natgillin/translations-raw huggingface dataset:
In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV). 
Pri tej kategoriji živali je potrebno cepivo uporabljati glede na presojo razmerja korist/tveganje odgovornega veterinarja oziroma v skladu z veljavnimi smernicami pristojnih nacionalnih organov glede cepljenja proti bolezni modrikastega jezika (BT).
• Revaccination 
• Ponovno cepljenje
In very rare cases it has been observed a transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination. 
V zelo redkih primerih se lahko do 24 ur po cepljenju prehodno poviša telesna temperatura, ki navadno ne preseže 1,1 °C.
*(below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission) 
*(pod stopnjo detekcije z validirano metodo RT-PCR pri 3,68 log10 RNA kopijah/ml, ni prenosa virusa)
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 doses (10 ml) 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 10 odmerkov (10 ml)
Name and address of the manufacturer of the biological active substance 
Ime in naslov izdelovalcev biološke zdravilne učinkovine
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis. 
Zato se je za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila potrebno odločiti od primera od primera.
Do not mix with any other veterinary medicinal product. 
Ne mešajte z drugimi zdravili za uporabo v veterinarski medicini.
Can be used during pregnancy and lactation in cows 
Lahko se uporablja v obdobju brejosti in laktacije pri kravah.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsak odmerek (1 ml) cepiva vsebuje:
Any person intending to manufacture, import, possess, sell, supply and/or use BTVPUR AlSap 1 must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use. 
Vsakdo, ki namerava proizvajati, uvažati, posedovati, prodajati, oskrbovati in/ali uporabljati BTVPUR AlSap 1, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred proizvodnjo, uvozom, posedovanjem, prodajo, oskrbo in/ali uporabo.
PACKAGE SIZE 100 doses (100 ml) 
VELIKOST PAKIRANJA 100 odmerkov (100 ml)
MARKETING AUTHORISATION NUMBER(S) EU/2/10/112/001 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/112/001
Once broached, use immediately 
Po odprtju uporabite takoj.
METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use 
NAČIN IN POT(I) UPORABE Subkutana uporaba.
Silicon antifoam Phosphate buffer Glycine buffer 
Silikon (proti penjenju) Fosfatni pufer Glicerinski pufer
NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 1 suspension for injection for sheep and cattle 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI BTVPUR AlSap 1 suspenzija za injiciranje za ovce in govedo
The vaccine contains inactivated Bluetongue Virus Serotype 1 with aluminium hydroxide and saponin adjuvants. 
Cepivo vsebuje inaktiviran virus bolezni modrikastega jezika, serotip 1, z aluminijevim hidroksidom in saponini kot dodatkoma.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required. 
SPC, tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
Administer one dose of 1 ml subcutaneously according to the following vaccination scheme: 
Injicirajte 1 ml odmerek v podkožje po naslednjem razporedu:
Al3+ (as hydroxide) 
(kot hidroksid)
Can be used during pregnancy in ewes. 
Lahko se uporablja v obdobju brejosti pri ovcah.
In very rare cases it has been observed a small local swelling at the injection site (at most 32 cm² in cattle and 24 cm² in sheep) which becomes residual 35 days later (≤ 1 cm2). 
V zelo redkih primerih se po cepljenju lahko na mestu dajanja pojavi prehodna manjša lokalizirana oteklina (največ 32 cm pri govedu in 24 cm pri ovcah), ki se občutno zmanjša v največ 35 dneh
PACKAGE LEAFLET FOR: BTVPUR AlSap 1 suspension for injection for sheep and cattle 
NAVODILO ZA UPORABO BTVPUR AlSap 1 suspenzija za injiciranje za ovce in govedo
Veterinary medicinal product subject to prescription. 
Zdravilo za uporabo v veterinarski medicini na veterinarski recept.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIKI DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml contains Bluetongue Virus 
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Vsak odmerek (1 ml) cepiva vsebuje virus modrega jezika:
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. 
Proizvodnja, uvoz, posedovanje, prodaja, oskrba in/ali uporaba BTVPUR AlSap 1 je lahko prepovedana v določeni državi članici na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
Special precautions for use in animals: Vaccinate healthy animals only. 
Posebni previdnostni ukrepi za uporabo pri živalih Cepite le zdrave živali.
The manufacture, import, possession sale, supply and/or use of BTVPUR AlSap 1 may be prohibited in a Member State on the whole or part of their territory pursuant to national legislation. 
Proizvodnja, uvoz, posedovanje, prodaja, oskrba in/ali uporaba BTVPUR AlSap 1 je lahko prepovedana vdržavi članici na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
Shelf life after first opening the immediate packaging: immediately Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP: 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini, po EXP.
Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by Bluetongue Virus Serotype 1. 
Aktivna imunizacija ovc in goveda proti virusu bolezni modrikastega jezika, serotip 1, za preprečitev viremije* in zmanjšanje kliničnih znakov.
1 bottle of 10 doses (1x 10 ml) 1 bottle of 50 doses (1 x 50 ml) 10 bottles of 50 doses (10 x 50 ml) 1 bottle of 100 doses (1 x 100 ml) 10 bottles of 100 doses (10 x 100 ml) 
1 steklenička z 10 odmerki (1 x 10 ml) 1 plastenka s 50 odmerki (1 x 50 ml) 10 plastenk s 50 odmerki (10 x 50 ml) 1 plastenka s 100 odmerki (1 x 100 ml) 10 plastenka s 100 odmerki (10 x 100 ml)
QUANTITY OF THE ACTIVE SUBSTANCE(S) Inactivated BTV 1 ...................................................................................................... ≥ 1.9 log10 pixels 
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Inaktiviran BTV 1, inaktiviran ............................................................................... ≥ 1,9 log10 pikslov
Type I glass bottle of 10 ml with butyl elastomere closure Box of 1 bottle of 10 doses (1 x 10 ml) 
10 ml steklenička (steklo tipa I) z butil elastomerno zaporko Škatla z 1 stekleničko z 10 odmerki (1 x 10 ml).
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). 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - Zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali) - Pogosti (pojavijo se pri 1 od 10 živali od 100 živali) - Občasni (pojavijo se pri 1 od 10 živali od 1.000 živali) - Redki (pojavijo se pri 1 od 10 živali od 10.000 živali) - Zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
Inactivated BTV1 ..................................................................................................... ≥ 1.9 log10 pixels* Aluminium hydroxide, Saponin, qs 1 dose (*) (*) see package leaflet 
Inaktiviran BTV 1, inaktiviran ............................................................................. ≥ 1,9 log10 pikslov* Aluminijev hidroksid, Saponin q.s.
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). 
Ovce - Prvi odmerek: od 1 meseca starosti pri predhodno necepljenih živalih (ali od 2,5 meseca starosti pri mladičih imunih ovc).
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). 
Govedo - Prvi odmerek: od 1 meseca starosti pri predhodno necepljenih živalih (ali od 2,5 meseca starosti pri mladičih imunih krav).
It induces an active and specific immunity against bluetongue virus serotype 1 in the vaccinated animal. 
Pri cepljeni živali sproži nastanek aktivne in specifične imunosti proti virusu bolezni modrikastega jezika, serotip 1.
Polypropylene bottle of 50 or 100 ml with butyl elastomere closure Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml) 
50 ali 100 ml polipropilenska plastenka z butil elastomerno zaporko Škatla z 1 plastenko s 100 odmerki (1 x 100 ml).
It induces an active and specific immunity against Bluetongue Virus Serotype 1 in the vaccinated animal. 
Pri cepljeni živali povzroči nastanek aktivne in specifične imunosti proti virusu bolezni modrikastega jezika, serotip 1.
EXPIRY DATE EXP {month/year} Once broached, use immediately. 
Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj.
Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml) 
Škatla z 1 plastenko s 50 odmerki (1 x 50 ml).
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml contains: 
Vsak odmerek (1 ml) cepiva vsebuje:
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 uporabnosti zdravila v pakiranju za prodajo (10 ml steklenička): 18 mesecev.
Active substances: 
Seznam pomožnih snovi
Inactivated Bluetongue Virus Serotype 1 ................................................................. ≥ 1.9 log10 pixels* (*) Antigen content (VP2 protein) by immuno-assay Adjuvants: . 
Virus bolezni modrikastega jezika, serotip 1, inaktiviran ................................... ≥ 1,9 log10 pikslov*
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) 
PODATKI NA ZUNANJI OVOJNINI Škatla z 1 stekleničko z 10 ml Škatla z 1 plastenko s 50 ml Škatla z 10 plastenkami s 50 ml Škatla z 1 plastenko s 100 ml Škatla z 10 plastenkami s 100 ml
Box of 10 bottles of 50 ml, 
Plastenka z 10 in 50 ml
Inactivated BTV 1 ....................................................................................................... ≥ 1.9 log10 pixels 
BTV 1, inaktiviran ................................................................................................. ≥ 1,9 log10 pikslov
Box of 1 bottle of 100 ml, 
Škatla z 1 stekleničko z 10 odmerki (1 x 10 ml).
The other studies took place in the USA and Japan respectively. 
Drugi študiji sta potekali v ZDA oziroma na Japonskem.
Treatment is repeated after one week, but the ears should not be cleaned for the second dose. 
Zdravljenje se ponovi po enem tednu, vendar se ušes pri drugem odmerjanju ne sme očistiti.
They often lead to the ear(s) being inflamed (red, swollen and sore) or painful. 
Pogosto povzročijo vnetje ušesa (ušes) (rdečico, otekanje in rano) ali bolečino.
Other information about Osurnia: 
Druge informacije o zdravilu Osurnia:
What benefit has Osurnia shown during the studies? 
Kakšne koristi je zdravilo Osurnia izkazalo med študijami?
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. 
Glavno merilo za učinkovitost v študijah v EU in na Japonskem je bilo zmanjšanje resnosti vnetja zunanjega ušesa 28 dni po prvotnem zdravljenju; v študiji v ZDA so klinično uspešnost merili po 45 dneh.
The European Commission granted a marketing authorisation valid throughout the European Union, for Osurnia on 31 July 2014. 
Evropska komisija je dovoljenje za promet z zdravilom Osurnia, veljavno po vsej Evropski uniji, izdala 31/07/2014.
Florfenicol is an antibiotic which works by blocking protein formation in bacterial cells. 
Florfenikol je antibiotik, ki deluje tako, da zavira tvorbo beljakovin v bakterijskih celicah.
The inside of the ear should be cleaned and dry before treatment. 
Pred zdravljenjem je treba notranjost ušesa očistiti in posušiti.
Terbinafine kills fungi by blocking the formation of ergosterol, an important part of fungal cell walls. 
Terbinafin ubije glivice, tako da zavira tvorbo ergosterola, pomembne sestavine glivične celične stene.
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 zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Osurnia večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
What is the risk associated with Osurnia? 
Kakšna tveganja so povezana z zdravilom Osurnia?
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%. 
V študiji v ZDA je bil delež uspešnosti pri psih, zdravljenih z zdravilom Osurnia, 65-odstoten, kar je bilo pomembno več kot pri psih, zdravljenih s placebom, pri katerih je bil delež uspešnosti 44-odstoten.
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 velik delež uspešnosti pri placebu je bil morda posledica učinka predhodnega čiščenja ušesa, zaradi formulacije zdravila pa se je ustvarila zaščitna obloga gela na površini sluhovoda.
It is available as a gel to be given into the ear. 
Na voljo je v obliki gela, ki se daje v uho.
Osurnia must not be used if the ear drum is perforated or in dogs with generalised demodicosis (mange caused by the mite Demodex canis). 
Zdravilo Osurnia se ne sme uporabljati, če je bobnič predrt ali pri psih z generalizirano demodikozo (parazitsko obolenje, ki ga povzroča pršica Demodex canis).
Ear infections in dogs can be caused by bacteria or yeasts/fungi. 
Ušesne infekcije pri psih lahko povzročijo bakterije ali kvasovke/glivice.
If the veterinary medicine is accidentally swallowed, immediate medical advice should be sought and the package leaflet or label shown to the doctor. 
Če je prišlo do nenamernega zaužitja zdravila, je treba takoj poiskati zdravniško pomoč in zdravniku pokazati navodilo za uporabo ali nalepko.
Two of the active substances in Osurnia terbinafine and florfenicol, act against possible causes of infection. 
Dve zdravilni učinkovini v zdravilu Osurnia, terbinafin in florfenikol, delujeta proti morebitnim vzrokom okužbe.
The third active ingredient, betamethasone acetate, is a corticosteroid, a medicine that reduces inflammation and pain. 
Tretja zdravilna učinkovina, betametazonacetat, je kortikosteroid, zdravilo za zmanjševanje vnetja in bolečine.
Why has Osurnia been approved? 
Zakaj je bilo zdravilo Osurnia odobreno?
Osurnia must also not be used in pregnant or breeding animals. 
Zdravilo Osurnia se ne sme uporabljati pri brejih ali vzrejnih živalih.
The contents of one tube of gel are given into each infected ear. 
V vsako okuženo uho iztisnite vsebino ene tube gela.
Osurnia is used to treat short lived or recurrent ear infections (otitis externa) due to Staphylococcus pseudintermedius (a bacterium) and Malassezia pachydermatitis (a yeast). 
Zdravilo Osurnia se uporablja za zdravljenje kratkotrajnih ali ponavljajočih se ušesnih infekcij (vnetja zunanjega ušesa) zaradi Staphylococcus pseudintermedius (bakterije) in Malassezia pachydermatis (glivice).
In the Japanese study Osurnia was as effective as the other medicine with 78% improvement in otitis externa in both treatment groups. 
V japonski študiji je bilo zdravilo Osurnia enako učinkovito kot primerjalno zdravilo z 78-odstotnim izboljšanjem vnetja zunanjega ušesa v obeh zdravljenih skupinah.
Terbinafine, florfenicol and betamethasone 
Osurnia terbinafin/florfenikol/betametazonacetat
In the EU study Osurnia was as effective as the comparator medicine with both treatments resulting in 63% reduction in severity of otitis externa. 
V študiji v EU je bilo zdravilo Osurnia enako učinkovito kot primerjalno zdravilo pri obeh zdravljenjih in je povzročilo 63-odstotno zmanjšanje resnosti vnetja zunanjega ušesa.
What is Osurnia used for? 
Za kaj se zdravilo Osurnia uporablja?
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). 
Pri psih z vnetjem zunanjega ušesa, ki ga povzročajo bakterijske ali glivične okužbe, so opravili tri terenske študije, v katerih so proučevali učinek zdravljenja po čiščenju ušesa s fiziološko raztopino; zdravljenje z dvema odmerkoma zdravila Osurnia v razmiku enega tedna so primerjali z drugim primerljivim zdravilom za zdravljenje ušesa ali placebom (zdravilom brez zdravilne učinkovine).
How has Osurnia been studied? 
Kako je bilo zdravilo Osurnia raziskano?
The US study involved 284 dogs, 190 of which were treated with Osurnia, while 90 dogs received placebo gel (dummy treatment). 
Študija v ZDA je vključila 284 psov, od katerih so jih 190 zdravili z zdravilom Osurnia, 90 pa jih je prejelo gel s placebom (zdravilom brez zdravilne učinkovine).
Osurnia is a veterinary medicine that contains three active substances: terbinafine, florfenicol and betamethasone acetate. 
Zdravilo Osurnia je zdravilo za uporabo v veterinarski medicini, ki vsebuje tri zdravilne učinkovine: terbinafin, florfenikol in betametazonacetat.
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 študijo so izvedli v EU pri 286 psih, od katerih so 148 psov, ki so prejeli zdravilo Osurnia, primerjali s 138 psi, pet dni zdravljenimi z drugim zdravilom za uho, ki vsebuje mikonazol (zdravilo proti glivičnim okužbam), gentamicin (antibiotik) in hidrokortizonaceponat (kortikosteroid).
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). 
Japonska študija je vključila 71 psov, od katerih so jih 49 zdravili z zdravilom Osurnia, 22 pa z drugim zdravilom za uho, ki vsebuje klotrimazol (zdravilo proti glivičnim okužbam), gentamicin (antibiotik) in betametazonvalerat (kortikosteroid).
What is Osurnia? 
Kaj je zdravilo Osurnia?
How does Osurnia work? 
Kako zdravilo Osurnia deluje?
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. 
Če zdravilo pride v stik z očmi, jih je treba sprati z vodo.
4 mg (1 mg/ml) 1 vial 
4 mg (1 mg/ml) 1 viala
4 mg (1 mg/ml) 5 vials 
4 mg (1 mg/ml) 5 vial
Immediate Packaging 
Velikost pakirania
Strength Pharmaceutical Form Route of Administration 
Farmacevtska oblika Pot uporabe Stična ovojnina Vsebina (koncentracija)
• The Committee considered the notification of the referral triggered by the United Kingdom under article 29(4) of Directive 2001/83/EC. 
• Odbor je upošteval obvestilo o napotitvenem postopku, ki ga je sprožilo Združeno kraljestvo skladno s členom 29(4) Direktive 2001/83/ES.
Overall summary of the scientific evaluation of didanosine and associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja didanozina in povezanih imen (glejte Prilogo I)
the Netherlands and France considered that the granting of the marketing authorisation constitutes a potential serious risk to public health. 
Nizozemska in Francija sta menili, da odobritev dovoljenja za promet z zdravilom predstavlja morebitno resno tveganje za javno zdravje;
However, both formulations are equivalent in terms of extent of absorption (i.e. AUC). 
Vendar pa sta obe formulaciji enakovredni kar zadeva obseg absorpcije (tj. AUC).
However, the 90% CI for Cmax was 100.36132.76%. 
Vendar je bil 90odstotni interval zaupanja za Cmax 100,36-132,76 %.
The only difference is the magnitude of the decrease, which is less for the test than for the reference product. 
Edina razlika je obseg zmanjšanja, ki je manjši pri testnem kot pri referenčnem zdravilu.
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. 
Referenčno zdravilo v EU je Videx EC (200, 250 in 400 mg) trde kapsule, ki je bilo prvič odobreno za uporabo 19. septembra 2000 v Združenem kraljestvu.
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). 
Glavnega pomisleka, ki sta ga izpostavili Francija in Nizozemska, med napotitvenim postopkom skupine CMD(h) ni bilo mogoče razrešiti, zato je bila zadeva posredovana Odboru za zdravila za uporabo v humani medicini (CHMP).
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. 
Upoštevali so, da so bili ti rezultati zunaj standardnega razpona 80-125 %; vendar so bili znotraj širših meril sprejemljivosti 70-143 %, ki se lahko uporabijo za zelo variabilna zdravila.
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 postopek se je končal na 210. dan, ko je večina zadevnih držav članic soglašala z zaključki poročila o oceni referenčne države članice z izjemo Francije in Nizozemske, ki sta izrazili zaskrbljenost zaradi možnega resnega tveganja za javno zdravje (PSRPH).
Evaluation 
Vrednotenje
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 predložil reference iz literature, ki so pokazale, da je za delovanje zdravila Didanosine najpomembnejši parameter vrednost AUC9,10,11,12,13.
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%. 
Glede na navedeno bi morala biti velikost vzorca, potrebna za izpolnjevanje standardnih meril biološke enakovrednosti, kar 232 preiskovancev, da bi dobili moč vsaj 80 %.
• Clinical significance of Cmax with Didanosine 
• Klinični pomen vrednosti Cmax za zdravilo Didanosine