natgillin/translations-raw huggingface dataset:
For more information about treatment with Numient, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Numient preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Numient, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Numient in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
In a study of 381 patients with early stage Parkinson's disease, Numient at various doses was more effective at improving symptoms than placebo (a dummy treatment). 
V študiji, v kateri je sodelovalo 381 bolnikov s Parkinsonovo boleznijo v zgodnji fazi, je bilo zdravilo Numient učinkovitejše pri izboljševanju simptomov kot placebo (zdravilo brez zdravilne učinkovine).
Numient contains levodopa which converts into dopamine in the brain and helps to restore dopamine levels. 
Zdravilo Numient vsebuje levodopo, ki se v možganih pretvori v dopamin in pomaga ponovno vzpostaviti ravni dopamina.
Both groups had off periods of about 36-37% at the start of the study. 
Pri obeh skupinah je ta delež na začetku študije znašal približno
In Numient, a portion of the active substances is released immediately, while the remaining is released gradually, leading to more steady levodopa levels. 
V zdravilu Numient se del zdravilnih učinkovin sprosti takoj, preostanek pa se sprošča postopoma, s čimer se dosežejo bolj stabilne ravni levodope.
For practical information about using Numient, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Numient naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
It must also not be used in patients taking medicines known as non-selective monoamine oxidase (MAO) inhibitors or in patients with a history of certain medical conditions. 
Prav tako ga ne smejo uporabljati bolniki, ki jemljejo zdravila, imenovana neselektivni zaviralci monoaminoksidaze, ali bolniki, ki so preboleli določene bolezni.
Another benefit is the way the active substances are formulated in Numient, which helps maintain more steady levodopa levels. 
Naslednja korist je način sproščanja zdravilnih učinkovin v zdravilu Numient, ki pomaga ohranjati stabilnejše ravni levodope.
It contains the active substances levodopa and carbidopa. 
Vsebuje zdravilni učinkovini levodopo in karbidopo.
The carbidopa in Numient stops the levodopa from converting into dopamine while still in the general circulation, before it has reached the brain. 
Karbidopa v zdravilu Numient preprečuje, da bi se levodopa v domapin pretvorila že v splošnem krvnem obtoku, torej še preden doseže možgane.
Numient is used in adults to treat the symptoms of Parkinson's disease, a progressive brain disorder that causes shaking and muscular stiffness and slows down movement. 
Zdravilo Numient se uporablja za zdravljenje simptomov Parkinsonove bolezni, tj. napredujoče bolezni možganov, ki povzroča tresenje in otrdelost mišic ter upočasnjuje izvajanje gibov, pri odraslih.
How is Numient used? 
Kako se zdravilo Numient uporablja?
Numient must not be used in patients with narrow angle glaucoma (an eye disorder) or pheochromocytoma (a tumour of the adrenal glands). 
Zdravila Numient ne smejo uporabljati bolniki z glavkomom z ozkim zakotjem (očesno boleznijo) ali feokromocitomom (tumorjem nadledvične žleze).
How does Numient work? 
Kako zdravilo Numient deluje?
Numient is available as capsules to be taken by mouth. 
Zdravilo Numient je na voljo v obliki kapsul, ki se jemljejo peroralno.
A second study compared Numient with another treatment containing levodopa and carbidopa in 393 patients with advanced Parkinson's disease. 
V drugi študiji, v kateri je sodelovalo 393 bolnikov z napredovalo Parkinsonovo boleznijo, so primerjali zdravilo Numient z drugim zdravilom, ki vsebuje levodopo in karbidopo.
Numient can only be obtained with a prescription and it is available in the following strengths: 
Izdaja zdravila Numient je le na recept.
These local reactions gradually reduce and disappear without need for treatment. 
Te lokalne reakcije se postopoma zmanjšajo in izginejo ne da bi bilo potrebno zdravljenje.
Before use allow the vaccine to reach room temperature. 
Pred uporabo naj cepivo doseže sobno temperaturo.
