natgillin/translations-raw huggingface dataset:
These reactions are usually mild to moderate and temporary, last for up to four weeks. 
Te reakcije so navadno blage do zmerno hude in začasne, saj trajajo do največ štiri tedne.
It is available as round, orange tablets (50 and 150 mg). 
Na voljo je v obliki okroglih, oranžnih tablet (50 in 150 mg).
The European Commission granted a marketing authorisation valid throughout the European Union, for Masivet to AB Science S.A. on 17 November 2008. 
Evropska komisija je dovoljenje za promet z zdravilom Masivet, veljavno po vsej Evropski uniji, odobrila družbi AB Science S.A. dne 17. novembra 2008.
Do not eat, drink or smoke while treating a dog. 
Med zdravljenjem psa ne jejte, pijte ali kadite.
What benefit has Masivet shown during the studies? 
Kakšne koristi je zdravilo Masivet izkazalo med študijami?
This means that it blocks some specific enzymes known as tyrosine kinases. 
To pomeni, da zavira točno določene encime, znane kot tirozin kinaze.
Four to six weeks after starting the treatment with Masivet, the veterinarian should check if the treatment is likely to be successful. 
Veterinar mora štiri do šest tednov po začetku zdravljenja z zdravilom Masivet preveriti, kakšna je verjetnost, da bo zdravljenje uspešno.
These enzymes can be found in some receptors on the surface of cells, including the c-kit receptor. 
Te encime lahko najdemo v nekaterih receptorjih na površini celic, med drugim tudi v receptorju c-kit.
What is the risk associated with Masivet? 
Kakšna tveganja so povezana z zdravilom Masivet?
If broken tablets, or the vomit, urine or faeces of a treated dog comes into contact with the skin or eyes, rinse immediately with plenty of water. 
Če pridejo zlomljene tablete, bruhanje, urin ali iztrebki zdravljenega psa v stik s kožo ali očmi, jih takoj sperite z veliko vode.
The tablets must be administered whole and should not be divided, broken or ground up. 
Tablete je treba dajati cele in se ne smejo razpoloviti, lomiti ali zdrobiti.
It is only used if the presence of a mutated form of the receptor protein c-kit in the tumours has been confirmed before the start of treatment. 
Uporablja se le, če je bila pred začetkom zdravljenja potrjena prisotnost mutirane oblike receptorske beljakovine c-kit v tumorjih.
The main study compared the effectiveness of Masivet at the recommended dose of 12.5 mg per kilogramme bodyweight once a day with placebo (a dummy treatment). 
V glavni študiji so učinkovitost priporočenega odmerka zdravila Masivet 12,5 mg na kilogram telesne mase enkrat dnevno primerjali s placebom (zdravilom brez zdravilne učinkovine).
Because this disease is a life threatening condition and the overall number of dogs affected is expected to be low, the CVMP guidelines on “Minor-Use-Minor-Species (MUMS) data requirements” were applied when assessing the dossier. 
Ker je ta bolezen življenjsko nevarna in se pričakuje majhno število prizadetih psov, so bile pri presoji dokumentacije uporabljene smernice CVMP o „zahtevah glede podatkov za manjšo uporabo pri manj pomembnih vrstah (MUMS)“.
The tablets are given by mouth, once a day. 
Tablete dajemo peroralno enkrat dnevno.
A number of studies with Masivet were carried out either in laboratory dogs or in animal patients at veterinary practises in Europe and in the USA. 
V veterinarskih ambulantah v Evropi in ZDA so pri laboratorijskih psih ali bolnih živalih izvedli številne študije zdravila Masivet.
In case of side effects, the veterinarian might decide to lower the dose of Masivet or to discontinue treatment. 
Veterinar se lahko v primeru neželenih učinkov odloči zmanjšati odmerek zdravila Masivet ali prekiniti zdravljenje.
The most common side effects with Masivet are gastrointestinal reactions (diarrhoea and vomiting) and hair loss. 
