FrancophonIA/ELRC3.0 huggingface dataset:
English: In infants/newborn infants younger than 3 months a transient, clinically not relevant increase in blood pigment levels “methaemoglobinaemia” is commonly observed up to 12 hours after EMLA is put on.
Croatian: Kod novorođenčadi i dojenčadi mlađe od 3 mjeseca često se vidi prolazan, klinički beznačajan porast razina krvnog pigmenta pod nazivom “methemoglobinemija” do 12 sati nakon nanošenja lijeka EMLA.
English: The usual dose is 1 g of cream (1g to 2 g for female genital skin) for each area of skin that is 10 cm2 (10 square centimetres) in size.
Croatian: - Uobičajena doza je 1 g kreme (1 g do 2 g za kožu ženskih spolnih organa) za svako područje kože veličine 10 cm2 (10 kvadratnih centimetara).
English: EMLA should not be applied to an impaired eardrum.
Croatian: EMLA se ne smije stavljati na oštećen bubnjić.
English: Application time: 30 minutes
Croatian: Prije odstranjivanja moluska Vrijeme primjene: 30 minuta
English: Hypersensitivity1, 2, 3
Croatian: Poremećaji imunološkog sustava preosjetljivost1, 2, 3
English: How to store EMLA
Croatian: Kako čuvati lijek EMLA
English: EMLA works by numbing the surface of the skin for a short time.
Croatian: EMLA djeluje tako da kratkotrajno umrtvi osjet na površini kože.
English: The usual dose is 1.5 g to 2 g of cream for each of area of skin that is 10 cm2 (10 square centimetres) in size.
Croatian: - Uobičajena doza je 1,5 g do 2 g kreme za svako područje kože veličine 10 cm2 (10 kvadratnih centimetara).
English: Up to 20 g and 200 cm2 for 1-5 hours6)
Croatian: Do 20 g i 200 cm2 tijekom 1-5 sati6)
English: Up to 10 g and 100 cm2 for 1-5 hours6)
Croatian: Do 10 g i 100 cm2 tijekom 1-5 sati6)
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Croatian: Emla Cream 5% Ova uputa je zadnji puta revidirana u <{MM/GGGG}> <{mjesec GGGG}>.
English: Plasma concentrations of lidocaine and prilocaine in both geriatric and non-geriatric patients following application of EMLA to intact skin are very low and well below potentially toxic levels.
Croatian: Plazmatske koncentracije lidokaina i prilokaina nakon primjene EMLA kreme na neoštećenoj koži vrlo su niske i znatno ispod potencijalno toksičnih razina i kod starijih bolesnika i kod onih koji nisu starije dobi.
English: Up to 2 g and 20 cm2 for one hour5)
Croatian: Do 2 g i 20 cm2 tijekom jednog sata5)
English: In particular, tell your doctor or pharmacist if you or your child have recently used or been given any of the following medicines:
Croatian: Naročito obavijestite svog liječnika ili ljekarnika ako ste Vi ili Vaše dijete nedavno uzimali ili primili neki od sljedećih lijekova: • lijekove za liječenje infekcija koji se zovu ‘sulfonamidi' i nitrofurantoin.
English: Genital mucosa
Croatian: Genitalna sluznica
English: Up to 1 g and 10 cm2 for one hour4)
Croatian: Do 1 g i 10 cm2 tijekom jednog sata4)
English: Application site warmth 2, 3
Croatian: toplina na mjestu primjene2, 3
English: The Netherland
Croatian: Nizozemska
English: There was no benefit of EMLA versus placebo for liquid nitrogen cryotherapy of common warts No adequate efficacy for circumcision could be demonstrated.
Croatian: EMLA krema nije ostvarila koristan učinak naspram placeba kod krioterapije običnih bradavica tekućim dušikom.
English: Methaemoglobinaemia1
Croatian: osjećaj pečenja1
English: Application site irritation3
Croatian: iritacija na mjestu primjene3
English: Use on the skin before small procedures (such as having a needle put in or minor skin operations):
Croatian: Primjena na kožu prije malih postupaka (primjerice uvođenja igle ili manjih operacija na koži): - Krema se nanosi na kožu u debelom sloju.
