FrancophonIA/ELRC3.0 huggingface dataset:
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 injicira).
English: Clinical experience with Fluenz is relevant to Fluenz Tetra because both vaccines are manufactured using the same process and have overlapping compositions.
Croatian: Fluenz relevantno je za Fluenz Tetra, jer su oba cjepiva proizvedena korištenjem istog procesa te im se sastavi preklapaju.
English: For administration in the other nostril, pinch and remove the dose-divider clip from plunger.
Croatian: Za primjenu u drugu nosnicu, primite i uklonite razdjeljivač doze s klipa.
English: Fluenz Tetra should under no circumstances be injected.
Croatian: Fluenz Tetra se ni u kojem slučaju ne smije injicirati.
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: 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 ponovnim cijepljenjem u drugoj sezoni.
English: For children who have not previously been vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks.
Croatian: Djeca koja prethodno nisu bila cijepljena protiv sezonske influence moraju primiti drugu dozu nakon razmaka od najmanje 4 tjedna.
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 oslabljen imunološki sustav.
English: Tel: +421 2 5737 7777
Croatian: o.z. Tel: +421 2 5737 7777
English: B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 254977)
Croatian: B/Phuket/3073/2013 - sličan soj (B/Phuket/3073/2013, MEDI 254977)
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 1,609 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 injicira, kod 476 dojenčadi i male djece u dobi od 6 do 23 mjeseca i 48,2% (12,7; 70,0) manje slučajeva kod 1609 djece u dobi od 24-71 mjeseca.
English: Fluenz demonstrated 55.7% (39.9, 67.6) fewer cases than injectable influenza vaccine in 3,686 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: Fluenz je pokazao 55,7% (39,9; 67,6) manje slučajeva bolesti nego cjepivo protiv influence koje se injicira, kod 3686 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 previously unvaccinated study participants who received one dose in year 1, efficacy was 57.7% (95% CI: 44.7, 67.9) and 56.3% (95% CI: 43.1, 66.7), respectively, thus supporting the need for two doses of vaccine in previously unvaccinated children.
Croatian: Kod sudionika ispitivanja koji prethodno nisu bili cijepljeni, a koji su primili jednu dozu u 1. godini, djelotvornost je bila 57,7% (95% CI: 44,7; 67,9) odnosno 56,3% (95% CI: 43,1; 66,7), što podupire potrebu za primjenom dvije doze cjepiva kod djece koja prethodno nisu cijepljena.
English: Musculoskeletal and connective tissue disorders Common: Myalgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često: mialgija
English: SINGLE-USE NASAL APPLICATOR
Croatian: APLIKATOR ZA NOS ZA JEDNOKRATNU UPORABU
English: Fluenz Tetra is manufactured according to the same process as Fluenz.
Croatian: Fluenz Tetra je proizveden u skladu s postupkom za cjepivo Fluenz.
English: PACK SIZE OF 1 SINGLE-USE NASAL APPLICATOR PACK SIZE OF 1 SINGLE-USE NASAL APPLICATOR (IN A TRI-FOLD CARTON) PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS (IN TRAYS) PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS
Croatian: VELIČINA PAKIRANJA: 1 APLIKATOR ZA NOS ZA JEDNOKRATNU UPORABU VELIČINA PAKIRANJA: 1 APLIKATOR ZA NOS ZA JEDNOKRATNU UPORABU (U PAKIRANJU S TROSTRUKIM PREKLOPOM) VELIČINA PAKIRANJA: 10 APLIKATORA ZA NOS ZA JEDNOKRATNU UPORABU (NA PODLOŠKU)
English: Fluenz Tetra must not be injected.
Croatian: Fluenz Tetra se ne smije ubrizgavati.
English: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Switzerland/3330/2017, MEDI 307134)
Croatian: A/Brisbane/02/2018 (H1N1)pdm09 - sličan soj (A/Switzerland/3330/2017, MEDI 307134)
English: Other possible side effects of Fluenz Tetra
Croatian: Druge moguće nuspojave cjepiva Fluenz Tetra
English: Table 2 Fluenz Relative Efficacy in Active-controlled Paediatric Studies with Injectable Influenza Vaccine
Croatian: Tablica 2: Relativna djelotvornost cjepiva Fluenz u aktivno kontroliranim pedijatrijskim ispitivanjima u odnosu na cjepivo protiv influence koje se injicira
English: It is not known whether Fluenz Tetra is excreted in human milk.
