FrancophonIA/ELRC3.0 huggingface dataset:
English: ChondroCelect must be administered by an appropriately qualified surgeon and is restricted to hospital use only.
Slovenian: Zdravilo ChondroCelect mora uporabljati ustrezno usposobljeni kirurg in je omejeno na bolnišnično uporabo.
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.
Slovenian: V neklinični študiji na ortotopnem modelu koze se je zdelo, da daje tehnika primerljive rezultate kot tehnika po Brittbergu, pod pogojem, da se dobro pritrditev doseže z uporabo šivov na robovih kolagenske membrane.
English: • Training material for surgeons
Slovenian: • gradivo za usposabljanje kirurgov
English: - have a growth plate of the knee that is not fully closed
Slovenian: - če imate rastno ploščo na kolenu, ki ni povsm zaprta.
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.
Slovenian: Sposobnost upravljanja vozil in strojev je lahko v obdobju rehabilitacije omejena in v tem obdobju morate dosledno upoštevati nasvete vašega zdravnika, kirurga ali fizioterapevta.
English: Therefore, based upon the safety profile of ChondroCelect, which requires the submission of 1yearly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years' time.
Slovenian: Zato je na podlagi varnostnega profila zdravila ChondroCelect, ki zahteva predložitev vsakoletnih PSUR, odbor CHMP sklenil, da mora imetnik dovoljenja za promet predložiti eno dodatno vlogo za podaljšanje v času 5 let.
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).
Slovenian: Pri bolnikih v sočutni uporabi je bila opažena večja pogostnost artrofibroze in zmanjšane gibljivosti v podskupini bolnikov s patelarno lezijo (8,2 % oziroma 13,1 %) v primerjavi z nepatelarno lezijo (0,6 % oziroma 2,6 %).
English: It will take at least four weeks to select and culture the cells to make ChondroCelect.
Slovenian: Za selekcijo in vzgojo celic za izdelavo zdravila ChondroCelect so potrebni najmanj štirje tedni.
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.
Slovenian: Bolniki, stari od 18 in 50 let, ki so imeli posamezno simptomatsko lezijo femoralnega kondila, veliko med 1 in 5 cm2, so izpolnjevali vključitvena merila.
English: Each product contains an individual treatment dose with sufficient number of cells to treat the predefined lesion size, as measured at biopsy procurement.
Slovenian: Vsak proizvod vsebuje individualni odmerek za zdravljenje z zadostnim številom celic za zdravljenje predhodno določene velikosti lezije, kot je izmerjeno pri biopsiji.
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.
Slovenian: Vnetje je sčasoma izzvenelo in parametri so se vrnili na izhodiščne vrednosti s samo nekaj zelo blagimi in lokalnimi znaki sinovitisa pri nekaterih živalih.
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.
Slovenian: Bolniki s patelofemoralno lezijo hrustanca, OCD, globino lezije >0,5 cm, predhodno transplantacijo meniskusa, predhodno mozaikoplastiko in predhodno mikrofrakturo v zadnjih 12 mesecih so bili izključeni.
English: What ChondroCelect is and what it is used for What you need to know before you use ChondroCelect
Slovenian: Kaj je zdravilo ChondroCelect in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo ChondroCelect
English: No interaction studies with any other type of fibrin glues were performed.
Slovenian: Interakcijske študije z drugimi vrstami fibrinskih lepil niso bile izvedene.
English: Re-intervention on the treated lesion for graft delamination or periost loosening occurred in 2 of 51 patients within 36 months after ChondroCelect implantation, compared to 7 of 61 patients treated with microfracture having generally insufficient or inadequate cartilage repair.
Slovenian: Ponovni poseg na zdravljeni leziji zaradi delaminacije vsadka ali zrahljanja periosta so izvedli pri 2 od 51 bolnikih v 36 mesecih od implantacije zdravila ChondroCelect v primerjavi s 7 od 61 bolnikov, zdravljenih s postopkom mikrofrakture, pri katerih je bilo izboljšanje hrustanca nezadostno ali neprimerno.
English: ChondroCelect should not be sterilised.
