natgillin/translations-raw huggingface dataset:
After dilution with 0.2 mL of sodium chloride solution, 0.1 mL of the diluted solution contains 0.125 mg of ocriplasmin.
Nakon razrjeđivanja s 0,2 ml otopine natrijeva klorida, 0,1 ml razrijeđene otopine sadržava 0,125 mg okriplazmina.
Patients with no ERM at baseline were more likely to achieve VMA resolution at Day 28 compared with those who had ERM at baseline.
U bolesnika bez ERM-a na početku ispitivanja postojala je veća sklonost povlačenja VMA do 28. dana nego u onih s ERM-om na početku ispitivanja.
In the integrated analysis of the National Eye Institute Visual Function Questionnaire-25 (VFQ-25), a numerical difference in favour of JETREA over placebo was shown in each sub-scale score, as well as the composite score.
U integriranoj analizi Upitnika za ocjenu funkcije vida Nacionalnog očnog instituta (VFQ-25),
The intravitreal toxicity of ocriplasmin has been evaluated in rabbits, monkeys and minipigs.
5.3 Neklinički podaci o sigurnosti primjene Intravitrealna toksičnost okriplazmina ispitana je u kunića, majmuna i patuljastih svinja.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I I PROIZVOĐAČ(I)
Visual acuity reduced*, visual impairment1), visual field defect2), vision blurred, retinal haemorrhage, vitreous haemorrhage, macular hole*, macular degeneration, retinal degeneration, macular oedema3), retinal oedema4), retinal pigment epitheliopathy, metamorphopsia, conjunctival oedema, eyelid oedema, vitritis, anterior chamber cell, anterior chamber flare, iritis, photopsia, conjunctival hyperaemia, ocular hyperaemia, vitreous detachment, eye irritation, dry eye, foreign body sensation in eyes, eye pruritus, ocular discomfort, photophobia, lacrimation increased
Smanjena vidna oštrina*, poremećaj vida1), poremećaj vidnog polja2), zamagljen vid, krvarenje mrežnice, krvarenje u staklovini, makularna rupa*, makularna degeneracija, degeneracija mrežnice, makularni edem3), edem mrežnice4), mrežnična pigmentna epiteliopatija, metamorfopsija, edem spojnice, edem vjeđe,
The vial and any unused portion of the solution must be discarded after single use.
Bočica i sva neiskorištena otopina moraju se baciti nakon jednokratne primjene.
The recommended dose is 0.125 mg (0.1 mL of the diluted solution) administered by intravitreal injection to the affected eye once as a single dose.
Preporučena doza je 0,125 mg (0,1 ml razrijeđene otopine) koja se daje intravitrealnom injekcijom u zahvaćeno oko jedanput u jednokratnoj dozi.
In the placebo-controlled pivotal phase III studies (TG-MV-006 and TG-MV-007), retinal breaks (tears and detachment) were reported in 1.9% of patients injected with JETREA vs. 4.3% injected with placebo.
U placebom kontroliranim pivotalnim ispitivanjima faze III (TG-MV-006 i TG-MV-007), rupture i odignuće mrežnice prijavljeni su u 1,9% bolesnika koji su primili injekciju JETREE i u 4,3% onih koji su primili injekciju placeba.
One vial of Jetrea contains 0.5 mg of ocriplasmin in 0.2 mL solution.
Jedna bočica Jetree sadržava 0,5 mg okriplazmina u 0,2 ml otopine.
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).
bolesnika u JETREA skupini u usporedbi s 10,1% u skupini placebo VMA se povukla 28. dana (p<0,001).
In the integrated data, the VMA resolution rate at Day 28 was higher in patients treated with JETREA compared to placebo in both the subgroup with VMA ≤ 1500 microns at baseline (34.7% vs. 14.6%, p<0.001) and with VMA > 1500 microns at baseline (5.9% vs. 0%, p=0.113).
nego u onih koji su primili placebo, i to i u podskupini s VMA ≤ 1500 mikrona na početku ispitivanja (34,7% nasuprot 14,6%, p<0,001) i u onoj s VMA > 1500 mikrona na početku ispitivanja (5,9% nasuprot 0%, p=0,113).
Jetrea is used to treat adults with an eye disease called vitreomacular traction (VMT), including when it is associated with a small hole in the macula (central part of the light-sensitive layer at the back of the eye).
uključujući kada je ona povezana s malom rupom u makuli (centralni dio sloja osjetljivog na svjetlost u pozadini oka).
Visually inspect the vial for particulate matter.
Vizualno provjerite da u bočici nema vidljivih čestica.
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).
Iglu zamijenite drugom prikladnom sterilnom iglom, iz štrcaljke pažljivo istisnite suvišan volumen lagano potiskujući klip tako da se vrh klipa poravna s oznakom za 0,1 ml na štrcaljki (odgovara količini od 0,125 mg okriplazmina) (Slika 4).
Inject 0.1 mL of the diluted solution immediately into the mid-vitreous.
Odmah injicirajte 0,1 ml razrijeđene otopine u središte staklovine.
JETREA must be administered by a qualified ophthalmologist experienced in intravitreal injections.
JETREU mora primjenjivati kvalificirani oftalmolog s iskustvom u davanju intravitrealnih injekcija.
The recommended dose is 0.125 mg in 0.1 mL of the solution administered by intravitreal injection to the affected eye once as a single dose.
Preporučena doza je 0,125 mg u 0,1 ml otopine koja se daje intravitrealnom injekcijom u zahvaćeno oko jedanput u jednokratnoj dozi.
Sodium hydroxide (NaOH) (for pH adjustment) Hydrochloric acid (HCl) (for pH adjustment) Water for injections
6.1 Popis pomoćnih tvari natrijev klorid (NaCl) manitol citratna kiselina natrijev hidroksid (NaOH)(za podešavanje pH) kloridna kiselina (HCl) (za podešavanje pH) voda za injekcije
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).
Iglu zamijenite drugom prikladnom sterilnom iglom, iz štrcaljke pažljivo istisnite suvišak volumena, lagano potiskujući klip tako da se vrh klipa poravna s oznakom za 0,1 ml na štrcaljki (odgovara količini od 0,125 mg okriplazmina).
The most clinically relevant adverse reactions included blindness transient, retinal tear, retinal detachment, lens subluxation and macular hole progression.
Klinički najrelevantnije nuspojave uključuju prolaznu sljepoću, rupturu mrežnice, odignuće mrežnice,
≥ 3 lines in BCVA without vitrectomy favoured JETREA at Month 6 (23.7% vs. 11.2%, p<0.001 for a gain ≥ 2 lines and 9.7% vs. 3.7%, p=0.008 for a gain ≥ 3 lines).
≥ 2 reda i 9,7 % nasuprot 3,7 %, p=0,008 za poboljšanje 3 reda).
JETREA must be prepared and administered by a qualified ophthalmologist experienced in intravitreal injections.
JETREU mora pripravljati i davati kvalificirani oftalmolog s iskustvom u davanju intravitrealnih injekcija.
JETREA 0.5 mg/0.2 mL concentrate for solution for injection ocriplasmin
JETREA 0,5 mg/0,2 ml koncentrat za otopinu za injekciju okriplazmin
JETREA 0.5 mg/0.2 mL concentrate for solution for injection
JETREA 0,5 mg/0,2 mL koncentrat za otopinu za injekciju
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
- oteklina površine oka - oteklina vjeđe - upala oka - bljeskovi svjetla u oku - crvenilo oka - nadražaj površine oka - suho oko - osjećaj stranog tijela u oku - svrbež oka
Once completely thawed, remove the protective blue polypropylene flip-off cap from the vial
Nakon potpunog odmrzavanja skinite zaštitnu plavu polipropilensku flip-off kapicu s bočice
A greater proportion of patients in the JETREA group had a ≥ 5 points improvement in VFQ-25
Veći udio bolesnika u JETREA skupini imao je poboljšanje ≥5 bodova u VFQ-25 kompozitnom rezultatu i u rezultatima podljestvica, bez obzira na vitrektomiju, u svim posjetima.
