natgillin/translations-raw huggingface dataset:
(Two medicines are bioequivalent when they produce the same levels of the active substance in the body.) 
(Dva su lijeka bioekvivalentna ako u tijelu proizvode iste razine djelatne tvari.)
With the skeleton still in place, the cells cannot divide and they eventually die. 
Ako im je kostur netaknut, stanice se ne mogu dijeliti i naposljetku umiru.
On 6 June 2016, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Docetaxel Sun, for the treatment of various types of cancer. 
Dana 6. lipnja 2016., tvrtka Sun Pharmaceutical Industries Europe B.V. službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoju prijavu za odobrenje za stavljanje u promet za Docetaxel Sun, za liječenje različitih vrsta raka.
What is Docetaxel Sun? 
Što je Docetaxel Sun?
It was to be available as a concentrate to make a solution for infusion (drip) into a vein. 
Trebao je biti dostupan kao koncentrat od kojeg se priprema otopina za intravensku infuziju (drip).
It was intended to be used on its own or in combination with other cancer medicines, depending on the type of cancer and the response to previous treatments. 
Trebao se primjenjivati kao monoterapija ili u kombinaciji s drugim lijekovima protiv raka, zavisno o vrsti raka i reakciji bolesnika na prethodne terapije.
Docetaxel Sun was developed as a ‘generic medicine'. 
Docetaxel Sun razvijen je kao „generički lijek”.
Docetaxel Sun was to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma (a type of stomach cancer) and cancer of the head and neck. 
Docetaxel Sun bio je predviđen za liječenje raka dojke, raka pluća nemalih stanica, raka prostate, želučanog adenokarcinoma (vrsta raka želuca) i raka glave i vrata.
Because Docetaxel Sun was developed as a generic medicine, the company presented the results of studies from the literature, and studies to show the quality of the medicine. 
Budući da je lijek Docetaxel Sun razvijen kao generički lijek, tvrtka je predstavila rezultate ispitivanja iz literature, i ispitivanja kojima se dokazuje kvaliteta lijeka.
The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions. 
Zahtjev je povučen nakon što je CHMP ocijenio inicijalnu dokumentaciju koju je tvrtka dostavila te je sastavio popis pitanja.
In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application for Docetaxel Sun for commercial reasons. 
U dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da povlači zahtjev za lijek Docetaxel Sun iz komercijalnih razloga.
In particular, the CHMP noted that the docetaxel in Docetaxel Sun and in Taxotere is contained in tiny droplets (micelles) made with another substance, polysorbate 80, that helps the docetaxel to dissolve. 
Konkretno, CHMP je istaknuo kako je docetaksel u lijekovima Docetaxel Sun i Taxotere sadržan u sitnim kapljicama (micelama) koje su načinjene s drugom tvari, polisorbatom 80, koji pomaže u razgrađivanju docetaksela.
Withdrawal of the marketing authorisation application for Docetaxel Sun (docetaxel) 
Povlačenje zahtjeva za odobrenje za stavljanje u promet lijeka Docetaxel Sun (docetaksel)
However, solutions containing micelles may behave differently from one another, and the CHMP considered that more information was needed to show that the Docetaxel Sun solution was similar enough in its composition and behaviour to Taxotere solution to allow a bioequivalence study to be omitted. 
Međutim, otopine koje sadrže micele mogu različito reagirati, i CHMP je smatrao da je potrebno više informacija kako bi se dokazalo da su sastav i djelovanje otopine lijeka Docetaxel Sun dovoljno slični otopini lijeka Taxotere da bi neprovođenje ispitivanja bioekvivalencije bilo opravdano.
This means that Docetaxel Sun was intended to be similar to a ‘reference medicine' already authorised in the European Union called Taxotere. 
To znači da je Docetaxel Sun sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Taxotere.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Docetaxel Sun could not have been approved for the treatment of cancer. 
Na temelju pregleda podataka, u trenutku povlačenja, CHMP je smatrao da postoje problemi te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Docetaxel Sun za liječenje raka.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Docetaxel Sun. 
Sukladno navedenome, u vrijeme povlačenja CHMP je smatrao kako tvrtka nije dostavila dostatne podatke koji bi poduprli zahtjev za Docetaxel Sun.
The company had not carried out a study to demonstrate that Docetaxel Sun is bioequivalent to the reference medicine, because this is not required if the medicines are simple solutions that are given into a vein. 
