natgillin/translations-raw huggingface dataset:
Irrigate as necessary prior to the implantation of Osigraft.
Pred vsaditvijo Osigrafta po potrebi izperite mesto vsaditve.
Where practical, surgical manipulations to the site should be completed prior to implantation of Osigraft.
Če je možno, končajte kirurške posege na tem mestu pred vsaditvijo Osigrafta.
Apply Osigraft to the prepared osseous tissue site using a sterile instrument such as a spatula or curette.
Nanesite Osigraft na pripravljeno mesto v kostnem tkivu s sterilnim instrumentom, na primer 7. spatulo ali žličko.
The amount of Osigraft used should approximate the size of the bone defect.
Količina Osigrafta mora približno ustrezati velikosti poškodbe kosti.
Do not use suction or irrigation directly at the implant site as the particles of Osigraft may be removed.
Mesta vsaditve ne sesajte ali izpirajte neposredno, ker lahko odstranite delce Osigrafta.
Remove excess fluid if necessary by suctioning adjacent to the implant site or carefully blotting the area with sterile sponge.
Če je 8. potrebno, odvečno tekočino odstranite s sesanjem ob mestu vsaditve ali s sterilno gobico previdno popivnajte območje vsaditve.
Close soft tissues around the defect containing Osigraft using suture material of choice.
Mehka tkiva v okolici poškodbe, ki vsebuje Osigraft, zašijte z materialom po izbiri.
Closure is critical for containment of the implant in the area of the defect.
Zaprtje teh 9. tkiv je pomembno, da se vsadek zadrži v območju poškodbe.
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.
Ko zaprete mehka tkiva v okolici poškodbe, jih po potrebi izperite in odstranite ostanke Osigrafta, ki so bili med zapiranjem morda odstranjeni.
Do not place a drain directly in the implant site.
Drenažne cevke ne postavljajte neposredno v mesto vsaditve.
If required, place it subcutaneously.
Če je potrebno, jo postavite pod 11. kožo.
Osigraft must not be used in treating patients who:
Osigrafta ne smete uporabljati pri bolnikih:
have a known hypersensitivity to the active substance or to collagen;
ki imajo znano preobčutljivost za aktivno učinkovino ali kolagen;
have skeletal immaturity;
ki so skeletno nezreli;
have known autoimmune disease, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren’ s syndrome and dermatomyositis/ polymyositis;
ki imajo znano avtoimunsko bolezen, vključno z revmatoidnim artritisom, sistemskim lupusom eritematozusom, sklerodermo, Sjögrenovim sindromom in dermatomiositisom/ polimiositisom;
have active infection at the site of non-union or active systemic infection;
ki imajo aktivno okužbo na mestu nezraslega zloma ali aktivno sistemsko okužbo;
have inadequate skin coverage and vascularity of the non-union site;
ki imajo neustrezno pokritost s kožo ali neustrezno prekrvavljenost na mestu nezraslega zloma;
would have application to vertebral fractures;
pri katerih bi se zdravilo uporabilo ob zlomih hrbtenice;
have a non-union resulting from pathological fractures, metabolic bone disease or tumours;
ki imajo nezrasel zlom, ki je posledica patoloških zlomov, presnovnih bolezni kosti ali tumorjev;
have any tumour in the vicinity of the non-union site;
ki imajo kakršenkoli tumor v bližini mesta nezraslega zloma;
are receiving chemotherapy, radiation treatment or immunosuppression;
ki prejemajo kemo -, radio - ali imunosupresivno terapijo.
Osigraft does not provide any biomechanical strength and should be used with internal or external fixation where initial mechanical stabilisation is required.
Osigraft ne ponuja nikakršne biomehanske opore.
However, external fixation may not provide sufficient immobilisation.
Če je potrebna mehanska stabilizacija, ga morate uporabljati z notranjo ali zunanjo učvrstitvijo.
Motion in the non-union site may disrupt the fracture healing process.
Zunanja učvrstitev morda ne bo ponujala zadostne
3 concomitant intramedullary nailing.
Premikanje na mestu nezraslega zloma lahko prekine proces zdravljenja.
Locking intramedullary rods have been used in the majority of cases.
V večini primerov so uporabili intramedularne palice na zaklep.
Use of Osigraft does not guarantee repair, additional surgeries may be required.
Uporaba Osigrafta ne zagotavlja okrevanja, zato bodo morda potrebne dodatne operacije.
Any material dislodged from the non-union site can cause ectopic ossification in the surrounding tissues with potential complications.
