FrancophonIA/ELRC3.0 huggingface dataset:
English: Ketek should not be used during and 2 weeks after treatment with CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John's wort).
Croatian: Ketek se ne smije primjenjivati tijekom i 2 tjedna nakon liječenja induktorima CYP3A4 (kao što su rifampicin, fenitoin, karbamazepin, fenobarbital, gospina trava).
English: If you have vision problems, faint or experience confusion or hallucination while taking Ketek, do not drive, operate heavy machinery or
Croatian: Ako imate smetnje vida, doživite nesvjesticu, smeteni ste ili imate halucinacije dok uzimate Ketek, nemojte voziti, upravljati teškim strojevima niti se upuštati u opasne aktivnosti.
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the
Croatian: Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s nadopunama Plana (RMP), dokumenti mogu biti podneseni istodobno.
English: The degree of inhibition with different CYP3A4 substrates is difficult to predict.
Croatian: Teško je predvidjeti stupanj inhibicije kod primjene različitih supstrata CYP3A4.
English: The majority of methicillin-resistant S. aureus (MRSA) express cMLSB.
Croatian: Većina sojeva S. aureus rezistentnih na meticilin (MRSA) izražava
English: The other side effects listed below are given with an estimation of the frequency with which they may occur with Ketek:
Croatian: Ostale nuspojave navedene su u nastavku uz procjenu učestalosti pojavljivanja kod primjene lijeka Ketek:
English: In patients of 12 to 18 years old, the treatment regimen will be:
Croatian: U bolesnika u dobi od 12 ili više godina:
English: - The active substance is telithromycin.
Croatian: - Djelatna tvar je telitromicin.
English: In studies with rats a reduction in fertility indices was observed at parentally toxic doses (see section
Croatian: U istraživanjima na štakorima opaženo je smanjenje indeksa plodnosti pri dozama toksičnim za roditelje (vidjeti dio 5.3).
English: Microcrystalline cellulose Povidone K25
Croatian: celuloza, mikrokristalična povidon K25 karmelozanatrij, umrežena magnezijev stearat
English: Ketek should not be used during and 2 weeks after treatment with CYP3A4 inducers.
Croatian: Ketek se ne smije primjenjivati za vrijeme i 2 tjedna nakon liječenja induktorima CYP3A4.
English: The plasma trough levels, Cmax, AUC and renal clearance were increased by 20%, 73%, 37% and 27% respectively, in healthy volunteers.
Croatian: U zdravih su se dobrovoljaca najniže koncentracije lijeka u plazmi povećale za 20%, Cmax za 73%, AUC za 37%, a bubrežni klirens za 27%.
English: Therefore the MIC breakpoint for telithromycin was set to categorise wild-type H. influenzae as having intermediate susceptibility.
Croatian: Stoga je granična vrijednost MIK-a za telitromicin postavljena tako da osjetljivost divljeg tipa H. influenzae ocjenjuje
English: QT/QTc interval prolongation, ventricular arrhythmia (including ventricular tachycardia, torsade de pointes) with potential fatal outcome (see section 4.4)
Croatian: Srčani poremećaji aritmija, hipotenzija, bradikardija produljenje QT/QTcintervala, ventrikularna artimija (uključujući ventrikularnu tahikardiju, torsades de pointes) s potencijalno smrtnim ishodom (vidjeti dio 4.4)
English: As for macrolides, H. influenzae is classified as intermediately susceptible.
Croatian: H. influenzae je klasificiran kao umjereno osjetljiv na makrolide.
English: Concomitant administration of Ketek and colchicine in patients with renal and/or hepatic impairment (see section 4.5).
Croatian: Istodobna primjena lijeka Ketek i kolhicina u bolesnika s oštećenjem bubrežne i/ili jetrene funkcije (vidjeti dio 4.5).
English: Exacerbations of myasthenia gravis have been reported in patients treated with telithromycin and sometimes occurred within a few hours of the first dose.
Croatian: U bolesnika liječenih telitromicinom prijavljene su egzacerbacije miastenije gravis, koje su se ponekad javljale unutar nekoliko sati nakon uzimanja prve doze.
English: The marketing authorisation holder of Ketek is:
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač Nositelj odobrenja za Ketek je:
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release:
Croatian: Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet:
English: Therefore, concomitant administration of CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John's wort) is likely to result in subtherapeutic levels of telithromycin and loss of effect.
