FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of InductOs with reamed nails in open tibial fracture repair is not recommended.
Slovenian: Uporaba zdravila InductOs s povrtanimi žeblji pri operativnem zdravljenju odprtih zlomov golenice ni priporočljiva.
English: If you have any question about the medical device, please ask your doctor.
Slovenian: Če imate kakšna vprašanja o medicinskem pripomočku, se posvetujte z zdravnikom.
English: The differentiated cells form trabecular bone as the matrix is degraded, with vascular invasion evident at the same time.
Slovenian: Diferencirane celice ob razpadanju matriksa tvorijo trabekularno kostno tkivo, sočasno pa je vidna vaskularna invazija.
English: • if you are allergic to dibotermin alfa or bovine collagen or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na dibotermin alfa ali goveji kolagen ali katero koli sestavino zdravila
English: • The Summary of Product Characteristics
Slovenian: • povzetek glavnih značilnosti zdravila in
English: Special warnings and precautions for use specific to acute tibia fractures
Slovenian: Posebna opozorila in previdnostni ukrepi pri uporabi, specifični za akutni zlom golenice
English: A post-hoc meta-analysis of 6 controlled clinical trials with data from patients treated with InductOs or autogenous bone graft administered using CE-marked interbody fusion devices or allograft bone spacers and various surgical approaches showed that, at 24 months post-surgery, InductOs was associated with a higher fusion success rate (95%, 241 out of 255 patients) compared with autogenous bone graft (85 %, 177 out of 209 patients), with an odds ratio of 3.26 (95% CI: 1.172, 9.075; P = 0.024).
Slovenian: Post-hoc meta-analiza šestih nadzorovanih kliničnih preskušanj s podatki bolnikov, zdravljenih z zdravilom InductOs ali z avtogenim kostnim presadkom, apliciranim z uporabo vstavka za interkorpusno fuzijo z oznako CE ali naprave za aplikacijo avtogenega kostnega presadka ter z različnimi kirurškimi pristopi, je pokazala, da je bilo 24 mesecev po operaciji zdravilo InductOs povezano z večjim deležem uspešnosti fuzije (95 %, 241 od 255 bolnikov) v primerjavi z avtogenim kostnim presadkom (85 %, 177 od 209 bolnikov), z razmerjem obetov 3,26 (95 % IZ: 1,172, 9,075: p=0,024).
English: Remodeling of the surrounding bone occurs in a manner that is consistent with the biomechanical forces placed on it.
Slovenian: Preoblikovanje okolnega trabekularnega kostnega tkiva poteka v skladu z biomehanskimi silami, ki delujejo na to tkivo.
English: The safety and efficacy of the use of InductOs in patients with known autoimmune disease have not been established.
Slovenian: Varnosti in učinkovitosti uporabe zdravila InductOs pri bolnikih z ugotovljeno avtoimunsko boleznijo niso ugotavljali.
English: Furthermore, non-clinical studies have indicated that the bone induced by InductOs, if fractured, can repair itself in a manner indistinguishable from native bone.
Slovenian: Še več, predklinične študije so tudi pokazale, da se v primeru zloma kost, inducirana z zdravilom InductOs, popravi na enak način kot nativna kost.
English: At 24 months post-operation, InductOs was demonstrated to be statistically non-inferior to autogenous bone graft with a success rate for radiologically determined fusion of 94.4% for InductOs versus 88.9% for autogenous bone graft (95% two-sided CI of the difference: -1.53, 12.46).
Slovenian: 24 mesecev po operaciji je bilo zdravilo InductOs dokazano statistično neinferiorno avtogenemu kostnemu presadku z uspešnostjo radiološko ocenjene fuzije zdravila InductOs 94,4 % in za avtogeni kostni presadek 88,9 % (95 % dvosmerni IZ za razliko: -1,53, 12,46).
English: Anti-dibotermin antibodies have been investigated in pregnant rabbits following hyper-immunisation with dibotermin alfa to experimentally induce anti-dibotermin alfa antibodies.
