FrancophonIA/ELRC3.0 huggingface dataset:
English: Fibrin sealant products differ significantly in their quantitative and qualitative composition.
Croatian: Proizvodi za zatvaranje rana od fibrina međusobno se značajno razlikuju po svojem kvantitativnom i kvalitativnom sastavu.
English: The use of fibrin glue inside the cartilage defect bed is not recommended as this may result in a significantly poorer outcome (see section 5.3).
Croatian: Upotreba fibrinskog ljepila unutar ležišta hrskavičnog defekta se ne preporučuje budući da može rezultirati značajno lošijim ishodom (vidjeti odjeljak 5.3).
English: PharmaCell Cell Manufacturing Facility B.V., Urmonderbaan 20B, 6167 RD Geleen, Netherlands
Croatian: PharmaCell Cell Manufacturing Facility B.V., Urmonderbaan 20B, 6167 RD Geleen, Nizozemska
English: A defect can be caused by acute trauma, such as a fall.
Croatian: Oštećenje može biti prouzročeno akutnom traumom, kao što je pad.
English: What ChondroCelect is and what it is used for
Croatian: Što je ChondroCelect i za što se koristi
English: The safety and efficacy in children and adolescents (aged less than 18) have not been established.
Croatian: Sigurnost i djelotvornost kod djece i adolescenata (mlađih od 18 godina) još nije ustanovljena.
English: Please tell your doctor or physical therapist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili fizioterapeuta ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Since this product will be used during your knee surgery, the hospital staff is responsible for the correct storage of the product both before and during its use, as well as for the correct disposal
Croatian: Budući da će se ovaj lijek koristiti tijekom operacije Vašeg koljena, bolničko osoblje je odgovorno za ispravno čuvanje lijeka prije i tijekom uporabe kao i za ispravno odlaganje.
English: Pain relief medicinal products should be used according to the recommendations of the responsible surgeon.
Croatian: Lijekovi za ublažavanje bolova trebaju se koristiti prema preporukama odgovornog kirurga.
English: The leaflet was approved in
Croatian: Ova uputa je odobrena u
English: The purpose is to repair the defect with healthy and functional cartilage over time.
Croatian: Svrha je popraviti oštećenje zdravom i funkcionalnom hrskavicom za buduće razdoblje.
English: After surgery, you will have to follow a rehabilitation program for approximately one year, to allow your knee to heal well.
Croatian: Nakon kirurškog zahvata pratit ćete program rehabilitacije u trajanju od oko godine dana, a kako bi se Vašem koljenu omogućilo dobro ozdravljenje.
English: Your doctor or physical therapist will give you more details on your rehabilitation.
Croatian: Vaš liječnik ili fizioterapeut ćeVam dati više podataka o rehabilitaciji.
English: Patients had to agree to actively participate in a strict rehabilitation protocol and follow-up program.
Croatian: Bolesnici su trebali pristati na aktivno sudjelovanje u strogom postupku rehabilitacije i programu praćenja.
English: ChondroCelect should not be sterilised.
Croatian: ChondroCelect se ne smije sterilizirati.
English: It protects the ends of our bones and allows our joints to function smoothly.
Croatian: Ono štiti krajnje dijelove naših kostiju i omogućuje neometan rad naših zglobova.
English: The adverse reactions listed are those that occurred most frequently, with treatment failure and delamination being the most serious.
Croatian: Nuspojave navedene iznad su se pojavljivale najčešće, a neuspjeh liječenja i delaminacija su najozbiljnije.
English: 6.5 Nature and contents of container and special equipment for use, administration or
Croatian: 6.5 Vrsta i sadržaj spremnikai posebna oprema za uporabu, primjenu ili ugradnju
English: Pt initials {patient initials}
Croatian: Inicijali bolesnika {inicijali bolesnika}
English: You should be very cautious when bending and putting weight on your treated knee.
Croatian: Morate biti vrlo oprezni prilikom sagibanja ili opterećivanja liječenog koljena.
English: 2.2 Qualitative and quantitative composition
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV
English: Store between 15°C - 25°C.
Croatian: Čuvati na temperaturi između 15°C - 25°C.
English: If, based on the benefit/risk assessment of the responsible surgeon treatment of patients below 18 years is considered, special attention should be given to ensure that the growth plate is completely closed.
Croatian: Ako se temeljem procjene odgovornog kirurga o koristi/riziku razmišlja o liječenju bolesnika mlađih od 18 godina, posebnu pozornost treba posvetiti provjeri je li ploča rasta u potpunosti formirana.
English: No specific safety signal was detected in these patients.
Croatian: Nije otkriveno nikakvo posebno sigurnosno upozorenje kod tih bolesnika.
English: Non-clinical data based on implantation of expanded cartilage cells in goats and mice did not reveal special hazard for humans.
Croatian: Neklinički podaci na temelju implantacije ekspandiranih stanica hrskavice kod koza i miševa ne ukazuju na poseban rizik za ljude.
English: • Training material for other healthcare professionals
Croatian: • Materijal za obuku ostalih zdravstvenih djelatnika
English: During the rehabilitation period, the level of weight-bearing will increase gradually, depending on your weight and the size of the cartilage defect.
Croatian: Za vrijeme rehabilitacije razina opterećenja postupno se povećava ovisno o Vašoj težini i veličini oštećenja hrskavice.
English: The efficacy of ChondroCelect was studied in a phase III, multicenter, randomized, controlled trial (TIG/ACT/01/2000) and the first two years of its 4-year extension phase (TIG/ACT/01/2000EXT).
Croatian: Djelotvornost lijeka ChondroCelect ispitivana je u fazi III, multicentričnog, randomiziranog i kontroliranog ispitivanja (TIG/ACT/01/2000) i tijekom prve dvije godine četverogodišnje faze produžetka (TIG/ACT/01/2000EXT).
English: - The use of ChondroCelect is generally not recommended when you are overweight (i.e. a Body Mass Index over 30) because it could compromise the result of the treatment.
Croatian: - Upotreba lijeka ChondroCelect uglavnom se ne preporučuje ako imate prekomjernu tjelesnu težinu (odnosno ako je indeks tjelesne mase veći od 30) zbog toga što bi to moglo ugroziti rezultate liječenja.
English: Therefore the treated knee should be protected according to the recommendations as outlined in the appropriate rehabilitation schedule, to avoid early damage which might lead to graft failure.
Croatian: Zbog toga se liječeno koljeno treba odgovarajuće zaštiti prema preporukama u odgovarajućem rasporedu rehabilitacije kako bi se izbjeglo rano oštećenje koje bi moglo dovesti do neuspjeha implantacije.
English: Fax: +32-(0)16 39 60 70 info@tigenix.com
Croatian: Faks: +32-(0)16 39 60 70 info@tigenix.com
English: It can also be caused by repetitive trauma, as a result of overweight or due to incorrect weight-bearing on the knee as a result of a knee deformity.
Croatian: Može ga prouzročiti i ponavljajuća trauma kao posljedica prekomjerne tjelesne težine ili zbog nepravilnog opterećenja koljena kao posljedice deformacije koljena.
English: For the group with a longer time since onset of symptoms there were no apparent differences between the 2 groups.
Croatian: Kod skupine s duljim razdobljem od nastanka simptoma nije bilo značajne razlike između dvije skupine ispitanika.
English: According to current literature the incidence of cartilage hypertrophy can be reduced by using a collagen membrane to cover the lesion site instead of using a periosteal flap (Gooding et al., 2006; Niemeyer et al., 2008).
Croatian: Prema trenutačno dostupnoj literaturi incidencija hipertrofije hrskavice može se smanjiti upotrebom kolagenske membrane za prekrivanje područja lezije umjesto periostalnog režnja (Gooding i sur., 2006; Niemeyer i sur., 2008).
English: The amount of cells to be administered is dependent on the size (surface in cm²) of the cartilage defect.
Croatian: Količina stanica koju treba primijeniti ovisi o veličini (površina u cm²) oštećene hrskavice.
English: Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX02
Croatian: Farmakoterapijska skupina: Ostali lijekovi za poremećaje mišićno-koštanog sustava, ATK oznaka: M09AX02
English: Scientific publications have shown that commercially available collagen membranes can be used as an alternative to the periost in ACI procedures.
Croatian: Znanstvene su publikacije pokazale da se komercijalno dostupne kolagenske membrane mogu koristiti kao alternativa za pokosnicu u ACI postupcima.
English: • Cartilage is a tissue that is present in every joint.
Croatian: • Hrskavica je tkivo koje se nalazi u svakom zglobu.
English: The safety data obtained in these patients do not indicate a particular safety concern, and confirm a lower incidence of hypertrophy as suggested by scientific literature on the use of collagen membranes versus periost.
Croatian: Sigurnosni podaci dobiveni kod tih bolesnika ne ukazuju na poseban sigurnosni problem i potvrđuju manju incidenciju hipertrofije kao što je to i navedeno u znanstvenoj literaturi o upotrebi kolagenskih membrana u odnosu na pokosnicu.
English: Post-marketing experience with respect to patient number, i.e. 444 patients and duration of follow-up is still quite limited, and doesn't warrant granting a renewal with unlimited validity.
