natgillin/translations-raw huggingface dataset:
Analytical determinations of the marker residues were carried out by high-performance liquid chromatography. 
Analitično določitev označevalcev ostankov so opravili z visokozmogljivo tekočinsko kromatografijo.
Veterinarians should strive to use narrow spectrum antibiotics if possible. 
Veterinarji morajo stremeti k uporabi ozkospektralnih antibiotikov, če je mogoče.
However, the self-cure effect for the Escherichia coli infections was not considered. 
Vendar učinka samoozdravitve okužb z Escherichia coli niso obravnavali.
PFIZER HELLAS A.E Mesogion Av 242 15451 N.Psichiko Greece 
PFIZER HELLAS A.E Mesogion Av 242 15451 N.Psichiko Grčija
The overall review indicates that over the six years covered by the data from the Netherlands, there was no evidence of significant and consistent increases in MIC levels of amoxycillin/clavulanic acid and cephalosporins. 
Skupni pregled kaže, da v šestih letih, za katera so bili na voljo podatki z Nizozemske, ni bilo dokazov o pomembnem ali stalnem povečanju vrednosti MIC za kombinacijo amoksicilina in klavulanske kisline ter cefalosporine.
The milk withdrawal period was supported by two residue depletion studies. 
Karenca za mleko je bila podprta z dvema študijam o izločanju ostankov.
This combination is effective against -lactamase producing organisms. 
Ta kombinacija deluje proti mikroorganizmom, ki proizvajajo -laktamazo.
List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, withdrawal period, marketing authorisation holders in the member states 
Seznam imen, farmacevtskih oblik, jakosti zdravila, živalskih vrst, karence, imetnikov dovoljenja za promet v državah članicah.
Amoxicillin residues were the limiting factor in liver and kidney. 
Ostanki amoksicilina so bili omejitveni dejavnik v jetrih in ledvicah.
Before the infusion is made, the teat end should be cleaned and disinfected. 
Pred vnosom zdravila je treba sesek očistiti in razkužiti.
Since no bio-accumulation in milk has been observed, a longer duration of treatment would have no impact on the withdrawal period. 
Ker ni bilo opaženo biološko kopičenje v mleku, daljše trajanje zdravljenja ne vpliva na karenco.
No statistical difference was shown clinically and bacteriologically between both products. 
Dokazali so, da med zdraviloma ni klinične ali bakteriološke statistično pomembne razlike.
Meat: 42 days. 
Meso: 42 dni.
Slovenia PFIZER Luxembourg SARL 
Slovenija PFIZER Luxembourg SARL
Based on the worst-case scenario where all quarters were treated according to the recommended posology, the withholding time of 84 hours or 7 milkings as claimed by the marketing authorisation holders was considered acceptable. 
Na osnovi najslabšega mogočega scenarija, kjer se vse štiri četrtine zdravijo s priporočenim odmerjanjem, se karenca 84 ur oz. 7 molž, kot jo priporočajo imetniki dovoljenja za promet z zdravilom, šteje za sprejemljivo.
After intramammary infusion, prednisolone can lead to a reduction in the local signs of inflammation (swelling and subsequent size of the infected quarter)” to be replaced with “Prednisolone is an anti-inflammatory corticosteroid.”. 
Prednizolon lahko po intramamarnem infundiranju pripomore k zmanjšanju lokalnih znakov vnetja (otekanje in posledična velikost vnete četrtine)“ zamenja z izjavo „Prednizolon je protivnetni kortikosteroid.“
Since the product has been shown to be efficacious for the claimed indication and no risk has been identified to its use from clinical trials and pharmacovigilance, the benefit/risk balance is deemed positive. 
Ker je bila za zdravilo dokazana učinkovitost pri navedeni indikaciji in v kliničnih preskušanjih in farmakovigilanci niso odkrili tveganj zaradi njegove uporabe, se razmerje med tveganji in koristmi šteje za pozitivno.
Therefore the marketing authorisation holders' proposal to remove such a recommendation from the product information was accepted by the CVMP. 
Zato je CVMP sprejel predlog imetnikov dovoljenja za promet z zdravilom, da se to priporočilo odstrani iz informacij o zdravilu.
