FrancophonIA/ELRC3.0 huggingface dataset:
English: • at increasing awareness about the risk of heterotopic ossification and the potential risk of medication errors and incorrect use of InductOs and providing guidance on how to manage these risks.
Danish: • at øge kendskabet til risikoen for heterotop ossifikation og den mulige risiko for medicineringsfejl og ukorrekt anvendelse af InductOs samt give retningslinjer for håndtering af disse risici.
English: InductOs is prepared immediately prior to use.
Danish: InductOs klargøres umiddelbart før brug.
English: In the absence of any experience, the repeat use of InductOs is not recommended.
Danish: På grund af manglende erfaring frarådes gentagen brug af InductOs.
English: Solvent: Water for injections
Danish: Solvens: Vand til injektionsvæsker
English: A close monitoring of the patient for any adverse reactions and the success of the treatment is recommended.
Danish: Omhyggelig monitorering af patienten for eventuelle bivirkninger og behandlingens succes anbefales.
English: The incidence of adverse reactions with InductOs was not affected by gender, age or race.
Danish: Forekomsten af bivirkninger ved brug af InductOs påvirkedes ikke af køn, alder eller race.
English: Remodeling of the surrounding bone occurs in a manner that is consistent with the biomechanical forces placed on it.
Danish: Remodellering af den omgivende knogle sker på en måde, der er i overensstemmelse med de biomekaniske kræfter, den udsættes for.
English: Heterotopic ossification
Danish: Heterotop ossifikation
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: All patients who were tested for neutralizing antibodies to bone morphogenetic protein-2 were negative.
Danish: Alle patienter, der blev testet for neutraliserende antistoffer mod knogle-morfogent protein-2, var negative.
English: Frequencies are defined as very common (≥1/10) or common (≥1/100 to <1/10).
Danish: Hyppighederme er defineret som meget almindelig (≥1/10) eller almindelig (≥1/100 til <1/10).
English: The possibility of an immune response to the product should be considered in cases where an undesirable effect with immunological background is suspected.
Danish: Muligheden for en immunreaktion mod præparatet skal evalueres i tilfælde, hvor der er mistanke om en bivirkning med immunologisk baggrund.
English: Dibotermin alfa was not detectable in serum.
Danish: Dibotermin alfa kunne ikke spores i serum.
English: Although patient outcome was not affected, an interaction between NSAIDs and InductOs cannot be excluded.
Danish: Selvom resultatet for patienten ikke blev påvirket, kan en interaktion mellem NSAID og InductOs ikke udelukkes.
English: 3.2 ml solvent
Danish: 3,2 ml solvens
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).
Danish: Der er ikke observeret nogen reaktioner med hyppigheden ikke almindelig (≥1/1.000 til <1/100), sjældene (≥1/10.000 til <1/1.000) eller meget sjælden (<1/10.000).
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30oC.
English: If you have any question about the medical device, please ask your doctor.
Danish: Hvis De har nogen spørgsmål om den medicinske anordning, skal De spørge lægen.
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.
Danish: Den medicinske anordning korrigerer rygsøjlens stilling, og InductOs fremmer knoglevæksten mellem de to ryghvirvler, så de fikseres permanent i korrekt stilling.
English: InductOs does not provide mechanical stability and should not be used to fill a void in the presence of compressive forces.
Danish: InductOs giver ikke mekanisk stabilitet og bør ikke anvendes til fyldning af et mellemrum ved tilstedeværelse af kompressive kræfter.
English: • Common (may affect up to 1 in 10 people):
Danish: Almindeligt (kan ramme op til 1 ud af 10 personer):
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.
Danish: InductOs indeholder bovint kollagen, et protein der stammer fra kvæg Nogle patienter kan udvikle antistoffer (udvikles af kroppen for at bekæmpe et fremmed protein) mod kollagenet i medicinen.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated exposure toxicity and genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter akut eller gentagen eksponering og genotoksicitet.
English: In some cases, the oedema was severe enough to result in airway compromise.
Danish: I nogle tilfælde var ødemet alvorligt nok til at være luftvejskompromitterende.
English: Considering the type of product, systemic exposure of the suckling infant is not expected, however a risk to the newborn/infant cannot be excluded.
Danish: Ud fra præparatets type forventes der ingen systemisk eksponering for det ammede barn, men en risiko for den nyfødte / spædbarnet kan dog ikke udelukkes.
English: When injected intravenously, the terminal half-life of dibotermin alfa was 16 minutes in rats and 6.7 minutes in cynomolgus monkeys.
Danish: Ved intravenøs injektion var sluthalveringstiden for dibotermin alfa 16 minutter hos rotte og 6,7 minutter hos cynomolgusabe.
