FrancophonIA/ELRC3.0 huggingface dataset:
English: Any degree of heart block or disorders of cardiac rhythm and coronary artery insufficiency.
Croatian: - nedavni infarkt miokarda Bilo koji stupanj srčanoj zastoja ili poremećaja srčanog ritma i suženja koronarnih arterija. - prateće liječenje inhibitorima monoaminooksidaze (MAOI) - teška bolest jetre - u djece mlađe od 6 godina.
English: Other sections of the SmPC
Croatian: Ostali dijelovi u sažetku opisa svojstava
English: The package leaflet was amended in accordance with the changes made to the SmPC.
Croatian: Uputa o lijeku dopunjena je u skladu s izmjenama u sažetku opisa svojstava lijeka.
English: 1 vial
Croatian: 1 bočica s
English: 36 hours.
Croatian: 36 sati.
English: HOUR: (Time zone)
Croatian: SAT: (Vremenska zona)
English: Your surgeon will inform you about this.
Croatian: Vaš će Vas kirurg obavijestiti o tome.
English: On the second visit the surgeon will:
Croatian: Na drugom posjetu kirurg će:
English: Although the risk is considered to be low and controlled in the manufacturing.
Croatian: Ipak, smatra se da je rizik nizak i kontroliran u proizvodnji.
English: Follow their advice carefully.
Croatian: Pažljivo slijedite njegove upute.
English: Date of latest renewal: 11/12/2017
Croatian: Datum posljednje obnove: 11/12/2017
English: Patient's Date of Birth:
Croatian: Datum rođenja bolesnika:
English: Only a very small number of children have been treated so far, so it is not known whether the medicine is safe for use in children or how effective it may be.
Croatian: Do sada je liječen samo vrlo malen broj djece pa nije poznato je li lijek siguran za primjenu u djece ili koliko je djelotvoran.
English: The picture shows where the limbus is in your eye.
Croatian: Slika pokazuje gdje se u Vašem oku nalazi limbus.
English: • Autologous means that they are your own cells.
Croatian: • Autologno znači da su to Vaše vlastite stanice.
English: • Sensitivity to light
Croatian: • osjetljivost na svjetlost
English: Holoclar must be applied no later than 15 minutes after opening the primary container.
Croatian: Holoclar se mora primijeniti najkasnije 15 minuta od otvaranja primarnog spremnika.
English: UNIQUE IDENTIFIER - 2D BARCODE <Not applicable.>
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD <Nije primjenjivo.>
English: This level of efficacy is similar to that observed in the treated patients overall.
Croatian: Ta razina djelotvornosti slična je onoj u ukupnom broju liječenih bolesnika.
English: EXPIRY DATE EXP : Day / Month / Year At time: Hour / Minute (CET)
Croatian: ROK VALJANOSTI EXP : dan / mjesec / godina Vrijeme: sat / minuta (SEV)
English: Holoclar.
Croatian: Holoclarom.
English: Currently available data are described in section 4.8 and 5.1, but no recommendation on posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8 i 5.1, međutim nije moguće dati preporuku o doziranju.
English: Although limited with regard to the number of subjects, data from both studies showed a success rate around 70% of treated cases in the elderly population.
Croatian: Iako ograničeni s obzirom na broj ispitanika, podaci iz oba ispitivanja pokazali su stopu uspjeha od približno 70% liječenih ispitanika u starijoj populaciji.
English: If you have any of the following problems with your eyes, they should be treated before this medicine is used:
Croatian: Ako imate bilo koji od sljedećih problema s očima, treba ih liječiti prije primjene ovog lijeka:
English: • The limbus is part of the eye.
Croatian: • Limbus je dio oka.
English: Any unused medicinal product or waste material must be returned to the manufacturer.
Croatian: Sav neiskorišteni lijek ili otpadni materijal mora se vratiti proizvođaču.
English: This is to protect it from contamination by bacteria.
Croatian: To je potrebno radi zaštite od kontaminacije bakterijama.
