natgillin/translations-raw huggingface dataset:
Previcox 57 mg chewable tablets for dogs Previcox 227 mg chewable tablets for dogs 
Previcox 57 mg žvečljive tablete za pse Previcox 227 mg žvečljive tablete za pse
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before the commencement of treatment with Previcox. 
Zato je potrebno preden začnemo z zdravljenjem z zdravilom Previcox počakati vsaj 24 ur.
Previcox 227 mg chewable tablets for dogs 
Previcox 227 mg žvečljive tablete za pse
In order to protect from moisture, store in the original package. 
Hranite na suhem mestu v originalni ovojnini.
Previcox 57 mg chewable tablets for dogs 
Previcox 57 mg žvečljive tablete za pse
Chewable tablet 
Žvečljive tablete
Previcox 227 mg chewable tablets Firocoxib 
Previcox 227 mg žvečljive tablete
Elimination is principally in the bile and gastrointestinal tract. 
Izloča se predvsem z žolčem in preko črevesja.
Pain and inflammation associated with osteoarthritis. 
Bolečina in vnetje, povezana z osteoartritisom pri psih.
Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk for renal toxicity. 
Izogibajte se sočasni uporabi z drugimi nefrotoksičnimi zdravili, ker obstaja povečana nevarnost toksičnega vpliva na ledvice.
Concurrent administration of potentially nephrotoxic drugs should be avoided. 
Izogibajte se sočasni uporabi z drugimi potencialno nefrotoksičnimi zdravili.
Previcox 57 mg chewable tablets Firocoxib 
Previcox 57 mg žvečljive tablete
Use this product under strict veterinary monitoring where there is a risk of gastrointestinal bleeding, or if the animal previously displayed intolerance to NSAIDs. 
Pri uporabi zdravila pri živalih, kjer obstaja tveganje za pojav želodčno-črevesnih krvavitev ali gre za živali z znano preobčutljivostjo na druga NSAID, morajo biti te živali pod strogim veterinarskim nadzorom.
Administer 5 mg per kg bodyweight once daily as presented in the table below for up to 3 days as needed, starting approximately 2 hours prior to surgery. 
Zdravimo po potrebi do 3 zaporedne dni; prvi odmerek damo približno 2 uri pred operativnim posegom.
Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of increased renal toxicity. 
hipovolemične ali imajo nizek krvni tlak, ker v teh primerih obstaja potencialna nevarnost za povečano toksičnost za ledvice.
Emesis and diarrhoea have occasionally been reported. 
Občasno se pojavljata bruhanje in driska.
Not applicable 
Navedba ni smiselna
Tranexamic acid 
Traneksamična kislina
Tranexamic acid had not previously been associated with an increased risk of mortality and this has remained unchanged post-publication of the BART study. 
Traneksamične kisline prej niso povezovali s povečanim tveganjem za smrtnost in to se niti po objavi študije BART ni spremenilo.
Tranexamic acid is a lysine analogue authorised for several indication since 1969. 
Traneksamična kislina je analog lizina in je že od leta 1969 odobrena za več indikacij.
Acute venous or arterial thrombosis should constitute a contraindication. 
Akutna venska ali arterijska tromboza bi morali predstavljati kontraindikacijo.
Detailed grounds for re-examination submitted by the marketing authorisation holder 
Podrobni razlogi za ponovno presojo, ki jih je predložil imetnik dovoljenja za promet
Therefore, the CHMP concluded that a PK study should not be requested as a condition at this point in time. 
Zato je odbor CHMP zaključil, da se farmakokinetična študija trenutno ne sme zahtevati kot pogoj.
The same is applicable for fibrinolytic conditions following consumption coagulopathy except in those with predominant activation of the fibrinolytic system with acute severe bleeding. 
Enako velja za fibrinolitična stanja po porabni koagulopatiji, razen pri bolnikih s prevladujočo aktivacijo fibrinolitičnega sistema z akutno hudo krvavitvijo.
This document presents the conclusions on tranexamic acid. 
