natgillin/translations-raw huggingface dataset:
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:
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.
Consequently the CVMP considered that the recommendations for prudent use in the SPC under section 4.5 Special precautions for use, should be amended as follows: “The product should be used for treatment of clinical mastitis only.
Posledično je CVMP menil, da je treba priporočila o preudarni rabi v poglavju 4.5 povzetka glavnih značilnosti zdravila Posebni previdnostni ukrepi spremeniti, kot sledi:
Harmonisation of the withdrawal periods
Uskladitev odmerjanja
3 syringes 12 syringes 24 syringes 300 syringes 350 syringes
3 injektorji 12 injektorjev 24 injektorjev 300 injektorjev
When any other milking routine is followed milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk for human consumption may only be taken at the 8th milking).
Če se uporablja drugačna shema molže, se sme mleko uporabiti za prehrano ljudi po preteku istega časovnega obdobja (npr. pri 3-krat dnevni molži, se sme mleko uporabiti za prehrano ljudi šele pri 8. molži).
Therefore the CVMP has recommended the variation of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Synulox Lactating Cow and associated names (see Annex I).
Zato je CVMP priporočil spremembo dovoljenj za promet z zdravilom Synulox Lactating Cow in povezanimi imeni (glejte Dodatek I), katerih povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Dodatku III.
Where any other milking routine is followed, milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk may be taken for human consumption at the 11th milking).
Če se uporablja drugačna shema molže, se sme mleko uporabiti za prehrano ljudi šele po preteku enakega časnovnega obdobja (npr. pri trikrat dnevni molži se sme mleko uporabiti za prehrano ljudi pri 11. molži).
In a Staphylococcus aureus challenge, a reduction of udder induration, udder swelling and inflammation was observed at some time-points following the product administration.
Pri izpostavitvi bakteriji Staphylococcus aureus so ugotovili zmanjšanje otrdline, otekanja in vnetja vimena v nekaterih časovnih točkah po dajanju zdravila.
The product is efficacious regarding the claimed indications, treatment of bovine clinical mastitis in lactating cows, including cases of infections associated with the following pathogens:
Zdravilo je učinkovito pri opisanih indikacijah, zdravljenju bovinega kliničnega mastitisa pri kravah v obdobju laktacije, vključno s primeri okužb zaradi naslednjih povzročiteljev:
Milk: 80 hours.
Mleko: 80 ur.
Therefore, while clinical cure and bacteriological cure have been demonstrated for the formulation it was considered that the marketing authorisation holders had not demonstrated the efficacy of prednisolone in the combination.
Zato se šteje, da imetniki dovoljenja za promet z zdravilom kljub dokazu klinične in bakteriološke ozdravitve za formulacijo niso dokazali učinkovitosti prednizolona v kombinaciji.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Amoxicillin
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E)
PACKAGE LEAFLET “Product name” (to be completed nationally) intramammary suspension for lactating cattle NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: To be completed nationally
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
Če ste preobčutljivi ali so vam svetovali, da ne smete rokovati s temi učinkovinami, ne smete priti v stik z zdravilom.
“In cases of infections caused by Staphylococcus aureus, a longer course of antibacterial therapy may be required.
„V primerih okužb zaradi Staphylococcus aureus je morda potrebno daljše protimikrobno zdravljenje.
Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis and Gram negative bacteria.
Klinična in bakteriološka učinkovitost zdravila Synulox Lactating Cow proti Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis in gramnegativnim bakterijam je bila enakovredna učinkovitosti primerjalnega zdravila.
Synulox Lactating Cow was non-inferior to the comparator.
Zdravilo Synulox Lactating Cow je bilo enakovredno primerjalnemu zdravilu.
The product is intended for the treatment of bovine clinical mastitis in lactating cows, including cases of infections associated with the following pathogens:
Zdravilo je namenjeno zdravljenju bovinega kliničnega mastitisa pri kravah v obdobju laktacije, vključno s primeri okužb zaradi naslednjih povzročiteljev:
Milk: 60 hours
Mleko: 60 ur
Prednisolone is an anti-inflammatory corticosteroid.
Prednizolon je kortikosteroid s protivnetnim delovanjem.
• the CVMP reviewed the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holders and considered all the overall submitted data; the CVMP, concluded that the overall benefit/risk balance for this product remains positive subject to the recommended changes in the product information.
