FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Če imate zaradi okvarjene medvretenčne ploščice v spodnjem delu hrbtenice hude bolečine in se drugi načini zdravljenja niso izkazali za učinkovite, morda pride v poštev operacija za fuzijo ledvenega dela hrbtenice.
English: • Unknown (cannot be estimated from available data): Increased breakdown of the bone
Slovenian: • neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov): zvečana razgradnja kosti.
English: Using sterile technique, place one syringe, one needle and the matrix inner package in the sterile field.
Slovenian: Ob uporabi sterilnega postopka položite eno brizgo, eno iglo in notranjo ovojnino z ogrodjem v sterilno polje.
English: • if you have an active infection at the surgery site.
Slovenian: • če imate akutno okužbo na operativnem mestu;
English: Product preparation
Slovenian: Priprava zdravila
English: An increased rate of infection was observed in the InductOs-treated group versus the standard of care control group (19% versus 9%, respectively; see section 4.4).
Slovenian: Višjo stopnjo okužb so opazili v skupini, zdravljeni z zdravilom InductOs, v primerjavi s skupino s standardno nego (19 % v primerjavi z 9 %, glejte poglavje 4.4).
English: Dibotermin alfa is an osteoinductive protein that results in the induction of new bone tissue at the site of implantation.
Slovenian: Dibotermin alfa je osteo-induktiven protein, ki spodbuja nastajanje novega kostnega tkiva na mestu implantacije.
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.
Slovenian: Medicinski pripomoček popravi položaj hrbtenice, zdravilo InductOs pa spodbudi rast kosti med vretencema, da se trajno učvrstita v pravilnem položaju.
English: Swirl the vial gently to aid reconstitution.
Slovenian: Previdno obračajte vialo, da pospešite rekonstitucijo.
English: The appropriate dose is determined by the volume of wetted matrix required for the intended indication.
Slovenian: Ustrezni odmerek je določen z volumnom navlaženega matriksa, ki je potreben za indikacijo, ki ji je zdravilo namenjeno.
English: 1 Observed during use in lumbar interbody fusion 2 Fluid collection includes localised oedema, pseudocyst and implant site effusion.
Slovenian: 1 Opaženo med uporabo pri interkorpusni fuziji ledvene hrbtenice 2 Kopičenje tekočine vključuje lokaliziran edem, psevdocisto in izliv na mestu vsaditve.
English: • Some patients may develop nerve pain due to localised fluid collection, which would require drainage or a surgical procedure to remove the fluid.
Slovenian: • Pri nekaterih bolnikih se lahko pojavi bolečina živca zaradi krajevno omejenega kopičenja tekočine, ki jo je treba odstraniti z drenažo ali kirurškim postopkom.
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.
Slovenian: Potrebni volumen zdravila InductOs je odvisen od medvretenčnega prostora ter od velikosti, oblike in notranjega volumna uporabljenega(ih) vstavka(ov) za interkorpusno fuzijo ledvene hrbtenice.
English: The proportion of patients healed after treatment with InductOs 1.5 mg/ml was significantly higher at all visits from 10 weeks to 12 months post-operative, suggesting accelerated fracture healing.
Slovenian: Delež bolnikov, ozdravljenih po terapiji z 1,5 mg/ml zdravila InductOs, je bil značilno večji ob vseh kontrolnih obiskih, od 10 tednov pa do 12 mesecev po operaciji, kar kaže na pospešeno celjenje zloma.
English: Over time, the sponge will gradually disappear as new bone is formed.
Slovenian: Sčasoma goba med nastajanjem kosti postopoma izgine.
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).
Slovenian: Ocenjena absolutna razlika deleža uspešnosti fuzije med zdravilom InductOs in avtogenim kostnim presadkom je bila 11,7 % (95 % IZ: 0,8 %, 22,5 %; p=0,035).
English: New bone formation and bone remodelling
Slovenian: Tvorba nove kosti in remodeliranje kosti
English: InductOs is indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.
Slovenian: Zdravilo InductOs je indicirano za zdravljenje akutnih zlomov golenice pri odraslih, kot dodatek k standardni oskrbi z uporabo redukcije odprtega zloma in intramedularne fiksacije z nepovrtanimi žeblji.
English: 3 Heterotopic ossification includes exostosis, extraskeletal ossification, postoperative heterotopic calcification, bone formation increased and implant site calcification.
Slovenian: 3 Heterotopično kostenenje vključuje eksostoze, zunajskeletno kostenenje, pooperativno heterotopično kalcifikacijo, zvečano tvorbo kosti in kalcifikacijo na mestu vsaditve.
