natgillin/translations-raw huggingface dataset:
In - vivo interaktionsforsøg med andre statiner er ikke udført, men Ketek kunne bevirke en lignende interaktion med lovastatin og atorvastatin, en mindre interaktion med cerivastatin og lille eller ingen interaktion med pravastatin og fluvastatin.
In vivo interaction studies with other statins have not been performed, but Ketek may produce a similar interaction with lovastatin and atorvastatin, a lesser interaction with cerivastatin and little or no interaction with pravastatin and fluvastatin.
Ketek må ikke anvende samtidig med simvastatin, atorvastatin og lovastatin.
Ketek should not be used concomitantly with simvastatin, atorvastastin and lovastatin.
Behandling med disse midler skal afbrydes under Ketek behandling.
Treatment with these agents should be interrupted during Ketek treatment.
Cerivastatin bør anvendes med forsigtighed og patienterne skal monitoreres omhyggeligt for tegn og symptomer på myopati og rhabdomyolyse.
Cerivastatin should be used with caution and patients should be carefully monitored for signs and symptoms of myopathy and rhabdomyolysis.
Benzodiazepiner Ved samtidig administration af midazolam med Ketek steg midazolam AUC 2, 2 gange efter intravenøs administration af midazolam og 6, 1 gang efter oral administration.
Benzodiazepins When midazolam was coadministered with Ketek, midazolam AUC was increased 2.2-fold after intravenous administration of midazolam and 6.1-fold after oral administration.
2, 5 gange.
The midazolam half- life was increased about 2.5-fold.
For de benzodiazepiner som ikke metaboliseres via CYP3A4 (temazepam, nitrazepam, lorazepam) er interaktion med telithromycin usandsynlig.
For those benzodiazepins which are not metabolized by CYP3A4 (temazepam, nitrazepam, lorazepam) an interaction with Ketek is unlikely.
Cyclosporin, tacrolimus, sirolimus På grund af dets CYP3A4 hæmningspotentiale, kan telithromycin øge blodkoncentrationerne af disse CYP3A4 substrater.
Cyclosporin, tacrolimus, sirolimus Due to its CYP3A4 inhibitory potential, telithromycin can increase blood concentrations of these CYP34A4 substrates.
5 Metoprolol Når metoprolol (et CYP2D6 substrat) blev administrret samtidig med Ketek, var der en let stigning på ca 38% af Cmax og af AUC for metoprolol, der var imidlerid ingen effekt på metoprolols eliminationshalveringstid.
5 Metoprolol 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.
Hos disse patienter bør samtidig administration af Ketek og metoprolol, et CYP2D6 substrat, ske med forsigtighed.
In these patients, co-administration of Ketek and metoprolol, a CYP2D6 substrate, should be considered with caution.
Ketek øger plasmakoncentrationen af digoxin.
Digoxin Ketek has been shown to increase the plasma concentrations of digoxin.
Trods dette er der ingen signifikante ændringer i EKG- parametrene, og der er ikke set tegn på digoxin- toksicitet.
There were no significant changes in ECG parameters and no signs of digoxin toxicity were observed.
Alligevel bør kontrol af se- digoxinniveauet overvejes ved samtidig anvendelse af digoxin og Ketek
Nevertheless, monitoring of serum digoxin level should be considered during concomitant administration of digoxin and Ketek.
Der er ikke nogen klinisk relevante farmakokinetiske interaktioner mellem Ketek og teofyllin, når dette gives som retardformulering.
Theophylline There is no clinically relevant pharmacokinetic interaction of Ketek and theophylline administered as extended release formulation.
Perorale antikoagulantia Øget antikoagulationsaktivitet er set hos patienter, der behandles samtidigt med antikoagulantia og antibiotika, telithromycin indbefattet.
Oral anticoagulants Increased anticoagulant activity has been reported in patients simultaneously treated with anticoagulants and antibiotics, including telithromycin.
Selv om Ketek har ingen klinisk relevant farmakokineteisk eller farmkodynamisk interaktion med warfarin efter enkeltdosis administartion, hyppigere monitorering af protrombintid/ INR (International Normalised Ratio) værdier bør overvejes under samtidig behandling.