• CVMP je pregledal povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so jih predlagali imetniki dovoljenj za promet z zdravilom, in obravnaval vse predložene podatke.
MARKETING AUTHORISATION NUMBER(S) To be completed nationally
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET
Meat and offal: 7 days Milk: 84 hours
Meso in organi: 7 dni Mleko: 84 ur
The product is presented in disposable intramammary syringes containing 200 mg amoxicillin as amoxicillin trihydrate, 50 mg clavulanic acid as potassium clavulanate and 10 mg prednisolone in 3 g suspension.
Zdravilo je na voljo v intramamarnih brizgah za enkratno uporabo, ki v 3 g suspenzije vsebujejo 200 mg amoksicilina v obliki amoksicilin trihidrata, 50 mg klavulanske kisline v obliki kalijevega klavulanata in 10 mg prednizolona.
However, it is recognised that in cases of infections caused by Staphylococcus aureus, a longer course of antibacterial therapy may be required.
Vendar je bilo ugotovljeno, da je v primerih okužb zaradi Staphylococcus aureus morda potrebno daljše protimikrobno zdravljenje.
Strengths Pharmaceutical form
Farmacevtska oblika
Therefore overall treatment length must be at the veterinarian's discretion but should be long enough to ensure complete resolution of intramammary infection.” A longer duration of treatment would not impact the recommended withdrawal periods for meat and milk.
Zato mora o skupnem trajanju zdravljenja presoditi veterinar, vendar mora biti dovolj dolgo, da se zagotovi popolna odprava intramamarne okužbe.“
Do not use in animals, which are known to be hypersensitive to ß-lactam antibiotics.
Ne uporabite v primeru preobčutljivosti na betalaktamske antibiotike.
Clavulanic acid inactivates -lactamases.
Klavulanska kislina inaktivira beta-laktamazo.
Milk: 60 hours.
Milk: 60 ur.
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
BESEDILO “SAMO ZA ŽIVALI”
Romania Pfizer Animal Health MA EEIG
Romunija Pfizer Animal Health MA EEIG
200 mg 50 mg 10 mg
200,0 mg klavulanska kislina 50,0 mg prednizolon
SPECIAL WARNINGS
Posebna opozorila
NAME OF THE VETERINARY MEDICINAL PRODUCT “Product name” (to be completed nationally) intramammary suspension for lactating cattle
Ime proizvoda (izpolni država članica) intramamarna suspenzija za krave v laktaciji
It is presented in disposable intramammary syringes containing 50 mg clavulanic acid as potassium clavulanate; 200 mg amoxicillin as amoxicillin trihydrate and 10 mg prednisolone in 3 g suspension.
Zdravilo je na voljo v intramamarnih brizgah za enkratno uporabo, ki v 3 g suspenzije vsebujejo 50 mg klavulanske kisline v obliki kalijevega klavulanata, 200 mg amoksicilina v obliki amoksicilin trihidrata in 10 mg prednizolona.
METHOD AND ROUTE(S) OF ADMINISTRATION Intramammary use.
NAČIN IN POT(I) UPORABE
MARKETING AUTHORISATION NUMBER To be completed nationally
ŠTEVILKA DOVOLJENJA ZA PROMET
Emulsifying Wax White Soft Paraffin Liquid Paraffin Light
Vosek, emulgirajoči Vazelin, beli Parafin, redko tekoči
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Escherichia coli (including -lactamase producing strains)
Escherichia coli (vključno s sevi, ki proizvajajo β-laktamazo)
Summary of product characteristics, labelling and package leaflet
Povzetek glavnih značilnosti zdravila, ovojnina in navodilo za uporabo
Milk: 84 hours, i.e. 7 milking times with 2 times a day milking or 11 milking times with 3 times a day milking.
7 molž pri shemi molže 2-krat dnevno ali 11 molž pri 3-krat dnevni molži.
Meat and offal: 7 days
Meso in organi: 7 dni
Based on the past and recent data, the incidence of pathogens producing β-lactamase, i.e. Staphylococcus aureus and Escherichia coli from cases of bovine mastitis can be considered as high in some regions.
