FrancophonIA/ELRC3.0 huggingface dataset:
English: Whilst not routinely indicated, the potential benefits of performing periodic testing for heartworm infection in individual cases should be considered by the responsible veterinarian.
Croatian: Iako se rutinski ne provodi, u pojedinim slučajevima odgovorni veterinar treba razmotriti potencijalne koristi od periodičnog testiranja na invaziju srčanim crvom.
English: Do not remove the pipette from the blister until ready to use.
Croatian: Ne vadite pipetu iz blistera dok nije spremna za primjenu.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju ozbiljnu nuspojavu ili druge nuspojave koje nisu opisane u uputi o VMP, molimo obavijestite svog veterinara.
English: The primary target of action of sarolaner in insects and acarines is functional blockade of ligand-gated chloride channels (GABA-receptors and glutamate-receptors).
Croatian: Primarni cilj djelovanja sarolanera kod insekata i akarina je funkcionalna blokada ligandom kontroliranih kloridnih kanala (GABAreceptori i receptori glutamata).
English: In cats, selamectin and sarolaner are low clearance compounds with long half-life values, 12.5 days and 41.5 days respectively, following topical administration.
Croatian: Kod mačaka su selamektin i sarolaner spojevi s niskim klirensom i s dugim poluvijekom trajanja od 12,5 dana, odnosno 41,5 dana nakon topikalne primjene.
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog gutanja treba odmah zatražiti savjet liječnika i pokazati mu upute o VMP ili etiketu.
English: - For the treatment and prevention of flea infestations (Ctenocephalides spp.).
Croatian: Za tretiranje i prevenciju infestacija buhama (Ctenocephalides spp.).
English: When replacing another heartworm preventive product in a heartworm disease prevention programme, the first dose of the product must be given within a month of the last dose of the former veterinary medicinal product.
Croatian: Kada proizvod zamjenjuje neki drugi proizvod za prevenciju pojave srčanog crva unutar programa prevencije pojave srčanih crva, prvu dozu proizvoda potrebno je dati unutar mjesec dana od zadnje doze prijašnjeg veterinarsko-medicinskog proizvoda.
English: Excipients: 0.2 mg/ml butylated hydroxytoluene.
Croatian: Pomoćne tvari: 0,2 mg/ml butilirani hidroksitoluen.
English: The primary route of elimination for sarolaner is biliary elimination of parent sarolaner, with contributions by metabolic clearance.
Croatian: Primarni put eliminacije sarolanera je eliminacija osnovnog sarolanera putem žuči, uz doprinos metaboličkog klirensa.
English: The veterinary medicinal product has immediate and persistent acaricidal effect for 5 weeks against Ixodes ricinus and Ixodes hexagonus, and 4 weeks against Dermacentor reticulatus and Rhipicephalus sanguineus.
Croatian: Ovaj veterinarsko-medicinski proizvod ima neposredan i trajan akaricidni učinak tijekom 5 tjedana na Ixodes ricinus i Ixodes hexagonus, a 4 tjedna na Dermacentor reticulatus i Rhipicephalus sanguineus.
English: Sarolaner does not interact with known insecticidal binding sites of nicotinic or other GABAergic insecticides such as neonicotinoids, fiproles, milbemycins, avermectins, and cyclodienes.
Croatian: Sarolaner nema interakcija s poznatim mjestima vezanja insekticida nikotinskih ili drugih GABA-ergičkih insekticida, poput neonikotinoida, fiprola, milbemicina, avermektina i ciklodiena.
English: Activity has also been demonstrated against heartworm (D. immitis) larvae.
Croatian: Također je dokazano djelovanje protiv larve srčanog crva (D. immitis).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/19/238/001-003
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/19/238/001-003
English: Holding the pipette upright, firmly depress the cap to puncture the applicator seal, then remove the cap.
Croatian: Držeći pipetu uspravno, čvrsto pritisnite poklopac kako biste probušili brtvu aplikatora, a zatim skinite poklopac.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this 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 Europske agencije za lijekove European Medicines Agency http://www.ema.europa.eu/.
English: For cats with, or at risk from, mixed parasitic infestations by ticks and fleas, lice, mites, gastrointestinal nematodes or heartworm.
Croatian: Za mačke koje su infestirane ili su pod rizikom od miješanih parazitskih infestacija krpeljima, buhama, ušima, grinjama, gastrointestinalnim nematodima ili srčanim crvima.
English: For optimal control of tick and fleas infestations, the veterinary medicinal product should be administered at monthly intervals and continued throughout the flea and/or tick season based on local epidemiological situations.
Croatian: Za optimalnu kontrolu infestacija krpeljima i buhama ovaj veterinarsko-medicinski proizvod potrebno je primjenjivati u intervalima od jednog mjeseca te nastaviti primjenu tijekom sezone buha i/ili krpelja na temelju lokalne epidemiološke situacije.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE Veterinarsko-medicinski proizvod se izdaje na veterinarski recept.
English: Apply topically to the skin at the base of the neck in front of the shoulder blades.
Croatian: Primijenite topikalno na kožu na bazi vrata ispred lopatica.
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 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) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: Učestalost nuspojava određena je sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuje 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 1000 tretiranih životinja) - rijetke (više od 1, ali manje od 10 životinja na 10000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10000 tretiranih životinja, uključujući izolirane slučajeve).
English: Disruption of these receptors by sarolaner prevents the uptake of chloride ions by GABA and glutamate gated ion channels, thus resulting in increased nerve stimulation and death of the target parasite.
Croatian: Sarolaner ometa ove receptore i time sprječava pohranu kloridnih iona u ionske kanale kontrolirane GABA-om i glutamatom, što rezultira povećanom stimulacijom živaca i smrću ciljnog parazita.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PIPETTE
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Spot-on use.
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE Primjena nakapavanjem.
English: - Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration.
Croatian: - Prevencija bolesti izazvane srčanim crvom Dirofilaria immitis, primjenom jedanput mjesečno.
English: Strength and number of pipettes to be administered Felisecto Plus 15 mg/2.5 mg (yellow cap)
Croatian: Jačina i broj pipeta koje treba primijeniti Felisecto Plus 15 mg/2,5 mg (žuti poklopac)
English: Sarolaner blocks GABA- and glutamate-gated chloride channels in the central nervous system of insects and acarines.
Croatian: Sarolaner blokira GABA-om i glutamatom kontrolirane kloridne kanale u središnjem živčanom sustavu insekata i akarina.
English: The product is harmful after ingestion.
Croatian: Ovaj je proizvod štetan u slučaju gutanja.
English: Cats ≤2.5 kg Cats >2.5-5 kg Cats >5-10 kg
Croatian: Mačke ≤2,5 kg Mačke >2,5-5 kg Mačke >5-10 kg
English: Selamectin has adulticidal, ovicidal and larvicidal activity against fleas.
Croatian: Selamektin ima adulticidno, ovicidno i larvicidno djelovanje protiv buha.
English: After accidental ingestion of a full product dose, transient gastrointestinal effects such as salivation, soft faeces, emesis, and reduced food consumption may occur, however these should resolve without treatment.
Croatian: Nakon nehotičnog gutanja pune doze proizvoda mogući su prolazni gastrointestinalni učinci poput slinjenja, meke stolice, povraćanja i smanjenog unosa hrane, međutim, trebali bi se povući bez liječenja.
English: Treatment of roundworm and hookworm infections A single dose of the product should be administered.
Croatian: Tretiranje infestacije paušima Treba primijeniti jednokratnu dozu proizvoda.
English: BATCH NUMBER Lot {number}
Croatian: BROJ PROIZVODNE SERIJE Lot {broj}
English: Pipette content (ml)
Croatian: Sadržaj pipete (ml)
English: 4.9 Amounts to be administered and administration route Spot-on use.
Croatian: 4.9 Količine koje se primjenjuju i put primjene
English: Avoid eye contact including hand-to-eye-contact.
Croatian: Izbjegavajte dodir s očima, uključujući dodirivanje oka rukom.
English: The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for 5 weeks.
Croatian: Ovaj veterinarskomedicinski proizvod neposredno i trajno ubija buhe i djeluje protiv novih infestacija tijekom 5 tjedana.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/19/238/001 (3 x 0.25 ml) EU/2/19/238/002 (3 x 0.5 ml) EU/2/19/238/003 (3 x 1 ml)
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/19/238/001 (3 x 0.25 ml)
English: METHOD AND ROUTE(S) OF ADMINISTRATION Spot-on use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Primjena nakapavanjem.
English: Mild to moderate alopecia at the application site, erythema and drooling have been uncommonly observed.
Croatian: Manje često zabilježeni su blaga do umjerena alopecija na mjestu aplikacije, eritem i slinjenje.
English: Felisecto Plus 60 mg/10 mg (green cap)
Croatian: Felisceto Plus 60 mg/10 mg (zeleni poklopac)
English: 0.5 ml
Croatian: 0,25 ml 0,5 ml 1 ml
English: Debris from selamectin-treated pets kills flea eggs and larvae not previously exposed to selamectin and thus may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Croatian: Debris s kućnih ljubimaca tretiranih selamektinom ubija jajašca i larve buha koji prethodno nisu bili izloženi selamektinu te time mogu pomoći u suzbijanju postojećih infestacija buhama iz okoliša, na području dostupnom životinji.
English: as well as several tick species such as Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus, and Rhipicephalus sanguineus.
Croatian: Sarolaner djeluje protiv odraslih buha (Ctenocephalides spp.), kao i nekoliko vrsti krpelja, kao što su Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus, i Rhipicephalus sanguineus.
English: Through its ovicidal and larvicidal action, the veterinary medicinal product may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Croatian: Svojim ovicidnim i larvicidnim djelovanjem ovaj veterinarsko-medicinski proizvod može pomoći u suzbijanju postojećih infestacija buhama iz okoliša, na području dostupnom životinji.
English: Use of this veterinary medicinal product is indicated in cats aged at least 8 weeks old and weighing at least 1.25 kg bodyweight.
Croatian: Upotreba ovog veterinarsko-medicinskog proizvoda indicirana je kod mačaka starih najmanje 8
English: Pipette content
Croatian: Sadržaj pipete
English: as well as mites (Otodectes cynotis), lice (Felicola subrostratus) and gastrointestinal nematodes (Toxocara cati, Ancylostoma tubaeforme).
Croatian: Selamektin djeluje protiv odraslih buha (Ctenocephalides spp.), kao i ušnih šugaraca (Otodectes cynotis), pauši (Felicola subrostratus) i gastrointestinalnih nematoda (Toxocara cati, Ancylostoma tubaeforme).
English: If significant ingestion occurs, transient gastrointestinal effects such as hypersalivation, emesis, soft faeces or reduced food consumption may be observed and should normally resolve without treatment.
Croatian: U slučaju gutanja značajne količine, mogući su prolazni gastrointestinalni učinci poput prekomjernog slinjenja, povraćanja, meke stolice ili smanjenog unosa hrane, ali ti se učinci obično povlače bez liječenja.
English: Nematodes: - Treatment of adult roundworms (Toxocara cati) and adult intestinal hookworms (Ancylostoma tubaeforme).
Croatian: Nematode: - Tretiranje odraslih oblića (Toxocara cati) i odraslih crijevnih nematoda (Ancylostoma tubaeforme).
English: The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for
Croatian: Ovaj veterinarsko medicinski proizvod neposredno i trajno ubija buhe i djeluje protiv novih infestacija tijekom 5
English: TARGET SPECIES
Croatian: CILJNE VRSTE ŽIVOTINJA Mačke
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each unit dose (pipette) delivers: Active substances: Felisecto Plus spot-on solution
Croatian: NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA Svaka jedinična doza (pipeta) sadržava:
English: Felisecto Plus 30 mg/5 mg (orange cap)
Croatian: Felisceto Plus 30 mg/5 mg (narančasti poklopac)
English: Use only according to the benefit-risk assessment by the prescribing veterinarian.
Croatian: Upotrebljavajte proizvod samo nakon što veterinar koji ga propisuje procijeni koristi i rizike.
English: This stops flea reproduction, breaks the flea lifecycle and may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Croatian: Ovime se zaustavlja reprodukcija buha, prekida životni ciklus buha, što može pomoći u kontroli postojećih infestacija buhama iz okoliša, na području dostupnom životinji.
English: Felisecto Plus >2.5-5 kg
Croatian: Felisecto Plus ≤2,5 kg Felisecto Plus >2,5-5 kg Felisecto Plus >5-10 kg
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 15 mg selamectin / 2.5 mg sarolaner 30 mg selamectin / 5 mg sarolaner 60 mg selamectin / 10 mg sarolaner
Croatian: KOLIČINA DJELATNE(IH) TVARI 15 mg selamektin/2,5 mg sarolaner 30 mg selamektin/5 mg sarolaner 60 mg selamektin/10 mg sarolaner
English: PACKAGE SIZE 3 pipettes 0.25 ml
Croatian: 3 pipete 0,25 ml 0,5 ml 1 ml
English: AUTHORISATION
Croatian: DODATAK
English: STATEMENT OF ACTIVE SUBSTANCES 15 mg selamectin/2.5 mg sarolaner 30 mg selamectin/5 mg sarolaner 60 mg selamectin/10 mg sarolaner
Croatian: SASTAV DJELATNIH TVARI 15 mg selamektin/2,5 mg sarolaner 30 mg selamektin/5 mg sarolaner
English: Dipropyleneglycol monomethyl ether
Croatian: Butilirani hidroksitoluen Dipropilenglikol monometil eter Izopropilni alkohol 6.2 Glavne inkompatibilnosti
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose (pipette) delivers: Active substances: Felisecto Plus spot-on solution
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna jedinična doza (pipeta) sadrži:
English: Butylated hydroxytoluene
Croatian: Otopina za nakapavanje
English: - Treatment of adult roundworms (Toxocara cati) and adult intestinal hookworms (Ancylostoma tubaeforme).
Croatian: Nematode - Liječenje protiv odraslih oblića (Toxocara cati) i odraslih crijevnih nematoda (Ancylostoma tubaeforme).
English: Spot-on solution.
Croatian: Primjena nakapavanjem.
English: Special precautions for storage
Croatian: 11. POSEBNE MJERE PRI ČUVANJU
English: Pipettes with yellow caps contain 0.25 ml of product and deliver 15 mg selamectin and 2.5 mg sarolaner Pipettes with orange caps contain 0.5 ml of product and deliver 30 mg selamectin and 5 mg sarolaner Pipettes with green caps contain 1 ml of product and deliver 60 mg selamectin and 10 mg sarolaner
Croatian: Pipete sa žutim poklopcima sadrže 0,25 ml proizvoda te daju 15 mg selamektina i 2,5 mg sarolanera.
English: Treatment of ear mites
Croatian: Tretiranje ušnih šugaraca
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Felisecto Plus ≤2.5 kg
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA FelisectoPlus 15 mg/2,5 mg otopina za nakapavanje na kožu za mačke ≤2,5 kg
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Felisecto Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Felisecto Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Felisecto Plus 60 mg/10 mg spot-on solution for cats >5-10 kg selamectin/sarolaner
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Felisecto Plus 15 mg/2,5 mg otopina za nakapavanje za mačke ≤2,5 kg Felisecto Plus 30 mg/5 mg otopina za nakapavanje za mačke >2,5-5 kg Felisecto Plus 60 mg/10 mg otopina za nakapavanje za mačke >5-10 kg selamektin/sarolaner
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Felisecto Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Felisecto Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Felisecto Plus 60 mg/10 mg spot-on solution for cats >5-10 kg
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Felisceto Plus 15 mg/2,5 mg otopina za nakapavanje za mačke ≤2,5 kg FeliscetoPlus 30 mg/5 mg otopina za nakapavanje za mačke >2,5-5 kg Felisceto Plus 60 mg/10 mg otopina za nakapavanje za mačke >5-10 kg
English: PACKAGE LEAFLET: Felisecto Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Felisecto Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Felisecto Plus 60 mg/10 mg spot-on solution for cats >5-10 kg
Croatian: UPUTA O VMP ZA Felisecto Plus 15 mg/2,5 mg otopina za nakapavanje za mačke ≤2,5 kg FelisectoPlus 30 mg/5 mg otopina za nakapavanje za mačke >2,5-5 kg Felisecto Plus 60 mg/10 mg otopina za nakapavanje za mačke >5-10 kg
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Felisecto Plus 15 mg/2.5 mg spot-on solution for cats Felisecto Plus 30 mg/5 mg spot-on solution for cats Felisecto Plus 60 mg/10 mg spot-on solution for cats
Croatian: Felisecto Plus 15 mg/2.5 mg otopina za nakapavanje na kožu za mačke FelisectoPlus 30 mg/5 mg otopina za nakapavanje na kožu za mačke Felisecto Plus 60 mg/10 mg otopina za nakapavanje na kožu za mačke
English: In addition, the company presented results from two other main studies.
Croatian: Nadalje, društvo je dostavilo rezultate iz dva druga glavna ispitivanja.
English: The usual dose is 10 mg once a day.
Croatian: Uobičajena doza je 10 mg jedanput na dan.
English: This summary was last updated in 01-2014.
Croatian: Sažetak je posljednji put ažuriran 01.2014.
