FrancophonIA/ELRC3.0 huggingface dataset:
English: Kigabeq 100 mg soluble tablets
Slovenian: Navodilo za uporabo Kigabeq 100 mg tablete za peroralno raztopino
English: Half a tablet (100 mg)
Slovenian: zvečer pol tablete (100 mg)
English: It is important that you tell the doctor promptly if there is any change in your child's vision.
Slovenian: Pomembno je, da zdravniku takoj poveste,
English: Check with the doctor or pharmacist if you are not sure.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
English: Hepatic impairment
Slovenian: bolečine v trebuhu
English: One soluble tablet of Kigabeq 100 mg contains 100 mg vigabatrin One soluble tablet of Kigabeq 500 mg contains 500 mg vigabatrin - The other ingredients are: crospovidone type B, mannitol, sodium stearyl fumarate
Slovenian: Kigabeq 500 mg tablete za peroralno raztopino Ena tableta za peroralno raztopino vsebuje 500 mg vigabatrina.
English: NAME OF THE MEDICINAL PRODUCT Kigabeq 100 mg soluble tablets vigabatrin
Slovenian: Kigabeq 100 mg tablete za peroralno raztopino vigabatrin
English: Very common side effects (may affect more than 1 in 10 people) excitation or restlessness tiredness and pronounced sleepiness joint pain
Slovenian: Drugi neželeni učinki so: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: The recommended starting dose is 40 mg/kg/day.
Slovenian: Rezistentna delna epilepsija (napadi žariščnega izvora) Priporočeni začetni odmerek je 40 mg/kg/dan.
English: Other side effects include:
Slovenian: UPORABNO DO:
English: PHARMACEUTICAL FORM AND CONTENTS 50 soluble tablets
Slovenian: 50 tablet za peroralno raztopino
English: Luxe mbourg/Luxemburg ORPHELIA Pharma SAS Tél/Tel: + 33 1 42 77 08 18
Slovenian: ORPHELIA Pharma SAS Tél/Tel: + 33 1 42 77 08 18
English: Adolescents and adults (>12 years old)
Slovenian: Mladostniki in odrasli (stari > 12 let) Skupina I 1 Skupina II 2 Skupina III Skupina I 3 Skupina II 4 Skupina III
English: INFORMATION IN BRAILLE Kigabeq 100 mg
Slovenian: Kigabeq 100 mg
English: PHARMACEUTICAL FORM AND CONTENTS 100 soluble tablets
Slovenian: 100 tablet za peroralno raztopino
English: The recommended dose is one tablet twice a day (every 12 hours) for 10 days.
Slovenian: Priporočeni odmerek je ena tableta dvakrat na dan (vsakih 12 ur) 10 dni
English: It is available as tablets (200 mg).
Slovenian: Na voljo je v obliki tablet (200 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dificlir on 5 December 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Dificlir, veljavno po vsej Evropski uniji, odobrila dne 5. decembra 2011.
English: The main measure of effectiveness was the number of patients that were cured after 10 days of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila okužba ozdravljena po 10 dneh zdravljenja.
English: The full EPAR for Dificlir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Dificlir je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: C. difficile are bacteria that are present naturally in the gut and do not cause any problems in healthy people.
Slovenian: C. difficile so bakterije, ki so naravno prisotne v črevesju in zdravim osebam ne povzročajo nikakršnih težav.
English: However, some antibiotics that are used to treat infections can interfere with the balance of 'good' bacteria in the gut.
Slovenian: Vendar pa lahko nekateri antibiotiki, ki se uporabljajo za zdravljenje okužb, porušijo ravnovesje „dobrih“ bakterij v črevesju.
English: The effects of Dificlir were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Dificlir so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: For more information about treatment with Dificlir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Dificlir preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Other information about Dificlir
Slovenian: Druge informacije o zdravilu Dificlir
English: When looking at the results of the two studies, 92 % of patients on Dificlir were cured compared with 90% of patients on vancomycin.
Slovenian: Ob primerjavi izsledkov dveh študij je bilo z zdravilom Dificlir ozdravljenih 92 % bolnikov, z vankomicinom pa 90 %.
English: When this happens, C. difficile bacteria can multiply and produce toxins (poisons), which cause illness such as diarrhoea and fever.
Slovenian: Ko pride do tega, se lahko bakterije C. difficile razmnožijo in proizvajajo toksine (strupe), ki povzročajo bolezni, kot sta driska in povišana temperatura.
English: The CHMP noted however, that there are uncertainties about the effects of Dificlir in certain groups of patients such as those with liver and kidney problems and recommended that further studies in this group should be carried out.
