FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Masivet?
Slovenian: Kaj je zdravilo Masivet?
English: Dogs under Masivet treatment should be regularly monitored for side effects by the veterinarian (at least monthly).
Slovenian: Zaradi morebitnega pojava neželenih učinkov mora veterinar redno (vsaj enkrat mesečno) pregledovati pse, ki jih zdravimo z zdravilom Masivet.
English: By blocking these receptors, Masivet might help to control cell division, preventing further development of the tumours with this particular mutation.
Slovenian: Zdravilo Masivet lahko prepreči nadaljnji razvoj tumorjev s to mutacijo, saj z zaviranjem teh receptorjev nadzoruje razmnoževanje celic.
English: The dose depends on the weight of the dog being treated..
Slovenian: Odmerek je odvisen od mase psa, ki ga zdravimo.
English: 2nd injection: after 3 weeks
Slovenian: 2. injekcija: po 3 tednih
English: ATC vet code: QI04AA02.
Slovenian: Oznaka ATC vet: QI04AA02.
English: Aluminium hydroxide (Al3+)
Slovenian: aluminijev hidroksid (Al3+)
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:
Slovenian: 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:
English: EU/2/11/131/006
Slovenian: EU/2/11/131/001 EU/2/11/131/005 EU/2/11/131/006
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).
Slovenian: *(Ciklična vrednost (Ct) ≥ 36 pri validirani metodi RT_PCR, kar kaže, da virusni genom ni prisoten)
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Bluetongue.
Slovenian: Uporaba tega cepiva je dovoljena le pod posebnimi pogoji zakonodaje EU o kontroli bolezni modrikastega jezika.
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
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
English: Date of last renewal: 18/04/2016
Slovenian: Datum pridobitve dovoljenja za promet: 05 avgust 2011 Datum zadnjega podaljšanja dovoljenja za promet: 18/04/2016
English: Administration of a two-fold overdose may be followed in most animals by a local reaction at the injection site.
Slovenian: Po dajanju dvakratnega prevelikega odmerka se lahko pri večini živali pojavi lokalna reakcija na mestu injiciranja.
English: Vaccination may be followed very commonly by a local reaction at the injection site.
Slovenian: Po cepljenju se zelo pogosto lahko pojavi lokalna reakcija na mestu injiciranja.
English: IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Inactivated viral vaccines - Bluetongue virus.
Slovenian: Farmakoterapevtska skupina: Inaktivirana virusna cepiva - virus bolezni modrikastega jezika.
English: 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.
Slovenian: Zato se za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila za uporabo v veterinarski medicine odločamo od primera do primera.
English: Potassium dihydrogen phosphate Disodium hydrogen phosphate dodecahydrate Sodium chloride
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi aluminijev hidroksid saponin tiomersal kalijev klorid kalijev dihidrogenfosfat natrijev hidrogenfosfat dodekahidrat natrijev klorid voda za injekcije
English: Shelf-life after first opening the immediate packaging: use immediately after broaching.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: Načeto uporabite takoj.
English: To stimulate active immunity against Bluetongue Virus, serotype 1 in sheep.
Slovenian: Za stimulacijo aktivne imunosti proti virusu bolezni modrikastega jezika, serotip 1, pri ovcah.
English: BATCH NUMBER Lot {number}
Slovenian: Lot { številka }
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. Once broached use immediately.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po
English: No data is available on safety in lactating animals.
Slovenian: Podatkov o varnosti uporabe pri živalih v laktaciji ni na voljo.
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
Slovenian: Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1 x 20ml, 1 x 100ml and 1 x 240 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla 1 x 20 ml, 1 x 100 ml in 1 x 240 ml
English: A transient increase in rectal temperature, not exceeding 1.2 °C, may occur very commonly during the 24 hours following vaccination.
Slovenian: Do 24 ur po cepljenju se zelo pogosto lahko pojavi prehodno povišanje rektalne temperature, ki ne presega 1,2 °C.
English: PACKAGE LEAFLET: Zulvac 1 Ovis suspension for injection for sheep
Slovenian: NAVODILO ZA UPORABO Zulvac 1 Ovis suspenzija za injiciranje za ovce
English: A transient increase in rectal temperature, not exceeding 0.6 °C, may occur during the 24 hours following administration of a two-fold overdose.
Slovenian: Do 24 ur po dajanju dvakratnega prevelikega odmerka se lahko pojavi prehodno povišanje rektalne temperature, ki ne presega 0,6 °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.
Slovenian: Za aktivno imunizacijo ovac, starejših od 1 in pol meseca starosti, za preprečitev* viremije, ki jo povzroča virus bolezni modrikastega jezika (BTV), serotip 1.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC(PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE ( UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 Aluminium hydroxide, saponin and thiomersal.
