FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, non-clinical studies have indicated that the bone induced by InductOs, if fractured, can repair itself in a manner indistinguishable from native bone.
Croatian: Nadalje, neklinička ispitivanja ukazala su na to da kost inducirana InductOsom ako je slomljena može spontano zacijeliti na isti način kao i prirodna kost.
English: 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.
Croatian: Kirurško područje izvan intervertebralnog prostora treba ispirati po potrebi, a svu tekućinu koja se iscijedi iz navlažene matrice treba isprati.
English: The safety and efficacy of InductOs in cervical spine surgery have not been established, and InductOs should not be used in this condition.
Croatian: Sigurnost i djelotvornost InductOsa kod kirurških zahvata na cervikalnoj kralježnici nisu utvrđene pa se InductOs ne smije koristiti u ovom stanju.
English: The effects of InductOs on pregnancy are not known.
Croatian: Trudnoća i dojenje Učinci InductOsa na trudnoću nisu poznati.
English: 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).
Croatian: 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).
English: Pharmacodynamic information specific to acute tibia fracture studies
Croatian: Farmakodinamičke informacije specifične za ispitivanja akutnog prijeloma tibije
English: 5 PHARMACOLOGICAL PROPERTIES
Croatian: 5 FARMAKOLOŠKA SVOJSTVA
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Croatian: DODATAK III OZNAČAVANJE I UPUTA O LIJEKU
English: 2/3 of the matrix
Croatian: 2/3 matrice
English: 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.
Croatian: U slučaju potrebe za kirurškom drenažom, dren se mora postaviti podalje od mjesta implantacije ili po mogućnosti jedan sloj površnije od mjesta implantacije.
English: • Two syringes (5 ml; polypropylene).
Croatian: • dvije štrcaljke (5 ml; polipropilen)
English: As a precaution, a physical barrier between the matrix and any neurological tissue must be re-created (see section 4.2).
Croatian: Kao mjera opreza, mora se ponovno stvoriti fizička pregrada između matrice i cjelokupnog živčanog tkiva (vidjeti dio
English: Localised oedema associated with the use of InductOs has been reported in patients undergoing cervical spine surgery.
Croatian: Lokalizirani edemi povezani s uporabom InductOsa uočeni su u bolesnika koji se podvrgavaju kirurškom zahvatu na cervikalnom dijelu kralježnice.
English: Dosing table for InductOs 12 mg pack Portion of InductOs wetted matrix (12 mg pack)
Croatian: Tablica s dozama InductOs pakiranja od 12 mg Udio InductOs navlažene matrice (pakiranje od 12 mg)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 sterile matrix (7.5 x 10 cm)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1 sterilna matrica (7,5 x 10 cm)
English: In the non-sterile field
Croatian: U nesterilnom polju
English: In an in vitro study, dibotermin alfa was shown to bind to fibrin-based haemostatic agents or sealants.
Croatian: U in vitro ispitivanju pokazalo se da se dibotermin alfa veže za hemostatike na temelju fibrina ili fibrinska ljepila.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Implantation.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Implantacija.
English: 6 PHARMACEUTICAL PARTICULARS
Croatian: 6 FARMACEUTSKI PODACI
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 sterile matrices (2.5 x 5 cm)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2 sterilne matrice (2,5 x 5 cm)
English: InductOs contains the active substance, dibotermin alfa.
Croatian: InductOs sadrži djelatnu tvar dibotermin alfa.
English: • Two syringes (10 ml; polypropylene).
Croatian: • dvije štrcaljke (10 ml; polipropilen)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 12 mg dibotermin alfa
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 12 mg dibotermina alfa
English: InductOs must be placed within the lumbar interbody fusion device(s) or in the anterior portion of the intervertebral disc space.
Croatian: InductOs se mora staviti unutar naprave (naprava) za lumbalnu interkorporalnu fuziju ili u prednji dio intervertebralnog prostora.
English: 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)
Croatian: 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)
English: Device dislocation can occur after the use of InductOs in spinal fusion surgery that may necessitate surgical revision (see section 4.8).
