natgillin/translations-raw huggingface dataset:
Repeated dose toxicity studies of 1, 3 and 6 months 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.
Other metabolites were detected in plasma, urine and faeces and represent less or equal than 3 % of plasma AUC.
Drugi presnovki, odkriti v plazmi, urinu in blatu, predstavljajo 3% plazemske AUC ali manj.
In vivo interaction studies with other statins have not been performed, but Levviax may produce a similar interaction with lovastatin and atorvastatin, a lesser interaction with cerivastatin and little or no interaction with pravastatin and fluvastatin.
Raziskav medsebojnega delovanja z drugimi statini in vivo ni bilo, vendar lahko zdravilo Levviax povzroči podobne interakcije z lovastatinom in atorvastatinom, manjše interakcije s cerivastatinom ter majhne ali sploh nobenih s pravastatinom in fluvastatinom.
Levviax is not recommended as first choice in patients with severe renal impairment (creatinine clearance <30ml/min) or patients with both severe renal impairment and co-existing hepatic impairment, as an optimal dosage format (600 mg) is not available.
Levviax 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.
Levviax is contraindicated in patients with a 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.
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 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.
Do not use Levviax after the expiry date which is stated on the pack.
Zdravila Levviax ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
The rate and extent of absorption is unaffected by food intake, and thus Levviax tablets can be given without regard to food.
Uživanje hrane ne vpliva na hitrost niti na obseg absorpcije, tako da je mogoče tablete Levviax jemati ne glede na hrano.
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 function is limited.
Pri bolnikih z blago, zmerno ali hudo okvaro jeter odmerka ni treba prilagoditi, če ni hudo prizadeto tudi delovanje ledvic, vendar so izkušnje z bolniki, ki imajo okvarjeno delovanje jeter, omejene.
• Effect of Levviax on other medicinal product
• Vpliv zdravila Levviax na druga zdravila
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.
Light orange, oblong, biconvex tablet, imprinted with H3647 on one side and 400 on the other.
Svetlo oranžne, podolgovate, bikonveksne tablete z oznako H3647 na eni strani in 400 na drugi.
METHOD AND, ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
Caution is warranted when Levviax is administered to patients taking other medicinal products with the potential to prolong QT interval (see section 4.4).
Previdnost je potrebna med uporabo zdravila Levviax pri bolnikih, ki jemljejo druga zdravila s potencialom za podaljšanje QT intervala (glejte poglavje 4.4).
They are available in packs of 10, 5x2, 14, 20 and 100 tablets.
Na voljo so v pakiranjih po 10, 5 x 2, 14, 20 in 100 tablet.
So, if any of the following happens, stop taking Levviax and tell your doctor immediately: - Allergic or skin reactions such as face swelling, general allergic reactions including allergic shock, or serious skin conditions associated with red spots, blisters.
Zdravilo Levviax zato nehajte jemati in takoj povejte svojemu zdravniku, če se pojavi karkoli od naslednjega: - Alergijske ali kožne reakcije, npr. oteklost obraza, splošne alergijske reakcije, vključno z alergijskim šokom, ali resne kožne spremembe, ki jih spremljajo rdeče lise, mehurji.
Staphylococcus aureus methicillin susceptible (MSSA)*
Staphylococcus aureus občutljiv za meticilin (MSSA)*
- Worsening of a condition called myasthenia gravis, a rare disease which causes muscle weakness.
- Poslabšanje stanja, imenovanega miastenija gravis, redke bolezni, ki povzroči šibkost mišic.
In vitro results have shown that telithromycin is affected by the erythromycin ermB or mefA related resistance mechanisms but to lesser extent than erythromycin.
Rezultati in vitro so pokazali, da na telitromicin vpliva odpornost proti eritromicinu po mehanizmih, povezanih z ermB ali mefA, vendar v manjši meri kot na eritromicin.
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 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).
The recommended dose of Levviax for adults and children of 12 years and older is two tablets of 400 mg once daily (800 mg once daily).
Priporočeni odmerek zdravila Levviax za odrasle in otroke od 12. leta dalje je dve 400 mg tableti enkrat na dan (800 mg enkrat na dan).
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 ogroženih podskupin.
Levviax 400 mg tablets are light orange, oblong, biconvex, film-coated tablet imprinted with “H3647” on one side and “400” on the other.
Levviax 400 mg tablete so svetlo oranžne, podolgovate, bikonveksne, filmsko obložene tablete z oznako "H3647" na eni strani in "400" na drugi.
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.