English: Symptoms often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, a feeling of being slowed down, feelings of anxiety and changes in weight.
Croatian: Simptomi najčešće uključuju duboku tugu, osjećaj bezvrijednosti, gubitak interesa za omiljene aktivnosti, poremećaje spavanja, osjećaj usporenosti, osjećaj tjeskobe i promjene u težini.
English: Supportive data from 52-week extensions of several of these studies suggested that the improvements that were seen were maintained longer-term.
Croatian: Podaci koji idu tome u prilog iz 52-tjednih proširenja nekoliko navedenih studija ukazuju da su se uočena poboljšanja dugoročno zadržala.
English: It is used to treat major depression in adults.
Croatian: Koristi se za liječenje velikih depresivnih epizoda u odraslih.
English: Side effects were usually mild or moderate, short-lasting and occurred in the first two weeks of treatment.
Croatian: Nuspojave su najčešće blage ili umjerene, kratkotrajne i nastupaju u prva dva tjedna liječenja.
English: Although there was limited information about the use of doses above 10 mg daily in the elderly this was addressed in the product information.
Croatian: Iako postoje ograničene informacije o primjeni doza jačih od 10 mg dnevno u starijih osoba, ovo je pobliže raspravljeno u informacijama o lijeku.
English: Effects on the gut such as nausea are more common in women than in men.
Croatian: Djelovanje na probavu, poput mučnine, uobičajenije je u žena nego u muškaraca.
English: The full EPAR for Brintellix 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) za lijek Brintellix nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients 65 years of age and over should be started on a lower dose of 5 mg daily.
Croatian: Bolesnici u dobi od 65 godina i stariji trebaju započeti terapiju sa slabijom dozom od 5 mg dnevno.
English: Major depression is a condition in which patients have mood disturbances that interfere with their everyday life.
Croatian: Velika depresivna epizoda je stanje u kojem bolesnici imaju poremećaje raspoloženja koji ometaju njihov svakodnevni život.
English: Serotonin is a neurotransmitter, a chemical that transmits signals between nerve cells.
Croatian: Serotonin je neurotransmiter, kemikalija koja odašilje signale među živčanim stanicama.
English: Brintellix can only be obtained with a prescription and is available as tablets (5, 10, 15 and 20 mg) and oral drops (20 mg/ml).
Croatian: Brintellix se izdaje samo na liječnički recept i dostupan je kao tablete (5, 10, 15 i 20 mg) te peroralne kapi (20 mg/ml).
English: Brintellix vortioxetine
Croatian: Brintellix vortioksetin
English: Lower doses may also be needed in patients taking certain medicines that reduce the breakdown of vortioxetine in the body and conversely higher doses may be considered in those taking medicines that increase the breakdown of vortioxetine.
Croatian: Slabije doze mogu također biti potrebne u bolesnika koji uzimaju određene lijekove kako bi se smanjila razgradnja vortioksetina u tijelu, a suprotno tome jače se doze trebaju uzeti u obzir u bolesnika koji uzimaju lijekove koji povećavaju razgradnju vortioksetina.
English: This is a summary of the European public assessment report (EPAR) for Brintellix.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Brintellix.
English: Because serotonin is involved in the control of mood, and can regulate the actions of other neurotransmitters that may be involved in depression and anxiety, these actions of vortioxetine are thought to result in its effect in improving depression.
Croatian: Budući da je serotonin uključen u kontrolu raspoloženja i može regulirati djelovanje drugih neurotransmitera koji mogu biti uključeni u depresiju i anksioznost, smatra se da ovo djelovanje vortioksetina rezultira njegovim učinkom ublažavanja depresije.
English: Brintellix must be used with care and sometimes in adjusted doses in patients taking certain other medicines; it must not be used in patients also taking medicines known as nonselective monoamine oxidase inhibitors (MAOIs) or selective monoamine oxidase A (MAO-A) inhibitors.
Croatian: Lijek Brintellix mora se pažljivo primjenjivati te se doze moraju povremeno prilagoditi u bolesnika koji uzimaju i druge lijekove; ne smije se koristiti u bolesnika koji uzimaju lijekove poznate pod nazivom neselektivni inhibitori monoaminooksidaze (MAOI) ili selektivni inhibitori monoaminooksidaze A (MAOA).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Brintellix on 18 December 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Brintellix vrijedi na prostoru Europske unije od 18. prosinca 2013.
English: It is not intended to provide practical advice on how to use Brintellix.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Brintellix.