natgillin/translations-raw huggingface dataset:
In the absence of any experience, the repeat use of InductOs is not recommended.
Zaradi pomanjkanja izkušenj ponovna uporaba zdravila InductOs ni priporočljiva.
In the sterile field
V sterilnem območju
In animal studies (rats) using InductOs containing radiolabelled dibotermin alfa, the mean residence time at the site of implantation was 4-8 days.
V študijah na živalih (podganah), kjer so uporabili zdravilo InductOs, ki je vsebovalo radioaktivno označeni dibotermin alfa, je bil povprečni čas zadrževanja na mestu implantacije 4-8 dni.
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.
To je kopija beljakovine, ki se imenuje beljakovina 2 za morfogenezo kosti (BMP-2) in naravno nastaja v telesu, kjer pomaga oblikovati novo kostno tkivo.
InductOs contains bovine collagen, a protein obtained from cattle Some patients may develop antibodies (made by your body to fight a foreign protein) against the collagen in the medicine.
Zdravilo Inductos vsebuje goveji kolagen, beljakovino, pridobljeno iz govedi Nekateri bolniki lahko razvijejo protitelesa (snovi, ki jih izdeluje vaše telo za borbo proti tujim beljakovinam) proti kolagenu v zdravilu.
Special consideration of risks and benefits should be given for patients who have previously received injectable collagen (see section 4.3).
Poseben premislek glede tveganja in potencialnih koristi je potreben pri bolnikih, ki so že kdaj prej prejeli kolagen v obliki injekcije (glejte poglavje 4.3).
The maximum dosage is limited to 24 mg (2 entire 12 mg pack matrices).
Največji dovoljeni odmerek je omejen na 24 mg (2 celotni 12-miligramski pakiranji matriksa).
InductOs was implanted directly onto the exposed dura following a laminectomy.
Zdravilo InductOs so vsadili direktno v izpostavljeno duro po laminektomiji.
• Any active malignancy or patient undergoing treatment for a malignancy
• katerim koli aktivnim malignim obolenjem ali pri bolnikih, ki se zdravijo zaradi malignega obolenja;
Dibotermin alfa
Odmerek dibotermina alfa
The available in vivo data on human tumour cell lines do not suggest a potential for promotion of tumour growth or metastasis.
Razpoložljivi podatki na humanih tumorskih celičnih linijah in vivo ne kažejo na potencial pospeševanja tumorske rašče ali metastaz.
• if the doctor treating you decides that you have inadequate blood supply at the fracture site.
• če zdravnik, ki vas zdravi, ugotovi, da je mesto vašega zloma nezadostno prekrvavljeno;
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.
Ker je dibotermin alfa protein, ki ga v cirkulaciji niso našli, ni verjetno, da bi lahko bil vpleten v farmakokinetične interakcije z drugimi zdravili.
Animal studies have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
• Persistent compartment syndrome or neurovascular residua of compartment syndrome
• trdovratnim utesnitvenim sindromom ali nevrovaskularnimi posledicami utesnitvenega sindroma;
The use of the product in pregnant women is not advised.
Uporabe tega zdravila pri nosečnicah ne priporočajo.
The solvent is a clear colourless liquid.
Vehikel je bistra, brezbarvna tekočina.
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.
Pri nekaterih plodovih z zmanjšano telesno maso se je zmanjšala okostenitev čelnic in temenic (pri 4 plodovih od 151), za katero na splošno menijo, da je reverzibilna, s protitelesi povezanih učinkov pa niso mogli izključiti.
No studies have been performed in patients with hepatic, renal or cardiac impairment.
Študij pri bolnikih z jetrno, ledvično ali srčno okvaro niso izvedli.
For use with unreamed nails, estimated rates of infection were similar between treatment and control groups in a study (21% versus 23%, respectively).
Pri uporabi z nepovrtanimi žeblji so bile ocenjene stopnje okužb med skupinami zdravljenja v študiji podobne (21 % v primerjavi s 23 %).
• You should inform your doctor if you have any bone disease.
• Zdravnika obvestite, če imate kakšno bolezen kosti.
Histological evidence from animal studies of lumbar interbody fusion using anterior or posterior surgical approaches showed dibotermin alfa administered with titanium, PEEK or allograft interbody devices was biocompatible and produced consistently high rates of fusion independent of surgical approach or device material with less fibrous tissue evident compared with autograft.
