FrancophonIA/ELRC3.0 huggingface dataset:
English: Vaccine recipients should be informed that FLUENZ is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts.
Croatian: Cijepljene osobe treba upozoriti da je FLUENZ živo oslabljeno virusno cjepivo te da postoji mogućnost prijenosa virusa na imunokompromitirane osobe.
English: Do not inject.
Croatian: Ne ubrizgavati.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 (e.g. gelatin), or to gentamicin (a possible trace residue), eggs or egg proteins (e.g. ovalbumin).
Croatian: Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1 (npr., želatinu), ili gentamicin (moguća ostatna tvar), jaja ili proteine jaja (npr., ovalbumin).
English: • FLUENZ is administered as a divided dose in both nostrils.
Croatian: • FLUENZ se primjenjuje kao podijeljena doza u obje nosnice.
English: Children and adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids.
Croatian: Djeca i adolescenti koji su klinički imunodeficijentni zbog bolesti ili imunosupresivne terapije kao što je to slučaj kod akutne i kronične leukemije, limfoma; simptomatske HIV infekcije; deficijencije staničnog imuniteta te visokih doza kortikosteroida.
English: FLUENZ should under no circumstances be injected.
Croatian: FLUENZ se ni u kojem slučaju ne smije injicirati.
English: No clinically meaningful changes in immune responses to measles, mumps, varicella, orally-administered poliovirus or FLUENZ have been observed.
Croatian: Nisu bile primjećene klinički značajne promjene u imunološkom odgovoru na ospice, zaušnjake, varičelu te oralno primijenjeni poliovirus ili cjepivo FLUENZ.
English: Fluenz is a trademark of MedImmune, LLC.
Croatian: Fluenz je zaštićeni robni žig tvrtke MedImmune, LLC.
English: Prophylaxis of influenza in individuals 24 months to less than 18 years of age.
Croatian: Profilaksa influence u osoba u dobi od 24 mjeseca do 18 godina.
English: Fertility No data exist regarding the possible effects of FLUENZ on male and female fertility.
Croatian: Ne postoje podaci o mogućim učincima cjepiva FLUENZ na mušku i žensku plodnost.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/661/002 < - 10 sprayers>
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/10/661/002< - 10 raspršivača>
English: It is not known whether FLUENZ is excreted in human milk.
Croatian: Nije poznato izlučuje li se FLUENZ u majčino mlijeko.
English: Do not administer FLUENZ to children and adolescents younger than 18 years of age receiving salicylate therapy (see section 4.3).
Croatian: Ne primjenjujte FLUENZ u djece i adolescenata mlađih od 18 godina koji primaju terapiju salicilatima (vidjeti dio 4.3).
English: Improved Efficacy (95% CI)
Croatian: Poboljšana djelotvornost (95% CI)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK SIZE OF 5 SINGLE-USE NASAL APPLICATORS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP VELIČINA PAKOVANJA OD 5 APLIKATORA ZA NOS ZA JEDNOKRATNU UPORABU
English: M = months b Reduction in culture-confirmed influenza illness relative to placebo.
Croatian: Smanjenje bolesti influence potvrđene kulturom u odnosu na placebo.
English: Other possible side effects of Fluenz
Croatian: Druge moguće nuspojave lijeka Fluenz
English: In an active-controlled clinical study (MI-CP111), an increased rate of hospitalisations (for any cause) through 180 days after final vaccination dose was observed in infants and toddlers 6-11 months of age (6.1% FLUENZ versus 2.6% injectable influenza vaccine).
Croatian: U kliničkom ispitivanju (MI-CP111) u kojem se kao aktivna kontrola koristilo cjepivo protiv influence koje se ubrizgava, primijećena je povećana stopa hospitalizacija dojenčadi i male djece u dobi od 6 do 11 mjeseci (iz bilo kojeg razloga) tijekom 180 dana nakon posljednje doze cjepiva FLUENZ (6,1% nakon cjepiva FLUENZ naspram 2,6% nakon cjepiva protiv influence koje se ubrizgava).
