natgillin/translations-raw huggingface dataset:
Tasimelteon and its most abundant metabolites have no appreciable affinity for more than 160 other pharmacologically relevant receptors.
Tasimelteon in njegovi količinsko najpomembnejši presnovki nimajo občutnejše afinitete do več kot 160
Because of individual differences in each person's body rhythms, it could take weeks or up to 3 months for an improvement in symptoms to be noticed.
Ker se biološki ritmi posameznikov razlikujejo, lahko traja nekaj tednov ali do tri mesece,
Uncommon: may affect up to 1 in 100 people - abnormal or change in taste - blood tests which show changes in the way the liver is working (aspartate aminotransferase and gamma-glutamyl transferase) - increase in daytime urination - nightmares - ringing in the ears - feeling foggy in the head
- nenavaden okus ali spremembe okusa, - preiskave krvi pokažejo spremembe v delovanju jeter (aspartat-aminotransferaza in gama glutamiltransferaza), - pogostejše uriniranje podnevi,
Sleep disorder, insomnia, abnormal dreams
nespečnost, nenormalne sanje nočne more
- To open the bottle, push the cap down and turn counter-clockwise.
- Plastenko odprete tako, da potisnete zaporko navzdol in jo obrnete v nasprotni smeri urinega kazalca.
Dose and timing
Odmerek in časovni razpored odmerjanja
If you forget to take HETLIOZ
Če ste pozabili vzeti zdravilo HETLIOZ
Date of first authorisation: 3 July 2015
Datum prve odobritve:
Smoking (moderate CYP1A2 inducer)
Kajenje (srednje močen induktor CYP1A2)
Tasimelteon acts as a Dual Melatonin Receptor Agonist (DMRA) with selective agonist activity at the MT1 and MT2 receptors.
Tasimelteon deluje kot dvojni agonist melatoninskih receptorjev (Dual Melatonin Receptor Agonist - DMRA) s selektivnim agonističnim učinkom na receptorja MT1 in MT2.
Caution should be used when administering HETLIOZ in combination with fluvoxamine or other strong CYP1A2 inhibitors, particularly those which also inhibit other enzymes involved in the clearance of HETLIOZ because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions (see section 4.5).
Previdnost je potrebna, kadar se zdravilo HETLIOZ uporablja v kombinaciji s fluvoksaminom ali drugimi močnimi zaviralci CYP1A2, zlasti tistimi, ki zavirajo tudi druge encime, ki sodelujejo pri očistku zdravila HETLIOZ, saj obstaja možnost za veliko povečanje izpostavljenosti tasimelteonu in večje tveganje za neželene učinke (glejte poglavje 4.5).
Patients were treated for approximately 12 weeks with tasimelteon 20 mg one hour prior to bedtime, at the same time every night.
Bolniki so približno 12 tednov jemali 20 mg tasimelteona eno uro pred spanjem,
The most abundant metabolites of tasimelteon have less than onetenth of the binding affinity of the parent molecule for both the MT1 and MT2 receptors.
Količinsko najpomembnejši presnovki tasimelteona imajo manj kot eno desetino vezavne afinitete matične molekule do receptorjev MT1 in MT2.
Strong CYP3A4 inhibitors (e.g. ketoconazole)
Močni zaviralci CYP3A4 (npr. ketokonazol)
- The other ingredients are lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate.
− Druge sestavine zdravila so brezvodna laktoza, mikrokristalna celuloza, premreženi natrijev karmelozat, koloidni silicijev dioksid in magnezijev stearat.
Daytime sleep on 25% most symptomatic days
Spanje podnevi v 25 % dni z najbolj izraženimi simptomi
If you stop taking HETLIOZ
Če ste prenehali jemati zdravilo HETLIOZ
The effectiveness of tasimelteon in the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) was established in two randomised, double-masked, placebo-controlled, multicentre, parallel-group studies (SET and RESET) in totally blind patients with Non-24.
Učinkovitost tasimelteona pri zdravljenju motnje ciklusa spanja in budnosti, ki ni usklajen s 24-urnim ciklusom dneva (ne-24-urni ciklus) so dokazali v dveh randomiziranih dvojno slepih s placebom kontroliranih multicentričnih študijah z vzporednimi skupinami (SET in RESET) pri popolnoma slepih bolnikih z ne-24-urnim ciklusom.
