natgillin/translations-raw huggingface dataset:
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC for marketing authorisations and marketing authorisation applications for medicinal products for which the clinical and/or bioanalytical parts of the bioequivalence studies were performed at Alkem Laboratories Limited during the period between March 2013 and March 2015; 
• Odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za dovoljenja za promet z zdravilom in vloge za pridobitev dovoljenja za promet z zdravilom za zdravila, za katera so bili klinični in/ali bioanalitski deli študij bioekvivalence opravljeni v družbi Alkem Laboratories Limited v obdobju med marcem 2013 in marcem 2015;
The Federal Institute of Drugs and Medical Devices (BfArM), Germany, and the Health Care Inspectorate (IGZ), Ministry of Health of the Netherlands performed a joint GCP inspection from 9 - 12 March 2015 at Alkem Laboratories Limited, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad - 410 208, India (Inspection references: BfArM: 2015 03 D / 2015_05_D, NL: VGR-1005124). 
Nemški zvezni inštitut za zdravila in medicinske pripomočke (BfArM) in nizozemski zdravstveni inšpektorat pri ministrstvu za zdravje (IGZ) sta med 9. in 12. marcem 2015 opravila skupni inšpekcijski pregled dobre klinične prakse v družbi Alkem Laboratories Limited, Oddelek za bioekvivalenco, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad - 410 208, Indija (referenca inšpekcijskega pregleda: BfArM: 2015 03 D / 2015_05_D, NL: VGR-1005124).
Intentional misrepresentation of data happened at the site in two different trials performed in 2013 and 2014. 
Na tej lokaciji je pri dveh različnih preskušanjih, opravljenih leta 2013 in 2014, prišlo do namernega izkrivljanja podatkov.
On 8 March 2016 the BfArM initiated a referral under Article 31 of Directive 2001/83/EC, and asked the CHMP to assess the potential impact of the above findings on the benefit-risk balance of marketing authorisation applications and medicinal products authorised on the basis of relevant trials performed at the inspected site between March 2013-March 2015, and issue a recommendation on whether the marketing authorisations should be maintained, varied, suspended or revoked. 
Inštitut BfArM je 8. marca 2016 sprožil napotitev v skladu s členom 31 Direktive 2001/83/ES in odbor CHMP zaprosil, naj oceni morebiten vpliv zgornjih izsledkov na razmerje med tveganji in koristmi vlog za pridobitev dovoljenja za promet z zdravilom in zdravil, odobrenih na podlagi ustreznih preskušanj, izvedenih na lokaciji, kjer je bil opravljen inšpekcijski pregled, med marcem 2013 in marcem 2015, in izda priporočilo o tem, ali je treba zadevna dovoljenja za promet z zdravilom ohraniti, spremeniti, začasno umakniti ali ukiniti.
The CHMP considered these data, however a conclusion on bioequivalence cannot be drawn from a simple comparison of dissolution profiles. 
Odbor CHMP je upošteval te podatke, vendar iz enostavne primerjave profilov raztapljanja ni mogoče sprejeti zaključka o bioekvivalenci.
However, the CHMP is of the opinion that the absence of the identification of any pharmacovigilance signals does not provide sufficient reassurance because it is not established that the pharmacovigilance activities may be designed to detect such a signal. 
da farmakovigilančni signali niso bili ugotovljeni, ne zagotavlja zadostne gotovosti, saj ni ugotovljeno, da so farmakovigilančne dejavnosti zasnovane na način, ki omogoča zaznavanje tovrstnih signalov.
The condition for the lifting of the suspension of the Marketing Authorisations, as applicable, is set out in Annex III. 
Pogoj za preklic začasnega umika dovoljenj za promet z zdravilom, kot je ustrezno, je določen v Prilogi III.
As the quality management system covered all parts of the trial and a failure of the system in particular in relation to the ECGs monitoring was detected and acknowledged by the site, this system was considered by BfArM to be insufficient and severe failures in other areas of the trial could not be excluded even if not detected. 
Ker je sistem vodenja kakovosti zajemal vse dele preskušanja, na lokaciji pa so odkrili in priznali odpoved sistema predvsem v povezavi s spremljanjem EKG, je inštitut BfArM ocenil, da je ta sistem nezadosten in torej ni mogoče izključiti hudih napak na drugih področjih preskušanja, tudi če niso bile odkrite.
Although Alkem agreed to the CAPAs and committed to implement them following the joint GCP inspection in March 2015, the fact that a second inspection in March 2016 by the MHRA identified critical/major findings during the period of concern further demonstrates that the quality management system in place during the period concerned by the procedure was suboptimal. 
