natgillin/translations-raw huggingface dataset:
However, the chance of a hazard occurring has been estimated very low and is minimized by routinely vaccinating all chickens on the premise at the same time and cleaning and disinfection after each production round. 
Ipak, šanse su vrlo male te su minimizirane rutinskim cijepljenjem svih pilića u prostoru, u isto vrijeme te čišćenjem i dezinficiranjem nakon svakog proizvodnog ciklusa.
Do not mix with any other veterinary medicinal product, except Nobilis IB Ma5 recommended for use with the veterinary medicinal product. 
Ne miješati s bilo kojim veterinarsko medicinskim proizvodom, osim s preporučenim veterinarsko medicinskim proizvodom Nobilis IB Ma5.
Ocular/intranasal administration or coarse spray gives the best responses and these should be the methods of choice, especially when vaccinating young chickens. 
Okularna/intranazalna primjena ili raspršivanje većih kapljica, daju najbolje imunosne odgovore i to bi trebala biti metoda izbora, pogotovo kod cijepljenja mladih pilića.
For the mixed products the onset of immunity is 3 weeks and the duration of immunity is 6 weeks for the claimed protection against the Massachusetts strains and the variant strain 4-91 of IBV. 
Za kombiniranu primjenu početak imuniteta je 3 tjedna, a trajanje imuniteta je 6 tjedana, za utvrđenu zaštitu protiv sojeva Massachusetts i varijantu soja 4-91 ZBK-a.
The vaccine may be delivered as a freeze-dried cake in a glass vial or as freeze-dried spheres in cups. 
Cjepivo može biti isporučeno kao liofilizirana peleta u staklenoj bočici ili kao liofilizirane kuglice u čašicama.
Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of spray administration, personal protective equipment consisting of masks with eye protection should be worn when handling the veterinary medicinal product. 
Kod primjene raspršivača, mora se pri rukovanju veterinarsko medicinskim proizvodom nositi oprema za osobnu zaštitu koja se sastoji od maske sa zaštitom za oči.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX with 1 vial, 10 vials or 10 cups of lyophilisate 
PODACI NA VANJSKOM PAKOVANJU KARTONSKA KUTIJA sa 1 bočicom, 10 bočica ili 10 čašica liofilizata
Water withholding should be kept as short as possible with a minimum of half an hour. 
Vrijeme trajanja uskraćivanja vode uvelike ovisi o klimatskim uvjetima i treba biti što je kraće moguće, a najmanje pola sata.
The vaccine should be given in the early morning as this is the main period of water intake or during the cool period on a hot day. 
Cjepivo dajemo u ranim jutarnjim satima, jer životinje tada popiju najviše vode ili u svježijem dijelu dana tokom vrućina.
The vaccine suspension should be spread evenly over the correct number of chickens, at a distance of 30-40 cm using a coarse spray, preferably when the chickens are sitting together in dim light. 
Suspenziju cjepiva treba pomoću raspršivača, s većim kapljicama, ravnomjerno raspršiti po točnom broju pilića, s udaljenosti od 30-40 cm, po mogućnosti, kada su pilići zajedno okupljeni pri prigušenom svjetlu.
1x 500 doses 1x 1,000 doses 1x 2,500 doses 1x 5,000 doses 1x 10,000 doses 10x 500 doses 10x 1,000 doses 10x 2,500 doses 10x 5,000 doses 10x 10,000 doses 
1x 500 doza 1x 1000 doza 1x 2500 doza 1x 5000 doza 1x 10000 doza 10x 500 doza 10x 1000 doza 10x 2500 doza 10x 5000 doza 10x 10000 doza
1,000 doses (3-100 spheres) 2,500 doses (3-100 spheres) 5,000 doses (3-100 spheres) 10,000 doses (3-100 spheres) 
1000 doza (3-100 kuglica) 2500 doza ( 3-100 kuglica) 5000 doza (3-100 kuglica) 10000 doza (3-100 kuglica)
Shelf life of the veterinary medicinal product in glass vials as packaged for sale: 9 months. 
Rok valjanosti veterinarsko medicinskog proizvoda pakiranog za prodaju u staklenim bočicama: 9 mjeseci.
Sealed aluminium laminate cup with a polypropylene (cup) and polypropylene/polyethylene (lid) contact layer containing 1,000; 2,500; 5,000 or 10,000 doses. 
Zapečaćena laminirana aluminijska čašica s kontaktnim slojem od polipropilena (čašica) i polipropilen/polietilena (poklopac) koja sadrži 1000, 2500, 5000 ili 10000 doza.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 
Učestalost nuspojava je određena prema slijedećim pravilima: - vrlo česte (više od 1 u 10 životinja pokazuju nuspojave za vrijeme trajanja jednog tretmana) - česte (više od jedne ali manje od 10 životinja od 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10,000 životinja) - vrlo rijetke (manje od 1 životinje na 10,000 životinja, uključujući izolirane slučajeve).
By adding approximately 2 grams of skimmed milk powder or 20 ml of liquid skimmed milk per litre of water the virus retains its activity longer. 
Dodavanje oko 2 grama obranog mlijeka u prahu ili 20 ml tekućeg obranog mlijeka po litri vode produžuje djelovanje aktivnosti virusnog cjepiva.
The spray apparatus should be free from sediments, corrosion and traces of disinfectants and ideally should be used for vaccination purposes only. 
Uređaj za raspršivanje ne smije sadržavati sediment, koroziju i tragove dezinficijensa, najbolje da se koristi samo za cijepljenje.
In case of the latter presentation the cups may contain 3 up to 100 spheres depending on the required dosages and production yields. 
Naredni dostupni oblici čašica mogu sadržavati od 3 do 100 kuglica ovisno o traženoj dozi i proizvodnim prinosa.
500 doses 1,000 doses 2,500 doses 5,000 doses 10,000 doses 
500 doza 1000 doza 2500 doza 5000 doza 10000 doza
The same volumes as for the single product should be used. 
Potrebno je upotrijebiti isti volumen kao kod davanja pojedinog cjepiva.
At least 3.6 log10 EID50 (1 dose) per animal by coarse spray, drinking water or intranasal/ocular administration. 
Najmanje 3,6 log10 EID50 (1 doza) po životinji raspršivanjem, u vodi za piće ili intranazalno/okularno.
For administration of the vaccine, as a general rule, dissolve 1,000 doses in one litre per age in days up to a maximum volume of 20 litres per 1,000 doses. 
Opće pravilo za cijepljenje je, otopiti 1000 doza u jednoj litri vode na starost pilića u danima, do maksimalne količine od 20 litara za 1000 doza.
The instructions on reconstitution of both lyophilisates and the subsequent application are to be followed as outlined above for spray and intranasal/ocular administration. 
Treba slijediti upute za rekonstituciju oba liofilizata i naknadnu aplikaciju kako je prethodno navedeno, za sprej ili intranazalno/okularnu primjenu.
Dissolve the vaccine in physiological saline solution or sterile distilled water (usually 30 ml per 1,000 doses, 75 ml per 2,500 doses) and administer by means of a standardized dropper. 
Cjepivo otopiti u fiziološkoj otopini ili sterilnoj destiliranoj vodi (obično 30 ml za 1000 doza, 75 ml za 2500 doza) i primijeniti pomoću standardne kapaljke.
One drop should be applied onto one nostril or one eye. 
Dajemo po jednu kap u nosnicu ili oko.
Shelf life after reconstitution according to directions: 2 hours. 
Rok valjanosti nakon rekonstituiranja prema uputama: 2 sata.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of their territory if it is established that: 
Prema članku 71. Direktive 2001/82/EZ, Europskog Parlamenta i Vijeća kako je izmijenjena, država članica može, sukladno nacionalnim odredbama zaštite zdravlja životinja, zabraniti proizvodnju,
Glass vial (type I hydrolytic glass) of 10 ml containing 500; 1,000; 2,500; 5,000 or 10,000 doses closed with a halogenobutyl rubber bung and sealed with a coded aluminium cap. 
Staklena bočica (tip I hidrolitičko staklo) od 10 ml, koja sadrži 500, 1000, 2500, 5000 ili 10000 doza zatvorena s halogenbutil gumenim čepom i aluminijskom kapicom s oznakom.
Read the product information of Nobilis IB Ma5 before use. 