Croatian: Nije poznato izlučuje li se Fluenz Tetra u majčino mlijeko.
English: Fluenz efficacy
Croatian: Djelotvornost cjepiva Fluenz
English: B/Colorado/06/2017 - like strain (B/Colorado/06/2017, MEDI 293454)
Croatian: B/Colorado/06/2017 - sličan soj (B/Colorado/06/2017, MEDI 293454)
English: PACK SIZE OF 5 SINGLE-USE NASAL APPLICATORS
Croatian: VELIČINA PAKIRANJA OD 5 APLIKATORA ZA NOS ZA JEDNOKRATNU UPORABU
English: The use of Fluenz Tetra should be based on official recommendations.
Croatian: Fluenz Tetra se smije upotrebljavati samo u skladu sa službenim preporukama.
English: What Fluenz Tetra contains
Croatian: Što Fluenz Tetra sadrži
English: Limited available evidence suggests that the trivalent Fluenz is not excreted in breastmilk.
Croatian: Dostupni su ograničeni dokazi koji upućuju na to da se trovalentno cjepivo Fluenz ne izlučuje u majčino mlijeko.
English: Immunisation must be carried out by nasal administration.
Croatian: Imunizacija se mora provesti nazalnom primjenom.
English: • Do not use with a needle.
Croatian: • Ne smije se primjenjivati putem igle.
English: A/Kansas/14/2017 (H3N2) - like strain (A/Kansas/14/2017, MEDI 308763)
Croatian: A/Kansas/14/2017 (H3N2) - sličan soj (A/Kansas/14/2017, MEDI 308763)
English: 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 injicira.
English: Respiratory, thoracic and mediastinal disorders Very common: Nasal congestion/rhinorrhoea
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često: nazalna kongestija/rinoreja Manje često: epistaksa
English: This observation with trivalent Fluenz is relevant to the use of Fluenz Tetra because Fluenz Tetra (influenza vaccine-liveattenuated, nasal) is identical to Fluenz with the only difference being the addition of a fourth strain (a second B strain) to Fluenz Tetra.
Croatian: Ova je opservacija o trovalentnom cjepivu Fluenz relevantna za primjenu cjepiva Fluenz Tetra jer je Fluenz Tetra (cjepivo protiv influence - atenuirani živi virus, nazalno) identičan s cjepivom Fluenz a jedina je razlika dodatak četvrtoga soja (drugi B soj) u Fluenz Tetra.
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: Check expiry date Product must be used before date on applicator label.
Croatian: Provjerite rok valjanosti Cjepivo se mora upotrijebiti prije datuma s naljepnice na aplikatoru.
English: • Fluenz Tetra is administered as a divided dose in both nostrils as described below.
Croatian: • Fluenz Tetra se primjenjuje kao podijeljena doza u obje nosnice, kako je dolje opisano.
English: This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 1 and 10.
Croatian: Cjepivo dolazi u obliku spreja za nos, suspenzije, u aplikatoru za nos za jednokratnu uporabu (0,2 ml), u veličinama pakiranja od 1 i 10 komada.
English: Figure 1 Fluenz Tetra Administration
Croatian: Slika 1 Primjena cjepiva Fluenz Tetra
English: Position the applicator With the patient in an upright position, place the tip just inside the nostril to ensure Fluenz Tetra is delivered into the nose.
Croatian: Postavite vrh malo unutar nosnice da osigurate da se Fluenz Tetra uštrca u nos.
English: 6 to 59 M 7,852 2004-2005
Croatian: SAD, Europa, Azija/ Oceanija od 6 do 59 M 7852 2004-2005
English: Overdose with Fluenz Tetra is unlikely due to its presentation as a pre-filled sprayer.
Croatian: Predoziranje cjepivom Fluenz Tetra nije vjerojatno budući da ono dolazi u obliku napunjenog raspršivača.
English: Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal) 2019/2020 season
Croatian: Fluenz Tetra sprej za nos, suspenzija Cjepivo protiv influence (živo atenuirano, za nos) Sezona 2019/2020
English: Fluenz Tetra will be given as a spray in each nostril.
Croatian: Fluenz Tetra se daje kao potisak u svaku nosnicu.
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 with Fluenz.
