natgillin/translations-raw huggingface dataset:
Annex II of Council Regulation (EEC) No 2377/ 90
Dodatek II Uredbe Sveta (EGS) No 2377/ 90
active substance a
Živalska vrsta
Animal Species
Druge
Other provisions
določbe
dl-α -tocopherol acetate b
dl- α- tokoferol acetata (vitamin kalijev kloridb (E508) kalijev dihidrogen fosfatc d
(Vitamin E)
E) (E340i)
All food-producing species
vse živali, namenjene za proizvodnjo živil vse živali, namenjene za proizvodnjo živil vse živali, namenjene za proizvodnjo živil
Potassium chloride Potassium dihydrogen phosphatec Sodium chlorided
vse živali, namenjene za proizvodnjo živil
(E508) (E340i)
(E339ii)
All food-producing species All food-producing species All food-producing species
vse živali, namenjene za proizvodnjo živil vse živali, namenjene za proizvodnjo živil
Disodium hydrogen phosphatee Polysorbate 80f
simetikong
(E339ii)
(dimetikon)
All food-producing species All food-producing species
vse živali, namenjene za proizvodnjo živil vse živali, namenjene za proizvodnjo živil
a b c d e f g h i
b c d e
Simethiconeg Mineral hydrocarbonsh Sorbitan mono-oleatei OJ No L122 of 12.05.99 OJ No L272 of 25.10.96 OJ No L272 of 25.10.96 OJ No L290 of 5.12.95 OJ No L272 of 25.10.96 OJ No L290 of 5.12.95 OJ No L290 of 5.12.95 OJ No L291 of 5.12.95 OJ No L272 of 25.10.96
L272 z dne 25. 10. 96
(Dimethicone)
g h i
All food-producing species All food-producing species All food-producing species
L272 z dne 25. 10. 96
11/ 34 ANNEX III
11/ 34 DODATEK III
13/ 34 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
13/ 34 PODATKI NA ZUNANJI OVOJNINI
Per dose of two ml:
V odmerku po 2 ml:
F4ab (K88ab) fimbrial adhesin F4ac (K88ac) fimbrial adhesin F5 (K99) fimbrial adhesin F6 (987P) fimbrial adhesin LT toxoid
Zdravilne učinkovine: najmanj 100 SR801 fimbrijski adhezin F4ab (K88ab) fimbrijski adhezin F4ac (K88ac) fimbrijski adhezin F5 (K99) fimbrijski adhezin F6 (987P) toksoid LT
at least 100 SR802 at least 100 SR80 at least 100 SR80 at least 100 SR80 at least 100 SR80
najmanj 100 SR80 najmanj 100 SR80 najmanj 100 SR80 najmanj 100 SR80
Liquid paraffin
tekoči parafin
IM injection of 2 ml
2 ml i. m.
EXP {month/ year} Once broached, use within 3 hours.
EXP {mesec/ leto} Načeto/ odprto zdravilo uporabite v 3 urah.
20 ml Glass 20 ml PET 50 ml Glass 50 ml PET
20 ml steklo 20 ml PET 50 ml steklo 50 ml PET
Batch:.......
Serija: ……….
15/ 34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 20 ml vial labels (EU/ 2/ 96/ 001/ 001 & EU/ 2/ 96/ 001/ 009 only)
15/ 34 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Nalepke na vialah po 20 ml (samo za EU/ 2/ 96/ 001/ 001 in EU/ 2/ 96/ 001/ 009)
IM injection
i. m.
Batch:......
Serija: ……….
16/ 34 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 50 ml vial labels (EU/ 2/ 96/ 001/ 002 & EU/ 2/ 96/ 001/ 010 only)
PRIMARNI OVOJNINI Nalepke na vialah po 50 ml (samo za EU/ 2/ 96/ 001/ 002 in EU/ 2/ 96/ 001/ 0010)
IM injection of 2 ml
Pred uporabo preberite navodila za uporabo.
Glass PET
steklo PET
Batch:.......
Serija: ………
18/ 34 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
18/ 34 PODATKI NA ZUNANJI OVOJNINI 20 ml & 50 ml (EU/ 2/ 96/ 001/ 003, EU/ 2/ 96/ 001/ 006, EU/ 2/ 96/ 001/ 004 & EU/ 2/ 96/ 001/ 007)
dl-α -tocopherol acetate
dl- alfa- tokoferol acetat
EU/ 2/ 96/ 001/ 003 EU/ 2/ 96/ 001/ 006 EU/ 2/ 96/ 001/ 004 EU/ 2/ 96/ 001/ 007 EU/ 2/ 96/ 001/ 005 EU/ 2/ 96/ 001/ 008
EU/ 2/ 96/ 001/ 003 EU/ 2/ 96/ 001/ 006 EU/ 2/ 96/ 001/ 004
20 ml Glass 20 ml PET 50 ml Glass 50 ml PET 100 ml Glass 100 ml PET
20 ml steklo 20 ml PET 50 ml steklo
20/ 34 PARTICULARS TO APPEAR ON THE OUTER PACKAGE 20 ml & 50 ml (EU/ 2/ 96/ 001/ 003, EU/ 2/ 96/ 001/ 004, EU/ 2/ 97/ 001/ 006 & EU/ 2/ 96/ 001/ 007)
20/ 34 PODATKI NA ZUNANJI OVOJNINI 100 ml (EU/ 2/ 96/ 001/ 005 & EU/ 2/ 96/ 001/ 008)
EU/ 2/ 96/ 001/ 003 EU/ 2/ 96/ 001/ 006 EU/ 2/ 96/ 001/ 004 EU/ 2/ 96/ 001/ 007
EU/ 2/ 96/ 001/ 005 EU/ 2/ 96/ 001/ 008
20 ml Glass 20 ml PET 50 ml Glass 50 ml PET
100 ml steklo 100 ml PET
Veterinary medicinal product subject to prescription.
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z nacionalnimi zahtevami.
22/ 34 PARTICULARS TO APPEAR ON THE OUTER PACKAGE 100 ml (EU/ 2/ 96/ 001/ 005 & EU/ 2/ 96/ 001/ 008)
22/ 34 PODATKI NA ZUNANJI OVOJNINI
100 ml (50 doses)
20 ml (10 odmerkov) 50 ml (25 odmerkov) 100 ml (50 odmerkov)
EU/ 2/ 96/ 001/ 005 EU/ 2/ 96/ 001/ 008
EU/ 2/ 96/ 001/ 003 EU/ 2/ 96/ 001/ 006 EU/ 2/ 96/ 001/ 004 EU/ 2/ 96/ 001/ 07 EU/ 2/ 96/ 001/ 005 EU/ 2/ 96/ 001/ 008
100 ml Glass 100 ml PET
20 ml steklo 20 ml PET 50 ml steklo 50 ml PET 100 ml steklo 100 ml PET
24/ 34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 20 ml vial labels (EU/ 2/ 96/ 001/ 003 & EU/ 2/ 96/ 001/ 006 only)
24/ 34 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Nalepke na vialah po 20 ml (samo za EU/ 2/ 96/ 001/ 003 in EU/ 2/ 96/ 001/ 006)
25/ 34 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 50 ml & 100 ml vial labels (EU/ 2/ 96/ 001/ 004, EU/ 2/ 96/ 001/ 005, EU/ 2/ 97/ 001/ 007 & EU/ 2/ 96/ 001/ 008 only)
PRIMARNI OVOJNINI Nalepke na vialah po 50 ml in 100 ml (samo za EU/ 2/ 96/ 001/ 004, EU/ 2/ 96/ 001/ 005, EU/ 2/ 97/ 001/ 0007 in EU/ 2/ 96/ 001/ 008)
50 ml Glass 50 ml PET 100 ml Glass 100 ml PET
50 ml steklo 50 ml PET 100 ml steklo 100 ml PET
28/ 34 PACKAGE LEAFLET FOR
28/ 34 NAVODILO ZA UPORABO ZA
Each dose (2 ml) of Porcilis Porcoli vaccine contains at least 100 SR803 each of the following components: the Escherichia coli LT toxoid and the Escherichia coli adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) and F6 (987P) in 941.4 mg liquid paraffin as adjuvant.
En odmerek (2 ml) cepiva Porcilis Porcoli vsebuje najmanj 100 SR801 vsake od naslednjih sestavin: toksoida LT Escherichie coli in adhezinov Escherichie coli F4ab (K88ab), F4ac (K88ac), F5 (K99) in F6 (987P) v 941, 4 mg tekočega parafina kot adjuvansa.
