natgillin/translations-raw huggingface dataset:
How to use Avamys
Kako uporabljati zdravilo Avamys
Transient ocular changes (see Clinical experience), vision blurred (see also section 4.4) Respiratory, thoracic and mediastinal disorders Very common
Očesne bolezni Ni znano prehodne očesne spremembe (glejte Klinične izkušnje), zamegljen vid (glejte tudi poglavje 4.4)
Data from large clinical trials were used to determine the frequency of adverse reactions.
Pogostnost neželenih učinkov je bila določena na osnovi podatkov iz obsežnih kliničnih preskušanj.
Follow the guide carefully to get full benefit from using Avamys
Natančno upoštevajte navodilo, da vam bo zdravilo Avamys koristilo v polni meri.
Based on these findings the average predicted exposure of 110 micrograms of intranasal fluticasone furoate in this patient population would not be expected to result in suppression of cortisol.
Pri predvideni izpostavljenosti po nazalni uporabi flutikazonfuroata v odmerku 110 mikrogramov pri bolnikih z zmerno okvaro jeter supresije kortizola ne pričakujemo.
Nasal spray, suspension.
pršilo za nos, suspenzija bela suspenzija
The recommended starting dose is two spray actuations (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 110 micrograms).
Priporočeni začetni odmerek sta dva vpiha (27,5 mikrogramov flutikazonfuroata na vpih) v vsako nosnico enkrat na dan (skupni dnevni odmerek 110 mikrogramov).
Taking Avamys:
Zdravilo Avamys:
How to use the nasal spray
Kako uporabljati pršilo za nos
In addition, consideration should be given to referring the patient to a paediatric specialist (see section
Presoditi je treba tudi o potrebnosti pregleda bolnika pri ustreznem specialistu (glejte poglavje 5.1).
 See Step-by-step guide to using the nasal spray, after Section 6.
 Glejte podrobno Navodilo za uporabo pršila za nos na koncu poglavja 6.
2 Remove the cap by squeezing firmly on the sides of the cap with your thumb and forefinger- see picture e.
Odstranite pokrovček tako, da ga s palcem in kazalcem trdno stisnete ob straneh - glejte sliko e.
Do not use Avamys if you are breast feeding unless your doctor or pharmacist tells you to.
Če dojite, zdravila Avamys ne smete uporabljati, razen če vam tako svetuje zdravnik ali farmacevt.
Always keep the cap on.
Pokrovček naj bo vedno nameščen.
Do not use Avamys if you are pregnant, or planning to become pregnant, unless your doctor or pharmacist tells you to.
Če ste noseči ali nameravate zanositi, zdravila Avamys ne smete uporabljati, razen če vam tako svetuje zdravnik ali farmacevt.
The recommended starting dose is one spray actuation (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 55 micrograms).
Priporočeni začetni odmerek je en vpih (27,5 mikrogramov flutikazonfuroata na vpih) v vsako nosnico enkrat na dan (skupni dnevni odmerek 55 mikrogramov).
14.2 ml Type I or Type III amber bottle (glass) fitted with a metering spray pump.
14, 2-ml steklenička jantarne barve iz stekla tipa I ali III, opremljena z odmernim pršilnikom.
Contents of the pack and other information Step-by-step guide to using the nasal spray
Shranjevanje zdravila Avamys Vsebina pakiranja in dodatne informacije Navodilo za uporabo pršila za nos
Elimination was primarily via the faecal route following oral and intravenous administration indicative of excretion of fluticasone furoate and its metabolites via the bile.
Izločanje po peroralni ali intravenski uporabi poteka predvsem z blatom, kar kaže, da se flutikazonfuroat in njegovi presnovki izločajo z žolčem.
When to use Avamys
Kdaj uporabljati zdravilo Avamys
Fluticasone furoate 110 micrograms once daily was not associated with hypothalamic-pituitary-adrenal (HPA) axis suppression in adult, adolescent or paediatric subjects.
Uporaba flutikazonfuroata v odmerku 110 mikrogramov enkrat na dan pri odraslih, mladostnikih in otrocih ni bila povezana z zavoro osi hipotalamus-hipofiza-nadledvični žlezi.