Najpogostejši neželeni učinki zdravila Masivet so gastrointestinalne reakcije (driska in bruhanje) ter izgubljanje dlake.
It should not be used in dogs that may be hypersensitive (allergic) to masitinib or any of the other ingredients. 
Ne sme se uporabljati pri psih, ki utegnejo biti preobčutljivi za (alergični na) masitinib ali katero koli drugo sestavino.
The study population included dogs whose tumours contained mutated or normal (‘wild-type') c-kit receptors. 
Študijska populacija je vključevala pse, katerih tumorji so imeli mutirane ali normalne („divji tip“) receptorje c-kit.
In the dogs whose tumours contained mutated c-kit receptors, it took longer for the tumour to get worse when dogs received Masivet (median of 241 days) than in those receiving placebo (median of 83 days). 
Pri psih, katerih tumorji so vsebovali mutirane receptorje c-kit, se je stanje tumorjev poslabšalo kasneje, če so prejemali zdravilo Masivet (povprečni čas preživetja 241 dni), kot pri tistih, ki so prejemali placebo (povprečni čas preživetja 83 dni).
Masivet must not be used in dogs with certain kinds of liver or kidney problems, or anaemia (low red blood cell counts) or neutropenia (low white blood cell counts). 
Zdravilo Masivet se ne sme uporabljati pri psih z nekaterimi vrstami jetrnih ali ledvičnih težav, anemijo (majhnim številom rdečih krvničk) ali nevtropenijo (majhnim številom belih krvničk).
Why has Masivet been approved? 
Zakaj je bilo zdravilo Masivet odobreno?
It must not be used in dogs less than six months of age or less than 4 kg in weight, or bitches that are pregnant or lactating. 
Zdravilo se ne sme uporabljati pri psih, starih manj kot šest mesecev ali težkih manj kot 4 kg, ali pri psicah v obdobju brejosti oziroma laktacije.
If Masivet is taken accidentally, seek medical advice immediately and show the Package Leaflet or the label to the doctor. 
Če zdravilo Masivet zaužijete nenamerno, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali nalepko.
The study included dogs of various breeds and both sexes with mast-cell tumours that had come back after surgery or could not be removed with surgery. 
V študijo so bili vključeni psi različnih pasem in obeh spolov z mastocitomi, ki so se ponovno pojavili po kirurškem posegu ali jih s kirurškim posegom ni bilo mogoče odstraniti.
It is used for tumours which are severe in character (grade 2 or 3) and which cannot be removed with surgery. 
Uporablja se za velike tumorje (2. ali 3. stopnja malignosti), ki jih ni mogoče odstraniti s kirurškim posegom.
Masivet is used to treat dogs with mast-cell tumours (a type of cancer). 
Zdravilo Masivet se uporablja za zdravljenje psov z mastocitomi (vrsta raka).
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Masivet exceed the risks for the treatment of non-resectable mast cell tumours (grade 2 or 3) that have a confirmed mutated c-kit tyrosine kinase receptor and recommended that Masivet be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Masivet pri zdravljenju mastocitomov (2. ali 3. stopnje), ki jih ni mogoče odstraniti kirurško in imajo potrjeno prisoten mutiran receptor tirozin kinaze c-kit, večje od z njim povezanih tveganj, in priporočil, da se za zdravilo Masivet odobri dovoljenje za promet.
Children should not have close contact with treated dogs, or their faeces or vomit. 
Otroci ne smejo priti v stik z zdravljenimi psi, njihovimi iztrebki ali bruhanjem.
The active substance in Masivet, masitinib, is a protein-tyrosine kinase inhibitor. 
Zdravilna učinkovina zdravila Masivet, masitinib, je zaviralec protein tirozin kinaze.
How does Masivet work? 
Kako zdravilo Masivet deluje?
Some types of mast-cell tumour are linked to a mutation that causes excessive action of c-kit and stimulates the mast cells to divide uncontrollably. 