English: The powder is white.
Slovenian: Ogrodje je bele barve.
English: InductOs is implanted after the completion of standard fracture and wound management (i.e. at the time of soft-tissue closure).
Slovenian: Zdravilo InductOs se implantira po zaključeni standardni oskrbi zloma in rane (to je ob zapiranju mehkih tkiv).
English: The maximum dosage is limited to 8 mg (5.3 cm3 of wetted matrix) of InductOs in the intervertebral disc space.
Slovenian: Največji dovoljeni odmerek je omejen na 8 mg (5,3 cm3 navlaženega matriksa) zdravila InductOs v medvretenčnem prostoru.
English: For instructions to implant the lumbar interbody fusion device, please refer to the manufacturer's instructions for use.
Slovenian: Navodila za implantacijo vstavka za interkorpusno fuzijo ledvene hrbtenice poiščite v izdelovalčevem navodilu za uporabo.
English: None of the patients with positive titers to bovine Type I collagen had cross-reacting antibodies to human type I collagen.
Slovenian: Pri nobenem bolniku s pozitivnim titrom na protitelesa proti govejemu kolagenu tipa I se niso pojavila navzkrižna protitelesa proti humanemu kolagenu tipa I.
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.
Slovenian: To samoomejevalno sposobnost gre verjetno pripisati izgubi dibotermina alfa z mesta implantacije, pa tudi prisotnosti inhibitorjev proteina za morfogenezo kosti (BMP - »Bone Morphogenetic Protein«) v okolnem tkivu.
English: Driving and using machines InductOs will not affect your ability to drive or operate machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo InductOs ne bo vplivalo na vašo sposobnost vožnje in upravljanja s stroji.
English: Frequencies
Slovenian: Pogostnosti
English: As a precaution, a physical barrier between the matrix and any neurological tissue must be re-created (see section 4.2).
Slovenian: Kot previdnostni ukrep je treba med matriksom in kakršnim koli živčnim tkivom ustvariti fizično pregrado (glejte poglavje 4.2).
English: Both dibotermin alfa and bovine Type I collagen have been found to elicit immune responses in patients.
Slovenian: Ugotovljeno je bilo, da tako dibotermin alfa kot tudi goveji kolagen tipa I pri bolnikih izzoveta imunski odgovor.
English: How to store InductOs You will not be required to store this product.
Slovenian: Shranjevanje zdravila InductOs Tega zdravila ne bo treba shranjevati vam.
English: Due to the angiogenic activity of InductOs, fluid collection (pseudocyst, localised oedema, implant site effusion) can occur, sometimes encapsulated, sometimes resulting in nerve compression and/or pain.
Slovenian: Zaradi angiogene aktivnosti zdravila InductOs se lahko začne kopičiti tekočina (psevdocista, lokalizirani edem, izliv na mestu vsaditve), včasih inkapsulirani, včasih pa povzročijo kompresijo živca in/ali bolečino.
English: Slowly inject the solvent into the vial containing the lyophilised dibotermin alfa.
Slovenian: Počasi vbrizgajte vehikel v vialo, ki vsebuje liofiliziran dibotermin alfa.
English: Post-Implantation Once InductOs is implanted, do not irrigate the wound.
Slovenian: Po namestitvi zdravila InductOs ne izpirajte rane.
English: Severity of fractures: Treatment with InductOs 1.5 mg/ml was significantly effective in all fracture classes, including severe Gustilo IIIB fractures (52% reduced risk of secondary interventions as compared to standard-care patients).
Slovenian: Resnost zloma: Zdravljenje z 1,5 mg/ml zdravila InductOs je bilo značilno učinkovito pri vseh skupinah zlomov, vključno s hudimi zlomi stopnje IIIb po Gustilovi klasifikaciji (52 % manjše tveganje sekundarnih posegov v primerjavi z bolniki, ki so imeli standardno oskrbo).
English: If you have broken your shin bone, InductOs is used, to help your fracture heal and to reduce the need for additional surgeries.
Slovenian: Če ste si zlomili golenico, zdravilo InductOs uporabimo zato, da pospešimo celjenje zloma in da zmanjšamo potrebo po dodatnih kirurških posegih.
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.
Slovenian: Čeprav v kliničnih študijah niso ugotovili povezave s kliničnim izidom ali neželenimi učinki, ne moremo izključiti možnosti pojava nevtralizirajočih protiteles ali preobčutljivostnih reakcij.
English: During handling and implantation, minimize fluid loss from the matrix.
Slovenian: Med pripravo zdravila in implantacijo zagotovite čim manjšo izgubo tekočine iz matriksa.
