FrancophonIA/ELRC3.0 huggingface dataset:
English: The subchondral plate should not be damaged.
Slovenian: Subhondralna plošča ne sme biti poškodovana.
English: Remaining spheroids must not be stored for later application.
Slovenian: Preostali sferoidi ne smejo biti shranjeni za nadaljnjo uporabo.
English: Additional statistical assessments were performed 24 and 36 months after treatment.
Slovenian: Dodatni statistični oceni sta bili opravljeni 24 in 36 mesecev po zdravljenju.
English: In general, these side effects are quite mild and disappear during the weeks following surgery.
Slovenian: Na splošno so precej blagi in v tednih po operaciji izginejo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10th July 2017
Slovenian: Datum prve odobritve: 10. julij 2017
English: Summary of safety profile
Slovenian: Povzetek varnostnega profila
English: • If you have any further questions, ask your doctor.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom.
English: Also it needs to be checked if the correct order number (lot number) is on the primary package.
Slovenian: Preveriti je treba tudi, ali je na primarni ovojnini pravilna številka naročila (številka serije).
English: • Specific testing and examination of the patient to ensure compliance with strictly defined clinical criteria
Slovenian: • bolnika je treba posebej testirati in pregledati, da je zagotovljena skladnost s strogo opredeljenimi kliničnimi merili,
English: The intention-to-treat (ITT) population consisted of 73 patients.
Slovenian: Populacija z namenom zdravljenja (ITT-intention-to-treat) je bila sestavljena iz 73 bolnikov.
English: Tell your doctor if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: How quickly this occurs depends for example on your body weight and the size of the cartilage defect.
Slovenian: Kako hitro se bo to zgodilo, je odvisno, na primer, od vaše telesne mase in velikosti poškodbe hrustanca.
English: Patients treated with Spherox have to undergo a specific rehabilitation program (see section 4.4).
Slovenian: Bolniki, zdravljeni z zdravilom Spherox, morajo opraviti poseben rehabilitacijski program (glejte poglavje 4.4).
English: 01-Mar-2021
Slovenian: 1. marec 2021
English: Store at temperatures between 1 °C and 10 °C.
Slovenian: Shranjujte pri temperaturi med 1 °C in 10 °C.
English: Information on adverse reactions in 177 patients from pivotal clinical trials are available.
Slovenian: Na voljo so informacije o neželenih učinkih pri 177 bolnikih iz osrednjih kliničnih preskušanj.
English: The spheroids look like small white to yellowish pearls.
Slovenian: Sferoidi so videti kot majhni beli do rumenkasti biseri.
English: Rehabilitation
Slovenian: Rehabilitacija
English: In absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
English: These defects can be caused by acute injury, such as a fall.
Slovenian: Te poškodbe lahko nastanejo zaradi akutne poškodbe, npr. padca.
English: During the rehabilitation period, the amount of weight you can put on the joint will increase gradually.
Slovenian: V rehabilitacijskem obdobju bo masa, s katero obremenite sklep, postopno naraščala.
English: Therefore, patients should consult their treating physician and follow his/her advice strictly.
Slovenian: Zato se morajo bolniki posvetovati s svojim lečečim zdravnikom in strogo upoštevati njegove nasvete.
English: ICRS grades were mostly IV A, followed by IIIB and IIIA (56, 23 and 10 patients respectively).
Slovenian: Stopnja po ICRS je bila v glavnem IV A, ki sta ji sledili IIIB in IIIA (56, 23 oziroma 10 bolnikov).
English: It protects the bones and allows our joints to work smoothly.
Slovenian: Ščiti kosti in omogoča brezhibno delovanje sklepov.
English: • Patients with not fully closed epiphyseal growth plate in the affected joint.
Slovenian: • Bolniki, pri katerih epifizealna rastna plošča v prizadetem sklepu ni popolnoma zaprta.
English: They can also be caused by repetitive injury, such as long-term incorrect weight bearing on the joint.
Slovenian: Lahko jih povzročijo tudi ponavljajoče se poškodbe, kot je dolgoročna nepravilna obremenitev sklepa.
English: In order to allow your joint to recover well, you will have to follow an individual rehabilitation program.
Slovenian: Da bo vaš sklep dobro okreval, boste morali izvajati individualni rehabilitacijski program.
