FrancophonIA/ELRC3.0 huggingface dataset:
English: ChondroCelect is an autologous product and should under no circumstances be administered to other patients.
Croatian: ChondroCelect je autologni lijek i ni u kojem se slučaju ne smije davati drugim bolesnicima.
English: • The surgical checklist to be completed at the operating theatre immediately prior to the first incision confirming the right patient, the right product, the right side of the implantation, and the type of biological membrane and fibrin sealant to be used in the procedure.
Croatian: • Kontrolni popis kirurga koji se mora popuniti u operacijskoj dvorani netom prije prvog reza kojim se potvrđuje identitet bolesnika, ispravnost lijeka, ispravno mjesto implantacije te vrsta biološke membrane i lijeka za zatvaranje rana od fibrina koji će se koristiti u postupku.
English: In the ChondroCelect group 77% of patients had a medial and 23% a lateral condyle defect.
Croatian: U skupini liječenoj lijekom ChondroCelect, 77% bolesnika imalo je oštećenje medijalnog, a 23% oštećenje lateralnog kondila.
English: - If you have an acute or recent history of bone or joint infections, you should be temporary deferred until documented recovery.
Croatian: Ako imate akutnu ili nedavnu povijest infekcije kostiju ili zglobova, trebate privremeno odgoditi primjenu sve do potvrđenog oporavka.
English: Each product contains an individual treatment dose with sufficient number of cells to treat the predefined lesion size, as measured at biopsy procurement.
Croatian: Svaki proizvod sadrži pojedinačnu dozu za liječenje s dovoljnim brojem stanica za liječenje prethodno određene veličine lezije koja je izmjerena prilikom biopsije.
English: Warnings and precautions Talk to your doctor, surgeon or physiotherapist before using ChondroCelect.
Croatian: Razgovarajte sa svojim liječnikom, kirurgom ili fizioterapeutom prije primjene lijeka ChondroCelect.
English: Each pack contains an individual treatment dose consisting of 1 to 3 vials, depending on the number of cells needed to treat the specific lesion size.
Croatian: Svako pakiranje sadrži pojedinačnu dozu za liječenje koja se sastoji od 1 do 3 bočice, ovisno o broju stanica potrebnih za liječenje lezije određene veličine.
English: Patients with lesions larger than 5 cm² have been treated under compassionate use only.
Croatian: Bolesnici s lezijama većim od 5 cm² liječeni su samo u programu milosrdne upotrebe.
English: This means that other knee problems such as lesions of the knee ligament or of the meniscus should be corrected before or during ChondroCelect implantation.
Croatian: To znači da ostali problemi s koljenom kao što su lezije ligamenata koljena ili meniska trebaju biti izliječeni prije ili tijekom implantacije lijeka ChondroCelect.
English: ChondroCelect is supplied as one individual treatment dose (falcon tube) contained in 1 to 3 Type I glass vials of 1 ml.
Croatian: ChondroCelect se isporučuje kao pojedinačna doza lijeka (falcon epruveta) koja se nalazi u 1 do 3 staklene bočice tipa
English: • Autologous means that your own cells are used to make ChondroCelect.
Croatian: • Autologno znači da su Vaše vlastite stanice korištene za izradu lijeka ChondroCelect.
English: The recommended dose of ChondroCelect is 0.8 to 1 million cells/cm², corresponding with 80 to 100 microlitre of product/cm² of defect.
Croatian: Preporučena doza lijeka ChondroCelect je 0,8 do 1 milijuna stanica po cm², što odgovara količini od 80 do 100 mikrolitara lijeka po cm² oštećenja.
English: However, ChondroCelect has not been evaluated in combination with collagen membranes in clinical studies, although a commercially available collagen membrane has been used in patients treated with ChondroCelect under compassionate use.
Croatian: Međutim, iako lijek ChondroCelect, tijekom kliničkih ispitivanja, nije ocijenjen u kombinaciji s kolagenskim membranama, ipak su se komercijalno dostupne kolagenske membrane koristile kod bolesnika liječenih lijekom ChondroCelect tijekom milosrdne uporabe.