English: Outside the intervertebral disc space, the surgical field should be irrigated as needed, and any fluid loss from the wetted matrix should be washed away.
Slovenian: Zunaj medvretenčnega prostora lahko kirurško polje izpirate po potrebi in vso izgubljeno tekočino iz navlaženega matriksa je treba odstraniti.
English: • Dibotermin alfa is a white powder presented in a glass vial.
Slovenian: • Dibotermin alfa je bel prašek v stekleni viali.
English: Failure to follow the method of administration of InductOs may compromise its safety and efficacy.
Slovenian: Če se ne boste ravnali po navodilih za način uporabe zdravila InductOs, boste ogrozili njegovo varnost in učinkovitost.
English: In the non-sterile field
Slovenian: V nesterilnem območju
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.
Slovenian: V kliničnih raziskavah prisotnost protiteles na kolagen ni bila povezana s pojavom neželenih učinkov, kot so alergije, niti ni bilo ugotovljeno, da bi protitelesa zmanjševala učinkovitost zdravila InductOs.
English: The medicinal product is administered by implantation.
Slovenian: Zdravilo se aplicira z implantacijo.
English: OTHER Medtronic BioPharma B.V.
Slovenian: Medtronic BioPharma B.V.
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.
Slovenian: Podatki iz kliničnih raziskav akutnih zlomov golenice so pokazali, da pri bolnikih, ki so prejemali glukokortikoide, uporaba zdravila InductOs ni bila povezana s pojavom kakršnih koli očitnih neželenih reakcij.
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.
Slovenian: Material za usposabljanje zdravstvenih delavcev mora vsebovati naslednje ključne elemente: o podroben opis postopka uporabe zdravila InductOs in ukrepov, ki so potrebni za preprečevanje napak pri zdravljenju in nepravilne uporabe ter za zmanjšanje tveganja za heterotopično osifikacijo iz Povzetka glavnih značilnosti zdravila.
English: For pain and disability (Oswestry score), the success rate was 72.9% in the group using InductOs versus 72.5% in the group using autogenous bone graft (95% two-sided CI of the difference: -11.2, 12.0).
Slovenian: Glede bolečin in invalidnosti (Oswestryjeva ocena) je bila uspešnost 72,9 % v skupini, ki je uporabljala zdravilo InductOs, v primerjavi z 72,5 % v skupini, ki je uporabljala avtogeni kostni presadek (95 % dvosmerni IZ za razliko: -11,2, 12,0).
English: This medicine contains less than 1 mmol (23 mg) sodium per maximum dose (two 12 mg packs), i.e. it is essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na največji odmerek (dve 12-miligramski pakiranji), kar v bistvu pomeni ‘brez natrija'.
English: • Use of InductOs may cause bone formation (heterotopic ossification) in the surrounding tissues, which can result in complications.
Slovenian: • Uporaba zdravila InductOs lahko povzroči nastajanje kostnega tkiva (heterotopično kostenenje) v okolnih tkivih, kar lahko privede do zapletov.
English: Heterotopic ossification
Slovenian: Heterotopično kostenenje
English: In the long-bone fracture studies, over 500 patients received InductOs.
Slovenian: V študijah zlomov dolgih kosti je več kot 500 bolnikov prejelo zdravilo InductOs.
English: • used with interbody fusion devices made from material other than titanium, PEEK or bone
Slovenian: • pri uporabi vsadkov za interkorpusno fuzijo, narejenih iz drugih materialov, razen iz titana,
English: InductOs must be prepared exactly in accordance with the directions for preparation (see section 6.6).
Slovenian: Zdravilo InductOs mora biti pripravljeno natančno v skladu z navodili za pripravo (glejte poglavje
English: Over 1700 patients have received InductOs in clinical studies.
Slovenian: V kliničnih študijah je več kot 1.700 bolnikov prejelo zdravilo InductOs.
English: If you are receiving InductOs for lower back spine fusion, your surgeon will remove the damaged disc that is causing the pain and replace it with a medical device filled with InductOs.
Slovenian: Če dobivate zdravilo InductOs za fuzijo ledvenega dela hrbtenice, bo kirurg odstranil okvarjeno medvretenčno ploščico, ki povzroča bolečine, in jo nadomestil z medicinskim pripomočkom, napolnjenim z zdravilom InductOs.
English: InductOs must not be used alone for this indication, but should be used with an approved (CE-marked) lumbar interbody fusion device(s).
Slovenian: Pri tej indikaciji zdravila InductOs ne smete uporabiti samega, temveč skupaj z odobrenim(i) (z oznako CE) vstavkom(i) za interkorpusno fuzijo ledvene hrbtenice.