English: Read all of this leaflet carefully before you are given with this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: • Training materials for surgeons and training materials for other health professionals
Slovenian: • gradivo za usposabljanje kirurgov in gradivo za usposabljanje drugih zdravstvenih delavcev,
English: A complete graft delamination is a serious complication which can be accompanied by pain.
Slovenian: Popolna delaminacija presadka je resen zaplet, ki ga lahko spremlja bolečina.
English: • the bones in the joint have not finished growing
Slovenian: • kosti v sklepu še niso nehale rasti;
English: In cases where the recommended dose was significantly exceeded (up to 170 spheroids/cm² in an investigator-initiated trial with a follow-up period of 12 months), no negative effects were observed.
Slovenian: V primerih, pri katerih je bil priporočeni odmerek znatno presežen (do 170 sferoidov/cm² pri preskušanju na pobudo raziskovalca z obdobjem spremljanja 12 mesecev), neželeni učinki niso bili opaženi.
English: After implantation, the patient should follow an appropriate rehabilitation schedule.
Slovenian: Po vsaditvi mora bolnik slediti ustreznemu časovnemu načrtu rehabilitacije.
English: None of the patients had received prior treatment with microfracture for their lesion less than one year before screening.
Slovenian: Pri nobenem od bolnikov lezije prej niso bile zdravljene z mikrofrakturiranjem manj kot eno leto pred presejanjem.
English: Further follow-up assessments of up to 5 years will be performed to generate long-term efficacy data on the treatment with Spherox.
Slovenian: Nadaljnja ocena za do 5-letno spremljanje bo opravljena za pridobitev dolgoročnih podatkov o učinkovitosti zdravljenja z zdravilom Spherox.
English: Side effects can occur with the following frequencies: Very common: may affect more than 1 in 10 people
Slovenian: Neželeni učinki se lahko pojavijo z naslednjo pogostnostjo: zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov
English: This suggests that there are no risks for the use of spheroids in humans.
Slovenian: To kaže, da pri uporabi sferoidov pri človeku ni tveganj.
English: Risk factors are in particular non-treatment of concomitant diseases, such as subchondral bone oedema.
Slovenian: Dejavnik tveganja je zlasti nezdravljenje sočasnih bolezni, kot je edem subhondralne kosti.
English: Prior to use, it must be verified if patient name matches the information of the patient/donor provided on the shipping documents and the product label.
Slovenian: Pred uporabo je treba preveriti, ali se ime bolnika ujema z informacijami o bolniku/darovalcu, navedenimi v odpremnih dokumentih in ovojnini zdravila.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Syringe: EXP {DD month YYYY} at {hours} CET
Slovenian: EXP {DD mesec LLLL} ob {čas} CET
English: Pivotal efficacy data were based on an interim analysis at 12 months after treatment.
Slovenian: Osrednji podatki o učinkovitosti temeljijo na vmesni analizi 12 mesecev po zdravljenju.
English: • The other ingredient is sodium chloride used as transport solution.
Slovenian: • Druga sestavina zdravila je natrijev klorid, uporabljen kot transportna raztopina.
English: Changes within each dose group were of similar magnitude, and the three between-group (pairwise) analyses did not reveal any statistically significant differences between the groups.
Slovenian: Spremembe znotraj posamezne skupine odmerkov so bile po velikosti podobne, v treh analizah med skupinami (parno) pa ni bilo odkritih nobenih statistično pomembnih razlik med skupinami.
English: This can occur because the sample taken is not of sufficient quality to manufacture the product.
Slovenian: Do tega lahko pride, če odvzeti vzorec ni dovolj kakovosten za proizvodnjo zdravila.
English: To be submitted annually Final study report:
Slovenian: Končno poročilo o študiji:
English: You may in that case notice symptoms, for example swelling or pain of the tissues around the joint.
Slovenian: V tem primeru lahko opazite simptome, kot so na primer oteklina ali bolečine tkiva okoli sklepa.
English: Post-authorisation efficacy study (PAES): 60-month follow-up data for study cod 16 HS 13.
Slovenian: Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): kontrolni podatki za obdobje 60 mesecev za študijo z oznako 16 HS 13.
English: • Infection with the hepatitits B virus (HBV), hepatitis C virus (HCV) or HIV I/II viruses.
Slovenian: • Okužba z virusom hepatitisa B (HBV), virusom hepatitisa C (HCV) ali virusom HIV I/II.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom,
English: 4.6 Fertility, pregnancy and lactation
Slovenian: 4.6 Plodnost, nosečnost in dojenje Nosečnost in dojenje
English: • reopening of a closed wound
Slovenian: • odprtje zaprte rane;
English: The total MOCART scores 3, 12, 18, 24 and 36 months after treatment did not differ substantially between the two treatment groups.