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.
Perorale kontraceptiva Der er ikke set farmakodynamiske eller klinisk relevant farmakokinetisk interaktion med lavdosis trifasiske perorale kontraceptiva hos raske forsøgspersoner.
Oral contraceptives There is no pharmacodynamic or clinically relevant pharmacokinetic interaction with low-dose triphasic oral contraceptives in healthy subjects.
Andre lægemidlers virkning på Ketek:
• Effect of other medicinal products on Ketek
Derfor vil samtidig administration af CYP3A4 inducere (fx rifampicin, phenytoin, carbamazepin, phenobarbital, St Johns wort) sandsynligvis resultere i subterapeutiske koncentrationer af telithromycin og tab af effekt.
Therefore, concomitant administration of CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John’ s wort) is likely to result in subtherapeutic levels of telithromycin and loss of effect.
Ketek bør ikke anvendes under og 2 uger efter behandling med CYP3A4 inducere.
Ketek should not be used during and 2 weeks after treatment with CYP3A4 inducers.
Interaktionsforsøg med itraconzol og ketoconazol, to CYP3A4 inhibitorer, viste at maximum plasmakoncentrationerne for telithromycin steg henholdsvis 1, 22 og 1, 51 gange og AUC henholdsvis 1, 54 og 2, 0 gange.
Interaction studies with itraconazole and ketoconazole, two CYP3A4 inhibitors, showed that maximum plasma concentrations of telithromycin were increased respectively by 1.22 and 1.51 fold and AUC by respectively 1.54 fold and 2.0 fold.
Ranitidin (indtaget 1 time før Ketek) og antacida indeholdende aluminium og magnesiumhydroksid har ingen klinisk relevant påvirkning af telithromycins farmakokinetik
Ranitidine (taken 1 hour before Ketek) and antacid containing aluminium and magnesium hydroxide has no clinically relevant influence on telithromycin pharmacokinetics.
5 gange af maternel plasmakoncentration.
6 Telithromycin is excreted in the milk of lactating animals, at concentrations about 5 times those of maternal plasma.
Ketek kan forårsage uønskede virkninger så som synsforstyrrelser, forvirring eller hallucinationer, som kan nedsætte evnen til at udføre visse opgaver.
Ketek may cause undesirable effects such as visual disturbances, confusion or hallucination which may reduce the capacity for the completion of certain tasks.
4. 4 og 4. 8).
If patients experience visual disorders, loss of consciousness, confusion or hallucination while taking Ketek, patients should not drive a motor vehicle, operate heavy machinery or engage in other hazardous activities (see sections 4.4 and 4.8).
Hos 2461 patienter behandlet med telithromycin i fase III kliniske forsøg samt igennem post - marketing erfaring blev følgende bivirkninger, der muligvis eller sandsynligvis kunne relateres til telithromycin, rapporteret.
In 2461 patients treated by Ketek in phase III clinical trials, and during postmarketing experience, the following undesirable effects possibly or probably related to telithromycin have been reported.
Meget almindelig > 1/ 10
Very common (≥ 1/ 10)
Almindelig > 1/ 100, < 1/ 10
Common (≥ 1/ 100 to < 1/ 10)
Ikke almindelig > 1/ 1. 000, < 1/ 100
Uncommon Rare (≥ 1/ 1,000 (≥ 1/ 10,000 to to < 1/ 100) < 1/ 1,000)
Meget sjælden < 1/ 10. 000
Very rare (< 1/ 10,000)
Frekvens ukendt (kan ikke estimeres ud fra forhåndenvære nde data) *
Frequency unknown (cannot be estimated from available data)*
Atriel arytmi, hypotension, bradykardi
Flush Atrial Palpitations arrhythmia, hypotension, bradycardia
QT/ QTc interval forlængelse
QT/ QTc interval prolongation
Forbigående bevidstheds - tab, paræstesi
Blood and the lymphatic system disorders
Parosmi
Eosinophilia
Ageusi, anosmi
Nervous system disorders
Mave - tarmkanalen
Dizziness, headache, disturbance of taste
Kvalme, opkastning, gastrointestinale smerter, flatulens
Vertigo somnolence, nervousness, insomnia,
Peroral Candida infektion, stomatitis, anoreksi, obstipation
Transient loss Parosmia of consciousness, paraesthesia
Pseufomembr Pankreatitis anøs colitis
Cases of rapid onset of exacerbation of myasthenia gravis have been reported (see sections 4.3 and 4.4).
