FrancophonIA/ELRC3.0 huggingface dataset:
English: 10 x 1,000 doses 10 x 2,500 doses 10 x 5,000 doses 10 x 10,000 doses
Croatian: 10 x 1000 doza 10 x 2500 doza 10 x 5000 doza 10 x 10000 doza
English: Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V.
Croatian: Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet: Intervet International B.V.
English: Reconstitute the lyophilisate immediately and entirely after opening of the cup.
Croatian: Rekonstituirajte liofilizat odmah i u cijelosti nakon otvaranja čašice.
English: 3) Mix thoroughly with a clean stirrer, ensuring that all vaccine is dissolved.
Croatian: 3) Temeljito promiješajte čistom miješalicom, provjeravajući je li se sve cjepivo otopilo.
English: The safety parameters of the mixed vaccines are not different from those described for the vaccines administered separately.
Croatian: Parametri neškodljivosti mješovitih cjepiva nisu drugačiji od onih opisanih za cjepiva koja se primjenjuju zasebno.
English: Apply coarse spray ≥250 microns.
Croatian: Primijenite grubo raspršivanje ≥250 mikrona.
English: Precautionary measures should be taken to prevent spreading to wildlife.
Croatian: Moraju se poduzeti mjere predostrožnosti zbog sprječavanja širenja virusa na divlje životinje.
English: Pharmacotherapeutic group: Immunologicals for aves, domestic fowl, live viral vaccine.
Croatian: Farmakoterapijska grupa: Imunološki pripravci za ptice, domaću perad, živo virusno cjepivo.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA ” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo
English: Chickens should be vaccinated against other prevalent IBV serotypes (e.g. Massachusetts) according to the local IB vaccination programme.
Croatian: Piliće treba cijepiti protiv ostalih prevalentnih serotipova IBV (npr. Massachusetts) u skladu s lokalnim programom cijepljenja protiv IB.
English: Cups may contain 3 spheres to up to 400 spheres depending on the required dosages and production yields.
Croatian: Čašice mogu sadržavati od 3 kuglice pa sve do 400 kuglica ovisno o potrebnim dozama i prinosu u proizvodnji.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Croatian: Ne koristiti ovaj veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatna tvar koja se sastoji od tvari biološkog podrijetla i namijenjena je za poticanje aktivne imunosti, na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
English: Shelf life after reconstitution according to directions: 2 hours.
Croatian: Rok valjanosti nakon rekonstitucije prema uputama: 2 sata.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Nobilis IB Ma5 for spray or oculonasal application.
Croatian: Dostupni su podaci o neškodljivosti i djelotvornosti koji pokazuju da se ovo cjepivo može miješati i primjenjivati s cjepivom Nobilis IB Ma5 s raspršivačem ili okulonazalno.
English: 2) Shake the vaccine suspension.
Croatian: 2) Protresite suspenziju cjepiva.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Croatian: Nisu dostupne informacije o neškodljivosti i djelotvornosti ovog cjepiva kada se koristi sa svim drugim veterinarsko-medicinskim proizvodima osim gore spomenutog proizvoda.
English: Merck Sharp & Dohme Animal Health, S.L.
Croatian: Merck Sharp & Dohme Animal HealthC/Zeppelin, 6 Pol.Ind.
English: 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).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e) ) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: Name and address of the manufacturers of the biological active substance
Croatian: Naziv i adresa proizvođača biološke djelatne tvari:
English: 1) The contents of a cup (1,000 doses only) can be added to Solvent Oculo/Nasal using the included adapter and administered after connecting the included dropper.
Croatian: 1) Sadržaj čašice (samo 1000 doza) može se dodati okulo/nazalnom otapalu pomoću adaptera uključenog u pakovanje i primijeniti nakon spajanja kapaljke uključene u pakovanje.
English: Shelf life of the lyophilisate as packaged for sale: 24 months.
Croatian: Rok valjanosti liofilizata kad je zapakiran za prodaju: 24 mjeseci.
English: Store in a refrigerator (2 C - 8 C).
Croatian: Čuvati u hladnjaku (2C - 8C).
English: In case of coarse spray, personal protective equipment consisting of masks with eye protection should be worn when handling the veterinary medicinal product.
Croatian: Kod primjene krupno kapljičastog raspršivača, mora se pri rukovanju veterinarsko medicinskim proizvodom nositi oprema za osobnu zaštitu koja se sastoji od maske sa zaštitom za oči.
English: Lyophilisate: Store in a refrigerator (2 C - 8 C).
Croatian: Liofilizat: Čuvati u hladnjaku (2 C - 8 C).
