the indication of...> (see section 4.3).>
Croatian: <{X} je kontraindiciran(a) u djece u dobi {od x do y} <godine(a)>, <mjeseci(a)> [ili u bilo kojoj drugoj bitnoj podskupini, npr. prema težini, pubertetu, spolu] <za indikaciju…> (vidjeti dio 4.3).>
English: <There is no relevant use of {X} <in the paediatric population> <in children aged {x to y} <years> <months> [or any other relevant subsets, e.g. weight, pubertal age, gender] <for the indication of...>.>
Croatian: <Nema relevantne primjene {X} <u pedijatrijskoj populaciji> <u djece u dobi {od x do y} <godine(a)>, <mjeseci(a)> [ili u bilo kojoj drugoj bitnoj podskupini, npr. prema težini, pubertetu, spolu] <za indikaciju…>.>
English: <2.2 Qualitative and quantitative composition> [For advanced therapy products only]
Croatian: <2.2 Kvalitativni i kvantitativni sastav>
English: <Medicinal product not subject to medical prescription.>
Croatian: <Lijek se izdaje bez recepta.>
English: <If you have any further questions on the use of this medicine, ask your <doctor> <,> <or> <pharmacist> <or nurse>.>
Croatian: <U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se <liječniku> <,> <ili> <ljekarniku>
English: <Medicinal product subject to medical prescription.>
Croatian: <Lijek se izdaje na recept.>
English: The European Medicines Agency will review any new information on the reference medicine every year and any updates for the reference medicine will also be included as appropriate in the information for X, such as this leaflet.>
Croatian: Europska agencija za lijekove će svake godine procjenjivati sve nove informacije o referentnom lijeku te će se informacije o lijeku X, kao što je ova uputa, ažurirati u skladu s referentnim lijekom.>
English: <Official batch release
Croatian: <Službeno puštanje serije lijeka u promet
English: The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.>
Croatian: Europska agencija za lijekove će svake godine procjenjivati sve nove informacije o ovom lijeku te će se ova uputa ažurirati prema potrebi.>
English: The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.>
Croatian: Europska agencija za lijekove će barem jednom godišnje procjenjivati nove informacije o ovom lijeku te će se ova uputa ažurirati prema potrebi.>
English: This means that <because of the rarity of this disease> <for scientific reasons> <for ethical reasons> it has been impossible to get complete information on this medicine.
Croatian: To znači da <s obzirom na malu učestalost bolesti> <zbog znanstvenih razloga> <zbog etičkih razloga> nije bilo moguće doći do potpunih informacija o ovom lijeku.
English: The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary accordingly to the reference medicinal product SmPC.>
Croatian: Europska agencija za lijekove svake će godine procjenjivati sve nove informacije koje postanu dostupne te će se tekst sažetka opisa svojstava lijeka ažurirati prema potrebi, u skladu s tekstom sažetka opisa svojstava referentnog lijeka.>
English: This means that <due to the rarity of the disease><for scientific reasons><for ethical reasons> it has not been possible to obtain complete information on the reference medicinal product.
Croatian: To znači da <s obzirom na malu učestalost bolesti> <zbog znanstvenih razloga> <zbog etičkih razloga> nije bilo moguće doći do potpunih informacija o referentnom lijeku.
English: 6.4 Special precautions for storage
Croatian: Posebne mjere za zbrinjavanje
English: The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary.>
Croatian: Europska agencija za lijekove svake će godine procjenjivati sve nove informacije koje postanu dostupne te će se tekst sažetka opisa svojstava lijeka ažurirati prema potrebi.>
English: <Traceability
Croatian: <Sljedivost
English: Strength Pharmaceutical Form
Croatian: Jačina Farmaceutski oblik Put primjene
English: Zinbryta daclizumab
Croatian: Zinbryta daklizumab
English: The full EPAR for Zinbryta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Zinbryta nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is 150 mg once a month by injection under the skin.
Croatian: Preporučena doza jest 150 mg koja se daje injekcijom pod kožu jedanput mjesečno.
English: The company that markets Zinbryta will issue educational materials for healthcare professionals and for patients about liver damage and how to prevent or reduce the damage.
Croatian: Tvrtka koja stavlja lijek Zinbryta u promet objavit će edukativne materijala za zdravstvene djelatnike i bolesnike o oštećenjima jetre i o tome kako ih spriječiti ili smanjiti.
English: Zinbryta works in a different way to existing treatments and has the advantage that it is given just once a month.
Croatian: Lijek Zinbryta djeluje na drugačiji način u odnosu na postojeće oblike liječenja, a prednost mu je ta što se daje samo jedanput mjesečno.
