natgillin/translations-raw huggingface dataset:
Vital pregnancy rate Ongoing pregnancy rate 
Delež vitalnih nosečnosti Delež potekajočih nosečnosti Delež živorojenih*
In the ENGAGE study, non-inferiority was demonstrated in ongoing pregnancy rates between Elonva and recFSH, with ongoing pregnancy rate defined as presence of at least one foetus with heart activity assessed at least 10 weeks after embryo transfer. 
V študiji ENGAGE so neinferiornost dokazali s primerjavo deležev potekajočih nosečnosti med zdravilom Elonva in (rek)FSH, pri čemer je bil delež potekajočih nosečnosti opredeljen kot prisotnost vsaj enega ploda z delovanjem srca (ocenjeno vsaj 10 tednov po prenosu zarodka).
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands 
Organon Kloosterstraat 6 5349 AB Oss Nizozemska
Nervous system disorders 
Zapleti žilnega sistema
Hypersensitivity reactions, both local and generalised, including rash* 
Bolezni imunskega sistema neznana pogostnost preobčutljivostne reakcije, tako lokalne kot generalizirane, vključno z izpuščajem*
In the PURSUE study, non-inferiority was demonstrated in vital pregnancy rate between Elonva and recFSH, with vital pregnancy rate defined as the percentage of subjects with at least one foetus with heart activity assessed 5 to 6 weeks after embryo transfer. 
V študiji PURSUE so neinferiornost dokazali s primerjavo deležev vitalnih nosečnosti med zdravilom Elonva in (rek)FSH, pri čemer je bil delež vitalnih nosečnosti opredeljen kot odstotek žensk z vsaj enim plodom z delujočim srcem (ocenjeno od 5 do 6 tednov po prenosu zarodka).
Table 2: Pregnancy Results from the Fresh Cycles of ENGAGE and PURSUE Intent-to-Treat Population (ITT) 
Preglednica 2: Rezultati nosečnosti iz ciklov z uporabo svežih zarodkov v študijah ENGAGE in PURSUE Populacija z namenom zdravljenja (ITT)
Pregnancy, puerperium and perinatal conditions 
Motnje v času nosečnosti, puerperija in perinatalnem obdobju občasni spontani splav
o have previously had a treatment cycle of controlled stimulation of the ovaries that resulted in the growth of more than 30 follicles with a size of 11 mm or larger o have a basal antral follicle count (the number of small follicles present in your ovaries at the beginning of a menstrual cycle) higher than 20 
o če imate bazalno število antralnih foliklov (število majhnih foliklov, ki so navzoči v jajčnikih ob začetku menstrualnega ciklusa) večje od 20.
Ovarian and other reproductive system neoplasms 
Novotvorbe na jajčnikih in na drugih delih reproduktivnega sistema
There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple treatment regimens for infertility treatment. 
Poročali so o nastanku tako benignih kot malignih novotvorb na jajčnikih in na drugih delih reproduktivnega sistema pri ženskah, ki so prejele več shem zdravljenja neplodnosti.
 Fibroid tumours of the uterus incompatible with pregnancy. 
- če imate fibroidne tumorje v maternici, ki onemogočajo normalno nosečnost.
Elonva may cause dizziness. 
Zdravilo Elonva lahko povzroči omotico.
- Keep this leaflet. 
- Pokrovček pustite na igli.
Do not use Elonva if you: - are allergic (hypersensitive) to corifollitropin alfa or any of the other ingredients of this medicine (listed in section 6) - have cancer of the ovary, breast, uterus, or brain (pituitary gland or hypothalamus) - have recently had unexpected vaginal bleeding, other than menstrual, without a diagnosed cause - have ovaries that do not work because of a condition called primary ovarian failure - have ovarian cysts or enlarged ovaries - have malformations of the sexual organs which make a normal pregnancy impossible - have fibroid tumours in the uterus which make a normal pregnancy impossible - have risk factor of OHSS (OHSS is a serious medical problem that can happen when the ovaries are overly stimulated. 
 Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1,  tumorji jajčnikov, dojk, maternice, hipofize ali hipotalamusa,  nenormalne (tj. nemenstrualne) vaginalne krvavitve brez znanega oz. diagnosticiranega vzroka,  primarna odpoved jajčnikov,  ciste na jajčnikih ali povečani jajčniki,  fibroidni tumorji maternice, ki so nezdružljivi z nosečnostjo,  malformacije reproduktivnih organov, ki so nezdružljive z nosečnostjo,  dejavniki tveganja za sindrom hiperstimulacije jajčnikov (OHSS):
150 micrograms 150 micrograms 
Ni raziskano 150 mikrogramov 150 mikrogramov
- Release your thumb from the plunger - The needle will withdraw automatically into the syringe where it will be locked permanently. 
- Igla se bo samodejno umaknila v injekcijsko brizgo in bo ostala v njej zaprta.
Number of oocytes retrieved 
Število dobljenih jajčec
The primary efficacy endpoint was number of oocytes retrieved. 
Primarni opazovani dogodek učinkovitosti je bilo število dobljenih jajčec.
- Keep the syringe pointing upwards - Remove the needle shield straight up and discard it - BE CAREFUL with the needle. 
- Z igle naravnost navzgor snemite pokrovček in ga zavrzite.
Do not use Elonva - if it has been stored out of the refrigerator for more than one month. 
Ne uporabljajte zdravila Elonva - če je bilo shranjeno zunaj hladilnika več kot en mesec, - če je bilo shranjeno zunaj hladilnika pri temperaturi več kot 25 ºC, - če opazite, da raztopina ni bistra, - če opazite, da sta injekcijska brizga ali igla poškodovani.
 Malformations of the reproductive organs incompatible with pregnancy. 
- če imate anomalije spolnih organov, ki onemogočajo normalno nosečnost.
There is an increased chance of having twins or even more than two babies, even when only one embryo is transferred into the uterus. 
Tudi v primeru, ko je bil v maternico prenesen le en zarodek, je večja verjetnost, da bo ženska rodila dvojčka ali celo več otrok.
Other medical conditions 
Druga bolezenska stanja
Fresh Cycles of PURSUE (35-42 years of age) (body weight greater than or equal to 50 kg) 
Cikli z upotabo svežih zarodkov v študiji PURSUE (35-42 let starosti) (telesna masa 50 kg ali več)
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni bolečina v hrbtu
1) postdose. 
1) in je podobna po dajanju
Pituitary suppression with a GnRH antagonist (ganirelix acetate injection at a daily dose of 0.25 mg) was used in each of the three clinical trials. 
V vseh treh kliničnih preskušanjih so zavirali delovanje hipofize z antagonistom GnRH (injekcija ganireliksacetata v dnevnem odmerku 0,25 mg).
Abdominal distension, vomiting, diarrhoea, constipation 
Bolezni prebavil pogosti slabost občasni napihnjenost trebuha, bruhanje, driska, zaprtje
The median total duration of stimulation was 9 days for both groups, indicating that one day of recFSH was required to complete ovarian stimulation from stimulation day 8 onwards (no recFSH was given on the day of hCG for this study). 
To kaže, da je bil za popolno stimulacijo jajčnikov od 8. dne stimulacije naprej potreben en dan uporabe (rek)FSH (v tej študiji na dan uporabe hCG ni bil prejet (rek)FSH).
Your doctor will do ultrasound scans of your ovaries to carefully monitor the number of maturing follicles. 
Za skrbno spremljanje števila zorečih foliklov bo zdravnik opravil ultrazvočni pregled jajčnikov.
- Hold the syringe with the grey cap pointing upwards - Tap the syringe gently with your finger to help air bubbles rise to the top. 
- S prstom nežno potrkajte po injekcijski brizgi, da bodo na vrh priplavali mehurčki zraka.
Twisting of the ovary could cause the blood flow to the ovary to be cut off. 
Torzija jajčnikov Torzija jajčnikov pomeni zasuk jajčnikov, kar lahko povzroči prekinitev pretoka krvi do jajčnikov.
In the ENSURE study, 396 healthy normal ovulatory women, aged 18 to 36 years with a body weight less than or equal to 60 kg, were treated for one cycle with 100 micrograms of Elonva and pituitary suppression with a GnRH antagonist as part of an ART program. 
V študiji ENSURE so pri 396 zdravih ženskah z normalno ovulacijo, starih od 18 do 36 let in s telesno maso 60 kg ali manj, v okviru programa ART opravili en ciklus zdravljenja s 100 mikrogrami zdravila Elonva in z zaviranjem hipofize z antagonistom GnRH.
Elonva is available in two strengths: 100 micrograms and 150 micrograms solution for injection. 
