natgillin/translations-raw huggingface dataset:
The most abundant metabolite is 8-hydroxy-ibafloxacin, which is also microbiologically active.
Presnovek, ki nastaja v največji količini, je 8- hidroksi- ibafloksacin, ki je tudi mikrobiološko aktiven.
Ibafloxacin and 8-hydroxy-ibafloxacin act synergystically.
Ibafloksacin in 8- hidroksi- ibafloksacin delujeta sinergistično.
For ibafloxacin (parent compound), MIC values ranging from 0.032 – 0.5 µg/ ml are observed for canine isolates of E. coli, Staphylococcus spp., Proteus mirabilis, strains of Pasteurella spp. and Salmonella spp.
MIK ibafloksacina (matične spojine) so v razponu 0, 032 do 0, 5 µg/ ml za E. coli, Staphylococcus spp., Proteus mirabilis, seve Pasteurella spp. in Salmonella spp., izolirane pri psih..
4.2 Pharmacokinetic properties
4. 2 Farmakokinetične lastnosti
5.
2/ 45 5.
5.1 Target species
5. 1 Ciljna živalska vrsta
2/ 42 5.2 Indications for use
5. 2 Indikacije za uporabo
Acute, uncomplicated urinary tract infections, caused by susceptible strains of Staphylococci, Proteus spp., Enterobacter spp., E. coli and Klebsiella spp.
Dermalne okužbe (pioderma – površinska in globoka, rane, abscesi), ki jih povzročajo občutljivi sevi stafilokokov, E. coli in Proteus mirabilis Akutne, nezapletene okužbe sečil, ki jih povzročajo občutljivi sevi stafilokokov, Proteus spp., Enterobacter spp., E. coli in Klebsiella spp.
Respiratory tract infections (upper tract) caused by susceptible strains of Staphylococci, E. coli, and Klebsiella spp.
Okužbe dihalnih poti (zgornjih), ki jih povzročajo občutljivi sevi stafilokokov, E. coli in Klebsiella spp.
5.3 Contra-indications
5. 3 Kontraindikacije
Do not use in combination with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures.
Ne uporabljajte pri psih s krči v anamnezi.
5.4 Undesirable effects
5. 4 Neželeni učinki
5.5 Special precautions for use
5. 5 Posebni previdnostni ukrepi
5.6 Use during pregnancy and lactation
5. 6 Uporaba v obdobju brejosti in laktacije
5.7 Interactions with other medicinal products and other forms of interaction
5. 7 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
5.8 Posology and method of administration
3/ 45 5. 8 Odmerjanje in način uporabe
Oral use, 15 mg ibafloxacin/ kg once daily.
Peroralno, 15 mg ibafloksacina/ kg 1- krat na dan.
In most cases, a 10-day treatment course will be sufficient.
Večinoma zadošča 10- dnevno zdravljenje.
The following dosage scheme is advised:
Da bi zdravilo pravilno odmerili in da ne bi bil odmerek premajhen, je treba telesno maso določiti, kolikor je možno natančno.
Ibaflin 30 mg Ibaflin 150 mg 0.5 1 1.5 2 0.5 1 1.5
Ibaflin Ibaflin 30 mg 150 mg 0, 5 1 1, 5 2 0, 5 1 1, 5
Ibaflin mg 0.5 1
Ibaflin 900 mg 0, 5 1
5.9 Overdose
5. 9 Preveliko odmerjanje
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.
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.
5.10 Special warnings for each target species
5. 10 Posebna opozorila za vsako ciljno živalsko vrsto
See section 5.5 See section 5.6
Glejte poglavje 5. 6.
5.11 Withdrawal period
5. 11 Karenca
5.12 Special precautions to be taken by the person administering the veterinary medicinal product to animals
5. 12 Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki daje zdravilo živalim
6.1 Major incompatibilities
6. 1 Glavne inkompatibilnosti
6.2 Shelf life
4/ 45 6. 2 Rok uporabnosti
150mg and 300mg tablets:
Tablete po 150 mg in 300 mg:
4 years 30mg and 900mg tablets:
4 leta Tablete po 30 mg in 900 mg:
4/ 42 6.3 Special precautions for storage
Posebna navodila za shranjevanje
6.4 Nature and contents of container
6. 4 Vrsta in vsebina vsebnika
30 mg tablets: - Carton box with 20 or 100 tablets in PVC/ aluminium heat sealed blisters 150 mg tablets: - Carton box with 10, 20 or 100 tablets in PVC/ aluminium heat sealed blisters
- zloženka z 20 ali s 100 tabletami v zavarjenih pretisnih omotih iz pvc in aluminija
- Carton box with 10, 20 or 100 tablets in PVC/ PVDC/ aluminium blisters
- zloženka z 10, 20 ali s 100 tabletami v zavarjenih pretisnih omotih iz pvc in aluminija - zloženka z 10, 20 ali s 100 tabletami v pretisnih omotih iz pvc, pvdc in aluminija
300 mg tablets: - Carton box with 8, 16 or 80 tablets in PVC/ aluminium heat sealed blisters
Tablete 300 mg:
- Carton box with 8, 16 or 80 tablets in PVC/ PVDC/ aluminium blisters
- 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
900 mg tablets: - Carton box with 5, 25 or 50 tablets in PVC/ aluminium heat sealed blisters.
- zloženka s 5, 25 ali 50 tabletami v zavarjenih pretisnih omotih iz pvc in aluminija
6.5 Special precautions for the disposal of unused medicinal product or waste materials, if any
6. 5 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Intervet International BV Wim de Körverstraat 35 5831 AN BOXMEER Nizozemska
Prohibition of sale, supply and/ or use
Prepoved prodaje, oskrbe in/ ali uporabe
Marketing Authorisation number(s)
Številka( e) dovoljenj( a) za promet
Date of first authorisation/ renewal of the authorisation
Datum pridobitve/ podaljšanja dovoljenja za promet
Date of revision of the text
Datum zadnje revizije besedila
Ibaflin 3% oral gel for dogs and cats Ibaflin 7.5% oral gel for dogs
Ibaflin 3%, peroralni gel za pse in mačke Ibaflin 7, 5%, peroralni gel za pse
Each (pre-filled syringe of) Ibaflin Oral Gel contains:
1 (napolnjena brizga) Ibaflin peroralnega gela vsebuje:
Ibaflin 3% Oral Gel:
Ibaflin 3%, peroralni gel:
30 mg of ibafloxacin per g of gel (equivalent to 30.9 mg/ ml); Ibaflin 7.5% Oral Gel:
30 mg ibafloksacina v 1 g gela (ustreza 30, 9 mg/ ml) Ibaflin 7, 5%, peroralni gel:
75 mg of ibafloxacin per g of gel (equivalent to 78.8 mg/ ml)
75 mg ibafloksacina v 1 g gela (ustreza 78, 8 mg/ ml)
Methyl parahydroxybenzoate (0.125%)
Metilparahidroksibenzoat (0, 125%)
4.1 Pharmacodynamic properties:
4. 1 Farmakodinamične lastnosti
QJ 01 MA 96 Ibafloxacin is a broad spectrum antibiotic with bactericidal action resulting from inhibition of bacterial DNA gyrase.
Njegovo delovanje temelji na zaviranju bakterijske DNA- giraze.
The most abundant metabolite is 8-hydroxy-ibafloxacin, which is also microbiologically active. lbafloxacin and 8-hydroxy-ibafloxacin act synergistically.
Ibafloksacin in 8- hidroksi- ibafloksacin delujeta sinergistično.
For ibafloxacin (parent compound), MIC values ranging from 0.032 – 0.5 µg/ ml are observed for canine isolates of E. coli, Staphylococcus spp. and Proteus mirabilis.
MIK ibafloksacina (matične spojine) so v razponu 0, 032 do 0, 5 µg/ ml za E. coli, Staphylococcus spp. in Proteus mirabilis v vzorcih, izoliranih pri psih.
In cats, relevant susceptible micro-organisms are E. coli, Staphylococcus spp., Pasteurella spp., Proteus spp. and Klebsiella spp.
Pri mačkah so občutljivi mikroorganizmi E. coli, Staphylococcus spp., Pasteurella spp., Proteus spp. in Klebsiella spp.
(MIC ≤ 0.5 µg ibafloxacin/ ml).
(MIK ≤ 0, 5 µg/ ml ibafloksacina).
4.2 Pharmacokinetic properties:
4. 2 Farmakokinetične lastnosti
5.
6/ 45 5.
6/ 42 5.2 Indications for use
5. 2 Indikacije za uporabo
- Dermal infections (pyoderma – superficial and deep, wounds, abscesses) caused by susceptible
- dermalne okužbe (pioderma – površinska in globoka, rane, abscesi), ki jih povzročajo občutljivi
pathogens such as Staphylococcus spp, E. coli and Proteus mirabilis.
mikroorganizmi, kot so Staphylococcus spp., E. coli in Proteus mirabilis
- Dermal infections (soft tissue infections – wounds, abscesses) caused by susceptible pathogens
- dermalne okužbe (okužbe mehkega tkiva – rane, abscesi), ki jih povzročajo občutljivi
such as Staphylococcus spp, E. coli, Proteus spp. and Pasteurella spp.
mikroorganizmi, kot so Staphylococcus spp., E. coli, Proteus spp. in Pasteurella spp.
- Upper respiratory tract infections caused by susceptible pathogens such as Staphylococcus spp, E.
- okužbe zgornjih dihalnih poti, ki jih povzročajo občutljivi mikroorganizmi, kot so
coli, Klebsiella spp. and Pasteurella spp.
Staphylococcus spp., E. coli, Klebsiella spp. in Pasteurella spp.
5.3 Contraindications
5. 3 Kontraindikacije
Ibaflin 7.5% Oral Gel should not be used in cats.
Ibaflin 7, 5% peroralnega gela ne smemo dajati mačkam.
5.4 Undesirable effects (frequency and seriousness)
5. 4 Neželeni učinki (pogostost in resnost)
5.7 Interaction with other medicinal products and other forms of interaction
5. 7 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Fluoroquinolones should not be used in combination with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures..
Fluorokinolonov ne smemo uporabljati v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi konvulzije.
7/ 42 5.8 Posology and method of administration
7/ 45 5. 8 Odmerjanje in način uporabe
Oral use, 15 mg ibafloxacin/ kg bodyweight once daily.
Peroralno, 15 mg ibafloksacina/ kg telesne mase, 1- krat na dan.
Cats and dogs Dogs
Psi in mačke Psi
Ibaflin 3% Oral Gel Ibaflin 7.5% Oral Gel
Ibaflin 3% peroralni gel Ibaflin 7, 5% peroralni gel
0.5 ml of gel per kg body weight 1 ml of gel per 5 kg body weight.
0, 5 ml gela na kg telesne mase 1 ml gela na 5 kg telesne mase
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).
Brizgo je treba nastaviti na izračunani odmerek s pomikom objemke na ustrezno mesto na batu (brizga s 15 ml – stopnje po 0, 5 ml, brizga s 30 ml – stopnje po 1, 0 ml).
5.9 Overdose (symptoms, emergency procedures, antidotes)
5. 9 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi)
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.
Peroralno dajanje odmerkov ibafloksacina po 75 mg/ kg na dan (petkratni priporočeni odmerek) v obdobju 90 dni, so psi dobro prenašali.
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.
Pri zdravih mačkah je 30- dnevno dajanje Ibaflin peroralnega gela v odmerkih po 15 do 75 mg/ kg povzročilo bruhanje oz. regurgitacijo in slinjenje.
