FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svojeg liječnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
Croatian: rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The spheroids look like small white to yellowish pearls.
Croatian: Sferoidi izgledaju kao mali bijeli do žućkasti biseri.
English: 01-Mar-2021
Croatian: 1. ožujka 2021.
English: • Specific testing and examination of the patient to ensure compliance with strictly defined clinical criteria
Croatian: • posebno testiranje i ispitivanje bolesnika kako bi se zajamčilo da ispunjava strogo određene kliničke kriterije
English: The treatment groups were balanced with respect to size, demography and disease background.
Croatian: Skupine za liječenje bile su uravnotežene s obzirom na veličinu, demografsku sliku i povijest bolesti.
English: OTHER SPECIAL WARNING(S), IF NECESSARY For autologous use only.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Samo za autolognu primjenu.
English: Patients treated with Spherox have to undergo a specific rehabilitation program (see section 4.4).
Croatian: Bolesnici liječeni lijekom Spherox moraju proći poseban program rehabilitacije (vidjeti dio 4.4.).
English: Furthermore, a multicentre, prospective, randomised, controlled clinical Phase III study is ongoing.
Croatian: Nadalje, u tijeku je multicentrično, prospektivno, randomizirano i kontrolirano kliničko ispitivanje faze III.
English: • Risk management plan (RMP)
Croatian: LIJEKA • Plan upravljanja rizikom (RMP)
English: In absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti ovaj lijek ne smije se miješati s drugim lijekovima.
English: Additional statistical assessments were performed 24 and 36 months after treatment.
Croatian: Dodatne statističke procjene bile su provedene 24 i 36 mjeseci nakon liječenja.
English: Rehabilitation program
Croatian: Program rehabilitacije
English: None of the patients had received prior treatment with microfracture for their lesion less than one year before screening.
Croatian: Ni jedan od bolesnika prethodno nije primio liječenje mikrofrakturom za leziju tijekom manje od godinu dana prije probira.
English: The intention-to-treat (ITT) population consisted of 73 patients.
Croatian: Populacija predviđena za liječenje (engl. intention-to-treat, ITT) sastojala se od 73 bolesnika.
English: Interim reports:
Croatian: Interim izvješća:
English: During the rehabilitation period, the amount of weight you can put on the joint will increase gradually.
Croatian: Tijekom razdoblja rehabilitacije, težina kojom možete opteretiti zglob postupno će se povećavati.
English: They are then expected to repair the defect with healthy and functional cartilage over time.
Croatian: Potom se očekuje da s vremenom isprave oštećenje zdravom i funkcionalnom hrskavicom.
English: A complete graft delamination is a serious complication which can be accompanied by pain.
Croatian: Potpuna delaminacija presatka ozbiljna je komplikacija koja može biti popraćena bolovima.
English: Implantation suspension.
Croatian: Suspenzija implantata.
English: The following adverse reactions considered surgery-related have been reported during the course of the clinical trials and/or from spontaneous sources:
Croatian: Sljedeće nuspojave za koje se smatralo da su bile povezane s kirurškim zahvatom, bile su prijavljene tijekom trajanja kliničkih ispitivanja i/ili iz spontanih izvora:
English: For intraarticular use.
Croatian: Za intraartikularnu primjenu.
English: This can occur because the sample taken is not of sufficient quality to manufacture the product.
Croatian: To se može dogoditi u slučaju kada uzorak nije dovoljno kvalitetan za proizvodnju lijeka.
English: Information on adverse reactions in 177 patients from pivotal clinical trials are available.
Croatian: Dostupne su informacije o nuspojavama u 177 bolesnika iz ključnih kliničkih ispitivanja.
English: Lawrence).
Croatian: Lawrenceu).
English: In general, these side effects are quite mild and disappear during the weeks following surgery.
Croatian: Te su nuspojave obično prilično blage i nestaju tijekom nekoliko tjedana nakon kirurškog zahvata.
English: Spheroids should be applied evenly on the defect ground and, if necessary, spread over the whole defect area by means of surgical instruments.
Croatian: Sferoide je potrebno ravnomjerno primijeniti na oštećenu površinu i, ako je potrebno, nanijeti preko cijelog oštećenog područja pomoću kirurških instrumenata.
English: Silicone oil serves as lubricant.
Croatian: Silikonsko ulje služi kao mazivo.
