qanastek/EMEA-V3 huggingface dataset:
Once prepared, InductOs contains dibotermin alfa at a concentration of 1.5 mg/ ml (12 mg per vial).
Ġaladarba jkun ippreparat, InductOs ikun fih dibotermin alfa f’ konċentrazzjoni ta ’ 1. 5 mg/ ml (12 mg f’ kull kunjett).
InductOs should not be used in concentrations higher than 1.5 mg/ ml (see section 4.9).
InductOs m’ għandux jintuża f’ konċentrazzjonijiet ogħla minn 1. 5 mg/ ml (ara sezzjoni 4. 9).
There is very limited experience of the efficacy and safety of the medicinal product in the elderly (> 65 years of age).
Hemm esperjenza limitata ta ’ l- effikaċja u s- sigurtà tal- prodott mediċinali fl- anzjani (> 65 sena).
2 Paediatric use is not recommended until further data become available.
L- użu pedjatriku mhuwiex rakkomandat sakemm informazzjoni addizzjonali ssir disponibbli.
Product preparation
2 Preparazzjoni tal- prodott
In the non-sterile field
Fil- kamp mhux sterili
Using sterile technique, place one syringe, one needle and the matrix inner package in the sterile field.
Bl- użu tat- teknika sterili, poġġi siringa waħda, labra waħda u l- pakkett ta ’ ġewwa tal- matriċi fil - kamp sterili.
Disinfect the stoppers of the dibotermin alfa and solvent vials.
Iddiżinfetta t- tappijiet ta ’ dibotermin alfa u tal- kunjetti tas- solvent.
Using the remaining syringe and needle from the kit, reconstitute the dibotermin alfa vial with 8.4 ml of solvent.
Billi tuża s- siringa u l- labra li jibqa ’ fil- kitt, irrikostitwixxi l- kunjett b’ dibotermin alfa bi 8. 4 ml tas- solvent.
Slowly inject the solvent into the vial containing the lyophilised dibotermin alfa.
Injetta s- solvent bil- mod ġol- kunjett li jkun fih dibotermin alfa lijofilizzat.
Swirl the vial gently to aid reconstitution.
Dawwar il - kunjett bil- mod biex tgħin biex issir ir- rikostituzzjoni.
Do not shake.
Iċċaqlaqx.
Discard syringe and needle after use.
Armi s- siringa u l- labra wara l - użu.
Disinfect the stopper of the reconstituted dibotermin alfa vial.
Iddiżinfetta t- tapp tal- kunjett ta ’ dibotermin alfa rikostitwit.
In the sterile field
Fil- kamp sterili
Peel open the interior package of the matrix and leave the matrix in its tray.
Iftaħ il- pakkett ta ’ ġewwa tal- matriċi u ħalli l- matriċi fit- trej tagħha.
Using aseptic transfer technique and the syringe and needle from step 1, withdraw 8 ml of the reconstituted dibotermin alfa solution from the vial in the non-sterile field holding up the inverted vial to facilitate withdrawal.
Billi tuża t- teknika asettika tat- trasferiment, u s- siringa u l- labra minn pass 1, iġbed 8 ml tas - soluzzjoni rikostitwita ta ’ dibotermin alfa mill- kunjett fil- kamp mhux sterili, filwaqt li żżomm il - kunjett ta ’ taħt fuq biex tiffaċilita l- ġbid.
Leaving the matrix in its tray, UNIFORMLY distribute the dibotermin alfa solution on the matrix following the pattern in the figure below.
Filwaqt li tħalli l- matriċi fit- trej tagħha, poġġi B’ MOD UNIFORMI s- soluzzjoni ta ’ dibotermin alfa fuq il- matriċi billi ssegwi l- mod muri fil- figura hawn taħt.
Wait a MINIMUM of 15 minutes before using the prepared InductOs product.
Stenna MINIMU ta ’ 15- il minuta qabel ma tuża l- prodott ippreparat ta ’ InductOs.
The product must be used within 2 hours after preparation.
Il- prodott għandu jintuża fi żmien sagħtejn wara li jkun ippreparat.
To prevent overloading the matrix, it is important to reconstitute the dibotermin alfa and to wet the entire sponge as described above.
Biex tevita li tgħabbi żżejjed lill- matriċi, hu importanti li tirrikostitwixxi dibotermin alfa u li xxarrab l - isponża kollha kif deskritt hawn fuq.
Follow instructions relevant to the planned surgery – anterior lumbar spine fusion or acute tibia fracture repair.
Segwi l- istruzzjonijiet rilevanti għall- operazzjoni ppjanata – fużjoni tas- sinsla tad- dahar lumbari anterjuri jew tiswija ta ’ ksur akut fil- qasba tas- sieq.
Instructions for use in anterior lumbar spine fusion surgery
Struzzjonijiet għall- użu għall- operazzjoni tal- fużjoni tas- sinsla tad- dahar lumbari anterjuri
InductOs should not be used alone for this indication, but must be used with the LT-CAGE Lumbar Tapered Fusion Device.
InductOs m’ għandux jintuża waħdu għal din l- operazzjoni, iżda jrid jintuża mal- LT- CAGE Tagħmir tal- Fużjoni Lumbari Tapered.
Failure to follow the product preparation instructions for InductOs may compromise its safety and effectiveness.
Jekk tonqos li ssegwi l- istruzzjonijiet għall- preparazzjoni tal- prodott għal InductOs, dan jista ’ jikkomprometti s- sigurtà u l- effettività tiegħu.
(see section 4.4)
Għandha tingħata attenzjoni biex jiġi evitat li timla żżejjed l- ispazju construct u/ jew intervertebrali (ara sezzjoni 4. 4).
Pre-Implantation
Qabel l- Impjantazzjoni
Cut the wetted matrix of InductOs into 6 equal (approximately 2.5 x 5 cm) pieces.
Aqta ’ l- matriċi mxarrba ta ’ InductOs f’ 6 biċċiet ugwali (madwar 2. 5 x 5 ċm).
During cutting and handling, avoid excessive fluid loss from InductOs.
Matul il- qtugħ u l - immaniġġjar, evita telf eċċessiv ta ’ fluwidu minn InductOs.
Do not squeeze.
Tagħfashiex.
The number of pieces of InductOs required is determined by the size of the LT-CAGE Lumbar Tapered Fusion Device being used.
In- numru ta ’ biċċiet meħtieġa ta ’ InductOs jiġu stabbiliti mid- daqs tal- LT- CAGE Tagħmir tal- Fużjoni Lumbari Tapered li jkun qed jintuża.
Using the table below, identify the number of 2.5 x 5 cm pieces of InductOs required for the size of LT-CAGE Lumbar Tapered Fusion Device.
Billi tuża t- tabella t’ hawn taħt, identifika n- numru ta ’ biċċiet 2. 5 x 5 ċm ta ’ InductOs li huma meħtieġa għad- daqs tal- LT- CAGE Tagħmir tal- Fużjoni Lumbari Tapered.
LT-CAGE Lumbar Tapered Fusion Device size (lead diameter x length)
Numru ta ’ biċċiet 2. 5 x 5 ċm ta ’ InductOs kull Daqs tal- LT- CAGE Tagħmir tal- Fużjoni LT- CAGE Tagħmir tal- Fużjoni Lumbari Lumbari Tapered
Number of 2.5 x 5 cm pieces of InductOs per LT-CAGE Lumbar Tapered Fusion Device
(dijametru tal- lead x tul)
Implantation
L- impjantazzjoni
4 Using forceps to avoid excessive squeezing, carefully roll the required number of InductOs pieces for each LT-CAGE device and insert each roll into the matching LT-CAGE Lumbar Tapered Fusion Device, as shown in the figure below.
4 Bl- użu tal- forċipi biex tevita għafis eċċessiv, irrombla bl- attenzjoni n- numru meħtieġ ta ’ biċċiet ta ’ InductOs għal kull tagħmir LT- CAGE u daħħal kull roll ġol- LT- CAGE Tagħmir tal- Fużjoni Lumbari Tapered li jkun jaqbel, kif muri fil- figura hawn taħt.
For instructions of implantation of the LT-CAGE Lumbar Tapered Fusion Device, please refer to the package leaflet for the LT-CAGE device.
Għal struzzjonijiet ta ’ l- impjantazzjoni tal- LT- CAGE Tagħmir tal- Fużjoni Lumbari Tapered, jekk jogħġbok irreferi għall- fuljett ta ’ tagħrif għat- tagħmir LT- CAGE.
Post-Implantation
Wara l- impjantazzjoni
Once InductOs and the LT-CAGE device are implanted, do not irrigate the wound region.
Ġaladarba InductOs u t- tagħmir LT- CAGE jkunu impjantati, ixxarrabx iż- żona fejn ikun hemm il - ferita.
If a surgical drain is required, place the drain remote from the implantation site or, preferably, one layer superficial to the implantation site.
Jekk ikun meħtieġ drejn kirurġiku, poġġi d- drejn ’ il bogħod mis- sit ta ’ l- impjantazzjoni, jew, preferibbilment, fis- saff li jmiss li jkun l- eqreb tal- ġilda esterna (bħal fascia jew muskolu) mill - impjantazzjoni tas- sit.
Instructions for use in acute tibia fractures
Struzzjonijiet għall- użu f’ każ ta ’ ksur akut fil- qasba tas- sieq
− Achieve definitive fracture reduction, fixation, and hemostasis prior to InductOs implantation.
− Wettaq b’ mod definittiv it- tnaqqis tal- ksur, it- twaħħil, u l- emostasi qabel l- impjantazzjoni ta ’ InductOs.
− InductOs does not provide mechanical stability and should not be used to fill spaces in the presence of compressive forces.
− InductOs ma jipprovdix stabbiltà mekkanika u m’ għandux jintuża biex jimla l- ispazji fil- preżenza ta ’ forzi kompressivi.
− Fold or cut InductOs as needed prior to implantation.
− Itwi jew aqta ’ InductOs kif meħtieġ qabel l- impjantazzjoni.
During handling, avoid excessive fluid loss from InductOs.
Matul l- immaniġġjar, evita telf eċċessiv ta ’ fluwidu minn InductOs.
Do not squeeze.
Tagħfsux.
If the surgical setting requires that only a portion of the product is needed, first prepare the entire InductOs product (following steps 1-8 above), and then cut the product to the desired size and discard the unused portion.
Jekk is- setting kirurġiku jkun jeħtieġ biss porzjon wieħed tal- prodott, l- ewwel ipprepara l- prodott sħiħ ta ’ InductOs (segwi passi 1- 8 hawn fuq), u mbagħad aqta ’ l- prodott għad- daqs mixtieq, u armi l- porzjon mhux użat.
InductOs is implanted after the completion of standard fracture and wound management, i. e. at the time of soft-tissue closure.
InductOs jiġi impjantat wara t- tlestija ta ’ l- immaniġġjar tal- ksur standard u tal- ferita, i. e. fil- ħin ta ’ l - għeluq tat- tessut artab.
The number of InductOs kits to use and the volume of InductOs to be implanted are determined by the fracture anatomy and the ability to close the wound without overly packing or compressing the product.
In- numru ta ’ kitts ta ’ InductOs li għandhom jintużaw u l- volum ta ’ InductOs li għandu jkun impjantat, ikunu stabbiliti mill- anatomija tal- ksur u l- kapaċità li tagħlaq il- ferita mingħajr ma tippakkja jew tikkompressa żżejjed il- prodott.
Generally, each fracture site is treated with the contents of one kit.
Ġeneralment, kull żona ta ’ ksur tkun ikkurata bil - kontenut ta ’ kitt wieħed.
The maximum dosage of InductOs is limited to 2 kits.
Id- dożaġġ massimu ta ’ InductOs hu limitat għal 2 kitts.
To the extent possible, the accessible surface area of the fracture (fracture lines and defects) should be covered with InductOs.
Sakemm ikun possibbli, il- wiċċ taż- żona aċċessibbli tal- ksur (il- linji u d- difetti tal- ksur) għandhom jinksew b’ InductOs.
Place InductOs so that it bridges the fracture region and makes good contact with the major proximal and distal fragments.
Poġġi InductOs b’ tali mod li jifforma pont fuq iż- żona tal- ksur u jkollu kuntatt tajjeb mal- biċċiet distali u prossimali maġġuri.
It is not necessary to overlay the contents of multiple kits to achieve the desired effect.
Mhux meħtieġ li trikkeb fuq xulxin il- kontenut ta ’ kitts multipli biex tikseb l- effett mixtieq.
During implantation, use forceps to handle InductOs to avoid excessive loss of fluid.
5 Matul l- impjantazzjoni, uża l- forċipi biex timmaniġġja InductOs biex tevita telf eċċessiv ta ’ fluwidu.
5 InductOs may be placed into a void (loosely packed), folded, rolled, or wrapped, as the geometry of the fracture requires.
InductOs jista ’ jitpoġġa f’ żona vojta (xi ftit ippakkjat), mitwi, irrumblat, jew imgeżwer, skond kif titlob il- ġeometrija tal- ksur.
Once InductOs is implanted, do not irrigate the wound.
Ġaladarba InductOs ikun impjantat, ixxarrabx il- ferita.
In order to achieve maximum potential efficacy, it is important to achieve complete soft-tissue coverage of InductOs following its implantation.
Biex tikseb l- effikaċja potenzjali massima, hu importanti li twettaq il- kopertura sħiħa tat- tessut artab ta ’ InductO wara l- impjantazzjoni tiegħu.
InductOs is contraindicated for patients with: • Hypersensitivity to the active substance or to any of the excipients • Skeletal immaturity • Any active malignancy or patient undergoing treatment for a malignancy • An active infection at the operative site • Persistent compartment syndrome or neurovascular residua of compartment syndrome • Pathological fractures such as those observed in (but not limited to) Paget’ s disease or in metastatic bone
InductOs hu kontra- indikat għal pazjenti li għandhom: • Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi. • Immaturità skeletrika • Kwalunkwe malinn attiv jew jekk il- pazjent ikun qed jingħata kura għal malinn • Infezzjoni attiva fis- sit kirurġiku • Is- sindrome tal- kompartiment persistenti jew fdal newrovaskulari tas- sindrome tal - kompartiment • Ksur patoloġiku bħal dak osservat (iżda mhux limitat għal) marda ta ’ Paget jew fl- għadam metastatiku
Care and caution should be used to prevent overfilling of the construct and/ or intervertebral space.
Għandha tingħata attenzjoni biex jiġi evitat li timla żżejjed l- ispazju construct u/ jew intervertebrali.
Localised oedema associated with the use of InductOs has been reported in patients undergoing cervical spine surgery.
Edema lokalizzata marbuta ma ’ l- użu ta ’ InductOs kienet irrappurtata f’ pazjenti li jkun qed ikollhom operazzjoni ċervikali fis- sinsla tad- dahar.
The oedema was delayed in onset and, in some cases, severe enough to result in airway compromise.
L- edema damet ma seħħet, u f’ xi każijiet, kienet severa biżżejjed biex tikkomprometti l- passaġġ tan- nifs.
The safety and efficacy of InductOs in cervical spine surgery have not been established and InductOs should not be used in this condition.
Is- sigurtà u l- effettività ta ’ InductOs f’ operazzjonijiet tas- sinsla tad- dahar ċervikali ma kinitx stabbilita, u InductOs m’ għandux jintuża f’ din il- kundizzjoni.
Formation of fluid collections (pseudocysts, localised oedema, implant site effusion), sometimes encapsulated, in some cases resulting in nerve compression and pain has been reported in patients undergoing spine surgery associated with the use of InductOs.
Il- formazzjoni ta ’ ġbir ta ’ fluwidu (psewdoċisti, edema lokalizzata, effużjoni fis- sit ta ’ l- impjant), xi kultant enkapsulata, li f’ xi każijiet irriżultat f’ kompressjoni tan- nervaturi u wġigħ, kienet irrappurtata f’ pazjenti li kien qed ikollhom operazzjoni fis- sinsla tad- dahar, assoċjata ma ’ l- użu ta ’ InductOs.
Many of these reports have occurred when InductOs was used in unapproved approaches/ devices or in a manner inconsistent with the instructions for use.
Ħafna minn dawn ir- rapporti seħħew meta InductOs intuża f’ metodi/ tagħmir mhux approvati, jew b’ tali mod li jkunu inkonsistenti ma ’ l- istruzzjonijiet għall- użu.
Clinical intervention (aspiration and/ or surgical removal) may be required if symptoms persist (see section 4.8).
Intervent kliniku (aspirazzjoni u/ jew tneħħija kirurġika) jista ’ jkun meħtieġ jekk is- sintomi jippersistu (ara sezzjoni 4. 8).
There are no data on the efficacy and safety of the product in concomitant use with bone graft.
M’ hemm l- ebda informazzjoni dwar l- effikaċja u s- sigurtà tal- prodott meta jintuża fl- istess ħin ma ’ trapjant ta ’ l- għadam.
In the absence of any experience, the repeated use of the medicinal product is not recommended.
Fl- assenza ta ’ kwalunkwe esperjenza, l- użu ripetut tal- prodott mediċinali mhuwiex rakkomandat.
Nerve compression associated with ectopic bone formation and InductOs use has been reported.
Il- kompressjoni tan- nervaturi assoċjata mal- formazzjoni ta ’ għadam ektopiku u l- użu ta ’ InductOs kienet irrappurtata.
Additional surgical intervention may be required.
Intervent kirurġiku addizzjonali jista ’ jkun meħtieġ.
InductOs can cause initial resorption of surrounding trabecular bone.
6 InductOs jista ’ jikkawża l- assorbiment mill- ġdid inizjali ta ’ l- għadam trabekulari tal- madwar.
Therefore, in the absence of clinical data, the product should not be used for direct applications to trabecular bone when transient bone resorption may create a risk of bone fragility.
Għalhekk, fl- assenza ta ’ informazzjoni klinika, il- prodott m’ għandux jintuża għal applikazzjonijiet diretti fuq għadam trabekulari, meta l- assorbiment mill- ġdid temporanju ta ’ l- għadam jista ’ joħloq riskju ta ’ fraġilità ta ’ l- għadam.
When InductOs was used with the LT-CAGE device (section 4.2) in clinical trials for anterior lumbar spine fusion, the frequency and severity of resorption of bone as evidenced by radiolucencies and/ or device migration was similar to that observed for patients treated with autogenous bone graft.
Meta InductOs intuża bit- tagħmir LT- CAGE (sezzjoni 4. 2) fi provi kliniċi għal fużjoni tas- sinsla tad- dahar lumbari anterjuri, il- frekwenza u s- severità ta ’ l- assorbiment mill- ġdid ta ’ l- għadam kif murija minn radiolucencies u/ jew iċ- ċaqliq tat- tagħmir kienu simili għal dak osservat għal pazjenti kkurati bi trapjant ta ’ l- għadam awtoġenu.
6 Use of InductOs may cause heterotopic ossification in the surrounding tissues, which can result in complications.
L- użu ta ’ InductOs jista ’ jikkawża ossifikazzjoni eterotopika fit- tessut tal- madwar, li tista ’ tirriżulta f’ kumplikazzjonijiet.
Exuberant bone formation at the site of implantation and ectopic bone formation have been observed.
Il- formazzjoni ta ’ għadam eċċessiv fis- sit ta ’ l- impjantazzjoni u formazzjoni ta ’ għadam ektopiku kienu osservati.
The safety and efficacy of the use of InductOs in patients with known autoimmune disease have not been established.
Is- sigurtà u l- effikaċja ta ’ l- użu ta ’ InductOs f’ pazjenti li hu magħruf li għandhom mard awtoimmuni, ma kinux stabbiliti.
These autoimmune diseases include rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/ polymyositis.
Dan il- mard awtoimmuni jinkludi artrite rewmatojde, lupus erythematosus sistemiku, skleroderma, is- sindrome ta ’ Sjögren jew dermatomijosite/ polimijosite.
The safety and efficacy of InductOs have not been demonstrated in patients with metabolic bone diseases.
Is- sigurtà u l- effikaċja ta ’ InductOs ma ntwerewx f’ pazjenti b’ mard metaboliku ta ’ l- għadam.
No studies have been performed in patients with hepatic or renal impairment.
Ma saru l- ebda studji fuq pazjenti b’ insuffiċjenza epatika jew renali.
Both dibotermin alfa and bovine Type I collagen have been found to elicit immune responses in patients.
Kemm dibotermin alfa kif ukoll il- kollaġen tal- baqar ta ’ Tip I, instabu li jikkawżaw risponsi immuni fil- pazjenti.
Anti-dibotermin alfa antibodies:
Antikorpi anti- dibotermin alfa:
In anterior lumbar spine fusion studies, 0.7% of patients receiving InductOs developed antibodies vs 0.8% of patients receiving autogenous bone graft.
Fi studji dwar il- fużjoni tas- sinsla tad- dahar lumbari anterjuri, 0. 7% tal- pazjenti li kienu qed jirċievu InductOs żviluppaw antikorpi, meta mqabbla ma ’ 0. 8% tal- pazjenti li kienu qed jirċievu trapjant ta ’ l- għadam awtoġenu.
In acute tibia fracture studies, 4.4% of patients receiving InductOs developed antibodies vs 0.6% in the control group.
Fi studji kliniċi li saru fuq il- ksur akut fil- qasba tas- sieq, 4. 4% tal- pazjenti li kienu qed jirċievu InductOs żviluppaw antikorpi meta mqabbla ma ’ 0. 6% fil- grupp tal- kontroll.
Anti-bovine Type I collagen antibodies:
Antikorpi ta ’ kontra l- kollaġen tal- baqar ta ’ Tip I:
13% of patients receiving autogenous bone graft.
Fi studji li saru dwar il- fużjoni tas- sinsla tad- dahar lumbari anterjuri, 19% tal- pazjenti li kienu qed jirċievu InductOs żviluppaw antikorpi kontra l - kollaġen tal- baqar ta ’ Tip I, meta mqabbla ma ’ 13% tal- pazjenti li kienu qed jirċievu trapjant ta ’ l - għadam awtoġenu.
11.8% of control patients.
Fi studji dwar ksur akut fil- qasba tas- sieq, 15. 7% tal- pazjenti li kienu qed jirċievu InductOs, żviluppaw antikorpi għall- kollaġen tal- baqar ta ’ Tip I, meta mqabbla ma ’ 11. 8% tal- pazjenti fil- grupp tal- kontroll.
In either of the 2 indications, no patients who tested positive for anti-bovine Type I collagen antibodies developed antibodies to human Type I collagen.
F’ kull waħda miż- 2 proċeduri, l- ebda pazjent li kellu riżultat pożittiv għat- test għall- antikorpi tal- kollaġen anti- bovin ta ’ Tip I ma żviluppa antikorpi għall- kollaġen uman ta ’ Tip I.
Although no clear 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.
Għalkemm fl- istudji kliniċi ma setgħet tkun osservata l- ebda rabta ċara mar- riżultat kliniku jew ma ’ l - effetti mhux mixtieqa, il- possibbiltà ta ’ żvilupp ta ’ antikorpi li jinnewtralizzaw jew reazzjonijiet tat- tip ta ’ sensittività eċċessiva, ma jistgħux jiġu esklużi.
Special consideration of risks and benefits should be given for patients who have previously received injectable collagen (see section 4.3).
Għandha tingħata konsiderazzjoni speċjali dwar ir - riskji u l- benefiċċji għal pazjenti li fil- passat kienu rċivew kollaġen li jista ’ jiġi injettat (ara sezzjoni 4. 3).
The possibility of an immune response to the product should be evaluated in cases where an undesirable effect with immunological background is suspected.
Il- possibbiltà ta ’ rispons immuni għall- prodott għandha tkun evalwata f’ każijiet fejn effett mhux mixtieq bi sfond immunoloġiku jkun issuspettat.
Special warnings and precautions for use specific to anterior lumbar spine fusion
Twissijiet speċjali u prekawzjonijiet għall- użu speċifiku għal proċeduri ta ’ fużjoni tas- sinsla tad- dahar lumbari anterjuri
The safety and efficacy of InductOs have not been established in the following conditions: • used with spinal implants other than the LT-CAGE device • implanted at locations other than L4 – S1 in the lower lumbar spine • used in surgical techniques other than anterior open or anterior laparoscopic approaches
Is- sigurtà u l- effikaċja ta ’ InductOs ma kinux stabbiliti fil- kundizzjonijiet li ġejjin: • meta jintuża ma ’ impjanti oħra fis- sinsla tad- dahar minbarra t- tagħmir LT- CAGE • meta jkun impjantat f’ postijiet oħrajn minbarra L4- S1 fis- sinsla tad- dahar lumbari tan- naħa t’ isfel • meta jintuża f’ tekniċi kirurġiċi oħrajn minbarra metodi anterjuri miftuħin jew metodi laparoskopiċi anterjuri
When degenerative disc disease was treated by a posterior lumbar interbody fusion procedure with cylindrical threaded cages and dibotermin alfa, posterior bone formation was observed in some instances.
7 Meta mard deġenerattiv tad- disk kien ikkurat bi proċedura ta ’ fużjoni interbody lumbari posterjuri, b’ gaġeġ threaded ċilindriċi u b’ dibotermin alfa, il- formazzjoni ta ’ l- għadam posterjuri kienet osservata f’ xi każijiet.
Special warnings and precautions for use specific to acute tibia fractures
Twissijiet speċjali u prekawzjonijiet għall- użu li huma speċifiċi għal ksur akut fil- qasba tas- sieq
InductOs is intended for use in patients with the following: • adequate fracture reduction and stabilization to ensure mechanical stability • adequate neurovascular status (e. g. absence of compartment syndrome, low risk of amputation) • adequate hemostasis (providing a relatively dry implantation site)
InductOs hu intenzjonat għall- użu f’ pazjenti li għandhom dawn li ġejjin: • tnaqqis adegwat tal- ksur u stabilizzazzjoni biex tiżgura l- istabbiltà mekkanika • stat newrovaskulari adegwat (eż. l- assenza tas- sindrome tal- kompartiment, riskju baxx ta ’ amputazzjoni) • emostasi adegwata (li tipprovdi sit ta ’ l- impjantazzjoni relattivament xott) • l- assenza ta ’ tiswija ta ’ difett segmentali kbir ta ’ għadam twil, li fih tista ’ sseħħ kompressjoni sinifikanti fit- tessut artab
The implant may only be administered to the fracture site under adequate vision and with utmost care (see section 4.2).
L- impjant jista ’ jitpoġġa biss fis- sit fejn ikun hemm il- ksur sit, meta l- kirurgu jkun jista ’ jara s- sit b’ mod adegwat u bl- akbar attenzjoni (ara sezzjoni 4. 2).
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).
Informazzjoni dwar l- effikaċja fil- ksur tal- qasba tas- sieq, hi disponibbli biss mill- provi kliniċi biss li fihom ksur miftuħ tal- qasba tas- sieq kien ikkurat bl- użu ta ’ twaħħil permezz ta ’ msiemer intramedullari (ara sezzjoni 5. 1).
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).
Fi studju kliniku li fih il- kanal intramedullari kien reamed mal - cortical chatter, kienet osservata żieda fir- rata ta ’ l- infezzjoni fil- grupp li kien ikkurat b’ InductOs meta mqabbel mal- grupp tal- kontroll tal- kura (ara sezzjoni 4. 8).
The use of InductOs with reamed nails in open tibial fracture repair is not recommended.
L- użu ta ’ InductOs b’ imsiemer reamed f’ operazzjoni biex ikun ikkurat ksur miftuħ tal- qasba tas- sieq mhuwiex rakkomandat.
InductOs does not provide mechanical stability and should not be used to fill space in the presence of compressive forces.
InductOs ma jipprovdix stabbiltà mekkanika u m’ għandux jintuża biex jimla l- ispazju fil- preżenza ta ’ forzi kompressivi.
Long-bone fracture and soft-tissue management procedures should be based on standard practice, including control of infection.
Ksur fl- għadam it- twil u proċeduri ta ’ l- immaniġġjar ta ’ tessut artab għandu jkun ibbażata fuq il- prattika standard, li tinkludi l- kontroll ta ’ l- infezzjoni.
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.
Minħabba li dibotermin alfa hu proteina u ma kienx identifikat fiċ- ċirkolazzjoni ġenerali, x’ aktarx li mhux ser jikkawża interazzjonijiet farmakokinetiċi bejn mediċina u oħra.
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 effect.
Informazzjoni minn studji kliniċi li saru fuq il- ksur akut fil- qasba tas- sieq, indikat li l- użu ta ’ InductOs f’ pazjenti li jkunu qed jirċievu l- glukokortikojdi, ma kien assoċjat ma ’ l- ebda effett avvers apparenti.
In preclinical studies, concurrent administration of glucocorticoids depressed bone repair (measured as a% change from control), but the effects of InductOs were not altered.
Fi studji ta ’ qabel l- użu kliniku, l- għoti tal- glukokortikojdi fl- istess ħin, naqqas il- fejqan ta ’ l- għadam (imkejjel bħala bidla f ’% mill- kontroll), iżda l- effetti ta ’ InductOs ma nbidlux.
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.
Fi provi kliniċi li saru fuq il- ksur akut fil- qasba tas- sieq, aktar pazjenti li ngħataw InductOs u li kienu qed jirċievu NSAIDs fl- istess ħin għal 14- il jum konsekuttiv, kellhom avvenimenti avversi minn ħfief sa moderati, li kienu assoċjati mal- fejqan tal- ferita (eż. it- tneħħija ta ’ likwidu mill- ferita) milli minn pazjenti li ngħataw InductOs li ma kinux qed jieħdu NSAIDs.
Although patient outcome was not affected, an interaction between NSAIDs and InductOs cannot be excluded.
Għalkemm ir- riżultat tal- pazjent ma kienx affettwat, an interazzjoni bejn NSAIDs u InductOs ma tistax tiġi eskluża.
Pregnancy There are no adequate data from the use of dibotermin alfa in pregnant women.
Tqala M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ dibotermin alfa waqt it- tqala.
Studies in animals have shown reproductive toxicity (see section 5.3).
Studji fuq il- bhejjem urew tossiċità riproduttiva (ara sezzjoni 5. 3).
Animal studies have been conducted that cannot rule out effects of anti-dibotermin alfa antibodies on embryo-foetal development (see section 5.3).
8 L- istudji li saru fuq l- annimali ma jistgħux jeskludu l- effetti ta ’ l- antikorpi anti- dibotermin alfa fuq l - iżvilupp embriju- fetali (ara sezzjoni 5. 3).
Due to the unknown risks to the fetus associated with the potential development of neutralising antibodies to dibotermin alfa, InductOs should not be used during pregnancy unless clearly necessary (see section 4.4).
Minħabba r- riskji mhux magħrufa għall- fetu marbuta ma ’ l - iżvilupp potenzjali ta ’ antikorpi li jinnewtralizzaw għal dibotermin alfa, InductOs m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar (ara sezzjoni 4. 4).
Women of childbearing potential should be advised to use effective contraception up to at least 12 months after treatment.
Nisa li jista ’ jkollhom it- tfal għandhom jingħataw parir biex jużaw kontraċezzjoni effettiva sa mill- anqas 12- il xahar wara l- kura.
It is unknown whether dibotermin alfa is excreted in human breast milk.
Mhuwiex magħruf jekk dibotermin alfa jitneħħiex fil- ħalib tas- sider uman.
The excretion of dibotermin alfa has not been studied in animals.
It- tneħħija ta ’ dibotermin alfa fil- ħalib ma ’ ġietx studjata fl- annimali.
Lactation is not recommended during treatment with InductOs.
Għalhekk, t- treddigħ mhuwiex rakkomandat matul il- kura b’ InductOs.
No studies on the effects on the ability to drive and use machines have been performed, but since InductOs has no systemic effect, it is not likely to interfere with the ability to drive or use machinery.
Ma saru l- ebda studji fuq l- effetti fuq il- ħila biex issuq u tuża l- magni, iżda billi InductOs m’ għandu l - ebda effett sistemiku, x’ aktarx li mhux ser jinterferixxi mal- ħila biex issuq jew tuża l- makkinarju.
Over 1490 patients have been evaluated in clinical studies, of which more than 955 received InductOs treatment.
Aktar minn 1490 pazjent kienu evalwati fi studji kliniċi, li minnhom, aktar minn 955 irċivew kura b’ InductOs.
In the long bone fracture studies, over 418 patients received InductOs.
Fi studji dwar ksur fl- għadam it- twil, aktar minn 418- il pazjent irċivew InductOs.
In the anterior lumber spine fusion studies, over 288 patients received InductOs.
