FrancophonIA/ELRC3.0 huggingface dataset:
English: Red, round, biconvex tablet, engraved with E277 on one side and ‘4' on other side
Croatian: Crvena, okrugla, bikonveksna tableta, s utisnutim E277 na jednoj strani i ‘4' na drugoj.
English: In a population pharmacokinetic analysis of patients with partial-onset seizures receiving perampanel up to 12 mg/day and patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in placebo-controlled clinical trials, a linear relationship was found between dose and perampanel plasma concentrations.
Croatian: U populacijskoj farmakokinetičkoj analizi bolesnika s parcijalnim napadajima koji su primali perampanel u dozi do 12 mg na dan i bolesnika s primarno generaliziranim toničko-kloničkim napadajima koji su primali perampanel u dozi do 8 mg na dan u placebom kontroliranim kliničkim ispitivanjima, pronašao se linearni odnos između doze i koncentracije perampanela u plazmi.
English: Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be increased by increments of 2 mg/day to 12 mg/day.
Croatian: Ovisno o kliničkom odgovoru pojedinog bolesnika i podnošljivosti doze od 8 mg na dan, doza se može povećavati za 2 mg na dan do 12 mg na dan.
English: Tell your doctor if you are taking or have recently taken these medicines as your dose may need to be adjusted.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzimali ove lijekove jer će Vam možda trebati prilagoditi dozu.
English: Clonazepam No influence
Croatian: <10% sniženje klonazepam nema utjecaja nema utjecaja lamotrigin nema utjecaja
English: Depending upon individual clinical response and tolerability at a dose of 8 mg/day (16 ml/day), the dose may be increased up to 12 mg/day (24 ml/day), which may be effective in some patients (see section 4.4).
Croatian: Ovisno o kliničkom odgovoru pojedinog bolesnika i podnošljivosti doze od 8 mg na dan (16 ml na dan), doza se može povisiti do 12 mg na dan (24 ml na dan), što može biti učinkovito u nekih bolesnika (vidjeti dio 4.4).
English: Drug metabolising enzyme induction
Croatian: Indukcija enzima koji metaboliziraju lijekove
English: Each ml contains 0.5 mg perampanel.
Croatian: Jedan ml sadrži 0,5 mg perampanela.
English: Each ml of oral suspension contains 0.5 mg perampanel
Croatian: Jedan ml oralne suspenzije sadrži 0,5 mg perampanela.
English: Lactose monohydrate Low-substituted hydroxypropyl cellulose Povidone K-29/32
Croatian: Jezgra laktoza hidrat nisko supstituirana hidroksipropilceluloza povidon K-29/32 magnezijev stearat (E470b)
English: In a population pharmacokinetic analysis of patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in a placebo-controlled clinical study, perampanel clearance was not influenced by baseline creatinine clearance.
Croatian: U populacijskoj farmakokinetičkoj analizi bolesnika s primarno generaliziranim toničko-kloničkim napadajima koji su primali perampanel u dozi do 8 mg na dan u placebom kontroliranom kliničkom ispitivanju, početni klirens kreatinina nije utjecao na klirens perampanela.
English: hypericum (St. John's Wort) (a medicine used to treat mild anxiety) and ketoconazole (a medicine used to treat fungal infections) may affect Fycompa.
Croatian: - Neki drugi lijekovi, kao što je rifampicin (lijek koji se primjenjuje za liječenje bakterijskih infekcija), gospina trava (kantarion) (lijek za liječenje blage tjeskobe) i ketokonazol (lijek za liječenje gljivičnih infekcija) mogu utjecati na Fycompu.
English: - It is also used to treat certain fits that affect all of your brain from the start (called “generalised seizures”) and cause convulsions or staring spells.
Croatian: - Također se primjenjuje za liječenje određenih napadaja koji zahvaćaju cijeli mozak od početka
English: Depending upon individual clinical response and tolerability at a dose of 8 mg/day (16 ml/day), the dose may be increased by increments of 2 mg/day (4 ml/day) to 12 mg/day (24 ml/day).
Croatian: Ovisno o kliničkom odgovoru pojedinog bolesnika i podnošljivosti doze od 8 mg na dan (16 ml na dan), doza se može povećavati za 2 mg na dan (4 ml na dan) do 12 mg na dan (24 ml na dan).
