FrancophonIA/ELRC3.0 huggingface dataset:
English: Autologous chondrocyte implantation (ACI) is based on the extraction of the patient's own chondrocytes isolated from healthy cartilage, their culture in vitro and their subsequent implantation into the cartilage defect.
Croatian: Implantacija autolognih hondrocita (ACI) temelji se na ekstrakciji hondrocita samog bolesnika izoliranih iz zdrave hrskavice, njihovu kultiviranju in vitro i naknadnoj implantaciji na oštećenu hrskavicu.
English: IKDC subscores as well as results from the IKDC Current Health Assessment Form and the modified Lysholm score also revealed overall improvements from baseline in both treatment groups with numerically slightly better results in the Spherox group but with no statistical significance.
Croatian: Pojedinačni rezultati prema IKDC-u te rezultati na temelju obrasca IKDC-a za procjenu zdravstvenog stanja (IKDC Current Health Assessment Form) i modificirani rezultati prema Lysholmovoj ljestvici također su pokazali ukupna poboljšanja u objema liječenim skupinama u odnosu na početne vrijednosti, uz numerički neznatno bolje rezultate u skupini liječenoj lijekom Spherox, koji statistički nisu značajni.
English: • blood clot in a deep vein (symptoms: e.g. swelling, pain, increased warmth in the affected area)
Croatian: • krvni ugrušak u dubokoj veni (simptomi: npr. oticanje, bol, pojačana toplina u zahvaćenom području)
English: Adverse reactions related to the surgical procedure:
Croatian: Nuspojave povezane s kirurškim zahvatom:
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena ispitivanja interakcija.
English: Spherox is delivered to the doctor in a container ready for application.
Croatian: Spherox se liječniku dostavlja u spremniku spremnom za primjenu.
English: 14513 Teltow, Germany Tel.: +49 3328 43460 Fax: +49 3328 434643 E-mail: info@codon.de
Croatian: +49 (0)3328 43 46 0, Fax: +49 (0)3328 43 46 43, E-mail: info@codon.de
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Croatian: Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
English: • swelling due to obstructed flow of tissue fluid via the lymph vessels
Croatian: • oticanje zbog ometenog protoka tekućine u tkivu putem limfnih žila
English: Also, during the rehabilitation period, the ability to drive and use machines may be restricted due to reduced mobility.
Croatian: sposobnost upravljanja vozilima i strojevima može biti ograničena u razdoblju rehabilitacije zbog smanjene pokretljivosti.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom planu upravljanja rizikom (RMP), koji se nalazi u modulu 1.8.2
English: The treatment of defect sizes up to 10 cm2 is eligible for single as well as adjacent defects (combined area).
Croatian: Liječenje oštećenja do 10 cm2 prikladno je za pojedinačna te za priliježuća oštećenja (kombinirano područje).
English: No clinical data on exposed pregnancies are available for autologous chondrocytes or spheroids from autologous chondrocytes.
Croatian: Ne postoje dostupni klinički podaci o utjecaju na trudnoću za autologne hondrocite ili sferoide iz autolognih hondrocita.
English: • Forms for documentation
Croatian: • obrascima za dokumentaciju.
English: In case of syringe as primary packaging unit: 1 syringe containing {Number of Spheroids} spheroids in a sterile tube
Croatian: Ako je štrcaljka primarno pakiranje: 1 štrcaljka sadrži {broj sferoida} sferoida u sterilnoj tubi
English: Be very careful when bending and putting weight on your treated joint.
Croatian: Budite pažljivi prilikom saginjanja i opterećivanja liječenog zgloba.
English: Resuming vigorous activity too soon may reduce the benefit and durability of Spherox.
Croatian: Prerano vraćanje intenzivnoj aktivnosti može umanjiti koristi i dugotrajnost učinaka lijeka Spherox.
English: Spherox contains so-called spheroids that consist of living cartilage cells with a non-cellular portion for the repair of cartilage defects.