English: If you are allergic to either of these ingredients, you will not be able to be given this medicine (see above under ‘You must not be given Holoclar').
Croatian: Ako ste alergični na bilo koji od ovih sastojaka, neće Vam se moći dati ovaj lijek (pogledajte gore pod „Ne smije Vam se dati Holoclar“).
English: Do not sterilise
Croatian: Ne sterilizirati
English: It is very important that you take all the medicines prescribed by your surgeon, otherwise Holoclar may not work.
Croatian: Jako je važno da uzimate sve lijekove koje Vam je propisao kirurg jer u suprotnom Holoclar možda neće djelovati.
English: No recommendation on posology can be made (see sections 4.8 and 5.1).
Croatian: Nije moguće dati preporuku o doziranju (vidjeti dijelove 4.8 i 5.1).
English: <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Do not store above 25°C or below 15°C.
Croatian: Ne čuvati na temperaturi iznad 25°C ili ispod 15°C.
English: Holoclar could contain potentially infected biological material.
Croatian: Holoclar može sadržavati potencijalno inficiran biološki materijal.
English: • Replace it with Holoclar
Croatian: • nadomjestiti je Holoclarom
English: The surgeon will be informed as early in the process as possible and should hence select an alternative treatment for the patient.
Croatian: Kirurg će biti obaviješten što je prije moguće tijekom proizvodnje te zatim treba odabrati alternativno liječenje za bolesnika.
English: The safety of Holoclar is demonstrated in the results obtained from the two retrospective clinical studies.
Croatian: Sigurnost primjene Holoclara dokazana je rezultatima prikupljenim iz dva retrospektivna klinička ispitivanja.
English: Visit 2: Holoclar implantation
Croatian: 2. posjet: Implantacija Holoclara
English: The biopsy must be received by the manufacturer within 24 hours from the procurement.
Croatian: Proizvođač mora primiti bioptat unutar 24 sata od uzimanja.
English: The treatment may be repeated if considered indicated by the treating physician.
Croatian: Liječenje se može ponoviti ako to smatra indiciranim nadležni liječnik.
English: See the educational material for further information.
Croatian: Za dodatne informacije pročitajte edukacijski materijal.
English: Email: info@chiesi.com
Croatian: Elektronička pošta: info@chiesi.com Proizvođač
English: Holoclar is implanted to repair the damaged surface of the eye in adults.
Croatian: Holoclar se implantira kako bi popravio oštećenu očnu površinu u odraslih.
English: Therefore, do not drive or use machines after having Holoclar put in your eye until your surgeon tells you that it is safe to do so.
Croatian: Zato nemojte upravljati vozilima ili raditi sa strojevima nakon stavljanja Holoclara u oko sve dok Vam Vaš kirurg ne kaže da je to sigurno.
English: DATE:
Croatian: DATUM:
English: The safety and efficacy of Holoclar in children and adolescents aged 0 to 18 years has not yet been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost Holoclara u djece i adolescenata u dobi od 0 do 18 godina nije još ustanovljena.
English: Do not irradiate (e.g. X-rays)
Croatian: Ne ozračivati (npr. X-zrakama)
English: Therefore, it can occur that Holoclar cannot be delivered.
Croatian: Zbog toga se može dogoditi da se Holoclar ne može dostaviti.
English: The education material should also include both an Educational Manual and a training programme which will incorporate verification of physicians' comprehension of the training provided.
Croatian: Edukacijski materijal također treba sadržavati Edukacijski priručnik i program obuke, koji uključuje provjeru jesu li liječnici razumjeli pruženu obuku.
English: A total of 75 (72.1%) treatments were reported with a successful outcome.
Croatian: Ukupno je zabilježeno 75 (72,1%) zahvata s uspješnim ishodom.
English: If you have an acute eye infection or swollen, red (inflamed) eyes, your treatment should be delayed until you have recovered.
Croatian: Ako imate akutnu infekciju oka ili su Vam oči natečene i crvene (upaljene), Vaše liječenje treba odgoditi dok se ne oporavite.
