FrancophonIA/ELRC3.0 huggingface dataset:
English: Osigraft should not be used during pregnancy unless the expected benefits to the mother are thought to outweigh the possible risks to the unborn child.
Croatian: Osigraft se ne treba primjenjivati tijekom trudnoće osim u slučaju ako se smatra da će očekivana korist za majku biti veća od potencijalnih rizika za nerođeno dijete.
English: Do not use Osigraft - if you are allergic to eptotermin alfa or collagen, the other ingredient of Osigraft (see section 6).
Croatian: Nemojte primati Osigraft ako ste alergični (preosjetljivi) na eptotermin alfa ili kolagen, drugi sastojak Osigrafta (vidjeti dio 6).
English: The surrounding muscle tissues are closed around the implanted medicine as is the skin on the top of the muscle.
Croatian: Okolna mišićna tkiva zatvaraju se oko implantiranog lijeka, kao i koža na površini mišića.
English: Studies with anti-OP-1 antibodies demonstrated some cross-reactivity with closely related BMP proteins BMP-5 and BMP-6.
Croatian: Studije s antitijelima anti-OP-1 pokazale su određenu ukriženu reaktivnost s blisko srodnim proteinima BMP, BMP-5 i BMP-6.
English: Using sterile technique, remove the vial from its packaging.
Croatian: Sterilnom tehnikom izvadite bočicu iz pakovanja.
English: Precaution for use
Croatian: Mjere opreza pri uporabi
English: EU/1/01/179/001
Croatian: BROJ ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/01/179/001
English: The new bone remodels naturally, cortices are formed and marrow elements are generated.
Croatian: Nova kost oblikuje se prirodno, stvaraju se korteks i elementi koštane srži.
English: Fertility There is no evidence to suggest that eptotermin alfa alters fertility.
Croatian: Plodnost Nema podataka koji bi pokazali da eptotermin alfa utječe na plodnost.
English: Implanted material dislodged from the non-union site can cause ectopic ossification in the surrounding tissues with potential complications.
Croatian: Implantirani materijal koji se pomakne s nesraslog mjesta može uzrokovati ektopično okoštavanje u okolnom tkivu s potencijalnim komplikacijama.
English: The primary package is maintained sterile within a blister pack, comprised of two (inner and outer) plastic trays and lids.
Croatian: Primarno pakovanje održava se sterilnim unutar blistera koji se sastoji od dva plastična dijela (unutarnjeg i vanjskog), podloge i poklopca.
English: Do not use suction or irrigation directly at the implant site as the particles of Osigraft may be removed.
Croatian: Nemojte koristiti sukciju ili irigaciju izravno na mjestu implantata jer se na taj način mogu ukloniti čestice Osigrafta.
English: The effect of anti-OP-1 antibodies on the bone healing process was studied in dogs following two long bone defects treated with repeat implantations.
Croatian: Učinak antitijela anti-OP-1 na cijeljenje kosti istraživan je kod pasa nakon dva oštećenja dugih kostiju koje su liječene ponovljenim implantacijama.
English: Antibodies often form as part of the body's response to treatment with some medicines one of these is Osigraft.
Croatian: Protutijela se često formiraju kao odgovor tijela na liječenje određenim lijekovima, a jedan od njih je i Osigraft.
English: If you are a nursing mother you should be treated with Osigraft only if your physician or surgeon considers the benefits to you outweigh the risks to your child.
Croatian: Ako ste dojilja, trebali biste biti liječeni Osigraftom samo ako liječnik ili kirurg smatra da je korist liječenja veća od rizika za Vaše dijete.
English: Each vial of Osigraft is reconstituted with 2 to 3 ml of sterile 9 mg/ml sodium chloride solution (0.9% w/v) prior to use.
Croatian: Osigrafta se prije primjene priprema s 2 do 3 ml sterilne otopine natrijevog klorida od 9 mg/ml (0,9% m/V).
English: Antibodies to OP-1 and bovine bone collagen type 1 were found after both exposures; the antibody peak concentration was higher after the second implantation.
Croatian: U obje izloženosti otkrivena su antitijela anti-OP-1 i koštani kolagen tipa 1; najviša koncentracija antitijela bila je viša nakon druge implantacije.
English: The reconstituted product should be used immediately.
Croatian: Pripremljeni lijek mora se odmah upotrijebiti.
English: common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data
Croatian: vrlo često (kod više od 1 na 10 bolesnika) često (pojavljuju se kod 1 do 10 na 100 bolesnika) manje često (pojavljuju se kod 1 do 10 na 1.000 bolesnika) rijetko (pojavljuju se kod 1 do 10 na 10.000 bolesnika) vrlo rijetko (pojavljuju se kod manje od 1 na 10.000 bolesnika) nepoznato (učestalost se ne može utvrditi iz dostupnih podataka)
English: Repeated use of Osigraft is not recommended because clinical trials of multiple surgical treatments at different times have not been undertaken in patients.
Croatian: Ne preporučuje se ponovna primjena Osigrafta, jer na bolesnicima još nisu bila provedena klinička ispitivanja višekratnih kirurških liječenja u različitim vremenskim razdobljima.
English: Blood and milk samples were collected at regular intervals and analysed using a solid phase enzyme-linked immunoassay (ELISA) test.
Croatian: U redovitim intervalima prikupljani su uzorci krvi i mlijeka te su analizirani enzimskim imunotestom (ELISA) krute faze.
English: Depending on the size of the bone defect, more than one 1 g vial of Osigraft may be required.
Croatian: Ovisno o veličini oštećenja kosti, možda će biti potrebno više od jedne bočice Osigrafta od 1 g.
English: Therefore, Osigraft may only be administered to the defect site under adequate vision and with utmost care.
Croatian: Stoga se Osigraft smije primjenjivati samo na mjesto defekta uz odgovarajuću preglednost i krajnje mjere opreza.
English: Antibodies are special proteins produced by the human body as part of the healing process in various diseases; one such illness is a virus infection.
Croatian: Protutijela su posebne bjelančevine nastale u ljudskom tijelu tijekom liječenja od raznih bolesti; jedna od takvih bolesti je virusna infekcija.
English: The following table of adverse reactions was compiled from those observed and recorded during clinical trials.
Croatian: Sljedeća tablica nuspojava prikazuje nuspojave uočene i zabilježene tijekom kliničkih ispitivanja.
English: As human IgG is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-fed during Osigraft therapy (see section 5.3).
Croatian: Budući da se ljudski IgG izlučuje u majčino mlijeko u ljudi, a nije poznat štetni potencijal za dojenče, žene ne bi smjele dojiti tijekom terapije Osigraftom (vidjeti dio 5.3).
English: The recommended maximum dose should not exceed 2 vials since efficacy in the treatment on non-unions requiring higher doses has not been established.
Croatian: Preporučena maksimalna doza ne smije prekoračiti 2 bočice jer nije utvrđena djelotvornost u liječenju nesraslih lomova za koje je potrebna veća doza.
English: The radiographic healing results of the Osigraft treatment group were slightly inferior compared to the autograft control group (68% and 79% respectively).
Croatian: Radiografski rezultati liječenja Osigraftom bili su nešto inferiorniji (68%) u usporedbi s kontrolnom skupinom liječenom autograftom (79%).
English: Depending on the size of the gap in the broken bone one or two vials of Osigraft may be administered.
Croatian: Ovisno o veličini rascjepa na slomljenoj kosti, može se primijeniti jedna ili dvije bočice Osigrafta.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: DATUM REVIZIJE TEKSTA Podrobnije informacije o ovom lijeku dostupne su na web stranicama Europske agencije za lijekove http://www.ema.europa.eu.
English: However, results from Osigraft implantation studies in animals demonstrate that the active substance eptotermin alfa is largely unavailable systemically.
