FrancophonIA/ELRC3.0 huggingface dataset:
English: * The OSS indicates the number of fully active drugs in a subject's Optimized Background Regimen (OBR) based on both current and available historical resistance test results.
Croatian: * OSS označava broj u cijelosti aktivnih lijekova u optimiziranom osnovnom režimu u ispitanika (engl.
English: Trogarzo 200 mg concentrate for solution for infusion ibalizumab
Croatian: Trogarzo 200 mg koncentrat za otopinu za infuziju ibalizumab
English: Recommended ibalizumab dose and number of vials per administration
Croatian: Preporučena doza ibalizumaba i broj bočica po primjeni
English: Ibalizumab should be administered as an intravenous infusion.
Croatian: Ibalizumab se mora primjenjivati u obliku intravenske infuzije.
English: Warnings and precautions
Croatian: Upozorenja i mjere opreza Pripazite na nuspojave
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trogarzo 200 mg sterile concentrate ibalizumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Trogarzo 200 mg sterilni koncentrat ibalizumab i.v.
English: Subjects on a failing ART regimen continued to receive their failing regimen in addition to the loading dose of ibalizumab.
Croatian: Ispitanici koji nisu reagirali na antiretrovirusni režim liječenja nastavili su primati režim liječenja koje nije bilo uspješno u kombinaciji s udarnom dozom ibalizumaba.
English: See Table 4 below for the appropriate number of vials required to prepare both the loading dose of 2,000 mg and the maintenance doses of 800 mg.
Croatian: Vidjeti tablicu 4 u nastavku za odgovarajući broj bočica potrebnih za pripremu udarne doze od 2000 mg i doze održavanja od 800
English: Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for developmental effects was 110 mg/kg.
Croatian: U uvjetima ispitivanja, razina doze bez opaženog štetnog učinka (NOAEL) za razvoj bila je
English: Gastrointestinal disorders diarrhoea, nausea, vomiting
Croatian: Poremećaji probavnog sustava proljev, mučnina, povraćanje
English: Week 25
Croatian: 31. listopada 2025.
English: Each vial contains 200 mg of ibalizumab (in 1.33 mL of solution).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 200 mg ibalizumaba (u 1,33 ml otopine).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 200 mg of ibalizumab
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 200 mg ibalizumaba
English: Tabulated summary of adverse reactions associated with ibalizumab System organ class
Croatian: Tablični sažetak nuspojava povezanih s primjenom ibalizumaba
English: What Trogarzo contains - The active substance is ibalizumab.
Croatian: Sadržaj pakiranja i druge informacije Što Trogarzo sadrži - Djelatna tvar je ibalizumab.
English: Following single-dose administrations of 10 and 25 mg/kg of ibalizumab, clearance is 0.5 to 0.36 mL/h/kg and elimination half-life is 37.8 and 64.1 hours, respectively.
Croatian: Nakon primjene pojedinačnih doza od 10 i 25 mg/kg ibalizumaba, klirens iznosi od 0,5 do 0,36
English: Ibalizumab dose
Croatian: Doza ibalizumaba
English: Trogarzo will be added to a drip (infusion bag) containing a sodium chloride (saline) solution before use.
Croatian: Prije primjene, lijek Trogarzo dodat će se u infuzijsku vrećicu koja sadrži otopinu natrijeva klorida
English: What Trogarzo looks like and contents of the pack Trogarzo is a colourless to slightly yellow, clear to slightly opalescent concentrate for solution for infusion (sterile concentrate), with no visible particles.
Croatian: Trogarzo je bezbojni do blago žuti, bistri do blago opalescentni koncentrat za otopinu za infuziju
English: See the table below for the appropriate number of vials required to prepare both the loading dose of 2,000 mg and the maintenance doses of 800 mg.
Croatian: U tablici u nastavku naveden je odgovarajući broj bočica potrebnih za pripremu udarne doze od 2000 mg i doze održavanja od 800
English: How to store Trogarzo
Croatian: Kako čuvati Trogarzo
English: Trogarzo contains the active substance ibalizumab.
Croatian: Trogarzo sadrži djelatnu tvar ibalizumab.
English: Ibalizumab administered as a single agent exhibits nonlinear pharmacokinetics at a dose range of 0.3-25 mg/kg.
Croatian: Linearnost/nelinearnost Ibalizumab primijenjen kao monoterapija pokazuje nelinearnu farmakokinetiku u rasponu doza od 0,3
English: • spots or swelling
Croatian: • mučnina ili povraćanje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (Contains 2 vials of 200 mg)
Croatian: KUTIJA (sadrži dvije bočice od 200 mg)
English: Common (may affect up to 1 in 10 people): skin rash
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba): • nevoljno drhtanje
English: No formal studies were conducted to examine the effects of renal impairment on the pharmacokinetics of ibalizumab.
Croatian: Nisu provedena službena ispitivanja kako bi se ispitali učinci oštećenja funkcije bubrega na farmakokinetiku ibalizumaba.
English: As a result, ibalizumab was discontinued.
Croatian: Kao rezultat toga, prekinuto je liječenje ibalizumabom.
English: Decreased susceptibility to ibalizumab was a finding in the majority of patients who experienced virologic failure up to week 24 in the pivotal study.
Croatian: Većina bolesnika koji su do 24. tjedna u pivotalnom ispitivanju doživjeli virološki neuspjeh imala je nalaz smanjene osjetljivosti na ibalizumab.
English: Ibalizumab was generally well tolerated in pregnant monkeys and in their offspring, when evaluated through 180 ± 2 days postpartum.
Croatian: Na temelju procjene razdoblja od 180 ± 2 dana nakon poroda, gravidni majmuni i njihovi potomci općenito su dobro podnosili ibalizumab.
English: One subject out of 153 was reported to have hypersensitivity (allergic reaction) on Day 21 (i.e. 7 days after the 2nd infusion of ibalizumab).
Croatian: Preosjetljivost Zabilježeno je da je jedan od 153 ispitanika imao reakciju preosjetljivosti (alergijska reakcija) na 21.
English: Hepatic impairment
Croatian: • omaglica • glavobolja
English: Hydrochloric acid Water for injections
Croatian: saharoza natrijev klorid polisorbat 80 histidin kloridna kiselina voda za injekcije
English: No formal studies were conducted to examine the effects of hepatic impairment on the pharmacokinetics of ibalizumab.
Croatian: Nisu provedena službena ispitivanja kako bi se ispitali učinci oštećenja funkcije jetre na farmakokinetiku ibalizumaba.
English: Subjects with baseline CD4 counts < 50 cells/mm3 were less likely to achieve a HIV-1 RNA of < 200 copies/mL (or < 50 copies/mL) than subjects with > 50 cells/mm3.
Croatian: kopija/ml (ili < 50 kopija/ml) u odnosu na ispitanike s > 50 stanica/mm3.
English: Sucrose
Croatian: • proljev
English: Hydrochloric acid (for pH-adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari saharoza natrijev klorid polisorbat 80 histidin kloridna kiselina (za prilagodbu pH vrijednosti) voda za injekcije
English: Hepatic impairment is not anticipated to impact the pharmacokinetics of ibalizumab.
Croatian: Očekuje se da oštećenje funkcije jetre neće utjecati na farmakokinetiku ibalizumaba.
English: Both subjects were discontinued from ibalizumab treatment.
Croatian: Liječenje ibalizumabom prekinuto je u oba ispitanika.
English: Name and address of the manufacturer of the biological active substance
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača biološke djelatne tvari
English: NAME OF THE MEDICINAL PRODUCT Trogarzo 200 mg concentrate for solution for infusion ibalizumab
Croatian: Uputa o lijeku: Informacije za bolesnika Trogarzo 200 mg koncentrat za otopinu za infuziju ibalizumab
English: No relevant remaining effect of ibalizumab is expected in cases of resistance development.
Croatian: slučaju razvoja rezistencije ne očekuje se da će ibalizumab imati relevantan učinak.
English: • dry mouth
Croatian: • suha koža
English: Renal impairment is not anticipated to impact the pharmacokinetics of ibalizumab.
Croatian: Očekuje se da oštećenje funkcije bubrega ne utječe na farmakokinetiku ibalizumaba.
English: Transmission of HIV
Croatian: Prenošenje HIV-a
English: What Trogarzo is and what it is used for 2.
Croatian: Što se nalazi u ovoj uputi: 1. Što je Trogarzo i za što se koristi
English: Serious side effects Talk to your doctor or nurse straight away if you get any of the following serious side effects: Signs of a new infection, changes in your immune system, can happen when you start using HIV medicines.
Croatian: • Znakovi nove infekcije i promjene u imunosnom sustavu do kojih može doći nakon što počnete uzimati lijekove protiv HIV-a.
English: Ibalizumab is administered intravenously (IV), after diluting the appropriate number of vials in 250 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Za pripremu ibalizumab otopine za infuziju smije se koristiti samo 0,9 %-tna otopina natrijeva klorida za injekciju (9 mg/ml).
English: (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: (za više informacije pogledajte „Ozbiljne nuspojave” u dijelu 4.).
English: decrease in viral load N=40
Croatian: N = 40
English: How to receive Trogarzo 4.
Croatian: Kako primati Trogarzo
English: This medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Prije primjene lijek vizualno pregledajte kako biste isključili prisutnost stranih čestica i promjene boje.
English: Opening date:…………
Croatian: Datum otvaranja:...............
English: Date of first authorisation: 19 June 2015
Croatian: Datum prvog odobrenja: 19. lipanj 2015.
English: Therefore, there is no evidence of efficacy in this paediatric patient population.
Croatian: Dakle, nema dokaza za djelotvornost u toj populaciji pedijatrijskih bolesnika.
English: Use within 6 months after opening.
Croatian: Iskoristiti u roku od 6 mjeseca nakon otvaranja.
English: • depression
Croatian: • depresije
English: Falls were more common in the elderly (≥65 years old).
Croatian: Padovi su bili češći u starijih osoba (≥ 65 godina)
English: In some cases, these symptoms have continued after stopping treatment.
Croatian: U nekim su se slučajevima ti simptomi nastavili nakon prestanka liječenja.
English: For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: Not statistically significantly different from placebo.
Croatian: Ne razlikuje se statistički značajno od placeba.
English: Bottle packs only: Once opened, use within 180 days.
Croatian: Samo za bočice: Nakon otvaranja iskoristiti u roku od 180 dana.
English: 3752 LB Bunschoten The Netherlands
Croatian: 3752 LB Bunschoten Nizozemska
English: Distribution: Duloxetine is approximately 96% bound to human plasma proteins.
Croatian: Distribucija: Približno 96% duloksetina veže se za ljudske proteine plazme.
English: The requirements for submission of periodic safety update 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 predaju periodičkih izvješća o neškodljivosti za ovaj lijek su navedeni u popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim naknadnim ažuriranjima objavljenim na europskom internetskom portalu za lijekove.
English: The following are reasons why Duloxetine Mylan may not be suitable for you.
Croatian: U nastavku su naveden razlozi zbog kojih Duloxetine Mylan možda nije prikladan za Vas.
English: Frequency estimate: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Croatian: Procjena učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000).
English: Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11%).
Croatian: Hrana produljuje vrijeme do postizanja vršne koncentracije sa 6 na 10 sati te donekle smanjuje opseg apsorpcije (za oko 11%).
English: • excessive vaginal bleeding shortly after birth (postpartum haemorrhage)
Croatian: • prekomjerno vaginalno krvarenje ubrzo nakon poroda (poslijeporođajno krvarenje)
English: There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRIs.
Croatian: Postoje izvješća o dugotrajnom poremećaju seksualne funkcije gdje su se simptomi nastavili unatoč prestanku liječenja SSRI-ovima/SNRI-om.
English: Abrupt discontinuation should be avoided.
Croatian: Nagli prekid liječenja mora se izbjegavati.
English: Pharmacotherapeutic group: Other antidepressants.
Croatian: Farmakoterapijska skupina: Ostali antidepresivi.
English: Using more than one of these medicines at the same time should be avoided.
Croatian: Morate izbjegavati istodobno uzimanje više od jednog takvog lijeka.
English: Do not drive or use any tools or machines until you know how Duloxetine Mylan affects you.
Croatian: Nemojte voziti niti rukovati alatima ni strojevima dok ne vidite kako će Duloxetine Mylan utjecati na Vas.
English: If your doctor has prescribed Duloxetine Mylan for a patient under 18 and you want to discuss this, please go back to your doctor.
Croatian: Ako je liječnik propisao lijek Duloxetine Mylan bolesniku mlađem od 18 godina i želite o tome razgovarati, vratite se svom liječniku.
English: Other psychiatric conditions for which Duloxetine Mylan is prescribed can also be associated with an increased risk of suicide-related events.
Croatian: Druga psihijatrijska stanja za koja se propisuje Duloxetine Mylan također mogu biti povezana s povećanim rizikom od događaja povezanih sa samoubojstvom.
English: Your doctor or midwife should be aware that you are taking duloxetine so they can advise you.
