FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that it is made by a cell that has received a gene (DNA), which makes the cell able to produce
Slovenian: To pomeni, da je ustvarjen s pomočjo celice, ki je prejela gen (DNK), kar celici omogoča, da ga proizvede.
English: The company has informed the CHMP that the withdrawal will not have any consequences for patients enrolled in any trials.
Slovenian: Družba je CHMP obvestila, da umik ne bo imel nobenih posledic za bolnike, ki sodelujejo v katerih koli preskušanjih.
English: Withdrawal of the marketing authorisation application for Kalbitor (ecallantide) EMA/888548/2011
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Kalbitor (ekallantid) EMA/888548/2011
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Kalbitor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation causes the swelling attacks seen in angioedema.
Slovenian: Povzetek mnenja Odbora za zdravila sirote za zdravilo Kalbitor je na voljo na spletni strani Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Kallikrein is part of a complex network of proteins (known as the kallikrein-kinin system) that has several effects in the body, one of which results in increased levels of a protein called bradykinin that causes the blood vessels to widen and leak fluid into the surrounding tissue.
Slovenian: Kallikrein je del zapletene mreže proteinov (znane kot sistem kallikrein-kinin), ki ima številne učinke na telo, med njimi povečano vrednost proteina, imenovanega bradikinin, ki povzroča širitev krvnih žil in uhajanje tekočine v okolno tkivo.
English: This means that documentation provided by the company and formulated lists of questions.
Slovenian: To pomeni, da je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
English: available as a solution for injection.
Slovenian: Bilo naj bi na voljo v obliki raztopine za injiciranje.
English: Afte assessed the company's responses to the last round of questions in an oral explan some unresolved issues.
Slovenian: Potem ko je CHMP ocenil odgovore družbe na zadnja vprašanja z ustno razlago, so nekatera vprašanja še vedno ostala nerešena.
English: Kalbitor was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 18 December 2002 for the treatment of angioedema.
Slovenian: Zdravilo Kalbitor je bilo dne 18. decembra 2002 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje angioedema.
English: What were the reasons given by the company for withdrawing the
Slovenian: Kakšni so bili razlogi družbe za umik vloge?
English: What was Kalbitor exp hereditary angioedema have attacks of swelling that can occur anywhere in face, limbs, gut and throat, causing discomfort and pain and sometimes in the difficulty in breathing.
Slovenian: Bolniki s prirojenim angioedemom imajo napade otekanja, ki se lahko pojavijo kjer koli v telesu, kot na primer na obrazu, v okončinah, prebavilih in grlu, kar povzroča nelagodje in bolečino, včasih ob napadih v grlu tudi težave pri dihanju.
English: What is Kalbitor?
Slovenian: Kaj je zdravilo Kalbitor?
English: The CH
Slovenian: dnevu“.
English: The letter from the company notifying the Agency of the withdrawal of the application is available.
Slovenian: Dopis, s katerim družba Agencijo obvešča o umiku vloge, je na voljo pod zavihkom „All documents“.
English: Kalbitor was expected to be used to treat symptoms of attacks of hereditary angioedema.
Slovenian: Kalbitor naj bi se uporabljal za zdravljenje simptomov napadov prirojenega angioedema.
English: Kalbitor is a medicine that contains the active substance ecallantide.
Slovenian: Kalbitor je zdravilo, ki vsebuje zdravilno učinkovino ekallantid.
English: l, the CHMP was of the opinion that the benefits of Kalbitor did not outweigh its risks.
Slovenian: Zato je CHMP v času umika menil, da koristi zdravila Kalbitor ne odtehtajo z njim povezanih tveganj.
English: he actions of kallikrein, Kalbitor is lantide in Kalbitor is produced by a method known as ‘recombinant DNA technology'.
Slovenian: Ekallantid v zdravilu Kalbitor je proizveden z metodo, imenovano „tehnologija rekombinantne DNK“.
English: Based on the review of the data and the company's resp time of the withdrawal, the CHMP had some concerns and was of the provisional o could not have be
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil nekatere zadržke in začasno menil, da zdravila Kalbitor ni mogoče odobriti.
English: How is Kalbitor expected to work?
Slovenian: Kako naj bi zdravilo Kalbitor delovalo?
English: 011, Dyax s.a. officially notified the Committee for Medicinal Products for Human ation for Kalbitor, treatment of symptoms of acute attacks of hereditary angioedema.
