natgillin/translations-raw huggingface dataset:
Based on the biliary elimination pathway of azithromycin, no drug interactions are expected between azithromycin and INTELENCE.
S obzirom na to da se azitromicin eliminira putem žuči, ne očekuje se interakcija azitromicina i lijeka INTELENCE.
Based on historical data, a decrease in etravirine exposure may be expected whereas an increase in rifabutin exposure and especially in 25-O-desacetyl-rifabutin may be expected.
Na temelju podataka iz prošlosti, može se očekivati smanjenje izloženosti etravirinu, a može se očekivati i povećanje izloženosti rifabutinu a osobito 25-O-dezacetil-rifabutinu.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Bolesnike treba savjetovati da potraže medicinski savjet ako osjete bol u zglobovima, ukočenost zglobova ili teškoće pri kretanju.
In mice, the key target organs identified were the liver and the coagulation system.
Kod miševa, ključni ciljni organi bili su jetra i koagulacijski sustav.
Confidence interval around observed difference of response rates; P-value from CMH test controlling for stratification factors = 0.0199 for de novo, and < 0.0001 for not de novo.
Interval pouzdanosti oko opažene razlike u stopama odgovora; P-vrijednost iz CMH testa za kontrolu stratifikacijskih faktora = 0,0199 za de novo i < 0,0001 za ne de novo.
Doing so could increase the risk of the virus developing resistance.
Prestankom uzimanja možete povećati rizik od razvoja otpornosti virusa na lijek.
INTELENCE has minor influence on the ability to drive and use machines.
INTELENCE malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
- Stratification: Randomisation was stratified by the intended use of ENF in the BR, previous use of darunavir and screening viral load.
- Stratifikacija: Randomizacija je bila stratificirana prema namjeri primjene ENF u BR, prethodnoj primjeni darunavira i probiru virusnog opterećenja.
It is not recommended to combine INTELENCE with any of the following medicines: - tipranavir/ritonavir, efavirenz, nevirapine, rilpivirine, indinavir, nelfinavir, atazanavir/cobicistat,
Ne preporučuje se kombinirati INTELENCE s bilo kojim od slijedećih lijekova: - tipranavir/ritonavir, efavirenz, nevirapin, rilpivirin, indinavir, nelfinavir, atazanavir/kobicistat,
Etravirine is a weak inhibitor of CYP2C9 and CYP2C19.
Etravirin je slabi inhibitor CYP2C9 i CYP2C19.
In vitro experiments with human liver microsomes (HLMs) indicate that etravirine primarily undergoes oxidative metabolism by the hepatic cytochrome CYP450 (CYP3A) system and, to a lesser extent, by the CYP2C family, followed by glucuronidation.
In vitro pokusi s mikrosomima humane jetre pokazuju da etravirin uglavnom prolazi oksidativni metabolizam putem sustava jetenog citokroma CYP450 (CYP3A), a u manjoj mjeri skupina izoenzima CYP2C, nakon čega slijedi glukuronidacija.
In a postmarketing retrospective cohort study aiming at substantiating the long-term safety profile of etravirine in HIV-1-infected children and adolescents receiving etravirine with other HIV-1 antiretrovirals (N = 182), Stevens-Johnson Syndrome was reported at a higher incidence (1%) than has been reported in adult clinical trials (<0.1%).
U retrospektivnom kohortnom ispitivanju provedenom nakon stavljanja lijeka u promet s ciljem potvrđivanja dugoročnog sigurnosnog profila etravirina u djece i adolescenata zaraženih virusom HIV-1 koji su primali etravirin zajedno s drugim antiretrovirusnim lijekovima za liječenje infekcije virusom HIV-1 (N = 182), prijavljena incidencija Stevens-Johnsonova sindroma (1%) bila je viša od one prijavljene u kliničkim ispitivanjima u odraslih (< 0,1%).
No unchanged drug was detected in urine so the impact of renal impairment on etravirine elimination is expected to be minimal.
Nije otkriven nepromijenjeni lijek u mokraći, pa se očekuje minimalan utjecaj oštećenja funkcije bubrega na eliminaciju etravirina.
The presence of K103N alone, which was the most prevalent NNRTI mutation in DUET-1 and DUET-2 at baseline, was not identified as a mutation associated with resistance to etravirine.
Prisutnost samo K103N, koja je na početku ispitivanja DUET-1 i DUET-2 bila NNRTI mutacija s najvećom prevalencijom, nije bila ustanovljena kao mutacija povezana s rezistencijom na etravirin.
HMG CO-A REDUCTASE INHIBITORS Atorvastatin
INHIBITORI HMG CO-A REDUKTAZE Atorvastatin
Population pharmacokinetic analysis in HIV infected patients showed that etravirine pharmacokinetics are not considerably different in the age range (18 to 77 years) evaluated, with 6 subjects aged 65 years or older (see sections 4.2 and 4.4).
