FrancophonIA/ELRC3.0 huggingface dataset:
English: Study (SPD503-315) was a 41 week long term maintenance of efficacy study which included an open-label phase (up to 13 weeks) followed by double-blind, placebo-controlled, randomised-withdrawal phase (up to 26 weeks), conducted in paediatric patients (children and adolescents aged 6-17 years old inclusive) (n=526 in the open-label phase and n=315 in the double-blind randomised-withdrawal phase) to assess the efficacy, safety, and tolerability of once-daily dosing with guanfacine (children: 1-4 mg/day, adolescents:1-7 mg/day) in the treatment of ADHD.
Croatian: Ispitivanje (SPD503-315) bilo je ispitivanje djelotvornosti dugotrajnog održavanja terapije u trajanju od 41 tjedna u kojem je nakon faze otvorenog tipa (do 13 tjedana) uslijedilo dvostruko slijepo, placebom kontrolirano, randomizirano ispitivanje ustezanja (do 26 tjedana) provedeno u pedijatrijskih bolesnika (djece i adolescenata u dobi od 6 do uključivo 17 godina) (n=526 u fazi otvorenog tipa i n=315 u dvostruko slijepoj, randomiziranoj fazi ustezanja) zbog procjene djelotvornosti, sigurnosti i podnošljivosti doziranja gvanfacina jedanput dnevno (djeca: 1-4 mg na dan, adolescenti: 1-7 mg na dan) u liječenju ADHD-a.
English: In phase II-III randomised double-blind monotherapy studies respective increases in QTc interval prolongation that exceeded change from baseline greater than 60 ms Fridericia-correction and Bazett-correction were 0 (0.0%) and 2 (0.3%) among placebo and 1 (0.1%) and 1 (0.1%) among Intuniv patients.
Croatian: U randomiziranim, dvostruko slijepim ispitivanjima monoterapijskog liječenja faze II-III, odgovarajuća povećanja produljenja QTc intervala koja su premašila promjenu od početne vrijednosti više od 60 ms nakon korekcije prema Fridericiji i korekcije prema Bazettu iznosila su 0 (0,0%) odnosno 2 (0,3%) u bolesnika koji su primali placebo te 1 (0,1%) odnosno 1 (0,1%) u bolesnika liječenih Intunivom.
English: In post-marketing experience, hypertensive encephalopathy has been very rarely reported upon abrupt discontinuation of Intuniv (see section 4.8).
Croatian: Nakon stavljanja lijeka na tržište vrlo rijetko je prijavljivana hipertenzivna encefalopatija nakon naglog prekida primjene lijeka Intuniv (vidjeti dio 4.8).
English: Crospovidone Type A Microcrystalline cellulose Silica, colloidal anhydrous Sodium laurilsulphate Polysorbate 80
Croatian: A mikrokristalična celuloza silicijev dioksid, koloidni, bezvodni natrijev laurilsulfat polisorbat 80 fumaratna kiselina gliceroldibehenat
English: Results show statistically significantly (p≤0.05) greater mean reductions at endpoint from Baseline (indicating improvement) in oppositional subscale of CPRS-R:L scores in the guanfacine group compared to placebo (10.9 points vs. 6.8 for guanfacine vs. placebo, respectively) and the effect size was 0.6 (p<0.001).
Croatian: veću srednju vrijednost smanjenja na kraju ispitivanja u odnosu na početak (što pokazuje poboljšanje) u rezultatu na podljestvici za procjenu opozicijskog ponašanja CPRS-R:L-a u skupini koja je uzimala gvanfacin u usporedbi s placebom (10,9 bodova za gvanfacin naspram 6,8 bodova za placebo), a veličina učinka bila je 0,6 (p<0,001).
English: Incidence Category
Croatian: Kategorija učestalosti
English: At the end of their double-blind treatment, a significantly larger proportion of subjects in the guanfacine compared with placebo group were normal or borderline mentally ill as measured by the clinical global impression of severity (CGI-S) that includes assessment of functioning.
Croatian: Na kraju dvostruko slijepog liječenja, prema mjerenju općeg kliničkog dojma težine (CGI-S) koje uključuje procjenu funkcioniranja, značajno veći udio bolesnika bio je normalan ili granično mentalno bolestan u skupini koja je primala gvanfacin u usporedbi sa skupinom koja je primala placebo.
English: Guanfacine showed significantly greater improvement compared to placebo regardless of time (AM or PM) of administration (placebo-adjusted LS mean difference of -9.4 and -9.8 for AM and PM dosing, respectively, p<0.001).