For the passive immunisation of piglets by active immunisation of sows and gilts to reduce mortality and clinical signs of neonatal enterotoxicosis, caused by those E. coli, which express the adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P), during the first days of life.
S tem se zmanjša smrtnost in klinični znaki neonatalne enterotoksikoze pujskov prve dni po rojstvu, ki jo povzročajo sevi E. coli, ki izločajo adhezine F4ab (K88ab), F4ac (K88ac), F5 (K99) ali F6 (987 P).
3 SR80= sero-response in 80% of vaccinated rabbits
1 SR80 = serološki odziv pri 80% vakciniranih kuncev
Basic vaccination:
Shema cepljenja:
A single revaccination should be carried out prior to each farrowing.
Revakcinacija: en odmerek pred vsako prasitvijo.
Before using the vaccine allow it to reach room temperature (15-25°C) and shake vigorously before use.
Pred uporabo počakajte, da se cepivo ogreje na sobno temperaturo (15 - 25 ºC) in ga dobro pretresite.
Store in a refrigerator (+2°C to +8°C).
Shranjujte na temnem mestu pri temperaturi +2 - +8 ºC.
Protect from light.
Cepivo ne sme zmrzniti.
Shelf-life after first opening:
Odprte viale:
It is therefore recommended that no other vaccine should be administered concurrently with the product.
Zato sočasno ni priporočljivo uporabljati drugih cepiv.
Do not mix with any other product.
Ne mešajte z drugimi zdravili.
In case of accidental self-injection, seek medical advice immediately and show the package insert or label to the physician.
V primeru nenamernega samo- injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
Any unused veterinary medical product or waste material derived from such veterinary medical 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.
The fimbrial adhesins F4ab, F4ac, F5 and F6 are responsible for the adhesion and the virulence of E. coli strains, which cause neonatal enterotoxicosis in piglets.
Fimbrijski adhezini F4ab, F4ac, F5 in F6 povzročajo virulenco sevov E. coli, ki so povzročitelji neonatalne enterotoksikoze pujskov.
These immunogens are incorporated in an adjuvant in order to enhance a prolonged stimulation of immunity.
Imunogeni so vgrajeni v emulzijo vode v olju, kar podaljša stimulativni učinek na razvoj imunosti.
31/ 34 PACKAGE LEAFLET FOR
31/ 34 NAVODILO ZA UPORABO ZA
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
NAVEDBA ZDRAVILNE UČINKOVIN( E) IN DRUGE( IH) SESTAVIN( E)
Each dose of two ml contains the F4ab (K88ab) fimbrial adhesin, the F4ac (K88ac) fimbrial adhesin, the F5 (K99) fimbrial adhesin, the F6 (987P) fimbrial adhesin and of LT toxoid, which induce a mean antibody titre of respectively ≥ 9.0 log2 Ab titre, ≥ 5.4 log2 Ab titre, ≥ 6.8 log2 Ab titre, ≥ 7.1 log2 Ab titre, and 6.8 log2 Ab titre after vaccination of mice with a 1/ 20 sow dose.
En odmerek po dva ml vsebuje fimbrijski adhezin F4ab (K88ab), fimbrijski adhezin F4ac (K88ac), fimbrijski adhezin F5 (K99), fimbrijski adhezin F6 (987P) in toksoid LT, ki spodbudijo srednji titer protiteles ≥ 9, 0 log2 titra protiteles, ≥ 5, 4 log2 titra protiteles, ≥ 6, 8 log2 titra protiteles, ≥ 7, 1 log2 titra protiteles in 6, 8 log2 titra protiteles po cepljenju miši z 1/ 20 odmerka za svinje.
The antigens are adjuvanted with 150 mg dl-α -tocopherol acetate per dose.
En odmerek antigenov vsebuje 150 mg dl- α- tokoferol acetate kot adjuvans.
Pigs (sows/ gilts)
Prašiči (svinje in mladice)
32/ 34 8.
32/ 34 8.
- Before using the vaccine allow it to reach room temperature.
- Pred uporabo počakajte, da se cepivo ogreje na sobno temperaturo.
- Shake well before use.
- Pred uporabo dobro pretresite.
- Use sterile syringes and needles.
- Uporabite sterilne brizge in igle.
Store in a refrigerator (+2°C to +8°C).
Shranjujte pri temperaturi +2 - +8 ºC.
Shelf-life after first opening:
Rok uporabnosti po prvem odpiranju:
In the case of accidental self-injection, seek medical advice immediately and show the package insert or label to the physician.
V primeru nenamernega samo- injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
Posatex is an ear drop suspension, white to off white in colour.
Zdravilo Posatex so kapljice za uho v obliki suspenzije bele do sivo- bele barve.
It is available in three pack sizes; 8.8, 17.5 and 35.1 ml bottles for dogs.
Na voljo je v treh oblikah pakiranja: stekleničkah po 8, 8, 17, 5 in 35, 1 ml za pse.
They often lead to the ear(s) being inflamed (red, swollen and itchy).
Pogosto povzročijo, da se uho( ušesa) vname( jo) (postanejo rdeča, zatečena in srbeča).
It works by blocking an enzyme called ‘ DNA gyrase’, which is important in allowing bacteria to make copies of their DNA.
Deluje tako, da zavira enzim, imenovan „ DNK giraza “, ki bakterijam omogoča, da izdelajo kopije svojega DNK.
Two large field trials were conducted one in Europe and one in the USA.
Dve večji preskušanji na terenu sta bila izvedeni eno v Evropi in eno v ZDA:
In both studies the effectiveness of Posatex was compared with that of ear drops containing three similar active substances.
V obeh študijah so učinkovitost zdravila Posatex primerjali z učinkovitostjo kapljic za uho, ki vsebujejo tri podobne zdravilne učinkovine.
Posatex at the recommended dose and following 7 days of treatment was as effective as the comparator medicine in improving the symptoms (redness, swelling, ear discharge, discomfort) of ear infections in dogs with acute or recurrent bacterial or fungal infections.
Zdravilo Posatex je bilo v priporočenem odmerku in po 7- dnevnem zdravljenju enako učinkovito kot primerjalno zdravilo pri izboljševanju simptomov (pordelost, otekanje, izcedek iz ušesa, nelagodnost) vnetij ušesa pri psih z akutnimi ali ponavljajočimi bakterijskimi ali glivičnimi vnetji.
The European Commission granted a marketing authorisation valid throughout the European Union, for Posatex to S-P Veterinary, United Kingdom on 23/ 06/ 2008.
Evropska komisija je dovoljenje za promet z zdravilom Posatex, veljavno po vsej Evropski uniji, odobrila družbi S- P Veterinary, Združeno kraljestvo, dne 23. 06. 2008.
Route of administration
Ciljne živalske vrste
Content
Vrsta ovojnine Vsebina
Orbifloxacin 8.5 mg/ ml Mometasone furoate (as monohydrate) 0.9 mg/ ml Posaconazole 0.9 mg/ ml
Orbifloksacin 8. 5 mg/ ml Mometazon furoat (kot monohidrat) 0. 9 mg/ ml Posakonazol 0. 9 mg/ ml
Bottle (HDPE)
Za zdravljenje ušes
8.8 ml
Polietilenska 8. 8 ml plastenka
17.5 ml
Polietilenska 17. 5 ml plastenka
Orbifloxacin 8.5 mg/ ml Ear drops, Mometasone furoate (as suspension monohydrate) 0.9 mg/ ml Posaconazole 0.9 mg/ ml
Orbifloksacin 8. 5 mg/ ml Mometazon furoat (kot monohidrat) 0. 9 mg/ ml Posakonazol 0. 9 mg/ ml
Orbifloxacin Mometasone furoate (as monohydrate) Posaconazole
Orbifloksacin Mometazon furoat (kot monohidrat) Posakonazol
8.5 mg/ ml 0.9 mg/ ml 0.9 mg/ ml
8. 5 mg/ ml 0. 9 mg/ ml 0. 9 mg/ ml
Ear drops suspension White to off-white oily suspension
Kapljice za uho, suspenzija Bela do sivo bela oljna suspenzija
Do not use in case of hypersensitivity to any of the ingredients of the veterinary medicinal product, to corticosteroids, to other azole antifungal agents and to other fluoroquinolones.
