FrancophonIA/ELRC3.0 huggingface dataset:
English: Telithromycin is not active against organisms that constitutively express the MLSB resistance determinant (cMLSB).
Slovenian: Telitromicin ni aktiven proti organizmom, ki imajo konstitutivno eksprimirano determinanto odpornosti MLSB (cMLSB).
English: Increased anticoagulant activity has been reported in patients simultaneously treated with anticoagulants and antibiotics, including telithromycin.
Slovenian: Pri bolnikih, ki so istočasno prejemali antikoagulante in antibiotike, vključno s telitromicinom, so poročali o povečani aktivnosti antikoagulantov.
English: Telithromycin is a semisynthetic derivative of erythromycin A belonging to the ketolides, a class of antibacterial agents related to macrolides.
Slovenian: Telitromicin je polsintetični derivat eritromicina A in spada med ketolide, skupino makrolidom
English: CYP3A4 substrates
Slovenian: Substrati encima CYP3A4
English: - Worsening of a condition called myasthenia gravis, a rare disease which causes muscle
Slovenian: - Poslabšanje stanja, imenovanega miastenija gravis, redke bolezni, ki povzroči šibkost mišic - Nepravilen srčni utrip.
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.
Slovenian: Izmeničen dnevni režim odmerjanja po 800 mg in 400 mg pri bolnikih s hudo okvaro ledvic približa AUC (0-48) zdravim prostovoljcem glede na podatke, pridobljene s simulacijo.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release:
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
English: Slight reductions in fertility indices were seen in rats at parentally toxic doses higher than 150 mg/kg.
Slovenian: Pri parenteralni aplikaciji toksičnih odmerkov, višjih od 150 mg/kg, so pri podganah opazili rahla znižanja indeksov plodnosti.
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.
Slovenian: Poročali so o redkih primerih omedlevanja (prehodne izgube zavesti), pred katerimi vam je lahko slabo (npr. navzeja, želodčne težave).
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
Slovenian: Sočasna uporaba z zdravili, ki podaljšujejo interval QT in so substrati za CYP3A4, kot so cisaprid, pimozid, astemizol, terfenadin, dronedaron, sakvinavir (glejte poglavje 4.5).
English: • When treating infections caused by known or suspected beta-lactam and/or macrolide resistant strains (according to history of patients or national and/or regional resistance data) covered by the antibacterial spectrum of telithromycin (see sections 4.4 and 5.1):
Slovenian: - Zdravljenje okužb, ki so jih ali bi jih lahko povzročili sevi, odporni proti betalaktamskim ali makrolidnim antibiotikom ali obojim (glede na anamnezo bolnika ali nacionalne in/ali regionalne podatke o odpornosti), ki jih pokriva protibakterijski spekter telitromicina (glejte akutnega poslabšanja kroničnega bronhitisa.
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.
Slovenian: Med sočasno uporabo midazolama in zdravila Ketek se je AUC midazolama po intravenski aplikaciji midazolama zvišala za 2,2-krat, po peroralni pa za 6,1-krat.
English: • colchicine (for gout).
Slovenian: • kolhicin (za zdravljenje protina).
English: This medicinal product does not require any special storage conditions.
Slovenian: Za shranjevanje zdravila ni posebnih temperaturnih omejitev.
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
Slovenian: Pomembno je, da so bolniki, ki prejemajo telitromicin, obveščeni o možnosti neželenega učinka povezanega z vidom, ki se lahko pojavi med zdravljenjem (glejte poglavji
English: Mean steady-state trough plasma concentrations of between 0.04 and 0.07 mg/l are reached within 3 to 4 days with once-daily dosing of telithromycin 800 mg. At steady-state AUC is approximately 1.5 fold increased compared to the single dose.
Slovenian: Povprečne najnižje plazemske koncentracije v stanju dinamičnega ravnovesja, ki znašajo od 0,04 do 0,07 mg/l, so dosežene po 3 do 4 dneh uporabe 800 mg telitromicina enkrat na dan. AUC v stanju dinamičnega ravnovesja se v primerjavi s posamičnim odmerkom zviša za približno 1,5-krat.
