natgillin/translations-raw huggingface dataset:
The tablets may be taken with or without food.
pogoltniti cele, z zadostno količino vode.
Consideration may be given to taking Levviax at bedtime, to reduce the potential impact of visual i
Tablete se lahko vzamejo s hrano ali brez nje.
disturbances and loss of consciousness (see section 4.4). dic
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). rav
2 No dosage adjustment is required in elderly patients based on age alone.
Pri starejših bolnikih odmerka ni treba prilagajati zgolj zaradi starosti.
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).
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Levviax pri otrocih pod 12 let ni priporočljiva (glejte poglavje 5. 2).
ed Impaired renal function:
t me Okvarjeno delovanje ledvic:
Levviax is not recommended as first choice in patients with severe renal impairment (creatinine clearance
Levviax se ne priporoča kot zdravilo prve izbire pri hudi okvari ledvic (očistek kreatinina < 30 ml/ min) ali pri bolnikih tako s
ris < 30ml/ min) or patients with both severe renal impairment and co-existing hepatic impairment, as an optimal dosage format (600 mg) is not available.
pro hudo okvaro ledvic kot s hkratno okvaro jeter, saj optimalni odmerek (600 mg) ni na voljo.
In haemodialysed patients, the posology should be adjusted so that Levviax 800 mg is given after the dialysis session (see also section 5.2).
Bolnikom na hemodializi je odmerjanje treba prilagoditi tako, da dobijo Levviax 800 mg po dializi (glejte poglavje 5. 2)
au Impaired hepatic function:
za Okvarjeno delovanje jeter:
No dosage adjustment is necessary in patients with mild, moderate, or severe hepatic impairment, unless renal function is severely impaired, however the experience in patients with impaired hepatic
Zato
Hence, Levviax should be used with caution (see also section 4.4 and 5.2).
nja je treba zdravilo Levviax uporabljati previdno (glejte tudi poglavje 4. 4 in 5. 2).
Levviax is contraindicated in patients with myasthenia gravis (see section 4.4).
4. 3 Kontraindikacije lje Zdravilo Levviax je kontraindicirano pri bolnikih z miastenijo gravis (glejte poglavje 4. 4). vo Preobčutljivost za zdravilno učinkovino, katerokoli makrolidno protibakterijsko zdravilo ali katerokoli pomožno snov. do
Levviax must not be used in patients with previous history of hepatitis and/ or jaundice associated with the use of telithromycin.
Zdravila Levviax ne smete uporabljati pri bolnikih z anamnezo hepatitisa in/ ali zlatenice, povezanih z uporabo telitromicina.
Concomitant administration of Levviax and any of the following substances is contraindicated: t uc
Kontraindicirana je sočasna uporaba zdravila Levviax in katerekoli od naslednjih snovi: cisaprida, eā
cisapride, ergot alkaloid derivatives (such as ergotamine and dihydroergotamine), pimozide, astemizole and terfenadine (see section 4.5). rod
derivatov ergot alkaloidov (kot sta ergotamin in dihidroergotamin), pimozida, astemizola in terfenadina (glejte poglavje 4. 5). av
Levviax should not be used concomitantly with simvastatin, atorvastatin and lovastastin.
Zdravila Levviax se ne sme uporabljati sočasno s simvastatinom, atorvastatinom in lovastastinom.
Treatment with these agents should be interrupted during Levviax treatment (see section 4.5).
Zdravljenje s temi zdravili je treba med zdravljenjem z zdravilom Levviax prekiniti (glejte poglavje 4. 5). nim
syndrome (if not excluded by ECG) and in patients with known acquired QT interval prolongation.
Levviax je kontraindiciran pri bolnikih z anamnezo kongenitalnega sindroma podaljšanega intervala QT ali družinsko anamnezo tega sindroma (če ni izključen z EKG) ter pri bolnikih s pridobljenim podaljšanjem intervala QT.
In patients with severely impaired renal and/ or hepatic function, concomitant administration of na
Pri bolnikih s hudo okvarjenim delovanjem ledvic in/ ali jeter je sočasna uporaba zdravila Levviax in ilo
Levviax and strong CYP3A4 inhibitors, such as protease inhibitors or ketoconazole, is contraindicated. i
močnih inhibitorjev CYP3A4, kot so npr. zaviralci proteaz ali ketokonazol, kontraindicirana.
4.4 Special warnings and precautions for use dic
4. 4 Posebna opozorila in previdnostni ukrepi rav
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 Me
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 Zd
with QT interval prolonging agents or potent CYP 3A4 inhibitors such as protease inhibitors and ketoconazole.
zdravila Levviax z zdravili, ki podaljšujejo interval QT, ali močnimi zaviralci CYP3A4, kot so npr. zaviralci proteaz in ketokonazol.
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.
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
3 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).
Poročila so vključevala smrtne izide in življenjsko nevarno akutno dihalno odpoved s hitrim nastopom (glejte poglavje 4. 8).
Alterations in hepatic enzymes have been commonly observed in clinical studies with telithromycin.
t me V kliničnih študijah s telitromicinom so pogosto opažali spremembe jetrnih encimov.
Post-marketing cases of severe hepatitis and liver failure, including fatal cases (which have generally
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)
ed been associated with serious underlying diseases or concomitant medications), have been reported (see section 4.8).
pro (glejte poglavje 4. 8).
ris 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.
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 občutljiv trebuh.
tho Due to limited experience, Levviax should be used with caution in patients with liver impairment (see section 5.2).
za Pri bolnikih z okvaro jeter je treba zdravilo Levviax zaradi omejenih izkušenj uporabljati previdno (glejte poglavje 5. 2).
Levviax may cause visual disturbances particularly in slowing the ability to accommodate and the
nja Zdravilo Levviax lahko povzroči motnje vida, še posebej upočasnitev sposobnosti za akomodacijo in sprostitve akomodacije.
au ability to release accommodation.
Motnje vida so vključevale zamegljen vid, težave s fokusiranjem in dvojni vid.
Visual disturbances included blurred vision, difficulty focusing, and diplopia.
Večina dogodkov je bila blagih do zmernih, vendar pa so poročali tudi o hudih primerih (glejte poglavji 4. 7 in 4. 8).
Most events were mild to moderate; however, severe cases have been reported.
Po pridobitvi dovoljenja za promet so poročali o prehodnih izgubah zavesti.
(see sections 4.7 and 4.8).
Posamezni primeri so bili vo povezani z vagalnim sindromom (glejte poglavji 4. 7 in 4. 8).
r ge There have been post-marketing adverse event reports of transient loss of consciousness including some cases associated with vagal syndrome (see sections 4.7 and 4.8). lon Consideration may be given to taking Levviax at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness.
potencialni vpliv na motnje vida in izgubo zavesti (glejte poglavje 4. 4).
Levviax should not be used during and 2 weeks after treatment with CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John’ s wort).
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.
Concomitant treatment with no
Med sočasno eā
these medicinal products is likely to result in subtherapeutic levels of telithromycin and therefore encompass a risk of treatment failure (see section 4.5).
uporabo teh zdravil obstaja možnost za pojav subterapevtskih koncentracij telitromicina in s tem za neuspeh zdravljenja (glejte poglavje 4. 5). av
treatment with other medicinal products that are metabolised by CYP3A4.
Levviax je zaviralec CYP3A4, zato se ga sme le v posebnih okoliščinah uporabiti med zdravljenjem z drugimi zdravili, ki se presnavljajo s CYP3A4.
In areas with a high incidence of erythromycin A resistance, it is especially important to take into rod
V predelih z veliko incidenco odpornosti proti eritromicinu A je posebno pomembno upoštevati razvoj nim
consideration the evolution of the pattern of susceptibility to telithromycin and other antibiotics.
vzorca dovzetnosti za telitromicin in druge antibiotike.
In community acquired pneumonia, efficacy has been demonstrated in a limited number of patients with risk factors such as pneumococcal bacteraemia or age higher than 65 years. lP
Pri pljučnicah, dobljenih v domačem okolju, je bila učinkovitost dokazana pri omejenem številu bolnikov z dejavniki tveganja, kakršna sta pnevmokokna bakteriemija ali starost nad 65 let. ilo
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 na
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.
Caution should be taken when S. aureus is the suspected pathogen and there is a likelihood of erythromycin resistance based on local epidemiology. i
Previdnost je potrebna, če je domnevni patogen S. aureus in je glede na rav
L. pneumophila is highly susceptible to telithromycin in vitro, however, the clinical experience of the dic
lokalno epidemiologijo verjetno, da je odporen proti eritromicinu.
treatment of pneumonia caused by legionella is limited.
