natgillin/translations-raw huggingface dataset:
Paediatric patients The pharmacokinetics of SIRTURO in paediatric patients have not been evaluated.
Pediatrični bolniki Farmakokinetike zdravila SIRTURO pri pediatričnih bolnikih niso proučevali.
The N-monodesmethyl metabolite (M2) is not thought to contribute significantly to clinical efficacy given its lower average exposure (23% to 31%) in humans and lower antimycobacterial activity (3- to 6-fold lower) compared to the parent compound.
N-monodesmetilni presnovek (M2)domnevno ne prispeva bistveno h klinični učinkovitosti, saj je povprečna izpostavljenost M2 pri človeku manjša od izpostavljenosti matični spojini (23% do 31%), njegova protibakterijska aktivnost pa je 3 do 6-krat manjša od aktivnosti izhodne učinkovine.
These subjects were excluded from the subgroup analysis by extent of resistance of M tuberculosis strain.
Ti preiskovanci so bili izključeni iz analize podskupine po obsegu odpornosti sevov M tuberculosis.
Mycobacterium xenopi, Mycobacterium novocastrense, Mycobacterium shimoidei and non-mycobacterial species are considered inherently resistant to bedaquiline.
Mycobacterium xenopi, Mycobacterium novocastrense, Mycobacterium shimoidei in bakterije, ki ne spadajo med mikobakterije, so opredeljene kot naravno odporne na bedakilin.
Bedaquiline was associated with effects in target organs which included monocytic phagocytic system (MPS), skeletal muscle, liver, stomach, pancreas and heart muscle.
Bedakilin je deloval na tarčne organe, med katerimi so monocitno-fagocitni sistem (MPS - Monocytic Phagocytic System), skeletne mišice, jetra, želodec, trebušna slinavka in srčna mišica.
Other medicines may affect SIRTURO.
Druga zdravila lahko vplivajo na delovanje zdravila SIRTURO.
In the SIRTURO group, all of the five deaths due to tuberculosis occurred in patients whose sputum culture status at last visit was ‘not converted'.
V skupini, ki je prejemala zdravilo SIRTURO je bilo pet smrti posledica tuberkuloze pri bolnikih, katerih kulture sputuma pri zadnjem obisku niso kazale konverzije (odsotnosti povzročitelja v kužnini).
If you are not sure, talk to your doctor or pharmacist before taking SIRTURO.
Če o tem niste prepričani, se pogovorite z zdravnikom ali farmacevtom, preden vzamete zdravilo SIRTURO.
SIRTURO should be used in combination with at least three medicinal products to which the patient's isolate has been shown to be susceptible in vitro.
Zdravilo SIRTURO je treba uporabljati v kombinaciji z najmanj tremi zdravili na katere je bolnikov izolat in vitro dokazano občutljiv.
Inherently resistant organisms Mycobacterium xenopi Mycobacterium novocastrense Mycobacterium shimoidei Non-mycobacterial species
Naravno odporni organizmi Mycobacterium xenopi Mycobacterium novocastrense Mycobacterium shimoidei
In the SIRTURO group, no or only minor differences in time to culture conversion and culture conversion rates were observed between patients with pre-XDR-TB and patients with MDRH&R-TB.
V skupini z zdravilom SIRTURO niso opažali razlik oziroma so opažali le manjše razlike v času do konverzije kulture med bolniki s pre-XDR-TB in bolniki z MDRH&R-TB.
efavirenz, etravirine, lopinavir/ritonavir to treat HIV infection (antiretroviral non-nucleoside reverse transcriptase inhibitors, antiretroviral protease inhibitors)
efavirenz, etravirin, lopinavir/ritonavir za zdravljenje okužbe z virusom HIV (zaviralci ne-nukleozidne reverzne transkriptaze, zaviralci proteaz)
Published data on patients treated with bedaquiline as part of therapy for drugresistant TB and lopinavir/ritonavir-based ART have shown that bedaquiline exposure (AUC) over 48 hours was increased approximately 2 fold.
Objavljeni podatki bolnikov, ki so prejemali bedakilin kot del sheme zdravljenja tuberkuloze, odporne proti zdravilom skupaj s protiretrovirusnim zdravljenjem na osnovi lopinavirja/ritonavirja so pokazali, da se je izpostavljenost bedakilinu (AUC) po 48 urah povečala za približno 2-krat.