Croatian: Gvanfacin je pokazao značajno veće poboljšanje u usporedbi s placebom bez obzira na vrijeme primjene (ujutro ili navečer) (placebu prilagođena razlika srednjih vrijednosti dobivenih metodom najmanjih kvadrata od -9,4 za doziranje ujutro i -9,8 za doziranje navečer, p<0,001).
English: 49.5-58.4 kg Max
Croatian: 49,5-58,4 kg Najviša doza = 6 mg
English: QT Prolonging medicinal products
Croatian: Lijekovi koji produljuju QT interval
English: Intuniv 1 mg prolonged-release tablets Intuniv 2 mg prolonged-release tablets Intuniv 3 mg prolonged-release tablets Intuniv 4 mg prolonged-release tablets
Croatian: Intuniv 1 mg tablete s produljenim oslobađanjem Intuniv 2 mg tablete s produljenim oslobađanjem Intuniv 3 mg tablete s produljenim oslobađanjem Intuniv 4 mg tablete s produljenim oslobađanjem
English: This leaflet was last revised in 09/2017.
Croatian: Ova uputa je zadnji puta revidirana u
English: • feeling unwell (malaise).
Croatian: • loše osjećanje (malaksalost).
English: Dose Titration Schedule for Adolescents (Aged 13-17 Years)
Croatian: Raspored titriranja doze za adolescente (u dobi od 13 do 17 godina) Skupina po težini a tjedan tjedan tjedan tjedan
English: What you need to know before you take Intuniv
Croatian: Što morate znati prije nego počnete uzimati Intuniv Nemojte uzimati Intuniv:
English: Adverse Drug Reactions Reported with Intuniv System/Organ Class
Croatian: Tablica 4. Nuspojave prijavljene uz Intuniv Klasifikacija organskih sustava Nuspojava
English: In post-marketing experience, hypertensive encephalopathy has been very rarely reported upon abrupt discontinuation of Intuniv (see section 4.4).
Croatian: Nakon stavljanja lijeka na tržište vrlo rijetko je prijavljivana hipertenzivna encefalopatija nakon naglog prekida primjene lijeka Intuniv (vidjeti dio 4.4).
English: How to store Intuniv
Croatian: Kako čuvati Intuniv
English: • Summary of Product Characteristics (SmPC) and Package Leaflet
Croatian: • Sažetak opisa svojstava lijeka (SPC) i uputa o lijeku
English: What Intuniv is used for
Croatian: Za što se Intuniv koristi
English: Each 3 mg tablet contains 37.81 mg of lactose (as monohydrate).
Croatian: Jedna tableta od 3 mg sadrži 37,81 mg laktoze (u obliku hidrata).
English: Blood pressure and heart rate increase upon discontinuation of Intuniv Blood pressure and pulse may increase following discontinuation of Intuniv.
Croatian: Porast krvnog tlaka i srčane frekvencije nakon prekida primjene lijeka Intuniv Nakon prekida primjene lijeka Intuniv može doći do porasta krvnog tlaka i pulsa.
English: 34-41.4 kg Max
Croatian: 34-41,4 kg Najviša doza = 4 mg
English: Patients treated with CYP3A4 and CYP3A5 inhibitors/inducers CYP3A4/5 inhibitors have been shown to have a significant effect on the pharmacokinetics of guanfacine when co-administered.
Croatian: Pokazalo se da inhibitori CYP3A4/5 imaju značajan učinak na farmakokinetiku gvanfacina kad se primjenjuju istovremeno.
English: • social therapy
Croatian: • socijalnu terapiju.
English: Somnolence/sedation, hypotension, bradycardia and syncope In the overall pool of guanfacine-treated patients, somnolence occurred in 40.6% and sedation in 10.2% of guanfacine-treated patients.
Croatian: U cjelokupnom objedinjenom skupu bolesnika liječenih gvanfacinom, somnolencija je nastala u 40,6%, a sedacija u 10,2% bolesnika liječenih gvanfacinom.
English: • indigestion (dyspepsia)
Croatian: • probavne tegobe (dispepsija)
English: 28 prolonged-release tablets 84 prolonged-release tablets
Croatian: 28 tableta s produljenim oslobađanjem 84 tablete s produljenim oslobađanjem
English: 41.5-49.4 kg Max
Croatian: 41,5-49,4 kg Najviša doza = 5 mg
English: 7 prolonged-release tablets 28 prolonged-release tablets 84 prolonged-release tablets
Croatian: 7 tableta s produljenim oslobađanjem 28 tableta s produljenim oslobađanjem 84 tablete s produljenim oslobađanjem
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.