English: 6.6 Special precautions for disposal and other handling Precautions to be taken before handling or administering the medicinal product Persons frequently applying or removing cream should ensure that contact is avoided in order to prevent the development of hypersensitivity.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Mjere opreza koje se moraju poduzeti prije rukovanja lijekom ili prije primjene lijeka
English: Adults only
Croatian: Starije osobe
English: PHARMACEUTICAL FORM AND CONTENTS [To be completed nationally] METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku.
English: Corneal irritation1
Croatian: Poremećaji oka iritacija rožnice1
English: Newborn infants and infants 0-2
Croatian: Novorođenčad i dojenčad od
English: How to use EMLA
Croatian: Kako primjenjivati lijek EMLA
English: The maximum observed plasma concentration for lidocaine, monoglycinexylidide and 2,6-xylidine were 0.41, 0.03 and 0.01 µg/mL respectively.
Croatian: Maksimalna opažena plazmatska koncentracija lidokaina bila je 0,41 µg/ml, monoglicineksilidida 0,03 µg/ml, a 2,6-ksilidina 0,01 µg/ml.
English: EMLA has no or negligible influence on the ability to drive and use machines when used at the recommended doses.
Croatian: Kad se primjenjuje u preporučenim dozama, EMLA ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Burning sensation2, 3 Application site pruritus 2, 3
Croatian: Opći poremećaji i reakcije na mjestu primjene osjećaj pečenja2, 3
English: EMLA and associated names (see Annex I) 25mg/g + 25mg/g cream [See Annex I - To be completed nationally]
Croatian: EMLA i pridružena imena (vidjeti Dodatak I) 25 mg/g + 25 mg/g krema [Vidjeti Dodatak I - ispunjava država članica]
English: Skin of female genital organs Prior to injection of local anaesthetics2)
Croatian: Prije injekcije lokalnih anestetika2)
English: Paediatric population Studies have been unable to demonstrate the efficacy of EMLA for heel lancing in newborn infants.
Croatian: Ispitivanja nisu pokazala djelotvornost EMLA kreme kod vađenja krvi iz pete novorođenčadi.
English: Immune system disorders
Croatian: Organski sustav
English: EMLA should not be applied to an impaired tympanic membrane.
Croatian: EMLA se ne smije nanositi na oštećen bubnjić.
English: When you use EMLA before being vaccinated with live vaccines (e.g. tuberculosis vaccine), you should return to your doctor or nurse after the time period requested to follow-up the vaccination result.
Croatian: Ako primijenite lijek EMLA prije nego što primite živo cjepivo (npr. cjepivo protiv tuberkuloze),
English: Application site paraesthesia2 such as tingling
Croatian: parestezija na mjestu primjene2, primjerice trnci toplina na mjestu primjene1
English: Skin and subcutaneous tissue disorders
Croatian: lidokain / prilokain Za kožu
English: minutes, the maximum plasma concentrations of lidocaine (range 0.05-0.25 µg/mL, one individual value of 0.84 µg/mL) and of prilocaine (0.02-0.08 µg/mL) were reached within 1 to 2.5 hours.
Croatian: Nakon jednokratne primjene 5 do 10 g EMLA kreme na ulkusima na nogama, na području do 64 cm2 tijekom 30 minuta, maksimalne plazmatske koncentracije lidokaina (raspon 0,05-0,25 µg/ml, jedna individualna vrijednost od 0,84 µg/ml) i prilokaina (0,02-0,08 µg/ml) postignute su unutar 1 do 2,5 sati.
English: Feeling light-headed or dizzy.
Croatian: - ošamućenost ili omaglica.
English: Your doctor, pharmacist or nurse will tell you where to put it.
Croatian: Vaš liječnik, ljekarnik ili medicinska sestra reći će
English: Cutaneous use SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: Their frequency of Adverse Reactions is listed by MedDRA System Organ Class (SOC) and at the preferred term level.
