natgillin/translations-raw huggingface dataset:
The ability of InductOs to support bone remodeling may be responsible for the biological and biomechanical integration of the new bone induced by InductOs with that of the surrounding bone.
Sposobnost InductOsa da podupre remodeliranje kosti može biti odgovorna za biološku i biomehaničku integraciju nove kosti čiji rast inducira InductOs s okolnom kosti.
The maximum dosage is limited to 8 mg (5.3 cm3 of wetted matrix) of InductOs in the intervertebral disc space.
Maksimalna doza ograničena je na primjenu 8 mg (5,3 cm3 navlažene matrice) InductOsa u intervertebralni prostor.
InductOs should not be used in patients with history or clinical suspicion of malignancy at the site of application (see section 4.3).
InductOs se ne smije koristiti kod bolesnika s anamnezom ili kliničkom sumnjom na zloćudnu bolest na mjestu primjene (vidjeti dio 4.3).
How to store InductOs
Kako čuvati InductOs
INFORMATION IN BRAILLE Justification for not including Braille accepted
16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma
The hollow geometry of the lumbar interbody fusion device must be carefully and loosely filled with the volume of InductOs corresponding to the internal volume of the device.
Šuplja geometrija naprave za lumbalnu interkorporalnu fuziju mora se pažljivo i mekano ispuniti volumenom lijeka InductOs koji odgovara unutarnjem volumenu naprave.
• Use of InductOs may cause bone formation (heterotopic ossification) in the surrounding tissues, which can result in complications.
• Uporaba InductOsa može uzrokovati stvaranje kosti (heterotopična osifikacija) okolnog tkiva koja može uzrokovati komplikacije.
Although no association with clinical outcome or undesirable effects could be observed in clinical studies, the possibility of developing neutralising antibodies or hypersensitivity-type reactions cannot be excluded.
Iako se nije mogla uočiti povezanost između kliničkog ishoda ili nuspojava u kliničkim ispitivanjima, mogućnost razvoja neutralizirajućih protutijela ili reakcija preosjetljivosti ne može se isključiti.
InductOs is indicated for single-level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non-operative treatment for this condition.
InductOs je indiciran za interkorporalnu fuziju jedne razine lumbalne kralježnice kao nadomjestak za autogeni koštani presadak u odraslih bolesnika s degenerativnom bolešću diska koji su se podvrgnuli nekirurškom liječenju ovog stanja tijekom najmanje 6 mjeseci.
In clinical studies, the presence of antibodies to collagen was not associated with side effects, such as allergies, nor was it shown to decrease the effectiveness of InductOs.
U kliničkim ispitivanjima prisutnost protutijela na kolagen nije bila povezana s nuspojavama poput alergija niti se pokazalo da smanjuje učinkovitost lijeka InductOs.
• One matrix (7.5 cm x 10 cm) in a blister package (polyvinyl chloride - PVC).
• jedna matrica (7,5 cm x 10 cm) u blister pakiranju (polivinilklorid - PVC)
The proportion of patients healed after treatment with InductOs 1.5 mg/ml was significantly higher at all visits from 10 weeks to 12 months post-operative, suggesting accelerated fracture healing.
Udio bolesnika izliječenih nakon liječenja InductOsom 1,5 mg/ml bio je znatno viši u svim posjetima od 10. tjedna do 12. mjeseca nakon kirurškog zahvata ukazujući na ubrzano cijeljenje prijeloma.
The matrix is in 1 piece of 7.5 cm x 10 cm.
Matrica je u 1 dijelu, dimenzija 7,5 x 10 cm.
Dibotermin alfa must only be used following reconstitution with the solvent and matrix provided in the InductOs pack.
Dibotermin alfa smije se koristiti samo nakon rekonstitucije s otapalom i matricom koji su priloženi u pakiranju InductOsa.
If you are receiving InductOs for a broken shin bone, your doctor will place InductOs around your broken bone when your fracture is treated.
Ako primate InductOs za liječenje prijeloma tibije, Vaš će liječnik položiti InductOs oko Vaše slomljene kosti prilikom liječenja prijeloma.