The following are examples of medicines patients with multi-drug resistant tuberculosis may take and which may potentially interact with SIRTURO:
Spodaj so primeri zdravil, ki jih lahko jemljejo bolniki s tuberkulozo, odporno proti več zdravilom in imajo lahko medsebojen učinek z zdravilom SIRTURO:
• you have had an abnormal heart reading (ECG) or heart failure;
• če je vaš zapis delovanja srca (EKG) nenormalen ali imate srčno popuščanje
If syncope occurs, an electrocardiogram should be obtained to detect any QT prolongation.
Ob pojavu sinkope, je potrebno pridobiti elektrokardiogram, da preverite morebitno podaljšanje intervala QT.
The primary outcome parameter was the time to sputum culture conversion (i.e. the interval between the first SIRTURO intake and the first of two consecutive negative liquid cultures from sputum collected at least 25 days apart) during treatment with SIRTURO or placebo (median time to conversion was 83 days for the SIRTURO group, 125 days for the placebo group (hazard ratio, 95% CI: 2.44 [1.57; 3.80]), p < 0.0001).
Primarni opazovani parameter je bil čas do konverzije kulture sputuma (kar pomeni interval med prejemom prvega odmerka zdravila SIRTURO in prvim od dveh zaporednih negativnih izvidov tekoče kulture iz vzorcev sputuma, ki sta bila odvzeta z najmanj 25-dnevnim presledkom) v času prejemanja zdravila SIRTURO oziroma placeba (mediani čas do konverzije je bil 83 dni za skupino, ki je prejemala zdravilo SIRTURO, 125 dni za skupino, ki je prejemala placebo (razmerje tveganja, 95% IZ: 2,44 [1,57; 3,80]), p < 0,0001).
As a precautionary measure, avoid the use of SIRTURO during pregnancy unless the benefit of therapy is considered to outweigh the risks.
Iz previdnostnih razlogov se med nosečnostjo zogibajte uporabi zdravila SIRTURO, razen v primeru, da ocenjene koristi zdravljenja presegajo tveganja.
At both week 24 and week 120, responder rates were higher for patients on 3 or more active substances (in vitro) in their background regimen.
Stopnja odziva po 24. in 120. tednu je bila večja pri bolnikih, ki so v okviru osnovne sheme zdravljenja prejemali 3 ali več zdravilnih učinkovin (in vitro).
Patients received SIRTURO (n = 79) or placebo (n = 81) for 24 weeks, both in combination with a preferred 5-drug background regimen (BR) consisting of ethionamide, kanamycin, pyrazinamide, ofloxacin, and cycloserine/terizidone.
Bolniki so 24 tednov prejemali zdravilo SIRTURO (n = 79) ali placebo (n = 81) v kombinaciji z osnovno shemo (BR), ki jo je sestavljalo 5 preferenčnih učinkovin: etionamid, kanamicin, pirazinamid, ofloksacin in cikloserin/terizidon.
In rats, concentrations of bedaquiline in milk were 6- to 12-fold higher than the maximum concentration observed in maternal plasma.
Pri podganah je bila koncentracija bedakilina v mleku 6 do 12-krat višja od najvišje koncentracije, ki so jo izmerili v plazmi mater.
A Phase IIb, placebo-controlled, double-blind, randomised trial (C208) evaluated the antibacterial activity, safety, and tolerability of SIRTURO in newly diagnosed patients with sputum smear-positive pulmonary MDRH&R- and pre-XDR-TB.
V s placebom nadzorovanem, dvojno slepem, randomiziranem preskušanju faze IIb (študija C208) so ocenjevali protibakterijsko aktivnost, varnost in prenašanje zdravila SIRTURO pri novo odkritih bolnikih s pozitivnim izvidom razmaza sputuma na prisotnost pljučne MDRH&R-TB in pre-XDR-TB.
• The other ingredients are: colloidal anhydrous silica, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polysorbate 20.
• Druge sestavine zdravila so: brezvoden koloidni silicijev dioksid, premrežen natrijev karmelozat, hipromeloza, laktoza monohidrat, magnezijev stearat, koruzni škrob, mikrokristalna celuloza, polisorbat 20.
