natgillin/translations-raw huggingface dataset:
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
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) 
Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2)
Once prepared, InductOs contains dibotermin alfa at a concentration of 1.5 mg/ml. 
Nakon pripreme, InductOs sadrži dibotermin alfa u koncentraciji od 1,5 mg/ml.
Matrix: bovine Type I collagen 
Matrica: goveđi kolagen tipa
In clinical trials when degenerative disc disease was treated by a posterior lumbar interbody fusion procedure with dibotermin alfa, posterior bone formation was observed in CT scans. 
Kad se u kliničkim ispitivanjima degenerativna bolest diska liječila postupkom lumbalne interkorporalne fuzije stražnjim pristupom u kojem se koristio dibotermin alfa, na CT snimcima opaženo je stvaranje kosti sa stražnje strane.
Implantation 
Implantacija
Clinical intervention (aspiration and/or surgical removal) may be required if symptoms persist (see section 4.8). 
Ako simptomi ustraju, može biti potrebna klinička intervencija (aspiracija i/ili kirurško uklanjanje) (vidjeti dio 4.8).
Remodeling of the surrounding bone occurs in a manner that is consistent with the biomechanical forces placed on it. 
Remodeliranje kosti oko implantata događa se na način sukladan biomehaničkim silama koje se primjenjuju na kost.
Furthermore, non-clinical studies have indicated that the bone induced by InductOs, if fractured, can repair itself in a manner indistinguishable from native bone. 
Nadalje, neklinička ispitivanja ukazala su na to da kost inducirana InductOsom ako je slomljena može spontano zacijeliti na isti način kao i prirodna kost.
Outside the intervertebral disc space, the surgical field should be irrigated as needed, and any fluid loss from the wetted matrix should be washed away. 
Kirurško područje izvan intervertebralnog prostora treba ispirati po potrebi, a svu tekućinu koja se iscijedi iz navlažene matrice treba isprati.
The safety and efficacy of InductOs in cervical spine surgery have not been established, and InductOs should not be used in this condition. 
Sigurnost i djelotvornost InductOsa kod kirurških zahvata na cervikalnoj kralježnici nisu utvrđene pa se InductOs ne smije koristiti u ovom stanju.
The effects of InductOs on pregnancy are not known. 
Trudnoća i dojenje Učinci InductOsa na trudnoću nisu poznati.
In the acute tibia fracture pivotal trial, InductOs increased the probability of fracture healing; patients treated with InductOs 1.5 mg/ml had a 44% reduced risk for treatment failure (secondary intervention to promote fracture healing) compared with patients in the standard-care group (RR = 0.56; 95% CI = 0.40 to 0.78). 
U glavnom ispitivanju akutnog prijeloma tibije, InductOs je povećao vjerojatnost zacjeljivanja prijeloma; bolesnici liječeni InductOsom 1,5 mg/ml imali su rizik od neuspjeha liječenja smanjen za 44% (sekundarna intervencija za poticanje liječenja prijeloma) u usporedbi s bolesnicima u skupini koja je primala standardno liječenje (RR = 0,56; 95% CI = 0,4 do 0,78).
Pharmacodynamic information specific to acute tibia fracture studies 
Farmakodinamičke informacije specifične za ispitivanja akutnog prijeloma tibije
5 PHARMACOLOGICAL PROPERTIES 
5 FARMAKOLOŠKA SVOJSTVA
ANNEX III LABELLING AND PACKAGE LEAFLET 
DODATAK III OZNAČAVANJE I UPUTA O LIJEKU
2/3 of the matrix 
2/3 matrice
If a surgical drain is required, the drain should be placed remotely from the implantation site or, preferably, one layer superficial to the implantation site. 
U slučaju potrebe za kirurškom drenažom, dren se mora postaviti podalje od mjesta implantacije ili po mogućnosti jedan sloj površnije od mjesta implantacije.
• Two syringes (5 ml; polypropylene). 
• dvije štrcaljke (5 ml; polipropilen)
As a precaution, a physical barrier between the matrix and any neurological tissue must be re-created (see section 4.2). 
Kao mjera opreza, mora se ponovno stvoriti fizička pregrada između matrice i cjelokupnog živčanog tkiva (vidjeti dio
Localised oedema associated with the use of InductOs has been reported in patients undergoing cervical spine surgery. 
Lokalizirani edemi povezani s uporabom InductOsa uočeni su u bolesnika koji se podvrgavaju kirurškom zahvatu na cervikalnom dijelu kralježnice.
Dosing table for InductOs 12 mg pack Portion of InductOs wetted matrix (12 mg pack) 
Tablica s dozama InductOs pakiranja od 12 mg Udio InductOs navlažene matrice (pakiranje od 12 mg)
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 sterile matrix (7.5 x 10 cm) 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1 sterilna matrica (7,5 x 10 cm)
In the non-sterile field 
U nesterilnom polju
In an in vitro study, dibotermin alfa was shown to bind to fibrin-based haemostatic agents or sealants. 
U in vitro ispitivanju pokazalo se da se dibotermin alfa veže za hemostatike na temelju fibrina ili fibrinska ljepila.
METHOD AND ROUTE(S) OF ADMINISTRATION Implantation. 
NAČIN I PUT(EVI) PRIMJENE LIJEKA Implantacija.
6 PHARMACEUTICAL PARTICULARS 
6 FARMACEUTSKI PODACI
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 sterile matrices (2.5 x 5 cm) 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2 sterilne matrice (2,5 x 5 cm)
InductOs contains the active substance, dibotermin alfa. 
