FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you are taking certain antidepressant medicines called non-selective MAO inhibitors (e.g.
Croatian: - ako imate rijetki oblik tumora nadbubrežne žlijezde koji se naziva feokromocitom. - ako uzimate određene lijekove protiv depresije koji se nazivaju neselektivni MAO inhibitori (npr. izokarboksazid i fenelzin).
English: Suicide attempt (see section 4.4), Disorientation, Dopamine dysregulation syndrome,
Croatian: agitacija, pokušaj samoubojstva (vidjeti dio 4.4), dezorijentacija,
English: - Co-administration with non-selective monoamine oxidase (MAO) inhibitors.
Croatian: Neselektivni inhibitori monoaminooksidaze (MAO)
English: - melanoma (a type of skin cancer) or suspicious skin growths or marks.
Croatian: - novi ili pojačani neprirodni pokreti tijela (diskinezija) - osjećaj omaglice pri ustajanju (niski krvni tlak) - melanom (vrsta raka kože) ili sumnjive izrasline ili promjene na koži.
English: Depression,
Croatian: halucinacije, depresija,
English: Capsule content
Croatian: 4 kapsule.
English: Orthostatic hypotension (see section 4.4),
Croatian: Krvožilni poremećaji ortostatska hipotenzija (vidjeti dio 4.4), hipertenzija,
English: See section 4.4 regarding withdrawal emergent hyperpyrexia and confusion.
Croatian: O nastupu hiperpireksije i konfuzije nakon prekida uzimanja levodope vidjeti u dijelu 4.4.
English: Make sure there are no capsules in the inhaler before you store it.
Croatian: Provjerite da u inhalatoru nema kapsula
English: • Dispose of the inhaler after you are finished all of the capsules in the carton.
Croatian: • Nakon što ste potrošili sve kapsule iz kutije, inhalator bacite.
English: Respiration abnormal, Dysphonia, Hiccups
Croatian: iritacija ždrijela dispneja, abnormalno disanje,
English: Capsule shell
Croatian: Plava kapica
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Sadržaj kapsule kolfoscerilpalmitat (DPPC)
English: Inbrija may cause dyskinesia.
Croatian: Inbrija može uzorkovati diskineziju.
English: Baseline mean (SD) LS mean change Mean diff. (95% CI) p-value
Croatian: Srednja vrijednost razlike (95% CI)
English: Each carton includes blisters of 4 capsules.
Croatian: Kapsule Svaka kutija sadrži blistere s po
English: Confusional state, Hallucination,
Croatian: Psihijatrijski poremećaji stanje konfuzije,
English: Inbrija and get urgent medical attention.
Croatian: Inbriju i opservacijske skupine.
English: Step 8: Breathe in deeply to inhale powder While keeping the inhaler level, close your lips firmly around the mouthpiece.
Croatian: Držeći inhalator u razini usta, čvrsto stisnite usne oko usnika.
English: Step 13: Store inhaler Make sure there are no capsules in the inhaler
Croatian: 13. korak: Čuvanje inhalatora
English: The median time to maximal plasma concentration of levodopa was 30 minutes after a dose of Inbrija 66 mg (2 x 33 mg capsules) compared to 45 minutes after a dose of carbidopa/levodopa 25 mg/100 mg immediate release tablets.
Croatian: Inbrije od 66 mg (2 kapsule od 33 mg) u usporedbi s 45 minuta nakon primjene karbidope/levodope u dozi 25 mg/100 mg u obliku tablete s trenutnim oslobađanjem.
English: On and off phenomenon, Somnolence,
Croatian: ON- i OFF-fenomen,
English: Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC
Croatian: • Periodička izvješća o neškodljivosti lijeka (PSUR-evi) Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7.
English: - if you get blurred vision, red eyes, severe eye and head pain, halos around lights, pupils of your eyes that are larger than normal size and feel sick.
Croatian: Nemojte primjenjivati Inbriju - ako ste alergični na levodopu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6). - ako Vam vid postane zamućen, pojavi Vam se crvenilo očiju, jaki bol u očima i glavi, kolobare (haloi) oko izvora svjetla, zjenice su Vam šire nego inače ili osjećate mučninu.
English: Dysgeusia,
Croatian: disfonija,
English: Blood bilirubin increased, Blood glucose increased, Blood creatinine increased, Blood uric acid increased, Haemoglobin decreased, Haematocrit decreased, Blood urine present, Blood urea increased, Blood alkaline phosphatase increased,
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kašalj infekcija gornjih dišnih putova, promijenjena boja iskašljaja, promijenjena boja nosnog iscjetka,
English: Inbrija has not specifically been studied in patients with hepatic impairment.