English: InductOs should not be used in patients with history or clinical suspicion of malignancy at the site of application (see section 4.3).
Slovenian: Zdravilo InductOs se ne sme uporabljati pri bolnikih z anamnezo ali kliničnim sumom na maligno bolezen na mestu uporabe (glejte poglavje 4.3).
English: To the extent possible, the accessible surface area of the fracture (fracture lines and defects) should be covered with InductOs.
Slovenian: V okviru možnosti z zdravilom InductOs prekrijte dostopne površine zloma (prelomne linije in defekte).
English: As a single use product, InductOs has not been tested for in vivo carcinogenicity (see also section 4.3).
Slovenian: Glede na to, da je zdravilo InductOs namenjeno za enkratno uporabo, ni bilo testirano za in vivo kancerogenost (glejte tudi poglavje 4.3).
English: • implanted at locations other than lumbar spine
Slovenian: • pri implantaciji na drugih mestih kot v ledveni hrbtenici;
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.
Slovenian: Zdravilo InductOs je indicirano za enonivojsko interkorpusno fuzijo ledvene hrbtenice kot nadomestilo za avtogeni kostni presadek pri odraslih z degenerativno boleznijo medvretenčnih ploščic, ki so bili zaradi te bolezni vsaj 6 mesecev konservativno zdravljeni.
English: There are no or limited amount of data from the use of dibotermin alfa in pregnant women.
Slovenian: Podatkov o uporabi dibotermina alfa pri nosečnicah ni oziroma so omejeni.
English: The effects of InductOs on pregnancy are not known.
Slovenian: Nosečnost in dojenje Vpliv zdravila InductOs na nosečnost ni znan.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Slovenian: PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna
English: InductOs is intended for use in patients with the following:
Slovenian: Zdravilo InductOs je namenjeno bolnikom, ki izpolnjujejo naslednje pogoje:
English: InductOs can cause initial resorption of surrounding trabecular bone as evidenced by radiolucency.
Slovenian: Zdravilo InductOs lahko povzroči začetno resorpcijo okolne trabekularne kosti, kar lahko prikažemo z radiolucenco.
English: Marketing Authorisation Holder and Manufacturer Medtronic BioPharma B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Medtronic BioPharma B.V.
English: The soaked sponge is then implanted where bone growth is needed.
Slovenian: Navlaženo gobo kirurg nato vsadi tja, kjer je potrebna rast kosti.
English: In lumbar interbody fusion studies, over 600 patients received InductOs.
Slovenian: V študijah interkorpusne fuzije ledvene hrbtenice je več kot 600 bolnikov prejelo zdravilo InductOs.
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.
Slovenian: Opazili so zoženje živčnega kanala in stenozo, niso pa opazili mineralizacije dure, stenoze hrbtenjače in nevroloških motenj po uporabi zdravila InductOs.
English: In non-clinical studies, concurrent administration of glucocorticoids depressed bone repair (measured as a % change from control), but the effects of InductOs were not altered.
Slovenian: V predkliničnih raziskavah je sočasna aplikacija glukokortikoidov zavirala reparacijo kosti (izmerjeno kot % spremembe v primerjavi s kontrolami), učinek zdravila InductOs pa ni bil prizadet.
English: − Keep this leaflet.
Slovenian: Glejte spodnjo shemo.
English: Placement of InductOs into trabecular bone resulted in transient resorption of the bone surrounding the implant, followed by replacement with new, more dense bone.
Slovenian: Namestitev zdravila InductOs v trabekularno kost povzroči prehodno resorpcijo kosti, ki obdaja implantat, to pa nato nadomesti novo, gostejše kostno tkivo.
English: In a pooled safety data analysis of 8 clinical trials at 24 months post-surgery, the frequency of patients with pseudarthrosis was approximately 2-fold lower following treatment with InductOs (4.8%, 22 out of 456 patients) compared with autogenous bone graft (12.7%, 31 out of 244 patients).
Slovenian: V združeni analizi varnostnih podatkov osmih kliničnih preskušanj 24 mesecev po operaciji je bila pogostnost bolnikov s psevdoartrozo približno dvakrat nižja po zdravljenju z zdravilom InductOs (4,8 %, 22 od 456 bolnikov) v primerjavi z avtogenim kostnim presadkom (12,7 %, 31 od 244 bolnikov).
English: System organ class
Slovenian: Organski sistem
English: The oedema was delayed in onset and, in some cases, severe enough to result in airway compromise (see section 4.4).
