FrancophonIA/ELRC3.0 huggingface dataset:
English: Using aseptic technique, dilute by adding 0.2 mL of sodium chloride 9 mg/mL (0.9%) solution for injection (sterile, preservative-free, non-buffered) into the JETREA vial and gently swirl the vial until the solutions are mixed.
Slovenian: dodajte 0,2 ml 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) za injiciranje (sterilno, brez konzervansov in pufrov), da jo razredčite in vialo nežno obračajte, dokler ni raztopina premešana.
English: After dilution, 0.1 mL contains 0.125 mg ocriplasmin.
Slovenian: Po redčenju 0,1 ml raztopine vsebuje 0,125 mg okriplazmina.
English: In the integrated data, 26.5% in the JETREA group compared with 10.1% in the placebo group achieved VMA resolution at Day 28 (p<0.001).
Slovenian: 10,1 % bolnikov v skupini s placebom 28. dan doseglo odpravo VMA (p <0,001).
English: See section 4.4 of the Summary of Product Characteristics for instructions on post-injection monitoring.
Slovenian: Za navodila za spremljanje po injiciranju glejte poglavje 4.4 Povzetka glavnih značilnosti zdravila.
English: Macular hole
Slovenian: OVOJNINAH VIALA
English: After dilution with 0.2 mL of sodium chloride solution, 0.1 mL of the diluted solution contains 0.125 mg of ocriplasmin.
Slovenian: Po redčenju z 0,2 ml raztopine natrijevega klorida vsebuje 0,1 ml razredčene raztopine 0,125 mg okriplazmina.
English: Common
Slovenian: Skupaj
English: Once completely thawed, remove the protective orange polypropylene flip-off cap from the vial.
Slovenian: S povsem odmrznjene viale odstranite zaščitno oranžno polipropilensko odmično zaporko.
English: Transient increases in IOP including transient blindness and non-perfusion of the optic nerve have been seen within 60 minutes of injection of JETREA.
Slovenian: V roku 60 minut po injiciranju zdravila JETREA so opazili prehodno zvišanje očesnega tlaka, vključno s prehodno slepoto in ne-perfundiranostjo vidnega živca.
English: Replace the needle with an appropriate sterile needle, carefully expel the excess volume from the syringe by slowly depressing the plunger so that the plunger tip aligns with the 0.1 mL line on the syringe (corresponding to 0.125 mg ocriplasmin) (Figure 6).
Slovenian: Iglo zamenjajte z ustrezno sterilno iglo, previdno iztisnite presežek volumna iz injekcijske brizge s počasnim pritiskanjem bata tako, da vrh bata poravnate s črto, ki označuje 0,1 ml na injekcijski brizgi (ustreza 0,125 mg okriplazmina) (slika 6).
English: Progression rates after Month 6, however, were higher in sham or placebo than in those treated with JETREA.
Slovenian: Vendar so bile pogostnosti napredovanja po 6 mesecih višje pri bolnikih, zdravljenih navidezno ali s placebom,
English: Replace the needle with an appropriate sterile needle, carefully expel the excess volume from the syringe by slowly depressing the plunger so that the plunger tip aligns with the 0.1 mL line on the syringe (corresponding to 0.125 mg ocriplasmin) (Figure 4).
Slovenian: Iglo zamenjajte z ustrezno sterilno iglo, previdno iztisnite presežek volumna iz injekcijske brizge s počasnim pritiskanjem bata tako, da vrh bata poravnate s črto, ki označuje 0,1 ml na injekcijski brizgi (ustreza 0,125 mg okriplazmina) (slika 4).
English: How Jetrea is given
Slovenian: Kako se daje zdravilo Jetrea
English: Retinal breaks (tears and detachment)
Slovenian: Razpoka mrežnice (raztrganje in odstop)
English: Replace the needle with an appropriate sterile needle, carefully expel the excess volume from the syringe by slowly depressing the plunger so that the plunger tip aligns with the 0.1 mL line on the syringe (corresponding to 0.125 mg ocriplasmin).
Slovenian: Iglo zamenjajte z ustrezno sterilno iglo, previdno iztisnite presežek volumna iz injekcijske brizge s počasnim pritiskanjen bata tako, da vrh bata poravnate s črto, ki označuje 0,1 ml na injekcijski brizgi (ustreza 0,125 mg okriplazmina).