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.
Danish: Da dibotermin alfa er et protein og ikke er blevet identificeret i den almindelige cirkulation, er det usandsynligt, at en farmakokinetisk interaktion med andre lægemidler opstår.
English: • Unknown (cannot be estimated from available data): Increased breakdown of the bone
Danish: Ukendt (kan ikke vurderes ud fra de tilgængelige data) Øget knoglenedbrydning
English: Generally, each fracture site is treated with the contents of one 12 mg pack.
Danish: Generelt behandles hver fraktur med indholdet af én 12 mg pakning.
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.
Danish: Indehaveren af markedsføringstilladelsen skal være enig med den relevante nationale myndighed om indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmedier, distributionsmetoder og eventuelle andre aspekter af programmet.
English: In two exploratory studies, pre- and post-surgery serum samples were collected from a few long-bone fracture patients.
Danish: I to eksplorative studier blev præ- og postoperative serumprøver indsamlet fra nogle få patienter med fraktur i lange knogler.
English: Forceps should be used to handle InductOs.
Danish: Der bør anvendes en tang til at håndtere InductOs.
English: • The sponge is white and it is presented in a plastic blister.
Danish: • Svampen er hvid og leveres i en blisterpakning af plastik.
English: The differentiated cells form trabecular bone as the matrix is degraded, with vascular invasion evident at the same time.
Danish: De differentierede celler danner trabekulær knogle efterhånden som matrix nedbrydes, således at vaskulær invasion samtidig er tydelig .
English: • An active infection at the operative site
Danish: • aktiv infektion på operationsstedet
English: • Water for injections is a clear colourless liquid presented in a glass vial.
Danish: • Vand til injektionsvæsker er en klar farveløs væske, der leveres i et hætteglas.
English: The oedema was delayed in onset and usually occurred in the first week post-operation.
Danish: Ødemet opstod sent og forekom i reglen i den første uge efter operationen.
English: InductOs must not be used alone for this indication, but should be used with an approved (CE-marked) lumbar interbody fusion device(s).
Danish: InductOs må ikke anvendes alene ved denne indikation, men skal anvendes sammen med et eller flere godkendte (CE-mærkede) lumbale interkorporale fusionsdevices.
English: • Some patients may develop antibodies (made by your body to fight a foreign protein) to InductOs.
Danish: • Visse patienter kan udvikle antistoffer (udvikles af kroppen til bekæmpelse af et fremmed protein) mod InductOs.
English: The frequency of adverse reactions in patients exposed to treatment with InductOs is presented in the table below.
Danish: Hyppigheden af bivirkninger hos patienter, der blev eksponeret for behandling med InductOs, er fremlagt I nedenstående tabel.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Danish: • overfølsomhed overfor det aktive stof eller over for et eller flere af hjælpestofferne anført i punkt 6.1
English: Post-Implantation Once InductOs is implanted, do not irrigate the wound.
Danish: Efter implantation Når InductOs er implanteret, må såret ikke skylles.
English: To achieve maximum potential efficacy, it is important to attain complete soft-tissue coverage of InductOs following its implantation.
Danish: For at opnå den størst mulige virkning er det vigtigt, at InductOs er dækket fuldstændigt af bløddele efter implantation.
English: The available in vivo data on human tumour cell lines do not suggest a potential for promotion of tumour growth or metastasis.
Danish: De tilgængelige in vivo-data for humane tumorcellelinjer tyder ikke på et potentiale for fremme af tumorvækst eller metastasering.
English: To prevent overloading the matrix, it is important to reconstitute the dibotermin alfa and to wet the entire matrix as described below.
Danish: For at undgå overdosering er det vigtigt at rekonstituere dibotermin alfa og fugte hele matrix som beskrevet nedenfor.
English: The medical staff will prepare InductOs in the operating room.
Danish: Lægerne vil klargøre InductOs på operationsstuen.
English: Localised infection
Danish: Lokal infektion
English: New bone formation and bone remodelling
Danish: Ny knogledannelse og knogleremodellering
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.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med InductOs undlades, idet der tages højde for fordelene ved amning for barnet og i forhold til de terapeutiske fordele for moderen.
English: No studies have been performed in patients with hepatic, renal or cardiac impairment.
Danish: Der er ikke udført studier hos patienter med nedsat lever-, nyre- eller hjertefunktion.
English: InductOs was implanted directly onto the exposed dura following a laminectomy.
Danish: InductOs blev implanteret direkte på den blottede dura efter en laminektomi.
English: • Two needles (stainless steel).
Danish: • to nåle (rustfrit stål)
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.
