natgillin/translations-raw huggingface dataset:
The manufacture, import, possession, sale, supply and/or use of BTVPUR AlSap 1 may be prohibited in a certain Member State on the whole or part of their territory pursuant to national legislation. 
Uvoz, proizvodnja, prodaja, posjedovanje, opskrba i/ili primjena BTVPUR AlSap 1 može biti zabranjena u određenim državama članicama na cijelom teritoriju ili na jednom njegovom dijelu sukladno nacionalnom zakonodavstvu.
METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use 
NAČIN I PUT(EVI) PRIMJENE Supkutana primjena.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
PROIZVOĐAČ BIOLOŠKI DJELATNE(IH) TVARI I PROIZVOĐAČ
- Rare (more than 1 but less than 10 animals in 10,000 animals). 
- Rijetko (više od 1 ali manje od 10 životinja u 10.000 životinja).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 ml 
PODACI NA UNUTARNJEM PAKOVANJU Bočica od 100 ml
QUANTITY OF THE ACTIVE SUBSTANCE(S) Inactivated BTV 1 ...................................................................................................... ≥ 1.9 log10 pixels 
Inaktivirani BTV 1 ...................................................................... ≥1,9 log10piksela
Not all pack sizes may be marketed Box of 1 bottle of 10 doses (1 x 10 ml) Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml) Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml) 
PODACI NA VANJSKOM PAKOVANJU Kutija s 1 bočicom od 10 ml Kutija s 1 bočicom od 50 ml Kutija s 10 bočica od 50 ml Kutija s 1 bočicom od 100 ml Kutija s 10 bočica od 100 ml
Silicon antifoam Phosphate buffer Glycine buffer 
6.1 Popis pomoćnih tvari aluminijev hidroksid saponin silikonsko sredstvo protiv pjenjenja fosfatni pufer glicinski pufer
The frequency of adverse reactions is defined using the following convention: - Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment). 
- Vrlo česte (više od 1 na 10 životinje koje su pokazivale nuspojavu (e) za vrijeme trajanja jednog tretmana).
In cattle - First injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune cattle). 
U goveda - Prva injekcija: od 1 mjeseca starosti u prethodno necijepljenih životinja (ili od 2,5 mjeseca starosti u mladih životinja rođenih od imunih krava).
In sheep - First injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune sheep). 
U ovaca - Prva injekcija: od 1 mjeseca starosti u prethodno necijepljenih životinja (ili od 2,5 mjeseca starosti u mladih životinja rođenih od imunih ovaca).
- Uncommon (more than 1 but less than 10 animals in 1,000 animals). 
- Manje često (više od 1 ali manje od 10 životinja u 1000 životinja).
Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml) 
Kutija s 10 bočica od 50 doza (10 x 50 ml).
Type I glass bottle of 10 ml with butyl elastomere closure Box of 1 bottle of 10 doses (1 x 10 ml) 
Staklena bočica (staklo tip I) od 10 ml s čepom iz butilnog elastomera.
*(below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission). 
Aktivna imunizacija ovaca i goveda za sprječavanje viremije* i za smanjenje kliničkih znakova uzrokovanih virusom bolesti plavog jezika serotip 1. (*vrijednosti ispod razine otkrivanja validiranom RT-PCR metodom na 3,68 log10 RNA copies/ml, ukazuje na odsutnost virusa zaraze).
*(below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission) 
Aktivna imunizacija ovaca i goveda za sprječavanje viremije* i za smanjenje kliničkih znakova uzrokovanih virusom bolesti plavog jezika serotip 1. *(vrijednosti ispod razine otkrivanja validiranom RT-PCR metodom na 3,68 log10 RNA copies/ml, ukazuje na odsutnost virusa zaraze)
Shelf life of the veterinary medicinal product as package for sale (100 ml bottle): 2 years Shelf life of the veterinary medicinal product as package for sale (50 ml bottle): 2 years Shelf life of the veterinary medicinal product as package for sale (10 ml bottle): 18 months Shelf life after first opening the immediate packaging: use immediately 
Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju (bočica od 10 ml): 18 mjeseci
Fertility: 
Nesenje:
Box of 10 bottles of 100 ml 
Kutija s 10 bočica od 100 doza (10 x 100 ml).