Slovenian: Družba Dyax s.a. je dne 11. novembra 2011 uradno obvestil Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Kalbitor, namenjenim zdravljenju simptomov akutnih napadov prirojenega angioedema.
English: The CHMP had concerns about hypersensitivity reactions, which were see treated with a medicine, and include reactions commonly known as allergic reactions.
Slovenian: Preobčutljivostne reakcije se pojavijo, ko imunski sistem reagira proti zdravilu, in vključujejo reakcije, ki so v splošnem znane kot alergijske reakcije.
English: The active substance in Kalbitor, ecallantide, blocks an enzyme in the blood called ‘kallikrein'.
Slovenian: Zdravilna učinkovina v zdravilu Kalbitor, ekallantid, v krvi blokira encim kallikrein.
English: Withdrawal of the marketing authorisation application for
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Kalbitor (ekallantid)
English: By blocking t expected to help reduce the swelling and related symptoms of angioedema.
Slovenian: Z zaviranjem dejavnosti kallikreina se pričakuje, da bo kalbitor pomagal zmanjšati oteklino in z njo povezane simptome angioedema.
English: The effects of Kalbitor were first tested in experimental models before being studie The company presented the results of two main studies in patients aged 1 hereditary angioedema.
Slovenian: Učinki zdravila Kalbitor so bili najprej preizkušeni na poskusnih modelih, šele nato so jih proučili pri ljudeh.
English: Therefore, at the time of the withdrawa application?
Slovenian: Kako daleč je bil postopek ocenjevanja vloge ob njenem umiku?
English: Hypersensitivity reactions occur when the body's immune system reacts against MP also had concerns related to the effectiveness of the proposed doses in heavier patients.
Slovenian: CHMP je imel še pomisleke v zvezi z učinkovitostjo predlaganih odmerkov zdravila pri težjih bolnikih.
English: There were 72 patients in one study and 96 in the other treated with either Kalbitor or placebo (a dummy treatment) w judged to be at risk of blockage of the airway were given additional treatments i The main measure of effectiveness was based on the improvement in pati hours.
Slovenian: Bolniki so bili v osmih urah po napadu zdravljeni bodisi z zdravilom Kalbitor bodisi s placebom (zdravilom brez zdravilne učinkovine).
English: the CHMP had evaluated the r the CHMP had ation, there were still onse to the CHMP lists of questions, at the pinion that Kalbitor en approved.
Slovenian: CHMP je imel pomisleke glede preobčutljivostnih reakcij, ki so bile opažene pri večjem deležu bolnikov, ki so se zdravili z zdravilom Kalbitor.
English: Pack size
Slovenian: Prašek
English: Immediate Packaging
Slovenian: Mehanizem delovanja
English: Strength Pharmaceutical Form Route of Administration
Slovenian: NAČIN IZDAJANJA ZDRAVILA
English: MA (EU) number (Invented) name
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: 28 vials + 28 prefilled syringes; 6 plungers
Slovenian: Dvanajst tednov so raziskovali tri (3) odmerke teduglutida, 0,0125 mg/kg/dan (n=8), 0,025 mg/kg/dan (n=14) in
English: Content (concentration)
Slovenian: Absorpcija
English: 28 vials + 28 prefilled syringes
Slovenian: Velikost pakiranja 28 vial praška z 28 napolnjenimi injekcijskimi brizgami.
English: 1 vial + 1 prefilled syringe
Slovenian: Revestive 5 mg prašek in vehikel za raztopino za injiciranje teduglutid
English: Annex IV Conditions of the Marketing Authorisation
Slovenian: Priloga IV Pogoji dovoljenja za promet z zdravilom
English: • Circulation, within 25 days of the Commission Decision, of the adopted Dear Healthcare Professional Communication as specified in the communication plan
Slovenian: • v 25. dneh po izdaji sklepa Komisije razpošljejo sprejeto „Neposredno obvestilo zdravstvenim delavcem” v skladu z načrtom obveščanja.
English: National Competent Authorities shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Slovenian: Pristojni državni organi morajo zagotoviti, da imetniki dovoljenj za promet z zdravilom izpolnijo naslednje pogoje:
English: one type I glass bottle of lyophilisate and one type I glass bottle of solvent, 1 syringe and 1 needle
Slovenian: Ena steklenica tipa I liofilizata in ena steklenica tipa I topila, 1 vbrizgalo in 1 iglo
English: These studies are still ongoing.
