FrancophonIA/ELRC3.0 huggingface dataset:
English: InductOs is indicated for single-level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non-operative treatment for this condition.
Danish: InductOs er indiceret ved enkelniveau lumbal interkorporal spinal fusion som erstatning for autogent knogletransplantat hos voksne med degenerativ diskussygdom, som i mindst 6 måneder er behandlet ikke-operativt for denne sygdom.
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.
Danish: InductOs evne til at understøtte genformningen af knoglen kan være årsagen til den biologiske og biomekaniske integration af den nye knogle med den omgivende knogle, som InductOs medfører.
English: InductOs should be placed bridging the fracture region and making good contact with the major proximal and distal fragments.
Danish: InductOs skal anbringes, så det dækker frakturområdet og opnår god kontakt med de større proksimale og distale fragmenter.
English: No impact on fertility was detected in non-clinical studies.
Danish: Der er ikke detekteret nogen indvirkning på fertiliteten i prækliniske studier.
English: • absence of large segmental defect repair of long bones, in which significant soft tissue compression can occur
Danish: • fravær af store segmentdefekter i lange knogler, som medfører risiko for kompression af blødt væv
English: Information from clinical studies in acute tibia fractures indicated that the use of InductOs in patients receiving glucocorticoids was not associated with any apparent adverse reactions.
Danish: Information fra kliniske studier af akutte tibiafrakturer indikerer at brug af InductOs hos patienter behandlet med glukokortikoider, ikke var forbundet med nogen åbenbare negative reaktioner.
English: Non-clinical studies have suggested that bone formation initiated by InductOs is a self-limiting process, forming a well-defined volume of bone.
Danish: Prækliniske studier har antydet, at knogledannelse, der fremkaldes af InductOs, er en selvbegrænsende proces, der danner en veldefineret mængde knogle.
English: Anti-dibotermin antibodies have been investigated in pregnant rabbits following hyper-immunisation with dibotermin alfa to experimentally induce anti-dibotermin alfa antibodies.
Danish: Anti-dibotermin antistoffer er undersøgt hos drægtige kaniner efter hyper-immunisering med dibotermin alfa for eksperimentelt at fremkalde anti-dibotermin alfa antistoffer.
English: For use with unreamed nails, estimated rates of infection were similar between treatment and control groups in a study (21% versus 23%, respectively).
Danish: Ved brug sammen med ikke-rømmede søm var de skønnede infektionshyppigheder sammenlignelige i behandlings- og kontrolgruppen i et studie (henholdsvis 21 % og 23 %).
English: Use of InductOs may cause heterotopic ossification at the site of implantation and/or the surrounding tissues, which may result in complications.
Danish: InductOs kan forårsage heterotop ossifikation på implantationsstedet og/eller de omgivende væv, hvilket kan resultere i komplikationer.
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.
Danish: InductOs må ikke implanteres posteriort for det lumbale interkorporale fusionsdevice, hvor der er mulighed for direkte adgang til spinalkanalen og/eller nerverødder.
English: Discard syringe and needle after use.
Danish: Kassér sprøjte og nål efter brug.
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.
Danish: • De skal informere Deres læge, hvis De lider af en autoimmun sygdom som f.eks. reumatoid artrit, systemisk lupus erythematosus, sklerodermi, Sjögrens syndrom eller dermatomyositis/polymyositis.
English: Although no association with clinical outcome or undesirable effects could be observed in clinical studies, the possibility of developing neutralising antibodies or hypersensitivity-type reactions cannot be excluded.
Danish: Selvom der ikke blev observeret nogen sammenhæng mellem det kliniske udbytte og den uønskede virkning i de kliniske studier, kan muligheden for at udvikle neutraliserende antistoffer eller hypersensitivitetsreaktioner ikke udelukkes.
English: InductOs has no or negligible influence on the ability to drive and use machines.
Danish: InductOs påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The safety and efficacy of InductOs have not been demonstrated in patients with metabolic bone diseases.
Danish: Sikkerhed og virkning af InductOs er ikke klarlagt hos patienter med metaboliske knoglesygdomme.