Croatian: Stoga će istodobna primjena s induktorima CYP3A4 (kao što su rifampicin, fenitoin, karbamazepin, fenobarbital, gospina trava) vjerojatno dovesti do subterapijske razine telitromicina i gubitka učinka.
English: However, the co-administration of both medicinal products should be separated by one hour in order to avoid possible digestive side effects such as nausea and vomiting.
Croatian: Treba, međutim, napraviti razmak od jednog sata između primjene lijeka Ketek i teofilina kako bi se izbjegle moguće nuspojave u probavnom sustavu, kao što su mučnina i povraćanje.
English: When telithromycin is discontinued, cyclosporin, tacrolimus or sirolimus levels must be again carefully monitored and their dose increased as necessary.
Croatian: Nakon prekida primjene telitromicina, ponovno se moraju pažljivo pratiti koncentracije ciklosporina, takrolimusa odnosno sirolimusa te po potrebi povećati njihova doza.
English: Telithromycin displays moderate non-linear pharmacokinetics.
Croatian: Telitromicin iskazuje umjerenu nelinearnu farmakokinetiku.
English: Telithromycin, and its principal human metabolites, were negative in tests on genotoxic potential in vitro and in vivo.
Croatian: Rezultati testova genotoksičnog potencijala telitromicina i njegovih glavnih metabolita u ljudi in vitro i in vivo su bili negativni.
English: In comparative trials, similar effects to those observed with clarithromycin were seen with an on-therapy ΔQTc >30 msec in 7.6% and 7.0% of cases, respectively.
Croatian: ΔQTc tijekom liječenja od > 30 ms u 7,6% odnosno 7,0% slučajeva.
English: Nevertheless, monitoring of serum digoxin level should be considered during concomitant administration of digoxin and Ketek.
Croatian: Ipak, treba razmotriti praćenje razine digoksina u serumu kada se primjenjuje
English: The absolute bioavailability is about 57% after a single dose of 800 mg.
Croatian: Nakon jedne doze od 800 mg apsolutna bioraspoloživost iznosi oko 57%.
English: - Severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a sign of serious bowel inflammation which may occur following treatment with antibiotics (very
Croatian: - težak, uporan ili krvav proljev praćen bolovima u trbuhu ili vrućicom, što može biti znak ozbiljne upale crijeva koja se može pojaviti nakon liječenja antibioticima (vrlo rijetko). - znakove i simptome bolesti jetre (hepatitis), kao što su žutilo kože i očiju, tamna mokraća,
English: Ketek 400 mg film-coated tablets Telithromycin
Croatian: Ketek 400 mg filmom obložene tablete telitromicin
English: The maximum total tissue concentration in epithelial lining fluid, alveolar macrophages, bronchial mucosa, tonsils and sinus tissue were 14.9±11.4 mg/l, 318.1±231 mg/l, 3.88±1.87 mg/kg, 3.95±0.53 mg/kg and 6.96±1.58 mg/kg, respectively.
Croatian: Maksimalna ukupna tkivna koncentracija u tekućini koja oblaže epitel iznosila je 14,9 ± 11,4 mg/l, u alveolarnim makrofagima 318,1 ± 231 mg/l, u bronhalnoj sluznici 3,88 ± 1,87 mg/kg, u tonzilama 3,95 ± 0,53 mg/kg, a u tkivu sinusa i 6,96 ± 1,58 mg/kg.
English: Alternatively, interruption in the treatment with the CYP3A4 substrate should be made during treatment with Ketek.
Croatian: Ako to nije moguće, treba prekinuti liječenje supstratom CYP3A4 tijekom primjene lijeka Ketek.
English: In patients with severely impaired renal and/or hepatic function, concomitant administration of Ketek and strong CYP3A4 inhibitors, such as protease inhibitors or azole antifungals (e.g. ketoconazole, fluconazole), is contraindicated.
Croatian: U bolesnika s teškim oštećenjem bubrežne i/ili jetrene funkcije kontraindicirana je istodobna primjena lijeka Ketek i snažnih inhibitora CYP3A4, poput inhibitora proteaze ili azolnih antimikotika (npr. ketokonazol, flukonazol).