English: Efficacy (95% CI)
Croatian: Djelotvornost (95% CI)
English: How to store Fluenz
Croatian: Kako čuvati Fluenz
English: 10 single-use nasal applicators (0.2 ml each)
Croatian: 10 aplikatora za nos za jednokratnu uporabu (0,2 ml svaki)
English: See section 6.6 for administration instructions.
Croatian: Za uputu o primjeni, vidjeti dio 6.6.
English: Pregnancy There are limited data from the use of FLUENZ in pregnant women.
Croatian: Trudnoća Podaci o primjeni cjepiva FLUENZ u trudnica su ograničeni.
English: Fluenz must only be used as a nasal spray.
Croatian: Fluenz se smije koristiti samo kao sprej za nos.
English: FLUENZ is supplied as a 0.2 ml suspension in a single-use nasal applicator (Type 1 glass), with nozzle (polypropylene with polyethylene transfer valve), nozzle tip-protector cap (synthetic rubber), plunger rod, plunger-stopper (butyl rubber), and a dose-divider clip.
Croatian: FLUENZ je dostupan kao 0,2 ml suspenzije u aplikatoru za nos za jednokratnu uporabu (staklo tip I) s mlaznicom (polipropilen s polietilenskim ventilom za prijenos), zaštitnim zatvaračem vrha mlaznice (od sintetičke gume), potisnikom klipa, čepom klipa (od butilne gume) i razdjeljivačem doze.
English: fewer cases than injectable
Croatian: manje slučajeva nego s cjepivom koje se ubrizgava
English: Figure 1 FLUENZ Administration
Croatian: Slika 1 Primjena cjepiva FLUENZ
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS (2 X 5 NASAL APPLICATORS)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU VELIČINA PAKOVANJA: 10 APLIKATORA ZA NOS ZA JEDNOKRATNU UPORABU (2 X 5 APLIKATORA ZA NOS)
English: The suspension is a colourless to pale yellow liquid that is clear to slightly cloudy.
Croatian: Suspenzija je bezbojna do blijedo žuta tekućina koja je bistra do blago zamućena.
English: FLUENZ has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine.
Croatian: FLUENZ je pokazao superiornost u 3 ispitivanja u kojima se kao aktivna kontrola koristilo cjepivo protiv influence koje se ubrizgavalo.
English: The co-administration of FLUENZ with inactivated vaccines has not been studied.
Croatian: Istodobna primjena cjepiva FLUENZ i inaktiviranih cjepiva nije ispitana.
English: This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 10.
Croatian: Cjepivo dolazi u obliku suspenzije za sprej za nos, u aplikatoru za nos za jednokratnu uporabu (0,2 ml), u veličinama pakovanja od 10.
English: FLUENZ demonstrated 64.4% (1.4, 88.8) fewer cases than injectable influenza vaccine in 476 infants and toddlers 6-23 months of age and 48.2% (12.7, 70.0) fewer cases in 1,579 children 24-71 months of age.
Croatian: FLUENZ je pokazao 64,4% (1,4; 88,8) manje slučajeva bolesti nego cjepivo protiv influence koje se ubrizgava kod 476 dojenčadi i male djece u dobi od 6 do 23 mjeseca i 48,2% (12,7; 70,0) manje slučajeva kod 1579 djece u dobi od 24-71 mjeseca.
English: Fluenz must not be injected.
Croatian: Fluenz se ne smije ubrizgavati.
English: Marketing Authorisation Holder: MedImmune, LLC, Lagelandseweg 78, 6545 CG Nijmegen, Netherlands, (Tel) +31 24 371 7310
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet: MedImmune, LLC, Lagelandseweg 78, 6545 CG Nijmegen, Nizozemska, (Tel) +31 24 371 7310
English: Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) have also been observed in the post-marketing setting.
Croatian: Nakon stavljanja cjepiva u promet bili su zabilježeni i vrlo rijetki slučajevi Gullian-Barréovog sindroma, a također je primijećena egzacerbacija simptoma Leighovog sindroma (mitohondrijska encefalomiopatija).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/661/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/10/661/002
English: • if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicine, or other treatment.
Croatian: • ako vam je liječnik rekao da zbog bolesti, lijekova ili drugih postupaka imate oslabljeni imunološki sustav.