English: Description of selected adverse reactions
Slovenian: Opis izbranih neželenih učinkov Zmanjšana ostrina vida
English: Once completely thawed, remove the protective blue polypropylene flip-off cap from the vial.
Slovenian: S povsem odmrznjene viale odstranite zaščitno modro polipropilensko odmično zaporko.
English: Uncommon side effects (may affect up to 1 in 100 patients): - transient severe decreased vision - difficulty in seeing well at night or in dim light - disturbance in your eye's reaction to the light that may increase your sensitivity to light (pupillary reflex impaired) - double vision - accumulation of blood in the front part of the eye - abnormal constriction of the pupil (black part in the centre of the eye) - different sized pupils - a scratch or scrape of the cornea (transparent layer that covers the front of the eye)
Slovenian: - težave z vidom ponoči ali pri zatemnitvi - motnja v odzivu vaših oči na svetlobo, ki lahko poveča občutljivost na svetlobo (zmanjšan refleks zenice) - dvojni vid
English: (17.1% and 6.4%) (p=0.003 and p=0.024, respectively).
Slovenian: (neodvisno od vitrektomije) v 6. mesecu (28,0 oz. 12,3 %) v primerjavi z bolniki, zdravljenimi s placebom (17,1 % oz. 6,4 %) (p = 0,003 oz. p = 0,024).
English: The difference continued to be statistically significant through Month 6 in each study (p≤0.024).
Slovenian: Razlika je bila še naprej v obeh študijah statistično pomembna do 6. meseca
English: One vial of Jetrea contains 0.375 mg of ocriplasmin in 0.3 mL solution.
Slovenian: Ena viala zdravila Jetrea vsebuje 0,375 mg okriplazmina v
English: Inject 0.1 mL of the solution immediately into the mid-vitreous.
Slovenian: Takoj injicirajte 0,1 ml raztopine v sredino steklovine.
English: No reproductive toxicology studies have been performed.
Slovenian: Študij toksičnosti o vplivu zdravila na sposobnost razmnoževanja niso izvedli.
English: A greater proportion of patients in the JETREA group had a ≥ 5 points improvement in VFQ-25
Slovenian: Višji delež bolnikov, zdravljenih z zdravilom JETREA, je pridobil ≥ 2 ali ≥ 3 vrstice pri BCVA
English: JETREA 0.5 mg/0.2 mL sterile concentrate ocriplasmin
Slovenian: JETREA 0,5 mg/0,2 ml sterilni koncentrat okriplazmin intravitrealna uporaba po razredčenju
English: After dilution with 0.2 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, 0.1 mL of the diluted solution contains 0.125 mg ocriplasmin.
Slovenian: Po redčenju z 0,2 ml raztopine 0,9-odstotnega natrijevega klorida (9 mg/ml) za injiciranje vsebuje
English: Jetrea must be prepared and administered by a qualified ophthalmologist experienced in intravitreal injections.
Slovenian: Zdravilo JETREA mora pripraviti in dati usposobljen oftalmolog, ki ima izkušnje z dajanjem intravitrealnih injekcij.
English: JETREA is administered by intravitreal injection only.
Slovenian: Spremljanje po injiciranju Zdravilo JETREA se daje samo v obliki intravitrealne injekcije.
English: Inject 0.1 mL of the diluted solution immediately into the mid-vitreous.
Slovenian: Takoj injicirajte 0,1 ml razredčene raztopine v sredino steklovine.
English: JETREA must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Slovenian: Zdravilo JETREA mora dati usposobljen oftalmolog, ki ima izkušnje z dajanjem intravitrealnih injekcij.
English: JETREA 0.5 mg/0.2 mL concentrate for solution for injection
Slovenian: JETREA 0,5 mg/0,2 ml koncentrat za raztopino za injiciranje
English: JETREA 0.5 mg/0.2 mL concentrate for solution for injection ocriplasmin
Slovenian: JETREA 0,5 mg/0,2 ml koncentrat za raztopino za injiciranje okriplazmin
English: Visually inspect the vial for particulate matter.
Slovenian: Vsebino viale preglejte in se prepričajte, da v njej ni delcev.
English: 1 vial contains 0.375 mg ocriplasmin in 0.3 mL solution (1.25 mg/mL).
Slovenian: 1 viala vsebuje 0,375 mg okriplazmina v 0,3 ml raztopine (1,25 mg/ml), kar zagotavlja uporabno količino za dajanje enkratnega odmerka 0,1 ml, ki vsebuje 0,125 mg okriplazmina.