The European Medicines Agency has deferred the obligation to submit the results of studies with SIRTURO in one or more subsets of the paediatric population in the treatment of multi-drug resistant Mycobacterium tuberculosis (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom SIRTURO za eno ali več podskupin pediatrične populacije za zdravljenje okužbe z bakterijo Mycobacterium tuberculosis, odporno na več zdravil (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
In a study in 44 healthy subjects receiving a single 800 mg dose of SIRTURO, adverse reactions were consistent with those observed in clinical studies at the recommended dose (see section 4.8).
V študiji s 44 zdravimi osebami, ki so prejele enkraten odmerek 800 mg zdravila SIRTURO, so bili neželeni učinki podobni tistim, ki so jih opažali v kliničnih študijah pri uporabi priporočenih odmerkov (glejte poglavje 4.8).
Other hepatotoxic medicinal products and alcohol should be avoided while on SIRTURO, especially in patients with diminished hepatic reserve.
V času zdravljenja z zdravilom SIRTURO se je treba izogibati uporabi drugih zdravil s toksičnim delovanjem na jetra in alkoholu, kar zlasti velja za bolnike z zmanjšano rezervo delovanja jeter.
Do not give this medicine to children and adolescents (under 18 years of age).
Tega zdravila ne smete dajati otrokom ali mladostnikom (starim manj kot 18 let), ker zdravila v tej starostni skupini bolnikov niso proučevali.
The other nine deaths among those treated with SIRTURO occurred after completion of treatment with this agent (range 86 911 days post SIRTURO; median 344 days).
Do ostalih devetih smrti v tej skupini je prišlo po zaključku zdravljenja (razpon 86-911 dni; mediana 344 dni po zaključku zdravljenja z zdravilom SIRTURO).
Bedaquiline specifically inhibits mycobacterial ATP (adenosine 5'-triphosphate) synthase, an essential enzyme for the generation of energy in Mycobacterium tuberculosis.
Bedakilin specifično zavira mikobakterijsko ATP-sintazo (adenozin-5'-trifosfat sintazo), encim, ki ga bakterija Mycobacterium tuberculosis nujno potrebuje za pridobivanje energije.
The imbalance in deaths is unexplained; no evidence has been found for a causal relationship with SIRTURO treatment.
Nesorazmerje v številu smrti ni pojasnjeno in vzročne povezave z zdravljenjem z zdravilom SIRTURO niso ugotovili.
Co-administration of bedaquiline and medicinal products that induce CYP3A4 may decrease bedaquiline plasma concentrations and reduce its therapeutic effect.
Sočasna uporaba bedakilina in zdravil, ki inducirajo encim CYP3A4, lahko zniža koncentracijo bedakilina v plazmi in zmanjša njegov terapevtski učinek.
SIRTURO was administered as 400 mg once daily for the first 2 weeks, and as 200 mg 3 times/week for the following 22 weeks.
Bolniki so prva 2 tedna prejemali 400 mg zdravila SIRTURO enkrat na dan, nadaljnjih 22 tednov pa 200 mg 3-krat na teden.
• latent infection with Mycobacterium tuberculosis
• latentne okužbe z bakterijo Mycobacterium tuberculosis.
Compared to the exposures (AUC) observed in subjects with MDR-TB in the bedaquiline phase II trials, the exposures (AUC) in rats at high doses were similar in males and 2-fold higher in females for bedaquiline, and 3-fold higher in males and 2-fold higher in females for M2.
V primerjavi z izpostavljenostjo zdravilu (AUC), opaženo pri preiskovancih z MDR-TB v študijah faze II z bedakilinom, je bila izpostavljenost (AUC) bedakilinu pri podganah ob uporabi visokih odmerkov podobna pri samcih in 2-krat večja pri samicah, izpostavljenost M2 pa 3-krat večja pri samcih in 2-krat večja pri samicah.
After the 24-week investigational period, the background regimen was continued to complete 18 to 24 months of total multi-drug resistant Mycobacterium tuberculosis treatment.
Po zaključku 24-tedenskega raziskovalnega obdobja so bolniki nadaljevali zdravljenje z osnovno shemo zdravil in tako zaključili zdravljenje okužbe s proti več zdravilom odporno bakterijo Mycobacterium tuberculosis, ki je trajalo skupno 18 do 24 mesecev.
If you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Če ne prenašate ali ne morete prebavljati nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
These lead to 2- to 8-fold increases in bedaquiline MICs, resulting in bedaquiline MICs ranging from 0.25 to 0.5 mg/l.
Te vodijo v 2 do 8-kratno zvečanje MIK bedakilina, s koncentracijami od 0,25 do 0,5 mg/l.
