FrancophonIA/ELRC3.0 huggingface dataset:
English: It may happen again when you take the next dose of Ketek.
Slovenian: Lahko se pojavijo tudi, ko zaužijete naslednji odmerek zdravila Ketek.
English: • a medicine called protease inhibitor (anti-HIV treatment)
Slovenian: • zdravilo imenovano proteazni inhibitor (za zdravljenje okužbe s HIV),
English: Effects were evident at plasma levels of free drug 8 to 13 times the expected clinical level.
Slovenian: Učinki so bili očitni pri plazemskih koncentracijah prostega zdravila, ki so bile od 8- do 13-krat višje od pričakovane klinične koncentracije.
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.
English: Ranitidine (taken 1 hour before Ketek) and antacid containing aluminium and magnesium hydroxide has no clinically relevant influence on telithromycin pharmacokinetics.
Slovenian: Ranitidin (zaužit 1 uro pred zdravilom Ketek) ali antacid z aluminijevim in magnezijevim hidroksidom nima klinično pomembnega vpliva na farmakokinetiko telitromicina.
English: The combination is contraindicated (see section 4.3).
Slovenian: Ta kombinacija je kontraindicirana (glejte poglavje 4.3).
English: - other medicines that can prolong the QT interval of the electrocardiogram (ECG), such as:
Slovenian: - druga zdravila, ki lahko podaljšajo interval QT v elektrodiagramu (EKG), kot so:
English: - if you suffer from myasthenia gravis, a rare disease which causes muscle weakness.
Slovenian: - če imate miastenijo gravis, redko bolezen, ki povzroča šibkost mišic.
English: Pharmacotherapeutic group: antibacterials for systemic use, macrolides, lincosamides and streptogramins, ATC Code: J01FA15.
Slovenian: Farmakoterapevtska skupina: protimikrobne učunkovine za sistemsko uporabo, makrolidi, linkozamidi in streptogramini, oznaka ATC: J01FA15.
English: 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.
Slovenian: Anamneza kongenitalnega sindroma podaljšanega intervala QT ali družinska anamneza tega sindroma (če ni izključen z EKG) ter pri bolnikih s pridobljenim podaljšanjem intervala QT.
English: The main circulating compound in plasma is telithromycin.
Slovenian: Glavna spojina, ki kroži v plazmi, je telitromicin.
English: L. pneumophila is highly susceptible to telithromycin in vitro, however, the clinical experience of the treatment of pneumonia caused by legionella is limited.
Slovenian: L. pneumophila je in vitro zelo občutljiva za telitromicin, a klinične izkušnje z zdravljenjem pljučnic, ki jih povzroča legionela, so omejene.
English: B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Romania
Slovenian: B-dul Theodor Pallady nr.50, sector 3, Bucureşti, cod 032266, Romunija
English: 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.
Slovenian: 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.
English: The rate and extent of absorption is unaffected by food intake, and thus Ketek tablets can be given without regard to food.
Slovenian: Uživanje hrane ne vpliva na hitrost niti na obseg absorpcije, tako da je mogoče tablete Ketek jemati ne glede na hrano.
English: 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.
Slovenian: 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.
English: Exposure to telithromycin in vitro did select for pneumococcal mutants with increased MICs of telithromycin, generally resulting in MIC values of ≤1 mg/l.
Slovenian: Izpostavljenost telitromicinu in vitro je povzročila selekcijo pnevmokoknih mutantov s povečanimi MIC telitromicina; to je na splošno povzročilo vrednosti MIC ≤ 1 mg/l.
English: 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.
Slovenian: 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.
English: There was evidence of reversibility upon cessation of treatment.
Slovenian: Ugotovljena je bila reverzibilnost po prekinitvi zdravljenja.
English: The absolute bioavailability is about 57% after a single dose of 800 mg.
Slovenian: Absolutna biološka uporabnost po enem 800 mg odmerku je približno 57%.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: V primerjalnih preskušanjih so opažali učinke, podobne kot pri klaritromicinu, z medterapijskim ΔQTc > 30 milisekund v 7,6% oz. 7,0% primerov.
English: The effect of ritonavir on telithromycin has not been studied and could lead to larger increase in telithromycin exposure.
Slovenian: Učinek ritonavirja na telitromicin ni raziskan; lahko bi povzročil izrazitejše zvečanje izpostavljenosti telitromicinu.