ATCvet code: QI08AA 
Oznaka ATC vet: QI08AA
Revaccination: 12 months after vaccination. 
Ponovno cepljenje: 12 mesecev po cepljenju.
Each dose of 0.5 ml contains: 
Vsak 0,5 ml odmerek vsebuje:
Onset of immunity: 1 week. 
Nastop imunosti: 1 teden.
No available data. 
Ni podatkov.
Keep the bottle in the outer carton in order to protect from light. 
Vialo shranjujte v zunanji ovojnini, da se zaščiti pred svetlobo.
Vaccination of rabbits induced the production of hemagglutination inhibition antibodies that persisted for at least 12 months. 
Cepljenje kuncev je sprožilo proizvajanje protiteles za inhibicijo hemaglutinacije, ki so učinkovala vsaj 12 mesecev.
Date of first authorisation: 22 September 2016 
Datum pridobitve dovoljenja za promet: 22/09/2016
Detailed information on this 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/).
Vial label (1, 10 or 40 doses) 
Viala (1, 10 ali 40 odmerkov)
Overdose (symptoms, emergency procedures, antidotes): No available data. 
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Ni podatkov.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. 
Tega zdravila na smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP.
Pregnant does should be handled with special care to avoid stress and risk of abortion 
Z brejimi kunčicami je potrebno ravnati previdno, da se zmanjša morebitni stres in tveganje za abortus.
Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients. 
Ne uporabite v primerih preobčutljivosti na učinkovino, na dodatek ali na katero koli pomožno snov.
Detailed information on this veterinary medicinal product us available on the website of the European Medicines Agency (http://www.ema.europa.eu) 
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/.)
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
SPC so dovoljene substance za katere tabela 1 priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
Shelf life after first opening the immediate packaging: Use immediately. 
Rok uporabnosti po prvem odpiranju stične ovojnine: Uporabite takoj.
Pharmacotherapeutic group: Inactivated viral vaccines for Leporidae, inactivated viral vaccine for rabbits. 
Farmakoterapevtska skupina: Imunološka zdravila za zajce in kunce (leporidae), inaktivirana virusna cepiva.
The vaccine provides protection only against RHDV2, cross protection against classical RHDV has not been demonstrated. 
Cepivo omogoča zaščito le proti virusu RHDV2, saj navzkrižna zaščita proti klasičnemu virusu RHDV
Incompatibilities: Do not mix with any other veterinary medicinal products. 
Inkompatibilnosti: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
Duration of immunity: 12 months demonstrated by challenge 
Trajanje imunosti: 12 mesecev dokazano s študijo izpostavljenosti.
Nodules or swelling (< 2 cm) can be very commonly observed in the injection site, which may last 24 hours. 
Na mestu injiciranja se zelo pogosto pojavijo noduli ali oteklina (< 2 cm), ki lahko trajajo 24 ur.
This slight temperature increase resolves spontaneously without treatment by day 5 post vaccination. 
Rahlo povišanje temperature se brez zdravljenja povrne na normalno vrednost do 5. dne po cepljenju.
Laboratory studies in pregnant doe in the last third of gestation have not been produced any evidence of a teratogenic, foetotoxic and maternotoxic effects. 
Z laboratorijskimi študijami na kunčicah v zadnji tretjini brejosti niso bili dokazani teratogeni, fetotoksični ali toksični učinki na mater.
If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. 
Če vam je bilo to zdravilo nenamerno injicirano, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodilo za uporabo.
Whitish emulsion. 
Belkasta emulzija.
Expert, prompt, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon. 
Potreben je strokoven, TAKOJŠEN, kirurški poseg ter morda tudi takojšnja incizija in izpiranje injiciranega mesta, zlasti če so prizadete tudi kite ali mehka tkiva prsta.
Administer 1 dose (0.5 ml) of the veterinary medicinal product to rabbits from the age of 30 days by subcutaneous injection in the lateral thoracic wall. 
