FrancophonIA/ELRC3.0 huggingface dataset:
English: - The Committee, in view of the presented data on efficacy and safety, considered that the Benefit / Risk balance for Actira and associated names in the “ The treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis” with the restrictions concerning empirical monotherapy was favourable; - The CHMP, as a consequence, recommended the amendment of the Summary of Product Characteristics sections 4.1, 4.2, 4.3, 4.4, 5.1 and 5.2 and Package Leaflet relevant sections as set out in Annex III for Actira and associated names (see Annex I).
Slovenian: - Odbor je ob upoštevanju predloženih podatkov o učinkovitosti in varnosti menil, da je razmerje med koristmi in tveganji za zdravilo Actira in z njim povezana imena pri „zdravljenju blagih do zmernih pelvičnih vnetnih bolezni, tj. okužb zgornjega genitalnega trakta, vključno s salpingitisom in endometritisom“, upoštevaje omejitve glede empirične monoterapije, ugodno.
English: Plasma
Slovenian: QUÍMICA
English: BE - Belgium Bayer AG 51368 Leverkusen Germany
Slovenian: PT - Portugalska Bayer AG 51368 Leverkusen Nemčija
English: EU/1/18/1335/001 POTELIGEO 4 mg/ml
Slovenian: EU/1/18/1335/001
English: Intravenous use Vial (glass)
Slovenian: Intravenska uporaba viala (steklo)
English: Dogs were followed for 18 weeks after treatment.
Slovenian: Pse so spremljali 18 tednov po zdravljenju.
English: Area vascularity should be maintained.
Slovenian: Ohraniti je treba vaskularizacijo območja.
English: Each kit contains:
Slovenian: Vsak komplet vsebuje:
English: Do not use more than 3.2 ml.
Slovenian: Ne uporabite več kot 3,2 ml.
English: 1 Burtt Road Andover MA 01810 USA
Slovenian: 1 Burtt Road Andover MA 01810 ZDA
English: For reconstitution.
Slovenian: Za rekonstitucijo.
English: Do not store above 25 C. Do not refrigerate.
Slovenian: Ne shranjujte pri temperaturi nad 25 C. Ne shranjujte v hladilniku.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu
English: It must not be re-sterilised.
Slovenian: Ni ga dovoljeno ponovno strerilizirati.
English: Instructions for preparation and use
Slovenian: Navodila za pripravo in uporabo
English: C. Implantation
Slovenian: C. Implantacija
English: Summary of the cumulative percent of fracture unions by week and treatment Weeks
Slovenian: Povzetek kumulativnega odstotka zacelitve kosti glede na teden in način zdravljenja Tedni
English: Treatment TruScient + SOC (n=84) SOC (n=42) SOC = standard of care
Slovenian: Zdravljenje TruScient + SOC (n=84) SOC (n=42) SOC = standardni postopki oskrbe
English: BMP-2 plays a critical role during foetal development.
Slovenian: BMP-2 ima pomembno vlogo v času razvoja ploda.
English: B. Prepare TruScient sponges in the sterile field:
Slovenian: B. Priprava gobic s TruScient v sterilnem območju:
English: TruScient is intended for single use only.
Slovenian: TruScient je namenjen samo za enkratno uporabo.
English: Figure 2: Preparation of TruScient sponges
Slovenian: Slika 2: Priprava gobic s TruScient
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinarian surgeon.
Slovenian: Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
English: Development of BMP-2 antibodies occurred in 6.9% of dogs receiving TruScient vs. 4.3% of dogs in the control group.
Slovenian: Do nastanka protiteles proti BMP-2 je prišlo pri 6,9 % psov, ki so prejeli TruScient in 4,3 % psov v kontrolni skupini.
English: Follow the instructions for preparation below.
Slovenian: Za pripravo upoštevajte spodnja navodila.
English: Dry the fracture site to the extent possible.
Slovenian: Mesto zloma osušite do največje možne mere.
English: Radiographic, biomechanical, and histological evaluation of the induced bone indicates that it functions biologically and biomechanically as native bone.
