natgillin/translations-raw huggingface dataset:
The final study report shall be submitted to the PRAC: 
Končno poročilo o študiji je treba odboru PRAC predložiti:
These should be submitted to the National Competent Authorities: By 12 January 2015 
do 12. januarja 2015
National competent authorities of Member State(s) or reference Member State(s), if applicable, shall ensure that the following conditions are fulfilled by the MAH(s): 
Pristojni nacionalni organi ene ali več držav članic ali referenčnih držav članic, če je to ustrezno, bodo zagotovili, da imetnik(i) dovoljenja za promet z zdravilom izpolnjuje(jo) naslednje pogoje:
The first interim report shall be submitted to the PRAC : 
Prvo vmesno poročilo je treba odboru PRAC predložiti:
These materials should ensure that prescriber are informed and the patients understand and acknowledge the risks associated with valproate in utero exposure. 
Ta gradiva morajo zagotoviti, da bodo zdravniki obveščeni in da bodo bolniki poznali ter razumeli tveganja, povezana z izpostavljenostjo valproatu in utero.
The study design should aim to evaluate and quantify the effectiveness of the risk minimisation measures, and should include a pre- and postimplementation analysis and assessment. 
Zasnova študije mora omogočati ovrednotenje in kvantifikacijo učinkovitosti ukrepov za zmanjšanje tveganja ter vključevati analizo ter oceno pred in po njihovem izvajanju.
The Marketing Authorisation Holders of valproate and related substances shall develop and submit educational materials according to agreed core elements. 
Imetniki dovoljenj za promet z zdravilom za valproat in sorodne učinkovine morajo pripraviti in predložiti izobraževalna gradiva ob upoštevanju dogovorjenih bistvenih delov.
The Marketing Authorisation Holders of valproate and related substances shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures and to further characterise the prescribing patterns for valproate. 
Imetniki dovoljenj za promet z zdravilom za valproat in sorodne učinkovine bodo izvedli študijo o uporabi zdravila, namenjeno oceni učinkovitosti ukrepov za zmanjšanje tveganja in podrobnejši opredelitvi vzorcev predpisovanja valproata.
10 (1 x 10) vial (multipack) 
10 (1 x 10) vial (pakiranje z več vialami)
10 mg/ml / 3 mg/ml 
10 mg/ml/ 3 mg/ml koncentrat za raztopino za intraokularno izpiranje intraokularna uporaba viala (steklena)
28 March 2014 
28. marec 2014
The re-examination procedure started on 11 June 2013. 
Postopek ponovnega pregleda se je začel 11. junija 2013.
International non-proprietary name (INN): barium selenate 
Mednarodno nelastniško ime (INN): barijev selenat
On 23 August 2013, the European Commission requested the CVMP to review its opinion, mainly to clarify some aspects related to consumer risk assessment. 
Evropska komisija je 23. avgusta 2013 zaprosila odbor CVMP, da ponovno pregleda mnenje, zlasti da bi razjasnili nekatere vidike, povezane z oceno tveganja za potrošnike.
The referral started on 15 September 2011. 
Napotitveni postopek se je začel 15. septembra 2011.
Written explanations were provided by the applicants and marketing authorisation holders on 14 November 2011 and on 30 November 2012. 
Predlagatelji in imetniki dovoljenja za promet z zdravilom so 14. novembra 2011 in 30. novembra 2012 predložili pisna pojasnila.
During its meeting of 14-16 May 2013 the CVMP appointed K. Törneke as rapporteur and K. Baptiste as co-rapporteur for the re-examination procedure. 
Na zasedanju odbora CVMP, ki je potekalo od 14. do 16. maja 2013, sta bila za poročevalko in soporočevalca v postopku ponovnega pregleda mnenja imenovana K. Törneke in K. Baptiste.
An oral explanation was given by the applicant/marketing authorisation holders on 6 March 2013. 
Predlagatelj oziroma imetniki dovoljenja za promet z zdravilom so 6. marca 2013 podali še ustna pojasnila.
On 26 April 2013, Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) notified the Agency of their intention to request a reexamination of the CVMP opinion of 10 April 2013. 
Družbi Cross Vetpharm Group Limited in Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) sta 26. aprila 2013 obvestili agencijo, da nameravata zahtevati ponovno presojo mnenja odbora CVMP z dne 10. aprila 2013.