Histological evidence from animal studies of lumbar interbody fusion using anterior or posterior surgical approaches showed dibotermin alfa administered with titanium, PEEK or allograft interbody devices was biocompatible and produced consistently high rates of fusion independent of surgical approach or device material with less fibrous tissue evident compared with autograft.
Histološki dokazi iz ispitivanja na životinjama pokazali su da je dibotermin alfa primijenjen s interkorporalnim napravama od titanija, PEEK-a ili alogenog presatka kod lumbalne interkorporalne fuzije pomoću prednjeg ili stražnjeg pristupa bio biokompatibilan i dosljedno je rezultirao visokim stopama fuzije neovisno o kirurškom pristupu ili materijalu naprave, kao i manjom količinom fibroznog tkiva, u usporedbi s autogenim presatkom.
If you have any question about the medical device, please ask your doctor.
Ako imate bilo kakva pitanja o ovom medicinskom proizvodu, molimo obratite se svom liječniku.
InductOs should be folded or cut as needed prior to implantation.
InductOs se prije implantacije mora presavinuti ili razrezati po potrebi.
InductOs may be used either in lower back spine fusion surgery or to repair fractures of the shin bone.
InductOs se može koristiti ili za kiruršku fuziju u donjem dijelu kralježnice ili za popravak prijeloma goljenične kosti.
7 MARKETING AUTHORISATION HOLDER
7 NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
• An active infection at the operative site
• aktivnom infekcijom na mjestu kirurškog zahvata
Care must be taken not to compress the product or overfill the volume intended for new bone formation (see section 4.4).
Potrebno je paziti da se lijek ne komprimira ili ne prepuni volumen namijenjen za stvaranje nove kosti (vidjeti dio 4.4).
In addition, several non-clinical studies indicate that there is a negative feedback mechanism at the molecular level that limits bone induction by BMPs.
Pored toga, nekoliko nekliničkih ispitivanja ukazalo je na postojanje mehanizma negativne povratne sprege na molekularnoj razini koja ograničava indukciju kosti koštanim morfogenetskim proteinima.
The powder is dissolved in the sterile water to form a solution that is used to soak the sponge.
Prašak se otopi u sterilnoj vodi tako da se dobije otopina kojom će se natopiti spužva.
An increased rate of infection was observed in the InductOs-treated group versus the standard of care control group (19% versus 9%, respectively; see section 4.4).
Povećana stopa infekcije primijećena je u bolesnika liječenih InductOsom naspram kontrolne skupine koja je liječena standardnim lijekom (19% naspram 9%; vidjeti dio 4.4).
Patients received (in a 1:1:1 ratio) standard care (control group) consisting of intramedullary (IM) nail fixation and routine soft-tissue management, standard care plus InductOs 0.75 mg/ml, or standard care plus InductOs 1.5 mg/ml.
Bolesnici koji su primali standardno liječenje (u omjeru 1:1:1) (kontrolna skupina) koji se sastoji od intramedularne (IM) fiksacije čavlom i rutinskog liječenja mekog tkiva, standardne skrbi plus InductOsa 0,75 mg/ml ili standardne skrbi plus InductOs 1,5 mg/ml.
Special warnings and precautions for use specific to acute tibia fractures
Posebna upozorenja i mjere opreza za uporabu specifična za akutne prijelome tibije
There are no or limited amount of data from the use of dibotermin alfa in pregnant women.
Nema podataka ili su podaci o primjeni dibotermina alfa u trudnica ograničeni.
Placement of InductOs into trabecular bone resulted in transient resorption of the bone surrounding the implant, followed by replacement with new, more dense bone.
Postavljanje lijeka InductOs u trabekularnu kost uzrokovalo je prolaznu resorpciju kosti oko implantata nakon čega slijedi zamjena s novom, gušćom kosti.
Non-clinical studies have suggested that bone formation initiated by InductOs is a self-limiting process, forming a well-defined volume of bone.
Neklinička ispitivanja pokazala se da je stvaranje kosti potaknuto InductOsom samoograničen proces kojim se stvara dobro definirani volumen kosti.
For pain and disability (Oswestry score), the success rate was 72.9% in the group using InductOs versus 72.5% in the group using autogenous bone graft (95% two-sided CI of the difference: -11.2, 12.0).
