FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you are still growing (skeletally immature).
Croatian: • ako još uvijek rastete (nezrelost kostura)
English: • Unknown (cannot be estimated from available data):
Croatian: • nepoznato (ne može se procijeniti iz dostupnih podataka):
English: Warnings and precautions to be discussed with your doctor
Croatian: Upozorenja i mjere opreza o kojima morate razgovarati sa svojim liječnikom
English: 6422 PJ Heerlen The Netherlands tel +31 (0) 45 566 8000 fax +31 (0) 45 566 8012
Croatian: 6422 PJ Heerlen Nizozemska tel +31 (0) 45 566 8000 faks +31 (0) 45 566 8012
English: Other medicines and InductOs
Croatian: Drugi lijekovi i InductOs
English: Over time, the sponge will gradually disappear as new bone is formed.
Croatian: S vremenom će spužva postupno nestati kako se nova kost bude stvarala.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite ovaj lijek.
English: • Healthcare professionals educational material
Croatian: • Edukacijski materijal za zdravstvene djelatnike
English: The clinical relevance of these effects is unknown.
Croatian: Klinički značaj ovih učinaka nije poznat.
English: Dispense onto matrix and wait 15 min.
Croatian: Nanesite na matricu i pričekajte 15 minuta.
English: The matrix is white.
Croatian: Matrica je bijela.
English: The powder is white.
Croatian: Prašak je bijeli.
English: This radiographic finding may be asymptomatic or symptomatic.
Croatian: Taj radiološki nalaz može biti asimptomatski ili simptomatski.
English: What you need to know before you receive InductOs
Croatian: Što morate znati prije nego primite InductOs
English: In case of overdose (i.e. a patient receives a concentration or amount of dibotermin alfa greater than recommended), treatment should be supportive.
Croatian: U slučaju predoziranja (tj. bolesnik primi koncentraciju ili količinu dibotermina alfa veću od preporučene), liječenje treba biti potporno.
English: Wait a MINIMUM of 15 minutes before using the prepared InductOs product.
Croatian: Pričekajte NAJMANJE 15 minuta prije uporabe pripremljenog lijeka InductOs.
English: The doctor will determine how much InductOs you will receive, depending on the size and number of fractures.
Croatian: Liječnik će odrediti koliko lijeka InductOs ćete primiti, ovisno o veličini i broju prijeloma.
English: • Unknown (cannot be estimated from available data): Increased breakdown of the bone
Croatian: • nepoznato (ne može se procijeniti iz dostupnih podataka): povećana razgradnja kosti
English: For these special populations, the physician is advised to give a careful consideration to the benefits and risks for the specific patient before using InductOs.
Croatian: Za ove posebne populacije preporučuje se da liječnik napravi pažljivu procjenu koristi i rizika za specifičnog bolesnika prije uporabe lijeka InductOs.
English: InductOs must be prepared exactly in accordance with the directions for preparation (see section 6.6).
Croatian: InductOs se mora pripremiti točno u skladu s uputama za pripremu (vidjeti dio 6.6).
English: Heterotopic ossification
Croatian: Heterotopična osifikacija
English: There were no other alterations in foetal external, visceral, or skeletal morphology.
Croatian: Nije bilo drugih promjena u vanjskoj, visceralnoj ili skeletnoj morfologiji fetusa.
English: The medical staff will prepare InductOs in the operating room.
Croatian: Medicinsko osoblje će pripremiti InductOs u operacijskoj dvorani.
English: What InductOs is and what it is used for
Croatian: Što je InductOs i za što se koristi
English: Bone formation outside the intervertebral disc space is not desirable as it may have a deleterious impact on local neurovascular structures.
Croatian: Stvaranje kosti izvan intervertebralnog prostora nije poželjno jer može štetno utjecati na lokalne neurovaskularne strukture.
English: Over 1700 patients have received InductOs in clinical studies.
Croatian: Preko 1700 bolesnika primilo je InductOs u kliničkim ispitivanjima.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: Store in original package in order to protect from light.
Croatian: Čuvati u originalnom pakiranju, radi zaštite od svjetlosti.
English: You should not receive InductOs
Croatian: Ne smijete primati InductOs
English: • implanted at locations other than lumbar spine
Croatian: • ugrađeni na lokacijama različitim od lumbalne kralježnice
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated exposure toxicity and genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, akutne i toksičnosti ponovljenih doza i genotoksičnosti.