Croatian: Spherox sadrži takozvane sferoide koji se sastoje od živućih stanica hrskavice s nestaničnim dijelom za popravak oštećenja hrskavice.
English: • Measures to ensure the traceability of the product and guarantee the identification of: patient data; diagnosis leading to the treatment; information on biopsy including date of the operation, adverse events reported during the procedure and quality of the biopsy; information on the implant, including all in-process controls and final product controls.
Croatian: • mjere kojima se osigurava sljedivost lijeka i jamči utvrđivanje: podataka o bolesniku, dijagnoze nakon koje je došlo do liječenja, informacija o biopsiji, uključujući datum operacije, štetnih događaja zabilježenih tijekom postupka i kvalitete biopsije, podataka o implantatu, uključujući sve kontrole tijekom postupka i kontrole konačnog proizvoda.
English: The spheroids are provided in a pre-filled syringe or an applicator (stem length 150 mm (co.fix 150)).
Croatian: Sferoidi su dostupni u napunjenoj štrcaljki ili aplikatoru (dužina cjevčice 150 mm („co.fix 150”)).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT {Number of spheroids} sph
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA {broj sferoida} sph
English: PARTICULARS TO APPEAR ON THE SECONDARY PACKAGING Tube
Croatian: PODACI KOJE MORA SADRŽAVATI SEKUNDARNO PAKIRANJE Tuba
English: Do not open the outer packaging before use to prevent microbial contamination.
Croatian: Kako bi se spriječila mikrobiološka kontaminacija, nemojte otvarati vanjsko pakiranje prije uporabe.
English: In order to allow your joint to recover well, you will have to follow an individual rehabilitation program.
Croatian: Kako bi se vaš zglob dobro oporavio, trebate slijediti program rehabilitacije prilagođen za vas osobno.
English: In case of application system co.fix 150 mm as primary packaging unit: EU/1/17/1181/001
Croatian: Ako je sustav za primjenu „co.fix 150 mm”, primarno pakiranje: EU/1/17/1181/001
English: As Spherox is used to repair cartilage defects of the joint and is therefore implanted during a surgical procedure, it is not recommended for use in pregnant or breast-feeding women.
Croatian: Budući da se lijek Spherox primjenjuje za popravak oštećenja hrskavice zgloba i da se stoga implantira tijekom kirurškog zahvata, ne preporučuje se za primjenu u trudnica niti dojilja.
English: Ex vivo produced spheroids were implanted in mice (subcutaneous implantation of cartilage explants with human spheroids) or in minipigs (autologous spheroids implanted in cartilage defects).
Croatian: Ex vivo proizvedeni sferoidi implantirani su u miševe (potkožna implantacija eksplantata hrskavice s humanim sferoidima) ili patuljaste svinje (autologni sferoidi implantirani u oštećenja hrskavice).
English: The safety and efficacy of Spherox in patients with cartilage defects outside the femoral condyle and the patella of the knee have not been established.
Croatian: Sigurnost i djelotvornost lijeka Spherox u bolesnika s oštećenjima hrskavice izvan područja femoralnog kondila i patele koljena još nisu ustanovljene.
English: Mainly, patients were treated with cartilage defects in knee.
Croatian: Bolesnici su uglavnom liječeni zbog oštećenja hrskavice u koljenu.
English: One applicator has a maximum capacity of 60 spheroids in a volume of up to 200 microlitre isotonic sodium chloride solution.
Croatian: Jedan aplikator ima kapacitet za najviše 60 sferoida u volumenu do 200 mikrolitara izotonične otopine natrijeva klorida.
English: The container may be a syringe or a special application system called co.fix that is a catheter with a stem length of 150 mm.
Croatian: Spremnik može biti štrcaljka ili poseban sustav za primjenu zvani „co.fix”koji je kateter s dužinom cjevčice od 150 mm.
