FrancophonIA/ELRC3.0 huggingface dataset:
English: a) The administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Croatian: kontrolu ili iskorjenjivanje bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živih životinja ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009
Croatian: Djelatna tvar koja se sastoje od tvari biološkog podrijetla, namijenjena je za stvaranje aktivne imunosti, na koju se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
English: Shelf-life after first opening the immediate packaging: use immediately after broaching.
Croatian: Rok valjanosti nakon prvog otvaranja unutarnjeg pakovanja: primijeniti neposredno nakon otvaranja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1 x 20ml, 1 x 100ml and 1 x 240 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Vanjska kartonska kutija 1 x 20 ml, 1 x 100 ml i 1 x 240 ml
English: In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used.
Croatian: Radi izbjegavanja slučajne kontaminacije cjepiva tijekom primjene većih doza preporučuje se upotreba sustava cijepljenja s višestrukim ubrizgavanjem.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka doza od 2 ml sadrži:
English: PACKAGE LEAFLET: Zulvac 1 Ovis suspension for injection for sheep
Croatian: Zulvac 1 Ovis suspenzija za injekciju za ovce
English: Vaccination may be followed very commonly by a local reaction at the injection site.
Croatian: Vrlo često može doći do lokalne reakcije na mjestu ubrizgavanja.
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Croatian: POSEBNA UPOZORENJA, AKO JE POTREBNO Pročitati uputu o VMP prije primjene.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. Once broached use immediately.
Croatian: Ne upotrebljavati ovaj veterinarsko-medicinski proizvod nakon datuma isteka roka valjanosti naznačenog na etiketi.
English: Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 Aluminium hydroxide, saponin and thiomersal.
Croatian: Inaktivirani virus bolesti plavog jezika, serotip 1, soj BTV-1/ALG2006/01 E1 Aluminijev hidroksid, saponin i tiomersal.
English: Onset of immunity: 21 days after completion of the primary vaccination scheme Duration of immunity: 12 months after completion of the primary vaccination scheme 4.3 Contraindications
Croatian: Početak imunosti: 21 dan nakon završetka primarne sheme cijepljenja Trajanje imunosti: 12 mjeseci nakon završetka primarne sheme cijepljenja
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Inactivated viral vaccines - Bluetongue virus.
Croatian: Farmakoterapijska grupa: inaktivirana virusna cjepiva -virus bolesti plavog jezika.
English: Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Croatian: Shemu revakcinacije treba utvrditi nadležno tijelo ili odgovorni veterinar uzimajući u obzir lokalnu epidemiološku situaciju.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/131/001
Croatian: 16. BROJEVI ODOBRENJA ZA STAVLJANJE U PROMET EU/2/11/131/001
English: The safety and the efficacy of the vaccine have not been established in breeding males.
Croatian: Neškodljivost i djelotvornost cjepiva nisu utvrđene za rasplodne mužjake.
English: Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1 *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
Croatian: Inaktivirani virus bolesti plavog jezika, serotip 1, soj BTV-1/ALG2006/01 E1 RP* ≥ 1 *Relativna potentnost dobivena testiranjem na miševima u usporedbi s referentnim cjepivom koje se pokazalo djelotvornim kod ovaca.
English: Cardboard box with one type II glass vial of either 100 ml (containing 50 doses) or 240 ml (containing 120 doses) with a chlorobutyl rubber stopper and aluminium cap.
Croatian: Kartonska kutija s jednom staklenom bočicom tipa II od 100 ml (koja sadrži 50 doza) ili 240 ml (koja sadrži 120 doza) s klorbutilnim gumenim čepom i aluminijskom kapicom.
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
Croatian: U ovoj kategoriji životinja cjepivo bi trebalo primjenjivati samo u skladu s procjenom odgovornog veterinara o odnosu koristi i rizika i/ili u skladu s odlukama nacionalnog nadležnog tijela o trenutačnim smjernicama cijepljenja protiv virusa bolesti plavog jezika (engl.
