FrancophonIA/ELRC3.0 huggingface dataset:
English: This is because BRANDNAME DRUG could cause hepatitis B to become active again, which can be fatal in some cases.
Croatian: To je potrebno jer NAZIV LIJEKA može uzrokovati ponovnu aktivaciju hepatitisa B što u nekim slučajevima može rezultirati smrtnim ishodom.
English: • Sliding of one part of the gut into an adjacent part of the gut (intussusception)
Croatian: • Uvlačenje jednog dijela crijeva u susjedni dio crijeva (intususcepcija)
English: Device- and Procedure-Related Adverse Reactions Gastrointestinal disorders
Croatian: Nuspojave povezane s postupkom i sustavom za primjenu lijeka Poremećaji probavnog sustava
English: Frequency ‘not known': Hepatitis B reactivation
Croatian: Učestalost „nepoznata": Ponovna aktivacija hepatitisa B Opis odabranih nuspojava:
English: Intussusception has also been reported post marketing.
Croatian: Intususcepcija je zabilježena i nakon stavljanja lijeka u promet.
English: • Inflamed colon (colitis).
Croatian: • Upala debelog crijeva (kolitis).
English: • The tube goes through the wall of the large intestine.
Croatian: • Penetracija sonde kroz stijenku debelog crijeva.
English: 4.8 Undesirable effects SOC: Investigations (frequency not known): - Blood androstenedione decreased (in females) - Blood testosterone decreased (in females) - Sex hormone binding globulin increased - Blood free testosterone decreased (in males) SOC: Reproductive system and breast disorders (frequency not known): - Ovarian macrocysts Premenopausal women: non-malignant ovarian macrocysts (with symptoms such as pelvic pain, bleeding) have been described.
Croatian: SOC: Pretrage (učestalost nepoznata): - Sniženje androstendiona u krvi (u žena) - Sniženje testosterona u krvi (u žena) - Povišenje globulina koji veže spolne hormone - Sniženje slobodnog testosterona u krvi (u muškaraca) SOC: Poremećaji reproduktivnog sustava i dojki (učestalost nepoznata): - Makrociste na jajnicima
English: Frequency not known - Ovarian macrocysts (with symptoms such as pelvic pain, bleeding) - Decreased androstenedione (precursor of sex hormones) in blood tests in females - Decreased testosterone (sex hormone) in blood tests in females - Sex hormone binding globulin (a protein which binds sex hormones) increased in blood tests - Decreased free testosterone (sex hormone) in blood tests in males
Croatian: Učestalost nepoznata - Makrociste na jajnicima (sa simptomima kao što su bol u zdjelici, krvarenje) - Sniženje androstendiona (prekursora spolnih hormona) u krvnim pretragama u žena - Sniženje testosterona (spolnog hormona) u krvnim pretragama u žena
English: • Food getting stuck around the tube causing it to block.
Croatian: • Začepljenje sonde zbog nakupljanja hrane oko sonde.
English: Uncommon: may affect up to 1 in 100 people
Croatian: Uputa o lijeku: 4. Moguće nuspojave Nuspojave povezane s pumpom ili sondom Manje često: mogu se javiti u do 1 na 100 osoba
English: Table 1 Tabulated summary of adverse reactions Infections and infestations
Croatian: Infekcije i infestacije
English: The recommended dose is one tablet daily, swallowed whole with water.
Croatian: Preporučena doza je jedna tableta na dan, koja se uzima cijela s vodom.
English: What are the benefits and risks of this medicine?
Croatian: Koje su koristi i rizici od ovog lijeka?
English: The full EPAR can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Treatment should be started by a doctor who has experience in the management of HIV infection.
Croatian: Liječenje mora započeti liječnik iskusan u upravljanju infekcijom HIV-om.
English: Patients should take the medicine regularly and avoid missing doses.
Croatian: Bolesnici bi trebali redovito uzimati lijek i ne preskakati doze.
English: The educational pack also contains recommendations for monitoring kidney function in patients taking the medicine.
Croatian: Edukativni paket sadrži i preporuke za nadzor bubrežne funkcije u bolesnika koji primjenjuju lijek.