Slovenian: Zdravila ChondroCelect ni treba sterilizirati.
English: ≥1/1,000 to <1/100
Slovenian: Občasni ≥1/1.000 do <1/100
English: Demonstration of efficacy is based on a randomised controlled trial evaluating the efficacy of Chondrocelect in patients with lesions between 1-5cm².
Slovenian: Dokaz učinkovitosti temelji na randomizirani nadzorovani študiji, s katero je bila raziskana učinkovitost zdravila ChondroCelect pri bolnikih z lezijami, velikimi od 1 do 5 cm2.
English: - You should resume physical activity according to the rehabilitation plan recommended by the physical therapist.
Slovenian: - S telesno dejavnostjo morate nadaljevati v skladu z rehabilitacijskim načrtom, ki ga priporoči fizioterapevt.
English: The training material for other healthcare professionals shall include the following key messages and components:
Slovenian: Gradivo za usposabljanje drugih zdravstvenih delavcev mora vsebovati naslednje ključne podatke in elemente:
English: These were generally mild and disappeared in the weeks following surgery.
Slovenian: Ti so bili na splošno blagi in so ponehali v tednih po posegu.
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.
Slovenian: To pomeni, da je treba druge težave s kolenom, kot so lezije kolenskih vezi ali meniskusa, odpraviti pred ali med implantacijo zdravila ChondroCelect.
English: TiGenix N.V., Romeinse straat 12/2, 3001 Leuven, Belgium Tel: +32-(0)16 39 60 60
Slovenian: TiGenix N.V., Romeinse straat 12/2, 3001 Leuven, Belgija Tel.: +32-(0)16 39 60 60
English: Concomitant asymptomatic cartilage lesions (ICRS grade I or II) might be present.
Slovenian: Pojavijo se lahko sočasne asimptomatske hrustančne lezije (stopnja I ali II po ICRS).
English: - ChondroCelect should be implanted in an otherwise healthy knee.
Slovenian: - Zdravilo ChondroCelect je treba implantirati v drugače zdravo koleno.
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.
Slovenian: ACI je pomembno, da zagotovite dober, neposredni stik vsajenih celic s poškodovano površino, ker je tovrsten stik bistvenega pomena za optimalno regeneracijo tkiva.
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.
Slovenian: Če se kirurg odloči, da je zdravljenje z zdravilom ChondroCelect primerno za vas, bo vzel majhen vzorec hrustančnih celic (biopt) iz vašega kolena.
English: During the rehabilitation period that follows treatment with ChondroCelect, patients should refer to their treating physician and follow their advice strictly.
Slovenian: Med obdobjem rehabilitacije, ki sledi zdravljenju z zdravilom ChondroCelect, se morajo bolniki posvetovati s svojim izbranim zdravnikom in dosledno upoštevati njegove nasvete.
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.
Slovenian: Zaradi kirurške narave uporabljenega postopka ima implantacija zdravila ChondroCelect pomemben vpliv na sposobnost vožnje in upravljanje strojev.
English: No specific safety signal was detected in these patients.
Slovenian: Pri teh bolnikih niso bili ugotovljeni pomisleki glede varnosti.
English: When a collagen membrane was used to seal the lesion site after application of ChondroCelect, the incidence of cartilage hypertrophy was reported to be 1.8% compared to 25% in the randomized, controlled trial alone.
Slovenian: Ko je bila za tesnjenje mesta lezije po uporabi zdravila ChondroCelect uporabljena kolagenska membrana, je bila poročana pogostnost hipertrofije hrustanca 1,8 % v primerjavi s 25 % v randomizirani, kontrolirani študiji.
English: In these patients, a periosteal flap was used to secure the implant.
Slovenian: Pri teh bolnikih je bila za učvrstitev implantata uporabljena zaplata periosta.
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.
Slovenian: Do sedaj je bilo zdravilu izpostavljenih le 907 bolnikov, vključno z bolniki, zdravljenimi z zdravilom ChondroCelect v kliničnih preskušanjih v podporo imetniku dovoljenja za promet z zdravilom ChondroCelect.