Slovenian: Vendar CHMP ugotavlja, da obstajajo negotovosti glede učinkov zdravila Dificlir pri nekaterih skupinah bolnikov, na primer tistih, ki imajo težave z jetri in ledvicami, ter priporoča, da se v tej skupini izvedejo nadaljnje študije.
English: EPAR summary for the public fidaxomicin
Slovenian: Povzetek EPAR za javnost fidaksomicin
English: This is a summary of the European public assessment report (EPAR) for Dificlir.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Dificlir.
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 Dificlir.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Dificlir, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: When it is swallowed most of the active substance does not get absorbed into the blood stream but acts locally on C. difficile bacteria in the gut.
Slovenian: Ko se pogoltne, se večina zdravilne učinkovine ne vsrka v krvni obtok, ampak deluje lokalno na bakterijo C. difficile v črevesju.
English: The most common side effects with Dificlir (seen in between 1 and 10 patients in 100) are nausea (feeling sick), vomiting and constipation.
Slovenian: Najpogostejši neželeni učinki zdravila Dificlir (opaženi pri 1 do 10 bolnikih od 100) so navzeja (slabost), bruhanje in zaprtje.
English: Dificlir must not be used in people who are hypersensitive (allergic) to fidaxomicin or any of the other ingredients.
Slovenian: Zdravila Dificlir ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) fidaksomicin ali katero koli drugo sestavino zdravila.
English: What benefit has Dificlir shown during the studies?
Slovenian: Kakšne koristi je zdravilo Dificlir izkazalo med študijami?
English: Why has Dificlir been approved?
Slovenian: Zakaj je bilo zdravilo Dificlir odobreno?
English: What is the risk associated with Dificlir?
Slovenian: Kakšna tveganja so povezana z zdravilom Dificlir?
English: The active substance in Dificlir, fidaxomicin, is an antibiotic that belongs to the class of macrocylic antibiotics.
Slovenian: Zdravilna učinkovina v zdravilu Dificlir, fidaksomicin, je antibiotik, ki pripada novi vrsti makrocikličnih antibiotikov.
English: The CHMP considered the severity of C. difficile infections and the drawbacks of current treatments and concluded that benefits of Dificlir are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je proučil resnost okužb z bakterijo C.difficile in slabosti sedanjih načinov zdravljenja ter zaključil, da so koristi zdravila Dificlir večje od z njim povezanih tveganj ter priporočil, da se zanj odobri dovoljenje za promet z zdravilom.
English: Dificlir has been compared with vancomycin (another antibiotic for C. difficile infections) in two main studies involving a total of 1,147 adult patients with mild to moderately severe C. difficile infection.
Slovenian: Zdravilo Dificlir so primerjali z vankomicinom (drugim antibiotikom za okužbe z bakterijo C. difficile) v dveh glavnih študijah, ki sta skupno vključevali 1 147 odraslih bolnikov z blažjo do zmerno hudo okužbo z bakterijo C. difficile.
English: At this point, a person is said to be infected with C. difficile.
Slovenian: Takrat velja, da je oseba okužena z bakterijo C. difficile.
English: Dificlir is used to treat adults with infections of the gut caused by bacteria called Clostridium difficile.
Slovenian: Zdravilo Dificlir se uporablja pri odraslih za zdravljenje okužb črevesja, ki jih povzroča bakterija Clostridium difficile.
English: For the full list of all side effects reported with Dificlir, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Dificlir, glejte navodilo za uporabo.
English: Dificlir is a medicine that contains the active substance fidaxomicin.
Slovenian: Dificlir je zdravilo, ki vsebuje zdravilno učinkovino fidaksomicin.
English: polymerase, which is used to produce the RNA that the bacteria need to make proteins.
Slovenian: Deluje tako, da zavira bakterijski encim, polimerazo RNK, ki se uporablja za tvorbo RNK, ki jo bakterija potrebuje pri tvorbi beljakovin.
English: This stops the C. difficile bacteria from growing and multiplying.
Slovenian: To preprečuje rast in razmnoževanje bakterije C. difficile.
English: How has Dificlir been studied?
Slovenian: Kako je bilo zdravilo Dificlir raziskano?
English: The CHMP considered that Dificlir was effective in curing C. difficile infections and was generally well tolerated with side effects that are similar to vancomycin.
Slovenian: CHMP je menil, da je zdravilo Dificlir učinkovito pri zdravljenju okužb z bakterijo C. difficile, bolniki zdravljenje na splošno dobro prenašajo z neželenimi učinki, podobnimi tistim pri vankomicinu.
English: What is Dificlir used for?
Slovenian: Za kaj se zdravilo Dificlir uporablja?
English: Dificlir was at least as effective as vancomycin in curing C. difficile infection.
Slovenian: Dificlir je bil pri zdravljenju okužbe z bakterijo C. difficile vsaj tako učinkovit kot vankomicin.
English: How is Dificlir used?
Slovenian: Kako se zdravilo Dificlir uporablja?
English: How does Dificlir work?
Slovenian: Kako zdravilo Dificlir deluje?
English: 6 February 2012
Slovenian: 6. februar 2012
English: The Committee adopted a positive opinion by majority on 10 November 2011.
Slovenian: Odbor je sprejel pozitivno mnenje z večino dne 10. novembra 2011.
English: The referral procedure started on 11 November 2009.
Slovenian: Napotitveni postopek se je začel 11. novembra 2009.
English: The final opinion was converted into a Decision by the European Commission on 6 February 2012.
Slovenian: Končno mnenje je bilo dne 6. februarja 2012 spremenjeno v odločbo Evropske komisije.
English: The Committee appointed Dr Karolina Törneke as rapporteur and Dr Michael Holzhauser-Alberti as co-rapporteur.
Slovenian: Odbor je imenoval dr. Karolino Törneke za poročevalko in dr. Michaela Holzhauser-Albertija za soporočevalca.
English: Article 34 of Directive 2001/82/EC
Slovenian: 34. člen Direktive 2001/82/ES.
English: Oral explanations were given on 4 May 2011.
Slovenian: Ustna pojasnila so bila podana 4. maja 2011.
English: International non-proprietary name (inn): benazepril hydrochloride
Slovenian: Mednarodno nelastniško ime (inn): benazepril hidroklorid
English: Fortekor and associated names
Slovenian: za zdravilo Fortekor in povezana imena
English: Written explanations were provided by the marketing authorisation holders on 24 May 2010 and 6 January 2011.
Slovenian: Imetniki dovoljenj za promet z zdravilom so podali pisna pojasnila 24. maja 2010 in 6. januarja 2011.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended product information in Annex III.
Slovenian: Seznam zadevnih imen izdelkov je podan v Prilogi I. Znanstveni zaključki so na voljo v Prilogi II, skupaj z dopolnjenimi informacijami o zdravilu v Prilogi III.
English: In line with the principles of referrals under Article 34(1) of Directive 2001/82/EC, on 16 September 2010 Sweden sent a revised referral notification under Article 34(1) of Directive 2001/82/EC and extended the scope of the referral procedure to all Fortekor and associated names tablet strengths and formulations.
Slovenian: V skladu z načeli napotitev po členu 34(1) Direktive 2001/82/ES, je Švedska dne 16. septembra 2010 poslala revidirano obvestilo o napotitvi po členu 34(1) Direktive 2001/82/ES in razširila obseg napotitvenega postopka na vse jakosti in farmacevtske oblike tablet Fortekor in povezanih imen.
English: Fortekor and associated names is a veterinary medicinal product containing benazepril hydrochloride presented in 2.5 mg, 5 mg and 20 mg flavoured tablets and 5 mg and 20 mg film-coated tablets intended for use in dogs and cats.
Slovenian: Fortekor in povezana imena so zdravila za uporabo v veterinarski medicini, ki vsebujejo benazepril hidroklorid v aromatiziranih tabletah po 2,5 mg, 5 mg in 20 mg ter v filmsko obloženih tabletah po 5 mg in 20 mg, namenjenih za uporabo pri psih in mačkah.
English: The product is intended for the treatment of heart failure in dogs and/or the treatment of chronic kidney disease in cats and dogs, and the approved indications and target species varied between the Member States.
Slovenian: Ta izdelek je namenjen za zdravljenje srčnega popuščanja pri psih in/ali za zdravljenje kronične ledvične bolezni pri mačkah in psih, ter za odobrene indikacije in ciljne vrste, ki se razlikujejo med državami članicami.
English: Benazeprilat is a highly potent and selective inhibitor of angiotensin converting enzyme, thus preventing the conversion of inactive angiotensin I to active angiotensin II and thereby also reducing synthesis of aldosterone.
Slovenian: Benazeprilat je visoko učinkovit in selektiven zaviralec angiotenzinske konvertaze, ki na ta način preprečuje pretvorbo neaktivnega angiotenzina I v aktivni angiotenzin II in s tem tudi zmanjšuje sintezo aldosterona.
English: Due to the divergent decisions taken by Member States concerning the authorisation of Fortekor and associated names (5 mg benazepril hydrochloride film-coated tablet) and differences between the summary of product characteristics of the product as authorised in the Member States, the issue was referred on 16 October 2009 by Sweden to the CVMP under Article 34(1) of Directive 2001/82/EC.
Slovenian: Zaradi različnih odločitev, ki so jih države članice sprejele v zvezi z odobritvijo zdravila Fortekor in povezanih imen (filmsko obložena tableta s 5 mg benazepril hidroklorida) ter razlik med povzetki glavnih značilnosti zdravila, ki so jih odobrile države članice, je Švedska dne 16. oktobra 2009 zadevo napotila na odbor CVMP v skladu s členom 34(1) Direktive 2001/82/ES.
English: An ad-hoc expert group meeting was held on 10 October 2011 and the marketing authorisation holders attended the meeting for an oral explanation.
Slovenian: Zasedanje ad-hoc izvedenske skupine je potekalo 10. oktobra 2011, imetniki dovoljenj za promet z zdravilom pa so se zasedanja udeležili, da so podali ustna pojasnila.
English: Based on the assessment of the currently available data and further to a consultation with the ad-hoc expert group, the CVMP considered that the benefit-risk balance for Fortekor and associated names remains positive, except for the chronic kidney disease in dogs, subject to variation of the marketing authorisations in accordance with the recommended product information.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in po posvetu z ad-hoc izvedensko skupino je odbor CVMP menil, da razmerje med tveganji in koristmi za zdravilo Fortekor in povezana imena ostaja pozitivno, z izjemo kronične ledvične bolezni pri psih, ki se v dovoljenjih za promet z zdravilom spremeni v skladu s priporočenimi informacijami o zdravilu.
English: Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat.
Slovenian: Benazepril hidroklorid je predzdravilo, ki se hidrolizira in vivo v svoj aktivni presnovek, benazeprilat.
English: holders' oral explanations to the Committee, the CVMP, at its May 2011 meeting, agreed that an ad-hoc expert group should be consulted regarding the scientific evidence base for angiotensin converting enzyme inhibitor in the treatment of chronic kidney disease in dogs.
Slovenian: posvetovati z ad-hoc izvedensko skupino v zvezi z znanstvenimi izsledki o zaviralcih angiotenzinske konvertaze pri zdravljenju kronične ledvične bolezni pri psih.
English: Opinion following an Article 34 referral for Fortekor and associated names EMA/965903/2011
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 34 za zdravilo Fortekor in povezana imena stran 2/2
English: The four remaining studies are summarised below.
Slovenian: Preostale štiri študije so povzete spodaj.
English: Member State EU/EEA
Slovenian: Država članica EU /EGP
English: Special warnings, if necessary
Slovenian: Posebna opozorila, če so potrebna
English: The Reference Member State was Ireland and the Concerned Member States were Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Greece, Spain, Finland, France, Hungary, Iceland, Latvia, Lithuania, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden.
Slovenian: Referenčna država članica je bila Irska, zadevne države članice pa Avstrija, Bolgarija, Ciper, Češka republika, Danska, Estonija, Grčija, Španija, Finska, Francija, Madžarska, Islandija, Latvija, Litva, Malta, Nizozemska, Norveška, Poljska, Portugalska, Romunija, Slovaška, Slovenija in Švedska.
English: It is noted that the study (2002) predates the introduction of that guideline (2005).
Slovenian: Omeniti je treba, da je bila študija (2002) izvedena pred objavo te smernice (2005).
English: Therefore, this scenario was not considered for sheep.
Slovenian: Ta scenarij zato za ovce ni bil obravnavan.
English: This method is however not considered suitable for substances with a log Pow above 4.
Slovenian: Vendar pa ta metoda ni ustrezna za snovi, ki imajo log Pow nad 4.
English: Although this study was well conducted other studies cannot be disregarded unless there is a sound reason for doing so (e.g. evidence of mistakes).
Slovenian: Četudi je bila ta študija izvedena dobro, pa ni mogoče zanemariti drugih študij, razen če obstaja očiten razlog za to (npr. prisotnost napak).
English: Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom
Slovenian: Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ Združeno Kraljestvo
English: However, this study is not available and cannot be requested in this referral.
Slovenian: Vendar pa ta študija ni na voljo in je v tem napotitvenem postopku ni mogoče zahtevati.
English: The log Pow of 4.4 can therefore only be considered as an indicator of the actual value.
Slovenian: Posledično je mogoče vrednost log Pow 4,4 upoštevati le kot približnega pokazatelja dejanske vrednosti.
English: The Committee noted that the final version of the product information achieved during the Coordination Group procedure at day 210 includes specific warnings concerning conditions of use in dairy cattle.