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
Slovenian: Če se med zdravljenjem z zdravilom Ketek pri bolnikih pojavijo motnje vida, izguba zavesti, zmedenost ali halucinacije, bolniki ne smejo voziti motornih vozil, upravljati s težkimi stroji ali se vključevati v druge nevarne aktivnosti (glejte poglavji 4.4 in
English: Each tablet contains 400 mg of telithromycin.
Slovenian: Ena tableta vsebuje 400 mg telitromicina.
English: It is important to tell your doctor if you are taking: - medicines containing phenytoin, and carbamazepine (for epilepsy)
Slovenian: Pomembno je, da zdravniku poveste, če jemljete: - zdravila, ki vsebujejo fenitoin ali karbamazepin (za epilepsijo), - rifampicin (antibiotik), - fenobarbital ali šentjanževko (zdravilo raslinskega izvora, ki se uporablja za zdravljenje blagih
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
Slovenian: Razmerje AUC/MIC se je izkazalo kot tisti farmakokinetični/farmakodinamični parameter, ki najbolje korelira z učinkovitostjo telitromicina.
English: The majority of methicillin-resistant S. aureus (MRSA) express cMLSB.
Slovenian: Večina proti meticilinu odpornih S. aureus (MRSA) ima eksprimirano
English: In studies with rats a reduction in fertility indices was observed at parentally toxic doses (see section
Slovenian: V študijah na podganah so pri parenteralni aplikaciji toksičnih odmerkov opazili zmanjšano plodnost (glejte poglavje 5.3).
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).
Slovenian: Tablete se lahko vzamejo s hrano ali brez Premisliti je treba o možnosti jemanja zdravila Ketek pred spanjem, da bi se tako zmanjšal potencialni vpliv na motnje vida in izgubo zavesti (glejte poglavje 4.4).
English: NAME OF THE MEDICINAL PRODUCT Ketek 400 mg film-coated tablets
Slovenian: IME ZDRAVILA Ketek 400 mg filmsko obložene tablete
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.
Slovenian: Med sočasno uporabo induktorjev CYP3A4 (kot so rifampicin, fenitoin, karbamazepin, fenobarbital, šentjanževka) zato obstaja možnost za pojav subterapevtskih koncentracij telitromicina in izgubo učinka.
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
Slovenian: Ta vključujejo antiaritmike razreda IA (npr. kvinidin, prokainamid, dizopiramid) in razreda III (npr. dofetilid, amiodaron), citalopram, triciklične antidepresive, metadon, nekatere antipsihotike (npr. fenotiazini), fluorokinolone (npr. moksifloksacin), nekatere antimikotike (npr. flukonazol, pentamidin) in nekatera protivirusna zdravila
English: Ventricular arrhythmias (including ventricular tachycardia, torsade de pointes) have been reported in patients treated with telithromycin and sometimes occurred within a few hours of the first dose (see
Slovenian: Pri bolnikih, ki so se zdravili s telitromicinom, so poročali o ventrikularni aritmiji (vključno z ventrikularno tahikardijo, torsade de pointes), katera se je včasih pojavila že v nekaj urah po zaužitju
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.
Slovenian: Celokupne tkivne koncentracije 24 ur po odmerku so bile 0,84 ± 0,65 mg/l v epitelijski tekočini, 162 ± 96 mg/l v alveolnih makrofagih, 0,78 ± 0,39 mg/kg v bronhialni sluznici, 0,72 ± 0,29 mg/kg v tonzilah in 1,58 ± 1,68 mg/kg v sinusih.
English: Two tablets are contained in each blister cavity.
Slovenian: Vsak predelek pretisnega omota vsebuje dve tableti.
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.
Slovenian: Najvišje celokupne tkivne koncentracije so bile 14,9 ± 11,4 mg/l v epitelijski tekočini, 318,1 ± 231 mg/l v alveolnih makrofagih, 3,88 ± 1,87 mg/kg v bronhialni sluznici, 3,95 ± 0,53 mg/kg v tonzilah in 6,96 ± 1,58 mg/kg v sinusih.
English: Consideration may be given to taking Ketek at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness.
Slovenian: Premisliti je treba o možnosti jemanja zdravila Ketek pred spanjem, da bi se tako zmanjšal potencialni vpliv na motnje vida in izgubo zavesti.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom, s farmacevtom ali
English: Oral administration of midazolam concomitantly with Ketek should be avoided.
Slovenian: Sočasni peroralni uporabi midazolama in zdravila Ketek se je treba izogibati.
English: If in doubt, talk to your doctor or pharmacist.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom ali s farmacevtom.
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
Slovenian: - če ste imeli določene težave s srcem, kot so koronarna bolezen srca, prekatne motnje srčnega ritma ali bradikardijo (spremembe v srčnem utripu ali v elektrokardiagramu), ali če ste imeli zaradi bolezni nenormalne določene krvne izvide, kot so nizke koncentracije kalija (hipokaliemijo), nizke koncentracije magnezija (hipomagneziemijo).
English: Pseudomembranou s colitis (see section 4.4)
Slovenian: Miastenija gravis (glejte poglavje 4.4).
English: If you notice any of the following, stop taking Ketek and tell your doctor immediately: - Allergic or skin reactions such as face swelling, general allergic reactions including allergic shock, or serious skin conditions associated with red spots, blisters (frequency not known).
Slovenian: Zdravilo Ketek zato nehajte jemati in takoj povejte svojemu zdravniku, če opazite karkoli od - Alergijske ali kožne reakcije, npr. oteklost obraza, splošne alergijske reakcije, vključno z alergijskim šokom, ali resne kožne spremembe, ki jih spremljajo rdeče lise, mehurji (pogostnost - Huda, trdovratna ali krvava driska, ki jo spremljajo bolečine v trebuhu ali zvišana telesna temperatura; lahko gre za znak resnega vnetja črevesa, ki se lahko pojavi po zdravljenju z - Znaki in simptomi bolezni jeter (hepatitis) kot so porumenelost kože in oči, temen urin, srbenje,
English: Transient loss of consciousness, paraesthesia
Slovenian: Psihiatrične motnje zmedenost, halucinacije
English: Concomitant administration with ergot alkaloid derivatives (such as ergotamine and
Slovenian: Sočasna uporaba z derivati ergot alkaloidov (kot sta ergotamin in dihidroergotamin) (glejte poglavje
English: Streptococcus pneumoniae
Slovenian: Streptococcus pneumoniae * Streptokoki skupine Viridans
English: - if you experience fainting (transient loss of consciousness) Talk to your doctor, pharmacist or nurse if you experience irregular heartbeat.
Slovenian: Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, če imate nepravilen srčni utrip.
English: CYP3A4 inducers
Slovenian: Induktorji encima CYP3A4
English: Alterations in hepatic enzymes have been commonly observed in clinical studies with telithromycin.
Slovenian: V kliničnih študijah s telitromicinom so pogosto opažali spremembe jetrnih encimov.
English: Alternatively, interruption in the treatment with the CYP3A4 substrate should be made during treatment with Ketek.
Slovenian: Zdravljenje s substratom CYP3A4 med terapijo z zdravilom Ketek je sicer treba prekiniti.
English: No dosage adjustment is necessary in patients with mild or moderate renal impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro ledvic odmerka ni treba prilagoditi.
English: If you have vision problems, faint or experience confusion or hallucination while taking Ketek, do not drive, operate heavy machinery or
Slovenian: Če imate med jemanjem zdravila Ketek težave z vidom, omedlite, ste zmedeni ali halucinirate, ne smete voziti vozil, upravljati s težkimi stroji ali se vključevati v nevarne aktivnosti.
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).
Slovenian: Zdravila Ketek se ne sme uporabljati med zdravljenjem z induktorji CYP3A4 (kot so rifampicin, fenitoin, karbamazepin, fenobarbital, šentjanževka) in še 2 tedna po zdravljenju z njimi.
English: Do not take a double dose to make up
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
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.
Slovenian: Pri odmerku 800 mg enkrat na dan je glavni razpolovni čas izločanja telitromicina od 2 do 3 ure, terminalni, manj pomembni razpolovni čas, pa približno 10 ur.
English: In haemodialysed patients, the posology should be adjusted so that Ketek 800 mg is given after the dialysis session (see also section 5.2).
Slovenian: Bolnikom na hemodializi je odmerjanje treba prilagoditi tako, da dobijo Ketek 800 mg po dializi
English: Staphylococcus aureus methicillin susceptible (MSSA)*
Slovenian: Staphylococcus aureus občutljiv za meticilin (MSSA)* Streptococcus agalactiae
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.