English: Pt N° {patient number}
Croatian: Broj bolesnika {broj bolesnika}
English: Inflammation resolved with time and parameters returned to baseline levels with only some very mild and local signs of synovitis remaining in a few animals.
Croatian: Upala je vremenom riješena i parametri su vraćeni na razinu početnih vrijednosti s nekim izrazito blagim znakovima sinovitisa koji su i dalje bili vidljivi kod nekoliko životinja.
English: More patients in the ChondroCelect treatment group, compared to patients in the microfracture group, had undergone previous knee surgery (88% versus 77%).
Croatian: Veći broj bolesnika u skupini liječenoj lijekom ChondroCelect, u usporedbi s onima podvrgnutih mikrofrakturi već je ranije imalo operacije koljena (88% u odnosu na 77%).
English: Patients with femoral epiphyseal growth plate that is not fully closed
Croatian: Bolesnici s nepotpuno zatvorenom femoralnom epifiznom pločom rasta.
English: Romeinse straat 12/2, 3001 LEUVEN Belgium info@tigenix.com
Croatian: Romeinse straat 12/2, 3001 LEUVEN Belgija info@tigenix.com
English: In the pivotal study of ChondroCelect, patients with these comorbidities of the knee were excluded from treatment.
Croatian: U pivotalnom ispitivanju lijeka ChondroCelect bolesnici s tim komorbiditetima koljena isključeni su iz liječenja.
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Croatian: Nositelj odobrenja mora osigurati da je farmakovigilancijski sustav, prikazan u Modulu 1.8.1. Odobrenja za stavljanje lijeka u promet, ustrojen i funkcionalan prije i nakon stavljanja lijeka u promet.
English: What ChondroCelect is and what it is used for What you need to know before you use ChondroCelect
Croatian: Što je ChondroCelect i za što se koristi Što morate znati prije primjene lijeka ChondroCelect Kako primjenjivati ChondroCelect
English: No interaction studies with any other type of fibrin glues were performed.
Croatian: Ispitivanja interakcija s drugim vrstama fibrinskih ljepila nisu provedena.
English: ≥1/100 to <1/10
Croatian: Često ≥1/100 i <1/10
English: This finding might be related to the inability to perform a progressive loading under nonweight bearing conditions post-surgery in these models and therefore cannot be fully extrapolated as such to the human situation.
Croatian: Ova opažanja mogu biti povezana s nemogućnošću postupnog opterećenja u uvjetima nesavladavanja vlastite težine tijekom postoperativnog opterećenja kod ovih modela te se stoga ne mogu u potpunosti,
English: Limited clinical data on exposed pregnancies are available.
Croatian: Dostupni su ograničeni klinički podaci o upotrebi autolognih stanica hrskavice u trudnica.
English: Only 907 patients have been exposed up to now, including patients treated with ChondroCelect within the clinical trials conducted to support the MA of ChondroCelect.
Croatian: Do sada je ovom lijeku izloženo samo 907 bolesnika, uključujući i bolesnike liječene ChondroCelectom u kliničkim ispitivanjima koja su provedena radi davanja odobrenja za
English: - You should resume physical activity according to the rehabilitation plan recommended by the physical therapist.
Croatian: - Tjelesnu aktivnost trebate nastaviti ponovo provoditi prema planu rehabilitacije kojuVam preporučuje Vaš fizioterapeut.
English: The median time since onset of knee injury was slightly longer in the ChondroCelect group than in the microfracture group (2.0 years versus 1.6 years).
Croatian: Medijan vremena od nastanka ozljede koljena bilo je nešto dulje kod skupine bolesnika liječenih lijekom ChondroCelect nego kod onih podvrgnutih mikrofrakturi (2 godine u odnosu na 1,6 godina).