Croatian: Vaš liječnik ili primalja trebaju znati da uzimate duloksetin, kako bi Vas mogli savjetovati.
English: These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Duloxetine Mylan, you should see your doctor.
Croatian: Navedeni lijekovi povećavaju rizik od nuspojava; ako uočite bilo koji neuobičajen simptom dok uzimate neki od ovih lijekova zajedno s lijekom Duloxetine Mylan, morate se javiti svom liječniku.
English: Age: Pharmacokinetic differences have been identified between younger and elderly females (≥65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose.
Croatian: Dob: Uočene su razlike u farmakokinetici između mlađih i starijih bolesnica (≥ 65 godina) (u starijih je osoba AUC oko 25% veći, a poluvijek oko 25% dulji), premda veličina ovih razlika nije dovoljna da bi se opravdalo prilagođavanje doze.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: In animal studies, duloxetine had no effect on male fertility, and effects in females were only evident at doses that caused maternal toxicity.
Croatian: U ispitivanjima na životinjama, duloksetin nije utjecao na plodnost u muškaraca, a učinci u žena bili su primjetni samo pri dozama koje su izazivale toksičnost za majku.
English: • fast and/or irregular heart beat
Croatian: • brzi ili nepravilni otkucaji srca
English: If your doctor thinks that you no longer need Duloxetine Mylan he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Croatian: Ako liječnik smatra da Vam Duloxetine Mylan više ne treba, uputit će Vas da dozu postupno smanjujete tijekom najmanje 2 tjedna prije nego što potpuno prestanete uzimati lijek.
English: The dose may be adjusted up to 120 mg a day based on your response to Duloxetine Mylan.
Croatian: Doza se može povisiti do 120 mg na dan, ovisno o Vašem odgovoru na lijek Duloxetine Mylan.
English: The safety results from this study were consistent with the known safety profile of duloxetine.
Croatian: Rezultati ovog ispitivanja vezani uz sigurnost lijeka bili su u skladu s poznatim sigurnosnim profilom duloksetina.
English: • If you take Duloxetine Mylan near the end of your pregnancy, your baby might have some symptoms when it is born.
Croatian: • Ako uzimate lijek Duloxetine Mylan pred kraj trudnoće, Vaša beba može imati određene simptome kada se rodi.
English: Biotransformation: Duloxetine is extensively metabolised and the metabolites are excreted principally in urine.
Croatian: Biotransformacija: Duloksetin se opsežno metabolizira, a metaboliti se izlučuju prvenstveno u mokraću.
English: Very rare side effects (may affect up to 1 in 10,000 people) • inflammation of the blood vessels in the skin (cutaneous vasculitis)
Croatian: Vrlo rijetke nuspojave (mogu se javiti u najviše 1 na 10 000 osoba) • upala krvnih žila u koži (kutani vaskulitis)
English: • If you take Duloxetine Mylan near the end of your pregnancy there is an increased risk of excessive vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders.
Croatian: • Ako uzimate lijek Duloxetine Mylan pred kraj trudnoće, postoji povećan rizik od prekomjernog vaginalnog krvarenja ubrzo nakon poroda, osobito ako u povijesti bolesti imate poremećaje krvarenja.
English: Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.
Croatian: Slučajevi ortostatske hipotenzije i sinkope prijavljeni su osobito na početku liječenja.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja fruktoze, malapsorpcijom glukoze i galaktoze ili insuficijencijom saharoze-izomaltaze ne smiju uzimati ovaj lijek.
English: • Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking Duloxetine Mylan.
Croatian: • Obavijestite svog liječnika ako zatrudnite ili pokušavate zatrudnjeti dok uzimate lijek Duloxetine Mylan.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internet stranicama Europske agencije za lijekove http://www.ema.europa.eu.
English: Elimination: The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 hours).
Croatian: Eliminacija: Poluvrijeme eliminacije duloksetina kreće se u rasponu od 8 do 17 sati (srednja vrijednost 12 sati).
English: Duloxetine Mylan should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: Duloxetine Mylan se u trudnoći smije uzimati samo ako moguća korist liječenja opravdava mogući rizik za plod.
English: However, as with any medicine, caution should be exercised when treating the elderly, especially with Duloxetine Mylan 120 mg per day for major depressive disorder or generalised anxiety disorder, for which data are limited (see sections 4.4 and 5.2).