Slovenian: Protitelesa proti diboterminu alfa so raziskovali pri brejih kunčjih samicah po hiperimunizaciji z diboterminom alfa, s katero so eksperimentalno povzročili nastanek protiteles proti diboterminu alfa.
English: InductOs is active at the site of implantation.
Slovenian: Zdravilo InductOs deluje na mestu implantacije.
English: Do not squeeze.
Slovenian: Ne stiskajte.
English: Once InductOs and the lumbar interbody fusion device(s) are implanted, the inside of the intervertebral disc space must not be irrigated.
Slovenian: Ko sta (so) zdravilo InductOs in vstavek (vstavki) za interkorpusno fuzijo ledvene hrbtenice implantirana(i), notranjosti medvretenčnega prostora ne smete izpirati.
English: In a clinical study in which the intramedullary canal was reamed to cortical chatter, an increased rate of infection was observed in the InductOs-treated group versus the standard of care control group (see section 4.8).
Slovenian: V klinični študiji, v kateri so povrtali intramedularni kanal do notranjega oboda kortikalisa, so v skupini, zdravljeni z zdravilom InductOs, opazili zvečano pogostnost infekcij v primerjavi s kontrolno skupino, ki je prejela standardno oskrbo (glejte poglavje 4.8).
English: Localised infection5*
Slovenian: Infekcijske in parazitske bolezni lokalizirana okužba5*
English: Implantation
Slovenian: Implantacija
English: When used in lower back fusion surgery, InductOs is used in combination with a medical device, which corrects the position of your spine.
Slovenian: Kadar se zdravilo InductOs uporablja za fuzijo ledvenega dela hrbtenice, se uporabi v kombinaciji z medicinskim pripomočkom, ki popravi položaj hrbtenice.
English: You should not receive InductOs
Slovenian: Ne jemljite zdravila InductOs
English: Special warnings and precautions for use specific to lumbar interbody fusion
Slovenian: Posebna opozorila in previdnostni ukrepi pri uporabi, specifični za interkorpusno fuzijo ledvene hrbtenice
English: • Two matrices (2.5 cm x 5 cm) in a blister package (polyvinyl chloride - PVC).
Slovenian: • dve ogrodji (2,5 cm x 5 cm) v pretisnem omotu (iz polivinilklorida - PVC),
English: • One matrix (7.5 cm x 10 cm) in a blister package (polyvinyl chloride - PVC).
Slovenian: • eno ogrodje (7,5 cm x 10 cm) v pretisnem omotu (iz polivinilklorida - PVC),
English: Formation of a fluid collection (pseudocyst, localised oedema, implant site effusion), sometimes encapsulated and in some cases resulting in nerve compression and pain, has been reported associated with the use of InductOs.
Slovenian: O kopičenju tekočine (psevdociste, lokaliziran edem, izliv okrog vsadka), včasih inkapsuliranem, ki v nekaterih primerih povzroči pritisk na živec in bolečino, so poročali v povezavi z uporabo zdravila
English: InductOs should be placed bridging the fracture region and making good contact with the major proximal and distal fragments.
Slovenian: Namestite zdravilo InductOs tako, da bo premostilo predel zloma in bo v tesnem stiku z večjimi proksimalnimi in distalnimi fragmenti.
English: What InductOs looks like and contents of the pack InductOs is supplied to your doctor as a kit for implanting during surgery.
Slovenian: Izgled zdravila InductOs in vsebina pakiranja Zdravniku je zdravilo InductOs na voljo v obliki kompleta za vsaditev med operacijo.
English: There is no information on the excretion of dibotermin alfa/metabolites in human milk.
Slovenian: Ni podatkov o tem, ali se dibotermin alfa oziroma njegovi presnovki izločajo v materino mleko.
English: - The other ingredients are sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide and polysorbate 80, water for injections, and bovine Type I collagen.
Slovenian: - Pomožne snovi so saharoza, glicin, glutaminska kislina, natrijev klorid, natrijev hidroksid in polisorbat 80, voda za injekcije in goveji kolagen tipa I.
English: In clinical trials when degenerative disc disease was treated by a posterior lumbar interbody fusion procedure with dibotermin alfa, posterior bone formation was observed in CT scans.
