FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 2 g of strontium ranelate.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna vrećica sadrži 2 g stroncijeva ranelata.
English: You should stop taking OSSEOR if you have to take oral tetracyclines such as doxycycline or quinolones such as ciprofloxacin (two types of antibiotics).
Croatian: Ako morate uzimati kroz usta tetracikline kao što je doksiciklin ili kinolone kao što je ciprofloksacin (dvije vrste antibiotika), morate prestati uzimati OSSEOR.
English: Other symptoms may be nausea/vomiting, sweating, shortness of breath, palpitations, (extreme) tiredness and/or dizziness.
Croatian: Drugi simptomi mogu biti: mučnina/povraćanje, znojenje, nedostatak zraka, osjećaj lupanja srca, (izrazit) umor i/ili omaglica.
English: − Blood clots in veins: pain, redness, swelling in your leg, sudden chest pain or difficulty breathing.
Croatian: - Krvni ugrušci u venama: bol, crvenilo, oteklina u nozi, iznenadna bol u prsištu ili poteškoće s disanjem.
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Croatian: Prilog IV Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: Musculoskeletal pain (muscle spasm, myalgia, bone pain, arthralgia and pain in extremity)
Croatian: Mišićno-koštana bol (spazam mišića, mialgija, bol u kostima, artralgija te bol u ekstremitetima)
English: In phase III studies, which demonstrated the anti-fracture efficacy of OSSEOR treatment, measured mean BMD increased from baseline with OSSEOR by approximately 4% per year at the lumbar spine and 2% per year at the femoral neck, reaching 13% to 15% and 5% to 6% respectively after 3 years, depending on the study.
Croatian: U ispitivanjima III. faze, kojima je dokazana djelotvornost OSSEOR -a u sprječavanju prijeloma, izmjerena BMD povećavala se pri uzimanju OSSEOR -a u odnosu na početnu vrijednost za oko 4 % godišnje u slabinskim kralješcima i oko 2 % godišnje u vratu bedrene kosti te se do kraja istraživanja, nakon 3 godine, ovisno o istraživanju, povećala za ukupno 13 % do 15 %, odnosno za 5 % do 6 %, ovisno o istraživanju.
English: Measurement of strontium concentration in iliac crest bone biopsies from patients treated for up to 60 months with strontium ranelate 2 g/day indicate that bone strontium concentrations may reach a plateau after about 3 years
Croatian: Mjerenja koncentracije stroncija u biopsijskom materijalu iz kriste ilijake bolesnika koji su do 60 mjeseci uzimali stroncijev ranelat u dozi od 2 g/dan pokazuju da koncentracija stroncija u kosti vjerojatno doseže plato nakon otprilike 3 godine terapije.
English: If you are taking medicines containing calcium, you should leave at least 2 hours before you take OSSEOR.
Croatian: Uzimate li lijekove koji sadržavaju kalcij, OSSEOR smijete uzeti tek nakon što prođu najmanje dva sata od uzimanja tih lijekova.
English: 84 sachets
Croatian: 84 vrećica
English: 100 sachets
Croatian: 100 vrećica
English: Peripheral oedema
Croatian: Periferni edemi
English: Aspartame (E951) Maltodextrin Mannitol (E421)
Croatian: 6.1 Popis pomoćnih tvari aspartam (E951) maltodekstrin manitol (E421)
English: At high doses, animal studies have shown reversible bone effects in the offspring of rats and rabbits treated during pregnancy (see section 5.3).
Croatian: Istraživanja u životinja pokazala su reverzibilne učinke na kost u mladunčadi ženki štakora i kunića, koje su primale velike doze stroncijeva ranelata za vrijeme graviditeta (vidjeti dio 5.3).
English: The elimination of strontium is time and dose independent.
Croatian: Eliminacija stroncija ne ovisi ni o vremenu ni o dozi.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Sachet
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Vrećica
English: Hypercholesterolaemia
Croatian: Hiperkolesterolemija
English: - Current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism.