Čeprav se je družba Alkem strinjala s korektivnimi in preventivni ukrepi in se po skupnem inšpekcijskem pregledu dobre klinične prakse marca 2015 zavezala k njihovi izvedbi, dejstvo, da so z drugim inšpekcijskim pregledom, ki ga je marca 2016 opravila agencija MHRA, v zadevnem obdobju ugotovili kritične/večje napake, nadalje dokazuje, da sistem vodenja kakovosti, vzpostavljen na lokaciji v obdobju, na katerega se nanaša postopek, ni bil optimalen.
Marketing authorisation holders (MAHs) have argued that pharmacovigilance data collected on their medicinal products have not indicated any problems which could be attributed to non-bioequivalence, such as reduced efficacy or worsened safety and tolerability. 
Več imetnikov dovoljenj za promet z zdravili je trdilo, da farmakovigilančni podatki, zbrani za njihova zdravila, niso pokazali nobenih težav, ki bi jih lahko pripisali odsotnosti bioekvivalence, kot so zmanjšana učinkovitost ali slabša varnost ali prenašanje.
In view of the inspection findings and the conclusion that there was a failure of the overall quality management system in place at the site, even of the ECG data for this particular study has no abnormalities, severe failures in other parts of the trial could not be excluded and all the data generated by the site during the period from March 2013 to March 2015 cannot be relied upon. 
Glede na izsledke inšpekcijskega pregleda in zaključek, da je odpovedal celoten sistem vodenja kakovosti, vzpostavljen na lokaciji, tudi v primeru, da podatki o EKG pri tej študiji niso vključevali nepravilnosti, ni mogoče izključiti hudih napak v drugih delih preskušanja, zato se ni mogoče zanesti na nobene podatke, pridobljene na lokaciji v obdobju med marcem 2013 in marcem 2015.
A later MHRA inspection (March 2016) has also resulted in one critical and 2 major observations, for which CAPAs have already been agreed with the inspectors. 
S poznejšim inšpekcijskim pregledom, ki ga je opravila agencija MHRA (marca 2016), so prav tako našli eno kritično in dve večji napaki.
Having assessed the alternative study, the CHMP considered that it supports bioequivalence of these medicinal products to the reference medicinal product Zinnat. 
Po oceni alternativne študije je odbor CHMP menil, da podpira bioekvivalenco omenjenih zdravil z referenčnim zdravilom Zinnat.
The MAH also submitted an expert report with a reassessment of the original bioequivalence study performed by Alkem, concluding that no abnormalities were observed with the ECG data. 
Imetnik dovoljenja za promet z zdravilom je predložil tudi strokovno poročilo, ki je vsebovalo ponovno oceno prvotne bioekvivalenčne študije, ki jo je opravila družba Alkem, v kateri so zaključili, da pri podatkih o EKG ni bilo nobenih nepravilnosti.
• The Committee concluded that the particulars supporting the marketing authorisation/marketing authorisation application are incorrect and that the benefit-risk balance is considered not favourable for: 
• Odbor je zaključil, da podatki, ki podpirajo dovoljenje za promet z zdravilom/vlogo za pridobitev dovoljenja za promet z zdravilom, niso ustrezni in da razmerje med tveganji in koristmi ni ugodno za:
The CHMP therefore recommends the suspension of the marketing authorisation for Riluzole Alkem. 
Odbor CHMP zato priporoča začasni umik dovoljenja za promet z zdravilom Riluzole Alkem.
For cefuroxime-containing products affected by this review (Cefuroxime Alkem, Cefuroxime Krka and Cefuroxime Ingen Pharma), bioequivalence to the EU reference medicinal product was established based on an alternative bioequivalence study conducted at a different facility (study 0258-16, Lambda therapeutic Research Inc.). 
Za zdravila, ki vsebujejo cefuroksim, na katera se nanaša ta pregled (Cefuroxime Alkem, Cefuroxime Krka in Cefuroxime Ingen Pharma), je bila bioekivalenca z referenčnim zdravilom, odobrenim v EU, ugotovljena z drugo študijo bioekvivalence, opravljeno v drugi ustanovi (študija 0258-16, Lambda therapeutic Research Inc.).
The arguments of the MAH were considered, including the results of the studies with the US and Australian originator medicines, the data submitted do not address the requirement to demonstrate bioequivalence vis-à-vis an EU reference medicinal product as required by Article 10 of Directive 2001/83/EC. 
