FrancophonIA/ELRC3.0 huggingface dataset:
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik Put primjene
English: Intravenous use, Subcutaneous use
Croatian: Intravenska primjena, Supkutana primjena
English: However, sexual stimulation is still needed.
Croatian: No, seksualna stimulacija je još uvijek potrebna.
English: It is a ‘generic medicine'.
Croatian: On je „generički lijek”.
English: This summary was last updated in 11-2014.
Croatian: Sažetak je posljednji put ažuriran 11.2014.
English: The dose is 5 mg once a day, but can be lowered to 2.5 mg once a day depending on how well it is tolerated.
Croatian: Doza iznosi 5 mg jednom na dan, no može se smanjiti na 2,5 mg jednom na dan ovisno o tome koliko se dobro lijek podnosi.
English: The dose may be increased to 20 mg for men who do not respond to the 10 mg dose.
Croatian: Doza se može povećati na 20 mg za muškarce koji ne odgovaraju na dozu od 10 mg.
English: The full EPAR and risk management plan summary for Tadalafil Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i plan upravljanja rizikom za lijek Tadalafil Mylan nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tadalafil Mylan can be used at a lower dose once a day in men who intend to use it frequently (twice a week or more), based on the doctor's judgment.
Croatian: Tadalafil Mylan se može koristiti u manjoj dozi jednom na dan u muškaraca koji ga namjeravaju koristiti češće (dva puta na tjedan ili češće), na temelju ocjene liječnika.
English: The maximum recommended dosing frequency is once per day, but continuous daily use of 10 or 20 mg Tadalafil Mylan is not recommended.
Croatian: Maksimalna preporučena učestalost doziranja je jednom na dan, no ne preporučuje se kontinuirana dnevna primjena od 10 ili 20 mg lijeka Tadalafil Mylan.
English: Patients with severely impaired liver or kidney function should not take more than 10 mg in one dose.
Croatian: Bolesnici s teškim oštećenjem funkcije jetre ili bubrega ne smiju uzimati više od 10 mg u jednoj dozi.
English: Men with erectile dysfunction do not have enough cGMP to produce or maintain an erection.
Croatian: Muškarci s erektilnom disfunkcijom nemaju dovoljno cGMP-a za stvaranje ili održavanje erekcije.
English: For Tadalafil Mylan to be effective in this condition, sexual stimulation is required.
Croatian: Da bi lijek Tadalafil Mylan bio djelotvoran u ovom stanju, potrebna je seksualna stimulacija.
English: This may reduce the problems with the flow of urine which are symptoms of benign prostatic hyperplasia.
Croatian: Ovo može smanjiti probleme s protokom urina, koji su simptomi benigne prostatične hiperplazije.
English: Tadalafil Mylan is used to treat men with erectile dysfunction (sometimes called impotence) when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity.
Croatian: Tadalafil Mylan koristi se za liječenje muškaraca s erektilnom disfunkcijom (koja se ponekad naziva impotencija) kada ne mogu postići, ili zadržati, ukrućeni penis (erekciju) dovoljno za zadovoljavajuću seksualnu aktivnost.
English: For treating erectile dysfunction, the recommended dose of Tadalafil Mylan is 10 mg taken ‘on demand' at least 30 minutes before sexual activity.
Croatian: Za potrebe liječenja erektilne disfunkcije, preporučena doza lijeka Tadalafil Mylan iznosi 10 mg i uzima se „prema potrebi” najmanje 30 minuta prije seksualne aktivnosti.
English: For treating men with benign prostatic hyperplasia, or men with both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day.
Croatian: Za potrebe liječenja muškaraca s benignom prostatičnom hiperplazijom ili muškaraca s benignom prostatičnom hiperplazijom i erektilnom disfunkcijom preporučena doza iznosi 5 mg na dan.
English: Once-a-day dosing is not recommended in patients with severely impaired kidney function, and should only be prescribed to patients with impaired liver function after a careful evaluation of the benefits and risks of taking the medicine.
Croatian: Doziranje jednom na dan ne preporučuje se u bolesnika s teškim oštećenjem funkcije bubrega, a bolesnicima s oštećenjem funkcije jetre treba ga propisivati nakon pažljive ocjene koristi i rizika primjene lijeka.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection.