Snovi, ki se odstranijo z mesta nezraslega sklepa, lahko povzročijo ektopično okostenitev z morebitnimi zapleti v obkostnih tkivih.
Therefore, Osigraft may only be administered to the defect site under adequate vision and with utmost care.
Torej smete Osigraft uporabljati le na mestu poškodbe pod ustreznim nadzorom in skrajno previdno.
Special care must be taken to prevent any leakage of Osigraft due to irrigation, defective closure of surrounding tissue or inadequate haemostasis.
Posebno morate biti previdni, da preprečite iztekanje Osigrafta zaradi izpiranja, nepravilnega zaprtja obkostnih tkiv ali neustrezne preprečitve krvavitve.
Antibodies to OP-1 protein were detected in 66% of patients in the tibial non-union study following the administration of Osigraft.
V študiji nezraslih zlomov golenice so po uporabi Osigrafta pri 66% bolnikov odkrili protitelesa proti beljakovini OP- 1.
Analysis of these antibodies showed that 9% had neutralizing capacity.
Analiza je pokazala, da 9% teh protiteles ima zmožnost nevtralizacije.
However, no association with clinical outcome or adverse event could be observed in clinical studies.
Vendar pri kliničnih raziskavah niso opazili povezave s kliničnim izidom ali neželenimi učinki.
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.
V primerih, kjer sumite na neželene učinke imunskega izvora, vključno s primeri, ko Osigraft ne učinkuje, morate pretehtati možnost imunskega odziva na Osigraft in opraviti ustrezne teste za prisotnost protiteles v serumu.
Repeated use of Osigraft cannot be recommended.
Ponavljajoče se uporabe zdravila Osigraft ni mogoče priporočiti.
Studies with anti-OP-1 antibodies demonstrated some cross-reactivity with closely related BMP proteins BMP-5 and BMP-6.
Študije s protitelesi proti OP- 1 so pokazale določeno navzkrižno reaktivnost s sorodnimi beljakovinami BMP, BMP- 5 in BMP- 6.
Anti-OP-1 antibodies have the ability to neutralise the in vitro biological activity of at least BMP-6.
Protitelesa proti OP- 1 lahko in vitro nevtralizirajo biološko aktivnost vsaj beljakovine BMP- 6.
Therefore, upon re- administration of Osigraft, a risk of developing autoimmunity towards the endogenous BMP proteins may exist.
Zato ob ponovni uporabi zdravila Osigraft obstaja tveganje za nastanek avtoimunosti proti endogenim beljakovinam BMP.
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.
Podatki iz postmarketinškega nadzora kažejo, da uporaba zdravila Osigraft v kombinaciji s sintetičnim polnilom za kosti lahko poveča pogostnost lokalnih vnetij, okužb in občasno premikanja vsajenega materiala.
Animal studies have been conducted that cannot rule out effects of anti-OP-1 antibodies on embryo- foetal development (see section 5.3).
Opravili so študije na živalih, ki so pokazale, da ni mogoče izključiti učinkov protiteles proti OP- 1 na razvoj zarodka in ploda (glejte poglavje 5. 3).
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).
Zaradi neznanega tveganja za plod, povezanega z morebitnim nastankom nevtralizirajočih protiteles proti beljakovini OP- 1, se sme zdravilo Osigraft med nosečnostjo uporabljati samo, kadar morebitne koristi prevladajo nad morebitnim tveganjem za plod (glejte poglavji 4. 4 in 5. 3).
Women of child-bearing potential should inform their surgeon of the possibility of pregnancy prior to treatment with Osigraft.
Ženske v rodni dobi morajo pred zdravljenjem z Osigraftom obvestiti zdravnika o možni zanositvi.
In animal studies, excretion of IgG class anti-OP-1 antibodies into milk has been shown.
V študijah na živalih so pokazali, da se protitelesa razreda IgG proti OP- 1 izločajo v mleko.
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).
Pri človeku se protitelesa IgG izločajo v mleko, morebitno tveganje za dojenčka pa je neznano, zato ženske med zdravljenjem z zdravilom Osigfraft ne smejo dojiti (glejte poglavje 5. 3).
Osigraft should be given to breast-feeding women only when the attending physician decides that the benefits outweigh the risks.
Z Osigraftom lahko doječe ženske zdravite le, če se zdravnik odloči, da potencialne koristi prevladajo nad možnim tveganjem.
4 Osigraft is implanted by an invasive surgical procedure, for example during open reduction of a fracture site.
4 Osigraft se vstavlja med invazivnim kirurškim posegom, na primer med odprto uravnavo mesta zloma.
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.
