FrancophonIA/ELRC3.0 huggingface dataset:
English: • Obligation to conduct post-authorisation measures Not applicable.
Croatian: • Obaveza provođenja mjera nakon davanja odobrenja
English: Before administration, ChondroCelect should be resuspended by gently tapping the vial to bring the cells back into suspension.
Croatian: Prije primjene lijek ChondroCelect treba resuspendirati laganim lupkanjem bočice kako bi se stanice vratile nazad u suspenziju.
English: Children and adolescents The use of ChondroCelect is not recommended in children and adolescents below 18 years.
Croatian: Primjena lijeka ChondroCelect se ne preporučuje u djece i adolescenata mlađih od 18 godina.
English: Adverse reactions occurred in 78.4% of the patients over a 36-months postoperative follow-up period..
Croatian: Tijekom postoperativnog razdoblja praćenja od 36 mjeseci nuspojave su se pojavile u 78,4%
English: NAME OF THE MEDICINAL PRODUCT ChondroCelect 10,000 cells/microlitre implantation suspension
Croatian: NAZIV LIJEKA ChondroCelect 10 000 stanica/mikrolitar suspenzija implantata
English: adverse reactions are presented in order of decreasing seriousness.
Croatian: nuspojave su poredane prema padajućem redoslijedu ozbiljnosti.
English: Most of the reported adverse reactions were expected as related to the open-knee surgical procedure..
Croatian: Većina prijavljenih nuspojava očekivani je rezultat kirurškog postupka na otvorenom koljenu..
English: This cartilage sample will be used to make ChondroCelect.
Croatian: Uzorak hrskavice upotrijebit će se za izradu lijeka ChondroCelect.
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.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
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.
Croatian: primijećena incidencija hipertrofije hrskavice bila je 1,8% u usporedbi s 25% u samom randomiziranom kontroliranom ispitivanju.
English: ChondroCelect is solely intended for autologous use and should be administered in conjunction with debridement (preparation of the defect bed), a physical seal of the lesion (placement of a biological membrane, preferentially a collagen membrane) and rehabilitation.
Croatian: Lijek ChondroCelect namijenjen je isključivo za autolognu primjenu i treba se primjenjivati u kombinaciji s debridmanom (kirurškim odstranjivanjem mrtvog tkiva), fizičkim zatvaranjem lezije (postavljenjem biološke, po mogućnosti kolagenske membrane) i rehabilitacijom.
English: Cases in which ChondroCelect cannot be supplied
Croatian: Slučajevi u kojima se lijek ChondroCelect ne može dostaviti
English: What ChondroCelect contains - The active substance of ChondroCelect consists of a treatment dose of viable autologous human cartilage cells in vials containing 4 million cells in 0.4 ml, corresponding to a concentration of
Croatian: Sadržaj pakiranja i druge informacije Što ChondroCelect sadrži - Djelatna tvar lijeka ChondroCelect sastoji se od doze za liječenje vijabilnim autolognim stanicama hrskavice ljudskog podrijetla u bočicama koje sadrže 4 milijuna stanica u 0,4 ml, što odgovara koncentraciji od 10 000 stanica po mikrolitru.
English: • Informed consent for the patients to be signed prior to the treatment with ChondroCelect
Croatian: • Informirani pristanak za sve bolesnike koji oni trebaju potpisati prije liječenja lijekom
English: If you have any further questions on the use of this medicine, ask your doctor or physical therapist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili fizioterapeutu.
English: ChondroCelect is intended solely for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI).
Croatian: ChondroCelect je namijenjen isključivo za autologno liječenje hrskavice i primjenjuje se u bolesnika postupkom implantacije autolognih hondrocita (eng.
English: Wound infection, Erysipelas, Erythema,
Croatian: Poremećaji kože i potkožnog tkiva infekcija rane, erizipel (crveni vjetar), eritem,
English: It will take at least four weeks to select and culture the cells to make ChondroCelect.
Croatian: Selekcija i uzgoj stanica za izradu lijeka ChondroCelect trajat će najmanje četiri tjedna.
English: Visit 2: ChondroCelect implantation
Croatian: 2. posjet: implantacija lijeka ChondroCelect
English: This is called ‘autologous chondrocyte implantation' (ACI).
Croatian: Autologous Chondrocyte Implantation, ACI).
English: - ChondroCelect is not recommended for the repair of cartilage defects in other locations than the femoral condyle.
Croatian: ChondroCelect se ne preporučuje za popravak oštećenja hrskavice na mjestima koja nisu femoralni kondil.
