FrancophonIA/ELRC3.0 huggingface dataset:
English: What InductOs looks like and contents of the pack InductOs is supplied to your doctor as a kit for implanting during surgery.
Croatian: Kako InductOs izgleda i sadržaj pakiranja InductOs se isporučuje liječniku kao set za implantaciju tijekom kirurškog zahvata.
English: • if you have an active infection at the surgery site.
Croatian: • ako imate aktivnu infekciju na mjestu kirurškog zahvata
English: The oedema was delayed in onset and usually occurred in the first week post-operation.
Croatian: Nastup edema je odgođen i obično se javljao u prvom tjednu nakon kirurškog zahvata.
English: As part of the pharmacological mechanism of action of dibotermin alfa, bone remodelling occurs (see section 5.1).
Croatian: Kao dio farmakološkog mehanizma djelovanja dibotermina alfa nastaje remodeliranje kosti (vidjeti dio 5.1).
English: No studies have been performed in patients with hepatic, renal or cardiac impairment.
Croatian: Nisu provedena ispitivanja na bolesnicima s oštećenjem jetre, bubrega ili srca.
English: Tell your doctor immediately, or go immediately to the emergency department of your nearest hospital if you have localised swelling, which may result in breathing difficulties, after InductOs has been used in surgery of the upper (neck) region of your spine.
Croatian: Odmah obavijestite svog liječnika ili se odmah obratite najbližoj službi hitne pomoći ako imate oticanje jednog dijela tijela koje može uzrokovati poteškoće u disanju nakon uporabe InductOsa u kirurgiji gornjeg (vratnog) dijela Vaše kralježnice.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Croatian: • preosjetljivošću na djelatnu tvar ili na bilo koju pomoćnu tvar navedenu u dijelu 6.1.
English: − Keep this leaflet.
Croatian: Sačuvajte ovu uputu.
English: The differentiated cells form trabecular bone as the matrix is degraded, with vascular invasion evident at the same time.
Croatian: Diferencirane stanice tvore trabekularnu kost kako se matrica razgrađuje dok je istovremeno očita i vaskularna invazija.
English: • for treating a fracture that is disease-related (e.g., fractures due to Paget's disease or cancer).
Croatian: • za liječenje prijeloma povezanih s nekom bolešću (npr. prijelomi zbog Pagetove bolesti ili karcinoma)
English: The available in vivo data on human tumour cell lines do not suggest a potential for promotion of tumour growth or metastasis.
Croatian: Dostupni in vivo podaci za ljudske tumorske stanične linije ne ukazuju na potencijal promocije rasta tumora ili metastaziranja.
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30°C.
English: The wetted matrix should be cut into 6 equal pieces (approximately 2.5 x 5 cm) as an aid for dose selection.
Croatian: Navlaženu matricu treba narezati u 6 jednakih dijelova (približnih dimenzija 2,5 x 5 cm), što pomaže kod odabira doze.
English: There is no information on the excretion of dibotermin alfa/metabolites in human milk.
Croatian: Nema podataka o izlučivanju dibotermina alfa/metabolita u majčino mlijeko u ljudi.
English: The use of the product in pregnant women is not advised.
Croatian: Ne preporučuje se uporaba lijeka na trudnicama.
English: InductOs is used instead of taking a bone graft from your hip; this avoids the problems and pain that can be caused by an operation to collect the bone graft.
Croatian: InductOs se koristi umjesto uzimanja koštanog presatka iz zdjelice; tako se izbjegavaju problemi i bol koji može biti uzrokovan kirurškim zahvatom uzimanja koštanog presatka.
English: The appropriate dose is determined by the volume of wetted matrix required for the intended indication.
Croatian: Odgovarajuća doza određuje se prema volumenu navlažene matrice potrebne za ciljanu indikaciju.
English: InductOs can cause initial resorption of surrounding trabecular bone as evidenced by radiolucency.
Croatian: InductOs može uzrokovati početnu resorpciju okolne trabekularne kosti, kako pokazuje radiolucencija.
English: If you have a lot of pain from a damaged disc in your lower back, and other treatments have not proven effective, you may be considered for lower back spine fusion surgery.
Croatian: Ako Vas jako boli zbog oštećenog diska u donjem dijelu kralježnice te se druge terapije nisu pokazale učinkovitima, možda će Vas se uzeti u obzir za kiruršku fuziju donjeg dijela kralježnice.
English: − If you have any further questions, ask your doctor.
Croatian: Ako imate dodatnih pitanja, obratite se svom liječniku.
English: The doctor treating you will implant InductOs during surgery.
Croatian: Liječnik koji Vas liječi ugradit će InductOs tijekom kirurškog zahvata.