English: It is only used in patients who have responded well to their current HIV treatment and who do not have an HIV infection that is resistant to treatment or not likely to respond to one of the active substances in the medicine.
Croatian: Primjenjuje se samo u bolesnika koji su dobro odgovorili na trenutačnu terapiju za liječenje infekcije HIV-om i koji nemaju HIV infekciju otpornu na liječenje ili vjerojatno neće odgovoriti na jednu od djelatnih tvari u lijeku.
English: It is recommended that the medicine be taken on an empty stomach, preferably at bedtime.
Croatian: Preporučuje se da se lijek uzme na prazan želudac, po mogućnosti prije odlaska na počinak.
English: The company that markets the medicine will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with tenofovir disoproxil-containing medicines such as this one.
Croatian: Tvrtka koja lijek stavlja u promet osigurat će da svi liječnici od kojih se očekuje da će propisivati lijek prime edukativni paket koji obuhvaća informacije o povećanom riziku od bolesti bubrega nakon primjene lijekova koji sadrže tenofovirdizoproksil, kao što je ovaj.
English: This medicine is available as tablets and can only be obtained with a prescription.
Croatian: Lijek je dostupan u obliku tableta i izdaje se samo na recept.
English: All three active substances block the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Croatian: Sve tri djelatne tvari blokiraju djelovanje reverzne transkriptaze, enzima koji proizvodi HIV, a koji virusu omogućuje reprodukciju u zaraženim stanicama.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva is a medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva primjenjuje se za liječenje odraslih osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: For more information about treatment with this medicine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju ovim lijekom pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Atripla, and do not need to be repeated for Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva.
Croatian: Ispitivanja koristi i rizika djelatne tvari u odobrenoj uporabi već su provedena s referentnim lijekom Atripla i ne treba ih ponavljati za lijek Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva.
English: This medicine should not be taken at the same time as other medicines that contain efavirenz, emtricitabine or tenofovir disoproxil, or lamivudine (another antiviral medicine).
Croatian: Ovaj se lijek ne smije uzimati istovremeno s drugim lijekovima koji sadržavaju efavirenz, emtricitabin ili tenofovirdisoproksil ili lamivudin (drugi antivirusni lijek).
English: This medicine contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Croatian: Ovaj lijek sadrži tri djelatne tvari: efavirenz, nenukleozidni inhibitor reverzne transkriptaze (NNRTI); emtricitabin, nukleozidni inhibitor reverzne transkriptaze; i tenofirdizoproksil, odnosno „prolijek” za tenofovir, što znači da se pretvara u djelatnu tvar tenofovir u tijelu.
English: Because Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva 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 lijek Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva generički lijek te da je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: What is Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva and what is it used for?
Croatian: Što je Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva i za što se koristi?
English: For practical information about using Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Therefore, the Agency's view was that, as for Atripla, the benefit outweighs the identified risk.
Croatian: Stoga je stav Agencije da korist nadmašuje identificirani rizik, kao i za lijek Atripla.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva keeps the amount of HIV in the blood at a low level.
Croatian: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva količinu HIV-a u krvi zadržava na niskoj razini.
English: This is a summary of the European public assessment report (EPAR) for Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva.
English: The Agency recommended that it be approved for use in the EU.
Croatian: Agencija je preporučila izdavanje odobrenja za stavljanje lijeka u promet.
English: The medicine contains the active substances efavirenz, emtricitabine and tenofovir disoproxil and is a ‘generic medicine'.
Croatian: Lijek sadržava djelatne tvari efavirenz, emtricitabin i tenofovirdisoproksil te je „generički lijek”.
English: For more information, see the summary of product characteristics (also part of the EPAR).
Croatian: Dodatne informacije nalaze se u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: Other information about Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
Croatian: Ostale informacije o lijeku Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
English: Efavirenz / emtricitabine / tenofovir disoproxil
Croatian: Efavirenz/emtricitabin/tenofovirdizoproksil
English: However, do not take two doses on the same day.
Croatian: Međutim, nemojte uzeti dvije doze istoga dana.
English: This will also help you to remember to use it.
Croatian: To će Vam pomoći i da se sjetite uzeti ga.
English: You can inhale this medicine anytime before or after food or drink.
Croatian: Možete inhalirati ovaj lijek u bilo kojem trenutku prije ili nakon uzimanja hrane ili pića.
English: However in 40% of cases symptoms continued for the entire 6month period.
Croatian: Međutim, u 40% slučajeva simptomi su se nastavili tijekom cijelog šestomjesečnog razdoblja.
English: Children and adolescents Do not give this medicine to children or adolescents below the age of 18 years.
Croatian: Nemojte davati ovaj lijek djeci ili adolescentima mlađima od 18 godina.
English: If you use this medicine once a day, it will help to reduce the effects of COPD on your everyday life.
Croatian: Ako primjenjujete ovaj lijek jedanput na dan, pomoći će Vam smanjiti učinke KOPB-a na Vaš svakodnevni život.
English: If this occurs, treatment should be discontinued immediately and alternative therapy instituted.
Croatian: Ako dođe do toga, liječenje treba odmah prekinuti i započeti alternativnu terapiju.
English: I coughed after inhaling - does this matter?
Croatian: Zakašljao/la sam nakon inahliranja - je li to važno?
English: The most common anticholinergic adverse reaction was dry mouth (2.4%).
Croatian: Najčešća antikolinergička nuspojava bila su suha usta (2,4%).
English: Elderly people You can use this medicine if you are aged 75 years and over at the same dose as for other adults.
Croatian: Možete koristiti ovaj lijek ako imate 75 godina ili više pri istoj dozi kao i druge odrasle osobe.
English: Each blister strip contains either 6 or 10 hard capsules.
Croatian: Svaki blister strip sadrži 6 ili 10 tvrdih kapsula.
English: Date of first authorisation: 28 September 2012 Date of latest renewal: 26 July 2017
Croatian: Datum posljednje obnove odobrenja: 26. srpnja 2017.
English: In addition, the corresponding frequency category for each adverse reaction is based on the following convention: 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); not known (cannot be estimated from the available data).
Croatian: Osim toga, odgovarajuća kategorija učestalosti za svaku nuspojavu temelji se na sljedećem načelu: 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); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: No new cases of dry mouth were reported in months 7-12.
Croatian: Nije bilo novih prijavljenih slučajeva suhih usta od 7. do 12. mjeseca.
English: This medicine contains lactose.
Croatian: Ovaj lijek sadrži laktozu.
English: Then take the next dose as usual.
Croatian: Zatim uzmite sljedeću dozu prema uobičajenom rasporedu.
English: Therefore the frequency was calculated from clinical trial experience.
Croatian: Zato je učestalost izračunata iz iskustva s kliničkim ispitivanjima.
English: - COPD is a long-term disease and you should use this medicine every day and not only when you have breathing problems or other symptoms of COPD.
Croatian: - KOPB je dugoročna bolest i trebate primijeniti ovaj lijek svaki dan, a ne samo kada imate poteškoće s disanjem ili druge simptome KOPB-a.
English: Hold breath
Croatian: Duboko udahnite
English: If a dose is missed, the next dose should be taken as soon as possible.
Croatian: Ako se preskoči doza, sljedeću dozu treba uzeti čim prije.
English: • High level of blood sugar (hyperglycaemia: typical symptoms include excessive thirst or hunger and frequent urination)
Croatian: • Visoka razina šećera u krvi (hiperglikemija: tipični simptomi uključuju pretjeranu žeđ ili glad i učestalo mokrenje)
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a signifcant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilokom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera koristi/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: This belongs to a group of medicines called bronchodilators.
Croatian: On pripada skupini lijekova koji se nazivaju bronhodilatatorima.
English: Patients should be instructed on how to administer the medicinal product correctly.
Croatian: Bolesnici se moraju uputiti kako pravilno primjenjivati lijek.
English: Other effects
Croatian: Drugi učinci
English: These were reported voluntarily from a population of uncertain size, and it is therefore not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Croatian: Ona su dobivena na dobrovoljnoj osnovi iz populacije nepoznate veličine pa stoga nije uvijek moguće pouzdano procijeniti učestalost ili utvrditi uzročnu vezu s izloženošću lijeku.