Hud og subkutane væv
Ageusia, anosmia,
Udslæt, urticaria, pruritus
Eye disorders
Eksem
Blurred vision
Erythema multiforme
Diplopia
7 Systemorgankl asser
7 System organ class
Sjælden > 1/ 10. 000, < 1/ 1. 000
Very rare (< 1/ 10,000)
Meget sjælden < 1/ 10. 000
Frequency unknown (cannot be estimated from available data)*
Frekvens ukendt (kan ikke estimeres ud fra forhåndenvære nde data) *
Oral Candida infection, stomatitis anorexia, constipation
Immunsystemet
Pancreatitis
Angioneurotisk ødem, anafylaktiske reaktioner inklusive anafylaktisk shock, hypersensivitet
Skin and subcutaneous tissue disorders
Lever og galdeveje Det reproduktive system og mammae
Rash, urticaria, pruritus
Forhøjede leverenzymer (ASAT, ALAT, basisk fosfatase) Vaginal Candida infektion
Hepato-biliary Increase in disorders liver enzymes (AST, ALT, alkaline phosphatase) Reproductive Vaginal system disorders Candida infection
4. 4)
Severe hepatitis and liver failure (see section 4.4)
Forvirring, hallucinationer
Psychiatric disorders * postmarketing experience.
* Post- marketing erfaringer
Confusion, hallucination
Synsforstyrrelser (< 1%) i forbindelse med brug af Ketek, inklusive sløret syn, svært ved at fokusere og diplopi, var mest milde til moderate.
Visual disturbances (< 1%) associated with the use of Ketek, including blurred vision, difficulty focusing and diplopia, were mostly mild to moderate.
4. 4 og 4. 7).
These events have not been associated with signs of ocular abnormality (see sections 4.4 and 4.7).
I sammenlignende kliniske forsøg, blev lignende virkninger som observeret under clarithromycin set på en on- terapi ΔQTc > 30 msec hos henholdsvis 7, 6% og 7% af tilfældene.
In comparative trials, similar effects to those observed with clarithromycin were seen with an on-therapy Δ QTc > 30 msec in 7.6% and 7.0% of cases, respectively.
Ingen patienter i nogen af grupperne viste en ΔQTc > 60 msec.
No patient in either group developed a Δ QTc > 60 msec.
Der var ingen rapporter på TdP eller andre alvorlige ventriculære arytmier eller relateret syncope i det kliniske program, og der blev ikke fundet risiko subgrupper.
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.
5. 1
8 5.
Macrolider, lincosamider og streptogramin, ATC- kode:
Pharmacotherapeutic group: macrolides, lincosamides and streptogramins, ATC Code:
Telithromycin er et semisyntetisk derivat af erythromycin A, og tilhører gruppen af ketolider, en ny gruppe af antibakterielle midler beslægtet med macrolider.
Telithromycin is a semisynthetic derivative of erythromycin A belonging to the ketolides, a class of antibacterial agents related to macrolides.
Telithromycin hæmmer proteinsyntesen ved at virke på ribosom- niveauet.
Telithromycin inhibits protein synthesis by acting at the ribosome level.
8 Telithromycins affinitet til den bakterielle 50S ribosom subunit er 10 gange højere end for erythromycin A, hvis stammerne er følsomme over for erythromycin A.
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.
Over for erythromycin A resistente stammer udviser telithromycin på grund af en MLSB resistensmekanisme i den bakterielle 50S subunit en 20 gange så høj affinitet sammenlignet med 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.
Telithromycin påvirker ribosomoversættelsen på det 23S ribosomale RNA- niveau. hvor det interagerer med område V og II.
Telithromycin interferes with the ribosome translation at the 23S ribosomal RNA level, where it interacts with domain V and II.
