natgillin/translations-raw huggingface dataset:
These maximal azagly-nafarelin concentrations are followed by a slow decline in circulating azagly-nafarelin concentrations lasting up to 12 months.
Po doseganju največje koncentracije raven azagli- nafarelina v obtoku do 12 mesecev počasi upada.
The apparent volume of distribution of azagly-nafarelin following intravenous bolus administration, at a dose equivalent to the content of one implant, is 0.12 l/ kg.
Navidezni volumen porazdelitve azagli- nafarelina je po intravenskem dajanju bolusa v odmerku, ki je enakovreden vsebnosti enega implantata, 0, 12 l/ kg.
Metabolism and excretion:
Presnova in izločanje:
The clearance of azagly-nafarelin following intravenous administration of the same dose is 0.46 l/ h and the elimination half-life is 1.8 hours.
Očistek azagli- nafarelina je po intravenskem dajanju enakega odmerka 0, 46 l/ h, razpolovni čas izločanja pa 1, 8 ure.
6.4 Special precautions for storage
10/ 34 6. 4 Posebna navodila za shranjevanje
12/ 37 ANNEX II
11/ 34 DODATEK II
13/ 37 A.
12/ 34 A.
Gonazon for dogs:
Gonazon za pse:
Intervet GesmbH Siemensstrasse 107 A-1210 Wien Austria
Intervet GesmbH Siemensstrasse 107 A- 1210 Wien Avstrija
Substance Azagly-nafarelin
Substanca
MRL status Annex II for Salmonidae1
Status MRL Dodatek II za Salmonidae1
Comments Not for use in fish from which eggs are produced for human consumption
Ni za uporabo pri ribah, katerih ikre so namenjene za prehrano ljudi.
Sodium acetate (tri-hydrate) Acetic acid (glacial) Benzyl alcohol
natrijev acetat (trihidrat) ocetna kislina (ledocet) benzilni alkohol
Annex II for all food producing species Annex II for all food producing species Annex II for all food producing species.
Dodatek II za vse živali za proizvodnjo živil Dodatek II za vse živali za proizvodnjo živil Dodatek II za vse živali za proizvodnjo živil.
Sodium hydroxide Included in Annex II for all food producing species Hydrochloric acid Annex II for all food producing species, for use as excipient.
dodatku II za vse živali za proizvodnjo živil
Water for Not within the scope of injections Council Regulation 2377/ 90
v okviru Odredbe sveta 2377/ 90
1 Regulation 1530/ 02 / OJL230 of 28 August 2002
1 Uredba 1530/ 02 / OJL230 z dne 28. avgusta 2002
15/ 37 ANNEX III
13/ 34 DODATEK III
16/ 37 A.
14/ 34 A.
17/ 37 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
15/ 34 PODATKI NA ZUNANJI OVOJNINI
18/ 37 8.
16/ 34 8.
Reductions in fecundity, egg quality and survival to the eyed-egg stage have been observed in fish treated with azagly-nafarelin too early in the spawning season.
Pri ribah, ki so jim dajali azagli- nafarelin prezgodaj v sezoni mrestenja, so zasledili manjšo plodnost, slabšo kakovost iker in slabše preživetje do stopnje z očmi.
It is recommended to strip fish after injection at intervals of approximately 50-100 degree days.
Ribe je po injekciji priporočljivo smukati v presledkih po približno 50– 100 dnevnih stopinj.
The long term effects of azagly-nafarelin on treated broodstock fish have not been studied.
Dolgoročni učinki azagly- nafarelina na plemenske ribe niso raziskani.
"Month/ Year" After dilution, the product should be used immediately.
''Mesec/ Leto'' Razredčeni izdelek morate takoj uporabiti.
For animal treatment only - to be supplied only on veterinary prescription.
Samo za živali
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM''
19/ 37 15.
17/ 34 15.
20/ 37 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
18/ 34 PODATKI NA ZUNANJI OVOJNINI
Azagly-nafarelin (18.5 mg)
Azagli- nafarelin (18, 5 mg)
Read the package leaflet before use.
Subkutana uporaba Pred uporabo preberite navodilo za uporabo.
21/ 37 11.