English: PHARMACEUTICAL FORM AND CONTENTS Nasal spray, suspension
Croatian: OBLIK I SADRŽAJ Sprej za nos, suspenzija
English: Peak incidence of vaccine virus recovery occurred 2-3 days post-vaccination in clinical studies.
Croatian: U kliničkim se ispitivanjima vršna incidencija prisutnosti virusa cjepiva javila 2 do 3 dana nakon cijepljenja.
English: Danmark AstraZeneca A/S Tlf: +45 43 66 64 62
Croatian: AstraZeneca A/S Tlf: +45 43 66 64 62
English: D153-P501 Asia/Oceania 12 to 35 M 2,764
Croatian: D153-P501 Azija/ Oceanija od 12 do 35 M 2764
English: In the same study, an increased rate of wheezing through 42 days was observed in infants and toddlers 6-23 months of age (5.9% FLUENZ versus 3.8% injectable influenza vaccine).
Croatian: U istom ispitivanju primijećena je povećana stopa piskanja pri disanju kod dojenčadi i male djece u dobi od 6 do 23 mjeseca tijekom 42 dana (5,9% nakon cjepiva FLUENZ naspram 3,8% nakon cjepiva protiv influence koje se ubrizgava).
English: D153-P514 Europe 6 to 71 M 2,085 2002-2003
Croatian: D153-P514 Europa od 6 do 71 M 2085 2002-2003
English: When the submission of a PSUR and the update of a RMP coincide, they should be submitted at the same time.
Croatian: Ukoliko se podnošenje periodičkog izvješća o neškodljivosti (PSUR) podudara s nadopunama Plana (RMP), oba dokumenta trebaju biti podnesena istodobno.
English: FLUENZ demonstrated 55.7% (39.9, 67.6) fewer cases than injectable influenza vaccine in 3,659 infants and toddlers 6-23 months of age and 54.4% (41.8, 64.5) fewer cases in 4,166 children 24-59 months of age.
Croatian: c FLUENZ je pokazao 55,7% (39,9; 67,6) manje slučajeva bolesti nego cjepivo protiv influence koje se ubrizgava kod 3659 dojenčadi i male djece u dobi od 6 do 23 mjeseca i 54,4% (41,8; 64,5) manje slučajeva kod 4166 djece u dobi od 24-59 mjeseci.
English: In study participants who received 2 doses in year 1 and placebo in year 2, efficacy in year 2 was 56.2% (95% CI: 30.5, 72.7) and 44.8% (95% CI: 18.2, 62.9), respectively, in D153-P501, thus supporting the need for second-season revaccination.
Croatian: d U sudionika ispitivanja koji su primili 2 doze u 1. godini i placebo u 2. godini, djelotvornost u 2. godini iznosila je 56,2% (95% CI: 30,5; 72,7) odnosno 44,8% (95% CI: 18,2; 62,9) u D153-P501, što podupire potrebu za ponovno cijepljenje u drugoj sezoni.
English: Do not use salicylates in children and adolescents younger than 18 years of age for 4 weeks after vaccination unless medically indicated as Reye's syndrome has been reported following the use of salicylates during wild-type influenza infection.
Croatian: Nemojte davati salicilate djeci i adolescentima mlađima od 18 godina tijekom 4 tjedna nakon cijepljenja osim ako to nije medicinski indicirano, jer je nakon primjene salicilata tijekom infekcije divljim tipom virusa influence zabilježen Reyev sindrom.
English: Respiratory, thoracic, and mediastinal disorders Very common: Nasal congestion/rhinorrhoea Uncommon: Epistaxis
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često: nazalna kongestija/rinoreja Manje često: epistaksa
English: You will not be given Fluenz
Croatian: (na primjer, bolesnik kome je presađena koštana srž i koji treba izolaciju).
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements for medical waste.
Croatian: Neiskorišteni lijek ili otpadni materijal valja zbrinuti sukladno lokalnim propisima za zbrinjavanje medicinskog otpada.
English: fewer cases than injectable c fewer cases than injectable
Croatian: manje slučajeva nego s cjepivom koje se ubrizgava c manje slučajeva nego s cjepivom koje se ubrizgava
English: This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2013/2014 season.