V tem dokumentu so predstavljeni sklepi o traneksamični kislini.
For some conditions modifications to the wording were proposed, in order to bring them in line with current scientific knowledge on the use of TXA. 
Za nekatere indikacije so bile predlagane spremembe besedila, da bi jih uskladili s sedanjimi znanstvenimi dognanji o uporabi traneksamične kisline.
The latest quality review of documents templates were taken into account during this review. 
Med tem pregledom je bil upoštevan zadnji pregled kakovosti predlog za dokumente.
One MAH for tranexamic acid containing medicinal products expressed its disagreement with the CHMP Opinion, focusing its grounds for re-examination on the following points: 
Eden od imetnikov dovoljenj za promet z zdravili, ki vsebujejo traneksamično kislino, je izrazil nesoglasje z mnenjem odbora CHMP in osredotočil svoje razloge za ponovno presojo na naslednje točke:
Having considered the detailed grounds for re-examination submitted by the MAH in writing, the CHMP considered that no additional conditions were necessary to ensure the safe and effective use of tranexamic acid. 
Po proučitvi podrobnih razlogov za ponovno presojo, ki jih je imetnik dovoljenja za promet pisno predložil, je odbor CHMP sklenil, da za zagotovitev varne in učinkovite uporabe traneksamične kisline niso potrebni nobeni dodatni pogoji.
The MAH was not convinced that the fulfilment of a condition such as performing a pharmacokinetic study in children was an essential condition for the safe and effective use of tranexamic acid IV in adults. 
• Imetnik dovoljenja za promet ni bil prepričan, da je izpolnitev pogoja, kot je izvedba farmakokinetične študije pri otrocih, osnovni pogoj za varno in učinkovito uporabo traneksamične kisline IV pri odraslih.
The Committee considered the procedure under Article 31 of Directive 2001/83/EC, for aprotinin, aminocaproic acid and tranexamic acid (see Annex I). 
• odbor je upošteval postopek po členu 31 Direktive 2001/83/ES za aprotinin, aminokaprojsko kislino in traneksamično kislino (glejte Prilogo I);
Therefore the CHMP concluded that the balance of risks and benefits for tranexamic acid is positive under normal conditions of use subject to the revision of the indications as follows: 
je odbor CHMP zaključil, da je razmerje med tveganji in koristmi za traneksamično kislino pozitivno pri običajnih pogojih uporabe in z naslednjo revizijo indikacij:
A list of indications for which the CHMP considered that the benefit risk balance remains positive is presented below. 
Seznam indikacij, za katere je odbor CHMP menil, da zanje ostaja razmerje med tveganji in koristmi pozitivno, je na voljo spodaj.
The Committee considered that the product information should be updated. 
• odbor je presodil, da je treba posodobiti informacije o zdravilih.
Having considered the data presented, the CHMP noted that there are ongoing PK studies in children that could provide valuable information. 
Ob upoštevanju predstavljenih podatkov je odbor CHMP ugotovil, da že potekajo farmakokinetične študije pri otrocih, ki bi lahko prinesle koristne informacije.
The results of the BART trial did not have a negative impact on the benefit risk profile of TXA. 
Rezultati preskušanja BART niso negativno vplivali na profil koristi in tveganja za traneksamično kislino.
Thromboembolic events, including interaction with oestrogens have been reported. 
Poročali so o trombemboličnih dogodkih, vključno z medsebojnim delovanjem z estrogeni.
In addition, information on convulsions and visual disturbances including impaired colour vision are adverse events which can be serious and have been reported, but these risks had not been considered in the current authorised product information. 
Poleg tega so med neželenimi učinki konvulzije in motnje vida, vključno s poslabšanjem barvnega vida, ki so lahko resne in o katerih so poročali, toda ta tveganja niso bila upoštevana v podatkih o zdravilih, ki so trenutno odobrena.
The final study results of these clinical trials should be considered before recommending the need of additional studies. 
Pred priporočanjem, da so potrebne dodatne študije, je treba upoštevati končne rezultate teh kliničnih preskušanj.