English: Jetrea contains the active substance ocriplasmin.
Slovenian: Zdravilo Jetrea vsebuje zdravilno učinkovino okriplazmin.
English: Ophthalmological examinations may be abnormal following the administration of JETREA.
Slovenian: Po dajanju zdravila JETREA lahko izvidi nekaterih oftalmoloških preiskav postanejo nenormalni.
English: Sodium hydroxide (NaOH) (for pH adjustment) Hydrochloric acid (HCl) (for pH adjustment) Water for injections
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid (NaCl) manitol citronska kislina natrijev hidroksid (NaOH) (za uravnavanje pH) klorovodikova kislina (HCl) (za uravnavanje pH) voda za injekcije
English: Discard the vial and any unused portion of the diluted solution after single use.
Slovenian: Vialo in vso količino neporabljene raztopine po enkratni uporabi zavrzite.
English: The adverse reactions with a reasonable possibility of causal relationship to the injection procedure or JETREA are listed by MedDRA system organ class and frequency using the following convention:
Slovenian: Neželeni učinki, za katere je vzročna povezava s postopkom injiciranja ali z zdravilom JETREA
English: EXPIRY DATE
Slovenian: - oteklost veke
English: Each vial contains 0.375 mg of ocriplasmin* in 0.3 mL solution (1.25 mg/mL).
Slovenian: Ena viala vsebuje 0,375 mg okriplazmina* v 0,3 ml raztopine (1,25 mg/ml), kar zagotavlja uporabno količino za dajanje enkratnega odmerka 0,1 ml, ki vsebuje 0,125 mg okriplazmina.
English: JETREA 0.375 mg/0.3 mL solution for injection
Slovenian: JETREA 0,375 mg/0,3 ml raztopina za injiciranje
English: At Month 24, the proportion of patients with ≥ 2 lines improvement from baseline in BCVA was greater in the JETREA group than in the sham group (50.5% vs. 39.1%).
Slovenian: V 24. mesecu je bil delež bolnikov z izboljšanjem za ≥ 2 vrstici od izhodišča pri BCVA večji v skupini, zdravljeni z zdravilom JETREA,
English: Using aseptic technique, withdraw all of the diluted solution using an appropriate sterile needle (slightly incline the vial to ease withdrawal) (Figure 5) and discard the needle after withdrawal of the vial contents.
Slovenian: Z aseptično tehniko izvlecite celotno razredčeno raztopino z ustrezno sterilno iglo (za lažji izvlek nekoliko nagnite vialo) (slika 5) in iglo zavrzite, ko vsebino viale izvlečete.
English: Preoperative antibiotic drops may be administered at the discretion of the treating ophthalmologist.
Slovenian: Po presoji oftalmologa lahko bolnik pred operacijo prejme antibiotične kapljice.
English: Hepatic impairment
Slovenian: Foramen makule
English: JETREA 0.375 mg/0.3 mL solution for injection ocriplasmin
Slovenian: JETREA 0,375 mg/0,3 ml raztopina za injiciranje okriplazmin
English: Single use.
Slovenian: Način uporabe
English: Pharmacotherapeutic group: Ophthalmologicals, Other ophthalmologicals, ATC code: S01XA22
Slovenian: ATC: S01XA22 Mehanizem delovanja
English: Using aseptic technique, withdraw all of the solution using an appropriate sterile needle (slightly incline the vial to ease withdrawal) (Figure 3) and discard the needle after withdrawal of the vial contents.
Slovenian: Z aseptično tehniko izvlecite celotno raztopino z ustrezno sterilno iglo (za lažji izvlek nekoliko nagnite vialo) (slika 3) in iglo zavrzite, ko vsebino viale izvlečete.
English: The vial and any unused portion of the diluted solution must be discarded after single use.
Slovenian: Vialo in neporabljeno količino razredčene raztopine morate po enkratni uporabi zavreči.
English: JETREA 0.375 mg/0.3 mL injection ocriplasmin
Slovenian: JETREA 0,375 mg/0,3 ml injekcija okriplazmin intravitrealna uporaba
English: The vial and any unused portion of the solution must be discarded after single use.
Slovenian: Vialo in neporabljeno količino raztopine morate po enkratni uporabi zavreči.
English: Your doctor/ophthalmologist may ask you to use antibiotic eye drops before and after the injection in order to prevent any possible eye infection.