English: BATCH NUMBER LOT: see reverse
Danish: BATCHNUMMER Lot: Se modsatte side
English: The matrix is in 1 piece of 7.5 cm x 10 cm.
Danish: Matrixen er i 1 stykke på 7,5 cm x 10 cm.
English: Localised oedema was common when InductOs was used for cervical spine fusion.
Danish: Lokalt ødem var almindeligt, når InductOs blev anvendt til cervikal spinal fusion.
English: What you need to know before you receive InductOs
Danish: Det skal De vide, før De begynder at bruge InductOs
English: METHOD OF ADMINISTRATION Read the Summary of Product Characteristics before use
Danish: ADMINISTRATIONSMETODE Læs produktresuméet før brug
English: Swirl the vial gently to aid reconstitution.
Danish: Skvulp forsigtigt hætteglasset for at fremme rekonstitution.
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.
Danish: Virkning og sikkerhed ved InductOs-behandling blev påvist i et randomiseret, kontrolleret, multicenter, ikke-interventionsstudie med 279 patienter i alderen 19-78 år behandlet med åben interkorporal fusion.
English: The estimated absolute difference in fusion success rate between InductOs and autogenous bone graft was 11.7% (95% CI: 0.8%, 22.5%; P = 0.035).
Danish: Den estimerede, absolutte forskel i fusions-succeshyppighed mellem InductOs og autogent knogletransplantat var 11,7 % (95 % CI: 0,8 %, 22,5 %; P = 0,035).
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).
Danish: Hvis der er risiko for lækage til spinalkanalen og nerveroden, skal der genskabes en fysisk barriere mellem matrixen og eventuelt neurologisk væv ved anvendelse af for eksempel lokal knogle eller allotransplantat (se pkt.
English: Dibotermin alfa is an osteoinductive protein that results in the induction of new bone tissue at the site of implantation.
Danish: Dibotermin alfa er et osteoinduktivt protein, der medfører induktion af nyt knoglevæv på implantationsstedet.
English: • used in surgical techniques other than lumbar interbody fusion To avoid exaggerated pharmacological effects of InductOs, care and caution should be used to prevent overfilling the lumbar interbody fusion device and/or the anterior portion of the intervertebral disc space.
Danish: • anvendt ved andre kirurgiske teknikker end lumbal interkorporal fusion For at undgå overdreven farmakologisk virkning af InductOs skal der udvises omhu og forsigtighed for at undgå overfyldning af det lumbale interkorporal fusionsdevice og/eller den anteriore del af det intervertebrale diskusrum.
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.
Danish: I reproduktionstoksicitetsstudier på rotter, hvor dibotermin alfa blev administreret intravenøst for at maksimere den systemiske optagelse, blev der observeret forøget føtal vægt og forøget føtal ossifikation, og en behandlingsrelateret virkning kunne ikke udelukkes.
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.
Danish: Histologiske resultater fra dyrestudier af lumbal interkorporal fusion ved anvendelse af anteriore eller posteriore operationsmetoder viste, at dibotermin alfa administreret med titan, PEEK eller allotransplantat interkorporal devices var biokompatibelt og frembragte konsekvent høje hyppigheder af fusion uafhængigt af operationsmetode eller devicemateriale med mindre synligt fibrøst væv sammenlignet med autotransplantat.
English: Definitive fracture reduction, fixation, and haemostasis should be achieved prior to InductOs implantation.
Danish: Der skal opnås fuldstændig frakturreduktion, fiksering og hæmostase forud for implantation af InductOs.
English: Device dislocation
Danish: Dislokation af device
English: In lumbar interbody fusion studies, over 600 patients received InductOs.
Danish: I studier med lumbal interkorporal fusion fik over 600 patienter InductOs.
English: For instructions to implant the lumbar interbody fusion device, please refer to the manufacturer's instructions for use.
Danish: For instruktioner i implantation af det lumbale interkorporale fusionsdevice henvises til fremstillerens brugsanvisning.
English: The maximum dosage is limited to 8 mg (5.3 cm3 of wetted matrix) of InductOs in the intervertebral disc space.
Danish: Den maksimale dosis er begrænset til 8 mg (5,3 cm3 våd matrix) InductOS i det intervertebrale diskusrum.
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.
Danish: Lokal infektion specifikt for den frakturerede ekstremitet var meget almindeligt (>1/10) hos patienter i et klinisk studie, hvor den intramedullære kanal blev oprømmet, til kontakt med knogle kunne høres.
English: Device dislocation can occur after the use of InductOs in spinal fusion surgery that may necessitate surgical revision (see section 4.8).
Danish: Der kan forekomme dislokation af device efter brug af InductOs ved spinal fusionskirurgi, hvilket kan nødvendiggøre kirurgisk revision (se pkt.
English: Glutamic acid Sodium chloride Polysorbate 80 Sodium hydroxide
Danish: Glutaminsyre Natriumchlorid Polysorbat 80
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.
Danish: Hvis kun en del af præparatet er nødvendigt ved den kirurgiske procedure, skal den våde matrix klippes til i den ønskede størrelse og den ubrugte del kasseres.
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.
Danish: InductOs virkning blev påvist i et multinational, randomiseret, kontrolleret, enkeltblindet studie af 450 patienter (aldersinterval 18 til 87 år; 81 % mænd) med åbne tibiaskaftfrakturer, der krævede kirurgisk indgreb.
English: Care must be taken not to compress the product or overfill the volume intended for new bone formation (see section 4.4).
Danish: Der skal udvises omhu med ikke at komprimere præparatet eller overfylde volumenet, der er beregnet til ny knogledannelse (se pkt.
English: It is not known if InductOs passes into breast milk.
Danish: Det vides ikke, om InductOs udskilles i mælken hos mennesker.
English: InductOs can cause initial resorption of surrounding trabecular bone as evidenced by radiolucency.
Danish: InductOs kan forårsage begyndende resorption af omgivende trabekulær knogle, hvilket er påvist ved radiolucens.
English: Device dislocation1* Fluid collection2*
Danish: Dislokation af device1* Væskeansamling2*
English: The proportion of patients healed after treatment with InductOs 1.5 mg/ml was significantly higher at all visits from 10 weeks to 12 months post-operative, suggesting accelerated fracture healing.
Danish: Andelen af patienter, som helede efter behandling med InductOs 1,5 mg/ml, var signifikant bedre ved alle besøg fra 10 uger til 12 måneder efter operationen, hvilket tyder på en accelereret frakturheling.
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).
Danish: På grund af den ukendte risiko for fosteret i forbindelse med potentiel udvikling af neutraliserende antistoffer mod dibotermin alfa bør InductOs ikke anvendes under graviditeten og til fertile kvinder, som ikke anvender sikker kontraception (se pkt.
English: InductOs must be prepared exactly in accordance with the directions for preparation (see section 6.6).
Danish: InductOs skal klargøres nøjagtigt ifølge anvisningerne til klargøring (se pkt.
English: InductOs is indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.
Danish: InductOs er indiceret til behandling af akut tibiafraktur hos voksne, som et supplement til standardbehandling ved reduktion af åbne brud og intramedullær, ikke-opboret sømfiksering.
English: The safety and efficacy of the use of InductOs in patients with known autoimmune disease have not been established.
Danish: Sikkerhed og virkning af InductOs hos patienter med kendt autoimmun sygdom er ikke klarlagt.
English: Do not store above 30°C.
Danish: Må ikke opbevares ved temperaturer over 30 oC.
English: InductOs is active at the site of implantation.
Danish: InductOs virker på implantationsstedet.
English: • Localised swelling, in some cases resulting in breathing difficulty, has been reported in patients when InductOs has been used in surgery of the upper (neck) region of the spine.
Danish: • Lokaliseret hævelse, som i nogle tilfælde har resulteret i vejrtrækningsbesvær, har været rapporteret hos patienter, ved brug af InductOs i forbindelse med operation af den øverste del af rygsøjlen (halsen).
English: − Keep this leaflet.
Danish: - Gem indlægssedlen.
English: InductOs contains the active substance, dibotermin alfa.
Danish: InductOs indeholder det aktive stof dibotermin alfa.
English: InductOs has been studied in a canine spinal implantation model.