Taking into account all the available information on safety and efficacy, the Committee agreed on the variation of the marketing authorisation with the balance of the risks and benefits considered positive in the following revised indications for TXA: 
Ob upoštevanju vseh razpoložljivih informacij o varnosti in učinkovitosti je Odbor pristal na spremembo dovoljenj za promet z zdravili, ker meni, da je razmerje med tveganji in koristmi pozitivno za naslednje revidirane indikacije za traneksamično kislino:
The safety profile of TXA has evolved since its authorisation, and safety data has accumulated over the years. 
Po odobritvi traneksamične kisline se je varnostni profil te učinkovine še povečal in podatkov o varnosti je bilo skozi leta čedalje več.
Overall summary of the scientific evaluation of referral on antifibrinolytics Tranexamic acid containing medicinal products (see Annex I) 
Splošni povzetek znanstvenega vrednotenja napotitve za antifibrinolitike Zdravila, ki vsebujejo traneksamično kislino (glejte Prilogo I)
The ongoing studies could provide some relevant PK data in different age stratum and some pharmacodynamic data, which is considered of interest. 
Potekajoče študije bi lahko prinesle nekatere pomembne farmakokinetične podatke za različne starostne skupine in nekaj farmakodinamičnih podatkov, ki bi lahko bili zanimivi.
The CHMP considered also the adverse reactions profile, including new adverse events (some of which serious) associated with the use of TXA. 
Upošteval je tudi profil neželenih učinkov, vključno z novimi neželenimi učinki (med katerimi je nekaj resnih), povezanih z uporabo traneksamične kisline;
This PK study had been requested by the CHMP in the article 31 referral on antifibrinolytics containing aprotinin, aminocaproic acid and tranexamic acid. 
To farmakokinetično študijo je zahteval odbor CHMP v napotitvenem postopku po členu 31 za antifibrinolitike, ki vsebujejo aprotinin, aminokaprojsko kislino in traneksamično kislino.
On the basis of the above, the Committee recommended the variation to the terms of the marketing authorisation for the medicinal products containing tranexamic acid referred to in Annex I for which the amendments to the product information are set out in annex III of the opinion. 
Na podlagi navedenega je Odbor priporočil spremembo pogojev za dovoljenja za promet z zdravili, ki vsebujejo traneksamično kislino, naštetimi v Prilogi I. Spremembe informacij o zdravilih so navedene v Prilogi III tega mnenja.
The MAHs are reminded that any new information on the use of TXA in children is considered valuable. 
Imetniki dovoljenj za promet z zdravili naj imajo v mislih, da vsakršne nove informacije o uporabi traneksamične kisline pri otrocih veljajo za koristne.
Dermatitis allergic, vascular disorders, such as malaise with hypotension, with or without loss of consciousness and arterial or venous thrombosis, and hypersensitivity reactions including anaphylaxis have been reported. 
Poročali so o alergijskem dermatitisu, žilnih motnjah, kot je slabo počutje s hipotenzijo, izgubo zavesti in arterijsko ali vensko trombozo ali brez njih, ter o preobčutljivostnih reakcijah, vključno z anafilaksijo.
In view of the identified serious limitations of the efficacy data, the available new evidence and/or current medical knowledge on the use of TXA, and considering the adverse reactions profile (some of which serious) associated with the use of TXA, the CHMP considered that some of these indications should be removed. 
Ob upoštevanju ugotovljenih resnih omejitev podatkov o učinkovitosti, razpoložljivih novih dokazov in/ali sedanjega medicinskega znanja o uporabi traneksamične kisline ter profila neželenih učinkov (med katerimi je nekaj resnih), povezanih z uporabo traneksamične kisline, je odbor CHMP menil, da je treba nekatere od teh indikacij odstraniti.
The MAH informed that for children, some recent pharmacokinetic studies conducted with tranexamic acid in the paediatric population should provide relevant information. 