English: Pivotal efficacy data were based on an interim analysis at 12 months after treatment.
Croatian: Ključni podaci o djelotvornosti temeljili su se na interim analizi 12 mjeseci nakon liječenja.
English: Remaining spheroids must not be stored for later application.
Croatian: Preostali sferoidi ne smiju se čuvati za kasniju primjenu.
English: How quickly this occurs depends for example on your body weight and the size of the cartilage defect.
Croatian: Brzina tog postupnog povećanja ovisi, primjerice, o vašoj tjelesnoj težini i veličini oštećenja hrskavice.
English: Driving cars and using machines may be limited during the rehabilitation period.
Croatian: Upravljanje vozilima i strojevima za vas može biti ograničeno u razdoblju rehabilitacije.
English: If the manufacturing of spheroids has failed or if the release criteria are not fulfilled, e.g. due to insufficient biopsy quality, the medicinal product cannot be delivered.
Croatian: Ako je proizvodnja sferoida bila neuspješna ili ako nisu ispunjeni kriteriji za otpremanje, npr. zbog nedostatne kvalitete biopsije, lijek se ne može dostaviti.
English: (osteoarthritis)
Croatian: (osteoartritis).
English: They can also be caused by repetitive injury, such as long-term incorrect weight bearing on the joint.
Croatian: Oštećenja također može uzrokovati ponavljajuća ozljeda, primjerice dugotrajno nepravilno opterećivanje zgloba težinom.
English: Ask your doctor or physical therapist if you have any further questions about treatment with Spherox.
Croatian: Obratite se svojem liječniku ili fizioterapeutu ako imate dodatnih pitanja o liječenju lijekom Spherox.
English: • Infection with the hepatitits B virus (HBV), hepatitis C virus (HCV) or HIV I/II viruses.
Croatian: • Infekcija virusom hepatitisa B (HBV), virusom hepatitisa C (HCV) ili virusima HIV I/II.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10th July 2017
Croatian: Datum prvog odobrenja: 10. srpnja 2017.
English: 1 syringe in a sterile tube
Croatian: 1 štrcaljka u sterilnoj tubi
English: These defects can be caused by acute injury, such as a fall.
Croatian: Oštećenja može uzrokovati akutna ozljeda, primjerice pad.
English: This suggests that there are no risks for the use of spheroids in humans.
Croatian: To ukazuje na to da ne postoje rizici pri primjeni sferoida u ljudi.
English: The spheroids self-adhere within 20 minutes onto the defect ground.
Croatian: Sferoidi sami prianjaju uz oštećenu površinu u roku od 20 minuta.
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.
Croatian: Promjene unutar svake dozne skupine bile su sličnih razmjera i usporedna analiza među skupinama (usporedba parova) nije otkrila nikakve statistički značajne razlike među njima.
English: If you get any of the following serious side effects, you should immediately contact a doctor:
Croatian: Ako primijetite bilo koju od sljedećih teških nuspojava, odmah obavijestite liječnika:
English: 2.2 Qualitative and quantitative composition
Croatian: 2.2 Kvalitativni i kvantitativni sastav
English: There are no data on possible effects of Spherox treatment on fertility.
Croatian: Ne postoje podaci o mogućim učincima liječenja lijekom Spherox na plodnost.
English: If Spherox is appropriate for you, the doctor takes a small cartilage sample from your joint.
Croatian: Ako se lijek Spherox pokaže odgovarajućim za vas, liječnik uzima mali uzorak hrskavice iz vašeg zgloba.
English: Rehabilitation
Croatian: Rehabilitacija
English: Sodium chloride
Croatian: Natrijev klorid
English: Therefore, patients should consult their treating physician and follow his/her advice strictly.
Croatian: Stoga se bolesnici trebaju savjetovati s liječnikom koji ih liječi i strogo slijediti njegove savjete.
English: Spherox consists of so-called spheroids.
Croatian: Spherox se sastoji od takozvanih sferoida.
English: Only resume physical activity when instructed by your doctor.
Croatian: Vratite se fizičkim aktivnostima tek kada vas na to uputi vaš liječnik.
English: Spherox is an autologous medicinal product and must not be given to any other patient than the donor.
Croatian: Spherox je autologni lijek i ne smije se davati drugim bolesnicima osim donatoru.
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.