Croatian: No, rezultati studija implantacija Osigrafta kod životinja pokazuju da se djelatna tvar, eptotermin alfa, većinom ne širi sustavno.
English: In animal studies, excretion of IgG class anti-OP-1 antibodies into milk has been shown.
Croatian: Studije na životinjama pokazale su da dolazi do izlučivanja antitijela klase IgG anti-OP-1 u mlijeko.
English: Animal studies were conducted that cannot rule out effects of anti-OP-1 antibodies on embryo-foetal development (see section 5.3).
Croatian: Provedene su studije na životinjama koje su pokazale da nije moguće isključiti učinke antitijela antiOP-1 na embriofetalni razvoj (vidjeti dio 5.3).
English: Experience from controlled clinical trials is limited to stabilisation of the fracture by intramedullary nailing.
Croatian: Iskustva iz kontroliranih kliničkih ispitivanja ograničena su na stabilizaciju frakture intramedularnim čavlima.
English: The pivotal clinical trial supporting the approval of Osigraft did not include the use of synthetic bone void fillers.
Croatian: U ključnim kliničkim ispitivanjima koja podržavaju odobravanje Osigrafta, nije korištena primjena sintetskih punila za kosti.
English: What Osigraft looks like and contents of the pack Osigraft is supplied as white to off-white powder packaged in an amber coloured glass vial (pack size of 1) within a blister pack, comprised of a plastic tray and lid, in a carton.
Croatian: Osigraft se isporučuje kao bijeli do bjelkasti prašak pakiran u staklenu bočicu jantarne boje (veličina pakovanja je 1) unutar blister pakovanja koji se sastoji od plastične podloge i poklopca, u kutiji.
English: Women should not breast-feed during the period immediately following treatment with Osigraft.
Croatian: Žene ne bi smjele dojiti tijekom razdoblja koje slijedi odmah nakon liječenja Osigraftom.
English: Debride fibrous, necrotic or sclerotic tissue and appropriately decorticate bone fragments so that the reconstituted Osigraft is in direct contact with bleeding bone and viable osseous tissue.
Croatian: Odstranite fibrozno, nekrotično ili sklerotično tkivo i na odgovarajući način odstranite kortikalne fragmente kosti kako bi pripremljeni Osigraft bio u izravnom dodiru s krvarećom kosti i živim koštanim tkivom.
English: During surgery Osigraft is placed directly at the injury site in contact with the damaged bone surfaces.
Croatian: Tijekom operacije Osigraft se postavlja izravno na slomljenu kost na mjestu ozljede u dodiru s površinom oštećene kosti.
English: Powder in a glass vial (Type 1, borosilicate) sealed with a stopper (butyl rubber) and a crimp cap (aluminium).
Croatian: Prašak u staklenoj bočici (tip 1, borosilikat) zatvorenoj čepom (butilna guma) i sigurnosnim zatvaračem (aluminij).
English: Pack size of 1 vial.
Croatian: Veličina pakovanja: 1 bočica.
English: Anti-OP-1 antibodies have the ability to neutralise the in vitro biological activity of at least BMP-6.
Croatian: Antitijela anti-OP-1 imaju sposobnost in vitro neutralizacije biološke aktivnosti barem proteina BMP-6.
English: The matrix is also osteoconductive and it allows bone in-growth into the defect area from the surrounding healthy bone.
Croatian: Matriks također ima osteokonduktivne osobine i omogućuje urastanje kosti iz okolne zdrave kosti u područje koštanog defekta.
English: Powder for suspension for implantation.
Croatian: Prašak za suspenziju za implantat.
English: Method of administration: Intraosseous use.
Croatian: Način primjene: Za intraosealnu primjenu.
English: Handle the crimp with care.
Croatian: Pažljivo postupajte sa zatvaračem.
English: The cellular events induced by the active substance take place within the collagen matrix.
Croatian: Stanični događaji koje potiče djelatna tvar odvijaju se unutar kolagenskog matriksa.
