FrancophonIA/ELRC3.0 huggingface dataset:
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Croatian: Vam se da ovaj lijek jer sadrži Vama važne podatke.
English: The proportion of patients with symptoms (pain, burning or photophobia) significantly decreased from pre-surgery (40 patients with at least one symptom; 38.5%) to one year after the procedure (12 patients; 11.5%).
Croatian: Udio bolesnika sa simptomima (bol, žarenje ili fotofobija) značajno se smanjio od prijeoperacijskog stanja (40 bolesnika s najmanje jednim simptomom; 38,5%) do godinu dana nakon zahvata (12 bolesnika; 11,5%).
English: When possible, concomitant eye problems should be corrected prior to Holoclar implantation.
Croatian: Popratne očne bolesti, kada je moguće, treba izliječiti prije implantacije Holoclara.
English: Other anaesthesiology procedures may be followed at the discretion of the surgeon.
Croatian: Mogu se primijeniti drugi anesteziološki postupci prema preporuci kirurga.
English: Post-biopsy treatment
Croatian: Liječenje nakon biopsije
English: Holoclar must not be irradiated or sterilised.
Croatian: Holoclar se ne smije ozračiti ili sterilizirati.
English: These results were confirmed in a sensitivity analysis where superficial neovascularisation was evaluated by an independent assessor from blinded photos of patients' eyes taken before and after Holoclar implantation.
Croatian: Ovi su podaci potvrđeni analizom osjetljivosti u kojoj je površinsku neovaskularizaciju procijenio neovisni procjenitelj na maskirani način uz pomoć fotografija očiju bolesnika snimljenih prije i poslije implantacije Holoclara.
English: The procedure of Holoclar administration include the use of antibiotics and corticosteroids (see section 4.2).
Croatian: Postupak primjene Holoclara uključuje primjenu antibiotika i kortikosteroida (vidjeti dio 4.2).
English: Handle with care, avoid any shaking, inverting or other mechanical stress.
Croatian: Pažljivo rukovati, izbjegavati protresanje, preokretanje ili drugi mehanički pritisak.
English: • Problems with cornea (erosion)
Croatian: • problemi s rožnicom (erozija)
English: If the Holoclar primary container is damaged, the visual appearance of the product is affected, visual particulates are identified, the product must not be used and must be returned to the manufacturer.
Croatian: Ako je primarni spremnik s Holoclarom oštećen, izgled lijeka promijenjen ili su vidljive čestice, lijek se ne smije primijeniti i mora se vratiti proizvođaču.
English: The cells are kept alive in a small sterile container.
Croatian: Stanice se održavaju živima u malom sterilnom spremniku.
English: Patients with acute ocular inflammation or infections should be deferred until recovery has been documented since inflammation may compromise treatment success.
Croatian: U bolesnika s akutnom upalom ili infekcijama oka zahvat treba odgoditi do dokumentiranog oporavka jer upala može ugroziti uspjeh liječenja.
English: - If you have any further questions, ask your surgeon.
Croatian: Ako imate dodatnih pitanja, obratite se svom kirurgu.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Holoclar in one or more subsets of the paediatric population in the treatment of limbal stem cell deficiency due to ocular burns (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Holoclar u jednoj ili više podskupina pedijatrijske populacije u liječenju nedostatka limbalnih matičnih stanica zbog opeklina oka (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Holoclar is given by surgery on your eye and this will impact on your ability to drive and use machines.
Croatian: Holoclar se primjenjuje kirurškim zahvatom na oku i to će utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: When categorical values for visual acuity were converted into the Logarithm of the Minimum Angle of Resolution (LogMAR), 47% of cases (40 over 85 with non-missing values) experienced an improvement equal or greater than 3 Snellen line equivalents.
Croatian: Kad su kategoričke vrijednosti za oštrinu vida preračunate u logaritam minimalnog kuta rezolucije (LogMAR), u 47% slučajeva (40 od 85 za koje nisu nedostajali podaci) postignuto je poboljšanje jednako ili veće od ekvivalenta 3 reda na Snellenovoj ploči.
English: Holoclar is intended solely for autologous use.
Croatian: Holoclar je namijenjen isključivo za autolognu primjenu.
English: • Bleeding around the site of the operation where Holoclar was inserted
Croatian: • krvarenje na mjestu kirurškog zahvata gdje je umetnut Holoclar
English: Two weeks after surgery, a topical corticosteroid treatment should be started with preservative-free dexamethasone 0.1% eye-drops, 1 drop three times per day for 2 weeks, then reduced to 1 drop twice daily for 1 week and 1 drop once daily for a further week.
Croatian: Dva tjedna nakon operacije treba započeti s topikalnom primjenom kortikosteroida kapima za oči s 0,1% deksametazona bez konzervansa; prva dva tjedna 1 kap tri puta na dan, zatim idući tjedan smanjiti na 1 kap dva puta na dan i zadnji tjedan 1 kap jednom dnevno.
English: Biopsy
Croatian: Biopsija
English: • Scarring of the conjunctiva (the protective layer over the white of your eye) with damage where it joins to the inside of the eyelids (fornix shortening)
Croatian: • ožiljke spojnice (zaštitni sloj preko bjeloočnice) s oštećenjem na mjestu gdje se spaja s vjeđama iznutra (skraćivanje forniksa)
English: Holoclar consists of a layer of your own cells which have been grown (ex vivo expanded) from a sample of limbal cells taken from your eye during a small surgical procedure called a biopsy.
Croatian: Holoclar se sastoji od sloja Vaših vlastitih stanica koje su uzgojene (umnožene ex vivo) iz uzorka limbalnih stanica uzetog iz Vašeg oka tijekom malog kirurškog zahvata koji se naziva biopsija.
English: The biopsy is performed using topical anaesthesia.
Croatian: Biopsija se izvodi uz topikalnu anesteziju.
English: Fifty-one patients (49.0%) had an improvement in visual acuity of at least one full line on a Snellen chart (or one category for the severely impaired cases).
Croatian: U pedeset i jednog bolesnika (49,0%) došlo je do poboljšanja oštrine vida za najmanje jedan cijeli red na Snellenovoj ploči (ili za jednu kategoriju u slučajevima teških oštećenja).
English: In the paediatric patients included in the studies HLSTM01 (age 13, 14 and 16 years) and HLSTM02 (age 8 and 14 years) the profile of adverse reactions was not different from the adult population.
Croatian: HLSTM01 (u dobi od 13, 14 i 16 godina) i HLSTM02 (u dobi od 8 i 14 godina) profil nuspojava nije bio različit od onoga u odrasloj populaciji.
English: Holoclar contains lethally-irradiated murine 3T3 fibroblast cells and may contain traces of foetal bovine serum.
Croatian: Holoclar sadrži letalno ozračene 3T3 mišje fibroblaste i može sadržavati tragove fetalnog goveđeg seruma.
English: In some cases it may be possible that the source limbal stem cells of the patient are not expandable or that the release criteria are not met, due to poor biopsy quality, patient characteristics, or manufacturing failure.
Croatian: U nekim slučajevima postoji mogućnost da se uzete limbalne matične stanice bolesnika ne mogu umnožiti ili nisu postignuti kriteriji za puštanje u promet zbog loše kvalitete bioptata, značajki bolesnika ili greške u proizvodnom postupku.
English: The HLSTM01 study enrolled a total of seven patients (6.7% of the study population) with an age at baseline of 65 years or above, and seven additional patients (24.1%) were included in HLSTM02.
Croatian: U ispitivanje HLSTM01 bilo je uključeno ukupno sedam bolesnika (6,7% ispitivane populacije) u dobi od 65 ili više godina na početku ispitivanja te je dodatnih sedam (24,1%) bilo uključeno u ispitivanje HLSTM02.
English: Immunohistochemical analysis of cornea taken from patients receiving keratoplasty after Holoclar treatment demonstrated that the transplanted stem cells establish a normal layer of stratified corneal epithelium, which do not migrate or invade basal ocular structures.
Croatian: Imunohistokemijska analiza rožnice uzete od bolesnika s keratoplastikom nakon liječenja Holoclarom pokazala je da transplantirane matične stanice uspostavljaju normalni sloj stratificiranog epitela rožnice, te da ne migriraju i ne invadiraju bazalne strukture oka.
English: Since this medicine will be used during your surgery, the hospital staff are responsible for the correct storage of the medicine before and during its use, as well as for the correct disposal.
Croatian: Budući da će se lijek primijeniti tijekom kirurškog zahvata, za pravilno čuvanje lijeka prije i tijekom primjene, kao i za pravilno odlaganje, odgovorno je bolničko osoblje.
English: On the day of surgery, the surgeon will anesthetise your eye and then will attach the edge of your new cornea with stitches to make sure that Holoclar stays in place.
Croatian: Na dan kirurškog zahvata, kirurg će Vam anestezirati oko i zatim pričvrstiti rub Vaše nove rožnice šavovima kako bi Holoclar ostao na mjestu.
English: Concomitant eyelids malposition, conjunctival scarring with fornix shortening, corneal anaesthesia and/or conjunctival anaesthesia or severe hypoaesthesia, pterygium and severe dry eye are potential complicating factors.
Croatian: Popratna malpozicija vjeđa, ožiljci spojnice sa skraćivanjem forniksa, anestezija rožnice i/ili anestezija spojnice ili teška hipoestezija, pterigij i težak oblik suhog oka mogu biti rizični čimbenici za komplikacije.
English: Benzalkonium chloride (as well as other quaternary ammonium compounds) is cytotoxic and eyedrops containing this preservative may damage the newly-regenerated corneal epithelium.
Croatian: Benzalkonijev klorid (kao i drugi kvarterni amonijevi spojevi) je citotoksičan i kapi za oči koje ga sadrže mogu oštetiti novostvoreni epitel rožnice.
English: Telephone: +3905212791 Telefax: +390521 774468 E-Mail: info@chiesigroup.com
Croatian: Telefaks: +390521 774468 elektronička pošta: info@chiesigroup.com
English: The administration should be followed by an appropriate antibiotic and anti-inflammatory treatment schedule, as recommended by the physician (see section 4.4).
Croatian: Nakon primjene treba uslijediti odgovarajuće antibiotsko i protuupalno liječenje, prema preporuci liječnika (vidjeti dio 4.4).
English: This layer of tissue is then implanted by a surgeon into the damaged cornea helping your eye to heal normally.
Croatian: Taj sloj tkiva kirurg zatim implantira u oštećenu rožnicu što pomaže Vašem oku da normalno zacijeli.
English: These tests included cell karyotype, cell growth in soft agar and growth factor-dependent proliferation.
Croatian: Ta su ispitivanja uključivala kariotipizaciju stanica, stanični rast u mekom agaru i proliferaciju ovisnu o čimbenicima rasta.
English: Store between 15 °C - 25 °C
Croatian: Čuvati na temperaturi između 15 °C i 25 °C
English: Each preparation of Holoclar is intended as a single treatment.
Croatian: Svaki pripravak Holoclara namijenjen je za jedan postupak liječenja.
English: After 2 weeks the systemic antibiotic administration should be stopped and the daily dose of prednisone should be tapered to 0.25 mg/kg (maximum 12.5 mg) per day for 1 week, to 0.125 mg/kg (maximum 5.0 mg) per day for the following week and then stopped.
Croatian: Nakon 2 tjedna sistemsku primjenu antibiotika treba obustaviti, a dnevnu dozu prednizona smanjiti na 0,25 mg/kg (najviše 12,5 mg) po danu tijekom jednog tjedna, zatim smanjiti na 0,125 mg/kg (najviše 5,0 mg) po danu u sljedećem tjednu i zatim obustaviti.
English: For relevant safety information, physicians should consult the SmPC of these medicinal products.
Croatian: Za relevantne informacije o sigurnosti primjene, liječnici bi trebali pročitati sažetak opisa svojstava tih lijekova.
English: Your eyelid will be taped closed for three days and your eye will be bandaged for 10 to 15 days after the implantation.
Croatian: Nakon implantacije tri dana će vam vjeđe biti zalijepljene trakom, a oko će Vam biti zavijeno 10 do 15 dana.
English: - There are two excipients: one is fibrin - a clear supportive layer used to keep Holoclar intact, the other one is a liquid containing amino acids, vitamins, salts and carbohydrates to store the cells in the vial called Dulbecco's Modified Eagles Medium supplemented with L-glutamine.
Croatian: - Sadrži i dvije pomoćne tvari: jedna je fibrin - prozirni nosač koji čuva Holoclar od oštećenja, a druga je tekućina koja sadrži aminokiseline, vitamine, soli i ugljikohidrate za čuvanje stanica u bočici i koja se zove Eagleova podloga modificirana po Dulbeccu obogaćena L-glutaminom).
English: As a precautionary measure, and in light of the requirement of the post-operative pharmacological treatment, it is preferable to avoid the use of Holoclar during pregnancy.
Croatian: Kao mjera opreza i budući da je poslije kirurškog zahvata potrebno farmakološko liječenje, preporučuje se izbjegavati primjenu lijeka Holoclar tijekom trudnoće.
English: The most serious side effects are problem with cornea (erosion) and perforation of the cornea, which may occur within the 3 months from Holoclar implantation.
Croatian: Naajozbiljnije nuspojave su problem s rožnicom (erozija) i perforacija rožnice, koje mogu nastati unutar 3 mjeseca od implantacije Holoclara.
English: • Remove the scarred surface of the cornea
Croatian: • ukloniti ožiljkastu površinu rožnice
English: Holoclar consists of a transparent circular sheet of 300,000 to 1,200,000 viable autologous human corneal epithelial cells (79,000 - 316,000 cells/cm2), including on average 3.5% (0.4 to 16%) limbal stem cells, and stem cell-derived transient amplifying and terminally differentiated cells, attached on a supportive 2.2 cm diameter fibrin layer and maintained in the transport medium.
Croatian: Holoclar se sastoji od prozirnog okruglog listića s 300 000 do 1 200 000 vijabilnih autolognih epitelnih stanica ljudske rožnice (79 000 - 316 000 stanica/cm2), uključujući prosječno 3,5% (0,4 do 16%) limbalnih matičnih stanica, te usmjerene progenitorske stanice i završno diferencirane stanice nastale iz matičnih stanica, pričvršćene na potporni fibrinski sloj promjera 2,2 cm i čuvaju se u transportnoj podlozi.
English: A minimum of 1 - 2 mm2 of undamaged limbus is required for biopsy.
Croatian: Za biopsiju je potrebno najmanje 1 - 2 mm2 neoštećenog limbusa.
English: Do not use eye-drops containing benzalkonium chloride and/or other preservatives.
Croatian: Nemojte koristiti kapi za oči koje sadrže benzalkonijev klorid i/ili druge konzervanse.
English: Fertility No clinical data on the effects of Holoclar on fertility are available.
Croatian: Nema dostupnih kliničkih podataka o učincima Holoclara na plodnost.
English: The efficacy of the medicinal product was evaluated in a multi-centre, case-series, non-controlled, retrospective cohort study in 106 patients (HLSTM01 study) of both genders, treated for the presence of a moderate to severe limbal stem cell deficiency (LSCD).
Croatian: Djelotvornost lijeka procijenjena je u multicentričnom, nekontroliranom, retrospektivnom, kohortnom ispitivanju serije slučajeva u 106 bolesnika (ispitivanje HLSTM01) oba spola, liječenih zbog umjerenog do teškog nedostatka limbalnih matičnih stanica (LSCD, engl. limbal stem cell deficiency).
English: In vitro studies have revealed no evidence of anchorage-independent growth indicative of tumorigenic potential.
Croatian: In vitro ispitivanja nisu dokazala rast neovisan o čvrstoj podlozi koji upućuje na tumorogeni potencijal.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Chiesi Farmaceutici S.P.A, Via Palermo 26/A 43122 Parma, Italy
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Chiesi Farmaceutici S.P.A, Via Palermo 26/A 43122 Parma, Italija
English: The following regimen is suggested: Doxycycline 100 mg tablets twice daily (or amoxicillin 500 mg twice daily) and prednisone orally at a daily dose of 0.5 mg/kg (to a maximum dose of 25 mg) per day should be administered from the day of surgery for 2 weeks.
Croatian: Predlaže se sljedeći režim: Treba davati doksiciklin tablete od 100 mg dva puta dnevno (ili amoksicilin od 500 mg dva puta dnevno) i prednizon peroralno u dnevnoj dozi od 0,5 mg/kg (do najveće doze od 25 mg) od dana operacije tijekom 2 tjedna.
English: The following additional risk minimisation measures are necessary for the safe and effective use of the product:
Croatian: Za sigurnu i djelotvornu primjenu ovog lijeka potrebne su sljedeće dodatne mjere minimizacije rizika:
English: The surgical nature of the underlying procedure for the implantation of Holoclar has a major influence on the ability to drive and use machines.
Croatian: Kirurška priroda osnovnog postupka implantacije Holoclara značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: What Holoclar contains - The active substance consists of 300,000 - 1,200,000 of your living eye cells, on average 3.5% of which are stem cells.
Croatian: Što Holoclar sadrži - Djelatna tvar se sastoji od 300 000 do 1 200 000 živih stanica Vašeg oka od kojih su prosječno 3,5% matične stanice.
English: PHARMACEUTICAL FORM Living tissue equivalent.
Croatian: OBLIK Ekvivalent živoga tkiva.
English: Each preparation of Holoclar contains an individual treatment dose with sufficient number of cells to cover the entire corneal surface.
Croatian: Svaki pripravak Holoclara sadrži individualnu terapijsku dozu s dovoljnim brojem stanica za pokrivanje cijele površine rožnice.
English: It is the rim surrounding the coloured centre (iris) of your eye.
Croatian: To je obruč koji okružuje šarenicu (iris) Vašeg oka.
English: At the time of product administration, the mean duration of the condition since the injury was 18 years (median 10 years), 99% of patients had corneal opacity and 90% of them had a severe impairment in visus (1/10th or less at Snellen chart).
Croatian: prosjek trajanja stanja nakon ozljede bio je 18 godina (medijan: 10 godina), 99% bolesnika imalo je zamućenje rožnice, a 90% njih imalo je teško oštećenje vida (1/10 ili manje prema Snellenovoj ploči).
English: Holoclar must be administered by an appropriately trained and qualified surgeon and is restricted to hospital use only.
Croatian: Holoclar mora primijeniti odgovarajuće obučen i osposobljen kirurg i to isključivo u bolnici.
English: You must not be given Holoclar: - if you are allergic to any of the ingredients of this medicine (listed in section 6) or to bovine serum and mouse cells
Croatian: - ako ste alergični na bilo koji sastojak ovog lijeka (naveden u dijelu 6.) ili na goveđi serum i mišje stanice.
English: Treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns.
Croatian: Liječenje odraslih bolesnika s umjerenim do teškim jednostranim ili obostranim nedostatkom limbalnih matičnih stanica (definiran prisutstvom površinske neovaskularizacije rožnice u najmanje dva kvadranta rožnice sa zahvaćanjem središnjeg dijela rožnice i teškim oštećenjem oštrine vida) zbog fizikalnih ili kemijskih opeklina oka.
English: This medicinal product is intended for autologous use only.
Croatian: Ovaj lijek namijenjen je samo za autolognu primjenu.
English: • Increased pressure in the eye (glaucoma)
Croatian: • povišen očni tlak (glaukom)
English: No interactions between Holoclar and the post-biopsy/post-operative treatment suggested in section 4.2 have been reported.
Croatian: Nisu zabilježene interakcije Holoclara s liječenjem nakon biopsije/nakon kirurškog zahvata predloženim u dijelu 4.2.
English: Holoclar is intended solely for use in autologous limbal stem cell regeneration in line with the approved therapeutic indication and should be administered under aseptic conditions in conjunction with limbal peritomy, undermining of the conjunctiva and excision of the corneal fibrovascular tissue in preparation of the defect bed.
