natgillin/translations-raw huggingface dataset:
Holoclar must be administered by an appropriately trained and qualified surgeon and is restricted to hospital use only. 
Zdravilo Holoclar mora aplicirati ustrezno podučen in usposobljen kirurg, uporablja pa se lahko le v bolnišnici.
Holoclar contains lethally-irradiated murine 3T3 fibroblast cells and may contain traces of foetal bovine serum. 
Zdravilo Holoclar vsebuje letalno obsevane fibroblastne celice 3T3 glodalca in lahko vsebuje sledove fetalnega govejega seruma.
- If you have any further questions, ask your surgeon. 
- Če imate dodatna vprašanja, se posvetujte s kirurgom.
In vitro studies have revealed no evidence of anchorage-independent growth indicative of tumorigenic potential. 
Študije in vitro niso razkrile dokazov rasti, neodvisne od pritrdišča, kar bi kazalo na tumorogeni potencial.
Benzalkonium chloride (as well as other quaternary ammonium compounds) is cytotoxic and eyedrops containing this preservative may damage the newly-regenerated corneal epithelium. 
Benzalkonijev klorid (in druge kvarterne amonijeve spojine) je citotoksičen, zato lahko kapljice za oko, ki vsebujejo ta konzervans, poškodujejo na novo regeneriran roženični epitelij.
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. 
Ni informacij o varnosti zdravila Holoclar pri otrocih, starih do 7 let, pri bolnikih, starih 8 do 17 let, pa so informacije omejene.
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. 
Imunohistokemična analiza roženice, pridobljene s keratoplastiko pri bolnikih po zdravljenju z zdravilom Holoclar, je pokazala, da presajene izvorne celice vzpostavijo normalno plast večslojnega epitelija roženice, ki ne migrira in ne vdira v bazalne očesne strukture.
Holoclar can only be prescribed and given by an eye surgeon in a hospital. 
Zdravilo Holoclar lahko predpiše in aplicira le očesni kirurg v bolnišnici.
Holoclar must not be irradiated or sterilised. 
Zdravila Holoclar se ne sme obsevati ali sterilizirati.
• Bleeding from the eye lid skin 
• krvavitev iz kože očesne veke
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 
Kaj morate vedeti, preden boste dobili zdravilo Holoclar Zdravila Holoclar vam ne smejo dati: - če ste alergični na katero koli sestavino tega zdravila (navedeno v poglavju 6) ali na goveji serum in mišje celice.
Holoclar must not be sterilised. 
Zdravila Holoclar se ne sme sterilizirati.
EXPIRY DATE EXP : Day / Month / Year At time: Hour / Minute (CET) 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: dan / mesec / leto
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. 
Pri pretvorbi vrednosti kategorij za ostrino vida v logaritem najmanjšega kota ločljivosti (LogMAR - Minimum Angle of Resolution) je prišlo v 47 % primerih (40 od 85, pri katerih vrednosti niso manjkale) do izboljšanja, ki je bilo enako ekvivalentom 3 črt po Snellenovi preglednici ali več.
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. 
Najresnejši neželeni učinki so težave z roženico (erozija) in perforacija roženice, ki se lahko pojavi v 3 mesecih po vsaditvi zdravila Holoclar.
Please read the package leaflets for the individual medicines you are given for further information on these medicines. 
Za nadaljnje informacije o teh zdravilih preberite navodila za uporabo posameznih zdravil, ki jih prejemate.
Following implantation, an appropriate regimen of topical and systemic anti-inflammatory and prophylactic antibiotic treatment must be given. 
Zdravljenje po operaciji Po implantaciji je treba dajati ustrezen režim topikalnega in sistemskega protivnetnega in profilaktičnega antibiotičnega zdravljenja.
Following the biopsy, an appropriate regimen of prophylaxis with an antibiotic treatment must be given. 
Po biopsiji je treba bolniku dajati ustrezen režim profilaktičnega antibiotičnega zdravljenja.
The eyelids are kept closed over the insert with a steri-strip band. 
Veke se zaprejo preko vsadka s pomočjo trakov Steri-strip.
• Inability for your eye to sense pain (anaesthesia of the cornea or conjunctiva or hypoaesthia) 
• nezmožnost zaznavanja bolečine v očesu (anestezija ali hipestezija roženice ali veznice);
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. 