English: • Anaesthetise your eye
Croatian: • Vam anestezirati oko
English: Data on the use of Holoclar in elderly populations are limited.
Croatian: Podaci o primjeni Holoclara u populaciji starijih osoba su ograničeni.
English: If you are pregnant, think you might be pregnant or you are breast-feeding, treatment with this medicine should be delayed.
Croatian: Ako ste trudni, mislite da bi mogli biti trudni ili dojite liječenje ovim lijekom treba odgoditi.
English: The amount of cells to be administered is dependent on the size (surface in cm²) of the corneal surface.
Croatian: Količina stanica koju treba primijeniti ovisi o veličini (površina u cm²) površine rožnice.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA <Not applicable.>
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM <Nije primjenjivo.>
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17/02/2015
Croatian: Datum prvog odobrenja: 17/02/2015
English: A total of 104 patients, aged between 13 and 79 years (mean 46.8 years) were included in the primary efficacy analysis.
Croatian: Ukupno su 104 bolesnika u dobi između 13 i 79 godina (prosjek: 46,8 godina) bila uključena u primarnu analizu djelotvornosti.
English: Holoclar is generally implanted under topical retrobulbar or parabulbar anaesthesia.
Croatian: Općenito se Holoclar implantira pod topikalnom retrobulbarnom ili parabulbarnom anestezijom.
English: Animal studies are not available with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama s obzirom na reproduktivnu toksičnost nisu dostupna (vidjeti dio 5.3).
English: There is only limited information in elderly (n=12, >65 year old) and very elderly (n= 2, 75-84 year old) patients.
Croatian: Postoje samo ograničeni podaci u starih (n=12, u dobi od >65 godina) i vrlo starih (n= 2, u dobi od 75 do 84 godina) bolesnika.
English: The following information is intended for healthcare professionals only: (The complete SmPC will be provided as a separate document in the medicine pack)
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima: (potpuni Sažetak opisa svojstava lijeka bit će priložen kao zaseban dokument u pakiranju lijeka)
English: OTHER SPECIAL WARNING(S), IF NECESSARY Potentially infected biological material.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Potencijalno inficiran biološki materijal.
English: The implantation must be followed by an appropriate monitoring schedule.
Croatian: Nakon implantacije mora slijediti odgovarajući plan kontrola.
English: Via Glauco Gottardi,100, Modena, 41100, Italy
Croatian: Via Glauco Gottardi,100, Modena, 41100, Italija
English: The most common adverse reactions are eye disorders.
Croatian: Najčešće nuspojave su poremećaji oka.
English: The following categories are used to rank the adverse reactions by frequency of occurrence: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Croatian: Nuspojave su razvrstane u sljedeće kategorije prema učestalosti pojavljivanja: 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
English: Most side effects affect the eye, some of which are caused by the surgery.
Croatian: Većina nuspojava zahvaća oko, a neke od njih uzrokovane su kirurškim zahvatom.
English: The container and closure should be carefully visually inspected for any derogation.
Croatian: Spremnik i zatvarač treba pažljivo pregledati zbog bilo kakvih odstupanja.
English: If the temperature monitored in the insulated box deviates from the storage conditions, contact the manufacturer.
Croatian: Ako temperatura prikazana na izolacijskoj kutiji odstupa od uvjeta čuvanja, obratite se proizvođaču.
English: When the eye is badly damaged by physical or chemical burns, lots of scarring can occur and the limbus can be damaged.
Croatian: Kada je oko teško oštećeno fizikalnim ili kemijskim opeklinama, može doći do stvaranja mnoštva ožiljaka i limbus može biti oštećen.
English: In such a case, please contact your surgeon.
Croatian: U tom slučaju, molimo da se obratite svom kirurgu.
English: This ingredient can damage the cells of which Holoclar is made.
Croatian: Taj sastojak može oštetiti stanice od kojih se sastoji Holoclar.
English: Holoclar is an autologous product and should under no circumstances be administered to anyone other than the donor patient.
Croatian: Holoclar je autologni lijek i ni pod kojim uvjetima se ne smije dati nikome osim bolesniku donoru.