English: Pack sizes
Croatian: Veličine pakovanja
English: Name and address of the manufacturer of the biological active substance(s)
Croatian: Naziv i adresa proizvođača biološki djelatnih tvari
English: To stimulate active immunity against Bluetongue Virus, serotype 1 in sheep.
Croatian: Za stimulaciju aktivne imunosti ovaca protiv virusa bolesti plavog jezika, serotipa 1.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Croatian: Sukladno članku 71. Direktive 2001/82/EZ i Europskog Parlamenta i Vijeća s izmjenama i dopunama, države članice, u skladu s nacionalnim zakonodavstvom mogu zabraniti proizvodnju, uvoz, posjedovanje,
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml and 240 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Etiketa za bočicu od 100 ml i 240 ml
English: Aluminium hydroxide
Croatian: Aluminijev hidroksid Saponin
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 August 2011
Croatian: Datum prvog odobrenja: 05/08/2011
English: No data is available on safety in lactating animals.
Croatian: Podaci o neškodljivosti primjene na životinjama u laktaciji nisu dostupni.
English: WITHDRAWAL PERIOD(S) Withdrawal period(s): Zero days.
Croatian: Karencija(e): nula dana.
English: The use in lactating animals is therefore not recommended.
Croatian: Ne preporuča se upotreba proizvoda kod životinja u laktaciji.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Per dose of 2 ml
Croatian: KOLIČINA DJELATNE(IH) TVARI Po dozi od 2 ml:
English: Cardboard box with one type I glass vial of 20 ml (containing 10 doses) with a chlorobutyl rubber stopper and aluminium cap.
Croatian: I od 20 ml (koja sadrži 10 doza) s klorbutilnim gumenim čepom i aluminijskom kapicom.
English: STATEMENT OF ACTIVE SUBSTANCES Per dose of 2 ml
Croatian: SASTAV DJELATNIH TVARI Po dozi od 2 ml:
English: A transient increase in rectal temperature, not exceeding 1.2 °C, may occur very commonly during the 24 hours following vaccination.
Croatian: NUSPOJAVE Tijekom 24 sata od cijepljenja vrlo često može doći do prolaznog povišenja rektalne temperature koje ne premašuje 1,2 °C.
English: For active immunisation of sheep from 1 and a half months of age for the prevention* of viraemia caused by Bluetongue Virus (BTV), serotypes 1.
Croatian: Za aktivnu imunizaciju ovaca nakon navršenih 1,5 mjeseci starosti radi prevencije* viremije uzrokovane virusom bolesti plavog jezika (engl.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČI ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: Marketing authorisation holder Zoetis Belgium SA Rue Laid Burniat 1
Croatian: Nositelj odobrenja za stavljanje u promet Zoetis Belgium SA
English: These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 9 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 63 days).
Croatian: U većini slučajeva te se reakcije manifestiraju kao otekline na mjestu ubrizgavanja (ne traju dulje od 9 dana) ili kao opipljivi čvorići (subkutani granulomi, mogu potrajati dulje od 63 dana).
English: These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 7 days) or of palpable nodules (subcutaneous granuloma possibly persisting for more than 48 days).
Croatian: U većini slučajeva te reakcije se manifestiraju kao otekline na mjestu ubrizgavanja (koje ne traju dulje od 7 dana) ili kao opipljivi čvorići (subkutani granulomi, mogu potrajati dulje od 48 dana).
English: These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 9 days) or of palpable nodules (subcutaneous granuloma possibly persisting for more than 63 days).
Croatian: U većini slučajeva se te reakcije manifestiraju kao otekline na mjestu ubrizgavanja (ne traju dulje od 9 dana) ili kao opipljivi čvorići (potkožni granulomi, mogu potrajati dulje od 63 dana).
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
English: Ctra.
Croatian: C.