Croatian: Ovo cjepivo odgovara preporuci SZO (za sjevernu hemisferu) i odluci EU za sezonu 2013/2014.
English: USA 15 to 71 M 1,259
Croatian: SAD od 15 do 71 M 1259
English: • if you are under 18 years of age and already taking acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever).
Croatian: • ako ste mlađi od 18 godina i uzimate acetilsalicilnu kiselinu (tvar koja je prisutna u mnogim lijekovima koji se koriste protiv bolova i za snižavanje vrućice), zato što u tom slučaju postoji rizik od vrlo rijetke, ali ozbiljne bolesti (Reyev sindrom).
English: NAME OF THE MARKETING AUTHORISATION HOLDER MedImmune, LLC
Croatian: ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET MedImmune, LLC
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION FLUENZ
Croatian: NAZIV GOTOVOG LIJEKA I PUT(EVI) PRIMJENE LIJEKA FLUENZ
English: b Reduction in culture-confirmed influenza illness relative to injectable influenza vaccine.
Croatian: Smanjenje bolesti influence potvrđene kulturom u odnosu na cjepivo protiv influence koje se ubrizgava.
English: Very rare (may affect up to 1 in 1,000,000 people):
Croatian: Vrlo rijetko (mogu se javiti u 1 na 1 000 000 osoba)
English: • DO NOT USE WITH A NEEDLE.
Croatian: • NE SMIJE SE PRIMJENJIVATI PUTEM IGLE.
English: Check expiry date Product must be used before date on applicator label.
Croatian: Cjepivo se mora upotrijebiti prije datuma sa naljepnice na aplikatoru.
English: FLUENZ is not indicated for use in infants and toddlers younger than 24 months (see section 4.4).
Croatian: FLUENZ nije indiciran za primjenu kod dojenčadi i male djece mlađe od 24 mjeseca (vidjeti dio 4.4).
English: NAME OF THE MEDICINAL PRODUCT FLUENZ nasal spray suspension Influenza vaccine (live attenuated, nasal) 2013/2014 season
Croatian: NAZIV GOTOVOG LIJEKA FLUENZ sprej za nos, suspenzija Cjepivo protiv influence (živo atenuirano, za nos) Sezona 2013/2014
English: FLUENZ should not be used in infants and toddlers below 24 months of age because of safety concerns (see section 4.4).
Croatian: FLUENZ se ne smije primjenjivati kod dojenčadi i male djece mlađe od 24 mjeseca zbog sigurnosnih razloga (vidjeti dio 4.4).
English: Study Number
Croatian: BROJ SERIJE
English: FLUENZ IS FOR NASAL USE ONLY.
Croatian: FLUENZ JE NAMIJENJEN SAMO ZA PRIMJENU
English: Influenza vaccine
Croatian: Cjepivo protiv influence
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SINGLE-USE NASAL APPLICATOR
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKOVANJE APLIKATOR ZA NOS ZA JEDNOKRATNU UPORABU
English: In circumstances where contact with severely immunocompromised individuals is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus.
Croatian: potrebno je prosuditi mogući rizik od prijenosa virusa influence iz cjepiva u odnosu na rizik od zaraze i prijenosa divljeg tipa virusa influence.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Primjena`
English: Table 2 FLUENZ Relative Efficacy in Active-controlled Paediatric Studies with Injectable
Croatian: Tablica 2: Relativna djelotvornost cjepiva FLUENZ u pedijatrijskom ispitivanju u kojem se kao aktivna kontrola koristilo cjepivo protiv influence koje se ubrizgava
English: The rate of hospitalisations was not increased in FLUENZ recipients 12 months and older.
Croatian: Stopa hospitalizacija nije bila povećana kod djece u dobi od 12 i više mjeseci koja su bila cijepljena cjepivom FLUENZ.
English: 11 to 24 M 1,150 2002-2003 78.4%
Croatian: Europa, Azija/ Oceanija, Latinska Amerika od 11 do 24 M 1150 2002-2003 78,4%
English: In a clinical study, an increase in hospitalisations was observed in infants and toddlers younger than 12 months after vaccination (see section 4.8).