English: • The product should not be placed in direct contact with certain types of bones.
Croatian: • Lijek se ne smije stavljati izravno u doticaj s određenim tipovima kosti.
English: • Two needles (stainless steel).
Croatian: • dvije igle (nehrđajući čelik).
English: InductOs should be used by an appropriately qualified surgeon.
Croatian: InductOs mora upotrebljavati kirurg s odgovarajućim kvalifikacijama.
English: • The sponge is white and it is presented in a plastic blister.
Croatian: • Spužva je bijela i nalazi se u plastičnom blisteru.
English: • adequate neurovascular status (e.g. absence of compartment syndrome, low risk of amputation)
Croatian: • odgovarajućim neurovaskularnim statusom (npr. odsutnošću kompartment sindroma, niskim rizikom od amputacije)
English: InductOs is prepared immediately prior to use.
Croatian: InductOs se priprema neposredno prije uporabe.
English: The MAH shall ensure that in each Member State where InductOs is marketed, all healthcare professionals who are expected to use InductOs are provided with the following educational package:
Croatian: Nositelj odobrenja osigurat će da u svakoj državi članici u kojoj se InductOs stavi u promet svi zdravstveni djelatnici za koje učekuje da će primjenjivati InductOs dobiju sljedeći edukacijski paket:
English: InductOs must not be used in concentrations higher than 1.5 mg/ml (see section 4.9).
Croatian: InductOs se ne smije koristiti u koncentracijama višim od 1,5 mg/ml (vidjeti dio 4.9).
English: InductOs is contraindicated for patients with:
Croatian: InductOs je kontraindiciran za bolesnike s:
English: Patients were followed for 12 months after soft-tissue closure.
Croatian: Bolesnike se nadziralo tijekom 12 mjeseci nakon zatvaranja mekog tkiva.
English: The healthcare professional educational material should contain:
Croatian: Edukacijski materijal za zdravstvene djelatnike treba sadržavati:
English: Generally, one 12 mg pack is used; however, a maximum of two 12 mg packs may be used.
Croatian: Općenito se koristi jedno pakiranje od 12 mg; međutim, maksimalno se mogu upotrijebiti dva pakiranja od 12 mg.
English: In this process, both bone resorption and formation occur.
Croatian: U ovom procesu događaju se i resorpcija i stvaranje kosti.
English: Considering the type of product, systemic exposure of the suckling infant is not expected, however a risk to the newborn/infant cannot be excluded.
Croatian: S obzirom na vrst lijeka, ne očekuje se sistemska izloženost dojenčeta; međutim, ne može se isključiti rizik za novorođenče/dojenče.
English: • Persistent compartment syndrome or neurovascular residua of compartment syndrome
Croatian: • trajnim kompartment sindromom ili neurovaskularnim reziduama kompartment sindroma
English: The medical device corrects the position of your spine, and InductOs encourages bone to grow between the two vertebrae to fix them permanently in the correct position.
Croatian: Medicinski proizvod ispravlja položaj Vaše kralježnice, a InductOs potiče rast kosti između dva kralješka kako bi ih se trajno učvrstilo u ispravnom položaju.
English: • Very common (may affect more than 1 in 10 people):
Croatian: • vrlo često (može zahvatiti više od 1 na 10 osoba):
English: InductOs is intended for use in patients with the following:
Croatian: InductOs je namijenjen za uporabu u bolesnika sa sljedećim:
English: Long-bone fracture and soft-tissue management procedures should be based on standard practice, including control of infection.
Croatian: Prijelom dugih kostiju i postupci liječenja mekog tkiva moraju se temeljiti na standardnoj praksi, uključujući i kontrolu infekcije.
English: The Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Nositelj odobrenja mora dogovoriti s Nacionalnim nadležnim tijelom sadržaj i oblik edukacijskog programa, uključujući komunikacijski medij, oblike distribucije i sve druge vidove programa.
English: • Whenever the risk management system is modified, especially as the result of new information being received that lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: Peak levels of circulating dibotermin alfa (0.1% of the implanted dose) were observed within 6 hours following implantation.
Croatian: Vršne razine cirkulirajućeg dibotermina alfa (0,1% implantirane doze) uočene su unutar 6 sati nakon implantacije.
English: Radiographic, biomechanical and histologic evaluation of the induced bone indicates that it functions biologically and biomechanically as native bone.
Croatian: Radiografska, biomehanička i histološka procjena inducirane kosti ukazuje da funkcionira biološki i biomehanički kao prirodna kost.