In the MPS of all species, pigment-laden and/or foamy macrophages were also seen in various tissues, consistent with phospholipidosis.
V monocitno-fagocitnem sistemu so pri vseh živalskih vrstah v različnih tkivih opažali s pigmentom napolnjene in/ali penaste makrofage, kar ustreza fosfolipidozi.
Follow-up monitoring of electrolytes should be performed if QT prolongation is detected (see sections 4.5 and 4.8).
Če pride do podaljšanja intervala QT je potrebno ponovno preveriti koncentracije elektrolitov (glejte poglavji 4.5 in 4.8).
No human data on the effect of bedaquiline on fertility are available.
Podatki o vplivu bedakilina na plodnost pri ljudeh niso na voljo.
The MAH will evaluate additional efficacy and safety data of bedaquiline in different treatment regimen compared to a regimen that does not include bedaquiline (confirmatory phase III study) following an agreed protocol.
Skladno z dogovorjenim protokolom bo MAH izvedel oceno dodatnih podatkov o učinkovitosti in varnosti bedakilina pri različnih režimih zdravljenja, v primerjavi z režimi, ki ne vsebujejo bedakilina (potrditvena študija faze III).
There are no data to support a lowered bedaquiline dose in such circumstances.
V teh primerih ni podatkov, ki bi podpirali zmanjšanje odmerka bedakilina.
Efavirenz is a moderate inducer of CYP3A4 activity and co-administration with bedaquiline may result in reduced bedaquiline exposure and loss of activity, and is, therefore, not recommended.
Efavirenz je zmeren induktor aktivnosti CYP3A4 in pri sočasni uporabi z bedakilinom lahko pride do zmanjšane izpostavljenosti bedakilinu ter izgube njegove učinkovitosti, zato sočasna uporaba ni priporočena.
The pharmacokinetic properties of bedaquiline have been evaluated in adult healthy subjects and in adult multi-drug resistant tuberculosis-infected patients.
Farmakokinetične lastnosti bedakilina so ocenjevali pri odraslih zdravih osebah in pri odraslih bolnikih s tuberkulozo, odporno na več zdravil.
Removal of unabsorbed bedaquiline may be aided by the administration of activated charcoal.
Neabsorbiran bedakilin je mogoče odstranjevati z uporabo aktivnega oglja.
After treatment cessation, all indications of toxicity exhibited at least partial recovery to good recovery.
Po prekinitvi zdravljenja je pri vseh znakih toksičnega delovanja prišlo do vsaj delnega izboljšanja, pri nekaterih pa je bilo izboljšanje precejšnje.
From week 3 onwards
Od 3. tedna dalje
In a population pharmacokinetic analysis of tuberculosis patients treated with SIRTURO, exposure to bedaquiline was found to be lower in Black patients than in patients from other race categories.
Po podatkih analize populacijske farmakokinetike pri bolnikih, ki imajo tuberkulozo in prejemajo zdravilo SIRTURO, je bila pri bolnikih črne rase izpostavljenost bedakilinu manjša kot pri bolnikih drugih rasnih kategorij.
an herbal product to relieve anxiety ciprofloxacin, erythromycin, clarithromycin to treat bacterial infections (antibacterials)
rastlinsko zdravilo za zdravljenje anksioznosti ciprofloksacin, eritromicin, klaritromicin za zdravljenje bakterijskih okužb (antibiotiki)
The plasma protein binding of the N-monodesmethyl metabolite (M2) in humans is at least 99.8%.
N-monodesmetilni presnovek (M2) se pri ljudeh veže na beljakovine v plazmi v najmanj 99,8%.
It is used in adults aged 18 years and over.
Zdravilo je namenjeno odraslim, starim najmanj 18 let.
All of these toxicities except effects on MPS were monitored clinically.
Vse navedene oblike toksičnega delovanja razen delovanja na monocitno-fagocitni sistem so klinično spremljali.
• The active substance is bedaquiline.
• Zdravilna učinkovina je bedakilin.
At week 120, sputum culture conversion was seen in 148/205 (72.2%) patients.
Po 120. tednu so opazili konverzijo kulture sputuma pri 148/205 (72,2%) bolnikih.
Bedaquiline and M2 did not inhibit the transporters P-gp, OATP1B1, OATP1B3, BCRP, OAT1, OAT3, OCT1, OCT2, MATE1 and MATE2 at clinically relevant concentrations in vitro.