Slovenian: V kliničnih preskušanjih, kjer so zdravili degenerativne bolezni medvretenčnih ploščic s posteriorno interkorpusno ledveno fuzijo z diboterminom alfa, so v nekaterih primerih na CT posnetkih opazili tvorbo kosti posteriorno.
English: The most common adverse reactions for InductOs in lumbar interbody fusion surgery were radiculopathic events, and in acute tibia fracture surgery it was localised infection.
Slovenian: Najpogostejši neželeni učinki za zdravilo InductOs pri operacijah interkorpusne fuzije ledvene hrbtenice so bili radikulopatski dogodki in lokalizirana okužba pri operacijah akutnega zloma golenice.
English: • adequate haemostasis (i.e., providing a relatively dry implantation site)
Slovenian: zagotavlja relativno suho mesto implantacije);
English: During two years follow-up in clinical trials for lumbar interbody fusion using a posterior approach, heterotopic ossification seen on radiographs occurred more often in patients treated with InductOs compared with autograft (see section 4.4).
Slovenian: V kliničnih preskušanjih za interkorpusno fuzijo ledvene hrbtenice z uporabo posteriornega pristopa se je v dveletnem obdobju spremljanja heterotopično kostenenje, vidno na rentgenskih posnetkih, pogosteje pojavilo pri bolnikih, ki so bili zdravljeni z zdravilom InductOs, v primerjavi z avtograftom (glejte poglavje 4.4).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Implantation.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Implantacija.
English: Care must be taken not to compress the product or overfill the volume intended for new bone formation (see section 4.4).
Slovenian: Pri uporabi je treba paziti, da zdravila ne boste stisnili in da ne boste prekomerno napolnili volumna, ki je namenjen za tvorbo nove kosti (glejte poglavje 4.4).
English: Matrix: bovine Type I collagen
Slovenian: Ogrodje: goveji kolagen tipa I
English: Clinical intervention (aspiration and/or surgical removal) may be required if symptoms persist (see section 4.8).
Slovenian: Če simptomi vztrajajo, utegne biti potreben kliničen poseg (aspiracija in/ali kirurška odstranitev) (glejte poglavje 4.8).
English: It is used in addition to standard treatment and care of shin bone fractures.
Slovenian: Uporablja se kot dodatek k standardni terapiji in oskrbi zlomov golenice.
English: Patients had received at least six months of non-operative treatment prior to treatment with InductOs for anterior lumbar spine fusion.
Slovenian: Bolniki so bili pred zdravljenjem z zdravilom InductOs za prednjo fuzijo ledvene hrbtenice deležni vsaj šestmesečnega konservativnega zdravljenja.
English: Once prepared, InductOs contains dibotermin alfa at a concentration of 1.5 mg/ml.
Slovenian: Ko je zdravilo InductOs pripravljeno, vsebuje dibotermin alfa v koncentraciji 1,5 mg/ml.
English: The safety and efficacy of InductOs have not been demonstrated in patients with metabolic bone diseases.
Slovenian: Varnost in učinkovitost zdravila InductOs pri bolnikih s presnovnimi boleznimi kosti nista dokazani.
English: 2/3 of the matrix
Slovenian: 2/3 matriksa
English: The powder is dissolved in the sterile water to form a solution that is used to soak the sponge.
Slovenian: Prašek je treba raztopiti v sterilni vodi, da nastane raztopina, s katero se navlaži goba.
English: Radiculopathic events1, 4
Slovenian: Bolezni živčevja radikulopatski dogodki1,4
English: In the acute tibia fracture pivotal trial, InductOs increased the probability of fracture healing; patients treated with InductOs 1.5 mg/ml had a 44% reduced risk for treatment failure (secondary intervention to promote fracture healing) compared with patients in the standard-care group (RR = 0.56; 95% CI = 0.40 to 0.78).
Slovenian: V akutnem ključnem preskusu pri bolnikih z akutnim zlomom golenice je zdravilo InductOs zvečalo verjetnost celjenja zloma; bolniki, zdravljeni z 1,5 mg/ml zdravila InductOs, so imeli za 44 % manjše tveganje neuspešnega zdravljenja (sekundarno intervencijo za pospešitev celjenja zloma) v primerjavi z bolniki iz skupine s standardno oskrbo (RR = 0,56; 95 % IZ = 0,40 - 0,78).
English: Concentration of wetted matrix
Slovenian: Koncentracija navlaženega matriksa
English: In two exploratory studies, pre- and post-surgery serum samples were collected from a few long-bone fracture patients.
Slovenian: V dveh eksplorativnih študijah so določenemu številu bolnikov z zlomi dolgih kosti odvzeli vzorce seruma pred operacijo in po njej.
English: If you are receiving InductOs for a broken shin bone, your doctor will place InductOs around your broken bone when your fracture is treated.
Slovenian: Če ste dobili zdravilo InductOs za zlomljeno golenico, bo zdravnik med kirurškim posegom namestil zdravilo InductOs okrog vaše zlomljene kosti.
English: BATCH NUMBER LOT: see reverse
Slovenian: ŠTEVILKA SERIJE Lot: glejte hrbtno stran
English: The proportion of patients with hardware failure (locking screws bent or broken) was significantly lower in the InductOs 1.5 mg/ml group as compared to standard-care group (11% versus 22%; P= 0.0174).
Slovenian: Delež bolnikov z okvaro materiala (zvit ali zlomljen zaklenjeni žebelj) je bil v skupini z 1,5 mg/ml zdravila InductOs v primerjavi s skupino, ki je imela standardno oskrbo, značilno manjši (11 % v primerjavi z 22 %; p = 0,0174).
English: Pharmacodynamic information specific to acute tibia fracture studies
Slovenian: Farmakodinamični podatki, specifični za raziskave akutnih zlomov golenice
English: InductOs 4 mg pack contains:
Slovenian: 4 mg pakiranje zdravila InductOs vsebuje:
English: Powder, solvent and matrix for implantation matrix contain: 1 vial with 12 mg dibotermin alfa 1 vial with 10 ml water for injections 1 sterile matrix (7.5 x 10 cm)
Slovenian: Prašek, vehikel in ogrodje za matriks za implantacijo vsebuje: 1 vialo z 12 mg dibotermina alfa 1 vialo z 10 ml vode za injekcije 1 sterilno ogrodje (7,5 x 10 cm) 2 brizgi (10 ml)
English: Anti-dibotermin alfa antibodies: In spine fusion studies, 1.3% of patients receiving InductOs developed antibodies to dibotermin alfa versus 0.8% of patients receiving autogenous bone graft.
Slovenian: Protitelesa proti diboterminu alfa: V raziskavah fuzije hrbtenice so se protitelesa proti diboterminu alfa pojavila pri 1,3 % bolnikov, ki so dobili zdravilo InductOs, in pri 0,8 % bolnikov, ki so dobili avtogeni kostni presadek.
English: The most severe adverse reaction is localised oedema in cervical spine surgery.
Slovenian: Najpogostejši resen neželeni učinek je lokaliziran edem pri operaciji vratne hrbtenice.
English: InductOs 12 mg pack contains:
Slovenian: 12 mg pakiranje zdravila InductOs vsebuje:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 sterile matrices (2.5 x 5 cm)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2 sterilna matriksa (2,5 x 5 cm)
English: Non-clinical studies have suggested that bone formation initiated by InductOs is a self-limiting process, forming a well-defined volume of bone.
Slovenian: Na osnovi predkliničnih študij lahko sklepamo, da je nastajanje kostnega tkiva, ki ga sproži zdravilo InductOs, proces, ki se sam od sebe zaustavi, ko se razvije natančno opredeljen volumen kostnega tkiva.
English: Dimensions of wetted matrix
Slovenian: Dimenzije navlaženega matriksa
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 4 mg (4 mg pack) or 12 mg (12 mg pack) dibotermin alfa.
Slovenian: Ena viala vsebuje 4 mg (4-miligramsko pakiranje) ali 12 mg (12-miligramsko pakiranje) dibotermina alfa.