Argumenti imetnika dovoljenja za promet z zdravilom so bili upoštevani, vključno z rezultati študij z originalnima zdraviloma, odobrenima v ZDA in Avstraliji, vendar se predloženi rezultati ne nanašajo na zahtevo po dokazu bioekvivalence z referenčnim zdravilom, odobrenim v EU, kot zahteva člen 10 Direktive 2001/83/ES.
Where the bioequivalence is not established, safety and efficacy cannot be extrapolated from the EU reference medicinal product to the generic medicinal product as the bioavailability of the active substance between the two medicinal products may differ. 
Kjer bioekvivalenca ni ugotovljena, varnosti in učinkovitosti referenčnega zdravila, odobrenega v EU, ni mogoče ekstrapolirati na generično zdravilo, saj se lahko biološka uporabnost učinkovine med zdraviloma razlikuje.
In addition, the MAH presented data to demonstrate that the US and Australian reference medicinal products are similar to the EU reference medicinal product, and that bioequivalence studies comparing the riluzole generic product under discussion to the US and Australian originators concluded in bioequivalence, therefore it is very likely that the product is also bioequivalent to the EU reference medicinal product. 
Poleg tega je imetnik dovoljenja za promet z zdravilom predložil podatke, s katerimi je dokazoval, da sta referenčni zdravili, odobreni v ZDA in Avstraliji, podobni zdravilu, odobrenemu v EU, in da so z študijami bioekvivalence, s katerimi so primerjali obravnavano generično zdravilo, ki vsebuje riluzol, z originalnima zdraviloma, odobrenima v ZDA in Avstraliji, dokazali bioekvivalenco, zato je torej zelo verjetno, da je zdravilo biološko enakovredno tudi referenčnemu zdravilu, odobrenemu v EU.
Taking the above into account, the benefit-risk balance of medicinal products for which bioequivalence is not established cannot be considered positive, as the possibility of safety/tolerability or efficacy issues cannot be excluded. 
Z upoštevanjem zgoraj navedenega razmerje med tveganji in koristmi zdravil, za katera bioekvivalenca ni ugotovljena, ne more veljati za pozitivno, saj ni mogoče izključiti možnosti pomislekov v zvezi z varnostjo/prenašanjem ali učinkovitostjo.
In the absence of the demonstration of bioequivalence vis-à-vis the EU reference medicinal product, the requirements of Article 10 of Directive 2001/83/EC cannot be considered fulfilled, the efficacy and safety of the concerned medicinal products cannot be established, hence the benefit-risk balance of these medicinal products cannot be considered positive. 
Ker bioekvivalenca z referenčnim zdravilom, odobrenim v EU, ni bila dokazana, zahteve člena 10 Direktive 2001/83/ES niso v celoti izpolnjene, varnosti in učinkovitosti zadevnih zdravil pa ni mogoče ugotoviti, zato tudi razmerje med tveganji in koristmi teh zdravil ne more biti pozitivno.
The applicant for the ibuprofen-containing medicinal product affected by the review (Ibuprofen Orion) did not submit alternative data to establish bioequivalence vis-à-vis an EU reference medicinal product. 
Predlagatelj za zdravilo, ki vsebuje ibuprofen, na katerega se nanaša ta pregled (Ibuprofen Orion) ni predložil drugih podatkov za ugotavljanje bioekvivalence z referenčnim zdravilom, odobrenim v EU.
For the riluzole-containing medicinal product affected by the review (Riluzole Alkem), the MAH provided some comparative dissolution data to claim that, as the multi-media dissolution profiles of cefuroxime and riluzole are similar to those of the reference products, the probability of the products being bioequivalent is high. 
Za zdravilo, ki vsebujejo riluzol, na katero se nanaša ta pregled (Riluzole Alkem), je imetnik dovoljenja za promet z zdravilom predložil nekaj primerjalnih podatkov o raztapljanju in na podlagi tega trdil, da je zaradi podobnosti profilov raztapljanja cefuroksima in riluzola v več medijih profilom raztapljanja referenčnih zdravil verjetnost, da sta zdravili biološko enakovredni, velika.
− Marketing authorisation applications for which no alternative bioequivalence data or a justification was submitted (annex IB). 