Følsomme ≤ 0, 5 mg/ l, resistente > 2 mg/ l
The recommended MIC breakpoints for telithromycin, separating susceptible organisms from intermediately susceptible organisms and intermediately susceptible organisms from resistant organisms, are: susceptible ≤ 0.5 mg/ l, resistant > 2 mg/ l.
Denne information giver kun en tilnærmet vejledning over sandsynligheden for om en mikroorganisme vil være følsom over for telithromycin.
This information provides only an approximate guidance on probabilities as to whether microorganisms will be susceptible to telithromycin.
Almindeligt følsomme arter Aerobe Gram- positive bakterier Staphylococcus aureus methicillin følsomme (MSSA) * Lancefield gruppe C og G streptococci (β hæmolytisk) Streptococcus agalactiae Streptococcus pneumoniae * Viridans gruppe streptococci Aerobe Gram- negative bakterier Legionella pneumophila Moraxella catarrhalis * Andre Chlamydophila pneumoniae * Chlamydia psittaci Mycoplasma pneumoniae * Arter, for hvilke erhvervet resistens kan udgøre et problem Aerobe Gram- positive bakterier Staphylococcus aureus methicillin følsomme (MSSA) * Streptococcus pyogenes * Aerobe Gram- negative bakterier Haemophilus influenzae * Haemophilus parainfluenzae Arveligt betingede resistente organismer Aerobe Gram- negative bakterier Acinetobacter Enterobacteriaceae Pseudomonas
9 Commonly susceptible species Aerobic Gram-positive bacteria Staphylococcus aureus methicillin susceptible (MSSA)* Lancefield group C and G (ß haemolytic) streptococci Streptococcus agalactiae Streptococcus pneumoniae * Viridans group streptococci Aerobic Gram- negative bacteria
* Klinisk effekt er blevet vist ved følsomme isolater til godkendte indikationer. $Naturlig intermediate følsomhed + ** Blandt MRSA er raten af MLSB resistente stammer mere end 80%, telithromycin er ikke aktiv overfor MLSBc.
∗ Clinical efficacy has been demonstrated for susceptible isolates in the approved clinical indications. $natural intermediate susceptibility +Among MRSA the rate of MLSBc resistant strains is more than 80%, telithromycin is not active against MLSBc.
9 Resistens
Resistance
In- vitro forsøg viste at telithromycin er påvirket af erythromycin ermB elle mefA beslægtede resistensmekanismer men i mindre udstrækning end erythromycin.
In vitro results have shown that telithromycin is affected by the erythromycin ermB or mefA related resistance mechanisms but to lesser extent than erythromycin.
For Streptococcus pneumoniae er der ikke kryds - eller co- resistens mellem telithromycin og andre antibakterielle klasser inklusive erythromycin A og/ eller penicillinresistens.
For Streptococcus pneumoniae, there is no cross- or co-resistance between telithromycin and other antibacterial classes including erythromycin A and/ or penicillin resistance.
For Streptococcus pyogenes forekommer krydsresistens for high- level erythromycin A resistente stammer.
For Streptococcus pyogenes, cross-resistance occurs for high-level erythromycin A resistant strains.
Effekt på oral og fækal flora
10 Effect on oral and faecal flora
I modsætning til clarithromycin opstod imidlertid ingen resistente stammer af alfa- streptokokker i saliva ved behandling med telithromycin.
However, in contrast to clarithromycin, no resistant strains of alpha streptococci emerged in saliva on treatment with telithromycin.
En gennemsnitlig maksimal plasmakoncentration på 2 mg/ l opnås indenfor 1- 3 timer efter en gang daglig dosering af 800 mg telithromycin.
A mean maximum plasma concentration of about 2 mg/ l is reached within 1-3 hour after dose with once-daily dosing of telithromycin 800 mg.
Absorptionsraten og – udbredelsen påvirkes ikke af fødeindtagelse, hvorfor Ketek tabletter kan gives uden hensyn til fødeindtagelse.
The rate and extent of absorption is unaffected by food intake, and thus Ketek tablets can be given without regard to food.
Gennemsnitlig minimum plasmakoncentration ved steady state på 0, 04 og 0, 07 mg/ l nås indenfor 3- 4 dage ved dosering én gang daglig af 800 mg telithromycin.