19/ 34 11.
22/ 37 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
20/ 34 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Azagly-nafarelin 1600 µg/ ml as azagly-nafarelin acetate.
Azagli- nafarelin, 1600 µg/ ml, v obliki azagli- nafarelin- acetata
Intraperitoneal (IP) use
Intraperitonealna (i. p.) uporaba
< Batch > < Lot > {number}
< Serija > < lot > {številka}
EXP {month/ year} After dilution, the product should be used immediately.
EXP {mesec/ leto} Razredčen izdelek morate takoj uporabiti.
For animal treatment only- to be supplied only on veterinary prescription.
Samo za živali.
23/ 37 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
21/ 34 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Sachet
Vrečka
Batch < number >
Serija < številka >
24/ 37 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
22/ 34 PODATKI, KI MORAJO BITI NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
METHOD AND ROUTE(S) OF ADMINISTRATION
POT( I) UPORABE ZDRAVILA
High standards of biosecurity must be observed at the time of injection in order to prevent introduction and spread of infectious diseases between broodstock fish.
23/ 34 Pri injiciranju je treba ravnati v skladu s visokimi standardi biološke varnosti, da bi preprečili vnos in širjenje kužnih bolezni med plemenskimi ribami.
"Month/ Year" After dilution, the product should be used immediately.
''Mesec/ Leto'' Razredčen izdelek je treba takoj uporabiti.
Store and transport at 2°C - 8°C (in a refrigerator).
Shranjujte in prevažajte pri temperaturi 2°C– 8 °C (v hladilniku).
For animal treatment only - to be supplied only on veterinary prescription.
Samo za živali.
17.
24/ 34 17.
27/ 37 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
25/ 34 PODATKI, KI MORAJO BITI NAVEDENI NA STIČNI OVOJNINI
< Batch > < Lot > {number}
< serija > < Lot > {številka}
28/ 37 B.
26/ 34 B.
29/ 37 PACKAGE LEAFLET Gonazon concentrate for solution for injection of female salmonid fish
27/ 34 NAVODILO ZA UPORABO Gonazon, koncentrat za raztopino za injiciranje za plemenke salmonidnih vrst rib
Benzyl alcohol
Pomožna snov: benzilni alkohol
30/ 37 8.
28/ 34 8.
The table below provides the required volume of concentrate and the required volume of solvent to obtain thepreferred injection volumes of 0.1 ml/ kg fish, 0.2 ml/ kg fish, 0.5 ml/ kg fish or 1 ml/ kg fish.
V tabeli sta navedena potrebna volumna koncentrata in topila za pripravo volumnov raztopine za injiciranje 0, 1 ml/ kg rib, 0, 2 ml/ kg rib, 0, 5 ml/ kg rib in 1 ml/ kg rib.
Preferred injection volume per kg fish (depending on fish size) * Total kg of fish
Primeren injekcijski volumen na kg rib (glede na velikost ribe) * Skupna teža rib Volumen
Store at 2 – 8°C (in a refrigerator).
Shranjujte pri temperaturi 2 ºC– 8 ºC (v hladilniku).
In case of accidental contact with either the skin or the eyes, rinse thoroughly with water.
Pazite, da si izdelka ne bi injicirali.
31/ 37 diluted solution are spilled onto the skin or into the eyes or in the case of accidental self-injection.
29/ 34 Če izdelek nanesete na kožo ali v oči, jih temeljito sperite z vodo.
The package insert or the label should be shown to the physician
Če na kožo ali v oči nanesete koncentrirano raztopino ali več mililitrov razredčene raztopine ali si raztopino nenamerno injicirate, se takoj posvetujte z zdravnikom in mu pokažite priloženo navodilo ali nalepko na izdelku.
32/ 37 PACKAGE LEAFLET Gonazon 18.5 mg implant for dogs
30/ 34 NAVODILO ZA UPORABO Gonazon 18, 5 mg, implantat za pse
Intervet GesmbH Siemensstraβ e 107 A-1210 Wien Austria
Intervet GesmbH Siemensstraβe 107 A- 1210 Wien Avstrija
Azagly-nafarelin 18.5 mg
Azagli- nafarelin 18, 5 mg
33/ 37 8.