Croatian: Tijekom normalne seksualne stimulacije, cGMP se proizvodi u penisu, gdje uzrokuje opuštanje mišića u spužvastom tkivu penisa (corpora cavernosa), omogućavajući protok krvi u tijelo penisa, čime se postiže erekcija.
English: The active substance of Tadalafil Mylan, tadalafil, belongs to a group of medicines called 'phosphodiesterase type 5 (PDE5) inhibitors'.
Croatian: Djelatna tvar lijeka Tadalafil Mylan, tadalafil, ubraja se u grupu lijekova naziva „inhibitori fosfodiesteraze tipa 5 (PDE5)”.
English: This is a summary of the European public assessment report (EPAR) for Tadalafil Mylan.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Tadalafil Mylan.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tadalafil Mylan has been shown to have comparable quality and to be bioequivalent to Cialis.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, dokazano kako Tadalafil Mylan posjeduje usporedivu kvalitetu te je bioekvivalentan lijeku Cialis.
English: This means that Tadalafil Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cialis.
Croatian: To znači da je Tadalafil Mylan sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Cialis.
English: Tadalafil Mylan can also be used in men to treat the signs and symptoms of benign prostatic hyperplasia (enlarged prostate gland that is not cancerous), which involve problems with the flow of urine.
Croatian: Tadalafil Mylan se može također koristiti za liječenje znakova i simptoma benigne prostatične hiperplazije (povećane prostate koja nije kancerogena), što obuhvaća probleme s protokom urina.
English: The medicine should be taken around the same time every day and the appropriateness of the once-a-day dosing should be re-assessed regularly.
Croatian: Lijek treba uzimati otprilike u isto vrijeme svaki dan, te je potrebna redovita ocjena primjerenosti doziranja jednom na dan.
English: Therefore, the CHMP's view was that, as for Cialis, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da, kao i kod lijeka Cialis, koristi nadmašuju utvrđene rizike.
English: Because Tadalafil Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Tadalafil Mylan generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: It is not intended to provide practical advice on how to use Tadalafil Mylan.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Tadalafil Mylan.
English: What measures are being taken to ensure the safe and effective use of Tadalafil Mylan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tadalafil Mylan?
English: By blocking the phosphodiesterase enzyme and preventing the breakdown of cGMP, Tadalafil Mylan also improves the blood flow to, and relaxes the muscles of, the prostate and bladder.
Croatian: Inhibirajući enzim fosfodiesterazu i sprječavajući razgradnju cGMP-a Tadalafil Mylan također poboljšava protok krvi i opušta mišiće prostate i mjehura.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tadalafil Mylan on 21 November 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Tadalafil Mylan na snazi u Europskoj uniji od 21. studenog 2014.
English: A risk management plan has been developed to ensure that Tadalafil Mylan is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Tadalafil Mylan.
English: What is Tadalafil Mylan and what is it used for?
Croatian: Što je Tadalafil Mylan i za što se koristi?
English: What are the benefits and risks of Tadalafil Mylan?
Croatian: Koje su koristi i rizici lijeka Tadalafil Mylan?
English: It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Croatian: Lijek djeluje inhibirajući enzim fosfodiesterazu, koji normalno razgrađuje tvar poznatu pod nazivom ciklički guanozin monofosfat (cGMP).
English: For more information about treatment with Tadalafil Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Tadalafil Mylan pročitajte u uputi o lijeku (također dio EPARa), odnosno obratite se svom liječniku ili ljekarniku.
English: The Committee recommended that Tadalafil Mylan be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Tadalafil Mylan u EU-u.
English: By blocking the breakdown of cGMP, Tadalafil Mylan restores erectile function.
Croatian: Inhibirajući razgradnju cGMP-a, Tadalafil Mylan uspostavlja erektilnu funkciju.
English: Tadalafil Mylan contains the active substance tadalafil.
Croatian: Tadalafil Mylan sadrži djelatnu tvar tadalafil.
English: Because Tadalafil Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Cialis.
Croatian: Budući da je Tadalafil Mylan generički lijek, ispitivanja na bolesnicima bile su ograničena na utvrđivanje činjenice je li riječ o bioekvivalentu referentnom lijeku Cialis.
English: Other information about Tadalafil Mylan
Croatian: Ostale informacije o lijeku Tadalafil Mylan
English: For practical information about using Tadalafil Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Tadalafil Mylan pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Tadalafil Mylan can only be obtained with a prescription.