Danish: Hos nogle fostre med nedsat kropsvægt var der nedsat ossifikation af frontale og parietale knogler (hos 4 ud af 151 fostre), hvilket almindeligvis betragtes som reversibelt, og antistof relateret virkning kunne ikke udelukkes.
English: Long-bone fracture and soft-tissue management procedures should be based on standard practice, including control of infection.
Danish: Behandling af fraktur af lange knogler og håndtering af bløddele bør være baseret på standardpraksis, der inkluderer kontrol af infektion.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet (se pkt.
English: The volume of InductOs to be implanted is determined by the fracture anatomy and the ability to close the wound without overly packing or compressing the product.
Danish: Volumenet af InductOs, der skal implanteres, afgøres af frakturens anatomi og muligheden for at lukke såret uden at pakke og presse præparatet for meget sammen.
English: Radiographic, biomechanical and histologic evaluation of the induced bone indicates that it functions biologically and biomechanically as native bone.
Danish: Radiografisk, biomekanisk og histologisk vurdering af det fremkaldte knoglevæv indikerer, at det biologisk og biomekanisk fungerer som patientens eget knoglevæv.
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.
Danish: Det er en kopi af et protein kaldet knoglemorfogenetisk protein 2 (BMP-2), der dannes naturligt af kroppen og medvirker ved dannelsen af nyt knoglevæv.
English: InductOs should be folded or cut as needed prior to implantation.
Danish: InductOs skal foldes eller klippes efter behov forud for implantationen.
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).
Danish: Under visse omstændigheder kan en overdrivelse af disse processer medføre komplikationer som nervekompression (på grund af heterotop ossifikation) eller dislokation af device (i forbindelse med knogleresorption eller osteolyse).
English: Compatibility has been demonstrated with titanium, polyetheretherketone (PEEK), and allograft bone.
Danish: Der er vist forenelighed med titan, polyetheretherketon (PEEK) og allotransplantatknogle.
English: • Some patients may develop nerve pain due to localised fluid collection, which would require drainage or a surgical procedure to remove the fluid.
Danish: • Visse patienter kan udvikle nervesmerter på grund af lokal væskeansamling, hvilket vil kræve anlæggelse af dræn eller kirurgisk indgreb for at fjerne væsken.
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.
Danish: Desuden indikerer flere prækliniske studier, at der er en negativ feedbackmekanisme på molekylærniveau, der begrænser BMP'ers knogleinduktion.
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.
Danish: Det konkluderes derfor, at dibotermin alfa på implantationsstedet langsomt frigøres fra matrix og hurtigt fjernes, når det optages i det systemiske kredsløb.
English: Special consideration of risks and benefits should be given for patients who have previously received injectable collagen (see section 4.3).
Danish: Særlig overvejelse af fordele og ulemper er nødvendig for patienter, som allerede har modtaget injektioner med kollagen (se afsnit 4.3).
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.
Danish: Den knogledannende proces udvikler sig fra implantatets yderside og ind mod centrum, til hele InductOs implantatet er erstattet af trabekulær knogle.
English: InductOs is implanted after the completion of standard fracture and wound management (i.e. at the time of soft-tissue closure).
Danish: InductOs implanteres efter afslutning af den normale fraktur- og sårbehandling (dvs. når bløddelene lukkes).
English: The implant may only be administered to the fracture site under adequate vision and with utmost care (see section 4.2).
Danish: Implantatet må kun anvendes på frakturstedet under passende visuel kontrol og med stor forsigtighed (se afsnit 4.2).
English: InductOs may be placed into a void (loosely packed), folded, rolled or wrapped, as the geometry of the fracture requires.
Danish: InductOs kan anbringes i et mellemrum (løst pakket), foldet, rullet eller viklet om afhængigt af frakturens geometri.
English: The appropriate dose is determined by the volume of wetted matrix required for the intended indication.
Danish: Den rette dosis bestemmes ved hjælp af volumenet af våd matrix, der er nødvendig til den pågældende indikation.
English: Dibotermin alfa has demonstrated variable effects on human tumour cell lines in vitro.
Danish: Dibotermin alfa har udvist variabel virkning på humane tumor-cellelinjer in vitro.
English: The safety and efficacy of InductOs in children below 18 years of age have not been established.
Danish: InductOs' sikkerhed og virkning til børn under 18 år er ikke klarlagt.
English: The soaked sponge is then implanted where bone growth is needed.
Danish: Den gennemvædede svamp implanteres herefter, hvor der er brug for knoglevækst.
English: Patients had received at least six months of non-operative treatment prior to treatment with InductOs for anterior lumbar spine fusion.
Danish: Patienterne fik mindst seks måneders ikke-operativ behandling forud for behandlingen med InductOs og spinalfusion.