English: Other cases in which ChondroCelect cannot be supplied
Croatian: Ostali slučajevi u kojima se lijek ChondroCelect ne može dostaviti
English: Fibrin glues are routinely used in ACI procedures to seal the outside margins and to improve the water-tightness of the compartment of the biological membrane used to cover the defect.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Fibrinska ljepila rutinski se upotrebljavaju u ACI postupcima za zatvaranje vanjskih rubova i za poboljšavanje vodonepropusnosti odjeljka biološke membrane koja se koristi za prekrivanje oštećenja.
English: Keep the product vial(s) within the falcon tube in the outer plastic screw top container in order to protect from light and bacterial/fungal contamination.
Croatian: Bočicu(e) lijeka čuvajte u falcon epruveti u vanjskom spremniku s plastičnim navojnim vrhom kako biste ju zaštitili od svjetla i bakterijske/gljivične kontaminacije.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL INTERMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: NAME OF THE MEDICINAL PRODUCT ChondroCelect
Croatian: NAZIV LIJEKA ChondroCelect
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.
Croatian: ChondroCelect ili, u nekim slučajevima, može se dogoditi da se stanice ne mogu uzgojiti u laboratoriju ili da stanice nakon umnažanja ne ispunjavaju sve uvjete kvalitete.
English: ChondroCelect 10,000 cells/microlitre implantation suspension.
Croatian: ChondroCelect10 000 stanica/mikrolitar suspenzija implantata.
English: Chondromalacia, Gonarthrosis
Croatian: tendonitis hondromalacija, gonartroza
English: Related to ChondroCelect:
Croatian: Povezano s lijekom ChondroCelect:
English: • The implantation procedure by knee-joint arthrotomy
Croatian: • Postupak implantacije putem artrotomije zgloba koljena
English: Implantation of ChondroCelect is to be performed during arthrotomy under sterile conditions and requires both preparation of the defect bed and a seal (biological membrane) to secure the implant.
Croatian: Implantacija lijeka ChondroCelect treba se obaviti tijekom artrotomije u sterilnim uvjetima, a za zaštitu implantata potrebna je priprema ležišta na dnu hrskavičnog defekta i zatvaranje lezije
English: EXPIRY DATE EXP {DD month YYYY} at {hours} CET SPECIAL STORAGE CONDITIONS Store between 15°C - 25°C.
Croatian: POSEBNE MJERE ČUVANJA Čuvati na temperaturi između 15°C - 25°C.
English: ChondroCelect is used to repair single symptomatic cartilage defects in the femoral condyle of the knee in adults.
Croatian: ChondroCelect se koristi za popravak pojedinačnog simptomatičnog oštećenja hrskavice femoralnog kondila koljena odrasle osobe.
English: • The handling of the biopsy harvest
Croatian: • Postupak uzimanja tkiva za biopsiju
English: Common side effects ( affects in 1 to 10 users in 100) include: restriction of knee motion (arthrofibrosis, decreased joint range of motion, decreased mobility), excessive amount of joint fluid in the joint (joint effusion), joint lock, joint inflammation (arthritis, bursitis, synovitis), cavity filled with fluid in the knee (bone cyst, synovial cyst), bone swelling, cartilage disorder (chondropathy), benign bony growth (exostosis), blood in a joint (haemarthrosis), joint instability, joint stiffness, loose body in joint, weakening of muscle (muscle atrophy, Trendelenburg's sign), degenerative joint disorder (osteoarthritis), tendon disorder, inflammation of the tendon (tendonitis), impaired healing, treatment failure, gait disturbance, implant site hypersensitivity, peripheral edema, fever (pyrexia), postoperative wound complication (wound site reaction) ,wound infection (including erysipelas), redness, scar overgrowth, itching, scar pain, wound loosening, wound secretion loosening of the graft or membrane (graft complication, graft delamination), injury (cartilage injury, joint injury), blood clot in the deep vein of the leg (deep vein thrombosis), large bruise (haematoma), superficial vein inflammation (phlebitis), nausea, pain or nerve disorder (pain in extremity, peripheral neuropathy, complex regional pain syndrome, autonomic neuropathy), syncope, apnea, arthroscopy.