Croatian: Nakon primjene InductOsa kod operacije fuzije kralježaka može doći do dislokacije naprave, zbog čega može biti neophodna kirurška revizija (vidjeti dio 4.8).
English: Dimensions of wetted matrix
Croatian: Dimenzije navlažene matrice
English: 3 PHARMACEUTICAL FORM
Croatian: 3 FARMACEUTSKI
English: 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.
Croatian: Sigurnost primjene i djelotvornost InductOsa kod kirurških zahvata na vratu nisu utvrđene pa se InductOs ne smije koristiti u ovom stanju.
English: 1/6 of the matrix
Croatian: 1/6 matrice
English: Concentration of wetted matrix
Croatian: Koncentracija navlažene matrice
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4 mg dibotermin alfa
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 4 mg dibotermina alfa
English: 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).
Croatian: 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).
English: This medicine contains less than 1 mmol (23 mg) sodium per maximum dose (two 12 mg packs), i.e. it is essentially ‘sodium-free'.
Croatian: 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.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Croatian: 14. NAČIN IZDAVANJA LIJEKA Lijek se izdaje na recept.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: The safety and efficacy of the use of InductOs in patients with known autoimmune disease have not been established.
Croatian: Sigurnost primjene i djelotvornost uporabe InductOsa u bolesnika s dijagnosticiranom autoimunom bolešću nisu utvrđene.
English: Leaving the matrix in its tray, UNIFORMLY distribute the dibotermin alfa solution on the matrix, following the pattern in the figure below.
Croatian: Dok je matrica na svojoj plitici JEDNOLIČNO raspodijelite otopinu dibotermina alfa na matricu pridržavajući se sheme u nastavku.
English: Volume of wetted matrix
Croatian: Volumen navlažene matrice
English: The most severe adverse reaction is localised oedema in cervical spine surgery.
Croatian: Najteže nuspojave bile su lokalizirani edem kod kirurškog zahvata na cervikalnom dijelu kralježnice.
English: One vial contains 4 mg dibotermin alfa.
Croatian: Jedna bočica sadrži 4 mg dibotermina alfa.
English: 4 mg pack:
Croatian: Pakiranje od 4 mg:
English: 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.
Croatian: 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.
English: 12 mg pack:
Croatian: Pakiranje od 12 mg:
English: Dosing table for InductOs 4 mg pack InductOs wetted matrices (4 mg pack)
Croatian: Tablica s dozama InductOs pakiranja od 4 mg Udio InductOs navlažene matrice (pakiranje od 4 mg)
English: NAME OF THE MEDICINAL PRODUCT Matrix for InductOs 1.5 mg/ml Bovine Type I collagen
Croatian: NAZIV LIJEKA Matrica za InductOs 1,5 mg/ml goveđi kolagen tipa
English: 3.2 ml solvent
Croatian: 3,2 ml otapalo
English: Using the remaining syringe and needle from the pack, reconstitute the dibotermin alfa vial with 3.2 ml of solvent.
Croatian: Koristeći preostalu štrcaljku i iglu iz pakiranja, rekonstituirajte bočicu dibotermina alfa s 3,2 ml otapala.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Powder for InductOs 1.5 mg/ml dibotermin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Prašak za InductOs 1,5 mg/ml dibotermin alfa
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for InductOs
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za InductOs voda za injekcije
English: Using the remaining syringe and needle from the pack, reconstitute the dibotermin alfa vial with 8.4 ml of solvent.
Croatian: Koristeći preostalu štrcaljku i iglu iz pakiranja, rekonstituirajte bočicu dibotermina alfa s 8,4 ml otapala.
English: InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix Dibotermin alfa
Croatian: InductOs 1,5 mg/ml prašak, otapalo i matrica za matricu implantata dibotermin alfa
English: Peel open the interior package of the matrices and leave the matrices in their trays.
Croatian: Otvorite unutarnje pakiranje matrica i ostavite matrice na pliticama.
English: BATCH NUMBER
Croatian: BROJ SERIJE Broj serije
English: 1/3 of the matrix
Croatian: 1/3 matrice
English: None of the patients with positive titers to bovine Type I collagen had cross-reacting antibodies to human type I collagen.
