FrancophonIA/ELRC3.0 huggingface dataset:
English: InductOs 4 mg pack contains:
Danish: InductOs 4 mg pakning indeholder:
English: The matrix is pre-cut in 2 pieces each of 2.5 x 5 cm.
Danish: Matrixen er i forvejen blevet klippet i 2 stykker på hver 2,5 x 5 cm.
English: Due to the angiogenic activity of InductOs, fluid collection (pseudocyst, localised oedema, implant site effusion) can occur, sometimes encapsulated, sometimes resulting in nerve compression and/or pain.
Danish: På grund af InductOs' angiogene aktivitet kan der forekomme væskeansamling (pseudocyste, lokalt ødem, effusion på implantationsstedet), sommetider indkapslede, sommetider med nervekompression og/eller smerter til følge.
English: The use of the product in pregnant women is not advised.
Danish: Præparatet bør ikke anvendes til gravide kvinder.
English: As a single use product, InductOs has not been tested for in vivo carcinogenicity (see also section 4.3).
Danish: Da InductOs er til engangsbrug, er det ikke blevet testet for in vivo-karcinogenicitet (se også pkt.
English: Although narrowing of the neuroforamen and stenosis was observed, no mineralization of the dura, no spinal cord stenosis, and no neurological deficits subsequent to the application of InductOs were observed.
Danish: Der blev ikke observeret nogen mineralisation af dura, ingen rygmarvsstenose eller neurologiske defekter efter påføring af InductOs.
English: Powder, solvent and matrix for implantation matrix contain:
Danish: Pulver, solvens og matrix til matrix til implantation indeholder:
English: Special warnings and precautions for use specific to lumbar interbody fusion
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen specielt ved lumbal interkorporal fusion:
English: Use of InductOs in patients undergoing cervical spine surgery in amounts lower than or similar to those for lumbar interbody fusion has been associated with reports of localised oedema severe enough to result in airway compromise (see section 4.4).
Danish: Brug af InductOs til patienter, der opereres i den cervikale del af rygsøjlen, i mængder, der er mindre end eller lig med de mængder, der anvendes til lumbal interkorporal fusion, er blevet forbundet med rapporter om lokalt ødem, der er tilstrækkeligt svært til at resultere i påvirkning af luftvejene (se pkt.
English: Patients received (in a 1:1:1 ratio) standard care (control group) consisting of intramedullary (IM) nail fixation and routine soft-tissue management, standard care plus InductOs 0.75 mg/ml, or standard care plus InductOs 1.5 mg/ml.
Danish: Patienterne modtog (i forholdet 1:1:1) standardbehandling (kontrolgruppe) omfattende intramedullær (IM) sømfiksering og rutinemæssig behandling af bløddele, standardbehandling plus InductOs 0,75 mg/ml, eller standardbehandling plus InductOs 1,5 mg/ml.
English: If you have a lot of pain from a damaged disc in your lower back, and other treatments have not proven effective, you may be considered for lower back spine fusion surgery.
Danish: Hvis De har mange smerter fra en ødelagt diskus i den nedre del af ryggen, og anden behandling ikke har vist sig effektiv, kan det være, De kan blive opereret for det. InductOs bruges i stedet for at tage et knogletransplantat fra hoften.
English: BATCH NUMBER Lot
Danish: BATCHNUMMER Lot:
English: Special warnings and precautions for use specific to acute tibia fractures
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen specielt ved akutte tibiafrakturer:
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, Bone Morphogenetic Proteins, ATC code: M05BC01
Danish: Knoglemorfogenetiske proteiner, ATC-kode: M05BC01
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.
Danish: I kliniske studier, hvor degenerativ diskussygdom blev behandlet ved hjælp af en posterior lumbal interkorporal fusionsprocedure med dibotermin alfa, observeredes posterior knogledannelse i CTscanninger.
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.
Danish: Lad matrixen ligge i bakken og fordel 1,4 ml dibotermin alfa-opløsning ENSARTET over hver af de to 2,5 x 5 cm matrixer som vist på figuren nedenfor.
English: InductOs 12 mg pack contains:
Danish: InductOs 12 mg pakning indeholder:
English: In the long-bone fracture studies, over 500 patients received InductOs.
Danish: I studier med fraktur af lange knogler fik mere end 500 patienter InductOs.
