natgillin/translations-raw huggingface dataset:
За животни, отглеждани днес в ЕИ/ЕИП за производство на храни, практическите проучвания показват, че субстанцията се използва предимно за прасета, включително групово лечение и превенция на диария, причинена от E. coli и Salmonella spp., като първи избор при лечението на неонатална диария, причинена от E. coli при малките прасета
For food-producing animals in the EU/EEA today, field studies have shown that it is used primarily for pigs including group treatments and prevention of diarrhoea caused by E. coli and Salmonella spp., as first-choice http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/10/WC500175671.pdf Commission Decision concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for all veterinary medicinal products containing "Colistin" to be administered orally ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm Lim LM et al. 2010 Resurgence of colistin: a review of resistance, toxicity, pharmacodynamics, and dosing.
Перорален прах Телета, агнета, ярета, жребчета, малки прасета, домашни птици и зайци.
Calves, lamb, kid, foals, piglets, poultry and rabbits.
Перорален прах Прасета
Chicken, pigs Oral use
Пилета и прасета
Oral solution Chickens and pigs
150 mg/g 500 000 IU/g
150 mg/g
Прасета, пилета (с изключение на кокошки носачки)
Pigs, chickens (other than laying hens in lay)
Ампицилин трихидрат Колистин сулфат
Ampicillin trihydrate Colistin sulphate
ПРИЛОЖЕНИЕ IV Заключения относно издаване на разрешение за употреба под условие, представени от Европейската агенция по лекарствата
Annex IV Conclusions on the granting of the conditional marketing authorisation and presented by the European Medicines Agency
Datum revizije besedila
Date of revision of the text
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMA) http://www.ema.europa.eu/.
Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
NEŽELENI UČINKI
UNDESIRABLE EFFECTS
Psi in mačke
Dogs and cats
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
4.8 Interaction with other medicinal products and other forms of interaction
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
For a full list of excipients, see section 6.1.
Če je potrebno in glede na klinično odzivanje, lahko z zdravljenjem nadaljujemo, dokler menimo, da je odzivanje nanj ustrezno.
If necessary and depending on the clinical response, treatment can be continued until the response is considered to be adequate.
Da ne bi prišlo do navzkrižne okužbe, iste brizge ne smemo uporabljati za različne živali.
In order to avoid any cross contamination, the same syringe should not be used for different animals.
Večinoma zadošča 10-dnevno zdravljenje.
In most cases, a 10 day-treatment course will be sufficient.
Priporočena je naslednja shema odmerjanja:
The following dosage scheme is advised:
Odmerek (število tablet)
Dosage (number of tablets)
Metilparahidroksibenzoat (0,125 %)
Methyl parahydroxybenzoate (0.125%)
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Zdravila ne uporabljajte v obdobju rasti.
Do not use during the period of growth.
Trajanje zdravljenja je odvisno od oblike in resnosti okužbe ter od odzivnosti na zdravljenje.
The duration of treatment depends on the nature and severity of the infection and on the response.
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN
THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Ni smiselno.
Not applicable.
3 leta Rok uporabnosti po prvem odpiranju: 8 tednov
Shelf-life after first opening: 8 weeks
Peroralni gel Intervet Productions S.A. Rue de Lyons 27460 Igoville Francija
Intervet Productions S.A. Rue de Lyons 27460 Igoville France
Do antagonizma lahko pride z nitrofurantoinom.
Antagonism may be observed with nitrofurantoin.
Vendar pa je tableto najbolje dajati v času hranjenja, da bi zagotovili največjo biološko uporabnost.
However, it is preferred to administer the tablet at feeding time to ensure maximal bioavailability.
ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Posebni previdnostni ukrepi za uporabo pri živalih
Special precautions for use in animals
Telesna masa (kg)
Body weight (kg)
4.4 Posebna opozorila za vsako ciljno živalsko vrsto
4.4 Special warnings for each target species
Ibaflin lahko dajemo ob kateremkoli času dneva, ne da bi se spremenila njegova učinkovitost.
Ibaflin can be administered at any time of the day without consequences for efficacy.
Imetnik tega dovoljenja za promet z zdravilom mora obvestiti Evropsko komisijo o načrtu
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Intervet GesmbH Siemensstrasse 107 A-1210 Dunaj Avstrija
Intervet GesmbH Siemensstrasse 107 A-1210 Wien Austria
Ne uporabljajte pri psih
Do not use in cats.
Pioderma se večinoma pojavlja kot sekundarno obolenje ob osnovni bolezni.
Pyoderma is mostly secondary to an underlying disease.
4.1 Ciljne živalske vrste
4.1 Target species
Pred uporabo preberite navodilo za uporabo.
Read the package insert before use.
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
6.6 Special precautions for the disposal of unused medicinal product or waste materials, if any
Če pri globoki piodermi ni zadovoljivega izboljšanja po 21 dneh zdravljenja, je treba o njem ponovno presoditi.
If in cases of deep pyoderma, sufficient improvement is not seen after a treatment course of 21 days, it is recommended that the treatment is reconsidered.
Odprto zdravilo uporabite v 8 tednih.
Once opened use within 8 weeks.
Priporočljivo je poiskati osnovni vzrok in žival ustrezno zdraviti.
It is advisable to determine the underlying cause and to treat the animal accordingly.
FARMACEVTSKA OBLIKA Peroralni gel
PHARMACEUTICAL FORM Oral gel
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
NAME OF THE VETERINARY MEDICINAL PRODUCT
O zdravljenju moramo ponovno presoditi, če se po 5 dneh klinično stanje ne izboljša.
The treatment should be reconsidered if after 5 days no improvement in the clinical condition is observed.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki.
Do not use after the expiry date stated on the label.
Preudarno je prihraniti uporabo fluorokinolonov za zdravljenje kliničnih stanj, ki se slabo odzivajo ali za katera pričakujemo, da so bodo slabo odzivala na druge skupine antibiotikov.
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 antibiotic.
Načeto brizgo smemo uporabiti samo za nadaljevanje zdravljenja iste živali.
Once a syringe is opened it should only be used to continue the treatment course in the same animal.
Ime in naslov imetnika dovoljenja za promet Intervet International B.V.
Name and address of the Marketing Authorisation Holder Intervet International B.V.
Tablete
Tablets
Sev, ki je odporen proti enemu fluorokinolonu, je odporen tudi proti drugim zdravilom iz skupine fluorokinolonov.
A strain which is resistant to a fluoroquinolone will also be resistant to other members of the class of fluoroquinolones.
6.1 Seznam pomožnih snovi metilparahidroksibenzoat (0,125 %) kalijev dihidrogenfosfat dinatrijev hidrogenfosfat dihidrat karbomer (karbopol 974 PNF) raztopina natrijevega hidroksida voda za injekcije
Methyl parahydroxybenzoate (0.125%) Potassium dihydrogen phophate Disodium hydrogen phosphate dihydrate Carbomer (carbopol 974 PNF) Sodium hydroxide solution Water for injections
Po večkratnem peroralnem dajanju doseže stabilno stanje po prvem ali drugem odmerku in se ne akumulira in ne inducira encimov biotransformacije.
After multiple oral administration, steady state is reached after the first or second dosing and no accumulation or induction of biotransformation enzymes occurs.
Shranjujte pri temperaturi do 25 ºC.
Do not store above 25°C.
20 ali 100 tablet 10, 20 ali 100 tablet 8, 16 ali 80 tablet 5, 25 ali 50 tablet
20 or 100 tablets 10, 20 or 100 tablets 8, 16 or 80 tablets 5, 25 or 50 tablets
Preveliko zanašanje na eno skupino antibiotikov lahko privede do odpornosti določene populacije bakterij.
Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population.
NASVET O PRAVILNI UPORABI ZDRAVILA
ADVICE ON CORRECT ADMINISTRATION
INDIKACIJE
INDICATIONS
Njegovo delovanje temelji na zaviranju bakterijske DNA-giraze.
Its action results from inhibition of bacterial DNA gyrase.
Da bi zdravilo pravilno odmerili in da ne bi bil odmerek premajhen, je treba telesno maso določiti, kolikor je možno natančno.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
OVOJNINAH IBAFLIN, TABLETE 30, 150, 300 in 900 mg
IBAFLIN TABLETS 30, 150, 300 AND 900 MG
Psi
Dogs
NAVODILO ZA UPORABO ZA TABLETE IBAFLIN
PACKAGE INSERT FOR INCLUSION WITH THE IBAFLIN TABLETS
Za ibafloksacin (in druge fluorokinolone) ni znanih antidotov, zato je treba pri vnosu prevelikega odmerka uvesti simptomatsko zdravljenje.
No specific antidotes for ibafloxacin (or other quinolones) are known, therefore, in case of overdosage symptomatic treatment should be given.
Brizge z neporabljenim gelom je treba po končanem zdravljenju zavreči.
Any syringes containing unused product should be disposed of once a course of treatment has been completed.
Gel dajemo zato ob času hranjenja, da bi zagotovili optimalno biološko uporabnost.
The gel should therefore be administered at feeding time to ensure maximal bioavailability.
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
DATUM IZTEKA ROKA UPORABNOSTI EXP {mesec/leto}
EXPIRY DATE EXP {month/year}>
Tablete 30 mg:
300 mg tablets:
20 tablet / 100 tablet 10 tablet / 20 tablet / 100 tablet 8 tablet / 16 tablet / 80 tablet 5 tablet / 25 tablet / 50 tablet
20 tablets / 100 tablets 10 tablets / 20 tablets / 100 tablets 8 tablets /16 tablets / 80 tablets 5 tablets /25 tablets / 50 tablets
C. PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Ni smiselno.
Prohibition of sale, supply and/or use Not applicable.
Presnovek, ki nastaja v največji količini, je 8-hidroksi-ibafloksacin, ki je tudi mikrobiološko aktiven.
The most abundant metabolite is 8-hydroxy-ibafloxacin, which is also microbiologically active.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA (Mesec/leto)
EXPIRY DATE (Month/year)
Ibaflin 7,5 % peroralnega gela ne smemo uporabljati pri mačkah.
Ibaflin 7.5% Oral Gel should not be used in cats.
Farmakodinamične lastnosti Farmakoterapevtska skupina: kinolonske protimikrobne učinkovine Oznaka ATCvet: QJ 01 MA 96
Pharmacotherapeutic group: antibacterial quinolone ATCvet code: QJ 01 MA 96
Farmakoterapevtska skupina: kinolonske protimikrobne učinkovine Oznaka ATCvet: QJ 01 MA
Pharmacotherapeutic group: antibacterial quinolone ATCvet code: QJ 01 MA
Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
If you notice any other side effects, please inform your veterinary surgeon.
Gel je priporočljivo dajati ob času hranjenja.
It is recommended that the gel is administered at the time of feeding.
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
BESEDILO “SAMO ZA ŽIVALI” Samo za živali.
THE WORDS "FOR ANIMAL TREATMENT ONLY" For animal treatment only.
1 (napolnjena brizga) Ibaflin peroralnega gela vsebuje:
QUALITATIVE AND QUANTITATIVE COMPOSITION Each (pre-filled syringe of) Ibaflin Oral Gel contains:
Psi in mačke Ibaflin 3 % peroralni gel
Cats and dogs Ibaflin 3% Oral Gel
Učinek na plodnost pri plemenskih samcih ni raziskan.
The influence on fertility in male breeding animals has not been investigated.
Datum pridobitve/podaljšanja dovoljenja za promet
Date of first authorisation/renewal of the authorisation
in Pasteurella spp.
and Pasteurella spp.
Klebsiella spp.
and Klebsiella spp.
CILJNE ŽIVALSKE VRSTE
Target species
Ibafloksacin je širokospektralen, baktericidni antibiotik.
Ibafloxacin is a broad spectrum, bactericidal antibiotic.
V primeru nenamernega zaužitja zdravila, zlasti pri otroku, se je treba posvetovati z zdravnikom.
Medicinal advice should be sought in the event of accidental ingestion, particularly by a child.
Pioderma (površinska in globoka), rane, abscesi, akutne nezapletene okužbe sečil in zgornjih dihalnih poti
Pyoderma (superficial and deep), wounds, abscesses, acute uncomplicated urinary tract infections and upper respiratory tract infections.
silicijev dioksid magnezijev stearat
Magnesium stearate
Ibafloksacin in 8-hidroksi-ibafloksacin delujeta sinergistično.
Ibafloxacin and 8-hydroxy-ibafloxacin act synergystically.
Indikacije za uporabo
4.2 Indications for use
ZA SHRANJEVANJE Shranjujte pri temperaturi do 25 ºC.
SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Ime in naslov imetnika dovoljenja za promet
Name and address of the Marketing Authorisation Holder
Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
Ibaflin 30 mg, tablete za pse Ibaflin150 mg, tablete za pse Ibaflin 300 mg, tablete za pse Ibaflin 900 mg, tablete za pse
Ibaflin 30 mg tablets for dogs Ibaflin 150 mg tablets for dogs Ibaflin 300 mg tablets for dogs Ibaflin 900 mg tablets for dogs
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
Special precautions to be taken by the person administering the product
Ibafloksacin je sintetična protimikrobna snov iz skupine fluorokinolonov.
Ibafloxacin is a synthetic antimicrobial substance of the fluoroquinolone class.
Študije varnosti za ciljno živalsko vrsto, izvedene pri psih, starih 8 mesecev, so pokazale, da ibafloksacin po peroralnem dajanju v odmerkih po 45 mg/kg telesne mase na dan (trikratni priporočeni odmerek) v obdobju 90 dni nima zaznavnih neželenih učinkov.
Target animal safety studies in dogs of 8 months of age demonstrated that, when administered orally at 45 mg/kg/day (three times the recommended dose) for a period of 90 days, ibafloxacin produced no observable adverse effects.
4.5 Posebni previdnostni ukrepi
4.5 Special precautions for use
s 100 tabletami v pretisnih omotih iz pvc, pvdc in aluminija Tablete 300 mg: - zloženka z 8, s 16 ali z 80 tabletami v zavarjenih pretisnih omotih iz pvc in aluminija - zloženka z 8, s 16 ali z 80 tabletami v pretisnih omotih iz pvc, pvdc in aluminija Tablete 900 mg:
- Carton box with 8, 16 or 80 tablets in PVC/aluminium heat sealed blisters - Carton box with 8, 16 or 80 tablets in PVC/PVDC/aluminium blisters 900 mg tablets: - Carton box with 5, 25 or 50 tablets in PVC/aluminium heat sealed blisters.
Antacidi lahko vplivajo na absorpcijo kinolonov iz prebavil.
Antacids can interfere with gastro-intestinal absorption of quinolones.
Po večkratnem peroralnem dajanju doseže stabilno stanje po prvem odmerku in se pri psih ne kopiči, pri mačkah pa so zasledili zmerno kopičenje.
After multiple oral administration, steady state is reached after the first dosing and no accumulation occurs in dogs whereas modest accumulation is observed in cats.
Pri zdravih mačkah je 30-dnevno dajanje Ibaflin peroralnega gela v odmerkih po 15 do 75 mg/kg povzročilo bruhanje oz.
When administered over a period of 30 days to healthy cats, Ibaflin oral gel produced vomiting/regurgitation and salivation at doses of 15 to 75 mg/kg.
6.1 Seznam pomožnih snovi kvas škrob celuloza laktoza natrijev lavrilsulfat
Sodium laurylsulphate Silica
Peroralno dajanje odmerkov ibafloksacina po 75 mg/kg na dan (petkratni priporočeni odmerek) v obdobju 90 dni, so psi dobro prenašali.
When administered orally at 75 mg/kg/day (five times the recommended dose) for a period of 90 days in dogs, ibafloxacin was well tolerated.
Pri psih je obdobje rasti pri različnih pasmah različno.
In dogs, this period depends on the breed.
FARMACEVTSKA OBLIKA Tableta
PHARMACEUTICAL FORM
in doseže največje ravni mikrobiološko aktivnih spojin v plazmi 1 do 2 uri po dajanju.
