FrancophonIA/ELRC3.0 huggingface dataset:
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 dostupne su na web stranici European Medicines Agency http://www.ema.europa.eu/.
English: EXP {month/year} Once opened, use within 6 months.
Croatian: EXP {mjesec/godina} Jednom otvoren, upotrijebiti unutar 6 mjeseci.
English: To be administered either mixed with food or directly into the mouth.
Croatian: Pomiješati sa hranom ili dati direktno u usta.
English: All major metabolites have been shown to be pharmacologically inactive.
Croatian: Svi glavni metaboliti pokazali su se farmakološki neaktivni.
English: Oral suspension
Croatian: Oralna suspenzija
English: 4941 SJ Raamsdonksveer THE NETHERLANDS
Croatian: 4941 SJ Raamsdonksveer Nizozemska
English: A clinical response is normally seen within 3-4 days.
Croatian: Klinički odgovor obično se javlja za 3-4 dana.
English: As for other species investigated, the main pathway of meloxicam biotransformation in cat is oxidation.
Croatian: Što se tiče ostalih ispitivanih vrsta, glavni put biotransformacije meloksikama u mačke je oksidacija.
English: Approximately 97% of meloxicam is bound to plasma proteins.
Croatian: Približno 97% meloksikama vezano je za bjelančevine plazme.
English: Date of last renewal: 08/09/2015
Croatian: Datum posljednjeg produljenja odobrenja: 08/09/2015
English: CONTENT BY WEIGHT; BY VOLUME OR BY NUMBER OF DOSES
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA
English: Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.
Croatian: Tako će za početak terapije prvog dana biti potreban dvostruki volumen održavanja.
English: A clinical response is normally seen within 7 days.
Croatian: Klinički odgovor obično se javlja u roku od 7 dana.
English: Oral suspension.
Croatian: Oralna suspenzija.
English: Yellow/ green suspension.
Croatian: Žuta/ zelena suspenzija.
English: Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.
Croatian: Meloksikam u mačaka ima uske granice terapijske sigurnosti, pa se klinički znakovi predoziranja mogu pojaviti pri relativno malim prekoračenjima doze.
English: Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 4.5 hours.
Croatian: Meloksikam se potpuno apsorbira nakon oralne primjene, a maksimalne koncentracije u plazmi postižu se nakon približno 4,5 sata.
English: In very rare cases elevated liver enzymes have been reported.
Croatian: U vrlo rijetkim slučajevima zabilježno je povišenje vrijednosti jetrenih enzima.
English: For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose of Meloxoral can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.
Croatian: Pri dužem liječenju, kad se primijeti klinički odgovor (nakon ≥ 4 dana) dozu Meloxorala može se prilagoditi na najnižu dozu djelotvornu za pojedinu životinju, vodeći računa da stupanj bola i upale povezanih s kroničnim poremećajima mišićno-koštanog sustava može s vremenom varirati.
English: In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and more frequent.
Croatian: U slučaju predoziranja očekuje se da će nuspojave, kao što je navedeno u dijelu 4.6, biti teže i učestalije.
English: Keep out of sight and reach of children.
Croatian: Čuvati izvan pogleda i dosega djece.
English: If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Croatian: Ako nastane nuspojava, potrebno je prekinuti liječenje i potražiti savjet veterinara.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 treated animals) - uncommon (more than 1 but less than 10 animals in 1,000 treated animals) - rare (more than 1 but less than 10 animals in 10,000 treated animals) - very rare (less than 1 animal in 10,000 treated animals, including isolated reports).
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: Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment.
Croatian: Prethodna primjena protuupalnih lijekova može rezultirati dodatnim ili pojačanim nuspojavama, tako da treba paziti da se prije početka liječenja takvi veterinarsko-medicinski proizvodi ne primjenjuju najmanje 24 sata.
English: In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.
Croatian: U vrlo rijetkim slučajevima zabilježeni su hemoragijski proljev, hematemeza, gastrointestinalne ulceracije i povišene vrijednosti jetrenih enzima.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i bočici.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Croatian: Izbjegavati primjenu u dehidriranih, hipovolemičnih ili hipotenzivnih životinja zbog povećanog potencijalnog rizika za razvoj bubrežne toksičnosti.
English: Avoid introduction of contamination during use.
Croatian: Za vrijeme primjene izbjegavati mogućnost kontaminacije.
English: Response to long-term therapy should be monitored at regular intervals by a veterinarian.
Croatian: Reakciju na dugotrajnu terapiju treba u pravilnim razmacima nadzirati veterinar..
English: These adverse reactions are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Croatian: Te su nuspojave u većini slučajeva prolazne i nestaju nakon prestanka liječenja, ali u vrlo rijetkim slučajevima mogu biti ozbiljne ili smrtonosne.
English: The detection of metabolites from the parent compound in urine and faeces, but not in plasma is indicative for their rapid excretion.
Croatian: Metaboliti iz ishodnog spoja mogu se otkriti u mokraći i izmetu, ali ne i u plazmi, što ukazuje na njihovo brzo izlučivanje.
English: Manufacturer for the batch release: Produlab Pharma B.V.
Croatian: Proizvođač odgovoran za puštanje serije u promet: Produlab Pharma B.V.
English: Sodium benzoate
Croatian: Pomoćna tvar: Natrijev benzoat
English: After each dose, the tip of the syringe should be wiped and the bottle cap screwed back on tightly.
Croatian: Nakon svake doze, potrebno je obrisati vrh štrcaljke, te čvrsto zatvoriti bočicu.
English: The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the maintenance dose.
Croatian: Štrcaljka pristaje na kapaljku bočice i ima ljestvicu mjernih oznaka za tjelesnu težinu u kg, koje odgovaraju dozi održavanja.
English: PACKAGE SIZES
Croatian: VELIČINE PAKOVANJA
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Croatian: Meloksikam je nesteroidni protuupalni lijek (NSPUL) iz skupine oksikama koji djeluje kočenjem sinteze prostaglandina, čime se postižu protuupalni, analgetički, antieksudativni i antipiretički učinci.
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Croatian: UVJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU OPSKRBE I PRIMJENE
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicable
Croatian: 13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
English: In case of overdose, adverse reactions, as listed in section 6 "Adverse reactions", are expected to be more severe and more frequent.
Croatian: U slučaju predoziranja očekuje se da će nuspojave, kao što je navedeno u dijelu 6 "Nuspojave", biti teže i učestalije.
English: These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Croatian: Te se nuspojave obično javljaju tijekom prvog tjedna liječenja i u većini su slučajeva su prolazne i nestaju nakon prestanka liječenja, ali u vrlo rijetkim slučajevima mogu biti ozbiljne ili smrtonosne.
English: Overdose (symptoms, emergency procedures, antidotes): In case of overdose symptomatic treatment should be initiated.
Croatian: Predoziranje (simptomi, hitni postupci, antidoti): U slučaju predoziranja potrebno je započeti simptomatsko liječenje.
English: Bottle of 125 or 180 ml
Croatian: Bočica od 125 ili 180 ml
English: The syringe should be stored in the carton box in between uses.
Croatian: Između primjena štrcaljku čuvati u kartonskoj kutiji.
English: Concurrent administration of potential nephrotoxic veterinary medicinal products should be avoided.
Croatian: Treba izbjegavati istodobnu primjenu potencijalno nefrotoksičnih veterinarskih lijekova.
English: Polyethylene bottle containing 10 ml, 25 ml, 50 ml, 125 ml or 180 ml with a tamper proof child resistant closure and a polypropylene measuring syringe.
Croatian: Polietilenska bočica koja sadrži 10 ml, 25 ml, 50 ml, 125 ml ili 180 ml sa sigurnosnim zatvaračem za zaštitu djece i polipropilenska mjerna štrcaljka.
English: België/Belgique/Belgien Dechra Veterinary Products N.V. Achterstenhoek 48
Croatian: België/Belgique/Belgien Dechra Veterinary Products N.V.
English: Bottle of 10, 25, 50, 125 or 180 ml.
Croatian: Bočica od 10, 25, 50, 125 ili 180 ml.
English: Marketing authorisation holder: Le Vet B.V
Croatian: Nositelj odobrenja za stavljanje u promet: Le Vet B.V.
English: The suspension can be given using the Meloxoral measuring syringe provided in the package.
Croatian: Suspenzija se može primjeniti pomoću Meloxoral mjerne štrcaljke koja se nalazi u pakiranju.
English: The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Croatian: Međutim, u razdoblju bez liječenja treba uzeti u obzir farmakokinetička svojstva prethodno primijenjenih veterinarsko-medicinskih proizvoda.
English: Alleviation of pain and inflammation in chronic musculo-skeletal disorders in cats.
Croatian: Ublažavanje bolova i upala kod kroničnih mišićno-koštanih poremećaja u mačaka.
English: Meloxoral must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Croatian: Meloxoral se ne smije primjenjivati zajedno s drugim nesteroidnim protuupalnim lijekovima ili glukokortikosteroidima.
English: Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Croatian: Meloksikam se pretežno nalazi u plazmi a izlučuje se uglavnom preko žuči, dok mokraća sadrži samo tragove ishodišnog spoja.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Croatian: 6.6 Posebne mjere opreza za odlaganje neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: In case of overdose symptomatic treatment should be initiated.
Croatian: U slučaju predoziranja potrebno je započeti simptomatsko liječenje.
English: Shelf life after first opening the container: 6 months.
Croatian: Rok valjanosti nakon prvog otvaranja spremnika: 6 mjeseci.
English: Disodium phosphate dodecahydrate Silica, colloidal anhydrous Hydroxyethylcellulose Citric acid monohydrate Sodium cyclamate Sucralose
Croatian: 6.1 Popis pomoćnih tvari natrijev benzoat sorbitol glicerol polisorbat 80 dinatrijfosfat dodekahidrat silika, koloidna bezvodna hidroksietilceluloza limunska kiselina monohidrat natrijev ciklamat sukroza anis aroma voda, pročišćena
English: Do not use in pregnant or lactating animals.
Croatian: Ne primjenjivati na gravidnim životinjama ili u razdoblju laktacije.
English: To avoid introduction of external contaminants during use, keep the provided syringes only for this product.
Croatian: Priložene štrcaljke koristiti samo za ovaj proizvod da bi se izbjegla mogućnost kontaminacije tijekom uporabe.
English: Meloxicam 0.5 mg. Yellow/ green suspension.
Croatian: Meloxicam 0,5 mg/ml Žuta/ zelena suspenzija.
English: Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg meloxicam/kg body weight.
Croatian: Liječenje treba nastaviti jedanput na dan (u razmacima od 24 sata) oralnom primjenom doze održavanja od 0,05 mg meloxicama/kg tjelesne težine.
English: Oral use.
Croatian: Oralna primjena.
English: Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
Croatian: Drugi nesteroidni protuupalni lijekovi, diuretici, antikoagulansi, aminoglikozidni antibiotici i tvari koje se čvrsto vežu na bjelančevine, mogu djelovati kompetitivno i tako potaknuti toksične učinke.
English: Lot {number}
Croatian: Serija {broj}
English: The suspension can be given using the measuring syringe provided in the package.
Croatian: Suspenzija se može primjeniti pomoću mjerne štrcaljke koja se nalazi u pakiranju.
English: Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Croatian: Povremeno su zabilježene nuspojave karakteristične za nesteroidne protuupalne lijekove (NSPUL) poput gubitka apetita, povraćanja, proljeva, okultnog krvarenja u izmetu, apatije i zatajenja bubrega.
English: Meloxicam 1.5 mg. Yellow/ green suspension.
Croatian: Meloksikam 1,5 mg /ml Žuta/ zelena suspenzija.
English: Luxembourg/Luxemburg Dechra Veterinary Products N.V. Achterstenhoek 48
Croatian: Luxembourg/Luxemburg Dechra Veterinary Products N.V.
English: Polyethylene bottle containing 5 ml, 10 ml or 25 ml with a tamper proof child resistant closure and a polypropylene measuring syringe.
Croatian: Polietilenska bočica od 5ml, 10ml ili 25ml sa sigurnosnim zatvaračem za zaštitu djece i polipropilenska mjerna štrcaljka.Ne moraju sve veličine pakovanja biti u prometu.
English: People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Croatian: Osobe preosjetljive na nesteroidne protuupalne lijekove (NSPUL) trebaju izbjegavati kontakt s ovim veterinarsko-medicinskim proizvodom.
English: Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.
Croatian: Liječenje treba nastaviti jedanput na dan (u razmacima od 24 sata) oralnom primjenom doze održavanja od 0,1 mg meloksikama/kg tjelesne težine.
English: Treatment should be discontinued after 14 days at the latest if no clinical improvement is apparent.
Croatian: U slučaju izostanka kliničkog poboljšanja, liječenje treba prekinuti najkasnije nakon 14 dana.
English: 3421 TV Oudewater THE NETHERLANDS
Croatian: 3421 TV Oudewater Nizozemska
English: A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Croatian: NOSITELJ ODOBRENJA ZA PROIZVODNJU ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: Tel: +385 1 33 88 602 info@genera.hr
Croatian: HR-10436 Rakov Potok Tel: +385 1 33 88 602 info@genera.hr
English: Each ml contains: Meloxicam 0.5 mg
Croatian: Jedan ml sadrži: Meloksikam 0,5 mg
English: Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
Croatian: Ako kliničko poboljšanje nije vidljivo, liječenje treba prekinuti najkasnije nakon 10 dana.
English: Dechra Veterinary Products Sp. z o.o.ul.
Croatian: Dechra Veterinary Products Sp. z o.o.ul. Modlinska 61
English: Suomi/Finland Dechra Veterinary Products O Stora Wäsby Orangeriet 3 194 37 Upplands Väsby Sweden
Croatian: Dechra Veterinary Products AB Stora Wäsby Orangeriet 3 194 37 Upplands Väsby Tel.
English: Each ml contains: Meloxicam 1.5 mg.
Croatian: Jedan ml sadrži: Meloksikam 1,5 mg
English: People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Croatian: Osobe preosjetljive na nesteroidne protuupalne lijekove trebaju izbjegavati kontakt s ovim veterinarskim proizvodom.
English: Bottle of 5, 10 or 25 ml
Croatian: Bočica od 5, 10 ili 25 ml
English: Pharmacotherapeutic group: Musculo-skeletal system, antiinflammatory and antirheumatic products, non-steroids.
Croatian: Farmakoterapijska grupa: Mišićno-koštani sustav, protuupalni i protureumatski proizvodi, nesteroidi ATCvet kod: QM01AC06
English: Bottles of 5, 10 or 25 ml.
Croatian: Bočica od 5, 10 ili 25 ml.
English: Produlab Pharma B.V. Forellenweg 16
Croatian: Produlab Pharma B.V.
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Croatian: 11. POSEBNE MJERE PRI ČUVANJU Držati izvan pogleda i dosega djece
English: Meloxicam 1.5 mg.
Croatian: Meloksikam 1,5 mg
English: Bottle of 10, 25 or 50 ml
Croatian: Bočica od 10, 25 i 50 ml
English: In cats, Meloxoral 0.5 mg/ml oral suspension for cats should be used.
Croatian: U mačaka treba primijeniti Meloxoral 0,5 mg/ml oralnu suspenziju za mačke.
English: Meloxicam 0.5 mg.
Croatian: Meloksikam 0,5 mg
English: Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day.
Croatian: Liječenje započinje jednokratnom doza od 0,1 mg meloxicama/kg tjelesne težine aplicinom oralno prvi dan.
English: Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day.
Croatian: Liječenje započinje jednokratnom dozom od 0,2 mg meloksikama/kg tjelesne težine apliciranom oralnoe prvi dan.
English: Meloxoral 0.5 mg/ml oral suspension for cats
Croatian: Meloxoral 0,5 mg/ml oralna suspenzija za mačke
English: PACKAGE LEAFLET: Meloxoral 0.5 mg/ml oral suspension for cats
Croatian: UPUTA O VMP: Meloxoral 0,5 mg/ml oralna suspenzija za mačke
English: PACKAGE LEAFLET: Meloxoral 1.5 mg/ml oral suspension for dogs
Croatian: UPUTA O VMP: Meloxoral 1,5 mg/ml oralna suspenzija za pse
English: Meloxoral 1.5 mg/ml oral suspension for dogs meloxicam
Croatian: Meloxoral 1,5 mg/ml oralna suspenzija za pse meloksikam
English: Meloxoral 0.5 mg/ml oral suspension for cats Meloxicam
Croatian: Meloxoral 0,5 mg/ml oralna suspenzija za mačke Meloksikam
English: The material is absorbed by the body in around 8 weeks.
Croatian: Tijelo apsorbira materijal nakon otprilike 8 tjedana.
English: Evarrest fibrinogen / thrombin
Croatian: Evarrest fibrinogen / trombin
English: Other information about Evarrest
Croatian: Druge informacije o Evarrestu
English: This summary was last updated in 09-2013.
Croatian: Sažetak je posljednji put obnovljen 09.2013.
English: However no more than two patches should be left in the patient as there has not been enough experience with larger quantities.
Croatian: No, u bolesniku se ne smije ostaviti više od dva pokrova s obzirom da ne postoji dovoljno iskustva s većim količinama.
English: The full EPAR for Evarrest can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) može se naći na internetskim stranicama Agencije: : ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Evarrest is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Evarrest koristi što je sigurnije moguće.
English: It must also not be used in patients with active infection or in contaminated areas.
Croatian: Također se ne smije koristiti u bolesnika s aktivnim upalama ili u kontaminiranim područjima.
English: It is made of absorbable material coated on one side with two active substances, fibrinogen and thrombin, and is available as 10.2 cm x 10.2 cm patches.
Croatian: Napravljen je od apsorbirajućeg materijala obloženog s jedne strane s dvije djelatne tvari, fibrogenom i trombinom, a dostupan je kao pokrovi veličine 10.2 cm x 10.2 cm.
English: Evarrest must not be used to repair the walls of large blood vessels, must not be applied to the inside of blood vessels and must not be used in closed spaces (such as openings in bones).
Croatian: Evarrest se ne smije koristiti za popravljanje stjenka velikih krvnih žila, ne smije se primjenjivati na unutarnju stranu krvnih stjenka i ne smije se koristiti u zatvorenim prostorima (poput otvora u kostima).
English: What measures are being taken to ensure the safe and effective use of Evarrest?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Evarrest?
English: It should only be used in a single layer with an overlap of 1 to 2 cm on the surrounding non-bleeding tissue.
Croatian: Smije se koristiti samo u jednom sloju s preklapanjem od 1 do 2 cm preko susjednog tkiva koje ne krvari.
English: Why is Evarrest approved?
Croatian: Zašto je Evarrest odobren?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Evarrest on 25 September 2013.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za Everrast vrijedi na prostoru Europske unije od 25. rujna 2013.
English: This is a summary of the European public assessment report (EPAR) for Evarrest.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Evarrest.
English: Evarrest should therefore only be used when standard methods for controlling bleeding are not sufficient.
Croatian: Evarrest se stoga smije koristiti samo kada standardne metode kontroliranja krvarenja nisu dostatne.
English: It is not intended to provide practical advice on how to use Evarrest.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Evarrest.
English: What is Evarrest and what is it used for?
Croatian: Što je Evarrest i za što se koristi?
English: Evarrest should only be used by experienced surgeons who will judge the amount to use based on the size and location of the bleeding area.
Croatian: Evarrest smiju koristiti samo iskusni kirurzi koji će procijeniti količinu za uporabu na temelju veličine i lokacije područja krvarenja.
English: Evarrest is made of absorbable material that can be left in the patients after surgery.
Croatian: Evarrest je napravljen od apsorbirajućeg materijala koji se može ostaviti u bolesnicima nakon kirurškog zahvata.
English: Thrombin works by cutting fibrinogen up into smaller units called fibrin, which then stick together to form clots.
Croatian: Trombin djeluje tako što reže fibrinogen u manje jedinice naziva fibrin, koji se zatim lijepe zajedno i tvore ugruške.
English: What are the risks associated with Evarrest?
Croatian: Koji su rizici povezani s lijekom Evarrest?
English: The CHMP concluded that the benefits of Evarrest outweigh its risks and recommended that it be granted marketing authorisation.
Croatian: CHMP je zaključio da koristi lijeka Evarrest nadmašuju njegove rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.