Zdravilo Holoclar je namenjeno samo za uporabo pri avtologni regeneraciji limbusnih matičnih celic skladno z odobreno terapevtsko indikacijo in ga je treba aplicirati v aseptičnih pogojih v povezavi z limbusno peritomijo, pripravo veznice in ekscizijo roženičnega fibrovaskularnega tkiva v smislu priprave ležišča okvare.
- 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. 
- Pomožni snovi sta dve: ena je fibrin - prosojna podporna plast, ki zagotavlja nepoškodovanost zdravila Holoclar, druga pa je tekoča in vsebuje aminokisline, vitamine, soli in ogljikove hidrate, s pomočjo katerih se celice shranijo v viali in se imenuje D-MEM (Dulbecco's Modified Eagles
Each square centimetre of Holoclar contains 79,000 - 316,000 cells. 
En kvadratni centimeter zdravila Holoclar vsebuje 79.000 - 316.000 celic.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Chiesi Farmaceutici S.P.A, Via Palermo 26/A 43122 Parma, Italy 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Chiesi Farmaceutici S.P.A, Via Palermo 26/A 43122 Parma, Italija
Handle with care, avoid any shaking, inverting or other mechanical stress. 
Z zdravilom ravnajte previdno in ga ne stresajte, ne obračajte in ne izpostavljajte drugim oblikam mehanskih obremenitev.
Eye-drops containing benzalkonium chloride, and/or other preservatives, must be avoided. 
Uporabi kapljic za oko, ki vsebujejo benzalkonijev klorid in/ali druge konzervanse, se je treba izogniti.
Fertility No clinical data on the effects of Holoclar on fertility are available. 
Kliničnih podatkov o učinkih zdravila Holoclar na plodnost ni.
Data on the use of Holoclar in patients with hepatic and renal impairment are not available. 
Podatkov o uporabi zdravila Holoclar pri bolnikih z okvarjenim delovanjem jeter in ledvic ni na voljo.
• 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) 
• brazgotine veznice (zaščitne plasti, ki prekriva beli del očesa) s poškodbo predela, kjer veznica prehaja v notranjost očesnih vek (skrajšanje forniksa)
A total of 104 patients, aged between 13 and 79 years (mean 46.8 years) were included in the primary efficacy analysis. 
V primarno analizo učinkovitosti so bili skupaj vključeni 104 bolniki, stari med 13 in 79 leti (povprečno 46,8 let).
After biopsy has been taken, your surgeon will prescribe a course of antibiotics for you to reduce the chance of an infection. 
Po biopsiji vam bo kirurg predpisal antibiotik, s katerim bo zmanjšal možnost za okužbo.
Each package contains an individual treatment dose which is large enough to cover your cornea. 
Eno pakiranje vsebuje odmerek za posamezno zdravljenje, ki je dovolj velik za prekritje roženice.
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. 
Kaj vsebuje zdravilo Holoclar - Zdravilna učinkovina je sestavljena iz 300.000 - 1.200.000 vaših živih očesnih celic, od katerih je povprečno 3,5 % matičnih celic.
Other anaesthesiology procedures may be followed at the discretion of the surgeon. 
Po presoji kirurga se lahko uporabijo drugi anesteziološki postopki.
Store between 15 °C - 25 °C 
Shranjujte pri temperaturi med 15 °C - 25 °C.
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 
Mednarodna, multicentrična, prospektivna, odprta, nekontrolirana intervencijska študija (HLSTM03) za ocenjevanje učinkovitosti in varnosti avtolognih kultiviranih presadkov iz limbusnih izvornih celic za obnovo epitelija roženice pri bolnikih s pomanjkanjem limbusnih izvornih celic zaradi očesnih opeklin.
Each preparation of Holoclar is intended as a single treatment. 
Vsak pripravek zdravila Holoclar je namenjen za enkratno zdravljenje.
What Holoclar looks like and contents of the pack Holoclar is a layer of cells for implantation into your eye. 
Izgled zdravila Holoclar in vsebina pakiranja Zdravilo Holoclar je plast celic za vsaditev v oko.
For information on the preparation and handling of Holoclar, please refer to section 6.6. 
Za podatke glede priprave in ravnanja z zdravilom Holoclar, glejte poglavje 6.6. 4.3 Kontraindikacije
The cells used to make Holoclar are known as autologous limbal cells: 
Celice, ki se uporabijo za izdelavo zdravila Holoclar, se imenujejo avtologne limbusne celice.
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). 