English: What ChondroCelect is and what it is used for
Slovenian: Kaj je zdravilo ChondroCelect in za kaj ga uporabljamo
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
Slovenian: Ker se bo zdravilo uporabilo med operacijo vašega kolena, je za pravilno shranjevanje pred njegovo uporabo in med njo ter za pravilno odstranjevanje odgovorno osebje bolnišnice.
English: In patients with a longer time since onset of symptoms, both treatments performed equally.
Slovenian: Pri bolnikih z daljšim časom od pojava simptomov , so bili rezultati pri obeh oblikah zdravljenja enaki.
English: The MAH shall perform the pharmacovigilance activities as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, sprejete v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah .
English: Patients could be treatment-naïve or might have undergone previous arthroscopic or other surgical repair procedure(s).
Slovenian: Bolniki so lahko nezdravljeni ali pa so morda že prestali predhodni(e) artroskopski(e) ali drug(e) kirurški(e) postopek(e) zdravljenja.
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.
Slovenian: Vendar pa zdravilo ChondroCelect ni bilo ocenjeno v kombinaciji s kolagenskimi membranami v kliničnih študijah, čeprav so bile komercialno razpoložljive kolagenske membrane uporabljene pri bolnikih, zdravljenih z zdravilom
English: However, the concomitant use of another type of fibrin glue with a synthetic fibrinolysis inhibitor (tranexamic acid) in the pivotal clinical trial did not reveal any safety signal.
Slovenian: Vendar pa ob sočasni uporabi druge vrste fibrinskega lepila s sintetičnim inhibitorjem fibrinolize (traneksamska kislina) v glavni klinični študiji ni bilo pomislekov glede varnosti.
English: In the ChondroCelect group 77% of patients had a medial and 23% a lateral condyle defect.
Slovenian: V skupini, zdravljeni z zdravilom ChondroCelect, je imelo 77 % bolnikov okvaro medialnega kondila in 23 % okvaro lateralnega kondila.
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.
Slovenian: Primeri, v katerih zdravila ChondroCelect ni mogoče uporabiti V nekaterih primerih je mogoče, da izvornih hondrocitov bolnika ni mogoče ekspandirati ali pa niso izpolnjena merila za sprostitev zaradi slabe kakovosti biopsije, profila bolnika ali proizvodne napake.
English: Related to surgical intervention of the knee
Slovenian: Povezano s kirurškim posegom na kolenu
English: Sixteen patients below 18 years have been treated with ChondroCelect under compassionate use.
Slovenian: Šestnajst bolnikov pod 18 let je bilo zdravljenih z zdravilom ChondroCelect po programu sočutne uporabe.
English: Visit 1: evaluation of the cartilage defect and biopsy On the first visit, the surgeon will evaluate your cartilage defect during an exploratory operation (arthroscopy).
Slovenian: Prvi obisk: ocena okvare hrustanca in biopsija Ob prvem obisku bo kirurg med eksplorativno operacijo (artroskopijo) ocenil vašo okvaro hrustanca.
English: In general, these side effects are quite mild and disappear in the weeks following surgery.
Slovenian: Na splošno so ti neželeni učinki blagi in prenehajo v tednih po operaciji.
English: ChondroCelect can only be prescribed and implanted by an orthopaedic surgeon in a hospital.
Slovenian: Zdravilo ChondroCelect lahko predpiše in implantira samo ortopedski kirurg v bolnišnici.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
English: Before administration, ChondroCelect should be resuspended by gently tapping the vial to bring the cells back into suspension.
Slovenian: Pred uporabo je treba zdravilo ChondroCelect resuspendirati z nežnim udarjanjem po viali, da se celice vrnejo v suspenzijo.
English: Dulbecco's Modified Eagles Medium (DMEM).
Slovenian: Eaglov medij, modificiran po Dulbeccu (DMEM).
English: Characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins.
Slovenian: Karakterizirane viabilne avtologne hrustančne celice, ekspandirane ex vivo, ki izražajo specifične markerske proteine.
English: ChondroCelect is therefore not recommended for use in children and adolescents below 18 years.