English: The mean maximum white blood cell concentration of telithromycin was 83±25 mg/l.
Slovenian: Povprečna najvišja koncentracija telitromicina v belih krvnih celicah je bila 83 ± 25 mg/l.
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the
Slovenian: Če predložitev PSUR in posodobitev RMP sovpadata, se lahko predložita sočasno.
English: If you accidentally take one tablet too many, nothing is likely to happen.
Slovenian: Če ste vzeli večji odmerek zdravila Ketek, kot bi smeli Če po nesreči vzamete eno tableto preveč, se najverjetneje ne bo zgodilo nič.
English: These changes in the pharmacokinetics of telithromycin do not necessitate dosage adjustment as telithromycin exposure remains within a well tolerated range.
Slovenian: Te spremembe farmakokinetike telitromicina ne zahtevajo prilagoditve odmerka, ker ostaja izpostavljenost telitromicinu znotraj območja, ki ga bolniki dobro prenašajo.
English: The other side effects listed below are given with an estimation of the frequency with which they may occur with Ketek:
Slovenian: Drugi neželeni učinki, našteti spodaj, navedeni z oceno pogostnosti, s katero se lahko pojavijo pri zdravilu Ketek so:
English: Treatment with these agents should be interrupted during Ketek treatment.
Slovenian: Zdravljenje s temi zdravili je treba med terapijo z zdravilom Ketek prekiniti.
English: Ketek is not recommended in this population.
Slovenian: Uporaba zdravila Ketek v tej populaciji ni priporočljiva.
English: 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.
Slovenian: 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.
English: Diarrhoea, nausea and dizziness were the most commonly reported adverse reactions in phase III clinical trials.
Slovenian: Driska, navzea in omotica so bili najbolj pogosto poročani neželeni učinki v tretji fazi kliničnih študij.
English: 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.
Slovenian: 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.
English: The induction gradually decreases during 2 weeks after cessation of treatment with CYP3A4 inducers.
Slovenian: Indukcija se postopoma zmanjša v 2 tednih po prenehanju zdravljenja z induktorji CYP3A4.
English: The pharmacokinetics of telithromycin is similar between males and females.
Slovenian: Farmakokinetika telitromicina je podobna pri moških in ženskah.
English: • saquinavir (anti-HIV treatment) - if you are taking other medicines containing any of the following active substances:
Slovenian: • sakvinavir (zdravljenje okužbe s HIV) - druga zdravila, ki vsebujejo katerokoli od sledečih zdravilnih učinkovin:
English: Telithromycin inhibits protein synthesis by interacting with domains II and V of the 23S ribosomal RNA of the 50S ribosome subunit.
Slovenian: Telitromicin zavira sintezo beljakovin z delovanjem na območji II in V ribosomske RNA 23S ribosomske podenote 50S.
English: At high doses embryotoxicity was apparent and an increase in incomplete ossification and in skeletal anomalies was seen.
Slovenian: Pri velikih odmerkih je bila očitna embriotoksičnost in pogosteje so opažali nepopolno osifikacijo ter anomalije okostja.
English: After oral administration, two-thirds of the dose is eliminated as metabolites and one-third unchanged.
Slovenian: Po peroralni uporabi se dve tretjini odmerka izločita v obliki presnovkov, ena tretjina pa nespremenjena.
English: No patient in either group developed a ΔQTc >60 msec.
Slovenian: Pri nobenem bolniku se ni niti v eni niti v drugi skupini pojavil ΔQTc > 60 milisekund.
English: 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.
Slovenian: 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.
English: These effects usually disappear during treatment or after completion of treatment with Ketek.
Slovenian: Ti neželeni učinki navadno med zdravljenjem ali po končanem zdravljenju z zdravilom Ketek izzvenijo.
English: - Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days.
Slovenian: - Tonzilitis/faringitis, ki ga povzroča Streptococcus pyogenes: 800 mg enkrat na dan 5 dni.
English: S.C. Zentiva S.A. B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Romania
Slovenian: S.C.Zentiva S.A B-dul Theodor Pallady nr.50, sector 3, Bucureşti, cod 032266, Romunija
English: Telithromycin, and its principal human metabolites, were negative in tests on genotoxic potential in vitro and in vivo.
Slovenian: Telitromicin in njegovi glavni presnovki pri človeku so dali negativen rezultat v poskusih genotoksičnega potenciala in vitro in in vivo.
English: Other metabolites were detected in plasma, urine and faeces and represent less or equal than 3% of plasma
Slovenian: Drugi presnovki, odkriti v plazmi, urinu in blatu, predstavljajo 3% plazemske AUC ali manj.
English: Refer also to sections “Do not take Ketek”, “Other medicines and Ketek” and “Driving and using
Slovenian: Glejte tudi poglavja "Ne jemljite zdravila Ketek", "Druga zdravila in zdravilo Ketek" in "Vpliv na sposobnost upravljanja vozil in strojev".
English: What Ketek looks like and contents of the pack
Slovenian: Izgled zdravila Ketek in vsebina pakiranja
English: As for macrolides, H. influenzae is classified as intermediately susceptible.
Slovenian: Tako kot pri makrolidih se H. influenzae uvršča med srednje občutljive.
English: No dosage adjustment is necessary in patients with mild, moderate, or severe hepatic impairment, however the experience in patients with impaired hepatic function is limited.
Slovenian: Pri bolnikih z blago, zmerno ali hudo okvaro jeter odmerka ni treba prilagoditi, vendar so izkušnje z bolniki, ki imajo okvarjeno delovanje jeter, omejene.
English: Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen.
Slovenian: Bolnikom je treba naročiti, naj prekinejo zdravljenje in se posvetujejo s svojim zdravnikom v primeru pojava znakov in simptomov bolezni jeter kot so anoreksija, zlatenica, temen urin, pruritus ali
English: Caution is warranted when Ketek is administered to patients taking other medicinal products with the potential to prolong the QT interval (see section 4.4).
Slovenian: Previdnost je potrebna med uporabo zdravila Ketek pri bolnikih, ki jemljejo druga zdravila s potencialom za podaljšanje QT intervala (glejte poglavje 4.4).
English: Telithromycin has been shown to decrease the Cmax by 34 % and AUC of sotalol by 20 % due to
Slovenian: Dokazano je, da telitromicin zniža Cmax sotalola za 34 %, AUC pa za 20%, zaradi zmanjšane
English: Ketek is an antibiotic of the type macrolides.
Slovenian: Ketek je makrolidni antibiotik.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Slovenian: Če je lokalna prevalenca odpornosti takšna, da je uporabnost tega zdravila vprašljiva pri vsaj nekaterih vrstah okužb, je po potrebi treba poiskati nasvet strokovnjaka.
English: • ketoconazole or fluconazole (anti-fungal treatment)
Slovenian: • ketokonazol ali flukonazol (antimikotično zdravljenje),
English: Visual disturbances included blurred vision, difficulty focusing, and diplopia.
Slovenian: Motnje vida so vključevale zamegljen vid, težave s fokusiranjem in dvojni vid.
English: Ketek is not recommended as first choice in patients with severe renal impairment (creatinine clearance <30 ml/min) or patients with both severe renal impairment and co-existing hepatic impairment, as an optimal dosage format (600 mg) is not available.
Slovenian: Ketek se ne priporoča kot zdravilo prve izbire pri hudi okvari ledvic (očistek kreatinina < 30 ml/min) ali pri bolnikih tako s hudo okvaro ledvic kot s hkratno okvaro jeter, saj optimalni odmerek (600 mg) ni na voljo.
English: Light orange, oblong, biconvex tablet, imprinted with ‘H3647' on one side and ‘400' on the other.
Slovenian: Svetlo oranžne, podolgovate, bikonveksne tablete z oznako ‘H3647' na eni strani in ‘400' na drugi.
English: When metoprolol (a CYP2D6 substrate) was coadministered with Ketek, metropolol Cmax and AUC were increased by approximately 38%, however, there was no effect on the elimination half-life of metoprolol.
Slovenian: Med sočasno uporabo metoprolola (substrata CYP2D6) in zdravila Ketek, sta se Cmax in AUC metoprolola zvišali za okrog 38%, vendar ni bilo učinka na razpolovno dobo izločanja metoprolola.
English: In both studies, higher renal elimination was observed in the hepatically impaired patients.
Slovenian: V obeh študijah so pri bolnikih z okvaro jeter opažali večje izločanje skozi ledvice.
English: If you accidentally take several tablets too many, contact your doctor or pharmacist.
Slovenian: Če po nesreči vzamete nekaj tablet preveč, se posvetujte s svojim zdravnikom ali farmacevtom.