English: All patients who were tested for neutralizing antibodies to bone morphogenetic protein-2 were negative.
Croatian: Svi bolesnici koji su testirani na neutralizirajuća protutijela na koštani morfogenetski protein-2 imali su negativan nalaz.
English: Generally, each fracture site is treated with the contents of one 12 mg pack.
Croatian: Općenito, svako se mjesto prijeloma liječi sadržajem jednog pakiranja od 12 mg.
English: Dibotermin alfa
Croatian: Doza dibotermina alfa
English: 4 CLINICAL PARTICULARS
Croatian: 4 KLINIČKI PODACI
English: The volume of InductOs to be implanted is determined by the fracture anatomy and the ability to close the wound without overly packing or compressing the product.
Croatian: Volumen lijeka InductOs za implantaciju određen je anatomijom prijeloma i sposobnošću zatvaranja rane bez prekomjernog pakiranja ili komprimiranja lijeka.
English: Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: InductOs 1.5 mg/ml was significantly effective (compared to standard care) in patients both with or without a history of smoking.
Croatian: InductOs 1,5 mg/ml bio je značajno djelotvoran (u usporedbi sa standardnom skrbi) u bolesnika s anamnezom pušenja ili bez nje.
English: Although patient outcome was not affected, an interaction between NSAIDs and InductOs cannot be excluded.
Croatian: Iako ishod liječenja bolesnika nije bio narušen, ne može se isključiti interakcija između InductOsa i NSAIL-a.
English: For use with unreamed nails, estimated rates of infection were similar between treatment and control groups in a study (21% versus 23%, respectively).
Croatian: Za uporabu s nebušenim čavlima procijenjene stope infekcije bile su slične između liječene i kontrolne skupine u ispitivanju (21% naspram 23%).
English: • if you have been diagnosed with or are being treated for cancer.
Croatian: • ako Vam je dijagnosticiran karcinom ili se liječite od karcinoma.
English: 4 Radiculopathic events includes radiculitis, lumbar radiculopathy, radicular pain, radiculitis lumbosacral, radiculopathy and sciatica.
Croatian: 4 Radikulopatski događaji uključuju radikulitis, lumbalnu radikulopatiju, radikularni bol, lumbosakralni radikulitis, radikulopatiju i išijas.
English: InductOs must not be used alone for this indication, but should be used with an approved (CE-marked) lumbar interbody fusion device(s).
Croatian: InductOs se za ovu indikaciju ne smije koristiti sam već ga treba koristiti zajedno s odobrenom (s oznakom CE) napravom za interkorporalnu lumbalnu fuziju.
English: The efficacy and safety of InductOs were demonstrated in a randomised, controlled, multicenter, non-inferiority study of 279 patients aged 19-78 years undergoing an open anterior lumbar interbody fusion procedure.
Croatian: Djelotvornost i sigurnost primjene InductOsa dokazane su u randomiziranom, kontroliranom, multicentričnom ispitivanju neinferiornosti 279 bolesnika u dobi od 19-78 godina podvrgnutih postupku otvorene prednje interkorporalne fuzije lumbalne kralježnice.
English: • You should inform your doctor if you have an autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome or dermatomyositis/polymyositis.
Croatian: • Obavijestite svog liječnika ako imate autoimunu bolest poput reumatoidnog artritisa, sistemskog lupusa eritematosusa, sklerodermije, Sjögrenova sindroma ili dermatomiozitisa/polimiozitisa.
English: New bone formation and bone remodelling
Croatian: Stvaranje nove kosti i remodeliranje kosti
English: In two exploratory studies, pre- and post-surgery serum samples were collected from a few long-bone fracture patients.
Croatian: U dva istraživačka ispitivanja, uzorci seruma prikupljeni su prije i poslije kirurškog zahvata od nekoliko bolesnika s prijelomima dugih kostiju.
English: Special consideration of risks and benefits should be given for patients who have previously received injectable collagen (see section 4.3).
Croatian: Treba posebno razmatrati rizike i koristi za bolesnike koji su prethodno primali kolagen u injekcijama (vidjeti dio 4.3).
English: It is concluded, therefore, that at the site of implantation, dibotermin alfa is slowly released from the matrix and rapidly cleared when taken up into the systemic circulation.
Croatian: Na temelju toga zaključuje se da se dibotermin alfa na mjestu implantacije polako otpušta iz matrice i ubrzano uklanja nakon ulaska u sistemski krvotok.
English: 1 matrix
Croatian: 1 matrica
English: Failure to follow the method of administration of InductOs may compromise its safety and efficacy.