Pročitati uputu za Nobilis IB Ma5 prije upotrebe.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials, derived from the use of such products 
6.6 Posebne mjere opreza za odlaganje neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
The vaccine should preferably be dissolved in distilled water or alternatively in cool, clean water. 
Cjepivo je bolje otopiti u destiliranoj vodi ili u hladnoj, čistoj vodi.
The volume of water for reconstitution should be sufficient to ensure an even distribution when sprayed onto the chickens. 
Količina vode za rekonstituciju cjepiva treba biti dovoljna da se pri raspršivanju osigura ravnomjerna raspodjela cjepiva.
Water should be withheld before vaccination to make the chickens thirsty. 
Prije cijepljenja pilićima uskratimo vodu kako bi bili žedni.
Care should be taken to avoid spread of the vaccine virus from vaccinated chickens to pheasants. 
Treba izbjeći širenje vakcinalnog virusa s pilića na fazane.
Nobilis IB 4-91 given at day-old can adversely affect the efficacy of turkey rhinotracheitis (TRT) vaccine given within 7 days. 
Primjena Nobilis IB 4-91 u jednodnevnih pilića može negativno utjecati na djelotvornost cjepiva protiv rinotraheitisa purana (TRT) primijenjenog unutar 7 dana.
The vaccine can be administered to 7-day and older chickens by drinking water. 
Pilićima u dobi od 7 dana i starijim pilićima cjepivo dajemo u vodu za piće.
≥3.6 log10 EID50 IBV per dose 
>3,6 log10 EID50 virusa ZB/ doza
Packaging: 
Pakovanja:
Vials: off-white/cream-coloured pellet. 
Bočice: krem bijela obojana peleta.
EU/2/98/006/001 (1,000 doses, vial) EU/2/98/006/002 (2,500 doses, vial) EU/2/98/006/003 (5,000 doses, vial) EU/2/98/006/004 (10,000 doses, vial) EU/2/98/006/005 (10x 1,000 doses, vials) EU/2/98/006/006 (10x 2,500 doses, vials) EU/2/98/006/007 (10x 5,000 doses, vials) EU/2/98/006/008 (10x 10,000 doses, vials) EU/2/98/006/009 (1x 500 doses, vial) 
EU/2/98/006/002 ( 2500 doza, bočice) EU/2/98/006/003 ( 5000 doza, bočice) EU/2/98/006/004 ( 10000 doza, bočice) EU/2/98/006/005 ( 10x1000 doza, bočice) EU/2/98/006/006 (10 x 2500 doza, bočice)
Vials: off-white/cream-coloured pellet Cups: off-white, predominantly sphere shaped 
Bočice: krem bijela obojana peleta Čašice: krem bijeli, pretežito okrugli oblici
THE WORDS “FOR ANIMAL TREATMENT ONLY” 
RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA” Samo za primjenu na životinjama.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL - Lyophilisate CUPS 
OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA NALJEPNICA - Liofilizat ČAŠICE
Nobilis IB 4-91 is intended to protect chickens against respiratory signs of disease caused by IBV variant strain 4-91 only and should not be used as a replacement for other IBV vaccines. 
Vakcina Nobilis IB 4-91 je namijenjena za zaštitu pilića protiv respiratornih znakova bolesti uzrokovanih varijantnim sojem virusa ZBK 4-91 i ne smije se primjenjivati kao zamjena za druga cjepiva, za virus ZB.
DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED 
14. DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA
The vaccine virus may spread from vaccinated to non-vaccinated chickens and appropriate care should be taken to separate vaccinated from non-vaccinated. 
Cjepni virus može se širiti s cijepljenih pilića na necijepljene, pa treba poduzeti odgovarajuće mjere da cijepljeni pilići budu odvojeni od necijepljenih.
EU/2/98/006/010 (10x 500 doses, vials) EU/2/98/006/011 (10x 1,000 doses, cups) EU/2/98/006/012 (10x 5,000 doses, cups) EU/2/98/006/013 (10x 10,000 doses, cups EU/2/98/006/014 (10x 2,500 doses, cups) 
EU/2/98/006/007 ( 10x 5000 doza, bočice) EU/2/98/006/008 ( 10x 10000 doza, bočice) EU/2/98/006/009 ( 1x 500 doza, bočice) EU/2/98/006/010 ( 10 x 500 doza, bočice) EU/2/98/006/011 ( 10x 1000 doza, čašice)
A sufficient number of water containers to provide adequate drinking space is essential. 