English: PACKAGE SIZE 20 ml (10 doses) 100 ml (50 doses) 240 ml (120 doses)
Croatian: 20 ml (10 doza)
English: EU/1/12/794/001
Croatian: EU/1/12/794/001 Adcetris
English: Adcetris 50 mg Powder for concentrate for solution for infusion
Croatian: 50 mg Prašak za koncentrat za otopinu za infuziju
English: MA (EU) number
Croatian: <EMA broj postupka> <Broj (EU) odobrenja>
English: In the first stage of treatment, a small part of healthy limbal tissue (1−2 mm2 in size) is taken from the patient in hospital and sent to the manufacturer on the same day.
Croatian: U prvoj fazi liječenja mali dio zdravog limbalnog tkiva (veličine 1−2 mm2) uzima se iz bolesnika u bolnici i šalje se proizvođaču istog dana.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Holoclar on 17 February 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Holoclar na snazi u Europskoj uniji od 17. veljače 2015.
English: Holoclar is intended for a single treatment, although treatment can be repeated if the doctor considers it necessary.
Croatian: Holoclar je namijenjen za jednokratnu primjenu, iako se terapija može ponoviti ukoliko to liječnik smatra potrebnim.
English: Other information about Holoclar
Croatian: Ostale informacije o lijeku Holoclar
English: It is not intended to provide practical advice on how to use Holoclar.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Holoclar.
English: Why is Holoclar approved?
Croatian: Zašto je Holoclar odobren?
English: Next, the cells in the tissue are grown in a laboratory and frozen until the date of surgery is confirmed.
Croatian: Zatim se stanice u tkivu uzgajaju u laboratoriju i zamrzavaju se sve do trenutka potvrde kirurškog zahvata.
English: There were also reductions in patients' symptoms, such as pain and inflammation, and improvements in vision.
Croatian: Prisutno je također smanjenje u simptomima bolesnika, poput boli i upale, te poboljšanja u vidu.
English: Holoclar has therefore been given ‘conditional approval'.
Croatian: Za lijek Holoclar izdano je „uvjetno odobrenje”.
English: This is a summary of the European public assessment report (EPAR) for Holoclar.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Holoclar.
English: Holoclar is a type of advanced therapy product called a ‘tissue engineered product'.
Croatian: Holoclar je vrsta lijeka za naprednu terapiju koji se naziva „medicinski proizvod dobiven iz tkiva”.
English: What measures are being taken to ensure the safe and effective use of Holoclar?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Holoclar?
English: What is Holoclar and what is it used for?
Croatian: Što je Holoclar i za što se koristi?
English: Educational material will also be provided to patients undergoing treatment.
Croatian: Edukacijski materijali također će biti dostavljeni bolesnicima koji idu na ovo liječenje.
English: Following the surgery, the patient should receive antibiotics and an appropriate antiinflammatory medicine.
Croatian: Nakon kirurškog zahvata, bolesnik treba primiti antibiotike i odgovarajući protuupalni lijek.
English: One year after Holoclar implantation, 75 out of 104 patients studied (72%) were judged to have had successful implants based on the presence of stable corneal surface with no surface defects and little or no ingrown blood vessels (a common feature of limbal stem-cell deficiency).
Croatian: Godinu dana nakon ugradnje lijeka Holoclar, kod 75 od 104 (72%) ispitanih bolesnika ocijenjeno je da je ugradnja bila uspješna na temelju prisutnosti stabilne površine rožnice bez površinskih nedostataka te s malo ili bez uraslih krvnih žila (zajednička karakteristika nedostatka limbalnih matičnih stanica).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Holoclar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Holoclar dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The full EPAR and risk management plan summary for Holoclar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i plan upravljanja rizikom za lijek Holoclar nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Because the number of patients with limbal stem-cell deficiency due to burns to the eyes is low, the disease is considered ‘rare', and Holoclar was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 November 2008.
Croatian: Budući da je broj bolesnika s nedostatkom limbalnih matičnih stanica malen, ta se bolest smatra „rijetkom” te je lijek Holoclar uvršten u skupinu lijekova za rijetke bolesti 7. studenog 2008.