Ne uporabite v primeru preobčutljivosti na katero koli zdravilno učinkovino v zdravilu kortikosteroide, druga protiglivična zdravila iz skupine azolov in druge fluorkinolone.
See section 4.7 (Use during pregnancy, lactation) of this SPC.
Glej poglavje 4. 7 (Uporaba v obdobju brejosti, laktacije ali nesnosti)
4.4 Special warnings
ali na
Bacterial and fungal otitis is often secondary in nature.
Posebna opozorila za ciljno živalsko vrsto
The underlying cause should be identified and treated.
Za postavitev pravilne diagnoze je potrebno ugotoviti primarni vzrok vnetja, ker so bakterije in glivice pogosto le sekundarni vzrok, ki povzroči vnetje zunanjega sluhovoda.
2/ 18 4.5 Special precautions for use
4. 5 Posebni previdnostni ukrepi
It is prudent to reserve fluoroquinolones for the treatment of clinical conditions, which have responded poorly or are expected to respond poorly to other classes of antibiotics.
Pomembno je da uporabimo fluorkinolone za zdravljenje takšnih kliničnih stanj, ki so slabo reagirala oz. predvidevamo, da bodo slabo odreagirala na zdravljenje z drugimi skupinami antibiotikov.
Use of the product should be based on susceptibility testing of isolated bacteria, and/ or other appropriate diagnostic tests.
2/ 18 Za uporabo tega zdravila se odločamo na osnovi testa občutljivosti izoliranih bakterij in/ ali katerega drugega primernega diagnostičnega testa.
Quinolone class drugs have been associated with cartilage erosions in weight-bearing joints and other forms of arthropathy in immature animals of various species.
Kinolone povezujejo z erozijo hrustanca na sklepih nog in drugimi artropatijami pri še nerazvitih živalih( mladičih) različnih vrst.
See section 4.10 Overdose.
Glej poglavje 4. 10 (Preveliko odmerjanje)
Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum is not perforated in order to avoid the risk of transmission of the infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus.
S tem se izognemo možnosti širjenja vnetja v srednje uho in preprečimo poškodbe, ki lahko nastanejo na ušesnem polžu in ušesnem preddvoru.
Wash hands carefully after applying the veterinary medicinal product.
Roke si je potrebno po ravnanju s kapljicami umiti.
In case of accidental exposure, rinse the affected area with copious quantities of water.
V kolikor pridejo kapljice v stik s kožo to mesto speremo z veliko količino vode.
4.7 Use during pregnancy, lactation
4. 7 Uporaba v obdobju brejosti, laktacije ali nesnosti
Do not use during the whole or part of the pregnancy.
Uporaba ni priporočljiva (v celotnem ali delnem obdobju brejosti).
Laboratory studies in puppies have shown evidence of arthropathy after systemic administration of orbifloxacin.
Laboratorijske študije, ki so jih opravili na mladičih so pokazale, da orbifloksacin, če ga uporabljamo sistemsko povzroča artropatije.
Compatibility with ear cleaners has not been demonstrated.
Kompatibilnost s sredstvi za čiščenje ušes ni bila dokazana.
Concurrent use with an ear cleaner with a high pH is not recommended.
Sočasno uporabo s sredstvom za čiščenje ušes, ki ima visok pH ne priporočamo.
3/ 18 4.9 Amounts to be administered and administration route
4. 9 Odmerjanje in način uporabe
Auricular use.
Za zdravljenje ušes.
One drop contains 244 µg orbifloxacin, 24 µg mometasone furoate and 24 µg posaconazole.
Ena kapljica vsebuje 244 µg orbifloksacina, 24 µg mometazon furoata and 24 µg posakonazola.
Shake the bottle thoroughly before use.
Pred uporabo stekleničko dobro pretresite.
Dogs weighing under 2 kg, apply 2 drops to the ear once a day.
Psom s telesno maso do 2 kg dajemo 2 kapljici zdravila v sluhovod enkrat dnevno.
Dogs weighing 2-15 kg, apply 4 drops to the ear once a day.
Psom s telesno maso od 2do 15 kg dajemo 4 kapljice zdravila v sluhovod enkrat dnevno.
Use at room temperature (do not instill cold material into the ear).
(Ne dajajte hladnega zdravila v uho.)
After application, the base of the ear may be massaged briefly and gently to allow the preparation to penetrate the lower part of the ear canal.
Po dajanju zdravila se naj bazo ušesa zmasira, da se omogoči delovanje zdravila tudi v globljih delih sluhovoda.
Administration of the recommended dose (4 drops per ear) 5 times daily for 21 consecutive days to dogs weighing 7.6 to 11.4 kg bodyweight caused a slight decrease in serum cortisol response after adrenocorticotropic hormone (ACTH) administration in an ACTH stimulation test.
Uporaba priporočenega odmerka (4 kapljice na uho) petkrat dnevno 21 zaporednih dni, je pri psih težkih 7, 6 do 11, 4 kg po adrenokortikotropični hormonski stimulaciji povzročila rahel padec serumske koncentracije kortizola.
Otologic - Corticosteroids and anti-infectives in combination.
Zdravila za ušesne bolezni - kortikosteroidi in antibiotiki v kombinaciji.
QS02CA91
Oznaka ATC vet: QS02CA91
The bactericidal action of orbifloxacin results from interference with the enzymes DNA topoisomerase II (DNA-gyrase) and DNA topoisomerase IV which are needed for the synthesis and maintenance of bacterial DNA.
Orbifloksacin je sintetični širokospektralni baktericidni antibiotik derivat kinolonske karboksilne kisline iz vrste fluorkinolonov. Baktericidno delovanje orbifloksacina je posledica motenega delovanja encima DNA topoizomeraze II (DNA giraza) in encima DNA topoizomeraze IV, ki sta potrebna za sintezo in vzdrževanje bakterijske DNA.
The mechanism by which posaconazole exerts fungicidal action involves the selective inhibition of the enzyme lanosterol 14-demethylase (CYP51) involved in ergosterol biosynthesis in yeasts and filamentous fungi.
Njegovo delovanje je vezano na selektivno inhibicijo encima lanosterol 14- demetilaza (CYP51), ki sodeluje pri biosintezi ergosterola pri kvasovkah in glivicah.
Posaconazole is 40– 100 times more potent in vitro against Malassezia pachydermatis than clotrimazole, miconazole and nystatin.
Posakonazol je in vitro 40- 100 krat bolj učinkovit proti Malassezia pachydermatis kot klotrimazol, mikonazol in nistatin.
4/ 18 Resistance to fluoroquinolones occurs by chromosomal mutation with three mechanisms: decrease of the bacterial wall permeability, expression of efflux pump, or mutation of enzymes responsible for the molecule’ s binding site.
Do rezistence na fluorkinolone pride zaradi treh mehanizmov, ki sodelujejo pri mutaciji kromosomov: zmanjšanje prepustnosti bakterijske stene, delovanja efflux črpalke in pa mutacije encima odgovornega za vezavo molekul.
The in vitro activity of orbifloxacin against pathogens isolated from clinical cases of canine otitis externa in an EU field trial conducted in 2000-2001 was:
V klinični študiji opravljeni pri psih, v letih 2000- 2001 na območju EU je bil učinek orbifloksacina in vitro na bakterije, ki so bile izolirane pri vnetjih zunanjega sluhovoda sledeč:
Minimum Inhibitory Concentrations vs.
4/ 18 Minimalna inhibitorna koncentracija vs.
N 10 19 9 18 96 19
N 10 11
Min 0.06 0.250 0.5 1 0.25 2
Min 0. 250 0. 06
Systemic absorption of the active ingredients was determined in single-dose studies with [14C]-orbifloxacin, [3H]-mometasone furoate and [14C]-posaconazole contained within the Posatex formulation and placed into the ear canals of normal Beagle dogs.
Sistemska absorbcija aktivnih učinkovin je bila dokazana v študiji, kjer so uporabili Posatex, ki je vseboval [14C] - orbifloksacin, [3H] - mometazon furoat and [14C] - posakonazol in ga dali v sluhovod zdravega psa, pasme Beagle.
Paraffin, Liquid Plasticised hydrocarbon gel (5% polyethylene in 95% mineral oil).
Parafinsko olje Plastificiran ogljikovodikov gel (5% polietilen in 95% mineralno olje)
Shelf-life after first opening the immediate packaging:
Rok uporabnosti zdravila po prvem odpiranju vsebnika:
Store in a refrigerator (2 °C – 8 °C).