English: InductOs should be placed bridging the fracture region and making good contact with the major proximal and distal fragments.
Croatian: InductOs se mora postaviti tako da premošćuje regiju prijeloma i stvara dobar kontakt s glavnim proksimalnim i distalnim fragmentima.
English: The remaining patients participated in studies using InductOs for indications not currently approved in the EU.
Croatian: Preostali bolesnici sudjelovali su u ispitivanjima uporabe InductOsa za indikacije koje trenutno nisu odobrene u Europskoj uniji.
English: • absence of large segmental defect repair of long bones, in which significant soft tissue compression can occur
Croatian: • odsutnošću popravka defekata velikih segmenata dugih kostiju u kojima može nastati značajna kompresija mekog tkiva
English: The safety and efficacy of InductOs in children below 18 years of age have not been established.
Croatian: Sigurnost primjene i djelotvornost InductOsa u djece mlađe od 18 godina još nisu utvrđene.
English: A decision must be made whether to discontinue breast-feeding or to abstain from InductOs therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom InductOs uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Solvent: Water for injections
Croatian: Otapalo: voda za injekcije
English: The frequency of this side effect is unknown and cannot be estimated from the available data.
Croatian: Učestalost ove nuspojave nije poznata i ne može se procijeniti iz dostupnih podataka.
English: For instructions to implant the lumbar interbody fusion device, please refer to the manufacturer's instructions for use.
Croatian: Za upute o implantaciji naprave za lumbalnu interkorporalnu fuziju, molimo pogledajte upute proizvođača za uporabu naprave.
English: In the absence of any experience, the repeat use of InductOs is not recommended.
Croatian: Budući da ne postoji nikakvo iskustvo, ne preporučuje se ponovna primjena InductOsa.
English: • adequate haemostasis (i.e., providing a relatively dry implantation site)
Croatian: • odgovarajućom hemostazom (tj. pod uvjetom da je mjesto implantacije relativno suho)
English: What InductOs is and what it is used for What you need to know before you receive InductOs How InductOs is given
Croatian: Što je InductOs i za što se koristi Što morate znati prije nego primite InductOs
English: Dibotermin alfa was not detectable in serum.
Croatian: Dibotermin alfa nije se mogao detektirati u serumu.
English: Clinical pharmacology studies demonstrate that the matrix alone is not osteoinductive and is no longer present in biopsies taken as early as 16 weeks post-implantation.
Croatian: Ispitivanja kliničke farmakologije pokazala su da sama matrica nije osteoinduktivna te da nije prisutna u bioptatima uzetim već 16 tjedana nakon implantacije.
English: InductOs does not provide mechanical stability and should not be used to fill a void in the presence of compressive forces.
Croatian: InductOs ne pruža mehaničku stabilnost i ne treba ga koristiti za popunjavanje šupljine u prisutnosti kompresivnih sila.
English: Frequencies are defined as very common (≥1/10) or common (≥1/100 to <1/10).
Croatian: Učestalosti su definirane kao vrlo često (≥ 1/10) ili često (≥ 1/100 do < 1/10).
English: Due to the unknown risks to the foetus associated with the potential development of neutralising antibodies to dibotermin alfa, InductOs is not recommended during pregnancy and in women of childbearing potential not using contraception (see section 4.4).
Croatian: Zbog nepoznatih rizika za fetus povezanih s mogućim razvojem neutralizirajućih protutijela na dibotermin alfa, InductOs se ne preporučuje tijekom trudnoće i u žena reproduktivne dobi koje ne koriste kontracepciju (vidjeti dio 4.4).
English: Entire matrix
Croatian: Cijela matrica
English: • Water for injections is a clear colourless liquid presented in a glass vial.
Croatian: • Voda za injekcije je bistra, bezbojna tekućina u staklenoj bočici.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Croatian: Za upute o rekonstituciji lijeka prije primjene, vidjeti dio 6.6.
English: To achieve maximum potential efficacy, it is important to attain complete soft-tissue coverage of InductOs following its implantation.
Croatian: Kako bi se postigla maksimalna moguća djelotvornost važno je postići potpunu pokrivenost InductOsa mekim tkivom nakon njegove implantacije.
English: InductOs may be placed into a void (loosely packed), folded, rolled or wrapped, as the geometry of the fracture requires.