InductOs sadrži djelatnu tvar dibotermin alfa.
• Two syringes (10 ml; polypropylene). 
• dvije štrcaljke (10 ml; polipropilen)
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 12 mg dibotermin alfa 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 12 mg dibotermina alfa
InductOs must be placed within the lumbar interbody fusion device(s) or in the anterior portion of the intervertebral disc space. 
InductOs se mora staviti unutar naprave (naprava) za lumbalnu interkorporalnu fuziju ili u prednji dio intervertebralnog prostora.
Powder, solvent and matrix for implantation matrix contain: 1 vial with 12 mg dibotermin alfa 1 vial with 10 ml water for injections 1 sterile matrix (7.5 x 10 cm) 
Prašak, otapalo i matrica za matricu implantata sadrži: 1 bočicu s 12 mg dibotermina alfa 1 bočicu s 10 ml vode za injekcije 1 sterilnu matricu (7,5 x 10 cm) 2 štrcaljke (10 ml)
Device dislocation can occur after the use of InductOs in spinal fusion surgery that may necessitate surgical revision (see section 4.8). 
Nakon primjene InductOsa kod operacije fuzije kralježaka može doći do dislokacije naprave, zbog čega može biti neophodna kirurška revizija (vidjeti dio 4.8).
Dimensions of wetted matrix 
Dimenzije navlažene matrice
3 PHARMACEUTICAL FORM 
3 FARMACEUTSKI
The safety and effectiveness of InductOs in spine surgery in the neck have not been established, and InductOs should not be used in this situation. 
Sigurnost primjene i djelotvornost InductOsa kod kirurških zahvata na vratu nisu utvrđene pa se InductOs ne smije koristiti u ovom stanju.
1/6 of the matrix 
1/6 matrice
Concentration of wetted matrix 
Koncentracija navlažene matrice
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4 mg dibotermin alfa 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 4 mg dibotermina alfa
The proportion of patients with healed soft-tissue wounds was significantly higher at the 6-week post-treatment visit in the InductOs 1.5 mg/ml group compared with the standard-care group (83% versus 65%; P= 0.0010). 
Udio bolesnika s izliječenim ranama mekog tkiva bio je znatno viši u posjetu 6. tjedna nakon kirurškog liječenja u skupini koja se liječila InductOsom 1,5 mg/ml u usporedbi sa skupinom koja je primala standardno liječenje (83% naspram 65%; P = 0,0010).
This medicine contains less than 1 mmol (23 mg) sodium per maximum dose (two 12 mg packs), i.e. it is essentially ‘sodium-free'. 
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po maksimalnoj dozi (dva pakiranja od 12 mg), tj. smatra se da je bez natrija.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. 
14. NAČIN IZDAVANJA LIJEKA Lijek se izdaje na recept.
The proportion of patients with hardware failure (locking screws bent or broken) was significantly lower in the InductOs 1.5 mg/ml group as compared to standard-care group (11% versus 22%; P= 0.0174). 
Udio bolesnika s kvarom metalnih dijelova (savijeni ili napuknuti vijci za zaključavanje) bio je znatno niži u skupini koja je primala InductOs 1,5 mg/ml u usporedbi sa skupinom koja je primala standardno liječenje (11% naspram 22%; P = 0,0174).
Using aseptic transfer technique and the syringe and needle from step 1, withdraw 8.0 ml of the reconstituted dibotermin alfa solution from the vial in the non-sterile field, holding up the inverted vial to facilitate withdrawal. 
Koristeći tehniku aseptičkog prijenosa te štrcaljku i iglu iz 1. koraka, izvucite 8,0 ml rekonstituirane otopine dibotermina alfa iz bočice u nesterilnom polju držeći bočicu okrenutu kako biste olakšali izvlačenje.
The safety and efficacy of the use of InductOs in patients with known autoimmune disease have not been established. 
Sigurnost primjene i djelotvornost uporabe InductOsa u bolesnika s dijagnosticiranom autoimunom bolešću nisu utvrđene.
Leaving the matrix in its tray, UNIFORMLY distribute the dibotermin alfa solution on the matrix, following the pattern in the figure below. 
Dok je matrica na svojoj plitici JEDNOLIČNO raspodijelite otopinu dibotermina alfa na matricu pridržavajući se sheme u nastavku.
Volume of wetted matrix 
Volumen navlažene matrice
The most severe adverse reaction is localised oedema in cervical spine surgery. 
Najteže nuspojave bile su lokalizirani edem kod kirurškog zahvata na cervikalnom dijelu kralježnice.
One vial contains 4 mg dibotermin alfa. 
Jedna bočica sadrži 4 mg dibotermina alfa.
4 mg pack: 
Pakiranje od 4 mg:
Using aseptic transfer technique and the syringe and needle from step 1, withdraw 2.8 ml of the reconstituted dibotermin alfa solution from the vial in the non-sterile field, holding up the inverted vial to facilitate withdrawal. 
Koristeći tehniku aseptičkog prijenosa te štrcaljku i iglu iz 1. koraka, izvucite 2,8 ml rekonstituirane otopine dibotermina alfa iz bočice u nesterilnom polju držeći bočicu okrenutu kako biste olakšali izvlačenje.
12 mg pack: 
Pakiranje od 12 mg:
Dosing table for InductOs 4 mg pack InductOs wetted matrices (4 mg pack) 
Tablica s dozama InductOs pakiranja od 4 mg Udio InductOs navlažene matrice (pakiranje od 4 mg)