Box of 1 bottle of 50 ml, 
Kutija s 1 bočicom od 50 doza (1 x 50 ml).
Box of 1 bottle of 100 ml, 
Kutija s 1 bočicom od 100 doza (1 x 100 ml).
Special precautions for use in animals: Vaccinate healthy animals only. 
Posebna upozorenja za upotrebu kod životinja:
Inactivated BTV 1 ....................................................................................................... ≥ 1.9 log10 pixels 
NAVOĐENJE DJELATNIH I DRUGIH TVARI Svaka doza od 1 ml sadrži virus bolesti plavog jezika Inaktivirani BTV 1 .................................................................................................... ≥1,9 log10piksela
EXPIRY DATE EXP {month/year} Once broached, use immediately 
Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: upotrijebiti odmah
Treatment is repeated after one week, but the ears should not be cleaned for the second dose. 
Tretman se ponavlja nakon tjedan dana, ali uši ne treba čistiti za drugu dozu.
The inside of the ear should be cleaned and dry before treatment. 
Unutrašnjost uha treba očistiti i posušiti prije tretmana.
The contents of one tube of gel are given into each infected ear. 
Sadržaj jedne tube gela daje se u svako inficirano uho.
The other studies took place in the USA and Japan respectively. 
Druga ispitivanja događala su se u SAD-u odnosno u Japanu.
Osurnia must also not be used in pregnant or breeding animals. 
Osurnia se također ne smije koristiti kod gravidnih ili laktirajućih životinja.
Other information about Osurnia: 
Druge informacije o lijeku Osurnia:
The main measure of effectiveness in the EU and Japanese studies was the reduction in severity of otitis externa 28 days after initial treatment; in the US study clinical success was measured after 45 days. 
Glavna mjera djelotvornosti u europskim i japanskim ispitivanjima bila je redukcija težine otitisa externe 28 dana nakon početnog liječenja; u američkom ispitivanju klinički uspjeh mjeren je nakon 45 dana.
They often lead to the ear(s) being inflamed (red, swollen and sore) or painful. 
Često uzrokuju upalu uha (ušiju) (crvenilo, oticanje i nadraženost uha) ili bolnost.
The European Commission granted a marketing authorisation valid throughout the European Union, for Osurnia on 31 July 2014. 
Europska komisija dodijelila je odobrenje za stavljanje u promet koje je na snazi na teritoriju Europske unije za proizvod Osurnia 31/07/2014.
The relatively high rate of success for the placebo might have been due to the effect of cleaning the ear beforehand and because the way the product was formulated produced a protective film of gel on the surface of the ear canal. 
Relativno visoka stopa uspjeha placeba može se pripisati učinku prethodnog čišćenja uha i formulaciji proizvoda koja stvara zaštitni film gela na površini ušnog kanala.
In the US study the Osurnia treated dogs had a success rate of 65% which was significantly higher than the placebo treated dogs with a success rate of 44%. 
U američkom ispitivanju psi liječeni Osurniom imali su 65-postotnu stopu uspjeha koja je bila znatno viša od pasa liječenih placebom sa stopom uspjeha od 44%.
If accidental exposure to the eyes occurs, the eyes should be rinsed with water and in case of accidental exposure to the skin, the skin should be washed with soap and water. 
Ako se dogodi slučajno izlaganje oka proizvodu, oči treba isprati vodom, a kod slučajnog izlaganja kože, kožu treba isprati sapunom i vodom.
The third active ingredient, betamethasone acetate, is a corticosteroid, a medicine that reduces inflammation and pain. 
Treći djelatni sastojak, betametazon acetat je kortikosteroid, lijek koji reducira upalu i bol.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Osurnia exceed the risks for the approved indications and recommended that Osurnia be given a marketing authorisation. 
Odbor za veterinarske lijekove (CVMP) zaključio je da koristi proizvoda Osurnia premašuju rizike za odobrene indikacije i preporučio izdavanje odobrenja za stavljanje u promet za lijek Osurnia.