Slovenian: Priporočeni odmerek je 0,125 mg. Da bi preprečili kakršnokoli očesno okužbo, vam bo lahko vaš zdravnik/oftalmolog naročil, da uporabljajte antibiotične kapljice za oko pred in po injiciranju.
English: Using aseptic technique, withdraw all of the diluted solution using an appropriate sterile needle (slightly incline the vial to ease withdrawal) and discard the needle after withdrawal of the vial contents.
Slovenian: Z aseptično tehniko izvlecite celotno razredčeno raztopino z ustrezno sterilno iglo (za lažji izvlek nekoliko nagnite vialo) in iglo zavrzite, ko vsebino viale izvlečete.
English: Using aseptic technique, withdraw all of the solution using an appropriate sterile needle (slightly incline the vial to ease withdrawal) and discard the needle after withdrawal of the vial contents.
Slovenian: Z aseptično tehniko izvlecite celotno raztopino z ustrezno sterilno iglo (za lažji izvlek nekoliko nagnite vialo) in iglo zavrzite, ko vsebino viale izvlečete.
English: After thawing
Slovenian: Okvara jeter
English: Pathological changes related to intraocular haemorrhage were observed in rabbits and monkeys.
Slovenian: Pri kuncih in opicah so opazili spremembe, povezane s krvavitvijo v oko.
English: The recommended dose is 0.125 mg.
Slovenian: 0,1 ml razredčene raztopine 0,125 mg okriplazmina.
English: Common side effects (may affect up to 1 in 10 patients): - decreased vision which may be severe - visual disturbances - decreased vision or blind spots in parts of the field of view - blurred vision - bleeding inside the eye - blind spot or blind area in the centre of the vision - distorted vision - swelling of the surface of the eye - swelling of the eyelid - inflammation of the eye - flashes of light in the eye - eye redness - irritation on the surface of the eye - dry eye - a feeling of having something in the eye - itching of the eye - eye discomfort - sensitivity to light - increased tear production
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - poslabšanje vida, ki je lahko hudo - motnje vida - poslabšanje vida ali slepe pege na delih vidnega polja - zamegljen vid
English: Sodium hydroxide (NaOH) (for pH adjustment) Water for injections
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol citronska kislina natrijev hidroksid (NaOH) (za uravnavanje pH) voda za injekcije
English: Post-injection monitoring
Slovenian: Volumen injekcije
English: Package leaflet: Information for the patient JETREA 0.375 mg/0.3 mL solution for injection
Slovenian: Navodilo za uporabo JETREA 0,375 mg/0,3 ml raztopina za injiciranje okriplazmin
English: Ocriplasmin
Slovenian: Odmerjanje
English: Package leaflet: Information for the patient JETREA 0.5 mg/0.2 mL concentrate for solution for injection
Slovenian: Navodilo za uporabo JETREA 0,5 mg/0,2 ml koncentrat za raztopino za injiciranje okriplazmin
English: Any unnecessary exposure should be avoided.
Slovenian: Izogibati bi se morali vsakršnemu nepotrebnemu izpostavljanju.
English: Do not use colistin as a substitute for good management practices.
Slovenian: Kolistina ne uporabljajte kot nadomestilo za dobre prakse upravljanja.
English: Hungary Biopol Fejlesztő és Kereskedelmi Kft.
Slovenian: Madžarska Biopol Fejlesztő és Kereskedelmi Kft.
English: This is in line with the previous assessment of the CVMP and the scientific advice to the European Commission.
Slovenian: To je v skladu s predhodno oceno CVMP in znanstvenimi nasveti, pripravljenimi za Evropsko komisijo.
English: It should be noted that three of the products in Annex I contain colistin in combination with vitamins.
Slovenian: Treba je opozoriti, da troje zdravil, navedenih v Prilogi I, vsebuje kolistin v kombinaciji z vitamini.
English: 683 23 Ivanovice na Hané Czech Republic
Slovenian: 683 23 Ivanovice na Hané Češka republika
English: Netherlands Eurovet Animal Health BV Postbus 179,
Slovenian: Nizozemska Eurovet Animal Health BV Postbus 179,
English: Treatment duration should not exceed 7 days.
Slovenian: Zdravljenje ne sme trajati več kot 7 dni.
English: Ilfov, Romania
Slovenian: Ilfov, Romunija
English: Romania CEVA SANTE ANIMALE ROMANIA SRL
Slovenian: Romunija CEVA SANTE ANIMALE ROMANIA SRL
English: Hungary Ceva-Phylaxia Zrt.
Slovenian: Madžarska Ceva-Phylaxia Zrt.
English: Hungary Vim Spectrum Hungary Kft. 1029 Budapest,
Slovenian: Madžarska Vim Spectrum Hungary Kft. 1029 Budapest,
English: “Transfer of resistance either on mobile genetic elements (such as plasmids) between bacteria or from animals to humans has not been reported.”
Slovenian: „O prenosu odpornosti prek mobilnih genetskih elementov (kot so plazmidi) med bakterijami ali z živali na ljudi ni bilo poročano.“
English: Following a request from the European Commission (EC), in July 2013 the CVMP and CHMP adopted scientific advice and detailed considerations on colistin1.
Slovenian: Na zahtevo Evropske komisije sta julija 2013 odbora CVMP in CHMP sprejela znanstvene nasvete in podrobne opombe o kolistinu1.
English: Romania PASTEUR - Filiala Filipesti SRL
Slovenian: Romunija PASTEUR - Filiala Filipesti SRL
English: Adyliget, Pipitér u. 5., Hungary
Slovenian: Adyliget, Pipitér u. 5., Madžarska
English: Colistin should not be used for the control of salmonellosis since it is not in line with control programmes for this disease and may present a risk to public and animal health.
Slovenian: Kolistina ne bi smeli uporabljati za nadzor salmoneloze, saj tovrstna uporaba ni v skladu s kontrolnimi programi za to bolezen in lahko pomeni tveganje za javno zdravje in zdravje živali.
English: Nevertheless, it is recognised that repeated or frequent use of an antimicrobial of the same class increases the risk of resistance development and transmission of such resistances to humans cannot be excluded.
Slovenian: Kljub temu je znano, da ponavljajoča se ali pogosta uporaba protimikrobnega zdravila istega razreda poveča tveganje razvoja odpornosti, prenosa tovrstne odpornosti na ljudi pa ni mogoče izključiti.
English: Data from the last report of the EMA European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)2 shows that polymixins (colistin) are used mostly in oral forms.
Slovenian: Podatki iz zadnjega poročila Evropske agencije za zdravila o evropskem uradnem nadzoru porabe veterinarskih protimikrobnih zdravil (ESVAC)2 kažejo, da se polimiksini (kolistin) uporabljajo zlasti v peroralnih oblikah.
English: Cobalto, 261/263 28770 Colmenar Viejo Spain
Slovenian: Cobalto, 261/263 28770 Colmenar Viejo Španija
English: 3 000 000 IU Tablet
Slovenian: 3 000 000 IU Tableta
English: Therefore, on 12 May 2014, the European Commission presented to the European Medicines Agency (‘the Agency') a referral notification under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing colistin as a sole active substance to be administered orally.
Slovenian: Evropska komisija je tako 12. maja 2014 Evropski agenciji za zdravila predložila obvestilo o napotitvi v skladu s členom 35 Direktive 2001/82/ES za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin kot edino zdravilno učinkovino in se uporabljajo peroralno.
English: Add, to all products and amend where applicable:
Slovenian: Pri vseh zdravilih dodati naslednje in spremeniti, kjer je ustrezno:
English: Thus, the use of colistin in horses is considered to present a serious risk in relation to target animal safety and is no longer supported.
Slovenian: Šteje se, da uporaba kolistina pri konjih pomeni resno tveganje, kar zadeva varnost ciljnih živalskih vrst, zato se ne podpira več.
English: Slovakia Tekro spol.
Slovenian: Slovaška Tekro spol.
English: 96-100 Skierniewice Poland
Slovenian: 96-100 Skierniewice Poljska
English: Romania LAVET PHARMACEUTICALS LTD.
Slovenian: Romunija LAVET PHARMACEUTICALS LTD.
English: V. del Commercio 28/30 41012 - Carpi (MO) Italy
Slovenian: V. del Commercio 28/30 41012 - Carpi (MO) Italija
English: Rua Cidade de santarém Zona Industrial Várzea, 2005-002 Santarém Portugal
Slovenian: Rua Cidade de santarém Zona Industrial Várzea, 2005-002 Santarém Portugalska
English: Hungary Chemifarma S.p.a, 47122 Forli,
Slovenian: Madžarska Chemifarma S.p.a, 47122 Forli,
English: Bulgaria Zavet Kiril and Metodiy str. 5 Zavet 7330
Slovenian: Bolgarija Zavet Kiril and Metodiy str. 5 Zavet 7330
English: Netherlands Virbac Laboratories 1ere Avenue, 2065 m L.I.D.,
Slovenian: Nizozemska Virbac Laboratories 1ere Avenue, 2065 m L.I.D.,
English: Therefore, any general indication referring to infectious or noninfectious diseases should be deleted.