Uporabite 1 odmerek (0,5 ml) cepiva za kunce starejše od 30 dni in ga vbrizgajte pod kožo v bočno torakalno steno.
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. 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovine biološkega izvora namenjene vzbujanju aktivne imunosti, niso vključene v Uredbo (ES)
Tel. +34 972 430660 Fax +34 972 430661 E-mail: hipra@hipra.com 
+34 972 430661 E-pošta: hipra@hipra.com
Potassium chloride Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Water for injections 
Seznam pomožnih snovi mineralno olje tiomersal sorbitan monooleat polisorbat 80 natrijev klorid kalijev klorid natrijev hidrogenfosfat dodekahidrat kalijev dihidrogenfosfat voda za injekcije
For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2). 
Za aktivno imunizacijo kuncev od 30. dneva starosti dalje, z namenom zmanjševanja poginov zaradi virusa hemoragične bolezni kuncev tipa 2 (RHDV2).
Laboratorios Hipra S.A. Avda. 
LaboratoriosHipra S.A. Avda.
To stimulate active immunity against the rabbit haemorrhagic disease type 2 virus (RHDV2). 
Za spodbujanje aktivne imunosti proti virusu hemoragične bolezni kuncev tipa 2 (RHDV2).
Shake well before administration. 
Pred uporabo dobro pretresite.
Special precautions for use in animals Vaccination is recommended where RHDV2 is epidemiologically relevant. 
Celjenje se priporoča le tam, kjer je virus RHDV2 epidemiološko relevanten.
A transient temperature increase slightly above 40 ºC might very commonly occur between two or three days following vaccination. 
Dva do tri dni po cepljenju se zelo pogosto pojavi prehodno povišanje telesne temperatura rahlo nad 40 ºC.
Type I colourless glass vials with 0.5 ml (1 dose), 5 ml (10 doses) and 20 ml (40 doses). 
Viale iz brezbarvnega stekla tipa I s 0,5 ml (1 odmerek), 5 ml (10 odmerki) in 20 ml (40 odmerki).
Special precautions to be taken by the person administering the veterinary medicinal product to animals: 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Namenjeno uporabniku:
17170 Amer (Girona) SPAIN 
17170- AMER (Girona) ŠPANIJA
Lethargy and/or inappetence may be observed very rarely in the first 48 hours after injection, based on post-authorisation pharmacovigilance reporting. 
Na podlagi farmakovigilančnega poročanja po izdaji dovoljenja za promet z zdravilom se lahko v prvih 48 urah po cepljenju zelo redko pojavita letargija in/ali zmanjšanje apetita.
Mineral oil: ………………..104.125 mg 
mineralno olje: ………………104,125 mg
Mineral oil…………104.125 mg 
mineralno olje………………104,125 mg
Thiomersal: ………………..0.05 mg 
tiomersal: ………………0,05 mg
la Selva, 135 17170 Amer (Girona) SPAIN 
la Selva, 135 17170- AMER (Girona) ŠPANIJA
Cardboard box of 1 glass vial of 40 doses (20 ml). 
Kartonska škatla z 1 stekleno vialo s 40 odmerki (20 ml).
1 x 40 doses (20 ml). 
1 x 40 odmerki (20 ml).
Thiomersal…………0.05 mg 
tiomersal………………0,05 mg
Laboratory studies in doe rabbits in the last third of gestation have not been produced any evidence of a teratogenic, foetotoxic and maternotoxic effects. 
Brejost Z laboratorijskimi študijami na kunčicah v zadnji tretjini brejosti niso bili dokazani teratogeni,
ERAVAC emulsion for injection for rabbits 
ERAVAC emulzija za injiciranje za kunce
Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037 …..≥70% cELISA40* (*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40. 
Virus hemoragične bolezni kuncev tipa 2(RHDV2), sev V-1037, inaktiviran……≥70 % cELISA40* (*) ≥ 70 % cepljenih kuncev bo imelo titer protiteles cELISA 40 ali več.
10 x 1 dose (0.5 ml). 
10 x 1 odmerek (0,5 ml) 1 x 10 odmerki (5 ml).
Cardboard box of 10 glass vials of 1 dose (0.5 ml). 
Kartonska škatla z 10 steklenimi vialami po 1 odmerek (0,5 ml) Kartonska škatla z 1 stekleno vialo z 10 odmerki (5 ml).
Rabbits. 
Faks.
Inactivated RHDV2, strain V-1037: ………….≥70% cELISA40 
RHDV2, sev V-1037, inaktiviran: ≥70% cELISA40 ≥ 70 % cepljenih kuncev bo imelo titer protiteles cELISA 40 ali več.
Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037: ……≥70% cELISA40* 
Virus hemoragične bolezni kuncev tipa 2 (RHDV2), sev V-1037, inaktivirani: ……≥70 % cELISA40* (*) ≥ 70 % cepljenih kuncev bo imelo titer protiteles cELISA 40 ali več.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI)
The full EPAR for Controloc Control 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) za zdravilo Controloc Control je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended dose of Controloc Control is one tablet once a day until symptoms have stopped. 
Priporočeni odmerek zdravila Controloc Control je ena tableta enkrat na dan, dokler simptomi ne izzvenijo.
The European Commission granted a marketing authorisation valid throughout the EU for Controloc Control on 12 June 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Controloc Control, veljavno po vsej Evropski uniji, odobrila dne 12. junija 2009.
It was also of the opinion that, based on the experience of the use of pantoprazole, the availability of Controloc Control without medical supervision is appropriate. 
Menil je tudi, da je glede na izkušnje z uporabo pantoprazola dostopnost zdravila Controloc Control brez medicinskega nadzora ustrezna.
Controloc Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Controloc. 
Zdravilo Controloc Control je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Controloc.
This is a summary of the European public assessment report (EPAR) for Controloc Control. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Controloc Control.
The most common side effects with Controloc Control (seen in around 1 patient in 100) are diarrhoea and headache. 
Najpogostejša neželena učinka zdravila Controloc Control (opažena pri približno 1 bolniku od 100) sta driska in glavobol.
For more information about treatment with Controloc Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Controloc Control preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Controloc Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients. 
Zdravila Controloc Control ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) pantoprazol, sojo ali katero koli drugo sestavino zdravila.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Controloc Control. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Controloc Control, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Controloc Control's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Zato je zaključil, da so koristi zdravila Controloc Control večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Controloc Control is used for the short-term treatment of the symptoms of acid reflux in adults. 
Zdravilo Controloc Control se uporablja za kratkotrajno zdravljenje simptomov kislega refluksa pri odraslih.
It is used for long-term treatments and is also used to treat a wider range of gastrointestinal diseases (conditions affecting the gut) than Controloc Control. 
Uporablja se za dolgotrajno zdravljenje in za zdravljenje širšega spektra bolezni prebavil (stanj, ki prizadenejo črevesje) kot zdravilo Controloc Control.
What benefit has Controloc Control shown during the studies? 
Kakšne koristi je zdravilo Controloc Control izkazalo med študijami?
Controloc Control is a medicine that contains the active substance pantoprazole. 
Zdravilo Controloc Control je zdravilo, ki vsebuje zdravilno učinkovino pantoprazol.
Other information about Controloc Control 
Druge informacije o zdravilu Controloc Control:
It must not be used with atazanavir (a medicine used to treat human immunodeficiency virus [HIV] infection). 
Zdravilo Controloc Control se ne uporabljati z atazanavirjem (zdravilom za zdravljenje okužbe z virusom človeške imunske pomanjkljivosti [HIV]).
The reference medicine, Controloc, is only available with a prescription. 
Referenčno zdravilo Controloc se izdaja le na recept.
The active substance in Controloc Control, pantoprazole, is a proton pump inhibitor. 
Zdravilna učinkovina zdravila Controloc Control, pantoprazol, je zaviralec protonske črpalke.
What is the risk associated with Controloc Control? 
Kakšna tveganja so povezana z zdravilom Controloc Control?
Why has Controloc Control been approved? 
Zakaj je bilo zdravilo Controloc Control odobreno?
How has Controloc Control been studied? 
Kako je bilo zdravilo Controloc Control raziskano?
How is Controloc Control used? 
Kako se zdravilo Controloc Control uporablja?
What is Controloc Control? 
Kaj je zdravilo Controloc Control?
What is Controloc Control used for? 
Za kaj se zdravilo Controloc Control uporablja?
How does Controloc Control work? 
Kako zdravilo Controloc Control deluje?
The company requested a re-examination of the initial opinion. 
Podjetje je zahtevalo ponoven pregled prvotnega mnenja.
The recommendation was confirmed after re-examination. 
To priporočilo je bilo po ponovnem pregledu potrjeno.
Doxorubicin has been available since the 1960s. 
Doksorubicin je na voljo od 60. let 20. stoletja.
EMA/295022/2019 EMEA/H/C/004110 
29. maja 2019 EMA/295022/2019 EMEA/H/C/004110
What consequences does this refusal have for patients in clinical trials? 
Kakšne so posledice zavrnitve vloge za bolnike, ki sodelujejo v kliničnih preskušanjih?
After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 29 May 2019. 
Po proučitvi razlogov za to zahtevo je odbor CHMP ponovno pregledal mnenje in 29. maja 2019 potrdil zavrnitev vloge za pridobitev dovoljenja za promet.
For more information on hybrid medicines, see the question-and-answer document here. 
Za več informacij o hibridnih zdravilih si oglejte dokument z vprašanji in odgovori, ki je na voljo tukaj.
It works by interfering with the DNA within cells, preventing them from making more copies of DNA and making proteins. 
Deluje tako, da ovira DNK v celicah, s čimer celicam preprečuje izdelavo nadaljnjih kopij DNK in tvorbo beljakovin.
This means that cancer cells cannot divide and they eventually die. 
To pomeni, da se rakave celice ne morejo deliti in posledično odmrejo.
Therefore, Caelyx was used instead. 
Zato so namesto njega uporabili zdravilo Caelyx.
What were the CHMP's main concerns that led to the refusal? 
Kateri so bili glavni zadržki, zaradi katerih je odbor CHMP predlagal zavrnitev vloge?
They also reduce the medicine's effects on non-cancer cells, so it is less likely to cause some side effects. 
Prav tako zmanjšajo učinke zdravila na nerakave celice, zato je pojav določenih neželenih učinkov manj verjeten.
Doxolipad was expected to be used to treat metastatic breast cancer in patients at risk of heart problems (‘metastatic' means the cancer has spread to other parts of the body), and cancer of the ovary in women whose previous treatment including a platinum-based cancer medicine has stopped working. 
Zdravilo Doxolipad naj bi se uporabljalo za zdravljenje metastatskega raka dojk pri bolnikih, pri katerih obstaja tveganje za težave s srcem („metastatski“ pomeni, da se je rak razširil na druge dele telesa), in raka jajčnikov pri ženskah, pri katerih predhodno zdravljenje z zdravilom proti raku na osnovi platine ni več učinkovito.
The company informed the CHMP that there are no ongoing clinical trials with Doxolipad in the EU. 
Podjetje je odbor CHMP obvestilo, da v EU trenutno ne poteka nobeno klinično preskušanje z zdravilom Doxolipad.
The applicant presented data from the scientific literature, and data from studies conducted in experimental models, including comparisons with another authorised doxorubicin medicine, Caelyx, which contains doxorubicin in pegylated liposomal form. 
Predlagatelj je predložil podatke iz znanstvene literature in podatke iz študij, opravljenih na eksperimentalnih modelih, vključno s primerjavo z drugim odobrenim zdravilom z doksorubicinom, zdravilom Caelyx, ki vsebuje doksorubicin v obliki pegiliranih liposomov.