English: Telithromycin is known to be a strong CYP3A4 inhibitor and is also a P-glycoprotein inhibitor.
Croatian: Poznato je da je telitromicin snažan inhibitor CYP3A4, ali i inhibitor P-glikoproteina.
English: This is shown in the table below.
Croatian: Nuspojave su prikazane u tablici koja slijedi.
English: In a multiple-dose study, 36 subjects with varying degrees of renal impairment, a 1.4-fold increase in Cmax,ss, and a 2-fold increase in AUC (0-24)ss at 800 mg multiple doses in the severe renally impaired group (CLCR < 30 ml/min) compared to healthy volunteers were observed and a reduced dosage of Ketek is recommended (see section 4.2).
Croatian: U ispitivanju s primjenom višekratnih doza u 36 ispitanika s različitim stupnjem oštećenja bubrežne funkcije u skupini ispitanika s teškim oštećenjem bubrega (CLCR < 30 ml/min) kod višekratne je primjene doza od 800 mg opaženo povećanje Cmax,ss od 1,4 puta kao i dvostruko povećanje AUC(0-24)ss u odnosu na zdrave dobrovoljce.
English: Telithromycin is not active against organisms that constitutively express the MLSB resistance determinant (cMLSB).
Croatian: Telitromicin nije djelotvoran protiv mikroorganizama s konstitutivnom ekspresijom odrednice rezistencije tipa MLSB (cMLSB).
English: Pharmacotherapeutic group: antibacterials for systemic use, macrolides, lincosamides and streptogramins, ATC Code: J01FA15.
Croatian: Farmakoterapijska skupina: antibiotici za sustavnu primjenu, makrolidi, linkozamidi i streptogramini,
English: Concomitant administration with medicinal products that prolong the QT interval and are CYP3A4 substrates, such as cisapride, pimozide, astemizole, terfenadine, dronedarone, saquinavir (see section
Croatian: Istodobna primjena lijekova koji produljuju QT-interval i koji su supstrati CYP3A4, kao što su cisaprid, pimozid, astemizol, terfenadin, dronedaron, sakvinavir (vidjeti dio 4.5).
English: The total clearance (mean ±SD) is approximately 58±5 l/h after an intravenous administration with renal clearance accounting for about 22% of this.
Croatian: Ukupan klirens (srednja vrijednost ± SD) nakon intravenske primjene iznosi približno 58±5 l/h, pri čemu je udio bubrežnog klirensa oko 22%.
English: These medicines must not be taken with Ketek: - medicinal products to control the blood level of cholesterol or other lipids like simvastatin, atorvastatin, or lovastatin, as the side effects of the medicinal products could be increased.
Croatian: Sljedeći lijekovi se ne smiju uzimati zajedno s lijekom Ketek: - lijekovi za kontrolu razine kolesterola ili drugih lipida u krvi, kao što su simvastatin, lovastatin ili atorvastatin, jer se mogu pojačati nuspojave tih lijekova. - drugi lijekovi koji mogu produljiti QT-interval na elektrokardiogramu (EKG-u), kao što su:
English: - In adults, Ketek is used to treat infections of the throat, infections of the sinuses (hollow cavities in the bones around the nose) and chest infections in patients with long standing breathing difficulties and lung infection (pneumonia).
Croatian: - U odraslih se Ketek koristi za liječenje infekcija grla, infekcija sinusa (šupljina u kostima oko nosa), infekcija dišnog sustava u bolesnika koji imaju dugotrajne poteškoće s disanjem te infekcija - U adolescenata u dobi od 12 ili više godina Ketek se koristi za liječenje infekcija grla.
English: Telithromycin is metabolised both by CYP450 isoenzymes and non-CYP enzymes.
Croatian: Telitromicin se metabolizira pomoću izoenzima CYP450 i enzima izvan CYP obitelji.
English: The total tissue concentration 24 h after dose in epithelial lining fluid, alveolar macrophages, bronchial mucosa, tonsils and sinus tissue were 0.84±0.65 mg/l, 162±96 mg/l, 0.78±0.39 mg/kg, 0.72±0.29 mg/kg and 1.58±1.68 mg/kg, respectively.
Croatian: Ukupna tkivna koncentracija 24 sata nakon primjene je u tekućini koja oblaže epitel iznosila 0,84 ± 0,65 mg/l, u alveolarnim makrofagima 162 ± 96 mg/l, u bronhalnoj sluznici 0,78 ± 0,39 mg/kg, u tonzilama 0,72 ± 0,29 mg/kg, a u tkivu sinusa 1,58 ± 1,68 mg/kg.
English: - some calcium channel blockers (e.g. verapamil, nifedipine, felodipine) (for heart disorders).
Croatian: - kolhicin (za liječenje gihta) - neke blokatore kalcijevih kanala (npr. verapamil, nifedipin, felodipin) (za liječenje srčanih
English: Concomitant administration of Ketek and colchicine is contraindicated in patients with renal and/or hepatic
Croatian: Istodobna primjena lijeka Ketek i kolhicina je kontraindicirana u bolesnika s oštećenjem bubrežne i/ili jetrene
English: Ketek contains the active substance telithromycin.
Croatian: Ketek sadrži djelatnu tvar telitromicin.
English: Ketek may cause visual disturbances particularly in slowing the ability to accommodate and the ability to release accommodation.
Croatian: Ketek može uzrokovati poremećaje vida, posebice usporavanje sposobnosti akomodacije i relaksacije oka.
English: - Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days.
Croatian: U bolesnika u dobi od 12 do 18 godina režim liječenja će biti: - tonzilitis/faringitis uzrokovan bakterijom Streptococcus pyogenes: 800 mg jedanput na dan tijekom 5 dana.
English: Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)
Croatian: Tél/Tel: +32 (0)2 710 54 00
English: If patients experience visual disorders, loss of consciousness, confusion or hallucination while taking Ketek, patients should not drive a motor vehicle, operate heavy machinery or engage in other hazardous activities (see sections
Croatian: Ako bolesnici dožive smetnje vida, gubitak svijesti, konfuziju ili halucinacije tijekom liječenja lijekom Ketek, ne smiju upravljati motornim vozilom, rukovati teškim strojevima niti se upuštati u druge opasne aktivnosti (vidjeti dio 4.4 i 4.8).
English: These include Class IA (e.g.quinidine, procainamide, disopyramide) and Class III (e.g. dofetilide, amiodarone) antiarrhythmic agents, citalopram, tricyclic antidepressants, methadone, some antipsychotics (e.g. phenothiazines), fluoroquinolones (e.g. moxifloxacin), some antifungals (e.g. fluconazole, pentamidine), and some
Croatian: To uključuje antiaritmike skupine IA (npr. kinidin, prokainamid, dizopiramid) i skupine III (npr. dofetilid, amiodaron), citalopram, tricikličke antidepresive, metadon, neke antipsihotike (npr. fenotiazine), fluorokinolone (npr. moksifloksacin), neke antimikotike (npr. flukonazol, pentamidin) i neke protuvirusne lijekove (npr. telaprevir).
English: Rare (≥1/10,000 to
Croatian: Manje često (≥ 1/1000 i
English: Each tablet contains 400 mg of telithromycin.
Croatian: Jedna tableta sadrži 400 mg telitromicina.
English: Two tablets are contained in each blister cavity.
Croatian: Svaka jažica na blisteru sadrži dvije tablete.
English: - if you experience fainting (transient loss of consciousness) Talk to your doctor, pharmacist or nurse if you experience irregular heartbeat.
Croatian: Razgovarajte sa svojim liječnikom, ljekarnikom ili medicinskom sestrom ako iskusite nepravilne
English: Common side effects (may affect up to 1 in 10 people) - nausea, vomiting, abdominal pain, flatulence (excess wind) - dizziness, headaches, disturbance of taste - vaginal Candida infection (fungal infection associated with local itching, burning and white discharge) - increase in liver enzymes (detected by blood test).
Croatian: - omaglica, glavobolja, poremećaj okusa - vaginalna infekcija kandidom (gljivična infekcija povezana s lokaliziranim svrbežom, pečenjem i bijelim iscjetkom) - povišene vrijednosti jetrenih enzima (ustanovljene krvnim pretragama).
English: sanofi-aventis Ireland Ltd. T/A SANOFI
Croatian: sanofi-aventis Ireland Ltd.
English: Due to the potential for the prolongation of the QT interval and increased risk of arrhythmia, ECG monitoring must take place.
