FrancophonIA/ELRC3.0 huggingface dataset:
English: Peak levels of circulating dibotermin alfa (0.1% of the implanted dose) were observed within 6 hours following implantation.
Slovenian: Najvišje koncentracije dibotermina alfa v obtoku (0,1 % implantiranega odmerka) so bile zabeležene v 6 urah po implantaciji.
English: • The sponge is white and it is presented in a plastic blister.
Slovenian: • Goba je bela in je dobavljena v plastičnem pretisnem omotu.
English: The medical staff will prepare InductOs in the operating room.
Slovenian: Medicinsko osebje bo pripravilo zdravilo InductOs v operacijski dvorani.
English: The safety and efficacy of InductOs in children below 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila InductOs pri otrocih, mlajših od 18 let, še nista bili dokazani.
English: • Two needles (stainless steel).
Slovenian: • dve igli (iz nerjavečega jekla).
English: • absence of large segmental defect repair of long bones, in which significant soft tissue compression can occur
Slovenian: • brez obsežnih reparacijskih procesov velikih segmentnih defektov dolgih kosti, pri katerih lahko pride do pomembne kompresije mehkih tkiv.
English: 6422 PJ Heerlen The Netherlands
Slovenian: 6422 PJ Heerlen Nizozemska
English: In case of overdose (i.e. a patient receives a concentration or amount of dibotermin alfa greater than recommended), treatment should be supportive.
Slovenian: bolnik prejme večjo koncentracijo ali količino dibotermina alfa, kot je priporočeno) mora biti zdravljenje podporno.
English: Failure to follow the product preparation instructions in section 6.6 and the method of administration in section 4.2 may compromise the safety and efficacy of InductOs.
Slovenian: Če se ne boste ravnali po navodilih za pripravo zdravila v poglavju 6.6 in po navodilih za način uporabe v poglavju 4.2, boste ogrozili varnost in učinkovitost zdravila InductOs.
English: Water for injections
Slovenian: Vehikel voda za injekcije
English: Long-bone fracture and soft-tissue management procedures should be based on standard practice, including control of infection.
Slovenian: Oskrba zlomov dolgih kosti in poškodb mehkih tkiv mora temeljiti na standardnih postopkih, vključno z obvladovanjem okužbe.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, Bone Morphogenetic Proteins, ATC code: M05BC01
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, proteini za morfogenezo kosti; oznaka ATC: M05BC01.
English: The Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora skupaj s pristojnim nacionalnim organom pripraviti vsebino in obliko izobraževalnega programa, vključno s komunikacijskimi mediji, načini distribucije in drugimi vidiki programa.
English: Frequencies are defined as very common (≥1/10) or common (≥1/100 to <1/10).
Slovenian: Pogostnosti neželenih učinkov so opredeljene kot zelo pogosti (≥1/10) ali pogosti (≥1/100 do <1/10).
English: Other medicines and InductOs
Slovenian: Druga zdravila in zdravilo InductOs
English: • Water for injections is a clear colourless liquid presented in a glass vial.
Slovenian: • Voda za injekcije je bistra, brezbarvna tekočina v stekleni viali.
English: Osteolysis* Resorption bone increased*
Slovenian: osteoliza* povečana resorpcija kosti*
English: Compatibility has been demonstrated with titanium, polyetheretherketone (PEEK), and allograft bone.
Slovenian: Združljivost je bila dokazana s titanom, polietereterketonom (PEEK) in homologno kostjo.
English: Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) is a human protein derived from a recombinant Chinese Hamster Ovary (CHO) cell line.
Slovenian: Dibotermin alfa (rekombinantni humani protein za morfogenezo kosti-2; rhBMP-2) je človeški protein, pridobljen iz rekombinantne vrste ovarijskih celic kitajskega hrčka (CHO - »Chinese Hamster Ovary«).
English: The number of secondary and subsequent interventions was significantly reduced for the InductOs patients, particularly with regard to more invasive interventions, such as bone graft and exchange nailing (P = 0.0326).
Slovenian: Pri bolnikih z zdravilom InductOs se je število sekundarnih in nadaljnjih intervencij značilno zmanjšalo, zlasti kar zadeva agresivnejše posege, kot so kostni vsadki in menjava žeblja (P = 0,0326).
English: A close monitoring of the patient for any adverse reactions and the success of the treatment is recommended.