English: Excipient with known effect: Each 2 mg tablet contains 78.5 mg of lactose (as monohydrate).
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta od 2 mg sadrži 78,5 mg laktoze (u obliku hidrata).
English: Orange, round, biconvex tablet, engraved with E275 on one side and ‘2' on other side
Croatian: Narančasta, okrugla, bikonveksna tableta, s utisnutim E275 na jednoj strani i ‘2' na drugoj.
English: Fycompa 2 mg, 4 mg film-coated tablets
Croatian: Fycompa 2 mg, 4 mg filmom obložene tablete
English: Green, round, biconvex tablet, engraved with E296 on one side and ‘10' on other side
Croatian: Zelena, okrugla, bikonveksna tableta, s utisnutim E296 na jednoj strani i ‘10' na drugoj.
English: Each tablet contains 8 mg perampanel.
Croatian: Jedna tableta sadrži 8 mg perampanela.
English: Blue, round, biconvex tablet, engraved with E297 on one side and ‘12' on other side
Croatian: Plava, okrugla, bikonveksna tableta, s utisnutim E297 na jednoj strani i ‘12' na drugoj.
English: Aggressive and hostile behaviour has been reported in patients receiving perampanel therapy.
Croatian: U bolesnika koji su primali terapiju perampanelom zabilježeni su slučajevi agresivnog i neprijateljskog ponašanja.
English: Fycompa 8 mg tablets Perampanel
Croatian: Fycompa 8 mg tablete perampanel
English: Excipient with known effect: Each 8 mg tablet contains 149.0 mg of lactose (as monohydrate).
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta od 8 mg sadrži 149,0 mg laktoze (u obliku hidrata).
English: Each film-coated tablet contains 8 mg perampanel.
Croatian: Jedna filmom obložena tableta sadrži 8 mg perampanela.
English: Each millilitre contains 0.5 mg of perampanel.
Croatian: Jedan mililitar sadrži 0,5 mg perampanela.
English: Pink, round, biconvex tablet, engraved with E294 on one side and ‘6' on other side
Croatian: Ružičasta, okrugla, bikonveksna tableta, s utisnutim E294 na jednoj strani i ‘6' na drugoj.
English: Gait disturbance Fatigue
Croatian: Opći poremećaji smetnje hoda umor
English: Excipient with known effect: Each 6 mg tablet contains 151.0 mg of lactose (as monohydrate).
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta od 6 mg sadrži 151,0 mg laktoze (u obliku hidrata).
English: Purple, round, biconvex tablet, engraved with E295 on one side and ‘8' on other side
Croatian: Ljubičasta, okrugla, bikonveksna tableta, s utisnutim E295 na jednoj strani i ‘8' na drugoj.
English: Push plunger of oral syringe completely down.
Croatian: Potisnite klip štrcaljke za usta do kraja prema dolje.
English: Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with perampanel treatment (see section 4.4).
Croatian: Prijavljene su teške kožne nuspojave (SCAR) povezane s liječenjem perampanelom, uključujući reakciju na lijek s eozinofilijom i sustavnim simptomima (DRESS) (vidjeti dio 4.4).
English: Patients should be up-titrated using 2 mg (4 ml) doses no faster than every 2 weeks based on tolerability and effectiveness.
Croatian: Bolesnike treba titrirati na temelju podnošljivosti i učinkovitosti povećavanjem doze za 2 mg (4 ml) u intervalima od najmanje 2 tjedna.
English: Excipient with known effect: Each 10 mg tablet contains 147.0 mg of lactose (as monohydrate).
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta od 10 mg sadrži 147,0 mg laktoze (u obliku hidrata).
English: Each tablet contains 12 mg perampanel.
Croatian: Jedna tableta sadrži 12 mg perampanela.
English: Each tablet contains 10 mg perampanel.
Croatian: Jedna tableta sadrži 10 mg perampanela.
English: The dose may be increased based on clinical response and tolerability by increments of 2 mg (4 ml) (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day (8 ml/day) to 8 mg/day (16 ml/day).