The Committee therefore adopted by majority a negative opinion on 10 April 2013, recommending suspension of the marketing authorisations for all concerned products. 
Odbor je zato dne 10. aprila 2013 z večino glasov sprejel negativno mnenje in priporočil začasen umik dovoljenj za promet za vsa zadevna zdravila.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the condition to lift the suspension of the marketing authorisations in Annex III. 
Seznam zadevnih imen zdravila je na voljo v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s pogojem za preklic začasnega umika dovoljenj za promet z zdravili v Prilogi III. Revidirano mnenje je bilo spremenjeno v sklep Evropske komisije 28. marca 2014.
Based on the evaluation of the available data, the CVMP considered that the benefit-risk balance for the concerned veterinary medicinal products was negative as, following treatment at recommended doses, barium selenate remains at injection sites for long time periods after treatment and, consequently, consumption of injection-site residues could pose a significant risk to human health. 
Na podlagi ocene razpoložljivih podatkov je odbor CVMP menil, da je razmerje med tveganji in koristmi za zadevna zdravila za uporabo v veterinarski medicini negativno, saj barijev selenat po zdravljenju s priporočenimi odmerki še dolgo časa ostane na mestih injiciranja, zaradi česar bi zaužitje ostankov z mesta injiciranja lahko predstavljalo veliko nevarnost za zdravje ljudi.
Opinion following an Article 350F referral for long-acting formulations for injection containing barium selenate for all food producing species EMA/197955/2014 
Mnenje v zvezi z napotitvijo v skladu s členom 350F za dolgodelujoče formulacije za injiciranje, ki vsebujejo barijev selenat, za vse živalske vrste za proizvodnjo živil EMA/197955/2014
Selenium is an essential micronutrient for both animals and man. Barium selenate has been used in slow-release injectable veterinary medicinal products for therapeutic and prophylactic use against selenium deficiencies in cattle and sheep. 
Barijev selenat se uporablja v zdravilih za injiciranje s počasnim sproščanjem, ki se uporabljajo v veterinarski medicini in so namenjena terapevtski in profilaktični uporabi proti pomanjkanju selena pri govedu ter ovcah.
On 6 November 2013, the CVMP adopted by majority a revised opinion confirming the recommendation included in its opinion of 17 July 2013, that the benefit-risk balance for the concerned veterinary medicinal products was negative and therefore the CVMP recommended the refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisations for the products concerned. 
Odbor CVMP je 6. novembra 2013 z večino glasov sprejel revidirano mnenje, s katerim je potrdil priporočilo, vključeno v mnenje odbora z dne 17. julija 2013, da je razmerje med tveganji in koristmi za zadevna zdravila za uporabo v veterinarski medicini negativno, in zato priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom ter začasen umik obstoječih dovoljenj za zadevna zdravila.
The consolidated detailed grounds for the re-examination were submitted by Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) on 10 June 2013. 
Družbi Cross Vetpharm Group Limited in Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) sta 10. junija 2013 predložili usklajene podrobne razloge za ponovni pregled.
Germany referred the matter to the CVMP due to serious human health concerns related to exposure to injection site residues from the use of long-acting barium selenatecontaining injectable veterinary medicinal products. 
Nemčija je zadevo napotila na odbor CVMP zaradi resnih tveganj za zdravje ljudi, povezanih z izpostavljenostjo ostankom na mestu injiciranja pri uporabi dolgodelujočih zdravil za injiciranje, ki vsebujejo barijev selenat in se uporabljajo v veterinarski medicini.
On 17 July 2013, the CVMP adopted by majority an opinion confirming the recommendation for suspension of the marketing authorisations for the concerned veterinary medicinal products. 
Odbor CVMP je 17. julija 2013 z večino glasov sprejel mnenje, s katerim je potrdil priporočilo o začasnem umiku dovoljenj za promet za zadevna zdravila za uporabo v veterinarski medicini.
Opinion following an Article 351 referral for long-acting formulations for injection containing barium selenate for all food producing species 
za dolgodelujoče formulacije za injiciranje, ki vsebujejo barijev selenat, za vse živalske vrste za proizvodnjo živil
On 14 September 2011, Germany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding all long-acting formulations for injection containing barium selenate for all food producing species. 