English: The number of primary packaging units delivered depends on the type of the primary packaging unit and the number of spheroids necessary for the specific defect size (10-70 spheroids/cm²).
Croatian: Broj dostavljenih primarnih pakiranja ovisi o vrsti primarnog pakiranja i broju sferoida potrebnih za određenu veličinu oštećenja (10-70 sferoida/cm²).
English: A debridement of the defect area is required.
Croatian: Potreban je debridman oštećenog područja.
English: No signs of inflammation, synovitis, infections, rejection, hypertrophy or immune toxicity, tumourigenicity or biodistribution were observed.
Croatian: Nisu zapaženi znakovi upale, sinovitisa, infekcija, odbijanja, hipertrofije ili toksičnosti za imunološki sustav,
English: A spheroid looks like a tiny pearl made of cartilage cells and cartilage material derived from your own body.
Croatian: Sferoid izgleda kao sitni biser sačinjen od stanica hrskavice i materijala hrskavice izvađenih iz vašeg tijela.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalost nuspojava prikazana je redoslijedom prema sve manjoj ozbiljnosti.
English: The implantation must be performed during a surgical procedure (preferably an arthroscopy or miniarthrotomy).
Croatian: Implantacija se mora obaviti tijekom kirurškog zahvata (poželjno tijekom artroskopije ili mini artrotomije).
English: Spherox is used to repair cartilage defects of knee in adults.
Croatian: Spherox se primjenjuje za popravak oštećenja hrskavice koljena u odraslih osoba.
English: Cases in which Spherox cannot be supplied
Croatian: Slučajevi u kojima se Spherox ne može primijeniti
English: One pre-filled syringe has a maximum capacity of 100 spheroids in a volume of up to 1000 microlitre isotonic sodium chloride solution.
Croatian: Jedna napunjena štrcaljka ima kapacitet za najviše 100 sferoida u volumenu do 1000 mikrolitara izotonične otopine natrijeva klorida.
English: To be submitted annually Final study report:
Croatian: Konačno izvješće o ispitivanju:
English: A tube may contain a maximum of two co.fix 150.
Croatian: Tuba može sadržavati najviše dva aplikatora „co.fix 150”.
English: Chondromalacia, Osteochondrosis, Osteonecrosis, Extraskeletal ossification
Croatian: Hondromalacija Osteohondroza Osteonekroza Ekstraskeletalna osifikacija
English: Graft delamination describes the partial or complete detachment of the formed tissue from the subchondral bone and the surrounding cartilage.
Croatian: Delaminacija presatka je djelomično ili potpuno odvajanje oblikovanog tkiva od subhondralne kosti i okolne hrskavice.
English: Spherox is not recommended for pregnant or breast-feeding women, as it is applied during surgery.
Croatian: Primjena lijeka Spherox ne preporučuje se u trudnica ili dojilja jer se primjenjuje tijekom kirurškog zahvata.
English: The following requirements need to be fulfilled before the product is prescribed and dispensed:
Croatian: Prije propisivanja i izdavanja lijeka moraju se ispuniti sljedeći uvjeti:
English: Due to the nature and intended clinical use of Spherox, conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Croatian: 5.2 Farmakokinetička svojstva Zbog prirode i namijenjene kliničke primjene lijeka Spherox, konvencionalna ispitivanja farmakokinetike, apsorpcije, raspodjele, metabolizma i eliminacije nisu primjenjiva.
English: In order to evaluate the long-term efficacy and safety of Spherox vs. microfracture in patients with cartilage defects of the knee with a defect size between 1 and < 4 cm2, the MAH should conduct and submit the results of the ongoing prospective, randomised, open label, multicentre study.
Croatian: Kako bi se ocijenila dugoročna djelotvornost i sigurnost lijeka Spherox u usporedbi s mikrofrakturama u bolesnika s oštećenjima hrskavice koljena gdje je veličina oštećenja između 1 i ˂4 cm2, nositelj odobrenja za stavljanje lijeka u promet treba provesti i dostaviti rezultate randomiziranog, otvorenog, multicentričnog ispitivanja koje je u tijeku.
English: Spheroids are spherical aggregates of ex vivo expanded human autologous chondrocytes and selfsynthesized extracellular matrix.
Croatian: Sferoidi su sferični agregati ex vivo proširenih ljudskih autolognih hondrocita i izvanstanične matrice koju su sami sintetizirali.
English: Follow the rehabilitation program, strictly, after implantation.
Croatian: Nakon implantacije strogo slijedite program rehabilitacije.
English: Spherox is used to treat defects up to 10 cm² in size.
Croatian: Spherox se primjenjuje za liječenje oštećenja veličine do 10 cm².
English: Physical activity should be resumed as recommended by the physician.
Croatian: Vraćanje fizičkoj aktivnosti dozvoljeno je prema preporuci liječnika.
English: Too early and vigorous activity may compromise the grafting and the durability of clinical benefit from Spherox.
Croatian: Prerana i intenzivna aktivnost može ugroziti ishod transplantacije i dugotrajnost kliničke koristi lijeka Spherox.
English: • you have advanced joint and bone inflammation with degeneration in the affected joint
Croatian: • imate uznapredovalu upalu zgloba i kostiju s degeneracijom u zahvaćenom zglobu
English: In case of syringe as primary packaging unit: EU/1/17/1181/002
Croatian: Ako je štrcaljka, primarno pakiranje: EU/1/17/1181/002
English: All parts of the pre-filled syringe are made of polypropylene, the sealing ring of isoprene.
Croatian: Svi dijelovi napunjene štrcaljke izrađeni su od polipropilena, a brtveni prsten od izoprena.
English: The pre-filled syringe consists of a luer lock, a sealing ring and a cover cap.
Croatian: Napunjena štrcaljka sastoji se od luer-lock spojnice, brtvenog prstena i pokrovnog čepa.
English: Application system co.fix 150 mm or
Croatian: Sustav za primjenu „co.fix 150 mm” ili
English: ICRS grades were mostly IV A, followed by IIIB and IIIA (56, 23 and 10 patients respectively).
Croatian: III.B i III.A (kod 56, 23 odnosno 10 bolesnika).
English: The pre-filled syringe is delivered with an application device (indwelling cannula or filter stem).
Croatian: Napunjena štrcaljka dostavlja se s pomagalom za primjenu (kanila za umetanje ili cjevčica s filtrom).
English: Spherox is implanted into the cartilage defect in the joint during the next operation.
Croatian: Spherox se implantira u oštećenje hrskavice u zglobu tijekom sljedeće operacije.
English: Your cartilage cells are extracted from this sample in a laboratory and are then grown to make the spheroids that constitute Spherox.
Croatian: Iz tog se uzorka u laboratoriju izvlače stanice vaše hrskavice koje se potom umnožavaju radi stvaranja sferoida koji čine lijek Spherox.
English: It must be administered by a specialised orthopedic surgeon and in a medical facility.
Croatian: Smije ga primjenjivati samo kirurg specijaliziran za ortopediju i samo u medicinskoj ustanovi.
English: Other joint problems should be corrected before or at the time of Spherox implantation.
Croatian: Potrebno je izliječiti druge probleme sa zglobom prije ili u vrijeme implantacije lijeka Spherox.
English: • impairment of walking
Croatian: • poremećaj hodanja
English: Hypertrophy, Graft delamination
Croatian: Hipertrofija Delaminacija presatka
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN
English: For information on preparation and handling of Spherox, please refer to section 6.6.
Croatian: Za informacije o pripremi i rukovanju lijekom Spherox vidjeti dio 6.6. 4.3 Kontraindikacije
English: • wound-related complication
Croatian: • komplikacije povezane s ranom
English: 10-70 spheroids are applied per square centimetre defect.