Croatian: Nakon toga, kirurška se rana može zatvoriti bez dodatnog pokrivanja liječenog područja (npr. periostalnim odignutim režnjem (engl. periosteal flap)) ili učvršćivanja sferoida uporabom fibrinskog ljepila.
English: The treatment of adults with Spherox is a two-step procedure:
Croatian: Liječenje odraslih lijekom Spherox postupak je koji se provodi u dvama koracima:
English: • reopening of a closed wound
Croatian: • ponovno otvaranje rane
English: • you are infected with HIV (the virus that causes AIDS), hepatitits B virus or with hepatitis C
Croatian: • ste zaraženi HIV-om (virus koji uzrokuje AIDS), virusom hepatitisa B ili virusom hepatitisa C
English: In a sheep study, also no biodistribution was observed after injection of spheroids into the knee joint.
Croatian: U ispitivanju na ovcama također nije opažena biodistribucija nakon injektiranja sferoida u zglob koljena.
English: Spherox is not recommended in children or adolescents below 18 years.
Croatian: Primjena lijeka Spherox ne preporučuje se u djece ili adolescenata mlađih od 18 godina.
English: The total MOCART scores 3, 12, 18, 24 and 36 months after treatment did not differ substantially between the two treatment groups.
Croatian: Ukupni rezultati prema sustavu bodovanja MOCART 3, 12, 18, 24 i 36 mjeseca nakon liječenja nisu se znatno razlikovali između dviju liječenih skupina.
English: Locally applied antibiotics or disinfectants may have potential toxicity on articular cartilage and it is not recommended that Spherox comes into direct contact with those substances.
Croatian: Lokalno primijenjeni antibiotici ili sredstva za dezinfekciju mogu biti potencijalno toksični za hrskavicu zgloba i ne preporučuje se da lijek Spherox dođe u izravni kontakt s takvim tvarima.
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.
Croatian: Prije primjene potrebno je provjeriti odgovara li bolesnikovo ime informacijama o bolesniku/donatoru u otpremnim dokumentima i na naljepnici lijeka.
English: No suspicion of potential tumourigenesis or increased prevalence of tumours due to the implanted spheroids was observed.
Croatian: Nije zabilježena suspektnost na moguću tumorogenezu niti povećanu prevalenciju tumora zbog implantiranih sferoida.
English: This is usually done as keyhole surgery through very small incisions (cuts), using a special instrument to look inside the knee (arthroscopy).
Croatian: To se obično čini minimalno invazivnom keyhole operacijom putem vrlo malih incizija (rezova) s pomoću posebnog instrumenta za pregled unutrašnjosti koljena (artroskopija).
English: • The patient should document the receipt and understanding of the information on the product
Croatian: • bolesnik mora potvrditi primitak lijeka i razumijevanje informacija o lijeku;
English: Your doctor or physical therapist will advise you.
Croatian: Savjetovat će vas vaš liječnik ili fizioterapeut.
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.
Croatian: Glavni cilj edukacijskog programa jest pružiti obuku kirurzima i ostalim zdravstvenim radnicima o ispravnoj nabavi, skladištenju, rukovanju i primjeni lijeka Spherox.
English: Compliance with an adequate rehabilitation programme after implantation (especially for patients with mental disorders or addiction) should be warranted.
Croatian: Potrebno je osigurati da se bolesnik pridržava odgovarajućeg programa rehabilitacije nakon implantacije (osobito u bolesnika s mentalnim poremećajima ili ovisnošću).
English: Other medicines and Spherox
Croatian: Drugi lijekovi i Spherox
English: • Training materials for surgeons and training materials for other health professionals
Croatian: • sažetku opisa svojstava lijeka • materijalima za obuku kirurga i materijalima za obuku ostalih zdravstvenih radnika
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.
Croatian: U slučajevima uzimanja znatno veće doze u odnosu na preporučenu (do170 sferoida/cm² u ispitivanju koje je pokrenuo ispitivač, uz razdoblje praćenja od 12 mjeseci) nisu opaženi negativni učinci.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskim stranicama Europske agencije za lijekove: http://www.ema.europa.eu.
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).
Croatian: Procjena ukupnog rezultata prema ljestvici KOOS za populaciju ITT pokazala je da su oba liječenja dovela do statistički značajnog poboljšanja u odnosu na početne vrijednosti (dan prije artroskopije).
English: Further follow-up assessments of up to 5 years will be performed to generate long-term efficacy data on the treatment with Spherox.