English: The most common side effect with Holoclar (seen in more than 1 patient in 10) is blepharitis (inflammation of the eye lid).
Croatian: Najčešća nuspojava lijeka Holoclar (uočena kod više od 1 na 10 bolesnika) je blefaritis (upala očnog kapka).
English: A risk management plan has been developed to ensure that Holoclar is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Holoclar.
English: The Committee noted that that moderate to severe forms of limbal stem-cell deficiency are serious conditions which, if untreated, can lead to severe reduction or complete loss of vision.
Croatian: Odbor je napomenuo da su umjereni do ozbiljni oblici nedostatka limbalnih matičnih stanica ozbiljna stanja koja, bez liječenja mogu rezultirati ozbiljnim smanjenjem ili potpunim gubitkom vida.
English: What are the risks associated with Holoclar?
Croatian: Koji su rizici povezani s lijekom Holoclar?
English: The conclusion on the benefit-risk balance of Holoclar is based on results of two retrospective studies (using past medical records), and the company is to provide further data from a prospective study (that records outcomes during the course of the study).
Croatian: Zaključak o omjeru koristi i rizika za lijek Holoclar temelji se na rezultatima retrospektivnih ispitivanja (primjenom prošle medicinske evidencije), a tvrtka treba dostaviti dodatne podatke o budućem ispitivanju (koje bilježi ishode tijekom trajanja ispitivanja).
English: As the side effects of Holoclar treatment are generally manageable, the CHMP concluded that Holoclar's benefits outweigh its risks and recommended that it be approved for use in the EU.
Croatian: Budući da se nuspojavama lijeka Holoclar u pravilu može upravljati, CHMP je zaključio da koristi od lijeka Holoclar nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: The company is to provide data on the benefits and risks of Holoclar from a prospective clinical study.
Croatian: Tvrtka treba također dostaviti podatke o koristima i rizicima lijeka Holoclar iz budućih kliničkih ispitivanja.
English: It consists of cells taken from the patient's limbus (at the edge of the cornea) and then grown in a laboratory so that they can be used to repair the damaged corneal surface.
Croatian: Sastoji se od stanica koje se uzimaju iz limbusa bolesnika (uz rub rožnice) te se zatim uzgajaju u laboratoriju tako da se mogu koristiti za popravak oštećene površine rožnice.
English: Before Holoclar is used, the damaged corneal surface tissue of the affected eye is removed.
Croatian: Prije primjene lijeka Holoclar uklanja se oštećeno površinsko tkivo zahvaćenog oka.
English: Since Holoclar has been granted a conditional approval, the company that markets Holoclar will provide further data on Holoclar.
Croatian: Budući da je lijek Holoclar dobio uvjetno odobrenje, tvrtka koja lijek Holoclar stavlja u promet mora dostaviti dodatne podatke o lijeku Holoclar.
English: In addition, the company that makes Holoclar will provide healthcare professionals with educational material on the safe use of this treatment, including on the selection and follow-up of patients and on reporting side effects.
Croatian: Nadalje, tvrtka koja proizvodi Holoclar dostavit će zdravstvenim djelatnicima edukacijske materijale o sigurnoj primjeni ove terapije, uključujući o odabiru i kontrolama bolesnika te o načinima prijave nuspojava.
English: Patients with this condition do not have enough limbal stem cells which normally act as a regeneration system, replenishing the outer corneal cells when they get damaged and when they age.
Croatian: Bolesnici s ovim stanjem nemaju dovoljno limbalnih matičnih stanica, koje normalno djeluju kao regeneracijski sustav, odbijajući vanjske stanice rožnice u slučaju oštećenja i starenja.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Holoclar treatment was effective in restoring healthy corneal surfaces in patients with moderate or severe limbal stem-cell deficiency caused by burns as well as in improving their symptoms and vision.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je terapija lijekom Holoclar podjednako učinkovita u uspostavljanju zdrave površine rožnice u bolesnika s umjerenim ili teškim nedostatkom limbalnih matičnih stanica uzrokovanim opeklinama kao i u poboljšavanju njihovih simptoma i vida.