Nekatere vrste mastocitomov so povezane z mutacijo, ki povzroča čezmerno delovanje beljakovine c-kit in spodbuja mastocite k nenadzorovanemu razmnoževanju.
What is Masivet used for? 
Za kaj se zdravilo Masivet uporablja?
How has Masivet been studied? 
Kako je bilo zdravilo Masivet raziskano?
Masivet contains masitinib, which belongs to a class of medicines having an anticancer action. 
Zdravilo Masivet vsebuje masitinib, ki spada v skupino zdravil z učinkom proti raku.
For a full list of all side-effects reported with Masivet, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Masivet, glejte navodilo za uporabo.
What is Masivet? 
Kaj je zdravilo Masivet?
Dogs under Masivet treatment should be regularly monitored for side effects by the veterinarian (at least monthly). 
Zaradi morebitnega pojava neželenih učinkov mora veterinar redno (vsaj enkrat mesečno) pregledovati pse, ki jih zdravimo z zdravilom Masivet.
By blocking these receptors, Masivet might help to control cell division, preventing further development of the tumours with this particular mutation. 
Zdravilo Masivet lahko prepreči nadaljnji razvoj tumorjev s to mutacijo, saj z zaviranjem teh receptorjev nadzoruje razmnoževanje celic.
The dose depends on the weight of the dog being treated.. 
Odmerek je odvisen od mase psa, ki ga zdravimo.
2nd injection: after 3 weeks 
2. injekcija: po 3 tednih
ATC vet code: QI04AA02. 
Oznaka ATC vet: QI04AA02.
Aluminium hydroxide (Al3+) 
aluminijev hidroksid (Al3+)
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: 
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta, z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove izdelavo, uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo zdravila za uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
EU/2/11/131/006 
EU/2/11/131/001 EU/2/11/131/005 EU/2/11/131/006
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome). 
*(Ciklična vrednost (Ct) ≥ 36 pri validirani metodi RT_PCR, kar kaže, da virusni genom ni prisoten)
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Bluetongue. 
Uporaba tega cepiva je dovoljena le pod posebnimi pogoji zakonodaje EU o kontroli bolezni modrikastega jezika.
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 
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
Date of last renewal: 18/04/2016 
Datum pridobitve dovoljenja za promet: 05 avgust 2011 Datum zadnjega podaljšanja dovoljenja za promet: 18/04/2016
Administration of a two-fold overdose may be followed in most animals by a local reaction at the injection site. 
Po dajanju dvakratnega prevelikega odmerka se lahko pri večini živali pojavi lokalna reakcija na mestu injiciranja.
Vaccination may be followed very commonly by a local reaction at the injection site. 
Po cepljenju se zelo pogosto lahko pojavi lokalna reakcija na mestu injiciranja.
IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Inactivated viral vaccines - Bluetongue virus. 
Farmakoterapevtska skupina: Inaktivirana virusna cepiva - virus bolezni modrikastega jezika.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. 
Zato se za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila za uporabo v veterinarski medicine odločamo od primera do primera.
Potassium dihydrogen phosphate Disodium hydrogen phosphate dodecahydrate Sodium chloride 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi aluminijev hidroksid saponin tiomersal kalijev klorid kalijev dihidrogenfosfat natrijev hidrogenfosfat dodekahidrat natrijev klorid voda za injekcije
Shelf-life after first opening the immediate packaging: use immediately after broaching. 
Rok uporabnosti po prvem odpiranju stične ovojnine: Načeto uporabite takoj.
To stimulate active immunity against Bluetongue Virus, serotype 1 in sheep. 
Za stimulacijo aktivne imunosti proti virusu bolezni modrikastega jezika, serotip 1, pri ovcah.
BATCH NUMBER Lot {number} 
Lot { številka }
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. Once broached use immediately. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po
No data is available on safety in lactating animals. 
Podatkov o varnosti uporabe pri živalih v laktaciji ni na voljo.