31/ 34 8.
For subcutaneous administration.
Priporočeni odmerek je en implantat za eno psico.
The recommended dose is one implant per bitch.
Implantat lahko uporabimo pri psicah od starosti štirih mesecev.
The implant may be administered to bitches from the age of four months.
Pri odraslih psicah je izdelek prvič najbolje uporabiti v metestrusu.
In adult bitches, the first treatment should be administered preferably in metoestrus.
Izdelek je v priporočenem odmerku neučinkovit pri psicah, starih sedem let in starejših.
- 6 years old
Povprečno
Gonazon should be injected subcutaneously, in the ventral anterior abdominal wall, in the region of the umbilicus, using aseptic technique.
Dajemo ga po naslednji metodi:
1).
Pripravimo majhno mesto (na primer 4 cm²) na ventralni, anteriorni abdominalni steni v predelu popka za aseptični postopek (slika 1).
Using aseptic technique, raise a small piece of skin in the region of the dog’ s umbilicus.
Z aseptično tehniko dvignemo majhen del kože v predelu popka.
2).
Iglo držimo tako, da je njena konica obrnjena navzgor in jo z eno potezo vbodemo pod kotom 30 stopinj podkožno v kožno gubo (slika 2).
3).
Ob tem se igla samodejno vrne, implantat pa ostane pod kožo (slika 3).
34/ 37
32/ 34
Fig.1
Slika 1
Fig.2
Slika 2
Fig.3
Slika 3
Do not use after the expiry date which is stated on the label ‘ EXP’ Do not store above 25°C.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po 'EXP'.
The implant may not be retained in a proportion (1.2%) of treated bitches.
Implantat pri določenem deležu (1, 2%) psic ne ostane na mestu.
37/ 37
34/ 34
This is a parasite belonging to the ‘ protozoa’ family that invades the digestive system causing diarrhoea.
To je zajedavec iz družine protozojev, ki vdre v prebavni sistem in povzroči drisko.
Halocur can be used: • to prevent diarrhoea in farms with a history of cryptosporidiosis (infection with Cryptosporidium), when it is given to newborn calves in the first 24 to 48 hours of life, • to reduce diarrhoea, when it is given in the 24 hours after the onset of diarrhoea.
Zdravilo Halocur se lahko uporablja: • za preprečevanje driske na kmetijah, na katerih se je že v preteklosti pojavljala kriptosporidioza (okužba s Cryptosporidium), če se daje novorojenim teletom v prvih 24 do 48 urah življenja, • za blažitev driske, če se daje v 24 urah po nastopu driske.
(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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged These studies compared treatment with Halocur to placebo.
(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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšne koristi je zdravilo Halocur izkazalo med raziskavami?
The European Commission granted a marketing authorisation, valid throughout the European Union for Halocur to Intervet International B. V. on 29 October 1999.
Evropska komisija je dovoljenje za promet z zdravilom Halocur, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B. V. dne 29. oktobra 1999.
Route of Administration
Način uporabe Ovojnina zdravila
New-born calves
Peroralna raztopina
oral use
Za teleta
HDPE plastic bottle
Za peroralno dajanje
490 ml
Plastenka po 490 ml 500 ml s 490 ml peroralne raztopine
500 ml bottle
Plastenka po 500 ml
13 days
13 dni
980 ml
Plastenka po 980 ml 1000 ml z 980 ml peroralne raztopine
1000 ml bottle
Plastenka po 1000 ml
HALOCUR 0.5 mg/ ml oral solution for calves
HALOCUR 0, 5 mg/ ml, peroralna raztopina za teleta
Halofuginone base (as lactate salt)
Halofuginon, baza (v obliki laktata)
For a full list of excipients, see section 6.1
For a full list of excipients, see section 6. 1
4.2 Indications for use, specifying the target species
4. 2 Indikacije za uporabo
• Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, in farms with history of cryptosporidiosis.
• Preprečevanje driske pri diagnozi okužbe s Cryptosporidium parvum na farmah, na katerih se je že v preteklosti pojavila kriptosporidioza.
Administration should start in the first 24 to 48 hours of age. • Reduction of diarrhoea due to diagnosed Cryptosporidium parvum.
Zdravilo začnemo dajati prvih 24 do 48 ur po rojstvu. • Ublažitev driske pri diagnozi okužbe s Cryptosporidium parvum.
4.4 Special warnings
4. 4 Neželeni učinki (pogostost in resnost)
2/ 12 4.5 Special precautions for use
Če zdravilo uporabljamo natančno po navodilu, nima neželenih učinkov.
Special precautions for use in animals
Posebni previdnostni ukrepi
To the user: • Repetitive contact with the product may lead to skin allergies. • Avoid skin and eye contact with the product.
Namenjeno uporabniku: • Večkratni stik z izdelkom lahko povzroči kožne alergije. • Pazite, da ne bi izdelek prišel v stik s kožo in očmi.
If an eye irritation persists, seek medical advice. • Wear protective gloves while handling the product. • Wash hands after use.
Če traja dražeč učinek na očeh dlje časa, se posvetujte z zdravnikom. • Uporabljajte zaščitne rokavice. • Po uporabi si umijte roke.
4.6 Adverse reactions (frequency and seriousness)
4. 6 Uporaba v obdobju brejosti in laktacije
None if used strictly as directed.
Navedba smiselno ni potrebna.
4.7 Use during pregnancy, lactation or lay
4. 7 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
4.8 Interaction with other medicinal products and other forms of interaction
4. 8 Posebna opozorila za vsako ciljno živalsko vrsto
None known.
Niso potrebna.
The dosage is:
Odmerjanje:
2 ml of HALOCUR / 10 kg bw / once a day for 7 consecutive days.
100 µg halofuginon baze/ kg telesne mase, 1- krat na dan, 7 zaporednih dni, to je 2 ml zdravila HALOCUR/ 10 kg telesne mase, 1- krat na dan, 7 zaporednih dni.
• 35 kg < calves ≤ 45 kg:
• 35 kg < teleta ≤ 45 kg:
8 ml of HALOCUR once a day during 7 consecutive days • 45 kg < calves < 60 kg:
8 ml zdravila HALOCUR, 1- krat na dan, 7 zaporednih dni • 45 kg < teleta < 60 kg:
12 ml of HALOCUR once a day during 7 consecutive days
12 ml zdravila HALOCUR, 1- krat na dan, 7 zaporednih dni
For smaller or higher weights, a precise calculation should be performed (2 ml/ 10 kg).
Za teleta z manjšo ali večjo telesno maso je treba odmerek natančno izračunati (2 ml/ 10 kg).
3/ 12 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Preveliko odmerjanje
13 days.
13 dni
Quinazolinone derivate, ATCvet code:
Farmakoterapevtska skupina: derivat kinazolinona, Oznaka ATCvet:
The concentrations to inhibit 50% and 90% of the parasites, in an in vitro test system, are IC50 < 0.1 µ g/ ml and IC90 of 4.5 µg/ ml respectively.
IC50 < 0, 1 µg/ ml in IC90 4, 5 µg/ ml.
5.2 Pharmacokinetic particulars
5. 2 Farmakokinetične lastnosti
The bioavailability of the drug in the calf, following single oral administration, is about 80%.
Biološka uporabnost zdravila je pri teletih po enkratnem peroralnem odmerku približno 80%.
The maximum concentration in plasma Cmax is 4 ng/ ml.
Največja koncentracija v plazmi (Cmax) je 4 ng/ ml.
The apparent volume of distribution is 10 l/ kg.
Navidezna prostornina porazdelitve je 10 l/ kg.
The terminal elimination half-life is 11.7 hours after IV administration and 30.84 hours after single oral administration.
Končna razpolovna doba izločanja je 11, 7 ure po intravenskem dajanju in 30, 84 ure po enkratnem peroralnem odmerku.
6.1 List of excipients
6. 1 List of excipients
6.2 Incompatibilities
6. 2 Inkompatibilnosti (glavne)
Shelf-life after first opening the container:
3 leta Rok uporabnosti po prvem odpiranju vsebnika:
4/ 12 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
MARKETING AUTHORISATION HOLDER
IME ALI IME PODJETJA TER NASLOV ALI REGISTRIRANI KRAJ POSLOVANJA IMETNIKA DOVOLJENJA ZA PROMET
29-Oct-04
29- okt- 99
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: // www. emea. europa. eu /.