Populacijska farmakokinetička analiza bolesnika zaraženih HIV-om pokazala je da farmakokinetika etravirina nije znatno različita u ispitivanom rasponu dobi (18 do 77 godina), pri čemu je 6 ispitanika bilo u dobi od 65 godina ili starijih (vidjeti dijelove 4.2 i 4.4).
Please refer to the product information of the associated boosted PI for the dose adjustment of rifabutin to be used.
Molimo pogledati informacije o povezanim IP-ima za prilagodbu doze rifabutina koja bi se trebala primijeniti.
The most frequent (incidence ≥ 10%) adverse reactions of all intensities reported for etravirine were rash, diarrhoea, nausea and headache.
Najučestalije nuspojave (incidencija ≥ 10%) na lijek svih intenziteta prijavljenih za etravirin bile su osip, dijareja, mučnina i glavobolja.
800 mg 3 times daily + etravirine 200 mg every 12 hours boceprevir
800 mg 3 puta dnevno + etravirin 200 mg svakih 12 sati boceprevir
In women receiving etravirine 200 mg twice daily, higher mean values for Cmax, AUC12h and Cmin were observed during pregnancy compared to postpartum.
Kod žena koje su uzimale etravirin 200 mg dva puta dnevno, zabilježene su više srednje vrijednosti Cmax, AUC12h i Cmin tijekom trudnoće u usporedbi s postpartalnim razdobljem.
Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake „Rok valjanosti“ ili „EXP“.
Etravirine efficacy in relation to NNRTI resistance at baseline has mainly been analysed with etravirine given in combination with darunavir/ritonavir (DUET-1 and DUET-2).
Djelotvornost etravirina u odnosu na rezistenciju prema NNRTI na početku liječenja bila je uglavnom analizirana kad se etravirin davao u kombinaciji s darunavirom/ritonavirom (DUET-1 i DUET-2).
Adverse reactions such as somnolence and vertigo have been reported in etravirine-treated patients and should be considered when assessing a patient's ability to drive or operate machinery (see section 4.8).
Nuspojave poput somnolencije i vrtoglavice prijavljene su kod bolesnika liječenih etravirinom i potrebno ih je uzeti u obzir pri procjeni bolesnikove sposobnosti upravljanja vozilima ili rada sa strojevima (vidjeti dio 4.8).
Overall de novo ENF
Ukupno de novo ENF
At week 48, 53.5% of all paediatric patients had a confirmed undetectable viral load < 50 HIV-1 RNA copies/ml according to the TLOVR algorithm.
U 48. tjednu, 53,5% od svih pedijatrijskih bolesnika imalo je potvrđeno nemjerljivo virusno opterećenje < 50 HIV-1 RNK kopija/ml prema TLOVR algoritmu.
Rash was mostly self-limiting, and generally resolved within 1-2 weeks on continued therapy (see section 4.4).
Osip je uglavnom bio samoograničavajući i obično je nestajao u roku od 1-2 tjedna uz kontinuirano liječenje (vidjeti dio 4.4).
It is not recommended to co-administer tipranavir/ritonavir and INTELENCE (see section 4.4).
Ne preporučuje se istodobno primjenjivati tipranavir/ritonavir i INTELENCE (vidjeti dio 4.4).
Itraconazole and ketoconazole are potent inhibitors as well as substrates of CYP3A4.
Itrakonazol i ketokonazol su snažni inhibitori a također i supstrati CYP3A4.
- Tell your doctor if you develop a rash.
- Upozorite svog liječnika ako Vam se razvije osip.
The combination of INTELENCE and atorvastatin can be given without any dose adjustments, however, the dose of atorvastatin may need to be altered based on clinical response.
INTELENCE se može dati u kombinaciji s atorvastatinom bez ikakve prilagodbe doze, međutim, dozu atorvastatina možda će trebati prilagoditi na temelju kliničkog odgovora.
No dose adjustment is suggested but caution is advised in patients with moderate hepatic impairment.
Nije predložena prilagodba doze, ali se savjetuje oprez kod bolesnika s umjerenim oštećenjem jetre.
Delay in stopping INTELENCE treatment after the onset of severe rash may result in a life-threatening reaction.
Odgoda prekida liječenja lijekom INTELENCE nakon pojave teškog osipa može za posljedicu imati po život opasnu reakciju.
The combination of INTELENCE with a boosted PI and rifabutin should be used with caution due to the risk of decrease in etravirine exposure and the risk of increase in rifabutin and 25-O-desacetyl-rifabutin exposures.