English: Pharmacodynamic information specific to lumbar interbody fusion studies
Slovenian: Farmakodinamični podatki, specifični za raziskave interkorpusne fuzije ledvene hrbtenice
English: InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix Dibotermin alfa
Slovenian: InductOs 1,5 mg/ml prašek, vehikel in ogrodje za matriks za implantacijo dibotermin alfa
English: 2 matrices
Slovenian: 2 matriksa
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated exposure toxicity and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, akutne toksičnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: In an in vitro study, dibotermin alfa was shown to bind to fibrin-based haemostatic agents or sealants.
Slovenian: V in vitro študiji so dokazali, da se dibotermin alfa veže na hemostatska zdravila ali tesnila na osnovi fibrina.
English: How InductOs is given
Slovenian: Kako se zdravilo InductOs daje
English: InductOs should be folded or cut as needed prior to implantation.
Slovenian: Pred implantacijo prepognite ali prerežite zdravilo InductOs, kot je potrebno.
English: InductOs has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo InductOs nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Disinfect the stopper of the reconstituted dibotermin alfa vial.
Slovenian: Razkužite zamašek viale z rekonstituiranim diboterminom alfa.
English: Device dislocation1* Fluid collection2*
Slovenian: Splošne težave in spremembe na mestu aplikacije premik vstavka1* kopičenje tekočine2*
English: 1/6 of the matrix
Slovenian: 1/6 matriksa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/226/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/02/226/001
English: In acute tibia fracture clinical trials, more InductOs patients receiving concomitant NSAIDs for 14 consecutive days experienced mild or moderate adverse events related to wound healing (e.g., wound drainage) than InductOs patients not taking NSAIDs.
Slovenian: V primerjavi z bolniki z zdravilom InductOs, ki niso prejemali NSAID, je v kliničnih raziskavah akutnih zlomov golenice več bolnikov z zdravilom InductOs, ki so sočasno 14 dni zaporedoma prejemali NSAID, navajalo blage do zmerne neželene učinke, povezane s celjenjem rane (npr. drenažo rane).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 sterile matrix (7.5 x 10 cm)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 sterilni matriks (7,5 x 10 cm)
English: • You should inform your doctor of any history of cancer.
Slovenian: • Zdravnika obvestite, če ste imeli v preteklosti raka.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/226/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/02/226/002
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Powder for InductOs 1.5 mg/ml dibotermin alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Prašek za InductOs 1,5 mg/ml dibotermin alfa implantacija
English: Patients were randomised to receive a titanium interbody fusion device filled with either InductOs or autogenous bone graft taken from the iliac crest.
Slovenian: Bolniki so bili randomizirani na terapijo z vstavkom za interkorpusno fuzijo iz titana, napolnjenim bodisi z zdravilom InductOs ali z avtogenim kostnim presadkom, odvzetim iz črevničnega grebena.
English: InductOs is contraindicated for patients with:
Slovenian: Zdravilo InductOs je kontraindicirano pri bolnikih s/z:
English: • Two syringes (5 ml; polypropylene).
Slovenian: • dve brizgi (5 ml; iz polipropilena),
English: In long-bone fracture studies, 13.0% of patients receiving dibotermin alfa with bovine Type I collagen matrix developed antibodies to bovine Type I collagen versus 5.3% of control patients.
Slovenian: V raziskavah zlomov dolgih kosti je 13,0 % bolnikov, ki so prejeli dibotermin alfa z matriksom iz govejega kolagena tipa I, razvilo protitelesa proti govejemu kolagenu tipa I, v primerjavi z 5,3 % bolnikov v kontrolni skupini.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for InductOs
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Vehikel za zdravilo InductOs voda za injekcije
English: Localised oedema was common when InductOs was used for cervical spine fusion.
Slovenian: Lokalizirani edem so pogosto opazili, ko so zdravilo InductOs uporabili za fuzijo vratne hrbtenice.
English: Definitive fracture reduction, fixation, and haemostasis should be achieved prior to InductOs implantation.
Slovenian: Pred implantacijo Pred implantacijo zdravila InductOs je treba doseči dokončno redukcijo zloma, fiksacijo in hemostazo.