Tvrtka nije provela ispitivanje kojim bi se dokazala bioekvivalentnost lijeka Docetaxel Sun s referentnim lijekom jer to nije potrebno ako su lijekovi jednostavne otopine koje se primjenjuju u venu.
No further studies were carried out because Docetaxel Sun is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere. 
Nisu provedena dodatna ispitivanja jer je Docetaxel Sun generički lijek koji se daje infuzijom i koji sadrži istu djelatnu tvar kao i referentni lijek Taxotere.
The active substance in Docetaxel Sun and Taxotere, docetaxel, belongs to the group of cancer medicines known as taxanes. 
Djelatna tvar u lijekovima Docetaxel Sun i Taxotere, docetaksel, pripada skupini lijekova za liječenje raka pod nazivom taksani.
Docetaxel Sun is a medicine that contains the active substance docetaxel. 
Docetaxel Sun je lijek koji sadrži djelatnu tvar docetaksel.
Docetaxel Sun is expected to work in the same way as the reference medicine, Taxotere. 
Docetaxel Sun je trebao djelovati na isti način kao i referentni lijek, Taxotere.
Withdrawal of the marketing authorisation application for Docetaxel Sun (docetaxel) EMA/396891/2016 
(docetaksel) EMA/396891/2016
The CHMP was assessing the company's responses to the questions at the time of the withdrawal. 
U trenutku povlačenja CHMP je ocjenjivao odgovore na pitanja koje je tvrtka dostavila.
What was Docetaxel Sun expected to be used for? 
Za što se Docetaxel Sun trebao koristiti?
How is Docetaxel Sun expected to work? 
Kako je Docetaxel Sun trebao djelovati?
Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply. 
unutarnji„kostur” koji im omogućuje diobu i umnožavanje.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom29 January 2016 
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom29. siječnja 2016.
EMEA/H/C/004236 
EMA/55039/2016 EMEA/H/C/004236
What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes? 
Koje posljedice ima ovo povlačenje za pacijente u kliničkim ispitivanjima ili u programima milosrdnog davanja lijekova?
It was to be available as tablets (5, 10, 15 and 30 mg) and as 10 and 15 mg orodispersible tablets (tablets that dissolve in the mouth). 
Trebao je biti dostupan u obliku tableta (od 5, 10, 15 i 30 mg) te u obliku orodisperzibilnih tableta od 10 i 15 mg (tableta koje se otapaju u ustima).
Its exact mechanism of action is unknown, but it attaches to several types of receptors on nerve cells in the brain. 
Točan mehanizam njegova djelovanja nije poznat, ali poznato je da se veže na nekoliko vrsta receptora na živčanim stanicama u mozgu.
This action disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that nerve cells use to communicate with neighbouring cells. 
To djelovanje ometa signale koje između moždanih stanica prenose „neurotransmiteri”, kemikalije koje živčane stanice koriste radi komunikacije sa susjednim stanicama.
This may help to reduce psychotic and manic symptoms and prevent them from returning. 
To može pomoći u smanjenju psihotičnih i maničnih simptoma te u sprečavanju ponovnog javljanja tih simptoma.
The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions. 
Zahtjev je povučen nakon što je CHMP ocijenio prvotnu dokumentaciju koju je tvrtka dostavila i sastavio popis pitanja.
Two medicines are bioequivalent when they produce the same levels of the active substance in the body. 
Dva su lijeka bioekvivalentna kada u tijelu proizvode iste razine djelatne tvari.
The company informed the CHMP that there were no consequences for patients in clinical trials. 
Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su uključeni u klinička ispitivanja.
This means that Aripiprazole Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify. 
To znači da je Aripiprazole Mylan sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Abilify.
This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but it has a weaker effect than the natural neurotransmitters. 
To znači da aripiprazol djeluje kao dopamin i 5hidroksitriptamin aktivacijom tih receptora, ali ima manji učinak od prirodnih neurotransmitera.
In its letter notifying the Agency of the withdrawal of application, the company stated that the reason for withdrawal was identification of manufacturing issues. 
U svom dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da povlači zahtjev zbog utvrđivanja problema u proizvodnji.
Aripiprazole Mylan was expected to be used to treat schizophrenia in patients aged 15 years or over. 