5.10 Special warnings for each target species
5. 10 Posebna opozorila za vsako živalsko vrsto
5.11 Withdrawal periods
5. 11 Karenca
5.12 Special precautions to be taken by the person administering the medicinal product to animals
5. 12 Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki daje zdravilo živalim
6.2 Shelf-life
6. 2 Rok uporabnosti
3 years Shelf-life after first opening:
3 leta Rok uporabnosti po prvem odpiranju vsebnika:
8/ 42 6.3 Special precautions for storage
Posebna navodila za shranjevanje
6.4 Nature and contents of container
8/ 45 6. 4 Vrsta in vsebina vsebnika
- carton box with 1 x 15 ml (0.5 ml steps) pre-filled syringe (Ibaflin 3% Oral Gel)
- - - -
- carton box with 5 x 15 ml (0.5 ml steps) pre-filled syringes (Ibaflin 3% Oral Gel)
zloženka z 1 napolnjeno brizgo s 15 ml (za nastavitev po 0, 5 ml) (Ibaflin 3% peroralni gel) zloženka s 5 napolnjenimi brizgami s 15 ml (za nastavitev po 0, 5 ml) (Ibaflin 3% peroralni gel) zloženka z 1 napolnjeno brizgo s 30 ml (za nastavitev po 1 ml) (Ibaflin 7, 5% peroralni gel) zloženka s 5 napolnjenimi brizgami s 30 ml (za nastavitev po 1 ml) (Ibaflin 7, 5% peroralni gel)
- carton box with 1 x 30 ml (1 ml steps) pre-filled syringe (Ibaflin 7.5% Oral Gel)
6. 5
6.5 Special precautions for the disposal of unused medicinal product or waste materials, if any
Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo
Any unused veterinary 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 nacionalnimi zahtevami.
Name and address of the marketing authorisation holder
Ime in naslov imetnika dovoljenja za promet
Marketing Authorisation number(s)
Številka dovoljenja za promet
9/ 42 ANNEX II
9/ 45 DODATEK II
MANUFACTURING AUTHORISATION FOR BATCH RELEASE
IMETNIK DOVOLJENJA
HOLDER
ZA
RESPONSIBLE
ODGOVOREN ZA SPROSTITEV SERIJE
STATEMENT OF THE MRLs
ZAOSTANKOVZDRAVILA (MRL)
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA SPROSTITEV SERIJE
Tablets Intervet GesmbH Siemensstrasse 107 A-1210 Wien Austria
Tablete Intervet GesmbH Siemensstrasse 107 A- 1210 Wien Avstrija
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Peroralni gel Intervet International bv Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
RESTRICTIONS REGARDING SUPPLY AND USE
POGOJI DOVOLJENJA ZA PROMET TER OMEJITVE GLEDE OSKRBE IN UPORABE
11/ 42 ANNEX III
11/ 45 DODATEK III
13/ 42 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
13/ 45 PODATKI NA ZUNANJI OVOJNINI
Ibaflin 30 mg tablets for dogs
Ibaflin 30 mg, tablete za pse
Read the package insert before use.
Peroralno, 15 mg/ kg telesne mase, 1- krat na dan Pred uporabo preberite priloženo navodilo.
(Month/ year)
(Mesec/ leto)
THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN"
BESEDILO ''ZDRAVILO SHRANJUJTE IZVEN DOSEGA IN POGLEDA OTROK''
Name and address of the Marketing Authorisation Holder Intervet International B. V.
Ime in naslov imetnika dovoljenja za promet Intervet International B. V.