• Imetnik dovoljenja za promet je poročal, da bi nekatere nedavne farmakokinetične študije, opravljene s traneksamično kislino pri pediatrični populaciji, morale dati ustrezne informacije o uporabi pri otrocih.
Scientific conclusions and grounds for variation to the terms of the marketing authorisations for tranexamic acid containing medicinal products presented by the EMA 
Znanstveni zaključki in razlogi za spremembo pogojev dovoljenj za promet z zdravili z vsebnostjo traneksamične kisline, ki jih je predstavila Evropska agencija za zdravila
The Committee considered that evidence from randomised clinical trials and observational studies support the use of tranexamic acid in patients undergoing dental or surgical procedures or at risk of complications from bleeding. 
• odbor meni, da dokazi iz randomiziranih kliničnih preskušanj in opazovalnih študij podpirajo uporabo traneksamične kisline pri bolnikih, ki imajo posege na zobeh in druge kirurške posege ter pri bolnikih, ki so v nevarnosti za zaplete zaradi krvavitve;
In addition to cardiac surgery, the CHMP considered that sufficient evidence is available on the safety and efficacy of TXA in other indications, including in patients undergoing dental or surgical procedures or at risk of complications from bleeding. 
Po mnenju odbora CHMP je poleg srčnih operacij na voljo dovolj dokazov o varnosti in učinkovitosti traneksamične kisline tudi za druge indikacije, vključno s posegi na zobeh in drugimi kirurškimi posegi ter pri bolnikih, ki so v nevarnosti za zaplete zaradi krvavitve.
In view of the identified serious limitations of the efficacy data, the available new evidence and/or current medical knowledge on the use of TXA, and considering the adverse reactions profile (some of which serious) associated with the use of TXA, the CHMP considered that for some of the therapeutic indications the benefits no longer outweigh the risks and therefore they should be removed. 
• ob upoštevanju ugotovljenih resnih omejitev podatkov o učinkovitosti, razpoložljivih novih dokazov in/ali sedanjega medicinskega znanja o uporabi traneksamične kisline ter profila neželenih učinkov (med katerimi je nekaj resnih), povezanih z uporabo traneksamične kisline, je odbor CHMP menil, da za nekatere terapevtske indikacije koristi ne odtehtajo več tveganj, zato je te indikacije treba odstraniti;
Haematuria and the risk for urethral obstruction should also be included as warnings. 
Med opozorila je treba vključiti tudi hematurijo in tveganje za obstrukcijo sečnice.
Grounds for amendment of the marketing authorisations of tranexamic acid containing medicinal products listed in Annex I 
Podlaga za spremembo dovoljenj za promet z zdravili, ki vsebujejo traneksamično kislino, naštetimi v Prilogi I
The CHMP identified that information on disseminated intravascular coagulation, visual disturbances including impaired colour vision, thromboembolism, haematuria and convulsions should be appropriately reflected through warnings and recommendations in the product information. 
Odbor CHMP je ugotovil, da morajo biti informacije o diseminirani intravaskularni koagulaciji, motnjah vida, vključno s poslabšanim barvnim vidom, trombembolizmu, hematuriji in konvulzijah ustrezno predstavljene kot opozorila in priporočila v informacijah o zdravilu.
The Committee considered all data provided by the MAHs in writing, including data available from literature reviews. 
• odbor je obravnaval vse podatke, ki so jih pisno predložili imetniki dovoljenj za promet z zdravili, vključno s podatki iz pregledov strokovne literature;
Tranexamic acid has also been associated with gastrointestinal adverse events, such as nausea, diarrhoea and vomiting. 
Traneksamična kislina je povezana tudi z neželenimi učinki na prebavila, kot so slabost, driska in bruhanje.
In particular the therapeutic indications were updated to reflect current scientific knowledge on the use of TXA; other changes to the product information were inclusion information on disseminated intravascular coagulation, visual disturbances including impaired colour vision, thromboembolism, haematuria and convulsions as warnings and recommendations. 
