qanastek/EMEA-V3 huggingface dataset:
The surrounding soft tissues, such as muscle and skin, are then closed around the implant.
It- tessuti rotob tal- madwar, bħalma huma l- muskolu u l- ġilda, imbagħad jingħalqu madwar l- impjant.
Generally, one vial is sufficient, but a further vial can be used if necessary.
Ġeneralment, kunjett wieħed huwa biżżejjed, iżda jista ’ jintuża kunjett ieħor jekk ikun hemm bżonn.
How does Osigraft work?
Kif jaħdem Osigraft?
The active substance in Osigraft, eptotermin alfa, acts on the bone structure.
Is- sustanza attiva f’ Osigraft, eptotermin alfa, taħdem fuq l- istruttura ta ’ l- għadam.
It is a copy of protein called osteogenic protein 1, also known as bone morphogenetic protein 7 (BMP-7), that is produced naturally by the body and which helps the formation of new bone tissue.
Hija kopja tal - proteina msejħa proteina 1 osteoġenika, magħrufa wkoll bħala proteina 7 morfoġenetika ta ’ l- għadam (BMP- 7), li tiġi magħmula naturalment mill- ġisem u li tgħin il- formazzjoni ta ’ tessut ta ’ l- għadam ġdid.
When implanted, eptotermin alfa stimulates the formation of new bone, helping to repair the broken bone.
Meta tkun impjantata, epotermin alfa tistimola l- formazzjoni ta ’ għadam ġdid, u tgħin fit- tiswija ta ’ l- għadam miksur.
Eptotermin alfa is produced by a method known as ‘ recombinant DNA technology’: it is made by cells that have received a gene (DNA), which makes them able to produce it.
Epotermin alfa hija magħmula b’ metodu magħruf bħala ‘ teknoloġija rekombinanti tad- DNA ’: hija magħmula minn ċelloli li rċievew ġene (DNA) li jagħmilhom kapaċi jipproduċuha.
The replacement eptotermin alfa acts in same way as naturally produced BMP-7.
Is- sostitut epotermin alfa jaħdem bl- istess mod bħal BMP- 7 magħmul b’ mod naturali.
How has Osigraft been studied?
Kif ġie studjat Osigraft?
The main study of Osigraft was carried out in 122 patients with unhealed tibial fractures who were treated either with the medicine or with an autograft.
L- istudju ewlieni ta ’ Osigraft sar f’ 122 pazjent bi ksur tat- tibja mhux imfejqa li kienu jew ittrattati bil - mediċina jew b’ awtograft.
The main measure of effectiveness, which was assessed after nine months, was whether the broken bone had healed.
Il- miżura ewlenija ta ’ l- effettività, li kienet stmata wara disa ’ xhur, kienet jekk l- għadma miksura kinitx fieqet.
This was detected by looking at signs of repair of the fracture on an X-ray, whether the patient had any pain and was able to bear weight on the tibia, and whether there was any need for further treatment of the fractured tibia.
Dan ġie osservat billi ġew studjati sinjali ta ’ tiswija tal- ksur bir - raġġi X, jekk il- pazjent kellux xi uġigħ u kienx kapaċi jiflaħ piż fuq it- tibja, u jekk kienx hemm bżonn ta ’ aktar trattament tat- tibja miksura.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Osigraft shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged X’ benefiċċju wera Osigraft waqt l- istudji?
Osigraft was at least as effective as bone autograft, the standard treatment.
Osigraft kien effettiv minn ta ’ l- anqas daqs awtograft ta ’ l- għadam li hija l- kura standard.
After nine months, 81% of the patients receiving Osigraft had responded to treatment (less pain and more weight bearing), compared with 77% of the patients treated with an autograft.
Wara disa ’ xhur, 81% tal- pazjenti li rċievew Osigraft kienu irrispondew għat- trattament (anqas uġigħ u jifilħu aktar piż), meta mqabbla ma ’ 77% tal- pazjenti ikkurati b’ awtograft.
What is the risk associated with Osigraft?
X’ inhu r- riskju assoċjat ma ’ Osigraft?
The most common side effects with Osigraft (seen in between 1 and 10 patients in 100) are erythema (redness), tenderness, swelling over the implant site, and heterotopic ossification (development of bone in abnormal areas) or myositis ossificans (abnormal bone growth in the muscle).
L- aktar effetti sekondarji komuni b’ Osigraft (li dehru f’ madwar pazjent 1 u 10 minn kull 100) huma eritima (ħmura), sensibilità, nefħa fis- sit ta ’ l- impjant, u ossifikazzjoni ħeterotopika (żvilupp ta ’ għadam f’ żoni anormali) jew myositis ossificans (żvilupp anormali ta ’ għadam fil- muskolu).
For the full list of all side effects reported with Osigraft, see the Package Leaflet.
Għal - lista sħiħa ta ’ l- effetti sekondarji kollha irrapportati b’ Osigraft, ara l- Fuljett ta ’ Tagħrif.
Osigraft should not be used in people who may be hypersensitive (allergic) to eptotermin alfa or to collagen.
Osigraft m’ għandux jintuża f’ nies li huma sensittivi żżejjed (allerġiċi) għal eptotermin alfa jew għal kollaġen.
Osigraft should also not be used by the following groups of patients: • skeletally immature (still growing), • with an autoimmune disease (where the immune system attacks parts of the body), • with an active infection at the surgery site or another serious infection, • without enough skin or blood supply at the fracture site, • where the fracture is disease-related (such as metabolic bone disease or cancer), • with have a tumour near the fracture, • receiving chemotherapy, radiation treatment or immunosuppression.
Osigraft m’ għandux jintuża mill- gruppi ta ’ pazjenti li ġejjin: • skelettrikament immaturi (għadhom qed jikbru), • b’ mard awto- immuni (fejn is- sistema immuni tattakka partijiet mill- ġisem), • b’ infezzjoni attiva fis- sit tal- kirurġija jew b’ infezzjoni serja oħra, • mingħajr biżżejjed ġilda jew forniment tad- demm fis- sit tal- frattura, • fejn il- frattura hija relatata mal- mard (bħalma huwa mard metaboliku ta ’ l- għadam jew kanċer), • li għandhom tumur fejn is- sit tal- frattura, • li qed jirċievu kemjoterapija, trattament bir- radjazzjoni jew immunosoppressjoni
Why has Osigraft been approved?
Għaliex ġie approvat Osigraft?