English: The safety profile is further characterised by other symptoms related to the anticholinergic effects, including signs of urinary retention, which were uncommon.
Croatian: Sigurnosni profil dodatno je karakteriziran drugim simptomima povezanim s antikolinergičkim učinkom, što uključuje znakove urinarne retencije, koji su bili manje česti.
English: Patients who do not experience improvement in breathing should be asked if they are swallowing the medicinal product rather than inhaling it.
Croatian: Bolesnike koji ne osjete poboljšanje u disanju treba pitati gutaju li lijek umjesto da ga udišu.
English: Blister Card
Croatian: Blister kartica
English: Each pack contains a device called an inhaler, together with capsules in blisters.
Croatian: Svako pakiranje sadrži uređaj koji se zove inhalator, zajedno s kapsulama u blisteru.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics, ATC code: R03BB06
Croatian: Farmakoterapijska skupina: Lijekovi za opstruktivne bolesti dišnih putova, antikolinergici, ATK oznaka: R03BB06
English: About 90% of systemic exposure following inhalation is due to lung absorption and 10% is due to gastrointestinal absorption.
Croatian: Oko 90% sistemske izloženosti nakon inhalacije uzrokovano je plućnom apsorpcijom, a 10% je uzrokovano gastrointestinalnom apsorpcijom.
English: Dry mouth was reported mainly during the first 4 weeks of treatment with a median duration of four weeks in the majority of patients.
Croatian: Suha usta bila su prijavljena uglavnog tijekom prva 4 tjedna liječenja s medijanom trajanja od četiri tjedna u većine bolesnika.
English: In both studies, the percentage of patients experiencing a moderate or severe exacerbation (defined as requiring treatment with systemic corticosteroids and/or antibiotics or hospitalisation) was reduced.
Croatian: U oba ispitivanja, postotak bolesnika koji su imali umjerenu ili tešku egzacerbaciju (definirano kao potreba za liječenjem sistemskim kortikosteroidima i/ili antibioticima ili hospitalizacijom) je bio smanjen.
English: Some side effects may be serious, but the frequency of these side effects is not known (frequency cannot be estimated from the available data)
Croatian: Neke nuspojave mogu biti ozbiljne, ali učestalost tih nuspojava nije poznata (učestalost se ne može procijeniti iz dostupnih podataka)
English: High doses of glycopyrronium may lead to anticholinergic signs and symptoms for which symptomatic treatment may be indicated.
Croatian: Velike doze glikopironija mogu dovesti do antikolinergičkih znakova i simptoma za koje bi moglo biti indicirano simptomatsko liječenje.
English: The majority of the reports of dry mouth were suspected to be related to the medicinal product and were mild, with none being severe.
Croatian: Za većinu prijavljenih slučajeva suhih ustiju sumnjalo se da su povezani s lijekom i bili su blagi, pri čemu nijedan nije bio težak.
English: For instructions on use of the medicinal product before administration, see section 6.6.
Croatian: Za upute o korištenju lijeka prije primjene vidjeti dio 6.6.
English: However, paradoxical bronchospasm has been observed with other inhalation therapy and can be life-threatening.
Croatian: Međutim, paradoksalni bronhospazam uočen je kod drugih inhalacijskih terapija i može biti opasan po život.
English: • Difficulty breathing with wheezing or coughing (signs of paradoxical bronchospasm)
Croatian: • Otežano disanje uz piskanje ili kašljanje (znakovi paradoksalnog bronhospazma)
English: • Voice alteration (hoarseness)
Croatian: • Promjena glasa (promuklost)
English: Tovanor Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older) (see section 4.8).
Croatian: Tovanor Breezhaler se može koristiti u preporučenoj dozi u starijih bolesnika (u dobi od 75 i više godina) (vidjeti dio 4.8).
English: - if you experience eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes.
Croatian: - ako osjetite bol ili nelagodu u oku, privremeno zamagljenje vida, vidne aure ili obojane slike zajedno s crvenim očima.
English: There are no data from the use of this medicine in pregnant women and it is not known whether the active substance of this medicine passes into human milk.