Croatian: Učestalost nuspojava navedena je prema MedDRA klasifikaciji organskih sustava i preporučenim pojmovima.
English: Application site erythema1, 2, 3
Croatian: eritem na mjestu primjene1, 2, 3
English: Application site oedema 1, 2, 3
Croatian: edem na mjestu primjene1, 2, 3
English: In studies of split-skin grafting in adults application for up to 7hours 40 minutes to the thigh or upper arm to an area of up to 1,500 cm2 resulted in maximum plasma concentrations not exceeding 1.1 µg/mL
Croatian: 7 sati i 40 minuta na bedru ili nadlaktici, na području do 1500 cm2, maksimalna koncentracija u plazmi nije premašila 1,1 µg/ml za lidokain i 0,2 µg/ml za prilokain.
English: 3) Plasma concentrations have not been determined in patients treated with doses of >10 g (see also Section 4) In adolescents weighing less than 20 kg the maximum dose of EMLA on genital mucosa should be proportionally reduced.
Croatian: 3) Nisu mjerene koncentracije u plazmi bolesnika liječenih dozama >10 g (vidjeti i dio 5.2).
English: Numbness (tingling) in the treated area during treatment of the genital mucosa Irritation of the treated skin during treatment of leg ulcers.
Croatian: - Utrnulost (trnci) na liječenom području tijekom primjene na sluznici spolnih organa
English: The incidences of the Adverse Drug Reactions (ADRs) associated with EMLA therapy is tabulated below.
Croatian: Incidencije nuspojava na lijek kod liječenja lijekom EMLA prikazane su u sljedećoj tablici.
English: Mechanical cleansing/debridement
Croatian: lidokain / prilokain
English: Transient local skin reactions (paleness, redness, swelling) in the treated area during treatment of skin, genital mucosa or leg ulcers.
Croatian: Česte (mogu se javiti u do 1 na 10 osoba) - prolazne lokalne kožne reakcije (bljedilo, crvenilo, oteklina) na liječenom području tijekom primjene na koži, sluznici spolnih organa ili ulkusima na nogama.
English: (especially after longer application times in children with atopic dermatitis or mollusca contagiosa)
Croatian: Poremećaji kože i potkožnog tkiva purpura1, petehije1 (osobito nakon duljeg vremena primjene kod djece s atopijskim dermatitisom ili zaraznim moluskama)
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally] INSTRUCTIONS ON USE Read the package leaflet before use.
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku.
English: Application site pallor 1,
Croatian: pruritus na mjestu primjene1
English: Adults and Adolescents It can also be used:
Croatian: Također se može koristiti:
English: A mild reaction (paleness or redness of the skin, slight puffiness, initial burning or itching) may occur on the area on which EMLA is used.
Croatian: Na mjestu primjene lijeka EMLA može nastupiti blaga reakcija (bljedilo ili crvenilo kože, blaga natečenost, početno peckanje ili svrbež).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION EMLA and associated names (see Annex I) 25mg/g + 25mg/g cream [See Annex I - To be completed nationally] lidocaine / prilocaine
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA EMLA i pridružena imena (vidjeti Dodatak I) 25 mg/g + 25 mg/g krema
English: The usual dose is 1 g of cream for each area of skin that is 10 cm² (10 square centimetres) in size, applied for 1 to 5 hours under a dressing.
Croatian: Uobičajena doza je 1 g kreme za svako područje kože veličine 10 cm² (10 kvadratnih centimetara),
English: Table 3 Adverse reactions System Organ Class
Croatian: Tablica 3 Nuspojave
English: NAME OF THE MEDICINAL PRODUCT EMLA and associated names (see Annex I) 25mg/g + 25mg/g cream [See Annex I - To be completed nationally]
Croatian: NAZIV LIJEKA EMLA i pridružena imena (vidjeti Dodatak I) 25 mg/g + 25 mg/g krema
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally] INSTRUCTIONS ON USE
Croatian: POPIS POMOĆNIH TVARI [Ispunjava država članica]
English: hour period.