The Committee for Medicinal products for Human Use (CHMP) decided that Osigraft’ s benefits are greater than its risks for the treatment of nonunion of tibia of at least nine month duration, secondary to trauma, in skeletally mature patients, where previous treatment with autograft has failed or use of autograft is unfeasible.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Osigraft huma akbar mir- riskji tiegħu għat- trattament ta ’ nuqqas ta ’ għaqid tat- tibja ta ’ l- anqas wara disa ’ xhur, wara trawma, f’ pazjenti skelettrikament maturi, fejn trattament preċedenti b’ awtograft ma jkunx irnexxa jew fejn l- użu ta ’ allograft ma kienx possibbli.
The Committee recommended that Osigraft be given marketing authorisation.
Il- Kumitat irrakkomanda li Osigraft jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Osigraft:
Tagħrif ieħor dwar Osigraft:
The European Commission granted a marketing authorisation valid throughout the European Union for Osigraft to Howmedica International S. de R.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Osigraft valida fl- Unjoni Ewropea kollha lil Howmedica International S. de R.
L. on 17 May 2001.
L. fis- 17 ta ’ Mejju 2001.
The marketing authorisation was renewed on 17 May 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 17 ta ’ Mejju 2006.
The full EPAR for Osigraft is available here.
L- EPAR sħiħ għal Osigraft huwa disponibbli minn hawn.
Osigraft 3.3 mg, powder for suspension for implantation
Osigraft 3. 3 mg, trab għal suspensjoni għall- impjantazzjoni
Each vial contains 1g powder with 3.3 mg of eptotermin alfa*
Kull kunjett fih 1g trab b’ 3. 3 mg ta ’ eptotermin alfa *
* Human Osteogenic protein produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology
* Protein ostejoġeniku uman ipproduċut miċ- ċelluli ta 'l- ovarju tal- ħamster Ċiniż (CHO) bit - teknoloġija rikombinanti tad- DNA
Osigraft is a white to off-white granular powder.
Osigraft hu trab granulari bejn abjad u off- white.
Treatment of nonunion of tibia of at least 9 month duration, secondary to trauma, in skeletally mature patients, in cases where previous treatment with autograft has failed or use of autograft is unfeasible.
It- trattament nonunjoni tat- tibja għal ta ’ l- anqas 9 xhur żmien, sekondarja għat- trawma, f’ pazjenti maturi skeletrali, f’ każi fejn it- trattament ta ’ qabel bl- awtotrapjant ma kienx irnexxa jew l- użu ta ’ l - awtotrapjant mhux prattiku.
Osigraft should be used by an appropriately qualified surgeon.
Osigraft għandu jintuża minn professur kwalifikat fl- użu adekwat tiegħu.
Depending on the size of the defect, more than a single 1 g vial of Osigraft may be required.
Għandu mnejn ikun hemm bżonn ta 'aktar minn kunjett wieħed ta ’ 1 g ta ’ Osigraft dejjem jiddependi mill- kobor tad- difett.
The maximum human dose should not exceed 2 vials since efficacy in the treatment on non-unions with gaps requiring higher doses has not been established.
Id- doża massima umana m’ għandhiex taqbeż 2 kunjetti għax l- effikaċja fit- trattament fuq non- unjonijiet b’ fetħiet li għandhom bżonn dożi ogħla ma ġietx stabbilita.
Osigraft is contraindicated in children (see section 4.3).
Osigraft hu kontra- indikat fit- tfal (ara sezzjoni 4. 3).
Osigraft is administered by direct surgical placement at the defect site in contact with the prepared bone surface.
Osigraft jingħata permezz ta ’ ippostjar dirett b’ operazzjoni fuq is- sit tad- difett f’ kuntatt mal- wiċċ ippreparat ta ’ l- għadma.
The surrounding soft tissues are then closed around the implant.
It- tessuti rotob tal- madwar imbagħad jingħalqu madwar l- impjant.
Experience from controlled clinical trials is limited to stabilisation of the fracture site using concomitant intramedullary nailing.
L - esperjenza minn esperimenti klinikali kkontrollati huma limitati għall- istabilizazzjoni tas- sit tal - frattura permezz ta ’ l- użu ta ’ tismir intramedullari konkomitanti.
Using sterile technique, remove the vial from its packaging.
Uża teknika sterili, neħħi l- kunjett mill- pakkett.
Lift the plastic flip-top and remove the crimp from the vial.
Neħħi l- għatu tal- plastik li tifflippjah u neħħi l- krimp mill- kunjett.
Handle the crimp with care.
Oqgħod attent kif taqbad il- krimp.
The edges of the crimp are sharp and may cut or damage gloves.
It- truf tal- krimp jaqtgħu u għandhom mnejn jaqtgħu jew jirrovinaw l- ingwanti.
Aligning your thumb with the internal gap of the stopper, pry up the edge of the stopper.
Allinja sebgħajk l- kbir ma ’ l- ispazju intern tat- tapp, iftaħ bis- saħħa it- tarf tat- tapp.
Once the vacuum is broken, remove the vial stopper while holding the vial upright to prevent loss of Osigraft.
Hekk kif jitneħħa l- vakum, neħħi t- tapp tal- kunjett waqt li tkun qed iżżomm l- kunjett dritt biex tevita ħela ta ’ Osigraft.
2 Do not insert a needle through the stopper.
Iddaħħalx labra ġot- tapp.
Puncture of the stopper with a needle may result in particles of stopper material contaminating the Osigraft.
Jekk it- tapp jittaqqab b’ labra, il- frak tal- materjal tat- tapp għandhom mnejn jikkontaminaw l- Osigraft.
Reconstitute the product as explained in section 6.6.
Irrikonstitwixxi l- prodott hekk kif inhu spjegat f’ sezzjoni 6. 6.
Debride fibrous, necrotic or sclerotic tissue and appropriately decorticate bone so that the reconstituted Osigraft is in direct contact with bleeding bone and viable osseous tissue.
Neħħi t- tessuti fibrużi, nekrotiċi jew sklerotiċi u neħħi kif suppost il- kopertura ħoxna ta ’ barra tal - - għadma biex l- Osigraft rikonstitwit ikun f' kuntatt dirett mal- għadma li joħroġ id- demm minnha u mat- tessut osseu vijabbli.
Provide adequate haemostasis to ensure that Osigraft is not dislodged from the surgical site.
Ipprovdi emostasi adegwata biex tkun ċert li l- Osigraft ma jinqalax mis- sit kirurġiku.
Irrigate as necessary prior to the implantation of Osigraft.
Aħsel bl - ilma kif suppost qabel l- impjantazzjoni ta 'Osigraft.
Where practical, surgical manipulations to the site should be completed prior to implantation of Osigraft.
Il- manipulazzjonijiet kirurġiċi għas- sit għandhom jintemmu qabel l- impjantazzjoni ta 'Osigraft, meta dan ikun prattiku.