Slovenian: Te študije še potekajo.
English: Other information about Humenza:
Slovenian: Druge informacije o zdravilu Humenza:
English: It should only be used for the influenza A (H1N1) flu pandemic that was officially declared by the World Health Organization on 11 June 2009.
Slovenian: Uporablja se samo proti pandemični gripi A (H1N1), ki jo je Svetovna zdravstvena organizacija uradno razglasila 11. junija 2009.
English: This means that there is more evidence to come about the medicine, in particular the results of further clinical studies in children, adolescents and adults.
Slovenian: To pomeni, da o zdravilu pričakujemo še več podatkov, zlasti rezultate nadaljnjih kliničnih študij pri otrocih, mladostnikih in odraslih.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Humenza to Sanofi Pasteur SA on 08 June 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Humenza, veljavno po vsej Evropski uniji, odobrila družbi Sanofi Pasteur SA dne 8. junija 2010.
English: However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.
Slovenian: Vendar pa bo med pandemijo cepljenje takih bolnikov morda vseeno upravičeno, če bo na razpolago oprema za oživljanje.
English: The seroprotection rates in elderly subjects were lower but a second dose was shown to bring about a further response.
Slovenian: Stopnja serozaščite pri starejših ljudeh je bila nižja, a se je pokazalo, da drugi odmerek sproži še dodaten odziv.
English: This will include information on its side effects and its safety in children, the elderly, pregnant women, patients with severe conditions and people who have problems with their immune systems.
Slovenian: Te informacije bodo vključevale podatke o njegovih neželenih učinkih ter varnosti njegove uporabe pri otrocih, starostnikih, nosečnicah, resno bolnih osebah in ljudeh, ki imajo težave z imunskim sistemom.
English: Three studies are being carried out with Humenza containing the H1N1 strain, one in 300 adults and 150 elderly patients (over 60 years of age), and two in a total of 700 children aged between six months and 17 years of age.
Slovenian: S cepivom Humenza, ki vsebuje sev H1N1 so bile opravljene tri študije, ena z 300 odraslimi in 150 starejšimi bolniki (nad 60 let) ter dve s skupno 700 otroki, starimi od šest mesecev do 17 let.
English: A second dose may be given after an interval of at least three weeks, particularly in children from six months to three years of age.
Slovenian: Po ne manj kot treh tednih se lahko da drugi odmerek, zlasti pri otrocih, starih od šest mesecev do treh let.
English: Which measures are being taken to ensure the safe use of Humenza?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Humenza?
English: This document is a summary of the European Public Assessment Report (EPAR) for Humenza.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Humenza.
English: The company that makes Humenza will supply further data on the medicine, in particular on its safety from a study in 3,000 subjects.
Slovenian: Družba, ki izdeluje cepivo Humenza, bo predložila nadaljnje podatke o zdravilu, zlasti o njegovi varnosti iz študije s 3 000 osebami.
English: Humenza should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace levels in the vaccine, such as ovalbumin (a protein in egg white), egg or chicken proteins, neomycin, octoxinol-9 and formaldehyde.
Slovenian: Cepivo Humenza se ne sme dajati osebam, ki so imele anafilaktično reakcijo (hudo alergijsko reakcijo) na katero koli sestavino cepiva ali na katero koli od snovi, ki se v sledeh nahajajo v cepivu, kot so ovalbumin (beljakovina v beljaku), jajčne ali piščančje beljakovine, neomicin, oktoksinol-9 in formaldehid.
English: What benefit has Humenza shown during the studies?
Slovenian: Kakšne koristi je zdravilo Humenza izkazalo med študijami?
English: Humenza is given according to official recommendations.
Slovenian: Cepivo Humenza se daje le v skladu z uradnimi priporočili.
English: Preliminary results from the three ongoing studies show that one dose of Humenza was able to trigger immunity to a satisfactory level in adults and children.
Slovenian: Prvi rezultati iz še ne zaključenih študij kažejo, da en odmerek cepiva Humenza sproži zadovoljivo raven imunosti pri odraslih in otrocih.
English: The company that makes Humenza will collect information on the safety of the vaccine while it is being used.
Slovenian: Družba, ki izdeluje zdravilo Humenza, bo zbrala informacije o varnosti cepiva med njegovo uporabo.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Humenza.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Humenza, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The company also presented information from studies in 641 adults carried out using an earlier version of Humenza, containing a ‘bird flu' strain H5N1.
Slovenian: Družba je predstavila tudi podatke iz študij s 641 odraslimi, ki so uporabljali prejšnjo obliko cepiva Humenza, ki je vsebovala sev „ptičje gripe“ H5N1.
English: The solvent contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Slovenian: Emulzija vsebuje tudi „adjuvans“ (spojino, ki vsebuje olje) za spodbujanje imunskega odziva.
English: The most common side effects with Humenza (seen with more than 1 in 10 doses of the vaccine) are headache, myalgia (muscle pain) and pain at the site of injection.
Slovenian: Najpogostejši neželeni učinki zdravila Humenza (opaženi pri več kot enem od 10 odmerkov cepiva) so glavobol, mialgija (bolečina v mišicah) in bolečina na mestu injiciranja.
English: Humenza is a vaccine.
Slovenian: Zdravilo Humenza je cepivo.
English: Humenza has been given ‘Conditional Approval'.
Slovenian: Za zdravilo Humenza je bila sprejeta „pogojna odobritev“.
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Slovenian: Pandemija gripe nastopi, ko se pojavi nov sev virusa gripe, ki se lahko brez težav širi s človeka na človeka, ker ljudje proti njemu niso imuni (zaščiteni).
English: Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Slovenian: Humenza cepivo proti pandemični gripi (H1N1) (z delci virionov, inaktivirano, z adjuvansom)
English: This second dose must be given to patients over 60 years of age.
Slovenian: Bolniki, starejši od 60 let, ta drugi odmerek morajo prejeti.
English: These studies are looking at the ability of Humenza to trigger the production of antibodies (‘immunogenicity') against the H1N1 flu strain.
Slovenian: V teh študijah so proučevali sposobnost cepiva Humenza, da sproži nastajanje protiteles („imunogenost“) proti sevu gripe H1N1.
English: Before use, the vaccine is made up by mixing together a suspension that contains the virus particles with a solvent.
Slovenian: Pred uporabo se cepivo pripravi z mešanjem suspenzije, ki vsebuje delce cepiva, in vehikla.
English: What information is still awaited for Humenza?
Slovenian: Katere informacije o zdravilu Humenza še pričakujemo?
English: The Committee decided that Humenza's benefits are greater than its risks for the prophylaxis of influenza in the officially declared H1N1 pandemic situation and recommended that it be given marketing authorisation.
Slovenian: Odbor je sklenil, da so koristi cepiva Humenza za preprečevanje uradno razglašene pandemije gripe H1N1večje od z njim povezanih tveganj ter priporočil, da se zanj odobri dovoljenje za promet.
English: What is the risk associated with Humenza?
Slovenian: Kakšna tveganja so povezana z zdravilom Humenza?
English: Humenza contains small amounts of haemagglutinins (proteins from the surface) of a virus called A(H1N1)v that is causing the current pandemic.
Slovenian: Cepivo Humenza vsebuje majhno količino hemaglutininov (beljakovin s površine) virusa, imenovanega A(H1N1), ki povzroča trenutno pandemijo.
English: For the full list of all side effects reported with Humenza, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Humenza, glejte navodilo za uporabo.
English: Why has Humenza been approved?
Slovenian: Zakaj je bilo zdravilo Humenza odobreno?
English: Humenza is a vaccine to protect against ‘pandemic' flu.
Slovenian: Zdravilo Humenza je cepivo za zaščito pred pandemično gripo.
English: The percentage of subjects who had a level of antibodies in their blood that was high enough to neutralise the H1N1 virus (seroprotection rate) was 100% in children and close to 100% in adults.
Slovenian: 100 % otrok in skoraj 100 % odraslih je imelo v krvi dovolj protiteles za nevtraliziranje virusa H1N1 (stopnja serozaščite).
English: Humenza contains a flu strain called A/California/7/2009 (H1N1)-like strain (NYMC X-179A).
Slovenian: Vsebuje sev gripe (NYMC X-179A), ki je podoben sevu A/California/7/2009 (H1N1).
English: Humenza is given as one dose, injected into the upper arm or thigh muscle.
Slovenian: Cepivo Humenza se daje v enkratnem odmerku z injiciranjem v mišico nadlahti ali stegensko mišico.
English: The full EPAR for Humenza can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Humenza je na voljo tukaj.
English: What is Humenza used for?
Slovenian: Za kaj se zdravilo Humenza uporablja?
English: How has Humenza been studied?
Slovenian: Kako je bilo zdravilo Humenza raziskano?