English: Implantation suspension
Croatian: Suspenzija implantata
English: Using fibrin glue in the defect bed instead of stitches to secure the implant resulted in an overall poor outcome, suggesting the need for a direct contact of the implanted cells with the defect bed
Croatian: Korištenje fibrinskog ljepila u ležištu na dnu hrskavičnog defekta umjesto šavova, u svrhu osiguranja implantata, rezultiralo je ukupno lošim ishodom i ukazalo na potrebu izravnog kontakta implantiranih stanica s ležištem na dnu hrskavičnog defekta.
English: The Marketing Authorisation Holder (MAH) shall ensure, prior to the distribution of the product to a particular healthcare establishment, that all surgeons and other healthcare professionals involved in the handling and administration of ChondroCelect or its components, as well as those involved in followup of patients treated with ChondroCelect in the healthcare establishment, receive training as per the educational programme described in the risk management plan.
Croatian: Nositelj odobrenja (MAH) mora omogućiti, prije isporuke lijeka određenoj zdravstvenoj ustanovi, u skladu s obrazovnim programom navedenom u Planu upravljanja rizikom, obuku svim kirurzima i ostalim zdravstvenim djelatnicima uključenima u rukovanje i davanje lijeka ChondroCelect ili njegovih sastavnih dijelova kao i onima uključenima u praćenje bolesnika liječenih lijekom
English: In general, these side effects are quite mild and disappear in the weeks following surgery.
Croatian: U pravilu, ove nuspojave su blage i nestaju u tjednima nakon kirurškog zahvata.
English: Other medicines and ChondroCelect
Croatian: Drugi lijekovi i ChondroCelect
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING White screw top container
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Bijeli spremnik s navojnim vrhom
English: 51 patients were treated with ChondroCelect, 61 patients were treated with microfracture.
Croatian: 51 bolesnik je liječen lijekom ChondroCelect, a 61 bolesnik je liječen primjenom mikrofrakture.
English: Patients with less than 3 years since onset of symptoms (n=27 in the ChondroCelect arm and n=32 in the microfracture arm) benefited most from ChondroCelect.
Croatian: Bolesnici kod kojih je proteklo manje od 3 godine od nastanka simptoma (n=27 u skupini ispitanika liječenih lijekom ChondroCelect i n=32 u skupini ispitanika podvrgnutih mikrofrakturi) imali su najveću korist od lijeka ChondroCelect.
English: Therefore it can occur that ChondroCelect cannot be delivered.
Croatian: Zbog toga se može dogoditi da se lijek ChondroCelect ne može isporučiti.
English: ChondroCelect must not be used in case of advanced osteoarthritis of the knee.
Croatian: ChondroCelect se ne smije upotrebljavati u slučaju napredovalog osteoartritisa koljena.
English: Sixteen patients below 18 years have been treated with ChondroCelect under compassionate use.
Croatian: Šesnaest bolesnika mlađih od 18 godina liječeno je lijekom ChondroCelect u programu milosrdne upotrebe.
English: Related to surgical intervention of the knee
Croatian: Povezano s kirurškim zahvatom na koljenu
English: Full technical details on the procedures associated with this implantation technique are provided in the ChondroCelect user manual.
Croatian: Svi tehnički podaci o postupcima koji su povezani s ovom tehnikom implantacije nalaze se u priručniku za korisnike lijeka ChondroCelect.
English: Due to the surgical nature of the underlying procedure, implantation with ChondroCelect has a major influence on the ability to drive and use machines.
Croatian: Zbog prirode kirurškog postupka implantacija s lijekom ChondroCelect značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Marketing Authorisation Holder: TiGenix N.V.
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet: TiGenix N.V.
English: Even if the surgeon has already taken a small sample of cartilage cells (a biopsy) needed to produce the product, it is possible that you will not be eligible for treatment with ChondroCelect.
Croatian: Čak i ako je kirurg postupkom biopsije već uzeo mali dio uzorka stanica hrskavice koje su potrebne za izradu lijeka, može se dogoditi da nećete biti podobni za liječenje lijekom ChondroCelect.
English: Treatment failure in the ChondroCelect group was generally related to delamination of the graft.