Fi studji dwar il- fużjoni tas- sinsla tad- dahar lumbari anterjuri, aktar minn 288 pazjent irċivew InductOs.
There have been post-marketing reports of localised oedema in patients undergoing cervical spine surgery associated with the use of InductOs.
Kien hemm rapporti wara li l- prodott beda jinbiegħ, ta ’ edema lokalizzata f’ pazjenti li kellhom operazzjoni fis- sinsla tad- dahar ċervikali, assoċjata ma ’ l- użu ta InductOs.
The oedema was delayed in onset and, in some cases, severe enough to result in airway compromise (see section 4.4).
L- edema damet ma seħħet, u f’ xi każijiet, kienet severa biżżejjed biex tikkomprometti l- passaġġ tan- nifs (ara sezzjoni 4. 4).
There have been post-marketing reports of formation of fluid collections (pseudocysts, localised oedema, implant site effusion), sometimes encapsulated, in some cases resulting in nerve compression and pain in patients undergoing spine surgery with Inductos (see section 4.4).
Kienu hemm rapporti wara li l- prodott beda jinbiegħ, tal- formazzjoni ta ’ ġbir ta ’ fluwidu (psewdoċisti, edema lokalizzata, effużjoni fis- sit ta ’ l- impjant), xi kultant enkapsulata, li f’ xi każijiet irriżultat f’ kompressjoni tan- nervaturi u wġigħ f’ pazjenti li kien qed ikollhom operazzjoni fis- sinsla tad- dahar b’ InductOs (ara sezzjoni 4. 4).
Nerve compression associated with ectopic bone formation has been reported in patients undergoing spine surgery with InductOs (see section 4.4).
Kompressjoni tan- nervaturi assoċjata ma ’ formazzjoni ta ’ għadam ektopiku kienet irrappurtata f’ pazjenti li kien qed ikollhom operazzjoni fis- sinsla tad- dahar b’ InductOs (ara sezzjoni 4. 4).
Placement of InductOs can cause initial resorption of trabecular bone (see section 4.4 and section 5.1).
It- tqegħid fil- post ta ’ InductOs jista ’ jikkawża l- assorbiment mill- ġdid inizjali ta ’ l- għadam trabekulari (ara sezzjoni 4. 4 u sezzjoni 5. 1).
Undesirable effects specific to use in anterior lumbar spine fusion The undesirable effects observed in anterior lumbar spine fusion patients were generally representative of the morbidity associated with spine fusion using autogenous bone graft taken from the iliac crest.
L- effetti mhux mixtieqa osservati f’ pazjenti li kellhom fużjoni tas- sinsla tad- dahar lumbari anterjuri kienu ġeneralment jirrappreżentaw il- morbożità assoċjata mal- fużjoni tas- sinsla tad- dahar bl- użu ta ’ trapjant ta ’ l- għadam awtoġenu meħud mill- iliac crest.
Very common (≥1/10) undesirable effects: accidental injury, neuralgia, back pain and bone disorder, were similar in both control and InductOs treatment groups.
Effetti mhux mixtieqa komuni ħafna (> 1/ 10): korriment aċċidentali, nevralġija, uġigħ fid- dahar u disturbi fl- għadam, kienu simili kemm fil- grupp tal- kontroll kif ukoll fil- grupp tal- kura b’ InductOs.
Undesirable effects specific to use in acute tibia fractures
L- effetti mhux mixtieqa osservati f’ pazjenti bi ksur ta ’ għadam twil kienu ġeneralment jirrappreżentaw il- morbożità assoċjata jew ma ’ trawma ortopedika jew mal- proċedura kirurġika.
The undesirable effects observed in long bone fracture patients were generally representative of the morbidity associated with either orthopaedic trauma or the surgical procedure.
Kienet osservata żieda fir- rata ta ’ l -
Localised infection specific to the fractured limb occurred in > 1/10 patients in a clinical study in which the intramedullary canal was reamed to cortical chatter.
9 infezzjoni fil- grupp li kien ikkurat b’ InductOs meta mqabbel mal- grupp tal- kontroll tal- kura standard (19% kontra 9%, rispettivament; ara sezzjoni 4. 4).
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) For use with unreamed nails, estimated rates of infection were similar between treatment groups in a study (21% versus 23% respectively).
Għall- użu ma ’ msiemer unreamed, l- istima tar- rati ta ’ infezzjoni kienet simili bejn il- gruppi tal- kura fi studju (21% kontra 23% rispettivament).
Common (≥1/100 to < 1/10) undesirable effects were observed with equal incidence in control and InductOs treatment groups, with the following four exceptions which were observed significantly more frequently in the InductOs treatment group than in the control group: • blood amylase increased (without overt signs of pancreatitis in InductOs treated patients), • tachycardia, • hypomagnesemia, • headache.
Effetti mhux mixtieqa komuni (> 1/ 100 sa < 1/ 10) kienu osservati b’ inċidenza ugwali fil- grupp tal - kontroll kif ukoll fil- grupp tal- kura b’ InductOs, bl- erba ’ eċċezzjonijiet li ġejjin kienu osservati b’ mod sinifikanti aktar b’ mod frekwenti fil- grupp tal- kura b’ InductOs milli fil- grupp tal- kontroll: • kien hemm żieda fl- amylase fid- demm (mingħajr sinjali ovvji ta ’ pankreatite, fil- pazjenti kkurati b’ InductOs), • takikardja. • ipomanjesemija, • uġigħ ta ’ ras.
Use of InductOs in patients undergoing cervical spine surgery in concentrations or amounts greater than those recommended in section 4.2 for the approved indications has been associated with reports of localised oedema (see section 4.4).
L- użu ta ’ InductOs f’ pazjenti li jkun qed ikollhom operazzjoni ċervikali fis- sinsla tad- dahar f’ konċentrazzjonijiet jew f’ ammonti akbar minn dawk rakkomandati f’ sezzjoni 4. 2 għall- proċedur approvati, kienu assoċjati ma ’ rapporti ta ’ edema lokalizzata (ara sezzjoni 4. 4i).
In the case of patients receiving concentrations or amounts greater than those recommended, treatment should be supportive.
Fil- każ ta ’ pazjenti li jkunu qed jirċievu konċentrazzjonijiet jew ammonti akbar minn dawk rakkomandati, il- kura għandha tkun ta ’ sapport.
9 5 PHARMACOLOGICAL PROPERTIES
5 TAGĦRIF FARMAKOLOĠIKU
Bone Morphogenetic Proteins, ATC code:
Proteini Morfoġenetiċi ta ’ Għadam, Kodiċi ATC:
Dibotermin alfa is an osteoinductive protein that results in the induction of new bone tissue at the site of implantation.
Dibotermin alfa hu proteina osteoinduttiva li tirriżulta fl- induzzjoni ta ’ tessut ġdid ta ’ l- għadam fis- sit ta ’ l- impjantazzjoni.
Dibotermin alfa binds to receptors on the surface of mesenchymal cells and causes cells to differentiate into cartilage- and bone-forming cells.
Dibotermin alfa jeħel mar- riċetturi fuq il- wiċċ ta ’ ċelluli mesenchymal u jikkawża liċ- ċelluli biex li jinbidlu f’ ċelluli li jiffurmaw il- kartilaġni u l- għadam.
The differentiated cells form trabecular bone as the matrix is degraded, with vascular invasion evident at the same time.
Dawn iċ- ċelluli mibdula jiffurmaw għadam trabekulari hekk kif il- matriċi tiddegrada, b’ invażjoni vaskulari li tkun evidenti fl - istess ħin.
The bone formation process develops from the outside of the implant towards the center until the entire InductOs implant is replaced by trabecular bone.
Il- proċess tal- formazzjoni ta ’ l- għadam jiżviluppa min- naħa ta ’ barra ta ’ l- impjant lejn iċ - ċentru, sakemm l- impjant sħiħ ta ’ InductOs ikun sostiwit minn għadam trabekulari.
Remodeling of the surrounding trabecular bone occurs in a manner that is consistent with the biomechanical forces placed on it.
L- immudellar mill- ġdid ta ’ l- għadam trabekulari jseħħ b’ mod li hu konsistenti mal- forzi bijomekkaniċi li jitqiegħdu fuqu.
Placement of InductOs into trabecular bone resulted in transient resorption of the bone surrounding the implant, followed by replacement with new, more dense bone.
It- tqegħid fil- post ta ’ InductOs ġol- għadam trabekulari rriżulta fl- assorbiment temporanju ta ’ l- għadam ta ’ madwar l- impjant, segwit minn sostituzzjoni ta ’ għadam ġdid u aktar dens.
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.
Il- ħila ta ’ InductOs li jissapportja l- immudellar mill- ġdid ta ’ l- għadam, tista ’ tkun responsabbli għall- integrazzjoni bijoloġika u bijomekkanika ta ’ l- għadam il- ġdid li jkun ġie ffurmat minn InductOs, ma ’ dak ta ’ l- għadam tal- madwar.
Radiographic, biomechanical, and histologic evaluation of the induced bone indicates that it functions biologically and biomechanically as native bone.
Evalwazzjoni radjografika, bijomekkanika, u istoloġika ta ’ l - għadam li jkun ġie ffurmat, tindika li dan jiffunzjona bijoloġikament u bijomekkanikament bħall - għadam naturali.
Furthermore, preclinical studies have indicated that the bone induced by InductOs, if fractured, can repair itself in a manner indistinguishable from native bone.
Flimkien ma ’ dan, studji ta ’ qabel l- użu kliniku indikaw li l- għadam li jkun ġie ffurmat minn InductOs, jekk jinkiser, jista ’ jirranġa lilu nnifsu b’ mod li ma jkunx jintgħaraf mill - għadam naturali.
Preclinical studies have suggested that bone formation initiated by InductOs is a self-limiting process, forming a well-defined volume of bone.
Studji ta ’ qabel l- użu kliniku ssuġġerrixxew li l- formazzjoni ta ’ l- għadam li tinbeda minn InductOs hu proċess li jillimita lilu nnifsu, u tifforma volum ta ’ għadam li jkun definit tajjeb.
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.
Din l- awto - limitazzjoni x’ aktarx li tiġri minħabba t- telf ta ’ dibotermin alfa mis- sit ta ’ l- impjant, kif ukoll minħabba l- preżenza ta ’ inibituri BMP fit- tessut tal- madwar.
In addition, several preclinical studies indicate that there is a negative feedback mechanism at the molecular level that limits bone induction by BMPs.
Flimkien ma ’ dan, diversi studji ta ’ qabel l- użu kliniku jindikaw li hemm mekkaniżmu negattiv tal- feedback fil- livell molekulari, li jillimita l - formazzjoni ta ’ l- għadam induzzjoni mill- BMPs.
Clinical pharmacology studies demonstrate that the matrix alone is not osteoinductive and is no longer present in biopsies taken as early as 16 weeks post-implantation.
10 Studji farmakoloġiċi kliniċi juru li l- matriċi waħidha mhijiex osteoinduttiva u ma tistabx iżjed f’ bijopsiji li jittieħdu wara 16- il ġimgħa wara l- impjantazzjoni.
Pharmacodynamic information specific to anterior lumbar spine fusion studies
Informazzjoni farmakodinamika speċifika għal studji dwar il- fużjoni tas- sinsla tad- dahar lumbari anterjuri
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.
L- effikaċja u s- sigurtà ta ’ InductOs intwerew fi studju randomised, ikkontrollat, multiċetriku, non - inferiority fuq 279 pazjent li kellhom bejn 19 – 78 sena, li kien qed ikollhom proċedura ta ’ fużjoni interbody lumbari anterjuri.
Patients had received at least six months of non-operative treatment prior to treatment with InductOs for anterior lumbar spine fusion.
Il- pazjenti kienu rċivew mill- anqas sitt xhur ta ’ kura mhux kirurġika qabel il- kura b’ InductOs għall- fużjoni tas- sinsla tad- dahar lumbari anterjuri.
Patients were randomised to receive the LT-CAGE Lumbar Tapered Fusion Device filled with either InductOs or autogenous bone graft taken from the iliac crest.
Il- pazjenti kienu randomised biex jirċievu l- LT- CAGE Tagħmir tal- Fużjoni Lumbari Tapered mimli jew b’ InductOs jew bit- trapjant ta ’ l- għadam awtoġenu meħud mill- iliac crest.
At 24 months post-operation, InductOs was demonstrated to be statistically non-inferior to autogenous bone graft.
Wara 24 xahar mill- operazzjoni, intwera li InductOs kien statistikament mhux inferjuri għat- trapjant ta ’ l- għadam awtoġenu.
The success rate for radiologically determined fusion was 94.4% for InductOs versus 88.9% (95% two-sided CI of the difference: -1.53, 12.46) for autogenous bone graft.
Ir- rata ta ’ suċċess għall- fużjoni stabbilita permezz tar- radjoloġija kienet ta ’ 94. 4% għal InductOs kontra 88. 9% (95% two- sided CI tad- differenza: - 1. 53, 12. 46) għat- trapjant ta ’ l - għadam awtoġenu.
For pain and disability (Oswestry score), the success rate was 72.9% versus 72.5% (95% two-sided CI of the difference: -11.2, 12.0).