Histološki dokazi iz živalskih študij interkorpusne fuzije ledvene hrbtenice z uporabo anteriornega ali posteriornega kirurškega pristopa so pokazali, da je bil dibotermin alfa, apliciran skupaj s titanom, PEEK ali interkorpusnimi homolognimi vstavki, biološko združljiv in je ustvaril dosledno visoke stopnje fuzije, neodvisno od kirurškega pristopa ali materiala pripomočka, z manj fibroznega tkiva v primerjavi z avtogenim presadkom.
What InductOs is and what it is used for What you need to know before you receive InductOs How InductOs is given
Kaj je zdravilo InductOs in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo InductOs Kako se zdravilo InductOs daje Možni neželeni učinki
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).
Zaradi neznanega tveganja za plod v zvezi z možnim razvojem nevtralizirajočih protiteles proti diboterminu alfa uporaba zdravila InductOs med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije, ni priporočljiva (glejte poglavje 4.4).
• Unknown (cannot be estimated from available data):
• neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
InductOs contains sodium
Zdravilo InductOs vsebuje natrij
• 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.
• Svojega zdravnika morate obvestiti, če imate avtoimunsko bolezen, npr. revmatoidni artritis, sistemski eritematozni lupus, sklerodermijo, Sjögrenov sindrom ali dermatomiozitis/polimiozitis.
The implant may only be administered to the fracture site under adequate vision and with utmost care (see section 4.2).
Implantat lahko namestimo v območje zloma le ob primerni vidljivosti in izredno pazljivo (glejte poglavje 4.2).
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.
Če je kirurški poseg tak, da je potreben samo del zdravila, navlaženi matriks obrežite do želene velikosti, neporabljeni del pa zavrzite.
Dibotermin alfa binds to receptors on the surface of mesenchymal cells and causes cells to differentiate into cartilage- and bone-forming cells.
Dibotermin alfa se veže na receptorje, ki se nahajajo na površju mezenhimskih celic, in povzroči, da se diferencirajo v celice, ki tvorijo hrustanec in kosti.
In this process, both bone resorption and formation occur.
V tem postopku pride do resorpcije in nastajanja kosti.
InductOs does not provide mechanical stability and should not be used to fill a void in the presence of compressive forces.
Zdravilo InductOs ne zagotavlja mehanske stabilnosti in se zato ne sme uporabljati za zapolnitev praznine ob delovanju kompresivnih sil.
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.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom InductOs, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
In some cases, the oedema was severe enough to result in airway compromise.
V nekaterih primerih je bil edem dovolj močno izražen, da je ogrozil prehodnost dihalne poti.
4 Radiculopathic events includes radiculitis, lumbar radiculopathy, radicular pain, radiculitis lumbosacral, radiculopathy and sciatica.
4 Radikulopatski dogodki vključujejo radikulitis, ledveno radikulopatijo, radikularno bolečino, lumbosakralni radikulitis, radikulopatijo in išias.
The bone formation process develops from the outside of the implant towards the centre, until the entire InductOs implant is replaced by trabecular bone.
Proces nastajanja kosti se razvija v smeri od zunanjih delov implantata proti sredini, dokler trabekularna kost ne nadomesti celotnega implantata zdravila InductOs.
Dibotermin alfa has demonstrated variable effects on human tumour cell lines in vitro.
Dibotermin alfa je pokazal različne učinke na humane tumorske celične linije in vitro.
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).
Podatki o učinkovitosti pri zlomih golenice so na voljo le iz kontroliranih kliničnih preskušanj, v katerih so odprte zlome golenice zdravili s pomočjo fiksacije z intramedularnim žebljem (glejte poglavje 5.1).
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).
Zato se ob pomanjkanju kliničnih podatkov zdravilo ne sme aplicirati neposredno na trabekularno kost, kjer bi prehodna resorpcija kosti lahko povzročila tveganje za pojav lomljivosti kosti (glejte poglavje 4.8).
Discard syringe and needle after use.
Brizgo in iglo po uporabi zavrzite.
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.
Zdravila InductOs ne smete implantirati posteriorno glede na vstavek za interkorpusno fuzijo ledvene hrbtenice, kjer je možen direkten dostop do spinalnega kanala in/ali korena(ov) živcev.
Localised infection specific to the fractured limb was very common (≥1/10) in patients in a clinical study in which the intramedullary canal was reamed to cortical chatter.