The withdrawal periods of 84 hours for milk and 7 days for meat and offal were adequately justified. 
Karenci 84 ur za mleko ter 7 dni za meso in drobovino sta bili zadostno utemeljeni.
Regarding the risk to prednisolone, tolerance of the product formulation is acceptable. 
V zvezi s tveganjem zaradi prednizolona je bilo prenašanje formulacije zdravila sprejemljivo.
If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. 
Če se pri ravnanju z zdravilom pojavijo kožni izpuščaji, se posvetujte z zdravnikom in mu pokažite to opozorilo.
As a conclusion, the residue depletion data support the withdrawal periods of 84 hours for milk and 7 days for meat and offal. 
Če povzamemo, podatki o izločanju ostankov podpirajo karenco 84 ur za mleko ter 7 dni za meso in drobovino.
• Indications; 
• indikacije,
Milk samples were collected from each animal immediately before the administration of the test product, then for the following 16 milkings, starting 12 hours after the last treatment. 
Vsaki živali so odvzeli vzorce mleka nemudoma pred dajanjem preskusnega zdravila in po naslednjih 16 molžah, z začetkom 12 ur po zadnjem zdravljenju.
Shelf life of the veterinary medicinal product as packaged for sale: 18 months. 
Rok uporabnosti zdravila v pakiranju za prodajo: 18 mesecev..
Notwithstanding the conclusions on the efficacy of prednisolone, the combination was deemed efficacious against the claimed pathogens. 
Brez upoštevanja zaključkov o učinkovitosti prednizolona se je kombinacija štela za učinkovito proti navedenim bolezenskim povzročiteljem.
The mean differential white blood cell counts were not significantly different at sampling times post treatment suggesting that the low levels of prednisolone did not markedly affect white blood cell counts. 
Diferencialna bela krvna slika v povprečju ni bila bistveno drugačna ob časih vzorčenja po zdravljenju, kar kaže, da nizke ravni prednizolona niso bistveno vplivale na število levkocitov.
While the clinical added value of prednisolone in Synulox Lactating Cow remains questionable, no risk arising from its use has been identified from clinical trials and pharmacovigilance. 
Čeprav ostaja klinična dodana vrednost prednizolona v zdravilu Synulox Lactating Cow vprašljiva, v kliničnih preskušanjih in farmakovigilanci niso odkrili tveganj zaradi njegove uporabe.
MANUFACTURER'S BATCH NUMBER Batch 
IZDELOVALČEVA ŠTEVILKA SERIJE
The reason for divergent national decisions regarding the authorisation of the products was mainly the justification of the combination of amoxicilline/clavulanic acid/prednisolone for the treatment of bovine mastitis. 
Razlog za razlike med nacionalnimi odločitvami glede odobritve zdravil je bil predvsem v utemeljitvi kombinacije amoksicilina, klavulanske kisline in prednizolona za zdravljenje bovinega mastitisa.
The product should be used for treatment of clinical mastitis only. 
Zdravilo se sme uporabljati samo za zdravljenje kliničnega mastitisa.
Prednisolone administered before Escherichia coli endotoxin challenge may reduce the quarter size at some time points within 8 hours. 
Uporaba prednizolona pred izpostavitvijo endotoksinu Escherichia coli lahko v nekaterih časovnih točkah do 8 ur zmanjša velikost četrtine vimena.
In a Streptococcus uberis challenge, a single administration of the product reduced the udder swelling 4 and 6 hours post treatment, but no significant action was seen on the cellular response. 
Pri izpostavitvi bakteriji Streptococcus uberis je en odmerek zdravila zmanjšal otekanje vimena v 4 in 6 urah po zdravljenju, vendar niso ugotovili pomembnega učinka na celični odziv.
The review of literature on the current level of resistance to amoxycillin/clavulanic acid among clinically significant mastitis pathogens indicates that resistance remains low. 
Pregled literature o trenutni ravni odpornosti proti kombinaciji amoksicilina in klavulanske kisline med klinično pomembnimi povzročitelji mastitisa je pokazal, da je odpornost nizka.