Croatian: Mora se učiniti i EKG zbog mogućeg produljenja QT-intervala i povećanog rizika od aritmije.
English: Consideration may be given to taking Ketek at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness.
Croatian: Može se razmotriti uzimanje Keteka prije odlaska na počinak kako bi se umanjio potencijalni utjecaj poremećaja vida i gubitka svijesti.
English: Concomitant administration with simvastatin, atorvastatin, and lovastatin.
Croatian: Istodobna primjena simvastatina, atorvastatina i lovastatina.
English: NAME OF THE MEDICINAL PRODUCT Ketek 400 mg film-coated tablets
Croatian: NAZIV LIJEKA Ketek 400 mg filmom obložene tablete
English: Telithromycin displays a tri-exponential decay from plasma, with a rapid distribution half-life of 0.17 h. The main elimination half-life of telithromycin is 2-3 h and the terminal, less important, half-life is about 10 h at the dose 800 mg once daily.
Croatian: Pri dozi od 800 mg jedanput na dan glavno poluvrijeme eliminacije telitromicina iznosi 2-3 h, a terminalni poluvijek, koji je manje bitan, iznosi približno 10 sati.
English: Severe hepatitis and liver failure (see section
Croatian: Poremećaji jetre i žuči teški hepatitis i zatajenje jetre (vidjeti dio 4.4)
English: Medicinal products with a potential to prolong QT interval Ketek is expected to increase the plasma levels of cisapride, pimozide, astemizole, terfenadine, dronedarone, saquinavir.
Croatian: Očekuje se da će Ketek povisiti koncentracije cisaprida, pimozida, astemizola, terfenadina, dronedarona i sakvinavira u plazmi.
English: The non-renal clearance is decreased as the dose is increased.
Croatian: Kako se doza povećava, nebubrežni klirens se smanjuje.
English: Angioneurotic oedema, anaphylactic reactions including anaphylactic shock, hypersensitivity Confusion, hallucination
Croatian: Poremećaji krvi i limfnog sustava Poremećaji imunološkog sustava angioneurotski edem, anafilaktičke reakcije, uključujući anafilaktički šok, preosjetljivost
English: Pharmacokinetic/Pharmacodynamic (PK/PD) relationship: The AUC/MIC ratio has been shown to be the PK/PD parameter that correlates best with the efficacy
Croatian: Pokazalo se da omjer AUC/MIK predstavlja PK/PD parametar koji najbolje korelira s djelotvornošću telitromicina.
English: Telithromycin, but not its major human metabolites, had inhibitory activity on HERG and Kv1.5 channels.
Croatian: Telitromicin je djelovao inhibitorno na kanale HERG i Kv1,5, dok njegovi glavni metaboliti u ljudi nisu.
English: Exposure to colchicine, a CYP3A4 and P-glycoprotein substrate, may therefore be expected to increase if Ketek and colchicine are co-administered.
Croatian: Stoga se kod istodobne primjene lijeka Ketek i kolhicina, supstrata CYP3A4 i P-glikoproteina, može očekivati povećana izloženost kolhicinu.
English: In 2,461 patients treated by Ketek in phase III clinical trials, and during post-marketing experience, the following undesirable effects possibly or probably related to telithromycin have been reported.
Croatian: Sljedeće nuspojave koje mogu biti ili vjerojatno jesu povezane s primjenom telitromicina prijavljene su u 2461 bolesnika liječenog lijekom Ketek u fazi III kliničkih ispitivanja i u razdoblju nakon stavljanja lijeka u promet.
English: Ketek should not be used by breast
Croatian: Dojilje ne smiju uzimati Ketek.
English: • Community-acquired pneumonia, mild or moderate (see section 4.4).
Croatian: U bolesnika u dobi od 18 ili više godina: • izvanbolnički stečene pneumonije, blage ili umjerene (vidjeti dio 4.4).