Za bol i onesposobljenost (rezultat ljestvice Oswestry) stopa uspjeha iznosila je 72,9% u skupini koja je primila InductOs naspram 72,5% u skupini koja je primila autogeni koštani presadak (95% dvostrani CI razlike: -11,2, 12,0).
Use of InductOs may cause heterotopic ossification at the site of implantation and/or the surrounding tissues, which may result in complications.
Uporaba InductOsa može uzrokovati heterotopičnu osifikaciju na mjestu ugradnje i/ili okolnog tkiva koja za posljedicu može imati komplikacije.
If you have broken your shin bone, InductOs is used, to help your fracture heal and to reduce the need for additional surgeries.
Ako ste slomili goljeničnu kost liječnik će upotrijebiti InductOs kako bi pomogao u zacjeljivanju prijeloma i smanjio potrebu za dodatnim kirurškim zahvatima.
Care and caution must be used to prevent overfilling the lumbar interbody fusion device and/or the anterior portion of the intervertebral disc space (see section 4.4).
Treba biti oprezan i pažljiv kako bi se spriječilo prekomjerno punjenje naprave za interkorporalnu lumbalnu fuziju i/ili prednjeg dijela intervertebralnog prostora (vidjeti dio 4.4).
Severity of fractures: Treatment with InductOs 1.5 mg/ml was significantly effective in all fracture classes, including severe Gustilo IIIB fractures (52% reduced risk of secondary interventions as compared to standard-care patients).
Težina prijeloma: Liječenje InductOsom 1,5 mg/ml bilo je značajno djelotvorno u svim klasama prijeloma, uključujući teške prijelome prema ljestvici Gustilo IIIB (za 52% reducirani rizik od sekundarnih intervencija u usporedbi s bolesnicima liječenim na standardni način).
The solvent is a clear colourless liquid.
Otapalo je bistra, bezbojna tekućina.
In some cases, the oedema was severe enough to result in airway compromise.
U nekim slučajevima edem je bio dovoljno jak da ugrozi prohodnost dišnih puteva.
The efficacy of InductOs was demonstrated in a multinational, randomized, controlled, single-blind study of 450 patients (age range 18 to 87 years; 81% male) with open tibial shaft fractures requiring surgical management.
Djelotvornost InductOsa dokazana je u višenacionalnom, randomiziranom, kontroliranom, jednostruko slijepom ispitivanju 450 bolesnika (u dobi od 18 do 87 godina; 81% muškaraca) s otvorenim prijelomima trupa tibije koja su zahtijevala kirurško liječenje.
• You should inform your doctor if you have kidney or liver disease.
• Trebate obavijestiti svog liječnika ako imate bilo koju bolest jetre ili bubrega.
Localised oedema was common when InductOs was used for cervical spine fusion.
Lokalizirani edem bio je čest kad se InductOs koristio za fuziju cervikalne kralježnice.
Typically, 4 mg (2.7 cm3 of wetted matrix) of InductOs is used in the intervertebral disc space.
Obično se primjenjuje 4 mg (2,7 cm3 navlažene matrice) InductOsa u intervertebralni prostor.
Localised infection5*
Infekcije i infestacije Lokalizirana infekcija5*
Compatibility has been demonstrated with titanium, polyetheretherketone (PEEK), and allograft bone.
Dokazana je kompatibilnost s titanijevim polietereterketonom (PEEK) i alogenim koštanim presatkom.
In a clinical study in which the intramedullary canal was reamed to cortical chatter, an increased rate of infection was observed in the InductOs-treated group versus the standard of care control group (see section 4.8).
U kliničkom ispitivanju u kojemu je intramedularni kanal proširen do granice korteksa, primijećen je povećana stopa infekcije u skupini liječenom InductOsom naspram kontrolne skupine liječene na standardni način (vidjeti dio 4.8).
It is used in addition to standard treatment and care of shin bone fractures.
Koristi se kao dodatak standardnom liječenju i skrbi za prijelome goljenične kosti.
Localised infection specific to the fractured limb was very common (≥1/10) in patients in a clinical study in which the intramedullary canal was reamed to cortical chatter.