Very common side effects (may affect more than 1 in 10 patients): - dark floating spots in the field of vision (floaters) - eye pain - bleeding on the surface of the eye - colour vision changes
- bol u oku - krvarenje na površini oka - promjene u raspoznavanju boja
Inject 0.1 mL of the solution immediately into the mid-vitreous.
Odmah injicirajte 0,1 ml otopine u središte staklovine.
Sodium hydroxide (NaOH) (for pH adjustment) Water for injections
6.1 Popis pomoćnih tvari manitol citratna kiselina natrijev hidroksid (NaOH) (za podešavanje pH) voda za injekcije
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.
6. Primjenom aseptičke tehnike, izvucite svu razrijeđenu otopinu koristeći prikladnu sterilnu iglu (malo nagnite bočicu radi lakšeg izvlačenja sadržaja) (Slika 5) te nakon izvlačenja sadržaja iz bočice, iglu bacite.
Each vial contains 0.5 mg of ocriplasmin* in 0.2 mL solution.
Jedna bočica sadržava 0,5 mg okriplazmina* u 0,2 ml otopine.
Ocriplasmin
FARMACEUTSKI
JETREA 0.375 mg/0.3 mL solution for injection
JETREA 0.375 mg/0.3 ml otopina za injekciju
Eye disorders
Makularna rupa
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.
Primjenom aseptičke tehnike, izvucite svu otopinu koristeći prikladnu sterilnu iglu (malo nagnite bočicu radi lakšeg izvlačenja sadržaja) (Slika 3) te nakon izvlačenja sadržaja iz bočice, iglu bacite.
Repeated administration
- pojačano suzenje
Once completely thawed, remove the protective orange polypropylene flip-off cap from the vial.
Nakon potpunog odmrzavanja, skinite zaštitnu narančastu polipropilensku flip-off kapicu s bočice.
JETREA 0.375 mg/0.3 mL solution for injection ocriplasmin
JETREA 0,375 mg/0,3 ml otopina za injekciju okriplazmin
Once completely thawed, remove the protective blue polypropylene flip-off cap from the vial.
Nakon potpunog odmrzavanja, skinite zaštitnu plavu polipropilensku flip-flap kapicu s bočice.
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.
Primjenom aseptičke tehnike, izvucite svu razrijeđenu otopinu, koristeći prikladnu sterilnu iglu (malo nagnite bočicu radi lakšeg izvlačenja) te nakon izvlačenja sadržaja bočice iglu bacite.
JETREA 0.375 mg/0.3 mL injection ocriplasmin
JETREA 0,375 mg/0,3 ml injekcija okriplazmin
1 vial contains 0.5 mg ocriplasmin.
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica sadržava 0,5 mg okriplazmina.
Discard the vial and any unused portion of the diluted solution after single use.
Nakon jednokratne primjene bacite bočicu i preostali neiskorišteni dio razrijeđene otopine.
Once completely thawed, remove the protective orange polypropylene flip-off cap from the vial
Nakon potpunog odmrzavanja s bočice skinite zaštitnu narančastu polipropilensku flip-off kapicu
A higher proportion of JETREA treated patients gained ≥ 2 or ≥ 3 lines in BCVA (irrespective of vitrectomy) at Month 6 (28.0% and 12.3%, respectively) compared with patients treated with placebo
Veći udio bolesnika liječenih JETREOM dobili su ≥ 2 ili ≥ 3 reda BCVA (bez obzira na vitrektomiju)
Solution for injection 1 vial
Otopina za injekciju
Talk to your doctor/ophthalmologist if you develop any of the additional side effects listed below:
Molimo obratite se liječniku/oftalmologu ako razvijete koji od dodatnih niže navedenih simptoma: Vrlo česte nuspojave (mogu se pojaviti u više od 1 na 10 bolesnika):
Discussion of the data available
Rasprava dostupnih podataka
Any unnecessary exposure should be avoided.
