FrancophonIA/ELRC3.0 huggingface dataset:
English: Micardis may also be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.
Croatian: Micardis se također može primjenjivati u kombinaciji s diureticima (tablete za mokrenje), kao što je hidroklorotiazid za koji se pokazalo da ima dodatan učinak snižavanja krvnog tlaka s Micardisom.
English: Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Croatian: Podaci iz kliničkih ispitivanja pokazali su da je dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS) kombiniranom primjenom ACE-inhibitora, blokatora angiotenzin II receptora ili aliskirena povezana s većom učestalošću štetnih događaja kao što su hipotenzija, hiperkalemija i smanjena bubrežna funkcija (uključujući akutno zatajenje bubrega), u usporedbi s primjenom samo jednog lijeka koji djeluje na RAAS (vidjeti dijelove 4.3, 4.4 i 5.1)
English: How to take Micardis
Croatian: Kako uzimati Micardis
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Micardis 20 mg tablets
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Micardis 20 mg tablete
English: ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Croatian: ACE-inhibitori i blokatori angiotenzin II receptora ne smiju se primjenjivati istodobno u bolesnika s dijabetičkom nefropatijom.
English: Pack sizes: Blister with 14, 28, 56, 84 or 98 tablets or perforated unit dose blisters with 28 x 1, 30 x 1 or 90 x 1 tablets; multipacks containing 360 (4 packs of 90 x 1) tablets
Croatian: Veličine pakiranja: blister s 14, 28, 56, 84 ili 98 tableta ili perforirani blisteri djeljivi na jedinične doze s 28 x 1, 30 x 1 ili 90 x 1 tableta; višestruka pakiranja koja sadrže 360 (4 pakiranja od 90 x 1) tableta.
English: For treatment of high blood pressure, the usual dose of Micardis for most patients is one 40 mg tablet once a day to control blood pressure over the 24 hour period.
Croatian: Za terapiju povišenog krvnog tlaka uobičajena doza Micardisa za većinu bolesnika je jedna tableta od 40 mg jedanput na dan za kontrolu krvnog tlaka tijekom 24 sata.
English: Micardis is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Croatian: Micardis se ne preporučuje u ranoj trudnoći i ne smije se uzimati ako ste trudni dulje od 3 mjeseca jer može izazvati teška oštećenja Vašeg djeteta ako se primjenjuje u ovom stadiju (vidjeti dio o trudnoći).
English: Micardis is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Croatian: Micardis se ne preporučuje u ranoj trudnoći te se ne smije uzimati ako ste trudni dulje od 3 mjeseca jer može izazvati teška oštećenja kod Vašeg djeteta ako se primjenjuje nakon trećeg mjeseca trudnoće.
English: In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo.
Croatian: Opis odabranih nuspojava Sepsa U ispitivanju PRoFESS uočena je povećana incidencija sepse s telmisartanom u usporedbi s placebom.
English: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting
Croatian: Bol u abdomenu, proljev, dispepsija, flatulencija, povraćanje Suha usta, nelagoda u želucu. disgeuzija
English: Micardis 20 mg tablets 3 years
Croatian: Micardis 20 mg tablete 3 godine
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/090/022
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/090/022
English: How to store Micardis
Croatian: Kako čuvati Micardis
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Croatian: Sepsa* (često nazvana „trovanje krvi“ je teška infekcija s upalnim odgovorom cijelog organizma), brzo oticanje kože i sluznice (angioedem).
English: (It is also better to avoid Micardis in early pregnancy see pregnancy section.)
Croatian: • Ako ste dulje od 3 mjeseca trudni (također je bolje izbjegavati Micardis u ranoj trudnoći - vidjeti dio o trudnoći).
English: Micardis 20 mg tablets EU/1/98/090/009 (14 tablets) EU/1/98/090/010 (28 tablets) EU/1/98/090/011 (56 tablets) EU/1/98/090/012 (98 tablets)
Croatian: Micardis 20 mg tablete EU/1/98/090/009 (14 tableta) EU/1/98/090/010 (28 tableta) EU/1/98/090/011 (56 tableta) EU/1/98/090/012 (98 tableta)
English: Micardis 40 mg and 80 mg tablets 4 years
Croatian: Micardis 40 mg i 80 mg tablete 4 godine
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia),low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Croatian: Sepsa* (često nazvana „trovanje krvi“ je teška infekcija s upalnim odgovorom cijelog organizma što može dovesti do smrtnog ishoda), povećanje određenih bijelih krvnih stanica (eozinofilija), nizak broj krvnih pločica (trombocitopenija), teška alergijska reakcija (anafilaktička reakcija), alergijska reakcija (npr. osip, svrbež, otežano disanje, piskanje, oticanje lica ili nizak krvni tlak), niske razine šećera u krvi (u bolesnika sa šećernom bolesti), osjećaj tjeskobe, izrazita pospanost, oštećen vid, ubrzani otkucaji srca (tahikardija), suhoća usta, nadražaj želuca, poremećaj osjeta okusa (disgeuzija), abnormalna funkcija jetre (vjerojatnost da će iskusiti ovu nuspojavu, veća je za bolesnike iz Japana), brzo oticanje kože i sluznice koji mogu dovesti do smrtnog ishoda (angioedem također sa smrtnim ishodom), ekcem (poremećaj kože), crvenilo kože, koprivnjača (urtikarija), težak osip od lijeka, bol u zglobovima (artralgija), bol u udovima, bol tetiva, simptomi nalik gripi, snižen hemoglobin (krvni protein), povišena razina mokraćne kiseline, povišeni jetreni enzimi ili kreatin fosfokinaza u krvi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/090/021
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/090/021
English: Povidone (K25) Meglumine Sodium hydroxide
Croatian: 6.1 Popis pomoćnih tvari povidon (K25) meglumin natrijev hidroksid sorbitol (E420) magnezijev stearat
English: White oblong tablets of 3.8 mm engraved with the code number '51H' on one side and the company logo on the other side.
Croatian: Bijele, duguljaste tablete od 3,8 mm s utisnutom oznakom „51H“ na jednoj strani i logom tvrtke na drugoj strani.
English: White oblong tablets of 4.6 mm engraved with the code number '52H' on one side and the company logo on the other side.
Croatian: Bijele, duguljaste tablete od 4,6 mm s utisnutom oznakom „52H“ na jednoj strani i logom tvrtke na drugoj strani.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 40 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA OD 360 (4 PAKIRANJA S 90 x 1 TABLETOM) - BEZ PLAVOG OKVIRA - 40 mg
English: INFORMATION IN BRAILLE Micardis 20 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Micardis 20 mg
English: INFORMATION IN BRAILLE Micardis 40 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Micardis 40 mg
English: INFORMATION IN BRAILLE Micardis 80 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Micardis 80 mg
English: Micardis 40 mg tablets EU/1/98/090/001 (14 tablets) EU/1/98/090/002 (28 tablets) EU/1/98/090/003 (56 tablets) EU/1/98/090/004 (98 tablets) EU/1/98/090/013 (28 x 1 tablets) EU/1/98/090/015 (84 tablets) EU/1/98/090/017 (30 x 1 tablets) EU/1/98/090/019 (90 x 1 tablets) EU/1/98/090/021 (4 x (90 x 1) tablets)
Croatian: Micardis 40 mg tablete EU/1/98/090/001 (14 tableta) EU/1/98/090/002 (28 tableta) EU/1/98/090/003 (56 tableta) EU/1/98/090/004 (98 tableta) EU/1/98/090/013 (28 x 1 tableta) EU/1/98/090/015 (84 tablete) EU/1/98/090/017 (30 x 1 tableta) EU/1/98/090/019 (90 x 1 tableta) EU/1/98/090/021 (4 x (90 x 1) tableta)
English: Micardis 40 mg tablets
Croatian: Micardis 40 mg tablete
English: Micardis 80 mg tablets EU/1/98/090/005 (14 tablets) EU/1/98/090/006 (28 tablets) EU/1/98/090/007 (56 tablets) EU/1/98/090/008 (98 tablets) EU/1/98/090/014 (28 x 1 tablets) EU/1/98/090/016 (84 tablets) EU/1/98/090/018 (30 x 1 tablets) EU/1/98/090/020 (90 x 1 tablets) EU/1/98/090/022 (4 x (90 x 1) tablets)
Croatian: Micardis 80 mg tablete EU/1/98/090/005 (14 tableta) EU/1/98/090/006 (28 tableta) EU/1/98/090/007 (56 tableta) EU/1/98/090/008 (98 tableta) EU/1/98/090/014 (28 x 1 tableta) EU/1/98/090/016 (84 tablete) EU/1/98/090/018 (30 x 1 tableta) EU/1/98/090/020 (90 x 1 tableta) EU/1/98/090/022 (4 x (90 x 1) tableta)
English: Micardis 40 mg and 80 mg tablets
Croatian: Micardis 40 mg i 80 mg tablete
English: Micardis 20 mg tablets Pack sizes: Blister with 14, 28, 56 or 98 tablets.
Croatian: Veličine pakiranja: Blister s 14, 28, 56 ili 98 tableta.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA NALJEPNICA NA VIŠESTRUKOM PAKIRANJU OD 360 (4 PAKIRANJA S 90 x 1 TABLETOM) - UKLJUČUJUĆI PLAVI OKVIR - 40 mg
English: Micardis 20 mg tablets
Croatian: Micardis 20 mg tablete
English: Micardis 80 mg tablets
Croatian: Micardis 80 mg tablete
English: What Micardis looks like and contents of the pack Micardis 40 mg tablets are white, oblong-shaped, and engraved with the code number '51H' on one side and the company logo on the other side.
Croatian: Micardis 40 mg tablete su bijele, duguljastog oblika s utisnutom oznakom „51H“ na jednoj i logom tvrtke na drugoj strani.
English: NAME OF THE MEDICINAL PRODUCT Micardis 20 mg tablets
Croatian: NAZIV LIJEKA Micardis 20 mg tablete
English: What Micardis looks like and contents of the pack Micardis 80 mg tablets are white, oblong-shaped and engraved with the code number '52H' on one side and the company logo on the other side.
Croatian: Micardis 80 mg tablete su bijele, duguljastog oblika s utisnutom oznakom „52H“ na jednoj i logom tvrtke na drugoj strani.
English: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased
Croatian: Povišeni kreatinin u krvi Sniženi hemoglobin, povišene vrijednosti mokraćne kiseline u krvi, povišeni jetreni enzimi, povišena kreatin-fosfokinaza u krvi za daljnje opise, molimo vidjeti pod “Opis odabranih nuspojava”.
English: Back pain (e.g. sciatica), muscle spasms, myalgia Arthralgia, pain in extremity, tendon pain (tendinitis like symptoms)
Croatian: Bol u leđima (npr. išijas), grčevi mišića, mijalgija, Artralgija, bol u ekstremitetima, bol tetiva (simptomi poput tendinitisa) Poremećaji bubrega i mokraćnog sustava Manje često:
English: NAME OF THE MEDICINAL PRODUCT Micardis 40 mg tablets telmisartan
Croatian: NAZIV LIJEKA Micardis 40 mg tablete telmisartan
English: Package leaflet: Information for the user Micardis 40 mg tablets Telmisartan
Croatian: Uputa o lijeku: Informacije za korisnika Micardis 40 mg tablete telmisartan
English: What Micardis looks like and contents of the pack Micardis 20 mg tablets are white, round and engraved with the code number '50H' on one side and the company logo on the other side.
Croatian: Micardis 20 mg tablete su bijele, okrugle s utisnutom oznakom „50H“ na jednoj i logom tvrtke na drugoj strani.
English: Package leaflet: Information for the user Micardis 20 mg tablets Telmisartan
Croatian: Uputa o lijeku: Informacije za korisnika Micardis 20 mg tablete telmisartan
English: NAME OF THE MEDICINAL PRODUCT Micardis 80 mg tablets telmisartan
Croatian: NAZIV LIJEKA Micardis 80 mg tablete telmisartan
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use
Croatian: 5. NAČIN I PUT(EVI) PRIMJENE LIJEKA Za primjenu kroz usta
English: Package leaflet: Information for the user Micardis 80 mg tablets Telmisartan
Croatian: Uputa o lijeku: Informacije za korisnika Micardis 80 mg tablete telmisartan
English: Boehringer Ingelheim RCV GmbH & Co KG Eesti Filiaal
Croatian: Boehringer Ingelheim RCV GmbH & CoKG Eesti Filiaal
English: NAME OF THE MEDICINAL PRODUCT Micardis 20 mg tablets telmisartan
Croatian: NAZIV LIJEKA Micardis 20 mg tablete telmisartan
English: КГклон България
Croatian: KГ - клонЂългария
English: Bradycardia
Croatian: Bradikardija Tahikardija
English: This risk persists until significant remission occurs.
Croatian: Ovaj rizik traje dok se ne dogodi značajna remisija.
English: Do this even if there are no signs of discomfort.
Croatian: Učinite to čak i ako nemate znakova nelagode.
English: The absolute bioavailability is 75%.
Croatian: Apsolutna bioraspoloživost je 75%.
English: These symptoms usually begin during the first 24 hours after the baby is born.
Croatian: Ovi simptomi obično počnu tijekom prvih 24 sata nakon rođenja djeteta.
English: Pruritus, including pruritus generalised
Croatian: Pruritus, uključujući generalizirani pruritus
English: Treatment should be continued for at least 6 months after you feel well again.
Croatian: Liječenje treba nastaviti najmanje 6 mjeseci nakon što se opet počnete osjećati dobro.
English: In the majority of instances, such complications began immediately or soon (<24 hours) after delivery.
Croatian: U većini slučajeva takve su komplikacije počele odmah ili uskoro (<24 sata) nakon poroda.
English: Medical follow-up in a specialised environment is recommended.
Croatian: Preporučuje se medicinsko praćenje u specijaliziranom okruženju.
English: These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Croatian: One mogu biti pojačane kada prvi put počnete liječenje antidepresivima jer svim ovim lijekovima treba vremena da djeluju, obično oko dva tjedna, ali ponekad i dulje.
English: Ask your doctor if you are uncertain.
Croatian: Pitajte svog liječnika ako niste sigurni.
English: Date of first authorisation: 18 December 2013 Date of latest renewal: 20 November 2018
Croatian: Datum posljednje obnove odobrenja: 20. studenog 2018
English: Take one tablet with a glass of water.
Croatian: Uzmite jednu tabletu s čašom vode.
English: Continue to take Brintellix even if it takes some time before you feel any improvement in your condition.
Croatian: Nastavite uzimati Brintellix čak i ako će biti potrebno neko vrijeme prije nego što osjetite bilo kakvo poboljšanje Vašeg stanja.
English: Belgique/België/Belgien
Croatian: België/Belgique/Belgien
English: Impact on human fertility has not been observed so far.
Croatian: Utjecaj na plodnost u ljudi do sada nije opažen.
English: Take Brintellix for as long as your doctor recommends.
Croatian: Uzimajte Brintellix onoliko dugo koliko to Vaš liječnik preporučuje.
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Croatian: S obzirom da se poboljšanje možda neće javiti tijekom prvih nekoliko tjedana liječenja ili više, bolesnike treba pomno nadzirati dok se ne dogodi takvo poboljšanje.
English: Do not stop taking Brintellix without talking with your doctor.
Croatian: Nemojte prestati uzimati Brintellix bez razgovora s liječnikom.
English: You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Croatian: Možete ih zamoliti da Vam kažu misle li da se Vaša depresija ili tjeskoba pogoršavaju, ili jesu li zabrinuti u vezi promjena u Vašem ponašanju.
English: Pack of 1 glass bottle.
Croatian: Pakiranje s 1 staklenom bocom.
English: In 1 case, anaphylactic shock was reported.
Croatian: U jednom je slučaju prijavljen anafilaktički šok.
English: [outer carton only] PC:
Croatian: [samo na vanjskoj kutiji] PC:
English: If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself.
Croatian: Ako ste depresivni i/ili imate poremećaje tjeskobe, ponekad možete imati misli o samoozljeđivanju ili samoubojstvu.
English: Talk to your doctor or pharmacist before taking Brintellix if you:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Brintellix ako:
English: Suicide/suicidal thoughts or clinical worsening
Croatian: Samoubojstvo/suicidalne misli ili kliničko pogoršanje
English: It belongs to a group of medicines called antidepressants.
Croatian: On pripada skupini lijekova koji se zovu antidepresivi.
English: Abnormal dreams
Croatian: Neuobičajeni snovi
English: Patients with severe depression or with depression and high levels of anxiety symptoms
Croatian: Bolesnici s teškom depresijom ili s depresijom i visokim razinama simptoma anksioznosti
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Croatian: Općenito, kliničko iskustvo je da se rizik od samoubojstva može povećati u ranim stadijima oporavka.
English: The mechanism behind this risk is unknown, and it is not known if this risk is also relevant for vortioxetine.
Croatian: Mehanizam koji dovodi do ovog rizika nije poznat i nije poznato da li se rizik također odnosi na vortioksetin.
