FrancophonIA/ELRC3.0 huggingface dataset:
English: The applicant Huvepharma NV submitted a marketing authorisation application, via the decentralised procedure, for Gutal according to Article 13(1) Directive 2001/82/EC, referring to the reference product ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff authorised in the United Kingdom.
Croatian: Podnositelj zahtjeva VMP-a Huvepharma NV podnio je zahtjev za izdavanjem odobrenja za stavljanje VMP-a u promet putem decentraliziranog postupka, za Gutal u skladu sa člankom 13. (1) Direktive 2001/82/EZ, referirajući se na referentni proizvod premiks za hranu za praščiće koja sadrži VMP ZincoTec cinkov oksid 100%, koji je odobren u Ujedinjenoj Kraljevini.
English: Manure from treated piglets should not be spread on vulnerable soil types, which have been identified as freely draining, acidic (pH ≤6), sandy soils.
Croatian: Gnojivo od tretiranih odojaka ne smije se rastresati na osjetljive vrste tla, za koje je utvrđeno da se slobodno isušuju, da su kisela (pH ≤6) ili pjeskovita.
English: CVMP reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal products (EMA/CVMP/ERAWP/409328/2010)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/03/WC500124187.pdf
Croatian: CVMP reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal products (EMA/CVMP/ERAWP/409328/2010)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/03/WC500124187.pdf manje od ukupne smjese).
English: The bioavailability of zinc, and therefore the environmental risk, varies between soil types.
Croatian: Bioraspoloživost cinka, a time i opasnost za okoliš, različiti su kod različitih vrsta tla.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS, IF ANY
Croatian: VETERINARSKOMEDICINSKOG PROIZVODA ILI OTPADNIH MATERIJALA, AKO POSTOJE
English: Overall summary of the scientific evaluation of Gutal 1000 g/kg premix for medicated feeding stuff for piglets (see Annex I)
Croatian: Cjelokupni sažetak znanstvene ocjene premiksa za hranu za praščiće koja sadrži VMP Gutal 1000 g/kg (vidjeti Dodatak I.)
English: Dilution with manure of untreated animals or sows is required so that the total amount of treated piglet manure is as low as possible and is never exceeding 40 %, the ratio when manure of weaned piglets and sows is stored together.
Croatian: Gnojivo je potrebno razrijediti gnojivom netretiranih životinja ili krmača, kako bi ukupna količina gnojiva od tretiranih odojaka bila što manja i kako ne bi premašivala udio od 40 %, što je omjer koji se koristi kod zajedničkog čuvanja gnojiva od odbijenih odojaka i krmača.
English: When spreading manure from treated animals, the minimum distance to surface water as defined in the national or local regulations has to be strictly respected, and at least a minimum buffer zone of 3 m applied, because the manure contains zinc which may cause adverse effects in the aquatic environment.
Croatian: Kod razastiranja gnojiva od tretiranih životinja, minimalnu udaljenost od podzemnih voda propisanu nacionalnim ili lokalnim propisima potrebno je strogo poštivati i potrebno je primijeniti tzv. tampon zonu minimalne veličine
English: mineral phases, e.g. iron (oxy)hydroxides and manganese oxides, as well as the organic matter content in sediments.
Croatian: Drugi parametri koji utječu na (snižavaju) bioraspoloživost cinka u sedimentima su prisutnost precipiranih mineralnih faza, primjerice željezo (oksi)hidroksideza i maganez oksideza, kao i udio organske tvari u sedimentima.
English: , 7.2 kg zinc ha a-1
Croatian: , 7,2 kg cinka ha a-1
English: , 3.3 kg zinc ha a-1
Croatian: , 3,3 kg cinka ha a-1
English: and 2.8 kg zinc ha a-1
Croatian: 2,8 kg cinka ha a-1
English: European Union Risk Assessment Report (EU RAR) on zinc (2010)http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/15064/1/lbna24587enn.pdf Environment Agency.
Croatian: European Union Risk Assessment Report (EU RAR) on zinc (2010)http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/15064/1/lbna24587enn.pdf istraživanja za EU RAR (2010.) više podataka je postalo dostupno (primjerice oni podaci koji se koriste za utvrđivanje Standarda kvalitete okoliša u UK
English: variable, where zinc sulfides are formed PNECs may be greatly exceeded before adverse effects are observed.
Croatian: Potonji može smanjiti bioraspoloživost cinka i, iako su razine su varijabilne, kada se formiraju cink sulfidi, PNEC-ovi se mogu uvelike premašiti prije nego se uoče nuspojave.
English: These issues remained unresolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started.
Croatian: Uredbe Komisije (EZ) br. 82/2008 od strane Koordinacijske skupine za međusobno priznavanje i decentralizirane postupke (veterinarske) (CMD(v)).
English: Grounds for the granting of the marketing authorisations for Gutal 1000 g/kg premix for medicated feeding stuff for piglets
Croatian: Razlozi za izdavanje odobrenja za stavljanje VMP-a u promet za premiks za hranu za praščiće koja sadrži VMP Gutal 1000 g/kg
English: At a site-specific level, PNEC bioavailability corrections in sediment as a result of AVS/SEM content in sediment, can be made if the necessary data are available; however, such data are scarce.
Croatian: U razini koja je specifična za lokaciju mogu se provesti ispravci bioraspoloživosti PNEC-a u sedimentu kao rezultat udjela AVS-a/SEM-a u sedimentu; no takvi su podaci nasumični: Stoga, iako se tlo i površinske vode mogu ispraviti s obzirom na bioraspoloživost, ispravak nije moguć za izračun PEC-ova u sedimentu u ovoj ocjeni rizika za okoliš.
English: • Since the marketing authorisation application was submitted in accordance with Article 13(1) of Directive 2001/82/EC and bioequivalence was accepted, the benefit-risk for Gutal is considered to be equivalent to that of the reference product, ZincoTec - Zinc Oxide 100% Premix for Medicated Feeding Stuff.
Croatian: • Budući da je zahtjev za odobrenje za stavljanje VMP-a u promet dostavljen u skladu sa člankom 13. (1) Direktive 2001/ 82 / EZ i bioekvivalencija je prihvaćena, omjer koristi i rizika za VMP Gutal smatraju se istim kao i onaj za referentni veterinarsko-medicinski proizvod, ZincoTec - cink oksid 100 % premiks za hranu koja sadrži VMP.
English: Since the marketing authorisation application was submitted in accordance with Article 13(1) of Directive 2001/82/EC and bioequivalence was accepted, the therapeutic benefits for Gutal are considered to be the same as those for the reference product, ZincoTec - Zinc Oxide 100% Premix for Medicated Feeding Stuff and have not been re-evaluated as part of this procedure.
Croatian: Budući da je zahtjev za odobrenje za stavljanje VMP-a u promet dostavljen u skladu sa člankom 13. (1) Direktive 2001/ 82 / EZ i bioekvivalencija je prihvaćena, terapeutske koristi za Gutal smatraju se istima kao i one za referentni veterinarsko-medicinski proizvod, ZincoTec - cink oksid 100 % premiks za hranu koja sadrži VMP, te nisu ponovno ocijenjene kao dio ovog postupka.
English: Since the marketing authorisation application was submitted in accordance with Article 13(1) of Directive 2001/82/EC, the therapeutic benefits for Gutal are considered to be the same as those for the reference product, ZincoTec - Zinc Oxide 100% Premix for Medicated Feeding Stuff and are not reevaluated under this procedure.
Croatian: Budući da je zahtjev za odobrenje za stavljanje VMP-a u promet dostavljen u skladu sa člankom 13. (1) Direktive 2001/ 82 / EZ, terapeutske koristi za Gutal smatraju se istima kao i one za referentni veterinarsko-medicinski proizvod, ZincoTec - cink oksid 100 % premiks za hranu koja sadrži VMP, te nisu ponovno ocijenjene kao dio ovog postupka.