Croatian: Tadalafil Mylan se izdaje samo na liječnički recept.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tadalafil Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Mylan nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Why is Tadalafil Mylan approved?
Croatian: Zašto je lijek Tadalafil Mylan odobren?
English: How is Tadalafil Mylan used?
Croatian: Kako se Tadalafil Mylan koristi?
English: How does Tadalafil Mylan work?
Croatian: Kako djeluje Tadalafil Mylan?
English: How has Tadalafil Mylan been studied?
Croatian: Kako je Tadalafil Mylan ispitivan?
English: This change may be permanent.
Croatian: Ova promjena može biti trajna.
English: • Only use one bottle at a time.
Croatian: • Koristite samo jednu bočicu istodobno.
English: Ask your pharmacist how to throw away medicines you no longer used.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite.
English: • Tilt your head or your child's head gently back.
Croatian: • Zabacite glavu ili glavu Vašeg djeteta nježno prema natrag.
English: Use in adults, including elderly patients
Croatian: Primjena kod odraslih, uključujući starije bolesnike
English: SE = Standard Error; CI = Confidence Interval;
Croatian: SP = standardna pogreška; CI = interval pouzdanosti;
English: Do not use a double dose to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu.
English: Contact with the skin
Croatian: Kontakt s kožom
English: Continue with the next dose as planned.
Croatian: Nastavite s slijedećom dozom kako je planirano.
English: No long-term safety data are available in the paediatric population.
Croatian: Nema dostupnih dugoročnih podataka o sigurnosti u pedijatrijskoj populaciji.
English: • If you use drops in both eyes, repeat the steps for the other eye.
Croatian: • Ako primjenjujete kapi na oba oka, ponovite ove korake na drugom oku.
English: You must throw away the bottle 4 weeks after you first opened it, to prevent infections, and use a new bottle.
Croatian: Bočicu morate baciti 4 tjedna nakon prvog otvaranja da bi se spriječile infekcije, i uzeti novu bočicu.
English: Do not open the pouch until you need to use the bottle.
Croatian: Ne otvarajte vrećicu sve dok ne trebate otvoriti bočicu.
English: Don't put in any more drops until it's time for your next regular dose.
Croatian: Nemojte ponovno kapati sve dok ne bude vrijeme za sljedeću redovnu dozu.
English: What IZBA is and what it is used for
Croatian: Što je IZBA i za što se koristi
English: Optimal effect is obtained if the dose is administered in the evening.
Croatian: Optimalan učinak postiže se ukoliko je doza primijenjena navečer.
English: For patients who wear contact lenses, please refer to section 4.4.
Croatian: Za bolesnike koji nose kontaktne leće, molimo vidjeti dio 4.4.
English: This is especially important in women who are pregnant or are attempting to become pregnant.
Croatian: Ovo je osobito važno kod trudnica ili žena koje planiraju trudnoću.
English: Do not use IZBA if you are pregnant.
Croatian: Ne koristite IZBU ako ste trudni.
English: Currently available data are described in section 5.1 but no recommendation on a posology below the age of 3 years can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.1, međutim nije moguće dati preporuku o doziranju u dobi ispod 3 godine.
English: No data are available for children less than 2 months old.
Croatian: Nema dostupnih podataka za djecu mlađu od 2 mjeseca.
English: • if you are allergic to travoprost or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na travoprost ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Read all of this leaflet carefully before you start using this medicine because it contains information important for you - Keep this leaflet.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: Treatment of a suspected oral ingestion is symptomatic and supportive.
Croatian: Liječenje kod suspektne oralne ingestije je simptomatsko i suportivno.
English: Before treatment is instituted, patients must be informed of the possibility of a permanent change in eye colour.
Croatian: Prije početka liječenja mora se upozoriti bolesnika na mogućnost trajne promjene boje oka.
English: This helps to stop IZBA getting into the rest of the body.
Croatian: Tako ćete spriječiti da IZBA prijeđe u ostatak tijela.
English: • Travoprost may be absorbed through the skin.
Croatian: • Travoprost se može apsorbirati kroz kožu.
English: This pressure can lead to an illness called glaucoma.
Croatian: Ovaj tlak može dovesti do bolesti koja se naziva glaukom.