Croatian: Provest će se daljnje ocjene tijekom praćenja do 5 godina radi dobivanja podataka o dugoročnoj djelotvornosti liječenja lijekom Spherox.
English: Hypertrophy of the transplant
Croatian: Hipertrofija transplantata
English: The surgical procedure will have a major influence on your ability to drive and use machines.
Croatian: Kirurški postupak imat će velik utjecaj na vašu sposobnost upravljanja vozilima i strojevima.
English: Even if the cartilage sample has already been taken, it may happen that you cannot be treated with Spherox.
Croatian: Čak i kada je liječnik već uzeo uzorak hrskavice, može se dogoditi da ne možete biti liječeni lijekom Spherox.
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.
Croatian: Bolesnicima s lokalnim ili akutnim upalama te nedavnim infekcijama kostiju ili zgloba potrebno je privremeno odgoditi liječenje sve dok se ne zabilježi oporavak od infekcije.
English: This may also be carried out by keyhole surgery.
Croatian: To se također može obaviti minimalno invazivnom keyhole operacijom.
English: Very important: Carefully comply with the recommendations of your doctor and physical therapist.
Croatian: Vrlo važno: Pažljivo slijedite preporuke svojeg liječnika ili fizioterapeuta.
English: The applicator is delivered with an application device (sterile injection syringe).
Croatian: Aplikator dolazi s pomagalom za primjenu (sterilna štrcaljka za injekciju).
English: Side effects appearing after the implantation of Spherox are mostly related to the surgery.
Croatian: Nuspojave koje se pojavljuju nakon implantacije lijeka Spherox uglavnom su povezane s kirurškim zahvatom.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskim stranicama Europske agencije za lijekove http://www.ema.europa.eu.
English: Spherox is intended for autologous use only.
Croatian: Spherox je namijenjen samo za autolognu primjenu.
English: Syringe: EXP {DD month YYYY} at {hours} CET
Croatian: Štrcaljka: EXP {DD mjesec GGGG} u {sati} SEV
English: • partial or complete detachment of the tissue beneath the bone and surrounding cartilage
Croatian: • djelomično ili potpuno odvajanje tkiva ispod kosti i okolne hrskavice
English: • The other ingredient is sodium chloride used as transport solution.
Croatian: • Drugi je sastojak natrijev klorid koji se upotrebljava kao prijenosna otopina.
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.
Croatian: Cilj ispitivanja je usporediti djelotvornost i sigurnost liječenja oštećenja hrskavice (1 do manje od 4 cm2) na femoralnom kondilu zgloba koljena lijekom Spherox i liječenje mikrofrakturom u razdoblju od 5 godina.
English: The mean patient age was 34 years (range 19 to 48 years) with a mean body mass index (BMI) of 25.2.
Croatian: Prosječna dob bolesnika bila je 34 godine (u rasponu od 19 do 48 godina) uz prosječni indeks tjelesne težine (BMI) od 25,2.
English: The MAH shall ensure that in each Member State where Spherox is marketed, all surgeons and other health professionals who are expected to prescribe and administer the product have access to the educational materials including:
Croatian: Nositelj odobrenja za stavljanje u promet osigurat će da u svakoj državi članici u kojoj je Spherox stavljen u promet, svi kirurzi i ostali zdravstveni radnici od kojih se očekuje da propisuju i primjenjuju Spherox imaju pristup edukacijskim materijalima, uključujući:
English: What Spherox contains
Croatian: Što Spherox sadrži
English: Thromboprophylaxis should be administered according to local guidelines.
Croatian: Tromboprofilaksu je potrebno primijeniti u skladu s lokalnim smjernicama.
English: You may in that case notice symptoms, for example swelling or pain of the tissues around the joint.
Croatian: U tom slučaju možete primijetiti simptome poput oticanja ili boli u tkivima oko zgloba.
English: To make the spheroids, a small cartilage sample is taken from part of one of your joints during a minor operation, and then grown in the laboratory to make the medicine.
Croatian: Kako bi se sferoidi proizveli, iz dijela jednog od vaših zglobova uzima se mali uzorak hrskavice tijekom manje operacije, koji se potom umnožava u laboratoriju radi izrade lijeka.
English: Precautions for use
Croatian: Mjere opreza pri uporabi
English: Defect sizes ranged from 0.5 to 4 cm2.