Croatian: Nakon stavljanja cjepiva Fluenz u promet bili su zabilježeni i vrlo rijetki slučajevi Gulliain-Barréovog sindroma, a također je primijećena egzacerbacija simptoma Leighovog sindroma (mitohondrijska encefalomiopatija).
English: Europe, Asia/ Oceania, Latin America
Croatian: Europa, Azija/ Oceanija, Latinska Amerika od 11 do 24 M 1150
English: Study Number
Croatian: Broj ispitivanja
English: Slovenská republika AstraZeneca AB, o.z.
Croatian: Slovenská republika AstraZeneca AB.
English: • Periodic safety update reports
Croatian: • Periodička izvješća o neškodljivosti lijeka
English: Driving and using machines • Fluenz Tetra has no or negligible influence on the ability to drive and use machines.
Croatian: • Fluenz Tetra nema nikakav utjecaj ili zanemariv utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: How Fluenz Tetra works
Croatian: Kako Fluenz Tetra djeluje
English: The safety experience with trivalent Fluenz is relevant to the use of Fluenz Tetra because Fluenz Tetra (influenza vaccine-live attenuated, nasal) is identical to Fluenz with the only difference being the addition of a fourth strain (a second B strain) to Fluenz Tetra.
Croatian: Fluenz je relevantno i za primjenu cjepiva Fluenz Tetra jer je Fluenz Tetra (cjepivo protiv influence -živo, atenuirano, za nos) identičan sa cjepivom Fluenz, a jedina je razlika dodatak četvrtoga soja (drugi tip B soj) u Fluenz Tetra.
English: Improved Efficacy (95% CI) Matched strains
Croatian: Poboljšana djelotvornost (95% CI) Podudarni sojevi
English: • if you are already taking acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever).
Croatian: • ako već 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: The co-administration of Fluenz Tetra with inactivated vaccines has not been studied.
Croatian: Istodobna primjena cjepiva Fluenz Tetra i inaktiviranih cjepiva nije ispitana.
English: The co-administration of trivalent Fluenz with the live attenuated vaccines: measles, mumps, rubella, varicella and orally-administered poliovirus has been studied.
Croatian: Ispitana je istodobna primjena trovalentnog cjepiva Fluenz sa živim atenuiranim cjepivima protiv ospica, zaušnjaka, rubele, varičele te peroralno primijenjenim poliovirusom.
English: - If you have any further questions, ask your doctor, nurse or pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se svom liječniku, medicinskoj sestri ili ljekarniku.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Number of Study Participants
Croatian: Broj sudionika u ispitivanju
English: Fluenz Tetra must only be used as a nasal spray.
Croatian: Fluenz Tetra se smije koristiti samo kao sprej za nos.
English: Paediatric studies
Croatian: Pedijatrijska ispitivanja
English: Very rare (may affect up to 1 in 10,000 people):
Croatian: Vrlo rijetko (mogu se javiti u do 1 na 10 000 osoba)
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: Spray in other nostril Place the tip just inside the other nostril and with a single motion, depress plunger as rapidly as possible to deliver remaining vaccine.
Croatian: Položite vrh malo unutar druge nosnice te jednim pokretom pritisnite klip što je brže moguće da biste uštrcali ostatak cjepiva.
English: Skin and subcutaneous tissue disorders Uncommon: Rash
Croatian: Poremećaji kože i potkožnog tkiva Manje često: osip
English: Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal)
Croatian: Fluenz Tetra sprej za nos, suspenzija cjepivo protiv influence (živo, atenuirano, za nos)
English: Peak incidence of vaccine virus recovery occurred 2-3 days post-vaccination in Fluenz clinical studies.
Croatian: U kliničkim ispitivanjima cjepiva Fluenz, vršna prisutnost virusa cjepiva javila se 2 do 3 dana nakon cijepljenja.
English: Improved Efficacy (95% CI) All strains regardless of match
Croatian: Poboljšana djelotvornost (95% CI) Svi sojevi bez obzira na podudarnost
English: The suspension is colourless to pale yellow, clear to slightly cloudy.
Croatian: Suspenzija je bezbojna do blijedo žuta, bistra do blago zamućena.
English: If you have any further questions on this vaccine, ask your doctor, nurse or pharmacist.