Potreban je dovoljan broj posuda s vodom kako bi pilićima osigurali dovoljnu količinu vode za piće, što je vrlo bitno.
Cups: off-white, predominantly sphere shaped. 
Čašice: krem bijeli, pretežito okrugli oblici.
Safety and efficacy data are available which demonstrate that Nobilis IB 4-91 can be administered to day-old chicks that are vaccinated either by the subcutaneous or in ovo route with Innovax-ND-IBD. 
Dostupni su podaci o neškodljivosti i učinkovitosti koji pokazuju da se Nobilis IB 4-91 može primijeniti jednodnevnim pilićima koji su cijepljeni supkutanom ili in ovo primjenom s Innovax-ND-IBD.
By adding skimmed milk to the drinking water the vaccine virus retains its activity longer. 
Dodavanjem obranog mlijeka u vodu za piće poboljšamo aktivnost virusnog cjepiva.
QUANTITY OF ACTIVE SUBSTANCE 
KOLIČINA DJELATNE(IH) TVARI
Active immunisation of chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91. 
Aktivna imunizacija pilića za smanjenje respiratornih znakova zaraznog bronhitisa uzrokovanih varijantnim sojem IB 4-91.
Ten times the maximum dose was shown to be safe for the target species by all the recommended routes and methods of administration. 
Deseterostruka maksimalna doza, kod svih preporučenih načina i metoda primjene, je sigurna za životinje kojima je proizvod namijenjen.
The appropriate number of vials should be opened under the water or the content of the cup(s) should be poured into the water. 
Odgovarajući broj bočica treba otvoriti pod vodom ili sadržaj čašica uliti u vodu.
SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY 
12. POSEBNE MJERE OPREZA ZA ODLAGANJE NEUPOTREBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
Nobilis IB 4-91 has been shown to be safe in layers and breeders during lay. 
Pokazalo se da je primjena Nobilis IB 4-91 neškodljiva u nesilica i rasplodnih pilenki u vrijeme nesenja.
Active immunisation against avian infectious bronchitis virus variant strain IB 4-91 which causes infectious bronchitis in chickens. 
Aktivna imunizacija protiv virusa zaraznog bronhitisa kokoši, varijantni soj IB 4-91, koji uzrokuje zarazni bronhitis u kokoši.
Broiler: The vaccine can be administered to 1-day-old chicks and older chickens by coarse spray or by intranasal/ocular administration. 
Pilići: cjepivo možemo dati jednodnevnim pilićima i starijim pilićima, raspršivanjem ili intranazalnom/okularnom primjenom.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Nobilis IB Ma5 for spray or intranasal/ocular administration to commercial chicks from one day of age onwards. 
Podaci o neškodljivosti i efikasnosti su dostupni i pokazuju da cjepivo može biti kombinirano i primijenjeno s Nobilis IB Ma5 kao sprej ili intranazalna/okularna primjena, konzumnim pilićima od 1
Intranasal/ocular administration 
Intranazalna/okularna primjena:
Live attenuated avian infectious bronchitis virus (IBV), variant strain 4-91: ≥ 3.6 log10 EID50* * EID50: 50% embryo infective dose - the virus titre required to produce infection in 50% of the embryos inoculated. 
Živi, atenuirani virus zaraznog bronhitisa kokoši (ZBK), varijantni soj 4-91: ≥ 3,6 log 10 EID50 * * EID50: 50% embrio infektivna doza: titar virusa koji uzrokuje infekciju u 50% virusom inokuliranih embrija.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) 
NAVOĐENJE DJELATNE TVARI I DRUGIH SASTOJAKA
Drinking water 
U vodi za piće:
The vials should be opened under water or the content of the cup(s) should be poured into the water. 
Bočice treba otvoriti pod vodom ili sadržaj čašica uliti u vodu.