Slovenian: Radiografski, biomehanski in histološki testi induciranega kostnega tkiva kažejo, da to tako biološko kot biomehansko deluje kot nativna kost.
English: The recommended dose is up to two sponges (2.5 x 5 cm) per dog.
Slovenian: Priporočeni odmerek je do dve gobici (2,5 x 5 cm) za psa.
English: 4.4 Special warnings for each target species
Slovenian: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto Jih ni
English: Sponge for TruScient
Slovenian: Goba za TruScient
English: Solvent: Water for injections
Slovenian: Vehikel: Voda za injekcije
English: Pharmacotherapeutic group: Bone Morphogenetic Proteins ATCvet code: QM05BC01
Slovenian: FARMAKOLOŠKE LASTNOSTI Farmakoterapevtska skupina: Proteini za morfogenezo kosti, oznaka ATC vet: QM05BC01
English: TruScient can cause initial resorption of surrounding trabecular bone.
Slovenian: TruScient lahko povzroči začetno resorpcijo okolne trabekularne kostnine.
English: *Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) is a human protein derived from a recombinant Chinese Hamster Ovary (CHO) cell line.
Slovenian: *Dibotermin alfa (rekombinantni humani protein za morfogenezo kosti-2; rhBMP-2) je človeški protein, pridobljen iz rekombinantne vrste ovarijskih celic kitajskega hrčka (CHO - Chinese Hamster Ovary).
English: Do not use in dogs that are skeletally immature, have an active infection at the operative site, pathological fracture, or any active malignancy.
Slovenian: Ne uporabite pri psih z nezrelim okostjem, aktivno okužbo v operativnem območju, patološkim zlomom ali katerimkoli malignim obolenjem.
English: EXP {month/year} Shelf life in the vial after reconstitution: 3 hours
Slovenian: EXP {mesec/leto} Rok uporabnosti po rekonstituciji: 3 ure
English: Clinical pharmacology studies demonstrate that the absorbable collagen sponge alone is not osteoinductive and is completely resorbed over time.
Slovenian: Klinične farmakološke študije kažejo, da sama kolagenska goba ni osteoinduktivna in se s časom popolnoma resorbira.
English: Glutamic acid
Slovenian: Glutaminska kislina
English: The influence of anti-BMP-2 antibody formation on foetal development has not been assessed.
Slovenian: Vpliva nastanka anti-BMP-2 protiteles na razvoj ploda niso preučili.
English: Wait a MINIMUM of 15 minutes before using the prepared sponges.
Slovenian: Počakajte NAJMANJ 15 minut, preden uporabite pripravljeni gobici.
English: It is concluded therefore that at the site of implantation dibotermin alfa is slowly released from the matrix and rapidly cleared when taken up into the systemic circulation.
Slovenian: Sklepamo lahko torej, da se na mestu implantacije dibotermin alfa iz matriksa sprošča počasi, medtem ko je njegovo odstranjevanje iz sistemske cirkulacije hitro.
English: Therefore, in the absence of clinical data, the veterinary medicinal product should not be used for direct applications to trabecular bone when transient bone resorption may create a risk of bone fragility and, thus, increase the risk of implant failure.
Slovenian: Ker ni na voljo kliničnih podatkov, se tega zdravila za uporabo v veterinarski medicini ne sme neposredno dajati na trabekularno kost v primerih, ko bi prehodna resorpcija kostnine lahko povzročila tveganje za lomljivost kosti in tako ogrozila uspešnost implantacije.
English: The antibody titers did not correlate with any adverse clinical sign including any immune mediated adverse events such as allergic reactions.
Slovenian: Titer protiteles ni bil v korelaciji s katerimkoli neželenim kliničnim znakom, vključno z imunsko pogojenimi neželenimi učinki kot so alergijske reakcije.
English: Investigators were aware of treatment assignment; reviewers assessing time to radiographic fracture union for each dog were masked to treatment.
