FrancophonIA/ELRC3.0 huggingface dataset:
English: Before initiation of therapy, evaluation of immune serostatus could be considered according to local guidelines.
Croatian: Prije početka terapije može se razmotriti provjera imunološkog serostatusa, sukladno nacionalnim smjernicama.
English: XEstimated frequency based on placebo-controlled clinical trials and
Croatian: XProcjena učestalosti na temelju placebom kontroliranih kliničkih ispitivanja i
English: In clinical trials, a single dose of infliximab 5 mg/kg was added unless contraindicated.
Croatian: U kliničkim se ispitivanjima dodavala jednokratna doza infliksimaba od 5 mg/kg, osim u slučaju kontraindikacije.
English: 2 Ciprofloxacin; flumequine; levofloxacin; lomefloxacin; moxifloxacin; norfloxacin; ofloxacin; pefloxacin; prulifloxacin; rufloxacin.
Croatian: 2 Ciprofloksacin; flumekin; levofloksacin; lomefloksacin; moksifloksacin; norfloksacin; ofloksacin; pefloksacin; prulifloksacin; rufloksacin.
English: Uncommon (may affect up to 1 in 100 people) Infections: […], cytomegalovirus infection
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba) Infekcije: […], citomegalovirusna infekcija
English: - if you have been diagnosed with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
Croatian: - ako vam je dijagnosticirano proširenje ili „napuhivanje“ velike krvne žile (aneurizma aorte ili aneurizma periferne velike krvne žile).
English: - if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
Croatian: - ako ste već prethodno doživjeli epizodu disekcije aorte (razdvajanje stijenki aorte).
English: Infliximab must not be used if gastrointestinal perforation or sepsis is suspected (see the Summary of Product Characteristics for infliximab).
Croatian: Infliksimab se ne smije primjenjivati ukoliko se sumnja na gastrointestinalnu perforaciju ili na sepsu (vidijeti sažetak opisa svojstava lijeka za infliksimab).
English: Coughing, wheezing and shortness of breath which may be accompanied by a high temperature
Croatian: Kašalj, piskanje pri disanju i nedostatak zraka mogu biti popraćeni visokom temperaturom
English: Fluoroquinolones for systemic and inhaled use2 - Aortic aneurysm and dissection (EPITT no 18651)
Croatian: Fluorokinoloni za sistemsku primjenu i inhaliranje 2aneurizma i disekcija aorte (EPITT br. 18651)
English: Pharmacodynamic properties
Croatian: 5.1. Farmakodinamička svojstva
English: Patients must be monitored for gastrointestinal signs and symptoms that may be indicative of immunerelated colitis or gastrointestinal perforation.
Croatian: Bolesnici se moraju nadzirati zbog znakova i simptoma probavnog sustava koji bi mogli ukazivati na imunološki uzrokovan kolitis ili gastrointestinalnu perforaciju.
English: What you need to know before you are administered LEMTRADA Warnings and precautions
Croatian: Što morate znati prije nego počnete primjenjivati lijek LEMTRADA Upozorenja i mjere opreza
English: Frequency ‘rare': Eosinophilic pneumoniaY
Croatian: Učestalost „rijetko”: Eozinofilna pneumonijaY
English: In clinical trials, immune-related colitis was associated with evidence of mucosal inflammation, with or without ulcerations, and lymphocytic and neutrophilic infiltration.
Croatian: U kliničkim ispitivanjima, imunološki uzrokovan kolitis bio je povezan s dokazanom upalom sluznice, s ulceracijama ili bez njih, i limfocitnom ili neutrofilnom infiltracijom.
English: YEstimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials.
Croatian: Procijenjena učestalost nuspojava prijavljenih tijekom praćenja nakon stavljanja lijeka u promet; nisu uočene u placebom kontroliranim kliničkim ispitivanjima.
English: Hydrochlorothiazide - Skin cancer (EPITT no 19138)
Croatian: Hidroklorotiazid - rak kože (EPITT br. 19138)
English: However, aAddition of an alternative immunosuppressive agent to the corticosteroid regimen may should be considered in corticosteroid-refractory immune-related colitis if other causes are excluded (including Cytomegalovirus (CMV) infection/reactivation evaluated with viral PCR on biopsy, and other viral, bacterial and parasitic etiology) be considered.
Croatian: Međutim, može se Potrebno je razmotriti dodavanje drugog imunosupresivnog lijeka kortikosteroidnom režimu kod imunološki uzrokovanog kolitisa refraktornog na kortikosteroide ako su isključeni drugi uzroci (uključujući citomegalovirusnu infekciju/reaktivaciju (CMV) provjerenu pomoću PCR-a na uzorku dobivenom biopsijom, te druge virusne, bakterijske i parazitarne etiologije).
English: Duloxetine - Interstitial lung disease (EPITT no 19175)
Croatian: Duloksetin - intersticijska plućna bolest (EPITT br. 19175)
English: - if you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular EhlersDanlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis).
Croatian: - ako u obiteljskoj povijesti bolesti imate aneurizmu aorte ili disekciju aorte, ili druge rizične faktore ili stanja zbog kojih ste skloniji pojavi aneurizme ili disekcije (npr. poremećaji vezivnog tkiva kao što je Marfanov sindrom ili vaskularni oblik Ehlers-Danlosova sindrom ili vaskularni poremećaji kao što je Takayasuov arteritis, arteritis orijaških stanica, Behcetova bolest, visoki krvni tlak ili poznata ateroskleroza).
English: Undesirable effects Tabulated list of adverse reactions Blood and lymphatic system disorders Frequency ‘uncommon': Thrombocytopenia
Croatian: Tablični popis nuspojava Poremećaji krvi i limfnog sustava Učestalost „manje često”: Trombocitopenija
English: Clinical presentation may include diarrhoea, increased frequency of bowel movements, abdominal pain, or haematochezia, with or without fever.
Croatian: Klinička slika može uključivati proljev, povećanu učestalost stolice, bol u abdomenu ili hematoheziju, s vrućicom ili bez nje.
English: Summary of Product Characteristics 4.8.
Croatian: Sažetak opisa svojstava lijeka 4.8.
English: Diarrhoea or colitis occurring after initiation of ipilimumab must be promptly evaluated to exclude infectious or other alternate etiologies.
Croatian: Proljev ili kolitis koji nastanu nakon uvođenja terapije ipilimumabom moraju se hitno ispitati kako bi se isključili infektivni ili drugi uzroci.
English: Frequency ‘rare': Interstitial lung diseaseX
Croatian: Učestalost „rijetko”: Intersticijska plućna bolestX
English: Infections and infestations: cytomegalovirus infection - frequency uncommon
Croatian: Infekcije i infestacije: citomegalovirusna infekcija - učestalost: manje često
English: Frequency ‘not known': Skin and lip cancer (Non-melanoma skin cancer)
Croatian: Moguće nuspojave Učestalost „nepoznata”: Rak kože i usana (nemelanomski rak kože)
English: Special warnings and precautions Immune-related gastrointestinal reactions:
Croatian: Posebna upozorenja i mjere opreza Imunološki uzrokovane nuspojave probavnog sustava:
English: Alemtuzumab - Cytomegalovirus infection (EPITT no
Croatian: Alemtuzumab - Citomegalovirusna infekcija (EPITT br.
English: Post-marketing cases of cytomegalovirus (CMV) infection/reactivation have been reported in patients with corticosteroid-refractory immune-related colitis.
Croatian: Slučajevi citomegalovirusne infekcije/reaktivacije (CMV) nakon stavljanja lijeka u promet prijavljeni su kod bolesnika s imunološki uzrokovanim kolitisom refraktornim na kortikosteroide.
English: Special warnings and precautions for use Infections
Croatian: Posebna upozorenja i mjere opreza pri uporabi Infekcije
English: Dimethyl fumarate (Tecfidera) - Immune thrombocytopenic purpura and thrombocytopenia (EPITT no
Croatian: Dimetil fumarat (Tecfidera) - imuna trombocitopenična purpura i trombocitopenija (EPITT br. 19192)
English: Undesirable effects Tabulated list of adverse reactions Respiratory, thoracic and mediastinal disorders
Croatian: Tablični popis nuspojava Poremećaji dišnog sustava, prsišta i sredoprsja
English: Ipilimumab - Cytomegalovirus gastrointestinal infection (EPITT no 19207)
Croatian: Ipilimumab - Citomegalovirusna infekcija probavnog sustava (EPITT br. 19207)
English: The experience from clinical trials on the management of corticosteroid-refractory diarrhoea or colitis is limited.
Croatian: Iskustvo u liječenju proljeva ili kolitisa refraktornih na kortikosteroide u kliničkim ispitivanjima je ograničeno.
English: Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed.
Croatian: Nemelanomski rak kože: Na temelju dostupnih podataka iz epidemioloških ispitivanja, između HCTZ-a i NMSC-a primijećena je povezanost ovisna o kumulativnoj dozi.
English: Cytomegalovirus (CMV) infections including cases of CMV reactivation have been reported in LEMTRADA-treated patients.
Croatian: U bolesnika liječenih lijekom LEMTRADA prijavljene su citomegalovirusne (CMV) infekcije, uključujući slučajeve reaktivacije CMV-a.
English: Stool infections work-up should be performed upon presentation of diarrhoea or colitis to exclude infectious or other alternate etiologies.
Croatian: Nakon pojave proljeva ili kolitisa potrebno je napraviti pretragu stolice na infektivne uzročnike kako bi se isključile infektivne ili neke druge etiologije.
English: Tell your doctor right away if you have symptoms of infection such as fever or swollen glands.
Croatian: Ako se pojave simptomi infekcije kao što su vrućica ili otečene žlijezde, odmah se obratite liječniku.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Učestalost „nepoznata”: Nemelanomski rak kože (karcinom bazalnih stanica i karcinom skvamoznih stanica)
English: *** E.g. for containers to be stored on a farm.
Croatian: for containers to be stored on a farm.
English: ANNEX II[Not applicable for MRP/DCP]
Croatian: DODATAK II[Not applicable for MRP/DCP]
English: <6 months.><…><1 year.><18 months.><2 years.><30 months.><3 years.><use immediately.>
Croatian: <6 mjeseci.><...><1 godina.><18 mjeseci.><2 godine.><30 mjeseci.><3 godine.>< odmah upotrijebiti.>
English: <Specific pharmacovigilance requirements:>
Croatian: <Specifični zZahtjevi farmakovigilancije:>
English: <For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Croatian: <Za bilo koju informaciju o ovom veterinarsko-medicinskom proizvodu molimo kontaktirajte lokalnog predstavnika nositelja odobrenja za stavljanje u promet.
English: <Official control authority batch release is required for this product.> [only for those immunological veterinary medicinal products which are listed for Official Control Authority Batch Release (OCABR) in accordance with Article 82 of Directive 2001/82/EC as amended.]
Croatian: <„Official control authority batch release“ certifikat je potreban za ovaj proizvod.> [only for those immunological veterinary medicinal products which are listed for Official Control Authority Batch Release (OCABR) in accordance with Article 82 of Directive 2001/82/EC as amended.]
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.>
Croatian: b) je bolest, za koju je proizvod namijenjen da pruži imunost, u velikoj mjeri odsutna s odnosnog područja.>
English: <{Invented name} should not enter water courses as this may be dangerous for fish and other aquatic organisms.>
Croatian: <{Izmišljeni naziv} ne treba odlagati u otvorene vode jer to može biti opasno za ribe i druge vodene organizme.>
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/000/000
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/00/000/000
English: OTHER INFORMATION>
Croatian: <15. OSTALE INFORMACIJE>
English: <None known.>
Croatian: <Nisu poznate.>
English: <The expiry date refers to the last day of that month.>
Croatian: <Rok valjanosti se odnosi na zadnji dan tekućeg mjeseca.>
English: <Do not use {name of product} if you notice {description of the visible signs of deterioration}.>
Croatian: <Ne primjenjujete {naziv proizvoda} ako primijetite {opis vidljivih znakova kvarenja}.>
English: <Alternatively you can report via your national reporting system {national system details}.> [For MRP/DCP only]
Croatian: <Alternativno, možete prijaviti putem nacionalnog sustava izvješćivanja {detalji nacionalnog sustava}.>
English: <Fertility:> <Do not use in breeding animals.>
Croatian: <Plodnost:> <Ne primjenjivati na rasplodnim životinjama.>
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA BLISTERIMA ILI TRAKAMA
English: ATC vet code: {lowest available level (e.g. subgroup for chemical substance)}.
Croatian: ATCvet kod: {najniži dostupni nivo (npr. podgrupa za kemijsku tvar)}
English: <5.1 Pharmacodynamic properties> <5.2 Pharmacokinetic particulars> <Environmental properties>
Croatian: <5.1 <Farmakodinamička svojstva> <5.2 <Farmakokinetički podaci>
English: <Laying birds:> <Do not use in <birds in lay><breeding birds> <and within 4 weeks before the onset start of the laying period>.>
Croatian: <Nesilice:> <Ne primjenjivati na <nesilicama za vrijeme nesenja><pticama za rasplod> <i 4 tjedna prije početak nesenja>.>
English: <According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Croatian: <Sukladno članku 71. Direktive 2001/82/EK i Europskog Parlamenta i Vijeća s izmjenama i dopunama, države članice, u skladu s nacionalnim zakonodavstvom mogu zabraniti proizvodnju, uvoz, posjedovanje, prodaju, opskrbu i/ili primjenu imunoloških veterinarsko-medicinskih proizvoda na cijelom ili na dijelu svog teritorija ako je utvrđeno da:
English: <Do not use within {X} weeks of onset the start of the laying period.>
Croatian: <Ne primjenjivati u roku od {X} tjedana od početka perioda nesenja.>
English: If pain persists for more than 12 hours after medical examination, seek medical advice again.
Croatian: sati nakon liječničkog pregleda, ponovo potražite pomoć liječnika.
English: Personnel involved in attending vaccinated {species} should follow general hygiene principles (changing clothes, wearing gloves, cleaning and disinfection of boots) and take particular care in handling animal waste and bedding materials litter from recently vaccinated {species}.>
Croatian: {vrstama životinja} trebale bi se pridržavati općih higijenskih principa (promjena odjeće, nošenje rukavica, čišćenje i dezinfekcija čizama) i s posebnom pozornošću rukovati s životinjskim otpadom ili ležajem od nedavno cijepljenih {vrste životinja}.> <Korisniku:
English: <Personal protective equipment consisting of {specify} should be worn when handling the veterinary medicinal product.>
Croatian: <Pribor za osobnu zaštitu koji se sastoji od {specificirati} treba koristiti pri rukovanju s veterinarskomedicinskim proizvodom.>
English: <The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.The data lock point (DLP) for the next PSUR would be {add DLP}.>[Only applicable, if justified after authorisation.]
Croatian: Ponovo treba podnositi periodička izvješća o neškodljivosti (PSUR) treba ponovo podnositi putem 6 mjesečnih izvješća (pokrivajući sva odobrena pakovanja proizvoda) uza naredne dvije godine, nakon kojih slijede godišnja izvješća za sljedeće dvije godine, a nakon toga u trogodišnjim intervalima.
English: <Immunocompromised persons are advised to avoid contact with the <vaccine><immunological veterinary medicinal product> and vaccinated animals during {period}.>
Croatian: <Imunokompromitiranim osobama savjetujemo izbjegavanje kontakta s <cjepivom><imunološkim veterinarsko-medicinskim proizvodom> i cijepljenom životinjom tijekom {period}.>
English: <The <vaccine><immunological veterinary medicinal product> can be pathogenic for humans.
Croatian: <Cjepivo><imunološki veterinarsko-medicinski proizvod> može biti patogeno za ljude.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the <label><carton><bottle><...> <after {abbreviation used for expiry date}>.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na <etiketi><kutiji><bočici> <…><poslije {skraćenica korištena za rok valjanosti}>.
English: Since this <vaccine> <immunological veterinary medicinal product> has been prepared with live, attenuated microorganisms, appropriate measures should be taken to prevent contamination of the handler and other people that collaborate in the process.>
Croatian: Budući da je <cjepivo><imunološki veterinarsko-medicinski proizvod> napravljeno(n) od živih, atenuiranih mikroorganizama, treba poduzeti primjerene mjere kako bi se izbjegla kontaminacija onoga tko rukuje cjepivom kao i pomoćnika koji sudjeluju pri cijepljenju.>
English: <Not applicable.>
Croatian: <Nije primjenjiva.>
English: <Special precautions for use in animals:> <Special precautions to be taken by the person administering the veterinary medicinal product to animals:> <Pregnancy:> <Lactation:> <Pregnancy and lactation:> <Lay:> <Fertility:> <Interaction with other medicinal products and other forms of interaction:> <Overdose (symptoms, emergency procedures, antidotes):> <Incompatibilities:>
Croatian: <Posebna upozorenja <za svaku od ciljnih vrsta životinja:> <Posebne mjere opreza prilikom primjene:> <Posebne mjere opreza prilikom primjene na životinjama:> <Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama:> <Graviditet:> <Laktacija:> <Graviditet i laktacija:> <Nesenje:> <Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija:> <Predoziranje (simptomi, hitni postupci, antidoti):> <Inkompatibilnosti:>
English: Any person intending to manufacture, import, possess, sell, supply and use <invented name> must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.> <Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.>
Croatian: Tko namjerava proizvoditi, uvesti, posjedovati, prodavati, opskrbljivati i/ili primjenjivati <izmišljeni naziv> mora se savjetovati s nadležnim tijelom odnosne države članice u pogledu važećih odredbi o cijepljenju prije proizvodnje, uvoza, posjedovanja, prodaje, opskrbe i/ili primjene.<Svaka osoba koja namjerava proizvoditi, uvoziti, posjedovati, prodavati, opskrbljivati i koristiti ovaj veterinarsko-medicinski proizvod mora prethodno konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi o cijepljenju, jer te aktivnosti mogu biti zabranjene u državi članici, u cijelosti ili samo na djelu njezinog teritorija, u skladu s nacionalnim zakonodavstvom.>
