natgillin/translations-raw huggingface dataset:
- 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.