FrancophonIA/ELRC3.0 huggingface dataset:
English: One hour after a single administration, plasma concentrations are greater than 1 µg/ml.
Slovenian: Eno uro po enkratnem dajanju je koncentracija v plazmi večja kot 1 μg/ml.
English: It has an antimicrobial activity similar to that of ceftiofur against the target pathogens.
Slovenian: Proti mikrobno delovanje je podobno ceftiofurjevemu proti ciljnim patogenim organizmom.
English: Treatment of acute post-partum (puerperal) metritis in cattle, in cases where treatment with another antimicrobial has failed.
Slovenian: Zdravljenje akutnega poporodnega (puerperalnega) metritisa pri govedu v primerih, ko zdravljenje z drugimi protimikrobnimi sredstvi ni bilo učinkovito.
English: Whenever possible, cephalosporins should only be used based on susceptibility testing.
Slovenian: Kadar je mogoče, uporabite cefalosporine na podlagi testa občutljivosti.
English: Meat and offal: 9 days.
Slovenian: Meso in organi: 9 dni.
English: Ceftiofur inhibits the bacterial cell wall synthesis, thereby exerting bactericidal properties.
Slovenian: Ceftiofur inhibira sintezo bakterijske celične stene in s tem izraža baktericidne lastnosti.
English: Approximately 60% and 15% of the dose are excreted in the urine and faeces, respectively, within 10 days after administration.
Slovenian: Približno 60% odmerka se izloči z urinom, 15% odmerka pa se izloči z blatom v 10 dneh po dajanju.
English: Meat and offal: 71 days.
Slovenian: Meso in organi: 71 dni.
English: Lactation: This veterinary medicinal product can be used during lactation.
Slovenian: Zdravilo za uporabo v veterinarski medicini se lahko se uporablja v obdobju laktacije.
English: OTHER INFORMATION Naxcel is available in 100 ml vials.
Slovenian: DRUGE INFORMACIJE Naxcel je na voljo vialah po 100 ml.
English: Bordetella bronchiseptica is inherently insensitive to ceftiofur in vitro.
Slovenian: Bordetella bronchiseptica je zaradi prenosa rezistence neobčutljiva na ceftiofur pri in-vitro preizkusih.
English: In very rare cases anaphylactic type reactions may occur following administration of the product.
Slovenian: V zelo redkih primerih se lahko po dajajnju zdravila pojavi anafilaktičen tip reakcije.
English: Pharmacotherapeutic group: Antibacterials for systemic use, third-generation cephalosporins.
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij, cefalosporini tretje generacije.
English: Ceftiofur is a third generation cephalosporin antibiotic, which is active against many Gram-positive and Gram-negative pathogens.
Slovenian: Ceftiofur spada v tretjo skupino cefalosporinskih antibiotikov, ki so aktivni proti številnim Gram pozitivnim in Gram negativnim patogenom.
English: Ceftiofur is well absorbed in cattle following base of the ear injection.
Slovenian: Ceftiofur se pri govedu dobro resorbira po injiciranju na bazi ušesa.
English: All mammalian food producing species
Slovenian: Vse vrste sesalcev za proizvod njo živil
English: Penicillins and cephalosporins such as ceftiofur may cause hypersensitivity in people and in animals following injection, inhalation, ingestion or skin contact.
Slovenian: Penicilini in cefalosporini kot je ceftiofur lahko povzročijo preobčutljivost pri ljudeh in pri živalih po injiciranju, inhalaciji, zaužitju ali pri stiku s kožo.
English: Desfuroylceftiofur is the principal active metabolite.
Slovenian: Desfurojilceftiofur je glavni aktivni metabolit.
English: Owing to the low toxicity of ceftiofur in pigs overdoses do not typically lead to any clinical signs, other than transient local swellings as described in section 6 (Adverse reactions).
Slovenian: Zaradi nizke toksičnosti ceftiofurja pri prašičih prekomerno odmerjanje praviloma ne povzroči drugih simptomov, razen prehodne lokalne otekline, kot je že opisano v poglavju 6 Neželeni učinki.
English: If you develop symptoms following exposure such as a skin rash or persistent eye irritation, you should seek medical advice and show the package leaflet or the label to the physician.
Slovenian: Če se po uporabi zdravila pokažejo simptomi, kot so npr. izpuščaj ali dolgotrajno draženje oči, se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: Official, national and regional antimicrobial policies should be taken into account when the product is used.
Slovenian: Pri uporabi zdravila upoštevajte uradne, nacionalne in lokalne protimikrobne doktrine.
English: Mild tissue reactions at the injection site, such as small areas (less than 6 cm²) of discolouration and small cysts have been observed for up to 42 days after injection.
Slovenian: Na mestu dajanja se lahko do 42 dni po dajanju opazijo blage tkivne reakcije kot manjša razbarvana mesta (manj kot 6 cm2) in manjše ciste.
English: Pasteurella multocida, Haemophilus parasuis and Streptococcus suis.
Slovenian: Pasteurella multocida, Haemophilus parasuis in Streptococcus suis.
English: 2,000 µg/kg Fat 2,000 µg/kg Liver 6,000 µg/kg Kidney 100 µg/kg Milk
Slovenian: 1000 µg/kg 2000 µg/kg 2000 µg/kg
English: It is essential that Naxcel is only administered subcutaneously at the base of ear location in non-edible tissue, as described in section 4.9, in order to comply with the meat withdrawal period.
Slovenian: Bistveno je, da se Naxcel daje samo subkutano na mestu na bazi ušesa v neužitno tkivo, kot je opisano v poglavju 4.9, da se zagotovi karenca za meso.
English: People with known hypersensitivity to penicillins and cephalosporins should avoid contact with this veterinary medicinal product.
Slovenian: Osebe z znano preobčutljivostjo na peniciline in cefalosporine naj se izogibajo stiku z zdravilom.
English: Treatment of acute post-partum (puerperal) metritis in cases where treatment with another antimicrobial has failed.
Slovenian: Zdravljenje akutnega poporodnega (puerperalnega) matritisa v primerih, ko zdravljenje z drugimi protimikrobnimi sredstvi ni bilo učinkovito.
English: In such cases, death has been attributed to intra-vascular administration of the product or anaphylaxis.
Slovenian: V takih primerih je bila smrt posledica intra vaskularnega dajanja zdravila ali anafilaktične reakcije.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription.
Slovenian: B POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
English: After administration, ceftiofur is quickly metabolised to desfuroylceftiofur, the principal active metabolite.
Slovenian: Po aplikaciji se ceftiofur hitro presnovi v desfuroilceftiofur, ki je glavni aktivni metabolit.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUG(IH) SESTAVIN
English: 4.2 Indications for use, specifying the target species Treatment of acute interdigital necrobacillosis in cattle also known as Panaritium or foot rot.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Zdravljenje akutne interdigitalne nekrobaciloze, poznane tudi kot Panaritium ali flegmona prsta, pri govedu.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL of 50 ml
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH 50 ml viala
English: • Administer in the posterior part of the ear base (see Figure 1).
Slovenian: Aplikacija na bazi ušesa: • Aplicirajte v posteriorni del baze ušesa (glej sliko 1).
English: Cardboard box with one type I glass vial of 50 ml or 100 ml with a chlorobutyl-isoprene rubber stopper and aluminium cap.
Slovenian: Kartonasta škatla z eno vialo iz stekla tipa 1 s 50 ml ali 100 ml s klorobutilno-izopirenskim gumijastim zamaškom in aluminijasto zaporko.
English: TARGET SPECIES Cattle.
Slovenian: CILJNE ŽIVALSKE VRSTE Prašiči.
English: Subcutaneous administration of Naxcel at the posterior aspect of the ear where it attaches to the head (base of ear).
Slovenian: Naxcel v posteriornem pogledu na bazi ušesa, kjer je pritrjeno na glavo (baza ušesa).
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European
English: Laboratory studies in mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Slovenian: Z laboratorjiskimi študijami na miših niso ugotovili teratogenih, fetotoksičnih ali maternotoksičnih učinkov.
English: STATEMENT OF ACTIVE SUBSTANCES Ceftiofur (as crystalline free acid)
Slovenian: Zdravilna učinkovina: Ceftiofur (kot kristalinična prosta kislina)
English: The active substance in Naxcel is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA ( MRL) Učinkovina v Naxcel je dovoljena učinkovina, kot je navedena v tabeli 1(dovoljene snovi) priloge Uredbe
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: {DD/MM/LLLL} Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European
English: It is recommended to limit injection volumes to a maximum of 4 ml.
Slovenian: Priporočamo, da volumen enega odmerka ne preseže 4 ml.
English: Shelf life after first opening the vial: 28 days.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dni.
English: Treatment of acute interdigital necrobacillosis (Panaritium, foot rot).
Slovenian: Zdravljenje akutne interdigitalne nekrobaciloze (Panaritium, flegmona prsta) pri govedu.
English: th generation, such as ceftiofur), it should be reflected that these are to be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other antimicrobials.
Slovenian: Sistemsko dajanje široko spektralnih cefalosporinov (3. in 4. generacije, kot je ceftiofur) naj bo rezervirano za zdravljenje kliničnih stanj, ki so se slabo odzvala ali se pričakuje, da se bodo slabo odzvala na uporabo drugih protimikrobnih sredstev.
English: It is essential that Naxcel is only administered subcutaneously at the base of ear location in non-edible tissue, in order to comply with the meat withdrawal period.
Slovenian: Bistveno je, da se Naxcel daje samo subkutano na mestu na bazi ušesa v neužitno tkivo, da se zagotovi karenca za meso.
English: Plasma concentrations above 0.2 µg/ml of ceftiofur and its metabolite are maintained for an appropriate period of time.
Slovenian: Koncentracija ceftiofura in desfuroilceftiofura v plazmi nad 0,2 µg/ml se ohrani dalj časa.
English: Increased use, including use of the product deviating from the instructions given in the summary of product characteristics (SPC), may increase the prevalence of bacteria resistant to ceftiofur.
Slovenian: Povečana uporaba, vključno z drugačno uporabo zdravila, kot je navedena v povzetku glavnih značilnosti zdravila (SPC), lahko poveča prevalenco bakterij rezistentnih na ceftiofur.
English: Do not use in cases of hypersensitivity to ceftiofur or other beta-lactam antibiotics, or to any of the excipients.
Slovenian: Ne uporabite v primerih preobčutljivosti na ceftiofur ali druge beta-laktamske antibiotike ali na katero koli pomožno snov.
English: th generation, such as ceftiofur), it should be reflected that these are to be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to more narrow spectrum antimicrobials.
Slovenian: Sistemsko dajanje široko spektralnih cefalosporinov (3. in 4. generacije, kot je ceftiofur) naj bo rezervirano za zdravljenje kliničnih stanj, ki so se slabo odzvala ali se pričakuje, da se bodo slabo odzvala na uporabo protimikrobnih sredstev z ožjim spektrom.
English: Maximum concentrations in plasma (4.2±0.9 µg/ml) are reached at approximately 22 hours after administration.
Slovenian: (4,2 ± 0,9 µg/ml) je dosežena po 22 urah po dajanju.
English: Oily vehicle (vegetable origin): Triglycerides, medium chain Cottonseed oil.
Slovenian: Trigliceridi, srednje verige Olje bombaževega semena.
English: Oily vehicle (vegetable origin).
Slovenian: Oljni vehikel (rastlinski izvor).
English: Laboratory studies in rats have shown no evidence of teratogenic effects but maternotoxic (soft faeces) and foetotoxic (reduced foetal weight) effects were observed.
Slovenian: Z laboratorijskimi študijami na podganah ni bilo dokazanih teratogenih učinkov, opaženi pa so bili toksični učinki na mater (mehko blato) in fetotoksični učinki (znižana teža fetusa).
English: Do not store above 25 °C.
Slovenian: Shranjujte pri temperaturi pod 25°C.
English: No specific studies have been conducted in pregnant cows.
Slovenian: Nobene specifične študije niso bile opravljene pri brejih kravah.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/05/2005.
Slovenian: Datum pridobitve dovoljenja za promet: 19/05/2005.
English: Total plasma concentrations above 0.2µg/ml and 1µg/ml of ceftiofur and its active metabolites are maintained for at least 7 and 4 days, respectively.
Slovenian: Skupna koncentracija ceftiofurja in njegovih aktivnih metabolitov v plazmi nad 0,2 μg/ml ostane vsaj 7
English: STATEMENT OF ACTIVE SUBSTANCES Active substance:
Slovenian: NAVEDBA UČINKOVIN(E) Zdravilna učinkovina:
English: Increased use, including use of the product deviating from the instructions given in the SPC, may increase the prevalence of bacteria resistant to ceftiofur.
Slovenian: Povečana uporaba, vključno z drugačno uporabo zdravila, kot je navedena v SPC-ju, lahko poveča prevalenco bakterij rezistentnih na ceftiofur.
English: Injection site swellings may result in mild to moderate pain in some animals in the initial days following injection.
Slovenian: Otekline na mestu injiciranja so lahko pri nekaterih živalih v začetnih dneh po injiciranju blago do srednje boleče.
English: Treatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis.
Slovenian: Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis in Streptococcus suis.
English: No specific studies have been conducted in breeding cattle.
Slovenian: Nobene specifične študije niso bile opravljene pri plemenskih živalih.
English: EXPIRY DATE EXP {month/year} Once broached, use by …
Slovenian: EXP {mesec/leto} Načeto/odprto zdravilo uporabite do ....
English: • Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.
Slovenian: • Zdravljenje septikemije, poliartritisa ali poliserozitisa, ki je povezan z okužbo s Streptococcus suis.
English: Increased use, including use of the product deviating from the instructions given above, may increase the prevalence of bacteria resistant to ceftiofur.
Slovenian: Povečana uporaba, vključno z drugačno uporabo zdravila, kot je navedena v SPCju, lahko poveča prevalenco bakterij rezistentnih na ceftiofur.
English: Treatment of acute interdigital necrobacillosis in cattle also known as Panaritium or foot rot.
Slovenian: Zdravljenje akutne interdigitalne nekrobaciloze, poznane tudi kot Panaritium ali flegmona prsta, pri govedu.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Ceftiofur 100 mg/ml
Slovenian: Ceftiofur 100 mg/ml
English: No specific studies have been conducted in pregnant cows or in breeding cattle.
Slovenian: Nobene specifične študije niso bile opravljene pri brejih kravah in plemenskih goveda.
English: Do not use in cases of hypersensitivity to ceftiofur or other β-lactam antibiotics, or to any of the excipients.
Slovenian: Ne uporabite v primeru preobčutljivosti na ceftiofur ali druge ß-laktamske antibiotike ali katero koli pomožno snov.
English: Naxcel must only be administered at the base of ear location in non-edible tissue in order to comply with the withdrawal period.
Slovenian: Naxcel se sme dati samo na mestu na bazi ušesa v neužitno tkivo, da se zagotovi karenca za meso.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (NI) ZA SPROŠČANJE SERIJ
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Owing to the low toxicity of ceftiofur in pigs overdoses do not typically lead to any clinical signs, other than transient local swellings as described in section 4.6 (Adverse reactions).
Slovenian: Zaradi nizke toksičnosti ceftiofurja pri prašičih prekomerno odmerjanje praviloma ne povzroči drugih simptomov, razen prehodne lokalne otekline, kot je že opisano v poglavju 4.6 Neželeni učinki.
English: Injection location for the subcutaneous administration of Naxcel at the posterior aspect of the ear where it attaches to the head (base of ear)
Slovenian: Slika 1. lokacija subkutane injekcije aplikacije zdravila Naxcel v posteriornem pogledu ušesa, kjer je pritrjeno na glavo
English: MARKETING AUTHORISATION NUMBER (S) EU/2/05/053/001-002
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET EU/2/05/053/001-002
English: Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.
Slovenian: Zdravljenje septikemije, poliartritisa ali poliserozitisa, ki je povezan s okužbo z Streptococcus suis.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/05/053/001 (100 ml)
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/05/053/001 (100ml)
English: At the recommended therapeutic dose, concentrations in plasma were higher than the MIC90 values
Slovenian: V priporočenem terapevtskem odmerku so bile koncentracije v plazmi za ciljne bakterije izolirane med kliničnimi študijami, tudi še 158 ur po začetku poskusa višje od MIC90 vrednosti (<0,2 mg/ml).
English: Dose of 5 mg ceftiofur/kg bodyweight (equivalent to 1 ml of Naxcel per 20 kg bodyweight) administered once in the neck by intramuscular injection.
Slovenian: 5 mg ceftiofurja/kg telesne mase (ekvivalentno 1 ml zdravila Naxcel na 20 kg telesne mase), z enkratnim intramuskularnim dajanjem v področje vratu.
English: No studies have been conducted in pregnant or lactating sows, or in breeding pigs.
Slovenian: Pri brejih svinjah, ali svinjah v laktaciji ter pri plemenskih živalih študije niso bile izvedene.
English: Figure 1.
Slovenian: ŠTEVILKA SERIJE
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Slovenian: BESEDILO “ ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ”
English: Do not store above 25 ˚C.
Slovenian: Shranjujte pri temperaturi pod 25 °C.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 100 mg/ml suspension for injection for pigs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Naxcel 100 mg/ml suspenzija za injiciranje za prašiče
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 100 mg/ml suspension for injection for pigs ceftiofur
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Naxcel 100 mg/ml suspenzija za injiciranje za prašiče ceftiofur
English: Do not use as prophylaxis in case of retained placenta.
Slovenian: Zdravilo se ne sme uporabljati za rutinsko profilakso retencije placente.
English: MRLs
Slovenian: i.m.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij Zoetis Belgium SA
English: Single subcutaneous injection of 6.6 mg ceftiofur/kg bodyweight (equivalent to 1 ml of Naxcel per 30 kg bodyweight) administered at the base of the ear.
Slovenian: Enkratna subkutana injekcija 6,6 mg ceftiofurja/kg telesne teže (kar ustreza 1 ml zdravila Naxcel na 30 kg telesne teže) aplicirana na bazi ušesa.
English: - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: - zelo pogosti (pri več kot 1,toda manj kot 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno posameznimi primeri).
English: WITHDRAWAL PERIOD(S) Meat and offal: 71 days.
Slovenian: Karenca: Meso in organi: 71 dni.
English: Excipient: Oily vehicle (vegetable origin).
Slovenian: Pomožna snov: Oljni vehikel (rastlinski izvor).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/05/053/003
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/05/053/003
English: PACKAGE LEAFLET: Naxcel 100 mg/ml suspension for injection for pigs
Slovenian: NAVODILO ZA UPORABO Naxcel 100 mg/ml suspenzija za injiciranje za prašiče
English: Do not use in cases of hypersensitivity to ceftiofur or other ß-lactam antibiotics, or to any of the excipients.
Slovenian: Ne uporabljajte zdravila pri živalih, ki so preobčutljive na ceftiofur ali druge ß-laktamske antibiotike ali katero koli pomožno snov.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno z posameznimi primeri).
English: PACKAGE LEAFLET: Naxcel 200 mg/ml suspension for injection for cattle
Slovenian: Naxcel 200 mg/ml suspenzija za injiciranje za govedo
English: 1,000 µg/kg Muscle For porcine species the fat MRL relates to ‘skin and fat in natural proportions'
Slovenian: »kožo in maščobo v naravnih proporcijah«.
English: Incompatibilities:
Slovenian: Učinkovina:
English: Ceftiofur is particularly active against the following target pathogens causing respiratory and other diseases in pigs: Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis.
Slovenian: Ceftiofur je aktiven predvsem proti naslednjim povzročiteljem respiratornih in drugih obolenj pri prašičih:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial of 100ml
Slovenian: PODATKI NA PRIMARNI OVOJNINI 100 ml viala
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 200 mg/ml suspension for injection for cattle ceftiofur
Slovenian: Naxcel 200 mg/ml suspenzija za injiciranje za govedo ceftiofur
English: Excipie nt(s): Oily vehicle (vegetable origin).
Slovenian: Pomožne snovi: Oljni vehikel (rastlinski izvor).
English: PACKAGE SIZE 100 ml
Slovenian: 100 ml 50 ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 200 mg/ml suspension for injection for cattle
Slovenian: NAVODILO ZA UPORABO Naxcel 200 mg/ml suspenzija za injiciranje za govedo
English: Pigs
Slovenian: Za prašiče je
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Single subcutaneous injection of 6.6 mg ceftiofur/kg bodyweight (equivalent to 1 ml of Naxcel per 30 kg bodyweight) administered at the base of the ear.
Slovenian: Enkratna subkutana injekcija 6.6 mg ceftiofurja/kg telesne teže (kar ustreza 1 ml zdravila Naxcel na 30 kg telesne teže) aplicirana na bazi ušesa.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN(NI) ZA SPROŠČANJE SERIJ
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF YASMINELLE AND ASSOCIATED NAMES (see Annex I)
Slovenian: ZAKLJUČNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA YASMINELLE IN POVEZANIH IMEN (glejte Dodatek I)
English: Invented Name Strength
Slovenian: Izmišljeno ime