Slovenian: Odbor je opozoril, da končna različica informacij o zdravilu, ki je bila sprejeta med postopkom usklajevalne skupine na 210. dan, vključuje posebna opozorila glede pogojev uporabe pri kravah molznicah.
English: Benefits have not been subject of this referral; they were considered in the preceding decentralised procedure.
Slovenian: Koristi niso bile predmet tega napotitvenega postopka, saj so bile obravnavane v predhodnem decentraliziranem postopku.
English: Cattle, sheep and pigs
Slovenian: Govedo, ovce in prašiči
English: During the decentralised procedure it was agreed that the authorisation of the generic product under the name "Dectomax" will not be issued until the reference product under the name "Dectomax" has either been withdrawn or renamed.
Slovenian: Med decentraliziranim postopkom je bilo dogovorjeno, da dovoljenje za promet generičnega zdravila z imenom „Dectomax“ ne bo izdano, dokler referenčno zdravilo z imenom „Dectomax“ ne bo umaknjeno ali preimenovano.
English: The product has claims for persistent efficacy ranging from 18 to 42 days.
Slovenian: Učinek zdravila naj bi trajal v razponu od 18 do 42 dni.
English: The following MRLs have been established in the EU for the active substance doramectin (Table 1 of the Annex to Regulation (EU) No 37/2010 for all mammalian food producing species:
Slovenian: Za zdravilno učinkovino doramektin so v EU določene naslednje mejne vrednosti ostankov (tabela 1 priloge k Uredbi (EU) št. 37/2010 za vse vrste sesalcev za proizvodnjo živil):
English: The weights of animals were below 250 kg. Only injection sites (500-600 g) were sampled.
Slovenian: Mase živali so bile pod 250 kg. Vzorčena so bila samo mesta injiciranja (500-600 g).
English: The applicant provided a targeted Phase II environmental risk assessment.
Slovenian: Predlagatelj je predložil ciljno usmerjeno oceno tveganja za okolje faze II.
English: Before addressing the issues of disagreement the following two changes to the initial application that were made during the decentralised procedure and the CVMP referral procedure should be noted:
Slovenian: Pred obravnavanjem spornih vprašanj je treba opozoriti na naslednji dve spremembi prvotne vloge, do katerih je prišlo med decentraliziranim postopkom in napotitvenim postopkom pri CVMP:
English: The product is applied by a single subcutaneous or intramuscular injection.
Slovenian: Zdravilo se daje z enkratno subkutano ali intramuskularno injekcijo.
English: It protects pigs against infection or reinfection with Sarcoptes scabiei for 18 days.
Slovenian: Prašiče 18 dni varuje pred okužbo ali ponovno okužbo z zajedavcem Sarcoptes scabiei.
English: The need for repeat treatments is reduced relative to other anthelmintic products.
Slovenian: Potreba po ponovnih zdravljenjih je zmanjšana v primerjavi z drugimi antihelmintiki.
English: The following text is proposed in section 4.5 (special precautions for use):
Slovenian: Predlaga se vključitev naslednjega besedila v oddelek 4.5 (posebni previdnosti ukrepi):
English: Additional benefits of this product are the same as the reference product.
Slovenian: Dodatne koristi tega zdravila so enake kot pri referenčnem zdravilu.
English: Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Slovenian: Obe spojini imata širok spekter antiparazitskega delovanja in tvorita podobno paralizo pri nematodih in parazitskih artropodih.
English: No data on the nature and rates of metabolites are available.
Slovenian: Podatki o naravi in ravneh presnovkov niso na voljo.
English: All except one were GLP studies and were carried out with the same formulation (plus or minus radioactive tracer).
Slovenian: Vse študije, razen ene, so bile skladne z dobro laboratorijsko prakso in so bile izvedene z isto formulacijo (z radioaktivnim sledilom ali brez njega).
English: It cannot be excluded that actual injection sites were missed in this study.
Slovenian: Ni mogoče izključiti možnosti, da so bila pri tej študiji dejanska mesta injiciranja zgrešena.
English: Injection sites at 35 and 56 days were not assayed.
Slovenian: Vzorčenje na mestu injiciranja 35. in 56. dan ni bilo izvedeno.
English: Conclusions regarding the environmental impact
Slovenian: Zaključki v zvezi z vplivom na okolje
English: However, no bioaccumulation study was provided; also no assessment of secondary poisoning was performed.
Slovenian: Vendar pa študija biološkega kopičenja ni bila posredovana, prav tako pa ni bila izvedena ocena sekundarne zastrupitve.