Croatian: Način primjene.
English: 1 g/10 cm2
Croatian: 0 - 3 mjeseca 1 g/10 cm2
English: Use on genital skin before injections of local anaesthetics EMLA can be used in this way on adults and adolescents over 12 years only.
Croatian: - EMLA se na ovaj način smije primjenjivati samo kod odraslih i adolescenata starijih od
English: The European Commission issued a decision on 20 June 2017.
Croatian: Europska komisija donijela je odluku 20. lipnja 2017.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 June 2017
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20. lipnja 2017.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/119)
Croatian: Ishod arbitražnog postupka u skladu s člankom 35. Direktive 2001/82/EZ (EMEA/V/A/119)
English: On 2 May 2016, Germany initiated a referral procedure under Article 35 of Directive 2001/82/EC for the aforementioned products.
Croatian: Njemačka je 2. svibnja 2016. pokrenula arbitražni postupak u skladu s člankom 35. Direktive 2001/82/EZ za navedene proizvode.
English: Veterinary medicinal products containing methylprednisolone hydrogen succinate are used for treatment of inflammatory or allergic conditions and also for treatment and prevention of shock conditions.
Croatian: Veterinarskomedicinski proizvodi koji sadrže metilprednizolon vodik sukcinat koriste se za liječenje upalnih ili alergijskih stanja, kao i za liječenje te prevenciju stanja šoka.
English: Germany considered that the withdrawal period of 6 days for cattle (meat and offal) treated with methylprednisolone hydrogen succinate-containing products might not be sufficient to ensure consumer safety.
Croatian: Njemačka je smatrala da razdoblje karencije od šest dana za goveda (meso i iznutrice) liječena proizvodima koji sadrže metilprednizolon vodik sukcinat možda nije dovoljno za osiguravanje sigurnosti potrošača.
English: In the absence of product-specific residue depletion data or any other information concerning residues of veterinary medicinal products containing methylprednisolone hydrogen succinate, the CVMP considered the available residue depletion data used for the establishment of maximum residue limits for methylprednisolone (EMEA/MRL/798/01)1.
Croatian: U nedostatku podataka o izlučivanju rezidua specifičnih za veterinarsko-medicinski proizvod ili bilo kojih drugih informacija koje se odnose na rezidue veterinarsko-medicinskih proizvoda koji sadrže metilprednizolon vodik sukcinat, CVMP je razmotrio dostupne podatke o izlučivanju rezidua koji su upotrijebljeni za utvrđivanje najvećih dopuštenih količina rezidua za metilprednizolon (EMEA/MRL/798/01)1.
English: Why were veterinary medicinal products containing methylprednisolone hydrogen succinate reviewed?
Croatian: Zašto su ocjenjivani veterinarsko-medicinski proizvodi koji sadrže metilprednizolon vodik sukcinat?
English: On 16 March 2017, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods for cattle (meat and offal) for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection.
Croatian: Europska agencija za lijekove (Agencija) dovršila je 16. ožujka 2017. ocjenjivanje sigurnosti potrošača u pogledu razdoblja karencije za goveda (meso i iznutrice) kod veterinarsko-medicinskih proizvoda koji sadrže metilprednizolon vodik sukcinat dostupnih u obliku otopine za injekciju.
English: What is methylprednisolone hydrogen succinate?
Croatian: Što je metilprednizolon vodik sukcinat?
English: The CVMP was requested to review all available residue depletion data and to recommend withdrawal periods for meat and offal derived from treated cattle.
Croatian: Od CVMP-a je zatraženo da pregleda sve dostupne podatke o izlučivanju rezidua i preporuči razdoblja karencije za meso i iznutrice dobivene od liječenih goveda.
English: Based on the evaluation of the currently-available data, the CVMP concluded that the benefit-risk balance for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection is not favourable in the absence of adequate residue depletion data to justify a withdrawal period of 6 days for cattle (meat and offal).