Croatian: U kliničkom ispitivanju, kod dojenčadi i male djece mlađe od 12 mjeseci primijećen je povećani broj hospitalizacija nakon cijepljenja (vidjeti dio 4.8).
English: The co-administration of FLUENZ with the live attenuated vaccines: measles, mumps, rubella, varicella, and orally-administered poliovirus has been studied.
Croatian: Ispitana je istodobna primjena cjepiva FLUENZ sa živim oslabljenim cjepivima protiv ospica, zaušnjaka, rubeole, varičele te peroralno primijenjenim poliovirusom.
English: The rate of wheezing was not increased in FLUENZ recipients 24 months and older.
Croatian: Stopa piskanja nije bila povećana kod djece u dobi od 24 i više mjeseci koja su bila cijepljena cjepivom FLUENZ.
English: remove the dose-divider clip from plunger.
Croatian: Uklonite razdjeljivač doze
English: Contains also: sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, water for injections.
Croatian: Cjepivo također sadrži: saharozu, kalijev hidrogenfosfat, kalijev dihidrogenfosfat, želatinu (svinjskog podrijetla, tip A), argininklorid, natrijev glutaminat hidrat, vodu za injekcije.
English: Dibasic potassium phosphate Monobasic potassium phosphate Gelatin (porcine, Type A) Arginine hydrochloride Monosodium glutamate monohydrate Water for injections
Croatian: 6.1 Popis pomoćnih tvari saharoza kalijev hidrogenfosfat kalijev dihidrogenfosfat želatina (svinjskog podrijetla, tip A) argininklorid natrijev glutaminat hidrat voda za injekcije
English: Method of administration Immunisation must be carried out by nasal administration.
Croatian: Način primjene Imunizacija se mora provesti nazalnom primjenom.
English: In a clinical study, an increased rate of wheezing was observed in infants and toddlers 12-23 months of age after vaccination (see section 4.8).
Croatian: U kliničkom je ispitivanju kod dojenčadi i male djece u dobi od 12 do 23 mjeseca primijećena povećana stopa piskanja pri disanju nakon cijepljenja (vidjeti dio 4.8).
English: Fluenz nasal spray suspension Influenza vaccine (live attenuated, nasal)
Croatian: Fluenz sprej za nos, suspenzija Cjepivo protiv influence (živo oslabljeno, za nos)
English: UK
Croatian: Ujedinjeno Kraljevstvo
English: Efficacy (95% CI)b Matched strains
Croatian: Poboljšana djelotvornost (95% CI)b
English: Position the applicator With the patient in an upright position, place the tip just inside the nostril to ensure Fluenz is delivered into the nose.
Croatian: Postavite vrh malo unutar nosnice da osigurate da je Fluenz uštrcan u nosnicu.
English: The other ingredients are sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate and water for injections.
Croatian: Pomoćne tvari su: saharoza, kalijev hidrogenfosfat, kalijev dihidrogenfosfat, želatina (svinjskog podrijetla, tip A), argininklorid, natrijev glutaminat hidrat i voda za injekcije.
English: Reassortant influenza virus* (live attenuated) of the following strains**: A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, MEDI 228029)
Croatian: A/California/7/2009 (H1N1) pdm09 kao soj (A/California/7/2009, MEDI 228029)
English: Uncommon (may affect up to 1 in 100 people):
Croatian: Manje često (mogu se javiti u 1 na 100 osoba):
English: METHOD AND ROUTE(S) OF ADMINISTRATION For nasal use only.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Samo za primjenu u nos.
English: D153-P513 Asia/ Oceania
Croatian: D153-P513 Azija/ Oceanija od 6 do 35 M 2107
English: General disorders and administration site conditions Very common: Malaise
Croatian: Opći poremećaji i reakcije na mjestu primjene Vrlo često: opća slabost Često: vrućica
English: NAME OF THE MEDICINAL PRODUCT FLUENZ nasal spray suspension Influenza vaccine (live attenuated, nasal)
Croatian: NAZIV GOTOVOG LIJEKA FLUENZ sprej za nos, suspenzija cjepivo protiv influence, živo, atenuirano, za nos
English: Common (may affect up to 1 in 10 people):
Croatian: Često (mogu se javiti u 1 na 10 osoba)
English: Region Age Range a
Croatian: Dobni raspon a
English: Matched strains
Croatian: Dobni raspona
English: Vistor hf.