Croatian: InductOs se može staviti u šupljinu (labavo pakiran), presavijen, uvijen ili omotan kako to zahtijeva geometrija prijeloma.
English: InductOs contains sodium
Croatian: InductOs sadrži natrij
English: If the surgical setting requires that only a portion of the product is needed, the wetted matrix should be cut to the desired size, and the unused portion must be discarded.
Croatian: Ako je kirurška situacija takva da je potreban samo dio ovog lijeka, navlaženu matricu treba odrezati na željenu veličinu, a neiskorišteni dio mora se baciti.
English: It is not known if InductOs passes into breast milk.
Croatian: Nije poznato prelazi li InductOs u majčino mlijeko.
English: Localised infection
Croatian: Lokalizirana infekcija
English: • at increasing awareness about the risk of heterotopic ossification and the potential risk of medication errors and incorrect use of InductOs and providing guidance on how to manage these risks.
Croatian: • Podići svijest o riziku od heterotopične osifikacije i mogućem riziku od pogrešaka u primjeni lijeka i neispravnoj primjeni InductOsa te dati smjernicu o tome kako upravljati tim rizicima.
English: These results were independently corroborated by a radiology panel blinded to treatment.
Croatian: Te je rezultate potvrdio nezavisni panel radiologa koji nisu imali pristup informacijama o liječenju.
English: • Common (may affect up to 1 in 10 people):
Croatian: • često (može zahvatiti do 1 na 10 osoba):
English: In some foetuses with decreased body weights, there were decreases in ossification of frontal and parietal bones (4 out of 151 foetuses), which is generally considered to be reversible, and antibody related effects could not be ruled out.
Croatian: U nekih fetusa sa smanjenom tjelesnom težinom postojala su smanjena u osifikaciji frontalnih i parijetalnih kostiju (4 od 151 fetusa) koja se općenito smatraju reverzibilnim te se učinci povezani s protutijelima ne mogu isključiti.
English: InductOs was implanted directly onto the exposed dura following a laminectomy.
Croatian: InductOs je implantiran izravno na otkrivenu duru nakon laminektomije.
English: • Pathological fractures such as those observed in (but not limited to) Paget's disease or in metastatic bone
Croatian: • patološkim prijelomima poput onih zabilježenih kod (ali koji nisu ograničeni na) Pagetove bolesti ili metastatske bolesti kostiju
English: Using sterile technique, place one syringe, one needle and the matrix inner package in the sterile field.
Croatian: Koristeći sterilnu tehniku, postavite jednu štrcaljku, jednu iglu i unutarnje pakiranje matrice u sterilno polje.
English: 6422 PJ Heerlen The Netherlands
Croatian: 6422 PJ Heerlen Nizozemska
English: Radiculopathic events1, 4
Croatian: Radikulopatski događaji1,4
English: In the sterile field
Croatian: U sterilnom polju
English: In some circumstances an exaggeration of these processes can lead to complications such as nerve compression (due to heterotopic ossification) or device dislocation (associated with bone resorption or osteolysis).
Croatian: U nekim okolnostima ti procesi su pojačani i mogu uzrokovati komplikacije poput kompresije živca (zbog heterotopične osifikacije) ili dislokacije naprave (povezane s resorpcijom kosti ili osteolizom).
English: How to store InductOs You will not be required to store this product.
Croatian: Kako čuvati InductOs Vi nećete trebati čuvati ovaj lijek.
English: It is a copy of a protein called bone morphogenetic protein 2 (BMP-2), which is produced naturally by the body and helps with the formation of new bone tissue.
Croatian: To je kopija proteina zvanog koštani morfogenetski protein 2 (BMP-2) koji se prirodno proizvodi u tijelu te pomaže u stvaranju novog koštanog tkiva.
English: In animal studies (rats) using InductOs containing radiolabelled dibotermin alfa, the mean residence time at the site of implantation was 4-8 days.
Croatian: U ispitivanjima na životinjama (štakori) u kojima se koristio InductOs koji je sadržavao radioaktivno označeni dibotermin alfa, srednja vrijednost vremena zadržavanja na mjestu implantacije iznosila je 4-8 dana.
English: If you think you have an allergic reaction to collagen, contact your doctor.
Croatian: Ako mislite da imate alergijsku reakciju na kolagen, obratite se svom liječniku.
English: Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) is a human protein derived from a recombinant Chinese Hamster Ovary (CHO) cell line.