Croatian: 10-70 sferoida primjenjuje se po kvadratnom centimetru oštećenja.
English: By surgery the spheroids are implanted to the defected cartilage area and stick to the defect site.
Croatian: Sferoidi se kirurškim zahvatom implantiraju na oštećeno područje hrskavice i nalijepe na mjesto oštećenja.
English: Untreated bone oedema corresponding with the cartilage defect to be treated may adversely affect the success of the procedure.
Croatian: Neliječeni edem kosti na području na kojem se nalazi oštećenje hrskavice koje je potrebno liječiti može štetno utjecati na uspjeh zahvata.
English: During treatment with Spherox surgery-related (implantation) or Spherox-related adverse reactions may occur.
Croatian: Tijekom liječenja lijekom Spherox mogu se javiti nuspojave povezane s kirurškim zahvatom (implantacijom) ili s lijekom Spherox.
English: • The active substance of Spherox are spheroids that consist of cartilage cells and cartilage material derived from your own body.
Croatian: • Djelatne tvari u lijeku Spherox su sferoidi koji se sastoje od stanica hrskavice i materijala hrskavice izvađenih iz vašeg tijela.
English: A GLP-compliant examination of biodistribution and tumourigenicity in NSG mice showed no signs of biodistribution and/or migration from implanted human spheroids.
Croatian: Ispitivanje biodistribucije ili tumorogenosti u laboratorijskih miševa tehnikom sekvencioniranja druge generacije (NSG), usklađeno s dobrom laboratorijskom praksom, pokazalo je da nema znakova biodistribucije ili migracije iz implantiranih humanih sferoida.
English: Each pre-filled syringe or applicator contains a specific number of spheroids according to the defect size (10-70 spheroids/cm2) to be treated.
Croatian: Svaka napunjena štrcaljka ili aplikator sadrži određen broj sferoida sukladno veličini oštećenja (10-70 sferoida/cm2) koje je potrebno liječiti.
English: Application system co.fix 150 mm: EXP {DD month YYYY} at {hours} CET
Croatian: Sustav za primjenu co.fix 150 mm: EXP {DD mjesec GGGG} u {sati} SEV
English: Talk to your doctor before you are given Spherox, if you have any other joint problems or excess weight, as this may reduce the success of the procedure.
Croatian: Ako imate drugih problema sa zglobom ili prekomjernu težinu, obratite se svojem liječniku prije primjene lijeka Spherox jer to može umanjiti uspješnost postupka
English: Prior to launch of Spherox in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the training programme and the controlled distribution programme, including communication media, distribution modalities and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka Spherox u promet u svakoj državi članici, nositelj odobrenja za stavljanje lijeka u promet mora dogovoriti sadržaj i oblik programa obuke i programa kontrolirane distribucije,
English: Spherox should preferably be implanted into an otherwise healthy joint.
Croatian: Poželjno je da se Spherox implantira u inače zdravi zglob.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Pouch
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će prvi PSUR za ovaj lijek dostaviti unutar 6
English: The applicator (stem length 150 mm (co.fix 150)) is packed in a sterile tube and additionally surrounded by an extra bag.
Croatian: Aplikator (dužina cjevčice 150 mm („co.fix 150”)) pakiran je u sterilnu tubu i obložen je dodatnom vrećicom.
English: 2.1 General description
Croatian: 2.1 Opći opis
English: Post-operative haemarthrosis occurs mainly in patients with a predisposition to haemorrhage or poor surgical haemorrhage control.
Croatian: Postoperativna hemartroza uglavnom se javlja u bolesnika s predispozicijom za krvarenje ili u bolesnika u kojih postoji slaba kontrola krvarenja tijekom kirurškog zahvata.
English: The applicator co.fix 150 is packed in a sterile tube and additionally surrounded by an extra bag.
Croatian: Aplikator „co.fix 150” pakira se u sterilnu tubu i obložen je dodatnom vrećicom.