Swelling of the face, lips or eyes or difficulty with breathing, are more serious symptoms and require urgent medical attention. 
Pri pojavu resnih kliničnih znakov kot so otekanje obraza, ustnic ali oči ali težavah z dihanjem, je potrebna takojšnja zdravniška pomoč.
Pfizer Oy Animal Health Tietokuja 4 
Norveška Pfizer Oy Animal Health Tietokuja 4
Therefore overall treatment length must be at the veterinarian's discretion but should be long enough to ensure complete resolution of intramammary infection. 
Celotni čas zdravljenja mora določiti veterinar, zdravljenje pa mora biti dovolj dolgotrajno, da se zagotovi popolna resolucija intramamarne okužbe.
Do not use after the expiry date stated on the label after “EXP”. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini po EXP.
Handle this product with great care to avoid exposure, taking all recommended precautions. 
S tem zdravilom rokujte previdno in upoštevajte vse previdnostne ukrepe, da bi preprečili izpostavljanje zdravilu.
A pharmacokinetic study demonstrated that prednisolone does not have a prolonged residence time in the milk/udder (about 8-10 hours post infusion, levels of prednisolone were less than 1µg/ml). 
V farmakokinetični študiji so dokazali, da prednizolon nima podaljšanega časa zadrževanja v mleku/vimenu (približno 8-10 ur po infundiranju so bile ravni prednizolona nižje od 1 µg/ml).
Milk: 14 days. 
Mleko: 14 dni.
Pharmacokinetic studies, performed with the finished product revealed individual concentrations of amoxicillin in milk above the MIC90 (2 µg/ml) for Staphylococcus aureus until 12 hours after the last infusion. 
Študije farmakokinetike, opravljene s končnim zdravilom, so pokazale posamezne koncentracije amoksicilina v mleku nad vrednostjo MIC90 (2 µg/ml) za Staphylococcus aureus do 12 ur po zadnjem infundiranju.
1. to assess if efficacy of Synulox Lactating Cow and associated names has been demonstrated for bovine mastitis in lactating cows, 
1. da oceni, ali je bila dokazana učinkovitost zdravila Synulox Lactating Cow in povezanih imen pri bovinem mastitisu pri kravah v obdobju laktacije;
Milk: 2 days 
Mleko: 2 dni
The identified isolates of ESBL carrying strains, particularly from mastitis pathogens does not appear to be increasing at a rate to cause major concern. 
Videti je, da se število odkritih izolatov sevov z ESBL, zlasti povzročiteljev mastitisa, ne povečuje tako hitro, da bi predstavljalo glaven zadržek.
Ireland Pfizer Healthcare Ireland, Trading as Pfizer Animal Health Ringaskiddy 
Pfizer Healthcare Ireland, Trading as Pfizer Animal Health Ringaskiddy County Cork Irska
Based on the two clinical trials described above it was not possible to draw a conclusion on the added value of prednisolone, because there was no comparison with a product including amoxicilline/cavulanic acid without prednisolone. 
Na osnovi zgoraj opisanih kliničnih preskušanj ni bilo mogoče sklepati o dodani vrednosti prednizolona, ker ni bilo primerjave z zdravilom s kombinacijo amoksicilina in klavulanske kisline brez prednizolona.
Considering that no product specific data have been provided in support of efficacy of an extended duration of treatment, the following recommendation has been included into the SPC under section 4.9 Amounts to be administered and administration route: 
Ob upoštevanju, da v podporo učinkovitosti pri podaljšanem trajanju zdravljenja niso bili predloženi podatki, specifični za zdravilo, je treba v poglavje 4.9 povzetka glavnih značilnosti zdravila Odmerjanje in pot uporabe vključiti naslednje priporočilo:
Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. 
Preobčutljivost na penicilinske antibiotike lahko vodi do navzkrižne reakcije s cefalosporinskimi antibiotiki in obratno.
According to the provided pharmacodynamic data, the claimed pathogens are sensitive to the clavulanic acid / amoxicillin combination. 
Glede na predložene farmakodinamične podatke so omenjeni bolezenski povzročitelji občutljivi za kombinacijo klavulanske kisline in amoksicilina.
