natgillin/translations-raw huggingface dataset:
There are no adequate data from the use of Ketek in pregnant women.
Ni zadostnih podatkov o uporabi zdravila Ketek pri nosečnicah.
The above serious side effects may require urgent medical attention.
Zgoraj omenjeni resni neželeni utegnejo zahtevati nujno medicinsko pomoč.
The safety and efficacy of Ketek in children below 12 years of age have not been established (see section 5.2).
Varnost in učinkovitost zdravila Ketek pri otrocih starih do 12 let ni bila dokazana (glejte poglavje 5.2).
- hallucination (seeing or hearing things that are not there)
- halucinacije (slišanje in videnje stvari, ki jih ni),
They typically occurred within a few hours after the first or second dose, recurred upon subsequent dosing, lasted several hours and were fully reversible either during therapy or following the end of treatment.
Značilno so se pojavile v nekaj urah po prvem ali drugem odmerku, se ponovile po nadaljnjem odmerjanju, trajale nekaj ur in bile povsem reverzibilne bodisi med zdravljenjem ali po njegovem koncu.
Do not use this medicine after the expiry date which is stated on the pack.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Ketek should not be used during pregnancy unless clearly necessary.
Zdravila Ketek ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Patients should be cautioned about the potential effects of these events on the ability to drive or operate machinery.
Bolnike je treba opozoriti na potencialne učinke takšnih dogodkov glede zmožnosti vožnje ali
Antibiotics stop the growth of bacteria which cause
Antibiotiki ustavijo rast bakterij, ki povzročajo okužbe.
∗ Clinical efficacy has been demonstrated for susceptible isolates in the approved clinical indications.
* Klinična učinkovitost je bila dokazana za občutljive izolate pri odobrenih kliničnih indikacijah.
- 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).
- če ste alergični na telitromicin, kateri koli makrolidni antibiotik ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
This may be a sign of bowel inflammation which can occur following treatment with antibiotics.
Morda gre za znak vnetja črevesa, ki se lahko pojavi po zdravljenju z antibiotiki.
If possible, take your tablets or the box with you to show the doctor or pharmacist.
Če je mogoče, vzemite s seboj tablete ali škatlico, da jih boste pokazali zdravniku ali farmacevtu.
If you stop taking the tablets too soon, the infection may return, or your
Če tablete nehate jemati prekmalu, se okužba lahko vrne ali se vam stanje
• dronedarone (for atrial fibrillation)
• dronedaron (za atrijsko fibrilacijo)
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
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
- increase of certain white blood cells, detected by blood test (eosinophilia).
- povečanje števila določenih belih krvnih celic, ugotovi se s preiskavo krvi (eozinofilija).
What you need to know before you take Ketek
Kaj morate vedeti, preden boste vzeli zdravilo Ketek
What Ketek is and what it is used for What you need to know before you take Ketek
Kaj je zdravilo Ketek in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ketek
They are available in packs of 10, 14, 20 and 100 tablets.
Na voljo so v pakiranjih po 10, 14, 20 in 100 tablet.
More than 80% of MRSA express cMLSB.
Več kot 80 % MRSA ima izraženo
Due to the potential for the prolongation of the QT interval and increased risk of arrhythmia, ECG monitoring must take place.
Zaradi možnega podaljšanja intervala QT in večjega tveganja za aritmije je potreben nadzor z EKG.
In 2,461 patients treated by Ketek in phase III clinical trials, and during post-marketing experience, the following undesirable effects possibly or probably related to telithromycin have been reported.
Pri 2.461 bolnikih, zdravljenih z zdravilom Ketek v kliničnih preskušanjih III. faze in med postmarketinško izkušnjo, so bili opisani naslednji neželeni učinki, ki so morda ali verjetno povezani s telitromicinom in so navedeni v tabeli.
The midazolam halflife was increased about 2.5-fold.
Razpolovni čas midazolama se je podaljšal za približno 2,5-krat.
Blood electrolytes (especially potassium) must be controlled.
Kontrolirati je treba elektrolite v krvi (zlasti kalij).
In clinical trials the effect on QTc was small (mean of approximately 1 msec).
V kliničnih preskušanjih je bil učinek na QTc majhen (v povprečju približno 1 milisekundo).
• pimozide (psychiatric problems)
• pimozid (pri psihiatričnih težavah)
This administration corresponds to free active substance systemic exposure levels of at least 9 times the expected levels in human after 1 month and less than the expected level in humans after 6 months, respectively.
Takšna uporaba ustreza sistemski izpostavljenosti proste zdravilne učinkovine in sicer vsaj 9-kratni pričakovani ravni pri človeku po 1 mesecu in manj kot 1kratni pričakovani ravni pri človeku po 6 mesecih.
You may experience this within a few hours of taking your daily dose of Ketek the first or second time.
Doživite jih lahko v nekaj urah po tem, ko prvič ali drugič zaužijete dnevni odmerek zdravila Ketek.
Limited data, obtained in paediatric patients 13 to 17 years of age, showed that telithromycin concentrations in this age group were similar to the concentrations in patients 18 to 40 years of age.
Podatki, ki jih je za pediatrične bolnike, stare od 13 do 17 let, malo, kažejo, da so koncentracije telitromicina v tej starostni skupini podobne koncentracijam pri bolnikih, starih od 18 do 40 let.
Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 ANTONY France
Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 ANTONY Francija
Available as packs of 10, 14, 20 and 100 tablets.
Na voljo so pakiranja po 10, 14, 20 in 100 tablet.
Based on observed data, a 600 mg daily dose is approximately equivalent with the target exposure observed in healthy subjects.
Glede na podatke je odmerek 600 mg približno ekvivalenten ciljni izpostavljenosti opazovani pri zdravih osebah.
The degree of inhibition with different CYP3A4 substrates is difficult to predict.
Stopnjo inhibicije z različnimi substrati CYP3A4 je težko predvideti.
The marketing authorisation holder of Ketek is:
Imetnik dovoljenja za promet z zdravilom Ketek je:
Most of them are mild and transient, but very rare cases of serious adverse liver reactions and liver failure, including fatal cases, have been reported.
Večina jih je blagih in prehodnih, toda poročali so o zelo redkih primerih resnih škodljivih jetrnih reakcij in odpovedi jeter, vključno s smrtnimi primeri.
Approximately one-third of telithromycin was eliminated unchanged; 20% in faeces and 12% in urine.
Približno ena tretjina telitromicina se je izločila nespremenjenega; 20% z blatom in 12% z urinom.
Its principal circulating metabolite represents approximately 13% of telithromycin AUC, and has little antimicrobial activity compared with the parent medicinal product.
Njegov glavni presnovek v obtoku predstavlja približno 13% AUC telitromicina in ima v primerjavi z matičnim zdravilom majhno protimikrobno delovanje.
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.
V predelih z veliko incidenco odpornosti proti eritromicinu A je posebno pomembno upoštevati razvoj vzorca dovzetnosti za telitromicin in druge antibiotike.
These changes in pharmacokinetics do not necessitate dosage adjustment.
Te spremembe farmakokinetike ne zahtevajo prilagoditve odmerka.
If pseudomembranous colitis is suspected, the treatment must be stopped immediately and patients should be treated with supportive measures
Če obstaja sum na psevdomembranski kolitis, je treba zdravljenje takoj prekiniti, bolnika pa zdraviti s podpornimi ukrepi
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, as some of them could affect or be
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda zečeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta, ker lahko nekatera
Patients should be informed that these adverse reactions may occur as early as after the first dose of medicinal product.
Bolnike je treba seznaniti, da seti neželeni učinki lahko pojavijo že po prvem odmerku zdravila.
The onset of the visual reaction may be sudden.
Nastop motnje vida je lahko nenaden.
Ketek is used to treat infections due to bacteria against which the medicine is active.
Ketek se uporablja za zdravljenje okužb z bakterijami, proti katerim to zdravilo deluje.
- medicines known to affect the way your heart beats (drugs that prolong the QT interval).
- zdravila, za katera je znano, da vplivajo na bitje vašega srca (zdravila, ki podaljšajo interval QT).
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
These symptoms may appear as early as after the first dose of Ketek.
Takšni simptomi se lahko pojavijo že po prvem odmerku zdravila Ketek.
Previous history of hepatitis and/or jaundice associated with the use of telithromycin.
Anamneza hepatitisa in/ali zlatenice, povezanih z uporabo telitromicina.
Visual disturbances (<1%) associated with the use of Ketek, including blurred vision, difficulty focusing and diplopia, were mostly mild to moderate, but severe reactions have also been reported.
Motnje vida (< 1%), povezane z uporabo zdravila Ketek, vključno z nejasnim vidom, težavami pri fokusiranju in diplopijo, so bile večinoma blage do zmerne, vendar so poročali tudi o hudih primerih.
Intravenous dosage of midazolam should be adjusted as necessary and monitoring of the patient should be undertaken.
Intravenski odmerek midazolama je treba prilagoditi, če je potrebno, bolnika pa je potrebno nadzirati.
If you stop taking the tablets too soon you may also create a bacterial resistance to the medicine.
Če tablete nehate jemati prekmalu, lahko poleg tega povzročite razvoj odpornosti bakterij proti
The increase exposure to metoprolol may be of clinical importance in patients with heart failure treated with metoprolol.
Povečana izpostavljenost metoprololu bi lahko bila klinično pomembna pri bolnikih s srčnim popuščanjem, zdravljenih z metoprololom.
When prescribing Ketek, consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1).
Pri predpisovanju zdravila Ketek je treba upoštevati uradne smernice za ustrezno uporabo protibakterijskih zdravil in podatke o lokalni prevalenci odpornosti (glejte tudi poglavji 4.4 in 5.1).
In similarity to some macrolides, telithromycin caused a prolongation of QTc interval in dogs and on action potential duration in rabbit Purkinje fibers in vitro.
Podobno kot nekateri makrolidi je telitromicin povzročil podaljšanje QTc intervala pri psih ter trajanje akcijskega potenciala v kunčjih Purkinjevih vlaknih in vitro.
Telithromycin is excreted in the milk of lactating animals, at concentrations about 5 times those of maternal plasma.
Telitromicin se izloča z mlekom doječih živali v koncentracijah, ki so približno 5-krat tolikšne kot v materini plazmi.
If any of these apply to you, or if you are not sure, tell your doctor before taking Ketek.
Če kaj od tega velja za vas ali če niste gotovi, se posvetujte z zdravnikom preden vzamete zdravilo
- if you or someone in your family are known to have an abnormality of electrocardiogram (ECG) called “long QT syndrome”.
- če imate vi ali kdo v vaši družini v elektrokardiogramu (EKG) nepravilnost, imenovano "sindrom podaljšanega intervala QT".
The same precautions should also apply to the other benzodiazepines which are metabolised by CYP3A4, (especially triazolam but also to a lesser extent alprazolam).
Ista opozorila je treba upoštevati pri drugih benzodiazepinih, ki se presnavljajo s CYP3A4 (zlasti pri triazolamu, v manjši meri pa tudi pri alprazolamu).
Caution should be taken when S. aureus is the suspected pathogen and there is a likelihood of erythromycin resistance based on local epidemiology.
Previdnost je potrebna, če je domnevni patogen S. aureus in je glede na lokalno epidemiologijo verjetno, da je odporen proti eritromicinu.
Hypokalaemia and quinidine had additive/supraadditive effects in vitro while potentiation was evident with sotalol.
Hipokaliemija in kinidin sta imela in vitro aditivne/supraaditivne učinke, pri sotalolu pa je bila opazna potenciacija.
It may happen again when you take the next dose of Ketek.
Lahko se pojavijo tudi, ko zaužijete naslednji odmerek zdravila Ketek.
• a medicine called protease inhibitor (anti-HIV treatment)
• zdravilo imenovano proteazni inhibitor (za zdravljenje okužbe s HIV),
Effects were evident at plasma levels of free drug 8 to 13 times the expected clinical level.
Učinki so bili očitni pri plazemskih koncentracijah prostega zdravila, ki so bile od 8- do 13-krat višje od pričakovane klinične koncentracije.
The recommended dose is 800 mg once a day i.e. two 400 mg tablets once a day.
Priporočeni odmerek je 800 mg enkrat na dan, tj. dve 400 mg tableti enkrat na dan.
Ranitidine (taken 1 hour before Ketek) and antacid containing aluminium and magnesium hydroxide has no clinically relevant influence on telithromycin pharmacokinetics.
Ranitidin (zaužit 1 uro pred zdravilom Ketek) ali antacid z aluminijevim in magnezijevim hidroksidom nima klinično pomembnega vpliva na farmakokinetiko telitromicina.
The combination is contraindicated (see section 4.3).
Ta kombinacija je kontraindicirana (glejte poglavje 4.3).
- other medicines that can prolong the QT interval of the electrocardiogram (ECG), such as:
- druga zdravila, ki lahko podaljšajo interval QT v elektrodiagramu (EKG), kot so:
- if you suffer from myasthenia gravis, a rare disease which causes muscle weakness.
- če imate miastenijo gravis, redko bolezen, ki povzroča šibkost mišic.
Pharmacotherapeutic group: antibacterials for systemic use, macrolides, lincosamides and streptogramins, ATC Code: J01FA15.
Farmakoterapevtska skupina: protimikrobne učunkovine za sistemsko uporabo, makrolidi, linkozamidi in streptogramini, oznaka ATC: J01FA15.
History of congenital or a family history of long QT syndrome (if not excluded by ECG) and in patients with known acquired QT interval prolongation.
Anamneza kongenitalnega sindroma podaljšanega intervala QT ali družinska anamneza tega sindroma (če ni izključen z EKG) ter pri bolnikih s pridobljenim podaljšanjem intervala QT.
The main circulating compound in plasma is telithromycin.
Glavna spojina, ki kroži v plazmi, je telitromicin.
L. pneumophila is highly susceptible to telithromycin in vitro, however, the clinical experience of the treatment of pneumonia caused by legionella is limited.
L. pneumophila je in vitro zelo občutljiva za telitromicin, a klinične izkušnje z zdravljenjem pljučnic, ki jih povzroča legionela, so omejene.
B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Romania
B-dul Theodor Pallady nr.50, sector 3, Bucureşti, cod 032266, Romunija
If you develop severe or prolonged or bloody diarrhoea during or after taking Ketek tablets, consult your doctor immediately since it may be necessary to interrupt the treatment.
Če se vam med jemanjem tablet Ketek ali po njem pojavi huda, dolgotrajna ali krvava driska, se nemudoma posvetujte z zdravnikom, ker bo zdravljenje morda treba prekiniti.
The rate and extent of absorption is unaffected by food intake, and thus Ketek tablets can be given without regard to food.
Uživanje hrane ne vpliva na hitrost niti na obseg absorpcije, tako da je mogoče tablete Ketek jemati ne glede na hrano.
The usual duration of treatment is 5 days for infections of the throat, infections of the sinuses, chest infections in patients with long standing breathing difficulties and 7 to 10 days for pneumonia.
Ponavadi traja zdravljenje 5 dni pri okužbah žrela, okužbah sinusov, okužbah pljuč pri bolnikih z dolgotrajnimi težavami z dihanjem ter od 7 do 10 dni pri pljučnici.
Exposure to telithromycin in vitro did select for pneumococcal mutants with increased MICs of telithromycin, generally resulting in MIC values of ≤1 mg/l.
Izpostavljenost telitromicinu in vitro je povzročila selekcijo pnevmokoknih mutantov s povečanimi MIC telitromicina; to je na splošno povzročilo vrednosti MIC ≤ 1 mg/l.
Experience of treatment of infections caused by penicillin/or erythromycin resistant S. pneumoniae is limited, but so far, clinical efficacy and eradication rates have been similar compared with the treatment of susceptible S. pneumoniae.
Izkušnje z zdravljenjem okužb, ki jih povzroča na penicilin ali eritromicin odporni S. pneumoniae, so omejene, vendar so bili klinična učinkovitost in deleži eradikacije doslej podobni kot pri zdravljenju dovzetnega S. pneumoniae.
There was evidence of reversibility upon cessation of treatment.
Ugotovljena je bila reverzibilnost po prekinitvi zdravljenja.
The absolute bioavailability is about 57% after a single dose of 800 mg.
Absolutna biološka uporabnost po enem 800 mg odmerku je približno 57%.
Although Ketek has no clinically relevant pharmacokinetic or pharmacodynamic interaction with warfarin after single dose administration, more frequent monitoring of prothrombin time/INR (International Normalised Ratio) values should be considered during concomitant treatment.
Čeprav po uporabi enega odmerka Ketek nima klinično pomembnih farmakokinetičnih ali farmakodinamičnih interakcij z varfarinom, je potrebno razmisliti o pogostejšem nadziranju protrombinskega časa/INR (»International Normalised Ratio«) med sočasnim zdravljenjem.
In comparative trials, similar effects to those observed with clarithromycin were seen with an on-therapy ΔQTc >30 msec in 7.6% and 7.0% of cases, respectively.
V primerjalnih preskušanjih so opažali učinke, podobne kot pri klaritromicinu, z medterapijskim ΔQTc > 30 milisekund v 7,6% oz. 7,0% primerov.
The effect of ritonavir on telithromycin has not been studied and could lead to larger increase in telithromycin exposure.
Učinek ritonavirja na telitromicin ni raziskan; lahko bi povzročil izrazitejše zvečanje izpostavljenosti telitromicinu.
The mean maximum white blood cell concentration of telithromycin was 83±25 mg/l.
Povprečna najvišja koncentracija telitromicina v belih krvnih celicah je bila 83 ± 25 mg/l.
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the
Če predložitev PSUR in posodobitev RMP sovpadata, se lahko predložita sočasno.
If you accidentally take one tablet too many, nothing is likely to happen.
Če ste vzeli večji odmerek zdravila Ketek, kot bi smeli Če po nesreči vzamete eno tableto preveč, se najverjetneje ne bo zgodilo nič.
These changes in the pharmacokinetics of telithromycin do not necessitate dosage adjustment as telithromycin exposure remains within a well tolerated range.
Te spremembe farmakokinetike telitromicina ne zahtevajo prilagoditve odmerka, ker ostaja izpostavljenost telitromicinu znotraj območja, ki ga bolniki dobro prenašajo.
The other side effects listed below are given with an estimation of the frequency with which they may occur with Ketek:
Drugi neželeni učinki, našteti spodaj, navedeni z oceno pogostnosti, s katero se lahko pojavijo pri zdravilu Ketek so:
Treatment with these agents should be interrupted during Ketek treatment.
Zdravljenje s temi zdravili je treba med terapijo z zdravilom Ketek prekiniti.
Ketek is not recommended in this population.
Uporaba zdravila Ketek v tej populaciji ni priporočljiva.
Studies in rats and rabbits were inconclusive with respect to potential for teratogenicity; there was equivocal evidence of adverse effects on foetal development at high doses.
Raziskave pri podganah in kuncih niso dale dokončnega odgovora o možni teratogenosti; dokazi o neželenih učinkih na fetalni razvoj ob velikih odmerkih so bili nezanesljivi.
Diarrhoea, nausea and dizziness were the most commonly reported adverse reactions in phase III clinical trials.
Driska, navzea in omotica so bili najbolj pogosto poročani neželeni učinki v tretji fazi kliničnih študij.
Repeated dose toxicity studies of 1, 3 and 6 month duration with telithromycin conducted in rat, dog and monkey showed that the liver was the principal target for toxicity with elevations of liver enzymes, and histological evidence of damage.
Raziskave toksičnosti pri ponavljajočih se odmerkih telitromicina pri podganah, psih in opicah, ki so trajale 1, 3 in 6 mesecev, so pokazale, da so glavna tarča toksičnosti jetra; pojavijo se zvišanje jetrnih encimov in histološki znaki okvare.
The induction gradually decreases during 2 weeks after cessation of treatment with CYP3A4 inducers.
Indukcija se postopoma zmanjša v 2 tednih po prenehanju zdravljenja z induktorji CYP3A4.
The pharmacokinetics of telithromycin is similar between males and females.
Farmakokinetika telitromicina je podobna pri moških in ženskah.
• saquinavir (anti-HIV treatment) - if you are taking other medicines containing any of the following active substances:
• sakvinavir (zdravljenje okužbe s HIV) - druga zdravila, ki vsebujejo katerokoli od sledečih zdravilnih učinkovin:
Telithromycin inhibits protein synthesis by interacting with domains II and V of the 23S ribosomal RNA of the 50S ribosome subunit.
Telitromicin zavira sintezo beljakovin z delovanjem na območji II in V ribosomske RNA 23S ribosomske podenote 50S.
At high doses embryotoxicity was apparent and an increase in incomplete ossification and in skeletal anomalies was seen.
Pri velikih odmerkih je bila očitna embriotoksičnost in pogosteje so opažali nepopolno osifikacijo ter anomalije okostja.
After oral administration, two-thirds of the dose is eliminated as metabolites and one-third unchanged.
Po peroralni uporabi se dve tretjini odmerka izločita v obliki presnovkov, ena tretjina pa nespremenjena.
No patient in either group developed a ΔQTc >60 msec.
Pri nobenem bolniku se ni niti v eni niti v drugi skupini pojavil ΔQTc > 60 milisekund.
In subjects over 65 (median 75 years), the maximum plasma concentration and AUC of telithromycin were increased approximately 2-fold compared with those achieved in young healthy adults.
Pri preiskovancih, starejših od 65 let (mediana 75 let), sta bili najvišja plazemska koncentracija in AUC telitromicina približno 2-krat višji kot pri mladih zdravih odraslih.
These effects usually disappear during treatment or after completion of treatment with Ketek.
Ti neželeni učinki navadno med zdravljenjem ali po končanem zdravljenju z zdravilom Ketek izzvenijo.
- Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days.
- Tonzilitis/faringitis, ki ga povzroča Streptococcus pyogenes: 800 mg enkrat na dan 5 dni.
S.C. Zentiva S.A. B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Romania
S.C.Zentiva S.A B-dul Theodor Pallady nr.50, sector 3, Bucureşti, cod 032266, Romunija
Telithromycin, and its principal human metabolites, were negative in tests on genotoxic potential in vitro and in vivo.
Telitromicin in njegovi glavni presnovki pri človeku so dali negativen rezultat v poskusih genotoksičnega potenciala in vitro in in vivo.
Other metabolites were detected in plasma, urine and faeces and represent less or equal than 3% of plasma
Drugi presnovki, odkriti v plazmi, urinu in blatu, predstavljajo 3% plazemske AUC ali manj.