English: RMMs.
Croatian: Cipar
English: Slovenia Huvepharma NV Uitbreidingstraat 80
Croatian: Slovenija Huvepharma NV Uitbreidingstraat 80
English: Slovakia Huvepharma NV Uitbreidingstraat 80
Croatian: Slovačka Huvepharma NV Uitbreidingstraat 80
English: Luxembourg Huvepharma NV Uitbreidingstraat 80
Croatian: Luksemburg Huvepharma NV Uitbreidingstraat 80
English: Bulgaria Huvepharma NV Uitbreidingstraat 80
Croatian: Bugarska Huvepharma NV Uitbreidingstraat 80
English: Romania Huvepharma NV Uitbreidingstraat 80
Croatian: Rumunjska Huvepharma NV Uitbreidingstraat 80
English: Denmark Huvepharma NV Uitbreidingstraat 80
Croatian: Estonija Huvepharma NV Uitbreidingstraat 80
English: ATCvet code: QI02AB .
Croatian: ATCvet kod: QI02AB .
English: However, in some cases, swelling may persist for up to 4 weeks.
Croatian: Međutim, u nekim slučajevima, oteklina se može održati kroz 4 tjedna.
English: Store and transport refrigerated (2 ºC - 8 °C) and protected from light.
Croatian: Čuvati i prevoziti rashlađeno (2 ºC do 8 °C) i zaštititi od svjetla.
English: White homogeneous emulsion.
Croatian: Bijela homogena emulzija.
English: This should be considered in case of herd vaccination.
Croatian: To se mora uzeti u obzir prilikom vakcinacije stada.
English: Duration of immunity: approximately the first 5 months of lactation.
Croatian: Trajanje imunosti: približno prvih 5 mjeseci laktacije.
English: Overdose (symptoms, emergency procedures, antidotes): No information is available.
Croatian: Predoziranje (simptomi, hitni postupci, antidoti): Nema dostupnih informacija.
English: 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: 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: Date of first authorisation: <{DD/MM/YYYY}>
Croatian: Datum prvog odobrenja: {DD/MM/GGGG}
English: Montanide ISA ............................................................................................................................907.1 mg
Croatian: Montanide ISA ............................................................................................................................ 907,1 mg Monofosforil lipid A (engl.
English: The full immunisation program should be repeated with each gestation.
Croatian: Cjelovit program imunizacije mora se ponoviti kod svakog graviditeta.
English: Protection of animals not vaccinated following this program has not been demonstrated.
Croatian: Nije dokazana zaštita životinja kod kojih se cijepljenje nije provodilo prema ovom programu.
English: Pregnancy and Lactation:
Croatian: Graviditet i laktacija:
English: Onset of immunity: approximately 36 days after the second dose.
Croatian: Početak imunosti: približno 36 dana nakon druge doze.
English: The whole herd should be immunised.
Croatian: Mora se imunizirati cijelo stado.
English: Pharmacotherapeutic group: Immunologicals for bovidae, inactivated bacterial vaccines for cattle.
Croatian: Farmakoterapijska grupa: Imunološki pripravci za bovidae, inaktivirana bakterijska cjepiva za goveda.
English: Allow the vaccine to reach a temperature of +15 to + 25 °C before administration.
Croatian: Prije primjene pričekajte da cjepivo dostigne temperaturu od +15 do +25 °C.
English: This swelling will have disappeared or be clearly reduced in size by 17 days post vaccination.
Croatian: Takva će oteklina nestati ili se jasno smanjiti kroz 17 dana nakon cijepljenja.
English: Immunisation has to be considered as one component in a complex intramammary infection control program that addresses all important udder health factors (e.g. milking technique, dry-off and breeding management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality and health monitoring) and other management practices.