Pri enainpetdesetih bolnikih (49,0 %) se je ostrina vida izboljšala za vsaj eno polno črto po Snellenovi preglednici (ali za eno kategorijo pri primerih s hudo okvaro).
General disorders and administration site conditions Metaplasia of the implant 
Splošne težave in spremembe na mestu aplikacije metaplazija implantata občasni
Moderate to severe LSCD was defined according to an invasion of at least two quadrants of the corneal surface by superficial neo vessels. 
Zmerno do hudo LSCD so opredelili v skladu z neovaskularizacijo površine roženice v vsaj dveh kvadrantih.
Via Palermo, 26/A, Parma, 43122, Italy Phone: +39 0521 2791 
Via Palermo, 26/A, Parma, 43122, Italija telefon: +39 0521 2791 faks: +39 0521 774468
Pregnancy There are no data for the use of Holoclar in pregnant women. 
Podatkov o uporabi zdravila Holoclar pri nosečnicah ni.
During the corneal repair process, the administered stem cells are intended to partially multiply, differentiate and migrate to regenerate corneal epithelium, as well as maintaining a reservoir of stem cells that can continually regenerate the corneal epithelium. 
V postopku popravila roženice je namen apliciranih matičnih celic delno razmnoževanje, diferenciacija in migracija za potrebe regeneracije roženičnega epitelija pa tudi ohranjanje rezervoarja matičnih celic za zagotavljanje nenehne obnove roženičnega epitelija.
Ex vivo expanded autologous human corneal epithelial cells containing stem cells. 
Ex vivo ekspandiran avtologen humani roženični epitelij, ki vsebuje matične celice.
Conventional non-clinical reproductive and developmental toxicity studies are not considered relevant, given the nature and the intended clinical use of the autologous product. 
Običajne predklinične študije vpliva na sposobnost razmnoževanja in razvojne toksičnosti zaradi narave in nameravane klinične uporabe avtolognega zdravila niso relevantne.
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. 
Najpogostejši neželeni učinek, povezan s kirurškim posegom, je bila krvavitev veznice (5 %), ki se je pojavila povečini v prvem dnevu po operaciji in je bila blage oblike.
If you have any of the following problems with your eyes, they should be treated before this medicine is used: 
Če imate katero od naslednjih težav z očesom, je treba te težave pred uporabo zdravila odpraviti: • nepravilnosti vek
• Growth of the conjunctiva over the cornea (pterygium) 
• rast veznice čez roženico (pterigij)
Adverse reactions reported in patients implanted with Holoclar are provided in the table. 
Neželeni učinki, o katerih so poročali pri bolnikih, ki so jim implantirali zdravilo Holoclar, so navedeni v preglednici.
Finally, the thermally insulated box is put in a zipped sealable bag for transportation. 
Na koncu je toplotno izolirana škatla položena v transportno vrečo, ki se zatesni z zadrgo.
• Overgrowth around the implant (metaplasia) 
• spremenjena rast celic okoli vsadka (metaplazija)
UNIQUE IDENTIFIER - HUMAN READABLE DATA <Not applicable.> 
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI < Navedba smiselno ni potrebna.>
This medicinal product is intended for autologous use only. 
To zdravilo je samo za avtologno uporabo.
The eye is subjected to ocular surface lavage with sterile balanced salt solution for eye irrigation followed by detachment of the conjunctiva from the limbus to expose the sample collection site of the cornea. 
Oko se izpostavi lavaži površine očesa z uravnoteženo sterilno fiziološko raztopino za izpiranje očesa, nato pa sledi odluščenje veznice od limbusa, da se izpostavi mesto na roženici za odvzem vzorca.
The excess of insert is trimmed and the edge covered with the conjunctiva applying 2 or 3 stitches (sutures) of vicryl or silk 8/0 in order to form a physical seal of the lesion and to secure the implant. 
Odvečni del vsadka se obreže, rob pa se prekrije z veznico in pritrdi z 2 ali 3 šivi iz vikrila ali svile 8/0, da se rana fizično zapre in implantat zavaruje.
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. 
Predlagan je naslednji režim: 2 tedna od dneva operacije je treba vsak dan dajati doksicilin 100 mg tablete dvakrat na dan (ali amoksicilin 500 mg dvakrat na dan) in peroralni odmerek prednizona 0,5 mg/kg na dan (do največjega odmerka 25 mg).
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. 