Slovenian: Raziskovalci so vedeli za način zdravljenja, poročevalci, ki so z radiogramom ocenjevali čas do zaceljenja kosti pri vsakem psu, niso imeli podatkov o zdravljenju.
English: Manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L.
Slovenian: Izdelovalec, odgovoren za sproščanje serij: Zoetis Manufacturing & Research Spain, S.L.
English: Solvent for TruScient Water for injections
Slovenian: Vehikel za TruScient Voda za injekcije
English: TruScient used in concentrations or amounts greater than those recommended is associated with excessive bone formation and increased generation of fluid-filled void spaces within the induced bone.
Slovenian: Uporaba zdravila TruScient v koncentracijah ali količinah, večjih od priporočenih, je povezana s prevelikim nastajanjem kostnine in povečanim nastankom s tekočino napolnjenih prostorov v zdravljeni kosti.
English: When injected intravenously, the terminal half-life of dibotermin alfa was 16 minutes in rats.
Slovenian: Po intravenski aplikaciji je bila končna razpolovna doba dibotermina alfa pri podganah 16 minut.
English: Place the prepared sponge so that it bridges the fracture and makes good contact with the major proximal and distal fracture fragments.
Slovenian: Pripravljeno gobico namestite tako, da bo premostila mesto zloma in bo v tesnem stiku z večjimi proksimalnimi in distalnimi fragmenti.
English: Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Slovenian: Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
English: In case of accidental spillage onto skin and eyes rinse off immediately.
Slovenian: V primeru nenamernega razlitja po koži ali v oči nemudoma sperite.
English: The ability of TruScient to support bone remodeling may be responsible for the biological and biomechanical integration of the new bone induced by TruScient with that of the surrounding bone.
Slovenian: Sposobnost zdravila TruScient, da podpira preoblikovanje kosti, je verjetno vzrok za biološko in biomehansko integracijo nove kosti, nastale po indukciji z zdravilom TruScient, z okolnim kostnim tkivom.
English: Although no clear association with clinical outcome or undesirable effects could be observed in clinical and safety studies, the possibility of developing neutralising antibodies or hypersensitivity-type reactions cannot be excluded.
Slovenian: Čeprav v kliničnih študijah in študijah varnosti niso opazili jasne povezave s kliničnim izidom ali pojavom neželenih učinkov, pa možnosti nastanka nevtralizirajočih protiteles ali preobčutljivostnih reakcij ni mogoče izključiti.
English: The safety, including potential immune responses and effectiveness of repeat TruScient administration have not been evaluated in dogs.
Slovenian: Varnosti vključno z morebitnimi imunskimi reakcijami in učinkovitosti pri ponavljajočem se dajanju zdravila pri psih niso ocenili.
English: Biomechanical data suggest these voids had little influence on the biomechanical properties of the induced bone or its integration with the abutting cortices.
Slovenian: Biomehanični podatki kažejo na to, da imajo ti prostori le majhen vpliv na biomehanične lastnosti inducirane kostnine ali njeno integracijo z ujemajočimi se korteksi.
English: This medicinal product should only be used in breeding, pregnant and lactating dogs following a risk/benefit assessment by the responsible veterinarian.
Slovenian: Pri vzrejnih psih, psicah v obdobju brejosti in laktacije uprabite zdravilo le po predhodni oceni koristi/tveganja odgovornega veterinarja.
English: Both rhBMP-2 and bovine Type I collagen can elicit an immune response in dogs.
Slovenian: Tako rhBMP-2 kot goveji kolagen tipa I lahko sprožita imunski odgovor pri psih.
English: The bone formation process develops from the outside of the prepared sponge towards the center until the entire prepared sponge is replaced by trabecular bone.
Slovenian: Proces nastajanja kosti se razvija v smeri od zunanjih delov implantata proti sredini, dokler trabekularna kost ne nadomesti celotnega implantata.
English: TruScient does not provide mechanical stability and should not be used to fill space in the presence of compressive forces.
Slovenian: TruScient ne zagotavlja mehanske stabilnosti in se ga ne sme uporabiti za zapolnitev prostora pri delovanju kompresijskih sil.