English: The most common side effects with Zinbryta (which may affect more than 1 in 100 people) are rash, increased liver enzymes in the blood, depression, inflamed and sore nose and throat, influenza and upper respiratory tract infection such as colds and lymphadenopathy (swollen glands).
Croatian: Najčešće su nuspojave lijeka Zinbryta (mogu se javiti u više od 1 na 100 osoba) osip, povećanje jetrenih enzima u krvi, depresija, upala i bol u nosu i grlu, gripa i infekcije gornjih dišnih putova poput prehlade i limfadenopatije (natečene žlijezde).
English: This is a summary of the European public assessment report (EPAR) for Zinbryta.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Zinbryta.
English: Treatment is associated with adverse effects on the liver and an increased risk of infections but the CHMP considered these could be managed with regular monitoring.
Croatian: Liječenje ovim lijekom povezuje se s nuspojavama na jetri i povećanim rizikom od infekcija, no CHMP je zaključio da se te nuspojave mogu kontrolirati uz redoviti nadzor.
English: attacking and damaging nerve cells.
Croatian: napadnu i oštete živčane stanice.
English: It is not intended to provide practical advice on how to use Zinbryta.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Zinbryta.
English: What measures are being taken to ensure the safe and effective use of Zinbryta?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zinbryta?
English: These cells form part of the body's immune system and they are activated by interleukin-2, a signalling protein in the body.
Croatian: Te su stanice dio imunosnog sustava tijela, a aktivira ih interleukin-2, signalna bjelančevina u tijelu.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zinbryta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Zinbryta nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zinbryta have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza koje zdravstveni djelatnici i bolesnici trebaju poštovati radi sigurne i učinkovite uporabe lijeka Zinbryta također se nalaze u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Daclizumab may also have other effects that reduce the immune system's damaging effects on nerve cells.
Croatian: Daklizumab može imati i druge učinke koji smanjuju oštećenja živčanih stanica uzrokovana imunosnim sustavom.
English: What is Zinbryta and what is it used for?
Croatian: Što je Zinbryta i za što se koristi?
English: Other information about Zinbryta
Croatian: Ostale informacije o lijeku Zinbryta
English: Why is Zinbryta approved?
Croatian: Zašto je Zinbryta odobren?
English: In one study involving 600 patients, Zinbryta was found to be more effective than placebo (a dummy treatment) at reducing relapses of the condition.
Croatian: U jednom ispitivanju koje je provedeno na 600 bolesnika pokazalo se da je lijek Zinbryta djelotvorniji od placeba (prividno liječenje) u smanjivanju relapsa bolesti.
English: In another study involving 1,841 patients, patients receiving Zinbryta 150 mg every 4 weeks had on average 0.22 relapses over a year compared with 0.39 in those receiving interferon beta-1a, another medicine used for multiple sclerosis.
Croatian: U drugom ispitivanju koje je provedeno na 1 841 bolesnika, bolesnici koji su primali 150 mg lijeka Zinbryta svaka četiri tjedna imali su u prosjeku 0,22 relapsa tijekom godine u usporedbi s 0,39 kod onih koji su primali interferon beta-1a, drugi lijek za liječenje multiple skleroze.
English: Patients should be trained to give themselves the injection using either a prefilled syringe or an injection pen device.
Croatian: Bolesnike treba osposobiti da si samostalno daju injekciju uporabom napunjene štrcaljke ili brizgalice.
English: Zinbryta can only be obtained with a prescription and treatment should be started by a doctor with experience in managing multiple sclerosis.
Croatian: Lijek Zinbryta izdaje se samo na liječnički recept, a liječenje treba započeti liječnik s iskustvom u liječenju multiple skleroze.
English: Patients receiving Zinbryta 150 mg every 4 weeks had on average 0.21 relapses over a year compared with 0.46 in those receiving placebo.
Croatian: Bolesnici koji su svaka četiri tjedna primali 150 mg lijeka Zinbryta imali su u prosjeku 0,21 relapsa tijekom godine u usporedbi s 0,46 kod onih koji su primali placebo.
English: By attaching to the T cells, daclizumab blocks interleukin-2, so preventing T cells from
Croatian: Vezivanjem na T-stanice, daklizumab onemogućuje djelovanje bjelančevine interleukin-2 i time sprječava T-stanice da
English: For more information about treatment with Zinbryta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Zinbryta pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: Zinbryta is a medicine used to treat adults with the relapsing forms of multiple sclerosis.
Croatian: Zinbryta je lijek koji se koristi za liječenje relapsnih oblika multiple skleroze u odraslih.
English: What are the risks associated with Zinbryta?
Croatian: Koji su rizici povezani s lijekom Zinbryta?
English: The most common serious side effects of Zinbryta are liver damage and severe skin reactions.
Croatian: Najčešće su teške nuspojave lijeka Zinbryta oštećenje jetre i teške kožne reakcije.