Name and address of the Manufacturing Authorisation Holder responsible for batch release Intervet GesmbH Siemensstrasse 107 A-1210 Wien Austria
Ime in naslov imetnika dovoljenja za proizvodnjo, odgovornega za sproščanje serij Intervet GesmbH Siemensstrasse 107 A- 1210 Wien Avstrija
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
ŠTEVILKA (- E) V REGISTRU ZDRAVIL SKUPNOSTI
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
POGOJI ALI OMEJITVE GLEDE NAČINA/ REŽIMA IZDAJE IN UPORABE
16/ 42 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
16/ 45 PODATKI NA ZUNANJI OVOJNINI
Ibaflin 150 mg tablets for dogs
Ibaflin 150 mg, tablete za pse
10 tablets / 20 tablets / 100 tablets
10 tablet / 20 tablet / 100 tablet
9.
17/ 45 9.
SPECIAL WARNING(S), IF NECESSARY
POSEBNA OPOZORILA
Do not use in dogs with a weight of less than 3 kg.
Ne uporabljajte ga pri psih s telesno maso pod 3 kg.
17/ 42 10.
10.
16.
18/ 45 16.
EU/ 2/ 00/ 022/ 05-6 / EU/ 2/ 00/ 022/ 01a – b / EU/ 2/ 00/ 022/ 02a-b
EU/ 2/ 00/ 022/ 05- 6 / EU/ 2/ 00/ 022/ 01a– b / EU/ 2/ 00/ 022/ 02a– b
Veterinary medicinal product subject to prescription
Zdravilo se izda le na recept.
18/ 42 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
19/ 45 PODATKI NA ZUNANJI OVOJNINI
Ibaflin 300 mg tablets for dogs
Ibaflin 300 mg, tablete za pse
8 tablets / 16 tablets / 80 tablets
8 tablet / 16 tablet / 80 tablet
Pyoderma, superficial and deep, wounds, abscesses, acute uncomplicated urinary tract infections and upper respiratory tract infections.
Pioderma (površinska in globoka), rane, abscesi, akutne nezapletene okužbe sečil in zgornjih dihalnih poti
9.
20/ 45 9.
Do not use during the period of growth and in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures.
Zdravila ne uporabljajte v obdobju rasti ali v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi krče.
19/ 42 10.
10.
16.
21/ 45 16.
EU/ 2/ 00/ 022/ 07-8 / EU/ 2/ 00/ 022/ 03a-b / EU/ 2/ 00/ 022/ 04a-b
EU/ 2/ 00/ 022/ 07- 8 / EU/ 2/ 00/ 022/ 03a– b / EU/ 2/ 00/ 022/ 04a– b
20/ 42 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
22/ 45 PODATKI NA ZUNANJI OVOJNINI
Ibaflin 900 mg tablets for dogs
Ibaflin 900 mg, tablete za pse
5 tablets / 25 tablets / 50 tablets
5 tablet / 25 tablet / 50 tablet
9.
23/ 45 9.
Do not use during the period of growth and in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures.
Zdravila ne uporabljajte v obdobju rasti in v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi krče.
21/ 42 10.
10.
THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN"
BESEDILO ''ZDRAVILO SHRANJUJTE IZVEN DOSEGA IN POGLEDA OTROL''
Keep out of the reach and sight of of children.
Zdravilo shranjujte izven dosega in pogleda otrok.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA Z APROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
16.
24/ 45 16.
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
ŠTEVILKA V REGISTRU ZDRAVIL SKUPNOSTI
22/ 42 PARTICULARS TO APPEAR ON TABLET BLISTERS
25/ 45 PODATKI NA PRETISNIH OMOTIH ZA TABLETE
Ibaflin 30 mg tablets for dogs / Ibaflin 150 mg tablets for dogs / Ibaflin 300 mg tablets for dogs / Ibaflin 900 mg tablets for dogs
Ibaflin 30 mg, tablete za pse / Ibaflin 150 mg, tablete za pse / Ibaflin 300 mg, tablete za pse / Ibaflin 900 mg, tablete za pse
23/ 42 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
26/ 45 PODATKI NA ZUNANJI OVOJNINI
CARTON BOX FOR 1 SYRINGE IBAFLIN 3% ORAL GEL / CARTON BOX FOR 5 SYRINGES IBAFLIN 3% ORAL GEL
ZLOŽENKA Z 1 BRIZGO IBAFLIN 3% PERORALNEGA GELA / ZLOŽENKA S 5 BRIZGAMI IBAFLIN 3% PERORALNEGA GELA
Ibaflin 3% oral gel for dogs and cats.