English: It is used in adult patients with moderate to severe limbal stem-cell deficiency caused by burns, including chemical burns, to the eyes.
Croatian: Koristi se u odraslih bolesnika s umjerenim do teškim nedostatkom limbalnih matičnih stanica uzrokovanim opeklinama, uključujući kemijske opekline oka.
English: Thawed cells are used to make Holoclar by growing them on a membrane made of a protein called fibrin.
Croatian: Odmrznute stanice koriste se za pripremu lijeka Holoclar tako što se uzgajaju na membrani izrađenoj od proteina naziva fibrin.
English: Antibiotics to prevent eye infection should be given to patients after limbal tissue has been taken from them.
Croatian: Antibiotik za sprječavanje infekcije oka treba primijeniti u bolesnika nakon uzimanja limbalnog tkiva iz bolesnika.
English: Holoclar, comprising the cells and the membrane, is then sent back to the hospital, where it is immediately surgically implanted in the patient's eye.
Croatian: Holoclar, koji se sastoji od stanica i membrane, zatim se šalje natrag u bolnicu, gdje se odmah ugrađuje kirurškim putem u oko bolesnika.
English: What information is still awaited for Holoclar?
Croatian: Koje se još informacije očekuju o lijeku Holoclar?
English: Holoclar must only be used by an appropriately trained and qualified eye surgeon in a hospital, and must only be given to the patient whose limbal cells were used to manufacture the medicine.
Croatian: Holoclar mora primijeniti odgovarajuće obučen i osposobljen kirurg i to isključivo u bolnici, te se smije primjenjivati samo u bolesnika čije se limbalne stanice koriste za proizvodnju lijeka.
English: What benefits of Holoclar have been shown in studies?
Croatian: Koje koristi lijeka Holoclar su dokazane u ispitivanjima?
English: For more information about treatment with Holoclar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Holoclar pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: How does Holoclar work?
Croatian: Kako djeluje Holoclar?
English: Once implanted in the eye, the corneal cells of Holoclar help to replace the corneal surface, while the limbal stem cells serve as a reservoir of new cells that continuously replenish the cornea.
Croatian: Nakon ugradnje u oko, stanice rožnice lijeka Holoclar pomažu pri zamjeni površine rožnice, dok limbalne matične stanice služe kao spremnik za nove stanice koje kontinuirano odbijaju rožnicu.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Holoclar, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Holoclar nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Holoclar ex vivo expanded autologous human corneal epithelial cells containing stem cells
Croatian: Holoclar ex vivo umnožene autologne epitelne stanice ljudske rožnice koje sadrže matične stanice
English: How is Holoclar used?
Croatian: Kako se Holoclar koristi?
English: Holoclar was shown to be effective in restoring a stable corneal surface in patients with moderate or severe limbal stem-cell deficiency caused by burns in a retrospective study using patients' past medical records.
Croatian: Dokazano je da je Holoclar djelotvoran u uspostavljanju stabilne površine rožnice u bolesnika s umjerenim do teškim nedostatkom limbalnih matičnih stanica uzrokovanim opeklinama u retrospektivnim ispitivanju na temelju prethodne medicinske evidencije bolesnika.
English: Holoclar is a stem-cell treatment used in the eye to replace damaged cells on surface (epithelium) of the cornea, the transparent layer in front of the eye covering the iris (the coloured part).
Croatian: Holoclar je terapija matičnim stanicama koja se primjenjuje na oko u svrhu zamjene oštećenih stanica na površini (epitelu) rožnice, prozirnog dijela ispred oka koji pokriva šarenicu (obojani dio).
English: The active substance in Holoclar is the patient's own limbal cells, which include cells from the surface of the cornea and limbal stem cells grown in a laboratory.
Croatian: Djelatna tvar lijeka Holoclar nalazi se u limbalnim stanicama bolesnika, koje uključuju stanice s površine rožnice i limbalne matične stanice uzgojene u laboratoriju.