Croatian: Dibotermin alfa (rekombinantni humani koštani morfogenetski protein-2; rhBMP-2) je humani protein proizveden na rekombinantnoj staničnoj liniji jajnika kineskog hrčka (CHO).
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 September 2002
Croatian: 9 DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: Swirl the vial gently to aid reconstitution.
Croatian: Lagano vrtite bočicu kako biste potpomogli rekonstituciju.
English: To prevent overloading the matrix, it is important to reconstitute the dibotermin alfa and to wet the entire matrix as described below.
Croatian: Za sprječavanje prepunjenosti matrice važno je rekonstituirati dibotermin alfa i natopiti cijelu matricu kako je to opisano u daljnjem tekstu.
English: The number of secondary and subsequent interventions was significantly reduced for the InductOs patients, particularly with regard to more invasive interventions, such as bone graft and exchange nailing (P = 0.0326).
Croatian: Broj sekundarnih i naknadnih intervencija znatno je smanjen za bolesnike koji su primali InductOs posebice s obzirom na invazivnija liječenja poput primjene koštanog presatka i izmjene čavala (P = 0,0326).
English: • Some patients may develop nerve pain due to localised fluid collection, which would require drainage or a surgical procedure to remove the fluid.
Croatian: • Neki bolesnici mogu razviti bol u živcu zbog lokaliziranog nakupljanja tekućine koja bi mogla zahtijevati drenažu ili kirurški zahvat za uklanjanje tekućine.
English: These data are supplemented with information from use of InductOs in the general population.
Croatian: Ti su podaci nadopunjeni informacijama iz uporabe InductOsa na općoj populaciji.
English: • Common (may affect up to 1 in 10 people): Additional bone growth, movement of the implanted medical device, localised fluid build-up and pain radiating from your back to your leg (sciatica)
Croatian: • često (može zahvatiti do 1 na 10 osoba): dodatan rast kosti, pokreti ugrađenog medicinskog proizvoda, lokalizirano nakupljanje tekućine i bol koji se širi iz leđa u nogu (išijas)
English: During handling and implantation, minimize fluid loss from the matrix.
Croatian: Tijekom rukovanja i implantacije smanjite gubitak tekućine iz matrice.
English: No reactions are observed with the frequency uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
Croatian: Nisu zabilježene nuspojave s učestalošću manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000) ili vrlo rijetko (< 1/10 000).
English: InductOs is implanted after the completion of standard fracture and wound management (i.e. at the time of soft-tissue closure).
Croatian: InductOs se ugrađuje nakon dovršetka standardnog liječenja prijeloma i rane (tj. u vrijeme zatvaranja mekog tkiva).
English: Failure to follow the product preparation instructions in section 6.6 and the method of administration in section 4.2 may compromise the safety and efficacy of InductOs.
Croatian: Nepridržavanje uputa za pripremu ovog lijeka u dijelu 6.6 i za način njegove primjene u dijelu 4.2 može narušiti sigurnost i djelotvornost InductoOsa.
English: • Healthcare professionals training material The healthcare professionals training material shall contain the following key elements: o Detailed description from the SmPC of the administration procedures of InductOs and of the measures that need to be taken to prevent medication errors, incorrect use, and minimise the risk of heterotopic ossification.
Croatian: • Materijal za obuku zdravstvenih djelatnika Materijal za obuku zdravstvenih djelatnika sadržavat će sljedeće ključne elemente: o Detaljni opis postupaka primjene InductOsa iz Sažetka opisa svojstava lijeka, kao i mjera koje treba poduzeti da bi se spriječile pogreške u primjeni lijeka, neispravna primjena i minimalizirao rizik od heterotopične osifikacije.
English: This self-limitation is likely due to the loss of dibotermin alfa from the implant site, as well as the presence of BMP inhibitors in the surrounding tissues.
Croatian: To samoograničenje je najvjerojatnije uzrokovano gubitkom diboterminom alfa na mjestu implantacije kao i prisutnošću inhibitora BMP-a u okolnom tkivu.
English: The safety and efficacy of InductOs have not been established in the following conditions:
Croatian: Sigurnost i djelotvornost InductOsa nisu utvrđene u sljedećim uvjetima:
English: When injected intravenously, the terminal half-life of dibotermin alfa was 16 minutes in rats and 6.7 minutes in cynomolgus monkeys.
Croatian: Prilikom intravenskog injiciranja, poluvijek dibotermina alfa iznosio je 16 minuta u štakora i 6,7 minuta u makaki majmuna.