Croatian: Međutim, kao i kod svih drugih lijekova, mora se s oprezom liječiti starije osobe, osobito kada se primjenjuje Duloxetine Mylan u dozi od 120 mg dnevno za liječenje velikog depresivnog poremećaja ili generaliziranog anksioznog poremećaja, za što su podaci ograničeni (vidjeti dijelove 4.4 i 5.2).
English: Some patients who stop taking Duloxetine Mylan suddenly have had symptoms such as:
Croatian: U nekih bolesnika koji naglo prestanu uzimati lijek Duloxetine Mylan jave se simptomi kao što su:
English: Use in children and adolescents under 18 years of age Duloxetine Mylan should not be used in the treatment of children and adolescents under the age of 18 years.
Croatian: Primjena u djece i adolescenata mlađih od 18 godina Duloxetine Mylan se ne smije primjenjivati u liječenju djece i adolescenata mlađih od 18 godina.
English: • Duloxetine Mylan may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol
Croatian: • Duloxetine Mylan može uzrokovati nuspojave kojih možda i niste svjesni, poput povišenih vrijednosti jetrenih enzima ili povišene koncentracije kalija, kreatin fosfokinaze, šećera ili kolesterola u krvi
English: Cases of aggression and anger have been reported particularly early in treatment or after treatment discontinuation.
Croatian: Slučajevi agresije i bijesa prijavljeni su osobito u ranoj fazi liječenja ili nakon prekida liječenja.
English: Marketing Authorisation Holder Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, France
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, Francuska
English: Gender: Pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females).
Croatian: Spol: Uočene su razlike u farmakokinetici između muškaraca i žena (prividni klirens iz plazme u žena je približno 50% manji).
English: Sexual dysfunction
Croatian: Poremećaj seksualne funkcije
English: Observational data have provided evidence of an increased risk (less than 2-fold) of postpartum haemorrhage following duloxetine exposure within the month prior to birth.
Croatian: Opservacijski podaci pružili su dokaze (manje od dvostruko) povećanog rizika od poslijeporođajnog krvarenja nakon izlaganja duloksetinu unutar mjesec dana prije poroda.
English: Your doctor may continue to give you Duloxetine Mylan when you are feeling better to prevent your depression or anxiety from returning.
Croatian: Liječnik Vam može nastaviti propisivati lijek Duloxetine Mylan i nakon što se počnete osjećati bolje, kako bi se spriječio povratak depresije ili tjeskobe.
English: What Duloxetine Mylan is and what it is used for
Croatian: Što je Duloxetine Mylan i za što se koristi
English: Major Depressive Disorder: Duloxetine was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
Croatian: Veliki depresivni poremećaj: Duloksetin je ispitan u kliničkom programu koji je obuhvatio 3158 bolesnika (1285 bolesnik-godina izloženosti) koji su zadovoljavali DSM-IV kriterije za veliki depresivni poremećaj.
English: Duloxetine was not genotoxic in a standard battery of tests and was not carcinogenic in rats.
Croatian: Duloksetin se nije pokazao genotoksičnim u standardnom kompletu testova niti kancerogenim u štakora.
English: During the 10-week acute treatment period, suicidal behaviours were reported (duloxetine 0/333 [0%], fluoxetine 2/225 [0.9%], placebo 1/220 [0.5%]).
Croatian: Tijekom 10-tjednog razdoblja akutnog liječenja prijavljena su suicidalna ponašanja (duloksetin 0/333 [0%], fluoksetin 2/225 [0,9%], placebo 1/220 [0,5%]).
English: Despite this, your doctor may prescribe Duloxetine Mylan for patients under 18 because he/she decides that this is in their best interests.
Croatian: Ipak, Vaš liječnik može propisati lijek Duloxetine Mylan bolesnicima mlađima od 18 godina ako procijeni da je to u njihovu najboljem interesu.
English: Do not stop taking Duloxetine Mylan, or change your dose, without talking to your doctor.
Croatian: Nemojte prestati uzimati lijek Duloxetine Mylan niti mijenjati dozu lijeka a da se prethodno niste posavjetovali sa svojim liječnikom.
English: Duloxetine Mylan starts to work in most people with depression or anxiety within two weeks of starting treatment, but it may take 2-4 weeks before you feel better.
Croatian: U većine osoba s depresijom ili tjeskobom Duloxetine Mylan počinje djelovati unutar dva tjedna nakon početka liječenja, ali može biti potrebno 2-4 tjedna prije nego što se počnete osjećati bolje.