RESET demonstrated the maintenance of entrainment with tasimelteon treatment compared to placebo withdrawal (aMT6s: 90% vs. 20% and cortisol: 80% vs. 20%).
Študija RESET je pokazala, da se je v skupini, ki je nadaljevala zdravljenje s tasimelteonom, utirjenost ohranila v primerjavi s skupino, ki je prekinila zdravljenje in ga nadaljevala s placebom (6SMT: 90 % v primerjavi z 20 % in kortizol: 80 % v primerjavi z 20 %).
Dark blue opaque, hard capsule marked with “VANDA 20 mg” in white ink.
Neprosojna temnomodra trda kapsula z belo oznako „VANDA 20 mg“.
If you accidentally take more HETLIOZ than your doctor recommended, contact your doctor at once or contact the nearest hospital for advice.
Če ste vzeli večji odmerek zdravila HETLIOZ, kot bi smeli Če ste pomotoma vzeli večji odmerek zdravila HETLIOZ, kot vam je priporočil zdravnik, se takoj posvetujte z njim ali se oglasite v najbližji bolnišnici.
It is used to treat Non-24-Hour Sleep-Wake Disorder (Non-24) in adults who are totally blind.
Uporablja se za zdravljenje motnje ciklusa spanja in budnosti, ki ni usklajen s 24-urnim ciklusom dneva (ne24-urni ciklus), pri odraslih, ki so popolnoma slepi.
In rats, the incidence of liver tumours was increased in males (adenoma and carcinoma) and females (adenoma) at 100 and 250 mg/kg/day; the incidence of tumours of the uterus (endometrial adenocarcinoma) and uterus and cervix (squamous cell carcinoma) were increased at 250 mg/kg/day.
(adenom in karcinom) in samicah (adenom), prav tako pa se je pri odmerku 250 mg/kg/dan povečala incidenca tumorjev na maternici (adenokarcinom endometrija) ter maternici in materničnem vratu
Contains lactose and Orange Yellow S (E110).
Vsebuje laktozo in oranžno rumeno S barvilo (E110).
The pharmacokinetic profile of a 20 mg dose of tasimelteon was compared among 8 subjects with mild hepatic impairment (Child-Pugh Score ≥5 and ≤6 points), 8 subjects with moderate hepatic impairment
Farmakokinetični profil 20-miligramskega odmerka tasimelteona so primerjali pri osmih osebah z blago okvaro jeter (≥ 5 in ≤ 6 točk na Child-Pughovi lestvici), osmih osebah z zmerno okvaro jeter (≥ 7 in ≤ 9 točk na Child-Pughovi lestvici) ter 13 primerljivih zdravih kontrolnih osebah.
In animal studies, administration of tasimelteon during pregnancy resulted in developmental toxicity (embryofoetal mortality, neurobehavioural impairment, and decreased growth and development in offspring) at doses greater than those used clinically.
V študijah na živalih so pri uporabi odmerkov tasimelteona, večjih od klinično priporočenih, v obdobju brejosti opazili toksičnost za razvoj (embriofetalno smrt, nevrološke vedenjske motnje ter upočasnjeno rast in razvoj mladičev).
Daytime sleep time on 25% most symptomatic days (minutes)(3),(4)
Spanje ponoči v 25 % noči z najbolj izraženimi simptomi (v minutah)(3) Spanje podnevi v 25 % dni z najbolj izraženimi simptomi (v minutah)(3),(4)
RESET was a randomised withdrawal trial in 20 patients with Non-24 (median age 55 years) that was designed to evaluate the maintenance of efficacy of tasimelteon after 12-weeks.
urnim ciklusom (mediana starosti 55 let) in ki je bila zasnovana za oceno ohranitve učinkovitosti tasimelteona po 12 tednih.
Clinical Response in Non-24-Hour Sleep-Wake Disorder The effectiveness of tasimelteon in the treatment of clinical symptoms, including the circadian sleep-wake cycle and clinical global functioning in patients with Non-24 was established in SET and RESET (Table 3).
Klinični odziv pri motnji ciklusa spanja in budnosti, ki ni usklajen s 24-urnim ciklusom dneva Učinkovitost tasimelteona pri zdravljenju kliničnih simptomov, vključno z izboljšanjem cirkadianega ciklusa spanja in budnosti ter splošnega delovanja po kliničnih merilih, pri bolnikih z ne-24-urnim ciklusom so dokazali v študijah SET in RESET (preglednica 3).