Croatian: Veličine oštećenja bile su u rasponu od 0,5 do 4 cm2.
English: The catheter of the applicator is made of thermoplastic polyurethane, the sealing plug on one side of acrylonitrile butadiene styrene and a silicone stopper on the other side.
Croatian: Kateter aplikatora izrađen je od termoplastičnog poliuretana, s brtvenim čepom na jednoj strani od akrilonitril-butadien-stirena i silikonskim čepom na drugoj strani.
English: Any unused product or waste material should be disposed in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: 21 14513 Teltow GERMANY
Croatian: 21 14513 Teltow
English: The analysis population comprised 102 patients (41 women, 61 men) aged 37 years on average (range from 18 to 49 years) with a mean body mass index (BMI) of 25.8.
Croatian: Analiziranu populaciju činila su 102 bolesnika (41 žena, 61 muškarac) u prosjeku od 37 godina (u rasponu od 18 do 49 godina) uz prosječni indeks tjelesne mase (BMI) od 25,8.
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.
Croatian: Spherox smije implantirati samo liječnik specijalist u medicinskoj ustanovi te se smije primjenjivati samo u bolesnika za kojeg je pripremljen.
English: If the primary or secondary packaging is damaged and therefore unsterile, Spherox must not be applied.
Croatian: Ako je primarno ili sekundarno pakiranje oštećeno i stoga nije sterilno, lijek Spherox ne smije se primjenjivati.
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.
Croatian: (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: For decision on treatment of facing defects (“kissing lesions” larger than ICRS grade II) the degree of overlap and location of the defects in the joint have to be taken into consideration.
Croatian: Pri odlučivanju o liječenju oštećenja koja su okrenuta jedna prema drugima (tzv. kissing lesions veće od II. stupnja prema ICRS-u) potrebno je uzeti u obzir stupanj preklapanja i lokaciju oštećenja u zglobu.
English: The MAH shall ensure that in each Member State where Spherox is marketed, a system aimed to control access to the product beyond the level of control ensured by routine risk minimisation measures.
Croatian: Nositelj odobrenja za stavljanje u promet mora zajamčiti da u svakoj državi u kojoj se lijek Spherox stavlja u promet postoji sustav za kontrolu pristupa lijeku izvan uobičajene razine nadzora koja je zajamčena rutinskim mjerama za smanjenje rizika.
English: What Spherox is and what it is used for
Croatian: Što je Spherox i za što se koristi
English: Spherox is administered to patients by intraarticular implantation.
Croatian: Spherox se daje bolesnicima intraartikularnom implantacijom.
English: • Patients with not fully closed epiphyseal growth plate in the affected joint.
Croatian: • Bolesnici kojima epifizna ploča rasta nije potpuno zatvorena u zahvaćenom zglobu.
English: What you need to know before you are given Spherox
Croatian: Što morate znati prije nego počnete primati Spherox
English: Spherox has been analysed in a prospective, randomized, uncontrolled open-label, multicentre Phase II clinical study including 75 patients with focal cartilage defects (ICRS grade III or IV) in the knee with a defect size of 4-10 cm2.
Croatian: Spherox je analiziran u prospektivnom, randomiziranom, nekontroliranom, otvorenom i multicentričnom kliničkom ispitivanju II. faze koje je uključivalo 75 bolesnika s fokalnim oštećenjima hrskavice (III. ili IV. stupnja prema ICRS-u) u koljenu s veličinom oštećenja od 4-10 cm2.
English: • Advanced osteoarthritis of the affected joint (exceeding grade II according to Kellgren and
Croatian: • Uznapredovali osteoartritis zahvaćenog zgloba (koji prelazi II. stupanj prema Kellgrenu i
English: • If you have any further questions, ask your doctor.
Croatian: • Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: Strictly follow the advice of your doctor or physical therapist.
Croatian: Strogo slijedite savjete svojeg liječnika ili fizioterapeuta.
English: KOOS (Knee Injury and Osteoarthritis Outcome Score) after 12, 24, 36, 48 and 60 months compared to before treatment could be observed.
Croatian: Knee Injury and Osteoarthritis Outcome Score) nakon 12, 24, 36, 48 i 60 mjeseci u odnosu na stanje prije liječenja.
English: Spherox is cultured and implanted as three-dimensional spheroids.
Croatian: Spherox se kultivira i implantira u obliku trodimenzionalnih sferoida.