Direktive 2011/82/ES za vse dolgodelujoče formulacije za injiciranje, ki vsebujejo barijev selenat, za vse živalske vrste za proizvodnjo živil.
29 January 2016 
04. april 2016
On 28 January 2015, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Tobramycin VVB. 
28. januarja 2015 je Evropska agencija za zdravila končala postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Tobramycin VVB.
This is a procedure where one Member State (the ‘reference Member State', in this instance Lithuania) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Bulgaria, Estonia, Hungary, Latvia, Poland and Romania). 
To je postopek, pri katerem ena država članica („referenčna država članica“, v tem primeru Litva) oceni zdravilo glede tega, ali se zanj lahko odobri dovoljenje za promet, ki bo veljavno v tej državi in drugih državah članicah („zadevnih državah članicah“, v tem primeru v Bolgariji, Estoniji, na Madžarskem, v Latviji, na Poljskem in v Romuniji).
However, the Member States were not able to reach an agreement and the Lithuanian medicines regulatory agency referred the matter to the CHMP for arbitration on 14 October 2015. 
Vendar države članice niso mogle doseči soglasja, zato je litovska regulativna agencija za zdravila 14. oktobra 2015 zadevo napotila na odbor CHMP v arbitražo.
Demonstration of clinical superiority is required because Tobi Podhaler is an orphan medicine and was granted market exclusivity in the EU at the time of its market authorisation in July 2011. 
Klinično superiornost je treba dokazati zato, ker je zdravilo Tobi Podhaler zdravilo sirota in mu je bila ob času izdaje dovoljenja za promet julija 2011 dodeljena tržna ekskluzivnost v EU.
Why was Tobramycin VVB reviewed? 
Zakaj je bilo zdravilo Tobramycin VVB pregledano?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Tobramycin VVB can be granted marketing authorisation in Lithuania and in the following Member States of the EU: Bulgaria, Estonia, Hungary, Latvia, Poland and Romania. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da se zdravilu Tobramycin VVB lahko izda dovoljenje za promet v Litvi in naslednjih državah članicah EU: Bolgariji, Estoniji, na Madžarskem, v Latviji, na Poljskem in v Romuniji.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Tobramycin VVB is clinically superior to Tobi Podhaler because a substantial proportion of patients are intolerant to Tobi Podhaler but can be treated with Tobramycin VVB. 
Na podlagi ovrednotenja trenutno razpoložljivih podatkov in znanstvene razprave znotraj odbora je odbor CHMP zaključil, da je zdravilo Tobramycin VVB klinično boljše od zdravila Tobi Podhaler, saj znaten delež bolnikov zdravila Tobi Podhaler ne prenaša, lahko pa se zdravijo z zdravilom Tobramycin VVB.
UAB VVB submitted Tobramycin VVB to the Lithuanian medicines regulatory agency for a decentralised procedure. 
Družba UAB VVB je predložila zdravilo Tobramycin VVB litovski regulativni agenciji za zdravila v decentralizirani postopek.
Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily and cause infections. 
Cistična fibroza je dedna bolezen, pri kateri se v pljučih kopiči gosta sluz, ki omogoča lažjo rast bakterij, kar povzroča okužbe.
A European Commission decision on this opinion will be issued in due course. 
Evropska komisija je sklep v zvezi s tem mnenjem izdala 04. aprila 2016.
What is Tobramycin VVB? 
Kaj je zdravilo Tobramycin VVB?
Tobramycin VVB is an antibiotic for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged 6 years and older who have cystic fibrosis. 
Zdravilo Tobramycin VVB je antibiotik, ki se uporablja za zdravljenje dolgotrajne okužbe pljuč z bakterijo Pseudomonas aeruginosa pri bolnikih, starih šest let in več, ki imajo cistično fibrozo.
The reason for the referral was a disagreement over whether Tobramycin VVB is clinically superior to Tobi Podhaler, another medicine containing tobramycin. 
Razlog za napotitev je bilo nesoglasje o tem, ali je zdravilo Tobramycin VVB klinično boljše od zdravila Tobi Podhaler, drugega zdravila, ki vsebuje tobramicin.
The CHMP therefore recommended that Tobramycin VVB be granted marketing authorisation in Lithuania as well as in the other concerned Member States. 
Odbor CHMP je zato priporočil, da se zdravilu Tobramycin VVB izda dovoljenja za promet v Litvi in drugih zadevnih državah članicah.
It works by disrupting the production of proteins that P. aeruginosa needs to build its cell walls, resulting in damage to the bacteria which eventually kills them. 
Deluje tako, da prekine tvorbo beljakovin, ki jih P. aeruginosa potrebuje za gradnjo celičnih sten.
Tobramycin VVB is a ‘hybrid medicine' that has been developed to be comparable to a ‘reference medicine' containing tobramycin called Tobi (300 mg/5 ml nebuliser solution). 
Zdravilo Tobramycin VVB je „hibridno zdravilo“, ki so ga razvili kot primerljivo „referenčnemu zdravilu“, ki vsebuje tobramicin, imenovanemu Tobi (300 mg/5 ml raztopina za nebulator).
Tobramycin VVB is to be available as a nebuliser solution (300 mg/5 ml) to be inhaled. 
Zdravilo Tobramycin VVB bo na voljo kot raztopina za nebulator (300 mg/5 ml) za vdihavanje.
The active substance in Tobramycin VVB, tobramycin, belongs to the group of antibiotics known as ‘aminoglycosides'. 
Zdravilna učinkovina zdravila Tobramycin VVB, tobramicin, spada v skupino antibiotikov, imenovano „aminoglikozidi“.
This means that during the period of market exclusivity similar products, such as Tobramycin VVB, cannot be placed on the market; there are, however, exceptions such as where clinically superiority over Tobi Podhaler can be shown. 
To pomeni, da v času tržne ekskluzivnosti podobnih zdravil, kot je zdravilo Tobramycin VVB, ni mogoče dati v promet.
budesonide / formoterol 
budezonid/formoterol
The European Commission granted a marketing authorisation valid throughout the European Union for Budesonide/Formoterol Teva Pharma B.V. on 19 November 2014. 
Evropska komisija je dovoljenje za promet z zdravilom Budesonide/Formoterol Teva Pharma B.V., veljavno po vsej Evropski uniji, izdala 19. novembra 2014.
This means that it is similar to a ‘reference medicine' containing the same active substances, but Budesonide/Formoterol Teva Pharma B.V. is given using a different inhaler. 
To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje isti zdravilni učinkovini, vendar se zdravilo Budesonide/Formoterol Teva Pharma B.V.
The full EPAR and risk management plan summary for Budesonide/Formoterol Teva Pharma B.V. can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Studies were carried out to show that Budesonide/Formoterol Teva Pharma B.V. is bioequivalent to the reference medicine (i.e. produces the same level of the active substance in the body) and that the two medicines act in the same way. 
biološko enakovredno referenčnemu zdravilu (tj. da dosega enako raven zdravilne učinkovine v telesu) in da obe zdravili enako delujeta.
This is a summary of the European public assessment report (EPAR) for Budesonide/Formoterol Teva Pharma B.V. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Budesonide/Formoterol Teva Pharma B.V.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Budesonide/Formoterol Teva Pharma B.V. 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler. 
v jakostih 160/4,5 mikrograma in 320/9 mikrogramov primerljivo raven kakovosti kot zdravilo Symbicort Turbohaler ter da mu je pri ustrezajočih jakostih biološko enakovredno.
What measures are being taken to ensure the safe and effective use of Budesonide/Formoterol Teva Pharma B.V.? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Budesonide/Formoterol Teva Pharma B.V.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Budesonide/Formoterol Teva Pharma B.V., including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The two active substances in Budesonide/Formoterol Teva Pharma B.V. are well known and are present in several medicines used to treat asthma, either alone or in combination with other medicines. 
sta dobro znani in sta prisotni v več zdravilih, ki se samostojno ali v kombinaciji z drugimi zdravili uporabljajo za zdravljenje astme.
What are the benefits and risks of Budesonide/Formoterol Teva Pharma B.V.? 
Kakšne so koristi in tveganja, povezani z zdravilom Budesonide/Formoterol Teva Pharma B.V.
For more information about treatment with Budesonide/Formoterol Teva Pharma B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Other information about Budesonide/Formoterol Teva Pharma B.V. 
Druge informacije o zdravilu Budesonide/Formoterol Teva Pharma B.V.
The Committee recommended that Budesonide/Formoterol Teva Pharma B.V. be given marketing authorisation. 
Priporočil je, da se za zdravilo Budesonide/Formoterol Teva Pharma B.V.
A risk management plan has been developed to ensure that Budesonide/Formoterol Teva Pharma B.V. is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Budesonide/Formoterol Teva Pharma B.V.
It is not intended to provide practical advice on how to use Budesonide/Formoterol Teva Pharma B.V. 
Za praktične informacije o uporabi zdravila Budesonide/Formoterol Teva Pharma B.V.
Why is Budesonide/Formoterol Teva Pharma B.V. approved? 
Zakaj je bilo zdravilo Budesonide/Formoterol Teva Pharma B.V.
How is Budesonide/Formoterol Teva Pharma B.V. used? 
Kako se zdravilo Budesonide/Formoterol Teva Pharma B.V.
An additional study was also used to support the main study and to demonstrate the vaccine's safety. 
V podporo glavni študiji in za dokazovanje varnosti cepiva je bila izvedena dodatna študija.
Adults over 80 years of age may need a double dose of the vaccine (one injection into each shoulder). 
Pri odraslih, starejših od 80 let, bo morda potreben dvojni odmerek cepiva (ena injekcija v vsako ramo).
The European Commission granted a marketing authorisation valid throughout the European Union for Prepandrix on 14 May 2008. 
Evropska komisija je dovoljenje za promet z zdravilom Prepandrix, veljavno po vsej Evropski uniji, odobrila dne 14. maja 2008.
The full EPAR for Prepandrix 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 cepivo Prepandrix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
For more information about treatment with Prepandrix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju s cepivom Prepandrix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This is a special type of vaccine that is intended to protect against a strain of flu that may cause a future pandemic. 
To je posebna vrsta cepiva, namenjena za zaščito proti sevu gripe, ki lahko povzroči prihodnjo pandemijo.
There are some data with a vaccine containing a similar H5N1 strain that support the use of half-doses (0.25 ml) in children three to nine years of age. 
Nekateri podatki o cepivu, ki vsebuje podoben sev virusa H5N1, podpirajo uporabo polovičnih odmerkov (0,25 ml) pri otrocih, starih od tri do devet let.
This is a summary of the European public assessment report (EPAR) for Prepandrix. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Prepandrix.
Prepandrix is given by injection into the shoulder or thigh as two 0.5 ml doses, at least three weeks apart. 
Prepandrix se daje z injiciranjem v ramensko ali stegensko mišico v dveh 0,5-mililitrskih odmerkih v razmiku najmanj treh tednov.
Other information about Prepandrix 
Druge informacije o zdravilu Prepandrix
Prepandrix must not be given to people who are hypersensitive (allergic) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate. 
Cepivo Prepandrix se ne sme dajati osebam, ki so preobčutljive za (alergične na) na katero koli sestavino zdravila ali na katero koli od snovi, ki se v sledeh (v zelo nizkih količinah) nahajajo v zdravilu, kot so jajca, piščančje beljakovine, ovalbumin (beljakovina v beljaku), formaldehid, gentamicinijev sulfat (antibiotik) in natrijev deoksiholat.
The participants received two injections of Prepandrix 21 days apart. 
Sodelujoči so prejeli dve injekciji cepiva Prepandrix v razmiku 21 dni.
Prepandrix contains a flu strain called ‘A/Indonesia/05/2005' (H5N1). 
Cepivo Prepandrix vsebuje sev gripe, imenovan „A/Indonesia/05/2005“ (H5N1).
The emulsion contains an ‘adjuvant' (a compound containing oil) to enhance the immune response. 
Cepivo vsebuje tudi „adjuvans“ (spojino, ki vsebuje olje) za povečanje imunskega odziva.
Health experts are concerned that a future flu pandemic could be caused by the H5N1 strain of the virus. 
Zdravstvene strokovnjake skrbi, da bi lahko naslednjo pandemijo gripe povzročil sev virusa H5N1.
The main study showed that Prepandrix containing the adjuvant produced an antibody response that met these criteria. 
Glavna študija je pokazala, da cepivo Prepandrix, ki vsebuje adjuvans, sproži odziv protiteles, ki izpolnjuje to merilo.
The CHMP decided that Prepandrix's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi cepiva Prepandrix večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.