Zdravilo Elonva je na voljo v dveh jakostih: Elonva 100 mikrogramov raztopina za injiciranje in Elonva 150 mikrogramov raztopina za injiciranje.
 Tumours of the ovary, breast, uterus, pituitary or hypothalamus. 
- če imate rak jajčnikov, dojk, maternice ali možganov (hipofize ali hipotalamusa).
ENGAGE (18-36 years of age) (body weight greater than 60 kg and less than or equal to 90 kg) 
ENGAGE (18-36 let starosti) (telesna masa več kot 60 kg do vključno 90 kg)
Multiple pregnancies and births have been reported for all gonadotropin treatments, including Elonva. 
Pri vseh vrstah zdravljenja z gonadotropini, vključno z zdravilom Elonva, so poročali o večplodnih nosečnostih in rojstvu več otrok.
Each pre-filled syringe contains 0.5 mL solution for injection. 
Vsaka napolnjena brizga vsebuje 0,5 ml raztopine za injiciranje.
Elonva 150 µg recFSH 300 IU 
Elonva 150 µg
In the ENGAGE Study, 1,506 healthy normal ovulatory women, aged 18 to 36 years with a body weight greater than 60 kg and less than or equal to 90 kg, were treated for one cycle with 150 micrograms of Elonva and pituitary suppression with a GnRH antagonist as part of an ART program. 
V študiji ENGAGE so pri 1.506 zdravih ženskah z normalno ovulacijo, starih od 18 do 36 let in s telesno maso od 60 kg do vključno 90 kg, v okviru programa ART opravili en ciklus zdravljenja s 150 mikrogrami zdravila Elonva in z zaviranjem hipofize z antagonistom GnRH.
PRE-FILLED SYRINGE LABEL 
NALEPKA NA NAPOLNJENI INJEKCIJSKI BRIZGI
In rare cases, severe OHSS may be life-threatening. 
V redkih primerih je lahko hud OHSS življenjsko nevaren, zato je natančen zdravniški nadzor zelo pomemben.
The median total duration of stimulation was 9 days for both groups, indicating that two days of recFSH were required to complete ovarian stimulation from stimulation day 8 onwards (recFSH was given on the day of hCG for this study). 
To kaže, da sta bila za popolno stimulacijo jajčnikov od 8. dne stimulacije naprej potrebna dva dneva uporabe (rek)FSH (v tej študiji sta bila (rek)FSH in hCG prejeta isti dan).
Storage by the patient 
Shranjevanje doma
 Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause. 
- če ste imeli pred kratkim nepričakovano krvavitev iz nožnice, razen menstruacijske, brez ugotovljenega vzroka.
ENSURE (18-36 years of age) (body weight less than or equal to 60 kg) 
ENSURE (18-36 let starosti) (telesna masa 60 kg ali manj)
In the PURSUE study, 1,390 healthy normal ovulatory women, aged 35 to 42 years with a body weight greater than or equal to 50 kg, were treated for one cycle with 150 micrograms of Elonva and pituitary suppression with a GnRH antagonist as part of an ART program. 
V študiji PURSUE so pri 1.390 zdravih ženskah z normalno ovulacijo, starih od 35 do 42 let in s telesno maso 50 kg ali več, v okviru programa ART opravili en ciklus zdravljenja s 150 mikrogrami zdravila Elonva in z zaviranjem hipofize z antagonistom GnRH.
Each syringe contains 0.5 mL solution. 
Ena brizga vsebuje 0,5 ml raztopine.
Fresh Cycles of ENGAGE (18-36 years of age) (body weight greater than 60 kg and less than or equal to 90 kg) 
Cikli z uporabo svežih zarodkov v študiji ENGAGE (18-36 let starosti) (telesna masa več kot 60 kg do vključno 90 kg)
Thromboembolic events, both in association with and separate from OHSS, have been reported following treatment with gonadotropins, including Elonva. 
Po zdravljenju z gonadotropini, vključno z zdravilom Elonva, so poročali o tromoemboličnih pojavih, tako povezanih, kot tudi nepovezanih z OHSS.
Body weight is a determinant of exposure to corifollitropin alfa. 
Izpostavljenost korifolitropinu alfa je odvisna od telesne mase.
How to store Elonva 
Shranjevanje zdravila Elonva
o A history of Ovarian Hyperstimulation Syndrome (OHSS). 
o če ste imeli sindrom hiperstimulacije jajčnikov (OHSS).