Croatian: Neuspjeh liječenja u skupini liječenoj lijekom ChondroCelectbio je uglavnom povezan sdelaminacijom presatka.
English: In this technique, a good fixation using stitches on the edges of the collagen membrane is required, in order to assure a direct contact of the implanted cells with the defect bed.
Croatian: U ovoj je tehnici potrebna dobra fiksacija, korištenjem šavova na rubovima kolagenske membrane, kako bi se osigurao izravan kontakt implantiranih stanica s ležištem na dnu hrskavičnog defekta.
English: Elderly population The use of ChondroCelect has not been studied in this age group.
Croatian: Starije osobe Primjena lijeka ChondroCelect nije ispitana u ovoj dobnoj skupini.
English: From a pre-clinical study in the orthotopic goat model it appeared that this technique provided comparable results as the Brittberg technique, on condition that a good fixation is established using stitches on the edges of the collagen membrane.
Croatian: činilo se da ova tehnika daje rezultate slične kao i Brittberg tehnika, pod uvjetom da je uspostavljena dobra fiksacija korištenjem šavova na rubovima kolagenske membrane.
English: Where possible, concomitant knee problems should be corrected prior to or at the latest at the time of ChondroCelect implantation.
Croatian: Kada je god to moguće, prateći problemi s koljenom trebali bi se izliječiti prije ili najkasnije prilikom implantacije lijeka ChondroCelect.
English: The safe use of ChondroCelect has not been demonstrated during pregnancy or breast-feeding.
Croatian: Nije dokazana sigurna upotreba lijeka ChondroCelect tijekom trudnoće ili dojenja.
English: Romeinse straat 12/2 3001 LEUVEN Belgium
Croatian: Romeinse straat 12/2 3001 LEUVEN Belgija
English: ChondroCelect is therefore not recommended for use in children and adolescents below 18 years.
Croatian: ChondroCelect se stoga ne preporučuje kod djece i adolescenata mlađih od 18 godina.
English: The safe use of ChondroCelect with other medicines has not been studied.
Croatian: Nije provedeno ispitivanje sigurne upotrebe lijeka ChondroCelect s drugim lijekovima.
English: ChondroCelect must be administered by an appropriately qualified surgeon and is restricted to hospital use only.
Croatian: ChondroCelect mora primjenjivati primjereno kvalificirani kirurg, a primjena je ograničena na bolničku primjenu.
English: • The handling of ChondroCelect and its preparation for the implantation
Croatian: • Rukovanje lijekom ChondroCelect i njegovim pripravcima za implantaciju
English: Dulbecco's Modified Eagles Medium (DMEM) (containing amino acids, vitamins, salts and carbohydrates).
Croatian: Dulbecco's Modified Eagles Medium, DMEM) (kojai sadrži aminokiseline, vitamine, soli i ugljikohidrate).
English: What you need to know before you use ChondroCelect
Croatian: Što morate znati prije primjene lijeka ChondroCelect
English: Seven patients treated with ChondroCelect needed re-intervention, compared to 10 patients in the microfracture group.
Croatian: U sedam bolesnika liječenih lijekom ChondroCelect bio je neophodan ponovni zahvat, u usporedbi s 10 bolesnika u skupini liječenoj mikrofrakturom.
English: To keep the cartilage cells in place, a biological membrane is sewn over the defect.
Croatian: Kako bi se stanice hrskavice održale na mjestu, preko oštećenja se prišiva biološka membrana.
English: ChondroCelect is not recommended for pregnant and breast-feeding women.
Croatian: ChondroCelect se ne preporučuje trudnicama i dojiljama.
English: • The femoral condyle is the end of the thigh bone, which forms part of your knee.
Croatian: • Femoralni kondil je završetak natkoljenične kosti koji čini dio Vašeg koljena.
English: If the surgeon decides that treatment with ChondroCelect is appropriate for you, he/she will take a small sample of cartilage cells (a biopsy) from your knee.