Mednje lahko sodijo okužba rane, osteomielitis, mehanski zapleti pri mehanski opori, hematom, odprtje rane, slabost, povišana telesna temperatura in bolečina.
The incidence of these events in clinical studies was > 10%.
Pogostost teh pojavov v kliničnih raziskavah je bila večja od 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.
Vendar ni bilo razlike v pogostosti teh neželenih učinkov v primerjavi z bolniki, pri katerih so opravili avtologno presajanje, razen osteomielitisa, ki je bil statistično bolj pogost v skupini bolnikov, zdravljenih z avtolognim presajanjem.
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.
V kliničnih raziskavah so pogosto (> 1/ 100, < 1/ 10) poročali o naslednjih neželenih učinkih: eritem, občutljivost, zatekanje na mestu vsadka in heterotopična okostenitev/ myositis ossificans.
It is an osteoinductive and osteoconductive medicinal product.
To je osteoinduktivno in osteokonduktivno zdravilo.
The collagen matrix is insoluble and consists of particles with a size range of 75-425µm.
Kolagenski matriks je netopen in je sestavljen iz delcev, velikih 75- 425 µm.
The Tibial Nonunion pivotal trial compared Osigraft with autograft, with a primary efficacy endpoint at 9 months post-treatment.
Primarna točka ocene učinkovitosti je bila 9 mesecev po zdravljenju.
Clinical outcomes of pain and weight-bearing were comparable to the autograft (81% success in the Osigraft group, 77% success in the autograft goup).
Klinični izidi pri bolečinah in prenašanju teže so bili primerljivi z avtolognim presadkom (81- odstotni uspeh v skupini, ki so jo zdravili z Osigraftom, in 77- odstotni uspeh v skupini, ki so jo zdravili z avtolognim presadkom).
The radiographic healing results of the Osigraft treatment group were slightly inferior compared to the autograft control group (68% and 79% respectively).
Radiografski rezultati celjenja so bili pri skupini, ki so jo zdravili z Osigraftom, nekoliko slabši (68%) kot pri kontrolni skupini, ki so jo zdravili z avtolognim presadkom (79%).
However, results from Osigraft implantation studies in animals demonstrate that the active substance eptotermin alfa is largely unavailable systemically.
Vendar rezultati raziskav vstavljanja Osigrafta pri živalih kažejo, da se učinkovina eptotermin alfa ne širi sistemsko.
5 In a 2 year subcutaneous implantation study in rats, heterotopic bone formation was observed, as expected.
Pri raziskavi dveletnega podkožnega vsadka pri podganah so po pričakovanjih opazili nastanek heterotropičnih kosti.
Sarcoma was associated with the long-term presence of the heterotopic bone.
Ta učinek,
This effect, termed solid state carcinogenicity, frequently has been observed in rats where solid materials (plastics or metals) were implanted subcutaneously.
5 imenovan karcinogenost trdnih snovi, so pogosto opazili pri podganah, ki so jim podkožno vsadili trdne snovi (plastične ali kovinske).
Heterotopic ossification may also occur following use.
Do heterotopične okostenitve lahko pride tudi po uporabi (glejte poglavje 4. 8 Neželeni učinki).
(See Section 4.8 Undesirable Effects.) However, there is evidence to suggest that heterotopic ossification is not linked to sarcoma in humans.
Vendar obstajajo dokazi, da heterotopična okostenitev ni povezana s pojavom sarkoma pri človeku.
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.
Učinek protiteles proti OP- 1 na celjenje kosti so raziskovali pri psih, po dveh okvarah dolgih kosti, zdravljenih s ponavljajočimi se vsaditvami.
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.
Po obeh izpostavitvah so odkrili protitelesa proti OP- 1 in kostni kolagen vrste 1, najvišja koncentracija protiteles pa je bila večja po drugi vsaditvi.
Controlled studies of the effects of exposure to eptotermin alfa on pre and postnatal development were performed in rabbit models.
Na kunčjih modelih so opravili nadzorovane študije učinkov izpostavljenosti eptoterminu alfa na pre - in postnatalni razvoj.
Eptotermin alfa in Freund’ s adjuvant was first administered subcutaneously with booster doses given after 14 and 28 days.
Obnovitvene odmerke so dali po 14 in 28 dneh.
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).
Pomembno visoke titre protiteles IgG proti OP- 1 so odkrili v mleku skozi celoten čas študije postnatalne faze do 28. dne laktacije (glejte poglavje 4. 6).