Slovenian: Edem se je pojavil z zapoznitvijo in je bil v nekaterih primerih tako hud, da je ogrozil dihalne poti (glejte poglavje 4.4).
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).
Slovenian: Vretenčni material in hrustančaste dele končnih vretenčnih plošč odstranite v skladu s standardno prakso, pri tem pa ohranite kortikalne dele končnih plošč, zagotovljena mora biti hemostaza (glejte poglavje 4.5).
English: The use of these products in close proximity to InductOs is not recommended as this may lead to bone formation at the site of implant of the fibrin-based haemostatic agent or sealant (see section 4.2).
Slovenian: Uporaba teh zdravil v neposredni bližini zdravila InductOs ni priporočljiva, saj lahko privede do nastanka kosti na mestu implantacije hemostatskega zdravila ali tesnila na osnovi fibrina (glejte poglavje 4.2).
English: Patients received (in a 1:1:1 ratio) standard care (control group) consisting of intramedullary (IM) nail fixation and routine soft-tissue management, standard care plus InductOs 0.75 mg/ml, or standard care plus InductOs 1.5 mg/ml.
Slovenian: Bolniki so prejeli (v razmerju 1:1:1) standardno oskrbo (kontrolna skupina), ki se sestoji iz fiksacije goleni z intramedularnim (IM) žebljem in rutinske oskrbe mehkih tkiv, standardno oskrbo in 0,75 mg/ml zdravila InductOs, ali standardno oskrbo in 1,5 mg/ml zdravila InductOs.
English: In some cases it may lead to nerve compression potentially requiring surgical intervention (see section 4.8).
Slovenian: V nekaterih primerih lahko privede do pritiska na živec, zaradi česar bo morda potreben kirurški poseg (glejte poglavje 4.8).
English: Powder: sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide and polysorbate 80 Solvent: water for injections
Slovenian: Prašek: saharoza, glicin, glutaminska kislina, natrijev klorid, natrijev hidroksid in polisorbat 80 Vehikel: voda za injekcije
English: • You should inform your doctor if you have kidney or liver disease.
Slovenian: • Zdravnika obvestite, če imate kakšno bolezen jeter ali ledvic.
English: These autoimmune diseases include rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis.
Slovenian: Te avtoimunske bolezni vključujejo revmatoidni artritis, sistemski eritematozni lupus, sklerodermijo, Sjögrenov sindrom in dermatomiozitis/polimiozitis.
English: To achieve maximum potential efficacy, it is important to attain complete soft-tissue coverage of InductOs following its implantation.
Slovenian: Da bi dosegli največjo možno učinkovitost, je pomembno, da po implantaciji poskrbite, da bo zdravilo InductOs popolnoma prekrito z mehkim tkivom.
English: Typically, 4 mg (2.7 cm3 of wetted matrix) of InductOs is used in the intervertebral disc space.
Slovenian: Praviloma uporabimo 4 mg (2,7 cm3 navlaženega matriksa) zdravila InductOs v medvretenčnem prostoru.
English: The doctor treating you will implant InductOs during surgery.
Slovenian: Zdravnik, ki vas zdravi, vam bo zdravilo InductOs vsadil med operacijo.
English: Dibotermin alfa must only be used following reconstitution with the solvent and matrix provided in the InductOs pack.
Slovenian: Dibotermin alfa se sme uporabljati le po rekonstituciji s priloženim vehiklom in ogrodjem, ki sta priložena v pakiranju zdravila InductOs.
English: Use of InductOs in patients undergoing cervical spine surgery in amounts lower than or similar to those for lumbar interbody fusion has been associated with reports of localised oedema severe enough to result in airway compromise (see section 4.4).
Slovenian: Uporaba zdravila InductOs pri bolnikih z operacijo vratne hrbtenice v količinah, ki so bile manjše ali podobne tistim za interkorpusno fuzijo ledvene hrbtenice, je bila povezana s poročili o lokaliziranem edemu, ki je bil dovolj hud, da je ogrozil dihalne poti (glejte poglavje 4.4).
English: 2 syringes (10 ml)
Slovenian: 2 brizgi (5 ml)
English: Read the Summary of Product Characteristics before use.
Slovenian: Pred uporabo preberite Povzetek glavnih značilnosti zdravila.
English: InductOs 1.5 mg/ml was significantly effective (compared to standard care) in patients both with or without a history of smoking.
Slovenian: Terapija z 1,5 mg/ml zdravila InductOs je bila (v primerjavi s standardno oskrbo) značilno bolj učinkovita tako pri kadilcih kot tudi pri nekadilcih.