Croatian: Iskustvo nakon stavljanja lijeka u promet u vezi broja bolesnika, tj. 444 bolesnika i trajanje razdoblja praćenja još je uvijek prilično ograničeno i ne jamči obnovu odobrenja na neograničeni rok.
English: In a study in sheep, the majority of animals showed penetration of the transplanted cells in subchondral bone; in two of these cases complete penetration of underlying bone marrow was observed.
Croatian: U ispitivanju na ovcama, kod većine životinja došlo je do penetriranja transplantiranih stanica u suphondralnu kost; u dva od tih slučajeva primijećena je potpuna penetracija koštane srži.
English: The implantation should be followed by an appropriate rehabilitation schedule for approximately one year, as recommended by the physician (see section 4.4).
Croatian: Nakon implantacije treba slijediti odgovarajući plan rehabilitacije u trajanju od približno jedne godine prema preporuci liječnika (pogledajte dio 4.4).
English: The product is packaged in several layers of packaging material which guarantee sterility and stable temperature conditions for 48 hours if stored at room temperature.
Croatian: Lijek se pakira u višeslojnoj ambalaži koja jamči sterilnost i stabilnost temperature u razdoblju od 48 sati ako se pohranjuje na sobnoj temperaturi.
English: • Training material for surgeons
Croatian: • Materijal za obuku kirurga
English: The safety data obtained in these patients do not indicate a particular safety concern.
Croatian: Sigurnosni podaci dobiveni na tim bolesnicima ne ukazuju na osobitu opasnost za sigurnost.
English: The educational programme for healthcare professionals contains the following components:
Croatian: Obrazovni program za zdravstvene djelatnike uključuje sljedeće dijelove:
English: Further clinical data in patients with larger lesions are foreseen to be collected in the future.
Croatian: U budućnosti je predviđeno i daljnje prikupljanje kliničkih podataka za bolesnike s većim lezijama.
English: The estimated benefit was larger in the ChondroCelect group but the results did not reach statistical significance.
Croatian: Procijenjena korist bila je veća u skupini liječenoj lijekom ChondroCelect, ali rezultati nisu bili statistički značajni.
English: Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of ChondroCelect remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Croatian: Na osnovu podataka koji su postali dostupni nakon izdavanja prvog odobrenja za stavljanje lijeka u promet, CHMP smatra da omjer korist/rizik lijeka ChondroCelect ostaje pozitivan, ali i da sigurnosni profil treba pozorno nadzirati iz sljedećih razloga:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 October 2009
Croatian: Datum prvog odobrenja: 5. listopada 2009
English: Hypersensitivity to any of the excipients listed in section 6.1, or to bovine serum.
Croatian: Preosjetljivost na neku od pomoćnih tvari navedenih u dijelu 6.1 ili na goveđi serum.
English: In the majority of the 370 patients included in the Compassionate Use Program, a collagen membrane instead of a periosteal flap was used to seal the defect.
Croatian: U većine od 370 bolesnika uključenih u program milosrdne upotrebe korištena je kolagenska membrana umjesto periostalnog režnja za zatvaranje oštećenja.
English: Details and information on the appropriate rehabilitation schedule is provided in the ChondroCelect user manual.
Croatian: Detalji i informacije o odgovarajućem planu rehabilitacije nalaze se u priručniku za korisnike lijeka
English: There are no data on possible effects of ChondroCelect treatment on fertility.
Croatian: Nema podataka o mogućim učincima liječenja ChondroCelectom na plodnost.
English: ChondroCelect is intended solely for autologous use.
Croatian: ChondroCelect je namijenjen isključivo za autolognu upotrebu.
English: The cells are kept alive in a small sterile vial.
Croatian: Stanice se održavaju živima u maloj sterilnoj bočici.
English: The Marketing Authorisation Holder (MAH) shall ensure that the medicinal product will be distributed only to Healthcare Establishments that meet criteria described in the Risk Management Plan.
Croatian: Nositelj odobrenja mora osigurati da se lijek distribuira samo zdravstvenim ustanovama koje ispunjavaju uvjete navedene u Planu upravljanja rizikom.
English: In the pivotal study there was no influence of Body Mass Index (BMI) on outcome but bibliographic data shows that a BMI over 30 may adversely affect the success of the procedure.
Croatian: U pivotalnom ispitivanju nije se pokazao utjecaj indeksa tjelesne mase (ITM) na ishod, ali podaci iz literature pokazuju da ITM veći od 30 može nepovoljno utjecati na ishod postupka.