Slovenian: Pričakovati je, da zdravilo Ketek zviša plazemske koncentracije cisaprida, pimozida, astemizola, terfenadina, dronedarona, sakvinavirja.
English: Species for which acquired resistance may be a problem Staphylococcus aureus methicillin resistant (MRSA)+
Slovenian: Staphylococcus aureus odporen za meticilin (MRSA)+
English: Concomitant administration of Ketek and colchicine in patients with renal and/or hepatic impairment (see section 4.5).
Slovenian: Sočasno jemanje zdravila Ketek in kolhicina pri bolnikih z okvaro ledvic in/ali jeter (glejte poglavje
English: Telithromycin displays moderate non-linear pharmacokinetics.
Slovenian: Telitromicin ima enostavno nelinearno farmakokinetiko.
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.
Slovenian: Med terapevtskim režimom odmerjanja 800 mg enkrat na dan sta bili pri bolnikih povprečna najvišja in najnižja plazemska koncentracija v stanju dinamičnega ravnovesja 2,9 ± 1,6 mg/l (razpon 0,027,6 mg/l) in 0,2 ± 0,2 mg/l (razpon 0,010-1,29 mg/l).
English: Exposure to colchicine, a CYP3A4 and P-glycoprotein substrate, may therefore be expected to increase if Ketek and colchicine are co-administered.
Slovenian: Znano je, da je telitromicin močan zaviralec CYP3A4 in zaviralec glikoproteina P. Pri sočasni uporabi zdravila Ketek in kolhicina zato lahko pričakujemo, da se bo izpostavljenost kolhicinu, CYP3A4 in substratu glikoproteina P povečala.
English: Reports have included death and life threatening acute respiratory failure with rapid onset (see section 4.8).
Slovenian: Poročila so vključevala smrtne izide in življenjsko nevarno akutno dihalno odpoved s hitrim nastopom
English: Concomitant administration of Ketek and colchicine is contraindicated in patients with renal and/or hepatic
Slovenian: Sočasna uporaba zdravila Ketek in kolhicina je kontraindicirana pri bolnikih z okvaro ledvic in/ali jeter (glejte poglavje
English: Hypersensitivity to the active substance, to any of the macrolide antibacterial agents, or to any of the
Slovenian: Preobčutljivost na zdravilno učinkovino, katero koli makrolidno protibakterijsko zdravilo ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: - if you are taking other medicines that can prolong the QT interval of the electrocardiogram
Slovenian: Zdravila, ki lahko podaljšajo interval QT
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.
Slovenian: Pri uporabi telitromicina pri podganah in psih v ponavljajočih odmerkih po 150 mg/kg/dan ali več 1 mesec oz. 20 mg/kg/dan ali več od 3 do 6 mesecev so opažali fosfolipidozo (znotrajcelično kopičenje fosfolipidov), ki je prizadela številne organe in tkiva (npr. jetra, ledvice, pljuča, priželjc, vranico, žolčnik, mezenterične bezgavke, prebavila).
English: Ketek should not be used during and 2 weeks after treatment with CYP3A4 inducers.
Slovenian: Zdravila Ketek se ne sme uporabljati med zdravljenjem z induktorji CYP3A4 in še 2 tedna po zdravljenju z njimi.
English: The affinity of telithromycin for the 50S ribosomal subunits of organisms susceptible to erythromycin A is 10-fold higher than that of erythromycin A.
Slovenian: Afiniteta telitromicina za podenoto 50S ribosoma za organizme občutljive na eritromicin je 10-krat večja kot afiniteta eritromicina A, kadar je sev občutljiv za eritromicin A. Pri sevih, ki so zaradi mehanizma odpornosti MLSB odporni proti eritromicinu A, pa ima telitromicin v primerjavi z eritromicinom A več kot 20-kratno afiniteto za bakterijsko podenoto 50S.
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.
Slovenian: Med uporabo 800 mg telitromicina enkrat na dan doseže povprečno najvišjo koncentracijo v plazmi približno 2 mg/l v 1 do 3 urah po odmerku.
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.
Slovenian: Pri bolnikih, starih 12 do 18 let, je shema zdravljenja: - Tonzilitis/faringitis, ki ga povzroča Streptococcus pyogenes: 800 mg enkrat na dan 5 dni.
English: - phenobarbital or St John's wort (herbal medicine used to treat mild depression) - medicines like tacrolimus, cyclosporin and sirolimus (for organ transplantation)
Slovenian: - zdravila, kot so takrolimus, ciklosporin in sirolimus (za presaditev organa),
English: There is no clinically relevant pharmacokinetic interaction of Ketek and theophylline administered as extended release formulation.
Slovenian: Med zdravilom Ketek in teofilinom, uporabljenim v obliki s podaljšanim sproščanjem, ni klinično pomembnih farmakokinetičnih interakcij.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 July 2001
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z
English: • Community-acquired pneumonia, mild or moderate (see section 4.4).
Slovenian: Pri bolnikih, starih 18. let in starejših: - Blage ali zmerne pljučnice, dobljene v domačem okolju (glejte poglavje 4.4).
English: Limit driving or other hazardous activities while taking Ketek.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Med jemanjem zdravila Ketek morate vožnjo vozil in opravljanje drugih nevarnih opravil omejiti.
English: Telithromycin, but not its major human metabolites, had inhibitory activity on HERG and Kv1.5 channels.
Slovenian: Telitromicin - ne pa njegovi glavni presnovki pri ljudeh - je deloval
English: -Renal impairment
Slovenian: Okvara ledvic:
English: Telithromycin does not induce expression of macrolide-lincosamide-streptogramin B (MLSB)
Slovenian: Telitromicin in vitro pri Staphylococcus aureus, Streptococcus pneumoniae ali Streptococcus pyogenes ne inducira ekspresije MLSB-posredovane odpornosti (odpornost proti makrolidom, linkozamidom in streptograminu B).
English: Very common side effects (may affect more than 1 in 10 people) - diarrhoea, usually mild and temporary.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) ali redki (pojavijo se lahko pri največ 1 od
English: Blood and the lymphatic system disorders
Slovenian: Bolezni reprodukcijskih organov in dojk nožnična okužba s Candido
English: Special populations
Slovenian: - Pediatrična populacija
English: Uncommon (may affect up to 1 in 100 people) or rare side effects (may affect up to 1 in 1,000 people) - constipation, loss of appetite (anorexia) - inflammation in the mouth, fungal infection in the mouth (Candida infection)
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) Dodatni neželeni učinki (pogostnost neznana - pogostnosti ni mogoče oceniti iz razpoložljivih podatkov), ki se lahko pojavijo z zdravilom Ketek, so: - nepravilnosti v elektrokardiogramu (EKG), t. i. podaljšanje intervala QT,
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.
Slovenian: Da pa bi se izognili možnim neželenim učinkom na prebavo, kot sta navzeja in bruhanje, mora med sočasnim jemanjem teh dveh zdravil od uporabe enega do uporabe drugega miniti ena ura.
English: Due to limited experience, Ketek should be used with caution in patients with liver impairment (see
Slovenian: Pri bolnikih z okvaro jeter je treba zdravilo Ketek zaradi omejenih izkušenj uporabljati previdno
English: MARKETING AUTHORISATION HOLDER
Slovenian: *postmarketinška izkušnja
English: Haemophilus influenzae
Slovenian: Chlamydophila pneumoniae*
English: Talk to your doctor, pharmacist or nurse if you experience visual disturbances (blurred vision, difficulty focusing, double vision).
Slovenian: Če imate težave z vidom (zamegljen vid, oteženo fokusiranje, dvojni vid), se o tem pogovorite z vašim zdravnikom, farmacevtom ali z medicinsko sestro.
English: • Effect of other medicinal products on Ketek
Slovenian: Shranjevanje zdravila Ketek
English: Hepatobiliary disorders
Slovenian: Streptococus species
English: Avastin has been authorised in the EU since 12 January 2005.
Slovenian: Zdravilo Avastin je v EU odobreno od 12. januarja 2005.
English: In addition, there was no benefit in terms of overall survival.
Slovenian: Poleg tega ni prišlo do nobenega izboljšanja kar zadeva skupno preživetje.