natgillin/translations-raw huggingface dataset:
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
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.
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.