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 
Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1 x 20ml, 1 x 100ml and 1 x 240 ml 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla 1 x 20 ml, 1 x 100 ml in 1 x 240 ml
A transient increase in rectal temperature, not exceeding 1.2 °C, may occur very commonly during the 24 hours following vaccination. 
Do 24 ur po cepljenju se zelo pogosto lahko pojavi prehodno povišanje rektalne temperature, ki ne presega 1,2 °C.
PACKAGE LEAFLET: Zulvac 1 Ovis suspension for injection for sheep 
NAVODILO ZA UPORABO Zulvac 1 Ovis suspenzija za injiciranje za ovce
A transient increase in rectal temperature, not exceeding 0.6 °C, may occur during the 24 hours following administration of a two-fold overdose. 
Do 24 ur po dajanju dvakratnega prevelikega odmerka se lahko pojavi prehodno povišanje rektalne temperature, ki ne presega 0,6 °C.
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. 
Za aktivno imunizacijo ovac, starejših od 1 in pol meseca starosti, za preprečitev* viremije, ki jo povzroča virus bolezni modrikastega jezika (BTV), serotip 1.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALEC(PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE ( UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJ
Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 Aluminium hydroxide, saponin and thiomersal. 
V odmerku 2 ml inaktiviran virus bolezni modrikastega jezika, serotip 1, sev BTV-1/ALG2006/01 E1 aluminijev hidroksid, saponin in tiomersal.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains: 
Vsak odmerek (2 ml) vsebuje:
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 
Trajanje imunosti: 12 mesecev po končanem osnovnem cepljenju.
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. 
Kartonasta škatla z vialo iz stekla tipa tipa II s klorobutilnim zamaškom in aluminijasto zaporko, ki vsebuje 100 ml (50 odmerkov) ali 240 ml (120 odmerkov cepiva).
Lactation: 
Laktacija :
Cardboard box with one type I glass vial of 20 ml (containing 10 doses) with a chlorobutyl rubber stopper and aluminium cap. 
Kartonasta škatla z vialo iz stekla tipa I s klorobutilnim zamaškom in aluminijasto zaporko, ki vsebuje 20 ml (10 odmerkov cepiva).
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. 
RP* ≥ 1 * Relativna potenca pri testu potence pri miših v primerjavi z referenčnim cepivom, ki je bilo učinkovito pri ovcah.
Adjuvant: 
Dodatka:
The entire content of the bottle should be used immediately after broaching and during the same procedure. 
Takoj po odpiranju porabite naenkrat celotno vsebino viale.
STATEMENT OF ACTIVE SUBSTANCES Per dose of 2 ml 
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 August 2011 
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
4 mg 
4 mg saponin
Name and address of the manufacturer of the biological active substance(s) 
Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin) Zoetis Manufacturing & Research Spain, S.L.
The use in lactating animals is therefore not recommended. 
Uporaba cepiva ni priporočljiva v obdobju laktacije.
Adcetris 50 mg Powder for concentrate for solution for infusion 
50 mg Prašek za koncentrat za raztopino za infundiranje
The European Commission granted a marketing authorisation valid throughout the European Union for Holoclar on 17 February 2015. 
Evropska komisija je dovoljenje za promet z zdravilom Holoclar, veljavno po vsej Evropski uniji, izdala 17. februarja 2015.
Other information about Holoclar 
Druge informacije o zdravilu Holoclar
What measures are being taken to ensure the safe and effective use of Holoclar? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Holoclar?
This is a summary of the European public assessment report (EPAR) for Holoclar. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Holoclar.
Holoclar is intended for a single treatment, although treatment can be repeated if the doctor considers it necessary. 
Zdravilo Holoclar je namenjeno za enkratno zdravljenje, ki pa ga je mogoče ponoviti, če zdravnik presodi, da je to potrebno.
The company is to provide data on the benefits and risks of Holoclar from a prospective clinical study. 
Družba mora zagotoviti podatke o koristih in tveganjih zdravila Holoclar iz prospektivne klinične študije.
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. 