Milk: 72 Hours 
Mleko: 72 Ur
The use of the product should preferably be based on susceptibility tests. 
Uporaba naj praviloma temelji na testiranju občutljivosti bakterij.
Pfizer Luxembourg SARL, o.z. 
Slovaška Pfizer Luxembourg SARL, o.z.
The comparator product was authorised for similar indications (Staphylococci, Streptococci, Escherichia coli), but has a different composition (penethamate, dihydrostreptomycin, framycetin and prednisolone) and a different interval of administration (24 hours for the comparator instead of 12 
Primerjalno zdravilo je bilo odobreno za podobne indikacije (stafilokoki, streptokoki in Escherichia coli), vendar ima drugačno sestavo (penetamat, dihidrostreptomicin, framicetin in prednizolon) in drugačen presledek med odmerki (24 ur za primerjano zdravilo, za zdravilo Synulox Lactating Cow pa 12 ur).
Clavulanic acid is a valuable addition to amoxicillin for efficacy against mastitis pathogens and caused the MIC of target pathogens to amoxicillin only to be greatly reduced. 
Klavulanska kislina je pomemben dodatek amoksicilinu za učinkovitost proti povzročiteljem mastitisa in je povzročila, da se je vrednost MIC ciljnih bolezenskih povzročiteljev v primerjavi z dajanjem samo amoksicilina zelo zmanjšala.
In combination with SYNULOX RTU: 
v kombinaciji s SYNULOX RTU:
Globally, the in vitro susceptibility of most mastitis pathogens was very high. 
Na splošno je bila občutljivost večine povzročiteljev mastitisa v pogojih in vitro zelo visoka.
There is little evidence of a real increase in amoxycillin/clavulanic acid resistance among the mastitic E. coli isolated in a number of European countries. 
Dokazov o dejanskem povečanju odpornosti proti kombinaciji amoksicilina in klavulanske kisline pri bakterijah E. coli, izoliranih v primeru mastitisov v številnih evropskih državah, je malo.
While these experimental studies showed a positive effect of prednisolone on udder inflammation at some time-points following treatment, there were statistical deficiencies (small numbers of cows included, no grouped statistical analyses of sets of data) that meant that conclusions could not be drawn on the significance of the observed effects. 
Čeprav so te izkustvene študije pokazale pozitiven učinek prednizolona na vnetje vimena v določenih časovnih točkah po zdravljenju, so imele statistične pomanjkljivosti (majhno število vključenih krav,
For Escherichia coli MIC90 (16 µg/ml), individual milk levels in amoxicillin were above the MIC90 for the period covering the first 2 infusions. 
Za vrednost MIC90 pri Escherichia coli (16 µg/ml) so bile posamezne ravni amoksicilina v mleku nad to vrednostjo v obdobju prvih dveh infundiranj.
• The efficacy of the product for the treatment of clinical mastitis in lactating dairy cows was compared with another veterinary medicinal product authorised in the United Kingdom. 
• Učinkovitost zdravila pri zdravljenju kliničnega mastitisa pri kravah molznicah so primerjali z drugim veterinarskim zdravilom, odobrenim v Združenem kraljestvu.
No adverse reactions are to be expected from an accidental overdose. 
Pri naključnem prevelikem odmerjanju ni pričakovati neželenh učinkov.
In regard to public health risk, gastrointestinal bacteria are not significantly exposed to antimicrobial after this intramammary administration and milk is (nearly always) pasteurised prior to human consumption so the risk to human health from potential resistant pathogens after intramammary treatment is far lower than that which would arise following systemic use. 
Z vidika javnega zdravja bakterije v prebavilih po intramamarnem dajanju niso bistveno izpostavljene protimikrobnemu zdravilu in mleko se pred uporabo v prehrani ljudi (skoraj vedno) pasterizira, zato je tveganje za zdravje ljudi zaradi morebitnih odpornih povzročiteljev po intramamarnem zdravljenju bistveno manjše od tveganja, ki bi nastalo po sistemski uporabi.
Amoxicillin is a broad spectrum bactericidal -lactam antibiotic. 
Amoksicilin je širokospektralni baktericidni beta-laktamski antibiotik.