English: Osigraft stimulates the growth of new bone as part of the treatment of a fracture non-union and needs the support of specialised surgical devices to stabilise the broken bone while it heals.
Croatian: Osigraft potiče rast nove kosti u sklopu liječenja nesraslog loma i zahtijeva potporu posebnih kirurških naprava kako bi se tijekom cijeljenja stabilizirala slomljena kost.
English: Osigraft is contraindicated in children and adolescents (less than 18 years old) and the skeletally immature (see section 4.3).
Croatian: Osigraft je kontraindiciran u djece i adolescenata (mlađih od 18 godina) i skeletno nezrelih osoba (vidjeti dio 4.3).
English: Sterile sodium chloride solution for injection and contents of the Osigraft vial are transferred to a sterile bowl and mixed with a sterile spatula or curette.
Croatian: Sterilna otopina natrijevog klorida za injekciju i sadržaj bočice Osigrafta prenose se u sterilnu zdjelicu i miješaju sterilnom spatulom ili kiretom.
English: If any of the side effects gets serious or if you notice any side effect not listed in this leaflet, please tell your doctor.
Croatian: Ako se bilo koja nuspojava pogorša ili ako uočite neku nuspojavu koja nije navedena u ovoj uputi, potrebno je obavijestiti liječnika.
English: When reconstituted, Osigraft has the consistency of wet sand, which facilitates its implantation and placement at bone site defects.
Croatian: Nakon pripreme, Osigraft ima konzistenciju mokrog pijeska, što olakšava njegovu implantaciju i podešavanje na mjestu koštanog defekta.
English: Women of childbearing potential are advised to use effective contraception up to at least 12 months after treatment.
Croatian: Ženama koje mogu zatrudnjeti savjetuje se da koriste učinkovitu kontracepciju najmanje 12 mjeseci nakon liječenja.
English: Osigraft is contraindicated in children and adolescents (less than 18 years old) and the skeletally immature (see section 4.2).
Croatian: Osigraft je kontraindiciran kod djece i adolescenata (mlađih od 18 godina) i skeletno nezrelih osoba (vidjeti dio 4.2).
English: Remove excess fluid if necessary by suctioning adjacent to the implant site or carefully blotting the area with sterile sponge.
Croatian: Ako je potrebno, uklonite višak tekućine usisavanjem pored mjesta implantata ili višak tekućine pažljivo upijte sterilnom spužvom.
English: Once the vacuum is broken, remove the vial stopper while holding the vial upright to prevent loss of powder.
Croatian: Nakon oslobađanja vakuuma, uklonite čep bočice uspravno držeći bočicu kako bi spriječili rasipanje praška.
English: The amount of Osigraft used should approximate the size of the bone
Croatian: Količina Osigrafta približno treba odgovarati veličini koštanog defekta.
English: Intraosseous use.
Croatian: Za intraosealnu primjenu.
English: Osigraft is only used by an appropriately qualified surgeon.
Croatian: Osigraft smije primijeniti samo odgovarajuće osposobljen kirurg.
English: Take special care with Osigraft The following are precautions for use of Osigraft to be discussed with your doctor.
Croatian: U nastavku slijede mjere opreza za primjenu Osigrafta koje treba razmotriti s liječnikom.
English: Women of childbearing potential should be advised to use effective contraception up to at least 12 months after treatment.
Croatian: Žene koje mogu zatrudnjeti treba savjetovati da koriste učinkovitu kontracepciju najmanje 12 mjeseci nakon liječenja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU VANJSKI KARTON
English: 3.3 mg of eptotermin alfa
Croatian: 3,3 mg eptotermina alfa
English: Posology Osigraft should be used by an appropriately qualified surgeon.
Croatian: Doziranje Osigraft treba primijeniti odgovarajuće osposobljen kirurg.
English: Motion in the non-union site may disrupt the fracture healing process.
Croatian: Pomicanje na mjestu nesraslog loma može prekinuti proces liječenja frakture.