Shranjujte v hladilniku (2°C - 8°C).
Once opened do not store above 25 °C.
Po odprtju ne shranjujte pri temperaturi nad 25 °C.
White opaque HDPE bottle with a white LDPE cap, a natural or white LDPE applicator and a sheath.
Bela neprozorna polietilenske plastenka z nastavkom za dajanje v uho.
Bottle sizes:
Velikost plastenk:
8.8, 17.5 and 35.1 ml.
8, 8; 17, 5 in 35, 1 ml.
5/ 18 Not all pack sizes may be marketed.
Ni nujno, da so v prometu vsa pakiranja.
6/ 18 ANNEX II
6/ 18 DODATEK II
S-P Bray Boghall Road County Wicklow Ireland
S- P Bray Boghall Road County Wicklow Irska
8/ 18 ANNEX III
8/ 18 DODATEK III
10/ 18 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 18 PODATKI NA ZUNANJI OVOJNINI PODATKI NA STIČNI OZ.
Bottle containing 8.8, 17.5 or 35.1 ml.
Plastenke vsebujejo 8. 8, 17. 5 or 35. 1 ml
Posatex ear drops suspension 8.5 mg orbifloxacin, 0.9 mg mometasone furoate (as the monohydrate) and 0.9 mg posaconazole per ml for dogs.
Posatex kapljice za uho, suspenzija za pse 8. 5 mg orbifloksacin, 0. 9 mg mometazon furoat (kot monohidrat) in 0. 9 mg posakonazol v ml
8.5 mg/ ml orbifloxacin, 0.9 mg/ ml mometasone furoate (as monohydrate) and 0.9 mg/ ml posaconazole.
8. 5 mg/ ml orbifloksacin, 0. 9 mg/ ml mometazon furoat (kot monohidrat) in 0. 9 mg/ ml posakonazol
PACKAGE SIZE
8. 8 ml 17. 5 ml 35. 1 mL
8.8 ml 17.5 ml 35.1 ml
CILJNA ŽIVALSKA VRSTA
5.
Psi
Treatment of acute external otitis, and acute exacerbations of recurrent external otitis.
Zdravljenje akutnih vnetij in akutnih poslabšanj kroničnih vnetij zunanjega sluhovoda.
For auricular use only.
Samo za zdravljenje ušes.
EXP {2 digits / year} Once opened use within 28 days.
Načeto zdravilo uporabite v 28dneh.
Store in a refrigerator Once opened do not store above 25º C.
Po odprtju ne shranjujte pri temperaturi nad 25 °C.
12/ 18 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
12/ 18 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
4.
KARENCA
For auricular use only.
Ni smiselna.
BATCH NUMBER
Številka serije:
Batch {number}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
7.
EXP:
EXP {2 digits/ year} Once opened use within 28 days.
Načeto zdravilo uporabite v 28 dneh.
14/ 18 PACKAGE LEAFLET Posatex ear drops suspension 8.5 mg orbifloxacin, 0.9 mg mometasone furoate (as the monohydrate) and 0.9 mg posaconazole per ml for dogs.
14/ 18 NAVODILO ZA UPORABO
Marketing authorisation holder
Imetnik dovoljenja za promet z zdravilom:
S-P Bray Boghall Road Bray County Wicklow Ireland
Schering Plough Boghall Road Bray, County Wicklow Irska
Posatex ear drops suspension 8.5 mg orbifloxacin, 0.9 mg mometasone furoate (as the monohydrate) and 0.9 mg posaconazole per ml for dogs.
Posatex kapljice za uho, suspenzija 8. 5 mg orbifloksacin, 0. 9 mg mometazon furoat (kot monohidrat) in 0. 9 mg posakonazol v ml
8.5 mg/ ml orbifloxacin, 0.9 mg/ ml mometasone furoate (as monohydrate) and 0.9 mg/ ml posaconazole.
8. 5 mg orbifloksacin, 0. 9 mg mometazon furoat (kot monohidrat) in 0. 9 mg posakonazol v ml
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER POT( I) IN NAČIN UPORABE ZDRAVILA
With dogs weighing under 2 kg, apply 2 drops to the ear once a day.
Psom s telesno maso do 2 kg dajemo 2 kapljici zdravila v sluhovod enkrat dnevno.