Croatian: Imunizaciju treba smatrati jednim od sastavnih dijelova kompleksnog programa kontrole infekcija, koji uključuje sve čimbenike važne za zdravo vime (npr. tehnika mužnje, upravljanje zasušivanjem i uzgojem, higijena, hranidba, nastambe, ležišta, udobnost krava, kvaliteta zraka i vode, nadzor zdravstvenog stanja) i druge načine upravljanja.
English: Local swelling more than 5 cm in diameter at the injection site is a very common reaction after administration of the vaccine.
Croatian: Lokalna oteklina veća od 5 cm u promjeru na mjestu injekcije predstavlja vrlo čestu reakciju nakon primjene cjepiva.
English: Bearing in mind that some cows had suffered more than one episode of Streptococcus uberis clinical intramammary infection, the incidence of cows with clinical intramammary infection was 52.5% lower in the vaccinated group than those of the placebo group (4.7% versus 9.9%), with a statistical significance of p<0.017.
Croatian: Ako se uzme u obzir činjenica da su neke krave imale više od jedne kliničke intramamarne infekcije uzrokovane bakterijom Streptococcus uberis, onda je incidencija krava s kliničkom intramamarnom infekcijom bila 52,5 % niža u cijepljenoj skupini nego u skupini koja je primila placebo (4,7 % naprama 9,9 %) pa je statistička značajnost iznosila p <
English: Administer one dose (2 ml) by deep intramuscular injection in the neck muscles according to the following immunisation program: - First dose at approximately 60 days before the expected parturition date
Croatian: Primijenite jednu dozu (2 ml) dubokom intramuskularnom injekcijom u vratne mišiće, i to prema sljedećem rasporedu imunizacije: - Prva doza 60 dana prije očekivanog termina teljenja
English: Carretera C63 Km 48, 300, Poligono Industrial El Rieral 17170 Amer (Girona) Spain
Croatian: Carretera C63 Km 48,300, Polígono Industrial El Rieral 17170 Amer (Girona) Spain
English: Monophosphoryl Lipid A (MPLA) Disodium phosphate dodecahydrate Potassium dihydrogen phosphate
Croatian: Monophosphoryl Lipid A, MPLA) Dinatrijev fosfat dodekahidrat
English: Subunit vaccine to stimulate active immunity against Streptococcus uberis.
Croatian: Podjedinično cjepivo za aktivnu imunizaciju protiv Streptococcus uberis.
English: Polyethylene (PET) vials of 10, 50 and 100 ml.
Croatian: Polietilenske (PET) bočice od 10, 50 i 100 ml.
English: LTA from BAC of Streptococcus uberis, strain 5616 Relative Potency ≥ 1 RPU
Croatian: KOLIČINA DJELATNE(IH) TVARI LTA iz BAC Streptococcus uberis, soj 5616 relativna potencija ≥ 1 RPU
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNIH TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals To the user:
Croatian: Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama:
English: A transient increase in rectal temperature (mean increase of 1 °C but may be up to 2 °C in individual animals) may very commonly occur in the first 24 hours after injection.
Croatian: Postoji velika vjerojatnost od prolaznog povišenja rektalne temperature (radi se o povišenju od 1°C, iako kod pojedinih životinja ono može iznositi i do 2 °C) u prva 24 sata nakon cijepljenja.
English: - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated)
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e) ) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - 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: Vial of 25 and 50 doses.
Croatian: Bočica od 25 i 50 doza.
English: EU/2/18/227/001-004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/18/227/001-004
English: 20 x 1 dose (1 vial of 2 ml)
Croatian: 20 x 1 doza (1 ampula od 2 ml)
English: UBAC emulsion for injection for cattle
Croatian: UBAC emulzija za injekciju za goveda
English: 25 doses (1 vial of 50 ml) 50 doses (1 vial of 100 ml) 25 doses (50 ml) 50 doses (100 ml)
Croatian: 5 doza (1 ampula od 10 ml) 25 doza (1 ampula od 50 ml) 50 doza (1 ampula od 100 ml)
English: <{MM/YYYY}>
Croatian: Lot {broj}
English: In a multicentre field study, the incidence of new cases of Streptococcus uberis clinical intramammary infection in the group vaccinated with UBAC was 50% lower than the incidence in the placebo group (6.1% versus 12.2%) which was statistically significantly different (p=0.012).
Croatian: UBAC 50 % niža od incidencije u skupini koja je primila placebo (6,1 % naprama 12,2 %), što je statistički značajna razlika (p = 0,012).
English: For active immunisation of healthy cows and heifers to reduce the incidence of clinical intramammary infections caused by Streptococcus uberis, to reduce the somatic cell count in
Croatian: Za aktivnu imunizaciju zdravih krava i junica radi smanjenja incidencije kliničkih intramamarnih infekcija uzrokovanih bakterijom Streptococcus uberis, smanjenja broja somatskih stanica u uzorcima mlijeka iz četvrtina vimena pozitivnih na Streptococcus uberis i smanjenja gubitaka u proizvodnji mlijeka zbog intramamarnih infekcija uzrokovanih bakterijom Streptococcus uberis.
English: Cardboard box with 20 glass vials of 1 dose.
Croatian: - Kartonska kutija s 20 staklenih ampula s po 1 dozom.
English: Cardboard box with 20 glass vials of 1 dose (2 ml).
Croatian: Kartonska kutija s 20 staklenih ampula od 1 doze (2 ml).
English: Cardboard box with 1 PET vial of 5, 25 and 50 doses.
Croatian: - Kartonska kutija s 1 plastičnom (PET) bocom s po 5, 25 i 50 doza.
English: 5 doses (1 vial of 10 ml)
Croatian: 5 doza (10 ml)
English: One dose (2 ml) contains: Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of Streptococcus uberis, strain
Croatian: Lipoteikoična kiselina (engl. lipoteichoic acid, LTA) iz adhezijske sastavnice biofilma (engl.
English: - Second dose at least 21 days before the expected parturition date - Third dose should be administered about 15 days after the calving.
Croatian: - Treća doza mora se primijeniti oko 15 dana nakon teljenja.
English: HIPRA DEUTSCHLAND GmbH
Croatian: HIPRA BENELUX NV
English: 5616 ≥ 1 RPU* *Relative Potency Units (ELISA)
Croatian: ≥ 1 RPU* *relativne jedinice potencije (engl.
English: Potassium chloride
Croatian: Kalijev dihidrogenfosfat
English: Vial label 1 dose and 5 doses
Croatian: Oznake ampula od 1 i 5 doza.
English: - First dose at approximately 60 days before the expected parturition date - Second dose at least 21 days before the expected parturition date - Third dose should be administered about 15 days after the calving.
Croatian: - Druga doza najmanje 21 dan prije očekivanog termina teljenja
English: Type I colourless glass vials of 3 ml.
Croatian: Bezbojne bočice od stakla tipa
English: Special warnings for each target species: Only healthy animals should be immunised.
Croatian: Posebna upozorenja za svaku od ciljnih vrsta životinja:
English: Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of Streptococcus uberis, strain 5616 .................................................................................................................................. ≥ 1 RPU*
Croatian: Biofilm Adhesion Component, BAC) iz Streptococcus uberis, soj 5616 ............................................... ≥ 1 RPU* *relativne jedinice potencije (engl.
English: Cardboard box with 1 PET vial of 50 doses (100 ml).
Croatian: Kartonska kutija s 1 PET bočicom od 50 doza (100 ml).
English: Cardboard box with 1 PET vial of 5 doses (10 ml).
Croatian: Kartonska kutija s 1 PET bočicom od 5 doza (10 ml).