Croatian: Ako imate dodatnih pitanja u vezi s ovim cjepivom, obratite se svom liječniku, medicinskoj sestri ili ljekarniku.
English: Contains also: sucrose, dipotassium phosphate, potassium dihydrogen phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, water for injections.
Croatian: Cjepivo također sadrži: saharozu, kalijev hidrogenfosfat, kalijev dihidrogenfosfat, želatinu (svinjskog porijekla, tip A), argininklorid, natrijev glutamat hidrat, vodu za injekcije.
English: Efficacy (95% CI) All strains regardless of match
Croatian: Djelotvornost (95% CI) Svi sojevi bez obzira na podudarnost
English: Fluenz Tetra is administered as a divided dose in both nostrils.
Croatian: Fluenz Tetra se primjenjuje kao podijeljena doza u obje nosnice.
English: • Fluenz Tetra is administered as a divided dose in both nostrils.
Croatian: • Fluenz Tetra se primjenjuje kao podijeljena doza u obje nosnice.
English: Dipotassium phosphate Potassium dihydrogen 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 porijekla, tip A) argininklorid natrijev glutamat hidrat voda za injekcije
English: • After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter.
Croatian: • Odmah ili ubrzo nakon primjene prve polovice doze u jednu nosnicu, primijenite drugu polovicu doze u drugu nosnicu.
English: Efficacy (95% CI) Matched strains
Croatian: Djelotvornost (95% CI) Podudarni sojevi
English: • nose bleed
Croatian: • krvarenje iz nosa
English: The other ingredients are sucrose, dipotassium phosphate, potassium dihydrogen 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 porijekla, tip A), argininklorid, natrijev glutamat hidrat i voda za injekcije.
English: How to store Fluenz Tetra
Croatian: Kako čuvati Fluenz Tetra
English: After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter.
Croatian: Odmah ili ubrzo nakon primjene prve polovice doze u jednu nosnicu, primijenite drugu polovicu doze u drugu nosnicu.
English: 12 to 35 M 2,764
Croatian: Azija/ Oceanija od 12 do 35 M 2764
English: See section 5 for advice on storage and disposal.
Croatian: Za savjet o čuvanju i zbrinjavanju cjepiva, vidjeti dio 5.
English: 6 to 35 M 1,041
Croatian: Azija/ Oceanija od 6 do 35 M 1041
English: Nasal spray, suspension 1 single-use nasal applicator (0.2 ml) 10 single-use nasal applicators (0.2 ml each)
Croatian: 1 aplikator za nos za jednokratnu uporabu 10 aplikatora za nos za jednokratnu uporabu (0,2 ml svaki)
English: See Table 1 and 2 for a summary of efficacy results in the paediatric population.
Croatian: Za sažetak rezultata ispitivanja djelotvornosti u pedijatrijskoj populaciji pogledajte tablice 1 i 2.
English: General disorders and administration site conditions Very common: Malaise
Croatian: Opći poremećaji i reakcije na mjestu primjene Vrlo često: opće loše stanje Često: pireksija
English: Fluenz Tetra immunogenicity
Croatian: Imunogenost cjepiva Fluenz Tetra
English: 11 to 24 M 1,150 2002-2003
Croatian: SAD od 15 do 71 M 1259
English: .................................................................................................................per 0.2 ml dose
Croatian: ............................................................................................................................po dozi od 0,2 ml
English: • runny or stuffy nose
Croatian: • curenje ili začepljenost nosa
English: How Fluenz Tetra is given
Croatian: Kako se primjenjuje Fluenz Tetra
English: For nasal use only.
Croatian: Samo za primjenu za nos.
English: 6 to 17 Y 2,211 2002-2003
Croatian: D153-P515 Europa od 6 do 17 G 2211 2002-2003
English: 6 to 71 M 2,085 2002-2003
Croatian: D153-P514 Europa od 6 do 71 M 2085 2002-2003
English: If any of these apply, tell your doctor, nurse or pharmacist.
Croatian: Ako se bilo što od navedenog odnosi na Vas, obavijestite svog liječnika, medicinsku sestru ili ljekarnika.
English: 6 to 35 M 1,886
Croatian: Afrika, Latinska Amerika od 6 do 35 M 1886
English: AstraZeneca S.p.A. Tel: +39 02 98011
Croatian: Tel: +39 02 98011
English: Fluenz Tetra is for nasal use only.
Croatian: Fluenz Tetra JE NAMIJENJEN SAMO ZA PRIMJENU ZA NOS.
English: Common (may affect up to 1 in 10 people):
Croatian: Često (mogu se javiti u do 1 na 10 osoba)
English: The concurrent use of Fluenz Tetra with antiviral agents that are active against influenza A and/or B viruses has not been evaluated.
Croatian: Istodobna primjena cjepiva Fluenz Tetra i antivirusnih lijekova koji djeluju protiv virusa influence
English: The European Commission issued a decision on 7 January 2016.
Croatian: Europska komisija objavila je odluku 7. siječnja 2016.
English: 7 January 2016
Croatian: 7. siječnja 2016.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a veterinary medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Poland, Portugal, Slovakia, Spain and The Netherlands).
Croatian: To je postupak u kojemu jedna država članica („referentna država članica”, u ovom slučaju Ujedinjena Kraljevina) ocjenjuje veterinarsko-medicinski proizvod radi izdavanja odobrenja za njegovo stavljanje u promet koje će biti valjano u toj državi i u drugim državama članicama („države članice sudionice u postupku”, u ovom slučaju Austrija, Belgija, Češka, Danska, Francuska, Grčka, Irska, Italija, Luksemburg, Mađarska, Nizozemska, Njemačka, Poljska, Portugal, Slovačka i Španjolska).
English: However, the Member States were not able to reach an agreement and the Veterinary Medicines Directorate of the United Kingdom referred the matter to the CVMP for arbitration on 28 May 2015.
Croatian: Međutim, države članice nisu uspjele postići dogovor i stoga je Uprava za veterinarske lijekove Ujedinjene Kraljevine uputila predmet CVMP-u na arbitražu 28. svibnja 2015.
English: Amoxicillin is a bactericidal antibiotic belonging to the semisynthetic penicillin group.
Croatian: Amoksicilin je baktericidni antibiotik iz skupine polusintetskih penicilina.
English: In addition, Denmark raised a concern that the advice for prudent use in the product information is insufficient.
Croatian: Osim toga, Danska je izrazila zabrinutost u pogledu toga da savjeti o opreznoj uporabi u informacijama o VMP-u nisu dovoljni.
English: The Committee recommended revised instructions on product administration and advice on prudent use to address responsible use in relation to development of antimicrobial resistance.
Croatian: Odbor je preporučio revidirane upute o primjeni VMP-a i savjete o opreznoj uporabi kako bi se riješio problem odgovorne uporabe s obzirom na razvoj antimikrobne rezistencije.
English: The grounds for the referral were concerns raised by Denmark that the marketing authorisation of Solamocta may present a potential serious risk to human and animal health.
Croatian: Razlog za upućivanje na arbitražu bila je zabrinutost koju je izrazila Danska da odobrenje za stavljanje VMP-a Solamocta u promet može predstavljati mogući ozbiljan rizik za zdravlje ljudi i životinja.
English: On 4 November 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the veterinary medicinal product Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys.
Croatian: Europska agencija za lijekove (Agencija) završila je 4. studenoga 2015. arbitražni postupak koji je pokrenut zbog neslaganja među državama članicama Europske unije (EU) u pogledu odobrenja veterinarsko-medicinskog praška Solamocta 697 mg/g za uporabu u pitkoj vodi za piliće, patke i pure.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that a satisfactory justification has been provided that the product, Solamocta, is eligible for a waiver from the requirement to demonstrate in vivo bioequivalence with the reference product in accordance with section 7.1.c) of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2) and that the excipients will not impact the bioavailability or safety of this product compared to the reference product.
Croatian: Na osnovi procjene trenutačno dostupnih podataka i provedene znanstvene rasprave u okviru Odbora, CVMP je zaključio da je pruženo zadovoljavajuće opravdanje za to da se na VMP Solamocta može primijeniti izuzeće od obveze dokazivanja in vivo bioekvivalencije u odnosu na referentni VMP u skladu s odjeljkom 7.1. točkom (c) CVMP-ovih smjernica o provedbi ispitivanja bioekvivalencije za veterinarsko-medicinske proizvode (EMA/CVMP/016/00-Rev.2) te da pomoćne tvari neće utjecati na bioraspoloživost ili sigurnost ovog VMP-a u usporedbi s referentnim VMP-om.