Lokalizirana infekcija ograničena na slomljeni ud događala se vrlo često (≥ 1/10) u bolesnika u kliničkom ispitivanju u kojem je intramedularni kanal proširen do unutarnjeg ruba kortikalisa.
The use of these products in close proximity to InductOs is not recommended as this may lead to bone formation at the site of implant of the fibrin-based haemostatic agent or sealant (see section 4.2).
Ne preporučuje se primjena tih lijekova u blizini InductOsa jer to može dovesti do stvaranja kosti na mjestu ugradnje hemostatika na temelju fibrina ili fibrinskog ljepila (vidjeti dio 4.2).
The bone formation process develops from the outside of the implant towards the centre, until the entire InductOs implant is replaced by trabecular bone.
Proces stvaranja kosti razvija se izvan implantata prema središtu sve dok se cijeli implantat
The safety and efficacy of InductOs have not been demonstrated in patients with metabolic bone diseases.
Sigurnost primjene i djelotvornost lijeka InductOs nisu dokazane u bolesnika s metaboličkim bolestima kostiju.
In non-clinical studies, concurrent administration of glucocorticoids depressed bone repair (measured as a % change from control), but the effects of InductOs were not altered.
U nekliničkim ispitivanjima istovremena primjena glukokortikoida potisnula je oporavak kosti (mjereno kao % promjene u odnosu na kontrolnu skupinu), ali učinci InductOsa nisu se promijenili.
Patients had received at least six months of non-operative treatment prior to treatment with InductOs for anterior lumbar spine fusion.
Bolesnici su tijekom najmanje šest mjeseci primali nekirurško liječenje prije samog kirurškog zahvata s InductOsom za prednju fuziju lumbalne kralježnice.
InductOs is indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.
InductOs je namijenjen za liječenje akutnih prijeloma tibije u odraslih bolesnika, kao pomoć u standardnoj skrbi primjenom redukcije otvorenog prijeloma i intramedularnom fiksacijom nebušenim čavlom.
Due to the angiogenic activity of InductOs, fluid collection (pseudocyst, localised oedema, implant site effusion) can occur, sometimes encapsulated, sometimes resulting in nerve compression and/or pain.
Zbog angiogene aktivnosti lijeka InductOs, može doći do nakupljanja tekućine (pseudociste, lokalizirani edem, efuzija na mjestu implantata) ponekad i enkapsuliranog, a ponekad može nastati i kompresija živca i/ili bol.
A close monitoring of the patient for any adverse reactions and the success of the treatment is recommended.
Preporučuje se pomno praćenje bolesnika zbog mogućeg razvoja nuspojava kao i nadzor uspješnosti liječenja.
Bone resorption increased
Pojačana resorpcija kosti
Powder, solvent and matrix for implantation matrix.
OBLIK Prašak, otapalo i matrica za matricu implantata.
• Some patients may develop antibodies (made by your body to fight a foreign protein) to InductOs.
Neki bolesnici mogu razviti protutijela (koje proizvodi vaše tijelo za borbu protiv stranih proteina) protiv kolagena u lijeku.
The matrix is pre-cut in 2 pieces each of 2.5 x 5 cm.
Matrica je već izrezana na 2 dijela, svaki dimenzija 2,5 x 5 cm.
In acute tibia fracture clinical trials, more InductOs patients receiving concomitant NSAIDs for 14 consecutive days experienced mild or moderate adverse events related to wound healing (e.g., wound drainage) than InductOs patients not taking NSAIDs.
U kliničkim ispitivanjima akutnih prijeloma tibije, više bolesnika koji su primali InductOs uz nesteroidne protuupalne lijekove (NSAIL) tijekom 14 uzastopnih dana iskusilo je blage ili umjerene štetne događaje povezane s cijeljenjem rana (npr. s drenažom rane) u odnosu na bolesnike na InductOsu koju nisu uzimali NSAIL-e.
Increased breakdown of the bone
povećana razgradnja kosti
InductOs 4 mg pack contains:
InductOs pakiranje od 4 mg sadrži:
Device dislocation
Dislokacija naprave
- The other ingredients are sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide and polysorbate 80, water for injections, and bovine Type I collagen.