Croatian: Inbrija nije posebno ispitana u bolesnika s oštećenjem jetrene funkcije.
English: Ink
Croatian: SN
English: - skin cancer; - lack of red blood cells so you are pale and feel tired; being more prone to infections because of a lack of white blood cells; lack of blood platelets which can lead to bruising and a tendency to bleed; - decreased appetite; - confusion; hallucinations; depression; anxiety; bad dreams; unable to sleep; abnormal thinking and perceptions, losing touch with reality; feeling agitated; suicidal; being disorientated; exaggerated feeling of happiness; increased sex drive; grinding of teeth; feeling paranoid and delusional; - movement disorder in which a person's muscles contract uncontrollably; sudden, sometimes unpredictable changes in symptoms, due to the return of Parkinson's disease symptoms; sleepiness; dizziness; worsening of Parkinson's disease; pins and needles; headache; tremors; seizure; sudden onset of sleep; restless legs syndrome; ataxia (disorder affecting co-ordination, balance and speech); distorted sense of taste; mental health disorders that affecting learning, memory, perception, and problem solving; Horner's syndrome (an eye disorder); dementia;
Croatian: - smetenost; halucinacije; depresija; tjeskoba; ružni snovi; nemogućnost spavanja; abnormalno razmišljanje i doživljavanje, gubitak dodira sa stvarnošću; osjećaj uznemirenosti; želja za samoubojstvom; dezorijentiranost; prekomjerni osjećaj sreće; pojačani spolni nagon; škrgutanje zubima; osjećaj paranoje i sumanutost;
English: Inbrija has not been studied in patients with hepatic impairment.
Croatian: Inbrija nije ispitana u bolesnika s oštećenjem jetrene funkcije.
English: Step 3: Twist and pull off white mouthpiece Twist and pull off the mouthpiece to separate it from the handle.
Croatian: 3. korak: Zakrenite, povucite i odvojite usnik
English: Abdominal pain, Constipation, Diarrhoea,
Croatian: Poremećaji probavnog sustava mučnina, povraćanje bol u abdomenu, konstipacija, proljev, suha usta, gastrointestinalno krvarenje,
English: Immune system disorder
Croatian: Poremećaji imunološkog sustava alergijski edem
English: Seizure,
Croatian: ataksija,
English: Pruritus,
Croatian: osip,
English: Dose adjustment of the antihypertensive medicinal products may be required during concomitant use of Inbrija.
Croatian: Kada se istodobno primjenjuje Inbrija može biti potrebno prilagoditi dozu antihipertenzivnih lijekova.
English: - Narrow-angle glaucoma.
Croatian: RMP-a.
English: It may harm them,
Croatian: Poremećaji oka zamagljen vid,
English: Gastrointestinal disorders
Croatian: propilenglikol kalijev hidroksid
English: Nausea, Vomiting
Croatian: glavobolja, tremor, napadaj,
English: Glossodynia,
Croatian: agranulocitoza,
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: Srednja vrijednost na početku (SD)
English: Cardiac rhythm disordersa (see section 4.4),
Croatian: Srčani poremećaji poremećaji srčanog ritmaa (vidjeti dio 4.4),
English: It is best to take tablets at the same time each day.
Croatian: Najbolje je da tablete uzimate svakoga dana u isto vrijeme.
English: Not known (cannot be estimated from the available data)*
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka)*
English: If you take more Ketek than you should
Croatian: Ako uzmete više Keteka nego što ste trebali
English: Adequate hydration should be maintained.
Croatian: Treba održavati odgovarajuću hidrataciju.
English: Date of latest renewal: 9 July 2011
Croatian: Datum posljednje obnove: 9. srpnja 2011.
English: If you forget to take a dose, take it as soon as possible.
Croatian: Ako zaboravite uzeti dozu lijeka, uzmite je što prije.
English: The onset of the visual reaction may be sudden.
Croatian: Nastup vizualne reakcije može biti iznenadan.
English: Your doctor will tell you how many Ketek tablets to take, at what time and for how long.
Croatian: Liječnik će Vam reći koliko Ketek tableta trebate uzeti te kada i koliko dugo ih trebate uzimati.
English: The combination should be used with caution.
Croatian: Ovu kombinaciju treba primjenjivati uz oprez.
English: What Ketek contains
Croatian: Što Ketek sadrži
English: Ketek may be taken with or without food.
Croatian: Ketek se može uzimati s hranom ili bez hrane.
English: If you accidentally take one tablet too many, nothing is likely to happen.
Croatian: Ako ste slučajno uzeti jednu tabletu previše, vjerojatno se ništa neće dogoditi.
English: Ketek is not recommended for use in children less than 12 years old.
Croatian: Ketek se ne preporučuje za primjenu u djece mlađe od 12 godina.
English: Corresponding data for humans is not available.
Croatian: Odgovarajući podaci za ljude nisu dostupni.
English: It may happen again when you take the next dose of Ketek.
Croatian: Može se ponoviti kada uzmete sljedeću dozu lijeka Ketek.
English: Ketek should not be used during pregnancy unless clearly necessary.
Croatian: Ketek se ne smije primjenjivati u trudnoći, osim ako to nije neophodno.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: These visual disturbances may happen suddenly and last several hours.
Croatian: Ove smetnje vida mogu se dogoditi iznenada i trajati nekoliko sati.
English: In the event of acute overdose the stomach should be emptied.
Croatian: U slučaju akutnog predoziranja treba isprati želudac.
English: The safety and efficacy of Ketek in children below 12 years of age have not been established (see section 5.2).
Croatian: Sigurnost i djelotvornost lijeka Ketek u djece mlađe od 12 godina nisu ustanovljeni (vidjeti dio 5.2).
English: Limit driving or other hazardous activities while taking Ketek.
Croatian: Ograničite vožnju i druge rizične aktivnosti dok uzimate Ketek.
English: What Ketek is and what it is used for
Croatian: Što je Ketek i za što se koristi
English: Ketek is not recommended in this population.
Croatian: Ketek se ne preporučuje za primjenu u ovoj populaciji.
English: However, if it is nearly time for your next dose skip the missed dose and take the next tablet at the usual time.
Croatian: Međutim, ako je uskoro vrijeme za sljedeću dozu, preskočite propuštenu dozu i uzmite sljedeću dozu u uobičajeno vrijeme.
English: The tablets should be swallowed whole with a sufficient amount of water.
Croatian: Tablete treba progutati cijele s dovoljno vode.
English: The volume of distribution is 2.9±1.0 l/kg.
Croatian: Volumen distribucije iznosi 2,9 ± 1,01 l/kg.
English: Take the complete course of tablets prescribed by your doctor, even if you begin to feel better before you have finished them all.
Croatian: Dovršite cijeli ciklus liječenja koji Vam je propisao liječnik, čak i ako se počnete osjećati bolje prije nego što ste potrošili sve tablete.
English: Ketek is indicated for the treatment of the following infections:
Croatian: Ketek je indiciran za liječenje sljedećih infekcija:
English: Swallow the tablets whole with a glass of water.
Croatian: Tablete progutajte cijele, s čašom vode.
English: What you need to know before you take Ketek
Croatian: Što morate znati prije nego počnete uzimati Ketek
English: The mechanisms are incompletely known.
Croatian: Mehanizmi djelovanja nisu u potpunosti poznati.
English: What Ketek looks like and contents of the pack
Croatian: Kako Ketek izgleda i sadržaj pakiranja
English: The midazolam halflife was increased about 2.5-fold.
Croatian: Poluvijek midazolama povećao se približno 2,5 puta.
English: What Ketek is and what it is used for What you need to know before you take Ketek
Croatian: Što je Ketek i za što se koristi Što morate znati prije nego počnete uzimati Ketek
English: More than 80% of MRSA express cMLSB.
Croatian: Više od 80% MRSA izražavaju cMLSB.
English: The above serious side effects may require urgent medical attention.
Croatian: Prethodno navedene ozbiljne nuspojave mogu zahtijevati hitno liječenje.
English: This should be taken into account when treating infections caused by H. influenzae.
Croatian: To treba uzeti u obzir u liječenju infekcija uzrokovanih bakterijom H. influenzae.
English: Refer also to sections “Do not take Ketek”, “Other medicines and Ketek” and “Driving and using
Croatian: Pročitajte i dijelove "Nemojte uzimati Ketek", "Drugi lijekovi i Ketek" i "Upravljanje vozilima i
English: Based on observed data, a 600 mg daily dose is approximately equivalent with the target exposure observed in healthy subjects.
Croatian: Na temelju zabilježenih podataka, dnevna doza od 600 mg je približno jednaka ciljnoj izloženosti opaženoj u zdravih osoba.
English: • dronedarone (for atrial fibrillation)
Croatian: • dronedaron (za fibrilaciju atrija)
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u
English: If you stop taking the tablets too soon, the infection may return, or your
Croatian: Ako prerano prestanete uzimati tablete, infekcija se može vratiti ili se
English: (See sections 4.3 and 4.5).