English: • The limbus contains limbal cells which normally help to maintain the health of your eye and some of these are stem cells which can make new cells.
Croatian: • Limbus sadrži limbalne stanice koje inače pomažu u održavanju zdravlja Vašeg oka, a neke od njih su matične stanice od kojih mogu nastati nove stanice.
English: Full technical details on the procedures associated with the use of Holoclar are provided in the educational manual.
Croatian: Svi tehnički detalji o postupcima povezanima s primjenom Holoclara nalaze se u edukacijskom priručniku.
English: These new cells can replace the damaged cells in your eye.
Croatian: Te nove stanice mogu nadomjestiti oštećene stanice Vašeg oka.
English: Conventional non-clinical reproductive and developmental toxicity studies are not considered relevant, given the nature and the intended clinical use of the autologous product.
Croatian: Konvencionalna neklinička ispitivanja reproduktivne i razvojne toksičnosti ne smatraju se značajnima s obzirom na prirodu i namjenu kliničke primjene autolognog lijeka.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/987/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/987/001
English: Blepharitis (10.5%), and corneal epithelium defect (3.5%) were the most common individual adverse reactions not related to the surgical procedure.
Croatian: Blefaritis (10,5%) i oštećenje epitela rožnice (3,5%) bile su najčešće pojedinačne nuspojave koje nisu povezane s kirurškim zahvatom.
English: The medicine is put in several layers of packaging which protect the medicine from bacteria and ensures that Holoclar is kept at a stable temperature for 36 hours, if stored at room temperature.
Croatian: Lijek je spremljen u nekoliko slojeva pakiranja koji ga štite od bakterija i osiguravaju održavanje stabilne temperature rijekom 36 sati, ako ga se čuva na sobnoj temperaturi.
English: Damage to the limbus stops normal healing, which means that the damage to your eye is never properly repaired.
Croatian: Oštećenje limbusa zaustavlja normalno cijeljenje, što znači da se oštećenje Vašeg oka ne može pravilno obnoviti.
English: Each preparation of Holoclar is made individually and is for a single treatment only, although treatments can be repeated.
Croatian: Svaki pripravak Holoclara napravljen je individualno i služi samo za jedan postupak liječenja, iako se liječenje može ponavljati.
English: Other cytotoxic agents must be avoided.
Croatian: Moraju se izbjegavati i druge citotoksične tvari.
English: When Holoclar is made, two ingredients from animals are used.
Croatian: U pripremi Holoclara koriste se dva životinjska sastojka.
English: Keep Holoclar within the steel container in the plastic bag until surgery.
Croatian: Čuvajte Holoclar u čeličnom spremniku u plastičnoj vrećici do kirurškog zahvata.
English: The nature and intended clinical use of Holoclar are such that conventional pharmacokinetic studies on absorption, biotransformation and elimination are not applicable.
Croatian: Priroda i namjena kliničke primjene Holoclara su takve da konvencionalna farmakokinetička ispitivanja apsorpcije, biotransformacije i eliminacije nisu primjenjiva.
English: Glaucoma (3.5%) was the most frequent adverse reaction considered related to the corticosteroid treatment (see sections 4.2 and 4.4).
Croatian: Glaukom (3,5%) je bio najčešća nuspojava koja se smatrala povezanom s kortikosteroidnim liječenjem (vidjeti dijelove 4.2 i 4.4).
English: One is foetal bovine serum which is from cows and is used to help grow your cells.
Croatian: Jedan je fetalni goveđi serum, koji se uzima od krava i pomaže Vašim stanicama u rastu.
English: There is no information on the safety of Holoclar in children up to 7 years of age and only limited information in patients 8 - 17 years of age.
Croatian: Nema podataka o sigurnosti primjene Holoclara u djece u dobi do 7 godina, a o primjeni u bolesnika u dobi od 8 do 17 godina podaci su ograničeni.
English: • Overgrowth around the implant (metaplasia)
Croatian: • pretjeran rast oko implantata (metaplazija)
English: Treatment with Holoclar is a two-step procedure.