Slovenian: Priporoča se tudi skrbno nadziranje pojava neželenih reakcij in uspeha zdravljenja pri bolniku.
English: EU/1/02/226/002
Slovenian: EU/1/02/226/001 EU/1/02/226/002
English: The frequency of this side effect is unknown and cannot be estimated from the available data.
Slovenian: Pogostnost je neznana in je ni mogoče oceniti iz razpoložljivih podatkov.
English: In some circumstances an exaggeration of these processes can lead to complications such as nerve compression (due to heterotopic ossification) or device dislocation (associated with bone resorption or osteolysis).
Slovenian: V nekaterih pogojih lahko pretirana procesa povzročita zaplete, kot sta kompresija živcev (zaradi heterotopične osifikacije) ali migracija vstavka (povezano z resorpcijo kosti ali osteolizo).
English: • Pathological fractures such as those observed in (but not limited to) Paget's disease or in metastatic bone
Slovenian: • patološkimi zlomi, kakršni so značilni tudi (ne pa samo) za Pagetovo bolezen ali kostne metastaze.
English: The frequency of adverse reactions in patients exposed to treatment with InductOs is presented in the table below.
Slovenian: Pogostnost neželenih učinkov pri bolnikih, izpostavljenih zdravljenju z zdravilom InductOs, je predstavljena v spodnji preglednici.
English: To prevent overloading the matrix, it is important to reconstitute the dibotermin alfa and to wet the entire matrix as described below.
Slovenian: Da boste preprečili preobremenitev matriksa, morate dibotermin alfa pripraviti in celotno ogrodje navlažiti, kot je opisano spodaj.
English: The safety and efficacy of InductOs have not been established in the following conditions:
Slovenian: Varnosti in učinkovitosti zdravila InductOs niso ugotovili v naslednjih okoliščinah:
English: In addition, several non-clinical studies indicate that there is a negative feedback mechanism at the molecular level that limits bone induction by BMPs.
Slovenian: Poleg tega številne predklinične študije kažejo, da na molekularnem nivoju deluje negativni povratni mehanizem, ki omejuje indukcijo kosti s strani BMP.
English: Patients were followed for 12 months after soft-tissue closure.
Slovenian: Bolnike so opazovali 12 mesecev po zaprtju mehkih tkiv (zašitju rane).
English: • for treating a fracture that is disease-related (e.g., fractures due to Paget's disease or cancer).
Slovenian: • za zdravljenje bolezenskih zlomov (npr. zlomi kot posledica Pagetove bolezni ali raka);
English: − If you have any further questions, ask your doctor.
Slovenian: - Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom.
English: • Some patients may develop antibodies (made by your body to fight a foreign protein) to InductOs.
Slovenian: • Pri nekaterih bolnikih se lahko razvijejo protitelesa (ki jih vaše telo izdela za borbo proti tuji beljakovini) proti zdravilu InductOs.
English: When injected intravenously, the terminal half-life of dibotermin alfa was 16 minutes in rats and 6.7 minutes in cynomolgus monkeys.
Slovenian: Po intravenski aplikaciji je bila končna razpolovna doba dibotermina alfa pri podganah 16 minut, pri opicah cinomolgus pa 6,7 minut.
English: • An active infection at the operative site
Slovenian: • akutno okužbo v operativnem območju;
English: • Common (may affect up to 1 in 10 people): Additional bone growth, movement of the implanted medical device, localised fluid build-up and pain radiating from your back to your leg (sciatica)
Slovenian: • pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): dodatna rast kosti, premikanje vsajenega medicinskega pripomočka, lokalizirano kopičenje tekočine in bolečina, ki izžareva iz hrbta v nogo (išias);
English: If you think you have an allergic reaction to collagen, contact your doctor.
Slovenian: Če menite, da imate alergijsko reakcijo na kolagen, se posvetujte s svojim zdravnikom
English: Lower back spine fusion surgery Talk to your doctor if you have any of the following:
Slovenian: Operacija za fuzijo ledvenega dela hrbtenice Posvetujte se s svojim zdravnikom, če imate kaj od naslednjega:
English: • Common (may affect up to 1 in 10 people):
Slovenian: • pogosti (pojavijo se lahko pri do 1 od 10 bolnikov):
English: • Healthcare professionals educational material
Slovenian: • izobraževalni material za zdravstvene delavce.