Għall- uġigħ u diżabilità (punteġġ Oswestry), ir- rata ta ’ suċċess kienet ta ’ 72. 9% kontra 72. 5% (95% two- sided CI tad- differenza: - 11. 2, 12. 0).
A single, multi-component endpoint, known as overall success was the primary variable of the study.
Riżultat aħħari wieħed, li fih ħafna komponenti, magħruf bħala s- suċċess totali, kien il- fattur primarju ta ’ l- istudju.
Overall success consists of the following primary efficacy and safety considerations:
Is- suċċess totali jikkonsisti fil- konsiderazzjonijiet ta ’ l- effikaċja u s- sigurtà primarja li ġejjin:
Radiographically demonstrated fusion 2.
Fużjoni murija permezz ta ’ radjografija 2.
Oswestry pain/disability improvement 3.
Titjib fl- uġigħ/ diżabilità Oswestry 3.
Maintenance or improvement in neurological status
Il- manteniment jew titjib ta ’ l- istat newroloġiku 4.
No Grade 3 or 4 adverse event classified as implant-associated or implant-/surgical procedure associated 5.
L- ebda avveniment avvers ta ’ Grad 3 jew 4 ikklassifikat li hu assoċjat ma ’ l- impjant jew assoċjat ma ’ proċedura ta ’ l- impjant/ kirurġika 5.
No additional surgical procedure performed that was classified as a “failure”
L- ebda proċedura kirurġika addizzjonali li twettqet ma kienet ikklassifikata bħala “ falliment ”
At 24 months post-operation, the overall success rate was 57.5% for InductOs versus 55.8% (95% two-sided CI of the difference: -10.72, 14.01) for autogenous bone graft.
Wara 24 xahar mill- operazzjoni, ir- rata ta ’ suċċess totali kienet ta ’ 57. 5% għal InductOs kontra 55. 8% (95% two- sided CI tad- differenza: - 10. 72, 14. 01) għat- trapjant ta ’ l- għadam awtoġenu.
An additional, non-comparative study of 134 patients who received anterior lumbar interbody fusion procedures via a laparoscopic surgical technique yielded similar success rates of 92.9% for fusion, 85.6% for pain and disability and 90.3% for neurological status.
Studju addizzjonali, mhux komparattiv, li sar fuq 134 pazjent li kellhom proċeduri ta ’ fużjoni interbody lumbari anterjuri permezz ta ’ teknika kirurġika laparoskopika, irriżulta f’ rati simili ta ’ suċċess ta ’ 92. 9% għal fużjoni, 85. 6% għal uġigħ u diżabilità, u 90. 3% għall- istat newroloġiku.
The study confirmed the applicability of anterior lumbar spine fusion using InductOs via laparoscopic surgical implantation techniques.
L - istudju kkonferma l- applikabilità tal- fużjoni tas- sinsla tad- dahar lumbari anterjuri bl- użu ta ’ InductOs permezz ta ’ tekniċi ta ’ l- impjantazzjoni kirurġiċi laparoskopiċi.
Pharmacodynamic information specific to acute tibia fracture studies
Informazzjoni farmakodinamika li hi speċifika għal studji dwar ksur akut fil- qasba tas- sieq
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.
L- effikaċja ta ’ InductOs intweriet fi studju multinazzjonali, randomized, ikkontrollat, single- blind ta ’ 450 pazjent (medda ta ’ età minn 18 sa 87 sena; 81% irġiel) li kellhom ksur miftuħ tax- xaft tal- qasba tas- sieq li kien jeħtieġ immaniġġjar kirurġiku.
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.
Il- pazjenti rċivew (fi proporzjon ta ’ 1: 1: 1) kura standard (il- grupp tal- kontroll) li kienet tikkonsisti fi twaħħil bl- imsiemer fiż- żona intramedullari (IM) u mmaniġġjar ta ’ rutina tat- tessut artab, kura standard flimkien ma ’ InductOs 0. 75 mg/ ml, jew kura standard flimkien ma ’ InductOs 1. 5 mg/ ml.
Patients were followed for 12 months after soft- tissue closure.
Il- pazjenti kienu segwiti għal 12- xahar wara l- għeluq tat - tessut artab.
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).
Fi prova importanti dwar ksur akut fil- qasba tas- sieq, InductOs żied il- probabbiltà tal- fejqan tal- ksur; pazjenti kkurati b’ InductOs 1. 5 mg/ ml kellhom riskju mnaqqas ta ’ 44% li l- kura ma tirnexxix (intervent sekondarju biex jippromwovi l- fejqan mill- ksur) meta mqabbla ma ’ pazjenti fil- grupp tal - kura standard (RR = 0. 56; 95% CI = 0. 40 sa 0. 78).
These results were independently corroborated by a radiology panel blinded to treatment.
Dawn ir- riżultati kienu indipendentement ikkonfermati minn panel radjoloġiku li kien blinded għall- kura.
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).
In- numru ta ’ interventi sekondarji u sussegwenti kien imnaqqas b’ mod sinifikanti għal pazjenti li ngħataw InductOs, partikularment fir - rigward ta ’ interventi aktar invażivi bħal trapjant ta ’ l- għadam u exchange nailing (P=0. 0326).
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.
11 Il- proporzjon ta ’ pazjenti li fiequ wara l- kura b’ InductOs 1. 5 mg/ ml kien ogħla b’ mod sinifikanti fil - viżti kollha minn 10 ġimgħat sa 12- il xahar wara l- operazzjoni, u dan jissuġġerixxi fejqan aktar mgħaġġel tal- ksur.
InductOs 1.5 mg/ml was significantly effective (compared to standard care) in patients both with or without a history of smoking.
InductOs 1. 5 mg/ ml kien effettiv b’ mod sinifikanti (meta mqabbel mal- kura standard) f’ pazjenti kemm b’ passat ta ’ tipjip u kemm mingħajru.
Severity of fractures:
Is- severità tal- ksur:
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).
Il- kura b’ InductOs 1. 5 mg/ ml kienet effettiva b’ mod sinifikanti fil- klassijiet kollha tal- ksur, li jinkludu ksur sever tat- tip Gustilo IIIB (riskju mnaqqas bi 52% ta ’ interventi sekondarji meta mqabbla ma ’ pazjenti li kienu qed jirċievu kura standard).
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% vs.
Il- proporzjon ta ’ pazjenti li kellhom fejqan ta ’ feriti fit- tessut artab, kien ogħla b’ mod sinifikanti fil - viżta ta ’ wara l- kura wara 6 ġimgħat fil- grupp ta ’ InductOs 1. 5 mg/ ml, meta mqabbel mal- grupp li kien qed jirċievi kura standard (83% kontra 65%; P=0. 0010).