5/ 12 ANNEX II
DODATEK II
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
STATEMENT OF THE MRLs
IZDELOVALEC
6/ 12 A.
ZDRAVILNE
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
UČINKOVIN) IN IMETNIK DOVOLJENJA ODGOVOREN ZA SPROSTITEV SERIJE
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca, odgovornega za sprostitev serije
Intervet Productions SA Rue de Lyons F-27460 Igoville France
Intervet Productions SA Rue de Lyons F- 27460 Igoville Francija
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
PREPOVED PRODAJE, OSKRBE IN/ ALI UPORABE
In accordance with Council Regulation (EEC) No 2377/ 90, as amended and in accordance with Article 34.4b of Regulation (EEC) No 726/ 2004 of 31 March 2004. Halofuginone is included in Annex I of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL)
Pharmacologically active
Dodatek I Uredbe Sveta (EGS) št.
substance
Farmakološko aktivna snov
MRLs (*)
Najvišje dovoljene količine zaostankov (MRL) (*)
Liver Kidney
Jetra
Muscle Fat
Ledvice Mišice Maščoba
7/ 12 ANNEX III
L 336 z dne 30. 12. 00 DODATEK III
9/ 12 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
OZNAČEVANJE PODATKI, KI MORAJO BITI NAVEDENI NA STIČNI OVOJNINI
500 ml bottle/ 1000 ml bottle
plastenka po 500 ml/ plastenka po 1000 ml
HALOCUR 0.5 mg/ ml oral solution for calves
HALOCUR, 0, 5 mg/ ml, peroralna raztopina za teleta
Halofuginone base (as lactate salt) Benzoic acid (E 210) Tartrazine (E 102)
Halofuginon, baza (v obliki laktata) Benzojska kislina (E 210) Tartrazin (E 102)
8 ml of HALOCUR once a day for 7 consecutive days • 45 kg < calves < 60 kg:
8 ml zdravila HALOCUR, 1- krat na dan, 7 zaporednih dni • 45 kg < teleta < 60 kg:
For smaller or higher weights, a precise calculation should be performed (2 ml/ 10 kg).
12 ml zdravila HALOCUR, 1- krat na dan, 7 zaporednih dni Za teleta z manjšo ali večjo telesno maso je treba odmerek natančno izračunati (2 ml/ 10 kg).
10/ 12 To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Zaradi natančnega odmerjanja je zdravilo treba dajati z brizgo ali ustrezno napravo za peroralno dajanje.
Rehydration may be necessary.
Če se pojavijo znaki, ki jih povzroča prevelik odmerek, moramo zdravljenje nemudoma prekiniti in žival hraniti z mlekom ali mlečnim nadomestkom brez dodanega zdravila. Včasih je potrebna rehidracija.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: • Repetitive contact with the product may lead to skin allergies. • Avoid skin and eye contact with the product.
Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki daje zdravilo živalim: • Večkratni stik z izdelkom lahko povzroči kožne alergije. • Pazite, da ne bi izdelek prišel v stik s kožo in očmi.
If an eye irritation persists, seek medical advice. • Wear protective gloves while handling the product. • Wash hands after use.
Če traja dražeč učinek v očeh dlje časa, se posvetujte z zdravnikom. • Uporabljajte zaščitne rokavice. • Po uporabi si umijte roke.
EXP: month/ year Once broached, use within 6 months.
EXP: mesec/ leto Načeto zdravilo porabite v 6 mesecih.
This medicinal product does not required any special storage conditions.
Za shranjevanje ni posebnih navodil.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
For animal treatment only.
HALOCUR ne sme priti v vodotoke, ker je lahko nevaren za ribe in druge vodne organizme.
To be supplied only on veterinary prescription.
Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z nacionalnimi zahtevami.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
< Batch > < Lot > < BN > number.
< Serija > {številka}
Ibaflin is available as tablets (30, 150, 300 and 900 mg) and as oral gels (3 and 7.5%).
Na voljo je v obliki tablet (30, 150, 300 in 900 mg) in v obliki peroralnih gelov (3% in 7, 5%).
Ibaflin is used to treat the infections in dogs and cats: • skin infections, including shallow and deep ‘ pyoderma’, infected wounds and abscesses caused by bacteria such as Staphylococci, E. coli, Proteus species and Pasteurella species, • upper respiratory tract infections caused by Staphylococci, E. coli and Klebsiella species.
Zdravilo Ibaflin se uporablja za zdravljenje okužb pri psih in mačkah: • okužb kože, vključno s površinsko in globoko „ piodermijo “, okuženih ran in abscesov, ki jih povzročajo bakterije, kot so na primer Staphylococci, E. coli, Proteus vrste in Pasteurella vrste, • okužb zgornjih dihalnih poti, ki jih povzročajo Staphylococci, E. coli in Klebsiella vrste.
Cats are treated using the 3% oral gel.
Za zdravljenje mačk se uporablja 3% peroralni gel.
The dose and duration of treatment depend on the nature and severity of the infection, the weight and species of the animal being treated, and the animal’ s response to treatment.
Odmerek zdravila in trajanje zdravljenja sta odvisna od narave in resnosti okužbe, telesne mase in vrste živali, ki jo zdravimo, ter od tega, kako se žival na zdravljenje odziva.
Ibafloxacin, is an antibiotic belonging to the class ‘ fluoroquinolones’.
Ibafloksacin je antibiotik, ki spada v skupino „ fluorokinolonov “.
It works by blocking an enzyme called ‘ DNA gyrase’, which is important in allowing bacteria to make copies of their DNA.
Deluje tako, da zavre encim imenovan „ DNA- giraza “, ki je pomemben zato, ker bakterijam omogoča, da izdelujejo kopije svoje DNA.
By blocking DNA gyrase, ibafloxacin prevents the bacteria from making DNA and stops them making proteins and growing, resulting in their death.
Z zavrtjem DNA- giraze ibafloksacin bakterijam prepreči tvorbo DNA, s čimer pri njih zaustavi tvorbo beljakovin in rast, kar ima za posledico njihovo odmrtje.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 46 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Ibaflin been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 46 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Ibaflin raziskano?
In these studies, the effects of Ibaflin were compared with those of other antibiotics (marbofloxacin, enrofloxacin or amoxicillin/ clavulanic acid).
V teh študijah so učinke zdravila Ibaflin primerjali z učinki drugih antibiotikov (marbofloksacina, enrofloksacina ali amoksicilina/ klavulanske kisline).
The oral gel was also at least as effective as the comparator antibiotic (amoxicillin/ clavulanic acid) in treating skin and upper respiratory tract infections in cats.
Prav tako je bil peroralni gel pri zdravljenju okužb kože in zgornjih dihalnih poti pri mačkah najmanj tako učinkovit kot za primerjavo uporabljen antibiotik (amoksicilin/ klavulanska kislina).
The European Commission granted a marketing authorisation valid throughout the European Union for Ibaflin to Intervet International B. V. on 13 June 2000.
Evropska komisija je dovoljenje za promet z zdravilom Ibaflin, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B. V. dne 13. junija 2000.
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Active substance Ibafloxacin 30 mg Ibafloxacin 150 mg Ibafloxacin 300 mg Ibafloxacin 900 mg
Ibafloksacin 30 mg Ibafloksacin 150 mg Ibafloksacin 300 mg Ibafloksacin 900 mg
4.1 Pharmacodynamic properties
4. 1 Farmakodinamične lastnosti
Pharmacotherapeutic group: antibacterial quinolone ATCvet code:
Farmakoterapevtska skupina: kinolonske protimikrobne učinkovine Oznaka ATCvet:
QJ 01 MA Ibaflin contains ibafloxacin as active ingredient.
QJ 01 MA Zdravilna učinkovina v Ibaflinu je ibafloksacin.
Its action results from inhibition of bacterial DNA gyrase.
Njegovo delovanje temelji na zaviranju bakterijske DNA- giraze.