V prvi fazi zdravljenja se bolniku v bolnišnici odvzame delček zdravega limbusnega tkiva (velikosti 1−2 mm2), ki se še isti dan pošlje proizvajalcu.
A risk management plan has been developed to ensure that Holoclar is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Holoclar je bil pripravljen načrt obvladovanja tveganj.
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. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Holoclar je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
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. 
Ker so neželeni učinki zdravila Holoclar na splošno obvladljivi, je CHMP zaključil, da so koristi zdravila Holoclar večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
There were also reductions in patients' symptoms, such as pain and inflammation, and improvements in vision. 
Poleg tega so pri bolnikih opazili ublažitev simptomov, kot sta bolečina in vnetje, ter izboljšanje vida.
What is Holoclar and what is it used for? 
Kaj je zdravilo Holoclar in za kaj se uporablja?
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. 
Ker je bolnikov s pomanjkanjem limbusnih matičnih celic zaradi opekline očesa malo, velja ta bolezen za redko, zato je bilo zdravilo Holoclar 7. novembra 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Next, the cells in the tissue are grown in a laboratory and frozen until the date of surgery is confirmed. 
Celice v tkivu se nato vzgojijo v laboratoriju in zamrznejo do potrjenega datuma kirurškega posega.
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. 
Odbor je opozoril, da so zmerne do hude oblike pomanjkanja limbusnih matičnih celic hude okvare, ki lahko, če se ne zdravijo, privedejo do hudega zmanjšanja ali popolne izgube vida.
What are the risks associated with Holoclar? 
Kakšna tveganja so povezana z zdravilom Holoclar?
It is not intended to provide practical advice on how to use Holoclar. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Holoclar has therefore been given ‘conditional approval'. 
Zdravilo Holoclar je zato pridobilo „pogojno dovoljenje za promet“.
What benefits of Holoclar have been shown in studies? 
Kakšne koristi je zdravilo Holoclar izkazalo v študijah?
Why is Holoclar approved? 
Zakaj je bilo zdravilo Holoclar odobreno?
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). 
Opredelitev razmerja med koristmi in tveganji pri zdravilu Holoclar temelji na rezultatih dveh retrospektivnih študij (ob uporabi zdravniških izvidov iz preteklosti), družba pa mora zagotoviti nadaljnje podatke iz prospektivne študije (pri kateri se beležijo rezultati tekom študije).
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. 
Bolniki s to okvaro nimajo dovolj limbusnih matičnih celic, ki običajno delujejo kot regeneracijski sistem in nadomeščajo zunanje roženične celice, ko se te poškodujejo in ko se starajo.
Following the surgery, the patient should receive antibiotics and an appropriate antiinflammatory medicine. 
Po kirurškem posegu je treba bolniku dajati antibiotike in ustrezno protivnetno zdravilo.
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). 
Eno leto po vsaditvi zdravila Holoclar se bili vsadki ocenjeni kot uspešni pri 75 od 104 (72 %) bolnikov, ki so bili obravnavani v študiji, merilo učinkovitosti pa je bil obstoj stabilne površine roženice brez okvar na površini in malo ali nič vraščenih krvnih žil (pogosta značilnost pomanjkanja limbusnih matičnih celic).
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. 
Poleg tega bo družba, ki izdeluje zdravilo Holoclar, zdravstvenim delavcem priskrbela izobraževalno gradivo o varni uporabi tega zdravila, ki bo vključevalo tudi informacije o izbiri in spremljanju bolnikov ter o poročanju o neželenih učinkih.
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. 
Vsebuje celice, ki se odvzamejo iz bolnikovega limbusa (na robu roženice) in se nato vzgojijo v laboratoriju, da bi jih lahko uporabili za popravilo poškodovane površine roženice.
Holoclar is a type of advanced therapy product called a ‘tissue engineered product'. 
Zdravilo Holoclar spada v skupino zdravil za napredno zdravljenje, ki se imenujejo „zdravila, izdelana s tkivnim inženirstvom“.
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. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Holoclar sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.