Treba izbjegavati svako nepotrebno izlaganje.
Do not use colistin as a substitute for good management practices.
Ne koristite kolistin kao zamjenu za dobru praksu upravljanja.
There is no current scientifically well founded justification for the different treatment periods available.
Ne postoji aktualno znanstveno dobro utemeljeno opravdanje za dostupna različita razdoblja terapije.
Hungary Biopol Fejlesztő és Kereskedelmi Kft.
Mađarska Biopol Fejlesztő és Kereskedelmi Kft.
Str. Principala nr. 944, Filipestii de Padure , Jud.
Principala nr. 944, Filipestii de Padure , Jud.
Next to that, treatment of subclinical Salmonella infections with the objective to reduce the number of bacteria might interfere with control programmes (e.g. Regulation 1177/2006; EFSA, 20105) for this disease.
Osim toga, liječenje subkliničkih infekcija Salmonella sa ciljem smanjivanja broja bakterija može interferirati s kontrolnim programima (primjerice Uredba 1177/2006; EFSA, 20105) za ovu bolest.
This is in line with the previous assessment of the CVMP and the scientific advice to the European Commission.
Ovo je u skladu s prethodnom ocjenom CVMP-a i znanstvenim savjetom Europske komisije.
Netherlands Eurovet Animal Health BV Postbus 179,
Nizozemska Eurovet Animal Health BV Postbus 179,
683 23 Ivanovice na Hané Czech Republic
683 23 Ivanovice na Hané Češka Republika
Following a request from the European Commission (EC), in July 2013 the CVMP and CHMP adopted scientific advice and detailed considerations on colistin1.
Po zahtjevu Europske Komisije (EK), u srpnju 2013. CVMP i CHMP usvojili su znanstveni savjet i detaljnija razmatranja o kolistinu1.
Pol. Industrial El Segre P. 410 25191
Industrial El Segre P. 410 25191
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.
Kolistin se ne smije koristiti za kontrolu salmoneloze budući da nije u skladu s kontrolnim programima za ovu bolest i može predstavljati rizik za javno i životinjsko zdravstvo.
EFSA Panel on Biological Hazards; Scientific Opinion on a Quantitative Microbiological Risk Assessment of Salmonella in slaughter and breeder pigs In EFSA Journal.
EFSA Panel on Biological Hazards; Scientific Opinion on a Quantitative Microbiological Risk Assessment of Salmonella in slaughter and breeder pigs In EFSA
Oral powder, white to almost white powder
Oralni prašak, bijeli do gotovo bijeli prašak
Responsible use principles
Načela odgovorne primjene
This group of antibiotics has a polypeptide structure, with mainly bactericidal activity and a medium antibacterial spectrum, which covers Gram-negative microorganisms only.
Ova grupa antibiotika ima polipeptidnu strukturu, s uglavnom bakterijskim djelovanjem i srednjim antibakterijskim spektrom koji pokriva samo gram-negativne mikroorganizme.
CEVA SALUD ANIMAL, S.A. Carabela La Niña nº 12 5ª planta
Španjolska CEVA SALUD ANIMAL, S.A. Carabela La Niña nº 12 5ª planta
Adyliget, Pipitér u. 5., Hungary
Adyliget, Pipitér u. 5., Mađarska
Treatment duration should not exceed 7 days.
Trajanje terapije ne smije iznositi više od 7 dana.
Romania PASTEUR - Filiala Filipesti SRL
Rumunjska PASTEUR - Filiala Filipesti SRL
In many cases the dose is recommended as 100 000 IU/kg for mammalians (non-poultry species), (range approximately 18 000 IU/kg to 250 000 IU/kg body weight), and of 75 000 IU/kg for poultry species (range approximately 19 200 IU/kg to 270 000 IU/kg body weight.
U mnogim slučajevima preporučena je doza od 100 000 IU/kg za sisavce (vrste koje nisu perad), (raspon od otprilike 18 000 IU/kg do 250 000 IU/kg tjelesne mase), te od 75 000 IU/kg za vrste peradi (raspon od otprilike 19 200 IU/kg do 270 000 IU/kg tjelesne mase).
96-100 Skierniewice Poland
96-100 Skierniewice Poljska
3 000 000 IU Tablet
3 000 000 IU Tableta
Romania CEVA SANTE ANIMALE ROMANIA SRL
Rumunjska CEVA SANTE ANIMALE RUMUNJSKA SRL
Hungary Chemifarma S.p.a, 47122 Forli,
Mađarska Chemifarma S.p.a, 47122 Forli,
“Transfer of resistance either on mobile genetic elements (such as plasmids) between bacteria or from animals to humans has not been reported.”
„Nema prijava o prijenosu rezistencije na mobilne genetičke elemente (poput plazmida) između bakterija ili sa životinja na ljude.”
Specific treatment recommendations shorter than 7 days should be maintained.
Treba zadržati specifične preporuke za terapiju kraću od 7 dana.
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.
Podaci dostupni iz posljednjeg izvještaja Europskog praćenja veterinarske potrošnje antimikrobika (ESVAC)2 pri EMA potvrđuju da se polimiksini (kolistin) koriste najčešće u oralnim oblicima.
In addition, further information in line with prudent use principles for antimicrobials should be added in the product literature.
Nadalje, treba dodati dodatne informacije o načelima razumne primijene za antimikrobike u literaturu proizvoda.
Pharmacotherapeutic group: Intestinal antiinfectives, antibiotics ATCvet code: QA07AA10
Farmakoterapijska grupa: Intestinalni antiinfektivni lijekovi, antibiotici ATCvet kod: QA07AA10
Some of the products included in the scope of this referral procedure are indicated for use in horses and, although not stated explicitly in the product literature, it is assumed that these products are used predominantly in foals.
Pojedini proizvodi uključeni u predmet ovog postupka upućivanja su indicirani za uporabu u konja te, iako nije eksplicitno navedeno u literaturi proizvoda, pretpostavlja se da se ovi proizvodi uglavnom koriste u ždrjebadi.
V. del Commercio 28/30 41012 - Carpi (MO) Italy
V. del Commercio 28/30 41012 - Carpi (MO) Italija
Netherlands Virbac Laboratories 1ere Avenue, 2065 m L.I.D.,
Nizozemska Virbac Laboratories 1ere Avenue, 2065 m L.I.D.,
The use of colistin for prophylaxis does not comply with responsible use principles.
Primjena kolistina za profilaksu ne udovoljava načelima odgovorne primjene.
42010 - Rio Saliceto (RE) Italy
42010 - Rio Saliceto (RE) Italija
Animal species
Životinske vrste
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.
Stoga se smatra da primjena kolistina u konja predstavlja ozbiljan rizik s obzirom na sigurnu primjenu u ciljnih životinja, te više nije podržana.
About 54% of the products concerned by this procedure contain general indications, whilst the remaining 46% contain specific indications, mainly gastrointestinal infections caused by colistin sensitive Enterobacteriaceae (e.g. E. coli and Salmonella).
Otprilike 54% proizvoda obuhvaćenih ovim postupkom sadrži općenite indikacije, dok preostalih 46% sadrži specifične indikacije, uglavnom gastrointestinalne infekcije uzrokovane Enterobacteriaceae (primjerice E. coli i Salmonella) osjetljivom na kolistin.
In conclusion the CVMP recommended to add advice in the SPC that the duration of treatment should be limited to the minimum time necessary for the treatment of the disease, and that treatment duration should not exceed 7 days.
Zaključno, CVMP je preporučio dodavanje savjeta u SPC-u da trajanje terapije treba ograničiti na minimalno vrijeme potrebno za liječenje bolesti, a da trajanje liječenja ne smije premašiti 7 dana.
Bulgaria Zavet Kiril and Metodiy str. 5 Zavet 7330
Bugarska Zavet Kiril and Metodiy str. 5 Zavet 7330
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.