Slovenian: V odmerku 2 ml inaktiviran virus bolezni modrikastega jezika, serotip 1, sev BTV-1/ALG2006/01 E1 aluminijev hidroksid, saponin in tiomersal.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains:
Slovenian: Vsak odmerek (2 ml) vsebuje:
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
Slovenian: Trajanje imunosti: 12 mesecev po končanem osnovnem cepljenju.
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.
Slovenian: 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).
English: Lactation:
Slovenian: Laktacija :
English: Cardboard box with one type I glass vial of 20 ml (containing 10 doses) with a chlorobutyl rubber stopper and aluminium cap.
Slovenian: Kartonasta škatla z vialo iz stekla tipa I s klorobutilnim zamaškom in aluminijasto zaporko, ki vsebuje 20 ml (10 odmerkov cepiva).
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.
Slovenian: RP* ≥ 1 * Relativna potenca pri testu potence pri miših v primerjavi z referenčnim cepivom, ki je bilo učinkovito pri ovcah.
English: Adjuvant:
Slovenian: Dodatka:
English: The entire content of the bottle should be used immediately after broaching and during the same procedure.
Slovenian: Takoj po odpiranju porabite naenkrat celotno vsebino viale.
English: STATEMENT OF ACTIVE SUBSTANCES Per dose of 2 ml
Slovenian: NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 August 2011
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
English: 4 mg
Slovenian: 4 mg saponin
English: Name and address of the manufacturer of the biological active substance(s)
Slovenian: Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin) Zoetis Manufacturing & Research Spain, S.L.
English: The use in lactating animals is therefore not recommended.
Slovenian: Uporaba cepiva ni priporočljiva v obdobju laktacije.
English: Adcetris 50 mg Powder for concentrate for solution for infusion
Slovenian: 50 mg Prašek za koncentrat za raztopino za infundiranje
English: Pack size
Slovenian: Adcetris
English: The European Commission granted a marketing authorisation valid throughout the European Union for Holoclar on 17 February 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Holoclar, veljavno po vsej Evropski uniji, izdala 17. februarja 2015.
English: Other information about Holoclar
Slovenian: Druge informacije o zdravilu Holoclar
English: What measures are being taken to ensure the safe and effective use of Holoclar?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Holoclar?
English: This is a summary of the European public assessment report (EPAR) for Holoclar.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Holoclar.
English: Holoclar is intended for a single treatment, although treatment can be repeated if the doctor considers it necessary.
Slovenian: Zdravilo Holoclar je namenjeno za enkratno zdravljenje, ki pa ga je mogoče ponoviti, če zdravnik presodi, da je to potrebno.
English: The company is to provide data on the benefits and risks of Holoclar from a prospective clinical study.
Slovenian: Družba mora zagotoviti podatke o koristih in tveganjih zdravila Holoclar iz prospektivne klinične študije.
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.
Slovenian: V prvi fazi zdravljenja se bolniku v bolnišnici odvzame delček zdravega limbusnega tkiva (velikosti 1−2 mm2), ki se še isti dan pošlje proizvajalcu.
English: A risk management plan has been developed to ensure that Holoclar is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Holoclar je bil pripravljen načrt obvladovanja tveganj.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: There were also reductions in patients' symptoms, such as pain and inflammation, and improvements in vision.
Slovenian: Poleg tega so pri bolnikih opazili ublažitev simptomov, kot sta bolečina in vnetje, ter izboljšanje vida.
English: What is Holoclar and what is it used for?
Slovenian: Kaj je zdravilo Holoclar in za kaj se uporablja?
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.
Slovenian: 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).
English: Next, the cells in the tissue are grown in a laboratory and frozen until the date of surgery is confirmed.
Slovenian: Celice v tkivu se nato vzgojijo v laboratoriju in zamrznejo do potrjenega datuma kirurškega posega.
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.
Slovenian: 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.
English: What are the risks associated with Holoclar?
Slovenian: Kakšna tveganja so povezana z zdravilom Holoclar?
English: It is not intended to provide practical advice on how to use Holoclar.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Holoclar has therefore been given ‘conditional approval'.
Slovenian: Zdravilo Holoclar je zato pridobilo „pogojno dovoljenje za promet“.
English: What benefits of Holoclar have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Holoclar izkazalo v študijah?
English: Why is Holoclar approved?
Slovenian: Zakaj je bilo zdravilo Holoclar odobreno?
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).
Slovenian: 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).
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.
Slovenian: 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.
English: Following the surgery, the patient should receive antibiotics and an appropriate antiinflammatory medicine.
Slovenian: Po kirurškem posegu je treba bolniku dajati antibiotike in ustrezno protivnetno zdravilo.
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).
Slovenian: 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).
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.
Slovenian: 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.
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.
Slovenian: 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.
English: Holoclar is a type of advanced therapy product called a ‘tissue engineered product'.