English: In multiple sclerosis, the body's immune (defence) system incorrectly attacks and damages the protective sheath around the nerve cells in the central nervous system (the brain and spinal cord).
Croatian: Imunosni (obrambeni) sustav bolesnika s multiplom sklerozom greškom napada i oštećuje zaštitnu ovojnicu oko živčanih stanica u središnjem živčanom sustavu (mozgu i leđnoj moždini).
English: The active substance in Zinbryta, daclizumab, is a monoclonal antibody that attaches to T cells.
Croatian: Djelatna tvar u lijeku Zinbryta, daklizumab, monoklonsko je protutijelo koje se veže na T-stanice.
English: For the full list of restrictions and of all side effects reported with Zinbryta, see the package leaflet.
Croatian: Potpuni popis svih ograničenja i nuspojava zabilježenih pri primjeni lijeka Zinbryta potražite u uputi o lijeku.
English: For practical information about using Zinbryta, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Zinbryta pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How is Zinbryta used?
Croatian: Kako se Zinbryta koristi?
English: How does Zinbryta work?
Croatian: Kako djeluje Zinbryta?
English: What benefits of Zinbryta have been shown in studies?
Croatian: Koje su koristi lijeka Zinbryta utvrđene u ispitivanjima?
English: Zinbryta contains the active substance daclizumab.
Croatian: Lijek Zinbryta sadrži djelatnu tvar daklizumab.
English: Multiple sclerosis is a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord.
Croatian: Multipla skleroza je bolest pri kojoj dolazi do upale koja oštećuje zaštitnu ovojnicu oko živčanih stanica u mozgu i leđnoj moždini. „Relaps” znači da dolazi do izbijanja simptoma kod bolesnika.
English: Zinbryta has been found to be effective in studies carried out over up to 3 years.
Croatian: U ispitivanjima koja su se provodila u razdoblju do tri godine utvrđena je djelotvornost lijeka Zinbryta.
English: Zinbryta has been found effective for treating relapsing multiple sclerosis in two main studies involving over 2,400 patients.
Croatian: U dvama glavnim ispitivanjima provedenima na više od 2 400 bolesnika pokazalo se da je lijek Zinbryta djelotvoran u liječenju relapsne multiple skleroze.
English: Your doctor will discuss this with you.
Croatian: Vaš liječnik će o tome s Vama porazgovarati.
English: Once removed from the refrigerator:
Croatian: Nakon što se izvadi iz hladnjaka:
English: 80.3% of these had pre-existing antibodies.
Croatian: 80,3% njih imalo je prethodno postojeća antitijela.
English: Dosing recommendations for elderly patients are the same as for adult patients.
Croatian: Preporuke za doziranje u starijih bolesnika iste su kao i u odraslih bolesnika.
English: Before you are given Parsabiv, tell your doctor if you have or have ever had:
Croatian: Prije nego dobijete Parsabiv, obavijestite svog liječnika ako imate ili ste ikada imali:
English: All effects were reversible upon cessation of treatment.
Croatian: Svi učinci bili su reverzibilni nakon prekida liječenja.
English: Body weight, gender, age, race
Croatian: Tjelesna težina, spol, dob, rasa
English: A risk to breastfed newborns/infants cannot be excluded.
Croatian: Ne može se isključiti rizik za novorođenče/dojenče.
English: It is not known whether Parsabiv can harm your unborn baby.
Croatian: Nije poznato može li Parsabiv naškoditi Vašem nerođenom djetetu.
English: Dose adjustment may be necessary at any time during treatment including the maintenance phase.
Croatian: Prilagodba doze može biti potrebna u bilo kojem trenutku liječenja, uključujući i fazu održavanja.
English: Do not use this medicine if you notice it has particles or it has changed colour.
Croatian: Nemojte primjenjivati ovaj lijek ako primijetite da sadrži čestice ili da je promijenio boju.
English: The safety and efficacy of etelcalcetide in children and adolescents less than 18 years has not yet been established.
Croatian: Sigurnost i djelotvornost etelkalcetida u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: 6 See section 4.4.
Croatian: 6 Vidjeti dio 4.4.
English: It is not known whether Parsabiv is safe and effective in children less than 18 years of age as it has not been studied in these patients.
Croatian: Nije poznato je li Parsabiv siguran i djelotvoran u djece mlađe od 18 godina jer nije ispitivan u tih bolesnika.
English: Do not use Parsabiv if you have very low levels of calcium in your blood.
Croatian: Nemojte primjenjivati Parsabiv ako imate vrlo nisku razinu kalcija u krvi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 November 2016
Croatian: Datum prvog odobrenja: 11. studenoga 2016.
