FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Marixino is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: S obzirom da je Marixino generički lijek i da je bioekvivalent referentom lijeku, smatra se da su njegove koristi i rizici isti kao u referentnog lijeka.
English: Therefore, the CHMP's view was that, as for Ebixa, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da, kao i kod lijeka Ebixa, koristi nadmašuju utvrđene rizike.
English: For more information about treatment with Marixino, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Marixino pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: For practical information about using Marixino, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Marixino bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: Marixino memantine
Croatian: memantin
English: For more information, see the package leaflet.
Croatian: Za više informacija vidjeti uputu o lijeku.
English: How is Marixino used?
Croatian: Kako se Marixino koristi?
English: No additional studies in patients were required as Marixino was shown to have comparable quality and is considered to be bioequivalent to the reference medicine, Ebixa.
Croatian: Nisu bila potrebna dodatna ispitivanja jer je Marixino pokazao usporedivu kvalitetu i smatra se bioekvivalentom referentnog lijeka, Ebixa. „Bioekvivalent“ znači da se od lijekova očekuje da proizvode iste razine djelatne tvari u tijelu.
English: How has Marixino been studied?
Croatian: Kako se Marixino ispitivao?
English: How does Marixino work?
Croatian: Marixino djeluje?
English: The company requested a re-examination of the opinion.
Croatian: Tvrtka je zatražila preispitivanje mišljenja.
English: How does the medicine work?
Croatian: Kako djeluje lijek?
English: What was the medicine expected to be used for?
Croatian: Za što se lijek trebao koristiti?
English: 15 September 2017 EMA/609151/2017 EMEA/H/C/004388
Croatian: EMA/609151/2017 EMEA/H/C/004388
English: At the time of the initial review, the CHMP had a number of concerns.
Croatian: U vrijeme prvog pregleda CHMP je izrazio zabrinutost za niz stvari.
English: The company that applied for authorisation is XBiotech Germany GmbH.
Croatian: Zahtjev za izdavanje odobrenja podnijela je tvrtka XBiotech Germany GmbH.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.
Croatian: Nakon razmatranja razloga za taj zahtjev, CHMP je preispitao prvotno mišljenje i potvrdio odbijanje izdavanja odobrenja za stavljanje lijeka u promet dana 14. rujna 2017.
English: growth and spread of cancer cells.
Croatian: pomažu rastu i širenju stanica raka.
English: Firstly, the study did not show clear improvements in either lean body mass or quality of life.
Croatian: Prvo, u glavnom se ispitivanju nisu pokazala jasna poboljšanja ni u pogledu čiste tjelesne mase ni kvalitete života.
English: The medicine was compared with placebo (a dummy treatment).
Croatian: Lijek je uspoređen s placebom (prividnim liječenjem).
English: Secondly, at that time, there appeared to be an increased risk of infection in patients taking the medicine, which was not considered acceptable in vulnerable patients who will be receiving palliative care.
Croatian: Drugo, u to vrijeme činilo se da u bolesnika koji su primali lijek postoji povećani rizik od infekcije, što se nije smatralo prihvatljivim za osjetljive bolesnike koji će primati palijativnu skrb.
English: However, insufficient safety data are available to properly assess its overall risks and the committee still had concerns about the medicine's benefits and manufacturing controls.
Croatian: Međutim, raspoložive sigurnosne informacije nisu dovoljne za pravilnu procjenu njegovih sveukupnih rizika, a Odbor i dalje nije otklonio zabrinutost zbog koristi lijeka i kontrole proizvodnog procesa.
English: The company informed the CHMP that it will continue to provide the medicine to all patients currently enrolled in clinical trials or compassionate use programmes.
Croatian: Tvrtka je obavijestila CHMP da će nastaviti opskrbu lijekom svih bolesnika koji su u ovom trenutku uključeni u klinička ispitivanja ili u programe milosrdnog davanja lijekova.
English: It was to be available as a concentrate to be made up into a solution for infusion.
Croatian: Lijek je trebao biti dostupan kao koncentrat za otopinu za infuziju.
English: Lastly, there were inadequate controls of the manufacturing process to ensure the medicine would have the same quality as the product used in clinical trials.
Croatian: Konačno, neodgovarajuće kontrole proizvodnog procesa ne mogu jamčiti da će lijek biti jednake kvalitete kao onaj koji se primjenjivao u kliničkim ispitivanjima.
English: The company presented results of a main study in 333 patients looking at the effects of this medicine on lean body mass (body weight excluding fat) and quality of life.
Croatian: Tvrtka je dostavila podatke iz glavnog ispitivanja koje je obuhvatilo 333 bolesnika i razmatralo učinke ovog lijeka na čistu tjelesnu masu (tjelesna težina bez masnog tkiva) te na kvalitetu života.
English: Such symptoms include cachexia, a form of muscle wasting with significant weight loss.
Croatian: Takvi simptomi uključuju kaheksiju, oblik gubitka mišića mase i značajni gubitak tjelesne težine.
English: The CHMP therefore maintained its opinion that the benefits of this medicine did not outweigh its risks and recommended that it be refused marketing authorisation.
Croatian: Stoga je mišljenje CHMP-a da koristi od ovoga lijeka ne nadmašuju s njim povezane rizike i preporučio je da se ne izda odobrenje za stavljanje lijeka u promet.
English: The medicine was expected to be used for treating debilitating symptoms of advanced colorectal cancer (cancer of the large intestine).
Croatian: Očekivalo se da će se lijek primjenjivati za liječenje onesposobljavajućih simptoma uznapredovalog kolorektalnog karcinoma (karcinom debelog crijeva).
English: During the re-examination, the Committee was reassured that no commonly reported side effects appear to be directly linked to this medicine.
Croatian: Odbor se uvjerio da nema nuspojava koje se uobičajeno prijavljuju koje bi izravno bile povezane s ovim lijekom.
English: By blocking the actions of human interleukin-1 alpha, the medicine was expected to slow down the growth of the cancer, thus relieving patients' symptoms.
Croatian: Očekivalo se da će lijek, blokiranjem djelovanja ljudskog interleukina-1 alfa, usporiti rast raka i time olakšati simptome u bolesnika.
English: The active substance is a protein that attaches to and blocks the actions of another protein called human interleukin-1 alpha, which is involved in many activities in the body including some that aid the
Croatian: Djelatna tvar je bjelančevina koji se pričvrsti na drugu bjelančevinu pod nazivom ljudski interleukin-1 alfa i blokira je, a ta je bjelančevina uključena u mnoge aktivnosti u tijelu, uključujući i neke koje
English: On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicine ‘Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech', intended for intended for treating debilitating symptoms of advanced colorectal cancer.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) usvojio je negativno mišljenje i preporučio da se ne izda odobrenje za stavljanje u promet lijeka Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech (ljudsko monoklonsko IgG1 protutijelo specifično za ljudski interleukin-1 alfa), namijenjenog za liječenje onesposobljavajućih simptoma uznapredovalog kolorektalnog karcinoma.
English: This is a medicine containing the active substance human IgG1 monoclonal antibody specific for human interleukin-1 alpha.
Croatian: To je lijek koji sadržava djelatnu tvar ljudsko monoklonsko IgG1 protutijelo specifično za ljudski interleukin-1 alfa.
English: What is Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech?
Croatian: Odbijanje odobrenja za stavljanje u promet ljudskog monoklonskog IgG1 protutijela specifičnog za ljudski interleukin-1 alfa XBiotech
English: There was no clinical effect.
Croatian: Nije bilo kliničkih učinaka.
English: The maximum dose should not be exceeded.
Croatian: Najviša doza ne smije biti prekoračena.
English: Over 80% of male dogs above 5 years of age are affected.
Croatian: Javlja se u preko 80% muških pasa preko 5 godina starosti.
English: Tablets can be given either directly into the mouth or with food.
Croatian: Tablete se mogu dati ili direktno u usta ili s hranom.
English: *No data are available for dogs less than 3 kg bodyweight
Croatian: * Nema dostupnih podataka za pse manje od 3 kg tjelesne mase.
English: Wash hands after administration.
Croatian: Oprati ruke nakon aplikacije
English: Dogs (male)
Croatian: Psi (muški)
English: If clinical response to treatment is considerably shorter than expected, a re-evaluation of the diagnosis is necessary.
Croatian: Ukoliko je klinički odgovor značajno kraći od očekivanog, potrebna je ponovna procjena postavljene dijagnoze.
English: This binding is reversible and not affected by other substances known to specifically bind to albumin.
Croatian: Ovo je vezanje reverzibilno i nije pod utjecajem drugih tvari za koje se zna da se specifično vežu za albumin.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Croatian: Nositelj odobrenja za stavljanje u promet mora obavijestiti Europsku komisiju o planovima stavljanja u promet veterinarsko medicinskog proizvoda odobrenog ovom odlukom.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Croatian: Pitajte vašeg veterinara kako odlagati proizvod koji vam više nisu potrebni.
English: Osaterone is eliminated within 14 days, mainly in faeces via biliary excretion (60%) and to a lesser extent (25%) in urine.
Croatian: Osateron se eliminira u 14 dana uglavnom putem fecesa kroz bilijarnu ekskreciju (60%) i u manjoj mjeri (25%) urinom.
English: This might lead to multiple non-specific clinical signs such as abdominal pain, difficulties in defaecation and urination, blood in urine and locomotive disorders.
Croatian: Dovodi do mnoštva ne specifičnih kliničkih znakova kao što su bol u abdomenu, poteškoće pri defekaciji ili mokrenju, pojave krvi u urinu ili motoričkih poremećaja.
English: The onset of clinical response to treatment is usually seen within 2 weeks.
Croatian: Početak kliničkog odgovora se obično uočava unutar 2 tjedna.
English: No adverse effects on semen quality have been observed.
Croatian: Nuspojave na kvalitetu sjemena nisu primijećene.
English: Carmellose calcium
Croatian: Kalcijev karmelozat
English: In clinical trials, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy.
Croatian: U kliničkim pokusima tretman veterinarsko medicinskim proizvodom nije prekidan a sve su se životinje oporavile bez ikakve posebne terapije.
English: After oral administration with food in dogs, osaterone acetate is rapidly absorbed (Tmax about 2 hours) and undergoes a first-pass effect mainly in the liver.
Croatian: Nakon peroralne aplikacije putem hrane psima, osateron acetat se brzo apsorbira (Tmax oko 2 sata) i podliježe efektu prvog prolaza uglavnom u jetrima.
English: In female laboratory animals, osaterone acetate caused serious adverse effects on reproductive functions.
Croatian: U ženki laboratorijskih životinja osateron acetat je uzrokovao ozbiljne nuspojave na reprodukcijske funkcije.
English: Fifteen days after the last administration, the mean plasma concentration is about 6.5 µg/l.
Croatian: Petnaest dana nakon zadnje aplikacije srednja koncentracija u plazmi je oko 6,5 µg/L.
English: It competitively prevents the binding of androgens to their prostatic receptors and blocks the transport of testosterone into the prostate.
Croatian: On kompeticijski inhibira vezanje androgena na njihove receptore u prostati i blokira transport testosterona do prostate.
English: Date of first authorisation: 11/01/2007 Date of latest renewal: 19/12/2011
Croatian: Datum posljednjeg produljenja odobrenja: 19/12/2011
English: 23 rd Klm National Road Athens-Lamia 145 65 Agios Stefanos Athens
Croatian: 23 rd Klm National Road Athens-Lamia 145 65 Agios Stefanos Athens - GREECE
English: Benign prostatic hypertrophy (BPH) is a natural consequence of ageing.
Croatian: Benigna hipertrofija prostate (BPH) je prirodna posljedica starenja.
English: Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju - 3 godine 6.4.
English: Osaterone acetate
Croatian: Osateron acetat
English: Transient behavioural changes such as increased or decreased activity, or more sociable behaviour, are common.
Croatian: Prolazne promjene ponašanja poput povišene ili umanjene aktivnosti ili izrazitije društvenosti su česte.
English: An overdose study (up to 1.25 mg/kg bodyweight for 10 days, repeated one month later) did not show undesirable effects except for a decrease of cortisol plasma concentration.
Croatian: Ispitivanjima predoziranja (do 1,25 mg / kg t.m. za 10 dana ponovljena nakon mjesec dana) nisu dokazane nuspojave sa izuzetkom sniženja koncentracije kortizola u plazmi.
English: Do not use after the expiry date stated on the blister after “EXP”
Croatian: Ne koristiti poslije isteka roka valjanosti naznačenog na blisteru poslije {EXP}
English: Tablet Round, white, biconvex tablet of 5.5 mm, 7 mm, 9 mm and 12 mm.
Croatian: Okrugla, bijela bikonveksna tableta veličine 5,5 mm, 7 mm, 9 mm i 12 mm
English: The clinical response persists for at least 5 months after treatment.
Croatian: Klinički odgovor traje najmanje 5 mjeseci nakon kraja primjene.
English: VIRBAC Tierarzneimittel GmbH Rögen 20
Croatian: VIRBAC Tierarzneimittel GmbH West Rögen 20
English: After repeated administration of osaterone acetate at 0.25 mg/kg/day for 7 days, the factor of accumulation is about 34 without change in the rates of absorption or elimination.