English: Do not mix with any other veterinary medicinal product, except Nobilis IB Ma5 or Solvent Oculo/Nasal recommended for use with the veterinary medicinal product.
Croatian: Ne miješati s drugim veterinarsko medicinskim proizvodima, osim s Nobilis IB Ma5 ili okulo/nazalnim otapalom preporučenim za upotrebu s veterinarsko-medicinskim proizvodom.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Croatian: Odluku o primjeni ovog cjepiva prije ili nakon bilo kojeg drugog veterinarsko medicinskog-proizvoda treba donositi od slučaja do slučaja.
English: Store below 25 °C.
Croatian: Čuvati ispod 25°C.
English: Shelf life of the solvent as packaged for sale: 4 years.
Croatian: Rok valjanosti otapala kad je zapakiran za prodaju: 4 godine.
English: For active immunisation of chickens in order to reduce respiratory signs of avian infectious bronchitis caused by QX-like variants of infectious bronchitis virus (IBV).
Croatian: Za aktivnu imunizaciju pilića s ciljem smanjivanja respiratornih znakova zaraznog bronhitisa kokoši uzrokovanog varijantama sličnim QX virusu zaraznog bronhitisa (IBV).
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Croatian: Wim de Körverstraat 35 NL 5831 AN Boxmeer Nizozemska
English: Nobilis IB Primo QX is intended to protect chickens against clinical signs of disease caused by IBV variant strain D388 only and should not be used as a replacement for other IBV vaccines.
Croatian: Nobilis IB Primo QX je namijenjen za zaštitu pilića od kliničkih zakova bolesti uzrokovane samo IBV varijantnim sojem D388 i ne smije se koristiti kao zamjena za druga IBV cjepiva.
English: To stimulate active immunity against the D388/QX type of avian infectious bronchitis virus.
Croatian: Za stimulaciju aktivne imunosti protiv D388/QX tipa virusa zaraznog bronhitisa kokoši.
English: 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.
Croatian: Zapečaćena aluminijska laminirana čašica sa kontaktnim slojem od polipropilen (čašica) i polipropilen/polietilen (poklopac) koja sadrži 1000, 2500, 5000 ili 10000 doza.
English: Measure the correct volume of water for the number of birds to be vaccinated
Croatian: Izmjerite ispravan volumen vode za broj ptica koje će biti cijepljene (ovisno o uređaju koji se upotrebljava).
English: A mild transient respiratory reaction (including nasal exudates) may very rarely occur for at least 10 days after vaccination.
Croatian: Vrlo rijetko se može pojaviti blaga, prolazna respiratorna reakcija (uključujući nazalne eksudate) tijekom najmanje 10 dana nakon cijepljenja.
English: LABEL - Lyophilisate CUPS
Croatian: NALJEPNICA - ČAŠICE liofilizata
English: Solvent: Store below 25 C.
Croatian: Otapalo: Čuvati ispod 25 C.
English: EU/2/14/174/002 (10 x 1,000 doses + 10 x 35 ml solvent) EU/2/14/174/003 (10 x 5,000 doses)
Croatian: EU/2/14/174/001 (10 x 1000 doza) EU/2/14/174/002 (10 x 1000 doza + 10 x 35 ml otapala) EU/2/14/174/003 (10 x 5000 doza) EU/2/14/174/004 (10 x 10000 doza) EU/2/14/174/005 (10 x 2500 doza)
English: Administer 1 dose of reconstituted vaccine by coarse spray or by oculonasal route to chickens from 1 day of age or older.
Croatian: Primijenite 1 dozu rekonstituiranog cjepiva pomoću raspršivača ili okulonazalnim putem pilićima u dobi od 1 dana ili starijima.
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Croatian: b) je bolest za koju je odnosni veterinarsko-medicinski proizvod namijenjen da pruži imunost, odsutna s tog područja.
English: The safety and efficacy of the veterinary medicinal product has not been established during lay.
Croatian: Neškodljivost i djelotvornost veterinarsko medicinskog proizvoda nisu utvrđene tijekom nesenja.
English: Vaccinated chickens may excrete the vaccine strain up to 20 days following vaccination.
Croatian: Cijepljeni pilići mogu izlučivati cjepni soj do 20 dana nakon cijepljenja.
English: 2) Add the contents of the correct number of cups while stirring.
Croatian: 2) Uz miješanje dodajte sadržaj točno određenog broja čašica.