Aripiprazole Mylan trebao se koristiti za liječenje shizofrenije u bolesnika u dobi od 15 ili više godina.
Aripiprazole Mylan was developed as a ‘generic medicine'. 
Aripiprazole Mylan razvijen je kao „generički lijek”.
What is Aripiprazole Mylan? 
Što je Aripiprazole Mylan?
It was also expected to be used to treat moderate to severe manic episodes and to prevent new manic episodes in adults with bipolar I disorder who have responded to the medicine in the past, and for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over with bipolar I disorder. 
Također se trebao koristiti za liječenje maničnih epizoda umjerenog do teškog stupnja te za sprječavanje novih maničnih epizoda u odraslih osoba s bipolarnim poremećajem tipa I. koji su u prošlosti pozitivno reagirali na lijek i za liječenje, u trajanju do 12 tjedana, maničnih epizoda umjerenog do teškog stupnja u bolesnika u dobi od 13 ili više godina s bipolarnim poremećajem tipa I.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Aripiprazole Mylan. 
Sukladno navedenome, u vrijeme povlačenja CHMP je smatrao kako tvrtka nije dostavila dostatne podatke koji bi poduprli zahtjev za Aripiprazole Mylan.
The CHMP considered that the dissolution tests required for the biowaiver had not been carried out according to existing recommendations and thus, bioequivalence for all the different strengths of tablets and orodispersible tablets had not been demonstrated. 
CHMP je smatrao da ispitivanja otapanja potrebna za izuzeće od ispitivanja bioekvivalencije nisu provedena sukladno postojećim preporukama i da stoga nije dokazana bioekvivalencija za sve različite jačine tableta i orodisperzibilne tablete.
Aripiprazole's action alters dopamine and 5-hydroxytryptamine activity, which is abnormal in schizophrenia and bipolar disorder. 
Djelovanje aripiprazola mijenja aktivnost dopamina i 5-hidroksitriptamina koja je abnormalna u slučaju shizofrenije i bipolarnog poremećaja.
agonist' on the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin). 
aripiprazol djeluje kao „parcijalni agonist” za receptore neurotransmitera dopamina i 5hidroksitriptamina (koji se također naziva serotonin).
The biowaiver removes the need to repeat bioequivalence studies for all the other strengths of Aripiprazole Mylan tablets. 
Izuzeće od ispitivanja bioekvivalencije otklanja potrebu za ponavljanjem ispitivanja bioekvivalentnosti za sve druge jačine tableta Aripiprazole Mylan.
The active substance in Aripiprazole Mylan, aripiprazole, is an antipsychotic medicine. 
Djelatna tvar u lijeku Aripiprazole Mylan, aripiprazol, jest antipsihotik.
The CHMP considered that the tests to support a biowaiver were not acceptable. 
CHMP je smatrao da ispitivanja provedena radi potpore izuzeću od ispitivanja bioekvivalencije nisu bila prihvatljiva.
Based on the review of the data, at the time of the withdrawal, the CHMP was of the provisional opinion that Aripiprazole Mylan could not have been approved for the treatment of schizophrenia and for the treatment and prevention of manic episodes in patients with bipolar I disorder. 
Na temelju pregleda podataka, u trenutku povlačenja privremeno mišljenje CHMP-a bilo je da nije moguće dati odobrenje za Aripiprazole Mylan za liječenje shizofrenije te liječenje i sprječavanje maničnih epizoda u bolesnika s bipolarnim poremećajem tipa I.
What was Aripiprazole Mylan expected to be used for? 
Za što se Aripiprazole Mylan trebao koristiti?
Because Aripiprazole Mylan is a generic medicine, the company had presented results of studies in volunteers to show that Aripiprazole Mylan 10-mg tablet and the 10-mg orodispersible tablet were bioequivalent to the corresponding tablets of the reference medicine, Abilify. 
Mylan generički lijek, tvrtka je dostavila rezultate ispitivanja provedenih na dobrovoljcima kako bi dokazala da su tableta od 10 mg i orodisperzibilna tableta od 10 mg lijeka Aripiprazole
How is Aripiprazole Mylan expected to work? 
Kako je Aripiprazole Mylan trebao djelovati?
Aripiprazole Mylan is a medicine that contains the active substance aripiprazole. 
Mylan je lijek koji sadrži djelatnu tvar aripiprazol.
officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aripiprazole Mylan, for the treatment of schizophrenia and the treatment and prevention of manic episodes in patients with bipolar I disorder. 