Zd
Me
To je treba upoštevati pri zdravljenju okužb, ki jih povzroča H. influenzae.
4 Telithromycin is an inhibitor of CYP3A4 and a weak inhibitor of CYP2D6.
t Telitromicin je zaviralec CYP3A4 in šibki zaviralec CYP2D6.
In vivo studies with simvastatin, midazolam and cisapride have demonstrated a potent inhibition of intestinal CYP3A4 and a moderate inhibition of hepatic CYP3A4.
In vivo raziskave s simvastatinom,
The degree of inhibition with different CYP3A4 substrates is difficult to predict.
me midazolamom in cisapridom so pokazale močno inhibicijo črevesnega CYP3A4 in zmerno inhibicijo jetrnega CYP3A4.
Hence, Levviax should not be used during treatment with medicinal products that are CYP3A4 substrates, unless plasma concentrations of the CYP3A4 substrate, efficacy or adverse events can be closely monitored.
Stopnjo inhibicije z različnimi substrati CYP3A4 je težko predvideti.
Alternatively, interruption in the treatment with the CYP3A4
Zato se zdravila Levviax ne sme uporabljati med zdravljenjem z zdravili, ki so substrati CYP3A4, razen kadar
ed substrate should be made during treatment with Levviax.
Zdravljenje s substratom CYP3A4 med terapijo z zdravilom Levviax je sicer treba prekiniti.
Medicinal products with a potential to prolong QT interval
Zdravila, ki lahko podaljšajo interval QT Pričakovati je, da zdravilo Levviax zviša plazemske koncentracije cisaprida, pimozida, astemizola in
ris Levviax is expected to increase the plasma levels of cisapride, pimozide, astemizole and terfenadine.
za terfenadina.
Concomitant administration of Levviax
Posledica so lahko podaljšanje QT intervala in motnje srčnega ritma, vključno z ventrikularno tahikardijo, ventrikularno fibrilacijo in torsade de pointes.
tho and any of these medicinal products is contraindicated (see section 4.3).
Sočasna uporaba zdravila Levviax in katerega od teh zdravil je kontraindicirana (glejte poglavje 4. 3).
Caution is warranted when Levviax is administered to patients taking other medicinal products with the potential to prolong QT interval (see section 4.4).
nja Previdnost je potrebna med uporabo zdravila Levviax pri bolnikih, ki jemljejo druga zdravila s potencialom za podaljšanje QT intervala (glejte poglavje 4. 4).
au Ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) By extrapolation from erythromycin A and josamycin, concomitant medication of Levviax and
lje Derivati alkaloidov ergot (kot sta ergotamin in dihidroergotamin) Po ekstrapolaciji z eritromicina A in josamicina bi lahko sočasno zdravljenje z zdravilom Levviax in alkaloidnimi derivati povzročilo hudo vazokonstrikcijo ("ergotizem") z možno nekrozo okončin.
r alkaloid derivatives could lead to severe vasoconstriction (“ ergotism”) with possibly necrosis of the
Ta vo kombinacija je kontraindicirana (glejte poglavje 4. 3).
ge extremities.
Statini do
Statins lon 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.
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.
Levviax no
Raziskav medsebojnega delovanja z drugimi statini in vivo ni bilo, vendar lahko zdravilo Levviax povzroči podobne interakcije z lovastatinom in atorvastatinom, manjše eā
should not be used concomitantly with simvastatin, atorvastastin and lovastatin.
Zdravila Levviax se ne sme uporabljati sočasno s simvastatinom, atorvastatinom in lovastatinom.
Cerivastatin should be used with caution and patients should be carefully monitored for signs and symptoms of myopathy. t uc
Cerivastatin je treba uporabljati av
The midazolam half- rod
Benzodiazepini Med sočasno uporabo midazolama in zdravila Levviax se je AUC midazolama po intravenski nim
life was increased about 2.5-fold.
Razpolovni čas midazolama se je podaljšal za približno 2, 5- krat.
For lP
Pri benzodiazepinih, ki se ne presnavljajo s ilo
those benzodiazepins which are not metabolized by CYP3A4 (temazepam, nitrazepam, lorazepam) an interaction with Levviax is unlikely. na
CYP3A4 (temazepam, nitrazepam, lorazepam), medsebojno delovanje z zdravilom Levviax ni verjetno. rav
Thus, when initiating telithromycin in patients already receiving any of theses i
Če se torej telitromicin uvede pri bolnikih, ki že dobivajo katero od teh imunosupresivnih Zd
immunosuppressive agents, cyclosporin, tacrolimus or sirolimus levels must be carefully monitored dic
zdravil, je treba koncentracije ciklosporina, takrolimusa ali sirolimusa natančno nadzorovati in njihove odmerke zmanjšati, če je potrebno.
When metoprolol (a CYP2D6 substrate) was coadministered with Levviax, metropolol Cmax and AUC were increased by approximately 38%, however, there was no effect on the elimination half-life of metoprolol.
Metoprolol Med sočasno uporabo metoprolola (substrata CYP2D6) in zdravila Levviax, sta se Cmax in AUC metoprolola zvišali za okrog 38%, vendar ni bilo učinka na razpolovno dobo izločanja metoprolola.
The increase exposure to metoprolol may be of clinical importance in patients with heart failure treated with metoprolol.
5 Povečana izpostavljenost metoprololu bi lahko bila klinično pomembna pri bolnikih s srčnim popuščanjem, zdravljenih z metoprololom.
5 Levviax has been shown to increase the plasma concentrations of digoxin.
Digoksin Dokazano je, da Levviax zviša koncentracije digoksina v plazmi.
The plasma trough levels, Cmax, AUC and renal clearance were increased by 20%, 73%, 37% and 27% respectively, in healthy volunteers.
t najnižje koncentracije v plazmi zvišale za 20%, Cmax za 73%, AUC za 37 in ledvični očistek za 27%.
There were no significant changes in ECG parameters and no signs of digoxin toxicity were observed.
me Pomembnih sprememb v parametrih EKG ni bilo in znakov toksičnosti digoksina niso opažali.
ed Theophylline There is no clinically relevant pharmacokinetic interaction of Levviax and theophylline administered as extended release formulation.
pro Teofilin Med zdravilom Levviax in teofilinom, uporabljenim v obliki s podaljšanim sproščanjem, ni klinično pomembnih farmakokinetičnih interakcij.
However, the co-administration of both medicinal products should be
Da pa bi se izognili možnim neželenim učinkom na prebavo, kot sta navzeja in bruhanje, mora med sočasnim jemanjem teh dveh zdravil od uporabe enega do
ris separated by one hour in order to avoid possible digestive side effects such as nausea and vomiting.
za uporabe drugega miniti ena ura.
Oral anticoagulants
Peroralni antikoagulanti Pri bolnikih, ki so istočasno prejemali antikoagulante in antibiotike, vključno s telitromicinom, so
tho Increased anticoagulant activity has been reported in patients simultaneously treated with anticoagulants and antibiotics, including telithromycin.
nja poročali o povečani aktivnosti antikoagulantov.
au (International Normalised Ratio) values should be considered during concomitant treatment.
Čeprav po uporabi enega odmerka Levviax nima klinično pomembnih farmakokinetičnih ali farmakodinamičnih interakcij z varfarinom, je potrebno razmisliti o pogostejšem nadziranju protrombinskega časa/ INR (» International Normalised Ratio «) med sočasnim zdravljenjem. lje Peroralni kontraceptivi vo Pri zdravih preiskovankah ni farmakodinamičnih ali klinično pomembnih farmakokinetičnih interakcij z nizkoodmernimi trifaznimi peroralnimi kontraceptivi. do
r There is no pharmacodynamic or clinically relevant pharmacokinetic interaction with low-dose
• Vpliv drugih zdravil na zdravilo Levviax
• Effect of other medicinal products on Levviax lon During concomitant administration of rifampicin and telithromycin in repeated doses, Cmax and AUC of telithromycin were on average decreased by 79% and 86% respectively.
Med sočasno uporabo induktorjev eā
The no
CYP3A4 (kot so rifampicin, fenitoin, karbamazepin, fenobarbital, šentjanževka) zato obstaja možnost za pojav subterapevtskih koncentracij telitromicina in izgubo učinka.
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.
Levviax should not be used during and 2 weeks after treatment with CYP3A4 inducers.
med zdravljenjem z induktorji CYP3A4 in še 2 tedna po zdravljenju z njimi.
Interaction studies with itraconazole and ketoconazole, two CYP3A4 inhibitors, showed that t uc
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 nim
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.
prvim za 1, 54- krat in z drugim za 2, 0- krat.
These changes in the pharmacokinetics of telithromycin do not necessitate dosage adjustment as telithromycin exposure remains within a well rod
Te spremembe farmakokinetike telitromicina ne zahtevajo prilagoditve odmerka, ker ostaja izpostavljenost telitromicinu znotraj območja, ki ga bolniki dobro prenašajo.
The combination should be used with caution.
Kombinacijo je treba uporabljati previdno. ilo
Ranitidine (taken 1 hour before Levviax) and antacid containing aluminium and magnesium hydroxide lP
Ranitidin (zaužit 1 uro pred zdravilom Levviax) ali antacid z aluminijevim in magnezijevim hidroksidom nima klinično pomembnega vpliva na farmakokinetiko telitromicina. rav
has no clinically relevant influence on telithromycin pharmacokinetics.
4. 6 Nosečnost in dojenje
4.6 Pregnancy and lactation na
Študije na živalih so pokazale vpliv Zd
Studies in animals have shown reproductive toxicity (see section 5.3).
na sposobnost razmnoževanja (glejte poglavje 5. 3).
should not be used during pregnancy unless clearly necessary. dic
Zdravila Levviax ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
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.
Levviax should not be used by Me
Doječe ženske ne smejo uporabljati zdravila Levviax.
Because of potential visual difficulties or loss of consciousness, patients should attempt to minimize activities such as driving a 6 motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment with Levviax.
Zaradi možnih težav z vidom ali izgube zavesti, morajo bolniki med zdravljenjem z zdravilom Levviax omejiti aktivnosti, kot so vožnja motornih
If patients experience visual disorders or loss of consciousness while taking Levviax patients should not drive a motor vehicle, operate heavy machinery or engage in other hazardous activities (see sections 4.4 and 4.8).
Če se med zdravljenjem
Patients should be informed that these undesirable effects may occur as early as after the first dose of medication.
me z zdravilom Levviax pri bolnikih pojavijo motnje vida ali izguba zavesti, bolniki ne smejo voziti motornih vozil, upravljati s težkimi stroji ali se vključevati v druge nevarne aktivnosti (glejte poglavji 4. 4 in 4. 8).
Patients should be cautioned about the potential effects of these events on the ability to
Bolnike je treba seznaniti, da seti neželeni učinkilahko pojavijo že po prvem odmerku
ed drive or operate machinery.
pro zdravila.
This is shown below.
za Pri 2461 bolnikih, zdravljenih z zdravilom Levviax v kliničnih preskušanjih III. faze, so bili opisani naslednji neželeni učinki, ki so morda ali verjetno povezani s telitromicinom in so navedeni spodaj.
tho Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
au System organ class Blood and the
nja Organski sistemi
Very common (≥ 1/ 10)
Zelo pogosti (≥ 1/ 10)
Uncommon (≥ 1/ 1,000 to < 1/ 100) Eosinophilia
Pogosti (≥ 1/ 100 do <
Rare (≥ 1/ 10,000 to < 1/ 1,000)
Občasni (≥ 1/ 1. 000 do
Very rare (< 1/ 10,000)
Redki (≥ 1/ 10. 000 do
Dizziness, headache,
Zelo redki (< 1/ 10. 000)
lon
lje 1/ 10)
Transient loss of
< 1/ 100)
Parosmia
< 1/ 1. 000)
disturbance of taste
Bolezni krvi in limfatičnega sistema
nervousness, insomnia,
vo
consciousness, paraesthesia
eozinofilija
Blurred vision
omotica, do
Diplopia
vrtoglavica,
Cardiovascular disorders
prehodna izguba parozmija
t
eā
Flush Palpitations
glavobol, motnje okusa
Atrial arrhythmia, hypotension, bradycardia
somnolenca, živčnost, nespečnost
Gastro-intestinal
zavesti, parestezije
Diarrhoea
Očesne bolezni Srčno- žilne bolezni
uc
av
Oral Candida
zamegljen vid pordevanje palpitacije
Pseudomembranous
diplopija atrijska aritmija, hipotenzija,
disorders
bradikardija psevdomembran oralna okužba Bolezni prebavil driska nim
vomiting, gastrointestinal pain, flatulence
navzea, bruhanje,
infection, stomatitis anorexia,
s Candido,
colitis
ski kolitis
constipation,, Hepato-biliary disorders
stomatitis, bolečine v anoreksija, prebavilih, zaprtje flatulenca Bolezni jeter, žolčnika in žolčevodov ilo