natgillin/translations-raw huggingface dataset:
Whenever possible, fluoroquinolones should only be used based on susceptibility testing.
Če je le mogoče, se zdravljenje s fluorokinoloni izvaja po predhodnem testiranju občutljivosti povzročiteljev.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains:
NAVEDBA ZDRAVILNE IČINKOVIN(E) IN DRUGE(IH) SESTAVINE(E) Vsaka tableta vsebuje:
Difloxacin is rapidly absorbed after oral administration to reach steady state plasma concentrations in a few hours after initiation of medication.
Difloksacin se po peroralnem dajanju hitro absorbira in doseže ustrezno koncentracijo v plazmi v nekaj urah po dajanju.
Edetic acid3
Edetična kislina 3
Difloxacin can be bactericidal against many Gram-negative micro-organisms and a selection of Gram-positive microorganisms.
Difloksacin učinkuje bakteriocidno na številne po Gramu negativne mikroorganizme in selektivno na po Gramu pozitivne mikroorganizme.
Difloxacin concentrations equal to or greater than the MICs for the relevant pathogens are achieved in all relevant tissues and maintained for as long as medication is continued.
Koncentracija difloksacina v različnih tkivih je enaka ali večja kot je MIC za relevantne mikroorganizme in traja toliko časa, kot traja zdravljenje.
PACKAGE SIZE 100 ml
VELIKOST PAKIRANJA 100 ml
The observed reactions were inappetence, emesis, diarrhoea, and anal irritation.
Kažejo se v zmanjšanju apetita, pojavu slabosti, driske in iritacije anusa.
MANUFACTURER'S BATCH NUMBER Lot {number}
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Serija:{številka}:
Potassium Hydroxide4 Propylene glycol5
Kalijev hidroksid 4 Propilenglikol 5
Manufacturer for the batch release Pfizer Olot, S.L.U.
Izdelovalec, odgovoren za sproščanje serije Pfizer Olot, S.L.U.
4.11 Withdrawal period Not applicable.
4.11 Karenca(e) Navedba ni smiselna.
A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC ZDRAVILA IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
PHARMACEUTICAL FORM Solution for injection.
FARMACEVTSKA OBLIKA Raztopina za injiciranje
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
C. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE UPORABE
CARTON LABEL - 1 X 250 ML BOTTLE / 1 X 1000 ML BOTTLE / 6 X 1000 ML BOTTLE VIAL LABEL 250 ml bottle / 1000 ml bottle
KARTONSKA OVOJNINA 1 X 250 ml STEKLENICA /1 X 1000 ML STEKLENICA / 6 X 1000 ML STEKLENICA
10 OJ No L 143 of 26.06.95 11 OJ No. L 240 of 10.09.99
10 OJ št. L 143 z dne 26.06.95 11 OJ št. L 240 z dne 10.09.99
Dicural 50 mg/ml, solution for injection for cattle and dogs is available in the following presentations: Dogs: 50 ml vial.
Dicural 50 mg/ml, raztopina za injiciranje za govedo in pse je na razpolago v naslednjih pakiranjih: Za pse: 50 ml viala
DOSAGE FOR EACH SPECIES, METHOD AND ROUTE OF ADMINISTRATION Dicural oral solution must be administrated daily via the drinking water in such a concentration that the dose is 10 mg/kg bodyweight.
ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER NAČIN UPORABE IN DAJANJA ZDRAVILA Dicural peroralna raztopina se daje dnevno v vodo za pitje v koncentraciji, ki zagotavlja odmerek 10 mg/kg.
Pharmacologically active substance
Farmakološko aktivna snov Živalska vrsta
People with a known hypersensitivity to quinolones should avoid any contact with the product.
Osebe z znano preobčutljivostjo na kinolone naj se izogibajo stiku z zdravilom.
Sodium starch glycollate Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide Sodium lauryl sulphate
Natrijev karboksimetilškrob Mikrokristalna celuloza Magnezijev stearat Silikondioksid, koloidni Natrijev laurilsulfat
Shelf-life after first opening the container: 1 month.
Rok uporabnosti po prvem odpiranju neposredne ovojnice: 1 mesec.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Podrobne informacije o produktu so na voljo na spletni strani Evropske agencije za zdravila http:/www.ema.europa.eu/
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http:www.ema.europa.eu/
After subcutaneous administration of difloxacin peak plasma levels of 1.4 -1.9 g/ml are achieved in 3.1 hours post dosing.
Po subkutanem dajanju doseže difloksacin največjo koncentracijo v plazmi 1,4-1,9 μg/ml v 3,1 urah po dajanju.
Dogs: Cardboard box with one glass vial of 50ml with a rubber stopper and aluminium cap.
Psi: Kartonska škatla s stekleno vialo za 50 ml, zaprto z gumijastim zamaškom in aluminijastim pokrovom.
The use of fluoroquinolones in combination with non-steroidal anti-inflammatory drugs (NSAIDs) may cause seizures.
Kombinacija fluorokinolonov in nesteroidnih antiinflamatorikov (NSAID) lahko pri epilepsiji sproži napad.
Histopathological changes were noted in the articular cartilage of weight bearing joints of young (3.5 months old) beagle dogs after the oral administration of difloxacin at doses of greater than 5 mg/kg/day (as the hydrochloride) for 90 days.
Opažene so histopatološke spremembe sklepnega hrustanca pri psih pasme beagle, ki so pri starosti 3,5 mesecev dobivali peroralno večji odmerek od 5 mg/kg 90 dni zapovrstjo.
These adverse reactions were self-limiting within one or two days and did not require additional treatment.
Ti neželeni učinki izginejo brez posebnega zdravljenja v enem do dveh dneh.
400 µg/kg 100 µg/kg 1400 µg/kg 800 µg/kg
400 μg/kg 100 μg/kg 1400 μg/kg 800 μg/kg
Animal Species
CILJNE ŽIVALSKE VRSTE
Cattle: None.
Govedo: Niso znane.
No specific antidotes for difloxacin (or other quinolones) are known, therefore in case of overdosage symptomatic treatment should be given.
Ni specifičnega antidota za difloksacin (in druge kinolone), zato je zdravljenje pri prevelikem odmerjanju simptomatsko.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml peroralne raztopine vsebuje:
A fraction of difloxacin (i.e. 7 - 18%) is eliminated via the urine.
Največ difloksacina (68-82%) se izloči z blatom, manjša količina (7-18%) pa z urinom.
Excipients: Benzyl alcohol
Nosilci: Benzilalkohol
Since no studies were performed in clinically lame birds, Dicural should not be used in birds with existing leg-weakness or in birds suffering from osteoporosis.
Pri klinično šepavih pticah niso bile opravljene študije, zato zdravila ne uporabljati pri pticah, ki šepajo ali imajo ugotovljeno osteoporozo.
In both species difloxacin may be conjugated (glucuronidated or sulphated), desmethylated into sarafloxacin or oxidised into N-oxide-difloxacin.
Pri obeh vrstah se difloksacin metabolizira v sarafloksacin (desmetil difloksacin) ali pa oksidira v Noksid-difloksacin.
Edetic acid Potassium hydroxide Propylene glycol Benzyl alcohol Purified water
Edetična kislina Kalijev hidroksid Propilenglikol Benzilakohol Prečiščena voda
Induction of resistance against quinolones can develop by mutations in the gyrase gene of bacteria and by changes in cell permeability towards quinolones
Mutacija gena giraze v bakterijski celici in sprememba v prepustnosti celične membrane na kinolone lahko pripelje do nastanka rezistence proti kinolonskim pripravkom.
Difloxacin Poultry1
Difloksacin Difloksacin Perutnina 1
All food-producing species
Vse živalske vrste, namenjene prehrani ljudi
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Ni dokazana varnost zdravila v obdobju brejosti in laktacije.
5 OJ No. L 45 of 15.02.97
5 OJ št. L 45 z dne 15.02.97
BATCH NUMBER Lot {number}
ŠTEVILKA SERIJE Serija: { številka}
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
MARKETING AUTHORISATION NUMBER(S) [Recommended, but not required on the immediate label] EU/2/97/003/017 - 100 ml
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL /Priporočeno, vendar ni obvezno na stični ovojnini/ EU/2/97/003/17 - 100 ml
Tissue to plasma ratios range from 0.6 (abdominal fat), 2.4 (lung), 4.5 (muscle) to 14.1 (liver).
Koncentracije difloksacina v organih so različne in znašajo od 0,6 v abdominalni maščobi do 2,4 v pljučih in 14,1 v jetrih.
Following an oral dose (a plain tablet) in dogs of 5 mg/kg bodyweight, difloxacin reached its average peak plasma concentration of 1.8 µg/ml in approximately 3 hours.
Difloksacin po peroralnem dajanju (tableta) v odmerku 5 mg/kg telesne mase pri psih doseže najvišjo koncentracijo v plazmi 1,8 μg v 3 urah.
At very high doses adverse effects on the nervous system (ataxia, unsteadiness, twitching, tremors, convulsions, etc.) may occur in cattle.
Pri zelo velikih odmerkih se pokažejo učinki na živčni sistem (ataksija, zanašanje, drgetanje, krči in drugo).
SPECIAL WARNING(S), IF NECESSARY People with a known hypersensitivity to quinolones should avoid any contact with the product.
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Osebe z znano preobčutljivostjo na kinolone naj se izogibajo direktnemu stiku z zdravilom.
Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial population.
Stalna uporaba iste vrste antibiotikov ima lahko za posledico rezistenco mikroorganizmov.
The recommended dose of difloxacin is 5 mg/kg bodyweight per day.
Priporočljiv dnevni odmerek difloksacina znaša 5 mg/kg telesne mase.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if any
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo
4 OJ No. L 272 of 25.10.96
4 OJ št. L 172 z dne 25.10.96
The oral administration of difloxacin at up to 5 times the recommended dose rate for 30 days did not result in any adverse reactions.
Peroralno dajanju petkrat večjih odmerkov difloksacina v obdobju 30 dni ni povzročilo nastanka neželenih učinkov.
1 OJ No. L 172 of 02.07.02
1 OJ št. L 172 z dne 02.07.02
Not permitted for use in laying birds producing eggs for human consumption.
Ni dovoljena uporaba pri pticah v obdobju valjenja, katerih jajca so namenjena za prehrano ljudi..
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
BESEDILO ”SAMO ZA ŽIVALI” Samo za živali.
SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
POSEBNA OPOZORILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25˚C.
Meat and offal (chicken and turkeys): 24 hours.
Meso in organi (piščancev in puranov): 24 ur
2 OJ No. L 172 of 02.07.02
2 OJ št. L 172 z dne 02.07.02
Difloxacin (as hydrochloride)
Difloksacin (v obliki klorida)
METHOD AND ROUTE OF ADMINISTRATION Subcutaneous use.
NAČIN UPORABE IN DAJANJA Subkutano dajanje.
For oral administration in drinking water.
Zdravilo se daje peroralno v vodo za pitje.
9 OJ No. L 45 of 15.02.97
9 OJ št. L 45 z dne 15.02.97
[MA Number recommended, but not required on the immediate label] EU/2/97/003/016
/Številka dovoljenja je priporočljiva, ni pa obvezna na stični ovojnini/ EU/2/97/003/016
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti
TARGET SPECIES Chickens (broilers and future breeders) and turkeys (young turkeys up to 2 kg body weight).
CILJNA ŽIVALSKA VRSTA Piščanci (brojlerji in piščanci za matično jato) in purani (mladi purani, težki do 2 kg)
Mycoplasma spp.
Mycoplasm spp.
Not for use in animals from which milk is produced for human consumption
Ni dovoljena uporaba pri živalih v laktaciji, katerih mleko je namenjeno prehrani ljudi.
Turkeys only - for the treatment of infections caused by Pasteurella multocida.
Pri puranih: Za zdravljenje infekcij, ki jih povzroča Pasteurella multocida.
It is well distributed in the body (Vd = 4.7 l/kg) and has a plasma elimination half-life of approximately 7 hours.
Dobro se distribuira po organizmu (Vd = 4,7 l/kg).
• Acute uncomplicated urinary tract infections caused by Escherichia coli or Staphylococcus spp.
• akutnih nekompliciranih infekcij urinarnega trakta, ki jih povzročata Escherichia coli ali Staphylococcus spp.,
Dicural Coated Tablets should only be used based on susceptibility testing.
Dicural filmsko obložene tablete uporabljajte le na osnovi predhodnih testiranj občutljivosti povzročiteljev.
MARKETING AUTHORISATION NUMBERS EU/2/97/003/016-018
ŠTEVILKA DOVOLJENJA ZA PROMET EU2/97/003/016-018
After subcutaneous administration of difloxacin peak plasma levels of 1.7 g/ml are achieved at 6 hours post dosing.
Po subkutanem dajanju doseže difloksacin največjo koncentracijo v plazmi 1,7 μg/ml v 6 urah po dajanju.
Cattle: Cardboard box with one glass vial of 50ml, 100ml or 250 ml with a rubber stopper and aluminium cap.
Kartonska škatla s stekleno vialo po 50, 100 ali 250 ml, zaprto z gumijastim zamaškom in aluminijastim pokrovom.
METHOD AND ROUTE OF ADMINISTRATION Oral use.
NAČIN UPORABE IN DAJANJA Peroralna uporaba.
TARGET SPECIES Cattle (calves and young cattle)
CILJNA ŽIVALSKA VRSTA Govedo (teleta in mlado govedo)
• Superficial pyoderma caused by Staphylococcus intermedius.
• površinske pioderme, ki jo povzroča Staphylococcus intermedius.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
The recommended dose is 2.5 mg difloxacin/kg bodyweight/day for 3 days (that is, 5ml/100 kg bodyweight/day).
Priporočljiv dnevni odmerek difloksacina znaša 2,5 mg/kg telesne mase v obdobju 3 dni ( to ustreza 5 ml/100 kg/dan).
The following organisms were tested and found to be susceptible to difloxacin in vitro:
Študije in vitro so pokazale, da so na difloksacin občutljivi naslednji mikroorganizmi:
PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE Dicural 50 mg/ml solution for injection for cattle OUTER CARTON for 100 ml vial / 250 ml vial / VIAL LABEL 100 ml vial / 250 ml vial
PODATKI NA ZUNANJI OVOJNINI IN NA STIČNI, OZ.PRIMARNI OVOJNINI Dicural 50mg/ml raztopina za injiciranje za goveda KARTONSKA ŠKATLA za 100 ml steklenico / 250 ml steklenico/ STIČNA OVOJNINA ZA 100 ml steklenico/ 250 ml steklenico
In the urine, liver, fat and kidneys the metabolites desmethyl-difloxacin and difloxacin N-oxide can be found in small amounts in addition to the major (parent) compound.
Največ difloksacina je v nespremenjeni obliki v blatu, urinu in v tkivih-jetrih, maščobi in ledvicah, manj pa v obliki metabolitov (desmetil difloksacina in difloksacin-N-oksida).
Dicural oral solution is a yellowish clear aqueous solution and is supplied in plastic white bottles with a screw cap containing 250 or 1000 ml oral solution.
Dicural peroralna raztopina je rumenkasta bistra vodna raztopina, pakirana v plastenke po 250 ali 1000 ml, zaprte z navojno zaporko.
Difloxacin Bovine2
Difloksacin Difloksacin Govedo 2
DATE OF RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE /PODALJŠANJA DOVOLJENJA ZA PROMET
Chickens and turkeys - for treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.
Piščanci in purani: zdravljenje kroničnih respiratornih infekcij, ki jih povzročajo na difloksacin občutljivi mikroorganizmi: Escherichia coli in Mycoplasma gallisepticum.
As for other quinolones, due to possible adverse effects on the articular cartilage of weight bearing joints, difloxacin should not be used during the rapid growth phase, that is, do not use in small-and medium breed dogs up to and including 8 months of age, in large breeds up to 1 year of age and in giant breeds up to 18 months of age.
Tako kot drugi fluorokinoloni tudi difloksacin učinkuje zaviralno na rast in obnavljanje sklepnega hrustanca, zato ga ne uporabite pri psih v fazi hitre rasti, ki je pri majhnih in srednje velikih pasmah psov do 8. meseca starosti, pri večjih pasmah do 1 leta, pri izredno velikih pasmah psov pa do 18.meseca starosti.
Marketing authorisation holder: Pfizer Limited
Imetnik dovoljenja za promet z zdravilom: Pfizer Limited
In target animal safety studies, subcutaneous administration was generally well tolerated.
Ciljne živali zdravilo na splošno dobro prenašajo.
WITHDRAWAL PERIOD Cattle: Meat and offal: 46 days
KARENCA Govedo:Meso in organi: 46 dni
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) Each ml contains:
NAVEDBA ZDRAVILNE IČINKOVIN(E) IN DRUGE(IH) SESTAVINE(E) Vsak ml peroralne raztopine vsebuje:
Target animal safety studies in chickens and turkeys demonstrated that, when administered in drinking water at 30 mg/kg (chickens) or 22 mg/kg (turkeys) for three times the recommended duration (15 consecutive days), difloxacin hydrochloride appeared to be safe for the birds.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni) Poskusi pri ciljnih živalskih vrstah so pokazali, da je difloksacinijev klorid v dnevnih predpisanih odmerkih (30 mg/kg pri piščancih in 22 mg/kg pri puranih) tudi pri trikrat daljšem dajanju (15 dni) varen za ptice.
Therapy should be re-evaluated if no improvement is seen within 5 days, or 10 days in the case of superficial pyoderma.
Z dajanjem difloksacina prenehamo, če po 5 dneh zdravljenja ni učinka, oziroma po 10 dneh pri zdravljenju pioderme.
Shelf-life after first use of the product: 28 days.
Rok uporabnosti zdravila po prvem odprtju vsebnika:28 dni.
MARKETING AUTHORISATION NUMBERS EU/2/97/003/004-015
ŠTEVILKA DOVOLJENJA ZA PROMET EU2/97/003/004-015
Do not store above 25°C.
Shranjujte pri temperaturi do 25˚ C.
For complicated respiratory disease the dose can be doubled to 5 mg/kg bodyweight/ day.
Pri hudih respiratornih obolenjih odmerek povečajte na 5 mg/kg telesne mase/dan.
If filled to the brim the measuring device provides 50ml.
Napolnjen do roba znaša 50 ml.
NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Limited
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Pfizer Limited
Chickens:
Karenca:
The use of difloxacin in pregnant or lactating bitches or male stud dogs is not recommended.
Uporaba ni priporočljiva pri samicah, ki so breje ali v obdobju laktacije ter pri samcih za razplod.
PACKAGE LEAFLET FOR Dicural 100 mg/ml oral solution for chickens and turkeys
Dicural 100 mg/ml, peroralna raztopina za piščance in purane
It is very well distributed in the body (Vd = 9.9 l/kg) and has a plasma elimination half-life of approximately 7 hours.
Po organizmu se dobro distribuira (Vd = 9,9 l/kg).
Following continuous oral dosing with Dicural oral solution at 10 mg/kg/day for five consecutive days the mean difloxacin steady state plasma concentrations are approximately 200 ng/ml.
Pri pet dnevnem dajanju peroralne raztopine Dicural v odmerku 10 mg/kg/dan znašajo plezemske koncentracije difloksacina približno 200 μg/ml.
Nitrofurantoin may impair quinolone efficacy if used concurrently in the treatment of urinary tract infections.
Fluorokinoloni in nitrofurani učinkujejo medsebojno antagonistično, posebno pri zdravljenju urinarnih infekcij.
PACKAGE LEAFLET FOR Dicural coated tablets for dogs
Dicural filmsko obložene tablete za pse
300 µg/kg 400 µg/kg 1900 µg/kg 600 µg/kg
300 μg/kg 400 μg/kg
Oral use.
NAČIN UPORABE
Difloxacin acts primarily through inhibition of bacterial DNA gyrase.
Difloksacin učinkuje tako, da inhibira DNA girazo mikroorganizmov.
The main metabolites are hydrolysable conjugates of difloxacin, the other metabolites are proportionally minor ones.
Glavni metabolit je hidroliziran konjugat difloksacina.
TARGET SPECIES Cattle (calves and young cattle)\ Dogs
CILJNE ŽIVALSKE VRSTE Govedo (teleta in mlado govedo) Psi
PACKAGE SIZE 10 tablets 20 tablets 100 tablets
VELIKOST PAKIRANJA 10 tablet
Do not use after the expiry date stated on the label after EXP
Zdravila ne smete uporabljati po datumu izteka uporabnosti, navedenega na nalepki.
Benzyl alcohol Propylene glycol Arginine
Benzilalkohol Propilenglikol Arginin
Difloxacin hydrochloride is bactericidal in activity and acts by inhibition of bacterial DNA gyrase.
Difloksacinijev klorid učinkuje bakteriocidno tako, da inhibira DNA girazo mikroorganizmov.
TARGET SPECIES Cattle (calves and young cattle) and dogs
CILJNA ŽIVALSKA VRSTA Govedo (teleta, mlado govedo) in psi
The fluoroquinolones exert their antibacterial effect against both replicating and non-replicating micro-organisms.
Fluorokinoloni imajo protimikrobno učinkovanje tako proti mikroorganizmom, ne glede na to, ali so v fazi replikacije ali ne.
Do not use after the expiry date stated on the carton after EXP.
Zdravila ne smete uporabljati po datumu izteka uporabnosti, navedenega na ovojnini.
MARKETING AUTHORISATION NUMBERS EU/2/97/003/001-003
ŠTEVILKA DOVOLJENJA ZA PROMET EU2/97/003/001-3
For complicated respiratory disease the dose can be doubled to 5 mg/kg bodyweight / day.
Pri hudih respiratornih obolenjih odmerek povečajte na 5 mg/kg/dan.
Medium Large
Srednji psi
Dicural oral solution should only be used based on susceptibility testing
Dicural peroralna raztopina se uporablja samo po predhodnih testih na občutljivost povzročitelja.
In turkeys difloxacin has a moderate oral bioavailability (approx. 58%).
Pri puranih je biološka uporabnost peroralno apliciranega difloksacina približno 58 %.
6.2 Incompatibilities
6.2 Glavne inkopatibilnosti
It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antibiotics.
Zato fluorokinolonskih pripravkov ne uporabljati za zdravljenje infekcij, kjer ni učinka ali pa je slabši od pričakovanega, ampak uporabite druge, ustrezne antibiotike.
White HDPE bottles with a screw cap containing 250ml or 1litre of Dicural oral solution.
Bela steklenica (HDPE) za 250 ml ali 1 liter, zaprta z navojno zaporko.
Muscle Skin + fat Liver Kidney
Mišičnina Koža in maščoba Jetra
A new injection site should be used each day.
Zdravilo aplicirajte vsaki dan na drugo mesto.
Active substance:
Preveliki odmerki:
After subcutaneous administration the bioavailability is 88% and the volume of distribution is 2.5 l/kg.
Po subkutanem dajanju je njegova biološka razpoložljivost 88%.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
BESEDILO ”ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” Zdravilo shranjujte nedosegljivo otrokom.
Chickens (broilers and future breeders) Turkeys (young turkeys up to 2 kg body weight).
CILJNE ŽIVALSKE VRSTE Piščanci (brojlerji in piščanci namenjeni za matično jato Purani (mladi purani, težki do 2 kg).
No additional chlorine, for example from the use of water chlorinators, or hydrogen peroxide should be added to the drinking water used with this product.
Vodi, v kateri je primešano zdravilo, ne dodajajte klorovih pripravkov (za kloriranje vode) ali vodikovega peroksida.
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Dogs treated orally with difloxacin (as hydrochloride) at 10 times the recommended dose for 10 days occasionally showed mild adverse reactions such as orange/yellowing discoloration of the faeces, emesis and hypersalivation.
Psi, ki so dobivali 10 dni zapovrstjo difloksacinijev klorid v 10 krat večjem odmerku od predpisanega, so pokazali rahle znake neželenih učinkov, kot so: rumeno-oranžno obarvanost blata, slabost in povečano slinjenje.
Marketing authorisation holder Pfizer Limited
Imetnik dovoljenja za promet z zdravilom Pfizer Limited
For the 250 ml bottle a separate measuring device is placed on the screw cap.
Pri 250 ml steklenici je merica priložena.
Name and address of the manufacturers responsible for batch release:
Ime in naslov izdelovalca zdravila, odgovornega za sproščanje serije: Za vse tri farmacevtske oblike:
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ACTIVE SUBSTANCES Difloxacin (as hydrochloride) 50 mg/ml
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Difloksacin (v obliki klorida) 50 mg/ml