- Ostali sastojci su saharoza, glicin, glutamatna kiselina, natrijev klorid, natrijev hidroksid i polisorbat 80, voda za injekcije i goveđi kolagen tipa I.
• Two matrices (2.5 cm x 5 cm) in a blister package (polyvinyl chloride - PVC).
• dvije matrice (2,5 cm x 5 cm) u blister pakiranju (polivinilklorid - PVC)
The use of InductOs with reamed nails in open tibial fracture repair is not recommended.
Uporaba InductOsa bušenim čavlima u otvorenim prijelomima tibije nije preporučena.
No impact on fertility was detected in non-clinical studies.
U nekliničkim ispitivanjima nije uočen utjecaj lijeka na plodnost.
At 24 months post-operation, InductOs was demonstrated to be statistically non-inferior to autogenous bone graft with a success rate for radiologically determined fusion of 94.4% for InductOs versus 88.9% for autogenous bone graft (95% two-sided CI of the difference: -1.53, 12.46).
Dvadeset i četiri mjeseca nakon kirurškog zahvata pokazalo se da je InductOs statistički neinferioran u odnosu na autogeni koštani presadak uz stopu uspjeha za radiološki potvrđenu fuziju od 94,4% za InductOs naspram 88,9% za autogeni koštani presadak (95% dvostrani CI razlike: -1,53, 12,46).
Glutamic acid Sodium chloride Polysorbate 80 Sodium hydroxide
Prašak: saharoza glicin glutamatna kiselina natrijev klorid polisorbat 80 natrijev hidroksid
• used with interbody fusion devices made from material other than titanium, PEEK or bone
• uporaba s napravama za interkorporalnu fuziju napravljenima od materijala koji nije titanij,
Once InductOs and the lumbar interbody fusion device(s) are implanted, the inside of the intervertebral disc space must not be irrigated.
Nakon ugradnje InductOsa i naprave(a) za lumbalnu interkorporalnu fuziju, unutrašnjost intervertebralnog prostora ne smije se ispirati.
Dibotermin alfa binds to receptors on the surface of mesenchymal cells and causes cells to differentiate into cartilage- and bone-forming cells.
Dibotermin alfa veže se na receptore na površini mezenhimalnih stanica i uzrokuje diferencijaciju stanica u stanice koje tvore hrskavicu i kost.
Powder: sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide and polysorbate 80 Solvent: water for injections
Prašak: saharoza, glicin, glutamatna kiselina, natrijev klorid, natrijev hidroksid i polisorbat 80 Otapalo: voda za injekcije
If you are receiving InductOs for lower back spine fusion, your surgeon will remove the damaged disc that is causing the pain and replace it with a medical device filled with InductOs.
Vaš će kirurg ukloniti oštećeni disk koji uzrokuje bol i zamijeniti ga s medicinskim proizvodom ispunjenim InductOsom.
InductOs 12 mg pack contains:
InductOs pakiranje od 12 mg sadrži:
Pharmacodynamic information specific to lumbar interbody fusion studies
Farmakodinamičke informacije specifične za ispitivanja lumbalne interkorporalne fuzije
• Any active malignancy or patient undergoing treatment for a malignancy
• bilo kojom zloćudnom bolesti ili za bolesnike koji se liječe od zloćudnih bolesti
Slowly inject the solvent into the vial containing the lyophilised dibotermin alfa.
Polako ubrizgajte otapalo u bočicu koja sadrži liofilizirani dibotermin alfa.
Localised fluid build-up
lokalizirano nakupljanje tekućine
Marketing Authorisation Holder and Manufacturer Medtronic BioPharma B.V.
Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač Medtronic BioPharma B.V.
The oedema was delayed in onset and, in some cases, severe enough to result in airway compromise (see section 4.4).
Nastup edema bio je odgođen, te u nekim slučajevima dovoljno jak da bi ugrozio prohodnost dišnih puteva (vidjeti dio 4.4).
A post-hoc meta-analysis of 6 controlled clinical trials with data from patients treated with InductOs or autogenous bone graft administered using CE-marked interbody fusion devices or allograft bone spacers and various surgical approaches showed that, at 24 months post-surgery, InductOs was associated with a higher fusion success rate (95%, 241 out of 255 patients) compared with autogenous bone graft (85 %, 177 out of 209 patients), with an odds ratio of 3.26 (95% CI: 1.172, 9.075; P = 0.024).