Croatian: Na temelju evaluacije trenutačno dostupnih podataka, CVMP je zaključio da omjer koristi i rizika za veterinarsko-medicinske proizvode koji sadrže metilprednizolon vodik sukcinat dostupne u obliku otopine za injekcije nije povoljan jer nedostaju prikladni podatci o izlučivanju rezidua kojima bi se opravdalo razdoblje karencije od šest dana za goveda (meso i iznutrice).
English: The CVMP recommended the refusal of the granting of a marketing authorisation for the target species cattle and variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate.
Croatian: CVMP je preporučio da se odbije izdavanje odobrenja za stavljanje u promet za ciljne vrste goveda i izmijene postojeća odobrenja za stavljanje u promet kako bi se uklonila sva upućivanja na ciljnu vrstu goveda za veterinarsko-medicinske proizvode koji sadrže metilprednizolon vodik sukcinat.
English: The CVMP recommended the refusal of the granting of a marketing authorisation for the target species cattle and variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection.
Croatian: CVMP je preporučio da se odbije izdavanje odobrenja za stavljanje u promet za ciljne vrste goveda i izmijene postojeća odobrenja za stavljanje u promet kako bi se uklonila sva upućivanja na ciljnu vrstu goveda za veterinarsko-medicinske proizvode koji sadrže metilprednizolon vodik sukcinat dostupne u obliku otopine za injekciju.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in the absence of appropriate residue depletion data, a withdrawal period for meat and offal derived from treated cattle cannot be set.
Croatian: Odbor za veterinarskomedicinske proizvode (CVMP) pri Agenciji zaključio je da se ne može utvrditi razdoblje karencije za meso i iznutrice dobivene od liječenih goveda zbog nedostatka odgovarajućih podataka o izlučivanju rezidua.
English: The warnings in the product information remain appropriate.
Croatian: Upozorenja sadržana u informacijama o proizvodu ostaju primjerena.
English: The application was submitted to France as reference Member State and to Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom as concerned Member States.
Croatian: Zahtjev je dostavljen Francuskoj kao referentnoj državi članici i Austriji, Belgiji, Bugarskoj, Cipru, Češkoj Republici, Danskoj, Estoniji, Finskoj, Njemačkoj, Grčkoj, Mađarskoj, Irskoj, Italiji, Latviji, Litvi, Luksemburgu, Nizozemskoj, Norveškoj, Poljskoj, Portugalu, Rumunjskoj, Slovačkoj, Sloveniji, Španjolskoj i Ujedinjenoj Kraljevini kao državama članicama u postupku.
English: The variation procedure (FR/V/0167/01/II/017) started on 28 January 2013.
Croatian: Postupak izmjene (FR/V/0167/01/II/017) pokrenut je dana 28. siječnja 2013.
English: Treatment failures between Day 8 and Day 18 were considered relapses.
Croatian: Neuspjeh terapije između 8. i 18. dana smatrao se relapsima.
English: The follow up of animals was sufficiently long as to observe the same clinical disease progression in the control group as in the field.
Croatian: Praćenje životinja bilo je dovoljno dugo kako bi se uočila ista klinička progresija u kontrolnoj skupini kao i na terenu.
English: 49071 Beaucouzé France
Croatian: 49071 Beaucouzé Francuska
English: The submitted studies are considered to be well conducted.
Croatian: Zaključeno je da su dostavljena ispitivanja dobro provedena.
English: Walton Manor, Walton Milton Keynes MK7 7AJ United Kingdom
Croatian: Walton Manor, Walton Milton Keynes MK7 7AJ Ujedinjeno Kraljevstvo
English: Mannheimia haemolytica was the most prevalent pathogen pre-treatment (142 isolates).
Croatian: Mannheimiahaemolytica bio je najčešći patogen prije liječenja (142 izolata).
English: for avoiding bias.
Croatian: kako bi se izbjegla pristranost.