English: Post-authorisation efficacy study (PAES): 60-month follow-up data for study cod 16 HS 13.
Croatian: Ispitivanje djelotvornosti lijeka nakon izdavanja odobrenja za stavljanje lijeka u promet (PAES): podaci iz praćenja tijekom 60 mjeseci za ispitivanje pod kodom
English: • The Prescriber checklist shall contain the following key messages: o Corroboration that the patient receiving the product is the right patient receiving the appropriate product o Confirmation of the appropriate side of the implantation o A reference to the fact that the patient has been informed and understands the benefits and risks of the product and the associated procedures
Croatian: o potvrdu da je bolesnik koji prima lijek ispravan bolesnik i da prima odgovarajući lijek o potvrdu o odgovarajućoj strani na kojoj se obavlja implantacija o potvrdu činjenice da je bolesnik obaviješten i da razumije koristi i rizike od lijeka i s time povezanih postupaka.
English: OTHER For autologous use only.
Croatian: Samo za autolognu primjenu.
English: With regard to the between-group analysis, the treatment with Spherox passed the test of non-inferiority compared with microfracture (Δ of 5.7 with lower bound of CI equal to -1.0 at the 12 months assessment, Δ of 6.1 with lower bound of CI equal to -0.4 at the 24 months assessment, results for KOOS at 36 months were consistent with the earlier time points).
Croatian: U pogledu analize među skupinama, liječenje lijekom Spherox prošlo je test neinferiornosti u usporedbi s mikrofrakturom (Δ od 5,7 s nižom granicom CI-a istovjetnom -1,0 na procjeni za 12 mjeseci, Δ od 6,1 s nižom granicom CI-a istovjetnom -0,4 na procjeni za 24 mjeseci,
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Croatian: Nositelj odobrenja za stavljanje u promet dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere:
English: BATCH NUMBER, DONATION AND PRODUCT CODES Pt Name, Pt ID: {Patient Name}, {Patient ID} Lot {Batch Number}
Croatian: 13. BROJ SERIJE, OZNAKE DONACIJE I PROIZVODA Ime bolesnika, identifikacijska oznaka bolesnika: {ime bolesnika}, {identifikacijska oznaka bolesnika}
English: BATCH NUMBER, DONATION AND PRODUCT CODES {Batch Number}
Croatian: BROJ SERIJE, OZNAKE DONACIJE I PROIZVODA {broj serije}
English: • ligament disorder
Croatian: • poremećaj ligamenata
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1181/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1181/001
English: Common: may affect up to 1 in 10 people
Croatian: Vrlo često: mogu se javiti u više od 1 na 10 osoba
English: • increase in size of the cartilage cells, softening of cartilage, disorder of bone formation, death of bone tissue, bone formation outside the skeleton.
Croatian: • povećanje veličine stanica hrskavice, omekšavanje hrskavice, poremećaj stvaranja kostiju,
English: White to yellowish spheroids of matrix-associated autologous chondrocytes in a clear, colourless solution.
Croatian: Bijeli do žućkasti sferoidi autolognih hondrocita vezanih na matricu, u bistroj, bezbojnoj otopini.
English: Visit 2: Spherox implantation
Croatian: 2. posjet Implantacija lijeka Spherox
English: A symptomatic hypertrophy of the transplant may occur during treatment with Spherox resulting in pain.
Croatian: Tijekom liječenja lijekom Spherox može se javiti simptomatska hipertrofija transplantata koja uzrokuje bol.
English: Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Regeneration & Joint Preservation Society [ICRS] grade III or IV) with defect sizes up to 10 cm2 in adults.
Croatian: Popravak simptomatskih oštećenja zglobne hrskavice femoralnog kondila i patele koljena (stupnja III ili IV prema Međunarodnom društvu za regeneraciju hrskavice i očuvanje zglobova [engl.
English: • accumulation of fluid in the joint
Croatian: • nakupljanje tekućine u zglobu