As with all intranasal corticosteroids, the total systemic burden of corticosteroids should be considered whenever other forms of corticosteroid treatment are prescribed concurrently.
Če se bolnik sočasno zdravi še s katerimkoli drugim kortikosteroidom, je, kot pri vseh nazalnih kortikosteroidih, treba upoštevati skupno sistemsko izpostavljenost kortikosteroidom.
Caution is recommended when co-administering fluticasone furoate with potent CYP3A inhibitors including cobicistat-containing products as an increase in the risk of systemic side effects is expected.
Pri sočasni uporabi flutikazonfuroata in katerega od močnih zaviralcev CYP3A4, vključno z zdravili, ki vsebujejo kobicistat, priporočamo previdnost, saj je pričakovati večje tveganje sistemskih neželenih učinkov ne moremo izključiti.
Breast-feeding It is unknown whether nasal administered fluticasone furoate is excreted in human breast milk.
Ni znano, če se flutikazonfuroat po nazalni uporabi izloča z materinim mlekom.
Fluticasone furoate nasal spray 110 micrograms once daily significantly improved ocular symptoms as well as improving patients' disease-related quality of life (RQLQ) compared to placebo in one study.
V primerjavi s placebom je flutikazonfuroat v obliki pršila za nos v odmerku 110 mikrogramov enkrat na dan v eni študiji pomembno izboljšal tako očesne simptome kot tudi z boleznijo povezano kakovost življenja bolnika (RQLQ).
The device is primed by pressing the mist release button for at least six spray actuations (until a fine mist is seen), whilst holding the device upright.
Pršilnik bolnik aktivira tako, da ga drži v pokončnem položaju in približno 6 krat pritisne na sprožilec (dokler se ne pojavi fina meglica).
At 110 micrograms, median concentrations in those subjects with quantifiable levels were 14.3 pg/ml and 14.4 pg/ml for 2-5 yrs and 6-11 yrs, respectively.
Pri otrocih z merljivimi vrednostmi flutikazonfuroata po uporabi 110 mikrogramskega odmerka je bila pri otrocih, starih od 2 do 5 let, mediana vrednost koncentracij 14,3 pg/ml, pri otrocih, starih od 6 do 11 let, pa 14,4 pg/ml.
- Keep this leaflet.
Odstranite pokrovček.
Mechanism of action: Pharmacotherapeutic group: Nasal preparations, corticosteroids.
Farmakoterapevtska skupina: Zdravila za zdravljenje bolezni nosne sluznice, kortikosteroidi, oznaka ATC: R01AD12
• steroid tablets or injected steroids
• kortikosteroide za injiciranje ali peroralno uporabo,
Median fluticasone furoate concentrations in those subjects with quantifiable levels at 55 micrograms were 18.4 pg/ml and 18.9 pg/ml for 2-5 yrs and 6-11 yrs, respectively.
Pri otrocih z merljivimi vrednostmi flutikazonfuroata po uporabi 55 mikrogramskega odmerka je bila pri otrocih, starih od 2 do 5 let, mediana vrednost koncentracij 18,4 pg/ml, pri otrocih, starih od 6 do 11 let, pa 18,9 pg/ml.
Further, there were no treatment-related increases in the incidence of tumours in two year inhalation studies in rats and mice.
Pri podganah in miših pri dveletnih študijah z uporabo zdravila v obliki inhalacij niso poročali o z zdravljenjem povezanem povečanju pojavnosti tumorjev.
Some people will not feel the full effects until several days after first using Avamys.
Kdaj se pokažejo učinki zdravljenja z zdravilom Avamys Pri nekaterih bolnikih se popolni učinki zdravljenja pokažejo šele več dni po prvi uporabi zdravila Avamys, vendar zdravilo običajno začne učinkovati že v 8 do 24 urah po uporabi.
Hepatic Impairment No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Okvara jeter Pri bolnikih z okvaro jeter odmerka ni treba prilagajati (glejte poglavje 5.2).
Avamys nasal spray is used to treat symptoms of allergic rhinitis including stuffy, runny or itchy nose, sneezing and watery, itchy or red eyes, in adults and children aged 6 years and over.