English: As part of the pharmacological mechanism of action of dibotermin alfa, bone remodelling occurs (see section 5.1).
Slovenian: Kot del farmakološkega mehanizma delovanja dibotermina alfa se pojavi remodeliranje kosti (glejte poglavje 5.1).
English: In the absence of any experience, the repeat use of InductOs is not recommended.
Slovenian: Zaradi pomanjkanja izkušenj ponovna uporaba zdravila InductOs ni priporočljiva.
English: In the sterile field
Slovenian: V sterilnem območju
English: In animal studies (rats) using InductOs containing radiolabelled dibotermin alfa, the mean residence time at the site of implantation was 4-8 days.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Special consideration of risks and benefits should be given for patients who have previously received injectable collagen (see section 4.3).
Slovenian: 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).
English: The maximum dosage is limited to 24 mg (2 entire 12 mg pack matrices).
Slovenian: Največji dovoljeni odmerek je omejen na 24 mg (2 celotni 12-miligramski pakiranji matriksa).
English: InductOs was implanted directly onto the exposed dura following a laminectomy.
Slovenian: Zdravilo InductOs so vsadili direktno v izpostavljeno duro po laminektomiji.
English: • Any active malignancy or patient undergoing treatment for a malignancy
Slovenian: • katerim koli aktivnim malignim obolenjem ali pri bolnikih, ki se zdravijo zaradi malignega obolenja;
English: Dibotermin alfa
Slovenian: Odmerek dibotermina alfa
English: The available in vivo data on human tumour cell lines do not suggest a potential for promotion of tumour growth or metastasis.
Slovenian: Razpoložljivi podatki na humanih tumorskih celičnih linijah in vivo ne kažejo na potencial pospeševanja tumorske rašče ali metastaz.
English: • if the doctor treating you decides that you have inadequate blood supply at the fracture site.
Slovenian: • če zdravnik, ki vas zdravi, ugotovi, da je mesto vašega zloma nezadostno prekrvavljeno;
English: As dibotermin alfa is a protein and has not been identified in the general circulation, it is an unlikely candidate for pharmacokinetic drug-drug interactions.
Slovenian: Ker je dibotermin alfa protein, ki ga v cirkulaciji niso našli, ni verjetno, da bi lahko bil vpleten v farmakokinetične interakcije z drugimi zdravili.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: • Persistent compartment syndrome or neurovascular residua of compartment syndrome
Slovenian: • trdovratnim utesnitvenim sindromom ali nevrovaskularnimi posledicami utesnitvenega sindroma;
English: The use of the product in pregnant women is not advised.
Slovenian: Uporabe tega zdravila pri nosečnicah ne priporočajo.
English: The solvent is a clear colourless liquid.
Slovenian: Vehikel je bistra, brezbarvna tekočina.
English: 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.
Slovenian: 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.
English: No studies have been performed in patients with hepatic, renal or cardiac impairment.
Slovenian: Študij pri bolnikih z jetrno, ledvično ali srčno okvaro niso izvedli.
English: For use with unreamed nails, estimated rates of infection were similar between treatment and control groups in a study (21% versus 23%, respectively).
Slovenian: Pri uporabi z nepovrtanimi žeblji so bile ocenjene stopnje okužb med skupinami zdravljenja v študiji podobne (21 % v primerjavi s 23 %).
English: • You should inform your doctor if you have any bone disease.
Slovenian: • Zdravnika obvestite, če imate kakšno bolezen kosti.
English: 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.
Slovenian: 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.
English: What InductOs is and what it is used for What you need to know before you receive InductOs How InductOs is given
Slovenian: 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
English: 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).
Slovenian: 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).
English: • Unknown (cannot be estimated from available data):
Slovenian: • neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
English: InductOs contains sodium
Slovenian: Zdravilo InductOs vsebuje natrij
English: • You should inform your doctor if you have an autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome or dermatomyositis/polymyositis.
Slovenian: • Svojega zdravnika morate obvestiti, če imate avtoimunsko bolezen, npr. revmatoidni artritis, sistemski eritematozni lupus, sklerodermijo, Sjögrenov sindrom ali dermatomiozitis/polimiozitis.
English: The implant may only be administered to the fracture site under adequate vision and with utmost care (see section 4.2).
Slovenian: Implantat lahko namestimo v območje zloma le ob primerni vidljivosti in izredno pazljivo (glejte poglavje 4.2).
English: 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.