Slovenian: Zdravilo Holoclar spada v skupino zdravil za napredno zdravljenje, ki se imenujejo „zdravila, izdelana s tkivnim inženirstvom“.
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.
Slovenian: 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.
English: What information is still awaited for Holoclar?
Slovenian: Katere informacije o zdravilu Holoclar še pričakujemo?
English: Holoclar ex vivo expanded autologous human corneal epithelial cells containing stem cells
Slovenian: Holoclar ex vivo ekspandiran avtologen humani roženični epitelij, ki vsebuje matične celice
English: The most common side effect with Holoclar (seen in more than 1 patient in 10) is blepharitis (inflammation of the eye lid).
Slovenian: Najpogostejši neželeni učinek zdravila Holoclar (ki lahko prizadene več kot 1 osebo od 10) je blefaritis (vnetje očesne veke).
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.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo zdravilo Holoclar učinkovito pri ponovni vzpostavitvi zdrave površine roženice pri bolnikih z zmernim ali hudim pomanjkanjem limbusnih matičnih celic zaradi opekline ter pri izboljšanju njihovih simptomov in vida.
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.
Slovenian: Zdravilo Holoclar lahko uporablja le ustrezno izšolan in usposobljen očesni kirurg v bolnišnici, daje pa se lahko le tistemu bolniku, katerega limbusne celice so bile uporabljene za izdelavo zdravila.
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.
Slovenian: Zdravilo Holoclar, ki je sestavljeno iz celic in membrane, se nato pošlje nazaj v bolnišnico, kjer se nemudoma kirurško vsadi v bolnikovo oko.
English: It is used in adult patients with moderate to severe limbal stem-cell deficiency caused by burns, including chemical burns, to the eyes.
Slovenian: Uporablja se pri odraslih bolnikih z zmernim do hudim pomanjkanjem limbusnih matičnih celic zaradi opekline očesa, vključno s kemično opeklino.
English: Educational material will also be provided to patients undergoing treatment.
Slovenian: Izobraževalno gradivo bodo prejeli tudi bolniki, ki bodo zdravljeni z zdravilom 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.
Slovenian: Ko se vsadijo v oko, roženične celice v zdravilu Holoclar pomagajo nadomestiti površino roženice, medtem ko limbusne matične celice služijo kot rezervoar za nove celice, ki nenehno obnavljajo roženico.
English: For more information about treatment with Holoclar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Holoclar preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Holoclar in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For practical information about using Holoclar, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Holoclar naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Before Holoclar is used, the damaged corneal surface tissue of the affected eye is removed.
Slovenian: Pred uporabo zdravila Holoclar se iz očesa odstrani poškodovano tkivo na površini roženice.
English: Thawed cells are used to make Holoclar by growing them on a membrane made of a protein called fibrin.
Slovenian: Odtaljene celice se uporabijo za izdelavo zdravila Holoclar, tako da se vzgojijo na membrani iz beljakovine, imenovane fibrin.
English: How does Holoclar work?
Slovenian: Kako zdravilo Holoclar deluje?
English: Since Holoclar has been granted a conditional approval, the company that markets Holoclar will provide further data on Holoclar.
Slovenian: Ker je zdravilo Holoclar pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, zagotovila nadaljnje podatke o tem zdravilu.
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.
Slovenian: Zdravilna učinkovina zdravila Holoclar so bolnikove lastne limbusne celice, ki vključujejo celice s površine roženice in limbusne matične celice, vzgojene v laboratoriju.
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).
Slovenian: Zdravilo Holoclar vsebuje matične celice in se uporablja v očesu za nadomestitev poškodovanih celic na površini (epiteliju) roženice, tj. prozorne plasti v sprednjem delu očesa, ki prekriva šarenico (obarvani del).
English: How is Holoclar used?
Slovenian: Kako se zdravilo Holoclar uporablja?
English: Antibiotics to prevent eye infection should be given to patients after limbal tissue has been taken from them.
Slovenian: Po odstranitvi limbusnega tkiva je treba bolniku dajati antibiotike, da se prepreči okužba očesa.
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.
Slovenian: Zdravilo Holoclar se je v retrospektivni študiji, v kateri so uporabili zdravniške izvide bolnikov iz preteklosti, izkazalo za učinkovito pri ponovnem vzpostavljanju stabilne površine roženice pri bolnikih z zmernim ali hudim pomanjkanjem limbusnih matičnih celic zaradi opekline.
English: International Non-proprietary Name (INN): cytarabine
Slovenian: Mednarodno nelastniško ime (INN): citarabin
English: The evaluation was finished and the CHMP would have given a negative opinion.
Slovenian: Ocenjevanje je bilo takrat končano, CHMP pa bi podal negativno mnenje.
English: They had concerns with the way the data were analysed.
Slovenian: Zadržki so se nanašali na način analize podatkov.