Apply Osigraft to the prepared osseous tissue site using a sterile instrument such as a spatula or curette.
Applika l- Osigraft fis- sit ippreparat tat- tessut osseu permezz ta ’ strument sterili bħal ngħidu aħna spatula jew kurette.
The amount of Osigraft used should approximate the size of the bone defect.
L- ammont ta ’ Osigraft użat għandu jkun bejn wieħed u ieħor daqs id- daqs tad- difett tal- għadma.
Do not use suction or irrigation directly at the implant site as the particles of Osigraft may be removed.
Tużax apparat li jiġbed l- arja jew irrigazzjoni direttament fis- sit ta ’ l- impjant għax il- frak ta ’ l - Osigraft għandhom mnejn jitneħħew.
Remove excess fluid if necessary by suctioning adjacent to the implant site or carefully blotting the area with sterile sponge.
Neħħi l- fluwidu żejjed jekk dan hu neċessarju billi tiġbed bl- arja ħdejn is- sit ta 'l- impjant jew billi tuxxuga bir- reqqa l- post permezz ta' sponża sterili.
Close soft tissues around the defect containing Osigraft using suture material of choice.
Agħlaq it- tessuti rotob madwar id- difett li fih Osigraft billi tuża materjal tas- sutura li trid int.
Closure is critical for containment of the implant in the area of the defect.
L - għeluq hu importanti ħafna biex l- impjant jinżamm fl- arja tad- difett.
After closure of the soft tissues around the defect, irrigate field, if necessary to remove any Osigraft, which may have become dislodged during soft tissue closure.
Wara l- għeluq tat- tessuti rotob madwar id- difett, aħsel il- post, jekk hemm bżonn biex tneħħi kwalunkwe Osigraft, li għandu mnejn inqala 'matul l- għeluq tat- tessut artab.
Do not place a drain directly in the implant site.
Tpoġġix drejn direttament fis- sit ta ’ l- impjant.
If required, place it subcutaneously.
Jekk hemm bżonn, poġġih taħt il- ġilda.
Osigraft must not be used in treating patients who:
Osigraft m’ għandux jintuża fit- trattament ta ’ pazjenti li:
have a known hypersensitivity to the active substance or to collagen;
għandhom sensittività eċċessiva magħrufa għas- sustanza attiva jew il- kollaġen:
have skeletal immaturity;
għandhom immaturità skletrali;
have known autoimmune disease, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren’ s syndrome and dermatomyositis/ polymyositis;
għandhom xi marda magħrufa tas- sistema ta ’ awtoimmun, inkluż artrite rematojdi, lupus eritematosuż sistemiku, sklerodermija, sindrom ta 'Sjögren, u dermatomijositi/ polimijositi;
have active infection at the site of non-union or active systemic infection;
għandhom infezzjoni attiva fis- sit ta ’ infezzjoni sistematika non- unjoni jew attiva:
have inadequate skin coverage and vascularity of the non-union site;
m’ għandhomx biżżejjed kopertura tal- ġilda u vaskularità tas- sit non- unjoni.
would have application to vertebral fractures;
kellhom applikazzjoni ta ’ fratturi vertebrali;
have a non-union resulting from pathological fractures, metabolic bone disease or tumours;
għandhom non- unjoni minħabba fratturi patoloġikali, mard jew tumuri metaboliċi ta 'l- għadam;
have any tumour in the vicinity of the non-union site;
għandhom tumur ħdejn is- sit non- unjoni;
are receiving chemotherapy, radiation treatment or immunosuppression;
qed jirċievu kemoterapija, trattament bir- radjazzjoni jew immunosuppressjoni.
Osigraft does not provide any biomechanical strength and should be used with internal or external fixation where initial mechanical stabilisation is required.
Osigraft ma jipprovdix kwalunkwe saħħa bijomekkanikali u għandu jintuża ma ’ twaħħil intern jew estern fejn hemm bżonn ta ’ stabilizzazzjoni mekkanikali inizjali.
However, external fixation may not provide sufficient immobilisation.
Imma, it- twaħħil estern għandu mnejn ma jipprovdix biżżejjed immobilizzazzjoni.
Motion in the non-union site may disrupt the fracture healing process.
Il- moviment fis- sit non- unjoni għandu mnejn ifixkel il- proċess tal- fejqan tal- frattura.
Experience from controlled clinical trials is limited to stabilisation of tibial non-union site using
L- esperjenza minn esperimenti klinikali kkontrollati huma limitati għall- istabilizazzjoni tas- sit non- unjoni tibjali permezz ta ’ l- użu ta ’ tismir intramedullari konkomitanti.
Locking intramedullary rods have been used in the majority of cases.
Fil- biċċa l- kbira tal- każi intużaw virgi intramedullari li jillokkjaw.
Use of Osigraft does not guarantee repair, additional surgeries may be required.
L- użu ta ’ Osigraft ma jiggarntix tiswija, għandhom mnejn ikun hemm bżonn ta ’ aktar operazzjonijiet.
Any material dislodged from the non-union site can cause ectopic ossification in the surrounding tissues with potential complications.
Kwalunkwe materjal li jinqala ’ mis- sit non- unjoni jista ’ jikkaġuna ossifikazzjoni ektopika fit- tessuti tal- madwar b’ komplikazzjonijiet potenzjali.
Therefore, Osigraft may only be administered to the defect site under adequate vision and with utmost care.
Mela, l- Osigraft għandu mnejn jingħata biss lis- sit tad - difett taħt kontroll visiv adegwat u bl- akbar kura.
Special care must be taken to prevent any leakage of Osigraft due to irrigation, defective closure of surrounding tissue or inadequate haemostasis.
Wieħed għandu joqgħod aktar u aktar attent biex jara li ma jkunx hemm tqattir ta 'Osigraft minħabba l- irrigazzjoni, għeluq difettuż tat- tessut tal- madwar jew emostasi mhux adekwata.
Antibodies to OP-1 protein were detected in 66% of patients in the tibial non-union study following the administration of Osigraft.
Antikorpi għal proteini OP- 1 instabu fil- każ ta ’ 66% tal- pazjenti fl- istudji non- unjoni tibjali wara l - għoti ta ’ l- Osigraft.
Analysis of these antibodies showed that 9% had neutralizing capacity.
L- analiżi ta ’ dawn l- antikorpi juru li 9% kellhom kapaċità li tinnewtralizza.
However, no association with clinical outcome or adverse event could be observed in clinical studies.
Imma, ma kienet osservata l- ebda assoċjazzjoni mar- riżultat klinikali jew episodju avvers fi studji klinikali.
An immune response to Osigraft should be considered and appropriate tests for the presence of antibodies in serum should be performed in cases where an immune-mediated undesirable effect is suspected, including cases where Osigraft is ineffective.
Wieħed għandu jżomm quddiem għajnejh li jista 'jkun hemm rispons ta ’ l- immun għal Osigraft u testijiet adekwati għal preżenza ta' antikorpi fis- serum għandhom isiru f' każijiet fejn effett mhux mixtieq medjat- immun hu suspettat, inklużi każi fejn l- Osigraft ma jkunx effettiv.
Repeated use of Osigraft cannot be recommended.
L- użu ripetut ta ’ Osigraft ma jistax ikun irrakkomandat.
Studies with anti-OP-1 antibodies demonstrated some cross-reactivity with closely related BMP proteins BMP-5 and BMP-6.
Studji bl- anti- korpi anti- OP- 1 urew xi kross - reattività ma ’ proteini BMP relattati mill- qrib BMP- 5 u BMP- 6.
Anti-OP-1 antibodies have the ability to neutralise the in vitro biological activity of at least BMP-6.
Anti- korpi Anti- OP- 1 għandhom il — ħila li jinnewtralizzaw l- attività bijoloġika in vitro ta ’ l- anqas ta ’ BMP- 6.
Therefore, upon re- administration of Osigraft, a risk of developing autoimmunity towards the endogenous BMP proteins may exist.
Mela, hekk kif jerġa ’ jingħata l- Osigraft, għandu mnejn ikun hemm riskju li jiżviluppaw awtoimmunità lejn il- proteini BMP endoġenużi
The use of Osigraft with a synthetic bone void filler may lead to a risk of increase in local inflammation, infection and occasional migration of the implanted materials and is therefore not recommended.
L- użu ta 'Osigraft b’ filler sintetiku biex jimla l- ispazju bejn l- għadam għandu mnejn jirriżulta f’ riskju ta ’ żieda fl- infjamazzjoni lokali, infezzjoni lokali u xi kultant migrazzjoni tal- materjal impjantat u għalhekk mhux irrakkomandat.
The pivotal clinical trial supporting the approval of Osigraft did not include the use of synthetic bone void fillers.
L- istudju kliniku pivotali li jappoġġja l- approvazzjoni ta ’ Osigraft ma kienx jinkludi l- użu ta ’ fillers sintetiċi li jimlew l- ispazju bejn l- għadam.
Post market surveillance data has signaled that the use of Osigraft in combination with a synthetic bone void filler may lead to an increase in local inflammation infection and occasional migration of the implanted materials.
Id- dejta ta ’ sorveljanza wara t- tqegħid fis- suq uriet li l- użu ta ’ Osigraft flimkien ma ’ filler sintetiku biex jimla l- ispazju bejn l- għadam għandu mnejn jirriżulta f ’ żieda fl- infjamazzjoni lokali, infezzjoni lokali u xi kultant migrazzjoni tal- materjal impjantat.
Due to the unknown risks to the foetus associated with the potential development of neutralizing antibodies to OP-1 protein, Osigraft should not be used during pregnancy unless the potential benefit justifies the potential risks to the foetus (see section 4.4 & section 5.3).
Studji li saru fuq bhejjem m’ humiex biżżejjed rigward l- effetti ta ’ anti- korpi ta ’ anti- OP- 1 fuq l - iżvilupp embriju/ fetu (ara sezzjoni 5. 3) Minħabba r- riskji mhux magħrufa għall- fetu assoċjati ma 'l - iżvilupp potenzjali ta' l- anti- korpi newtralizzanti għall- protein OP- 1, Osigraft m' għandux jintuża matul it- tqala għajr meta l- benefiċċju potenzjali jiġġustifika r- riskji potenzjali għall- fetu (ara sezzjoni 4. 4 & sezzjoni 5. 3).
Women of childbearing potential should be advised to use effective contraception up to at least 12 months after treatment.
Nisa li jistgħu joħorġu tqal għandhom jingħataw parir li għandhom jużaw mezz ta ’ kontraċezzjoni li hu effettiv sa ta ’ l- anqas 12- il xahar wara t- trattament.
Women of child-bearing potential should inform their surgeon of the possibility of pregnancy prior to treatment with Osigraft.
Nisa li jistgħu joħorġu tqal għandhom jagħrfu lill- kirurġiku tagħhom dwar il- possibilità tat- tqala qabel it- trattament bl- Osigraft.
In animal studies, excretion of IgG class anti-OP-1 antibodies into milk has been shown.
Fi studji fuq bhejjem, intwera li kien hemm it- tkeċċija ta ’ antikorpi anti- OP- 1 tal- klassi ta ’ IgG fil - ħalib.
As human IgG is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during Osigraft therapy (see Section 5.3).
Peress li l- IgG uman jinżel fil- ħalib uman, u l- potenzjal tal- ħsara għat- tarbija mhux magħruf, in - nisa m’ għandhomx ireddgħu waqt li jkunu qed jirċievu terapija b’ Osigraft (ara Sezzjoni 5. 3).
Osigraft should be given to breast-feeding women only when the attending physician decides that the benefits outweigh the risks.
Osigraft għandu jingħata biss lil nisa li qed ireddgħu meta it- tabib kuranti jiddeċiedi li l- benefiċċji huma akbar
It is recommended that breast-feeding be discontinued following treatment.
Hu rrakkomandat lit- treddigħ jitwaqqaf wara t– trattament.
Not relevant.
M’ għandux x’ jaqsam.
4 Osigraft is implanted by an invasive surgical procedure, for example during open reduction of a fracture site.
Osigraft hu impjantat permezz ta ’ proċedura kirurġika invasiva, pereżempju matul ir- riduzzjoni miftuħa tas- sit tal- frattura.
Adverse events following such surgery and not specifically associated with the product may include wound infection, osteomyelitis, mechanical complications of mechanical support, hematoma, dehiscence, nausea, fever and pain.
Episodji avversi wara tali operazzjoni u li mhumiex assoċjati b’ mod speċifiku mal- prodott għandhom mnejn jinkludu infezzjoni tal- ferita, ostejomijeliti, komplikazzjonijiet mekkanikali tas- sapport mekkanikali, ematoma, dejisċenza, tqallih, deni u wġigħ.
The incidence of these events in clinical studies was > 10%.
L- inċidenza ta ’ dawn l- episodji fi studji klinikali kienu > 10%.
However, there were no differences in the incidence of these adverse events compared with patients who received bone autograft, except in the case of osteomyelitis for which the incidence of osteomyelitis was statistically higher in the autograft group.