English: This issue remained unsolved and therefore a CMDv procedure under Article 13(1) of Commission Regulation (EC) No 1234/2008 has started on 6 November 2013.
Croatian: Ovo je pitanje ostalo otvoreno, te je stoga CMDv pokrenuo postupak u skladu s člankom 13. stavkom 1. Uredbe Komisije (EZ) br. 1234/2008 dana 6. studenog 2013.
English: Risk management or mitigation measures
Croatian: Upravljanje rizikom ili mjere smanjivanja rizika
English: Intervet GesmbH Siemensstrasse 107 1210 Wien Austria
Croatian: Intervet GesmbH Siemensstrasse 107 1210 Wien Austrija
English: The MIC90 of the total population of M. bovis was 4 µg/ml.
Croatian: MIC90 ukupne populacije bakterije M. bovis iznosio je 4 µg/ml.
English: • the CVMP considered that no specific risk of antimicrobial resistance has been identified with the use of this product at the recommended dose;
Croatian: • CVMP je zaključio da nije utvrđen rizik od antimikrobne rezistencije prilikom uporabe ovog proizvoda u preporučenoj dozi;
English: INN Pharmaceutical form Strength Animal species
Croatian: INN Farmaceutski oblik Jačina Ciljna vrsta životinja
English: There are too many uncertainties in the PK/PD analysis to justify the dose.
Croatian: Prisutan je prevelik broj nesigurnosti u analizi FK/FD kako bi se opravdala doza.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Croatian: Popis naziva, farmaceutskog oblika , jačine veterinarsko medicinskog proizvoda, ciljne vrste,načina primjene, nositelja odobrenja u državama članicama
English: The tested group was compared to two control groups, one negative control (saline) and a positive control.
Croatian: Testna skupina je uspoređena s dvije kontrolne skupine, jednom negativnom kontrola (otopina) i pozitivnom kontrolom.
English: An additional statistical analysis has been carried out to demonstrate non-inferiority of florfenicol in comparison to the positive control with regards to the clinical cure rate on Day 7.
Croatian: Provedena je dodatna statistička analiza kako bi se dokazala neinferiornost florfenikolina u usporedbi s pozitivnom kontrolom u vezi s kliničkom stopom liječenja 7. dana.
English: Based on the absence of standardised method to determine MIC, it is difficult to follow resistance evolution in the different publications.
Croatian: Na temelju nepostojanja standardizirane metode za utvrđivanje MIK-a, teško je pratiti kretanje rezistencije u različitim publikacijama.
English: Intervet Ireland Ltd. Magna Drive Magna Business Park Citywest Rd.
Croatian: Magna Drive Magna Business Park Citywest Rd.
English: The differences in daily failure rates from Day 5 to Day 18 between the two treatment groups were not statistically significant at any of these days nor was the overall difference in cumulative failure rates from Day 5 to Day 18 (29.9% vs. 23.6%; p = 0.3682).
Croatian: Razlike u dnevnim stopama neuspjeha od 5. dana do 18. dana između dvije terapijske skupine nisu bile statistički značajne u bilo kojem od ovih dana, niti je cjelokupna razlika u kumulativnim stopama neuspjeha od 5. dana do 18. dana (29,9% u odnosu na 23,6%; p = 0,3682) bila od značaja.
English: Mycoplasma bovis was next with 63 isolates followed by Pasteurella multocida (50 isolates).
Croatian: Mycoplasma bovis bio je sljedeći sa 63 izolata, nakon čega je slijedio Pasteurellamultocida (50 izolata).
English: The experimental study performed in 2008 was blinded, randomised, and compliant with good clinical practice (GCP).
Croatian: Eksperimentalno ispitivanje provedeno 2008. bilo je slijepo, randomizirano i u skladu s dobrom kliničkom praksom (DKP).
English: This is in line with the recommendations of the CVMP guideline on statistical principles (EMA/CVMP/EWP/81976/2010)
Croatian: Ovo je u skladu s preporukama navedenima u smjernicama CVMP-a o statističkim načelima (EMA/CVMP/EWP/81976/2010)