English: It contains parts of influenza (flu) viruses that have been inactivated (killed).
Slovenian: Zdravilo Humenza je cepivo, ki se daje z injiciranjem.Vsebuje dele virusov influence (gripe), ki so bili inaktivirani (uničeni).
English: How is Humenza used?
Slovenian: Kako se zdravilo Humenza uporablja?
English: How does Humenza work?
Slovenian: Kako zdravilo Humenza deluje?
English: What is Humenza?
Slovenian: Kaj je zdravilo Humenza?
English: The use of protective gloves is recommended.
Slovenian: Priporočljiva je uporaba zaščitnih rokavic.
English: Fipronil: Absolute bioavailability: 9.5 %.
Slovenian: Fipronil: Absolutna biološka razpoložljivost: 9,5 %.
English: Wash hands thoroughly after use.
Slovenian: Po uporabi si temeljito umijte roke.
English: ATCvet code: QP53AX65.
Slovenian: Oznaka ATC vet: QP53AX65.
English: Do not administer orally or via any other route.
Slovenian: Ne dajajte peroralno ali na kateri koli drug način.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/05/2011.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 06/05/2011.
English: In these cases do not treat more frequently than once a fortnight.
Slovenian: Tudi v teh primerih zdravila ni priporočljivo nanašati pogosteje kot enkrat na 14 dni.
English: Children should not be allowed to play with treated dogs until the application site is dry.
Slovenian: Otroci se ne smejo igrati z zdravljenim psom, dokler ni mesto nanosa suho.
English: For this reason the transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.
Slovenian: Zato v neugodnih razmerah prenosa bolezni ne moremo popolnoma izključiti.
English: The CVMP at their meeting on 18 February 2016 decided that one additional five-year renewal was required in view of the outstanding pharmacovigilance data that were undergoing evaluation at the time of the renewal procedure and to ensure that the MAH's pharmacovigilance system is adequate to enable collection and evaluation of adverse events in line with the requirements.
Slovenian: CVMP je na sestanku 18.2.2016 odločil, da je potrebno dodatno petletno podaljšanje dovoljenja za promet, zaradi določenih farmakovigilančnih podatkov, ki so bili v času tega podaljšanja za promet v postopku evaluacije, ter za zagotovitev, da je farmakovigilančni sistem dovolj učinkovit za zbiranje in ocenjevanje neželenih učinkov v skladu z veljavnimi zahtevami.
English: This results in uncontrolled activity of the central nervous system and death of insects or acari.
Slovenian: Posledica je nenadzorovano delovanje centralnega živčnega sistema in smrt insektov ali zajedavcev.
English: Elimination of fleas and ticks within 24 hours.
Slovenian: Eliminacija bolh in klopov v 24 urah.
English: 29, avenue Tony Garnier FR-69007 Lyon France.
Slovenian: FR-69007 Lyon Francija
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli resne stranke učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
English: (S)-Methoprene is extensively degraded into carbon dioxide and acetate that are subsequently incorporated into endogenous materials.
Slovenian: (S)-metopren se v največji meri razgradi v ogljikov dioksid in acetat, ki se posledično vključujeta v endogene snovi.
English: Do not smoke, drink or eat whilst handling.
Slovenian: Med dajanjem zdravila je prepovedano kaditi, piti ali jesti.
English: For dogs over 60 kg, use the appropriate combination of two pipettes that most closely matches the bodyweight.
Slovenian: Pri psih, težjih od 60 kg, uporabite kombinacijo dveh merilnih kapalk, ki najbolj ustrezata telesni teži živali.
English: BATCH NUMBER {number}
Slovenian: ŠTEVILKA SERIJE {številka}
English: CERTIFECT should not enter water courses as this may be dangerous for fish and aquatic organisms.
Slovenian: CERTIFECT ne sme priti v vodotoke, ker je lahko nevaren za ribe in druge vodne organizme.
English: Fipronil's major metabolite on the haircoat of the dog and in the blood stream is the sulfone derivative.
Slovenian: Najpomembnejši metabolit učinkovine fipronil na dlaki in v krvi psa je sulfonski derivat.
English: Fipronil sulfone is produced on the haircoat (mean concentrations < 16 % of fipronil during the first month after treatment).
Slovenian: Fipronil sulfon nastaja na dlaki (srednje koncentracije < 16 % učinkovine fipronil v prvem mesecu po zdravljenju).