Imma, kien hemm differenzi fl- inċidenza ta ’ dawn l - episodji avversi a paragun ma 'pazjenti li ngħataw awtotrapjant, barra mill- każ ta' ostejomijeliti li għalihom l- inċidenza ta 'ostejomijeliti kienet statistikament ogħla fil- grupp ta ’ l- awtotrapjant.
The following undesirable effects were commonly (> 1/ 100, < 1/ 10) reported in clinical trials: erythema, tenderness, swelling over the implant site, and heterotopic ossification/ myositis ossificans.
L- effetti mhux mixtieqa li ġejjin kienu komuni (> 1/ 100, < 1/ 10) fi studji kliniċi: eritema, dak li jkun iweġġa ’ malajr, nefħa fuq is- sit ta ’ l- impjant, ossifikazzjoni eterotopika/ mijosite ossifikanti.
Bone Morphogenetic Proteins, ATC code:
Proteini Morfoġenetiċi ta ’ l- Għadma, kodiċi ATC:
It is an osteoinductive and osteoconductive medicinal product.
Hu prodott mediċinali ostejoinduktiv u ostejokonduktiv.
Eptotermin alfa, the active substance, initiates bone formation through the induction of cellular differentiation in mesenchymal cells, which are recruited to the implant site from bone marrow, periosteum and muscle.
Eptotermin alfa, is- sustanza attiva, tibda l- formazzjoni ta 'l- għadma permezz ta' l- induzzjoni tad - differentjazzjon ċellulari fiċ- ċelluli mesenkimali, li huma reklutati għas- sit ta 'l- impjant mill- mudullum tal- għadma, il- perjosteum u l- muskoli.
Once bound at the cell surface, the active substance induces a cascade of cellular events leading to the formation of chondroblasts and osteoblasts, which play a key role in the bone formation process.
Hekk kif tintrabat mal- wiċċ taċ- ċellula, is- sustanza attiva tinduċi kaskada ta 'episodji ċellulari li twassal għall- formazzjoni ta' kondroblasti u ostejoblasti, li għandhom sehem importanti fil- proċess tal- formazzjoni ta 'l- għadma.
The collagen matrix is insoluble and consists of particles with a size range of 75-425µm.
Il- matrix tal- kollaġen ma jdubx u jikkonsisti fi frak li għandhom firxa ta ’ qies ta '75- 425µm.
This provides an appropriate bioresorbable scaffold for the anchorage dependent cell proliferation and differentiation processes induced by the active substance.
Dan jipprovdi pjattaforma adekwata bijoresorbabbli indutti mis- sustanza attiva biex ikun hemm proliferazzjoni u differentjazzjoni taċ - ċelluli li jinħtieġu l- ankrar.
The cellular events induced by the active substance take place within the collagen matrix.
L- episodji ċellulari indutti mis- sustanza attiva jseħħu fi ħdan il- matrix tal - kollaġen.
The matrix is also osteoconductive and it allows bone in-growth into the defect area from the surrounding healthy bone.
Il- matrix hi wkoll ostjokonduktiva u tħalli l- iżvilupp tal- għadma ġewwa l- arja tad- difett mill- għadma b’ saħħitha li hemm fil- madwar.
The new bone formed is mechanically and radiographically comparable to normal bone.
L- għadma ġdida li tifforma hi mekkanikalment u radjografikalment komparabbli mal- għadma normali.
The new bone remodels naturally, cortices are formed and marrow elements are generated.
L- għadma l- ġdida terġa ’ timmudella b' mod naturali, il- kortiċi jifformaw u l- elementi tal- mudullun jkunu ġenerati.
However, use of Osigraft does not guarantee repair; additional surgery may be required.
Biss l- użu ta ’ Osigraft ma jiggarntix tiswija, għandhom mnejn ikun hemm bżonn ta ’ aktar operazzjonijiet.
The Tibial Nonunion pivotal trial compared Osigraft with autograft, with a primary efficacy endpoint at 9 months post-treatment.
L- istudju pivotali Nonunjoni Tibjali ipparaguna Osigraft ma ’ l- awtotrapjant, bl- aħħar stadju ta ’ proċess primarju ta ’ effikaċja 9 xhur wara t- trattament.
Clinical outcomes of pain and weight-bearing were comparable to the autograft (81% success in the Osigraft group, 77% success in the autograft goup).
Ir- riżultati kliniċi ta ’ l- uġigħ u jekk dak li jkun jiflaħx il- piż kienu komparabbli ma ’ l- awtotrapjant (suċċess ta ’ 81% fil- grupp Osigraft, suċċess ta ’ 77% fil- grupp awtotrapjant).
The radiographic healing results of the Osigraft treatment group were slightly inferior compared to the autograft control group (68% and 79% respectively).
Ir- riżultati tal- fejqan radjografiku tal- grupp tat- trattament ta ’ l- Osigraft kienu kemm kemm aktar inferjuri a paragun tal- grupp tal- kontroll ta ’ l- awtotrapjant (68% u 79% rispettivament).
There are no data on the pharmacokinetics of the active substance in man.
5 M’ hemm l- ebda tagħrif dwar il- farmkokinetiċi tas- sustanza attiva fil- bniedem.
However, results from Osigraft implantation studies in animals demonstrate that the active substance eptotermin alfa is largely unavailable systemically.
Imma, r- riżultati mill - istudji ta ’ l- impjantazzjoni ta ’ Osigraft f’ annimali juru lis- sustanza attiva eptotermin alfa mhix normalment disponibbli mil- lat sistemikaliku.
Single dose and repeat dose studies in a range of animal models (rats, dogs and primates) were performed.
Saru studji ta ’ doża waħda u dawk ripetuti fuq firxa ta ’ modelli ta ’ annimali (firien, klieb u primati).
The results of these showed no unanticipated or systemic effects of toxicity during the observation period and after administration.
Ir- riżultati ta ’ dawn urew li ma kien hemm l- ebda effett mhux mistenni jew sistemiku tat- tossiċità matul il- perijodu ta ’ l- osservazzjoni u wara l- għoti.
5 In a 2 year subcutaneous implantation study in rats, heterotopic bone formation was observed, as expected.
Fi studju li dam sentejn ta ’ l- impjantazzjoni taħt il- ġilda, fil- firien kienet osservata il- formazzjoni eterotopika tal- għadma, kif kien mistenni.
This effect, termed solid state carcinogenicity, frequently has been observed in rats where solid materials (plastics or metals) were implanted subcutaneously.
Sarkoma kienet assoċjata mal- preżenza fuq żmien twil tal - għadma eterotopika Dan l- effett, magħruf bħala karkinoġeniċità fi stat solidu, dehret ta 'spiss fil- firien meta kienu impjantati materjali solidi (plastik u metalli) taħt il- ġilda.