MARKETING AUTORISATION NUMBER(S)
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
After oral administration of radiolabelled telithromycin, 76 % of the radioactivity was recovered from faeces, and 17 % from the urine.
Po peroralni uporabi radioaktivno označenega telitromicina so določili 76% radioaktivnosti v blatu in 17 % v urinu.
- if you develop severe or prolonged or bloody diarrhoea during or after taking Levviax tablets, consult your doctor immediately since it may be necessary to interrupt the treatment.
- če se vam med jemanjem tablet Levviax ali po njem pojavi huda, dolgotrajna ali krvava driska; v tem primeru se nemudoma posvetujte z zdravnikom, ker bo zdravljenje morda treba prekiniti.
Blood and the lymphatic system disorders
Bolezni krvi in limfatičnega sistema eozinofilija
• Effect of other medicinal products on Levviax
• Vpliv drugih zdravil na zdravilo Levviax
Levviax tablets are presented in blister packs.
Tablete Levviax so pakirane v pretisnih omotih.
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.
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.
•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 poglavji 4.4 in 5.1).
Rare cases of transient loss of consciousness (fainting), which may be preceded by vagal symptoms (malaise, gastrointestinal distress), have been reported.
Poročali so redkih primerih prehodne izgube zavesti (omedlevanje), pred katero se lahko pojavijo vagalni simptomi (slabost, gastrointestinalne težave).
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.
Zato se zdravila Levviax ne sme uporabljati med zdravljenjem z zdravili, ki so substrati CYP3A4, razen kadar je mogoče natančno nadzorovati plazemske koncentracije, učinkovitost ali neželene učinke takšnega substrata.
In adults, Levviax can be used to treat infections of the throat, infections of the sinuses, chest infections in patients with long standing breathing difficulties and pneumonia.
Pri odraslih se Levviax lahko uporablja za zdravljenje okužb žrela, okužb sinusov, okužb pljuč pri bolnikih z dolgotrajnimi težavami z dihanjem in pljučnico.
The affinity of telithromycin for the 50S bacterial subunit of ribosome is 10 fold higher than that of erythromycin A when the strain is susceptible to erythromycin A. Against erythromycin A resistant strains, due to an MLSB mechanism of resistance, telithromycin shows a more than 20 fold affinity compared to erythromycin A in the 50S bacterial subunit.
Afiniteta telitromicina za podenoto 50S bakterijskega ribosoma je 10-krat večja kot afiniteta eritromicina A, kadar je sev občutljiv za eritromicin A. Pri sevih, ki so zaradi mehanizma odpornosti MLSB odporni proti eritromicinu A, pa ima telitromicin v primerjavi z eritromicinom A več kot 20kratno afiniteto za bakterijsko podenoto 50S.
Telithromycin does not induce MLSB resistance in vitro to Staphylococcus aureus, Streptococcus pneumoniae, and Streptococcus pyogenes, an attribute related to its 3 keto function.
Telitromicin in vitro ne inducira odpornosti MLSB pri Staphylococcus aureusu, Streptococcus pneumoniae in Streptococcus pyogenesu; ta lastnost je povezana z njegovo 3-keto funkcijo.
Levviax is an inhibitor of CYP3A4 and should only be used under specific circumstances during 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.
For those benzodiazepins which are not metabolized by CYP3A4 (temazepam, nitrazepam, lorazepam) an interaction with Levviax is unlikely.
Pri benzodiazepinih, ki se ne presnavljajo s CYP3A4 (temazepam, nitrazepam, lorazepam), medsebojno delovanje z zdravilom Levviax ni verjetno.
If any of these undesirable effects are troublesome, severe, or do not wear off as treatment goes on, tell your doctor.
Če je kateri od teh neželenih učinkov moteč, hud ali med nadaljevanjem zdravljenja ne mine, povejte svojemu zdravniku.
Levviax has been shown to increase the plasma concentrations of digoxin.
Dokazano je, da Levviax zviša koncentracije digoksina v plazmi.
Like all medicines Levviax can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Levviax neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Telithromycin is an inhibitor of CYP3A4 and CYP2D6, but has no or limited effect on CYP1A, 2A6, 2B6, 2C8, 2C9, 2C19 and 2E1.
Telitromicin je zaviralec CYP3A4 in CYP2D6, na CYP1A, 2A6, 2B6, 2C8, 2C9, 2C19 in 2E1 pa ima majhen učinek ali ga sploh nima.
Levviax may cause visual disturbances particularly in slowing the ability to accommodate and the ability to release accommodation.
Zdravilo Levviax lahko povzroči motnje vida, še posebej upočasnitev sposobnosti za akomodacijo in sprostitve akomodacije.