English: Hydrolysed gelatine Pancreatic digest of casein Disodium phosphate dihydrate
Croatian: Hidrolizirana želatina Pankreasni digest kazeina Dinatrijev fosfat dihidrat
English: 1,000 doses (3-100 spheres) 2,500 doses (3-100 spheres) 5,000 doses (3-100 spheres) 10,000 doses (3-400 spheres)
Croatian: 1000 doza (3 - 100 kuglica) 2500 doza (3 - 100 kuglica) 5000 doza (3 - 100 kuglica) 10000 doza (3 - 400 kuglica)
English: For the mixed products the onset of immunity is 3 weeks and the duration of immunity is 8 weeks for the claimed protection against Massachusetts and QX-like strains of IBV.
Croatian: Kod izmiješanih pripravaka imunost nastupa nakon 3 tjedna, a trajanje imunosti je 8 tjedana za sojeve Massachussets i sojeve IBV-a slične QX.
English: The vaccine virus is capable of spreading to in contact birds for a minimum of 20 days after vaccination and appropriate care should be taken to separate vaccinated from non-vaccinated chickens.
Croatian: Cjepni virus može se širiti kontaktom ptica tijekom minimalno 20 dana nakon cijepljenja te treba paziti da se cijepljeni pilići odvoje od necijepljenih.
English: The premises must be cleaned and disinfected after each production round.
Croatian: Nakon svakog proizvodnog ciklusa, prostorije se moraju očistiti i dezinficirati.
English: The IB D388 vaccine should only be applied in hatcheries to chickens from 1 day of age or older if adequate controls are in place to avoid the spread of the vaccine virus to birds that will be transported to non-IB QX exposed flocks.
Croatian: IB D388 vakcina treba se primjenjivati u valionicama kod pilića starih 1 dan ili starijih ako se primjenjuje odgovarajuća kontrola kako bi se izbjeglo širenje vakcinalnog virusa na ptice koje će se premjestiti u jata koja nisu izložena QX soju virusa zaraznog bronhitisa.
English: Lyophilisate: Off white, predominantly sphere shaped.
Croatian: Liofilizat: krem boje, pretežno okruglog oblika.
English: Solvent (Solvent Oculo/Nasal):
Croatian: Otapalo (okulo/nazalno otapalo):
English: 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Croatian: 6.6 Posebne mjere opreza prilikom odlaganja neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: CARDBOARD BOX with 10 cups of lyophilisate
Croatian: KARTONSKA KUTIJA s 10 čašica liofilizata
English: Packaging:
Croatian: Pakovanje:
English: After reconstitution, administer 1 dose of vaccine by coarse spray or by the oculonasal route of administration to chickens from 1 day of age or older.
Croatian: Nakon rekonstitucije, primijenite 1 dozu cjepiva pomoću raspršivača ili okulonazalnim putem pilićima u dobi od 1 dana ili starijima.
English: Chickens.
Croatian: Pilići.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Croatian: Posebne mjere predostrožnosti koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama
English: The vaccine has been demonstrated to provide protection against QX-like variant.
Croatian: Pokazalo se da vakcina osigurava zaštitu od varijantnog soja virusa sličnog QX soju.
English: Low density polyethylene (LDPE) vial of 35 ml with a halogenobutyl rubber stopper and aluminium cap.
Croatian: Bočica od polietilena niske gustoće (LDPE) od 35 ml s čepom od halogenobutilne gume i aluminijskim poklopcem.
English: It is important to avoid introduction of the IB D388 vaccine virus into premises in which the wild type strain is not present.
Croatian: Važno je izbjeći uvođenje D388 vakcinalnog virusa zaraznog bronhitisa u prostore u kojima divlji soj virusa nije prisutan.
English: Read the package leaflet of Nobilis IB Ma5 before use.
Croatian: Prije upotrebe pročitajte upute o Nobilis IB Ma5.
English: Solvent (Solvent Oculo/Nasal): blue-coloured solution.
Croatian: Otapalo (okulo/nazalno otapalo): plava otopina.
English: Oculonasal use.
Croatian: Okulonazalna primjena.
English: Do not use in birds in lay or within 4 weeks before the start of the laying period.
Croatian: Ne upotrebljavati u nesilica ili unutar 4 tjedna prije početka razdoblja nesenja.
English: Lyophilisate for oculonasal suspension
Croatian: Liofilizat za okulonazalnu suspenziju
English: The protection against other circulating IB strains has not been investigated.
Croatian: Zaštita protiv drugih sojeva virusa zaraznog bronhitisa nije istražena.
English: Read the vaccine package before use.
Croatian: Pročitajte uputu o cjepivu prije primjene.