English: Post procedural tenderness (Tenderness)
Croatian: Osjetljivost nakon postupka (osjetljivost)
English: After closure of the soft tissues around the bone defect, irrigate field if necessary to remove any of the product which may have become dislodged during soft tissue closure.
Croatian: Nakon zatvaranja mekog tkiva oko koštanog defekta, isperite područje kako biste uklonili sve ostatke lijeka koji su se tijekom zatvaranja mekog tkiva možda izmješteni.
English: Treatment of non-union of tibia of at least 9 month duration, secondary to trauma, in skeletally mature patients, in cases where previous treatment with autograft has failed or use of autograft is unfeasible.
Croatian: Liječenje nesraslog loma goljenične kosti u trajanju od najmanje 9 mjeseci, uzrokovanog traumom, u skeletno zrelih pacijenata, u slučajevima kada prethodna liječenja autograftom nisu uspjela ili primjena autografta nije provediva.
English: Special care is taken during surgery to prevent Osigraft leaking into the surrounding tissue in order to avoid the possibility of new bone growing outside the treated non-union location.
Croatian: Tijekom operacije treba poduzeti posebne mjere opreza kako Osigraft ne bi iscurio u okolno tkivo te da bi se izbjegla mogućnost rasta nove kosti izvan liječenog mjesta nesraslog loma.
English: In clinical studies, the following undesirable effects have been reported: Common reported side effects included: discoloration of the wound site, erythema (redness of the skin), tenderness, and swelling over the implant site, heterotopic ossification / myositis ossificans (bone formation outside of the fracture area).
Croatian: U kliničkim ispitivanjima prijavljene su sljedeće nuspojave: Često prijavljene nuspojave uključuju: promjena boje kože na mjestu ozljede, eritem (crvenilo kože), osjetljivost i oticanje iznad mjesta implantacije, heterotopična osifikacija / osificirajući miozitis (formiranje koštanog tkiva izvan područja loma).
English: Irrigate as necessary prior to the implantation of Osigraft.
Croatian: Prema potrebi mjesto isperite prije implantacije Osigrafta.
English: Musculoskeletal and connective tissue disorders Bone formation increased (Heterotopic ossification / Myositis ossificans)
Croatian: Povećano formiranje koštanog tkiva (heterotopična osifikacija / osificirajući miozitis)
English: The active substance is eptotermin alfa (a recombinant human Osteogenic protein 1 produced in a recombinant Chinese hamster ovary (CHO) cell line).
Croatian: Djelatna je tvar eptotermin alfa (rekombinirani humani osteogenski protein-1 proizveden tehnologijom rekombinantne DNK na staničnoj liniji jajnika kineskog hrčka(CHO)).
English: Special care must be taken to prevent any leakage of Osigraft due to wound irrigation, defective closure of surrounding tissue or inadequate haemostasis.
Croatian: Posebne mjere opreza moraju se provoditi kako bi se spriječilo curenje Osigrafta uslijed ispiranja rane, lošeg zatvaranja okolnog tkiva ili neadekvatne hemostaze.
English: This provides an appropriate bioresorbable scaffold for the anchorage dependent cell proliferation and differentiation processes induced by the active substance.
Croatian: Tako se stvara odgovarajući biološki razgradljivi nosilac proliferacije stanica ovisne o sidrenju i proces diferencijacije koji potiče djelatna tvar.
English: Osigraft should be given to breast-feeding women only when the attending physician decides that the benefits outweigh the risks.
Croatian: Osigraft treba dati dojiljama samo ako nadležni liječnik odluči da korist opravdava potencijalne rizike.
English: 5 How to store Osigraft
Croatian: KAKO PRIMJENJIVATI OSIGRAFT
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 Dodatak I: Sažetak opisa svojstava, dio 4.2).
English: Antibodies
Croatian: Antitijela
English: The use of Osigraft with a synthetic bone void filler may lead to a risk of increase in local inflammation, infection and occasional migration of the implanted materials and is therefore not recommended (see section 4.5).