Ibaflin 3%, peroralni gel za pse in mačke
STATEMENT OF ACTIVE SUBSTANCE AND OTHER SUBSTANCES
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
1 adjustable pre-filled multidose syringe, containing 15 ml. / Carton box containing 5 adjustable pre-filled multidose syringes, each containing 15 ml Ibaflin 3% oral gel.
1 nastavljiva, napolnjena večodmerna brizga s 15 ml / Zloženka s 5 nastavljivimi, napolnjenimi, večodmernimi brizgami s 15 ml Ibaflin 3% peroralnega gela
pathogens such as Staphylococcus spp., E. coli and Proteus mirabilis.
mikroorganizmi, kot so Staphylococcus spp., E. coli in Proteus mirabilis
such as Staphylococcus spp., E. coli, Proteus spp. and Pasteurella spp.
mikroorganizmi, kot so Staphylococcus spp., E. coli, Proteus spp. in Pasteurella spp.
- Upper respiratory tract infections caused by susceptible pathogens such as Staphylococcus spp., E.
- okužbe zgornjih dihalnih poti, ki jih povzročajo občutljivi mikroorganizmi, kot so
7.
27/ 45 7.
15 mg per kg bodyweight = 0.5 ml of gel per kg bodyweight Read the package insert before use.
Peroralno, 15 mg/ kg telesne mase, 1- krat na dan 15 mg/ kg telesne mase = 0, 5 ml gela/ kg telesne mase Pred uporabo preberite priloženo navodilo.
(Month/ year) Once opened use within 8 weeks
(Mesec/ leto) Načeto zdravilo porabite v 8 tednih.
Any unused veterinary product or waste material 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 nacionalnimi zahtevami.
15.
28/ 45 15.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IN THE EEA IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
Intervet International B. V.
Ime in naslov imetnika dovoljenja za proizvodnjo, odgovornega za sproščanje serij Intervet International B. V.
26/ 42 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
29/ 45 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
IBAFLIN 3% ORAL GEL ADJUSTABLE MULTIDOSE SYRINGE
NASTAVLJIVA VEČODMERNA BRIZGA IBAFLIN 3% PERORALNEGA GELA
Ibaflin 3% oral gel for dogs and cats
Ibaflin 3%, peroralni gel za pse in mačke
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
VSEBINA, IZRAŽENA S PROSTORNINO
Oral use, 15 mg per kg bodyweight once daily (i. e.
Peroralno, 15 mg/ kg telesne mase, 1- krat na dan (t. j.
Read the package insert before use.
0, 5 ml gela/ kg telesne mase) Pred uporabo preberite priloženo navodilo.
EXP {month/ year} > Once opened use within 8 weeks.
EXP {mesec/ leto} Načeto zdravilo porabite v 8 tednih.
27/ 42 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
30/ 45 PODATKI NA ZUNANJI OVOJNINI
CARTON BOX FOR 1 SYRINGE IBAFLIN 7.5% ORAL GEL / CARTON BOX FOR 5 SYRINGES IBAFLIN 7.5% ORAL GEL
ZLOŽENKA Z 1 BRIZGO IBAFLIN 7, 5% PERORALNEGA GELA / ZLOŽENKA S 5 BRIZGAMI IBAFLIN 7, 5% PERORALNEGA GELA
Ibaflin 7.5% oral gel for dogs.
Ibaflin 7, 5%, peroralni gel za pse
Carton box containing 1 adjustable pre-filled multidose syringe, containing 30 ml Ibaflin 7.5% oral gel. / Carton box containing 5 adjustable pre-filled multidose syringes, containing 30 ml Ibaflin 7.5% oral gel.