Dana 8. siječnja 2016. tvrtka Mylan S.A.S. službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) da želi povući svoju zahtjev za odobrenje za stavljanje u promet lijeka Aripiprazole Mylan za liječenje shizofrenije te liječenje i sprječavanje maničnih epizoda u bolesnika s bipolarnim poremećajem tipa I.
To support an application for a ‘biowaiver', the company also presented laboratory tests to show that other strengths of Aripiprazole Mylan tablets dissolve in an identical way to the reference medicine. 
Kako bi poduprla zahtjev za izuzeće od ispitivanja bioekvivalencije, tvrtka je također dostavila rezultate laboratorijskih ispitivanja koji pokazuju da se druge jačine tableta Aripiprazole
Date of first autorisation: 06.11.2001 / Date of last renewal: 21.11.2006 
Datum prvog odobrenja 06.11.2001 / Datum zadnje obnove: 21.11.2006.
These clinical signs disappear within 7 days without any particular treatment. 
Ovi simptomi nestaju u roku od 7 dana bez ikakvog posebnog tretmana.
Αθηνών - Λαμίας, T.K.14452, Μεταμόρφωση, Ελλάδα 
13o χλμ Ε.Ο. Αθηνών - Λαμίας, T.K.14452, Μεταμόρφωση, Ελλάδα
EXP: {month/year} 
EXP {mjesec/godina}
1515 Tsutsui, Masaki-Cho, Iyogun 
1515 Tsutsui, Masaki-Cho, lyogun
These parameters return to normal in the week following the last injection. 
Ove se vrijednosti vraćaju u normalu kroz tjedan dana nakon posljednje aplikacije.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder. 
Za bilo kakve informacije o ovom veterinarsko-medicinskom proizvodu molimo da kontaktirate lokalnog zastupnika, nositelja odobrenja za stavljanje u promet.
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals. 
a) će primjena veterinarsko-medicinskog proizvoda na životinjama interferirati s provedbom nacionalnog programa otkrivanja, kontrole i suzbijanja bolesti životinja ili će izazvati poteškoće u certificiranju odsutnosti zaraze u živim životinjama ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 
Ako primjetite nuspojave, čak i ako nisu već navedene na ovom pakiranju ili ako mislite da lijek nije djelovao, molimo potražite pomoć vašeg veterinara.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their territory if it is established that: 
Sukladno članku 71 Direktive 2001/82/EZ i Europskog Parlamenta i Vijeća koja je dopunjena, države članice zabranjuju ili mogu zabraniti uvoz, prodaju, opskrbu i/ili primjenu veterinarsko-medicinskog proizvoda na cijelom teritoriju ili na jednom njegovom dijelu ako je utvrđeno da:
Store and transport refrigerated (2 °C - 8 °C). 
Čuvati i prevoziti na hladnom (2 C - 8 C).
No information on the induction of long-term side effects is available in dog and cat, especially for autoimmune disorders. 
Nema informacija o dugoročnim nuspojavama kod pasa i mačaka naročito glede autoimunih poremećaja.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. 
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta i laktacije.
• in anaemic cats, mortality rate of about 60% at 4, 6, 9 and 12 months was reduced by approximately 30% following treatment with interferon. 
• kod anemičnih mačaka stopa smrtnosti od 60% u 4., 6., 9., i 12. mjesecu bila je smanjena približno oko 30% po tretmanu interferonom.
The use of supplementary supportive treatments improves prognosis. 
Korištenje dodatne potporne terapije tijekom liječenja popravlja prognozu.
*MU : Million Units 
MJ* : Milijun jedinica
Sodium hydroxide 0.2 M Sodium chloride D-Sorbitol 
Natrijev hidroksid 0,2 M Natrijev klorid D-sorbitol
Sodium chloride Water for injections 
Natrijev klorid Voda za injekcije
Do not use after the expiry date stated on the label. 
Ne koristiti poslije isteka roka valjanosti označenog na etiketi.
• slight increase of body temperature. 
• blagi porast tjelesne temperature.
Interaction with other medicinal products and other forms of interaction 
Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija
After injection it is quickly bound to specific receptors of a large variety of cells. 
U kratkom vremenu poslije aplikacije brzo se veže na specifične receptore različitih stanica.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://emea.europa.eu/. 
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.>
In cats infected by FIV, mortality was low (5%) and was not influenced by the treatment. 
U mačaka inficiranih sa FIV stopa uginuća bila je mala (5%) i tretman na nju nije utjecao.
STATEMENT OF THE MRLs 
IZJAVA O MRL
Pharmacotherapeutic group: Interferons ATCvet code : QL03AB 
Farmakoterapijska grupa: Interferoni ATCvet kod: QL03 AB
It is mainly in cells infected by virus that the mechanism of replication is stopped both by destruction of mRNA and by inactivation of translation proteins (2'5' oligo-adenylate synthetase activation). 
U stanicama zaraženim virusom dolazi do prekida mehanizma razmnožavanja virusa uništavanjem mRNA i inaktivacijom translacijskih proteina (aktivacija 2'5' oligo adenilat sintetaze).
Detailed information on this product is available on the website of the European Medicines Agency http://emea.europa.eu/. 
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
The exact mechanism of action of interferon omega is not perfectly known, but may involve enhancement of the non-specific defence of the body, in particular in the dog against canine parvovirosis and in the cat against feline retrovirosis (FeLV, FIV). 
Točan mehanizam djelovanja interferona omega nije sasvim poznat ali može uključivati pojačavanje nespecifičnih obrambenih mehanizama organizma, posebice kod pasa protiv parvoviroze i kod mačaka protiv retroviroze (FeLV, FIV).
Lyophilisate: white pellet. 
Liofilizat: bijela peleta.
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory. 
b) bolest za koju je dotični veterinarsko-medicinski proizvod predviđen za pružanje imuniteta, nije nazočna na tom području.
However, as specific information on possible interactions of interferon with other products are missing, supplementary supportive treatments should be used cautiously and after a thorough risk/benefit analysis. 
Ipak, pošto nema specifičnih informacija o interakcijama interferona s ostalim proizvodima, potpornu terapiju treba koristiti oprezno i nakon podrobne analize koristi i rizika.
Purified gelatin of porcine origin 
Pročišćena svinjska želatina
Any person intending to import, sell, supply and/or use VIRBAGEN OMEGA must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use. 
Svaka osoba koja namjerava uvoziti, prodavati, opskrbljivati i/ili primjenjivati VIRBAGEN OMEGA mora se prethodno konzultirati s nadležnim tijelom odnosne države članice u pogledu važećih odredbi o cijepljenju prije uvoza, prodaje, opskrbe i/ili primjene.,
Interferon does not act directly and specifically on the pathogenic virus, but exerts its effect by inhibition of the internal synthesis mechanisms of the infected cells. 
Interferon ne djeluje direktno i specifično na patogeni virus ali djeluje na unutrašnje mehanizme sinteze u zaraženim stanicama.
Name and address of the manufacturer of the biological active substance 
Naziv i adresa proizvođača biološki djelatne tvari
No information is available on the safety and efficacy from the concurrent use of this product with any vaccine. 
Nema informacija o neškodljivosti i djelotvornosti istovremenog korištenja ovog proizvoda s bilo kojim cjepivom.
• slight increase of respiratory rate 
• blagi porast frekvencije disanja
Such side effects have been described after multiple and long-term administration of type I interferon in man. 
Takve nuspojave su bile opisane poslije višestrukog i dugoročnog unošenja interferona tipa i kod ljudi.
• in non-anaemic cats, mortality rate of 50 % in cats infected by FeLV was reduced by 20% following treatment with interferon. 
• kod neanemičnih mačaka stopa smrtnosti od 50% kod mačaka inficiranih sa FeLV smanjena je za 20% po tretmanu interferonom.
For dogs, it is recommended that no vaccines should be administered until the animal appears to have recovered. 
Za pse se ne preporuča koristi niti jedno cjepivo dok životinja ne oporavi.
SPECIAL WARNING(S) Special warnings for each target species 
12. POSEBNO(A) UPOZORENJE(A) Posebna upozorenja za svaku od ciljnih vrsta životinja
Type I glass vial closed with stopper made with butyl rubber polymer coated with a fluorocarbon polymer resin. 
I zatvorena čepom od gumenog butil polimera presvučena smolom od fluorkarbon polimera.
For the full list of excipients, see section 6.1. 
Pomoćne tvari: Potpuni popis pomoćnih tvari vidi u djelu 6.1.