Croatian: Ako se nešto od gore navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku ili ljekarniku prije nego što uzmete ovaj lijek.
English: Some of these side effects are more likely to occur at the start of treatment and may disappear as you continue with your treatment, if you experience any of these side effects contact your doctor straight away.
Croatian: Vjerojatnost nastanka nekih od ovih nuspojava veća je na početku liječenja i one mogu nestati s nastavkom liječenja.
English: Blood pressure and heart rate increase upon discontinuation Blood pressure and pulse may increase following discontinuation of Intuniv.
Croatian: Porast krvnog tlaka i srčane frekvencije nakon prekida primjene lijeka Nakon prekida primjene lijeka Intuniv može doći do porasta krvnog tlaka i pulsa.
English: 7 prolonged-release tablets 28 prolonged-release tablets
Croatian: 7 tableta s produljenim oslobađanjem 28 tableta s produljenim oslobađanjem
English: Intuniv 1 mg pack sizes: 7 or 28 tablets.
Croatian: Intuniv 1 mg veličine pakiranja: 7 ili 28 tableta.
English: Effects on height, weight and Body Mass index (BMI) Children and adolescents treated with Intuniv may show an increase in their BMI.
Croatian: U djece i adolescenata liječenih Intunivom može nastupiti povećanje ITM-a.
English: Each 4 mg tablet contains 50.42 mg of lactose (as monohydrate).
Croatian: Jedna tableta od 4 mg sadrži 50,42 mg laktoze (u obliku hidrata).
English: Intuniv 1 mg tablet
Croatian: Intuniv 1 mg tableta
English: Intuniv 2 mg tablet EU/1/15/1040/003-005
Croatian: Intuniv 2 mg tableta EU/1/15/1040/003-005
English: CYP3A4 and CYP3A5 inhibitors
Croatian: Inhibitori CYP3A4 i CYP3A5
English: o somnolence and sedation o hypotension o bradycardia
Croatian: Somnolencija/sedacija, hipotenzija, bradikardija i sinkopa
English: Intuniv 4 mg tablet EU/1/15/1040/008-009
Croatian: Intuniv 4 mg tableta EU/1/15/1040/008-009
English: Intuniv 3 mg tablet EU/1/15/1040/006-007
Croatian: Intuniv 3 mg tableta EU/1/15/1040/006-007
English: Intuniv 4 mg tablet
Croatian: Intuniv 4 mg tableta
English: Intuniv 2 mg tablet
Croatian: Intuniv 2 mg tableta
English: 12.34mm x 6.10mm oblong shaped, green tablets debossed with ‘4MG' on one side and ‘503' on the other side.
Croatian: Zelene tablete dugoljastog oblika, dimenzija 12,34 mm x 6,10 mm, s utisnutom oznakom ‘4MG' na jednoj strani i ‘503' na drugoj strani.
English: Each 2 mg tablet contains 44.82 mg of lactose (as monohydrate).
Croatian: Jedna tableta od 2 mg sadrži 44,82 mg laktoze (u obliku hidrata).
English: Intuniv 4 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine.
Croatian: Intuniv 4 mg tableta Jedna tableta sadrži 4 mg gvanfacina u obliku gvanfacinklorida.
English: Intuniv 2 mg pack sizes: 7, 28 or 84 tablets.
Croatian: Intuniv 2 mg veličine pakiranja: 7, 28 ili 84 tablete.
English: Each 1 mg tablet contains 22.41 mg of lactose (as monohydrate).
Croatian: Jedna tableta od 1 mg sadrži 22,41 mg laktoze (u obliku hidrata).
English: Intuniv 1 mg tablet EU/1/15/1040/001-002
Croatian: Intuniv 1 mg tableta EU/1/15/1040/001-002
English: Aprepitant
Croatian: Doziranje
English: Strong CYP3A4/5 inhibitors CYP3A4 inducers
Croatian: Jaki inhibitori CYP3A4/5 Induktori CYP3A4
English: Guanfacine also showed significant improvement in learning, school and family functioning as measured with the (WFIRS-P score).
Croatian: Prema rezultatu na ljestvici WFIRS-P, skupina koja je primala gvanfacin također je pokazala značajno poboljšanje u učenju i funkcioniranju u školi i obitelji.