Croatian: Poslije ponovljene aplikacije osateron acetata u dozi od 0,25 mg/kg/dan tijekom 7 dana, faktor akumulacije je oko 3-4 bez promjene u stopi apsorpcije ili eliminacije.
English: Osaterone acetate and its metabolite are bound to plasma proteins (around 90% and 80% respectively), mainly to albumin.
Croatian: Osateron acetata i njegov glavni metabolit vežu se za proteine plazme (prvi oko 90%, drugi oko 80%) uglavnom za albumin.
English: Re-evaluation by the veterinarian should take place 5 months after treatment or earlier if clinical signs recur.
Croatian: Veterinar treba napraviti ponovnu procjenu 5 mjeseci poslije zadnje primjene ili ranije, ukoliko se klinički znakovi vrate.
English: All these adverse reactions are reversible without any specific treatment.
Croatian: Sve ove nuspojave nestaju bez ikakvog specifičnog liječenja.
English: Use with caution in dogs with a history of liver disease, as safety of use of the product in these dogs has not been thoroughly investigated, and as treatment of some dogs with liver disease has resulted in reversible elevation of ALT and ALP in clinical trials.
Croatian: U pasa s bolesti jetre savjetuje se oprez jer neškodljivost kod primjene proizvoda u ovakvih pasa nije ispitana i jer je tretman nekih pasa sa oboljelom jetrom tijekom kliničkih pokusa rezultirao sa reverzibilnim povišenjem ALT i AST.
English: A single oral dose of 40 mg osaterone acetate in human males was followed by a sporadic decrease in FSH, LH and testosterone, reversible after 16 days.
Croatian: Jednokratna peroralna doza od 40 mg osateron acetata u muškaraca bila je praćena mjestimičnim umanjenjem FSH, LH i testosterona što je vraćeno za 16 dana.
English: BPH is a development and enlargement of the prostate due to the male hormone testosterone.
Croatian: BPH je razvoj i povećanje prostate uzrokovana muškim hormonom testosteronom.
English: Appropriate monitoring should be implemented in dogs under stress (e.g. postoperative) or those with hypoadrenocorticism.
Croatian: Psi pod stresom (npr. post-operacijskim) ili oni sa hipoadrenokorticizmom bi trebali biti pod odgovarajućim nadzorom.
English: Elimination is slow with a mean half-life (T½) of about 80 hours.
Croatian: Eliminacija je spora sa srednjim vremenom (T1/2) od oko 80 sati.
English: Transient side-effects of changes in the hair coat such as hair loss or hair modification have been seen very rarely following administration of Ypozane.
Croatian: Prolazne nuspojave se mogu javiti u vidu promjena na krznu, gubitak dlake ili promjene na dlakama koje se javljaju jako rijetko nakon primijene Ypozana.
English: After a dose of 0.25 mg/kg/day, the mean maximum concentration (Cmax) in plasma is about 60 µg/l.
Croatian: Poslije doze od 0,25 mg/kg/dan srednja maksimalna koncentracija (Cmax) u plazmi je oko 60µg/L.
English: Use with caution in dogs with a history of liver disease.
Croatian: Koristiti uz oprez u pasa koji u anamnezi imaju oboljenje jetre.
English: The response to an ACTH stimulation test may also be suppressed for several weeks after administration of osaterone.
Croatian: Odgovor na test stimulacije adrenokortikotropnog hormona (ACTH) mogao bi također biti suprimiran na nekoliko tjedana poslije aplikacije osaterona.
English: In the case of accidental ingestion by a person, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju da se nehotice proguta, odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: Osaterone acetate is converted to its main, 15β-hydroxylated metabolite, which is also pharmacologically active.
Croatian: Pretvorba osateron acetata odvija se do njegova glavnog 15β-hydroksi metabolita koji je također farmakološki aktivan.
English: Osaterone acetate is a steroid chemically related to progesterone, and as such it has potent progestagen and potent anti-androgen activity.
Croatian: Osateron acetat je steroid kemijski srodan progesteronu, i kao takav ima jaku progestagensku i protuandrogenu aktivnost.
English: Osaterone is a steroid anti-androgen, which inhibits the effects of an excess production of male hormone (testosterone).
Croatian: Osateron je protuandrogeni steroid koji inhibira efekte prekomjerne produkcije muškog hormona (testosterona).