Mean steady-state trough plasma concentrations of between 0.04 and 0.07 mg/ l are reached within 3 to 4 days with once-daily dosing of telithromycin 800 mg.
1, 5 gange højere end ved enkeltdosering.
At steady-state AUC is approximately 1.5 fold increased compared to the single dose.
Genemsnitlige maksimum og minimum plasmakoncentrationer ved steady state hos patienter var 2, 9±1, 6 mg/ l (interval 0, 02- 7, 6 mg/ ml) og 0, 2±0, 2 mg/ l (interval 0, 010- 1, 29 mg/ l) under et terapeutisk 800 mg daglig dosis regime.
Mean peak and trough plasma concentrations at steady state in patients were 2.9±1.6 mg/ l (range 0.02- 7.6 mg/ l) and 0.2±0.2 mg/ l (range 0.010 to 1.29 mg/ l), during a therapeutic 800 mg once-daily dose regimen.
60% til 70%. Telithromycin fordeles bredt i hele kroppen.
The in vitro protein binding is approximately 60% to 70%.
Fordelingsvolumen er 2, 9 ± 1, 0 l/ kg.
The volume of distribution is 2.9±1.0 l/ kg.
Hurtig fordeling af telithromycin i vævet resulterer i signifikant højere telithromycinkoncentrationer i de fleste mål- væv end i plasma.
Rapid distribution of telithromycin into tissues results in significantly higher telithromycin concentrations in most target tissues than in plasma.
De maksimale totale vævskoncentrationer i epitelomkranset væske, alveolære makrofager, bronchial mucosa,, tonsiller og sinusvæv var henholdsvis 14, 9 ± 11, 4 mg/ l, 318, 1 ± 231 mg/ l, 3, 88 ± 1, 87 mg/ kg, 3, 95 ± 0, 53 mg/ kg og 6, 96 ± 1, 58 mg/ kg.
The maximum total tissue concentration in epithelial lining fluid, alveolar macrophages, bronchial mucosa, tonsils and sinus tissue were 14.9±11.4 mg/ l, 318.1±231 mg/ l, 3.88±1.87 mg/ kg, 3.95±0.53 mg/ kg and 6.96±1.58 mg/ kg, respectively.
De totale vævskoncentrationerne 24 timer efter dosis i epitelomkranset væske, alveolære makrofager, bronchial mucosa, tonsiller, og sinusvæv var henholdsvis 0, 84 ± 0, 65 mg/ l, 162 ± 96 mg/ l, 0, 78 ± 0, 39 mg/ kg, 0, 72 ± 0, 29 mg/ kg og 1, 58 ± 1, 68 mg/ kg.
The total tissue concentration 24 h after dose in epithelial lining fluid, alveolar macrophages, bronchial mucosa, tonsils and sinus tissue were 0.84±0.65 mg/ l, 162±96 mg/ l, 0.78±0.39 mg/ kg, 0.72±0.29 mg/ kg and 1.58±1.68 mg/ kg, respectively.
Den genemsnitlig maksimum telithromycin koncentration i hvide blodlegemer var 83 ± 25 mg/ l.
The mean maximum white blood cell concentration of telithromycin was 83±25 mg/ l.
10 Metabolisme
Metabolism
Efter peroral administration udskilles 2/ 3 af en dosis som metabolitter og 1/ 3 uomdannet.
After oral administration, two-thirds of the dose is eliminated as metabolites and one-third unchanged.
13% af telithromycin AUC, og har ringe antimikrobiel virkning sammenlignet med modersubstansen.
Its principal circulating metabolite represents approximately 13% of telithromycin AUC, and has little antimicrobial activity compared with the parent medicinal product.
Andre metaboliter blev påvist i plasma, urin og fæces og udgør mindre end eller er lig med 3% af plasma AUC.
Other metabolites were detected in plasma, urine and faeces and represent less or equal than 3% of plasma AUC.
Telithromycin metaboliseres både af CYP450. isoenzymer og non- Cyp enzymer.
Telithromycin is metabolized both by CYP450 isoenzymes and non-CYP enzymes.