After oral administration in dogs, ibafloxacin is rapidly absorbed with maximum plasma levels of microbiologically active compounds obtained at 1-2 hours after administration.
B. POGOJI DOVOLJENJA
B. CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING
Ne uporabite pri psih z znano preobčutljivostjo za kinolone.
Do not use in dogs with known quinolone hypersensitivity.
Zdravila ne uporabljajte pri psih v dobi rasti, ker lahko okvari
Do not use in dogs during the period of growth as articular cartilage may be affected.
Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi zahtevami.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Po večkratnem peroralnem dajanju doseže stabilno stanje po prvem odmerku in se pri psih ne kopiči.
After multiple oral administration, steady state is reached after the first dosing and no accumulation occurs in dogs.
Ibaflin 3 %, peroralni gel: 30 mg ibafloksacina v 1 g gela (ustreza 30,9 mg/ml) Ibaflin 7,5 %, peroralni gel: 75 mg ibafloksacina v 1 g gela (ustreza 78,8 mg/ml) Pomožne snovi
Ibaflin 3% Oral Gel: 30 mg of ibafloxacin per g of gel (equivalent to 30.9 mg/ml); Ibaflin 7.5% Oral Gel: 75 mg of ibafloxacin per g of gel (equivalent to 78.8 mg/ml) Excipients
Siemensstraße 107
Siemensstraße 107 1210 Vienna Austria
Zdravila ne uporabljajte pri mačkah do 8 mesecev starosti, ker ni na voljo podatkov o učinku
Do not use in cats up to 8 months of age as no information is available on the influence of ibafloxacin on developing articular cartilage in the cat during the period of rapid growth as articular cartilage may be affected.
OZNAČEVANJE IN NAVODILO ZA UPORABO
ANNEX III LABELLING AND PACKAGE INSERT
Z 1 BRIZGO IBAFLIN 3 % PERORALNEGA GELA / ZLOŽENKA S 5 BRIZGAMI IBAFLIN 3 % PERORALNEGA GELA
CARTON BOX FOR 1 SYRINGE IBAFLIN 3% ORAL GEL / CARTON BOX FOR 5 SYRINGES IBAFLIN 3% ORAL GEL
Zdravilo se pretežno izloča z urinom in blatom.
The main excretory routes are via urine and faeces.
Ibaflin lahko dajemo med brejostjo.
Ibaflin can be used during pregnancy.
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Lahko se uporablja v obdobju brejosti.
4.7 Use during pregnancy, lactation or lay
Odmerek v mg
mg administered
Ne smemo ga uporabljati pri psih in mačkah z znano preobčutljivostjo za kinolone.
Do not use in dogs and cats with known quinolone hypersensitivity.
Tablete po 150 mg in 300 mg: 4 leta Tablete po 30 mg in 900 mg: 3 leta
150mg and 300mg tablets: 4 years 30mg and 900mg tablets: 3 years 6.4 Special precautions for storage Do not store above 25°C.
Ibafloksacin 30 mg Ibafloksacin 150 mg Ibafloksacin 300 mg Ibafloksacin 900 mg
Ibaflin 30 mg: ibafloxacin 30 mg Ibaflin 150 mg: ibafloxacin 150 mg Ibaflin 300 mg: ibafloxacin 300 mg Ibaflin 900 mg: ibafloxacin 900 mg
4.9 Odmerjanje in pot uporabe
4.9 Posology and method of administration
MIK ibafloksacina (matične spojine) so v razponu 0,032 do 0,5 µg/ml za E. coli, Staphylococcus spp.
For ibafloxacin (parent compound), MIC values ranging from 0.032 - 0.5 µg/ml are observed for canine isolates of E. coli, Staphylococcus spp.
Varnost zdravila ni raziskana pri psicah v obdobju laktacije in pri brejih mačkah in mačkah v obdobju laktacije.
The safety of the veterinary medicinal product has not been established in lactating dogs and in pregnant and lactating cats.
in Proteus mirabilis v vzorcih, izoliranih pri psih.
and Proteus mirabilis.
Zdravila ne uporabljajte v obdobju rasti ali v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi krče.