Croatian: Nepridržavanje uputa za način primjene InductOsa može narušiti njegovu sigurnost i djelotvornost.
English: • Dibotermin alfa is a white powder presented in a glass vial.
Croatian: • Dibotermin alfa je bijeli prašak u staklenoj bočici.
English: InductOs is active at the site of implantation.
Croatian: InductOs je aktivan na mjestu implantacije.
English: System organ class
Croatian: Klasifikacija organskih sustava
English: Device dislocation1* Fluid collection2*
Croatian: Dislokacija naprave1* Nakupljanje tekućine2*
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
English: In some cases it may lead to nerve compression potentially requiring surgical intervention (see section 4.8).
Croatian: U nekim slučajevima to može dovesti do kompresije živca, što potencijalno može zahtijevati kiruršku intervenciju (vidjeti dio 4.8).
English: Although narrowing of the neuroforamen and stenosis was observed, no mineralization of the dura, no spinal cord stenosis, and no neurological deficits subsequent to the application of InductOs were observed.
Croatian: Iako je uočeno sužavanje neuroforamena i stenoza, nije došlo do mineralizacije dure, stenoze kralježničke moždine te neuroloških deficita kao posljedica primjene InductOsa.
English: Driving and using machines InductOs will not affect your ability to drive or operate machines.
Croatian: Upravljanje vozilima i strojevima InductOs neće utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: • You should inform your doctor if you have any bone disease.
Croatian: • Trebate obavijestiti svog liječnika ako imate bilo koju bolest kostiju.
English: In reproductive toxicity studies in rats, where dibotermin alfa was administered intravenously to maximize systemic exposure, increased foetal weight and increased foetal ossification was observed and a treatment-related effect could not be ruled out.
Croatian: U ispitivanjima reproduktivne toksičnosti na štakorima gdje se dibotermin alfa primjenjivao intravenski kako bi se maksimalno povećala sistemska ekspozicija, uočena je povećana fetalna težina i fetalna osifikacija, a učinci povezani s liječenjem nisu se mogli isključiti.
English: InductOs has been studied in a canine spinal implantation model.
Croatian: InductOs je proučavan na modelu spinalne implantacije u pasa.
English: The maximum dosage is limited to 24 mg (2 entire 12 mg pack matrices).
Croatian: Maksimalna doza ograničena je na 24 mg (2 cijele matrice iz pakiranja od 12 mg).
English: When used in lower back fusion surgery, InductOs is used in combination with a medical device, which corrects the position of your spine.
Croatian: Kad se koristi kod kirurškog zahvata fuzije u donjem dijelu kralježnice, InductOs se koristi u kombinaciji s medicinskim proizvodom koji ispravlja položaj Vaše kralježnice.
English: InductOs has no or negligible influence on the ability to drive and use machines.
Croatian: InductOs ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The incidence of adverse reactions with InductOs was not affected by gender, age or race.
Croatian: Na incidenciju nuspojava s lijekom InductOs nisu utjecali spol, dob ili rasa.
English: The frequencies of adverse reactions identified during post-marketing use of InductOs are not known as these reactions were reported from a population of uncertain size.
Croatian: Učestalosti nuspojava koje su identificirane tijekom uporabe InductOsa nakon stavljanja u promet nisu poznate jer su te reakcije zabilježene na populaciji čija veličina nije sa sigurnošću utvrđena.
English: The required volume of InductOs is determined by the intervertebral disc space and the size, shape, and internal volume of the lumbar interbody fusion device(s) being used.
Croatian: Potrebni volumen lijeka InductOs određen je intervertebralnim prostorom i veličinom, oblikom i unutarnjim volumenom naprave (naprava) za lumbalnu interkorporalnu fuziju koja se koristi.
English: 3 Heterotopic ossification includes exostosis, extraskeletal ossification, postoperative heterotopic calcification, bone formation increased and implant site calcification.
Croatian: 3 Heterotopična osifikacija uključuje egzostozu, izvanskeletnu osifikaciju, poslijeoperacijsku heterotopičnu kalcifikaciju, pojačano stvaranje kosti i kalcifikaciju mjesta ugradnje.
English: Therefore, in the absence of clinical data, the product should not be used for direct applications to trabecular bone where transient bone resorption may create a risk of bone fragility (see section 4.8).
Croatian: Stoga se u odsutnosti kliničkih podataka lijek ne smije koristiti za izravnu primjenu na trabekularnu kost kada prolazna resorpcija kosti može uzrokovati rizik od lomljivosti kosti (vidjeti dio 4.8).
English: The soaked sponge is then implanted where bone growth is needed.