Kombinacija lijeka INTELENCE s pojačanim IP-ima i rifabutinom trebala bi se upotrebljavati s oprezom zbog rizika od smanjenja izlaganja etravirinu i zbog rizika povećanja rifabutina i izloženosti 25-O-desacetilrifabutinu.
Your doctor will advise you how to deal with your symptoms and whether INTELENCE must be stopped; - headache; - diarrhoea, nausea.
Liječnik će Vam savjetovati kako da postupite u vezi s tim simptomima i morate li prestati uzimati INTELENCE; - glavobolja; - proljev, mučnina.
Rifabutin 300 mg once daily
Rifabutin 300 mg jedanput dnevno
If you belong to this age group, please discuss the use of INTELENCE with your doctor.
Ako pripadate toj dobnoj skupini, molimo Vas da zajedno s Vašim liječnikom razmotrite možete li uzimati INTELENCE.
Population pharmacokinetic analysis of etravirine in HIV infected patients indicated no apparent difference in the exposure to etravirine between Caucasian, Hispanic and Black subjects.
Analiza populacijske farmakokinetike etravirina u bolesnika zaraženih HIV-om nije pokazala vidljive razlike u izloženosti etravirinu između bijelaca, ispitanika latinoameričkog podrijetla i crnaca.
INTELENCE tablets contain lactose.
INTELENCE tablete sadrže laktozu.
The study enrolled patients on a stable but virologically failing antiretroviral treatment regimen, with a confirmed HIV-1 RNA plasma viral load ≥ 500 copies/ml.
Ispitivanje je uključilo bolesnike sa stabilnom, ali virološki neuspješnom, antiretrovirusnom shemom liječenja s potvrđenim HIV-1 RNK virusnim opterećenjem u plazmi ≥ 500 kopija/ml.
Following virologic failure of an etravirine-containing regimen it is not recommended to treat patients with efavirenz and/or nevirapine.
Nakon neuspjelog virološkog odgovora na liječenje koji uključuje etravirin, ne preporučuje se bolesnike liječiti efavirenzom i/ili nevirapinom.
Immunologic parameters
Imunološki parametri
8 weeks after opening the bottle.
8 tjedana nakon otvaranja boce.
Close monitoring for virologic response and for rifabutin related adverse reactions is recommended.
Preporučuje se pažljivo motrenje virološkog odgovora i nuspojava vezanih uz rifabutin.
The evidence of efficacy of etravirine is based on 48-week data from 2 Phase III trials DUET-1 and DUET-2.
Dokaz djelotvornosti etravirina temelji se na podacima dobivenima u 2 ispitivanja faze III, DUET-1 i DUET-2, u trajanju od 48 tjedana.
Confidence interval around observed difference of response rates; P-value = 0.0408.
Interval pouzdanosti oko opažene razlike u stopama odgovora; P-vrijednost = 0,0408.
P-value < 0.0001 for mean decrease in HIV-1 RNA; P-value = 0.0006 for mean change in CD4 cell count.
P-vrijednost < 0,0001 za prosječno smanjenje HIV-1 RNK; P-vrijednost = 0,0006 za prosječnu promjenu broja CD4 stanica.
C-etravirine showed that < 1.2% of the administered dose of etravirine is excreted in the urine.
-etravirinom pokazali su da se < 1,2% primijenjene doze etravirina izluči u mokraći.
INTELENCE tablets should be stored in the original bottle and keep the bottle tightly closed in order to protect from moisture.
Tablete INTELENCE treba čuvati u originalnoj boci i bocu čuvajte čvrsto zatvorenu radi zaštite od vlage.
Rarely, during INTELENCE treatment, you can experience severe skin rash with blisters or peeling skin, particularly around the mouth or eyes or hypersensitivity reaction (allergic reaction including rash and fever but also swelling of the face, tongue or throat, difficulty in breathing or swallowing) which could be potentially life-threatening.
Rijetko tijekom liječenja lijekom INTELENCE možete doživjeti težak kožni osip praćen mjehurićima ili ljuštenjem kože, osobito oko usta ili očiju, ili reakciju preosjetljivosti koja potencijalno može biti opasna po život (alergijska reakcija koja uključuje osip i vrućicu, ali i oticanje lica, jezika ili grla, teškoće s disanjem ili gutanjem).
Medicinal products that affect etravirine exposure
Lijekovi koji utječu na izloženost etravirinu
< 400 HIV-1 RNA copies/ml n (%)
< 400 HIV-1 RNK kopija/ml n (%)
In clinical trials, the frequency, type and severity of adverse reactions in paediatric patients were comparable to those observed in adults.
U kliničkim su ispitivanjima učestalost, vrsta i težina nuspojava u pedijatrijskih bolesnika bile usporedive s onima primijećenima u odraslih.