English: STORAGE CONDITIONS
Croatian: UVJETI ČUVANJA
English: Administration routes:
Croatian: Putevi primjene:
English: SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Croatian: 12. POSEBNE MJERE OPREZA PRI ODLAGANJU NEUPOTREBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: Withdrawal period: zero days.
Croatian: Karencija: nula dana.
English: Live attenuated avian infectious bronchitis virus, strain D388: 10
Croatian: Živi atenuirani virus zaraznog bronhitisa kokoši; soj D388: 10
English: Lyophilisate and solvent for oculonasal suspension Lyophilisate for oculonasal suspension.
Croatian: Liofilizat i otapalo za suspenziju za okulonazalnu suspenziju Liofilizat za okulonazalnu suspenziju
English: This vaccine should only be used after it has been established that the QX-like IBV variant strain is epidemiologically relevant.
Croatian: Ovo cjepivo treba se upotrebljavati samo nakon utvrđivanja epidemiološke važnosti varijantnog soja virusa sličnog QX soju virusa zaraznog bronhitisa.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Croatian: Za odlaganje nepotrebnog materijala pitajte svog veterinara.
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet:
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
English: Spray or oculonasal administration.
Croatian: Primjena raspršivačem ili okulonazalno.
English: Chickens
Croatian: Pilići
English: Solvent Oculo/Nasal
Croatian: Okulo/nazalno otapalo
English: Each dose of reconstituted vaccine contains: Live attenuated avian infectious bronchitis virus, strain D388: 104.0 - 105.5 EID50
Croatian: Svaka doza rekonstituiranog cjepiva sadrži: Živi atenuirani virus zaraznog bronhitisa kokoši; soj D388: 10
English: Cardboard box with 10 cups of lyophilisate (1,000 doses per 42 mm diameter cup (3-100 spheres)) + cardboard box with 10 x 35 ml vial of solvent supplemented with dropper and adapter.
Croatian: Kartonska kutija s 10 čašica liofilizata (1000 doza po čašici promjera 42 mm (3-100 kuglica)) + kartonska kutija s 10 x 35 ml bočica otapala opremljenih kapaljkom i adapterom.
English: Nobilis IB Primo QX lyophilisate for oculonasal suspension for chickens
Croatian: Nobilis IB Primo QX, liofilizat za okulonazalnu suspenziju za piliće
English: Solvent for oculonasal suspension.
Croatian: Otapalo za okulonazalnu suspenziju
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Croatian: PODACI NA VANJSKOM PAKOVANJU
English: 50% egg infective dose For the full list of excipients, see section 6.1.
Croatian: Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: Solvent Oculo/Nasal should be used for oculonasal application.
Croatian: Za okulonazalnu primjenu mora se koristiti okulo/nazalno otapalo.
English: 4.5 Special precautions for use
Croatian: 4.5 Posebne mjere predostrožnosti za primjenu Posebne mjere predostrožnosti za primjenu na životinjama
English: PACKAGE LEAFLET: Nobilis IB Primo QX lyophilisate and solvent for oculonasal suspension for chickens Nobilis IB Primo QX lyophilisate for oculonasal suspension for chickens
Croatian: UPUTA O VMP: Nobilis IB Primo QX, liofilizat i otapalo za okulonazalnu suspenziju, za piliće Nobilis IB Primo QX liofilizat za okulonazalnu suspenziju za piliće
English: Very mild inflammatory changes have occasionally been found in the kidneys of specific pathogen free (SPF) chickens after administration of a 10 fold overdose.
Croatian: Nakon primjene 10 puta veće doze, u bubrezima SPF pilića povremeno su prisutne vrlo blage upalne promjene.
English: Nobilis IB Primo QX lyophilisate and solvent for oculonasal suspension for chickens Nobilis IB Primo QX lyophilisate for oculonasal suspension for chickens
Croatian: Nobilis IB Primo QX, liofilizat i otapalo za okulonazalnu suspenziju, za piliće Nobilis IB Primo QX, liofilizat za okulonazalnu suspenziju, za piliće
English: Lay:
Croatian: Nesenje:
English: Cardboard box with 10 cups of lyophilisate (10,000 doses per 61 mm diameter cup (3-400 spheres)).
Croatian: Kartonska kutija s 10 čašica liofilizata (10000 doza po čašici promjera 61 mm (3- 400 kuglica)).
English: Solvent Oculo/Nasal for chickens
Croatian: Okulo/nazalno otapalo za piliće
English: Cardboard box with 10 cups of lyophilisate (1,000 doses per 42 mm diameter cup (3-100 spheres)).
Croatian: Kartonska kutija s 10 čašica liofilizata (1000 doza po čašici promjera 42mm (3-100 kuglice)).
English: Oculonasal use:
Croatian: Okulonazalna primjena:
English: Cardboard box with 10 cups of lyophilisate (5,000 doses per 42 mm diameter cup (3-100 spheres)).
Croatian: Kartonska kutija s 10 čašica liofilizata (5000 doza po čašici promjera 42mm (3-100 kuglice)).
English: See package leaflet.
Croatian: NAZIV OTAPALA
English: Cardboard box with 10 cups of lyophilisate (2,500 doses per 42 mm diameter cup (3-100 spheres)).
Croatian: Kartonska kutija s 10 čašica liofilizata (2500 doza po čašici promjera 42mm (3-100 kuglica)).
English: Cardboard box with 10 cups of lyophilisate (2,500 doses per 42 mm diameter cup (3-100 spheres))
Croatian: Kartonska kutija s 10 čašica liofilizata (2500 doza po čašici promjera 42mm (3-100 kuglice)).
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Nakon primjene 10 puta veće doze, u bubrezima SPF pilića povremeno su prisutne vrlo blage upalne promjene.
English: It can be found here (in English only).
Croatian: Dokument je dostupan ovdje (samo na engleskom jeziku).
English: Current text to be deleted is struck through.
Croatian: Trenutni tekst kojeg treba obrisati je precrtan.
English: Uncommon Rare Not known
Croatian: Rijetko Nepoznato
English: When used concomitantly, a dose reduction of propofol may be considered.
Croatian: Kod istodobne primjene može se razmotriti smanjenje doze propofola.
English: Common side effects (may affect up to 1 in 10 people) - Collection of fluid around the heart (pericardial effusion)
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba) - Nakupljanje tekućine oko srca (perikardijalni izljev)
English: Summary of product characteristics 4.8.
Croatian: Sažetak opisa svojstava lijeka 4.8.
English: The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals' which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals.
Croatian: Tekst informacija o lijeku u ovom dokumentu preuzet je iz dokumenta naziva "Preporuke PRAC-a vezane uz signale" koji sadrži cijeli tekst preporuka PRAC-a kojim se ažuriraju informacije o lijeku kao i opću smjernicu o upravljanju signalima.
English: Adopted at the 9-12 January 2017 PRAC
Croatian: Usvojeno na sjednici PRAC-a 9. - 12. siječnja 2017.
English: Propofol; valproate - Pharmacokinetic drug interaction leading to an increased propofol exposure (EPITT no 18696)
Croatian: Propofol; valproat - farmakokinetička interakcija lijekova koja rezultira povećanim izlaganjem propofolu (EPITT br.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/5725/2017
Croatian: Novi tekst informacija o lijeku - izvadci iz preporuka PRAC-a vezanih uz signale EMA/PRAC/38540/2017
English: New product information wording - Extracts from PRAC recommendations on signals
Croatian: Novi tekst informacija o lijeku - izvadci iz preporuka PRAC-a vezanih uz signale
English: Class
Croatian: Nuspojave
English: New text to be added to the product information is underlined.
Croatian: Novi tekst koji se dodaje informacijama o lijeku je podcrtan.
English: Interaction with other medicinal products and other forms of interaction A need for lower propofol doses has been observed in patients taking valproate.
Croatian: Zapažena je potreba za nižim dozama propofola u bolesnika koji uzimaju valproat.
English: Undesirable effects Tabulated list of adverse reactions System Organ
Croatian: Tablični popis nuspojava Klasifikacija organskih sustava
English: Pericardial effusion
Croatian: Perikardijalni izljev
English: Azacitidine - Pericarditis and pericardial effusion (EPITT no 18733)
Croatian: Azacitidin - perikarditis i perikardijalni izljev (EPITT br.
English: Summary of product characteristics (propofol) 4.5.
Croatian: Sažetak opisa svojstava lijeka (propofol)
English: The apparent volume of distribution is approximately 155 litres.
Croatian: Prividni volumen distribucije iznosi približno 155 litara.
English: Both of these cases were fatal.
Croatian: Oba slučaja imala su smrtni ishod.
English: Date of first authorisation: 18 February 2019
Croatian: Datum prvog odobrenja: 18. veljače 2019.
English: It may be taken at any time of the day but it is recommended to be taken at the same time every day.
Croatian: Može se uzeti u bilo koje doba dana, ali preporučuje ga se uzimati svakog dana u isto vrijeme.
English: Treatment Difference [95% Cl]
Croatian: Terapijska razlika [95% Cl]
English: • inability to sleep
Croatian: • nemogućnost spavanja
English: Healthy volunteers
Croatian: Zdravi dobrovoljci