Avamys pršilo za nos uporabljamo pri odraslih in otrocih, starih 6 let in starejših, za zdravljenje simptomov alergijskega rinitisa, vključno z zamašenostjo nosu in izcedkom iz njega, srbenjem nosu, kihanjem, solzenjem in srbenjem ali pordelostjo oči.
Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.
Bolezni imunskega sistema Redki preobčutljivostne reakcije, vključno z anafilaksijo, angioedemom, izpuščajem in urtikarijo
In vivo studies have revealed no evidence of cleavage of the furoate moiety to form fluticasone.
S študijami in vivo cepitve furoata do flutikazona niso dokazali.
However, it may take several days of treatment to achieve maximum benefit, and the patient should be informed that their symptoms will improve with continuous regular use (see section 5.1).
Bolniku je treba pojasniti, da se bodo simptomi izboljšali le pri neprekinjeni in redni uporabi (glejte poglavje 5.1).
Immune system disorders Rare
Zelo redki perforacija nosnega pretina
Therefore, no clinical studies have been conducted to investigate interactions of fluticasone furoate on other drugs.
Klinične študije, ki bi vrednotile interakcije med flutikazonfuroatom in drugimi zdravili, zato niso bile izvedene.
• Check the nasal spray for damage
• Preverite pršilo za nos glede okvare.
Very rare
Ni znano
Each spray delivers 27.5 micrograms of fluticasone furoate.
Pri enem vpihu se sprosti 27,5 mikrogramov flutikazonfuroata.
It is best to store your Avamys nasal spray upright.
Pršilo za nos Avamys je najbolje shranjevati v pokončnem položaju.
- If you get any side effects, talk to your doctor or pharmacist or nurse.
- Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Very rare side effects (may affect up to 1 in 10,000 people) • Small holes (perforations) in the ridge inside the nose that separates the nostrils.
• majhne luknjice (perforacije) v nosni pregradi, ki ločuje nosnici.
There are no data with intranasal fluticasone furoate in patients with hepatic impairment.
Pri bolnikih z okvaro jeter ni podatkov o nazalni uporabi flutikazonfuroata.
Avamys nasal spray is for administration by the intranasal route only.
Pršilo za nos Avamys je namenjeno le za nazalno uporabo.
If you get any side effects talk to your doctor, pharmacist or nurse.
Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril (total daily dose 55 micrograms) may be effective for maintenance.
Ko je dosežen zadosten nadzor simptomov, je zdravljenje možno vzdrževati že z enim vpihom v vsako nosnico (skupni dnevni odmerek 55 mikrogramov).
Avamys 27.5 micrograms/spray nasal spray suspension Fluticasone furoate
Avamys 27,5 mikrogramov/vpih pršilo za nos, suspenzija flutikazonfuroat
Fluticasone furoate nasal spray 110 micrograms once daily significantly improved nasal symptoms as well as patients' perception of overall response to therapy compared to placebo in three studies.
Celoletni alergijski rinitis pri odraslih in mladostnikih V primerjavi s placebom je flutikazonfuroat v obliki pršila za nos v odmerku 110 mikrogramov enkrat na dan v vseh treh študijah pomembno izboljšal tako nosne simptome kot tudi bolnikov vtis o celotnem odzivu na zdravljenje.
Avamys 27.5 micrograms per spray nasal spray suspension Fluticasone furoate
Avamys 27, 5 mikrogramov na vpih pršilo za nos, suspenzija flutikazonfuroat
In perennial allergic rhinitis, fluticasone furoate nasal spray 55 micrograms once daily exhibited a more consistent efficacy profile than fluticasone furoate nasal spray 110 micrograms once daily over 4 weeks' treatment.
Pri celoletnem alergijskem rinitisu je bil v času 4-tedenskega zdravljenja profil učinkovitosti flutikazonfuroata v obliki pršila za nos v odmerku 55 mikrogramov enkrat na dan doslednejši kot pri uporabi flutikazonfuroata v obliki pršila za nos v odmerku 110 mikrogramov enkrat na dan. Post hoc analiza po 6 in 12 tednih v isti študiji, kot tudi 6-tedenska študija varnosti osi hipotalamus-hipofizanadledvični žlezi, podpirata učinkovitost flutikazonfuroata v obliki pršila za nos v odmerku 110 mikrogramov enkrat na dan.
You must prepare the nasal spray:
Pršilo za nos morate pripraviti:
AVAMYS 27.5 micrograms/spray, nasal spray suspension
AVAMYS 27,5 mikrogramov/vpih pršilo za nos, suspenzija
Renal Impairment No dose adjustment is required in this population (see section 5.2).
Okvara ledvic Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati (glejte poglavje 5.2).
Growth retardation has been reported in children receiving nasal corticosteroids.
Pri otrocih, ki so prejemali nazalne kortikosteroide, je bil opisan zaostanek v rasti.
Distribution
Porazdelitev:
In the majority of patients fluticasone furoate is not quantifiable (< 10 pg/ml) following intranasal dosing of 110 micrograms once daily.
Po nazalnem odmerku 110 mikrogramov enkrat na dan flutikazonfuroata pri večini bolnikov ni možno meriti (< 10 pg/ml).
The intranasal device should be shaken before use.
Pred uporabo je treba pršilnik dobro pretresti.
There was no evidence for higher quantifiable levels of fluticasone furoate in younger children (less than 6 years of age).
Pri mlajših otrocih (mlajših od 6 let) niso poročali o višjih merljivih vrednostih flutikazonfuroata.
Onset of action has been observed as early as 8 hours after initial administration.
Začetek delovanja so opazili že 8 ur po prvi uporabi, vendar pa se največja korist lahko pokaže šele nekaj dni po začetku zdravljenja.
Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses.
Pri otrocih, ki so se zdravili s priporočenimi odmerki nazalnih kortikosteroidov, so poročali o zaostanku v rasti.
Nasal use.
nazalna uporaba
There is a step-by-step guide to using the nasal spray after Section 6 of this leaflet.
Na koncu poglavja 6 tega besedila je podrobno navodilo za uporabo pršila za nos.
Hepatic impairment
Bolezni živčevja Pogosti glavobol
Glucose anhydrous Dispersible cellulose Polysorbate 80
6.1 Seznam pomožnih snovi brezvodna glukoza disperzibilna celuloza polisorbat 80 benzalkonijev klorid dinatrijev edetat prečiščena voda
Each spray actuation delivers 27.5 micrograms of fluticasone furoate.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Pri enem vpihu se sprosti 27,5 mikrogramov flutikazonfuroata.
Reporting of side effects
Poročanje neželenih učinkov
Uncommon side effects (may affect up to 1 in 100 people) • Pain, burning, irritation, soreness or dryness in the inside of the nose.
• bolečina, pekoč občutek, draženje, bolečnost ali suhost v notranjosti nosu.
How to store Avamys
Shranjevanje zdravila Avamys
Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness.
Občasni rinalgija, težave v nosu (vključno s pekočim občutkom v nosu, draženjem nosu in bolečnostjo nosu), suhost nosu
How much to use
Način uporabe
Laboratoire GlaxoSmithKline Tél.
France Laboratoire GlaxoSmithKline
• Always keep the cap on the nasal spray when you are not using it.
• Kadar pršila za nos ne uporabljate, naj bo na njem vedno nameščen pokrovček.
It may harm them, even if their signs of illness seem the same as yours.
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
STEP-BY-STEP GUIDE TO USING THE NASAL SPRAY
NAVODILO ZA UPORABO PRŠILA ZA NOS
What Avamys contains The active substance is fluticasone furoate.
Zdravilna učinkovina je flutikazonfuroat.
It will damage the nasal spray
S tem boste namreč poškodovali pršilo za nos.
Invented name Pharmaceutical form
Izmišljeno ime Farmacevtska oblika
The study was not considered further as it contained insufficient detail.
Ta študija se ni dodatno obravnavala, ker je vsebovala premalo podrobnosti.
OVERALL SUMMARY OF THE SCIENTIFIC CONCLUSIONS 1.
SPLOŠNI POVZETEK ZNANSTVENIH ZAKLJUČKOV 1.
All validity criteria of the guideline were fulfilled.
Izpolnjena so bila vsa merila veljavnosti iz smernice.
It is not clear to what extent a population recovery may have occurred at the end of the test period.
Ni jasno, v kakšnem obsegu je do konca preskusa lahko prišlo do obnovitve populacije.
The difference in DT50 and DT90 values are relative small.
Razlike med vrednostmi DT50 in DT90 so sorazmerno majhne.
Only two data points are available, i.e. the start and end of the study, where unfortunately no precise level of concentration recovery was reported (less than 20%).
Na voljo sta samo dve podatkovni točki, tj. začetek in konec študije brez navedbe točnega izkoristka koncentracij (manj od 20 %).
2.3.4 Microorganisms
2.3.4 Mikroorganizmi
The number and variation in the soil types are considered acceptable.
Število vrst zemlje in razlike med njimi se štejejo za sprejemljive.
GROUNDS FOR RECOMMENDATION OF THE GRANTING OF A MARKETING AUTHORISATION
PODLAGA ZA PRIPOROČILO ODOBRITVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
Assessment of the environmental risk
Ocena tveganja za okolje
This is a major reason why the EU (EMEA/CVMP) has made the testing of cyanobacteria mandatory for all antibiotics.
To je glavni razlog, da je EU (EMEA/CVMP) za vse antibiotike uvedla obvezno preskušanje na cianobakterijah.
11-12 Pol. Ind. La Borda 08140 Caldes de Montbui SPAIN
La Borda 08140 Caldes de Montbui ŠPANIJA
The growth rates are unlikely to have been exponential, and therefore the tests are likely to have been conducted under sub-optimal sensitivity.
Hitrosti rasti verjetno niso bile eksponentne, zato so bili preskusi verjetno opravljeni z občutljivostjo, ki je pod optimalno.
The correlation between measured parameters and dry weight of biomass should have been reported.
Moralo bi se navesti ujemanje med izmerjenimi parametri in suho maso biomase.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, POTI UPORABE IN PREDLAGATELJEV V DRŽAVAH ČLANICAH
The soil characteristics and resulting DT50 and DT90 values were: DT50: 141, 103, 99 and 149 days; DT90: 469, 342, 330 and 495 days.
Pridobljene vrednosti DT50 in DT90, ki so značilne za prst, so bile: DT50: 141, 103, 99 in 149 dni; DT90: 469, 342, 330 in 495 dni.
If a less conservative approach is taken, the geometric mean of the four DT50 values could be used, i.e. 121 days.
Če izberemo manj konzervativen pristop, lahko uporabimo geometrično povprečje štirih vrednosti DT50, tj. 121 dni.
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so končne različice, dogovorjene med postopkom Usklajevalne skupine.
With the existing disappearance data it would be necessary to use a time-weighted-average approach.
Z obstoječimi podatki o razgradnji je treba uporabiti pristop tehtanega povprečja v določenem časovnem intervalu.
Antibiotics are likely to be toxic to algae and cyanobacteria.
Antibiotiki so verjetno toksični za alge in cianobakterije.
No further consideration is made to the data of the green algae as this was more than 50 times less sensitive to enrofloxacin.
Podatki za zelene alge se nadalje niso obravnavali, saj so te več kot 50-krat manj občutljive na enrofloksacin.
The calculations for the minor species turkeys were not considered further in this referral as the risk in any case will be lower.
Izračuni za purane kot skupine MUMS se v tem napotitvenem postopku niso obravnavali, saj bo tveganje v vsakem primeru manjše.
The Committee recognised that the design of the study had deficiencies but agreed that the results can be used for the PEC calculations.
Odbor priznava, da ima zasnova študije napake, vendar se strinja, da se lahko rezultati uporabijo za izračune PKO.
The Koc was calculated as 110,885 l kg/1(geometric mean).
Izračunali so Koc 110 885 l kg/1(geometrično povprečje).
The product is intended to be used for the treatment of diseases of the respiratory and alimentary tracts of bacterial or mycoplasmal origin in chickens and turkeys.
Zdravilo je namenjeno zdravljenju bolezni dihal in prebavil, ki jih povzročijo bakterije ali mikoplazme pri kokoših in puranih.
The study by Robinson et al 2005 is, overall, a well reported scientific paper, which has been published in a well established international peer reviewed Journal.