Lokalizirana okužba, specifična za zlomljeno okončino, se je pojavila zelo pogosto (>1/10) pri bolnikih v klinični študiji, v kateri so intramedularni kanal povrtali do notranjega oboda kortikalisa.
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.
Sposobnost zdravila InductOs, da podpira preoblikovanje kosti, je verjetno vzrok za biološko in biomehansko integracijo nove kosti, nastale po indukciji z zdravilom InductOs, z okolnim kostnim tkivom.
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.
Pogostnost neželenih učinkov, ki so jih opredelili v obdobju trženja zdravila InductOs, niso znani, saj velikost populacije poročanih učinkov ni ugotovljena.
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.
Učinkovitost in varnost zdravila InductOs je dokazala randomizirana, kontrolirana multicentrična raziskava neinferiornosti pri 279 bolnikih, starih od 19 do 78 let, ki jim je bila narejena prednja ledvena interkorpusna fuzija.
• if you have been diagnosed with or are being treated for cancer.
• če so vam postavili diagnozo raka ali se zdravite zaradi te bolezni.
The efficacy of InductOs was demonstrated in a multinational, randomized, controlled, single-blind study of 450 patients (age range 18 to 87 years; 81% male) with open tibial shaft fractures requiring surgical management.
Učinkovitost zdravila InductOs je bila dokazana v multinacionalni, randomizirani, kontrolirani, enojno slepi študiji, v katero je bilo vključenih 450 bolnikov (razpon starosti od 18 - 87 let; 81 % moških) z odprtim zlomom golenice, zaradi katerega je bila potrebna kirurška obravnava.
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.
Zdravilo InductOs se uporablja namesto odvzema kostnega presadka iz kolčnice, s čimer se izognete težavam in bolečinam, ki jih lahko povzroči operacija za odvzem kostnega presadka.
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).
Neželeni učinki občasne (≥1/1.000 do <1/100), redke (≥1/10.000 do <1/1.000) ali zelo redke (<1/10.000) pogostnosti se niso pojavili.
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).
Če je možno uhajanje v spinalni kanal in koren živca, je treba med matriksom in kakršnim koli živčnim tkivom ustvariti fizično pregrado, na primer lokalno kost ali alograft (glejte poglavje 4.5).
Although patient outcome was not affected, an interaction between NSAIDs and InductOs cannot be excluded.
Čeprav ni bilo vpliva na rezultate zdravljenja, interakcij med NSAID in zdravilom InductOs ni mogoče izključiti.
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.
Sklepamo lahko torej, da se na mestu implantacije dibotermin alfa iz matriksa sprošča počasi, medtem ko je njegovo odstranjevanje iz sistemske cirkulacije hitro.
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.
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.
• Unknown (cannot be estimated from available data): Increased breakdown of the bone
• neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov): zvečana razgradnja kosti.
Using sterile technique, place one syringe, one needle and the matrix inner package in the sterile field.
Ob uporabi sterilnega postopka položite eno brizgo, eno iglo in notranjo ovojnino z ogrodjem v sterilno polje.
• if you have an active infection at the surgery site.
• če imate akutno okužbo na operativnem mestu;
Product preparation
Priprava zdravila
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).
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).
Dibotermin alfa is an osteoinductive protein that results in the induction of new bone tissue at the site of implantation.
Dibotermin alfa je osteo-induktiven protein, ki spodbuja nastajanje novega kostnega tkiva na mestu implantacije.
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.
Medicinski pripomoček popravi položaj hrbtenice, zdravilo InductOs pa spodbudi rast kosti med vretencema, da se trajno učvrstita v pravilnem položaju.
Swirl the vial gently to aid reconstitution.
Previdno obračajte vialo, da pospešite rekonstitucijo.
The appropriate dose is determined by the volume of wetted matrix required for the intended indication.
Ustrezni odmerek je določen z volumnom navlaženega matriksa, ki je potreben za indikacijo, ki ji je zdravilo namenjeno.
1 Observed during use in lumbar interbody fusion 2 Fluid collection includes localised oedema, pseudocyst and implant site effusion.
1 Opaženo med uporabo pri interkorpusni fuziji ledvene hrbtenice 2 Kopičenje tekočine vključuje lokaliziran edem, psevdocisto in izliv na mestu vsaditve.
• Some patients may develop nerve pain due to localised fluid collection, which would require drainage or a surgical procedure to remove the fluid.