English: • Hold the bottle, pointing down, between your thumb and fingers.
Croatian: • Bočicu držite okrenuto naopako, između palca i prstiju.
English: Package leaflet : Information for the user
Croatian: Uputa o lijeku: Informacije za korisnika
English: The short-term safety profiles in the different paediatric subsets were also similar (see section 5.1).
Croatian: Kratkoročni sigurnosni profili u različitim pedijatrijskim podskupinama također su bili slični (vidjeti dio 5.1).
English: Do not use this medicine after the expiry date which is stated on the bottle and the box after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji nakon „EXP“.
English: 95% CI *One subject had missing data at 8 AM at Week 6; one had missing data at 4 PM at Month 3.
Croatian: *Za jednu osobu nedostaju podaci u 8 h u Tjednu 6; za jednu nedostaju podaci u 16 h u Mjesecu 3.
English: The drop will go in here (picture 2).
Croatian: U taj prostor ćete ukapati kap (slika 2).
English: • IZBA may increase the length, thickness, colour and/or number of your eyelashes.
Croatian: • IZBA može povećati dužinu, debljinu, boju i/ili broj trepavica.
English: If a dose is missed, treatment should be continued with the next dose as planned.
Croatian: Ako se preskoči jedna doza, liječenje je potrebno nastaviti sa sljedećom dozom kako je planirano.
English: Date of first authorisation: 20 February 2014 Date of latest renewal:
Croatian: Datum prvog odobrenja: 20. veljače 2014.
English: Travoprost is an ester prodrug.
Croatian: Travoprost je esterski predlijek.
English: The long-term effects on the melanocytes and any consequences thereof are currently unknown.
Croatian: Dugotrajni učinci na melanocite i bilo koja posljedica u svezi s tim trenutno nisu poznati.
English: Do not stop using IZBA without first speaking to your doctor or the doctor treating your child, the pressure in your eye or your child's eye will not be controlled which could lead to loss of sight.
Croatian: Nemojte prekidati primjenu IZBE bez da ste se posavjetovali sa liječnikom ili liječnikom Vašeg djeteta, tlak u Vašem oku ili oku Vašeg djeteta neće biti pod kontrolom, što može dovesti do gubitka vida.
English: Hence, despite the very small amounts of travoprost used by patients in eye drops, a risk to the environment cannot be excluded.
Croatian: Stoga, unatoč vrlo maloj količini travoprosta koju koriste bolesnici u kapima za oči, rizik za okoliš se ne može isključiti.
English: The safety and efficacy of travoprost have not been established in this age group.
Croatian: Sigurnost i djelotvornost travoprosta nisu ustanovljene u ovoj dobnoj skupini.
English: Therefore, no need for dose adjustment at the lower concentration of active ingredient is anticipated.
Croatian: Stoga, nije predviđena potreba za prilagođavanjem doze kod niže koncentracije djelatne tvari.
English: Reduction of the intraocular pressure in man starts about 2 hours after administration and maximum effect is reached after 12 hours.
Croatian: Sniženje intraokularnog tlaka kod čovjeka počinje kroz približno 2 sata nakon ukapavanja i maksimalni učinak se dosegne nakon 12 sati.
English: If you stop using IZBA
Croatian: Ako prestanete uzimati IZBU
English: Travoprost is considered a persistent, bioaccumulative and toxic (PBT) substance.
Croatian: Travoprost se smatra perzistentnom, bioakumulacijskom i toksičnom (PBT) tvari.
English: Changes in the eyelids including unusual hair growth or in the tissues around the eye have also been observed.
Croatian: Promjene na vjeđama uključujući neuobičajen rast dlaka ili na tkivima oko oka također su zabilježene.
English: If you could become pregnant you must use adequate contraception whilst you use IZBA.
Croatian: Ako postoji mogućnost da zatrudnite, morate koristiti odgovarajuću kontracepciju dok primjenjujete IZBU.
English: You should check with your doctor, the doctor treating your child or pharmacist if you are not sure.
Croatian: Provjerite s liječnikom, liječnikom Vašeg djeteta ili ljekarnikom ako niste sigurni.
English: IZBA may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes.
Croatian: IZBA može postupno promijeniti boju očiju povećanjem broja melanosoma (pigmentna zrnca) u melanocitima.
English: It should be noted that travoprost is considered a PBT substance (see section 5.3).