What is Osurnia? 
Što je Osurnia?
Florfenicol is an antibiotic which works by blocking protein formation in bacterial cells. 
Florfenikol je antibiotik koji djeluje blokadom nastanka proteina u stanicama bakterija.
Osurnia must not be used if the ear drum is perforated or in dogs with generalised demodicosis (mange caused by the mite Demodex canis). 
Osurnia se ne smije koristiti ako je bubnjić uha perforiran ili kod pasa s generaliziranom demodikozom (šuga uzrokovana grinjom Demodex canis).
Ear infections in dogs can be caused by bacteria or yeasts/fungi. 
Infekcije uha u pasa mogu biti uzrokovane bakterijom ili kvascima/gljivicama.
Terbinafine kills fungi by blocking the formation of ergosterol, an important part of fungal cell walls. 
Terbinafin ubija gljivice blokadom nastanka ergosterola, važnog dijela stjenke stanica gljiva.
What is the risk associated with Osurnia? 
Koji su rizici povezani s lijekom Osurnia?
Osurnia is a veterinary medicine that contains three active substances: terbinafine, florfenicol and betamethasone acetate. 
Osurnia je veterinarsko-medicinski proizvod koji sadrži tri djelatne tvari: terbinafin, florfenikol i betametazon acetat.
The benefit/risk balance may be found in the scientific discussion module of this EPAR. 
Omjer koristi/rizika može se naći u modulu ovog EPAR-a koji sadrži znanstvene rasprave.
The US study involved 284 dogs, 190 of which were treated with Osurnia, while 90 dogs received placebo gel (dummy treatment). 
Američko ispitivanje uključivalo je 284 psa od kojih je 190 bilo liječeno Osurnijom dok je 90 pasa primilo placebo gel (slijepo liječenje).
Why has Osurnia been approved? 
Zašto je lijek Osurnia odobren?
It is available as a gel to be given into the ear. 
Dostupan je u obliku gela koji se stavlja u uho.
Two of the active substances in Osurnia terbinafine and florfenicol, act against possible causes of infection. 
Dvije djelatne tvari u proizvodu Osurnia, terbinafin i florfenikol djeluju protiv mogućih uzročnika infekcije.
If the veterinary medicine is accidentally swallowed, immediate medical advice should be sought and the package leaflet or label shown to the doctor. 
Međutim, ako osoba slučajno proguta veterinarsko-medicinski proizvod, potrebno je odmah potražiti savjet liječnika i pokazati mu naljepnicu proizvoda ili uputu o proizvodu.
Terbinafine, florfenicol and betamethasone 
Terbinafin/florfenikol/betametazon acetat
Three field studies were conducted in dogs with otitis externa caused by bacterial or fungal infections, investigating the effect of treatment following cleaning out of the ear with saline solution; treatment with two doses of Osurnia, one week apart, was compared with another comparable ear medicine or with placebo (dummy treatment). 
Tri terenska ispitivanja provedena su na psima s otitisom externa koji je uzrokovan bakterijskim ili gljivičnim infekcijama, istražujući učinak terapije nakon čišćenja vanjskog dijela uha fiziološkom otopinom; liječenje s dvije doze Osurnije, u razmaku od tjedan dana uspoređeno je s drugim usporedivim lijekom za uho ili placebom (slijepo liječenje).
In the Japanese study Osurnia was as effective as the other medicine with 78% improvement in otitis externa in both treatment groups. 
Osurnia je bila jednako djelotvorna kao i drugi lijekovi sa 78-postotnim poboljšanjem u otitisu externi u obje terapijske skupine.
What is Osurnia used for? 
Za što se Osurnia koristi?
Osurnia is used to treat short lived or recurrent ear infections (otitis externa) due to Staphylococcus pseudintermedius (a bacterium) and Malassezia pachydermatitis (a yeast). 
Osurnia se koristi za liječenje kratkoročnih ili povratnih infekcija uha (otitis externa) uzrokovanih Staphylococcus pseudintermedius (bakterija) i Malassezia pachydermatitis (kvasac).
In the EU study Osurnia was as effective as the comparator medicine with both treatments resulting in 63% reduction in severity of otitis externa. 
Osurnia je bila jednako djelotvorna kao i usporedni lijek s obje terapije koje su rezultirale u 63-postotnoj redukciji težine otitisa externe.
The Japanese study involved 71 dogs; 49 dogs were treated with Osurnia and 22 dogs with another ear medicine containing clotrimazole (for fungal infections), gentamicin (an antibiotic) and betamethasone valerate (corticosteroid). 
Japansko ispitivanje uključivalo je 71 psa; 49 pasa liječeno je Osurnijom, a 22 psa liječena su lijekom za uho koji sadrži klotrimazol (za gljivične infekcije), gentamicin (kao antibiotik) i betametazon valerat (kortikosteroid).
The first was an EU study involving 286 dogs in which 148 dogs given Osurnia were compared with 138 dogs treated with another ear medicine containing miconazole (a medicine against fungal infections), gentamicin (an antibiotic) and hydrocortisone aceponate (a corticosteroid) for five consecutive days. 
Prvo je bilo europsko ispitivanje koje je uključivalo 286 pasa tretiranih s lijekom za uho koji je sadržavao mikonazol (lijek protiv gljivičnih infekcija), gentamicin (antibiotik) i hidrokortizon aceponat (kortikosteroid) tijekom pet uzastopnih dana.
How does Osurnia work? 
Kako djeluje Osurnia?
What benefit has Osurnia shown during the studies? 
Osurnia su utvrđene tijekom ispitivanja?
EPAR summary for the public 
U europskom ispitivanju
How has Osurnia been studied? 
Kako se Osurnia ispitivala?
0.25 mg Capsule, hard 
0,25 mg Kapsula, tvrda
1 vial 
(Zaštićeno) ime
Abstract 318. 
Sažetak 318.
Results of the bioequivalence studies 
Rezultati studija bioekvivalencije
Scientific conclusions and grounds for positive opinion presented by the European Medicines Agency 
Znanstveni zaključci i razlozi za pozitivno mišljenje koje je prikazala Europska agencija za lijekove
Paper presented at 8th conference on Retrovirus and opportunistic infections. 
Papir prikazan na 8. konferenciji o retrovirusima i oportunističkima infekcijama.
• The Committee considered the notification of the referral triggered by the United Kingdom under article 29(4) of Directive 2001/83/EC. 
• Povjerenstvo je razmatralo obavijest o procjeni koju je zatražila Ujedinjena Kraljevina u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ.
the Netherlands and France considered that the granting of the marketing authorisation constitutes a potential serious risk to public health. 
Nizozemska i Francuska smatrale su da izdavanje odobrenja za lijek sadrži potencijalni ozbiljan rizik za javno zdravlje.
However, the 90% CI for Cmax was 100.36132.76%. 
Međutim, 90 %-tni CI za Cmax iznosio je 100,36 - 132,76 %.
The applicant provided literature references which showed that for the action of Didanosine, AUC is the most important parameter9,10,11,12,13. 
Predlagatelj je predao reference za literaturu koje su pokazale da je za djelovanje didanozina AUC najvažniji parametar9,10,11,12,13.
• Dosing recommendations for didanosine 
• Preporuke za doziranje didanozina
The reference product in EU is Videx EC (200, 250 and 400 mg) hard capsules, first authorised in the United Kingdom (UK) on 19 September 2000. 
Referentni lijek u EU-u su Videx EC (200, 250 i 400 mg) tvrde kapsule, odobrene prvi put u Ujedinjenoj Kraljevini (UK) 19. rujna 2000.
The only difference is the magnitude of the decrease, which is less for the test than for the reference product. 
Jedina je razlika u jačini pada, koji je manji za testni nego za referentni lijek.
The application for Didanosine and associated names was considered under Article 10.3 of Directive 2001/83/EC in all Concerned Members States (CMSs). 
Primjena didanozina i pridruženih naziva razmatrana je u skladu s člankom 10.3 Direktive 2001/83/EK u svim državama članicama na koje se to odnosi.
Irrespective of whether Didanosine is taken with or without food, the virological response is based on the total drug exposure. 
Neovisno o tome uzima li se didanozin s hranom ili bez nje, virološki odgovor temelji se na ukupnoj izloženosti lijeku.
The decentralised procedure was closed on day 210, with most of the CMSs agreeing with the conclusions of the reference Member State (RMS)'s assessment report except France and the Netherlands which raised a potential serious risk to public health (PSRPH). 
Decentralizirani postupak zaključen je 210. dana, a većina država članica na koje se to odnosi složila se sa zaključcima iz izvješća referente države članice, osim Francuske i Nizozemske koje su izjavile prigovor u vezi potencijalno ozbiljnih rizika za javno zdravstvo (PSRPH).
A referral was thus triggered at the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMD(h)). 
Procjena je stoga potaknuta pri grupi za Koordinaciju za međusobno priznavanje i decentralizirane postupke - za humane lijekove (CMD(h)).
However, both formulations are equivalent in terms of extent of absorption (i.e. AUC). 
Međutim, obje su formulacije jednake u smislu stupnja apsorpcije (tj. AUC).
It is acknowledged that these results were outside the standard range of 80 - 125%; however these were within the wider acceptance criteria of 70 - 143% which may be used for highly variable drugs. 
Potvrđeno je da su ti rezultati bili izvan standardnog raspona od 80-125 %, međutim bili su unutar širih kriterija prihvatljivosti od 70-143 % koji se mogu koristiti za visoko varijabilne lijekove.
Berenguer J et al. Didanosine, Lamivudine, and Efavirenz versus Zidovudine, Lamivudine, and Efavirenz for the Initial Treatment of HIV Type 1 Infection: Final Analysis (48 Weeks) of a Prospective, Randomized, Noninferiority Clinical Trial, GESIDA 3903 HIV/AIDS. 
Didanosine, Lamivudine, and Efavirenz versus Zidovudine, Lamivudine, and Efavirenz for the Initial Treatment of HIV Type 1 Infection: Final Analysis (48 Weeks) of a Prospective, Randomized, Noninferiority Clinical Trial, GESIDA 3903 HIV/AIDS.
• Clinical significance of Cmax with Didanosine 
• Klinički značaj Cmax-a s didanozinom
The major concern raised by France and the Netherlands could not be solved during the CMD(h) referral and the issue was therefore referred to the Committee for Medicinal Products for Human Use (CHMP). 
Glavna bojazan koju su izrazile Francuska i Nizozemska ne mogu se riješiti tijekom procjene CMD(h) te je problem stoga upućen Povjerenstvu za humane lijekove Europske agencije za lijekove (CHMP).
The applicant claimed that differences in plasma concentrations of didanosine are not of clinical relevance as such since it may not result in changes in the intracellular triphosphate concentrations. 
Predlagatelj je tvrdio da razlike u plazmatskim koncentracijama didanozina nisu klinički značajne kao takve jer ne mogu rezultirati promjena unutarstaničnih koncentracija trifosfata.
Clinical Infectious Diseases 1993; 16: S26-S31 
Clinical Infectious Diseases 1993; 16: S26-S31 6 Drusano GL et al.
1 Note for Guidance on the investigation of bioavailability and bioequivalence (EMA/CPMP/EWP/QWP/1401/98) 2 Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms 
1 Napomena za Upute za ispitivanje bioraspoloživosti i bioekvivalencije (EMA/CPMP/EWP/QWP/1401/98) 2 Smjernice o farmakokinetičkoj i kliničkoj procjeni doziranih oblika s modificiranim otpuštanjem
Considering this, the sample size that may be required to meet the standard bio-equivalence criteria would be as high as 232 subjects to obtain power of at least 80%. 
Uzimajući to u obzir, veličina uzorka koja bi se mogla zahtijevati za ispunjavanje kriterija standardne bioekvivalencije trebala biti do 232 ispitanika kako bi se postigla snaga testa od 80 %.
However, the observed effect of food is lower and the Committee is of the opinion that this is not clinically relevant based on considerations relating to the mechanism of action and, in particular, that Didanosine and associated names is to be administrated on an empty stomach. 
Međutim, uočeni učinak hrane je niži i Povjerenstvo je smatralo da to nije klinički značajno na temelju razmatranja mehanizma djelovanja i posebice činjenice da se didanozin i lijekovi pridruženih naziva moraju davati natašte.
Background 
Podloga
The administration of the reference product with a high fat meal significantly decreases the AUC (19%) and Cmax (46%) of didanosine. 
Primjena referentnog lijeka s punomasnim obrokom znatno smanjuje AUC (19 %) i Cmax (46 %) didanozina.
Therefore, it is considered that the fact that both formulations have been used for the same indications and at similar doses suggests that AUC is more relevant for ensuring efficacy of didanosine in antiviral therapy, and the changes in Cmax are unlikely to compromise antiviral efficacy. 
Stoga se smatra da činjenica da su obje formulacije korištene za iste indikacije i pri sličnim dozama ukazuje da je AUC važniji za osiguravanje djelotvornosti didanozina u antivirusnoj terapiji te da nije vjerojatno da će promjene u Cmax ugroziti antivirusnu djelotvornost.
Didanosine is intended to be administrated on en empty stomach as stated in the proposed Summary of Product Characteristics (SmPC): “Didanosine absorption is reduced in the presence of food, and hence Didanosine gastro-resistant capsules should be administrated on an empty stomach (at least 2 hours before or 2 hours after a meal)”. 
Didanozin je namijenjen za primjenu na prazan želudac kako je to navedeno u predloženom sažetku opisa svojstava lijeka (SmPC): „Apsorpcija didanozina smanjena je u prisutnosti hrane i stoga želučanootporne kapsule didanozina treba primijeniti na prazan želudac (najmanje 2 sata prije ili poslije obroka)”.
Didanosine has to be first converted intracellularly to its active metabolite ddATP (responsible for antiviral activity) which has a significantly longer intracellular half-life (about 43 hours) as compared with plasma half-life of didanosine. 
Didanozin treba prvo konvertirati u stanici u njegov aktivni metabolit ddATP (koji je odgovoran za antivirusnu aktivnost) koja ima znatno dulji unutarstanični poluživot (oko 43 sata) u usporedbi plazmatskim poluživotom didanozina.
In addition, the objecting Members States considered that the arguments provided by the applicant did not sufficiently address the consequences of the difference observed in didanosine pharmacokinetics in the fed state between test and reference products. 
Osim toga, države članice koje su se protivile smatrale su da argumenti koje je podnio predlagatelj nisu dostatni za objašnjenje posljedica razlika uočenih u farmakokinetici didanozina, u stanju kad su bolesnici bili siti između testnih i referentnih lijekova.
• The Committee reviewed all the data submitted by the applicant in order to support the bioequivalence between Didanosine and associated names and the reference product. 
• Povjerenstvo je pregledalo sve predane podatke kako bi poduprlo bioekvivalenciju između didanozina i pridruženih naziva i referentnog lijeka.
The Committee acknowledged that the conventional criterion for bioequivalence for maximum plasma concentration (Cmax) was outside the 80-125% acceptability limits. 
Povjerenstvo je priznalo da su standardni kriteriji za bioekvivalenciju za maksimalnu plazmatsku koncentraciju (Cmax) bili izvan granica prihvatljivosti od 80 do 125 %.
Overall summary of the scientific evaluation of didanosine and associated names (see Annex I) 
Ukupni sažetak znanstvene procjene didanozina i pridruženih naziva (vidjeti Prilog I.)
This is attributed to the delay in absorption rate of enteric coated formulation which is reflected in the Tmax which is about 2 hours for the enteric coated formulation compared to 0.67 hours for the buffered tablet. 
To se pripisuje odgodi u brzini apsorpcije enterički obloženih formulacija što se odražava u Tmax koji iznosi otprilike 2 sata za enterički obloženu formulaciju u usporedbi sa 0,67 sati za puferirane tablete.