A statistically significant increase in foetal malformations (misaligned sternabrae) was seen in litters of the OP-1 immunized group.
Pri potomcih skupine, ki je bila imunizirana proti OP- 1, so opazili statistično pomembno povečanje fetalnih deformacij (neporavnanost sternabre).
(See 4.6 Pregnancy & Lactation).
Klinični pomen teh ugotovitev za uporabo končnega izdelka pri človeku ni gotov (glejte 4. 6 Nosečnost in dojenje).
Bovine collagen (vacuum dried)
Goveji kolagen (vakuumsko posušen).
The reconstituted product should be used immediately.
Rekonstituirano zdravilo morate uporabiti takoj.
Store in a refrigerator (2°C - 8°C) Keep the blister pack in the outer carton
Vsebnik shranjujte v zunanji ovojnini.
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).
6 Osigraft je na voljo v steklenih vialah (vrsta 1, borosilikat), ki vsebujejo po 1 g praška, zaprtih z zamaškom (butilna guma) in zaporko (aluminij).
Pack size of 1 vial.
Velikost pakiranja je 1 viala
Reconstitution with the solvent (not provided).
Rekonstitucija z vehiklom (ni priložen).
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.
Vsako vialo Osigrafta je treba pred uporabo rekonstituirati z 2 do 3 ml sterilne 9 mg/ ml raztopine natrijevega klorida za injiciranje (0, 9% m/ 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.
Ustrezno količino sterilne raztopine natrijevega klorida za injiciranje in vsebino viale zdravila Osigraft je treba prenesti v sterilno posodo ter premešati s sterilno spatulo ali žličko.
Administration When reconstituted, Osigraft has the consistency of wet sand, which facilitates its implantation and placement at bone site defects.
Uporaba Po rekonstituciji ima Osigraft konsistenco mokrega peska, kar olajša vsaditev in namestitev na mestu poškodbe kosti.
Division of Stryker Corporation Raheen Industrial Estate Raheen Limerick Ireland
Division of Stryker Corporation Raheen Industrial Estate Raheen Limerick Irska
Tel +353-61-498200 Fax +353-61-498247
Tel.: +353- 61- 498200 Fax: +353- 61- 498247
17 May 2006
Datum pridobitve 17. maj 2001 Datum podaljšanja dovoljenja za promet 17. maj 2006
Raheen Industrial Estate Raheen Limerick Ireland
Division of Stryker Corporation Raheen Industrial Estate Raheen Limerick Irska
• OTHER CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• DRUGI POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
The Marketing Authorisation Holder will continue to submit yearly PSURs.
Imetnik dovoljenja za promet z zdravilom bo tudi v prihodnje pošiljal letna poročila PSUR.
Osigraft 3.3 mg, powder for suspension for implantation. eptotermin alfa.
Osigraft 3, 3 mg prašek za suspenzijo za vstavljanje. 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.
* Človeški osteogeni protein, pridobljen iz celic jajčnikov kitajskega hrčka (Chinese Hamster Ovary – CHO) s tehnologijo rekombinantne DNA.
Bovine collagen.
Goveji kolagen.
Powder for suspension for implantation, (1 g in a vial - Pack size of 1).
Prašek za suspenzijo za vstavljanje, (1 g v viali; velikost pakiranja je 1).
For intraosseous implantation.
Za intraosno vstavljanje.
EXPIRY DATE
"Uporabno do" ali "EXP":
Keep the blister packs in the outer carton.
Vsebnike shranjujte v zunanji ovojnini.
Division of Stryker Corporation Raheen Business Park Limerick Ireland
Division of Stryker Corporation Raheen Business Park Limerick Irska
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA( E) DOVOLJENJAZA PROMET
Intraosseous use.
Intraosna uporaba.
Osigraft 3.3 mg, powder for suspension for implantation eptotermin alfa
Osigraft 3, 3 mg prašek za suspenzijo za vstavljanje eptotermin alfa
- If you have further questions, ask your doctor.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
- If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet,
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni
What Osigraft is and what it is used for 2.
Kaj je Osigraft in za kaj ga uporabljamo 2.
Before you use Osigraft 3.
Kaj morate vedeti, preden boste uporabili Osigraft 3.
How to use Osigraft 4.
Kako uporabljati zdravilo Osigraft 4.
Possible side effects 5 How to store Osigraft 6.
Shranjevanje zdravila Osigraft 6.
Osigraft contains eptotermin alfa, a bone morphogenetic protein that induces new bone formation as part of the healing process.