English: The safety of the veterinary medicinal product has not been established during breeding, pregnancy and lactation.
Slovenian: Varnost zdravila med parjenjem, v obdobju brejosti in laktacije ni bila ugotovljena.
English: 1 vial (solvent)
Slovenian: 1 viala (vehikel)
English: For accurate dosing ensure there are no suspended air bubbles in the transfer volumes.
Slovenian: Za natančno odmerjanje zagotovite, da v količinah, ki jih prenašate, ni suspendiranih zračnih mehurčkov.
English: In animal studies (rats) using radiolabelled dibotermin alfa on absorbable collagen sponge, the mean residence time at the site of implantation was 4-8 days.
Slovenian: V študijah na živalih (podganah), kjer so uporabili zdravilo TruScient, ki je vsebovalo radioaktivno označeni dibotermin alfa na vpojni kolagenski gobi, je bil povprečni čas zadrževanja na mestu implantacije 4-8 dni.
English: In order to avoid excessive postoperative swelling, use only the amount of prepared TruScient sponge needed to achieve coverage of accessible fracture lines and defects (less than one to up to two prepared sponges).
Slovenian: Da bi preprečili povečano postoperativno otekanje, uporabite najmanjšo količino pripravljene TruScient gobice, potrebne za prekritje dostopnih prelomnih linij in defektov (manj kot eno do dve pripravljeni gobici).
English: Treatment of diaphyseal fractures as an adjunct to standard surgical care using open fracture reduction in dogs.
Slovenian: Zdravljenje diafiznih zlomov kot dodatek k standardni oskrbi z uporabo odprte redukcije zloma pri psih.
English: TruScient is active at the site of implantation.
Slovenian: Zdravilo TruScient deluje na mestu implantacije.
English: The efficacy and safety of the veterinary medicinal product for the treatment of diaphyseal fractures was evaluated in a randomised, controlled, multicenter clinical field study involving dogs randomised to treatment with the veterinary medicinal product plus Standard Of Care (SOC) [n=84] or SOC [n=42] alone.
Slovenian: Učinkovitost in varnost zdravila za zdravljenje diafiznih zlomov so ocenjevali v randomizirani, kontrolirani, multicentrični klinični študiji na terenu, pri kateri so pse naključno razporedili v skupiniena je prejela zdravilo ter standardne postopke oskrbe (Standard Of Care - SOC) [n=84], druga pa samo standardne postopke oskrbe [n=42].
English: Use only the amount of prepared sponge needed to achieve coverage of accessible fracture lines and defects (less than one up to two prepared sponges).
Slovenian: Uporabite samo toliko pripravljene gobice kot je potrebujete za pokritje dostopnih prelomnih linij in defektov (manj kot eno do dve pripravljeni gobici).
English: Swirl the vial gently to aid reconstitution.
Slovenian: Vialo previdno obračajte, da pospešite rekonstitucijo.
English: If only a portion of a prepared sponge is required, first prepare the entire package (following steps 1 - 9 above), then cut or fold the prepared sponge as needed prior to implantation.
Slovenian: Če potrebujete le del pripravljene gobice, morate najprej pripraviti celotno pakiranje zdravila (po zgoraj opisanem postopku, točke od 1-9), gobico nato razrežete ali zvijete tik pred implantacijo.
English: In the case of dogs receiving concentrations or amounts greater than those recommended, treatment of adverse effects, where required, should be symptomatic.
Slovenian: V primeru, da je pes prejel zdravilo v koncentraciji ali količini, večji od priporočene, in je potrebno zdraviti neželene učinke, uporabite simptomatsko zdravljenje.
English: BMP-2 antibody response to TruScient was evaluated in 133 dogs receiving surgery for diaphyseal fractures stabilised with internal fixation.
Slovenian: Nastanek protiteles proti BMP-2 zaradi uporabe zdravila TruScient so ocenili pri 133 psih, pri katerih so z operacijo diafizni zlom stabilizirali z interno fiksacijo.