Posodobljene so bile zlasti terapevtske indikacije glede na sedanje znanstveno znanje o uporabi traneksamične kisline, druge spremembe informacij o zdravilih pa je predstavljala vključitev informacij o diseminirani intravaskularni koagulaciji, motnjah vida, vključno s poslabšanjem barvnega vida, trombembolizmu, hematuriji in konvulzijah v obliki opozoril in priporočil.
The MAHs should present this information to national competent authorities when final results for the studies become available. 
Ko bodo na voljo dokončni rezultati študij, morajo imetniki dovoljenj za promet z zdravili te podatke predstaviti nacionalnim pristojnim organom.
The Committee considered the available scientific data, including evidence from new studies, on the efficacy of TXA. 
• odbor CHMP je obravnaval razpoložljive znanstvene podatke o učinkovitosti traneksamične kisline, vključno z odkritji iz novih študij.
Member State EU/EEA 
Država članica / EEA
Allergic reactions to these substances may occasionally be serious. 
Alergijske reakcije na te učinkovine so občasno lahko resne.
Porto Salvo 2470 Oeiras Portugal 
Porto Salvo 2470 Oeiras Portugalska
Animals were slaughtered at 12, 24, 36, 48 and 72 hours after the last treatment. 
Živali so bile zaklane 12, 24, 36, 48 in 72 ur po zadnjem zdravljenju.
Do not use in cases associated with Pseudomonas. 
Ne uporabite v primerih, povezanih s Pseudomonas.
The CVMP was asked to address the following specific points: 
Državi članici sta CVMP prosili za obravnavo naslednjih specifičnih zadev:
1123 Budapest Hungary 
1123 Budapest Madžarska
Experimental studies have been provided to support this statement. 
V podporo tej trditvi so bile predložene izkustvene študije.
Rzymowskiego 34 02 - 697 Warszawa Poland 
Rzymowskiego 34 02 - 697 Warszawa Poljska
The posology was supported by the two clinical trials performed in the United Kingdom and France (please see above). 
Odmerjanje je bilo podprto z dvema kliničnima preskušanjema, opravljenima v Združenem kraljestvu in Franciji (glejte zgoraj).
For a full list of excipients see section 6.1. 
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
Wash hands after use. 
Po uporabi zdravila si umijte roke.
The benefit of prednisolone is considered as indirect and is expected to be of short term. 
Koristi prednizolona se štejejo kot posredne in so po pričakovanjih kratkotrajne.
1210 Wien Austria 
1210 Wien Avstrija
Milk: 
Mleko:
811 09 Bratislava Slovak Republic 
811 09 Bratislava Slovaška
No special precautions. 
Ni posebnih opozoril.
Hungary Pfizer Kft. Alkotás u. 53. 
Madžarska Pfizer Kft. Alkotás u. 53.
Recommendations for prudent use 
Priporočila o preudarni uporabi
However the presence of prednisolone in the product does not represent a risk for the animal or public health. 
Vendar prisotnost prednizolona v zdravilu ne predstavlja tveganja za živali ali javno zdravje.
23/25 Avenue Du Docteur Lannelongue 75014 Paris France 
23/25 Avenue Du Docteur Lannelongue 75014 Paris Francija
One syringe (3 g) contains: 
En injektor (3 g) vsebuje:
Therefore a positive clinical anti-inflammatory impact of prednisolone remains questionable. 
Zato pozitiven klinični protivnetni učinek prednizolona ostaja vprašljiv.
PFIZER ITALIA Via Valbiondone 113 00188 Roma Italy 
PFIZER ITALIA Via Valbiondone 113 00188 Roma Italija
Appropriate recommendations for prudent use of the product were recommended. 
Priporočena so bila ustrezna priporočila o preudarni rabi zdravila.
Due to the divergent national decisions taken by Member States concerning the authorisation of Synulox Lactating Cows and associated names and differences between the summary of product characteristics (SPC) of the product as authorised in the Member States, the issue was referred on 26 March 2010 by Belgium and Denmark to the CVMP under Article 34(1) of Directive 2001/82/EC. 