Croatian: Čep klipa
English: The concurrent use of FLUENZ with antiviral agents that are active against influenza A and/or B viruses has not been evaluated.
Croatian: Istodobna primjena cjepiva FLUENZ i antivirusnih lijekova koji djeluju protiv virusa influence
English: e a
Croatian: A.
English: B/Massachusetts/2/2012-like strain (B/Massachusetts/2/2012, MEDI 237751)
Croatian: B/Massachusetts/2/2012 kao soj (B/Massachusetts/2/2012, MEDI 237751) .......................................................................................................po dozi od 0,2 ml * umnoženih u oplođenim kokošjim jajima iz jata zdravih kokoši.
English: ATCvet code: QM01AH90.
Croatian: ATCvet kod: QM01AH90.
English: Do not exceed the recommended dose.
Croatian: Ne prekoračiti preporučenu dozu.
English: Duration of treatment will be dependent on the response observed.
Croatian: Trajanje liječenja će ovisiti o primijećenom odgovoru.
English: Tablets can be administered with or without food.
Croatian: Tablete se mogu davati s hranom ili bez nje.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, protuotrovi), ako je nužno
English: Date of first authorisation: 13/09/2004 Date of last renewal: 29/05/2009
Croatian: Datum posljednjeg produljenja odobrenja: 29/05/2009.
English: Overdose studies were not conducted in animals over 14 months of age.
Croatian: Ispitivanja predoziranja nisu provedena u životinja starijih od 14 mjeseci.
English: Firocoxib is approximately 96 % bound to plasma proteins.
Croatian: Firokoksib se 96 % veže na proteine plazme.
English: Each tablet contains:
Croatian: Jedna tableta sadrži:
English: Very rare (affects less than 1 animal in 10,000)
Croatian: Vrlo rijetko (zahvaća manje od 1 životinje u 10.000)
English: If such use cannot be avoided, those dogs require careful veterinary monitoring.
Croatian: Ako je takva primjena neizbježna, takvi psi trebaju pažljiv nadzor veterinara.
English: 4 Chemin de Calquet 31000 Toulouse France
Croatian: 4, Chemin du Calquet 31000 Toulouse Francuska
English: - 1 cardboard box containing 10 tablets in one blister - 1 cardboard box containing 30 tablets in three blisters - 1 cardboard box containing 180 tablets in eighteen blisters - 1 cardboard box containing 60 tablets in one bottle
Croatian: - 1 kartonska kutija sadrži 10 tableta u jednom blisteru - 1 kartonska kutija sadrži 30 tableta u tri blistera - 1 kartonska kutija sadrži 180 tableta u osamnaest blistera - 1 kartonska kutija sadrži 60 tableta u jednoj bočici
English: The elimination half-life (t½) is 7.59 (± 1.53) hours.
Croatian: Poluvijek uklanjanja (t˝1/2) je 7,59 (± 1,53) sati.
English: Return halved tablets to the blister and keep out of the reach of children.
Croatian: Prepolovljenu tabletu vratite u blister i čuvajte izvan dosega djece.
English: The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Croatian: U tom razdoblju bez lijekova, međutim, treba uzeti u obzir farmakokinetička svojstva prethodno upotrijebljenih proizvoda.
English: 5 mg/kg once daily.
Croatian: 5 mg/kg jednom dnevno.
English: The chewable tablets (57 mg or 227 mg) are available in the following pack sizes:
Croatian: Tablete za žvakanje (57 mg ili 227 mg) dostupne su u sljedećim veličinama pakovanja:
English: Osteoarthritis:
Croatian: Osteoartritis:
English: Use in very young animals, or animals with suspected or confirmed impairment of renal, cardiac or hepatic function may involve additional risk.
Croatian: Primjena kod vrlo mladih životinja ili životinja sa suspektnim ili potvrđenim oštećenjem funkcije bubrega, srca ili jetre može izazvati dodatni rizik.
English: Wash hands after use of the product.
Croatian: Nakon primjene operite ruke.