INFORMATION IN BRAILLE Levviax
PODATKI V BRAILLOVI PISAVI Levviax
Levviax may cause undesirable effects such as visual disturbances which may reduce the capacity for the completion of certain tasks.
Levviax lahko povzroči neželene učinke, kot so motnje vida, ki lahko zmanjšajo zmožnost za opravljanje nekaterih nalog.
If you have 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.
Če imate 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.
In patients with severely impaired renal and/or hepatic function, concomitant administration of Levviax and strong CYP3A4 inhibitors, such as protease inhibitors or ketoconazole, is contraindicated.
Pri bolnikih s hudo okvarjenim delovanjem ledvic in/ali jeter je sočasna uporaba zdravila Levviax in močnih inhibitorjev CYP3A4, kot so npr. zaviralci proteaz ali ketokonazol, kontraindicirana.
Telithromycin, but not its major human metabolites, had inhibitory activity on HERG and Kv1.5 channels.
Telitromicin - ne pa njegovi glavni presnovki pri ljudeh - je deloval zaviralno na kanale HERG in Kv1,5.
Post-marketing cases of severe hepatitis and liver failure, including fatal cases (which have generally been associated with serious underlying diseases or concomitant medications), have been reported (see section 4.8).
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).
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.
If you accidentally take one tablet too many, nothing is likely to happen.
Če ste vzeli večji odmerek zdravila Levviax, kot bi smeli Če po nesreči vzamete eno tableto preveč, se najverjetneje ne bo zgodilo nič.
The total clearance (mean ±SD) is approximately 58±5 l/h after an intravenous administration with renal clearance accounting for about 22 % of this.
Skupni očistek (povprečje ± SD) po intravenski uporabi je približno 58 ± 5 l/h, pri čemer gre okoli 22% tega na račun ledvičnega očistka.
Concomitant administration of Levviax and any of the following substances is contraindicated: cisapride, ergot alkaloid derivatives (such as ergotamine and dihydroergotamine), pimozide, astemizole and terfenadine (see section 4.5).
Kontraindicirana je sočasna uporaba zdravila Levviax in katerekoli od naslednjih snovi: cisaprida, derivatov ergot alkaloidov (kot sta ergotamin in dihidroergotamin), pimozida, astemizola in terfenadina (glejte poglavje 4.5).
You should not use Levviax if you are taking certain medicinal products to control the blood level of cholesterol or other lipids, like simvastatin.
Zdravila Levviax ne smete uporabljati, če jemljete določena zdravila za obvladovanje koncentracije holesterola ali drugih maščob v krvi, npr. simvastatin.
No dosage adjustment is required in elderly patients based on age alone.
Starejši: Pri starejših bolnikih odmerka ni treba prilagajati zgolj zaradi starosti.
Very rare side effects(less than 1 out of 10,000 patients) which may occur with Levviax are : Disturbance of smell, muscle cramps.
Zelo redki neželeni učinki (manj kot 1 od 10.000 bolnikov), ki se lahko pojavijo z zdravilom Levviax, so: motnje voha, mišični krči.
Treatment with these agents should be interrupted during Levviax treatment.
Zdravljenje s temi zdravili je treba med terapijo z zdravilom Levviax prekiniti.
Because of potential visual difficulties or loss of consciousness, patients should attempt to minimize activities such as driving a 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 vozil, upravljanje s težkimi stroji ali vključevanje v druge nevarne aktivnosti.
It is particularly important for your doctor to know if you are taking medicines containing phenytoin, and carbamazepine (for epilepsy), rifampicin (antibiotic), phenobarbital or St John's wort, medicines like tacrolimus, cyclosporin and sirolimus (for organ transplantation), or metoprolol (against heart disorder) or the anti HIV medicine ritonavir.
Posebno pomembno je, da zdravniku poveste, če jemljete zdravila, ki vsebujejo fenitoin ali karbamazepin (za epilepsijo), rifampicin (antibiotik), fenobarbital ali šentjanževko, zdravila, kot so takrolimus, ciklosporin in sirolimus (za presaditev organa), ali metoprolol (proti določenim srčnim motnjam) ali zdravilo proti HIV, ritonavir.
Ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) By extrapolation from erythromycin A and josamycin, concomitant medication of Levviax and alkaloid derivatives could lead to severe vasoconstriction (“ergotism”) with possibly necrosis of the extremities.
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.
What Levviax looks like and contents of the pack
Izgled zdravila Levviax in vsebina pakiranja
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 dose.
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.
Additional side effects which may occur with Levviax are: abnormality of electrocardiogram (ECG) called prolongation of QT interval and inflamed pancreas (pancreatitis).
Dodatni neželeni učinki, ki se lahko pojavijo z zdravilom Levviax, so: nepravilnosti v elektrokardiogramu (EKG), t. i. podaljšanje intervala QT, in vnetje trebušne slinavke (pankreatitis).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg of telithromycin.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka filmsko obložena tableta vsebuje 400 mg telitromicina.
In patients of 12 to 18 years old, the treatment regimen will be: - Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days.
Pri bolnikih, starih 12 do 18 let, je shema zdravljenja: - Tonzilitis/faringitis, ki ga povzroča Streptococcus pyogenes: 800 mg enkrat na dan 5 dni.
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)
If you have vision problems or faint while taking Levviax do not drive, operate heavy machinery, or engage in dangerous activities.
Če imate med jemanjem zdravila Levviax težave z vidom ali omedlite, ne smete voziti vozil, upravljati s težkimi stroji ali se vključevati v nevarne aktivnosti.
Aventis Pharma S.p.A. Strada Statale No 17, km22 67019 Scoppito (L'Aquila) Italy
Strada Statale No 17, km22 67019 Scoppito (L'Aquila) Italija
Due to limited experience in patients with decreased metabolic capacity of the liver, Levviax should be used with caution in patients with hepatic impairment (see also section 4.4).
Zaradi omejenih izkušenj pri bolnikih z zmanjšano presnovno kapaciteto jeter je treba zdravilo Levviax pri bolnikih z jetrno okvaro uporabljati previdno (glejte tudi poglavje 4.4).
The most common side effect (10 or more out of 100 patients) which may occur with Levviax is diarrhoea, usually mild and temporary.
Najpogostejši neželeni učinek (10 ali več na 100 bolnikov), ki se lahko pojavi pri zdravljenju z zdravilom Levviax, je driska; ponavadi je blaga in prehodna.
In the elderly:
-Starejše osebe
In patients of 18 years and older: • Community-acquired pneumonia, mild or moderate (see section 4.4).
Pri bolnikih, starih 18. let in starejšihi: - Blage ali zmerne pljučnice, dobljene v domačem okolju (glejte poglavje 4.4).
Hypersensitivity to the active substance, to any of the macrolide antibacterial agents, or to any of the excipients.
Preobčutljivost za zdravilno učinkovino, katerokoli makrolidno protibakterijsko zdravilo ali katerokoli pomožno snov.
Concomitant administration of Levviax 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).
Magyarország sanofi-aventis zrt., Magyarország Tel: +36 1 505 0050
Magyarország sanofi-aventis zrt., Magyrország Tel: +36 1 505 0050
Hypromellose 6 cp Titanium dioxide E171 Yellow iron oxide E172 Red iron oxide E172
Obloga tablete: smukec makrogol 8000 hipromeloza 6 cp titanov dioksid E171 rumeni železov oksid E172 rdeči železov oksid E172
You should not use Levviax with medicines containing ergotamine or dihydroergotamine tablets or ergotamine inhalers for migraine, terfenadine or astemizole for allergic problems, cisapride for digestive problems and pimozide for psychiatric problems.
Zdravila Levviax ne smete uporabljati z zdravili, ki vsebujejo ergotamin, tabletami dihidroergotamina ali inhalatorji ergotamina za migreno, s terfenadinom ali astemizolom za alergijske težave, cisapridom za prebavne motnje ali pimozidom za psihiatrične motnje.
Common (≥1/100 to
Pogosti (≥ 1/100 do <
While exposure to telithromycin did select for pneumococcal mutants with increased MICs, the MICs remained within the proposed susceptibility range.
Izpostavljenost telitromicinu lahko povzroči selekcijo pnevmokoknih mutantov z zvečanimi MIK, vendar so MIK ostale znotraj pričakovanega območja občutljivosti.
• When treating infections caused by known or suspected beta-lactam and/or macrolide resistant strains (according to history of patients or national and/or regional resistance data) covered by the antibacterial spectrum of telithromycin (see sections 4.4 and 5.1):
- Zdravljenje okužb, ki so jih ali bi jih lahko povzročili sevi, odporni proti betalaktamskim ali makrolidnim antibiotikom ali obojim (glede na anamnezo bolnika ali nacionalne in/ali regionalne podatke o odpornosti), ki jih pokriva protibakterijski spekter telitromicina (glejte poglavji 4.4 in 5.1): - akutnega poslabšanja kroničnega bronhitisa.
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.