English: OÜ ZOOVETVARU Uusaru 5
Croatian: OÜ ZOOVETVARU Pärnasalu 31
English: Administer 0.25 - 0.5 mg osaterone acetate per kilogram bodyweight, once a day, for 7 days as follows:
Croatian: Aplicirati 0,25 - 0,5 mg osateron acetata po kilogramu tjelesne mase, jednom dnevno, tokom 7 dana kao što slijedi:
English: REGARDING SUPPLY OR USE
Croatian: POGLEDU OPSKRBE I PRIMJENE
English: Also, the major metabolite of osaterone acetate (15β-hydroxylatedosaterone acetate) has anti-androgenic activity.
Croatian: Također, glavni metabolit osateron acetata (15β-hydroksilirani -osateron acetat) ima protu-androgenu aktivnost.
English: PACKAGE SIZE 7 tablets.
Croatian: VELIČINA PAKOVANJA 7 tableta
English: Number of tablet per day
Croatian: Broj tableta na dan Trajanje terapije
English: NL-3771 AH-Barneveld Tel: 31 (0) 342 427 100
Croatian: NL-3771 ND-Barneveld Tel: 31 (0) 342 427 100
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/ ZABRANA PRODAJE, OPSKRBE I/ILI PRIMJENE
English: A transient reduction of plasma cortisol concentration may occur; this may continue for several weeks after administration.
Croatian: Može doći do prolaznog umanjenja kortizola u plazmi što može trajati nekoliko tjedana od primjene proizvoda.
English: Therefore, women of child bearing age should avoid contact with, or wear disposable gloves, when administering the product.
Croatian: Stoga se ženama u plodnom razdoblju savjetuje da izbjegavaju kontakt sa proizvodom ili da tijekom njegove aplikacije nose rukavice za jednokratnu primjenu.
English: Osaterone acetate inhibits the effects of an excess of male hormone (testosterone) through various mechanisms.
Croatian: Osateron acetat inhibira efekte suviška testosterona preko više mehanizama.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED :
Croatian: 14. DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA
English: 15 mg tablet
Croatian: 15 mg tableta
English: MANUFACTURER'S BATCH NUMBER Batch {number}
Croatian: 17. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
Croatian: 13. RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA
English: A transient reduction in plasma cortisol occurs in most treated animals.
Croatian: U većine tretiranih životinja zapaža se prolazna promjena kortizola u plazmi.
English: Treatment of benign prostatic hypertrophy (BPH) in male dogs.
Croatian: Liječenje benigne hipertrofije prostate (BPH) u muških pasa.
English: Marketing authorisation holder and manufacturer:
Croatian: Nositelj odobrenja za stavljanje u promet i proizvođač
English: 1.875 mg tablet
Croatian: 1,875 mg tableta
English: Other adverse reactions, including transient vomiting and/or diarrhoea, polyuria/polydipsia or lethargy occur uncommonly.
Croatian: Druge nuspojave uključujući prolazno povraćanje i/ili proljev, poliuriju/polidipsiju, letargiju javljaju se rijetko.
English: Transient modifications of appetite can be observed, either increased (very common) or decreased (very rare).
Croatian: Vrlo često dolazi do prolaznih promjena u apetitu, bilo da je riječ o povećanju apetita (jako često) ili o smanjenju apetita (jako rijetko).
English: Lactose monohydrate
Croatian: Lakotoza monohidrat
English: A decision to retreat at this or at a later time point should be based on veterinary examination taking into account the risk benefit profile of the product.
Croatian: Odluka o ponovnoj primjeni u tom trenutku ili kasnije trebala bi biti donijeta na osnovu veterinarskog pregleda i procjene rizika i dobiti od proizvoda.
English: RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only - to be supplied only on veterinary prescription.
Croatian: U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo Samo za primjenu na životinjama
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For oral use.
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE
English: VIRBAC NEDERLAND BV Postbus 313
Croatian: VIRBAC NEDERLAND BV Hermesweg 15
English: PHARMACEUTICAL FORM Tablet.
Croatian: OBLIK Tableta
English: Each tablet contains 1.875 mg, 3.75 mg, 7.5 mg or 15 mg osaterone acetate Excipients:
Croatian: Svaka tableta sadržava: 1,875 mg, 3,75 mg, 7,5 mg ili 15 mg osateron acetata Pomoćne tvari:
English: A decision to retreat at this or at a later time point should be based on veterinary examination taking into account the risk benefit profile of the medicine.
Croatian: Odluka o ponovnoj primjeni u tom trenutku ili kasnije trebala bi biti donijeta na osnovu veterinarskog pregleda i procjene rizika i dobiti u odnosu na proizvod.