Croatian: (tendonitis), slabo zarastanje, neuspjeh liječenja, poremećaj hoda, preosjetljivost na mjestu implantacije, periferni edem, vrućica (pireksija), komplikacija rane nakon operacije (reakcija na mjestu rane), infekcija rane (uključujući erizipel), crvenilo, prekomjeran rast ožiljka, svrbež, bol ožiljka, razdvajanje rane, iscjedak iz rane, opuštanje presatka ili membrane (komplikacije s presatkom, delaminacija presatka), ozljeda (ozljeda hrskavice, ozljeda zgloba), krvni ugrušak u dubokoj nožnoj veni (duboka venska tromboza), velika modrica (hematom), površinska upala vena (flebitis), mučnina, bol ili poremećaj živaca (bol u udovima, periferna neuropatija, kompleksni regionalni bolni sindrom, autonomna neuropatija), sinkopa, apneja, artroskopija.
English: Dispose of in accordance with local requirements.
Croatian: OD LIJEKA, AKO JE POTREBNO Odlagati u skladu s važećim lokalnim propisima.
English: - have a growth plate of the knee that is not fully closed
Croatian: Ako imate nepotpuno zatvorenu ploču rasta koljena
English: - The other ingredient is sterile, buffered Dulbecco's Modified Eagles Medium (DMEM), a liquid containing amino acids, vitamins, salts and carbohydrates to store the cells in the vial.
Croatian: Modified Eagles Medium, DMEM), tekućina koja sadrži aminokiseline, vitamine, soli i ugljikohidrate za pohranu stanica u bočici.
English: There are no data on the use of ChondroCelect during breast-feeding.
Croatian: Nema podataka o primjeni ChondroCelecta za vrijeme dojenja.
English: Depending on the location, the size of the lesion and the patient's profile, appropriate rehabilitation instructions have been developed.
Croatian: Odgovarajuće upute za rehabilitaciju razvijene su ovisno o položaju, veličini lezije i profilu bolesnika.
English: Graft complication, Graft delamination, Cartilage injury, Injury,
Croatian: postoperativna komplikacija rane, svrbež, bol ožiljka, dehiscencija rane, iscjedak iz rane
English: Most side effects of ChondroCelect implantation are side effects related to open-knee surgery.
Croatian: Većina nuspojava vezana uz implantaciju lijeka ChondroCelect odnosi se na operaciju na otvorenom koljenu.
English: EXP {DD month YYYY} at {hours} CET
Croatian: ROK VALJANOSTI Rok valjanosti {DD mjesec GGGG} u {sati} po srednjeeuropskom vremenu
English: Autonomic neuropathy, Complex regional pain syndrome,
Croatian: Poremećaji živčanog sustava autonomna neuropatija, kompleksni regionalni bolni sindrom, bol u udovima, periferna neuropatija, sinkopa,
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.
Croatian: a, CHMP zaključuje da nositelj odobrenja mora, nakon 5 godina, podnijeti zahtjev za još jednu obnovu.
English: Each vial of product contains 4 million autologous human cartilage cells in 0.4 ml cell suspension, corresponding to a concentration of 10,000 cells/microlitre.
Croatian: TVARI Svaka bočica sadrži 4 milijuna autolognih stanica hrskavice ljudskog porijekla u 0,4 ml što odgovara koncentraciji od 10 000 stanica po mikrolitru.
English: The falcon tube is placed in a plastic screw top container together with surgery materials (one sterile syringe of 1 ml, one 18G intravenous catheter and two pieces of Vicryl 6.0) and a temperature monitor.
Croatian: 1 falcon epruveta s 1, 2 ili 3 bočice (x 0,4 ml) Bočice se isporučuju s kirurškim materijalom (jedna sterilna štrcaljka od 1 ml, jedan intravenski kateter 18G i dva komada pribora za šivanje Vicryl 6.0)
English: At this time point 41 patients were evaluated in the ChondroCelect arm and 49 were evaluated in the microfracture arm.
Croatian: Do tada je ocijenjen 41 bolesnik u skupini ispitanika liječenih lijekom ChondroCelect i 49 u skupini ispitanika liječenih mikrofrakturom.
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.
Croatian: Popravak pojedinačnog simptomatičnog oštećenja hrskavice femoralnog kondila koljena (stupnja III
English: Although it is thought that these reactions are mostly surgery-related, a potential influence of the expanded chondrocytes cannot be completely excluded.
Croatian: Iako se smatra da su te reakcije uglavnom povezane s kirurškim postupkom,
English: Concomitant knee problems like early osteoarthritis, osteochondritis dissecans (OCD), instability of the knee, cartilage lesions at other locations than the femoral condyle, lesions of knee ligaments or of the meniscus, varus or valgus malalignment (abnormal weight distribution in the knee), and inflammatory joint disease are potential complicating factors.
Croatian: Česti problemi s koljenom kao što su rani osteoartritis, disekantni osteohondritis (eng. osteochondritis dissecans, OCD), nestabilnost koljena, lezije hrskavice koje se javljaju na drugim mjestima osim na femoralnom kondilu, lezije ligamenata koljena ili meniskusa, varusna ili valgusna deformacija
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.
Croatian: Ipak, upotreba druge vrste fibrinskog ljepila sa sintetičkim inhibitorom fibrinolize
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1, 2 or 3 vials x 0.4 ml
Croatian: 1, 2 ili 3 bočice x 0,4 ml
English: Description of selected adverse reactions
Croatian: Opis odabranih nuspojava Artrofibroza
English: Uncommon side effects (affects in 1 to 10 users in 1,000 include: anxiety, dermal and visual hypersensitivity ), migraine, mini stroke (transient ischaemic attack), fat entering the circulatory system (fat embolism), vein blockage and inflammation (thrombophlebitis), blockage in a lung artery (lung embolism), itching scar, pain at the front of the knee (chondromalacia), breakdown of knee tissue (gonartrhosis, atrophy), discomfort, chronic inflammation (granulomatous lesion).
Croatian: Manje česte nuspojave (pojavljuju se kod 1 do 10 korisnika od 1 000) uključuju: tjeskoba, kožna i vizualna preosjetljivost, migrena, mali moždani udar (tranzitorna ishemijska ataka), mast koja ulazi u cirkulacijski sustav (masna embolija), blokada i upala vena (tromboflebitis), blokada plućne arterije
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.
Croatian: Do ponovnog zahvata na mjestu lezije zbog delaminacije presatka ili labavljenja pokosnice došlo je kod 2 od 51 bolesnika u roku od 36 mjeseci nakon implantacije lijeka
English: Impaired healing, Implant site hypersensitivity, Peripheral edema, Pyrexia
Croatian: slabo zacjeljivanje, preosjetljivost mjesta implantacije, periferalni edem, pireksija atrofija, nelagoda, granulomatozna lezija
English: In the subgroup of patients with recent symptom onset (< 3 years) the clinical benefit of ChondroCelect over microfracture was significantly larger, confirming the results at 36 months after treatment.
Croatian: U podskupini bolesnika s nedavnom pojavom simptoma (<3 godine) klinička korist liječenjem lijekom
English: Tabulated list of adverse reactions They are listed by System Organ Class and frequency.
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava i učestalosti.
English: Psychiatric disorders
Croatian: Psihijatrijski poremećaji tjeskoba
English: • The schedule of follow-up of patients
Croatian: • Farmakovigilancijski sustav
English: Hyperesthesia, Migraine,
Croatian: atrofija mišića,
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) of the biological active substance(s) PharmaCell Cell Manufacturing Facility B.V.
Croatian: Naziv i adresa proizvođača biološke(ih) djelatne(ih) tvari
English: Deep vein thrombosis, Haematoma, Superficial phlebitis
Croatian: Krvožilni poremećaji duboka venska tromboza, hematom, površinski flebitis masna embolija, tromboflebitis
English: - If you get any of the side effects, talk to your doctor, surgeon or physical therapist.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, kirurga ili fizioterapeuta.
English: Cartilage hypertrophy
Croatian: Hipertrofija hrskavice
English: Treatment with ChondroCelect: a two-step procedure.
Croatian: Liječenje lijekom ChondroCelect: postupak u dvije faze 1. posjet: procjena oštećenja hrskavice i biopsija
English: Complete joint haemostasis must be achieved prior to membrane fixation and cell implantation.
Croatian: Prije učvršćenja membrane i implantacije stanica treba se postići potpuna hemostaza zgloba.
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.
Croatian: Budući da se ChondroCelect koristi za popravak oštećenja hrskavice i implantira primjenom ACI
English: What ChondroCelect looks like and contents of the pack ChondroCelect is a cell suspension (a fluid) for implantation.
Croatian: ChondroCelect je stanična suspenzija (tekućina) implantata.
English: Nervous system disorders
Croatian: Poremećaji probavnog sustava mučnina
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja apneja plućna embolija
English: Very common side effects (affects more than 1 user in 10) include: joint pain (arthralgia), overgrowth of cartilage cells (cartilage hypertrophy), crackling or clicking sensation when articulating the knee (joint crepitation), and joint swelling.
Croatian: (artralgija), prekomjerni rast stanica hrskavice (hipertrofija hrskavice), osjećaj pucketanja ili škljocanja kada se savija koljeno (krepitacija zgloba) i naticanje zgloba.