SET Study Clinical response (Entrainment + N24CRS
Response Scale - N24CRS).
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Hard capsule core Lactose anhydrous Microcrystalline cellulose Croscarmellose sodium Silica, colloidal anhydrous Magnesium sterate
Jedro trde kapsule brezvodna laktoza mikrokristalna celuloza natrijev karmelozat, premreženi silicijev dioksid, koloidni, brezvodni magnezijev stearat
No dose adjustment is necessary for patients with mild or moderate hepatic impairment (see section 5.2).
Pri bolnikih z blago ali zmerno okvaro jeter odmerka ni treba prilagajati (glejte poglavje 5.2).
Potential for other medicinal products to affect tasimelteon CYP1A2 and CYP3A4 are enzymes identified to play a role in the metabolism of tasimelteon, with a minor role for CYP2C9/C19.
CYP1A2 in CYP3A4 sta encima, ki dokazano sodelujeta pri presnovi tasimelteona, medtem ko imata CYP2C9/C19 manjšo vlogo.
One HDPE bottle per paperboard carton.
V eni kartonasti škatli je ena plastenka iz HDPE.
Caution should be used when administering HETLIOZ in combination with rifampin or other CYP3A4 inducers because of a potentially large decrease in tasimelteon exposure with reduced efficacy (see section
Previdnost je potrebna, kadar se zdravilo HETLIOZ uporablja v kombinaciji z rifampinom ali drugimi induktorji CYP3A4, saj obstaja možnost za veliko zmanjšanje izpostavljenosti tasimelteonu in manjšo učinkovitost (glejte poglavje 4.5).
HETLIOZ hard capsules are opaque dark blue printed with “VANDA 20 mg” in white.
Trde kapsule zdravila HETLIOZ so neprozorne, temnomodre in imajo belo oznako „VANDA 20 mg“.
Tasimelteon exhibits a greater affinity for the MT2 as compared to the MT1 receptor.
Tasimelteon kaže večjo afiniteto do receptorja MT2 kot do receptorja MT1.
There was no increase in tumours at the lowest dose tested in rats, which is approximately 10 times the recommended human doseon a mg/m2 basis.
Pri najmanjšem odmerku, ki so ga preskusili na podganah in je bil približno 10-krat večji od priporočenega odmerka pri človeku na podlagi mg/m2, niso opazili povečanja števila tumorjev.
Propylene glycol Sodium hydroxide Povidone K17
Belo črnilo za tisk šelak propilenglikol natrijev hidroksid povidon K17 titanov dioksid
HETLIOZ 20 mg hard capsules tasimelteon
HETLIOZ 20 mg trde kapsule tasimelteon
CGI-C (LS mean)
CGI-C (povprečje najmanjših kvadratov)
HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.
Zdravilo HETLIOZ je indicirano za zdravljenje motnje ciklusa spanja in budnosti, ki ni usklajen s 24-urnim ciklusom dneva (ne-24-urni ciklus), pri popolnoma slepih odraslih.
HETLIOZ 20 mg hard capsules
HETLIOZ 20 mg trde kapsule
Renal impairment No dose adjustment is recommended for patients with renal impairment (see section 5.2).
Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati (glejte poglavje 5.2).
Common: may affect up to 1 in 10 people - change in sleeping pattern - difficulty in sleeping - dizziness - dry mouth - tiredness - indigestion - feeling sick in the stomach - blood tests which show changes in the way the liver is working (alanine aminotransferase) - unusual dreams - sleepiness
- suha usta, - utrujenost, - prebavne motnje, - slabost v želodcu, - preiskave krvi pokažejo spremembe v delovanju jeter (alanin-aminotransferaza),
Taking HETLIOZ
Jemanje zdravila HETLIOZ
HETLIOZ contains the active substance tasimelteon.
Zdravilo HETLIOZ vsebuje zdravilno učinkovino tasimelteon.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
HETLIOZ contains Orange Yellow S (E110)
Zdravilo HETLIOZ vsebuje barvilo oranžno rumeno S (E110)
Therefore, no dose adjustment is needed in patients with mild or moderate hepatic impairment.
Pri bolnikih z blago ali zmerno okvaro jeter odmerka zato ni treba prilagajati.
HETLIOZ contains lactose
Zdravilo HETLIOZ vsebuje laktozo
Because symptoms of nighttime sleep disruption and daytime sleepiness are cyclical in patients with Non-24, with severity varying according to the state of alignment of the individual patient's circadian rhythm with the 24-hour day (least severe when fully aligned, most severe when 12 hours out of alignment), efficacy endpoints for nighttime total sleep time and daytime nap duration were based on the 25% of nights with the least nighttime sleep, and the 25% of days with the most daytime nap time.
Glede na to, da se simptomi prebujanja ponoči in zaspanosti podnevi pri bolnikih z ne-24-urnim ciklusom pojavljajo v ciklusih, pri čemer je stopnja izraženosti simptomov odvisna od stanja usklajenosti cirkadianega ritma posameznega bolnika s 24-urnim dnevom (najmanj izraženi so ob popolni usklajenosti, najbolj pa ob
Push the cap down and turn counter-clockwise to open the bottle.
Plastenko odprete tako, da potisnete zaporko navzdol in jo obrnete v nasprotni smeri urinega kazalca.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 30-COUNT BOTTLE
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PLASTENKO S 30 KAPSULAMI
Entrainment in Non-24-Hour Sleep-Wake Disorder
Utirjenje pri motnji ciklusa spanja in budnosti, ki ni usklajen s 24-urnim ciklusom dneva
HETLIOZ contains lactose.
Zdravilo HETLIOZ vsebuje laktozo.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR 30-COUNT BOTTLE
PODATKI NA PRIMARNI OVOJNINI NALEPKA ZA PLASTENKO S 30 KAPSULAMI
Entrainment plus a score ≥3 on this scale, called Non-24 Clinical Response Scale (N24CRS) was required to be classified as a clinical responder.
Za bolnike z odzivom so šteli tisti, pri katerih so zabeležili utirjenje in rezultat ≥ 3 na lestvici, imenovani lestvica za oceno kliničnega odziva bolnikov z ne-24-urnim ciklusom (Non-24 Clinical
Titanium dioxide Brilliant Blue FCF Erythrosine
Obloga trde kapsule želatina titanov dioksid briljantno modro FCF eritrozin oranžno rumeno S (E110)
Aspartate aminotransferase increased, gamma-glutamyl transferase increased
Preiskave zvišana raven alaninaminotransferaze zvišana raven aspartataminotransferaze, zvišana raven gamaglutamiltransferaze
Tasimelteon functions as a DMRA at the MT1 and MT2 receptors.
Tasimelteon deluje kot dvojni agonist melatoninskih receptorjev MT1 in MT2.
- medicines known to reduce the activity of an enzyme called ‘CYP3A4'.
- zdravila, ki dokazano zmanjšujejo aktivnost encima, imenovanega „CYP1A2“.
Ear and labyrinth disorders
vključno z motnjami labirinta tinitus
How to take HETLIOZ
Kako jemati zdravilo HETLIOZ
In pregnant rabbits administered tasimelteon during the period of organogenesis, embryolethality and embryofoetal toxicity (reduced foetal body weight and delayed ossification) were observed at the highest dose tested (200 mg/kg/day).
so pri največjem preskušenem odmerku (200 mg/kg/dan) opazili smrt zarodkov in toksičnost za zarodek in plod (zmanjšano telesno maso ploda in zapoznelo osifikacijo).
Non-24 Scale of Clinical Response
Lestvica za oceno kliničnega odziva bolnikov z ne-24-urnim ciklusom
No dose adjustment is necessary for patients with renal impairment.
Pri bolnikih z okvaro ledvic odmerka zato ni treba prilagajati.
A composite scale of 4 measures of duration and timing of nighttime and daytime sleep and global functioning was used to evaluate clinical response in SET.
V študiji SET so za ocenjevanje kliničnega odziva uporabili lestvico, sestavljeno iz štirih meril, povezanih s trajanjem in časom spanja ponoči in podnevi ter splošnim delovanjem.
Caution should be used when administering tasimelteon in combination with fluvoxamine or other strong CYP1A2 inhibitors such as ciprofloxacin and enoxacin because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions: the AUC0-inf and Cmax of tasimelteon increased by 7-fold and 2-fold, respectively, when co-administered with fluvoxamine 50 mg (after 6 days of fluvoxamine 50 mg per day).
Močni zaviralci CYP1A2 (npr. fluvoksamin, ciprofloksacin in enoksacin) Pri uporabi tasimelteona v kombinaciji s fluvoksaminom ali drugimi močnimi zaviralci CYP1A2, kot sta ciprofloksacin in enoksacin, je potrebna previdnost, saj obstaja možnost za veliko povečanje izpostavljenosti tasimelteonu in večje tveganje za neželene učinke: AUC0-∞ in Cmaks tasimelteona sta se pri sočasni uporabi
Phenolic glucuronidation is the major phase II metabolic route.
faze presnove je glukuronidacija fenolne skupine.
Tell your doctor if you have an allergy to Orange Yellow S (E110).
Če ste alergični na oranžno rumeno S (E110), se posvetujte z zdravnikom.
Renal and urinary disorders
Antagonisti adrenergičnih receptorjev beta
An example is fluvoxamine, which is used to treat depression and obsessive compulsive disorder (OCD).
To je na primer fluvoksamin, ki se uporablja za zdravljenje depresije in obsesivno-kompulzivne motnje (OKM); - zdravila, ki dokazano zmanjšujejo aktivnost encima, imenovanega „CYP3A4“.
Somnolence, dizziness
- omotičnost,
Nervous system disorders
Bolezni živčevja glavobol somnolenca, omotica disgevzija
How to store HETLIOZ
Shranjevanje zdravila HETLIOZ
Check with your doctor or pharmacist if you are not sure.
posvetujte z zdravnikom ali farmacevtom.
How HETLIOZ works
Kako zdravilo HETLIOZ deluje
CLINICAL PARTICULARS 4.1 Therapeutic indications
Terapevtske indikacije
An example is rifampicin, which is used to treat tuberculosis (TB).
To je na primer rifampicin, ki se uporablja za zdravljenje tuberkuloze (TB); - zdravila, ki dokazano zmanjšujejo aktivnost encima, imenovanega „CYP2C19“.
Smokers (smoking is a moderate CYP1A2 inducer) Tasimelteon exposure decreased by approximately 40% in smokers, compared to non-smokers (see section
Izpostavljenost tasimelteonu se je pri kadilcih zmanjšala za približno 40 % v primerjavi z nekadilci (glejte poglavje 4.5).
Tasimelteon This medicine is subject to additional monitoring.
Navodilo za uporabo HETLIOZ 20 mg trde kapsule tasimelteon Za to zdravilo se izvaja dodatno spremljanje varnosti.
EXPIRY DATE
urnem ciklusu
- medicines known to increase the activity of an enzyme called ‘CYP3A4'.
To je na primer ketokonazol, ki se uporablja za zdravljenje glivičnih okužb; - zdravila, ki dokazano povečujejo aktivnost encima, imenovanega „CYP3A4“.
GENERAL CLASSIFICATION FOR SUPPLY
Seznam pomožnih snovi
Nighttime sleep on 25% most symptomatic nights >45 minutes increase in average nighttime sleep duration
Spanje ponoči v 25 % noči z najbolj izraženimi simptomi
Route of Administration
Številka EU dovoljenja za promet
At present, the annual cost of support measures for these products is around €100,000.
Trenutno znašajo letni stroški podpornih ukrepov za ta zdravila približno 100 000 EUR.
They often contribute to the work of more than one scientific committee and various working parties.
Pogosto sodelujejo pri delu več kot enega znanstvenega odbora in različnih delovnih skupin.
The adopted preliminary draft budget (PDB) for 2010 totals €211.8 million.
Sprejeti predhodni osnutek proračuna (PDB) za leto 2010 znaša 211,8 milijona EUR.
This includes an estimated fee revenue of €158.3 million and a requested Community contribution of €46 million.
To zajema pričakovane prihodke iz pristojbin v višini 158,3 milijona EUR in zahtevani prispevek Skupnosti v višini 46 milijonov EUR.
A further report will be provided at the June meeting.
Naslednje poročilo bo predstavljeno na junijskem sestanku.
The Management Board welcomed the opinion of the Committee as it is of importance to many Member States.