Slovenian: Skupne vrednosti MOCART 3, 12, 18, 24 in 36 mesecev po zdravljenju se med zdravljenima skupinama niso bistveno razlikovale.
English: (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
Slovenian: občasni (od ≥ 1/1 000 do < 1/100), redki (od ≥ 1/10 000 do < 1/1 000), zelo redki (< 1/10 000) in neznana pogostnost (iz razpoložljivih podatkov je ni mogoče oceniti).
English: Furthermore, a multicentre, prospective, randomised, controlled clinical Phase III study is ongoing.
Slovenian: Nadalje poteka multicentrična prospektivna randomizirana kontrolirana klinična študija III. faze.
English: Compliance with an adequate rehabilitation programme after implantation (especially for patients with mental disorders or addiction) should be warranted.
Slovenian: Po vsaditvi je treba zagotoviti skladnost z ustreznim rehabilitacijskim programom (še posebej pri bolnikih z duševnimi motnjami ali zasvojenostjo).
English: Interim reports:
Slovenian: Vmesna poročila:
English: The following requirements need to be fulfilled before the product is prescribed and dispensed:
Slovenian: Pred predpisovanjem in izdajanjem zdravila je treba izpolniti naslednje zahteve:
English: The main objectives of the educational programme are to provide training to surgeons and other health professionals on proper procurement, storage, handling and administration of Spherox.
Slovenian: Glavni cilj izobraževalnega programa je zagotavljanje usposabljanja kirurgov in drugih zdravstvenih delavcev o pravilnem naročanju, shranjevanju in dajanju zdravila Spherox ter ravnanju z njim.
English: It must be administered by a specialised orthopedic surgeon and in a medical facility.
Slovenian: Dajati ga mora specialist ortopedski kirurg in v zdravstveni ustanovi.
English: Spheroids should be applied evenly on the defect ground and, if necessary, spread over the whole defect area by means of surgical instruments.
Slovenian: Sferoidi morajo biti na površino poškodbe naneseni enakomerno in po potrebi po vsem območju poškodbe razmazani s kirurškimi instrumenti.
English: The treatment of adults with Spherox is a two-step procedure:
Slovenian: Zdravljenje odraslih z zdravilom Spherox poteka v dveh korakih:
English: 2.2 Qualitative and quantitative composition
Slovenian: 2.2 Kakovostna in količinska sestava
English: No suspicion of potential tumourigenesis or increased prevalence of tumours due to the implanted spheroids was observed.
Slovenian: Opažen ni bil noben sum morebitne tumorogeneze ali povečane prevalence tumorjev zaradi implantiranih sferoidov.
English: If you get any of the following serious side effects, you should immediately contact a doctor:
Slovenian: Če opazite katerega koli od naslednji hudih neželenih učinkov, se takoj posvetujte z zdravnikom:
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Spherox is an autologous medicinal product and must not be given to any other patient than the donor.
Slovenian: Zdravilo Spherox je avtologno zdravilo in se ne sme dajati nobenemu drugemu bolniku razen darovalcu.
English: Physical activity should be resumed as recommended by the physician.
Slovenian: S telesno dejavnostjo mora bolnik začeti tako, kot priporoča zdravnik.
English: The spheroids self-adhere within 20 minutes onto the defect ground.
Slovenian: Sferoidi se po 20 minutah samodejno prilepijo na površino poškodbe.
English: • pain of the front knee or kneecap
Slovenian: • bolečina sprednjega dela kolena ali pogačice;
English: Cartilage tissue is present in every joint as a hard smooth layer on the surface of bone ends.
Slovenian: Hrustančno tkivo je prisotno v vsakem sklepu kot trda gladka plast na površini konca kosti.
English: If Spherox is appropriate for you, the doctor takes a small cartilage sample from your joint.
Slovenian: Če je zdravilo Spherox za vas primerno, zdravnik odvzame majhen vzorec hrustanca iz vašega sklepa.
English: Any unused product or waste material should be disposed in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: Afterwards, the surgical wound can be closed without any additional cover of the treated area (e.g. periosteal flap), or any fixation of spheroids by using fibrin glue.