Zloženka z 1 nastavljivo, napolnjeno, večodmerno brizgo s 30 ml Ibaflin 7, 5% peroralnega gela / Zloženka s 5 nastavljivimi, napolnjenimi, večodmernimi brizgami s 30 ml Ibaflin 7, 5% peroralnega gela
15 mg per kg bodyweight = 1 ml of gel per 5 kg bodyweight Read the package insert before use.
Peroralno, 15 mg/ kg telesne mase, 1- krat na dan 15 mg/ kg telesne mase = 1 ml gela/ kg telesne mase Pred uporabo preberite priloženo navodilo.
SPECIAL WARNING(S), IF NECESSARY
POSEBNO( A) OPOZORILO( A), ČE JE (SO) POTREBNO( A)
(Month/ year) Once opened use within 8 weeks.
(Mesec/ leto) Načeto zdravilo porabite v 8 tednih.
29/ 42 Name and address of the Manufacturing Authorisation Holder responsible for batch release
32/ 45 Ime in naslov imetnika dovoljenja za proizvodnjo, odgovornega za sproščanje serij
30/ 42 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
33/ 45 PODATKI, KI OVOJNINAH
IBAFLIN 7.5% ORAL GEL ADJUSTABLE MULTIDOSE SYRINGE
NASTAVLJIVA VEČODMERNA BRIZGA IBAFLIN 7, 5% PERORALNEGA GELA
Ibaflin 7.5% oral gel for dogs
Ibaflin 7, 5%, peroralni gel za pse
Read the package insert before use.
1 ml gela/ 5 kg telesne mase) Pred uporabo preberite priloženo navodilo.
32/ 42 PACKAGE INSERT
35/ 45 NAVODILO ZA UPORABO
STATEMENT OF THE ACTIVE SUBSTANCE
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
Intervet International B. V.
Imetnik dovoljenja za promet Intervet International B. V.
Intervet GesmbH Siemensstrasse 107 A 1210 Vienna Austria
Imetnik dovoljenja za proizvodnjo, odgovoren za sproščanje serij Intervet GesmbH Siemensstrasse 107 A- 1210 Wien Avstrija
Acute, uncomplicated urinary tract infections, caused by susceptible strains such as Staphylococci, Proteus spp., Enterobacter spp., E. coli and Klebsiella spp.
Dermalne okužbe (pioderma – površinska in globoka, rane, abscesi), ki jih povzročajo občutljivi sevi, kot so stafilokoki, E. coli in Proteus mirabilis Akutne, nezapletene okužbe sečil, ki jih povzročajo občutljivi sevi, kot so stafilokoki, Proteus spp., Enterobacter spp., E. coli in Klebsiella spp.
DOSAGE FOR EACH SPECIES
ODMERJANJE ZA VSAKO ŽIVALSKO VRSTO
Ibaflin Ibaflin 30 mg 150 mg 0.5 1 1.5 2 0.5 1 1.5
Ibaflin Ibaflin 30 mg 150 mg 0, 5 1 1, 5 2 0, 5 1 1, 5
METHOD AND ROUTE OF ADMINISTRATION
NAČIN UPORABE IN DAJANJA ZDRAVILA
DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED
DATUM ZADNJE REVIZIJE NAVODIL ZA UPORABO
Target animal safety studies in beagle 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.
Študije varnosti za ciljno živalsko vrsto, izvedene pri psih, pasme beagle, 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.
35/ 42 PACKAGE INSERT FOR INCLUSION WITH THE 3% ORAL GEL SYRINGE PACKAGES
38/ 45 NAVODILO ZA UPORABO
Ibaflin 3% oral gel
Ibaflin 3%, peroralni gel
30 mg of ibafloxacin per g of gel (equivalent to 30.9 mg/ ml);
30 mg ibafloksacina v 1 g gela (ustreza 30, 9 mg/ ml)