Danish: InductOs er blevet afprøvet i en spinal implantationsmodel på hunde.
English: Placement of InductOs into trabecular bone resulted in transient resorption of the bone surrounding the implant, followed by replacement with new, more dense bone.
Danish: Anbringelse af InductOs i trabekulært knoglevæv medførte forbigående resorption af knoglen omkring implantatet efterfulgt af erstatning med nyt, tættere knoglevæv.
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).
Danish: Information om virkning er kun til rådighed fra kliniske studier, hvor åbne tibiale frakturer blev behandlet med intramedullær sømfiksering (se afsnit 5.1).
English: Marketing Authorisation Holder and Manufacturer Medtronic BioPharma B.V.
Danish: Indehaver af markedsføringstilladelsen og fremstiller Medtronic BioPharma B.V.
English: Severity of fractures: Treatment with InductOs 1.5 mg/ml was significantly effective in all fracture classes, including severe Gustilo IIIB fractures (52% reduced risk of secondary interventions as compared to standard-care patients).
Danish: Frakturens sværhedsgrad: Behandling med InductOs 1,5 mg/ml var signifikant mere effektiv i alle frakturklasser, inklusive alvorlige Gustilo IIIB-frakturer (52 % reduceret risiko for sekundære interventioner sammenlignet med patienter, der modtog standardbehandling).
English: The effects of InductOs on pregnancy are not known.
Danish: Graviditet og amning Virkningerne af InductOs hos gravide er ikke kendt.
English: Patients were randomised to receive a titanium interbody fusion device filled with either InductOs or autogenous bone graft taken from the iliac crest.
Danish: Patienterne blev randomiseret til et titan interkorporale fusionsdevice fyldt med enten InductOs eller autogent knogletransplantat fra hoftebenskammen.
English: • Pathological fractures such as those observed in (but not limited to) Paget's disease or in metastatic bone
Danish: • patologiske frakturer som de, der observeres ved Paget´s sygdom eller ved metastatiske knogler
English: • Skeletal immaturity
Danish: • umodent skelet
English: What InductOs looks like and contents of the pack InductOs is supplied to your doctor as a kit for implanting during surgery.
Danish: InductOs' udseende og pakningsstørrelse InductOs leveres til lægen som et sæt til implantation ved operation.
English: The powder is dissolved in the sterile water to form a solution that is used to soak the sponge.
Danish: Pulveret opløses i det sterile vand, og opløsningen bruges til at gennemvæde svampen.
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.
Danish: De hyppigste bivirkninger for InductOs ved lumbal interkorporal fusionskirurgi var radikulopatiske hændelser og ved akut tibiafrakturkirurgi lokaliseret infektion.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller , der er ansvarlig for batchfrigivelse
English: When used in lower back fusion surgery, InductOs is used in combination with a medical device, which corrects the position of your spine.
Danish: Ved operation i den nedre del af rygsøjlen anvendes InductOs sammen med en medicinsk anordning, som korrigerer rygsøjlens stilling.
English: If you get any side effects, talk to your doctor.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge.
English: As per standard practice, disc material and the cartilaginous portions of the vertebral endplates should be removed, preserving the cortical portions of the endplates, and haemostasis should be achieved (see section 4.5).
Danish: I henhold til standardpraksis skal diskusmateriale og de kartilaginøse dele af de vertebrale endeplader fjernes, mens de kortikale dele af endepladerne bevares, og der skal opnås hæmostase (se pkt.
English: If you are receiving InductOs for lower back spine fusion, your surgeon will remove the damaged disc that is causing the pain and replace it with a medical device filled with InductOs.
Danish: Hvis De behandles med InductOs i den nedre del af rygsøjlen, vil kirurgen fjerne den ødelagte diskus, som forårsager smerten, og erstatte den med en medicinsk anordning fyldt med InductOs.
English: These autoimmune diseases include rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis.
Danish: Disse autoimmune sygdomme omfatter reumatoid artrit, systemisk lupus erythematosus, sklerodermi, Sjøgrens syndrom og dermatomyositis/polymyositis.
English: InductOs should not be used in patients with history or clinical suspicion of malignancy at the site of application (see section 4.3).
Danish: IductOs bør ikke anvendes til patienter med maligniteter i anamnesen eller ved mistanke om kliniske maligniteter på applikationsstedet (se pkt.
English: In non-clinical studies, concurrent administration of glucocorticoids depressed bone repair (measured as a % change from control), but the effects of InductOs were not altered.
Danish: I prækliniske studier med samtidig administration af glukokortikoider blev knogleopbygningen nedsat (målt som en % ændring fra kontrolgruppen), men virkningen af InductOs blev ikke ændret.
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.
Danish: Dannelse af en væskeansamling (pseudocyste, lokalt ødem, ekssudat på implantationsstedet), nogle gange indkapslet og i visse tilfælde med nervekompression og smerter til følge, er rapporteret i forbindelse med InductOs.
English: In some cases it may lead to nerve compression potentially requiring surgical intervention (see section 4.8).
Danish: I nogle tilfælde kan det føre til nervekompression, der potentielt kan kræve kirurgisk intervention (se pkt.
English: • Dibotermin alfa is a white powder presented in a glass vial.
Danish: • Dibotermin alfa er et hvidt pulver, der leveres i et hætteglas.
English: If you have broken your shin bone, InductOs is used, to help your fracture heal and to reduce the need for additional surgeries.
Danish: Hvis De har brud på skinnebenet, anvendes InductOs til at få bruddet til at hele hurtigere og for at reducere behovet for yderligere kirurgi.
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).
Danish: I mangel på kliniske data bør præparatet derfor ikke appliceres direkte på trabekulær knogle, hvor forbigående knogleresorption kan udgøre en risiko for knogleskørhed (se pkt.
English: Typically, 4 mg (2.7 cm3 of wetted matrix) of InductOs is used in the intervertebral disc space.
Danish: Der anvendes typisk 4 mg (2,7 cm3 våd matrix) InductOs i det intervertebrale diskusrum.
English: Once InductOs and the lumbar interbody fusion device(s) are implanted, the inside of the intervertebral disc space must not be irrigated.
Danish: Når InductOs og det/de lumbale interkorporale fusionsdevice (s) er implanteret, må indersiden af det intervertebrale diskusrum ikke skylles.
English: • You should inform your doctor if you have any bone disease.
Danish: • De skal informere Deres læge, hvis De lider af en knoglesygdom.
English: Generally, one 12 mg pack is used; however, a maximum of two 12 mg packs may be used.
Danish: Generelt behandles en fraktur med indholdet af én 12 mg pakning, men der kan anvendes maksimalt to 12 mg pakninger.
English: Lumbar interbody fusion surgery
Danish: Lumbal interkorporal fusionskirurgi
English: You should not receive InductOs
Danish: Brug ikke InductOs
English: OTHER Medtronic BioPharma B.V.
Danish: ANDET Medtronic BioPharma B.V.
English: In clinical studies, the presence of antibodies to collagen was not associated with side effects, such as allergies, nor was it shown to decrease the effectiveness of InductOs.
Danish: I kliniske studier blev tilstedeværelsen af antistoffer mod kollagen ikke sat i forbindelse med bivirkninger som fx allergier, og der blev heller ikke påvist nogen reduktion i virkningen af InductOs.
English: As a precaution, a physical barrier between the matrix and any neurological tissue must be re-created (see section 4.2).
Danish: Som en forsigtighedsforanstaltning skal der genskabes en fysisk barriere mellem matrixen og eventuelt neurologisk væv (se pkt.
English: Outside the intervertebral disc space, the surgical field should be irrigated as needed, and any fluid loss from the wetted matrix should be washed away.
Danish: Uden for det intervertebrale diskusrum skal operationsfeltet skylles efter behov, og eventuel væske fra den våde matrix skal vaskes væk.
English: The wetted matrix should be cut into 6 equal pieces (approximately 2.5 x 5 cm) as an aid for dose selection.
Danish: Den våde matrix skal klippes i 6 ens stykker (ca. 2,5 x 5 cm) som en hjælp til dosisvalg.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl altid lægen, hvis De bruger anden medicin eller har gjortdet for nylig.