Staphylococcus aureus in Escherichia coli, v primerih bovinega mastitisa na določenih območjih štejemo za visoko.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES One dose (3 g)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
Harmonisation of the posology
Uskladitev karence
Cattle Meat: 7 days Milk: 60 hours In combination with SYNULOX RTU:
Amoxicillin (as amoxicillin trihydrate) Clavulanic acid (as potassium clavulanate) Prednisolone intramamarna suspenzija govedo Meso: 7 dni Mleko: 60 ur V kombinaciji s SYNULOX RTU:
Lithuania Pfizer Animal Health MA EEIG
Bolgarija Pfizer Animal Health MA EEIG
In cases of infections caused by Staphylococcus aureus, a longer course of antibacterial therapy may be required.
Pri okužbah s Staphylococcus aureus bo morda potrebno daljše protimikrobno zdravljenje.
Prednisolone:
Karenca:
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
Synulox comp. vet Amoxicillin (as amoxicillin trihydrate) Clavulanic acid (as potassium clavulanate) Prednisolone
Synulox comp. vet Amoxicillin (as amoxicillin trihydrate) Clavulanic acid (as potassium clavulanate) Prednisolone intramamarna emulzija govedo Meso: 6 dni Mleko: 5 dni
DATE OF RENEWAL OF THE AUTHORISATION To be completed nationally
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
• Escherichia coli (including β-lactamase producing strains).
• Escherichia coli (vključno s sevi, ki tvorijo laktamaze beta).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Polyethylene syringe
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
• Escherichia coli (including β-lactamase producing strains) A review of the susceptibility of the mastitis pathogens against amoxicillin-clavulanic acid indicates that the major bacterial causes of bovine mastitis continue to be susceptible to clavulanate potentiated amoxicillin.
Pregled občutljivosti povzročiteljev mastitisa za kombinacijo amoksicilina in klavulanske kisline kaže, da so poglavitni bakterijski povzročitelji bovinega mastitisa še vedno občutljivi za amoksicilin v kombinaciji s klavulanatom.
However it was noted that the self-cure effect was not considered regarding
Vendar je bilo ugotovljeno, da v primerih okužb z Escherichia coli ni bil upoštevan učinek samoozdravitve.
Amoxicillin (as amoxicillin trihydrate) Clavulanic acid (as potassium clavulanate) Prednisolone
Amoxicillin (as amoxicillin trihydrate) Clavulanic acid (as potassium clavulanate) Prednisolone intramamarna suspenzija govedo Užitna tkiva: 4 dni
Meat and offal: 7 days Milk: 84 hours.
Meso in organi: 7 dni Mleko: 84 ur, t.j.
Potassium clavulanate equivalent to clavulanic acid
Zdravilne učinkovine amoksicilin trihidrat, ekvivalenten amoksicilinu kalijev klavunalat, ekvivalenten klavulanski kislini prednizolon
4.4 Special warnings
4.3 Kontraindikacije
Consequently the CVMP considered that since the added value of prednisolone in the product has not been demonstrated, the following statement in the SPC under section 5.
Posledično je CVMP menil, da se zaradi nedokazane dodane vrednosti prednizolona v zdravilu naslednja izjava v poglavju 5 povzetka glavnih značilnosti zdravila Farmakološke lastnosti: „Prednizolon je glukokortikoid s protivnetnimi lastnostmi.
NAME OF THE VETERINARY MEDICINAL PRODUCT “Product name” (to be completed nationally
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
10 mg
odmerek (3 g)
Milk (cows milked twice daily): 60 hours (i.e. at the 5th milking) after the last treatment.
Mleko (2-krat dnevna molža): 60 ur (t.j.
OTHER INFORMATION To be completed nationally
Izpolni država članica
Staphylococci (including -lactamase producing strains) Streptococci (including S.agalactiae, S.dysgalactiae and S.uberis) Escherichia coli (including -lactamase producing strains)
Za zdravljenje kliničnih primerov mastitisa, vključno s primeri, povezanimi z okužbo z naslednjimi povzročitelji: stafilokoki (vključno s sevi, ki proizvajajo β-laktamazo), streptokoki (vključno s Streptococcus agalactiae, S. dysgalactiae in S. uberis), Escherichia coli (vključno s sevi, ki proizvajajo β-laktamazo)
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
Synulox
amoksicilin
Swab teat end with appropriate disinfectant before treatment.
Posebni previdnostni ukrepi za uporabo pri živalih Pred zdravljenjem razkužite vrh seska s primernim razkužilom.
WITHDRAWAL PERIOD Withdrawal period:
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Amoxicillin was the limiting active substance to determine the withdrawal period in milk.
Omejitvena zdravilna učinkovina za določitev karence za mleko je bil amoksicilin.