English: Synovitis and subchondral bone injuries have been reported in animal models and are possible risks with the use of ChondroCelect.
Croatian: Sinovitis i ozljede subhondralne kosti primijećene su u životinjskim modelima te su mogući rizici kod upotrebe ChondroCelecta.
English: During the ACI procedure it is important to ensure that a good, direct contact of the implanted cells with the defect bed is obtained as such contact is of paramount importance for optimal tissue regeneration.
Croatian: Tijekom ACI postupka, važno je osigurati dobar, izravni kontakt implantiranih stanica s ležištem budući da je takav kontakt od presudnog značaja za optimalnu regeneraciju tkiva.
English: • The need for screening of donors using patient questionnaire and laboratory tests for hepatitis C,
Croatian: • Potrebu za probir donora korištenjem upitnika za bolesnike te provedbom laboratorijskih pretraga za hepatitis C, hepatitis B, HIV i sifilis
English: In vitro interaction studies were performed with a commercially available fibrin glue containing aprotinin (a fibrinolysis inhibitor of bovine origin).
Croatian: Provedena su in vitro ispitivanja interakcija s komercijalno dostupnim fibrinskim ljepilom koje sadrži aprotinin (inhibitor fibrinolize goveđeg podrijetla).
English: In some cases it can be possible that the source chondrocytes of the patient are not expandable or that the release criteria are not met, due to poor biopsy quality, patient characteristics, or manufacturing failure.
Croatian: U nekim određenim slučajevima postoji mogućnost da se izvorni hondrociti bolesnika ne mogu ekspandirati ili da nisu ispunjeni kriteriji puštanja lijeka zbog loše kvalitete biopsije, karakteristika bolesnika ili pogreške u proizvodnji.
English: Patients with patellofemoral cartilage lesion, OCD, depth of lesion >0.5 cm, prior meniscal transplant, prior mosaicplasty and prior microfracture within the last 12 month were excluded.
Croatian: Bolesnici s patelofemoralnom lezijom hrskavice, OCD, dubinom lezije>0,5 cm, s prethodno obavljenom transplantacijom meniska, prethodnom mozaikoplastikom i prethodno obavljenom mikrofrakturom u zadnjih 12 mjeseci bili su isključeni.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/563/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/563/001
English: During the rehabilitation period that follows treatment with ChondroCelect, patients should refer to their treating physician and follow their advice strictly.
Croatian: Tijekom razdoblja rehabilitacije koje slijedi nakon liječenja lijekom ChondroCelect bolesnici se trebaju obratiti svojim liječnicima i strogo se pridržavati njihovih savjeta.
English: These were generally mild and disappeared in the weeks following surgery.
Croatian: Ove su nuspojave općenito bile blage i nestale su u tjednima nakon kirurškog zahvata.
English: Conventional reproductive and developmental toxicity studies are not considered relevant, given the nature and the intended clinical use of the autologous cell therapy product.
Croatian: Konvencionalna istraživanja reproduktivne i razvojne toksičnosti ne smatraju se relevantnima zbog prirode i namjere kliničke upotrebe lijeka za liječenje pomoću autolognih stanica.
English: The nature and intended clinical use of ChondroCelect are such that conventional studies on pharmacokinetics, absorption, distribution, metabolism and elimination are not applicable.
Croatian: Priroda i namijenjena klinička primjena lijeka ChondroCelect takve su da uobičajena ispitivanja o farmakokinetici, apsorpciji, distribuciji, metabolizmu i izlučivanju iz organizma nisu primjenjiva.
English: If the ChondroCelect vial is damaged or its sterility has been compromised, the product must not be used and must be shipped back to TiGenix.
Croatian: Ako je bočica lijeka ChondroCelect oštećena ili je ugrožena njegova sterilnost, lijek se ne smije primjenjivati i mora se vratiti tvrtki TiGenix.
English: The training materials for surgeons shall include the following key messages and components:
Croatian: Materijal za obuku kirurga treba uključivati sljedeće ključne poruke i dijelove:
English: Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Croatian: Učestalost je definirana prema sljedećoj konvenciji: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do
English: Patients aged between 18 and 50 years, who had a single symptomatic cartilage lesion between 1 and 5 cm2 of the femoral condyles met the inclusion criteria.
Croatian: Bolesnici u dobi od 18 do 50 godina koji su imali pojedinačnu simptomatsku leziju hrskavice femoralnog kondila veličine od 1 do 5 cm2 ispunjavali su kriterije za uključivanje.