Post-hoc metaanaliza podataka iz 6 kontroliranih kliničkih ispitivanja s bolesnicima liječenima InductOsom ili autogenim koštanim presatkom koji su bili primijenjeni pomoću naprava za interkorporalnu fuziju s oznakom CE ili umetaka (engl. spacers) od alogene kosti i raznim kirurškim pristupima pokazala je da je, 24 mjeseca nakon operacije, InductOs bio povezan s višom stopom uspješnih fuzija (95%, 241 od 255 bolesnika) u usporedbi s autogenim koštanim presatkom (85%, 177 od 209 bolesnika), uz omjer šansi od 3,26 (95% CI: 1,172, 9,075; P = 0,024).
Use of InductOs in patients undergoing cervical spine surgery in amounts lower than or similar to those for lumbar interbody fusion has been associated with reports of localised oedema severe enough to result in airway compromise (see section 4.4).
Uporaba InductOsa u bolesnika koji će se podvrgnuti kirurškom zahvatu na vratnoj kralježnici u količinama manjim ili sličnim onima za lumbalnu interkorporalnu fuziju povezana je s izvješćima o lokaliziranom edemu, koji je bio dovoljno jak da bi ugrozio prohodnost dišnih puteva (vidjeti dio 4.4).
2 matrices
2 matrice
In a pooled safety data analysis of 8 clinical trials at 24 months post-surgery, the frequency of patients with pseudarthrosis was approximately 2-fold lower following treatment with InductOs (4.8%, 22 out of 456 patients) compared with autogenous bone graft (12.7%, 31 out of 244 patients).
U analizi objednjenih podataka o sigurnosti primjene iz 8 kliničkih ispitivanja 24 mjeseca nakon operacije, učestalost bolesnika s pseudoartrozom bila je približno dvaput niža nakon liječenja InductOsom (4,8%, 22 od 456 bolesnika) u usporedbi s autogenim koštanim presatkom (12,7%, 31 od 244 bolesnika).
These autoimmune diseases include rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis.
Te autoimune bolesti uključuju reumatoidni artritis, sistemski eritematozni lupus, sklerodermiju, Sjögrenov sindrom i dermatomiozitis/polimiozitis.
Patients were randomised to receive a titanium interbody fusion device filled with either InductOs or autogenous bone graft taken from the iliac crest.
Bolesnici su bili nasumično odabrani za primanje naprave za interkorporalnu fuziju od titanija ispunjenu bilo lijekom InductOs ili autogenim koštanim presatkom uzetim s ilijačnog grebena.
2 needles
2 igle
Anti-dibotermin alfa antibodies: In spine fusion studies, 1.3% of patients receiving InductOs developed antibodies to dibotermin alfa versus 0.8% of patients receiving autogenous bone graft.
Protutijela na dibotermin alfa: U ispitivanjima fuzije kralježnice, 1,3% bolesnika koji su primali InductOs razvilo je protutijela na dibotermin alfa naspram 0,8% bolesnika koji su primili autogeni koštani presadak.
Special warnings and precautions for use specific to lumbar interbody fusion
Posebna upozorenja i mjere opreza za uporabu specifični za interkorporalnu fuziju lumbalne kralježnice
Leaving the matrix in its tray, UNIFORMLY distribute 1.4 ml of dibotermin alfa solution on each of the two 2.5 x 5 cm matrices, following the pattern in the figure below.
Dok je matrica na svojoj plitici JEDNOLIČNO raspodijelite 1,4 ml otopine dibotermina alfa na svaku od dvije matrice dimenzija 2,5 x 5 cm, pridržavajući se sheme u nastavku.
The most common adverse reactions for InductOs in lumbar interbody fusion surgery were radiculopathic events, and in acute tibia fracture surgery it was localised infection.
Najčešće nuspojave InductOsa kod operacije interkorporalne fuzije lumbalne kralježnice bili su radikulopatski događaji te lokalizirana infekcija kod kirurškog liječenja akutnog prijeloma tibije.
How InductOs is given
Kako se InductOs primjenjuje