English: • if you have an active infection at the surgery site.
Danish: • hvis De har en aktiv infektion på operationsstedet.
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.
Danish: Denne selvbegrænsning skyldes sandsynligvis tabet af dibotermin alfa fra implantationsstedet samt tilstedeværelsen af BMP-hæmmere i det omgivende væv.
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).
Danish: Antallet af efterfølgende og senere interventioner var signifikant reduceret for de patienter, som blev behandlet med InductOs, især for de mere invasive interventioner som knogletransplantation og udskiftning af søm (P = 0,0326).
English: Very common
Danish: Hyppighed Meget almindelig almindelig
English: Tell your doctor immediately, or go immediately to the emergency department of your nearest hospital if you have localised swelling, which may result in breathing difficulties, after InductOs has been used in surgery of the upper (neck) region of your spine.
Danish: Fortæl omgående lægen det eller gå til nærmeste skadestue, hvis De får lokal hævelse, som kan medføre åndedrætsbesvær, efter at InductOs er blevet anvendt ved en operation i den øverste (hals) del af rygsøjlen.
English: Dibotermin alfa must only be used following reconstitution with the solvent and matrix provided in the InductOs pack.
Danish: Dibotermin alfa må kun bruges efter rekonstitution med solvenset og matrixen, der leveres i InductOs-pakningen.
English: If you think you have an allergic reaction to collagen, contact your doctor.
Danish: Hvis De mener, De kan være allergisk over for kollagen, så kontakt lægen.
English: None of the patients with positive titers to bovine Type I collagen had cross-reacting antibodies to human type I collagen.
Danish: Ingen af patienterne med positive titre for bovin type I-kollagen havde krydsreagerende antistoffer mod human type 1-kollagen.
English: In animal studies (rats) using InductOs containing radiolabelled dibotermin alfa, the mean residence time at the site of implantation was 4-8 days.
Danish: I dyrestudier (rotte) med radiomærket dibotermin alfa i InductOs, var middel-residualtiden på implantationsstedet 4-8 dage.
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.
Danish: Hulrummet af det lumbale interkorporale fusionsdevice skal fyldes omhyggeligt og løst med den mængde InductOs, der svarer til devicets indre volumen.
English: Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Implantation.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Implantation.
English: Heterotopic ossification1, 3*
Danish: Heterotop ossifikation1,3*
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.
Danish: • Undervisningsmateriale til læger og sundhedspersonale Undervisningsmaterialet til læger og sundhedspersonale skal indeholde følgende nøgleelementer: o En detaljeret beskrivelse fra produktresuméet af administrationsmetoderne for InductOs og af de forsigtighedsregler, der skal tages for at forhindre medicineringsfejl, ukorrekt anvendelse og minimere risikoen for heterotop ossifikation.
English: Entire matrix
Danish: Hele matrixen
English: It is used in addition to standard treatment and care of shin bone fractures.
Danish: Det anvendes som supplement til standardbehandling og pleje af skinnebensbrud.
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.
Danish: Det nødvendige volumen af InductOs bestemmes af det intervertebrale diskusrum og størrelsen, formen og det indre volumen af det/de anvendte lumbale interkorporale fusionsdevice(r).
English: Lower back spine fusion surgery Talk to your doctor if you have any of the following:
Danish: Fusionsoperation i den nederste del af rygsøjlen Tal med lægen, hvis De oplever noget af følgende:
English: The doctor treating you will implant InductOs during surgery.
Danish: Lægen, som behandler Dem, vil implantere InductOs under operationen.
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.
Danish: Dibotermin alfa (rekombinant humant knogle-morfogenetisk protein-2; rhBMP-2) er et humant protein, der er fremstillet ved rekombinant teknologi i en cellelinje fra kinesiske hamsteres æggestokke (CHO).
English: Dibotermin alfa binds to receptors on the surface of mesenchymal cells and causes cells to differentiate into cartilage- and bone-forming cells.
Danish: Dibotermin alfa binder til receptorer på overfladen af mesenchymale celler og får cellerne til at dele sig i brusk- og knogledannende celler.
English: There were no other alterations in foetal external, visceral, or skeletal morphology.
Danish: Der var ikke andre føtale morfologiske forandringer med hensyn til ydre og indre organer eller skelettet.
English: Clinical intervention (aspiration and/or surgical removal) may be required if symptoms persist (see section 4.8).
Danish: Klinisk intervention (dræn og/eller operativ fjernelse) kan være nødvendig, hvis symptomerne varer ved (se pkt.
English: Using sterile technique, place one syringe, one needle and the matrix inner package in the sterile field.
Danish: Med steril teknik anbringes en sprøjte, en nål og den indre matrix-emballage i det sterile område.