Slovenian: Potem je mogoče kirurško rano zapreti brez dodatnega pokrivanja zdravljenega območja (npr. periostalnega režnja) in brez kakršnega koli fiksiranja sferoidov s fibrinskim lepilom.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študij medsebojnega delovanja niso izvedli.
English: For intraarticular use.
Slovenian: Za intraartikularno uporabo
English: No signs of inflammation, synovitis, infections, rejection, hypertrophy or immune toxicity, tumourigenicity or biodistribution were observed.
Slovenian: Opaženih ni bilo nobenih znakov vnetja, sinovitisa, okužb, zavrnitve, hipertrofije ali imunske toksičnosti ter tumorogenosti ali biološke porazdelitve.
English: The applicator is delivered with an application device (sterile injection syringe).
Slovenian: Aplikator je dobavljen z napravo za aplikacijo (sterilno injekcijsko brizgo).
English: • you are infected with HIV (the virus that causes AIDS), hepatitits B virus or with hepatitis C
Slovenian: • če ste okuženi z virusom HIV (virusom, ki povzroča AIDS), virusom hepatitisa B ali virusom hepatitisa C.
English: The treatment of defect sizes up to 10 cm2 is eligible for single as well as adjacent defects (combined area).
Slovenian: Zdravljenje poškodb velikosti do 10 cm2 je upravičeno za posamične in sosednje poškodbe (združeno območje).
English: The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora prvo PSUR za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
English: Mainly, patients were treated with cartilage defects in knee.
Slovenian: Večinoma so bili zdravljeni bolniki s poškodbami hrustanca v kolenu.
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov izdelovalca biološke učinkovine
English: This is usually done as keyhole surgery through very small incisions (cuts), using a special instrument to look inside the knee (arthroscopy).
Slovenian: To je običajno opravljeno z endoskopsko operacijo, ki poteka prek zelo majhnih incizij (rezov) s posebnim instrumentom za pogled v notranjost kolena (z artroskopijo).
English: Visit 1: Evaluation of the cartilage defect, sample and blood taking
Slovenian: Prvi obisk: ocena poškodbe hrustanca, odvzem vzorca in krvi
English: Follow the rehabilitation program, strictly, after implantation.
Slovenian: Rehabilitacijski program Po vsaditvi strogo upoštevajte rehabilitacijski program.
English: Further patient scores, e.g. the International Knee Documentation Committee (IKDC; subjective evaluation of the knee) and the Lysholm score showed after 12, 24, 36, 48 and 60 months also a significant improvement in comparison to the value before treatment.
Slovenian: Drugi vprašalniki za bolnike, npr. vprašalnik mednarodnega odbora za dokumentacijo kolenskega sklepa (IKDC - International Knee Documentation Committee, namenjen subjektivni oceni kolena) in vprašalnik po Lysholmu, so po 12, 24, 36, 48 in 60 mesecih prav tako pokazali znatno izboljšanje v primerjavi z vrednostmi pred zdravljenjem.
English: Patients with local inflammations or acute as well as recent bone or joint infections should be temporarily deferred until the recovery from the infection is documented.
Slovenian: Previdnostni ukrepi Zdravljenje bolnikov z lokalnim vnetjem ali akutnimi in nedavnimi okužbami kosti ali sklepov je treba začasno odložiti, dokler ni dokazano, da je okužba ozdravljena.
English: Spherox is not recommended in children or adolescents below 18 years.
Slovenian: Zdravilo Spherox ni priporočljivo za otroke ali mladostnike, stare manj kot 18 let.
English: Very important: Carefully comply with the recommendations of your doctor and physical therapist.
Slovenian: Zelo pomembno: Priporočila svojega zdravnika ali fizioterapevta skrbno upoštevajte.
English: Be very careful when bending and putting weight on your treated joint.
Slovenian: Pri upogibanju in obremenjevanju zdravljenega sklepa bodite zelo previdni.
English: There are no data on possible effects of Spherox treatment on fertility.
Slovenian: Podatkov o možnih učinkih zdravljenja z zdravilom Spherox na plodnost pri človeku ni.
English: Twenty-five patients were treated with 10-30 spheroids/cm² defect, 25 with 40-70 spheroids/cm² defect and 25 with 3-7 spheroids/cm² defect.
Slovenian: Petindvajset bolnikov je bilo zdravljenih z 1030 sferoidi/cm² poškodbe, 25 s 40-70 sferoidi/cm² poškodbe in 25 s 3-7 sferoidi/cm² poškodbe.
