FrancophonIA/ELRC3.0 huggingface dataset:
English: Aventis Pharma S.p.A. Strada Statale No 17, km22 67019 Scoppito (L'Aquila) Italy
Slovenian: Strada Statale No 17, km22 67019 Scoppito (L'Aquila) Italija
English: Due to limited experience in patients with decreased metabolic capacity of the liver, Levviax should be used with caution in patients with hepatic impairment (see also section 4.4).
Slovenian: Zaradi omejenih izkušenj pri bolnikih z zmanjšano presnovno kapaciteto jeter je treba zdravilo Levviax pri bolnikih z jetrno okvaro uporabljati previdno (glejte tudi poglavje 4.4).
English: The most common side effect (10 or more out of 100 patients) which may occur with Levviax is diarrhoea, usually mild and temporary.
Slovenian: Najpogostejši neželeni učinek (10 ali več na 100 bolnikov), ki se lahko pojavi pri zdravljenju z zdravilom Levviax, je driska; ponavadi je blaga in prehodna.
English: In the elderly:
Slovenian: -Starejše osebe
English: In patients of 18 years and older: • Community-acquired pneumonia, mild or moderate (see section 4.4).
Slovenian: Pri bolnikih, starih 18. let in starejšihi: - Blage ali zmerne pljučnice, dobljene v domačem okolju (glejte poglavje 4.4).
English: Hypersensitivity to the active substance, to any of the macrolide antibacterial agents, or to any of the excipients.
Slovenian: Preobčutljivost za zdravilno učinkovino, katerokoli makrolidno protibakterijsko zdravilo ali katerokoli pomožno snov.
English: Concomitant administration of Levviax and any of these medicinal products is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba zdravila Levviax in katerega od teh zdravil je kontraindicirana (glejte poglavje 4.3).
English: Magyarország sanofi-aventis zrt., Magyarország Tel: +36 1 505 0050
Slovenian: Magyarország sanofi-aventis zrt., Magyrország Tel: +36 1 505 0050
English: Hypromellose 6 cp Titanium dioxide E171 Yellow iron oxide E172 Red iron oxide E172
Slovenian: Obloga tablete: smukec makrogol 8000 hipromeloza 6 cp titanov dioksid E171 rumeni železov oksid E172 rdeči železov oksid E172
English: You should not use Levviax with medicines containing ergotamine or dihydroergotamine tablets or ergotamine inhalers for migraine, terfenadine or astemizole for allergic problems, cisapride for digestive problems and pimozide for psychiatric problems.
Slovenian: Zdravila Levviax ne smete uporabljati z zdravili, ki vsebujejo ergotamin, tabletami dihidroergotamina ali inhalatorji ergotamina za migreno, s terfenadinom ali astemizolom za alergijske težave, cisapridom za prebavne motnje ali pimozidom za psihiatrične motnje.
English: Common (≥1/100 to
Slovenian: Pogosti (≥ 1/100 do <
English: While exposure to telithromycin did select for pneumococcal mutants with increased MICs, the MICs remained within the proposed susceptibility range.
Slovenian: Izpostavljenost telitromicinu lahko povzroči selekcijo pnevmokoknih mutantov z zvečanimi MIK, vendar so MIK ostale znotraj pričakovanega območja občutljivosti.
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 poglavji 4.4 in 5.1): - akutnega poslabšanja kroničnega bronhitisa.
English: When simvastatin was coadministered with Levviax, 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 simvastatine acid AUC.
Slovenian: Med sočasno uporabo simvastatina in zdravila Levviax so ugotovili 5,3-kratno zvišanje Cmax simvastatina in 8,9-kratno zvišanje njegove AUC ter 15-kratno zvišanje Cmax simvastatinske kisline in 11-kratno zvišanje njene AUC.
English: - if you experience visual disturbances (blurred vision, difficulty in focusing, double vision) - if you experience transient loss of consciousness (fainting).
Slovenian: - če imate težave z vidom (zamegljen vid, oteženo fokusiranje, dvojni vid).
English: Levviax is contraindicated in patients with myasthenia gravis (see section 4.4).
Slovenian: Zdravilo Levviax je kontraindicirano pri bolnikih z miastenijo gravis (glejte poglavje 4.4).
English: If you are breast-feeding do not take Levviax tablets.
Slovenian: Če dojite, ne jemljite tablet Levviax.
English: - If you have further questions, ask your doctor or your pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
English: If in doubt, talk to your doctor or pharmacist.
Slovenian: Če ste v dvomih, se posvetujte z zdravnikom ali s farmacevtom.
English: Atrial arrhythmia, hypotension, bradycardia
Slovenian: Srčno-žilne bolezni pordevanje palpitacije atrijska aritmija, hipotenzija, bradikardija
English: Taking Levviax tablets may cause side effects such as visual disturbances, which may reduce the capacity to carry out certain tasks.
Slovenian: Jemanje tablet Levviax lahko povzroči neželene učinke, kot so motnje vida, ki lahko zmanjšajo zmožnost za opravljanje določenih nalog.
English: If you forget to take Levviax
Slovenian: Če ste pozabili vzeti zdravilo Levviax
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 sorodnih protibakterijskih zdravil.
English: However, in contrast to clarithromycin, no resistant strains of alpha streptococci emerged in saliva on treatment with telithromycin.
Slovenian: V nasprotju s klaritromicinom pa se med zdravljenjem s telitromicinom v slini niso pojavili odporni sevi streptokokov alfa.
English: As with macrolides, due to a potential to increase QT interval, Levviax should be used with care in patients with coronary heart disease, a history of ventricular arrhythmias, uncorrected hypokalaemia and or hypomagnesaemia, bradycardia (<50 bpm), or during concomitant administration of Levviax with QT interval prolonging agents or potent CYP 3A4 inhibitors such as protease inhibitors and ketoconazole.
Slovenian: Zaradi možnosti podaljšanja intervala QT je treba zdravilo Levviax - tako kot makrolide - uporabljati previdno pri bolnikih s koronarno boleznijo srca, z anamnezo ventrikularnih aritmij, nekorigirano hipokaliemijo in/ali hipomagneziemijo, bradikardijo (< 50 utripov/min) ter med sočasno uporabo zdravila Levviax z zdravili, ki podaljšujejo interval QT, ali močnimi zaviralci CYP3A4, kot so npr. zaviralci proteaz in ketokonazol.
English: Levviax is not recommended for use in children below 12 years of age due to lack of data on safety and efficacy (see section 5.2).
Slovenian: Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Levviax pri otrocih pod 12 let ni priporočljiva (glejte poglavje 5.2).
English: Consideration may be given to taking Levviax at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness (see section 4.4).
Slovenian: Premisliti je treba o možnosti jemanja zdravila Levviax pred spanjem, da bi se tako zmanjšal potencialni vpliv na motnje vida in izgubo zavesti (glejte poglavje 4.4).
English: For Streptococcus pyogenes, cross-resistance occurs for high-level erythromycin A resistant strains.
Slovenian: Pri Streptococcus pyogenes se navzkrižna odpornost pojavi pri sevih, zelo odpornih proti eritromicinu A.
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 Levviax is recommended (See Section 4.2.).
Slovenian: V raziskavi z večkratnimi odmerki, v katero so vključili 36 oseb z različno stopnjo okvare ledvic, so v skupini bolnikov s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) v primerjavi z zdravimi prostovoljci pri večkratnih odmerkih po 800 mg ugotovili 1,4-kratno povečanje Cmax, ss in 2-kratno povečanje AUC (0-24h)ss, zato je priporočeno zmanjšanje odmerka zdravila Levviax (glejte poglavje 4.2).
English: Aerobic Gram-positive bacteria
Slovenian: Aerobne grampozitivne bakterije
English: Telithromycin is metabolized both by CYP450 isoenzymes and non-CYP enzymes.
Slovenian: Telitromicin se presnavlja tako z izoencimi CYP450 kot z ne-CYP encimi.
English: The plasma trough levels, Cmax, AUC and renal clearance were increased by 20 %, 73 %, 37 % and 27% respectively, in healthy volunteers.
Slovenian: Pri zdravih prostovoljcih so se najnižje koncentracije v plazmi zvišale za 20%, Cmax za 73%, AUC za 37 in ledvični očistek za 27%.
English: Telithromycin is metabolized primarily by the liver.
Slovenian: Telitromicin se presnavlja predvsem v jetrih.
English: Levviax should not be used concomitantly with simvastatin, atorvastastin and lovastatin.
Slovenian: Zdravila Levviax se ne sme uporabljati sočasno s simvastatinom, atorvastatinom in lovastastinom.
English: Nevertheless, monitoring of serum digoxin level should be considered during concomitant administration of digoxin and Levviax.
Slovenian: Kljub temu je treba med sočasno uporabo digoksina in zdravila Levviax razmisliti o nadziranju koncentracije digoksina v serumu.
English: The manufacturer of Levviax is: Aventis Pharma S.p.A.
Slovenian: Izdelovalec zdravila Levviax je: Aventis Pharma S.p.A.