Croatian: (Vidjeti dio 4.3 i 4.5).
English: Antibiotics stop the growth of bacteria which cause
Croatian: Antibiotici zaustavljaju rast bakterija koje uzrokuju infekcije.
English: The in vitro protein binding is approximately 60% to 70%.
Croatian: Vezivanje telitromicina za proteine in vitro iznosi oko 60% do 70%.
English: Limited data, obtained in paediatric patients 13 to 17 years of age, showed that telithromycin concentrations in this age group were similar to the concentrations in patients 18 to 40 years of age.
Croatian: Ograničeni podaci dobiveni u pedijatrijskih bolesnika u dobi od 13 do 17 godina pokazali su da su koncentracije telitromicina u ovoj dobnoj skupini podjednake koncentracijama u bolesnika u dobi od 18 do 40 godina.
English: If you stop taking the tablets too soon you may also create a bacterial resistance to the medicine.
Croatian: Ako prerano prestanete uzimati tablete, također se može razviti rezistencija bakterija na lijek.
English: No patient in either group developed a ΔQTc >60 msec.
Croatian: Ni u jednog bolesnika ni iz jedne skupine nije došlo do ΔQTc od > 60 ms.
English: This may be a sign of bowel inflammation which can occur following treatment with antibiotics.
Croatian: To može biti znak upale crijeva koja se može pojaviti nakon liječenja antibioticima.
English: They are available in packs of 10, 14, 20 and 100 tablets.
Croatian: Dostupno u pakiranjima od 10, 14, 20 i 100 tableta.
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, as some of them could affect or be
Croatian: Obavijestite liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta jer neki od njih mogu djelovati na Ketek ili Ketek može utjecati na njih.
English: Elderly population
Croatian: Populacija starijih osoba
English: To reduce the potential impact of visual disturbances take the tablets before going to bed (see also
Croatian: Kako biste smanjili potencijalni učinak smetnji vida, tablete uzmite prije odlaska u krevet (također
English: These symptoms may appear as early as after the first dose of Ketek.
Croatian: Ovi se simptomi mogu pojaviti već nakon prve doze lijeka Ketek.
English: If possible, take your tablets or the box with you to show the doctor or pharmacist.
Croatian: Ako je moguće, uzmite sa sobom tablete ili kutiju i pokažite ih liječniku ili ljekarniku.
English: In community acquired pneumonia, efficacy has been demonstrated in a limited number of patients with risk factors such as pneumococcal bacteraemia or age higher than 65 years.
Croatian: Djelotvornost u izvanbolnički stečenoj pneumoniji dokazana je u malog broja bolesnika s faktorima rizika poput pneumokokne bakterijemije ili dobi iznad 65 godina.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: These effects usually disappear during treatment or after completion of treatment with Ketek.
Croatian: Ovi učinci obično nestaju tijekom liječenja ili nakon završetka liječenja lijekom Ketek.
English: Talk to your doctor, pharmacist or nurse if you experience visual disturbances (blurred vision, difficulty focusing, double vision).
Croatian: Razgovarajte sa svojim liječnikom, ljekarnikom ili medicinskom sestrom ako iskusite smetnje vida (zamagljen vid, teškoće u fokusiranju, dvoslike).
English: Patients should be cautioned about the potential effects of these events on the ability to drive or operate machinery.
Croatian: Bolesnike treba upozoriti na moguće učinke ovih događaja na sposobnost upravljanja vozilima i rada sa
English: - Acute exacerbation of chronic bronchitis,
Croatian: - akutna egzacerbacija kroničnog bronhitisa,
English: No dosage adjustment is required in elderly patients based on age alone.
Croatian: Nije potrebno prilagođavati dozu u starijih bolesnika samo na temelju dobi.
English: These changes in pharmacokinetics do not necessitate dosage adjustment.
Croatian: Ove promjene u farmakokinetici ne zahtijevaju prilagodbu doze.
English: This leaflet was last revised in <MM/YYYY> <month YYYY>.
Croatian: Ova uputa je zadnji puta revidirana u <MM/GGGG> <mjesec GGGG>.
English: Ketek tablets are presented in blister packs.
Croatian: Ketek tablete nalaze se u blister pakiranjima.
English: If you are pregnant do not take Ketek as the safety of this medicine in pregnancy is insufficiently established.
Croatian: Ketek jer nije dovoljno utvrđena sigurnost primjene ovog lijeka u trudnoći.
English: These events have not been associated with signs of ocular abnormality (see sections 4.4 and 4.7).
Croatian: Ovi događaji nisu bili udruženi sa znakovima očnih abnormalnosti (vidjeti dio 4.4 i 4.7).