Efter peroral administration af radiomærket telithromycin genfindes 76% af radioaktiviteten i fæces, og 17% i urinen.
After oral administration of radiolabelled telithromycin, 76% of the radioactivity was recovered from faeces, and 17% from the urine.
1/ 3 af telithromycin udskilles uomdannet, 20% i fæces og 12% i urin.
Approximately one-third of telithromycin was eliminated unchanged; 20% in faeces and 12% in urine.
Telithromycin viser moderat non- lineær parkokinetik.
Telithromycin displays moderate non-linear pharmacokinetics.
Den non- renale clearance m nedsættes når dosis forøges. Total clearance er ca.
The non-renal clearance is decreased as the dose is increased.
58±5 L/ time efter intravenøs hvoraf den renale clearance er på 22%.
The total clearance (mean ±SD) is 11 approximately 58±5 l/ h after an intravenous administration with renal clearance accounting for about 22% of this.
Telithromycin viser en trieksponentiel fjernelse fra plasma med en hurtig distributionshalveringstid på 0, 17 time.
Telithromycin displays a tri-exponential decay from plasma, with a rapid distribution half-life of 0.17 h.
10 timer ved en dosis på 800 mg en gang daglig.
The main elimination half-life of telithromycin is 2-3 h and the terminal, less important, half-life is about 10 h at the dose 800 mg once daily.
4. 2.).
-Renal impairment In a multiple-dose study, 36 subjects with varying degrees of renal impairment, a 1.4-fold increase in Cmax, ss, and a 2-fold increase in AUC (0-24)ss at 800 mg multiple doses in the severe renally impaired group (CLCR < 30 mL/ min) compared to healthy volunteers were observed and a reduced dosage of Ketek is recommended (See Section 4.2.).
Baseret på simulations data, kan et alternativ dagligt dosis regime på 800 mg og 400 mg til patienter med alvorlig nedsat nyrefunktion nærme sig AUC (0- 48 t) hos raske individer, som får 800 mg en gang daglig.
Based on simulation data, an alternating daily dosing regimen of 800 mg and 400 mg in patients with severe renal impairment can approximate the AUC (0-48h) in healthy subjects receiving 800 mg once daily.
- Nedsat leverfunktion I et enkelt dosis forsøg (800 mg) med 12 patienter og et fler dosis forsøg (800 mg) med 13 patienter med mild til alvorlig nedsat leverfunktion (Child Pugh Class A, B og C), var Cmax, AUC og t½ af telithromycin tilsvarende det, som blev opnået hos alders - og kønssammenlignelige raske personer.
-Hepatic impairment In a single-dose study (800 mg) in 12 patients and a multiple-dose study (800 mg) in 13 patients with mild to severe hepatic insufficiency (Child Pugh Class A, B and C), the Cmax, AUC and t1/ 2 of telithromycin were similar compared to those obtained in age- and sex-matched healthy subjects.
4. 4).
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).
- Ældre forsøgspersoner Hos forsøgspersoner over 65 (median 75 år) var den maksimale plasmakoncentration og AUC for telithromycin øget 2 gange i forhold til unge raske voksne.
-Elderly subjects 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.
- Børn Telithromycins farmakokinetik hos børn under 12 år er endnu ikke undersøgt.
-Paediatric patients The pharmacokinetics of telithromycin in paediatric population less than 12 years old have not yet been studied.
I kliniske forsøgspopulationer omfatter farmakokinetikanalyser begrænsede data på pædiatriske patienter i alderen 13- 17 år, hvilket viser at koncentrationen af telithromycin i denne aldersgruppe svarer til koncentrationer på patienter i alderen 18- 40 år.
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.
11 - Køn Telithromycins farmakokinetik er ens for mænd og kvinder.
-Gender The pharmacokinetics of telithromycin are similar between males and females.
Plasma ekspositioner baseret på frie fraktioner af det aktive stof, ved koncentrationer med ingen observerede bivirkninger, nås i interval på 1, 6 til 13 gange den forventede kliniske eksposition.
Plasma exposures based on free fraction of active substance, at the no observed adverse effect levels ranged from 1.6 to 13 times the expected clinical exposure.