Croatian: - Postojeći ili prethodni događaji venske tromboembolije (VTE), uključujući duboku vensku trombozu i plućnu emboliju.
English: Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome and toxic epidermal necrolysis* (see section
Croatian: Teške kožne nuspojave (SCARs): StevensJohnsonov sindrom i toksična epidermalna nekroliza* (vidjeti dio 4.4)#
English: No dose adjustment is required in patients with hepatic impairment(see section 5.2).
Croatian: U bolesnika s oštećenom funkcijom jetre dozu ne treba prilagođavati (vidjeti dio 5.2).
English: An a-posteriori analysis was performed on a subgroup of patients from the TROPOS study of particular medical interest and at high-risk of fracture [defined by a femoral neck BMD T-score ≤3 SD (manufacturer's range corresponding to -2.4 SD using NHANES III) and an age ≥ 74 years (n=1,977, i.e. 40% of the TROPOS study population)].
Croatian: Provedena je i a posteriori analiza podskupine bolesnica u ispitivanju TROPOS, koja je bila od osobitog medicinskog interesa i u koje je postojao visok rizik od prijeloma [definiran vrijednostima BMD vrata bedrene kosti ≤ -3 SD (raspon proizvođača lijeka, jednak je rasponu od -2,4 SD prema ljestvici NHANES III) i dobi ≥ 74 godine (n=1977, tj. oko 40 % populacije uključene u istraživanje TROPOS)].
English: o Current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism.
Croatian: o Postojećim ili prethodnim događajima venske tromboembolije (VTE), uključujući duboku vensku trombozu i plućnu emboliju.
English: Nausea, diarrhoea, headache, eczema, memory trouble, fainting fit, pins and needles, dizziness, vertigo.
Croatian: Mučnina, proljev, glavobolja, ekcem, poteškoće s pamćenjem, nesvjestica, trnci i bockanje, omaglica, vrtoglavica.
English: Disturbances in consciousness Memory loss
Croatian: Glavobolja Poremećaji svijesti Gubitak pamćenja Omaglica Parestezija
English: − Heart attack: sudden crushing pains in your chest which may reach your left arm, jaw, stomach, back and/or shoulders.
Croatian: Često (mogu se pojaviti u do 1 na 10 osoba) - Srčani udar: iznenadna, razarajuća bol u prsištu koja može ići u lijevu ruku, vilicu, želudac, leđa i/ili ramena.
English: Posology The recommended dose is one 2 g sachet once daily by oral administration.
Croatian: Doziranje Preporučena dnevna doza je jedna vrećica od 2 g jedanput na dan peroralnom primjenom.
English: Seizures, oral irritation (such as mouth ulcers and gum inflammation), hair loss, feeling confused, feeling unwell, dry mouth, skin irritation.
Croatian: Napadaji, iritacija usne šupljine (kao npr. vrijed u ustima ili upala desni), gubitak kose, osjećaj smetenosti, loše osjećanje, suha usta, iritacija kože.
English: In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase in myocardial infarction has been observed in OSSEOR treated patients compared to placebo (see section 4.8).
Croatian: Iz zbirnih podataka iz randomiziranih placebom kontroliranih ispitivanja bolesnika s osteoporozom u postmenopauzi primijećen je značajan porast infarkta miokarda kod bolesnika liječenih OSSEOR-om u usporedbi s placebom (vidjeti dio 4.8).
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final study report for the medicinal product mentioned above, the scientific conclusions of CHMP are as follows:
Croatian: Postauthorisation safety study, PASS) za gore spomenuti lijek, znanstveni zaključci CHMP-a su sljedeći:
English: Annex IV
Croatian: PRILOG III.
English: Serum transaminase increased (in association with hypersensitivity skin reactions)
Croatian: Povišene serumske transaminaze (povezano s kožnim reakcijama preosjetljivosti)
English: − Signs of severe hypersensitivity reactions (DRESS): initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature (uncommon), increased levels of liver enzymes seen in blood tests (uncommon) an increase in a type of white blood cell (eosinophilia) (rare) and enlarged lymph nodes (uncommon).