Croatian: Ovisno o kliničkom odgovoru i podnošljivosti, ta se doza može povećavati za 2 mg (4 ml) (bilo svaki tjedan, bilo svaka 2 tjedna, uzimajući u obzir poluvijek kako je opisano niže) do doze održavanja od 4 mg na dan (8 ml na dan) do 8 mg na dan (16 ml na dan).
English: Each tablet contains 4 mg perampanel.
Croatian: Jedna tableta sadrži 4 mg perampanela.
English: Fycompa 8 mg film-coated tablets 8 mg - packs of 7, 28, 84 and 98
Croatian: Fycompa 8 mg filmom obložene tablete 8 mg - pakiranje od 7, 28, 84 i 98 tableta
English: Each tablet contains 6 mg perampanel.
Croatian: Jedna tableta sadrži 6 mg perampanela.
English: Patients should be up-titrated using 2 mg doses no faster than every 2 weeks based on tolerability and effectiveness.
Croatian: Bolesnike treba titrirati na temelju podnošljivosti i učinkovitosti povećavanjem doze za 2 mg u intervalima od najmanje 2 tjedna.
English: Excipient with known effect: Each 12 mg tablet contains 145.0 mg of lactose (as monohydrate).
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta od 12 mg sadrži 145,0 mg laktoze (u obliku hidrata).
English: Each tablet contains 2 mg perampanel.
Croatian: Jedna tableta sadrži 2 mg perampanela.
English: Each film-coated tablet contains 10 mg perampanel.
Croatian: Jedna filmom obložena tableta sadrži 10 mg perampanela.
English: Excipient with known effect: Each 4 mg tablet contains 157.0 mg of lactose (as monohydrate).
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta od 4 mg sadrži 157,0 mg laktoze (u obliku hidrata).
English: Lamotrigine
Croatian: Levodopa
English: Fycompa 8 mg film-coated tablets
Croatian: Fycompa 8 mg filmom obložene tablete
English: Each film-coated tablet contains 12 mg perampanel.
Croatian: Jedna filmom obložena tableta sadrži 12 mg perampanela.
English: Fycompa 10 mg tablets Perampanel
Croatian: Fycompa 10 mg tablete perampanel
English: Post-marketing use
Croatian: Primjena nakon stavljanja lijeka u promet
English: Each film-coated tablet contains 4 mg perampanel.
Croatian: Jedna filmom obložena tableta sadrži 4 mg perampanela.
English: Fycompa 8 mg film-coated tablets Perampanel
Croatian: Fycompa 8 mg filmom obložene tablete perampanel
English: Each film-coated tablet contains 6 mg perampanel.
Croatian: Jedna filmom obložena tableta sadrži 6 mg perampanela.
English: Fycompa 12 mg tablets Perampanel
Croatian: Fycompa 12 mg tablete perampanel
English: Each film-coated tablet contains 2 mg perampanel.
Croatian: Jedna filmom obložena tableta sadrži 2 mg perampanela.
English: Titanium dioxide (E171) Ferric oxide, yellow (E172) Ferric oxide, red (E172)
Croatian: Film-ovojnica hipromeloza 2910 talk makrogol 8000 titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
English: Fycompa 2 mg tablets Perampanel
Croatian: Fycompa 2 mg tablete perampanel
English: Fycompa 4 mg tablets Perampanel
Croatian: Fycompa 4 mg tablete perampanel
English: Fycompa 6 mg tablets Perampanel
Croatian: Fycompa 6 mg tablete perampanel
English: How to store Fycompa
Croatian: Kako čuvati Fycompu
English: Fycompa 12 mg film-coated tablets 12 mg - packs of 7, 28, 84 and 98
Croatian: Fycompa 12 mg filmom obložene tablete 12 mg - pakiranje od 7, 28, 84 i 98 tableta
English: 7 Turn upright and remove the oral syringe.
Croatian: Bocu vratite u uspravni položaj i izvucite štrcaljku.