Zaradi različnih nacionalnih odločitev držav članic glede odobritve zdravila Synulox Lactating Cow in povezanih imen ter razlik med povzetki glavnih značilnosti zdravila , odobrenimi v državah članicah, sta Belgija in Danska dne 26. marca 2010 zadevo napotili na CVMP v skladu s členom 34(1) Direktive 2001/82/ES.
Veterinární divizeAnumal Health Stroupežnického 17 150 00 Praha 5 
Veterinární divizeAnumal Health Stroupežnického 17 150 00 Praha 5 Češka
Do not store above 25°C. 
Shranjujte pri temperaturi do 25
00330 Helsinki Finland 
00330 Helsinki Norveška
The tolerance of the product formulation was acceptable. 
Prenašanje formulacije zdravila je bilo sprejemljivo.
After 24 hours, the levels were too low in comparison with the MIC90. 
Po 24 urah so bile ravni glede na vrednost MIC90 prenizke.
Use of the product should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria and take into account official and local antimicrobial policies. 
Uporaba zdravila mora temeljiti na lokalnih (na ravni regije, kmetije) epidemioloških podatkih o občutljivosti ciljnih bakterij in upoštevanju uradnih in lokalnih protimikrobnih smernic.
Values were below the maximum residue limits from the 5th milking and the half-life was estimated to be less than 12 hours. 
Vrednosti so bile pod mejno vrednostjo ostankov po 5. molži in razpolovna doba je bila ocenjena na manj kot 12 ur.
No immune modulating effects of prednisolone were observed. 
Imunsko modulirajoči učinki prednizolona niso bili opaženi.
Efficacy against the target pathogens 
Učinkovitost proti ciljnim bolezenskim povzročiteljem
Rivium Westlaan 142 2909 LD Capelle a/d Ijssel 
Nizozemska Pfizer Rivium Westlaan 142 2909 LD Capelle a/d Ijssel
Low density polyethylene syringes packed in cartons containing 3, 12, 24 or 300 syringes. 
Brizge iz polietilena nizke gostote, pakirane v kartonske škatle, ki vsebujejo 3, 12, 24 ali 300 brizg.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 
Če opazite kakršne koli resne stranske učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
After the third infusion, the MIC90 of Escherichia coli was covered well for 10 hours and the levels were partially acceptable at 12 hours. 
Po tretjem infundiranju je bila vrednost MIC90 za Escherichia coli zagotovljena 10 ur, ravni pa so bile delno sprejemljive še po 12 urah.
Intramammary suspension 
Intramamarna suspenzija
Overall summary of the scientific evaluation of Synulox Lactating Cow and associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Synulox Lactating Cow in povezanih imen (glejte Dodatek I)
The comparator product had a different composition (cloxacillin-ampicillin combination). 
Primerjalno zdravilo je imelo drugačno sestavo (kombinacijo kloksacilina in ampicilina).
Regarding the efficacy against Escherichia coli, it is recognised that the product may not be indicated in case of self-cure. 
V zvezi z učinkovitostjo proti Escherichia coli se šteje, da zdravilo morda ni indicirano v primeru samoozdravitve.
The Minimum Inhibitory Concentration (MIC) of a number of different mastitis pathogens from a range of EU Member States and therefore from a range of husbandry conditions were reviewed. 
Pregledane so bile minimalne inhibitorne koncentracije (MIC) številnih povzročiteljev mastitisa iz različnih držav članic EU, tj. iz razpona različnih pogojev živinoreje.
By using the most conservative method of calculating the time to safe concentration and including the 5th milking in the calculations, a withdrawal period of 6.1 milkings or 73.4 hours was calculated which is rounded to 7 milkings or 84 hours. 
Z uporabo najbolj konzervativne metode izračuna časa do varne koncentracije in vključitvijo 5 molž v izračune je bila določena karenca 6,1 molže oz. 73,4 ure, kar je bilo zaokroženo na 7 molž oz. 84 ur.