Zdravilo Holoclar je sestavljeno iz prosojnega okroglega lističa s 300.000 do 1.200.000 viabilnimi celicami avtolognega humanega roženičnega epitelija (79.000 - 316.000 celic/cm2), kar vključuje povprečno 3,5 % (0,4 do 16 %) limbusnih matičnih celic in iz matičnih celic pridobljene prehodne celice ter dokončno diferencirane celice, pritrjene na podporno fibrinsko plast premera 2,2 cm. Vzdrževane so v transportnem gojišču.
The biopsy is placed in the sterile test tube supplied containing transport medium. 
Bioptični vzorec se da v priloženo sterilno testno epruveto, ki vsebuje transportno gojišče.
How Holoclar is given 
Kako se daje zdravilo Holoclar
Final CSR December 
Končno poročilo klinične študije december 2020
Holoclar is intended solely for autologous use. 
Zdravilo Holoclar je namenjeno izključno avtologni uporabi.
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. 
Na dan operacije vam bo kirurg omrtvičil oko in s šivi pritrdil novo roženico, da bo preprečil premikanje zdravila Holoclar.
Other medicines and Holoclar Some eye-drops contain a preservative called ‘benzalkonium chloride'. 
Nekatere kapljice za oko vsebujejo konzervans, imenovan benzalkonijev klorid.
Reports of glaucoma included adverse reactions of intraocular pressure. 
Poročila o glavkomu so vključevala neželene učinke očesnega tlaka.
Kidney and liver problems Please talk with your surgeon before the start of treatment if you have liver or kidney disease. 
Če imate bolezen jeter ali ledvic, se pred začetkom zdravljenja pogovorite s svojim kirurgom.
Animal studies are not available with respect to reproductive toxicity (see section 5.3). 
Ni razpoložljivih študij na živalih o vplivu zdravila na sposobnost razmnoževanja (glejte poglavje
Holoclar is supplied as one individual treatment dose contained in a screw-cap container. 
Zdravilo Holoclar je na voljo kot en individualni odmerek zdravljenja v vsebniku z navojnim zamaškom.
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. 
Roženica laboratoriju ni mogoče vzgojiti, ali če vzgojene celice ne izpolnjujejo vseh zahtev po kakovosti.
An incision of 2 x 2 mm is made to remove the biopsy. 
Za odvzem bioptičnega vzorca naredi vreznina 2 x 2 mm.
• 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. 
• Limbus vsebuje limbusne celice, ki običajno pomagajo ohranjati oko zdravo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PLASTIC BAG (TERTIARY) 
PLASTIČNA VREČA (TERCIARNA)
• Eye disorders - stickiness of the eyelid, bloodshot eyes, swelling of the eye, perforation of the cornea and eye irritation 
• očesne motnje - lepljiva očesna veka, podplute oči, otekle oči, perforacija roženice in draženje očesa
The most serious adverse reactions are corneal perforation and ulcerative keratitis, which may occur within the 3 months from Holoclar implantation and are related to the corneal epithelial instability, and syncope vasovagal occurring in the first day after surgery due to eye pain. 
3 mesecih od implantacije zdravila Holoclar in sta povezana z nestabilnostjo roženičnega epitelija ter vazovagalna sinkopa v prvih dneh po operaciji zaradi bolečine v očesu.
Breast-feeding As a precautionary measure, Holoclar is not recommended for implant during breast-feeding. 
Iz previdnostnih razlogov se implantacija zdravila Holoclar med dojenjem ne priporoča.
• Anaesthetise your eye 
• omrtvičil oko
For relevant safety information, physicians should consult the SmPC of these medicinal products. 
Za povezane informacije v zvezi z varnostjo naj zdravnik prebere Povzetek glavnih značilnosti za ta zdravila.
Injury, poisoning and procedural complications 
Poškodbe in zastrupitve in zapleti pri posegih raztrganje šiva občasni
Each container contains 3.8 cm2 of autologous human corneal epithelium attached on a fibrin support and covered with transport medium. 
En vsebnik vsebuje 3,8 cm2 avtolognega človeškega roženičnega epitelija, pritrjenega na fibrinsko podporo in prekritega s transportnim gojiščem.
This layer of tissue is then implanted by a surgeon into the damaged cornea helping your eye to heal normally. 
Kirurg nato to plast tkiva vsadi v poškodovano roženico, kar očesu pomaga pri normalnem celjenju.