− vloge za pridobitev dovoljenja za promet z zdravilom, za katere niso bili predloženi alternativni podatki o bioekvivalenci ali utemeljitev (Priloga IB);
− Authorised medicinal products for which alternative bioequivalence data or a justification was submitted but considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB); 
− odobrena zdravila, za katera so bili predloženi alternativni podatki o bioekvivalenci ali utemeljitev, ki pa so bili za odbor CHMP nezadostni, da bi lahko ugotovili bioekvivalenco z referenčnim zdravilom, odobrenim v EU (Priloga IB);
As regards the marketing authorisation application for Ibuprofen Orion, the CHMP considers that the applicant did not establish bioequivalence to the EU reference medicinal product and therefore the marketing authorisation application does not currently fulfil the criteria for authorisation. 
Kar zadeva vlogo za pridobitev dovoljenja za promet z zdravilom za zdravilo Ibuprofen Orion, je odbor CHMP menil, da predlagatelj ni dokazal bioekvivalence z referenčnim zdravilom, odobrenim v EU, zato trenutno vloga za pridobitev dovoljenja za promet z zdravilom ne izpolnjuje meril za pridobitev dovoljenja.
This was neither avoided nor detected by the quality management system, which was in place at the site during this time period. 
Sistem vodenja kakovosti, vzpostavljen na lokaciji v tem obdobju, tega ni ne preprečil ne zaznal.
If the bioavailability of the generic product is lower than the bioavailability of the reference medicinal product, this may result in a lower than intended exposure to the active substance, leading potentially to a decrease in efficacy, a delay or even a lack of therapeutic effect. 
V primeru, da je biološka uporabnost zdravila manjša od biološke uporabnosti referenčnega zdravila, bi to pomenilo, da so bolniki učinkovini izpostavljeni v manjši meri od načrtovane, kar bi lahko povzročilo manjšo učinkovitost, zapoznelo terapevtsko učinkovitost ali celo njeno odsotnost.
If the bioavailability of the generic product is higher than the bioavailability of the reference medicinal product, this may result in a higher than intended exposure of patients to the active substance, leading potentially to an increase in the incidence or severity of adverse effects. 
V primeru, da je biološka uporabnost zdravila večja od biološke uporabnosti referenčnega zdravila, bi to pomenilo, da so bolniki učinkovini izpostavljeni v večji meri od načrtovane, kar bi lahko povzročilo večjo pogostnost ali resnost neželenih učinkov.
c. Marketing authorisations for medicinal products for which the bioequivalence vis-à-vis the EU reference medicinal product has been established (annex IA) should be maintained, as the benefit risk balance of these marketing authorisation is considered favourable. 
c. Dovoljenja za promet z zdravili, za katera je bila ugotovljena bioekvivalenca z referenčnim zdravilom, odobrenim v EU (Priloga IA), naj se ohranijo, saj je razmerje med tveganji in koristmi za ta dovoljenja za promet z zdravilom ugodno.
d. Bioequivalence vis-à-vis the EU reference medicinal product has been established for marketing authorisation applications listed in annex IA. 
d. Bioekvivalenca z referenčnim zdravilom, odobrenim v EU, je bila ugotovljena za vloge za pridobitev dovoljenja za promet z zdravilom, navedene v Prilogi IA.
• The Committee concluded that, for both marketing authorisations and marketing authorisation applications referred to in annex IA, there was alternative data to establish bioequivalence vis-àvis the EU reference medicinal product. 
• Odbor je zaključil, da so bili za dovoljenja za promet z zdravilom in vloge za pridobitev dovoljenja za promet z zdravilom iz Priloge IA predloženi alternativni podatki za dokaz bioekvivalenci z referenčnim zdravilom, odobrenim v EU.
The data generated at the site can therefore not be relied upon to establish bioequivalence of products to the EU reference medicinal product. 
Ni se torej mogoče zanašati, da bi s podatki, pridobljenimi na lokaciji, ugotovili bioekvivalenco loško enakovrednost zdravil z referenčnim zdravilom, odobrenim v EU.
Therefore CHMP concluded that bioequivalence to the EU reference medicinal product is not established for Riluzole Alkem. 