Upravni odbor je pozdravil mnenje Odbora, saj je pomembno za veliko držav članic.
The Agency adopted a record number of positive opinions in the area of initial evaluations.
Agencija je sprejela rekordno število pozitivnih mnenj na področju začetnega vrednotenja.
The public consultation regarding the proposed policy is planned to start in mid June and finish at the end of September 2009.
Začetek javnega posvetovanja o predlagani politiki je načrtovan za sredino junija, konec pa za konec septembra 2009.
The Board discussed the topic and offered divergent views.
Odbor je razpravljal o temi in ponudil različne poglede.
The year 2010 is the final year covered by the current road map.
Leto 2010 je zadnje leto, ki ga pokriva sedanji časovni načrt.
The pilot will commence in April 2009 and will run for three months.
Pilotni projekt se bo začel aprila 2009 in bo trajal tri mesece.
The PDB includes an increase in the establishment plan of 37 posts, with a maximum number of 567 temporary agents.
PDB vključuje razširitev načrta delovnih mest za 37 delovnih mest, pri čemer je lahko začasnih uslužbencev največ 567.
The first centralised vaccine against bluetongue
Prvo centralizirano cepivo proti bolezni modrikastega jezika
Review of the remuneration system
Pregled sistema plačevanja nadomestil
Collaboration with the FDA
Sodelovanje z uradom FDA
Following the entry into force of the proposed additional measures, the cost may rise to an annual figure of €500,000 and, depending on the actual uptake, may even be significantly higher.
Po začetku veljavnosti predlaganih dodatnih ukrepov bi se stroški lahko povišali na 500 000 EUR letno in bi bili lahko glede na dejanski vnos celo bistveno višji.
The Agency delivered on all core business commitments and implemented its 2008 priorities.
Agencija je uspešno izpolnila vse ključne poslovne obveznosti in izvedla prednostne naloge za leto 2008.
Point 16 on Governance of EU agencies was deferred to the June meeting.
Točka 16 o upravljanju agencij EU je bila preložena na junijski sestanek.
The Board will discuss this proposal at a future meeting.
Odbor bo o tem predlogu razpravljal na enem od prihodnjih sestankov.
Options for adopting a new logo for the Agency are being explored.
Možnosti za sprejetje novega logotipa Agencije se še preverjajo.
Overall, the changes of the structure will ensure more accountability at various management levels, and will make the organisation better positioned to operate in the present conditions.
Splošno gledano, bodo spremembe strukture zagotovile večjo odgovornost na različnih ravneh upravljanja, zaradi česar bo organizacija v boljšem položaju za delovanje v sedanjih okoliščinah.
The Agency will also consider ways to promote use of its official name rather than the acronym ‘EMEA', which has limited recognition outside of the Agency's closest stakeholder groups.
Agencija bo tudi preučila načine za spodbujanje rabe svojega uradnega imena namesto kratice „EMEA“, ki je relativno neprepoznavna zunaj kroga najbližjih skupin zainteresiranih strani Agencije.
It was also stressed that the volume and complexity of procedures exert a lot of pressure on national scientific resources, with scientists having to spend increasingly more time at the Agency.
Poudarjeno je bilo tudi, da obseg in zapletenost postopkov zelo pritiskata na nacionalne znanstvene vire, saj morajo znanstveniki vedno več časa posvetiti delu v Agenciji.
The European Commission made a reservation regarding the level of the Community contribution in the 2010 budget, pending the completion of the budgetary process in the institutions.
Evropska komisija je izrazila pridržek v zvezi s stopnjo prispevka Skupnosti v proračun za leto 2010, ki velja do konca proračunskih postopkov v institucijah.
The EMEA's recommendation is an important step towards the availability of vaccines for use in vaccination campaigns across the EU and the protection of animal health in Europe.
Priporočilo agencije EMEA je pomemben korak k zagotavljanju razpoložljivosti cepiv za uporabo v programih cepljenja v EU in zaščiti zdravja živali v Evropi.
Work is ongoing at the two agencies on arrangements for the reciprocal assignment of staff.
V obeh agencijah poteka delo v skladu s sporazumi za obojestransko napotitev osebja.
This can be considered during the ongoing evaluation of the Agency.
To bi bilo mogoče med ocenjevanjem Agencije, ki poteka.