Croatian: Holoclar je namijenjen samo za regeneraciju autolognih limbalnih matičnih stanica sukladno odobrenoj terapijskoj indikaciji i treba ga primijeniti u aseptičnim uvjetima zajedno s limbalnom peritomijom, odižući spojnicu, uz eksciziju fibrovaskularnog tkiva rožnice za pripremu ležišta oštećenja.
English: Pregnancy There are no data for the use of Holoclar in pregnant women.
Croatian: Nema podataka o primjeni Holoclara u trudnica.
English: Multinational, multicentre, prospective, open-label, uncontrolled interventional study (HLSTM03) to assess the efficacy and safety of autologous cultivated limbal stem cells grafting for restoration of corneal epithelium in patients with limbal stem cell deficiency due to ocular burns
Croatian: Multinacionalno, multicentrično, prospektivno, otvoreno nekontrolirano intervencijsko ispitivanje (HLSTM03) za procjenu djelotvornosti i sigurnosti presađivanja uzgojenih autolognih limbalnih matičnih stanica za obnovu epitela rožnice u bolesnika s nedostatkom limbalnih matičnih stanica zbog opeklina oka
English: Holoclar is a medicine used for replacing damaged cells of the cornea (the clear layer that covers the coloured iris at the front of the eye) including limbal cells which normally help to maintain the health of your eye.
Croatian: Holoclar je lijek koji se koristi za nadomještanje oštećenih stanica rožnice (proziran sloj koji pokriva šarenicu i prednji dio oka) uključujući limbalne stanice koje prirodno pomažu u održavanju zdravlja
English: Finally, the thermally insulated box is put in a zipped sealable bag for transportation.
Croatian: Naposljetku, termoizolacijska kutija spremljena je u zatvorenu vrećicu sa zip zatvaračem za transport.
English: Before the biopsy, the surgeon will give you eyedrops to anaesthetise your eye and surgically take the biopsy.
Croatian: Prije biopsije kirurg će Vam ukapati kapi za anesteziju oka i zatim kirurški uzeti bioptat.
English: After biopsy has been taken, your surgeon will prescribe a course of antibiotics for you to reduce the chance of an infection.
Croatian: Nakon biopsije kirurg će Vam propisati antibiotik kako bi se smanjila mogućnost infekcije.
English: Holoclar is supplied as one individual treatment dose contained in a screw-cap container.
Croatian: Holoclar se isporučuje kao jedna individualna terapijska doza sadržana u spremniku zatvorenom navojnim zatvaračem.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Holoclar
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Holoclar
English: • Eye disorders - stickiness of the eyelid, bloodshot eyes, swelling of the eye, perforation of the cornea and eye irritation
Croatian: • poremećaji oka - ljepljivost vjeđa, krvave oči, oticanje oka, pucanje rožnice i nadraženost oka
English: Even if the surgeon has already taken a small sample of limbal cells (a biopsy) needed to produce the medicine, it is possible that you will not be able to have treatment with Holoclar.
Croatian: Drugi slučajevi u kojima se ne može primijeniti Holoclar Čak i ako je kirurg već uzeo mali uzorak limbalnih stanica (bioptat) potreban za pripremu lijeka, moguće je da se postupak liječenja Holoclarom ipak neće moći provesti.
English: Following implantation, an appropriate regimen of topical and systemic anti-inflammatory and prophylactic antibiotic treatment must be given.
Croatian: Nakon implantacije se mora provesti primjereno topikalno i sistemsko protuupalno i profilaktičko antibiotsko liječenje.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Holoclar Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: • Growth of the conjunctiva over the cornea (pterygium)
Croatian: • rast spojnice preko rožnice (pterigij)
English: Fibrin support.
Croatian: Fibrinski nosač.
English: Post-operative treatment
Croatian: Liječenje nakon operacije
English: Holoclar can only be prescribed and given by an eye surgeon in a hospital.
Croatian: Kako se daje Holoclar Holoclar može propisati i dati samo oftalmološki kirurg u bolnici.