FrancophonIA/ELRC3.0 huggingface dataset:
English: If telithromycin treatment is deemed necessary, these patients may be treated with alternating daily doses of 800 mg and 400 mg, starting with the 800 mg
Croatian: Ako se liječenje telitromicinom smatra neophodnim, takve se bolesnike može liječiti naizmjeničnim davanjem dnevnih doza od 800 mg i 400 mg, počevši s dozom
English: >0.5 mg/l
Croatian: > 0,5 mg/l > 0,5 mg/l > 8 mg/l > 0,5 mg/l
English: If pseudomembranous colitis is suspected, the treatment must be stopped immediately and patients should be treated with supportive measures
Croatian: Posumnja li se na pseudomembranski kolitis, liječenje se mora odmah prekinuti, a bolesnika liječiti potpornom i/ili specifičnom terapijom.
English: In in vitro studies the activity of telithromycin was reduced against organisms that express the erythromycin erm(B) or mef(A) related resistance mechanisms.
Croatian: U ispitivanjima in vitro aktivnost telitromicina bila je smanjena protiv organizama koji iskazuju mehanizme rezistencije na eritromicin povezane s ekspresijom gena erm(B) ili mef(A).
English: Furthermore, telithromycin is able to block the formation of the
Croatian: Osim toga, telitromicin može blokirati stvaranje ribosomskih podjedinica
English: The induction gradually decreases during 2 weeks after cessation of treatment with CYP3A4 inducers.
Croatian: Indukcija se postupno smanjuje tijekom 2 tjedna nakon prestanka liječenja induktorima CYP3A4.
English: Ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) By extrapolation from erythromycin A and josamycin, concomitant medication of Ketek and alkaloid derivatives could lead to severe vasoconstriction (“ergotism”) with possibly necrosis of the extremities.
Croatian: Derivati ergot alkaloida (poput ergotamina i dihidroergotamina) Sudeći prema iskustvu s eritromicinom A i josamicinom, istodobna primjena lijeka Ketek i derivata alkaloida može dovesti do teške vazokonstrikcije ("ergotizma") s mogućom nekrozom udova.
English: • saquinavir (anti-HIV treatment) - if you are taking other medicines containing any of the following active substances:
Croatian: • sakvinavir (za liječenje HIV infekcije) - ako uzimate druge lijekove koji sadrže neku od sljedećih djelatnih tvari:
English: Strong CYP3A4 inhibitors must not be co-administered with Ketek in patients with severe renal/or hepatic dysfunction (see section 4.3).
Croatian: Snažni inhibitori CYP3A4 ne smiju se primjenjivati zajedno s lijekom Ketek u bolesnika s teškim oštećenjem bubrežne ili jetrene funkcije (vidjeti dio 4.3).
English: Phospholipidosis (intracellular phospholipid accumulation) affecting a number of organs and tissues (e.g., liver, kidney, lung, thymus, spleen, gall bladder, mesenteric lymph nodes, GI-tract) has been observed in rats and dogs administered telithromycin at repeated doses of 150 mg/kg/day or more for 1 month and 20 mg/kg/day or more for 3-6 months.
Croatian: Fosfolipidoza (intracelularna akumulacija fosfolipida) koja zahvaća brojne organe i tkiva (npr. jetru, bubrege, pluća, timus, slezenu, žučni mjehur, mezenterijske limfne čvorove, probavni sustav) zabilježena je u štakora i pasa koji su primali telitromicin u višekratnim dozama od 150 mg/kg na dan ili više tijekom mjesec dana, odnosno 20 mg/kg na dan tijekom 3-6 mjeseci.
English: In some organisms that are resistant to erythromycin A due to inducible expression of the MLSB resistance determinant, the affinity of telithromycin for the 50S ribosomal subunit is more than 20
Croatian: U nekim organizmima koji su rezistentni na eritromicin A zbog inducibilne ekspresije odrednice rezistencije tipa MLSB, afinitet telitromicina za ribosomsku podjedinicu 50S je više od 20 puta veći od afiniteta eritromicina A.
English: Telithromycin has been shown to decrease the Cmax by 34 % and AUC of sotalol by 20 % due to
Croatian: Pokazalo se da telitromicin smanjuje Cmax sotalola za 34% i bioraspoloživost (AUC) za 20% zbog
English: Telithromycin is an inhibitor of CYP3A4 and a weak inhibitor of CYP2D6.
Croatian: Telitromicin je inhibitor CYP3A4 i slab inhibitor CYP2D6.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
English: - The other ingredients are microcrystalline cellulose, povidone (K25), croscarmellose sodium, magnesium stearate in the tablet core as well as talc, macrogol (8000 ), hypromellose (6 cp), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) in the film-coating.
Croatian: - Drugi sastojci su mikrokristalična celuloza, povidon (K25), umrežena karmelozanatrij i magnezijev stearat u jezgri tablete te talk, makrogol (8000), hipromeloza (6cp), titanijev dioksid (E171), žuti željezov oksid (E172) i crveni željezov oksid (E172) u film ovojnici.
English: When midazolam was coadministered with Ketek, midazolam AUC was increased 2.2-fold after intravenous administration of midazolam and 6.1-fold after oral administration.
Croatian: Kad se midazolam davao istodobno s lijekom Ketek, AUC midazolama povećao se 2,2 puta nakon intravenske, a 6,1 puta nakon peroralne primjene midazolama.
English: Patients with concomitant treatment of pravastatin, rosuvastatin or fluvastatin should be carefully monitored for signs and symptoms of myopathy and rhabdomyolysis.
Croatian: Bolesnike koji istodobno uzimaju pravastatin, rosuvastatin ili fluvastatin treba pomno nadzirati zbog mogućih pojava znakova i simptoma miopatije i rabdomiolize.
English: Ketek 400 mg tablets are light orange, oblong, biconvex, film-coated tablets imprinted with “H3647” on one side and “400” on the other.
Croatian: Ketek 400 mg tablete su svijetlonarančaste, ovalne, bikonveksne filmom obložene tablete, s utisnutom oznakom "H3647" na jednoj i "400" na drugoj strani.
English: During concomitant administration of rifampicin and telithromycin in repeated doses, Cmax and AUC of telithromycin were on average decreased by 79% and 86% respectively.
Croatian: Tijekom istodobne primjene rifampicina i telitromicina u ponovljenim dozama, Cmax telitromicina snižen je za prosječno 79%, a AUC za prosječno 86%.
English: Treatment with these agents should be interrupted during Ketek treatment.
Croatian: Primjena ovih lijekova mora se privremeno prekinuti tijekom liječenja lijekom Ketek.
English: There is no clinically relevant pharmacokinetic interaction of Ketek and theophylline administered as extended release formulation.
Croatian: Nema klinički značajne farmakokinetičke interakcije lijeka Ketek i teofilina primijenjenog u obliku s produljenim oslobađanjem.
English: No carcinogenicity studies have been conducted with telithromycin.
Croatian: Nisu provedena ispitivanja kancerogenosti telitromicina.
English: The rate and extent of absorption is unaffected by food intake, and thus Ketek tablets can be given without regard to food.
Croatian: Unos hrane ne utječe na brzinu i opseg apsorpcije pa se Ketek tablete mogu davati neovisno o obroku.
English: Streptococcus pneumoniae does not demonstrate cross-resistance between erythromycin A and
Croatian: Streptococcus pneumoniae ne pokazuje križnu rezistenciju između eritromicina A i telitromicina.
English: Telithromycin is also a P-glycoprotein inhibitor.
Croatian: Telitromicin je i inhibitor P-glikoproteina.
English: The recommended European Committee for Antimicrobial Susceptibility Testing (EUCAST) MIC clinical breakpoints are presented below:
Croatian: Europski odbor za ispitivanje osjetljivosti na antibiotike (EUCAST) preporučio je sljedeće granične vrijednosti MIK-a u kliničkoj primjeni:
English: Concomitant administration of Ketek with drugs that are substrates of P-glycoprotein might result in increased exposure to the P-glycoprotein substrates such as digoxin and dabigatran etexilate.
Croatian: Istodobna primjena lijeka Ketek s lijekovima koji su supstrati za P-glikoprotein mogla bi dovesti do povećane izloženosti supstratima P-glikoproteina, poput digoksina i dabigatraneteksilata.
English: Hence, Ketek should not be used during treatment with medicinal products that are CYP3A4 substrates, unless plasma concentrations of the CYP3A4 substrate, efficacy or adverse reactions can be closely monitored.
Croatian: Stoga se Ketek ne smije davati tijekom primjene lijekova koji su supstrati CYP3A4, osim ako se mogu pomno nadzirati koncentracije supstrata CYP3A4 u plazmi, djelotvornost ili nuspojave lijeka.
English: • ergotamine or dihydroergotamine (tablets or inhaler for migraine) - if you have kidney problems (severely impaired renal function) and/or liver problems (severely impaired hepatic function), other medicines containing any of the following active substances:
Croatian: • ergotamin ili dihidroergotamin (tablete ili inhalator za liječenje migrene) - ako imate tegoba s bubrezima (teško oštećenje bubrežne funkcije) i/ili tegoba s jetrom (teško oštećenje jetrene funkcije), drugi lijekovi koji sadrže neku od sljedećih djelatnih tvari:
English: If you feel you are suffering from a side effect, tell a doctor immediately to get advice before taking
Croatian: Ako smatrate da imate neku nuspojavu, odmah o tome obavijestite liječnika kako bi Vam dao savjet prije uzimanja sljedeće doze.
English: Following oral administration, telithromycin is fairly rapidly absorbed.
Croatian: Nakon peroralne primjene telitromicin se razmjerno brzo apsorbira.
English: It is important that patients prescribed telithromycin should be informed that visual adverse reactions may occur during the treatment (see sections 4.7 and
Croatian: Važno je da bolesnici kojima je propisan telitromicin budu informirani kako se vizualne nuspojave mogu pojaviti tijekom liječenja (vidjeti dio 4.7 i 4.8).
English: Ketek should therefore not be used concomitantly with simvastatin, atorvastatin, or lovastatin (see section 4.3).
Croatian: Ketek se stoga ne smije primjenjivati istodobno sa simvastatinom, atorvastatinom ili lovastatinom (vidjeti dio 4.3).
English: Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 ANTONY France
Croatian: 20, Avenue Raymond Aron F-92160 ANTONY Francuska
English: - if you are allergic to telithromycin, to any of the macrolide antibiotics or to any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na telitromicin, neki makrolidni antibiotik ili neki drugi sastojak ovog lijeka
English: Species for which acquired resistance may be a problem Staphylococcus aureus methicillin resistant (MRSA)+
Croatian: Vrste kod kojih stečena rezistencija može predstavljati Aerobne gram-pozitivne bakterije Staphylococcus aureus rezistentan na meticilin (MRSA)+
English: When simvastatin was coadministered with Ketek, there was a 5.3-fold increase in simvastatin Cmax, an 8.9-fold increase in simvastatin AUC, a 15-fold increase in simvastatin acid Cmax and an 11-fold increase in simvastatin acid AUC.
Croatian: Kada se simvastatin primjenjivao istodobno s lijekom Ketek, Cmax simvastatina povećao se 5,3 puta, a njegov AUC 8,9 puta, dok se Cmax simvastatinske kiseline povećao 15 puta, a AUC 11 puta.
English: There have been post-marketing adverse reaction reports of transient loss of consciousness including some cases associated with vagal syndrome (see sections 4.7 and 4.8).
Croatian: U izvješćima o nuspojavama nakon stavljanja lijeka u promet prijavljeni su slučajevi prolaznog gubitka svijesti, uključujući neke slučajeve povezane s vagusnim sindromom (vidjeti dio 4.7 i 4.8).
English: In a single-dose study (800 mg) in 12 patients and a multiple-dose study (800 mg) in 13 patients with mild to severe hepatic insufficiency (Child Pugh Class A, B and C), the Cmax, AUC and t1/2 of telithromycin were similar compared to those obtained in age- and sex-matched healthy subjects.
Croatian: U ispitivanju s primjenom jedne doze (800 mg) u 12 bolesnika i u ispitivanju s primjenom višekratnih doza (800 mg) u 13 bolesnika s blagim do teškim oštećenjem jetre (Child Pugh stadij A, B i C), Cmax, AUC i t1/2 telitromicina bili su slični onima u zdravih osoba iste dobi i spola.
English: Treatment with these agents should be interrupted during Ketek treatment (see section 4.5).
Croatian: Primjenu ovih lijekova potrebno je privremeno prekinuti tijekom liječenja lijekom Ketek (vidjeti dio 4.5).
English: Concomitant administration of Ketek and any of these medicinal products is contraindicated (see section 4.3).
Croatian: Kontraindicirana je istodobna primjena lijeka Ketek i bilo kojeg od tih lijekova (vidjeti dio 4.3).
English: If possible take the tablets before going to bed, to reduce the potential impact of visual disturbances and loss of consciousness.
Croatian: Po mogućnosti uzimajte tablete prije odlaska na počinak kako bi se smanjio mogući utjecaj poremećaja vida i gubitka svijesti.
English: A mean maximum plasma concentration of about 2 mg/l is reached within 1-3 hour after dose with once-daily dosing of telithromycin 800 mg.
Croatian: Prosječna maksimalna koncentracija u plazmi od oko 2 mg/l postiže se 1-3 sata nakon primjene doze od 800 mg telitromicina jedanput na dan.
English: - Community-acquired pneumonia: 800 mg once a day for 7 to 10 days, - Acute exacerbation of chronic bronchitis: 800 mg once a day for 5 days, - Acute sinusitis: 800 mg once a day for 5 days, - Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days.
Croatian: U bolesnika u dobi od 18 ili više godina režim liječenja će, sukladno indikaciji, biti: - izvanbolnički stečena pneumonija: 800 mg jedanput na dan tijekom 7 do 10 dana, - akutna egzacerbacija kroničnog bronhitisa: 800 mg jedanput na dan tijekom 5 dana, - akutni sinusitis: 800 mg jedanput na dan tijekom 5 dana, - tonzilitis/faringitis uzrokovan bakterijom Streptococcus pyogenes: 800 mg jedanput na dan tijekom 5 dana.
English: Talk to your doctor, pharmacist or nurse before taking Ketek: - if you have had certain heart problems such as coronary heart disease, ventricular arrhythmias, bradycardia (changes in heart rate or electrocardiogram) or if you have had certain abnormal blood tests due to medical conditions such as low levels of potassium (hypokalaemia), low levels
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Ketek: - ako ste imali određene srčane tegobe kao što su koronarna bolest srca, ventrikularne aritmije, bradikardija (promjene srčanog ritma ili elektrokardiograma) ili ako ste ste imali neke poremećaje u rezultatima krvnih pretraga uzrokovanih medicinskim stanjima kao što su niska razina kalija (hipokalijemija) ili niska razina magnezija (hipomagnezijemija).
English: Ketek has been shown to increase the plasma concentrations of digoxin, a P-glycoprotein substrate.
Croatian: Pokazalo se da Ketek povisuje koncentracije digoksina, supstrata P-glikoproteina, u plazmi.
English: Based on simulation data, an alternating daily dosing regimen of 800 mg and 400 mg in patients with severe renal impairment can approximate the AUC (0-48h) in healthy subjects receiving 800 mg once daily.
Croatian: Na temelju podataka dobivenih simulacijom, režimom naizmjenične primjene dnevnih doza od 800 mg i 400 mg u bolesnika s teškim oštećenjem bubrežne funkcije može se postići AUC(0-48h) približno jednak onome u zdravih ispitanika koji primaju dozu od 800 mg
English: • colchicine (for gout).
Croatian: • kolhicin (za liječenje gihta).
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Croatian: Kada je lokalna prevalencija rezistencije takva da je korist lijeka barem u nekim vrstama infekcija upitna, po potrebi treba potražiti savjet stručnjaka.
English: There is no pharmacodynamic or clinically relevant pharmacokinetic interaction with low-dose triphasic oral contraceptives in healthy subjects.
Croatian: U zdravih ispitanika nema farmakodinamičkih niti klinički značajnih farmakokinetičkih interakcija s trofaznim oralnim kontraceptivima s niskim dozama hormona.
English: In areas with a high incidence of erythromycin A resistance, it is especially important to take into consideration the evolution of the pattern of susceptibility to telithromycin and other antibiotics.
Croatian: A posebno je važno uzeti u obzir razvoj modela osjetljivosti uzročnika na telitromicin i ostale antibiotike.
English: Rare cases of fainting (transient loss of consciousness), which may be preceded by a general feeling of being sick (e.g. nausea, stomach upsets) have been reported.
Croatian: Prijavljeni su rijetki slučajevi nesvjestice (prolaznog gubitka svijesti), kojima može prethoditi opći osjećaj slabosti (npr. mučnina, nadražen želudac).
English: The patients should be carefully observed and given symptomatic and supportive treatment.
Croatian: Bolesnike valja pažljivo nadzirati te poduzeti mjere simptomatskog i potpomog liječenja.
English: Concomitant administration of strong CYP3A4 inhibitors (such as telithromycin) and calcium channel blockers that are metabolized by CYP3A4 (e.g. verapamil, nifedipine, felodipine) may result in hypotension, bradycardia or loss of consciousness, and should therefore be avoided.
Croatian: Istodobna primjena snažnih inhibitora CYP3A4 (poput telitromicina) i blokatora kalcijevih kanala koji se metaboliziraju putem CYP3A4 (npr. verapamil, nifedipin, felodipin) može izazvati hipotenziju, bradikardiju ili gubitak svijesti, pa je stoga treba izbjegavati.
English: Reports have included death and life threatening acute respiratory failure with rapid onset (see section 4.8).
Croatian: Prijavljeni slučajevi uključivali su one sa smrtnim ishodom i po život opasnim akutnim zatajenjem disanja s naglim nastupom (vidjeti dio 4.8).
English: This could result in QT interval prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and torsades de pointes.
Croatian: To može rezultirati produljenjem QT-intervala i srčanim aritmijama, uključujući ventrikulamu tahikardiju, ventrikulamu fibrilaciju i torsades de pointes.
English: In addition, rare cases of transient loss of consciousness, which may be preceded by vagal symptoms, have been reported (see section 4.8).
Croatian: Osim toga, prijavljeni su rijetki slučajevi prolaznog gubitka svijesti kojima mogu prethoditi simptomi vagusnog sindroma (vidjeti dio 4.8).
English: Due to its CYP3A4 inhibitory potential, telithromycin can increase blood concentrations of these CYP34A4 substrates.
Croatian: S obzirom na inhibicijski potencijal prema CYP3A4, telitromicin može povećati koncentracije navedenih supstrata CYP3A4.
English: No dosage adjustment is necessary in patients with mild or moderate renal impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem bubrega.
English: Due to limited experience, Ketek should be used with caution in patients with liver impairment (see
Croatian: Zbog ograničenog iskustva, Ketek treba primjenjivati uz oprez u bolesnika s narušenom funkcijom
English: In vivo studies with simvastatin, midazolam and cisapride have demonstrated a potent inhibition of intestinal CYP3A4 and a moderate inhibition of hepatic CYP3A4.
Croatian: U ispitivanjima in vivo, simvastatin, midazolam i cisaprid su pokazali snažnu inhibiciju intestinalnog CYP3A4 te umjerenu inhibiciju jetrenog CYP3A4.
English: However, patients should be carefully monitored for signs and symptoms of myopathy and rhabdomyolysis when co-treated with pravastatin, rosuvastatin and fluvastatin.
Croatian: Međutim, bolesnike trebaju biti pomno nadzirati kako bi se uočili znakovi i simptomi miopatije i rabdomiolize kada se istodobno liječe pravastatinom, rosuvastatinom i fluvastatinom.
English: Post-marketing cases of severe hepatitis and liver failure, including fatal cases (which have generally been associated with serious underlying diseases or concomitant medicinal products), have been reported (see section 4.8).
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi teškog hepatitisa i zatajenja jetre, uključujući i one sa smrtnim ishodom (koji su u pravilu bili povezani s ozbiljnim osnovnim bolestima ili istodobno primijenjenim lijekovima) (vidjeti dio 4.8).
English: Thus, when initiating telithromycin in patients already receiving any of theses immunosuppressive agents, cyclosporin, tacrolimus or sirolimus levels must be carefully monitored and their doses decreased as necessary.
Croatian: Stoga se prilikom uvođenja telitromicina u bolesnika koji već primaju neki od ovih imunosupresivnih lijekova moraju pažljivo nadzirati koncentracije ciklosporina, takrolimusa odnosno sirolimusa te po potrebi smanjiti njihova doza.
English: Telithromycin is metabolised primarily by the liver.
Croatian: Telitromicin se primarno metabolizira u jetri.
English: Light orange, oblong, biconvex tablet, imprinted with ‘H3647' on one side and ‘400' on the other.
Croatian: Svijetlonarančasta, ovalna, bikonveksna tableta, s utisnutom oznakom 'H3647' na jednoj i '400' na
English: The tablets may be taken Consideration may be given to taking Ketek at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness (see section 4.4).
Croatian: Može se razmotriti uzimanje lijeka Ketek prije odlaska na počinak kako bi se umanjio potencijalni utjecaj poremećaja vida i gubitka svijesti (vidjeti dio 4.4).
English: Because of potential visual difficulties, loss of consciousness, confusion or hallucination, patients should attempt to minimize activities such as driving a motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment with Ketek.
Croatian: Zbog mogućih smetnji vida, gubitka svijesti, konfuzije ili halucinacija, tijekom liječenja lijekom Ketek bolesnici trebaju smanjiti aktivnosti kao što su upravljanje motornim vozilima, rukovanje teškim strojevima ili druge opasne aktivnosti.
English: Taking Ketek may cause side effects such as visual disturbances, confusion or hallucination which may reduce the capacity to carry out certain tasks.
Croatian: Ketek može izazvati nuspojave kao što su smetnje vida, smetenost ili halucinacije, koje mogu smanjiti sposobnost izvođenja određenih poslova.
English: In both studies, higher renal elimination was observed in the hepatically impaired patients.
Croatian: U oba je ispitivanja opažena veća eliminacija putem bubrega u bolesnika s oštećenom funkcijom jetre.
English: Caution is warranted when Ketek is administered to patients taking other medicinal products with the potential to prolong the QT interval (see section 4.4).
Croatian: Nalaže se oprez kod primjene lijeka Ketek u bolesnika koji uzimaju druge lijekove koji mogu produljiti QT-interval (vidjeti dio 4.4).
English: The major CYP450 enzyme involved in the metabolism of telithromycin is CYP3A4.
Croatian: Glavni enzim citokroma P450 uključen u metabolizam telitromicina je CYP3A4.
English: • cisapride (digestive problems)
Croatian: • cisaprid (za probavne tegobe)
English: Streptococcus pyogenes that show high-level resistance to erythromycin A are cross-resistant to
Croatian: Sojevi Streptococcus pyogenes koji iskazuju visoku razinu rezistencije na eritromicin imaju i križnu
English: The correlation between macrolide MICs and clinical outcome is weak for H. influenzae.
Croatian: Kod H. influenzae je korelacija između MIK-a makrolida i kliničkog ishoda slaba.
English: Effects were evident at plasma levels of free drug 8 to 13 times the expected clinical level.
Croatian: Učinci su zabilježeni pri 8 do 13 puta većoj koncentraciji slobodnog lijeka u plazmi od one očekivane u kliničkoj primjeni.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg of telithromycin.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 400 mg telitromicina.
English: Diarrhoea, particularly if severe, persistent and /or bloody, during or after treatment with Ketek may be caused by pseudomembranous colitis (see section 4.8).
Croatian: Bolest uzrokovana bakterijom Clostridium difficile Proljev tijekom ili nakon liječenja Ketek, osobito ako je jak, uporan i/ili krvav, može biti posljedica pseudomembranskog kolitisa (vidjeti dio 4.8).