Croatian: Treba napomenuti da se travoprost smatra PBT tvari (vidjeti dio 5.3).
English: No dosage adjustment is necessary in these patients (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u ovih bolesnika (vidjeti dio 5.2).
English: After discontinuation of therapy, no further increase in brown iris pigment has been observed.
Croatian: Nakon prestanka terapije nije zapaženo daljnje povećanje smeđeg pigmenta šarenice.
English: Unilateral treatment can result in permanent heterochromia.
Croatian: Liječenje jednog oka može dovesti do trajne heterokromije.
English: In patients with known predisposing risk factors for iritis/uveitis, IZBA should be used with caution.
Croatian: U bolesnika s poznatim predisponirajućim rizičnim faktorima za iritis/uveitis, IZBA se treba koristiti s oprezom.
English: Women who are pregnant or attempting to become pregnant should exercise appropriate precautions to avoid direct exposure to the contents of the bottle.
Croatian: Žene koje su trudne ili planiraju trudnoću, moraju obratiti pozornost na potrebne mjere opreza da spriječe izravan dodir sa sadržajem bočice.
English: IZBA is used to reduce high pressure in the eye in adults, adolescents and children from 3 years old onward.
Croatian: IZBA se koristi za sniženje visokog tlaka u oku kod odraslih osoba, adolescenata i djece od 3 godine starosti nadalje.
English: Due to the low plasma concentrations and rapid elimination following topical dosing, the elimination half-life of active free acid in man could not be determined.
Croatian: Zahvaljujući niskoj koncentraciji u plazmi i brzoj eliminaciji nakon topikalnog doziranja, poluvrijeme eliminacije aktivne slobodne kiseline u čovjeka ne može se odrediti.
English: Patients received either travoprost 0.004% once daily or timolol 0.5% (or 0.25% for subjects younger than 3 years old) twice daily.
Croatian: Bolesnici su primali ili travoprost 0,004% jednom dnevno ili timolol 0,5% (ili 0,25% za ispitanike mlađe od 3 godine) dvaput dnevno.
English: Women of childbearing potential/contraception
Croatian: Žene reproduktivne dobi/kontracepcija
English: If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.
Croatian: Ako dođe do zamućenja vida kod ukapavanja, bolesnik mora pričekati dok mu se ne razbistri vid prije nego vozi ili upotrebljava strojeve.
English: Other medicines and IZBA
Croatian: Drugi lijekovi i IZBA
English: Prostaglandins and prostaglandin analogues are biologically active materials that may be absorbed through the skin.
Croatian: Prostaglandini i analozi prostaglandina su biološki aktivne tvari koje se mogu apsorbirati kroz kožu.
English: Pack sizes: 1 or 3 bottles.
Croatian: Veličine pakiranja: 1 ili 3 bočice.
English: Animal studies have shown excretion of travoprost and metabolites in breast milk.
Croatian: Studije na životinjama su pokazale izlučivanje travoprosta i metabolita u mlijeko.
English: EXP Discard 4 weeks after first opening
Croatian: EXP Baciti 4 tjedna nakon prvog otvaranja.
English: Reproduction toxicity studies have been undertaken in rat, mice and rabbit by systemic route.
Croatian: Provedene su studije reproduktivne toksičnosti u štakora, miša i kunića sistemskim putem.
English: There are no data on the effects of travoprost on human fertility.
Croatian: Nema podataka o učinku travoprosta na plodnost kod čovjeka.
English: If any of the medicinal product comes into contact with the skin, it should be washed off straight away.
Croatian: Ukoliko bilo koja količina lijeka dođe u dodir s kožom, odmah je treba isprati.
English: The patient should remove the protective overwrap immediately prior to initial use.
Croatian: Bolesnik treba otvoriti zaštitni vanjski omot neposredno prije prve primjene.
English: Eye colour change
Croatian: Promjena boje oka
English: IZBA should therefore be used with caution in patients with active intraocular inflammation.
Croatian: Stoga se IZBA treba primjenjivati s oprezom kod bolesnika s aktivnom intraokularnom upalom.
English: IZBA has not been specifically studied in a clinical trial involving paediatric subjects.
Croatian: IZBA nije bila specifično ispitivana u kliničkom ispitivanju koje je uključivalo pedijatrijske ispitanike.