English: Common: feeling drowsy (sedation), feeling dizzy (hypotension), slow heart beat (bradycardia).
Croatian: Zabilježene su sljedeće ozbiljne nuspojave: često: osjećaj omamljenosti (sedacija), osjećaj omaglice (hipotenzija), usporeni otkucaji srca (bradikardija); manje često: osjećaj nesvjestice ili gubitak svijesti (sinkopa).
English: 7.14mm round, white to off-white tablets debossed with ‘1MG' on one side and ‘503' on the other side.
Croatian: Bijele do gotovo bijele, okrugle tablete, promjera 7,14 mm, s utisnutom oznakom ‘1MG' na jednoj strani i ‘503' na drugoj strani.
English: Treatment groups
Croatian: Terapijs ke skupine
English: • diarrhoea, abdominal discomfort or constipation
Croatian: • proljev, nelagoda u trbuhu ili zatvor
English: Skin and subcutaneous tissue disorders Rash
Croatian: Poremećaji kože i potkožnog tkiva osip često pruritis manje često
English: • need to urinate frequently (pollakiuria)
Croatian: • potreba za učestalim mokrenjem (polakizurija)
English: Intuniv 3 mg tablet 7.94mm round, green tablets debossed with ‘3MG' on one side and ‘503' on the other side.
Croatian: Zelene, okrugle tablete, promjera 7,94 mm, s utisnutom oznakom ‘3MG' na jednoj strani i ‘503' na drugoj strani.
English: EU/1/15/1040/003 7 prolonged-release tablets EU/1/15/1040/004 28 prolonged-release tablets EU/1/15/1040/005 84 prolonged-release tablets
Croatian: EU/1/15/1040/003 7 tableta s produljenim oslobađanjem EU/1/15/1040/004 28 tableta s produljenim oslobađanjem EU/1/15/1040/005 84 tablete s produljenim oslobađanjem
English: Intuniv 4 mg pack sizes: 28 or 84 tablets.
Croatian: Intuniv 4 mg veličine pakiranja: 28 ili 84 tablete.
English: Downward titration and discontinuation
Croatian: Postupno snižavanje doze i prestanak liječenja
English: Intuniv 3 mg pack sizes: 28 or 84 tablets.
Croatian: Intuniv 3 mg veličine pakiranja: 28 ili 84 tablete.
English: Telithromycin
Croatian: Oralni metilfenidat
English: 12.34mm x 6.10mm oblong shaped, white to off-white tablets debossed with ‘2MG' on one side and “503” on the other side.
Croatian: Bijele do gotovo bijele tablete dugoljastog oblika, dimenzija 12,34 mm x 6,10 mm, s utisnutom oznakom ‘2MG' na jednoj strani i “503” na drugoj strani.
English: • Each 2 mg tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine
Croatian: • Jedna tableta od 2 mg sadrži 2 mg gvanfacina u obliku gvanfacinklorida.
English: Moderate CYP3A4/5 inhibitors
Croatian: Umjereni inhibitori CYP3A4/5
English: • Each 1 mg tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine
Croatian: • Jedna tableta od 1 mg sadrži 1 mg gvanfacina u obliku gvanfacinklorida.
English: • The 1 mg prolonged-release tablets are round and white, hard tablets, debossed with 1MG on one side and 503 on the other side.
Croatian: • Tablete s produljenim oslobađanjem od 1 mg okrugle su, bijele, tvrde tablete s utisnutom oznakom 1MG na jednoj strani i 503 na drugoj strani.
English: Tell your doctor if you cannot swallow the tablet whole.
Croatian: Ako tabletu ne možete progutati cijelu, recite to svojem liječniku.
English: • The 4 mg prolonged-release tablets are oval and green, hard tablets, debossed with 4MG on one side and 503 on the other side.
Croatian: • Tablete s produljenim oslobađanjem od 4 mg ovalne su i zelene, tvrde tablete s utisnutom oznakom 4MG na jednoj strani i 503 na drugoj strani.
English: • reduced heart rate
Croatian: • usporeni puls
English: Chloramphenicol
Croatian: Gvanfaci n
English: 58.5 kg and above
Croatian: 58,5 kg i više Najviša doza = 7 mg
English: • The 2 mg prolonged-release tablets are oval and white, hard tablets, debossed with 2MG on one side and 503 on the other side.
Croatian: • Tablete s produljenim oslobađanjem od 2 mg ovalne su, bijele, tvrde tablete s utisnutom oznakom 2MG na jednoj strani i 503 na drugoj strani.
English: • Each 4 mg tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine
Croatian: • Jedna tableta od 4 mg sadrži 4 mg gvanfacina u obliku gvanfacinklorida.
English: EU/1/15/1040/001 7 prolonged-release tablets EU/1/15/1040/002 28 prolonged-release tablets
Croatian: EU/1/15/1040/001 7 tableta s produljenim oslobađanjem EU/1/15/1040/002 28 tableta s produljenim oslobađanjem
English: EU/1/15/1040/008 28 prolonged-release tablets EU/1/15/1040/009 84 prolonged-release tablets
Croatian: EU/1/15/1040/008 28 tablete s produljenim oslobađanjem EU/1/15/1040/009 84 tablete s produljenim oslobađanjem
English: Respiratory, thoracic, and mediastinal disorders Asthma
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja astma manje često
English: • The 3 mg prolonged-release tablets are round and green, hard tablets, debossed with 3MG on one side and 503 on the other side.
Croatian: • Tablete s produljenim oslobađanjem od 3 mg okrugle su i zelene, tvrde tablete s utisnutom oznakom 3MG na jednoj strani i 503 na drugoj strani.
English: Psychiatric disorders Depression
Croatian: Depresori SŽS-a
English: • Each 3 mg tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine
Croatian: • Jedna tableta od 3 mg sadrži 3 mg gvanfacina u obliku gvanfacinklorida.
English: • chest pain
Croatian: • suha usta
English: EU/1/15/1040/006 28 prolonged-release tablets EU/1/15/1040/007 84 prolonged-release tablets
Croatian: EU/1/15/1040/006 28 tableta s produljenim oslobađanjem EU/1/15/1040/007 84 tablete s produljenim oslobađanjem
English: Intuniv 2 mg prolonged-release tablets Guanfacine
Croatian: Intuniv 2 mg tablete s produljenim oslobađanjem gvanfacin
English: Intuniv 3 mg prolonged-release tablets Guanfacine
Croatian: Intuniv 3 mg tablete s produljenim oslobađanjem gvanfacin
English: Intuniv 4 mg prolonged-release tablets Guanfacine
Croatian: Intuniv 4 mg tablete s produljenim oslobađanjem gvanfacin
English: Methacrylic acid-Ethyl acrylate copolymer Lactose monohydrate Povidone
Croatian: • Drugi sastojci su hipromeloza, metakrilatna kiselina-etilakrilat kopolimer, laktoza hidrat,
English: Each tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine.
Croatian: Jedna tableta sadrži 2 mg gvanfacina u obliku gvanfacinklorida.
English: Intuniv 1mg prolonged-release tablets Intuniv 2mg prolonged-release tablets Intuniv 3mg prolonged-release tablets Intuniv 4mg prolonged-release tablets
Croatian: Intuniv 1 mg tablete s produljenim oslobađanjem Intuniv 2 mg tablete s produljenim oslobađanjem Intuniv 3 mg tablete s produljenim oslobađanjem Intuniv 4 mg tablete s produljenim oslobađanjem gvanfacin
English: Intuniv 1 mg prolonged-release tablets Guanfacine
Croatian: Intuniv 1 mg tablete s produljenim oslobađanjem gvanfacin
English: Each tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine.
Croatian: Jedna tableta sadrži 1 mg gvanfacina u obliku gvanfacinklorida.
English: Vascular disorders Hypotension
Croatian: Oštećenje funkcije jetre
English: Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine.
Croatian: Jedna tableta sadrži 3 mg gvanfacina u obliku gvanfacinklorida.
English: Atomoxetine
Croatian: Atomokse tin
English: • The other ingredients are hypromellose, methacrylic acid-ethyl acrylate copolymer, lactose monohydrate, povidone, crospovidone (Type A), microcrystalline cellulose, silica colloidal anhydrous, sodium laurilsulphate, polysorbate 80, fumaric acid, glyceryl dibehenate.
Croatian: HIV infekcije ciprofloksacin, kloramfenikol, klaritromicin, eritromicin, rifabutin, rifampicin, telitromicin bakterijskih infekcija flukonazol, itrakonazol, posakonazol gljivičnih infekcija krizotinib, imatinib raka diltiazem, verapamil kardiovaskularnih stanja boceprevir, telaprevir virusnog hepatitisa subokson ovisnosti o drogama bosentan kardiovaskularnih stanja (npr. stezanje krvnih žila u plućima)
English: Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine.