Each batch is shipped in a temperature-controlled thermally insulated box for organ transplant. 
Vsaka serija je opremljena s toplotno izolirano škatlo za prevoz organov z nadzorom temperature.
Transport medium (Dulbecco's Modified Eagles Medium supplemented with L-glutamine) Fibrin support. 
Transportno gojišče (D-MEM (Dulbecco's Modified Eagles Medium) obogaten z L-glutaminom) fibrinska podpora
The following information is intended for healthcare professionals only: (The complete SmPC will be provided as a separate document in the medicine pack) 
(Celoten povzetek glavnih značilnosti zdravila bo podan kot ločen dokument v pakiranju zdravila.)
The sealed bag is put in a non-sterile, thermally insulated box for organ transportation with a temperature monitor. 
Zaprta vreča je položena v nesterilno, toplotno izolirano škatlo za prevoz organov skupaj z merilcem temperature.
Keep Holoclar within the steel container in the plastic bag until surgery. 
Do operacije shranjujte zdravilo Holoclar v jeklenem vsebniku v plastični vrečici.
OTHER M.A.H: CHIESI FARMACEUTICI S.P.A 
DRUGI PODATKI Imetnik dovoljenja za promet z zdravilom: CHIESI FARMACEUTICI S.P.A
A minimum of 1 - 2 mm2 of undamaged limbus is required for biopsy. 
Za biopsijo mora biti ohranjenega vsaj 1 - 2 mm2
What you need to know before you are given Holoclar 
Kaj je zdravilo Holoclar in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Holoclar Kako se daje zdravilo Holoclar
On the second visit the surgeon will: 
2. obisk: Vsaditev zdravila Holoclar Ob drugem obisku vam bo kirurg:
NAME OF THE MEDICINAL PRODUCT Holoclar 79,000 - 316,000 cells/cm2 living tissue equivalent 
IME ZDRAVILA Holoclar 79.000 - 316.000 celic/cm2 ekvivalent živega tkiva
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. 
Možni dejavniki za zaplete so: nepravilni položaj očesnih vek, brazgotina veznice s skrajšanjem forniksa, roženična ali veznična anestezija ali huda hipestezija, pterigij in hude oblike suhega očesa.
Uncommon: may affect up to 1 in 100 people 
• vnetje roženice Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
Ask your surgeon if you have any further questions about the treatment with Holoclar. 
Če imate dodatna vprašanja o zdravljenju z zdravilom Holoclar, se posvetujte s kirurgom.
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). 
V času apliciranja zdravila je bilo povprečno trajanje stanja od poškodbe 18 let (mediana 10 let), 99 %
Your eyelid will be taped closed for three days and your eye will be bandaged for 10 to 15 days after the implantation. 
Veke na operiranem očesu bodo zlepljene skupaj s pomočjo posebnega lepilnega traku še tri dni po posegu, preko očesa pa boste še 10 do 15 dni po posegu nosili obvezo.
- If you get any side effects, talk to your surgeon. 
- Če opazite kateri koli neželeni učinek, se posvetujte s kirurgom.
If you get any side effects, talk to your surgeon. 
Če opazite kateri koli neželeni učinek, se posvetujte s kirurgom.
UNIQUE IDENTIFIER - 2D BARCODE <Not applicable.> 
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
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. 
Roženica je prosojna plast, ki prekriva obarvano šarenico na sprednjem delu očesa, vključno z limbusnimi celicami, ki običajno pomagajo ohranjati vaše oko zdravo.
BATCH NUMBER, DONATION AND PRODUCT CODES Batch: 
ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV ŠTEVILKA SERIJE:
Before the biopsy, the surgeon will give you eyedrops to anaesthetise your eye and surgically take the biopsy. 
Pred biopsijo vam bo kirurg dal kapljice za oko, s katerimi bo oko omrtvičil.
Conventional pharmacodynamic studies for Holoclar have not been performed Clinical efficacy and safety 
Običajnih farmakodinamičnih študij za zdravilo Holoclar niso opravili.
PHARMACEUTICAL FORM Living tissue equivalent. 
FARMACEVTSKA OBLIKA ekvivalent živega tkiva prosojen, okrogel listič
• Infection of the cornea 
• okužba roženice
BATCH NUMBER<, DONATION AND PRODUCT CODES> 
ŠTEVILKA SERIJE<, ENOTNE OZNAKE DAROVANJA IN IZDELKOV> ŠTEVILKA SERIJE: