natgillin/translations-raw huggingface dataset:
• The results of the safety studies indicated that the product is safe for horses. • The vaccine has been shown to protect animals from the disease through a reduction of the number of viraemic horses.
• Rezultati raziskav o varnosti so pokazali, da je izdelek varen za konje. • Dokazano je bilo, da cepivo zaščiti živali pred boleznijo z zmanjšanjem števila viremičnih konjev.
What is the risk associated with Duvaxyn WNV?
Kakšna tveganja so povezana z zdravilom Duvaxyn WNV?
It is sometimes associated with pain and mild depression.
Včasih jih spremljata bolečina in blaga depresija.
In some cases a higher temperature may occur for up to 2 days.
V nekaterih primerih se lahko pojavi povišana telesna temperatura, ki traja do 2 dni.
In case of accidental self-injection, ingestion or spillage onto skin, seek medical advice immediately and show the package leaflet or label to the physician.
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino zdravila.
What is the time to allow before milk can be taken from the animal for human consumption?
Koliko časa mora preteči, preden se lahko mleko živali uporabi za prehrano ljudi?
Why has Duvaxyn WNV been approved?
Zakaj je bilo zdravilo Duvaxyn WNV odobreno?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Duvaxyn WNV outweigh the risks for the treatment of West Nile virus disease in horses and recommended that Duvaxyn WNV be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da koristi zdravila Duvaxyn WNV pri zdravljenju bolezni, ki jo povzroča virus West Nile pri konjih, odtehtajo z njim povezana tveganja, in priporočil, da se za zdravilo Duvaxyn WNV odobri dovoljenje za promet.
The benefit-risk balance can be found in module 6 of this EPAR.
Razmerje med koristmi in tveganji najdete v modulu 6 tega evropskega javnega poročila o oceni zdravila (EPAR).
Other information about Duvaxyn WNV:
Druge informacije o zdravilu Duvaxyn WNV:
The European Commission granted a marketing authorisation valid throughout the European Union, for Duvaxyn WNV to MAH on 21.11.2008.
Evropska komisija je dovoljenje za promet z zdravilom Duvaxyn WNV, veljavno po vsej Evropski uniji, odobrila imetniku dovoljenja za promet dne 21. 11. 2008.
Information on the prescription status of this product may be found on the label/ outer package.
Informacije o predpisovanju tega zdravila najdete na nalepki/ zunanji ovojnini.
This summary was last updated on 21.11.2008.
Povzetek je bil nazadnje posodobljen 21. 11. 2008.
Page 2/ 2 ©EMEA 2008
Stran 2/ 2 ©EMEA 2008
Pharmaceutical Target species Form
Farmacevtska oblika
Route of administration
Ciljna živalska vrsta
Packaging
Način uporabe Ovojnina zdravila
Package size
Velikost Karenca pakiranja
EU/ 2/ 08/ 086/ 001 Duvaxyn WNV RP 1.0 - 2.2
Duvaxyn WNV RP 1. 0 - 2. 2
Polypropylene syringe with latex-free rubber tip
Polipropilenska brizga z gumijastim zamaškom brez lateksa
EU/ 2/ 08/ 086/ 002 Duvaxyn WNV RP 1.0 - 2.2
Duvaxyn WNV RP 1. 0 - 2. 2
EU/ 2/ 08/ 086/ 003 Duvaxyn WNV RP 1.0 - 2.2
Duvaxyn WNV RP 1. 0 - 2. 2
Duvaxyn WNV - emulsion for injection for horses
Duvaxyn WNV – emulzija za injiciranje za konje
Inactivated West Nile Virus, strain VM-2
Inaktiviran virus West Nile, sev VM- 2
RP* 1.0- 2.2
RP * 1. 0- 2. 2
*Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
* Relativna učinkovitost (Relative Potency) pri in vitro metodi v primerjavi z referenčnim cepivom, ki je bilo učinkovito pri konjih.
MetaStim ™ (SP Oil)
MetaStim™ (SP olje)
For a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi,
4.1 Target Species
4. 1 Ciljne živalske vrste
4.2 Indications for use specifying the target species
4. 2 Indikacije za uporabo pri ciljnih živalskih vrstah
For the active immunisation of horses of 6 months of age or older against West Nile Virus disease by reducing the number of viraemic horses.
Za aktivno imunizacijo konjev starih 6 mesecev ali več proti bolezni West Nile, z zmanjševanjem števila viremičnih konj.
3 weeks after primary vaccination course.
3 tedne po prvem krogu cepljenja.
12 months after primary vaccination course.
12 mesecev po prvem krogu cepljenja.
Only healthy animals should be vaccinated.
Cepite samo zdrave konje.
2 Vaccination may interfere with existing sero-epidemiological surveys.
Cepljenje lahko ovira obstoječime sero- epidemiološkime postopke.
However, since the IgM response following vaccination is infrequent, a positive IgM-ELISA test result is a strong indicator of natural infection with West Nile Virus.
Vendar pa je porast IgM po cepljenju redek, zato je pozitiven ELISA rezultat IgM močan pokazatelj naravne infekcije z virusom West Mile.
It is therefore recommended not to vaccinate foals of less than 6 months of age.
Zato ni priporočljivo cepiti žrebet mlajših od 6 mesecev.
In case of accidental self-injection, ingestion or spillage onto skin, seek medical advice immediately and show the package leaflet or label to the physician.
V primeru nenamernega samo- injiciranja, zaužitja ali razlitja po koži se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
A small number of animals may show transient local reactions in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter) that resolve spontaneously within 1 to 2 days.
Majhno število živali ima lahko po cepljenju prehodne lokalne reakcije v obliki blage lokalne otekline ne mestu injiciranja (maksimalno 1 cm v premeru), ki izginejo sponatno v 1 do 2 dneh.
It is sometimes associated with pain and mild depression.
Včasih jih spremlja bolečina in blaga depresija.
In some cases hyperthermia may occur for up to 2 days.
V nekaterih primerih se lahko pojavi hipertermija, ki traja do 2 dni.
As a consequence, it cannot be excluded that transient immunodepression that may be observed during pregnancy could interfere with vaccine uptake.
Zato se ne more izključiti, da prehodna imunodepresija, ki se lahko pojavi med brejostjo, interferira z učinkovitostjo cepiva.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Odločitev o uporabi tega cepiva sočasno z drugimi zdravili je odvisna od posameznega primera.
Administer one dose (1 ml), by deep intramuscular injection in the neck region, according to the following schedule:
Odmerek (1 ml) aplicirajte globoko intramuskularno na področje vratu po naslednjem programu:
• Primary vaccination course: first injection from 6 months of age, second injection 3-5 weeks later. • Revaccination: a sufficient degree of protection should be achieved after an annual booster injection with a single dose although this schedule has not been fully validated.
- Prvi krog cepljenja: prva injekcija od 6 meseca starosti, druga injekcija 3- 5 tednov
Following the administration of a double dose of vaccine, no adverse reactions other than those described under section 4.6 have been observed.
Po dajanju dvojnega odmerka cepiva ni bilo opaziti nobenih drugih neželenih učinkov razen tistih, opisanih v poglavju 4. 6.
Immunologicals for Equidae – Inactivated viral vaccines - West Nile Virus vaccine
Imunološka zdravila za ekvide – Inaktivirana virusna cepiva – Cepivo proti virusu West Nile
ATCv code:
Oznaka ATC vet:
The vaccine stimulates active immunity against West Nile Virus.
Cepivo stimulira aktivno imunost proti virusu West Nile.
Shelf life of the veterinary product as packaged for sale:
Rok uporabnosti zdravila v pakiranju za prodajo:
Single-dose (1ml) polypropylene syringe closed with latex-free type I rubber tip.
6. 5 Vrsta ovojnine in vsebina Enoodmerna (1 ml) polipropilenska brizga zaprta z zamaškom iz gume tipa I brez lateksa.
Box of 5, 10, or 25 syringes.
Škatla s 5, 10, ali 25 brizgami.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali snovi
Fort Dodge Animal Health Limited Flanders Road Hedge End Southampton SO30 4QH United Kingdom
Fort Dodge Animal Health Limited Flanders Road Hedge End Southampton SO30 4QH Združeno kraljestvo
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. 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, EMEA) http: // www. emea. europa. eu.
The import, sale, supply and/ or use of Duvaxyn WNV is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Uvoz, prodaja, oskrba in/ ali uporaba Duvaxyn WNV je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
Any person intending to import, sell, supply and/ or use Duvaxyn WNV must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ ali uporabljati Duvaxyn WNV, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ ali uporabo.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC( IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Name and address of the manufacturer of the biological active substance:
Ime in naslov izdelovalca( izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin).
Fort Dodge, Iowa 50501 USA
Fort Dodge, Iowa 50501 ZDA
Fort Dodge Laboratories (Ireland) Finisklin Industrial Estate Sligo Ireland
Ime in naslov izdelovalca( izdelovalcev) zdravila, odgovornega za sproščanje serije Fort Dodge Laboratories (Irska) Finisklin Industrial Estate Sligo Irska
According to Article 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/ or use of Duvaxyn WNV on the whole or part of their territory if it is established that:
Skladno z 71. členom Direktive 2001/ 82/ ES Evropskega parlamenta in Sveta, države članice repovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih kužnih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE OF THE PRODUCT
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE
The following substances contained in the final product are included in Annex II of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
Snovi, ki jih vsebuje končno cepivo, so vključene v Dodatek II Uredbe Sveta (ES) No 2377/ 90 kot je navedeno v tabeli:
Pharmacologically active substances
7 Farmakološko aktivna snov
Pluronic L121 (poloxamer) Annex II for all food Commission Regulation No 2796/ 95 producing species Polysorbate 80 (Polyoxyethylene sorbitan monooleate)
Pluronik L121 (poloksamer)
Annex II for all food producing species
Dodatek II za vse živali, ki so namenjene za prehrano ljudi
Commission Regulation No.
Regulativa komisije št.
Squalane
Polisorbat 80 (Polioksietilen sorbitan oleat)
The CVMP considered during its July 2007 meeting that no MRL application would be required for this substance.
Dodatek II za vse živali, ki so namenjene za prehrano ljudi
ANNEX III
2796/ 95
7
Skvalan
LABELLING AND PACKAGE LEAFLET
CVMP je na sestanku julija 2007 sprejela sklep, da za to snov ni potrebna navedba MRL.
8 A.
8 DODATEK III
9 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
OZNAČEVANJE
Box of 5, 10, 25 single-dose polypropylene syringes.
Škatla s 5, 10, ali 25 enoodmernimi polipropilenskimi brizgami.
Duvaxyn WNV emulsion for injection for horses
Duvaxyn WNV emulzija za injiciranje za konje
1x 5 single-dose syringes.
1x 5 enoodmernih brizg.
1x 10 single-dose syringes.
1x 10 enoodmernih brizg.
1x 25 single-dose syringes.
1x 25 enoodmernih brizg.
Store and transport refrigerated (2°C – 8°C).
Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
Disposal: read the package leaflet.
Odpadne snovi: pred uporabo preberite navodilo za uporabo.
The import, sale, supply and/ or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory, see package leaflet for further information.
Uvoz, prodaja, oskrba in/ ali uporaba tega zdravila je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja; za nadaljnje informacije glej navodilo za uporabo.
Fort Dodge Animal Health Ltd Flanders Road, Hedge End Southampton SO30 4QH United Kingdom
Fort Dodge Animal Health Ltd Flanders Road, Hedge End Southampton SO30 4QH Združeno kraljestvo
11 16.
12 16.
12 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
13 PODATKI, KI OVOJNINAH
Inactivated West Nile Virus, strain VM-2 (RP = 1.0 - 2.2).
KOLIČINA ZDRAVILNE( IH) UČINKOVIN( E)
14 Duvaxyn WNV Emulsion for injection For use in horses
NAVODILO ZA UPORABO
Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH United Kingdom
Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH Združeno kraljestvo
Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo, Ireland
Fort Dodge Laboratories Irska Finisklin Industrial Estate Sligo, Irska
The use of Duvaxyn WNV reduces the number of animals with viraemia after natural infection, but may not systematically prevent it.
Uporaba Duvaxyn WNV zniža število konjev z viremijo po naravni infekciji, je pa ne prepreči.
16 Special precautions for use in animals
17 Posebni previdnostni ukrepi za uporabo pri živalih Cepljenje lahko ovira obstoječime sero- epidemiološkime postopke.
In case of accidental self-injection, ingestion or spillage onto skin, seek medical advice immediately and show the package leafletor label to the physician.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samo- injiciranja, zaužitja ali razlitja po koži se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. 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, EMEA) http: // www. emea. europa. eu
Box of 5 single-dose polypropylene syringes.
Škatla s 5 enoodmernimi polipropilenskimi brizgami.
Box of 10 single-dose polypropylene syringes.
Škatla z 10 enoodmernimi polipropilenskimi brizgami.
Box of 25 single-dose polypropylene syringes.
Škatla z 25 enoodmernimi polipropilenskimi brizgami.
It is available in a 10 ml bottle.
Na voljo je v 10- mililitrski steklenički.
They often lead to the ear(s) being inflamed (red, swollen and itchy).
Vnetja ušes pri psih lahko povzročijo bakterije ali glivice, zaradi česar se uho( ušesa) vname( jo) (postanejo rdeča, zatečena in srbeča).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Easotic shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšne koristi je zdravilo Easotic izkazalo med študijami?
Mild reddening of the ear has been seen in around 2% of dogs.
Opažena je bila blaga pordelost ušesa pri okoli 2% psov.
The European Commission granted a marketing authorisation valid throughout the European Union, for Easotic to Virbac S. A. on 20/ 11/ 2008.
Evropska komisija je dovoljenje za promet z zdravilom Easotic, veljavno po vsej Evropski uniji, odobrila družbi Virbac S. A. dne 20. novembra 2008.
This summary was last updated in November 2008.
Povzetek je bil nazadnje posodobljen 11- 2008.
Hydrocortisone aceponate:
Hydrokortizon aceponat:
1.11 mg/ ml Miconazole (as nitrate form):
1, 11 mg/ ml Miconazolev obliki nitrata:
15.1 mg/ ml Gentamicin (as sulphate form):
15, 1 mg/ ml Gentamicin v obliki sulfata:
Bottle (PP)
Večodmerni vsebnik s črpalko
Easotic, ear drops suspension, for dogs
Easotic, kapljice za uho, suspenzija, za pse.
Hydrocortisone aceponate Miconazole as nitrate Gentamicin as sulphate
Hidrokortizon aceponat Mikonazol v obliki nitrata Gentamicin v obliki sulfata
For a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi si oglejte poglavje 6. 1.
Ear drops suspension.
Kapljice za uho, suspenzija.
A white suspension.
4.
Do not use in case of hypersensitivity to the active substance or to any of the excipients, to corticosteroids, to other azole antifungal agents and to other aminoglycosides.
Ne uporabljajte v primeru preobčutljivosti na zdravilne učinkovine ali na katero koli pomožno snov, na kortikosteroide, ostala azolna protiglivična sredstva in druge aminoglikozide.
Do not use in dogs with generalised demodecosis.
4. 4.
4.5 Special precautions for use
4. 5 Posebni previdnostni ukrepi za uporabo
2/ 20 Use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing and take into account official and local antimicrobial policies.
2/ 20 Uporaba zdravila za uporabo v veterinarski medicini mora temeljiti na osnovi identifikacije in testiranju občutljivosti povzročitelja ter pri tem upoštevati uradno in lokalno antimikrobno strategijo.
Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria and fungi resistant to gentamicin and miconazole respectively and may decrease the effectiveness of treatment with aminoglycosides and azole antifungal agents, due to the potential for cross resistance.
Uporaba zdravila za uporabo v veterinarski medicini, ki odstopa od navodil, ki jih vsebuje povzetek glavnih značilnosti zdravila, lahko poveča prevalenco bakterij in glivic, odpornih na gentamicin oziroma na mikonazol, ter lahko zmanjša učinkovitost zdravljenja z aminoglikozidi in azolnimi protiglivičnimi sredstvi zaradi možne križne odpornosti.
Mild to moderate redness of the ear was common (2.4% of treated dogs).
Pogosta je blaga do zmerna pordelost ušesa (2, 4% zdravljenih psov).
Papules were observed uncommonly (less than 1% of treated dogs).
Občasno se pojavijo papule (pri manj kot 1% zdravljenih psov).
The use of auricular preparations may be associated with hearing impairment, usually temporary, and primarily in geriatric dogs.
Uporaba avrikularnih preparatov lahko povzroči okvare sluha (običajno začasne), predvsem pri starejših psih.
If this occurs, treatment should be stopped.
V tem primeru je treba prekiniti zdravljenje.
4.8 Interaction with other medicinal products and other forms of interaction
4. 8 Interakcija z drugimi zdravili in druge oblike interakcij
One ml contains 1.11 mg hydrocortisone aceponate, 15.1 mg miconazole (as nitrate) and 1505 IU gentamicin (as sulphate).
En mililiter vsebuje 1, 11 mg hidrokortizon aceponata, 15, 1 mg mikonazola (kot nitrata) in 1505 IU gentamicina (kot sulfata).
Shake the bottle thoroughly before first administration and prime the pump.
Pred prvo uporabo dobro pretresite stekleničko in napolnite črpalko.
3/ 20 Introduce the atraumatic canula in the ear canal.
Uvedite atravmatsko kanilo v ušesni kanal.
The airless pump allows the product to be administered whatever the position of the bottle is.
Brezzračna črpalka omogoča dajanje zdravila ne glede na položaj črpalke.
ins / ear / day for 5 days
3/ 20 1 odmerek / uho / dan v petih dneh
After application, the base of the ear may be massaged briefly and gently to allow the preparation to penetrate to the lower part of the ear canal.
Po uporabi lahko za kratek čas in nežno masirate koren ušesa, tako da preparat prodre tudi v nižji del ušesnega kanala.
The product as presented allows treating a dog suffering from bilateral otitis.
Predstavljeno zdravilo omogoča zdravljenje psov, ki imajo bilateralno vnetje ušesa.
The veterinary medicinal product should be used at room temperature (i. e. do not instill cold product).
Zdravilo za uporabo v veterinarski medicini uporabljajte pri sobni temperaturi (tj. ne vkapajte hladnega zdravila).
At 3 and 5 times the recommended dose, no local or general adverse reactions were observed with the exception of some dogs showing erythema and papulae in the ear canal.
Pri tri - in petkrat večjem odmerku od priporočenega niso bile opažene lokalne ali splošne škodljive reakcije z izjemo nekaterih psov, pri katerih so se pojavile rdečica in papule v ušesnem kanalu.
Otologicals – Corticosteroids and anti-infectives in combination ATCvet code:
Farmakoterapevtska skupina: otologiki – kortikosteroidi v kombinaciji z antiinfektivi Oznaka ATC vet:
Hydrocortisone aceponate belongs to the diesters class of the glucocorticosteroids with a potent intrinsic glucocorticoid activity which means a relief of both inflammation and pruritus leading to an improvement of clinical signs observed in otitis externa.
Hidrokortizon aceponat spada v diestersko skupino glukokortikosteroidov z močnim notranjim glukokortikoidnim delovanjem, kar pomeni, da lajša tako vnetja kot srbečico, kar vodi k izboljšanju kliničnih znakov, značilnih za vnetje zunanjega sluhovoda.
4/ 20 Miconazole nitrate is a synthetic imidazole derivative with a pronounced antifungal activity.
Mikonazol selektivno preprečuje sintezo ergosterola, ki je bistvena sestavina membrane kvasovk in glivic,
Miconazole selectively inhibits the synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis.
4/ 20 vključno z vrsto Malassezia pachydermatis.
Its spectrum of activity includes Gram-positive and Gram-negative bacteria, such as the following pathogenic organisms isolated from the ears of dogs:
Njegov spekter delovanja vključuje grampozitivne in gramnegativne bakterije, kot so naslednji patogeni organizmi, izolirani iz pasjih ušes:
Staphylococcus intermedius, Streptococcus spp., Pseudomonas aeruginosa, Proteus mirabilis, Escherichia coli, etc… The in-vitro activity of gentamicin against pathogens isolated from clinical cases of canine otitis externa in EU field trials between 2004 and 2007 was:
Staphylococcus intermedius, Streptococcus spp., Pseudomonas aeruginosa, Proteus mirabilis, Escherichia coli itd.
MIC50 (µg/ ml)
MIK50 (µg/ ml)
MIC90 (µg/ ml)
MIK90 (µg/ ml)
Range of MIC (µg/ ml)
Obseg MIK (µg/ ml)
0.5 8 4 2 Between 1 and 16
0. 031– 16 0. 06– 8 0. 031– 4 0. 031– 2
MIC- minimum inhibitory concentration
MIK - minimalna inhibitorna koncentracija