Croatian: Liječenje Holoclarom je posupak u dva koraka.
English: The other ingredient is a special kind of inactivated mouse cell which is used to grow your limbal cells.
Croatian: Drugi sastojak je posebna vrsta inaktiviranih mišjih stanica koje se koriste za uzgoj Vaših limbalnih stanica.
English: Non-clinical safety data were limited to in vitro testing of tumorigenicity of the human autologous cell cultures.
Croatian: Neklinički podaci o sigurnosti primjene bili su ograničeni na in vitro ispitivanje tumorogenosti ljudskih autolognih staničnih kultura.
English: There have been no formal compatibility studies with Holoclar therefore this medicinal product should not be used with other medicinal products during the post-surgical period until the corneal epithelium integrity is fully restored.
Croatian: Nisu provedena formalna ispitivanja kompatibilnosti s Holoclarom i zato se ovaj lijek ne smije primjenjivati s drugim lijekovima tijekom razdoblja nakon kirurškog zahvata sve dok se cjelovitost epitela rožnice potpuno ne obnovi.
English: It will take several weeks to produce Holoclar.
Croatian: Priprema Holoclara trajat će nekoliko tjedana.
English: The container is put in a secondary plastic container which is then put in a sealed sterile plastic bag.
Croatian: Spremnik je stavljen u sekundarni plastični spremnik koji je zatim stavljen u zapečaćenu sterilnu plastičnu vrećicu.
English: Visit 1: Biopsy taken
Croatian: 1. posjet: Uzimanje bioptata
English: Holoclar is prepared individually from your own cells to match you, and must not be used for anyone other than yourself.
Croatian: Holoclar je pripremljen individualno od Vaših vlastitih stanica kako bi odgovarao Vama i ne smije se dati nikom drugom.
English: Patient's Forename and Surname:
Croatian: Ime i prezime bolesnika:
English: Each package contains an individual treatment dose which is large enough to cover your cornea.
Croatian: Svako pakiranje sadrži individualnu dozu za liječenje koja je dovoljno velika za pokrivanje Vaše rožnice.
English: Additional clinically-relevant parameters were evaluated as secondary efficacy assessments.
Croatian: Dodatni klinički važni pokazatelji procijenjeni su u sekundarnoj procjeni djelotvornosti.
English: After surgery, you will be prescribed a course of medicines to ensure full healing: antibiotics to reduce the chance of an infection and steroids to reduce swelling and irritation.
Croatian: Nakon kirurškog zahvata bit će Vam propisani lijekovi kako bi se osigurao potpun oporavak: antibiotici za smanjenje mogućnosti infekcije i steroidi za smanjenje oticanja i iritacije.
English: On the first visit, the surgeon will carry out a biopsy, which means removing a very small amount of tissue containing limbal cells (from your eye).
Croatian: Na prvom posjetu kirurg će napraviti biopsiju, što znači da će uzeti vrlo malu količinu tkiva s limbalnim stanicama (iz Vašeg oka).
English: Hypersensitivity to any of the excipients listed in section 6.1 or to bovine serum and murine 3T3-J2 cells.
Croatian: Preosjetljivost na neku od pomoćnih tvari navedenih u dijelu 6.1 ili na goveđi serum i mišje 3T3-J2
English: What Holoclar is and what it is used for
Croatian: Što je Holoclar i za što se koristi
English: Therefore, following treatment with Holoclar, driving and using machines must be limited and patients should follow the advice of their treating physician.
Croatian: Zbog toga se nakon postupka s Holoclarom upravljanje vozilima i rad sa strojevima mora ograničiti i bolesnici se trebaju pridržavati savjeta nadležnog liječnika.
English: The most frequently occurring reaction related to the surgical procedure was conjunctival haemorrhage (5%) which appears mostly during the first day after surgery and tends to be mild in intensity and disappears within a few days without treatment.