Ovarian torsion, adnexa uteri pain, premature ovulation, breast pain 
OHSS, bolečine v medenici, neugodje v medenici, občutljivost dojk občasni torzija jajčnikov, bolečine v materničnih adneksih, prezgodnja ovulacija, bolečine v dojkah
Two of these four women became pregnant during the same treatment cycle in which antibodies were detected, suggesting that the presence of non-neutralizing antibodies after stimulation with Elonva is not clinically relevant. 
To kaže, da prisotnost nenevtralizirajočih protiteles po stimulaciji z zdravilom Elonva ni klinično pomembna.
In patients with mild, moderate or severe renal insufficiency the rate of elimination of corifollitropin alfa may be reduced (see sections 4.2 and 5.2). 
Pri bolnicah z blago, zmerno ali hudo ledvično insuficienco je lahko stopnja izločanja korifolitropina alfa zmanjšana (glejte poglavji 4.2 in 5.2), zato uporaba zdravila Elonva pri teh ženskah ni priporočljiva.
Reproductive system and breast disorders 
Motnje reprodukcije in dojk pogosti
Components of the Elonva syringe with needle 
Deli injekcijske brizge zdravila Elonva z iglo
- While waiting for the disinfectant to dry, break the label perforation and pull off the needle-cap - Leave the needle shield on the needle - Place the needle shield (containing the needle) on a clean dry surface, while preparing the syringe. 
- Medtem ko čakate, da se razkužilo posuši, pretrgajte perforacijo na nalepki in snemite zaščitno zaporko igle.
This justifies replacement of the first seven injections of daily (rec)FSH with a single subcutaneous injection of Elonva in COS for the development of multiple follicles and pregnancy in an ART program (see section 4.2). 
Zaradi dolgega razpolovnega časa izločanja so po uporabi priporočenega odmerka serumske koncentracije korifolitropina alfa zadostne, da ohranjajo rast več foliklov ves teden, kar opraviči zamenjavo prvih sedmih vsakodnevnih injekcij (rek)FSH z eno samo subkutano injekcijo zdravila Elonva pri nadzorovani stimulaciji jajčnikov, da bi dosegli razvoj več foliklov in zanositev v programu asistirane reprodukcije (glejte poglavje 4.2).
Talk to your doctor before using Elonva. 
Pred začetkom uporabe zdravila Elonva se posvetujte z zdravnikom.
Table 3: Pregnancy Results from the FTET cycles of ENGAGE and PURSUE Intent-to-Treat Population (ITT) 
Preglednica 3: Rezultati nosečnosti iz FTET ciklov študij ENGAGE in PURSUE Populacija z namenom zdravljenja (ITT)
Ovarian torsion has been reported after treatment with gonadotropins, including Elonva. 
Po zdravljenju z gonadotropini, vključno z zdravilom Elonva, so poročali o torziji jajčnikov.
Elonva 100 micrograms solution for injection Elonva 150 micrograms solution for injection 
Elonva 100 mikrogramov raztopina za injiciranje Elonva 150 mikrogramov raztopina za injiciranje
Each Elonva 150 micrograms solution for injection pre-filled syringe contains 150 micrograms in 0.5 millilitre (mL) solution for injection. 
Ena napolnjena injekcijska brizga zdravila Elonva 150 mikrogramov raztopina za injiciranje vsebuje 150 mikrogramov korifolitropina alfa v 0,5 mililitra (ml) raztopine za injiciranje.
Elonva 100 µg recFSH 150 IU 
Elonva 100 µg
Each Elonva 100 micrograms solution for injection pre-filled syringe contains 100 micrograms in 0.5 millilitre (mL) solution for injection. 
Ena napolnjena injekcijska brizga zdravila Elonva 100 mikrogramov raztopina za injiciranje vsebuje 100 mikrogramov korifolitropina alfa v 0,5 mililitra (ml) raztopine za injiciranje.
Elonva 100 micrograms solution for injection 
Elonva 100 mikrogramov raztopina za injiciranje
Box 20 5340 BH Oss The Netherlands 
Kloosterstraat 6, 5349 AB Oss P.O. Box 20, 5340 BH Oss Nizozemska
Elonva 100 micrograms solution for injection Elonva 150 micrograms solution for injection corifollitropin alfa 
Elonva 100 mikrogramov raztopina za injiciranje Elonva 150 mikrogramov raztopina za injiciranje korifolitropin alfa
- A single 100-microgram dose is recommended in women who weigh less than or equal to 60 kilograms and who are 36 years of age or younger. 