English: The recommended dose of Ketek for adults and children of 12 years and older is two tablets of 400 mg once daily (800 mg once daily).
Slovenian: Priporočeni odmerek zdravila Ketek za odrasle in otroke od 12. leta dalje je dve 400 mg tableti enkrat na dan (800 mg enkrat na dan).
English: If you have kidney problems (severe renal insufficiency) you should take alternating daily doses of 800 mg (two tablets of 400 mg) and 400 mg (one tablet of 400 mg), starting with the 800 mg dose.
Slovenian: Če imate težave z ledvicami (hudo ledvično popuščanje), jemljite izmenično dnevni odmerek 800 mg (dve 400 mg tableti) in 400 mg (ena 400 mg tableta), z začetnim odmerkom 800 mg.
English: To reduce the potential impact of visual disturbances take the tablets before going to bed (see also
Slovenian: Da zmanjšate možen vpliv težav z vidom, zaužijte zdravilo Ketek pred spanjem (glejte tudi poglavje
English: • terfenadine or astemizole (allergic problems)
Slovenian: • terfenadin ali astemizol (pri alergijskih težavah)
English: After oral administration of radiolabelled telithromycin, 76% of the radioactivity was recovered from faeces, and 17% from the urine.
Slovenian: Po peroralni uporabi radioaktivno označenega telitromicina so določili 76% radioaktivnosti v blatu in 17 % v urinu.
English: Rapid distribution of telithromycin into tissues results in significantly higher telithromycin concentrations in most target tissues than in plasma.
Slovenian: Zaradi hitre porazdelitve v tkiva je koncentracija telitromicina v večini ciljnih tkiv pomembno višja kot v plazmi.
English: Diarrhoea, particularly if severe, persistent and /or bloody, during or after treatment with Ketek may be caused by pseudomembranous colitis (see section 4.8).
Slovenian: Driska, zlasti če je huda, trdovratna in/ali krvava, je lahko med zdravljenjem z zdravilom Ketek ali po njem posledica psevdomembranskega kolitisa (glejte poglavje 4.8).
English: - medicines containing digoxin (for heart disorders) or dabigatran (for prevention of blood clots)
Slovenian: - zdravila, ki vsebujejo digoksin (za zdravljenje srčnih motenj) ali dabigatran (za preprečevanje
English: - if you have had a liver disease (hepatitis and/or jaundice) while taking Ketek in the past.
Slovenian: - če ste imeli jetrno bolezen (hepatitis in/ali zlatenico) med jemanjem zdravila Ketek kdaj v
English: Angioneurotic oedema, anaphylactic reactions including anaphylactic shock, hypersensitivity Confusion, hallucination
Slovenian: angionevrotični edem, anafilaktične reakcije vključno z anafilaktičnim šokom, preobčutljivost
English: Ketek 400 mg tablets are light orange, oblong, biconvex, film-coated tablets imprinted with “H3647” on one side and “400” on the other.
Slovenian: Ketek 400 mg tablete so svetlo oranžne, podolgovate, bikonveksne, filmsko obložene tablete z oznako "H3647" na eni strani in "400" na drugi.
English: In vivo studies with simvastatin, midazolam and cisapride have demonstrated a potent inhibition of intestinal CYP3A4 and a moderate inhibition of hepatic CYP3A4.
Slovenian: In vivo raziskave s simvastatinom, midazolamom in cisapridom so pokazale močno inhibicijo črevesnega CYP3A4 in zmerno inhibicijo jetrnega CYP3A4.
English: In in vitro studies the activity of telithromycin was reduced against organisms that express the erythromycin erm(B) or mef(A) related resistance mechanisms.
Slovenian: V študijah in vitro je bila aktivnost telitromicina zmanjšana proti organizmom, ki imajo eksprimirane z erm (B) ali mef (A) povezane mehanizme odpornosti proti eritromicinu.
English: - if you have kidney problems (severely impaired renal function) and/or liver problems (severely impaired hepatic function), do not take Ketek while taking other medicines containing any of the following active substances:
Slovenian: - če imate težave z ledvicami (hudo okvaro ledvic) in/ali težave z jetri (hudo okvaro jeter), ne jemljite zdravila Ketek skupaj z zdravili, ki vsebujejo katero od naslednjih zdravilnih učinkovin:
English: Colchicine intoxication, including fatal cases, has been reported in patients treated with colchicine and strong CYP 3A4 inhibitors.
Slovenian: O zastrupitvah s kolhicinom, vključno s smrtnimi primeri, so poročali pri bolnikih, zdravljenih s kolhicinom in močnimi zaviralci CYP3A4.
English: If you feel you are suffering from a side effect, tell a doctor immediately to get advice before taking
Slovenian: Če se vam zdi, da imate kakšen neželen učinek, to takoj povejte zdravniku, da vam bo svetoval,
English: - some calcium channel blockers (e.g. verapamil, nifedipine, felodipine) (for heart disorders).
Slovenian: - nekatere zaviralce kalcijevih kanalčkov (npr. verapamil, nifedipin, felodipin) (za srčne motnje).
English: For those benzodiazepines which are not metabolised by CYP3A4 (temazepam, nitrazepam, lorazepam) an interaction with Ketek is unlikely.
Slovenian: Pri benzodiazepinih, ki se ne presnavljajo s CYP3A4 (temazepam, nitrazepam, lorazepam), medsebojno delovanje z zdravilom Ketek ni verjetno.
English: The recommended European Committee for Antimicrobial Susceptibility Testing (EUCAST) MIC clinical breakpoints are presented below:
Slovenian: Spodaj so prikazane priporočene klinične mejne vrednosti MIC po EUCAST (European Committee on
English: Post-marketing cases of severe hepatitis and liver failure, including fatal cases (which have generally been associated with serious underlying diseases or concomitant medicinal products), have been reported (see section 4.8).
Slovenian: V postmarketinškem obdobju so poročali o primerih hudega hepatitisa in odpovedi jeter, vključno s smrtnimi primeri (ki so bili praviloma povezani z resnimi osnovnimi boleznimi ali sočasnimi zdravili) (glejte poglavje 4.8).
English: This could result in QT interval prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and torsades de pointes.
Slovenian: Posledica so lahko podaljšanje QT intervala in motnje srčnega ritma, vključno z ventrikularno tahikardijo, ventrikularno fibrilacijo in torsade de pointes.
English: Ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) By extrapolation from erythromycin A and josamycin, concomitant medication of Ketek and alkaloid derivatives could lead to severe vasoconstriction (“ergotism”) with possibly necrosis of the extremities.
Slovenian: Derivati alkaloidov ergot (kot sta ergotamin in dihidroergotamin) Po ekstrapolaciji z eritromicina A in josamicina bi lahko sočasno zdravljenje z zdravilom Ketek in alkaloidnimi derivati povzročilo hudo vazokonstrikcijo ("ergotizem") z možno nekrozo okončin.
English: Due to limited experience in patients with decreased metabolic capacity of the liver, Ketek 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 Ketek pri bolnikih z jetrno okvaro uporabljati previdno (glejte tudi poglavje 4.4).
English: Telithromycin is an inhibitor of CYP3A4 and a weak inhibitor of CYP2D6.
Slovenian: Telitromicin je zaviralec CYP3A4 in šibki zaviralec CYP2D6.
English: During concomitant administration of rifampicin and telithromycin in repeated doses, Cmax and AUC of telithromycin were on average decreased by 79% and 86% respectively.
Slovenian: Med sočasnim zdravljenjem z rifampicinom in telitromicinom v ponavljajočih se odmerkih se je Cmax telitromicina v povprečju znižala za 79%, njegova AUC pa za 86%.
English: The total clearance (mean ±SD) is approximately 58±5 l/h after an intravenous administration with renal clearance accounting for about 22% of this.
Slovenian: Skupni očistek (povprečje ± SD) po intravenski uporabi je približno 58 ± 5 l/h, pri čemer gre okoli 22% tega na račun ledvičnega očistka.
English: Ketek is an inhibitor of CYP3A4 and should only be used under specific circumstances during treatment with other medicinal products that are metabolised by CYP3A4.
Slovenian: Ketek je zaviralec CYP3A4, zato se ga sme le v posebnih okoliščinah uporabiti med zdravljenjem z drugimi zdravili, ki se presnavljajo s CYP3A4.
English: If any of these undesirable effects are troublesome, severe, or do not wear off as treatment goes on,
Slovenian: Če je kateri od teh neželenih učinkov moteč, hud ali med nadaljevanjem zdravljenja ne mine, povejte