English: Tolerability and safety
Croatian: Podnošljivost i sigurnost
English: Tell your doctor if you are taking any of the following medicines:
Croatian: Obavijestite svog liječnika ako uzimate bilo koji od sljedećih lijekova:
English: If you take more Brintellix than you should
Croatian: Ako uzmete više Brintellixa nego što ste trebali
English: Mania/hypomania
Croatian: Manija/hipomanija
English: Thoughts of suicide and worsening of your depression
Croatian: Misli o samoubojstvu i pogoršanje depresije
English: After the depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the antidepressive response.
Croatian: Nakon što se depresivni simptomi povuku, preporučuje se nastavak liječenja u trajanju od najmanje 6 mjeseci radi konsolidacije antidepresivnog odgovora.
English: The drops can be mixed with water, juice or other non-alcoholic drinks.
Croatian: Kapi se mogu miješati s vodom, sokom ili drugim bezalkoholnim pićima.
English: The efficacy of vortioxetine increased with increasing dose.
Croatian: Djelotvornost vortioksetina povećava se s povećanjem doze.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Croatian: U nedostatku ispitivanja inkompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.
English: Taking these medicines together with Brintellix may increase the risk of serotonin syndrome.
Croatian: Uzimanje ovih lijekova zajedno s Brintellixom može povećati rizik od serotoninskog sindroma.
English: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Croatian: Depresija je povezana s povećanim rizikom od suicidalnih misli, samoozljeđivanja i samoubojstva (događaji povezani sa samoubojstvom).
English: Other medicines and Brintellix
Croatian: Drugi lijekovi i Brintellix
English: Similar effects were seen in the rabbit at sub-therapeutic exposure.
Croatian: Slični učinci su opaženi u zečeva pri subterapijskoj izloženosti.
English: - if you are allergic to vortioxetine or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na vortioksetin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: In the majority of cases, no symptoms or mild symptoms were reported.
Croatian: U većini slučajeva nisu prijavljeni nikakvi simptomi ili su oni bili blagi.
English: Brintellix should only be administered to pregnant women if the expected benefits outweigh the potential risk to the foetus.
Croatian: Brintellix treba primjenjivati kod trudnica samo ako očekivane koristi nadmašuju potencijalni rizik za fetus.
English: The requirements for submission of periodic safety reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Have the container and any remaining tablets available.
Croatian: Imajte sa sobom spremnik i sve preostale tablete.
English: Brintellix with alcohol
Croatian: Brintellix s alkoholom
English: Turn the bottle completely upside down.
Croatian: Okrenite bočicu potpuno naopako.
English: Brintellix is not recommended in children and adolescents under 18 years due to lack of information for this age group.
Croatian: Brintellix se ne preporučuje za primjenu u djece i adolescenata mlađh od 18 godina zbog nedostatka informacija za ovu starosnu skupinu.
English: In the dedicated study in elderly, vortioxetine was also effective in these patients.
Croatian: U ispitivanju posvećenim starijim je vortioksetin također bio učinkovit u ovih bolesnika.
English: This leaflet was last revised in MM/YYYY Other sources of information
Croatian: Ova uputa je zadnji puta revidirana u MM/GGGG Ostali izvori informacija
English: If you take more than the prescribed dose of Brintellix, contact your doctor or nearest hospital emergency department immediately.
Croatian: Ako uzmete više od propisane doze Brintellixa, odmah se obratite svom liječniku ili hitnoj službi najbliže bolnice.
English: The most frequently reported symptoms were nausea and vomiting.
Croatian: Najčešće prijavljeni simptomi bili su mučnina i povraćanje.
English: Sexual dysfunction
Croatian: Spolna disfunkcija
English: Brintellix oral drops are not to be mixed with other medicinal products.
Croatian: Brintellix oralne kapi ne smiju se miješati s drugim lijekovima.
English: The mean volume of distribution (Vss) is 2,600 L, indicating extensive extravascular distribution.
Croatian: Srednja vrijednost volumena distribucije (Vss) je 2600 L, što upućuje na opsežnu ekstravaskularnu distribuciju.
English: Target organ toxicity was restricted to kidneys (rats) and liver (mice and rats).
Croatian: Toksičnost ciljanih organa bila je ograničena na bubrege (štakori) i jetru (miševi i štakori).
English: Gastrointestinal adverse reactions, such as nausea, occurred more frequently in women than men.
Croatian: Gastrointestinalne nuspojave kao što je mučnina pojavljivale su se češće u žena nego u muškaraca.