Croatian: Natopljena spužva se potom ugrađuje na mjesto gdje je potreban rast kosti.
English: • if you are allergic to dibotermin alfa or bovine collagen or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na dibotermin alfa ili goveđi kolagen ili bilo koji drugi sastojak ovog lijeka
English: As a single use product, InductOs has not been tested for in vivo carcinogenicity (see also section 4.3).
Croatian: Kao lijek za jednokratnu primjenu, InductOs nije ispitan na kancerogenost in vivo. (vidjeti također dio 4.3).
English: To the extent possible, the accessible surface area of the fracture (fracture lines and defects) should be covered with InductOs.
Croatian: Dostupno područje prijeloma treba prekriti dokle je to moguće (linije prijeloma i defekte) lijekom InductOs.
English: Definitive fracture reduction, fixation, and haemostasis should be achieved prior to InductOs implantation.
Croatian: Potrebno je postići definitivnu redukciju prijeloma, fiksaciju i hemostazu prije implantacije InductOsa.
English: The medicinal product is administered by implantation.
Croatian: Lijek se primjenjuje implantacijom.
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 4 mg (4 mg pack) or 12 mg (12 mg pack) dibotermin alfa.
Croatian: 2 KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 4 mg (pakiranje od 4 mg ) ili 12 mg (pakiranje od 12 mg) dibotermina alfa.
English: InductOs must not be implanted posterior to the lumbar interbody fusion device where direct access to the spinal canal and/or nerve root(s) is possible.
Croatian: InductOs se ne smije ugraditi iza naprave za lumbalnu interkorporalnu fuziju gdje je moguć izravni pristup kralježničnoj moždini i/ili korijenu živca (korijenima živaca).
English: If leakage into the spinal canal and the nerve root is possible, a physical barrier between the matrix and any neurological tissue must be re-created by using, for example, local bone or allograft (see section 4.5).
Croatian: Ako postoji mogućnost da matrica iscuri u kralježnični kanal i korijen živca, mora se ponovno napraviti fizička pregrada između matrice i živčanog tkiva pomoću, na primjer, lokalne kosti ili alogenog presatka (vidjeti dio 4.5).
English: Dibotermin alfa is an osteoinductive protein that results in the induction of new bone tissue at the site of implantation.
Croatian: Dibotermin alfa je osteoinduktivni protein koji rezultira indukcijom novog koštanog tkiva na mjestu implantacije.
English: Information from clinical studies in acute tibia fractures indicated that the use of InductOs in patients receiving glucocorticoids was not associated with any apparent adverse reactions.
Croatian: Informacije dobivene iz kliničkih ispitivanja kod akutnih prijeloma tibije ukazuju na to da uporaba InductOsa u bolesnika koji primaju glukokortikoide nije povezana s bilo kojom očitom nuspojavom.
English: As per standard practice, disc material and the cartilaginous portions of the vertebral endplates should be removed, preserving the cortical portions of the endplates, and haemostasis should be achieved (see section 4.5).
Croatian: Prema standardnoj praksi, materijal intervertebralnog diska i hrskavične dijelove vertebralnih završnih ploča treba ukloniti uz očuvanje kortikalnih dijelova završnih ploča i postići hemostazu (vidjeti dio 4.5).
English: Anti-dibotermin antibodies have been investigated in pregnant rabbits following hyper-immunisation with dibotermin alfa to experimentally induce anti-dibotermin alfa antibodies.
Croatian: Protutijela na dibotermin ispitana su u gravidnih kunića nakon hiperimunizacije diboterminom alfa kako bi se eksperimentalno inducirala protutijela na dibotermin alfa.
English: • if the doctor treating you decides that you have inadequate blood supply at the fracture site.
Croatian: • ako Vaš liječnik utvrdi da mjesto prijeloma ne dobiva dovoljno krvi
English: OTHER Medtronic BioPharma B.V.
Croatian: DRUGO Medtronic BioPharma B.V.
English: • Localised swelling, in some cases resulting in breathing difficulty, has been reported in patients when InductOs has been used in surgery of the upper (neck) region of the spine.
Croatian: • Lokalizirano oticanje koje u nekim slučajevima uzrokuje poteškoće u disanju zabilježeno je u bolesnika prilikom uporabe InductOsa u kirurgiji gornje (vratne) regije kralježnice.
English: The implant may only be administered to the fracture site under adequate vision and with utmost care (see section 4.2).
Croatian: Implantat se može primijeniti na mjesto prijeloma uz odgovarajući vizualni pristup i krajnje pomno (vidjeti dio 4.2).
English: Dibotermin alfa has demonstrated variable effects on human tumour cell lines in vitro.
Croatian: Dibotermin alfa pokazao je različite učinke na linije humanih tumorskih stanica in vitro.
English: Efficacy information in tibia fracture is available only from controlled clinical trials in which open tibial fractures were treated using intramedullary nail fixation (see section 5.1).
Croatian: Informacije o djelotvornosti u liječenju prijeloma tibije dostupne su samo u kontroliranim kliničkim ispitivanjima u kojima su otvoreni prijelomi tibije bili liječeni intramedularnom fiksacijom čavlima (vidjeti dio 5.1).
English: • used in surgical techniques other than lumbar interbody fusion To avoid exaggerated pharmacological effects of InductOs, care and caution should be used to prevent overfilling the lumbar interbody fusion device and/or the anterior portion of the intervertebral disc space.
Croatian: • uporaba u kirurškim tehnikama različitim od lumbalne interkorporalne fuzije Da bi se izbjegli pretjerani farmakološki učinci InductOsa, potrebno je pažljivo i oprezno spriječiti prekomjerno punjenje naprave za lumbalnu interkorporalnu fuziju i/ili prednji dio intervertebralnog prostora.
English: The estimated absolute difference in fusion success rate between InductOs and autogenous bone graft was 11.7% (95% CI: 0.8%, 22.5%; P = 0.035).
Croatian: Procijenjena apsolutna razlika između InductOsa i autogenog koštanog presatka u stopi uspješnih fuzija iznosila je 11,7% (95% CI: 0,8%, 22,5%; P = 0,035).
English: As dibotermin alfa is a protein and has not been identified in the general circulation, it is an unlikely candidate for pharmacokinetic drug-drug interactions.
Croatian: Dibotermin alfa je protein koji nije identificiran kao općeprisutan u organizmu te nije vjerojatno da će uzrokovati farmakokinetičke interakcije između lijekova.
English: The ability of InductOs to support bone remodeling may be responsible for the biological and biomechanical integration of the new bone induced by InductOs with that of the surrounding bone.
Croatian: Sposobnost InductOsa da podupre remodeliranje kosti može biti odgovorna za biološku i biomehaničku integraciju nove kosti čiji rast inducira InductOs s okolnom kosti.
English: The maximum dosage is limited to 8 mg (5.3 cm3 of wetted matrix) of InductOs in the intervertebral disc space.
Croatian: Maksimalna doza ograničena je na primjenu 8 mg (5,3 cm3 navlažene matrice) InductOsa u intervertebralni prostor.
English: InductOs should not be used in patients with history or clinical suspicion of malignancy at the site of application (see section 4.3).
Croatian: InductOs se ne smije koristiti kod bolesnika s anamnezom ili kliničkom sumnjom na zloćudnu bolest na mjestu primjene (vidjeti dio 4.3).
English: How to store InductOs
Croatian: Kako čuvati InductOs
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma
English: The hollow geometry of the lumbar interbody fusion device must be carefully and loosely filled with the volume of InductOs corresponding to the internal volume of the device.
Croatian: Šuplja geometrija naprave za lumbalnu interkorporalnu fuziju mora se pažljivo i mekano ispuniti volumenom lijeka InductOs koji odgovara unutarnjem volumenu naprave.
English: • Use of InductOs may cause bone formation (heterotopic ossification) in the surrounding tissues, which can result in complications.
Croatian: • Uporaba InductOsa može uzrokovati stvaranje kosti (heterotopična osifikacija) okolnog tkiva koja može uzrokovati komplikacije.
English: Although no association with clinical outcome or undesirable effects could be observed in clinical studies, the possibility of developing neutralising antibodies or hypersensitivity-type reactions cannot be excluded.
Croatian: Iako se nije mogla uočiti povezanost između kliničkog ishoda ili nuspojava u kliničkim ispitivanjima, mogućnost razvoja neutralizirajućih protutijela ili reakcija preosjetljivosti ne može se isključiti.
English: InductOs is indicated for single-level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non-operative treatment for this condition.
Croatian: InductOs je indiciran za interkorporalnu fuziju jedne razine lumbalne kralježnice kao nadomjestak za autogeni koštani presadak u odraslih bolesnika s degenerativnom bolešću diska koji su se podvrgnuli nekirurškom liječenju ovog stanja tijekom najmanje 6 mjeseci.
English: In clinical studies, the presence of antibodies to collagen was not associated with side effects, such as allergies, nor was it shown to decrease the effectiveness of InductOs.
Croatian: U kliničkim ispitivanjima prisutnost protutijela na kolagen nije bila povezana s nuspojavama poput alergija niti se pokazalo da smanjuje učinkovitost lijeka InductOs.