English: SPECIAL WARNING(S) <None.>
Croatian: 12. POSEBNO(A) UPOZORENJE(A) <Nema.>
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance
: <Adjuvant
:> <Excipient
:>
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Djelatna<e> tvar<i> <Adjuvans<i>:> <Pomoćna<e> tvar<i>:>
English: <EXP {month/year}> <Once <broached><opened><diluted><reconstituted> <use by…> <use within…> <use immediately>.>
Croatian: <Jednom <odčepljen> <otvoren> <razrijeđen> <rekonstituiran> <upotrijebiti do…> <upotrijebiti u…> <odmah upotrijebiti>.>
English: <Batch><Lot> {number}
Croatian: <Serija> < Lot > {broj}
English: During this time, the contact of immunosuppressed and unvaccinated {species} with vaccinated {species} should be avoided.>
Croatian: Za to vrijeme, treba izbjegavati kontakt imunosupresivnih i necijepljenih {vrste životinja} s cijepljenim {vrste životinja}.
English: <Lactation:> <Not applicable.>
Croatian: <Laktacija:> <Nije primjenjivo>
English: To the physician:
Croatian: <Liječniku:
English: <PHARMACOLOGICAL><IMMUNOLOGICAL> PROPERTIES Pharmacotherapeutic group: {group}.
Croatian: <FARMAKOLOŠKA> <IMUNOLOŠKA> SVOJSTVA Farmakoterapijska grupa: {grupa}.
English: <The safety of the veterinary medicinal product has not been established during <pregnancy><lactation><lay>.>
Croatian: <Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme <graviditeta><laktacije><nesenja>.>
English: <Not applicable.> <Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.>
Croatian: <Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.>
English: <The <vaccine><immunological veterinary medicinal product><veterinary medicinal product> should not be used if {description of the visible signs of deterioration}.>
Croatian: <Cjepivo><imunološki veterinarsko-medicinski proizvod><veterinarsko-medicinski proizvod> ne treba koristiti ako {opis vidljivih znakova kvarenja}.>
English: <People with known hypersensitivity to {INN} should <avoid contact with the veterinary medicinal product.><administer the veterinary medicinal product with caution.>>
Croatian: <Osobe preosjetljive na {INN} trebaju <izbjegavati kontakt s veterinarsko-medicinskim proizvodom.>< oprezno primjenjivati veterinarsko medicinski proizvod.>>
English: <Protect from light.> <Store in a dry place.> <Protect from direct sunlight.>
Croatian: <Zaštiti od direktnog sunčevog svjetla.>
English: A decision to use this <vaccine><immunological veterinary medicinal product> before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.>
Croatian: Odluku o primjeni ovog <cjepiva><imunološkog veterinarsko-medicinskog proizvoda> prije, odnosno poslije primjene bilo kojeg drugog veterinarsko-medicinskog proizvoda treba donositi od slučaja do slučaja.
English: <This veterinary medicinal product does not require any special temperature storage conditions.>*****
Croatian: <Ovaj veterinarsko-medicinski proizvod ne zahtijeva nikakve posebne temperaturne uvijete čuvanja.>*****
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 Europskean Medicines agencije za lijekovey http://www.ema.europa.eu/.
English: <The manufacture, import, possession, sale, supply and/or use of {invented name} may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: <Uvoz, proizvodnja, uvoz, posjedovanje, prodaja, opskrba i/ili primjena {izmišljeni naziv} je ili može biti zabranjena u određenim državama članicama na cijelom ili na dijelu njihovog teritorija sukladno nacionalnim propisima.
English: The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of {name of the active substance(s)} in {name of the product} in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 37/2010 as follows:
Croatian: Odbor za medicinske proizvode za primjenu u veterini je predložio uključivanje {naziv djelatne(ih) tvari} u {naziv proizvoda} u tablicu 1 (Dozvoljene tvari) Dodatka Uredbe Komisije (EU) br. 37/2010 kako slijedi: