FrancophonIA/ELRC3.0 huggingface dataset:
English: Similarly, in cultures of human Burkitt's B-lymphoma cells, the production of immunoglobulin M protein in response to IL-6 was dose-dependently inhibited by siltuximab.
Croatian: Slično, u kulturama ljudskih Burkittovih stanica B-limfoma, proizvodnja proteina imunoglobulina
English: Nervous system disorders very common
Croatian: Poremećaji živčanog sustava vrlo često omaglica, glavobolja
English: Durable tumour & symptomatic response (investigator review)
Croatian: Sekundarne mjere ishoda djelotvornosti Trajni tumorski odgovor i simptomatski odgovor (procjena ispitivača)
English: Haemoglobina
Croatian: Hemoglobina
English: Oropharyngeal pain
Croatian: • osjećaj vrtnje
English: In mice dosed subcutaneously with an anti-mouse IL-6 monoclonal antibody,
Croatian: U miševa kojima je supkutano primijenjeno anti-mišje IL-6 monoklonsko protutijelo, nisu opaženi učinci na plodnost ženki ili mužjaka.
English: Posology
Croatian: Ringaskiddy
English: (Study 2).
Croatian: (nezavisna procjena)
English: Each 400 mg vial should be reconstituted with 20 mL of single-use water for injections to yield a 20 mg/mL solution.
Croatian: Svaka se bočica s 400 mg treba rekonstituirati s 20 ml vode za injekcije za jednokratnu primjenu kako bi se dobila otopina koncentracije 20 mg/ml.
English: Durable tumour & symptomatic response (independent review)
Croatian: Primarna mjera ishoda djelotvornosti Trajni tumorski odgovor i simptomatski odgovor (nezavisna procjena)
English: Malignancy
Croatian: Malvern
English: Skin and subcutaneous tissue disorders very common
Croatian: Poremećaji kože i potkožnog tkiva vrlo često osip, pruritus, ekcem
English: You may be more likely to get infections while you are being treated with SYLVANT.
Croatian: Tijekom liječenja lijekom SYLVANT možete biti skloniji infekcijama.
English: • stomach pain or discomfort, constipation, diarrhoea, heartburn, ulcers (sores) in the mouth,
Croatian: • bol ili nelagoda u trbuhu, zatvor, proljev, žgaravica, čirevi u ustima, mučnina, povraćanje
English: Medicinal products subject to restricted medical prescription (See Annex I: Summary of Product
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: Each 100 mg vial should be reconstituted with 5.2 mL of single-use water for injections to yield a 20 mg/mL solution.
Croatian: Svaka se bočica sa 100 mg mora rekonstituirati s 5,2 ml vode za injekcije za jednokratnu primjenu kako bi se dobila otopina koncentracije 20 mg/ml.
English: SYLVANT 100 mg powder for concentrate for solution for infusion 8 mL Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 100 mg of siltuximab.
Croatian: I od 8 ml s elastomernim zatvaračem i aluminijskim prstenom s “flip-off” poklopcem koja sadrži 100 mg siltuksimaba.
English: SYLVANT 100 mg powder for concentrate for solution for infusion Each single-use vial contains 100 mg siltuximab powder for concentrate for solution for infusion.
Croatian: SYLVANT 100 mg prašak za koncentrat za otopinu za infuziju Jedna bočica za jednokratnu primjenu sadrži 100 mg siltuksimab praška za koncentrat za otopinu za infuziju.
English: Secondary efficacy endpoints
Croatian: Mjere ishoda djelotvornosti
English: Immune system disorders common
Croatian: Poremećaji imunološkog sustava često anafilaktička reakcija
English: Each single-use vial contains 400 mg siltuximab.
Croatian: Jedna bočica za jednokratnu primjenu sadrži 400 mg siltuksimaba.
English: SYLVANT 400 mg powder for concentrate for solution for infusion Each single-use vial contains 400 mg siltuximab powder for concentrate for solution for infusion.
Croatian: SYLVANT 400 mg prašak za koncentrat za otopinu za infuziju Jedna bočica za jednokratnu primjenu sadrži 400 mg siltuksimab praška za koncentrat za otopinu za infuziju.
English: SYLVANT 100 mg powder for concentrate SYLVANT 400 mg powder forconcentrate siltuximab
Croatian: SYLVANT 100 mg prašak za koncentrat SYLVANT 400 mg prašak za koncentrat siltuksimab i.v.
English: Each vial should be reconstituted with 5.2 mL of single-use water for injections to yield a 20 mg/mL solution.
Croatian: Svaka se bočica mora rekonstituirati s 5,2 ml vode za injekcije za jednokratnu primjenu kako bi se dobila otopina koncentracije 20 mg/ml.
English: SYLVANT 100 mg powder for concentrate for solution for infusion SYLVANT 400 mg powder for concentrate for solution for infusion siltuximab
Croatian: SYLVANT 100 mg prašak za koncentrat za otopinu za infuziju SYLVANT 400 mg prašak za koncentrat za otopinu za infuziju siltuksimab
English: SYLVANT 100 mg powder for concentrate for solution for infusion SYLVANT 400 mg powder for concentrate for solution for infusion
Croatian: SYLVANT 100 mg prašak za koncentrat za otopinu za infuziju SYLVANT 400 mg prašak za koncentrat za otopinu za infuziju
English: • rash, itchy skin rash (eczema)
Croatian: • osip, kožni osip koji svrbi (ekcem)
English: Each vial contains 100 mg of siltuximab.
Croatian: Jedna bočica sadrži 100 mg siltuksimaba.
English: Each single-use vial contains 100 mg siltuximab.
Croatian: Jedna bočica za jednokratnu primjenu sadrži 100 mg siltuksimaba.
English: Each vial contains 400 mg of siltuximab.
Croatian: Jedna bočica sadrži 400 mg siltuksimaba.
English: SYLVANT 400 mg powder for concentrate for solution for infusion 30 mL Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 400 mg of siltuximab.
Croatian: I od 30 ml s elastomernim zatvaračem i aluminijskim prstenom s “flip-off” poklopcem koja sadrži 400 mg siltuksimaba.
English: Characteristics, section 4.2).
Croatian: (vidjeti dio 6.6).
English: Localised oedema
Croatian: Prijavljivanje nuspojava
English: negative.
Croatian: Co.
English: Metabolism and nutrition disorders very common
Croatian: Poremećaji metabolizma i prehrane vrlo često hipertrigliceridemija, hiperuricemija često hiperkolesterolemija
English: • common cold
Croatian: • obična prehlada
English: Musculoskeletal and connective tissue disorders very common
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva vrlo često artralgija, bol u udovima
English: (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8)
Croatian: SYLVANT je indiciran za liječenje odraslih bolesnika s multicentričnom Castlemanovom bolešću (MCD, engl. multicentric Castleman's disease), koji su negativni na virus humane imunodeficijencije (HIV) i na humani herpes virus-8 (HHV-8).
English: <2D barcode carrying the unique identifier included.>
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
English: • The active substance is siltuximab.
Croatian: • Djelatna tvar je siltuksimab.
English: The effects of various covariates on siltuximab PK were assessed in the analyses.
Croatian: U analizama su procijenjeni učinci raznovrsnih kovarijabli na farmakokinetiku siltuksimaba.
English: Each vial should be reconstituted with 20.0 mL of single-use water for injections to yield a 20 mg/mL solution.
Croatian: Svaka se bočica treba rekonstituirati s 20 ml vode za injekcije za jednokratnu primjenu kako bi se dobila otopina koncentracije 20 mg/ml.
English: General disorders and administration site conditions very common
Croatian: Opći poremećaji i reakcije na mjestu primjene vrlo često lokalizirani edem
English: Most of these dogs also received additional treatment.
Croatian: Većina ovih pasa primila je također dodatno liječenje.
English: This summary was last updated in April 2015.
Croatian: Sažetak je posljednji put ažuriran u veljači 2015.
English: Other information about Cerenia:
Croatian: Druge informacije o VMP-u Cerenia:
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Cerenia on 29/09/2006.
Croatian: Europska komisija dodijelila je odobrenje za stavljanje u promet koje je na snazi na teritoriju Europske unije za proizvod Cerenia dana 29.09.2006.
English: Cerenia was generally well tolerated.
Croatian: Cerenia se načelno dobro podnosi.
English: Other reported side effects were decreased activity levels and tiredness.
Croatian: Druge prijavljene nuspojave su smanjene razine aktivnosti i umor.
English: What is Cerenia?
Croatian: Što je Cerenia?
English: Since this was mainly observed in dogs with an empty stomach, it is recommended to feed a light meal or snack a while before the tablets are given.
Croatian: Budući da je to uglavnom uočeno u pasa s praznim želucom, preporuča se hranjenje pasa laganim obrokom ili poslasticom određeno vrijeme prije davanja tablete.
English: Only one out of 16 dogs given Cerenia vomited after receiving morphine, whilst 14 out of 15 dogs given placebo vomited, and in this group, nine of the dogs that vomited did so more than once.
Croatian: Samo jedan od 16 pasa koji su primili VMP Cerenia povraćao je nakon što je primio morfij, dok je 14 od 15 pasa koji su primili placebo povraćali, a u ovoj grupi, devet pasa od ukupnog broja pasa koji su povraćali povraćalo je više od jednom.
English: The measures of effectiveness were evidence of retching, vomiting, intensity of nausea and improvements in the speed of recovery by for example measuring time to sit up and stand.
Croatian: Mjere djelotvornosti su bili dokazi gađenja, povraćanja, intenzitet mučnine i poboljšanje u brzini oporavka primjerice mjerenjem vremena potrebnog da se životinja posjednje i uspravi.
English: It is available as tablets (16, 24, 60 and 160 mg) for dogs, and as a solution for injection (10 mg/ml) under the skin or into a vein for dogs and cats.
Croatian: Dostupan je kao tablete (16, 24, 60 i 160 mg) za pse, i kao otopina za injekciju ispod kože (10 mg/ml) za pse i mačke.
English: This document is a summary of the European Public Assessment Report.
Croatian: Ovaj dokument je sažetak europskoga javnog izvješća o procjeni veterinarsko-medicinskog proizvoda.
English: By preventing the attachment of substance P to the receptors, Cerenia prevents them from being activated and so reduces nausea and vomiting.
Croatian: P to the receptors, Cerenia prevents them from being activated and so reduces nausea and vomiting.
English: A large number of studies with Cerenia were carried out either in laboratory dogs and cats or in animal patients at veterinary practices in several European countries and in the USA.
Croatian: Veliki broj ispitivanja VMP-a Cerenia proveden je na laboratorijskim psima i mačkama ili na životinjskim bolesnicima u veterinarskim praksama u nekoliko europskih država u SAD-u.
English: Since maropitant could affect heart activity, Cerenia should be used with caution in animals with certain heart conditions.
Croatian: Budući da maropitant može utjecati na srčanu aktivnost, Cerenia se mora koristiti oprezno u životinja s određenim bolestima srca.
English: The CVMP concluded that the benefits of Cerenia exceed its risks and recommended that Cerenia be given a marketing authorisation.
Croatian: CVMP je zaključio da koristi VMP-a Cerenia premašuju rizike i preporučio je da se za VMP Cerenia izda odobrenje za izdavanje lijeka u promet.
English: Information on the prescription status of this product can be found on the label/outer package.
Croatian: Informacije o tome je li za ovaj proizvod potreban veterinarski recept možete naći na etiketi/vanjskom dijelu pakiranja.
English: Cerenia is a medicine that contains the active substance maropitant.
Croatian: Cerenia je veterinarsko-medicinski proizvod koji sadrži djelatnu tvar maropitant.
English: Also, the treatment of vomiting should only be together with other supportive measures or other veterinary therapy while addressing the underlying causes of the vomiting.
Croatian: Također, liječenje povraćanja mora se provoditi samo zajedno s drugim potpornim mjerama ili drugim veterinarskim terapijama dok se dok se razlozi povraćanju koji se nalaze u podlozi uklanjanju.
English: What is Cerenia used for?
Croatian: Za što se Cerenia koristi?
English: What is the risk associated with Cerenia?
Croatian: Koji su rizici povezani s VMP-om Cerenia?
English: A further study involving dogs looked at the prevention of nausea and vomiting before and after surgery.
Croatian: Daljnje ispitivanje koje je obuhvatilo pse istražilo je spriječavanje mučnine i povraćanja prije i nakon kirurškog zahvata.
English: Why has Cerenia been approved?
Croatian: Zašto je VMP Cerenia odobren?
English: The benefit-risk balance can be found in the scientific discussion module of this EPAR.
Croatian: Omjer koristi i rizika dostupan je u modulu znanstvene rasprave ovog EPAR-a.
English: In cats, treatment of vomiting is with the injection only.
Croatian: U slučaju mačaka, terapija povraćanja provodi se samo injekcijom.
English: In the study looking at the effect of Cerenia before and after surgery, Cerenia was effective at preventing vomiting asociated with the use of morphine.
Croatian: U ispitivanju koje je istražilo djelovanje VMP-a Cerenia prije i nakon kirurškog zahvata, Cerenia je bila djelotvorna u sprječavanju povraćanja povezanog s primjenom morfija.
English: the animal owner can administer the tablets to the dog.
Croatian: U slučaju kontrolne terapije, vlasnik životinje može dati tabletu psu.
English: For dogs, the treatment of vomiting should be started with the injection, since vomiting animals might throw the intact tablet up again.
Croatian: U slučaju pasa, liječenje povraćanja treba započeti injekcijom budući da životinje koje povraćaju mogu povratiti nerazgrađenu tabletu.
English: A common side effect of the tablets when used at a high dose of 8 mg/kg in dogs (for motion sickness) was vomiting before the car journey started.
Croatian: Najčešće nuspojave tableta ako se koriste u velikim dozama od 8 mg/kg u pasa (za bolest kretanja) bilo je povraćanje prije početka putovanja automobilom.
English: As injection under the skin causes pain in cats, the animal will need to be restrained when treated.
Croatian: Budući da injekcija uzrokuje bol u mačaka, životinju se mora držati prilikom davanja terapije.
English: Since Cerenia has not been studied in very young dogs or cats, or in pregnant or lactating bitches or queens, use of Cerenia in these animals should be discussed with your veterinarian.
Croatian: Budući da se VMP Cerenia nije ispitivao u vrlo mladih pasa ili mačaka, ili u gravidnih kujica ili mačaka ili kujica ili mačaka u laktaciji, primjena VMP-a Cerenia u ovih životinja mora se dogovoriti s veterinarom.
English: Cerenia solution for injection is used in dogs both to prevent nausea and vomiting before and after an operation and to improve recovery from general anaesthesia after use of morphine.
Croatian: Cerenia otopina za injekciju koristi se u pasa za spriječavanje mučnine i povraćanja prije i nakon operacije sa ciljem poboljšavanja oporavka od opće anestezije nakon primjene morfija.
English: In order to study the effect of Cerenia in motion sickness, dogs prone to vomiting when travelling were taken on car journeys lasting several hours for up to two consecutive days.
Croatian: Kako bi se ispitalo djelovanje VMP-a Cerenia protiv bolesti kretanja, psi koji su skloni povraćanju prilikom putovanja u automobilu koja traju po nekoliko sati do maksimalno dva uzastopna dana.
English: Dogs received either Cerenia soluton for injection or placebo 45 minutes before the administration of morphine for sedation and pain relief prior to anaesthesia .
Croatian: Psi koji prime Cerenia otopinu za injekciju ili placebo 45 minuta prije primjene morfija za smirenje i ublažavanje boli prije anestezije.
English: The active substance in Cerenia, maropitant, is broken down in the liver and therefore it is recommended to be used with caution in animals with liver disease.
Croatian: Djelatna tvar lijeka Cerenia, maropitant, razgrađuje se u jetri te se stoga preporuča primjena opreza prilikom uzimanja u životinja s oštećenjem jetre.
English: Handling Cerenia does not represent a particular risk for people.However, maropitant can produce short lived eye irritation and in the case of accidental eye exposure, the eyes should be flushed with plenty of water and medical attention sought.
Croatian: No, maropitant može uzrokovati kratkotrajnu nadraženost očiju i u slučaju slučajnog izlaganja očiju lijeku, oči se moraju isprati s dovoljno vode te odmah potražiti pomoć liječnika.
English: In case of accidental ingestion or self-injection medical advice should be sought immediately and the package leaflet or the label shown to the physician.
Croatian: U slučaju da se nehotice proguta ili dođe do samoubrizgavanja VMP-a, odmah potražiti pomoć liječnika i pokažite mu oputu o VMP ili etiketu.
English: For follow-up treatment,
Croatian: By preventing the attachment of substance
English: What benefit has Cerenia shown during the studies?
Croatian: Koje koristi VMP-a Cerenia su utvrđene tijekom ispitivanja?
English: Cerenia solution for injection is given to dogs and cats once daily under the skin or into a vein (1 mg per kg bodyweight) for up to five days.
Croatian: Cerenia otopina za injekciju daje se psima i mačkama jednom dnevno ispod kože (1ml po 10 kg tjelesne težine) do maksimalno pet dana.
English: Cerenia tablets are given to dogs at a dose of 2 mg maropitant per kg bodyweight once daily to prevent or treat vomiting for up to 14 days.
Croatian: Cerenia tablete se primjenjuju u pasa u dozi od 2 mg maropitanta po kg tjelesne težine jednom dnevno kako bi se spriječilo ili liječilo povraćanje do maksimalno 14 dana.
English: Cerenia tablets are given to dogs at a dose of 8 mg maropitant per kg bodyweight once daily to prevent vomiting due to motion sickness for a maximum of two consecutive days.
Croatian: Cerenia tablete se primjenjuju u pasa u dozi od 8 mg maropitanta po kg tjelesne težine jednom dnevno kako bi se sprječilo povraćanje uzrokovano bolešću putovanja tijekom maksimalno dva uzastopna dana.
English: For the treatment of vomiting, the effect of Cerenia (or a placebo) was examined in sick dogs that were vomiting for various reasons, for example because of a gastrointestinal infection.
Croatian: Tijekom liječenja povraćanja, djelovanje VMP-a Cerenia (ili placeba) ispitano je u bolesnih pasa koji su povraćali uslijed nekoliko razloga, primjerice zbog gastrointestinalne infekcije.
English: A very common side effect in cats was evidence of pain from injection under the skin and this may be reduced by injection of the product at refrigerated temperature.
Croatian: Uobičajena nuspojava u mačaka bio je bolan odgovor na injekciju te se to može smanjiti injekcijom VMP-a pri hladnoj temperaturi.
English: The animals received either Cerenia tablets at a dose of 8 mg/kg bodyweight or a placebo for up to two consecutive days.
Croatian: Životinje koje prime Cerenia tablete u dozi od 8 mg/kg tjelesne težine ili placebo do maksimalno dva uzastopna dana.
English: Dogs were treated with either 1 mg/kg (injection given under the skin) or 2 mg/kg (tablet) once daily up to five days.
Croatian: Psi su liječeni 1 mg/kg (injekcijom) ili 2 mg/kg (tabletom) jednom dnevno u razdoblju od pet dana.
English: For the treatment of vomiting, the effect of Cerenia compared with placebo was examined in sick cats that were vomiting for various reasons.
Croatian: Za liječenje povraćanja, djelovanje VMP-a Cerenia uspoređenog s placebom ispitano je u bolesnih mačaka koje su povraćale zbog ozbiljnih razloga.
English: For the prevention of vomiting, Cerenia was studied in cats which received either Cerenia or placebo before another substance known to trigger vomiting was given to them.
Croatian: Za spriječavanje povraćanja, Cerenia je ispitana u mačaka koje su primile VMP Cerenia ili placebo prije druge tvari za koju je poznato da potiče povraćanje.
English: For the prevention of vomiting, Cerenia was studied in dogs which received either Cerenia or a placebo (a dummy tablet or injection) before another substance known to trigger vomiting (such as certain cancer medicines) was given to them.
Croatian: Za sprječavanje povraćanja, Cerenia se ispitivao u pasa koji su primili VMP Cerenia ili placebo (lažnu tabletu ili injekciju) prije nego što su primili drugu tvar za koju je poznato da potiče povraćanje (poput primjerice određenih anticitostatika).
English: Cats were treated with 1 mg/kg (injection given under the skin) once daily up to five days.
Croatian: Mačke su liječene s 1 mg/kg (injekcijom) jednom dnevno do pet dana.
English: How has Cerenia been studied?
Croatian: Kako se VMP Cerenia ispitivao?
English: How does Cerenia work?
Croatian: Cerenia djeluje?
English: Invented name Strength
Croatian: Zaštićeno ime
English: Treatment is started as soon as possible and usually within 6 days after symptoms start.
Croatian: S liječenjem se započinje što je prije moguće, a obično u roku od 6 dana od pojave simptoma.
English: Further information on Dectova can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dectova.
Croatian: Više informacija o lijeku Dectova nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/dectova.
English: When the neuraminidases are blocked, the virus cannot spread.
Croatian: Ako su neuraminidaze inhibirane, virus se ne može širiti.
English: The recommended dose for adults is 600 mg twice daily for 5 to 10 days while for children the dose is adjusted based on weight.
Croatian: Preporučena doza za odrasle osobe jest 600 mg dvaput na dan tijekom 5 - 10 dana, a u djece doza ovisi o tjelesnoj težini.
English: Complicated influenza is a severe flu infection that requires hospitalisation of the patient.
Croatian: Komplicirana influenca teška je infekcija virusom gripe koja zahtijeva hospitalizaciju bolesnika.
English: The main measure of effectiveness was how long it took for patients to leave hospital or for 4 out of the following 5 flu symptoms to resolve: fever, decreased levels of oxygen in the blood, raised breathing rate, raised heart rate and abnormal blood pressure.
Croatian: Glavno mjerilo učinkovitosti bilo je vrijeme potrebno da bolesnici napuste bolnicu ili da se povuku četiri od sljedećih pet simptoma gripe: vrućica, smanjena razina kisika u krvi, ubrzano disanje, ubrzani otkucaji srca i abnormalni krvni tlak.
English: The most serious side effect is liver injury.
Croatian: Najozbiljnija nuspojava je oštećenje jetre.
English: What measures are being taken to ensure the safe and effective use of Dectova?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Dectova?
English: Lower doses are given to adults and children with reduced kidney function.
Croatian: Odraslim osobama i djeci sa smanjenom funkcijom bubrega daju se manje doze.
English: Since Dectova has been authorised under exceptional circumstances, the company that markets the medicine will conduct two observational studies in patients with complicated influenza to obtain further data on the effectiveness.
Croatian: Budući da je lijek Dectova odobren u „iznimnim okolnostima”, tvrtka koja lijek stavlja u promet provest će dva opservacijska ispitivanja na bolesnicima s kompliciranom gripom radi dobivanja dodatnih podataka o učinkovitosti.
English: Side effects reported with Dectova are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Dectova pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The medicine is used when the virus is resistant to other flu treatments or when other antiviral treatments, including inhaled zanamivir are not suitable for the patient.
Croatian: Lijek se primjenjuje kada je virus otporan na druge terapije protiv gripe ili kada druge protuvirusne terapije, uključujući zanamivir za inhalacijsku primjenu, nisu prikladne za određenog bolesnika.
English: The European Medicines Agency therefore decided that Dectova's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Dectova nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.