- Za ženske, ki tehtajo 60 kilogramov ali manj in so stare 36 let ali manj, je priporočljiv enkraten odmerek 100 mikrogramov.
Elonva 150 micrograms solution for injection 
Elonva 150 mikrogramov raztopina za injiciranje
In addition, ectopic pregnancy and multiple gestations have been reported. 
Poleg tega so poročali o ektopični nosečnosti in večplodni nosečnosti, ki naj bi bili povezani z asistirano reprodukcijo ali posledično nosečnostjo.
- Keep the syringe pointing upwards - Screw the needle shield (containing the needle) clockwise onto the syringe. 
- Pokrovček (v katerem je igla) v smeri urnega kazalca privijte na injekcijsko brizgo.
Elonva 150 micrograms injection corifollitropin alfa 
Elonva 150 mikrogramov injekcija korifolitropin alfa s.c.
Elonva 100 micrograms injection corifollitropin alfa 
Elonva 100 mikrogramov injekcija korifolitropin alfa s.c.
- Keep the syringe pointing upwards - Unscrew the syringe cap counter-clockwise. 
- Odvijte zaščitno zaporko brizge nasprotno smeri urnega kazalca.
Each pre-filled syringe contains 150 micrograms of corifollitropin alfa in 0.5 mL solution for injection. 
Ena napolnjena injekcijska brizga vsebuje 150 mikrogramov korifolitropina alfa v 0,5 ml raztopine za injiciranje.
Always use Elonva exactly as your doctor has told you. 
Pri uporabi zdravila Elonva natančno upoštevajte zdravnikova navodila.
Injection site haematoma, injection site pain, irritability 
Splošne težave in spremembe na mestu aplikacije pogosti utrujenost občasni hematom na mestu injiciranja, bolečina na mestu injiciranja, razdražljivost
Each pre-filled syringe contains 150 micrograms of corifollitropin alfa* in 0.5 mL solution for injection. 
Ena napolnjena injekcijska brizga vsebuje 150 mikrogramov korifolitropina alfa* v 0,5 ml raztopine za injiciranje.
Each pre-filled syringe contains 100 micrograms of corifollitropin alfa in 0.5 mL solution for injection. 
Ena napolnjena injekcijska brizga vsebuje 100 mikrogramov korifolitropina alfa v 0,5 ml raztopine za injiciranje.
Elonva 150 micrograms solution for injection corifollitropin alfa 
Elonva 150 mikrogramov raztopina za injiciranje korifolitropin alfa
OHSS, pelvic pain, pelvic discomfort, breast tenderness 
bat brizga raztopina zaščitna zaporka perforacija igla zaščitna zaporka pokrovček
Elonva 100 micrograms solution for injection corifollitropin alfa 
Elonva 100 mikrogramov raztopina za injiciranje korifolitropin alfa
Each pre-filled syringe contains 100 micrograms of corifollitropin alfa* in 0.5 mL solution for injection. 
Ena napolnjena injekcijska brizga vsebuje 100 mikrogramov korifolitropina alfa* v 0,5 ml raztopine za injiciranje.
- Now take the syringe between index and middle finger in the upward position - Place your thumb on the plunger - Carefully push the plunger upwards until a tiny droplet appears at the tip of the needle. 
- Zdaj s kazalcem in sredincem primite injekcijsko brizgo in jo držite obrnjeno pokonci.
Ovarian and other reproductive system tumours 
Tumorji na jajčnikih in na drugih delih rodil
There have been reports of ovarian and other reproductive system tumours in women who have had infertility treatment. 
Pri ženskah, ki so se zdravile zaradi neplodnosti, so poročali o nastanku tumorjev na jajčnikih in na drugih delih rodil.
calendar blister (OPA/alu/PVC/alu) 
peroralna uporaba koledarski pretisni omot (OPA/alu/PVC/alu)
Immediate Packaging Pack size calendar blister (PVC/PE/PVdC/alu) 
Velikost pakiranja peroralna uporaba koledarski pretisni omot (PVC/PE/PVdC/alu)
MA (EU) number (Invented) name 
Številka EU Izmišljeno ime
5 vials + 5 cartridges 
5 vial + 5 vložkov
Pack size powder: vial (glass); solvent: vial (glass) 
Prašek: viala (steklo) Vehikel: viala (steklo)
1 vial + 1 cartridge 
1 viala + 1 vložek
Immediate Packaging Content (concentration) 
Velikost pakiranja
This summary was last updated on 31.01.2008. 