English: An increased rate of infection was observed in the InductOs-treated group versus the standard of care control group (19% versus 9%, respectively; see section 4.4).
Danish: En øget infektionshyppighed blev observeret i den InductOs-behandlede gruppe i forhold til kontrolgruppen, der fik standardbehandling (henholdsvis 19 % og 9 %; se pkt.
English: Osteolysis* Resorption bone increased*
Danish: Osteolyse* Øget knogleresorption*
English: • One matrix (7.5 cm x 10 cm) in a blister package (polyvinyl chloride - PVC).
Danish: • en matrix (7,5 cm x 10 cm) i en blisterpakning (polyvinylchlorid - PVC)
English: In a pooled safety data analysis of 8 clinical trials at 24 months post-surgery, the frequency of patients with pseudarthrosis was approximately 2-fold lower following treatment with InductOs (4.8%, 22 out of 456 patients) compared with autogenous bone graft (12.7%, 31 out of 244 patients).
Danish: I en analyse af puljede sikkerhedsdata fra 8 kliniske studier 24 måneder efter operation var frekvensen af patienter med pseudoartrose ca. 2 gange lavere efter behandling med InductOs (4,8 %, 22 ud af 456 patienter) sammenlignet med autogent knogletransplantat (12,7 %, 31 ud af 244 patienter).
English: Dosing table for InductOs 12 mg pack Portion of InductOs wetted matrix (12 mg pack)
Danish: Doseringstabel for InductOs 12 mg pakning Del af InductOs våd matrix (12 mg pakning)
English: InductOs may be used either in lower back spine fusion surgery or to repair fractures of the shin bone.
Danish: InductOs kan bruges enten ved operation af den nedre del af rygsøjlen eller til reparation af brud på skinnebenet.
English: This medicinal product contains less than 1 mmol (23 mg) sodium per maximum dose (two 12 mg packs), i.e. it is essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 ng) natrium pr. maksimumdosis (to 12 mg pakninger), dvs. det er næsten 'natriumfrit'.
English: Do not shake.
Danish: Ryst ikke.
English: This medicine contains less than 1 mmol (23 mg) sodium per maximum dose (two 12 mg packs), i.e. it is essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23) mg natrium pr. maksimumdosis (to 12 mg pakninger), dvs. det er stort set 'natrium-frit'.
English: 2 syringes (10 ml)
Danish: 2 sprøjter (10 ml)
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.
Danish: I kliniske studier med akut tibiafraktur oplevede flere InductOs-patienter, som samtidig tog NSAID i 14 sammenhængende dage, lette eller moderate bivirkninger i forbindelse med sårheling (f.eks. ekssudat) end InductOs-patienter, der ikke tog NSAID.
English: The use of these products in close proximity to InductOs is not recommended as this may lead to bone formation at the site of implant of the fibrin-based haemostatic agent or sealant (see section 4.2).
Danish: Anvendelse af disse stoffer i umiddelbar nærhed af InductOs frarådes, da det kan føre til knogledannelse på implantationsstedet for det fibrinbaserede hæmostatikum eller vævsklæber (se pkt.
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).
Danish: I en to-årig opfølgningsperiode af kliniske studier med lumbal interkorporal fusion ved anvendelse af en posterior metode forekom heterotop ossifikation obsereret på røntgenbilleder oftere hos patienter behandlet med InductOs sammenlignet med autotransplantat (se pkt.
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).
Danish: En post-hoc-metaanalyse af 6 kontrollerede kliniske studier med data fra patienter behandlet med InductOs eller autogent knogletransplantat, der blev administreret ved anvendelse af CE-mærkede interkorporale fusionsdevices eller allotransplantat-knoglespacere og forskellige operationsmetoder, viste, at InductOs 24 måneder efter operation var forbundet med en højere succeshyppighed for fusion (95 %, 241 ud af 255 patienter), sammenlignet med autogent knogletransplantat (85 %, 177 ud af 209 patienter) med en odds ratio på 3,26 (95 % CI: 1,172, 9,075; P = 0,024).
English: For pain and disability (Oswestry score), the success rate was 72.9% in the group using InductOs versus 72.5% in the group using autogenous bone graft (95% two-sided CI of the difference: -11.2, 12.0).