Croatian: Primjena Osigrafta sa sintetskim punilom za kosti može dovesti do rizika od lokalne upale, infekcije i povremenog premještanja implantiranog materijala i stoga se ne preporučuje (vidjeti dio 4.5).
English: The weight of the offspring in the treated group was noted to be less than that of the control group during the observation period.
Croatian: U razdoblju promatranja uočeno je da je tjelesna težina potomaka u skupini koja je liječena manja od kontrolne skupine.
English: The potential for harm to the breast-feed infant is unknown.
Croatian: Nije poznato postoje li štetna djelovanja na dojenče.
English: These newly formed antibodies have not been found to cause any harm to patients.
Croatian: Još nisu utvrđena štetna djelovanja novonastalih protutijela kod bolesnika.
English: including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome
Croatian: imaju autoimunu bolest, uključujući reumatoidni artritis, sistemski eritematozni lupus, sklerodermiju, Sjögrenov sindrom i dermatomiozitis/polimiozitis;
English: Lift the plastic flip-top and remove the crimp from the vial.
Croatian: Na bočici podignite plastični poklopac i uklonite zatvarač.
English: Post market surveillance data has signalled that the use of the product in combination with a synthetic bone void filler may lead to an increase in local inflammation, infection and occasional migration of the implanted materials and it is therefore not recommended.
Croatian: Postmarketinški podaci praćenja ukazuju na to da primjena lijeka u kombinaciji sa sintetskim punilom za kosti može dovesti do pojačanja lokalne upale, infekcije i povremenog premještanja implantiranog materijala i stoga se ne preporučuje.
English: Repeated use of the product cannot be recommended.
Croatian: Nije preporučljiva ponovna primjena lijeka.
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Croatian: • U roku od 60 dana od novih važnih saznanja (farmakovigilancijskih ili u sklopu minimalizacije rizika)
English: Closure is critical for containment of the implant in the area of the bone defect.
Croatian: Zatvaranje mekog tkiva važno je kako bi se implantat zadržao na području koštanog defekta.
English: No association with clinical outcome or adverse event could be observed in clinical studies.
Croatian: U kliničkim studijama nije uočena veza s kliničkim ishodom ili štetnim događajem.
English: Apply the reconstituted product to the prepared osseous site using a sterile instrument such as a spatula or curette.
Croatian: Nanesite pripremljeni lijek na pripravljeno mjesto na kosti pomoću sterilnog instrumenta kao što je spatula ili kireta.
English: The Tibial Nonunion pivotal trial compared Osigraft with autograft, with a primary efficacy endpoint at 9 months post-treatment.
Croatian: U ključnom ispitivanju nesraslog sloma goljenične kosti uspoređivan je Osigraft i autograft uz primarni ishod djelotvornosti 9 mjeseci nakon liječenja.
English: Where practical, surgical manipulations to the site should be completed prior to implantation of the product.
Croatian: Ako je primjenjivo, kirurški postupak na kirurškom mjestu treba završiti prije implantacije lijeka.
English: Antibodies to eptotermin alfa were found in sera from pooled foetal and umbilical cord blood at levels that correlated to that of the maternal blood.
Croatian: Razine antitijela na eptotermin alfa koje su pronađene u serumu iz prikupljene fetalne krvi i krvi iz pupkovine odgovarale su razini u krvi majke.
English: Sarcoma was associated with the long-term presence of the heterotopic bone.
Croatian: Uz dugoročnu prisutnost heterotopične kosti bio je povezan nastanak sarkoma.
English: Medicinal product subject to medical prescription.
Croatian: NAČIN PROPISIVANJA LIJEKA Lijek se izdaje na recept.
English: Marketing Authorisation Holder Olympus Biotech International Limited 40 Upper Mount Street Dublin 2
Croatian: Nositelj odobrenja za stavljanje u promet gotovog lijeka Olympus Biotech International Limited 40 Upper Mount Street