Slovenian: Zato bi morali izbrisati vsakršne splošne indikacije, ki se nanašajo na nalezljive ali nenalezljive bolezni.
English: Smarjeska Cesta 6
Slovenian: Šmarješka cesta 6
English: There is no current scientifically well founded justification for the different treatment periods available.
Slovenian: Za različno trajanje zdravljenja trenutno ni znanstveno dobro utemeljene razlage.
English: 42010 - Rio Saliceto (RE) Italy
Slovenian: 42010 - Rio Saliceto (RE) Italija
English: The prophylactic use of colistin and any extended use that is not in line with good veterinary practice present a risk from resistance perspective and is not justifiable from a scientific point of view.
Slovenian: Profilaktična uporaba kolistina in vsakršna dolgotrajna uporaba, ki ni v skladu z dobro veterinarsko prakso, pomeni tveganje z vidika odpornosti in z znanstvenega vidika ni upravičena.
English: Via San Zeno, 99/A 25124 Brescia Italy
Slovenian: Via San Zeno, 99/A 25124 Brescia Italija
English: Romania DELOS IMPEX' 96 SRL Str. Horia,
Slovenian: Romunija DELOS IMPEX' 96 SRL Str. Horia,
English: 4.4 Special warnings for each target species Add, to all products:
Slovenian: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto Pri vseh zdravilih dodati:
English: These factors indicate that a longer duration of treatment than the one indicated, leading to unnecessary exposure is not recommended”.)
Slovenian: Ti dejavniki kažejo, da trajanje zdravljenja, daljše od navedenega, ki vodi k nepotrebni izpostavljenosti, ni priporočljivo.“).
English: Bulgaria Gabropharm OOD 16 Alei Vazrajdane str., app. 42
Slovenian: Bolgarija Gabropharm OOD 16 Alei Vazrajdane str., app. 42
English: In addition to the measures described above the CVMP recommended to include the following special precautions for use in animals in order to ensure responsible use of colistin in animals: “Do not use colistin as a substitute for good management practices.
Slovenian: Poleg zgoraj opisanih ukrepov je CVMP priporočil, da se vključijo naslednji posebni previdnostni ukrepi za uporabo pri živalih, da bi zagotovili preudarno uporabo kolistina pri živalih: „Kolistina ne uporabljajte kot nadomestilo za dobre prakse upravljanja.
English: Netherlands A.A.-Vet Diergeneesmiddelen N.V., Loofklapper 6-8, 8256 SL Biddinghuizen, Netherlands
Slovenian: Nizozemska A.A.-Vet Diergeneesmiddelen N.V., Loofklapper 6-8, 8256 SL Biddinghuizen, Nizozemska
English: Bulgaria Farma SIS OOD 4 San Stefano str.
Slovenian: Bolgarija Farma SIS OOD 4 San Stefano str.
English: Overall summary of the scientific evaluation of veterinary medicinal products containing colistin to be administered orally (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil za uporabo v veterinarski medicini, ki vsebujejo zdravilno učinkovino kolistin in se uporabljajo peroralno (glejte Prilogo I)
English: This advice critically reviews recent information on the use of colistin in food-producing animals in the EU, its effect on the development of resistance to this category of antimicrobial agents in bacterial species that are of importance for human and animal health, and the possible impact on human and animal health.
Slovenian: Nasvet vsebuje kritičen pregled najnovejših informacij o uporabi kolistina pri živalskih vrstah za prehrano ljudi v EU, njegovem učinku na razvoj odpornosti proti tej kategoriji protimikrobnih zdravil pri vrstah bakterij, ki so pomembne za zdravje ljudi in živali, ter o njihovem morebitnem učinku na zdravje ljudi in živali.
English: These factors indicate that a longer duration of treatment than the one indicated in section 4.9, leading to unnecessary exposure, is not recommended.
Slovenian: Ti dejavniki kažejo, da trajanje zdravljenja, daljše od trajanja, navedenega v poglavju 4.9, ki vodi k nepotrebni izpostavljenosti, ni priporočljivo.
English: Hungary VMD.
Slovenian: Madžarska VMD.