English: Spherox can only be implanted by a specialist doctor in a medical facility and must only be used in the patient for whom it has been prepared.
Slovenian: Zdravilo Spherox lahko vsadi le zdravnik specialist v zdravstveni ustanovi in je lahko uporabljeno le za bolnika, za katerega je pripravljeno.
English: Store between 1 °C and 10 °C, do not freeze, do not irradiate, do not open the outer packaging before use to prevent microbial contamination.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi med 1 °C in 10 °C, ne zamrzujte, ne obsevajte, ne odpirajte zunanje ovojnine pred uporabo, da preprečite okužbe z mikrobi.
English: Adverse reactions related to the surgical procedure:
Slovenian: Neželeni učinki, povezani s kirurškim postopkom:
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.
Slovenian: • ukrepe za zagotavljanje sledljivosti zdravila in zagotovilo o prepoznavanju: podatkov o bolniku; diagnoze, ki je vzrok za zdravljenje; informacij o biopsiji, vključno z datumom operacije; neželenih učinkov, o katerih so poročali med postopkom, in kakovostjo biopsije; informacij o implantatu, vključno z vsemi kontrolami med postopkom in kontrolami končnega zdravila.
English: The surgical procedure will have a major influence on your ability to drive and use machines.
Slovenian: Kirurški poseg bo pomembno vplival na vašo sposobnost vožnje in upravljanja strojev.
English: Your doctor or physical therapist will advise you.
Slovenian: Svetoval vam bo vaš zdravnik ali fizioterapevt.
English: The objective of the study is to compare the efficacy and safety of the treatment of cartilage defects (1 to less than 4 cm2) at the femoral condyle of the knee joint with Spherox and microfracture treatment over a period of 5 years.
Slovenian: Cilj študije je primerjava učinkovitosti in varnosti zdravljenja poškodb hrustanca (velikosti od 1 do manj kot 4 cm2) na femoralnem kondilu kolenskega sklepa z zdravilom Spherox in zdravljenja takih poškodb z mikrofrakturiranjem v obdobju 5 let.
English: Even if the cartilage sample has already been taken, it may happen that you cannot be treated with Spherox.
Slovenian: Tudi če je bil vzorec hrustanca že odvzet, se lahko zgodi, da ne boste mogli biti zdravljeni z zdravilom Spherox.
English: The assessment of the ‘overall KOOS' for the ITT population showed that both treatments yielded a statistically significant improvement relative to baseline (day before arthroscopy).
Slovenian: Ocena „skupne vrednosti KOOS“ za populacijo ITT je pokazala, da je bilo glede na izhodišče (dan pred artroskopijo) pri obeh zdravljenjih doseženo statistično pomembno izboljšanje.
English: A GLP-compliant examination of biodistribution and tumourigenicity in NSG mice showed no signs of biodistribution and/or migration from implanted human spheroids.
Slovenian: Pregled biološke porazdelitve in tumorogenosti v skladu z dobro laboratorijsko prakso pri NSG miših ni pokazal nobenih znakov biološke porazdelitve in/ali migracije iz implantiranih humanih sferoidov.
English: What you need to know before you are given Spherox 3.
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Spherox 3.
English: Strictly follow the advice of your doctor or physical therapist.
Slovenian: Strogo upoštevajte nasvet vašega zdravnika ali fizioterapevta.
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.
Slovenian: Podvrednosti IKDC in rezultati obrazca IKDC za trenutno oceno zdravja (Current Health Assessment Form) ter prilagojena vrednost po Lysholmu so pri obeh skupinah zdravljenja tudi pokazali skupno izboljšanje v primerjavi z izhodiščem, pri čemer so bili rezultati nekoliko boljši v skupini zdravljenja z zdravilom Spherox, vendar razlika ni bila statistično pomembna.
English: Do not use Spherox if
Slovenian: Zdravila Spherox ne uporabljajte, če
English: They are then expected to repair the defect with healthy and functional cartilage over time.
Slovenian: Pričakuje se, da bodo z zdravim in funkcionalnim hrustancem sčasoma popravili poškodbo.
English: They are transported in a clear colourless solution.
Slovenian: Transportirani so v bistri brezbarvni raztopini.
English: The mean patient age was 34 years (range 19 to 48 years) with a mean body mass index (BMI) of 25.2.
Slovenian: Povprečna starost bolnikov je znašala 34 let (v razponu od 19 do 48 let), povprečni indeks njihove telesne mase (BMI) pa 25,2.