Heterotopic ossification commonly occurs in humans following accidental or surgical trauma.
Ossifikazzjoni eterotopika spiss dehret fil- bnedmin wara trawma aċċidentali jew kirugika.
Heterotopic ossification may also occur following use.
Ossifikazzjoni eterotopika għandha mnejn tiġri wara l- użu.
(See Section 4.8 Undesirable Effects.) However, there is evidence to suggest that heterotopic ossification is not linked to sarcoma in humans.
(Ara Sezzjoni 4. 8 Effetti Mhux Mixtieqa) Imma, hemm xhieda li tissuġġerixxi li l- ossifikazzjoni eterotopika mhix marbuta mas- sarkoma fil - bnedmin.
The effect of anti-OP-1 antibodies on the bone healing process was studied in dogs following two long bone defects treated with repeat implantations.
L- effett ta ’ l- antikorpi ta ’ l- anti- OP1 fuq il- proċess tal- fejqan ta ’ l- għadma kien studjat fil- klieb wara li żewġ difetti fl- għadma it- twila kienu kkurati b’ impjanti ripetuti.
The results of radiological and histological examinations in this non-clinical study showed bone healing with the initial and repeat exposure in the same animal.
Ir- riżultati ta ’ l- eżamijiet radjoloġikali u istoloġikali f' dan l- istudju mhux kliniku wrew li kien hemm l- fejqan tal- għadma bl- esponiment inizjali u ripetut fl- istess annimal.
Antibodies to OP-1 and bovine bone collagen type 1 were found after both exposures; the antibody peak concentration was higher after the second implantation.
Anti- korpi għall- OP- 1 u l- kollaġen tip 1 tal- għadma bovin instabu wara ż- żewġ esponimenti; l- ogħla konċentrazzjoni ta 'anti- korpi kienet ogħla wara t- tieni impjant.
The antibody levels declined towards baseline during the follow-up period.
Il - livelli ta 'anti- korpi tbaxxew għall- linjabażi matul il- perijodu tal- follow- up.
Controlled studies of the effects of exposure to eptotermin alfa on pre and postnatal development were performed in rabbit models.
Kien hemm studji kkontrollati ta ’ l- effetti ta ’ l- esponiment għall- eptotermin alfa fuq l- iżvilupp ta 'qabel u wara t- twelid fuq kapjuni ta ’ fniek.
Eptotermin alfa in Freund’ s adjuvant was first administered subcutaneously with booster doses given after 14 and 28 days.
Eptotermin alfa fl- adjuvant ta ’ Freund ngħata l- ewwel taħt il- ġilda b’ dożi booster li ngħataw wara 14 u 28- il ġurnata.
Blood and milk samples were collected at regular intervals and analysed using a solid phase enzyme-linked immunoassay (ELISA) test.
Inġabru kampjuni tad- demm u l- ħalib f’ intervalli regulari u kienu analizzati permezz ta ’ l- użu tat- test immunoassay marbut ma 'l- enzima f’ fażi solida (ELISA).
Detectable levels of IgG and IgM antibodies to eptotermin alfa developed and were found in the serum of all exposed adult animals.
Kienu osservati li żviluppaw livelli ta 'anti- korpi IgG u IgM għall- eptotermin alfa u nstabu fis- serum ta ’ l- annimali kollha adulti li kienu esposti.
Antibodies to eptotermin alfa were found in sera from pooled foetal and umbilical cord blood at levels that correlated to that of the maternal blood.
L- anti- korpi għall- eptotermin alfa nstabu fis- sera tad- demm ippuljat tal- fetu u tal- kurdun taż- żokra f’ livelli li kien ikkorrelat ma ’ dak tad- demm ta 'l- omm.
Antibodies were detectable in adults and offspring during the gestation and lactation periods.
L- anti- korpi kienu osservati f' adulti u trabi matul il- perijodu tal- ġestazzjoni u tat- treddigħ.
Significantly high titers of IgG class anti-OP-1 antibodies were detected in milk throughout the whole post-natal phase study until the lactation day 28 (see section 4.6).
Kienu osservati titri għoljin b’ mod sinifikanti ta ’ anti- korpi ta 'klassi IgG u anti- OP- 1 fil - ħalib matul il- fażi ta' l- istudju kollu ta ’ wara t- twelid sat- 28 ġurnata tat- treddigħ (ara sezzjoni 4. 6).
A statistically significant increase in foetal malformations (misaligned sternabrae) was seen in litters of the OP-1 immunized group.
Kienet osservat żjieda sinifikanti statistikali fil- malformazzjonijiet fetali (sternabrae mhux allinjati sewwa) f’ boton tal- grupp OP- 1 immunizzat.
In another study a difference in body weight gain was seen in the immunized adult females between lactation days 14 to 21 when compared to the control animals.
Fi studju ieħor kien osservat differenza fil- piż tal- ġisem f’ dawk tas- sess femminili li kienu adulti u immunizzati bejn il- ġranet 14 u 21 tat- treddigħ meta kienu pparagunati ma 'l- annimali tal- kontroll.
The weight of the offspring in the treated group was noted to be less than that of the control group during the observation period.
Il- piż tat- trabi fil- grupp ikkurat kien innotat li kien inqas minn dak tal- grupp tal- kontroll matul il- perijodu ta 'osservazzjoni.
The clinical implications of these observations for human use of the finished product remain uncertain.
L- implikazzjonijiet kliniċi ta 'dawn l- osservazzjonijiet għall- użu uman tal- prodott lest għadhom inċerti.
(See 4.6 Pregnancy & Lactation).
(Ara 4. 6 Tqala u Treddigħ).
Bovine collagen (vacuum dried)
Bovine collagen (imnixxef fil- vakjum)
In the absence of comparability studies, this medicinal product must not be mixed with other medicinal products.
6 Peress li ma sarux studji li juri liema huma l- prodotti li jipparagunaw miegħu, dan il- prodott mediċinali m' għandux jitħallat ma 'prodotti mediċinali oħra.
The reconstituted product should be used immediately.
Il- prodott rikonstitwit għandu jintuża minnufih.
Store in a refrigerator (2°C - 8°C) Keep the blister pack in the outer carton
Aħżen fil- friġġ (2°C - 8°C) Żomm il- pakkett ta ’ l- istrixxi fil- kartuna ta ’ barra.
6 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Osigraft is supplied in a glass vial (Type 1, borosilicate) containing 1 g of powder, sealed with a stopper (butyl rubber) and a crimp cap (aluminium).