• Pri nekaterih bolnikih se lahko pojavi bolečina živca zaradi krajevno omejenega kopičenja tekočine, ki jo je treba odstraniti z drenažo ali kirurškim postopkom.
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.
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.
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.
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.
Over time, the sponge will gradually disappear as new bone is formed.
Sčasoma goba med nastajanjem kosti postopoma izgine.
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).
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).
New bone formation and bone remodelling
Tvorba nove kosti in remodeliranje kosti
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.
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.
3 Heterotopic ossification includes exostosis, extraskeletal ossification, postoperative heterotopic calcification, bone formation increased and implant site calcification.
3 Heterotopično kostenenje vključuje eksostoze, zunajskeletno kostenenje, pooperativno heterotopično kalcifikacijo, zvečano tvorbo kosti in kalcifikacijo na mestu vsaditve.
The powder is white.
Ogrodje je bele barve.
InductOs is implanted after the completion of standard fracture and wound management (i.e. at the time of soft-tissue closure).
Zdravilo InductOs se implantira po zaključeni standardni oskrbi zloma in rane (to je ob zapiranju mehkih tkiv).
The maximum dosage is limited to 8 mg (5.3 cm3 of wetted matrix) of InductOs in the intervertebral disc space.
Največji dovoljeni odmerek je omejen na 8 mg (5,3 cm3 navlaženega matriksa) zdravila InductOs v medvretenčnem prostoru.
For instructions to implant the lumbar interbody fusion device, please refer to the manufacturer's instructions for use.
Navodila za implantacijo vstavka za interkorpusno fuzijo ledvene hrbtenice poiščite v izdelovalčevem navodilu za uporabo.
None of the patients with positive titers to bovine Type I collagen had cross-reacting antibodies to human type I collagen.
Pri nobenem bolniku s pozitivnim titrom na protitelesa proti govejemu kolagenu tipa I se niso pojavila navzkrižna protitelesa proti humanemu kolagenu tipa I.
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.
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.
Driving and using machines InductOs will not affect your ability to drive or operate machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo InductOs ne bo vplivalo na vašo sposobnost vožnje in upravljanja s stroji.
Frequencies
Pogostnosti
As a precaution, a physical barrier between the matrix and any neurological tissue must be re-created (see section 4.2).
Kot previdnostni ukrep je treba med matriksom in kakršnim koli živčnim tkivom ustvariti fizično pregrado (glejte poglavje 4.2).
Both dibotermin alfa and bovine Type I collagen have been found to elicit immune responses in patients.
Ugotovljeno je bilo, da tako dibotermin alfa kot tudi goveji kolagen tipa I pri bolnikih izzoveta imunski odgovor.
How to store InductOs You will not be required to store this product.
Shranjevanje zdravila InductOs Tega zdravila ne bo treba shranjevati vam.
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.
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.
Slowly inject the solvent into the vial containing the lyophilised dibotermin alfa.
Počasi vbrizgajte vehikel v vialo, ki vsebuje liofiliziran dibotermin alfa.
Post-Implantation Once InductOs is implanted, do not irrigate the wound.
Po namestitvi zdravila InductOs ne izpirajte rane.
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).
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).
If you have broken your shin bone, InductOs is used, to help your fracture heal and to reduce the need for additional surgeries.
Če ste si zlomili golenico, zdravilo InductOs uporabimo zato, da pospešimo celjenje zloma in da zmanjšamo potrebo po dodatnih kirurških posegih.
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.
Čeprav v kliničnih študijah niso ugotovili povezave s kliničnim izidom ali neželenimi učinki, ne moremo izključiti možnosti pojava nevtralizirajočih protiteles ali preobčutljivostnih reakcij.
During handling and implantation, minimize fluid loss from the matrix.
Med pripravo zdravila in implantacijo zagotovite čim manjšo izgubo tekočine iz matriksa.
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.
Zunaj medvretenčnega prostora lahko kirurško polje izpirate po potrebi in vso izgubljeno tekočino iz navlaženega matriksa je treba odstraniti.
• Dibotermin alfa is a white powder presented in a glass vial.
• Dibotermin alfa je bel prašek v stekleni viali.
Failure to follow the method of administration of InductOs may compromise its safety and efficacy.
Če se ne boste ravnali po navodilih za način uporabe zdravila InductOs, boste ogrozili njegovo varnost in učinkovitost.
In the non-sterile field
V nesterilnem območju
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.
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.
The medicinal product is administered by implantation.
Zdravilo se aplicira z implantacijo.