English: The amount of prepared sponge placed is determined by the fracture anatomy and the ability to close the wound with minimal compression of the sponge.
Slovenian: Količino pripravljene gobice, ki jo potrebujete, določite glede na anatomijo zloma in možnostjo zaprtja rane s kar najmanjšo kompresijo na implantat.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI
English: No studies have been performed in dogs with known autoimmune diseases.
Slovenian: Študij pri psih z znano avtoimuno boleznijo niso izvedli.
English: This self-limitation is likely due to the loss of dibotermin alfa from the application site, as well as the presence of BMP inhibitors in the surrounding tissues.
Slovenian: To samoomejevalno sposobnost gre verjetno pripisati izgubi dibotermina alfa z mesta implantacije, pa tudi prisotnosti inhibitorjev proteina za morfogenezo kosti (BMP - Bone Morphogenetic Protein) v okolnem tkivu.
English: Sodium hydroxide (pH adjustment agent) Hydrochloric acid (pH adjustment agent)
Slovenian: Natrijev hidroksid (za korekcijo pH) Klorovodikova kislina (za korekcijo pH)
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life in the vial after reconstitution according to directions: 3 hours Discard any unused veterinary medicinal product.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti Rok uporabnosti po rekonstituciji v skladu z navodili: 3 ure Zavrzite neuporabljeno zdravilo.
English: Do not refrigerate.
Slovenian: Zdravilo ne sme zmrzniti.
English: Observed clinical signs were listed as adverse reactions for TruScient when they exceeded in intensity and/or duration of what would be considered normal for fracture healing after Standard of Care (SOC).
Slovenian: Opaženi klinični znaki so bili uvrščeni med neželene učinke zdravila TruScient, če je bila njihova intenzivnost in/ali trajanje večja kot pri znakih, ki spremljajo normalno zdravljenje zloma kosti v skladu s standardom zdravljenja (Standard of Care - SOC).
English: The results demonstrated that TruScient was effective in reducing the time to radiographic fracture union when added to SOC compared to treatment with SOC alone regardless of fracture type (open or closed).
Slovenian: Rezultati so pokazali, da je bil TruScient v kombinaciji s standardnimi postopki oskrbe učinkovit pri skrajšanju časa do radiografsko potrjene zacelitve kosti v primerjavi s samimi standardnimi postopki oskrbe, ne glede na vrsto zloma (odprt, zaprt).
English: No studies have been performed in dogs with metabolic bone diseases.
Slovenian: Študij pri psih s presnovnimi boleznimi kosti niso izvedli.
English: 10 ml Do not use more than 3.2 ml for reconstitution
Slovenian: 10 ml Za rekonstitucijo ne uporabite več kot 3,2 ml.
English: Two sterile sponges 2.5 x 5 cm in a polyvinyl chloride (PVC) blister package sealed with a Tyvek lid.
Slovenian: Dve sterilni gobi, 2,5 x 5 cm v polivinilkloridnem (PVC) pretisnem omotu, neprodušno zaprtem s pokrovom iz Tyveka
English: Remodeling of the surrounding trabecular bone occurs in a manner that is consistent with the biomechanical forces placed on it.
Slovenian: Preoblikovanje okolnega trabekularnega kostnega tkiva poteka v skladu z biomehanskimi silami, ki delujejo na to tkivo.
English: Excessive bone and fluid filled cysts remodel into normal bone over time.
Slovenian: Odvečna kostnina in s tekočino napolnjene ciste se s časom spremnijo v normalno kostnino.
English: The differentiated cells form trabecular bone as the sponge is degraded, with vascular invasion evident at the same time.
Slovenian: Diferencirane celice ob razpadanju gobice tvorijo trabekularno kostno tkivo, sočasno pa je vidna vaskularna invazija.
English: Kit for implant
Slovenian: Komplet za implantacijo
English: Prepare sponges at least 15 minutes prior to use and use within 2 hours of wetting the sponges.
Slovenian: Gobice pripravite vsaj 15 minut pred uporabo in jih uporabite v 2 urah po navlažitvi.