English: TiGenix N.V., Romeinse straat 12/2, 3001 Leuven, Belgium Tel: +32-(0)16 39 60 60
Croatian: TiGenix N.V., Romeinse straat 12/2, 3001 Leuven, Belgija Tel: +32-(0)16 39 60 60
English: In studies in goats, mild signs of synovitis were observed in the majority of the animals, including controls at 10 weeks post surgery.
Croatian: U ispitivanju na kozama primijećeni su blagi znakovi sinovitisa kod većine životinja uključujući i kontrole 10 tjedana nakon kirurškog zahvata.
English: Characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins.
Croatian: Karakterizirane vijabilne autologne stanice hrskavice razvijene ex vivo koje eksprimiraju specifične markerske proteine.
English: Demonstration of efficacy is based on a randomised controlled trial evaluating the efficacy of Chondrocelect in patients with lesions between 1-5cm².
Croatian: Dokaz djelotvornosti temelji se na randomiziranom kontroliranom ispitivanju kojim je ispitivana djelotvornost lijeka ChondroCelect u bolesnika s lezijama veličine između 1-5cm².
English: Using fibrin glue only, instead of stitches, to secure the implant is not recommended.
Croatian: Korištenje samo fibrinskog ljepila, umjesto šavova, u svrhu osiguranja implantata se ne preporučuje.
English: The surgeon will be informed as early in the process as possible, and should hence select an alternative treatment for the patient concerned.
Croatian: Kirurg će o tome biti obaviješten čim to postupak dopušta i zatim će, sukladno tome, trebati odabrati drugi način liječenja dotičnog bolesnika.
English: In the compassionate use patients, a higher incidence of arthrofibrosis and decreased joint range of motion was observed in a subgroup of patients with a patellar lesion (8.2% and 13.1% respectively) compared to non-patellar lesions (0.6% and 2.6% respectively).
Croatian: Kod bolesnika u programu milosrdne upotrebe primijećena je veća incidencija artrofibroze i smanjene pokretljivosti zglobova u podgrupi bolesnika s patelarnom lezijom (8,2% odnosno 13,1%) u usporedbi s onima s nepatelarnom lezijom (0,6% odnosno 2,6%).
English: In a randomized, controlled study in the target population, 51 patients were treated with ChondroCelect.
Croatian: U randomiziranom, kontroliranom ispitivanju ciljane populacije 51 bolesnik je liječen lijekom ChondroCelect.
English: The surgical procedure will have a major influence on your ability to drive and use machines.
Croatian: Kirurški postupak imat će velikog utjecaja na Vašu sposobnost upravljanja vozilom i rad sa strojevima.
English: An arthroscopy is performed through very small incisions in the skin, using a narrow telescope (arthroscope) to look at the inside of the knee.
Croatian: Artroskopija se provodi kroz vrlo mali rez na koži pomoću tankog teleskopa (artroskopa) kako bi se mogla vidjeti unutrašnjost koljena.
English: Driving cars and using machines may be limited during the rehabilitation period, and the advice of your doctor, surgeon or physical therapist should be strictly followed during this period.
Croatian: Tijekom rehabilitacije može biti ograničena sposobnost upravljanja vozilom i rada sa strojevima, a tijekom ovog razdoblja strogo morate slijediti savjet Vašeg liječnika, kirurga ili fizioterapeuta.
English: The marketing authorisation holder shall submit the periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive
English: The CHMP decided that the MAH should continue to submit 1-yearly PSURs.
Croatian: CHMP je odlučio da nositelj odobrenja nastavi podnositi godišnje PSUR-ove.
English: In patients with a longer time since onset of symptoms, both treatments performed equally.
Croatian: U bolesnika s duljim vremenom od pojave simptoma, oba oblika liječenja imala su podjednaku učinkovitost.
English: Prior to implantation match the patient name to the patient/donor identification on the shipment documentation and product vial.
Croatian: Prije implantacije provjerite usklađenost imena bolesnika i identifikacije bolesnika/donora na dokumentaciji za slanje i bočici lijeka.
English: Patients could be treatment-naïve or might have undergone previous arthroscopic or other surgical repair procedure(s).
Croatian: Bolesnici prethodno nisu bili liječeni ili su prethodno bili podvrgnuti artroskopiji ili nekom drugim kirurškom postupku(postupcima) popravka.
English: Conventional pharmacodynamic studies for ChondroCelect have not been performed.
Croatian: Uobičajena farmakodinamička ispitivanja lijeka ChondroCelect nisu provedena.
English: ChondroCelect 10,000 cells/microlitre implantation suspension Characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Croatian: ChondroCelect 10 000 stanica/mikrolitar suspenzija implantata Karakterizirane vijabilne autologne stanice hrskavice razvijene ex vivo koje eksprimiraju specifične markerske proteine