Pri klinično pomembnih koncentracijah bedakilin in M2 in vitro nista zavirala prenašalcev P-gp, OATP1B1, OATP1B3, BCRP, OAT1, OAT3, OCT1, OCT2, MATE1 in MATE2.
Other antituberculosis medicinal products
Drugi tuberkulostatiki
Central laboratory drug susceptibility testing results became available for one additional placebo subject after the week 24 interim analysis.
Za enega dodatnega preiskovanca iz skupine, ki je prejemala placebo, so bili rezultati testiranja občutljivosti v centralnem laboratoriju razpoložljivi po vmesni analizi po 24 tednih.
Adverse drug reactions for SIRTURO were identified from pooled Phase IIb clinical trial data (both controlled and uncontrolled) containing 335 patients who received SIRTURO in combination with a background regimen of tuberculosis medicinal products.
Neželene učinke zdravila SIRTURO so ugotavljali iz združenih podatkov kliničnih študij faze IIb (nadzorovanih in nenadzorovanih), v katere je bilo vključenih 335 bolnikov, ki so prejemali zdravilo SIRTURO v kombinaciji z zdravili osnovne sheme zdravljenja tuberkuloze.
The impact of high baseline bedaquiline MICs, the presence of Rv0678 based mutations at baseline, and/or increased post-baseline bedaquiline MICs on microbiologic outcomes is unclear because of the low incidence of such cases in the Phase II trials.
Ni povsem jasno, kako na mikrobiološke izide vplivajo visoke izhodiščne vrednosti MIK bedakilina, prisotnost mutacij Rv0678 ob izhodišču in/ali zvišanje vrednosti MIK bedakilina po izhodišču, saj je bila incidenca takih primerov v študijah faze II nizka.
There is limited information available on the potential for a pharmacodynamic interaction between bedaquiline and medicinal products that prolong the QT interval.
Podatki o možnih farmakodinamičnih interakcijah med bedakilinom in zdravili, ki podaljšujejo interval QT, so omejeni.
SIRTURO treatment initiation is not recommended in patients with the following, unless the benefits of bedaquiline are considered to outweigh the potential risks:
Zdravljenje z zdravilom SIRTURO ni priporočeno (razen če koristi zdravljenja z bedakilinom ne odtehtajo morebitnih tveganj) pri bolnikih:
In vitro and in vivo genotoxicity tests indicated that bedaquiline did not have any mutagenic or clastogenic effects.
Pri testih genotoksičnosti in vitro in in vivo se je pokazalo, da bedakilin ne deluje mutageno ali klastogeno.
For patients with full characterisation of resistance status, 76% (84/111) were infected with an MDRH&R-TB strain and 24% (27/111) with a pre-XDR-TB strain.
Med bolniki z vsemi značilnostmi rezistence je bilo 76% (84/111) okuženih s sevom MDRH&R-TB, 24% (27/111) pa s sevom pre-XDR-TB.
Each tablet contains bedaquiline fumarate equivalent to 100 mg bedaquiline.
Ena tableta vsebuje bedakilinijev fumarat v količini, ki ustreza 100 mg bedakilina.
ketoconazole, fluconazole to treat fungal infections (antifungals)
ketokonazol, flukonazol za zdravljenje okužb z glivicami (antimikotiki)
Check with your doctor or pharmacist.
Pogovorite se z zdravnikom ali farmacevtom.
These subjects were excluded from the subgroup analysis by extent of resistance of Mycobacterium tuberculosis strain.
Ti posamezniki so bili izključeni iz analize podskupin po obsegu odpornosti sevov Mycobacterium tuberculosis.
Treatment with SIRTURO should be initiated and monitored by a physician experienced in the management of multi-drug resistant Mycobacterium tuberculosis.
Zdravljenje z zdravilom SIRTURO mora uvesti in nadzorovati zdravnik z izkušnjami pri zdravljenju okužbe z bakterijo Mycobacterium tuberculosis, ki je odporna proti več zdravilom.
There are no clinical data on the safety and efficacy of bedaquiline when co-administered with antiretroviral agents.
Ni kliničnih podatkov o varnosti in učinkovitosti bedakilina pri sočasni uporabi s protiretrovirusnimi učinkovinami.
In a population pharmacokinetic analysis of tuberculosis patients treated with SIRTURO no clinically relevant difference in exposure between men and women were observed.
