natgillin/translations-raw huggingface dataset:
Movement disorders including dystonia, dyskinesia and hypertonia, have been reported in patients treated with vigabatrin for infantile spasms. 
Pri bolnikih, zdravljenih z vigabatrinom zaradi infantilnih spazmov, so poročali o motnjah gibanja, vključno z distonijo, diskinezijo in hipertonijo.
Each soluble tablet contains 100 mg vigabatrin. 
Ena tableta za peroralno raztopino vsebuje 100 mg vigabatrina.
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications. 
Pri bolnikih, ki so bili zdravljeni z zdravili proti epilepsiji za več indikacij, so poročali o samomorilnih mislih in vedenju.
Pregnancy and breast-feeding This medicine is not intended for use in women of child-bearing potential or in breast-feeding women. 
To zdravilo ni namenjeno uporabi pri ženskah v rodni dobi ali ženskam, ki dojijo.
0.5 to 1 g/day 
od 10 do 15 kg: od 0,5 do 1 g/dan od 15 do 30 kg: od 1 do 1,5 g/dan
Epidemiology of VFD in patients with refractory partial epilepsy was observed in an observational, open-label, multicentre, comparative, parallel group, Phase IV study, including 734 patients, at least 8 years old, with refractory partial epilepsy for at least one year. 
734 bolnikov, starih vsaj 8 let, pri katerih je bila refraktarna delna epilepsija prisotna vsaj eno leto, so ugotovili epidemiologijo izpadov vidnega polja pri bolnikih z refraktarno delno epilepsijo.
If your child develops symptoms like sleepiness, reduced consciousness and movements (stupor) or confusion, tell your child's doctor who may reduce the dose or stop Kigabeq treatment. 
(omamljenost) ali zmedenost, to povejte njegovemu zdravniku, ki lahko zmanjša odmerek ali zdravljenje z zdravilom Kigabeq ustavi.
Uncommon side effects (may affect up to 1 in 100 people) lack of coordination or fumbling more severe psychological problems such as feeling elated or over-excited, which causes unusual behaviour, and feeling detached from reality skin rash 
več resnih psiholoških težav, kot je občutek vzhičenosti ali prevelike vznemirjenosti, ki povzroča nenavadno vedenje, in občutek ločenosti od resničnosti; kožni izpuščaj.
500 mg tablet size: 16.0 mm x 9.0 mm 
500 mg, velikost tablete: 16,0 mm x 9,0 mm 100 mg, velikost tablete: 9,4 mm x 5,3 mm
Proposed doses for second titration step (100 mg/kg/day) (Day 6) 
(100 mg/kg/dan) (6. dan)
Kigabeq 100 mg soluble tablets EU/1/18/1302/001 
EU/1/18/1302/001 100 tablet za peroralno raztopino - 100 mg EU/1/18/1302/002 50 tablet za peroralno raztopino - 500 mg
Pack size: 50 soluble tablets. 
Velikost pakiranja: 50 tablet za peroralno raztopino
One tablet (500 mg) 
ena tableta (500 mg)
Pack size: 100 soluble tablets. 
Velikost pakiranja: 100 tablet za peroralno raztopino
Kigabeq is for oral or gastric use and may be taken before or after meals. 
Zdravilo Kigabeq se daje peroralno ali prek gastrične sonde in ga je mogoče jemati pred obroki ali po njih.
Your child should not ride a bicycle, climb or take part in hazardous activity if the child has symptoms like drowsiness or dizziness with Kigabeq. 
Če so se pri vašem otroku zaradi zdravila Kigabeq pojavili simptomi, kot je zaspanost ali omotica, ne sme kolesariti, plezati ali sodelovati pri nevarnih dejavnostih.
Dissolution of soluble tablet 
Raztapljanje tablete za peroralno raztopino
Two tablets (100 mg) 
dve tableti (100 mg)
One tablet (100 mg) 
ena tableta (100 mg)
Three tablets (100 mg) 
tri tablete (100 mg)
Soluble tablet 
Tableta za peroralno raztopino
Asymptomatic and transient Magnetic Resonance Imaging (MRI) abnormalities in the brain have been observed in some infants treated with vigabatrin for infantile spasms. 
motnje gibanja in nepravilnosti na slikah možganov, slikanih z magnetno resonanco, pri majhnih dojenčkih, zdravljenih zaradi infantilnih spazmov.
Half a tablet (500 mg) 
pol tablete (500 mg)
Psychiatric disorders 
Pediatrična populacija Psihiatrične motnje
Gastric administration should be used for children who cannot swallow, but can be fed by enteral route. 
Pri otrocih, ki ne morejo požirati, mogoče pa jih je hraniti enteralno, je treba zdravilo dati prek gastrične sonde.
Proposed doses for first titration step (75 mg/kg/day) (Day 3) 
(75 mg/kg/dan) (3. dan)
Crospovidone type B Mannitol 
- Druge sestavine so krospovidon tip B, manitol, natrijev stearilfumarat.
Four tablets (100 mg) 
štiri tablete (100 mg)
NAME OF THE MEDICINAL PRODUCT Kigabeq 500 mg soluble tablets vigabatrin 
Kigabeq 500 mg tablete za peroralno raztopino vigabatrin
Kigabeq 100 mg soluble tablets For children aged 1 month to less than 7 years 
Zdravilo Kigabeq je indicirano za zdravljenje dojenčkov in otrok, starih od 1 meseca do manj kot 7 let,
1 x 500 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening 
1 x 500-mg tableta zjutraj 1 x 500-mg in 1 x 100-mg tableta zvečer
The recommended starting dose is 50 mg/kg/day. 
Monoterapija za infantilne spazme (Westov sindrom) Priporočeni začetni odmerek je 50 mg/kg/dan.
One tablet (500 mg) and one tablet (100 mg) 
ena tableta (500 mg) in ena tableta (100 mg)
Kigabeq 500 mg soluble tablets 
Kigabeq 500 mg tablete za peroralno raztopino
Two and a half tablets (100 mg) 
dve tableti in pol (100 mg)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 1 BOTTLE OF 100 SOLUBLE TABLETS OF KIGABEQ 100 MG 
ŠKATLA, KI VSEBUJE 1 PLASTENKO S 100 TABLETAMI ZA PERORALNO RAZTOPINO ZDRAVILA KIGABEQ 100 MG
Pregnancy 
Otroci
Ask your child's doctor to show you how to give this medicine. 
O tem, kako dajati to zdravilo, vprašajte otrokovega zdravnika.
One and a half tablets (500 mg) 
ena tableta in pol (500 mg)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 1 BOTTLE OF 50 SOLUBLE TABLETS OF KIGABEQ 500 MG 
ŠKATLA, KI VSEBUJE 1 PLASTENKO S 50 TABLETAMI ZA PERORALNO RAZTOPINO ZDRAVILA KIGABEQ 500 MG
1 x 500 mg and 1 x 100 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening 
1 x 500-mg in 1 x 100-mg tableta zvečer 1 x 500-mg in 1 x 100-mg tableta zjutraj 1 x 500-mg in 1 x 100-mg tableta zvečer
Four and a half tablets (100 mg) 
štiri tablete in pol (100 mg)
Three and a half tablets (100 mg) 
tri tablete in pol (100 mg)
Breastfeeding 
vigabatrin
One and a half tablets (100 mg) 
ena tableta in pol (100 mg)
Kigabeq 100 mg soluble tablets 
Navodilo za uporabo Kigabeq 100 mg tablete za peroralno raztopino
Half a tablet (100 mg) 
zvečer pol tablete (100 mg)
It is important that you tell the doctor promptly if there is any change in your child's vision. 
Pomembno je, da zdravniku takoj poveste,
Check with the doctor or pharmacist if you are not sure. 
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
Hepatic impairment 
bolečine v trebuhu
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 
Kigabeq 500 mg tablete za peroralno raztopino Ena tableta za peroralno raztopino vsebuje 500 mg vigabatrina.
NAME OF THE MEDICINAL PRODUCT Kigabeq 100 mg soluble tablets vigabatrin 
Kigabeq 100 mg tablete za peroralno raztopino vigabatrin
Very common side effects (may affect more than 1 in 10 people) excitation or restlessness tiredness and pronounced sleepiness joint pain 
Drugi neželeni učinki so: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
The recommended starting dose is 40 mg/kg/day. 
Rezistentna delna epilepsija (napadi žariščnega izvora) Priporočeni začetni odmerek je 40 mg/kg/dan.
Other side effects include: 
UPORABNO DO:
PHARMACEUTICAL FORM AND CONTENTS 50 soluble tablets 
50 tablet za peroralno raztopino
Adolescents and adults (>12 years old) 
Mladostniki in odrasli (stari > 12 let) Skupina I 1 Skupina II 2 Skupina III Skupina I 3 Skupina II 4 Skupina III
PHARMACEUTICAL FORM AND CONTENTS 100 soluble tablets 
100 tablet za peroralno raztopino
The recommended dose is one tablet twice a day (every 12 hours) for 10 days. 
Priporočeni odmerek je ena tableta dvakrat na dan (vsakih 12 ur) 10 dni
It is available as tablets (200 mg). 
Na voljo je v obliki tablet (200 mg).
The European Commission granted a marketing authorisation valid throughout the European Union for Dificlir on 5 December 2011. 
Evropska komisija je dovoljenje za promet z zdravilom Dificlir, veljavno po vsej Evropski uniji, odobrila dne 5. decembra 2011.
The main measure of effectiveness was the number of patients that were cured after 10 days of treatment. 
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila okužba ozdravljena po 10 dneh zdravljenja.
The full EPAR for Dificlir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
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.
C. difficile are bacteria that are present naturally in the gut and do not cause any problems in healthy people. 
C. difficile so bakterije, ki so naravno prisotne v črevesju in zdravim osebam ne povzročajo nikakršnih težav.
However, some antibiotics that are used to treat infections can interfere with the balance of 'good' bacteria in the gut. 
Vendar pa lahko nekateri antibiotiki, ki se uporabljajo za zdravljenje okužb, porušijo ravnovesje „dobrih“ bakterij v črevesju.
The effects of Dificlir were first tested in experimental models before being studied in humans. 
Učinki zdravila Dificlir so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
For more information about treatment with Dificlir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
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.
Other information about Dificlir 
Druge informacije o zdravilu Dificlir
When looking at the results of the two studies, 92 % of patients on Dificlir were cured compared with 90% of patients on vancomycin. 
Ob primerjavi izsledkov dveh študij je bilo z zdravilom Dificlir ozdravljenih 92 % bolnikov, z vankomicinom pa 90 %.
When this happens, C. difficile bacteria can multiply and produce toxins (poisons), which cause illness such as diarrhoea and fever. 
Ko pride do tega, se lahko bakterije C. difficile razmnožijo in proizvajajo toksine (strupe), ki povzročajo bolezni, kot sta driska in povišana temperatura.
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. 
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.
EPAR summary for the public fidaxomicin 
Povzetek EPAR za javnost fidaksomicin
This is a summary of the European public assessment report (EPAR) for Dificlir. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Dificlir.
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. 
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.
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. 
Ko se pogoltne, se večina zdravilne učinkovine ne vsrka v krvni obtok, ampak deluje lokalno na bakterijo C. difficile v črevesju.
The most common side effects with Dificlir (seen in between 1 and 10 patients in 100) are nausea (feeling sick), vomiting and constipation. 
Najpogostejši neželeni učinki zdravila Dificlir (opaženi pri 1 do 10 bolnikih od 100) so navzeja (slabost), bruhanje in zaprtje.
Dificlir must not be used in people who are hypersensitive (allergic) to fidaxomicin or any of the other ingredients. 
Zdravila Dificlir ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) fidaksomicin ali katero koli drugo sestavino zdravila.
What benefit has Dificlir shown during the studies? 
Kakšne koristi je zdravilo Dificlir izkazalo med študijami?
Why has Dificlir been approved? 
Zakaj je bilo zdravilo Dificlir odobreno?
What is the risk associated with Dificlir? 
Kakšna tveganja so povezana z zdravilom Dificlir?
The active substance in Dificlir, fidaxomicin, is an antibiotic that belongs to the class of macrocylic antibiotics. 
Zdravilna učinkovina v zdravilu Dificlir, fidaksomicin, je antibiotik, ki pripada novi vrsti makrocikličnih antibiotikov.
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. 
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.
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. 
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.
At this point, a person is said to be infected with C. difficile. 
Takrat velja, da je oseba okužena z bakterijo C. difficile.
Dificlir is used to treat adults with infections of the gut caused by bacteria called Clostridium difficile. 
Zdravilo Dificlir se uporablja pri odraslih za zdravljenje okužb črevesja, ki jih povzroča bakterija Clostridium difficile.
For the full list of all side effects reported with Dificlir, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Dificlir, glejte navodilo za uporabo.
Dificlir is a medicine that contains the active substance fidaxomicin. 
Dificlir je zdravilo, ki vsebuje zdravilno učinkovino fidaksomicin.
polymerase, which is used to produce the RNA that the bacteria need to make proteins. 
Deluje tako, da zavira bakterijski encim, polimerazo RNK, ki se uporablja za tvorbo RNK, ki jo bakterija potrebuje pri tvorbi beljakovin.
This stops the C. difficile bacteria from growing and multiplying. 
To preprečuje rast in razmnoževanje bakterije C. difficile.
How has Dificlir been studied? 
Kako je bilo zdravilo Dificlir raziskano?
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. 
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.
What is Dificlir used for? 
Za kaj se zdravilo Dificlir uporablja?
Dificlir was at least as effective as vancomycin in curing C. difficile infection. 
Dificlir je bil pri zdravljenju okužbe z bakterijo C. difficile vsaj tako učinkovit kot vankomicin.
How is Dificlir used? 
Kako se zdravilo Dificlir uporablja?
How does Dificlir work? 
Kako zdravilo Dificlir deluje?
6 February 2012 
6. februar 2012
The Committee adopted a positive opinion by majority on 10 November 2011. 
Odbor je sprejel pozitivno mnenje z večino dne 10. novembra 2011.
The referral procedure started on 11 November 2009. 
Napotitveni postopek se je začel 11. novembra 2009.
The final opinion was converted into a Decision by the European Commission on 6 February 2012. 
Končno mnenje je bilo dne 6. februarja 2012 spremenjeno v odločbo Evropske komisije.
The Committee appointed Dr Karolina Törneke as rapporteur and Dr Michael Holzhauser-Alberti as co-rapporteur. 
Odbor je imenoval dr. Karolino Törneke za poročevalko in dr. Michaela Holzhauser-Albertija za soporočevalca.
Article 34 of Directive 2001/82/EC 
34. člen Direktive 2001/82/ES.
Oral explanations were given on 4 May 2011. 
Ustna pojasnila so bila podana 4. maja 2011.
International non-proprietary name (inn): benazepril hydrochloride 
Mednarodno nelastniško ime (inn): benazepril hidroklorid
Fortekor and associated names 
za zdravilo Fortekor in povezana imena
Written explanations were provided by the marketing authorisation holders on 24 May 2010 and 6 January 2011. 
Imetniki dovoljenj za promet z zdravilom so podali pisna pojasnila 24. maja 2010 in 6. januarja 2011.
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. 
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.
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. 
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.
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. 
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.
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. 
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.
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. 
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.
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. 
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.
An ad-hoc expert group meeting was held on 10 October 2011 and the marketing authorisation holders attended the meeting for an oral explanation. 
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.
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. 
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.
Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat. 
Benazepril hidroklorid je predzdravilo, ki se hidrolizira in vivo v svoj aktivni presnovek, benazeprilat.
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. 
posvetovati z ad-hoc izvedensko skupino v zvezi z znanstvenimi izsledki o zaviralcih angiotenzinske konvertaze pri zdravljenju kronične ledvične bolezni pri psih.
Opinion following an Article 34 referral for Fortekor and associated names EMA/965903/2011 
Mnenje v zvezi z napotitvijo v skladu s členom 34 za zdravilo Fortekor in povezana imena stran 2/2
The four remaining studies are summarised below. 
Preostale štiri študije so povzete spodaj.
Member State EU/EEA 
Država članica EU /EGP
Special warnings, if necessary 
Posebna opozorila, če so potrebna
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. 
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.
It is noted that the study (2002) predates the introduction of that guideline (2005). 
Omeniti je treba, da je bila študija (2002) izvedena pred objavo te smernice (2005).
Therefore, this scenario was not considered for sheep. 
Ta scenarij zato za ovce ni bil obravnavan.
This method is however not considered suitable for substances with a log Pow above 4. 
Vendar pa ta metoda ni ustrezna za snovi, ki imajo log Pow nad 4.
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). 
Četudi je bila ta študija izvedena dobro, pa ni mogoče zanemariti drugih študij, razen če obstaja očiten razlog za to (npr. prisotnost napak).
Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom 
Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ Združeno Kraljestvo
However, this study is not available and cannot be requested in this referral. 
Vendar pa ta študija ni na voljo in je v tem napotitvenem postopku ni mogoče zahtevati.
The log Pow of 4.4 can therefore only be considered as an indicator of the actual value. 
Posledično je mogoče vrednost log Pow 4,4 upoštevati le kot približnega pokazatelja dejanske vrednosti.