Danish: For smerte og handicap (Oswestry score) var positivt udfald 72,9 % i gruppen, der fik InductOs, versus 72,5 % i gruppen, der fik autogen knogletransplantat (95 % to-sidet konfidensinterval for forskellen: -11,2; 12,0).
English: InductOs must be placed within the lumbar interbody fusion device(s) or in the anterior portion of the intervertebral disc space.
Danish: InductOs skal anbringes i det/de lumbale interkorporale fusionsdevice(s) eller i den anteriore del af det intervertebrale diskusrum.
English: No clinical data are available; potential risk for human is unknown.
Danish: Den potentielle risiko for mennesker er ukendt.
English: Other medicines and InductOs
Danish: Brug af anden medicin sammen med InductOs
English: 2/3 of the matrix
Danish: 2/3 af matrixen
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).
Danish: 24 måneder efter operationen påvistes det, at InductOs statistisk set var non-inferiort til autogent knogletransplantat med et positivt udfald ved røntgenologisk bestemt fusion på 94,4 % for InductOs mod 88,9 % for autogent knogletransplantat (95 % to-sidet konfidensinterval for forskellen: -1,53; 12,46).
English: Pharmacodynamic information specific to acute tibia fracture studies
Danish: Farmakodynamiske oplysninger specielt fra studier af akut tibiafraktur:
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.
Danish: Hvis De behandles med InductOs for skinnebensbrud, vil Deres læge ad kirurgisk vej anbringe InductOs omkring bruddet på knoglen, når Deres fraktur behandles.
English: The most severe adverse reaction is localised oedema in cervical spine surgery.
Danish: Den alvorligste bivirkning er lokalt ødem ved cervikal spinalkirurgi.
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).
Danish: Der skal udvises omhu og forsigtighed for at undgå overfyldning af det lumbale interkorporale fusionsdevices og/eller den anteriore del af det intervertebrale diskusrum (se pkt.
English: InductOs 1.5 mg/ml was significantly effective (compared to standard care) in patients both with or without a history of smoking.
Danish: Behandling med InductOs 1,5 mg/ml var signifikant mere effektiv (sammenlignet med standardbehandling) for alle patienter, uanset om de var/havde været rygere eller ej.
English: In an in vitro study, dibotermin alfa was shown to bind to fibrin-based haemostatic agents or sealants.
Danish: Det er i et in vitro-studie blevet vist, at dibotermin alfa binder til fibrinbaserede hæmostatika og vævsklæbere.
English: Read the Summary of Product Characteristics before use.
Danish: Læs produktresuméet før brug.
English: As part of the pharmacological mechanism of action of dibotermin alfa, bone remodelling occurs (see section 5.1).
Danish: Som en del af dibotermin alfas farmakologiske virkning forekommer knogleremodellering (se pkt.
English: Powder, solvent and matrix for implantation matrix.
Danish: Pulver, solvens og matrix til matrix til implantation.
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).
Danish: I det centrale studie af akut tibiafraktur øgede InductOs sandsynligheden for frakturheling; patienter som blev behandlet med InductOs 1,5 mg/ml havde en 44 % reduktion af risiko for mislykket behandling (sekundær intervention for at fremme frakturhelingen) sammenlignet med patienterne i gruppen med standardbehandling (RR=0,56; 95 % CI=0,40 til 0,78).
English: The oedema was delayed in onset and, in some cases, severe enough to result in airway compromise (see section 4.4).
Danish: Ødemet opstod forsinket i begyndelsen og var i nogle tilfælde så alvorligt, at det var luftvejskompromitterende (se pkt.
English: Slowly inject the solvent into the vial containing the lyophilised dibotermin alfa.
Danish: Injicer langsomt solvensen i hætteglasset, der indeholder den frysetørrede dibotermin alfa.
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.
Danish: Yderligere har prækliniske studier indikeret, at hvis der opstår fraktur på en InductOs-induceret knogle, reparerer dette sig selv på en måde, som ikke er til at skelne fra patientens eget knoglevæv.
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 September 2002
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: • You should inform your doctor if you have kidney or liver disease.
Danish: • De skal fortælle det lægen, hvis De lider af en nyre- eller leversygdom.
English: The maximum dosage is limited to 24 mg (2 entire 12 mg pack matrices).
Danish: Maksimaldosis er 24 mg (2 hele 12 mg paknings-matrixer).
English: 4 mg pack:
Danish: 4 mg pakning:
English: The use of InductOs with reamed nails in open tibial fracture repair is not recommended.
Danish: Brug af InductOs sammen med opboret sømfiksering til behandling af åben tibiafraktur anbefales ikke.
English: • Two matrices (2.5 cm x 5 cm) in a blister package (polyvinyl chloride - PVC).
Danish: • to matrixer (2,5 cm x 5 cm) i en blisterpakning (polyvinylchlorid - PVC)
English: Pharmacodynamic information specific to lumbar interbody fusion studies
Danish: Farmakodynamiske oplysninger specielt fra studier af interkorporal fusion:
English: Using aseptic transfer technique and the syringe and needle from step 1, withdraw 8.0 ml of the reconstituted dibotermin alfa solution from the vial in the non-sterile field, holding up the inverted vial to facilitate withdrawal.
Danish: Ved hjælp af aseptisk teknik og kanyle og nål fra trin 1, udtages 8,0 ml af den rekonstituerede dibotermin alfa-opløsning fra hætteglasset i det ikke-sterile område ved at holde hætteglasset med bunden i vejret for at lette udtrækningen.
English: Matrix: Bovine Type I collagen
Danish: Matrix: Bovint type 1-kollagen
English: Both dibotermin alfa and bovine Type I collagen have been found to elicit immune responses in patients.
Danish: Immunrespons Både dibotermin alfa og bovin type 1-kollagen kan fremkalde immunreaktion hos patienten.
English: Matrix: bovine Type I collagen
Danish: Matrix: Bovin type 1-kollagen
English: The proportion of patients with healed soft-tissue wounds was significantly higher at the 6-week post-treatment visit in the InductOs 1.5 mg/ml group compared with the standard-care group (83% versus 65%; P= 0.0010).
Danish: Andelen af patienter med helede sår i bløddelene var signifikant højere ved besøget 6 uger efter behandlingen i den gruppe, der modtog InductOs 1,5 mg/ml, sammenlignet med den gruppe, der modtog standardbehandling (83 % vs. 65 %; P = 0,0010).
English: The safety and effectiveness of InductOs in spine surgery in the neck have not been established, and InductOs should not be used in this situation.
Danish: Sikkerheden og virkningen af InductOs ved operation af rygsøjlen i nakken er ikke fastslået, hvorfor det ikke kan anbefales at anvende InductOs i forbindelse med denne operation.
English: Using aseptic transfer technique and the syringe and needle from step 1, withdraw 2.8 ml of the reconstituted dibotermin alfa solution from the vial in the non-sterile field, holding up the inverted vial to facilitate withdrawal.
Danish: Ved hjælp af aseptisk teknik og kanyle og nål fra trin 1 udtages 2,8 ml af den rekonstituerede dibotermin alfa-opløsning fra hætteglasset i det ikke-sterile område ved at holde hætteglasset med bunden i vejret for at lette udtrækningen.
English: Driving and using machines InductOs will not affect your ability to drive or operate machines.
Danish: Trafik- og arbejdssikkerhed InductOs påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: Post-Implantation
Danish: Efter implantation
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).
Danish: Andelen af patienter med materialefejl (låseskruer bøjet eller knækket) var signifikant lavere i InductOs 1,5 mg/ml gruppen sammenlignet med den gruppe, der modtog standardbehandling (11 % vs. 22 %; P = 0,0174).
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.
Danish: Anti-dibotermin alfa antistoffer: I studier med spinal fusion udviklede 1,3 % af patienterne behandlet med InductOs antistoffer mod dibotermin alfa sammenlignet med 0,8 % af patienterne behandlet med autogent knogletransplantat.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for InductOs
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til InductO
English: 12 mg pack:
Danish: 12 mg pakning:
English: Using the remaining syringe and needle from the pack, reconstitute the dibotermin alfa vial with 3.2 ml of solvent.
Danish: Ved hjælp af den anden sprøjte og nålen fra pakningen rekonstitueres indholdet af dibotermin alfa hætteglasset med 3,2 ml solvens.
English: 1/6 of the matrix
Danish: 1/6 af matrixen
English: • Two syringes (5 ml; polypropylene).
Danish: • to sprøjter (5 ml, polypropylen)
English: Once prepared, InductOs contains dibotermin alfa at a concentration of 1.5 mg/ml.
Danish: Efter klargøring indeholder InductOs dibotermin alfa med en koncentration på 1,5 mg/ml.
English: Leaving the matrix in its tray, UNIFORMLY distribute the dibotermin alfa solution on the matrix, following the pattern in the figure below.
Danish: Lad matrixen ligge i bakken og fordel dibotermin alfa-opløsningen ENSARTET over matrix som vist på figuren nedenfor.
English: Sucrose
Danish: Saccharose
English: If a surgical drain is required, the drain should be placed remotely from the implantation site or, preferably, one layer superficial to the implantation site.
Danish: Hvis der er behov for kirurgisk dræn, skal drænet anbringes på afstand af implantationsstedet eller helst et lag over implantationsstedet.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 sterile matrix (7.5 x 10 cm)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1 steril matrix (7,5 x 10 cm)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 sterile matrices (2.5 x 5 cm)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 2 sterile matrixer (2,5 x 5 cm) ANDET
English: Powder: sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide and polysorbate 80 Solvent: water for injections
Danish: Pulver: Saccharose, glycin, glutaminsyre, natriumchlorid, natriumhydroxid og polysorbat 80.
English: What InductOs contains - The active substance in InductOs is dibotermin alfa (also called recombinant human Bone
Danish: InductOs indeholder: - Aktiv stof: Dibotermin alfa (også kaldet rekombinant humant morfogenetisk knogleprotein,
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 4 mg (4 mg pack) or 12 mg (12 mg pack) dibotermin alfa.
Danish: Et hætteglas indeholder 4 mg (4 mg pakning) eller 12 mg (12 mg pakning) dibotermin alfa.
English: • Two syringes (10 ml; polypropylene).
Danish: • to sprøjter (10 ml, polypropylen)
English: Morphogenetic Protein-2), 4 mg (4 mg pack) or 12 mg (12 mg pack).
Danish: rhBMP-2), 4 mg (4 mg pakning) eller 12 mg (12 mg pakning).
English: Using the remaining syringe and needle from the pack, reconstitute the dibotermin alfa vial with 8.4 ml of solvent.
Danish: Ved hjælp af den anden sprøjte og nålen fra pakningen rekonstitueres indholdet af dibotermin alfa hætteglasset med 8,4 ml solvens.
English: Acute tibia fracture surgery
Danish: Akut tibiafrakturkirurgi
English: Peel open the interior package of the matrix and leave the matrix in its tray.
Danish: Åbn den indre matrix-emballage og lad matrix ligge i deres bakke.
English: The safety and efficacy of InductOs in cervical spine surgery have not been established, and InductOs should not be used in this condition.
Danish: InductOs' sikkerhed og virkning ved operation af den cervikale del af rygsøjlen er ikke klarlagt, derfor kan InductOs ikke anbefales ved denne operation.
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).
Danish: I et klinisk studie med opboring af den intramedullære kanal til det punkt, hvor der blev opnået kontakt med den kortikale siden af knoglen, blev der observeret en øget infektionshyppighed i den gruppe, som blev behandlet med InductOs, i forhold til kontrolgruppen, som fik standardbehandling (se pkt.
English: Pre-Implantation
Danish: Før implantation
English: 2 needles
Danish: 2 nåle
English: In long-bone fracture studies, 6.3% of patients receiving dibotermin alfa with bovine Type I collagen matrix developed antibodies to dibotermin alfa versus 1.3% in the control group.
Danish: I studier med fraktur af lange knogler udviklede 6,3 % af patienterne, behandlet med dibotermin alfa med bovin type 1-kollagenmatrix, antistoffer mod dibotermin alfa sammenlignet med 1,3 % i kontrolgruppen.
English: Concentration of wetted matrix
Danish: Koncentration af våd matrix
English: • You should inform your doctor of any history of cancer.
Danish: • De skal informere Deres læge, hvis De har haft kræft - uanset hvilken type.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Powder for InductOs 1.5 mg/ml dibotermin alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Pulver til InductOs 1,5 mg/ml dibotermin alfa
English: InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix Dibotermin alfa
Danish: InductOs 1,5 mg/ml pulver, solvens og matrix til matrix til implantation Dibotermin alfa
English: Bone resorption increased
Danish: Forøget knogleresorption
English: 1/3 of the matrix
Danish: 1/3 af matrixen