Osigraft jingħata f’ kunjett tal- ħġieġ (Tip 1, borosilicate) li fih 1 g ta ’ trab, magħluq b’ għatu (tal- lastiku butil) u għatu krimp (aluminju).
The primary package is maintained sterile within a blister pack, comprised of two (inner and outer) plastic trays and lids.
Il- pakkett primarju jinżamm sterili ġewwa pakkett ta ’ l- istrixxi, li fih żewġ (wieħed ġewwa u l- ieħor barra) trejiet tal- plastik u għotjien.
Pack size of 1 vial.
Il- pakkett fih kunjett wieħed.
Each vial of Osigraft is reconstituted with 2 to 3 ml of sterile 9 mg/ ml sodium chloride solution (0.9% w/ v) prior to use.
Rikonstituzzjoni mas- solvent (mhux pprovdut) Kull kunjett ta ’ Osigraft qabel ma jintuża hu rikonstiwit minn 2 sa 3 ml ta ’ soluzzjoni sterili ta ’ klorid tas- sodju ta ’ konċentrazzjoni ta ’ 9mg/ ml (0. 9% w/ v).
An appropriate quantity of sterile sodium chloride solution for injection and contents of the Osigraft vial are transferred to a sterile bowl and mixed with a sterile spatula or curette.
Soluzzjoni sterili ta ’ kwantita adegwata ta ’ sodium chloride għall- injezzjoni u l- kontenuti tal- kunjett Osigraft huma ttrasferiti għall- skutella sterili u mħallta bi spatula jew kurett sterili.
After reconstitution, the single use suspension for implantation should be used immediately.
Wara r- rikonstituzzjoni, is- sospensjoni li tintuża darba għall - impjantazzjoni għandha tintuża minnufih.
Administration When reconstituted, Osigraft has the consistency of wet sand, which facilitates its implantation and placement at bone site defects.
L- Għoti Meta jkun rikonstitwit, Osigraft għandu l- konsistenza ta ’ ramel imxarrab, li jiffaċilita l- impjantazzjoni u tpoġġija fis- sit tad- difetti ta 'l- għadma.
Disposal Any unused product or waste material should be disposed of in accordance with local requirements.
Rimi Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Division of Stryker Corporation Raheen Industrial Estate Raheen Limerick Ireland
Taqsima ta ’ Stryker Corporation Raheen Industrial Estate Raheen Limerick Irlanda
EU/ 1/ 01/ 179/ 001
UE/ 1/ 01/ 179/ 001
17 May 2001 Date of latest renewal:
17 ta ’ Mejju 2001 Data ta ’ l- aħħar tiġdid:
17 May 2006
17 ta 'Mejju 2006
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott mediċinali tinsab fuq il- website ta 'l- Aġenzija Ewropeja dwar il- mediċini (EMEA) http: // www. emea. europa. eu /
8 A.
8 ANNESS II
Name and address of the manufacturer(s) of the biological active substance
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Howmedica International S. de R.
Howmedica International S deR L.
• OTHER CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
The Marketing Authorisation Holder will continue to submit yearly PSURs.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq ser ikompli jipprovdi PSURs kull sena.
10 A.
10 ANNESS III
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
11 A. TIKKETTA
Osigraft 3.3 mg, powder for suspension for implantation. eptotermin alfa.
Osigraft 3. 3 mg, trab għal suspensjoni għall- impjantazzjoni. eptotermin alfa.
1 g powder contains 3.3 mg eptotermin alfa*. * Human Osteogenic protein produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
1 g ta ’ trab fih 3. 3 mg eptotermin alfa *. * Protein Ostejoġeniku uman ipproduċut miċ- ċelluli ta 'l- ovarju tal- ħamster Ċiniż (CHO) bit - teknoloġija rikombinanti tad- DNA.
Bovine collagen.
Bovine collagen.
Powder for suspension for implantation, (1 g in a vial - Pack size of 1).
Trab għal suspensjoni għall- impjantazzjoni, (1 g fil- kunjett – Daqs ta 'pakkett ta ’ 1).
For intraosseous implantation.
Għall- impjantazzjoni intrajossew.
Keep the blister packs in the outer carton.
Żomm il- pakketti ta ’ l- istrixxi fil- kartuna ta ’ barra.
Howmedica International S. de R.
Howmedica International S. deR. L.
Division of Stryker Corporation Raheen Business Park Limerick Ireland
Taqsima ta ’ Stryker Corporation Raheen Business Park Limerick Irlanda
Lot {number}
Lot {Numru}
13 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
14 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
FOIL FOR THE BLISTER PACK (OUTER) FOR THE VIAL
FOJL TAL- PAKKETT TA ’ L- ISTRIXXI (TA ’ BARRA) GĦALL- KUNJETT
Intraosseous use.
Għall- użu intrajossew.
Read the package leaflet before use.
Aqra l- fuljett tal- pakkett qabel ma tużah.
3.3 mg
3. 3 mg
Do not open before use.
Tiftħux qabel ma tużah.
14 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
EXPIRY DATE
DATA TA ’ JISKADI
Osigraft 3.3 mg, powder for suspension for implantation eptotermin alfa
Osigraft 3. 3 mg, trab għal suspensjoni għall- impjantazzjoni eptotermin alfa
- If you have further questions, ask your doctor.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib tiegħek.
- If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex
What Osigraft is and what it is used for 2.
X’ inhu Osigraft u għalxiex jintuża 2.
Before you use Osigraft 3.
Qabel ma tuża Osigraft 3.
How to use Osigraft 4.
Kif għandek tuża Osigraft 4.
Possible side effects 5 How to store Osigraft 6.
Effetti sekondarji li jista ’ jkollu 5 Kif taħżen Osigraft 6.
WHAT OSIGRAFT IS AND WHAT IT IS USED FOR
X’ INHU OSIGRAFT U GĦALXIEX JINTUŻA
Osigraft contains eptotermin alfa, a bone morphogenetic protein that induces new bone formation as part of the healing process.
Osigraft fih eptotermin alfa, proteina morfoġeniku tal- għadma li jinduċa l- formazzjoni ta ’ għadma ġdida bħala parti mill- proċess tal- fejqan.
Osigraft is used in the treatment of nonunion (fractures which have failed to heal) of tibia of at least 9 month duration, secondary to trauma (following injury), in skeletally mature patients, in cases where previous treatment with autograft (transplanted bone from your hip) has failed or use of autograft is not feasible.