Croatian: Ako kirurg odluči da Vam odgovara liječenje lijekom ChondroCelect, on/ona će postupkom biopsije uzeti mali uzorak stanica hrskavice iz
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot {lot number}
Croatian: BROJ SERIJE, OZNAKE DONACIJE I PROIZVODA Serija {broj serije}
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Croatian: • Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik.
English: Each vial contains 0.4 ml of autologous human cartilage cells suspension and is closed with a chlorobutyl stopper and aluminium seal.
Croatian: Svaka bočica sadrži 0,4 ml suspenzije autolognih stanica hrskavice ljudskog podrijetla i zatvorena je čepom od klorobutila i aluminijskim prstenom.
English: The product is made from a small sample of cartilage cells (a biopsy) taken from your knee.
Croatian: Lijek je dobiven iz malog uzorka stanica hrskavice koje su postupkom biopsije uzete iz Vašeg koljena.
English: Too early and vigorous activity may compromise the grafting and the durability of clinical benefit from ChondroCelect.
Croatian: Prerana i preintenzivna aktivnost može ugroziti primanje presatka i trajnost kliničke koristi lijeka ChondroCelect.
English: ≥1/1,000 to <1/100
Croatian: Manje često ≥1/1000 i <1/100
English: Histological examination of the repair biopsy at 12 months showed superior structural repair in the ChondroCelect arm compared to the microfracture arm.
Croatian: Histološko ispitivanje materijala biopsije s mjesta liječenja nakon 12 mjeseci pokazalo je bolji strukturalni oporavak kod skupine ispitanika liječenih lijekom ChondroCelect u usporedbi sa skupinom ispitanika liječenom mikrofrakturom.
English: Patients with acute or recent history of bone or joint infections should be temporary deferred until documented recovery.
Croatian: Liječenje bolesnika s akutnom ili nedavnom infekcijom kostiju ili zglobova treba se privremeno odgoditi sve do potvrđenog ozdravljenja.
English: For information on preparation and handling of ChondroCelect, please refer to section 6.6.
Croatian: Za informacije o pripremi i rukovanju lijekom ChondroCelect, vidjeti dio 6.6. 4.3 Kontraindikacije
English: ChondroCelect can only be prescribed and implanted by an orthopaedic surgeon in a hospital.
Croatian: Kako primjenjivati ChondroCelect ChondroCelect može propisati i implantirati samo kirurg − ortoped u bolnici.
English: Driving cars and using machines may be limited during the rehabilitation period.
Croatian: Tijekom rehabilitacije možda će postojati ograničenja za upravljanje vozilima i rad sa strojevima.
English: The vials are placed in a sterile falcon tube with a plastic screw top.
Croatian: Bočice se nalaze u sterilnoj falcon epruveti s plastičnim navojnim vrhom.
English: There was continuous improvement up to 36 months in the clinical outcome measure KOOS (the Knee Injury and Osteoarthritis Outcome Score) in both treatment arms.
Croatian: 36 mjeseci u mjeri kliničkog ishoda KOOS (rezultat mjerenja ishoda nakon oštećenja koljena i osteoartritisa; engl. the Knee Injury and Osteoarthritis Outcome Score) u obje liječene skupine.
English: These studies have demonstrated that this type of fibrin sealant can be safely used with ChondroCelect.
Croatian: Ova su ispitivanja pokazala da se ta vrsta sredstva za zatvaranje na bazi fibrina može sigurno upotrebljavati u kombinaciji s lijekom ChondroCelect.
English: - ChondroCelect should be implanted in an otherwise healthy knee.
Croatian: - ChondroCelect treba se implantirati u koljeno koje je po svim ostalim kriterijima zdravo.
English: In clinical studies with ChondroCelect a periosteal flap was used as a biological membrane.
Croatian: Tijekom kliničkih ispitivanja provedenih s lijekom ChondroCelect kao biološka membrana koristio se periostalni režanj.
English: Upon implantation, the patient should follow an appropriate rehabilitation schedule and physical activity should be resumed as recommended by the physician.