Študija Robinsona et al. (2005) je na splošno dobro napisan znanstveni prispevek, ki je bil objavljen v dobro uveljavljeni mednarodni recenzirani reviji.
A comprehensive set of data needed to conduct an environmental risk assessment according to the VICH and CVMP guidelines was provided.
Predložen je bil obsežen niz podatkov, ki so potrebni za ocene tveganja za okolje v skladu s smernicami VICH in CVMP.
The submitted environmental risk assessment report is based on new studies initiated by the applicant and on bibliographical data extracted from peer reviewed journals.
Predloženo poročilo ocene tveganja za okolje temelji na novih študijah, ki jih je začel predlagatelj izvajati, ter na bibliografskih podatkih iz recenziranih revij.
The EC50 values for M. aeruginosa and P. subcapitata were 49 and 3,100 µg/l, respectively.
Vrednost EC50 za M. aeruginosa je bila 49, za P. subcapitata pa 3,100 µg/l.
Risk characterisation is calculated from the risk quotient (RQ), which should be less than 1 in all taxonomic levels to consider that enrofloxacin does not represent a risk to the environment.
Opis tveganja se izračuna iz količnika tveganja (KT), ki mora biti nižji od 1 za vse taksonomske ravni, da se šteje, da enrofloksacin ne pomeni tveganja za okolje.
The geometric mean of these two EC50 values is 15.9 µg/l.
Geometrično povprečje teh dveh vrednosti EC50 je 15,9 µg/l.
Other data are taken from peer reviewed articles published in the open literature.
Drugi podatki so bili vzeti iz recenziranih člankov, objavljenih v dostopni literaturi.
If one assumes a worst case situation, then the highest DT50 should be used for further assessment (e.g. PECSoil-plateau calculations).
Če si predstavljamo najslabšo situacijo, lahko za nadaljnjo oceno (npr. izračun PKOzemlja-plato) uporabimo največjo vrednost DT50.
In particular the adequacy of the data provided in respect to the environmental risk assessment regarding these two points was questioned.
Predvsem je obstajal dvom glede zadostnosti podatkov, predloženih pri oceni tveganja za okolje.
The seeds were placed in a natural sandy soil containing the test item at nominal concentrations of 10, 31.6, 100, 316 and 1000 mg enrofloxacin/kg dry soil (cucumber, lettuce, mung bean, oat and wheat) and 3, 12, 48, 192 and 768 mg enrofloxacin/kg dry soil (rye), respectively.
Semena so položili v naravno peščeno zemljo, ki je vsebovala preskušano snov v nazivnih koncentracijah 10, 31,6, 100, 316 in 1 000 mg enrofloksacina/kg suhe prsti (kumara, zelena solata, fižol, oves in pšenica) oziroma 3, 12, 48, 192 in 768 mg enrofloksacina/kg suhe zemlje(rž).
Application of the CVMP guideline Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 and GL38 results in an estimate of PECsurfacewater of 0.019 µg/l.
Z uporabo smernice CVMP za oceno vpliva zdravil za uporabo v veterinarski medicini na okolje ob smernicah VICH GL6 in GL38 dobimo oceno PKOpovršinska voda 0,019 µg/l.
A conservative PNEC value could hence be established at 10 µg/l.
Lahko se določi konzervativna vrednost PKBU 10 µg/l.
The disappearance of non-labelled enrofloxacin was investigated according to OECD guideline 307 in four soils with different content of organic carbon and clay and pH values.
Razpadanje neoznačenega enrofloksacina so preiskali skladno s smernico OECD 307 v štirih vzorcih zemlje z različno vsebnostjo organskega ogljika in gline ter različnimi vrednostmi pH.
Given the uncertainty of the fate and disappearance of enrofloxacin during the course of the test, the CVMP cannot support using the nominal concentrations for the establishment of EC50 values.
CVMP glede na negotovost usode in razgradnjo enrofloksacina med preskusom ne more podpreti uporabe nazivnih koncentracij za določitev vrednosti EC50.
For the treatment of salmonellosis treatment should be extended to 5 days.
Zdravljenje salmoneloze naj se podaljša na