English: Fycompa 4 mg film-coated tablets 4 mg - packs of 7, 28, 84 and 98
Croatian: Fycompa 4 mg filmom obložene tablete 4 mg - pakiranje od 7, 28, 84 i 98 tableta
English: Fycompa contains lactose
Croatian: Fycompa sadrži laktozu
English: Fycompa 10 mg film-coated tablets 10 mg - packs of 7, 28, 84 and 98
Croatian: Fycompa 10 mg filmom obložene tablete 10 mg - pakiranje od 7, 28, 84 i 98 tableta
English: Fycompa 10 mg film-coated tablets Perampanel
Croatian: Fycompa 10 mg filmom obložene tablete perampanel
English: Fycompa 12 mg film-coated tablets Perampanel
Croatian: Fycompa 12 mg filmom obložene tablete perampanel
English: Fycompa 10 mg film-coated tablets
Croatian: Fycompa 10 mg filmom obložene tablete
English: Fycompa 12 mg film-coated tablets
Croatian: Fycompa 12 mg filmom obložene tablete
English: How to take Fycompa
Croatian: Kako uzimati Fycompu
English: Fycompa 2 mg film-coated tablets
Croatian: Fycompa 2 mg filmom obložene tablete
English: Fycompa 4 mg film-coated tablets
Croatian: Fycompa 4 mg filmom obložene tablete
English: Fycompa 6 mg film-coated tablets 6 mg - packs of 7, 28, 84 and 98
Croatian: Fycompa 6 mg filmom obložene tablete 6 mg - pakiranje od 7, 28, 84 i 98 tableta
English: The cap fits properly when the PIBA is in place.
Croatian: Zatvarač dobro zatvara bocu kada je nastavak umetnut.
English: Levetiracetam No influence
Croatian: <10% sniženje zonisamid nema utjecaja nema utjecaja
English: Fycompa 6 mg film-coated tablets
Croatian: Fycompa 6 mg filmom obložene tablete
English: Fycompa 6 mg film-coated tablets Perampanel
Croatian: Fycompa 6 mg filmom obložene tablete perampanel
English: 4 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets - packs of 7, 28, 84 and 98
Croatian: Fycompa je dostupna u pakiranjima od: tableta od 2 mg - pakiranja od 7, 28 i 98 tablete od 4 mg, 6 mg, 8 mg, 10 mg, 12 mg - pakiranja od 7, 28, 84 i 98
English: Fycompa 2 mg film-coated tablets Perampanel
Croatian: Fycompa 2 mg filmom obložene tablete perampanel
English: Fycompa 4 mg film-coated tablets Perampanel
Croatian: Fycompa 4 mg filmom obložene tablete perampanel
English: The dose may be increased based on clinical response and tolerability by increments of 2 mg (4 ml/day) (either weekly or every 2 weeks, as per half-life considerations described below) to a maintenance dose of up to 8 mg/day (16 ml/day).
Croatian: Ovisno o kliničkom odgovoru i podnošljivosti, ta se doza može povećavati za 2 mg (4 ml) (bilo svaki tjedan, bilo svaka 2 tjedna, uzimajući u obzir poluvijek kako je opisano niže) do doze održavanja od najviše 8 mg na dan (16 ml na dan).
English: The dose may be increased based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks, as per half-life considerations described below) to a maintenance dose of up to 8 mg/day.
Croatian: Ovisno o kliničkom odgovoru i podnošljivosti, ta se doza može povećavati za 2 mg (bilo svaki tjedan, bilo svaka 2 tjedna, uzimajući u obzir poluvijek kako je opisano niže) do doze održavanja od najviše 8 mg na dan.
English: The dose may be increased based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day to 8 mg/day.
Croatian: Ovisno o kliničkom odgovoru i podnošljivosti, ta se doza može povećavati za 2 mg (bilo svaki tjedan, bilo svaka 2 tjedna, uzimajući u obzir poluvijek kako je opisano niže) do doze održavanja od 4 mg na dan do 8 mg na dan.
English: Film coating Hypromellose 2910 Talc
Croatian: Film-ovojnica hipromeloza 2910 talk makrogol 8000 titanijev dioksid (E171)
English: How to use Fycompa
Croatian: Fycompom.
English: (called a “secondary generalisation”).
Croatian: (zovu se “generalizirani napadaji”) i uzrokuju konvulzije ili epizode zurenja.