Slovenian: Če je kirurški poseg tak, da je potreben samo del zdravila, navlaženi matriks obrežite do želene velikosti, neporabljeni del pa zavrzite.
English: Dibotermin alfa binds to receptors on the surface of mesenchymal cells and causes cells to differentiate into cartilage- and bone-forming cells.
Slovenian: 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.
English: In this process, both bone resorption and formation occur.
Slovenian: V tem postopku pride do resorpcije in nastajanja kosti.
English: InductOs does not provide mechanical stability and should not be used to fill a void in the presence of compressive forces.
Slovenian: Zdravilo InductOs ne zagotavlja mehanske stabilnosti in se zato ne sme uporabljati za zapolnitev praznine ob delovanju kompresivnih sil.
English: 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.
Slovenian: 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.
English: In some cases, the oedema was severe enough to result in airway compromise.
Slovenian: V nekaterih primerih je bil edem dovolj močno izražen, da je ogrozil prehodnost dihalne poti.
English: 4 Radiculopathic events includes radiculitis, lumbar radiculopathy, radicular pain, radiculitis lumbosacral, radiculopathy and sciatica.
Slovenian: 4 Radikulopatski dogodki vključujejo radikulitis, ledveno radikulopatijo, radikularno bolečino, lumbosakralni radikulitis, radikulopatijo in išias.
English: The bone formation process develops from the outside of the implant towards the centre, until the entire InductOs implant is replaced by trabecular bone.
Slovenian: Proces nastajanja kosti se razvija v smeri od zunanjih delov implantata proti sredini, dokler trabekularna kost ne nadomesti celotnega implantata zdravila InductOs.
English: Dibotermin alfa has demonstrated variable effects on human tumour cell lines in vitro.
Slovenian: Dibotermin alfa je pokazal različne učinke na humane tumorske celične linije in vitro.
English: Efficacy information in tibia fracture is available only from controlled clinical trials in which open tibial fractures were treated using intramedullary nail fixation (see section 5.1).
Slovenian: 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).
English: Therefore, in the absence of clinical data, the product should not be used for direct applications to trabecular bone where transient bone resorption may create a risk of bone fragility (see section 4.8).
Slovenian: 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).
English: Discard syringe and needle after use.
Slovenian: Brizgo in iglo po uporabi zavrzite.
English: InductOs must not be implanted posterior to the lumbar interbody fusion device where direct access to the spinal canal and/or nerve root(s) is possible.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The ability of InductOs to support bone remodeling may be responsible for the biological and biomechanical integration of the new bone induced by InductOs with that of the surrounding bone.
Slovenian: 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.
English: The frequencies of adverse reactions identified during post-marketing use of InductOs are not known as these reactions were reported from a population of uncertain size.
Slovenian: Pogostnost neželenih učinkov, ki so jih opredelili v obdobju trženja zdravila InductOs, niso znani, saj velikost populacije poročanih učinkov ni ugotovljena.
English: The efficacy and safety of InductOs were demonstrated in a randomised, controlled, multicenter, non-inferiority study of 279 patients aged 19-78 years undergoing an open anterior lumbar interbody fusion procedure.
Slovenian: 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.
English: • if you have been diagnosed with or are being treated for cancer.
Slovenian: • če so vam postavili diagnozo raka ali se zdravite zaradi te bolezni.
English: 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.
Slovenian: 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.
English: InductOs is used instead of taking a bone graft from your hip; this avoids the problems and pain that can be caused by an operation to collect the bone graft.
Slovenian: 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.
English: 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).
Slovenian: 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.
English: If leakage into the spinal canal and the nerve root is possible, a physical barrier between the matrix and any neurological tissue must be re-created by using, for example, local bone or allograft (see section 4.5).
Slovenian: 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).
English: Although patient outcome was not affected, an interaction between NSAIDs and InductOs cannot be excluded.
Slovenian: Čeprav ni bilo vpliva na rezultate zdravljenja, interakcij med NSAID in zdravilom InductOs ni mogoče izključiti.
English: It is concluded, therefore, that at the site of implantation, dibotermin alfa is slowly released from the matrix and rapidly cleared when taken up into the systemic circulation.
Slovenian: Sklepamo lahko torej, da se na mestu implantacije dibotermin alfa iz matriksa sprošča počasi, medtem ko je njegovo odstranjevanje iz sistemske cirkulacije hitro.