natgillin/translations-raw huggingface dataset:
Concomitant treatment with these medicinal products is likely to result in subtherapeutic levels of telithromycin and therefore encompass a risk of treatment failure (see section 4.5). 
Med sočasno uporabo teh zdravil obstaja možnost za pojav subterapevtskih koncentracij telitromicina in s tem za neuspeh zdravljenja (glejte poglavje 4.5).
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. 
Med sočasno uporabo simvastatina in zdravila Ketek 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.
There is no pharmacodynamic or clinically relevant pharmacokinetic interaction with low-dose triphasic oral contraceptives in healthy subjects. 
Pri zdravih preiskovankah ni farmakodinamičnih ali klinično pomembnih farmakokinetičnih interakcij z nizkoodmernimi trifaznimi peroralnimi kontraceptivi.
>0.5 mg/l 
Odporni > 0,5 mg/l > 0,5 mg/l > 8 mg/l > 0,5 mg/l
If possible take the tablets before going to bed, to reduce the potential impact of visual disturbances and loss of consciousness. 
Če je možno tablete jemljite pred spanjem, da bi se tako zmanjšal možen vpliv na motnje vida in izgubo zavesti.
Concomitant administration with simvastatin, atorvastatin, and lovastatin. 
Sočasna uporaba s simvastatinom, atorvastatinom in lovastastinom.
Due to its CYP3A4 inhibitory potential, telithromycin can increase blood concentrations of these CYP34A4 substrates. 
Zaradi potenciala za zaviranje CYP3A4 lahko telitromicin zviša koncentracije teh substratov CYP3A4 v krvi.
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 
Če je zdravljenje s telitromicinom potrebno, je treba bolnike zdraviti alternirajoče, z izmeničnimi dnevnimi odmerki 800 mg in 400 mg in začetnim odmerkom 800 mg.
Plasma exposures based on free fraction of active substance, at the no observed adverse effect levels ranged from 1.6 to 13 times the expected clinical exposure. 
Glede na prosto frakcijo zdravilne učinkovine, je bila plazemska izpostavljenost ob koncentracijah, pri katerih ni opaznih neželenih učinkov, od 1,6- do 13-kratne pričakovane klinične izpostavljenosti.
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. 
Zaradi možnih težav z vidom, izgube zavesti, zmedenosti ali halucinacije morajo bolniki med zdravljenjem z zdravilom Ketek omejiti aktivnosti, kot so vožnja motornih vozil, upravljanje s težkimi stroji ali vključevanje v druge nevarne aktivnosti.
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. 
Z zdravilom Ketek ne smete uporabljati naslednjih zdravil: - zdravila za obvladovanje koncentracije holesterola ali drugih maščob v krvi,kot je simvastatin, atorvastatin ali lovastatin, ker se lahko neželeni učinki zdravil povečajo.
The major CYP450 enzyme involved in the metabolism of telithromycin is CYP3A4. 
Glavni encim CYP450, udeležen v presnovi telitromicina, je CYP3A4.
When telithromycin is discontinued, cyclosporin, tacrolimus or sirolimus levels must be again carefully monitored and their dose increased as necessary. 
Po koncu uporabe telitromicina je treba koncentracije ciklosporina, takrolimusa ali sirolimusa znova natančno nadzorovati in njihove odmerke zvečati, če je potrebno.
• Tonsillitis/pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide resistant S. pyogenes, when mediated by ermTR or mefA (see sections 4.4 and 5.1). 
Pri bolnikih, starih 12 let in starejših: - Tonzilitisa/faringitisa, ki ga povzroča Streptococcus pyogenes, kot alternativa, kadar betalaktamski antibiotiki niso primerni v državah/regijah s signifikantno prevalenco proti makrolidom odpornega S. pyogenes, če je odpornost posledica ermTR ali mefA (glejte
Streptococcus pneumoniae does not demonstrate cross-resistance between erythromycin A and 
Streptococcus pneumoniae ne kaže navzkrižne odpornosti med eritromicinom A in telitromicinom.
Therefore the MIC breakpoint for telithromycin was set to categorise wild-type H. influenzae as having intermediate susceptibility. 
Zato je bila mejna vrednost MIC za telitromicin postavljena tako, da opredeljuje občutljivost divjega tipa H. influenzae
If you are breast-feeding do not take Ketek. 
Če dojite, ne jemljite zdravila Ketek.
The correlation between macrolide MICs and clinical outcome is weak for H. influenzae. 
1Pri H. influenzae je korelacija med MIC makrolidov in kliničnim izidom šibka.
Ketek may cause adverse reactions such as visual disturbances, confusion or hallucination which may reduce the capacity for the completion of certain tasks. 
Ketek lahko povzroči neželene učinke, kot so motnje vida, zmedenost ali halucinacije, ki lahko zmanjšajo zmožnost za opravljanje nekaterih nalog.
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 
Pri nekaterih organizmih, ki so zaradi inducibilne ekspresije determinante odpornosti MLSB odporni proti eritromicinu A, je afiniteta telitromicina za ribosomsko podenoto 50S več kot 20-krat tolikšna kot afiniteta eritromicina A.
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. 
Pri bolnikih s hudo okvarjenim delovanjem ledvic in/ali jeter je sočasna uporaba zdravila Ketek in močnih inhibitorjev CYP3A4, kot so npr. zaviralci proteaz ali azolski antimikotiki (npr. ketokonazol, flukonazol), kontraindicirana.
- 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. 
- 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).
Telithromycin is an inhibitor of CYP3A4 and CYP2D6, but has no or limited effect on CYP1A, 2A6, 2B6, 2C8, 2C9, 
Telitromicin je zaviralec CYP3A4 in CYP2D6, na CYP1A, 2A6, 2B6, 2C8, 2C9, 2C19 in 2E1 pa ima majhen učinek ali ga sploh nima.
There were no reports of TdP or other serious ventricular arrhythmias or related syncope in the clinical program and no subgroups at risk were identified. 
V kliničnem programu niso poročali o torsade de pointes ali drugih resnih ventrikularnih aritmijah ali s tem povezanih sinkopah; prav tako niso odkrili nobenih
Calcium channel blockers that are metabolized by CYP3A4 
Zaviralci kalcijevih kanalčkov, ki se presnavljajo s CYP3A4
itching, loss of appetite or abdominal pain (uncommon). 
izguba apetita ali bolečine v trebuhu (občasno).
Reproduction toxicity studies showed reduced gamete maturation in rat and adverse effects on fertilization. 
Raziskave vpliva na sposobnost razmnoževanja so pri podganah pokazale zmanjšano dozorevanje gamet in neželene učinke na oploditev.
- 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) 
- izpuščaj, koprivnica (urtikarija), srbenje, ekcem, - zaspanost, nespečnost (insomnija), živčnost, vrtoglavica, - mravljinčenje v rokah in stopalih (parestezija), - motnje vida (nejasen vid, težave pri fokusiranju, dvojni vid) (prosimo preberite poglavje 2), - pordevanje, omedlevanje (prehodna izguba zavesti), - spremembe v srčnem utripu (npr. počasno bitje srca) ali nepravilnosti v elektrokardiogramu
These hepatic reactions were observed during or immediately after treatment, and in most cases were reversible after discontinuation of telithromycin. 
Te jetrne reakcije so opazili med ali takoj po zdravljenju in so bile večinoma
If telithromycin is co-administered with dabigatran etexilate close clinical monitoring (looking for signs of bleeding or anaemia) should be exercised. 
Če telitromicin uporabljamo sočasno z dabigatran eteksilatom, je treba izvajati skrben klinični nadzor, da bi odkrili znake krvavitve ali anemije.
Interaction studies with itraconazole and ketoconazole, two CYP3A4 inhibitors, showed that maximum plasma concentrations of telithromycin were increased respectively by 1.22 and 1.51 fold and AUC by respectively 1.54 fold and 2.0 fold. 
V raziskavah interakcij z itrakonazolom in ketokonazolom, zaviralcema CYP3A4, se je najvišja koncentracija telitromicina v plazmi s prvim zvišala za 1,22-krat in z drugim za 1,51-krat, AUC pa s prvim za 1,54-krat in z drugim za 2,0-krat.
Taking Ketek may cause side effects such as visual disturbances, confusion or hallucination which may reduce the capacity to carry out certain tasks. 
Jemanje zdravila Ketek lahko povzroči neželene učinke, kot so motnje vida, zmedenost ali halucinacije, ki lahko zmanjšajo zmožnost za opravljanje določenih nalog.
Exacerbations of myasthenia gravis have been reported in patients treated with telithromycin and sometimes occurred within a few hours of the first dose. 
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.
- 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). 
- Pri odraslih se zdravilo Ketek uporablja za zdravljenje okužb žrela, okužb sinusov (prazne votline v kosteh okrog nosa) in okužb pljuč pri bolnikih z dolgotrajnimi težavami z dihanjem in - Pri mladostnikih starih 12 let ali več se z zdravilom Ketek zdravi okužbe žrela.
In addition, rare cases of transient loss of consciousness, which may be preceded by vagal symptoms, have been reported (see section 4.8). 
Poročali so tudi o redkih primerih prehodne izgube zavesti, pred katero se lahko pojavijo vagalni simptomi (glejte poglavje 4.8).
Concomitant administration of Ketek and any of these medicinal products is contraindicated (see section 4.3). 
Sočasna uporaba zdravila Ketek in katerega od teh zdravil je kontraindicirana (glejte poglavje 4.3).
- The active substance is telithromycin. 
- Zdravilna učinkovina je telitromicin.
Ketek tablets are presented in blister packs. 
Tablete Ketek so pakirane v pretisnih omotih.
Due to a potential to increase the QT interval, Ketek should be used with care in patients with coronary heart disease, a history of ventricular arrhythmias, uncorrected hypokalaemia and/or hypomagnesaemia, or bradycardia (<50 bpm), during concomitant administration of Ketek with QT interval prolonging agents, or in patients concomitantly treated with potent CYP 3A4 inhibitors such as protease inhibitors or azole antifungals (e.g. ketoconazole, fluconazole) (see sections 4.3 and 4.5). 
Zaradi možnosti podaljšanja intervala QT je treba zdravilo Ketek uporabljati previdno pri bolnikih s koronarno boleznijo srca, z anamnezo ventrikularnih aritmij, nekorigirano hipokaliemijo in/ali hipomagneziemijo, ali bradikardijo (< 50 utripov/min), med sočasno uporabo zdravila Ketek z zdravili, ki podaljšujejo interval QT, ali pri bolnikih, ki se sočasno zdravijo z močnimi zaviralci CYP3A4, kot so npr. zaviralci proteaz ali azolski antimikotiki (npr. ketokonazol, flukonazol) (glejte poglavji 4.3 in 4.5).
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). 
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) - 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).
Ketek should therefore not be used concomitantly with simvastatin, atorvastatin, or lovastatin (see section 4.3). 
Zdravila Ketek se tako ne sme uporabljati sočasno s simvastatinom, atorvastatinom ali lovastatinom (glejte poglavje 4.3).
Ketek has been shown to increase the plasma concentrations of digoxin, a P-glycoprotein substrate. 
Dokazano je, da Ketek zviša koncentracije digoksina, substrata glikoproteina P, v plazmi.
Nevertheless, monitoring of serum digoxin level should be considered during concomitant administration of digoxin and Ketek. 
Kljub temu je treba med sočasno uporabo digoksina in zdravila Ketek razmisliti o nadziranju koncentracije digoksina v serumu.
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). 
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 Ketek (glejte poglavje 4.2).
Telithromycin is metabolised primarily by the liver. 
Telitromicin se presnavlja predvsem v jetrih.
Patients with concomitant treatment of pravastatin, rosuvastatin or fluvastatin should be carefully monitored for signs and symptoms of myopathy and rhabdomyolysis. 
Bolnike je treba med sočasnim zdravljenjem s pravastatinom, rosuvastatinom in fluvastatinom natančno spremljati glede znakov in simptomov miopatije in rambomiolize.
Telithromycin is metabolised both by CYP450 isoenzymes and non-CYP enzymes. 
Telitromicin se presnavlja tako z izoencimi CYP450 kot z ne-CYP encimi.
+ Telithromycin is not active against organisms that constitutively express the MLSB resistance determinant (cMLSB). 
+ Telitromicin ni aktiven proti organizmom, ki imajo konstitutivno eksprimirano determinanto odpornosti MLSB (cMLSB).
Ketek 400 mg film-coated tablets Telithromycin 
Ketek 400 mg filmsko obložene tablete telitromicin
These events have not been associated with signs of ocular abnormality (see sections 4.4 and 4.7). 
Nastop motenj vida je lahko nenaden.Ti dogodki niso bili povezni z znaki abnormalnosti na očeh (glejte poglavji 4.4 in 4.7).
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. 
Sočasna uporaba močnih zaviralcev CYP3A4 (kot je telitromicin) in zaviralcev kalcijevih kanalčkov, ki se presnavljajo s CYP3A4 (npr. verapamil, nifedipin, felodipin), lahko povzroči hipotenzijo, bradikardijo ali izgubo zavesti, zato se ji moramo izogibati.
What Ketek contains 
Kaj vsebuje zdravilo Ketek
The plasma trough levels, Cmax, AUC and renal clearance were increased by 20%, 73%, 37% and 27% respectively, in healthy volunteers. 
Pri zdravih prostovoljcih so se najnižje koncentracije v plazmi zvišale za 20%, Cmax za 73%, AUC za 37 in ledvični očistek za 27%.
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. 
Telitromicin zavira tudi glikoprotein P. Sočasno jemanje zdravila Ketek in zdravil, ki so substrati za glikoprotein P, lahko povzroči povečano izpostavljenost substratom za glikoprotein P, kot sta digoksin in dabigatran eteksilat.
Following oral administration, telithromycin is fairly rapidly absorbed. 
Telitromicin se po peroralni uporabi precej hitro absorbira.
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). 
Med njimi so zdravila, ki se uporabljajo za zdravljenje nenormalnega srčnega ritma (antiaritmiki, kot so kinidin, amiodaron), za zdravljenje depresije (citalopram, triciklični antidepresivi), metadon, nekateri antipsihotiki (fenotiazini), nekateri antibiotiki (fluorokinoloni kot je moksifloksacin), nekateri antimikotiki (flukonazol, pentamidin), in nekatera protivirusna zdravila
These effects showed a tendency to regress after cessation of treatment. 
Ti učinki so po koncu zdravljenja kazali nagnjenost k vračanju v prejšnje stanje.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg of telithromycin. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 400 mg telitromicina.
In these patients, co-administration of Ketek and metoprolol, a CYP2D6 substrate, should be considered with caution. 
Pri teh bolnikih je potrebna previdnost ob sočasnem jemanju zdravila Ketek in metoprolola, substrata CYP2D6.
Ketek may be taken with or without food. 
Zdravilo Ketek skupaj s hrano, pijačo in alkoholom Ketek lahko jemljete s hrano ali brez nje.
• cisapride (digestive problems) 
• cisaprid (pri prebavnih težavah)
Telithromycin is not active against organisms that constitutively express the MLSB resistance determinant (cMLSB). 
Telitromicin ni aktiven proti organizmom, ki imajo konstitutivno eksprimirano determinanto odpornosti MLSB (cMLSB).
Increased anticoagulant activity has been reported in patients simultaneously treated with anticoagulants and antibiotics, including telithromycin. 
Pri bolnikih, ki so istočasno prejemali antikoagulante in antibiotike, vključno s telitromicinom, so poročali o povečani aktivnosti antikoagulantov.
Telithromycin is a semisynthetic derivative of erythromycin A belonging to the ketolides, a class of antibacterial agents related to macrolides. 
Telitromicin je polsintetični derivat eritromicina A in spada med ketolide, skupino makrolidom
CYP3A4 substrates 
Substrati encima CYP3A4
- Worsening of a condition called myasthenia gravis, a rare disease which causes muscle 
- Poslabšanje stanja, imenovanega miastenija gravis, redke bolezni, ki povzroči šibkost mišic - Nepravilen srčni utrip.
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. 
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.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release: 
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
Slight reductions in fertility indices were seen in rats at parentally toxic doses higher than 150 mg/kg. 
Pri parenteralni aplikaciji toksičnih odmerkov, višjih od 150 mg/kg, so pri podganah opazili rahla znižanja indeksov plodnosti.