Croatian: Najčešća nuspojava povezana s kirurškim zahvatom bilo je krvarenje spojnice (5%) koje se većinom javljalo prvog dana nakon operacije te je bilo blagog intenziteta i povlačilo se unutar nekoliko dana bez liječenja.
English: Success of the procedure was evaluated based on the presence of a stable corneal epithelium (i.e. absence of epithelial defects) without significant recurrence of neovascularisation (no more than one quadrant without central corneal involvement) at 12 months post-intervention.
Croatian: Uspjeh zahvata procijenjen je na temelju prisutnosti stabilnog epitela rožnice (tj. bez oštećenja epitela) bez značajnog recidiva neovaskularizacije (ne više od jednog kvadranta bez zahvaćenosti središnjeg dijela rožnice) 12 mjeseci nakon intervencije.
English: Holostem Terapie Avanzate S.R.L, presso Centro di Medicina Rigenerativa “Stefano Ferrari”, Via Glauco Gottardi 100, 41100 Modena, Italy
Croatian: Holostem Terapie Avanzate S.R.L, presso Centro di Medicina Rigenerativa “Stefano Ferrari”, Via Glauco Gottardi 100, 41100 Modena, Italija
English: An incision of 2 x 2 mm is made to remove the biopsy.
Croatian: Učini se incizija od 2 x 2 mm kako bi se uzelo bioptat.
English: Prior to implantation the patient's name should be carefully checked with the patient/donor identification on the shipment documentation and product container.
Croatian: Prije implantacije treba pažljivo provjeriti odgovara li ime bolesnika identifikacijskim podacima bolesnika/donora na dokumentima za otpremu i spremniku s lijekom.
English: Do not use this medicine after the expiry date which is stated on the label.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti (EXP) navedenog na naljepnici.
English: Exceptions include non-topical antibiotics for prophylaxis and corticosteroids during the immediate post-operative period.
Croatian: Iznimka su ne-topički antibiotici za profilaksu i kortikosteroidi u razdoblju neposredno nakon kirurškog zahvata.
English: Keep the steel primary container tightly closed to protect from bacterial, fungal and viral contamination.
Croatian: Čelični primarni spremnik čuvati čvrsto zatvoren radi zaštite od bakterijske, gljivične i virusne kontaminacije.
English: By taking some healthy limbal cells, a new layer of healthy tissue is grown in the laboratory on a supporting layer of fibrin, a protein scaffold.
Croatian: Uzimanjem zdravih limbalnih stanica, u laboratoriju se može uzgojiti novi sloj zdravog tkiva na potpornom sloju fibrina, proteinskom nosaču.
English: Via Palermo, 26/A, Parma, 43122, Italy Phone: +39 0521 2791
Croatian: Via Palermo, 26/A, Parma, 43122, Italija Telefon: +39 0521 2791
English: Holoclar must not be sterilised.
Croatian: Holoclar se ne smije sterilizirati.
English: The cells used to make Holoclar are known as autologous limbal cells:
Croatian: Stanice koje se koriste za izradu Holoclara još se zovu autologne limbalne stanice:
English: This is the case if the biopsy is not good enough to make Holoclar, the cells cannot be grown in the laboratory or the grown cells do not meet all the quality requirements.
Croatian: To se može dogoditi u slučaju da bioptat nije dovoljno dobar da bi se pripremio Holoclar, stanice se ne mogu uzgojiti u laboratoriju ili uzgojene stanice nisu dovoljno kvalitetne.
English: For the manufacture of Holoclar, a biopsy of 1 - 2 mm2 of undamaged limbus is required.
Croatian: Za proizvodnju Holoclara potreban je bioptat veličine 1 - 2 mm2 neštećenog limbusa.
English: The proportion of patients with improvement in visual acuity was higher among those without a scar of the corneal stroma (15/18 patients, 83.3%) than in those with scarring (36/81 patients, 44.4%).
Croatian: Udio bolesnika s poboljšanjem oštrine vida bio je veći među onima bez ožiljka u stromi rožnice (15/18 bolesnika, 83,3%) nego u onih s ožiljkom (36/81 bolesnika, 44,4%).