Croatian: Nijedan od bolesnika s pozitivnim titrom na goveđi kolagen tipa
English: Anti-bovine Type I collagen antibodies: In spine fusion studies, 13.5% of patients receiving InductOs developed antibodies to bovine Type I collagen versus 14.3% of patients receiving autogenous bone graft.
Croatian: Protutijela na goveđi kolagen tipa I: U ispitivanjima fuzije kralježnice, 13,5% bolesnika koji su primali InductOs razvilo je protutijela na goveđi kolagen tipa
English: METHOD OF ADMINISTRATION Implantation.
Croatian: NAČIN PRIMJENE LIJEKA Implantacija.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, Bone Morphogenetic Proteins, ATC code: M05BC01
Croatian: Farmakoterapijska skupina: Pripravci za liječenje bolesti kostiju, koštani morfogenetski proteini.
English: Heterotopic ossification1, 3*
Croatian: Heterotopična osifikacija1,3* Osteoliza* Pojačana resorpcija kosti*
English: Formation of a fluid collection (pseudocyst, localised oedema, implant site effusion), sometimes encapsulated and in some cases resulting in nerve compression and pain, has been reported associated with the use of InductOs.
Croatian: Prijavljeno je nakupljanje tekućine povezano s primjenom InductOsa (pseudocista, lokalizirani edem, izljev na mjestu implantata); tekućina je ponekad enkapsulirana, a u nekim slučajevima dovodi do kompresije živca i boli.
English: The possibility of an immune response to the product should be considered in cases where an undesirable effect with immunological background is suspected.
Croatian: U slučajevima sumnje na nuspojave imunološkog podrijetla treba procijeniti mogućnost imunološkog odgovora na lijek.
English: Peel open the interior package of the matrix and leave the matrix in its tray.
Croatian: Otvorite unutarnje pakiranje matrice i ostavite matricu na plitici.
English: Disinfect the stopper of the reconstituted dibotermin alfa vial.
Croatian: Dezinficirajte čep rekonstituirane bočice s diboterminom alfa.
English: Cervical spine surgery
Croatian: Kirurški zahvat na cervikalnom dijelu kralježnice
English: EXPIRY DATE EXP: see reverse
Croatian: ROK VALJANOSTI Rok valjanosti: vidjeti na poleđini
English: • Powder in a vial (20 ml; Type I glass) with a stopper (bromobutyl rubber).
Croatian: • prašak u bočici (20 ml; staklo tipa I) s čepom (bromobutilna guma)
English: Post-Implantation
Croatian: Nakon implantacije
English: In lumbar interbody fusion studies, over 600 patients received InductOs.
Croatian: Preko 500 bolesnika primilo je InductOs u ispitivanjima prijeloma dugih kostiju, dok je više od 600 bolesnika primilo InductOs u ispitivanjima lumbalne interkorporalne fuzije.
English: Discard syringe and needle after use.
Croatian: Nakon uporabe zbrinite štrcaljku i iglu.
English: • Skeletal immaturity
Croatian: • nezrelim kosturom
English: Pre-Implantation
Croatian: Prije implantacije
English: When reconstituted, contains 1.5 mg/ml dibotermin alfa.
Croatian: Nakon rekonstitucije sadrži 1,5 mg/ml dibotermina alfa.
English: • You should inform your doctor of any history of cancer.
Croatian: • Trebate obavijestiti svog liječnika ako ste bolovali od karcinoma.
English: 1 NAME OF THE MEDICINAL PRODUCT InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix
Croatian: 1 NAZIV LIJEKA InductOs 1,5 mg/ml prašak, otapalo i matrica za matricu implantata
English: 8 MARKETING AUTHORISATION NUMBER(S) EU/1/02/226/001
Croatian: 8 BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/226/001
English: Acute tibia fracture surgery
Croatian: Kirurško liječenje akutnog prijeloma tibije
English: • Powder in a vial (10 ml; Type I glass) with a stopper (bromobutyl rubber).
Croatian: • prašak u bočici (10 ml; staklo tipa I) s čepom (bromobutilna guma)
English: BATCH NUMBER LOT: see reverse
Croatian: BROJ SERIJE Serija: vidjeti na poleđini
English: After reconstitution, InductOs contains 1.5 mg/ml dibotermin alfa.
Croatian: Nakon rekonstitucije, InductOs sadrži 1,5 mg/ml dibotermina alfa.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
English: Forceps should be used to handle InductOs.
Croatian: Kod rukovanja lijekom InductOs mora se koristiti pinceta.
English: Disinfect the stoppers of the dibotermin alfa and solvent vials.
Croatian: Dezinficirajte čepove bočica s diboterminom alfa i otapalom.
English: If you get any side effects, talk to your doctor.
Croatian: Ako primijetite bilo koju nuspojavu, obavijestite svog liječnika.
English: 1 vial with 4 mg dibotermin alfa 1 vial with 10 ml water for injections 2 sterile matrices (2.5 x 5 cm) 2 syringes (5 ml)
Croatian: Prašak, otapalo i matrica za matricu implantata sadrži: 1 bočicu s 4 mg dibotermina alfa 1 bočicu s 10 ml vode za injekcije 2 sterilne matrice (2,5 x 5 cm) 2 štrcaljke (5 ml)
English: Glycine
Croatian: STERILNO
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 12 MG PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA ZA PAKIRANJE OD 12 MG
English: The frequency of adverse reactions in patients exposed to treatment with InductOs is presented in the table below.
Croatian: Učestalost nuspojava u bolesnika izloženih liječenju InductOsom prikazana je u tablici u nastavku.
English: Read the Summary of Product Characteristics before use.
Croatian: Prije uporabe pročitajte Sažetak opisa svojstava lijeka.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/226/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/226/001
English: METHOD OF ADMINISTRATION Read the Summary of Product Characteristics before use
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte Sažetak opisa svojstava lijeka
English: In long-bone fracture studies, 6.3% of patients receiving dibotermin alfa with bovine Type I collagen matrix developed antibodies to dibotermin alfa versus 1.3% in the control group.
Croatian: U ispitivanjima prijeloma dugih kostiju, 6,3% bolesnika koji su primili dibotermin alfa s matricom od goveđeg kolagena tipa
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 4 MG PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA ZA PAKIRANJE OD 4 MG
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/226/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/226/002
English: Morphogenetic Protein-2), 4 mg (4 mg pack) or 12 mg (12 mg pack).
Croatian: Što InductOs sadrži - Djelatna tvar u lijeku InductOs je dibotermin alfa (koji se još naziva rekombinantni humani koštani morfogenetski protein-2), 4 mg (pakiranje od 4 mg) ili 12 mg (pakiranje od 12 mg).
English: During two years follow-up in clinical trials for lumbar interbody fusion using a posterior approach, heterotopic ossification seen on radiographs occurred more often in patients treated with InductOs compared with autograft (see section 4.4).
Croatian: Heterotopična osifikacija opažena na rendgenskim snimkama češće je nastajala u bolesnika liječenih InductOsom nego autolognim presatkom (vidjeti dio 4.4) tijekom dvogodišnjeg praćenja u sklopu kliničkih ispitivanja lumbalne interkorporalne fuzije pomoću stražnjeg pristupa.
English: Excipients
Croatian: Učestalosti
English: Lumbar interbody fusion surgery
Croatian: Interkorporalna fuzija lumbalne kralježnice
English: NAME OF THE MEDICINAL PRODUCT InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix Dibotermin alfa
Croatian: Uputa o lijeku: Informacija za bolesnika InductOs 1,5 mg/ml prašak, otapalo i matrica za matricu implantata dibotermin alfa
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING TRAY TOP LID LABEL FOR 12 MG PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA ZA GORNJI POKLOPAC PLITICE ZA PAKIRANJE OD 12 MG
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MATRIX LABEL FOR 12 MG PACK
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA MATRICU ZA PAKIRANJE OD 12 MG
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: (navedene u dijelu 6)
English: Fluid collection
Croatian: Nakupljanje tekućine
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MATRIX LABEL FOR 4 MG PACK
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA MATRICU ZA PAKIRANJE OD 4 MG
English: Post-Implantation Once InductOs is implanted, do not irrigate the wound.
Croatian: InductOsa nemojte ispirati ranu.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING TRAY TOP LID LABEL FOR 4 MG PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA ZA GORNJI POKLOPAC PLITICE ZA PAKIRANJE OD 4 MG
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 12 mg dibotermin alfa.
Croatian: TVARI Jedna bočica sadrži 12 mg dibotermina alfa.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL PROTEIN LABEL FOR 12 MG PACK
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S PROTEINIMA ZA PAKIRANJE OD 12 MG
English: METHOD OF ADMINISTRATION Read the Summary of Product Characteristics before use.
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte Sažetak opisa svojstava lijeka.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL PROTEIN LABEL FOR 4 MG PACK
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S PROTEINIMA ZA PAKIRANJE OD 4 MG
English: 1 Observed during use in lumbar interbody fusion 2 Fluid collection includes localised oedema, pseudocyst and implant site effusion.
Croatian: Nakupljanje tekućine uključuje lokalizirani edem, pseudocistu i izljev na mjestu implantata.
English: Fractures of the shin bone
Croatian: PEEK ili kost
English: In long-bone fracture studies, 13.0% of patients receiving dibotermin alfa with bovine Type I collagen matrix developed antibodies to bovine Type I collagen versus 5.3% of control patients.
Croatian: U ispitivanjima prijeloma dugih kostiju, 13,0% bolesnika koji su primali dibotermin alfa s matricom od goveđeg kolagena tipa
English: Both dibotermin alfa and bovine Type I collagen have been found to elicit immune responses in patients.
Croatian: Imunološki odgovor Otkriveno je da i dibotermin alfa i goveđi kolagen tipa
English: Lower back spine fusion surgery
Croatian: Kirurška fuzija donjeg dijela kralježnice
English: Frequencies
Croatian: Često
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg dibotermin alfa.
Croatian: TVARI Jedna bočica sadrži 4 mg dibotermina alfa.
English: General disorders and administration site conditions
Croatian: Opći poremećaji i reakcije na mjestu primjene
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING TRAY UNDERSIDE OF LID STICKER FOR 12 MG PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA NA UNUTARNJOJ STRANI POKLOPCA PLITICE ZA PAKIRANJE OD 12 MG
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING TRAY UNDERSIDE OF LID STICKER FOR 4 MG PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA NA UNUTARNJOJ STRANI POKLOPCA PLITICE ZA PAKIRANJE OD 4 MG
English: 5 Observed during use in acute tibia fractures * Additional information provided below
Croatian: 5 Zabilježeno tijekom uporabe u liječenju akutnih prijeloma tibije.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL SOLVENT LABEL FOR 12 MG PACK
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S OTAPALOM ZA PAKIRANJE OD 12 MG
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL SOLVENT LABEL FOR 4 MG PACK
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S OTAPALOM ZA PAKIRANJE OD 4 MG
English: Bovine Type I collagen
Croatian: I razvilo je protutijela na goveđi kolagen tipa
English: 09 December 2015 EMA/685398/2015
Croatian: 9. prosinca 2015. EMA/685398/2015
English: Dried bilberry fruit should only be used in adults and children over the age of 12 years.
Croatian: Osušen borovničin plod smije se koristiti samo u odraslih osoba i djece starije od 12 godina.
English: What are the HMPC conclusions on its medicinal uses?
Croatian: Koji su zaključci HMPC-a o medicinskoj uporabi?
English: A doctor or a qualified healthcare practitioner should be consulted if symptoms persist for more than 3 days when treating mild diarrhoea or for more than 1 week for inflammation of the lining of the mouth.
Croatian: Potrebno je obratiti se liječniku ili kvalificiranom zdravstvenom djelatniku ako simptomi traju dulje od tri dana tijekom liječenja blagog proljeva ili dulje od jednog tjedna kod upale sluznice usne šupljine.