English: Constipation, anorexia (loss of appetite), stomatitis (inflammation in themouth), oral Candida infection (fungal infection), hepatitis, rash, urticaria (hives), pruritus (itching), eczema, somnolence, insomnia, nervousness, vertigo, paraesthesia (tingling of the hands or feet), , visual disturbances (blurred vision, difficulty in focusing, double vision), , flushes, transient loss of consciousness (fainting), arrhythmia, bradycardia or palpitations (changes in heart rate or in ECG), hypotension (low blood pressure), eosinophilia (increase of certain white blood cells, detected by blood test).
Slovenian: Občasni ali redki neželeni učinki (1 na 10.000 do manj kot 1 na 100 bolnikov), ki se lahko pojavijo pri zdravljenju z zdravilom Levviax, so: - zaprtje, anoreksija (izguba teka), stomatitis (vnetje v ustih), peroralna okužba s Candido (glivična okužba), hepatitis, izpuščaj, urtikarija (koprivnica), pruritus (srbenje), ekcem, zaspanost, nespečnost, živčnost, vrtoglavica, parestezije (mravljinčenje v rokah in stopalih), motnje vida (nejasen vid, težave pri fokusiranju, dvojni vid), pordevanje, prehodna izguba zavesti (omedlevanje), motnje srčnega ritma, bradikardija ali palpitacije (spremembe v srčnem utripu ali na EKG), hipotenzija (nizek krvni tlak), eozinofilija (povečanje števila določenih belih krvnih celic, ugotovi se s preiskavo krvi).
English: - The active substance is telithromycin - 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.
Slovenian: - Pomožne snovi v jedru tablete so mikrokristalna celuloza, povidon K25, premreženi natrijev karmelozat, magnezijev stearat ter v filmski oblogi smukec, makrogol 8000, hipromeloza 6 cp, titanov dioksid E171, rumeni železov oksid E172, rdeči železov oksid E172.
English: When midazolam was coadministered with Levviax, 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 Levviax se je AUC midazolama po intravenski aplikaciji midazolama zvišala za 2,2-krat, po peroralni pa za 6,1-krat.
English: If you stop taking Levviax
Slovenian: Če ste prenehali jemati zdravilo Levviax
English: Oral administration of midazolam concomitantly with Levviax should be avoided.
Slovenian: Sočasni peroralni uporabi midazolama in zdravila Levviax se je treba izogibati.
English: Streptococcus pneumoniae * Viridans group streptococci Aerobic Gram- negative bacteria
Slovenian: Streptococcus agalactiae Streptococcus pneumoniae * Streptokoki skupine Viridans
English: Vaginal Candida infection
Slovenian: Bolezni reprodukcijskih organov nožnična okužba s Candido
English: In these patients, co-administration of Levviax and metoprolol, a CYP2D6 substrate, should be considered with caution.
Slovenian: Pri teh bolnikih je potrebna previdnost ob sočasnem jemanju zdravila Levviax in metoprolola, substrata CYP2D6.
English: -Renal impairment
Slovenian: -Okvara ledvic
English: Ireland sanofi-aventis Ltd. Tel: +353 (0) 1 403 56 00
Slovenian: Ireland sanofi-aventis Pharma Ltd. Tel: +353 (0) 1 403 5600
English: Increase in liver enzymes (AST, ALT, alkaline phosphatase)
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišanje jetrnih encimov (AST, ALT, alkalne fosfataze)
English: Name and address of the manufacturer responsible for batch release:
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serije
English: Medicinal products with a potential to prolong QT interval Levviax is expected to increase the plasma levels of cisapride, pimozide, astemizole and terfenadine.
Slovenian: Pričakovati je, da zdravilo Levviax zviša plazemske koncentracije cisaprida, pimozida, astemizola in terfenadina.
English: sanofi-aventis Oy Puh/Tel: +358 (0) 201 200 300
Slovenian: Suomi/Finland sanofi-aventis Oy Puh/Tel: +358 (0) 201 200 300
English: As with nearly all antibacterial agents, diarrhoea, particularly if severe, persistent and /or bloody, during or after treatment with Levviax may be caused by pseudomembranous colitis.
Slovenian: Driska, zlasti če je huda, trdovratna in/ali krvava, je lahko med zdravljenjem z zdravilom Levviax ali po njem - tako kot pri skoraj vseh protibakterijskih zdravilih - posledica psevdomembranskega kolitisa.
English: Opaque PVC/Aluminium perforated unit dose blisters.
Slovenian: Perforirani neprosojni PVC/aluminijasti pretisni omot za enkratni odmerek.
English: - if you have had certain heart problems such as coronary heart disease, ventricular arrhythmias, bradycardia or if you have had certain abnormal blood tests due to medical conditions such as hypokalaemia, hypomagnesaemia.
Slovenian: Bodite posebno pozorni pri jemanju zdravila Levviax - če ste imeli določene težave s srcem, kot so koronarna bolezen srca, prekatne motnje srčnega ritma ali bradikardijo, ali če ste imeli zaradi bolezni nenormalne določene krvne izvide, npr. hipokaliemijo, hipomagneziemijo.
English: Slovenská republika sanofi-aventis Pharma Slovakia s.r.o.
Slovenian: sanofi-aventis Pharma Slovakia s.r.o.
English: Levviax 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 Levviax 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: The recommended dose is 800 mg once a day i.e. two 400 mg tablets once a day.
Slovenian: Priporočeni odmerek je 800 mg enkrat na dan, tj. dve 400 mg tableti enkrat na dan. Tablete je treba pogoltniti cele, z zadostno količino vode.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Aventis Pharma S.A.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Aventis Pharma S.A.
English: Treatment with these agents should be interrupted during Levviax treatment (see section 4.5).
Slovenian: Zdravljenje s temi zdravili je treba med zdravljenjem z zdravilom Levviax prekiniti (glejte poglavje
English: Due to limited experience, Levviax should be used with caution in patients with liver impairment (see section 5.2).
Slovenian: Pri bolnikih z okvaro jeter je treba zdravilo Levviax zaradi omejenih izkušenj uporabljati previdno (glejte poglavje 5.2).
English: if you have had a hepatitis and/or jaundice while taking Levviax in the past.
Slovenian: - če ste imeli hepatitis in/ali zlatenico med jemanjem zdravila Levviax kdaj v preteklosti - če jemljete določena zdravila za uravnavanje koncentracije holesterola ali drugih maščob v krvi.
English: The marketing authorisation holder of Levviax is: Aventis Pharma S.A.
Slovenian: Imetnik dovoljenja za promet z zdravilom Levviax je: Aventis Pharma S.A.
English: In adolescents of 12 years and older, Levviax can be used to treat: infections of the throat.
Slovenian: Pri mladostnikih starih 12 let ali več je z zdravilom Levviax mogoče zdraviti okužbe žrela.
English: - if you suffer from myasthenia gravis, a rare disease which causes muscle weakness.
Slovenian: Ne jemljite zdravila Levviax - če imate miastenijo gravis, redko bolezen, ki povzroča šibkost mišic.
English: HOW TO TAKE LEVVIAX
Slovenian: KAKO JEMATI ZDRAVILO LEVVIAX
English: Alternatively, interruption in the treatment with the CYP3A4 substrate should be made during treatment with Levviax.
Slovenian: Zdravljenje s substratom CYP3A4 med terapijo z zdravilom Levviax je sicer treba prekiniti.
English: What Levviax contains
Slovenian: Kaj vsebuje zdravilo Levviax
English: Mean peak and trough plasma concentrations at steady state in patients were 2.9±1.6 mg/l (range 0.027.6 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: Possible side effects How to store Levviax Further Information
Slovenian: Shranjevanje zdravila Levviax Dodatne Informacije
English: NAME OF THE MEDICINAL PRODUCT Levviax 400 mg film-coated tablets Telithromycin
Slovenian: Levviax 400 mg filmsko obložene tablete telitromicin
English: Impaired hepatic function:
Slovenian: Okvarjeno delovanje ledvic:
English: THE MARKETING AUTHORISATION HOLDER Medicinal product subject to medical prescription
Slovenian: NAČIN IZDAJANJA ZDRAVILA Izdaja zdravila je le na recept.
English: Species for which acquired resistance may be a problem Aerobic Gram-positive bacteria Staphylococcus aureus methicillin resistant (MRSA)+ Streptococcus pyogenes*
Slovenian: Vrste, pri katerih je pridobljena odpornost lahko problem Aerobne grampozitivne bakterije Staphylococcus aureus odporen za meticilin (MRSA)+ Streptococcus pyogenes* Aerobne gramnegativne bakterije Haemophilus influenzae$* Haemophilus parainfluenzae$ Inherentno odporni organizmi Aerobne gramnegativne bakterije Acinetobacter Enterobacteriaceae Pseudomonas Pseudomonas * Klinična učinkovitost je bila dokazana za občutljive izolate pri odobrenih kliničnih indikacijah.
English: Levviax should not be used during and 2 weeks after treatment with CYP3A4 inducers.
Slovenian: Zdravila Levviax se ne sme uporabljati med zdravljenjem z induktorji CYP3A4 in še 2 tedna po zdravljenju z njimi.
English: What Levviax is and what it is used for Before you take Levviax.
Slovenian: Kaj je zdravilo Levviax in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Levviax Kako jemati zdravilo Levviax Možni neželeni učinki
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Levviax 400 mg film-coated tablets
Slovenian: NAVODILO ZA UPORABO Levviax 400 mg filmsko obložene tablete
English: Musculoskeletal, connective tissue
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišični krči
English: Opaque PVC/Aluminium blisters
Slovenian: Neprosojni PVC/aluminijasti pretisni omoti.
English: NAME OF THE MEDICINAL PRODUCT Levviax 400 mg film-coated tablets.
Slovenian: IME ZDRAVILA Levviax 400 mg filmsko obložene tablete
English: 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).
Slovenian: Drugi neželeni učinki, ki se pri zdravljenju z zdravilom Levviax lahko pojavijo pogosto (1 do 10 na 100 bolnikov), so: - slabost, bruhanje, bolečine v trebuhu, napenjanje (čezmerni vetrovi), omotica, glavoboli, motnje okusa, nožnična okužba s Candido (glivična okužba, ki jo spremlja lokalno srbenje, pekoč občutek in bel izcedek), zvišanje jetrnih encimov (ugotovi se s preiskavo krvi).
English: Exacerbations of myasthenia gravis have been reported in patients treated with telithromycin and sometimes occurred within a few hours of the first dose.Reports have included death and life threatening acute respiratory failure with rapid onset (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili s telitromicinom, so poročali o poslabšanjih miastenije gravis, katera so se včasih pojavila že v nekaj urah po zaužitju prvega odmerka.
English: There is no clinically relevant pharmacokinetic interaction of Levviax and theophylline administered as extended release formulation.
Slovenian: Med zdravilom Levviax in teofilinom, uporabljenim v obliki s podaljšanim sproščanjem, ni klinično pomembnih farmakokinetičnih interakcij.
English: Parosmia
Slovenian: Druge
English: Limit driving or other hazardous activities while taking Levviax.
Slovenian: Med jemanjem zdravila Levviax morate vožnjo vozil in opravljanje drugih nevarnih opravil omejiti.
English: Lancefield group C and G ( ß haemolytic ) streptococci Streptococcus agalactiae
Slovenian: streptokoki skupine C in G po Lancefieldovi (ßhemolitični)
English: In patients of 18 years and older, according to the indication, the treatment regimen will be: - 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 18 let in starejših, je shema zdravljenja glede na indikacijo: - Pljučnica, dobljena v domačem okolju: 800 mg enkrat na dan od 7 do 10 dni.
English: Tablet core:
Slovenian: Okvarjeno delovanje jeter:
English: HOW TO STORE LEVVIAX
Slovenian: SHRANJEVANJE ZDRAVILA LEVVIAX
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 400 mg of telithromycin
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka filmsko obložena tableta vsebuje 400 mg telitromicina.
English: Oral Candida infection, stomatitis anorexia, constipation, ,
Slovenian: Bolezni prebavil driska navzea, bruhanje, bolečine v prebavilih, flatulenca oralna okužba s Candido , stomatitis, anoreksija, zaprtje psevdomembran ski kolitis
English: Italia sanofi-aventis S.p.A. Tel. +39 02 393 91
Slovenian: Tel. +39 02 393 91
English: Most events were mild to moderate; however, severe cases have been reported.
Slovenian: Večina dogodkov je bila blagih do zmernih, vendar pa so poročali tudi o hudih primerih (glejte poglavji 4.7 in 4.8).
English: During post-marketing experience the following reactions have been reported (frequency unknown): -Immune system disorders: Angioneurotic oedema, anaphylactic reactions including anaphylactic shock -Cardiac disorders: QT/QTc interval prolongation -Gastrointestinal disorders: Pancreatitis, -Hepato-biliary disorders: Severe hepatitis and liver failure (see section 4.4) -Nervous system disorders: Cases of rapid onset of exacerbation of myasthenia gravis have been reported (see sections 4.3 and 4.4).
Slovenian: Med postmarketinškim obdobjem so poročali o naslednjih reakcijah (pogostost neznana): - Bolezni imunskega sistema: angionevrotični edem, anafilaktične reakcije vključno z anafilaktičnim šokom.
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT Not applicable
Slovenian: DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Enterobacteriaceae
Slovenian: do{MM/LLLL}
English: Vertigo somnolence, nervousness, insomnia,
Slovenian: Bolezni živčevja omotica, glavobol, motnje okusa vrtoglavica, somnolenca, živčnost, nespečnost prehodna izguba zavesti, parestezije parozmija