Ta povzetek je bil nazadnje posodobljen 31.01.2008.
• The results of the safety studies indicated that the product is safe for chickens. 
• Rezultati raziskav o varnosti so pokazali, da je izdelek varen za piščance.
Because of the current epidemiological situation of avian influenza and the consequent threat to both human and animal health the committee recommended the granting of a Marketing Authorisation. 
Zaradi trenutne epidemiološke situacije v zvezi z aviarno influenco in posledične grožnje za zdravje ljudi in živali je odbor priporočil odobritev dovoljenja za promet z zdravilom.
The data on the effectiveness of the vaccine was based on published scientific papers and internal company reports. 
Podatki o učinkovitosti cepiva so temeljili na objavljenih znanstvenih razpravah in internih poročilih podjetja.
This is because control of avian influenza is the responsibility of national veterinary authorities in consultation with the European Commission. 
Nadzor nad aviarno influenco je namreč v pristojnosti nacionalnih veterinarskih organov v povezavi z Evropsko komisijo.
Studies were carried out in one-day-old and 2 to 4 week-old chickens free of any infection. 
Raziskave so se izvajale na en dan starih in 2 do 4 tedne starih piščancih, ki niso bili okuženi.
This vaccine has some of the same ingredients but different antigens (viruses), two of which are produced using the same process to that used for the avian influenza antigen of Nobilis Influenza. 
To cepivo ima nekaj enakih sestavin, vendar različne antigene (viruse), od katerih se dva proizvajata po istem postopku, kot se uporablja za antigen aviarne influence zdravila Nobilis Influenza.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)? 
Koliko časa je potrebno počakati, preden se žival lahko zakolje in meso uporabi za prehrano ljudi (karenca)?
They included studies in other avian species (ducks, turkeys, pheasants), and studies using either the subcutaneous or intramuscular routes. 
Vključevali so tudi raziskave na drugih vrstah ptic (race, purani, fazani) in raziskave z uporabo subkutanega ali intramuskularnega načina dajanja.
When it is given to chickens, the birds' immune system (their natural defence mechanism) learns how to make antibodies (a special type of protein) to fight the disease. 
Ko ga piščanec prejme, se imunski sistem ptic (njihov naravni obrambni mehanizem) nauči tvoriti protitelesa (posebno vrsto beljakovine) za boj proti bolezni.
In the future, if the birds are exposed to the avian flu virus, the immune system will be able to make those antibodies quicker and this will help them fight the disease. 
Če bodo ptice v prihodnosti izpostavljene virusu aviarne influence, bo njihov imunski sistem ta protitelesa tvoril hitreje in to jim bo pomagalo v boju proti bolezni.
The Committee for Medicinal Products for Veterinary use concluded that the vaccine has been shown to be effective in preventing clinical disease in poultry and could be a useful tool in controlling an outbreak of avian influenza infection. 
Odbor za zdravila za uporabo v veterinarski medicini je sklenil, da je bila dokazana učinkovitost cepiva pri preprečevanju kliničnih bolezni pri perutnini in je lahko uporaben pripomoček pri nadzorovanju izbruha okužbe z aviarno influenco.
The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis Influenza H5N6 to Intervet International BV on 31.01.2008. 
Evropska komisija je dovoljenje za promet z zdravilom Nobilis Influenza H5N6, veljavno po vsej Evropski uniji, odobrila družbi Intervet International BV dne 31.01.2008.
The vaccine was assessed in the context of an emergency situation which means that further studies with Nobilis H5N6 are still ongoing and will be assessed. 
Cepivo je bilo ocenjeno v izrednih razmerah, kar pomeni, da nadaljnje raziskave z zdravilom Nobilis Influenza H5N6 še vedno potekajo in bodo ovrednotene v prihodnosti.
This strain has been chosen because it protects birds against virulent H5N1 field strains (cross-protection), while allowing differentiation of vaccinated from infected birds. 
Ta sev je bil izbran, ker varuje ptice pred virulentnimi divjimi sevi H5N1 (navzkrižna zaščita), hkrati pa omogoča razlikovanje cepljenih ptic od okuženih ptic.