English: As dibotermin alfa (rhBMP-2) is a protein and has not been identified in the general circulation, it is an unlikely candidate for pharmacokinetic drug-drug interactions.
Slovenian: Ker je dibotermin alfa protein, ki ga v cirkulaciji niso našli, ni verjetno, da bi lahko bil vpleten v farmakokinetične interakcije z drugimi zdravili.
English: Two sponges made of Bovine Type I collagen.
Slovenian: Dve gobici iz govejega kolagena tipa I.
English: 1 vial (lyophilisate)
Slovenian: 1 viala (liofilizat)
English: Failure to follow the instructions may compromise the safety and effectiveness of the medicinal product.
Slovenian: Neupoštevanje navodil lahko ogrozi varnost in učinkovitost zdravila.
English: Cut or fold the prepared sponge as needed prior to placement.
Slovenian: Gobico prerežite ali zvijte kot je potrebno, preden jo namestite.
English: During placement, use forceps to handle the prepared sponge to avoid excessive fluid loss.
Slovenian: Med nameščanjem gobice na ustrezno mesto uporabite forceps, da bi preprečili preveliko iztekanje tekočine.
English: Bone plates should not be covered with the prepared sponge in order to facilitate plate removal if needed following fracture healing.
Slovenian: Ploščice ne smete prekriti z gobico, da se omogoči morebitna odstranitev ploščice, če bi bilo to potrebno po zaključenem zdravljenju.
English: TruScient should be used by an appropriately qualified veterinarian.
Slovenian: TruScient sme uporabljati le primerno usposobljen doktor veterinarske medicine.
English: Date of first authorisation: 14/12/2011 Date of last renewal:
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 14/12/2011
English: EXP {month/year} Discard the remaining solvent after reconstitution.
Slovenian: EXP {mesec/leto} Po rekonstituciji zavrzite preostanek vehikla.
English: Shelf life in the vial after reconstitution: 3 hours Discard any unused veterinary medicinal product.
Slovenian: Rok uporabnosti po rekonstituciji: 3 ure Zavrzite neuporabljeno zdravilo.
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov izdelovalca(izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin).
English: TruScient 0.66 mg kit for implant for dogs
Slovenian: TruScient 0,66 mg komplet za implantacijo za pse
English: Slowly inject the 3.2 ml of solvent into the lyophilisate vial (see Figure 1) to achieve a 0.2 mg/ml solution of rhBMP-2.
Slovenian: Počasi vbrizgajte 3,2 ml vehikla v vialo z liofilizatom (glejte Sliko 1), da dobite 0,2 mg/ml raztopino rhBMP-2
English: Using sterile technique, transfer the two 3 ml syringes with needles and the sponges inner package into the sterile field.
Slovenian: Z uporabo sterilne tehnike prenesite dve 3-ml brizgi z iglama in gobici v stični ovojnini v sterilno območje.
English: TruScient should not be mixed with other agents.
Slovenian: Zdravila TruScient ne smete mešati z drugimi zdravili.
English: Sponge: Bovine Type I collagen
Slovenian: Goba: Goveji kolagen tipa I
English: Preclinical studies have suggested that bone formation initiated by TruScient is a self-limiting process, forming a well-defined volume of bone.
Slovenian: Na osnovi predkliničnih študij lahko sklepamo, da je nastajanje kostnega tkiva, ki ga sproži zdravilo TruScient, proces, ki se sam od sebe zaustavi, ko se razvije natančno opredeljen volumen kostnega tkiva.
English: Very common (more than 1 in 10 animals) Mild to moderate Lameness Firm swelling within the first 3 weeks postoperatively which recedes gradually over several months Soft swelling which recedes within 3 weeks
Slovenian: Zelo pogosti (pojavijo se pri 1 od 10 živali) Blagi do zmerni šepanje čvrsta oteklina do 3 tedne po operaciji, ki postopma izgine v nekaj mesecih mehka oteklina, ki izgine v treh tednih