Lyophilisate for oculonasal suspension/use in drinking water 
Liofilizat za okulonazalnu suspenziju / primjenu u vodi za piće
Future layers and breeders: The vaccine can be administered to future layers and breeders from day old onwards via intranasal/ocular route or coarse spray. 
Buduće nesilice i rasplodni pilići: Cjepivo možemo dati budućim nesilicama i rasplodnim pilićima u dobi od jednog dana i više, intranazalnim/okularnim putem ili raspršivanjem (veće kapljice).
In-use shelf life after mixing: 2 hours. 
Nakon miješanja rok valjanosti: 2 sata
Name and address of the manufacturer of the biological active substance Intervet International B.V. 
Naziv i adresa proizvođača biološki djelatne) tvari
Lyophilisate for oculonasal suspension/use in drinking water. 
Liofilizat za okulonazalnu suspenziju / primjenu u vodi za piće,
THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN" 
14. RIJEČI “ČUVATI IZVAN DOSEGA
Live attenuated infectious bronchitis virus strain 4-91 ≥ 3.6 log10 EID50* per dose *EID50: 50% embryo infective dose 
Živi, oslabljeni virus zaraznog bronhitisa kokoši, soj 4-91: 3,6 log 10 EID50. * po dozi * EID50: 50% embrio infektivna doza
Cardboard box with 10 cups of 2,500 doses. 
Kutija s 10 čašica od 2500 doza.
Coarse spray, oculonasal or in drinking water use. 
Okulonazalna primjena, raspršivanje ili u vodi za piće.
Lyophilisate 
Liofilizat
Nobilis IB 4-91 lyophilisate for oculonasal suspension/use in drinking water 
Nobilis IB 4-91 liofilizat za okulonazalnu suspenziju / primjenu u vodi za piće
Nobilis IB 4-91 lyophilisate for oculonasal suspension/use in drinking water for chickens 
Nobilis IB 4-91, liofilizat za okulonazalnu suspenziju / primjenu u vodi za piće za piliće
Oculonasal use, spray or drinking water 
Okulonazalna primjena, raspršivanje ili u vodi za piće
Spray method 
SAŽETAK OPISA SVOJSTAVA
Cardboard box with 10 cups of 5,000 doses. 
Kutija s 10 čašica od 5000 doza.
Cardboard box with 1 or 10 vials of 2,500 doses. 
Kutija s 1 ili 10 bočica s 2500 doza.
Ensure that the nasal drop is inhaled before freeing the bird. 
Prije nego pilića pustimo, provjerimo da li je kapljica u nosu udahnuta.
Cardboard box with 10 cups of 1,000 doses. 
Kutija s 10 čašica od 1000 doza.
Cardboard box with 1 or 10 vials of 500 doses. 
Kutija s 1 ili 10 bočica s 500 doza.
PACKAGE LEAFLET: Nobilis IB4-91 lyophilisate for oculonasal suspension/use in drinking water for chickens 
UPUTA O VMP Nobilis IB 4-91, liofilizat za okulonazalnu suspenziju / primjenu u vodi za piće za piliće
Cardboard box with 10 cups of 10,000 doses. 
Kutija s 10 čašica od 10000 doza.
Cardboard box with 1 or 10 vials of 5,000 doses. 
Kutija s 1 ili 10 bočica s 5000 doza.
Cardboard box with 1 or 10 vials of 1,000 doses. 
Kutija s 1 ili 10 bočica s 1000 doza.
Guideline 
INDIKACIJE
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 
DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUTEVI PRIMJENE Raspršivanjem, okulonazalno ili putem vode za piće.
Cardboard box with 1 or 10 vials of 10,000 doses. 
Kutija s 1 ili 10 bočica s 10000 doza.
This is expected to help prevent further heart problems. 
Očekuje se da će to pomoći u sprečavanju daljnjih srčanih problema.
Patients also took other medicines 
Bolesnici su uzimali i
The company provided the results of one study involving over 10,000 patients who had had a heart attack. 
Tvrtka je dostavila rezultate jednog ispitivanja u kojem je obrađeno više od 10 000 bolesnika koji su imali srčani udar.
14 December 2018 EMA/865778/2018 EMEA/H/C/004754 
EMA/865778/2018 EMEA/H/C/004754
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you. 