Croatian: Nakon implantacije bolesnik mora slijediti odgovarajući plan rehabilitacije te plan tjelesne aktivnosti prema preporuci liječnika.
English: A technical variant of the ACI procedure is the cell seeding method, whereby the cells are seeded onto a collagen membrane prior to implantation.
Croatian: Tehnička varijanta ACI postupka je metoda nacjepljivanja stanica, pri čemu se stanice nacjepljuju na kolagensku membranu prije implantacije.
English: Do not use ChondroCelect if you: are allergic to any of the ingredients of ChondroCelect (listed in section 6) or to bovine serum suffer from advanced osteoarthritis (degenerative joint disease) in your knee.
Croatian: Nemojte primjenjivati ChondroCelect - Ako ste alergični na bilo koji sastojak lijeka ChondroCelect (naveden u dijelu 6) ili na goveđi serum
English: ChondroCelect was compared to the procedure of microfracture in the repair of symptomatic single cartilage lesions of the femoral condyles of the knee.
Croatian: ChondroCelect je uspoređen s postupkom mikrofrakture prilikom popravka pojedinačnih simptomatskih lezija hrskavice femoralnog kondila koljena.
English: Too early and vigorous activity may compromise the implant and the durability of clinical benefit from ChondroCelect.
Croatian: Prerana i preintenzivna aktivnost može ugroziti implantat i trajnost kliničke koristi lijeka ChondroCelect.
English: No statistically significant difference could be observed in clinical benefit between ChondroCelect and microfracture at that point in time.
Croatian: U tom trenutku, nisu opažene statistički značajne razlike u kliničkoj koristi između skupine liječene lijekom ChondroCelect i skupine liječene mikrofrakturom.
English: How to store ChondroCelect
Croatian: Kako čuvati ChondroCelect
English: During open-knee surgery, the cartilage cells are implanted into the cartilage defect.
Croatian: Tijekom operacije na otvorenom koljenu, stanice hrskavice se implantiraju u oštećenje hrskavice.
English: - If you have any further questions, ask your doctor, surgeon or physical therapist.
Croatian: - Ako imate dodatnih pitanja, obratite se svom liječniku, kirurgu ili fizioterapeutu.
English: The training material for other healthcare professionals shall include the following key messages and components:
Croatian: • Protokol praćenja Materijal za obuku ostalih zdravstvenih djelatnika treba uključivati sljedeće ključne poruke i dijelove:
English: Overall, the clinically relevant benefit of ChondroCelect implantation observed over baseline after 36 months was maintained up to 60 months after treatment.
Croatian: Sveukupno, klinički značajna korist implantacije lijeka ChondroCelect opažena nakon 36 mjeseci u odnosu na osnovicu održana je i
English: ChondroCelect consists of autologous cultured cartilage cells.
Croatian: ChondroCelect se sastoji od autolognih stanica hrskavice uzgojenih u kulturi.
English: Before re-suspension the cells are settled to the bottom of the container forming an off-white layer and the excipient is a clear colourless liquid.
Croatian: Prije resuspenzije stanice se nalaze na dnu spremnika i tvore bjelkasti sloj, a pomoćna tvar je prozirna bezbojna tekućina.
English: OTHER SPECIAL WARNING(S), IF NECESSARY For autologous use only.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Lijek smije upotrijebiti samo bolesnik kojemu je propisan.
English: Arthrofibrosis
Croatian: • artrofibroza
English: In these patients, a periosteal flap was used to secure the implant.
Croatian: U tih se bolesnika za učvršćivanje implantata koristio periostalni režanj.
English: After the 5 year follow-up period, 37 patients were evaluated in the ChondroCelect arm and 40 in the microfracture arm.
Croatian: Nakon 5-godišnjeg razdoblja praćenja, procijenjeno je 37 bolesnika u skupini liječenoj lijekom ChondroCelect i 40 bolesnika u skupini podvrgnutoj mikrofrakturi.
English: Do not use this medicine after the expiry date which is stated on the container and vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na spremniku i bočici nakon oznake „Rok valjanosti“.