English: Titanium dioxide (E171) Ferric oxide, red (E172)
Croatian: Film-ovojnica hipromeloza 2910 talk makrogol 8000 titanijev dioksid (E171) željezov oksid, crveni (E172)
English: 1000 doses
Croatian: 1000 doza
English: Date of first authorisation: 14/06/2011 Date of last renewal: 17/05/2016
Croatian: Datum prvog odobrenja: 14/06/2011 Datum posljednjeg produljenja odobrenja: 17/05/2016
English: One dose (30 µl) contains:
Croatian: Jedna doza (30 µl) sadrži:
English: See also section 4.7
Croatian: Također pogledati odjeljak 4.7.
English: MAH Number: EU/2/11/126/001 To be supplied only on veterinary prescription.
Croatian: Broj odobrenja: EU/2/11/126/001 Izdaje se samo na veterinarski recept.
English: Avoid introduction of contamination.
Croatian: Izbjeći kontaminaciju.
English: The MS-H vaccine should always be protected from direct sunlight.
Croatian: Cjepivo MS-H treba uvijek biti zaštićeno od direktne sunčeve svjetlosti.
English: This may occur during the whole life of the vaccinated bird.
Croatian: To se može dogoditi čitav tijekom života cijepljene ptice.
English: Once thawed, use within 2 hours.
Croatian: Kad se otopi, upotrijebiti u roku od 2 sata.
English: Do not thaw at higher temperatures or for longer time periods.
Croatian: Ne otapati na većim temperaturama ili na duže vremenske periode.
English: Allow the bird to blink before releasing it.
Croatian: Pustite da ptica trepne prije ispuštanja kapi.
English: DO7 PF53
Croatian: Dublin DO7 PF53 Ireland
English: Do not use antibiotics with anti-Mycoplasma activity 2 weeks before or 4 weeks after vaccination.
Croatian: Ne koristiti antibiotike s djelovanjem protiv mikoplazmi, 2 tjedna prije ili 4 tjedna poslije cijepljenja.
English: Do not use after the expiry date which is stated on the label.
Croatian: Ne koristiti poslije isteka roka valjanosti naznačenog na etiketi.
English: Ireland
Croatian: France
English: Chickens from 5 weeks of age
Croatian: Pilići od 5 tjedana starosti
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, se sastoji od tvari biološkog podrijetla, namijenjena je za stvaranje aktivnog imuniteta na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
English: If necessary, further differentiation of the 2 Mycoplasma species can be done by using PCR in a laboratory.
Croatian: Ako je nužno, za daljnju diferencijaciju 2 vrste mikoplazmi može se koristiti PCR u laboratoriju.
English: The animal will be immune for 40 weeks after the vaccination.
Croatian: Životinja će biti imuna 40 tjedana poslije cijepljenja.
English: Invert the dropper bottle or prepare the device allowing a single drop to form at the tip and fall freely into the open eye, gently flooding it.
Croatian: Okrenuti bocu s kapaljkom ili pripremiti uređaj koji omogućava da se na vrhu formira kapljica i slobodno padne u otvoreno oko i blago ga natopi.
English: Chickens should be vaccinated once by applying one eye drop (30 µl) from 5 weeks of age and at least 5 weeks before the onset of the laying period.
Croatian: Piliće treba cijepiti jedanput, primjenom jednom kapi za oči (30 µl) počevši od 5 tjedana starosti i najmanje 5 tjedana prije početka perioda nesenja.
English: Mix the contents of the bottle by gentle agitation during thawing.
Croatian: Promiješati sadržaj boce blagim mućkanjem tijekom otapanja.
English: du Plessis Beuscher 35220 Chateaubourg France
Croatian: 35220 Chateaubourg France
English: Use at room temperature (22-27°C) within 2 hours after thawing.
Croatian: Koristiti na sobnoj temperaturi (22-27°C) u roku dva sata nakon otapanja.
English: Invert the bottle repeatedly following thawing to ensure the contents have resuspended.
Croatian: Okretati bocu u više navrata nakon otapanja kako bi se osiguralo da je sadržaj ponovo otopljen.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, PUT(EVI) I NAČIN PRIMJENE
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije za lijekove (http://www.ema.europa.eu/).
English: Onset of immunity: 4 weeks after vaccination.
Croatian: Početak imuniteta: 4 tjedna nakon cijepljenja.
English: Special precautions should be taken to avoid spreading of the vaccine strain to other bird species.
Croatian: Posebne mjere opreza valja primijeniti kako bi se izbjeglo širenje cjepnog soja na druge vrste ptica.
English: Testing for the presence of M. synoviae in the flock is normally by way of the rapid serum agglutination test (RSAT) with blood samples being tested within 24 hours of collection.
Croatian: Testiranje na prisustvo M. synoviae u jatu obično se obavlja testom brze aglutinacije seruma (RSAT), a uzorci krvi se ispituju u roku od 24 sata od njihovog uzimanja.
English: • Hold the bird with its head tilted to one side.
Croatian: • Držati pticu tako da joj je glava nagnuta na jednu stranu.
English: After removal from the deep freeze, further short term storage is allowed at or below -18°C for no more than 4 weeks.
Croatian: Poslije uklanjanja iz zamrzivača, dozvoljeno je kratkotrajno čuvanje na ili ispod -18°C ne duže od 4 tjedna.
English: Plastic LDPE bottle of 30 ml (1,000 doses) with butyl rubber stopper sealed with an aluminium cap.
Croatian: Plastična LDPE boca od 30 ml (1000 doza) s butil gumenim čepom zapečaćena aluminijskim zatvaračem.
English: Although no data are available on the matter, it is likely that vaccination with this product will also induce a positive antibody response to Mycoplasma gallisepticum and may therefore interfere with the serological monitoring of Mycoplasma gallisepticum.
Croatian: Iako o tome ne postoje podaci, vjerojatno je da će cijepljenje ovim proizvodom također izazvati pozitivnu reakciju antitijela na Mycoplasmu gallisepticum i time može ometati serološki nadzor Mycoplasme gallisepticum.
English: Glenorie Manufacturing Facility Bioproperties Pty Ltd 11-13 Moores Rd, Glenorie, NSW, 2157 Australia
Croatian: 11-13 Moores Rd, Glenorie, NSW, 2157 Australia
English: Eye drops, suspension.
Croatian: Kapi za oči, suspenzija.
English: Modified Frey's medium containing phenol red and swine serum.
Croatian: Modificirani Freyev medij koji sadrži crveni fenol i svinjski serum.
English: Hold the bird with its head tilted to one side.
Croatian: Držati pticu tako da joj je glava nagnuta na jednu stranu.
English: Vaccinate all birds in a flock at the same time.
Croatian: Cijepiti istovremeno sve ptice u jatu.
English: Samples that can be used for PCR include swabs taken from pathological sites such as trachea, palatine cleft, air sacs or joints.
Croatian: Uzorci koji se mogu upotrijebiti za PCR su brisevi uzeti s patoloških lokaliteta kao što su dušnik, nepčana duplja, zračne vrećice ili zglobovi.
English: Shelf life after thawing and first opening the immediate packaging: 2 hours.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 2 sata.
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: Stoga, odluku o primjeni ovog cjepiva prije ili poslije bilo kojeg drugog veterinarsko-medicinskog proizvoda treba donositi od slučaja do slučaja.
English: The duration of immunity to reduce air sac lesions has been demonstrated to be 40 weeks post vaccination.
Croatian: Dokazano je trajanje imuniteta za smanjenje lezija zračnih vrećica 40 tjedana poslije cijepljenja.
English: • No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Croatian: • Nema dostupnih podataka o neškodljivosti i djelotvornosti ovog cjepiva kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom.
English: They should not be given within 2 weeks after vaccination.
Croatian: Njih ne treba davati prva dva tjedna nakon cijepljenja.
English: The components of the excipient listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u ovom veterinarsko medicinskom proizvodu.
English: Such antibiotics include e.g. tetracycline, tiamulin, tylosin, quinolones, lincospectin, gentamicin or macrolide antibiotics.
Croatian: Ti antibiotici uključuju npr. tetracikcline, tiamuline, tilosine, kinolone, inkospektine, gentamicin ili makrolidne antibiotike.
English: • Do not mix with any other veterinary medicinal product.
Croatian: • Ne miješati ni s jednim drugim veterinarsko-medicinskim proizvodom.