In the second study 20 healthy lactating dairy cows were treated 3 times, by the intramammary route, with the test product at the dosage of 1 syringe infused into each quarter via the teat canal, immediately after milking, for 3 consecutive milkings. 
V drugi študiji so 20 zdravih krav molznic trikrat zdravili intramamarno s preskusnim zdravilom v odmerku 1 brizge, infundirane v vsako četrtino skozi kanal seska nemudoma po molži po 3 zaporednih molžah.
The tissue samples were analysed for amoxicillin, clavulanic acid and prednisolone by the validated HPLC method. 
Vzorce tkiva so analizirali glede amoksicilina, klavulanske kisline in prednizolona z validirano metodo HPLC.
The main sections of disharmony of the existing SPCs related to: 
Največja neskladja med obstoječimi povzetki glavnih značilnosti zdravila so bila:
Meat and offal: 
Meso in drobovina:
With cows milked twice daily, milk for human consumption may only be taken the 7th milking after the last treatment. 
Pri kravah, ki se jih molze dvakrat dnevno, se sme mleko uporabiti za prehrano ljudi pri sedmi molži po zdravljenju.
Synulox Lactating Cow was shown to be efficacious regarding the main mastitis pathogens: Staphylococci, Streptococci and Escherichia coli. 
Za zdravilo Synulox Lactating Cow so dokazali, da je učinkovito proti naslednjim glavnim povzročiteljem mastitisa: stafilokoki, streptokoki in Escherichia coli.
The longer than necessary withdrawal period provides a margin of safety that covers any concerns relating to cases of prolonged duration of treatment. 
Karenca, ki je daljša od obvezne, zagotavlja varnostno mejo v primeru zadržkov zaradi primerov podaljšanega zdravljenja.
• the CVMP considered the primary scope of the referral regarding the efficacy of the product for the treatment of bovine mastitis in lactating cows and the added value of the prednisolone in the product; 
• CVMP je obravnaval primarni obseg napotitve v zvezi z učinkovitostjo zdravila pri zdravljenju bovinega mastitisa pri kravah v obdobju laktacije in dodano vrednostjo prednizolona v zdravilu.
As a conclusion, the marketing authorisation holders could not demonstrate the efficacy of prednisolone when included in the combination. 
Posledično imetniki dovoljenja za promet z zdravilom niso uspeli dokazati učinkovitosti prednizolona v kombinaciji.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS Active ingredients: 
NAVEDBA ZDRAVILNIH UČINKOVIN IN DRUGIH SESTAVIN
In the first study performed in 8 lactating dairy cows, amoxicillin was the limiting active substance to determine the withdrawal period which, according to these data, should be set at 7 milkings (84 hours). 
V prvi študiji, opravljeni na 8 kravah molznicah, je bil amoksicilin omejitvena zdravilna učinkovina za določitev karence, ki bi se po teh podatkih morala določiti pri 7 molžah (84 ur).
Two clinical trials have been provided for Synulox Lactating Cow and associated names: 
Za zdravilo Synulox Lactating Cow in povezana imena sta bili opravljeni dve klinični preskušanji:
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. 
Penicilinski in cefalosporinski antibiotiki lahko po injekcijskem vnosu, po vdihavanju, zaužitju ali preko kože, povzročijo preobčutljivostno reakcijo (alergija).
Cattle (lactating cows). 
Govedo (krave v laktaciji)
DATE OF REVISION OF THE TEXT To be completed nationally 
DATUM REVIZIJE BESEDILA
Kent CT13 9NJ United Kingdom 
Kent CT13 9NJ Združeno kraljestvo
The combination of amoxicillin and clavulanic acid has a broad spectrum antimicrobial activity including -lactamase producing organisms. 
Kombinacija amoksicilina in klavulanske kisline ima širok spekter protimikrobnega delovanja, vključno z organizmi, ki tvorijo laktamaze beta.
The contents of one syringe should be infused into each affected quarter via the teat canal, immediately after milking, at 12 hour intervals for three consecutive milkings. 
Vsebino ene brizge je treba infundirati v vsako prizadeto četrtino skozi kanal seska nemudoma po molži v 12-urnih presledkih po treh zaporednih molžah.