English: - rash, hives (urticaria), itching, eczema - drowsiness, difficulties in falling asleep (insomnia), nervousness, vertigo - tingling of the hands or feet (paraesthesia) - visual disturbances (blurred vision, difficulty in focusing, double vision)(please read section 2) - flushes, fainting (transient loss of consciousness) - changes in heart rate (e.g. slow beating) or abnormality of electrocardiogram (ECG)
Croatian: Manje česte (mogu se javiti u manje od 1 na 100 osoba) ili rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba) - zatvor, gubitak teka (anoreksija) - upala u ustima, gljivična infekcija u ustima (infekcija kandidom) - problemi s jetrom (hepatitis) - osip, koprivnjača (urtikarija), svrbež, ekcem - pospanost, poteškoće sa spavanjem (nesanica), nervoza, vrtoglavica - trnci u šakama ili stopalima (parestezije) - smetnje vida (zamagljen vid, teškoće u fokusiranju, dvoslike) (molimo pročitajte dio 2) - naleti crvenila, nesvjestica (prolazni gubitak svijesti) - promjene srčanog ritma (npr. usporeno kucanje srca) ili poremećaji na elektrokardiogramu (EKG) - nizak krvni tlak (hipotenzija) - povišene vrijednosti određenih bijelih krvnih stanica, koje se otkrivaju krvnim pretragama
English: Alterations in hepatic enzymes have been commonly observed in clinical studies with telithromycin.
Croatian: U kliničkim ispitivanjima telitromicina često su opažene promjene vrijednosti jetrenih enzima.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku, ljekarniku ili
English: If any of these undesirable effects are troublesome, severe, or do not wear off as treatment goes on,
Croatian: Ako su neke od tih nuspojava zabrinjavajuće, teške ili se ne smanjuju s nastavkom liječenja, obavijestite o tome svog liječnika.
English: If in doubt, talk to your doctor or pharmacist.
Croatian: Ako niste sigurni, upitajte svog liječnika ili ljekarnika.
English: Mean peak and trough plasma concentrations at steady state in patients were 2.9±1.6 mg/l (range 0.02-7.6 mg/l) and 0.2±0.2 mg/l (range 0.010 to 1.29 mg/l), during a therapeutic 800 mg once-daily dose regimen.
Croatian: Tijekom primjene terapijskih doza od 800 mg jedanput na dan prosječna vršna koncentracija lijeka u plazmi u stanju dinamičke ravnoteže bila je 2,9 ± l ,6 mg/l (raspon 0,02-7,6 mg/l), a prosječna najniža koncentracija 0,2 ± 0,2 mg/l (raspon od 0,010 do 1,29 mg/l).
English: If telithromycin is co-administered with dabigatran etexilate close clinical monitoring (looking for signs of bleeding or anaemia) should be exercised.
Croatian: Ako se telitromicin primjenjuje istodobno s dabigatraneteksilatom, potreban je poman klinički nadzor bolesnika (kako bi se uočili mogući znakovi
English: These include medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, amiodarone), for depression (citalopram, tricyclic antidepressants), methadone, some antipsychotics (phenothiazines), some antibiotics (fluoroquinolones such as moxifloxacin), some antifungals (fluconazole, pentamidine), and some antiviral drugs (telaprevir).
Croatian: amiodarona), za liječenje depresije (citalopram, triciklički antidepresivi), metadon, neke antipsihotike (fenotiazine), neke antibiotike (fluorokinolone poput moksifloksacina), neke antimikotike (flukonazol, pentamidin) i neke antivirusne lijekove (telaprevir) - lijekove koji sadrže digoksin (za liječenje srčanih poremećaja) ili dabigatran za sprječavanje
English: - if you are taking other medicines that can prolong the QT interval of the electrocardiogram
Croatian: Lijekovi koji mogu produljiti QT-interval
English: mediated resistance in vitro in Staphylococcus aureus, Streptococcus pneumoniae, or Streptococcus
Croatian: Aerobne gram-pozitivne bakterije Staphylococcus aureus osjetljiv na meticilin (MSSA)* Streptococcus pneumoniae * vrste iz roda Streptococcus streptokoki iz skupine Viridans
English: Check with you doctor or pharmacist
Croatian: Provjerite sa svojim liječnikom ili ljekarnikom ako niste sigurni.
English: Oral administration of midazolam concomitantly with Ketek should be avoided.
Croatian: Treba izbjegavati istodobnu peroralnu primjenu midazolama i lijeka Ketek.
English: Sanofi - Produtos Farmacêuticos, Lda.
Croatian: Sanofi Malta Ltd.
English: Pseudomembranou s colitis (see section 4.4)
Croatian: Poremećaji probavnog sustava pseudomembranski kolitis (vidjeti dio 4.4)