Zato je odbor CHMP zaključil, da za zdravilo Riluzole Alkem bioekvivalenca z referenčnim zdravilom, odobrenim v EU, ni ugotovljena.
b. Marketing authorisation applications for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB) do not satisfy the criteria for authorisation, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisation is considered not favourable pursuant to Article 26 of Directive 2001/83/EC. 
b. Vloge za pridobitev dovoljenja za promet z zdravili, za katere podatki o bioekvivalenci ali njena utemeljitev niso bili predloženi oziroma za katera je odbor CHMP menil, da zadevni podatki ne zadostujejo za ugotovitev bioekvivalence z referenčnim zdravilom, odobrenim v EU (Priloga IB), ne izpolnjujejo meril za pridobitev dovoljenja, saj podatki v podporo dovoljenjem za promet niso ustrezni in razmerje med tveganji in koristmi za ta dovoljenja za promet z zdravili v skladu s členom 26 Direktive 2001/83/ES ni ugodno.
a. Marketing authorisations for medicinal products for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB) should be suspended, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisation is considered not favourable pursuant to Article 116 of Directive 2001/83/EC. 
a. Dovoljenja za promet z zdravili, za katera niso bili predloženi podatki o bioekvivalenci ali njena utemeljitev oziroma za katera je odbor CHMP menil, da zadevni podatki ne zadostujejo za ugotovitev bioekvivalence z referenčnim zdravilom, odobrenim v EU (Priloga IB), naj se začasno umaknejo, saj podatki v podporo dovoljenjem za promet niso ustrezni in razmerje med tveganji in koristmi za ta dovoljenja za promet z zdravili v skladu s členom 116 Direktive 2001/83/ES ni ugodno.
Therefore BfArM considered that this affects the trustworthiness of the data generated by the site (clinical and bioanalytical) in the time period from the beginning of the first study in March 2013 until the date when the inspection took place in March 2015, as it must be assumed that critical deficiencies could not be detected by the quality management system at the site in the meantime, because corrective actions and preventive actions (CAPAs) were only implemented after the inspection. 
Zato je inštitut BfArM ocenil, da to vpliva na zanesljivost podatkov, pridobljenih na tej lokaciji (kliničnih in bioanalitskih) v obdobju od začetka prve študije marca 2013 do dneva inšpekcijskega pregleda marca 2015.
Alternative data were submitted to demonstrate the bioequivalence of Cefuroxime Alkem, Cefuroxime Krka and Cefuroxime Ingen Pharma to an EU reference medicinal product. 
Za dokaz bioekvivalence zdravil Cefuroxime Alkem, Cefuroxime Krka in Cefuroxime Ingen Pharma z referenčnim zdravilom, odobrenim v EU, so bili predloženi alternativni podatki.
The bioequivalence to the EU reference medicinal product is therefore not established. 
Bioekvivalenca z referenčnim zdravilom, odobrenim v EU, torej ni ugotovljena.
Having assessed the alternative data, the CHMP recommends the maintenance of the marketing authorisations for Cefuroxime Alkem and Cefuroxime Krka and concludes that, with regards to the Cefuroxime Ingen Pharma marketing authorisation application, bioequivalence has been demonstrated vis-à-vis the EU reference medicinal product using alternative data. 
Kar zadeva vlogo za pridobitev dovoljenja za promet z zdravilom za zdravilo Cefuroxime Ingen Pharma, zaključuje, da je bila bioekvivalenca z referenčnim zdravilom, odobrenim v EU, z alternativnimi podatki dokazana.
(as hydroxide) 
(kot hidroksid)
• Revaccination Annual. 
• Ponovno cepljenje Letno.
• Primary vaccination 
• Osnovno cepljenje
Detailed information of 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/).
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. 
Če opazite kakršne koli stranske učinke, tudi tiste ki niso navedeni v tem navodilu za uporabo ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
Apply usual aseptic procedures. 
Ravnajte v skladu z običajnimi načeli asepse.
a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or 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) bi uporaba zdravila ovirala izvajanje nacionalnega programa za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
The level of efficacy for other species may differ from that observed in sheep and cattle. 
Učinkovitost pri drugih vrstah se lahko razlikuje od dokazane učinkovitosti pri ovcah in govedu.
(**)Strain-specific pass levels 
(**)Sev-specifični nivo
Vaccinate healthy animals only. 
Cepite le zdrave živali.
Any person intending to manufacture, import, possess, sell, supply and use of BTVPUR containing serotypes 1, 2, 4 and 8 must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation. 
Vsakdo, ki namerava proizvajati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in uporabljati to zdravilo s serotipi 1, 2, 4 in 8, se mora najprej posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja, saj so lahko te dejavnosti prepovedane v državi članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Bluetongue. 
Uporaba tega zdravila za uporabo v veterinarski medicini je dovoljena samo pod posebnimi pogoji, ki jih za nadzor nad boleznijo modrikastega jezika predpisuje zakonodaja Evropske skupnosti.
BOEHRINGER INGELHEIM Animal Health UK Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ United Kingdom 
BOEHRINGER INGELHEIM Animal Health UK Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Združeno Kraljestvo