Slovenian: Zdravila ChondroCelect se zato ne priporoča za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
English: Marketing Authorisation Holder: TiGenix N.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom: TiGenix N.V.
English: 1 falcon tube with 1, 2 or 3 vials (x 0.4 ml)
Slovenian: 1 epruveta Falcon z 1, 2 ali 3 vialami (x 0,4 ml)
English: Histological examination of the repair biopsy at 12 months showed superior structural repair in the ChondroCelect arm compared to the microfracture arm.
Slovenian: Histološka preiskava biopsije zdravljenega mesta pri 12 mesecih je pokazala boljšo strukturno ozdravljenje roke, zdravljene z zdravilom ChondroCelect, v primerjavi z roko, zdravljeno z mikrofrakturo.
English: Treatment failure in the ChondroCelect group was generally related to delamination of the graft.
Slovenian: Neuspešno zdravljenje v skupini zdravila ChondroCelect je bilo običajno povezano z delaminacijo kanala.
English: Patients with lesions larger than 5 cm² have been treated under compassionate use only.
Slovenian: Bolniki z lezijami, večjimi od 5 cm2, so bili zdravljeni samo po programu sočutne uporabe.
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.
Slovenian: Običajne študije vpliva na sposobnost razmnoževanja in razvoja glede na naravo in nameravano klinično uporabo zdravila za zdravljenje iz avtolognih celic ne pridejo v poštev.
English: In clinical studies with ChondroCelect a periosteal flap was used as a biological membrane.
Slovenian: V kliničnih študijah z zdravilom ChondroCelect je bila kot biološka membrana uporabljena zaplata periosta.
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.
Slovenian: Artroskopija se izvede skozi zelo majhne reze v koži, pri čemer se z uporabo ozkega teleskopa (artroskopa) pogleda notranjost kolena.
English: ChondroCelect must not be used in case of advanced osteoarthritis of the knee.
Slovenian: Zdravila ChondroCelect se ne sme uporabljati v primeru napredovalega osteoartritisa kolena.
English: Patients with acute or recent history of bone or joint infections should be temporary deferred until documented recovery.
Slovenian: Zdravljenje bolnikov z akutno ali nedavno zgodovino infekcije kosti ali sklepa je treba odložiti do dokumentirane ozdravitve.
English: In the pivotal study of ChondroCelect, patients with these comorbidities of the knee were excluded from treatment.
Slovenian: V glavni študiji zdravila ChondroCelect so bili bolniki s temi komorbidnostmi kolen (sočasnimi obolenji kolen) izključeni iz zdravljenja.
English: Repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults.
Slovenian: Zdravljenje posameznih simptomatskih okvar hrustanca femoralnega kondila kolena (stopnja III ali IV po Mednarodni organizaciji za zdravljenje hrustanca (International Cartilage Repair Society [ICRS])
English: 51 patients were treated with ChondroCelect, 61 patients were treated with microfracture.
Slovenian: 51 bolnikov je bilo zdravljenih z zdravilom ChondroCelect, 61 bolnikov pa z mikrofrakturo.
English: - If you have an acute or recent history of bone or joint infections, you should be temporary deferred until documented recovery.
Slovenian: - Če imate akutno ali nedavno zgodovino infekcije kosti ali sklepa, je treba vaše zdravljenje odložiti do dokumentirane ozdravitve.
English: Scientific publications have shown that commercially available collagen membranes can be used as an alternative to the periost in ACI procedures.
Slovenian: Znanstvene publikacije so pokazale, da je mogoče komercialno razpoložljive kolagenske membrane uporabljati kot alternativo za periost v postopkih ACI - Autologous Chondrocyte Implantation.
English: Do not use this medicine after the expiry date which is stated on the container and vial after EXP.
Slovenian: Zdravila ChondroCelect ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vsebniku in na viali poleg oznake EXP.
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.
Slovenian: 0,8 do 1 milijon celic/cm², kar ustreza 80 do 100 mikrolitrom proizvoda/cm² okvare.
English: Romeinse straat 12/2, 3001 LEUVEN Belgium info@tigenix.com
Slovenian: Romeinse straat 12/2, 3001 LEUVEN Belgija info@tigenix.com
English: As ChondroCelect is used to repair a cartilage defect of the knee and is implanted with the ACI procedure using open-knee surgery, it is not recommended during pregnancy.
Slovenian: Ker se zdravilo ChondroCelect uporablja za zdravljenje okvar kolenskega hrustanca in se vsadi s postopkom ACI - Autologous Chondrocyte Implantation z odprto operacijo na kolenu, ni priporočljivo med nosečnostjo.
English: Conventional pharmacodynamic studies for ChondroCelect have not been performed.
Slovenian: Običajne študije farmakodinamike za zdravilo ChondroCelect niso bile izvedene.
English: • Autologous means that your own cells are used to make ChondroCelect.
Slovenian: • Avtologno pomeni, da se za izdelavo zdravila ChondroCelect uporabijo vaše celice.
English: Too early and vigorous activity may compromise the implant and the durability of clinical benefit from ChondroCelect.
Slovenian: Prezgodnja in preveč intenzivna dejavnost lahko ogrozi implantat in trajnost kliničnih koristi zdravila ChondroCelect.
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.
Slovenian: Bolniki z manj kot 3 leti od pojava simptomov (n=27 v skupini, zdravljeni z zdravilom ChondroCelect, in n=32 bolnikov, zdravljenih s postopkom mikrofrakture) so imeli od zdravila ChondroCelect največ koristi.
English: The safe use of ChondroCelect with other medicines has not been studied.
Slovenian: Študija varne uporabe zdravila ChondroCelect z drugimi zdravili ni bila izvedena.
English: Details and information on the appropriate rehabilitation schedule is provided in the ChondroCelect user manual.
Slovenian: Podrobnosti in informacije o ustreznem rehabilitacijskem programu so na voljo v navodilih za bolnika za zdravilo ChondroCelect.
English: Therefore it can occur that ChondroCelect cannot be delivered.
Slovenian: Zato se lahko zgodi, da zdravila ChondroCelect ni mogoče uporabiti.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom (MAH) mora določeni zdravstveni ustanovi pred dobavo zdravila v skladu z izobraževalnim programu, opisanem v načrtu za obvladovanje tveganj, zagotoviti usposabljanje vseh kirurgov in drugih zdravstvenih delavcev, ki uporabljajo in dajejo zdravilo ChondroCelect ali njegove sestavine, ter vseh, ki sodelujejo pri nadaljnjem spremljanju bolnikov, zdravljenih z zdravilom CondroCelect v zdravstveni ustanovi.
English: Dulbecco's Modified Eagles Medium (DMEM) (containing amino acids, vitamins, salts and carbohydrates).
Slovenian: Eaglov medij, modificiran po Dulbeccu (DMEM) (ki vsebuje aminokisline, vitamine, soli in ogljikove hidrate).
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
Slovenian: Uporaba fibrinskega lepila na okvarjeni ploskvi namesto na šivih za pritrditev vsadka je imela za posledico splošen slab rezultat, ki kaže, da je potreben neposreden stik vsajenih celic z okvarjeno ploskvijo.
English: Autonomic neuropathy, Complex regional pain syndrome,
Slovenian: Bolezni živčevja avtonomna nevropatija, sindrom kompleksne regionalne bolečine, bolečine v udu,
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.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji.
English: • The femoral condyle is the end of the thigh bone, which forms part of your knee.
Slovenian: • Femoralni kondil je konec stegenske kosti, ki tvori del kolena.
English: This is the case if the biopsy is of insufficient quality to make ChondroCelect, or in some instances, it may be the cells cannot be grown in the laboratory or that the cells after expansion do not meet all the quality requirements Your surgeon will be informed and might have to select an alternative treatment for you.
Slovenian: To se zgodi v primeru, če je biopt nezadostne kakovosti, da bi izdelali zdravilo ChondroCelect, v nekaterih primerih pa se lahko zgodi, da celic ni mogoče vzgojiti v laboratoriju ali da celice po ekspanziji ne izpolnjujejo vseh kakovostnih predpisov.