Osigraft jintuża fit- trattament nonunjoni (fratturi li ma kinux fiequ) tat- tibja li ilha hekk ta ’ l- anqas 9 xhur, sekondarja għat- trawma (wara korriment), f’ pazjenti li huma maturi skeletrali, f’ każi fejn it - trattament ta 'qabel b’ awtotrapjant (għadma trapjantata minn ġenbek) ma ħadimx jew l- użu ta ’ awtotrapjant mhux possibbli.
BEFORE YOU USE OSIGRAFT
QABEL MA TUŻA OSIGRAFT
Do not use Osigraft
Tużax Osigraft
- If you are allergic to eptotermin alfa or collagen, the other ingredient of Osigraft.
- Jekk int allerġiku/ a għall- eptotermin alfa jew kollaġen, l- ingredjent l- ieħor ta ’ Osigraft.
- If you are skeletally immature (still growing).
- Jekk int immatur skeletrali (għadek qed tikber)
- If you have an autoimmune disease (disease arising from or directed against your own tissues),
- Jekk għandek xi marda awtoimmuna (marda kaġun minn jew diretta kontra t- tessuti tiegħek
including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren’ s syndrome and dermatomyositis/ polymyositis.
stess), inkluża artrite rewmatojdika, lupus eritematosuż sistemiku, skleroderma, sindrom ta ’ Sjögren, u dermatomijositi/ polimijositi.
- If you have active infection at the site of non-union (inflammation and drainage at the site of
- Jekk għandek infezzjoni attiva fis- sit non- unjoni (infjammazzjoni u tnixxija fis- sit tal -
injury) or active systemic infection.
korriment) jew infezzjoni attiva sistemika.
- If your doctor determines that you have inadequate skin coverage (at the fracture site) and
- Jekk it- tabib tiegħek jiddeċiedi li għandek kopertura inadekwata tal- ġilda (fis- sit tal- frattura) u
inadequate blood supply at the non-union site.
kwantità mhux adekwata tad- demm fis- sit non- unjoni.
- For application to vertebral (spine) fractures.
- Għall- applikazzjoni tal- fratturi (xewka) vertebrali.
- For treating non-union resulting from pathological (disease-related) fractures, metabolic bone
- Għat- trattament non- unjoni minħabba fratturi patoloġikali (li għandhom x’ jaqsmu mal- mard),
disease or tumours.
mard metaboliku tal- għadam jew tumuri.
- When there are any tumours in the area of the non-union site.
- Fejn hemm kwalunkwe tumuri fiż- żona tas- sit non- unjoni.
- If you are receiving chemotherapy, radiation treatment or immunosuppression
- Jekk qed jirċievu kemoterapija, trattament bir- radjazzjoni jew immunosuppressjoni.
Take special care with Osigraft The following are precautions for use of Osigraft to be discussed with your doctor.
Oqgħod attent ħafna b’ Osigraft Dawn li ġejjin huma prekawzjonijiet għall- użu ta ’ Osigraft li għandhom jiġu diskussi mat- tabib tiegħek.
Osigraft does not aid in the support of weight and does not stabilise the fracture.
Osigraft ma jgħinx lil dak li jkun jistrieħ fuqha u ma jistabilizzax il- frattura.
Therefore, it should be used with internal or external bone fixation devices.
Mela, għandu jintuża ma 'apparat tal- fissazzjoni interna jew esterna ta ’ l- għadma.
However, external fixation may not provide
Imma, il- fissazzjoni esterna għandha mnejn ma tipprovdix biżżejjed stabilità.
17 sufficient stability.
18 fejqan tal- frattura.
Experience from controlled clinical trials is limited to stabilisation of the tibial non-union site (lower leg) using intramedullary nailing (internal fixation device).
L- esperjenza minn esperimenti kliniċi kkontrollati hija limitata għall - istabilizzazzjoni tas- sit non- unjoni tibjali (parti t’ isfel tar- riġel) permezz ta ’ l- użu ta ’ tismir intramedullari (apparat tat- fissazzjoni interna).
Locking intramedullary nails have been used in the majority of cases.
Fil- biċċa l- kbira tal- każi intużaw virgi intramedullari li jillokkjaw.
Use of Osigraft does not guarantee repair; additional surgeries may be required.
L- użu ta ’ Osigraft ma jiggarntix tiswija, għandhom mnejn ikun hemm bżonn ta ’ operazzjonijiet oħra.
Any material dislodged from the non-union site can cause bone formation (ectopic ossification) in the surrounding tissues with potential complications.
Kwalunkwe materjal li jinqala ’ mis- sit non- unjoni jista ’ jikkaġuna formazzjoni ta ’ l- għadma (ossifikazzjoni ektopika) fit- tessuti tal- madwar b’ komplikazzjonijiet potenzjali.
Therefore, Osigraft may only be administered to the defect site under adequate vision and with utmost care.
Mela, l- Osigraft għandu mnejn jingħata biss lis- sit tad- difett taħt kontroll visiv adegwat u bl- akbar kura.
Special care must be taken to prevent any leakage of Osigraft due to irrigation, defective closure of surrounding tissue or inadequate haemostasis (control of bleeding).
Wieħed għandu joqgħod aktar u aktar attent biex jara li ma jkunx hemm tqattir ta 'Osigraft minħabba l - irrigazzjoni, għeluq difettuż tat- tessut tal- madwar jew emostasi mhux adekwata (kontroll tal- ħruġ tad - demm).
Antibodies to OP-1 protein were detected in 66% of patients in the tibial non-union study following the administration of Osigraft.
Fl- istudji non- unjoni tibjali li sar wara l- għoti ta ’ l- Osigraft instabu antikorpi għal proteini OP- 1 fil - każ ta ’ 66% tal- pazjenti.
However, no association with clinical outcome or adverse event could be observed in clinical studies.
Imma, ma kienet osservata l- ebda assoċjazzjoni mar- riżultat kliniku jew episodju avvers fi studji kliniċi.
An immune response to Osigraft should be considered and appropriate tests for the presence of antibodies in serum should be performed in cases where an immune-mediated undesirable effect is suspected, including cases where Osigraft is ineffective.
Wieħed għandu jżomm quddiem għajnejh li jista 'jkun hemm rispons ta ’ l- immun għal Osigraft u għandhom isiru testijiet adekwati għal preżenza ta' antikorpi fis- serum f' każijiet meta jkun suspettat il- preżenza ta ’ l- effett mhux mixtieq medjat- immun, inklużi każi fejn l- Osigraft ma jkunx effettiv.
Studies with anti-OP-1 antibodies demonstrated some cross-reactivity with closely related BMP proteins BMP-5 and BMP-6.
L- istudji b’ anti- korpi anti- OP- 1 urew li kien hmm xi kross- reattività mal- proteini BMP li huma relattati mill- qrib BMP- 5 u BMP- 6.