V analizi populacijske farmakokinetike pri bolnikih, ki imajo tuberkulozo in prejemajo zdravilo SIRTURO, niso opažali klinično pomembnih razlik v izpostavljenosti med moškimi in ženskami.
In the 120-week C208 trial where SIRTURO was administered for 24 weeks in combination with a background regimen, more deaths occurred in the SIRTURO treatment group than in the placebo group (see section 5.1).
V 120-tedenski študiji C208, v kateri so zdravilo SIRTURO odmerjali 24 tednov v kombinaciji z osnovno shemo, je v skupini z zdravilom SIRTURO prišlo do več smrtnih primerov kot v skupini s placebom (glejte poglavje 5.1).
At week 24, sputum culture conversion was seen in 163/205 (79.5%) patients.
Po 24 tednih zdravljenja so opazili konverzijo kulture sputuma pri 163/205 (79,5%) bolnikov.
A single-dose study of SIRTURO in 8 subjects with moderate hepatic impairment (Child-Pugh B) demonstrated exposure to bedaquiline and M2 (AUC672h) was 19% lower compared to healthy subjects.
Študija enkratnega odmerjanja zdravila SIRTURO pri 8 osebah z zmerno okvaro jeter (razreda Child-Pugh B) je pokazala, da je izpostavljenost bedakilinu in presnovku M2 (AUC672h) za 19% manjša kot pri zdravih osebah.
In the Phase IIb, open label study (C209), where patients with no treatment options received other QTprolonging medicinal products used to treat tuberculosis, including clofazimine, concurrent use with SIRTURO resulted in additive QT prolongation, proportional to the number of QT prolonging medicinal products in the treatment regimen.
V odprti študiji faze IIb (C209) v kateri so bolniki, pri katerih ni bilo druge možnosti, za zdravljenje tuberkuloze prejeli tudi druge učinkovine, ki podaljšujejo interval QT (vključno s klofaziminom) je sočasna uporaba z zdravilom SIRTURO vodila v dodatno podaljšanje intervala QT, ki je bilo sorazmerno s številom učinkovin, ki podaljšujejo interval QT v shemi zdravljenja.
Due to the potential risk of adverse reactions due to an increase in systemic exposure, prolonged co-administration of bedaquiline and moderate or strong CYP3A4 inhibitors (e.g. ciprofloxacin, erythromycin, fluconazole, clarithromycin, ketoconazole, ritonavir) used systemically for more than 14 consecutive days should be avoided.
Zaradi možnosti povečanja tveganja za neželene učinke pri povečanju sistemske izpostavljenosti zdravilu se je treba izogibati dolgotrajnejši sočasni uporabi bedakilina in zmernih ali močnih zaviralcev CYP3A4 (npr. ciprofloksacin, eritromicin, flukonazol, klaritromicin, ketokonazol, ritonavir) s sistemskim vnosom, ki bi trajala več kot 14 zaporednih dni.
The largest mean increase from baseline values in QTcF in the placebo group during the first 24 weeks was 6.2 ms (also at week 18) (see section 4.4).
V prvih 24 tednih je največje povprečno podaljšanje intervala QTcF, glede na izhodiščno vrednost, v skupini s placebom znašalo 6,2 ms (tudi po 18 tednih) (glejte poglavje 4.4).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI TRAKU
The most frequent adverse drug reactions (> 10.0% of patients) during treatment with SIRTURO in the controlled trials were nausea (35.3% in the SIRTURO group vs 25.7% in the placebo group), arthralgia (29.4% vs 20.0%), headache (23.5% vs 11.4%), vomiting (20.6% vs 22.9%) and dizziness (12.7% vs 11.4%).
V nadzorovanih kliničnih študijah so bili v času zdravljenja z zdravilom SIRTURO najbolj pogosti neželeni učinki (pri > 10,0% bolnikov): navzea (35,3% v skupini z zdravilom SIRTURO v primerjavi s 25,7% v skupini s placebom), artralgija (29,4% v primerjavi z 20,0%), glavobol (23,5% v primerjavi z 11,4%), bruhanje (20,6% v primerjavi z 22,9%) in omotičnost (12,7% v primerjavi z 11,4%).
• abnormal reading on the electrocardiogram called “QT prolongation”.
• nenormalnost na elektrokardiogramu (EKG), ki se imenuje "podaljšanje intervala QT".