English: Arthroscopy
Croatian: • artralgija
English: You can recognize most of the joint- related side effects if you have symptoms like pain, snapping, grinding, locking, swelling, bending limitations and stiffness in the knee.
Croatian: Većinu nuspojava vezanih uz zglobove možete prepoznati ako imate simptome kao što su bol,
English: Photophobia, Transient ischaemic attack
Croatian: Trendelenburgov simptom hiperestezija, migrena, fotofobija, tranzitorna ishemijska ataka
English: If you get any side effects, talk to your doctor or physical therapist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili fizioterapeuta.
English: Implantation suspension.
Croatian: OBLIK I SADRŽAJ Suspenzija implantata.
English: Gastrointestinal disorders
Croatian: Pretrage artroskopija
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).
Croatian: Prilikom prvog posjeta kirurg će procijeniti oštećenje
English: Scar pain,
Croatian: poremećaj tetive,
English: Arthritis,
Croatian: (artroskopije).
English: Ineffective therapeutic product,
Croatian: UČINKOVITU PRIMJENU LIJEKA
English: Hypertrophic scar, Postoperative wound complication, Pruritus,
Croatian: Trendelenburgov znak), degenerativni poremećaj zgloba (osteoartritis), poremećaj tetiva, upala tetive
English: Given the local nature of ChondroCelect adverse reactions on the nursing infant are not anticipated.
Croatian: ChondroCelecta, ne očekuju se nuspojave na dijete koje se doji.
English: Skin and subcutaneous tissue disorders
Croatian: Mogu se pojaviti popratne asimptomatične lezije hrskavice
English: Haemarthrosis, Joint instability, Joint stiffness, Loose body in joint, Mobility decreased, Muscle atrophy, Osteoarthritis, Synovial cyst, Synovitis,
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva artrofibroza, smanjen opseg pokretljivosti zgloba, zglobni izljev, blokada zgloba, artritis, artropatija, cista kosti, oticanje kosti, burzitis, hondropatija, egzostoza, hemartroza, nestabilnost zgloba, krutost zgloba, slobodno tijelo u zglobu, smanjena pokretljivost,
English: Apnoea
Croatian: OBLIK
English: Atrophy,
Croatian: Dulbecco's
English: In addition, no patient had a definitive recurrence during the 3.7 years of follow-up.
Croatian: Nadalje, nijedan bolesnik nije imao definitivan povrat bolesti tijekom 3,7 godina praćenja.
English: These hormones can be measured in your blood.
Croatian: Razina ovih hormona može se mjeriti u krvi.
English: It is comprised of two non-covalently linked subunits.
Croatian: Sastoji se od dvije nekovalentno povezane podjedinice.
English: In clinical trials this was not seen.
Croatian: To nije primijećeno u kliničkim ispitivanjima.
English: This may lead to increased risk of headache and nausea.
Croatian: To može dovesti do povećanog rizika od glavobolje i mučnine.
English: It is important to note that the microbiological safety depends on the aseptic conditions during the preparation of the solution.
Croatian: Važno je napomenuti da mikrobiološka sigurnost otopine ovisi o aseptičkim uvjetima tijekom njezine pripreme.
English: The elimination halflife was 22 ± 9 hours.
Croatian: Poluvrijeme eliminacije iznosilo je 22 ± 9 sati.
English: Date of first authorisation: 9 March 2000 Date of last renewal: 9 March 2010
Croatian: Datum posljednje obnove odobrenja: 9.ožujka 2010.
English: No special precautions for elderly patients are necessary.
Croatian: Nisu potrebne posebne mjere opreza u starijih osoba.
English: Use aseptic technique.
Croatian: Primijenite aseptičku tehniku.
English: The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The median follow-up was 6.5 years (4.5 to 7.6 years).
Croatian: Medijan razdoblja praćenja je bio 6,5 godina (4,5 do 7,6 godina).
English: 45, 51, 68, 74, 76 and 80 New York Avenue Framingham, MA 01701
Croatian: 45, 51, 55, 68, 74, 76 and 80 New York Avenue Framingham,
English: The median follow-up was 5.4 years (0.5 to 9.2 years).
Croatian: Medijan razdoblja praćenja je bio 5,4 godine (0,5 do 9,2 godine).
English: The most commonly reported adverse reactions are nausea and headache, occurring in approximately 11%, and 6% of patients, respectively.
Croatian: Najčešće prijavljene nuspojave su mučnina i glavobolja, koje se javljaju u približno 11%, odnosno 6%