Croatian: Nema podataka o primjeni ovog lijeka u trudnica i nije poznato izlučuje li se djelatna tvar ovog lijeka u majčino mlijeko.
English: These may be signs of an acute attack of narrow-angle glaucoma.
Croatian: To bi mogli biti znakovi akutnog napada glaukoma uskog kuta.
English: Reproduction studies and other data in animals do not indicate a concern regarding fertility in either males or females (see section 5.3).
Croatian: Ispitivanja reprodukcije i drugi podaci u životinja ne upućuju na zabrinutost oko plodnosti u žena ili muškaraca (vidjeti dio 5.3).
English: Excipient(s) with known effect: Each capsule contains 23.6 mg lactose (as monohydrate).
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom: Svaka kapsula sadrži 23,6 mg laktoze (u obliku hidrata).
English: Do not use this medicine to treat a sudden attack of breathlessness or wheezing.
Croatian: Ne koristite ovaj lijek za liječenje iznenadnog napada gubitka zraka ili piskanja.
English: Hydroxylation resulting in a variety of mono-and bis-hydroxylated metabolites and direct hydrolysis resulting in the formation of a carboxylic acid derivative (M9) were seen.
Croatian: Uočena je hidroksilacija koja je rezultirala raznim mono- i bis-hidroksiliranim metabolitima te direktna hidroliza koja je rezultirala stvaranjem derivata karboksilne kiseline (M9).
English: • Feeling of pressure or pain in the cheeks and forehead
Croatian: • Osjećaj pritiska ili boli na obrazima i čelu
English: Some elderly patients above 75 years of age experienced headache (frequency common) and urinary tract infection (frequency common).
Croatian: Neki stariji bolesnici iznad dobi od 75 godina osjetili su glavobolju (kategorija učestalosti često) i infekcije mokraćnog trakta (kategorija učestalosti često).
English: • Stomach discomfort after meals
Croatian: • Nelagoda u želucu nakon obroka
English: How long to continue your treatment with Tovanor Breezhaler - Keep using this medicine for as long as your doctor tells you.
Croatian: Koliko dugo nastaviti liječenje Tovanor Breezhalerom - Nastavite primijenjivati ovaj lijek dokle god Vam liječnik kaže.
English: Gastrointestinal effects including gastroenteritis and dyspepsia were also observed.
Croatian: Gastrointestinalni učinci koji su uključivali gastroenteritis i dispepsiju također su bili uočeni.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Tovanor Breezhaler and to contact their doctor immediately should any of these signs or symptoms develop.
Croatian: Bolesnike treba obavijestiti o znakovima i simptomima akutnog glaukoma uskog kuta i uputiti ih da prestanu koristiti Tovanor Breezhaler te da se odmah obrate svom liječniku ako se pojavi bilo koji od tih znakova i simptoma.
English: How to inhale Tovanor Breezhaler - In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine as inhalation powder.
Croatian: Kako inhalirati Tovanor Breezhaler - U ovom pakiranju naći ćete inhalator i kapsule (u blisterima) koji sadrže lijek kao prašak inhalata.
English: The capsules must be administered only using the Tovanor Breezhaler inhaler (see section 6.6).
Croatian: Kapsule se moraju primjenjivati isključivo korištenjem Tovanor Breezhaler inhalatora (vidjeti dio 6.6).
English: There is no relevant use of Tovanor Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Croatian: Nema relevantne primjene Tovanor Breezhalera u pedijatrijskoj populaciji (mlađih od 18 godina) u indikaciji KOPB-a.
English: A greater than 4-fold selectivity for the human M3 receptors over the human M2 receptor has been demonstrated using radioligand binding studies.
Croatian: Dokazana je selektivnost za humane M3 receptore koja je više od 4 puta veća od one za humani M2 receptor u ispitivanjima vezanja radioaktivnog liganda.
English: Cardiac disorders Atrial fibrillation
Croatian: Srčani poremećaji Fibrilacija atrija
English: The recommended dose is the inhalation of the content of one capsule once daily using the Tovanor Breezhaler inhaler.
Croatian: Preporučena doza je inhalacija sadržaja jedne kapsule jedanput na dan korištenjem Tovanor Breezhaler inhalatora.