Croatian: Jedna tableta sadrži 4 mg gvanfacina u obliku gvanfacinklorida.
English: Adverse Drug Reactions Reported with Intuniv
Croatian: Sadržaj pakiranja i druge informacije Što Intuniv sadrži
English: Nausea and vertigo.
Croatian: • mučnina i povraćanje
English: There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer.
Croatian: Kad se primjenjivao istovremeno s rifampinom, induktorom CYP3A4, došlo je do značajnog sniženja brzine i opsega izloženosti gvanfacinu.
English: Saquinavir
Croatian: FARMACEUTSKI
English: Dose= 4 mg
Croatian: 25 kg i više Najviša doza = 4 mg
English: What is colistin?
Croatian: Što je kolistin?
English: 14 July 2016
Croatian: 14. srpnja 2016.
English: Following a request from the European Commission, in July 2013 the CVMP and CHMP adopted scientific advice and detailed considerations on colistin
Croatian: Na zahtjev Europske komisije, CVMP i CHMP usvojili su u srpnju 2013. znanstveni savjet i detaljna razmatranja o kolistinu
English: The European Commission issued a decision on 14 July 2016.
Croatian: Europska komisija objavila je odluku dana 14. srpnja 2016.
English: 2 restricting the indications, target species, and duration of treatment of the concerned products, as well as adding prudent use warnings to the product information.
Croatian: 2 o ograničavanju indikacija, ciljanih vrsta i trajanja liječenja za dotične proizvode i dodavanju upozorenja o opreznoj uporabi u informacije o proizvodu.
English: This advice critically reviewed information on
Croatian: U tom su savjetu kritički preispitane informacije o primjeni kolistina u
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/111)
Croatian: Ishod postupka upućivanja u skladu s člankom 35. Direktive 2001/82/EZ (EMEA/V/A/111)
English: Colistin is used for the treatment and prevention of diseases caused by sensitive bacteria (e.g. Escherichia coli) in pigs, poultry, rabbits, cattle, sheep and goats.
Croatian: Kolistin se upotrebljava za liječenje i sprečavanje bolesti uzrokovanih osjetljivim bakterijama (npr. Escherichia coli) u svinja, peradi, zečeva, goveda, ovaca i koza.
English: These include veterinary medicinal products containing combinations of colistin with 14 different antimicrobial substances, belonging to different classes e.g. β-lactams, tetracyclines, macrolides, sulfonamides and trimethoprim (see Annex I on the 'All documents' tab).
Croatian: One uključuju veterinarsko-medicinske proizvode koji sadrže kombinacije kolistina s 14 različitih antimikrobnih tvari koje pripadaju različitim klasama, npr. β-laktamazama, tetraciklinima, makrolidima, sulfonamidima i trimetoprimima (vidjeti Prilog I. u kartici „Svi dokumenti”).
English: the use of colistin in food-producing animals in the EU, its effect on the development of resistance to this category of antimicrobial agents in bacterial species that are of importance for human and animal health and the possible impact on human and animal health.
Croatian: životinja koje se upotrebljavaju za proizvodnju hrane u EU-u, njegovim učincima na razvoj rezistencije na ovu kategoriju antimikrobnih agensa u bakterijskih vrsta koje su važne za zdravlje ljudi i životinja te mogućem utjecaju na zdravlje ljudi i životinja.
English: Combinations of colistin with other antimicrobials are available for group treatments of gastro-intestinal and respiratory infections in food-producing animals in different European Member States.
Croatian: Kombinacije kolistina s drugim antimikrobnim lijekovima dostupne su za skupno liječenje gastrointestinalnih i respiratornih infekcija u životinja koje se upotrebljavaju za proizvodnju hrane u različitim državama članicama EU-a.
English: Proprietary data, scientific references and expert reports were provided in this Article 35 referral procedure in support of some indications of some of the products included in the scope of the procedure.
Croatian: U tom postupku upućivanja u skladu s člankom 35. dostavljeni su podaci proizvođača, znanstveni referentni izvori i stručna izvješća koji idu u prilog određenim indikacijama nekih od proizvoda obuhvaćenih ovim postupkom.
English: Questions and answers on veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally EMA/461505/2016
Croatian: Pitanja i odgovori o veterinarsko-medicinskim proizvodima koji sadrže kolistin u kombinaciji s drugim antimikrobnim tvarima za oralnu primjenu EMA/461505/2016