English: What Parsabiv is and what it is used for
Croatian: Što je Parsabiv i za što se koristi
English: Pack sizes of 1, 6, 12 and 42 vials.
Croatian: Veličine pakiranja od 1, 6, 12 i 42 bočice.
English: Other medicines and Parsabiv
Croatian: Drugi lijekovi i Parsabiv
English: Not known: frequency cannot be estimated from the available data • Allergic reactions (including anaphylactic reactions)
Croatian: Nepoznato: učestalost se ne može procijeniti iz dostupnih podataka • Alergijske reakcije (uključujući anafilaktičke reakcije)
English: ATC code: H05BX04
Croatian: ATK oznaka: H05BX04
English: You and your doctor should decide if you should use Parsabiv.
Croatian: Vi i Vaš liječnik trebate odlučiti smijete li primjenjivati Parsabiv.
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: Niže su navedene nuspojave prema sljedećoj konvenciji učestalosti: 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 (ne može se procijeniti iz dostupnih podataka).
English: These may be signs that your calcium levels are too low (hypocalcaemia).
Croatian: Ovo mogu biti znakovi da je Vaša razina kalcija preniska (hipokalcijemija).
English: Do not use Parsabiv if you are allergic to etelcalcetide or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Parsabiv ako ste alergični na etelkalcetid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Tell your doctor if you are taking cinacalcet or have recently taken cinacalcet.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli cinakalcet.
English: Parsabiv has not been tested in pregnant women.
Croatian: Parsabiv nije ispitan u trudnica.
English: a p < 0.001 versus placebo b p = 0.003 versus placebo
Croatian: a p < 0,001 naspram placeba b p = 0,003 naspram placeba
English: As a precautionary measure, it is preferable to avoid the use of Parsabiv during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Parsabiv tijekom trudnoće.
English: Parsabiv should not be administered more frequently than 3 times per week.
Croatian: Parsabiv se ne smije primjenjivati češće od 3 puta tjedno.
English: The predominant biotransformation product (albumin bound) was minimally active in vitro.
Croatian: Prevladavajući produkt biotransformacije (vezan na albumin) bio je minimalno aktivan in vitro.
English: Overdose of etelcalcetide may lead to hypocalcaemia with or without clinical symptoms and may require treatment.
Croatian: Predoziranje etelkalcetidom može dovesti do hipokalcijemije s ili bez kliničkih simptoma i može zahtijevati liječenje.
English: The mean age of patients across the 2 studies was 58.2 (range 21 to 93) years.
Croatian: Srednja dob bolesnika u 2 ispitivanja bila je 58,2 (u rasponu od 21 do 93) godine.
English: Other laboratory assays may have different cut-offs for the lower limit of the normal range.
Croatian: Drugi laboratorijski testovi mogu imati druge granične vrijednosti za donju granicu normalnog raspona.
English: Your doctor will monitor your blood calcium levels.
Croatian: Vaš liječnik će pratiti Vašu razinu kalcija u krvi.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including those medicines obtained without a prescription, or any other medicines that lower serum calcium.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i lijekove dobivene bez recepta, ili bilo koje druge lijekove koji snižavaju razinu kalcija u serumu.
English: The dose may be increased up to 15 mg or lowered down to 2.5 mg depending on your response.
Croatian: Doza se može povećati do 15 mg ili smanjiti do 2,5 mg, ovisno o Vašem odgovoru.
English: Tell your doctor if you are pregnant, think you may be pregnant, or plan to get pregnant when taking Parsabiv.
Croatian: Obavijestite svog liječnika ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete tijekom liječenja lijekom Parsabiv.
English: Dose adjustments based on PTH levels
Croatian: Prilagodbe doze na temelju razina PTH
English: The extent and duration of the reduction in PTH increased with increasing dose.
Croatian: Stupanj i trajanje sniženja razine PTH povećavali su se s povećanjem doze.
English: However certain symptoms of low calcium levels (such as fits or convulsions) can affect your ability to drive or operate machinery.
Croatian: Međutim, određeni simptomi niske razine kalcija (poput napadaja ili konvulzija) mogu utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
English: Demographic and baseline characteristics between the two groups in each study were similar.
Croatian: Demografske i početne karakteristike između dvije skupine bile su slične u oba ispitivanja.
English: Very low levels of PTH over long periods can result in a type of abnormal bone structure known as adynamic bone which can only be diagnosed by biopsy.
Croatian: Vrlo niska razina PTH tijekom dugih razdoblja može rezultirati vrstom abnormalne strukture kostiju poznate kao adinamična koštana bolest koja se može dijagnosticirati samo biopsijom.
English: Demographics and other baseline characteristics were similar to the placebo-controlled studies.
Croatian: Demografske i druge početne karakteristike bile su slične onima u placebom kontroliranim ispitivanjima.