English: • Two syringes (10 ml; polypropylene).
Slovenian: • dve brizgi (10 ml; iz polipropilena),
English: If a surgical drain is required, the drain should be placed remotely from the implantation site or, preferably, one layer superficially to the implantation site.
Slovenian: Če je potrebna kirurška drenaža, namestite dren tako, da je odmaknjen od mesta implantacije, po možnosti pa eno plast bolj površinsko od mesta implantacije.
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.
Slovenian: V študijah vpliva na sposobnost razmnoževanja pri podganah v primerih, ko so dibotermin alfa aplicirali intravensko za maksimizacijo sistemske izpostavljenosti, so opazili zvečanje mase in osifikacije plodu.
English: InductOs may be used either in lower back spine fusion surgery or to repair fractures of the shin bone.
Slovenian: Zdravilo InductOs se lahko uporablja bodisi pri operaciji za fuzijo ledvenega dela hrbtenice ali za zdravljenje zlomov golenice.
English: Acute tibia fracture surgery
Slovenian: Operacija za akutni zlom golenice
English: InductOs must be placed within the lumbar interbody fusion device(s) or in the anterior portion of the intervertebral disc space.
Slovenian: Zdravilo InductOs moramo namestiti v vstavek(ke) za interkorpusno fuzijo ledvene hrbtenice ali v prednji del medvretenčnega prostora.
English: METHOD OF ADMINISTRATION Implantation.
Slovenian: POSTOPEK UPORABE Implantiranje.
English: Leaving the matrix in its tray, UNIFORMLY distribute 1.4 ml of dibotermin alfa solution on each of the two 2.5 x 5 cm matrices, following the pattern in the figure below.
Slovenian: ENAKOMERNO nanesite 1,4 ml raztopine dibotermina alfa na vsakega od obeh ogrodij velikosti 2,5 x 5 cm, ki ju pustite v njunem pladnju.
English: Anti-bovine Type I collagen antibodies: In spine fusion studies, 13.5% of patients receiving InductOs developed antibodies to bovine Type I collagen versus 14.3% of patients receiving autogenous bone graft.
Slovenian: Protitelesa proti govejemu kolagenu tipa I: V študijah fuzije hrbtenice so se protitelesa proti govejemu kolagenu tipa I pojavila pri 13,5 % bolnikov, ki so dobili zdravilo InductOs, in pri 14,3 % bolnikov, ki so dobili avtogeni kostni presadek.
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.
Slovenian: Votlo geometrijo vstavka za interkorpusno fuzijo ledvene hrbtenice previdno in narahlo napolnite z volumnom zdravila InductOs, ki ustreza notranjemu volumnu vstavka.
English: Volume of wetted matrix
Slovenian: Volumen navlaženega matriksa
English: Generally, each fracture site is treated with the contents of one 12 mg pack.
Slovenian: Običajno se za vsako mesto zloma uporabi vsebina enega 12-miligramskega pakiranja.
English: Care and caution must be used to prevent overfilling the lumbar interbody fusion device and/or the anterior portion of the intervertebral disc space (see section 4.4).
Slovenian: Skrbno pazite, da ne boste preveč napolnili vstavka za interkorpusno fuzijo ledvene hrbtenice in/ali prednjega dela medvretenčnega prostora (glejte poglavje 4.4).
English: METHOD OF ADMINISTRATION Read the Summary of Product Characteristics before use.
Slovenian: POSTOPEK UPORABE Pred uporabo preberite Povzetek glavnih značilnosti zdravila.
English: 1 NAME OF THE MEDICINAL PRODUCT InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix
Slovenian: IME ZDRAVILA InductOs 1,5 mg/ml prašek, vehikel in ogrodje za matriks za implantacijo
English: Localised fluid build-up
Slovenian: lokalizirano kopičenje tekočine;
English: 3.2 ml solvent
Slovenian: 3,2 ml vehikla
English: InductOs has been studied in a canine spinal implantation model.
Slovenian: Zdravilo InductOs so proučevali na modelu vsaditve v hrbtenico psa.