Ako sudjelujete u kliničkom ispitivanju te vam je potrebno više informacija o liječenju, obratite se nadležnom liječniku.
Patients were given canakinumab Novartis at different doses (50, 150 or 300 mg) or placebo (a dummy treatment) once every three months for up to six years. 
Bolesnicima je dan kanakinumab Novartis u različitim dozama (50, 150 ili 300 mg) ili placebo (prividno liječenje) jednom svaka tri mjeseca u trajanju do šest godina.
The main measure of effectiveness was the decrease in the number of serious events such as heart attack, stroke or death. 
Glavna mjera djelotvornosti bilo je smanjenje broja ozbiljnih stanja kao što su srčani udar, moždani udar ili smrt.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it would not be possible for them to reply to the Agency's concerns within the agreed timeframe. 
U svojem dopisu kojim je obavijestila Agenciju o povlačenju zahtjeva, tvrtka je navela da ne može odgovoriti na zabrinutosti Agencije unutar dogovorenog vremenskog roka.
The beneficial effects seen were considered modest, particularly in patients who also took statins, and were not considered to outweigh the increased risks of serious infections in patients treated with the medicine. 
Zabilježene koristi smatrane su skromnima, osobito u bolesnika koji su također uzimali statine te se nije smatralo da nadmašuju povećani rizik od ozbiljnih infekcija u bolesnika liječenih tim lijekom.
IL-1 beta is part of the immune system (the body's natural defences) and is involved in the inflammatory processes associated with heart and blood vessels problems. 
IL-1 beta dio je imunološkog sustava (prirodne obrane tijela) i povezan je s upalnim procesima izazvanim problemima sa srcem i krvnim žilama.
It was to be available as a solution for injection under the skin in pre-filled pens and pre-filled syringes. 
Trebao je biti dostupan kao otopina za supkutanu injekciju u napunjenim brizgalicama i štrcaljkama.
By attaching to IL-1 beta, canakinumab blocks its activity and reduces inflammation. 
Vezivanjem na IL-1 betu, kanakinumab blokira njegovu aktivnost i smanjuje upalu.
The CHMP also questioned the appropriateness of the measure chosen by the company to select patients and to monitor the effectiveness of canakinumab Novartis. 
CHMP je također doveo u pitanje primjerenost mjere koju je tvrtka odabrala za selekciju bolesnika i praćenje djelotvornosti kanakinumaba Novartis.
After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues. 
Nakon što je CHMP ocijenio odgovore tvrtke na posljednji niz pitanja, još su uvijek postojale neke nedoumice.
The active substance in canakinumab Novartis, canakinumab, is a monoclonal antibody (a type of protein) which has been designed to recognise and attach to interleukin 1 (IL-1) beta. 
Aktivna tvar u kanakinumabu Novartis, kanakinumab, monoklonsko je protutijelo (vrsta bjelančevine) namijenjeno prepoznavanju i vezivanju na interleukin 1 (IL-1) betu.
The company informed the CHMP that, while an extension to the above-mentioned study will stop, other studies investigating canakinumab for the treatment of other conditions will continue as planned. 
Tvrtka je izvijestila CHMP da će se, iako će se produljenje gore navedenog ispitivanja zaustaviti, ostala ispitivanja kanakinumaba za liječenje drugih stanja nastaviti prema planu.
How far into the evaluation was the application when it was withdrawn? 
U kojoj je fazi bila procjena zahtjeva kad je povučen?
Canakinumab Novartis was expected to be used to prevent serious events such as stroke, heart attack or death in patients who have already had a heart attack. 
Očekivalo se da će se kanakinumab Novartis primjenjivati za sprječavanje ozbiljnih stanja kao što su moždani udar, srčani udar ili smrt u bolesnika koji su već imali srčani udar.
In particular, the CHMP was of the opinion that the data provided by the company was not robust enough to clearly demonstrate that canakinumab Novartis is effective in all patients who have had a heart attack. 
CHMP je osobito smatrao da podatci koje je tvrtka dostavila nisu dovoljno čvrsti kao jasni pokazatelji djelotvornosti kanakinumaba Novartis kod svih bolesnika koji su imali srčani udar.