Croatian: Rijetko (mogu se pojaviti u do 1 na 1000 osoba) - Znakovi teških reakcija preosjetljivosti (DRESS): započinju simptomima sličnim gripi i osipom na licu koji se širi, praćen visokom temperaturom (manje često), povišenim razinama jetrenih enzima što se vidi u krvnim pretragama (manje često), povećanim brojem određene vrste bijelih krvnih stanica (eozinofilija) (rijetko) te povećanim limfnim čvorovima (manje često).
English: Patients who have the HLA-A*33:03 and/or the HLA-B*58:01 genes are more likely to develop a serious skin reaction than those who do not have the genes.
Croatian: Veća je vjerojatnost razvoja ozbiljnih kožnih reakcija kod bolesnika koji imaju gen HLA-A*33:03 i/ili HLA-B*58:01 od onih koji ovaj gen nemaju.
English: If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after OSSEOR.
Croatian: Uzimate li antacide (lijekovi protiv žgaravice), smijete ih uzeti tek nakon što prođu najmanje dva sata od uzimanja OSSEOR-a.
English: If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) or DRESS (e.g. rash, fever, eosinophilia and systemic involvement (e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, OSSEOR treatment should be discontinued immediately.
Croatian: Ukoliko su prisutni simptomi ili znakovi SJS ili TEN (npr. progresivni kožni osip s mjehurićima ili mukoznim lezijama) ili DRESS (npr. osip, vrućica, eozinofilija i sustavni simptomi (npr. adenopatija, hepatitis, intersticijska nefropatija, intersticijska bolest pluća) treba odmah prekinuti primjenu OSSEOR-a.
English: In an a-posteriori analysis of patients from the pooled SOTI and TROPOS studies with baseline lumbar spine and / or femoral neck BMD in the osteopenic range and without prevalent fracture but with at least one additional risk factor for fracture (N=176), OSSEOR reduced the risk of a first vertebral fracture by 72% over 3 years (incidence of vertebral fracture 3.6% with strontium ranelate vs. 12.0% with placebo).
Croatian: Združena a posteriori analiza podataka iz ispitivanja SOTI i TROPOS o bolesnicama čija je BMD lumbalne kralješnice i/ili vrata bedrene kosti na početku ispitivanja bila u rasponu osteopenije, bez prisutnosti prijeloma, no s najmanje jednim dodatnim čimbenikom rizika za prijelom (N = 176), pokazala je da je OSSEOR tijekom 3 godine smanjio rizik od prvog prijeloma kralješnice za 72 % (incidencija prijeloma kralješnice 3,6 % u skupini koja je uzimala stroncijev ranelat naspram 12,0 % u skupini koja je uzimala placebo).
English: • Prescriber guide and checklist • Patient alert card
Croatian: • Uputu za propisivača i listu provjere
English: HLA-A*33:03 and HLA-B*58:01 alleles have been identified as potential genetic risk factors for strontium ranelate-associated SJS/TEN in Han Chinese patients from a retrospective, case-control, pharmacogenetic study.
Croatian: U retrospektivnom, farmakogenetičkom ispitivanju parova, aleli HLA-A*33:03 i HLA-B*58:01 identificirani su kao potencijalni genetski čimbenici rizika za SJS/TEN povezan s primjenom stroncijevog ranelata u Han kineskih bolesnika.
English: o If symptoms or signs of Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) (e.g. rash, fever, eosinophilia and systemic involvement, e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, OSSEOR treatment should be discontinued immediately.
Croatian: o Ukoliko su prisutni simptomi ili znakovi Stevens-Johnsonova sindroma (SJS), toksične epidermalne nekrolize (TEN) ili osipa uzrokovanog lijekom uz eozinofiliju i sustavne simptome (DRESS) (npr. osip, vrućica, eozinofilija i sustavni simptomi npr. adenopatija, hepatitis, intersticijska nefropatija, intersticijska bolest pluća), treba odmah prekinuti primjenu OSSEOR-a.
English: In patients over 80 years of age at inclusion, a pooled analysis of SOTI and TROPOS studies showed that OSSEOR reduced the relative risk of experiencing new vertebral fractures by 32% over 3 years (incidence of 19.1% with strontium ranelate vs. 26.5% with placebo).
Croatian: Združena analiza podataka iz ispitivanja SOTI i TROPOS u bolesnica starijih od 80 godina pri uključivanju u ispitivanje, pokazala je da je OSSEOR tijekom 3 godine smanjio relativni rizik od novih prijeloma kralješnice za 32 % (incidencija prijeloma 19,1 % u skupini koja je uzimala stroncijev ranelat naspram 26,5 % u skupini koja je uzimala placebo).
English: The CHMP is of the opinion that the terms of the marketing authorisation of the medicinal product mentioned above should be varied.
Croatian: Stajalište je CHMP-a da je potrebna izmjena uvjeta odobrenja za stavljanje lijeka u promet za gore spomenuti lijek.
English: Blood and lymphatic disorders Uncommon
Croatian: Poremećaji krvi i limfnog sustava
English: In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase of myocardial infarction has been observed in strontium ranelate treated patients as compared to placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% CI = [1.07 ; 2.38]).
Croatian: Iz zbirnih podataka iz randomiziranih placebom kontroliranih ispitivanja bolesnica s osteoporozom u poslijemenopauzi primijećen je značajan porast infarkta miokarda kod bolesnica liječenih stroncijevim ranelatom u usporedbi s placebom (1,7% naspram 1,1 %), s relativnim rizikom od 1,6 (95% CI = [1,07 ; 2,38]).
English: LIST OF EXCIPIENTS Also contains aspartame (E 951).
Croatian: POPIS POMOĆNIH TVARI Također sadrži aspartam (E951).
English: Bone marrow failure# Eosinophilia (in association with hypersensitivity skin reactions)
Croatian: Zatajenje koštane srži# Eozinofilija (povezano s kožnim reakcijama preosjetljivosti)
English: If the patient has developed SJS, TEN or DRESS with the use of OSSEOR, OSSEOR must not be re-started in this patient at any time.
Croatian: Ukoliko je bolesnik razvio SJS, TEN ili DRESS za vrijeme primjene OSSEOR-a, kod takvog bolesnika se nikad ne smije ponovno započeti liječenje s OSSEOR-om.
English: A. MANUFACTURER(S)RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Intake of strontium ranelate with calcium or food reduces the bioavailability of strontium by approximately 60-70%, compared with administration 3 hours after a meal.
Croatian: Uzimanjem stroncijeva ranelata s kalcijem ili s hranom smanjuje se bioraspoloživost stroncija za oko 60-70 % u
English: In vitro, strontium ranelate: - increases bone formation in bone tissue culture as well as osteoblast precursor replication and collagen synthesis in bone cell culture.
Croatian: Stroncijev ranelat in vitro: - pospješuje stvaranje kosti u kulturama koštanoga tkiva, kao i umnažanje preteča osteoblasta i sintezu kolagena u kulturi koštanih stanica, - smanjuje resorpciju kosti slabeći diferencijacijsku i resorpcijsku sposobnost osteoklasta.
English: Where possible, screening for HLA-A*33:03 and HLA-B*58:01 alleles could be considered before starting treatment with OSSEOR in patients of Han Chinese origin.
Croatian: Kada je to moguće, prije započinjanja liječenja OSSEOR-om u bolesnika Han kineskog podrijetla, može se razmotriti probir na alele HLA-A*33:03 i HLA-B*58:01.
English: − Signs of potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis): initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Croatian: Vrlo rijetko (mogu se pojaviti u do 1 na 10 000 osoba) - Znakovi potencijalno po život opasnih osipa na koži (Stevens-Johnson-ov sindrom, toksična epidermalna nekroliza): započinje pojavom crvenih pjega poput mete ili kružnih mrlja često sa mjehurićem u sredini na trupu.
English: Package leaflet: Information for the patient OSSEOR 2 g granules for oral suspension Strontium ranelate
Croatian: Uputa o lijeku: Informacija za bolesnika OSSEOR 2 g granule za oralnu suspenziju stroncijev ranelat
English: - if you have severe kidney disease.
Croatian: - ako imate rizik za nastanak krvnih ugrušaka - ako imate tešku bolest bubrega.
English: If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis or DRESS with the use of OSSEOR, you must not be re-started on OSSEOR at any time If you are of Asian origin, you may be at higher risk of skin reactions.
Croatian: Ukoliko ste razvili simptome Stevens-Johnson-ov sindroma ili toksične epidermalne nekrolize ili DRESS-a tijekom primjene OSSEOR-a, ne smijete nikad više ponovo započeti liječenje OSSEORom.
English: Tel: +39 06 669081
Croatian: Stroder S.r.l. Tel: +39 06 669081
English: Pyrexia (in association with hypersensitivity skin reactions) Malaise
Croatian: Pireksija (povezano s kožnim reakcijama preosjetljivosti)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 2 g strontium ranelate.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna vrećica sadrži 2 g stroncijeva ranelata.
English: Hypersensitivity skin reactions (rash, pruritus, urticaria, angioedema)
Croatian: tkiva pruritus, urtikarija, angioedem)
English: NAME OF THE MEDICINAL PRODUCT OSSEOR 2 g granules for oral suspension
Croatian: NAZIV LIJEKA OSSEOR 2 g granule za oralnu suspenziju
English: No dose adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance) (see sections 4.4 and
Croatian: U bolesnika s blago do umjereno oštećenom funkcijom bubrega (klirens kreatinina 30-70 ml/min) dozu ne treba prilagođavati (vidjeti dijelove 4.4 i 5.2).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/004 56 sachets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/287/004 56 vrećica
English: In postmenopausal women, strontium ranelate reduces the risk of vertebral and hip fractures (see section 5.1).
Croatian: Kod žena u poslijemenopauzi, stroncijev ranelat smanjuje rizik nastanka prijeloma kralježnice i kuka (vidjeti dio
English: Itching, hives, skin rash, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), bone, limb, muscle and/or joint pain, muscle cramps.
Croatian: Vrlo često (mogu se pojaviti u više od 1 na 10 osoba) Svrbež, koprivnjača, kožni osip, angioedem (kao što je oticanje lica, jezika ili grla, poteškoće u disanju ili gutanju), bol u kostima, udovima, mišićima i/ili u zglobovima, grčevi u mišićima.
English: Lymphadenopathy (in association with hypersensitivity skin reactions)
Croatian: Limfadenopatija (povezano s kožnim reakcijama preosjetljivosti)
English: of treatment.
Croatian: • Uputu o lijeku
English: - Temporary or permanent immobilisation due to e.g. post-surgical recovery or prolonged bed rest. - Established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Croatian: - Dokazana, postojeća ili prethodna ishemijska bolest srca, periferna arterijska bolest i/ili cerebrovaskularna bolest u anamnezi.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za primjenu kroz usta
English: o Temporary or permanent immobilisation due to e.g. post-surgical recovery or prolonged bed rest. o Hypersensitivity to the active substance (strontium ranelate) or any of the excipients.
Croatian: - Privremena ili trajna imobilizacija zbog npr. oporavka poslije operacije ili produljenog mirovanja u krevetu.
English: OTHER Read the package leaflet before use
Croatian: Prije uporabe pročitati uputu o lijeku
English: Diarrhoea and Loose stools Vomiting
Croatian: Proljev i meke stolice
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog Vrlo često
English: OSSEOR is contra-indicated in patients with a past history of venous thromboembolic events (see section 4.3) and should be used with caution in patients at risk of VTE.
Croatian: VTE u anamnezi (vidjeti dio 4.3), a mora se primjenjivati s oprezom u osoba s povećanim rizikom od VTE.
English: NAME OF THE MEDICINAL PRODUCT OSSEOR 2 g granules for oral suspension Strontium ranelate
Croatian: OSSEOR 2 g granule za oralnu suspenziju stroncijev ranelat
English: New vertebral fracture over the 1
Croatian: Novi prijelom kralješnice tijekom 1. godine
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/287/001
English: Marketing Authorisation Holder Les Laboratoires Servier 50, rue Carnot
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Les Laboratoires Servier
English: Seizures
Croatian: Mučnina
English: st year
Croatian: Rok valjanosti
English: Strength Pharmaceutical Form Route of administration Packaging
Croatian: Doza Farmaceutski oblik Put primjene Unutarnje pakiranje
English: Milk: 108 hours
Croatian: Mlijeko: 108 sati
English: Hence, extrapolation is not warranted.
Croatian: Stoga ekstrapolacija nije opravdana.
English: Meat and offal: 42 days.
Croatian: Meso i iznutrice: 42 dana.
English: It is ineffective against Enterobacteriaceae.
Croatian: Neučinkovit je protiv Enterobacteriaceae.
English: Cattle,
Croatian: Goveda,
English: INN Strength Pharmaceutical form
Croatian: Jačina Farmaceutski oblik
English: Sheep: Intramuscular
Croatian: Ovce: Intramuskularna
English: Hence, the Committee concluded that the data is considered to have a limited value for the scope of this referral procedure.
Croatian: Stoga je Odbor zaključio da ti podatci imaju ograničenu vrijednost za područje primjene ovog arbitražnog postupka.
English: Diagonal, 609-615 08028 Barcelona Spain
Croatian: Diagonal, 609-615 08028 Barcelona
English: As the animals in the study were treated twice daily, as opposed to once daily as usually recommended, the study design can be considered to represent a worst-case scenario.
Croatian: Budući da su životinje obuhvaćene ispitivanjem liječene dvaput dnevno, za razliku od jednom dnevno koliko se obično preporučuje, može se smatrati da izvedba ispitivanja predstavlja najgori mogući scenarij.
English: However, the actual residue concentrations were not given, and the study was done using a single injection rather than repeated injections.
Croatian: Međutim, nisu navedene stvarne koncentracije rezidua, a ispitivanje je provedeno na temelju jedne injekcije, a ne ponovljenih injekcija.
English: Quality, target animal safety, user safety, and the environmental risk for the concerned veterinary medicinal products have not been assessed in this referral procedure.
Croatian: Kvaliteta, sigurnost ciljane životinje, sigurnost korisnika i rizik za okoliš za predmetne veterinarskomedicinske proizvode nisu procijenjeni u ovom arbitražnom postupku.
English: However, to address certain deficiencies in the data set, an additional safety factor of 30% was considered necessary resulting in a withdrawal period of 28 days.
Croatian: Međutim, kako bi se riješili određeni nedostatci u skupu podataka, zaključeno je da je potreban dodatni čimbenik sigurnosti od 30 %, što je rezultiralo razdobljem karencije od 28 dana.
English: Two days after the last dose, tylosin could no longer be detected in sheep milk.
Croatian: Dva dana nakon posljednje doze tilozin se više nije mogao otkriti u mlijeku ovaca.
English: Sheep (meat) is considered a major food producing species.
Croatian: Ovce (meso) smatraju se više zastupljenom životinjskom vrstom koja se koristi za proizvodnju hrane.
English: After analysis of the residue data for the injection site using the recommended EMA statistical software (WT 1.4), it was concluded that not all the statistical requirements (i.e., F-test) were met.
Croatian: Nakon analize podataka o reziduama za mjesto primjene injekcije korištenjem preporučenog statističkog softvera EMA-e (WT 1.4), zaključeno je da nisu ispunjeni svi statistički zahtjevi (tj. F-test).