Intramammary administration of prednisolone seems not affect the functions of neutrophils. 
Zdi se, da intramamarno dajanje prednizolona ne vpliva na funkcijo nevtrofilcev.
Calcium Sodium Aluminosilicate (dried) Mineral Oil (Formula A) 
Kalcij natrijev aluminijev silikat, suh Mineralno olje (Formula A)
While a withdrawal period of 3 days could have been derived from the dataset, a withdrawal time of 7 days was recommended by the marketing authorisation holders. 
Čeprav bi bilo iz podatkov mogoče izpeljati karenco 3 dni, so imetniki dovoljenja za promet z zdravilom priporočili karenco 7 dni.
Inappropriate use of the product may increase the prevalence of bacteria resistant to ß-lactam antibiotics and may decrease the effectiveness of treatment with ß-lactam antibiotics, due to the potential for crossresistance. 
Neustrezna uporaba zdravila lahko poveča prevalenco bakterij, rezistentnih na beta-laktamske antibiotike in lahko zmanjša učinkovitost zdravljenja z beta-laktamskimi antibiotiki zaradi možnosti razvoja navzkrižne rezistence.
The withdrawal period was supported by a residue depletion study where 20 cows received an infusion of one injector per quarter of Synulox Lactating Cow in all 4 quarters of the udder at 12-hour intervals following 3 consecutive milkings. 
Karenca je bila podprta s študijo o izločanju ostankov, v kateri je 20 krav prejelo infuzijo enega injektorja zdravila Synulox Lactating Cow na četrtino v vse 4 četrtine vimena v 12-urnih presledkih po 3 zaporednih molžah.
The product is formulated for the treatment of bovine clinical mastitis in lactating cows. 
Zdravilo je formulirano za zdravljenje bovinega kliničnega mastitisa pri kravah v obdobju laktacije.
• In another study the efficacy of Synulox Lactating Cow for the treatment of clinical mastitis in the lactating dairy cow was compared with another veterinary medicinal product authorised in France. 
• V drugi študiji so učinkovitost zdravila Synulox Lactating Cow za zdravljenje kliničnega mastitisa pri kravah molznicah primerjali z drugim veterinarskim zdravilom, odobrenim v Franciji.
• Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis); 
• streptokoki (vključno s S. agalactiae, S. dysgalactiae in S. uberis),
2. if efficacy is confirmed, to assess if efficacy of amoxicilline/clavulanic acid/prednisolone combination is superior to treatment with amoxicilline/clavulanic acid alone, 3. to consider whether the benefit/risk balance of this product is positive and, if not, whether the marketing authorisations should be (i) amended, (ii) revoked or (iii) suspended on grounds of safety and efficacy. 
3. da ugotovi, ali je razmerje med tveganji in koristmi zdravila pozitivno, in če ni, ali je treba na osnovi varnosti in učinkovitosti dovoljenja za promet z zdravilom (i) dopolniti, (ii) preklicati ali (iii) začasno umakniti.
Synulox Lactating Cow and associated names is a pale cream/buff coloured oily suspension containing clavulanic acid, amoxicillin and prednisolone in a base designed to disperse rapidly in milk. 
Zdravilo Synulox Lactating Cow in povezana imena je oljna suspenzija svetlo kremne/bež barve, ki vsebuje amoksicilin, klavulansko kislino in prednizolon v bazi, ki je namenjena hitri razpršitvi v mleku.
Added value of prednisolone in the combination The current SPC indicates that prednisolone has an anti-inflammatory action which helps to reduce the potentially destructive swelling and inflammation associated with mastitis, without affecting the white cell response to infection. 
Trenutna različica povzetka glavnih značilnosti zdravila kaže, da prednizolon deluje protivnetno, kar pomaga zmanjšati morebitno destruktivno otekanje in vnetje, povezano z mastitisom, ne da bi vplival na odziv levkocitov na okužbo.
Avoid use of the product in herds where no β-lactamase producing Staphylococci strains have been isolated. 
Izogibajte se uporabi zdravila v čredah, kjer ni bilo izoliranih sevov streptokokov, ki proizvajajo βlaktamazo.