English: They typically occurred within a few hours after the first or second dose, recurred upon subsequent dosing, lasted several hours and were fully reversible either during therapy or following the end of treatment.
Croatian: Obično bi nastupili unutar nekoliko sati nakon prve ili druge doze, ponovno se javili nakon sljedećih doza, trajali nekoliko sati te bi se u potpunosti povukli ili tijekom terapije ili nakon završetka liječenja.
English: Telithromycin is widely distributed throughout the body.
Croatian: Telitromicin se opsežno raspodjeljuje po cijelom tijelu.
English: The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Croatian: Prevalencija rezistencije za određene vrste može se razlikovati po zemljopisnim regijama i vremenskim razdobljima te je poželjno imati lokalne podatke o rezistenciji, osobito kod liječenja teških infekcija.
English: • Effect of other medicinal products on Ketek
Croatian: • Učinak drugih lijekova na Ketek
English: Increased anticoagulant activity has been reported in patients simultaneously treated with anticoagulants and antibiotics, including telithromycin.
Croatian: Prijavljena je pojačana antikoagulantna aktivnost u bolesnika istodobno liječenih antikoagulansima i antibioticima, uključujući telitromicin.
English: This administration corresponds to free active substance systemic exposure levels of at least 9 times the expected levels in human after 1 month and less than the expected level in humans after 6 months, respectively.
Croatian: Te doze odgovaraju razini sistemske izloženosti slobodne djelatne tvari koja je najmanje 9 puta veća od očekivanih vrijednosti u ljudi nakon mjesec dana, odnosno manja od očekivanih vrijednosti u ljudi nakon 6 mjeseci primjene.
English: There were no significant changes in ECG parameters and no signs of digoxin toxicity were observed.
Croatian: Nisu zabilježene značajne promjene EKG parametara niti znakovi toksičnosti digoksina.
English: If you develop severe or prolonged or bloody diarrhoea during or after taking Ketek tablets, consult your doctor immediately since it may be necessary to interrupt the treatment.
Croatian: Ako dobijete težak, dugotrajan ili krvav proljev tijekom ili nakon uzimanja Ketek tableta, odmah se javite svom liječniku jer će možda biti potrebno prekinuti liječenje.
English: Approximately one-third of telithromycin was eliminated unchanged; 20% in faeces and 12% in urine.
Croatian: Približno jedna trećina telitromicina eliminirala se u nepromijenjenom obliku: 20% u fecesu i 12% u mokraći.
English: Do not use this medicine after the expiry date which is stated on the pack.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji.
English: Detailed information on this medicinal product is available on the website of the European Medicines
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove:
English: Ketek is used to treat infections due to bacteria against which the medicine is active.
Croatian: Ketek se koristi za liječenje infekcija uzrokovanih bakterijama protiv kojih je ovaj lijek djelotvoran.
English: - if you suffer from myasthenia gravis, a rare disease which causes muscle weakness.
Croatian: - ako bolujete od miastenije gravis, rijetke bolesti koja uzrokuje slabost mišića.
English: • pimozide (psychiatric problems)
Croatian: • pimozid (za psihijatrijske tegobe)
English: There are no adequate data from the use of Ketek in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni lijeka Ketek u trudnica.
English: Most events were mild to moderate; however, severe cases have been reported.
Croatian: Većina slučajeva bila je blagog do umjerenog intenziteta, no prijavljeni su i teški slučajevi.
English: Visual disturbances (<1%) associated with the use of Ketek, including blurred vision, difficulty focusing and diplopia, were mostly mild to moderate, but severe reactions have also been reported.
Croatian: Poremećaji vida (< 1%) povezani s primjenom lijeka Ketek, uključujući zamagljen vid, otežano fokusiranje i diplopiju, većinom su bili blagi do umjereni, ali prijavljene su i teške reakcije.
English: There was evidence of reversibility upon cessation of treatment.
Croatian: Postoje dokazi o reverzibilnosti nakon prestanka liječenja.
English: The exposure of pravastatin, rosuvastatin and to a lesser extent fluvastatin, may be increased due to possible involvement of transporters proteins, but this increase is expected to be lesser than interactions involving CYP3A4 inhibition.
Croatian: Izloženost pravastatinu, rosuvastatinu i, u manjoj mjeri, fluvastatinu može se povećati zbog mogućeg utjecaja transportnih proteina, ali se očekuje da će taj porast biti manji od interakcija koje uključuju inhibiciju CYP3A4.
English: The significance of these findings for humans is unknown.
Croatian: Nije poznat značaj tih podataka za ljude.