English: Cardboard box with 1 PET vial of 25 doses (50 ml).
Croatian: Kartonska kutija s 1 PET bočicom od 25 doza (50 ml).
English: Streptococcus uberis intramammary infections.
Croatian: NAČIN I PUT(EVI) PRIMJENE Intramuskularna primjena.
English: 1 dose (2 ml) 5 doses (10 ml)
Croatian: 1 doza (2 ml)
English: Once broached use immediately.
Croatian: ROK VALJANOSTI EXP {mjesec/godina} Upotrijebiti odmah po otvaranju.
English: HIPRA UK AND IRELAND, Ltd. Tel: (+44) 0115 912 4320
Croatian: HIPRA DEUTSCHLAND GmbH Tel: (+49) 211 698236 - 0
English: Name and address of the manufacturer of the biological active substance:
Croatian: Naziv i adresa proizvođača biološki djelatne(ih) tvari Laboratorios Hipra, S.A.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, applicants in the member states
Croatian: Popis naziva, farmaceutskih oblika, jačine lijeka, puta primjene i podnositelja zahtjeva u državama članicama
English: Invented Name
Croatian: (Zaštićen) Naziv
English: After first opening: 7 months
Croatian: Nakon prvog otvaranja: 7 mjeseci
English: Ensure it is well fixed.
Croatian: Provjerite da je dobro pričvršćen.
English: Abnormal and aggressive behaviours
Croatian: Abnormalna i agresivna ponašanja
English: When you will first start taking Keppra, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
Croatian: Kad prvi put počnete uzimati Keppru, liječnik će Vam propisati manju dozu tijekom 2 tjedna prije davanja najmanje uobičajene doze.
English: • Drink the whole contents of the glass/baby's bottle.
Croatian: • Popijte cijeli sadržaj čaše/dječje bočice.
English: Keppra is used:
Croatian: Keppra se koristi:
English: Do not use after 7 months of first opening the bottle.
Croatian: Nemojte primjenjivati nakon 7 mjeseci od prvog otvaranja boce.
English: You may take Keppra with or without food.
Croatian: Keppru možete uzeti sa ili bez hrane.
English: Date of opening only for the outer carton
Croatian: Datum otvaranja samo za vanjsku kutiju
English: If discontinuation is considered, please refer to section 4.2.
Croatian: Ako se razmatra prekid liječenja, molimo pogledajte dio 4.2.
English: If such behaviours are noticed, treatment adaptation or gradual discontinuation should be considered.
Croatian: Ako se takva ponašanja primijete, potrebno je razmotriti prilagodbu ili postupni prekid liječenja.
English: It also contains maltitol liquid; patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Croatian: Također sadrži tekući maltitol, pa bolesnici s nasljednim problemima nepodnošljivosti za fruktozu ne smiju uzimati ovaj lijek.
English: Other medicines and Keppra
Croatian: Drugi lijekovi i Keppra
English: • Close the bottle with the plastic screw cap.
Croatian: • Zatvorite bocu plastičnim navojnim zatvaračem.
English: • Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or your family and friends notice important changes in mood or behaviour.
Croatian: • Neuobičajene misli, osjećaj razdražljivosti ili reagiranje agresivnije nego obično, ili ako Vi ili Vaša obitelj i prijatelji primijete važne promjene raspoloženja ili ponašanja.
English: Date of first authorisation: 29 September 2000 Date of latest renewal: 20 August 2015
Croatian: Datum posljednje obnove: 20. kolovoza 2015.
English: Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins ( 10 %).
Croatian: Levetiracetam kao ni njegov primarni metabolit ne vežu se značajno za proteine plazme (<10%).
English: • A small number of people being treated with anti-epileptics such as Keppra have had thoughts of harming or killing themselves.
Croatian: • mali broj ljudi liječenih antiepilepticima kao što je Keppra imali su misli o samoozljeđivanju ili samoubojstvu.