Do not use during the period of growth or in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures.
Z 1 BRIZGO IBAFLIN 7,5 % PERORALNEGA GELA / ZLOŽENKA S 5 BRIZGAMI IBAFLIN 7,5 % PERORALNEGA GELA
CARTON BOX FOR 1 SYRINGE IBAFLIN 7.5% ORAL GEL / CARTON BOX FOR 5 SYRINGES IBAFLIN 7.5% ORAL GEL
ZDRAVILA Peroralno, 15 mg ibafloksacina/kg 1-krat na dan.
Oral use, 15 mg ibafloxacin/kg once daily.
Pri psih doseže največjo raven v plazmi v 2 urah pri dajanju
In dogs the maximum plasma levels were observed at 2 hours when administered with or without food.
Varnost zdravila ni raziskana med laktacijo.
The safety of the veterinary medicinal product has not been established during lactation.
Ibaflin 7,5 %, peroralni gel: 75 mg ibafloksacina v 1 g gela (ustreza 78,8 mg/ml) Pomožne snovi
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S) Ibaflin 7.5% Oral Gel: 75 mg of ibafloxacin per g of gel (equivalent to 78.8 mg/ml) Excipients
Ibafloksacin je širokospektralen, baktericidni antibiotik iz skupine kinolonov.
Ibafloxacin is a broad spectrum bactericidal antibiotic from the quinolone group.
Varnost zdravila ni raziskana pri brejih mačkah ter pri psicah in mačkah v obdobju laktacije.
The safety of the veterinary medicinal product has not been established in pregnant cats and in lactating dogs and cats.
trženja za zdravilo, odobreno
MARKETING AUTHORISATION HOLDER
s pomikom objemke na ustrezno mesto na batu (brizga s 30 ml - stopnje po 1,0 ml).
The syringe should be adjusted to the calculated dosage by setting the ring on the appropriate place on the plunger (steps of 0.5 ml for the 15 ml syringe and 1.0 ml for the 30 ml syringe).
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ibaflin 3 %, peroralni gel za pse in mačke
NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel for dogs and cats
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ibaflin 3 %, peroralni gel
NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel
Ibaflin 3 %, peroralni gel: 30 mg ibafloksacina v 1 g gela (ustreza 30,9 mg/ml) Pomožne snovi
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S) Ibaflin 3% Oral Gel: 30 mg of ibafloxacin per g of gel (equivalent to 30.9 mg/ml); Excipients
0,5 ml gela na kg telesne mase
0.5 ml of gel per kg body weight
Farmakokinetični podatki
Pharmacokinetic particulars
Osebe z znano preobčutljivostjo za kinolone se morajo izogibati stiku z izdelkom.
Persons with known hypersensitivity to quinolones should avoid contact with the product.
Na veterinarski recept.
Veterinary medicinal product subject to prescription.
Številka dovoljenja za promet EU/2/00/022/09-12
Marketing Authorisation number(s) EU/2/00/022/09-12
Shranjujte nedosegljivo otrokom.
Keep out of the reach and sight of children.
Končna razpolovna doba izločanja iz plazme je približno 4 do 5 ur. Izloča se pretežno z urinom
Terminal plasma halflife is approximately 4-5 hours.
Kinolonov ne smemo uporabljati v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi konvulzije.
Quinolones should not be used in combination with nonsteroidal anti-inflammatory drugs (NSAID) in dogs with a history of seizures.
Varnost zdravila ni raziskana pri psicah v obdobju laktacije.
The safety of the veterinary medicinal product has not been established in lactating dog.
ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
Bela, nastavljiva večodmerna napolnjena brizga iz polietilena visoke gostote (HDPE, telo, bat in objemka)
White adjustable multidose pre-filled syringe consisting of high density polyethylene (HDPE, barrel, plunger and ring) and low density polyethylene (LDPE, cap and seal).
Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
DODATEK III
B. PACKAGE INSERT
in Salmonella spp., izolirane pri psih.
and Salmonella spp.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ibaflin 7,5 %, peroralni gel za pse
NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 7.5% oral gel for dogs