Osigraft vsebuje eptotermin alfa, protein za morfogenezo kosti, ki sproža nastajanje kosti med procesom celjenja.
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.
Uporablja se za zdravljenje vsaj 9 mesecev starih nezraslih zlomov (zlomov, ki se niso zacelili) golenice po poškodbi pri bolnikih z zrelim skeletom, če predhodno zdravljenje z avtolognim presadkom (presajena kost iz lastnega kolka) ni uspelo ali kadar zdravljenje z avtolognim presadkom ni mogoče.
BEFORE YOU USE OSIGRAFT
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO OSIGRAFT
Do not use Osigraft
Ne uporabljajte zdravila Osigraft
- If you are allergic to eptotermin alfa or collagen, the other ingredient of Osigraft.
- če ste alergični na eptotermin alfa ali kolagen, pomožno snov v zdravilu Osigraft.
- If you are skeletally immature (still growing).
- Če ste skeletno nezreli (če še rastete).
- If you have an autoimmune disease (disease arising from or directed against your own tissues),
- če imate avtoimunsko bolezen (bolezen, ki izhaja iz vaših lastnih tkiv ali deluje proti njim),
including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren’ s syndrome and dermatomyositis/ polymyositis.
vključno z reumatoidnim artritisom, sistemskim lupusom eritematozusom, sklerodermo, Sjögrenovim sindromom in dermatomiositisom/ polimiositisom;
- If you have active infection at the site of non-union (inflammation and drainage at the site of
- če imate aktivno okužbo na mestu nezraslega zloma (vnetje ali drenažo na mestu poškodbe) ali
injury) or active systemic infection.
aktivno sistemsko okužbo;
- If your doctor determines that you have inadequate skin coverage (at the fracture site) and
- če zdravnik oceni, da mesto nezraslega zloma ni ustrezno pokrito s kožo ali dovolj prekrvavljeno;
- For application to vertebral (spine) fractures.
- pri vertebralnih zlomih (zlomih hrbtenice);
- For treating non-union resulting from pathological (disease-related) fractures, metabolic bone
- za zdravljenje nezraslih zlomov, ki so nastali zaradi patoloških zlomov (povezanih z boleznimi),
disease or tumours.
metabolnih bolezni kosti ali tumorjev;
- When there are any tumours in the area of the non-union site.
- če so v bližini mesta nezraslega zloma tumorji;
- If you are receiving chemotherapy, radiation treatment or immunosuppression
- če prejemate kemo -, radio - ali imunosupresivno terapijo.
Take special care with Osigraft The following are precautions for use of Osigraft to be discussed with your doctor.
Bodite posebno pozorni pri uporabi zdravila Osigraft V nadaljevanju so navedeni previdnostni ukrepi pri uporabi Osigrafta, o katerih se posvetujte s svojim zdravnikom.
Osigraft does not aid in the support of weight and does not stabilise the fracture.
Osigraft ne pomaga pri podpori teže in ne učvrsti zloma.
Therefore, it should be used with internal or external bone fixation devices.
Zato se mora uporabljati z zunanjimi ali notranjimi učvrstitvami.
However, external fixation may not provide
Zunanja učvrstitev morda ne bo zadostovala za stabilnost.
Motion in the non-union site may prevent the fracture healing process.
17 so omejene na stabilizacijo mesta nezraslega zloma v goleni s sočasno intramedularno učvrstitvijo z vijaki (notranja učvrstitev).
Locking intramedullary nails have been used in the majority of cases.
V večini primerov so uporabili intramedularne palice na zaklep.
Use of Osigraft does not guarantee repair; additional surgeries may be required.
Uporaba Osigrafta ne zagotavlja okrevanja, zato bodo morda potrebne dodatne operacije.
Any material dislodged from the non-union site can cause bone formation (ectopic ossification) in the surrounding tissues with potential complications.
Snovi, ki se odstranijo z mesta nezraslega sklepa, lahko povzročijo (ektopično okostenitev) tvorbo kosti z morebitnimi zapleti v obkostnih tkivih.
Therefore, Osigraft may only be administered to the defect site under adequate vision and with utmost care.
Zato se sme Osigraft uporabljati le na mestu poškodbe pod ustreznim nadzorom in skrajno previdno.
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).
Posebno previdno morate ravnati zato, da preprečite iztekanje Osigrafta zaradi izpiranja, nepravilnega zaprtja obkostnih tkiv ali neustrezne hemostaze (preprečitve krvavitve).