Bez obzira na navedeno, prepoznato je kako ponovljena ili česta uporaba antimikrobika iste klase može povećati rizik od razvoja rezistencije, a ne može se isključiti prijenos takve rezistencije na ljude.
Via San Zeno, 99/A 25124 Brescia Italy
Via San Zeno, 99/A 25124 Brescia Italija
Thus, any pathogens other than non-invasive E. coli that are typically not associated with non-invasive gastrointestinal infections, and/or associated with general infections should be taken out of the SPC.
Stoga, bilo koji drugi patogeni osim neinvanzivne E. coli koji se tipično ne povezuju s neinvazivnim gastrointestinalnim infekcijama, i/ili se povezuju s općenitim infekcijama treba ukloniti iz SPC-a.
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.
Ovaj savjet daje kritički osvrt na najnovije informacije o primjeni kolistina u životinja koje se koriste u proizvodnji hrane u EU, njegovom djelovanju na razvoj rezistencije u ovoj kategoriji antimikrobnih sredstava koji su važni za ljudsko i životinjsko zdravlje, kao i moguće djelovanje na zdravlje ljudi i životinja.
Doxal Italia S.p.a. largo Donegani 2 20121 - Milano Italy
Doxal Italia S.p.a. largo Donegani 2 20121 - Milano Italija
Zone d'activites du bois de teillay
Francuska Deltavit Zone d'activites du bois de teillay
Netherlands A.A.-Vet Diergeneesmiddelen N.V., Loofklapper 6-8, 8256 SL Biddinghuizen, Netherlands
Nizozemska A.A.-Vet Diergeneesmiddelen N.V., Loofklapper 6-8, 8256 SL Biddinghuizen, Nizozemska
Whenever possible, colistin should only be used based on susceptibility testing.
Kada je to moguće, kolistin treba koristiti samo na temelju testiranja podložnosti.
Bulgaria Gabropharm OOD 16 Alei Vazrajdane str., app. 42
Bugarska Gabropharm OOD 16 Alei Vazrajdane str., app. 42
Bulgaria Farma SIS OOD 4 San Stefano str.
Bugarska Farma SIS OOD 4 San Stefano str.
The recommended treatment period is similar for poultry and non-poultry species, 3-5 days or 5-7 days for most products, but for some products the treatment period is up to 10-15 days.
Preporučena razdoblja terapije su slična za vrste peradi i vrste koje nisu perad, 3-5 dana ili 5-7 dana za većinu proizvoda, no za pojedine proizvode razdoblje terapije iznosi 10-15 dana.
Laboratoires Biove 3 Rue De Lorraine 62510 Arques France
Francuska Laboratoires Biove 3 Rue De Lorraine 62510 Arques
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States
Popis naziva, farmaceutskih oblika, jačina veterinarskomedicinskog proizvoda, životinjskih vrsta, podnositelja zahtjeva/nositelja odobrenja u državama članica
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.
Uz prethodno opisane mjere, CVMP je preporučio uključivanje sljedećih specijalnih mjera opreza za primjenu u životinja kako bi se osigurala odgovorna primjena kolistina u životinja: „Ne koristite kolistin kao zamjenu za dobru praksu upravljanja.
Duration of treatment should be limited to the minimum time necessary for the treatment of the disease.
Trajanje terapije treba ograničiti na minimalno vrijeme potrebno za liječenje bolesti.
1ere Avenue 2065 M L I D 06516 Carros Cedex France
Francuska VIRBAC 1ere Avenue 2065 M L I D 06516 Carros Cedex Francuska
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.
Profilaktička primjena kolistina i bilo kakva produljena primjena koja nije u skladu s dobrom veterinarskom praksom predstavlja rizik sa stajališta rezistencije i ne može se opravdati sa znanstvenog stajališta.
Buckinghamshire, HP7 9FB United Kingdom
Buckinghamshire, HP7 9FB Ujedinjena Kraljevina