The pharmacokinetic properties of etravirine have been evaluated in adult healthy subjects and in adult and paediatric treatment-experienced HIV-1 infected patients.
Farmakokinetička svojstva etravirina procijenjena su u odraslih zdravih ispitanika te u odraslih i pedijatrijskih bolesnika zaraženih virusom HIV-1 koji su prethodno bili liječeni.
Table 7: Population pharmacokinetic estimates of etravirine 200 mg twice daily in HIV-1 infected adult subjects (integrated data from Phase III trials at week 48)*
Tablica 7: Populacijska farmakokinetička procjena za etravirin 200 mg dva puta dnevno u odraslih ispitanika zaraženih HIVom-1 (integrirani podaci iz ispitivanja faze III u 48. tjednu)*
Co-infection with HBV (hepatitis B virus) or HCV (hepatitis C virus) Caution should be exercised in patients co-infected with hepatitis B or C virus due to the current limited data available.
Istodobna infekcija virusom hepatitisa B (HBV) ili hepatitisa C (HCV) Potreban je oprez kod bolesnika koji istodobno imaju infekciju virusom hepatitisa B ili C, s obzirom na to da su trenutno raspoloživi podaci ograničeni.
Swallow the INTELENCE tablet(s) whole with a glass of water.
Tabletu(e) lijeka INTELENCE progutajte cijele s čašom vode.
Virologic parameters
Virološki parametri
The rash is usually mild to moderate.
Osip je obično blagog do umjerenog intenziteta.
No human data on the effect of etravirine on fertility are available.
Ne postoje podaci o učinku etravirina na plodnost u čovjeka.
0.035 mg once daily
0,035 mg jedanput dnevno.
- Virologic response was defined as achieving a confirmed undetectable viral load (< 50 HIV-1 RNA copies/ml).
- Virološki odgovor je definiran kao postizanje potvrđenog nemjerljivog virusnog opterećenja (< 50 HIV-1 RNK kopija/ml).
Dose adjustments for these HMG Co-A reductase inhibitors may be necessary.
Za ove inhibitore HMG Co-A reduktaze može biti potrebna prilagodba doze.
ANTIARRHYTHMICS Digoxin
ANTIARITMICI Digoksin
The breakpoints for reduced efficacy with etravirine (> 2 etravirine-associated mutations at baseline, see clinical results section) applies when etravirine is given in combination with a boosted protease inhibitor.
Točka promjene u kojoj se smanjuje djelotvornost etravirina (> 2 mutacije povezane s etravirinom na početku liječenja, vidjeti dio s kliničkim rezultatima) primjenjiva je kada se etravirin daje u kombinaciji s pojačanim inhibitorima proteaze.
The incidence of rash was higher in women compared to men in the etravirine arm in the DUET trials (rash ≥ grade 2 was reported in 9/60 [15.0%] women versus 51/539 [9.5%] men; discontinuations due to rash were reported in 3/60 [5.0%] women versus 10/539 [1.9%] men) (see section 4.4).
U ispitivanjima DUET incidencija osipa bila je veća kod žena nego kod muškaraca u skupini koja je primala etravirin (osip ≥ stupanj 2 bio je prijavljen u 9/60 [15,0%] žena naspram 51/539 [9,5%] muškaraca; prekidi zbog osipa bili su prijavljeni u 3/60 [5,0%] žena naspram 10/539 [1,9%] muškaraca) (vidjeti dio 4.4).
ANTIFUNGALS Fluconazole 200 mg once in the morning fluconazole
200 mg jedanput ujutro flukonazol
In vitro and in vivo studies with etravirine revealed no evidence of a mutagenic potential.
Ispitivanja etravirina in vitro i in vivo nisu pokazala mutageni potencijal.
The recommended dose of INTELENCE is 200 mg twice a day.
Preporučena doza lijeka INTELENCE je 200 mg dva puta dnevno.
Etravirine is a weak inducer of CYP3A4.
Etravirin slabo inducira djelovanje CYP3A4.
Unchanged etravirine in faeces is likely to be unabsorbed drug.
Nepromijenjeni etravirin u stolici vjerojatno je neapsorbirani lijek.
If you are taking any of these, ask your doctor for advice.
Ukoliko uzimate bilo koji od tih lijekova, obratite se svom liječniku za savjet.
The pharmacokinetics of etravirine have not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Farmakokinetika etravirina nije ispitivana kod bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C).
As a general rule, it is recommended that mothers infected by HIV do not breastfeed their babies under any circumstances in order to avoid transmission of HIV.
Kao opće pravilo, majkama inficiranim HIV-om, preporučuje se da ne doje ni pod kojim uvjetima radi izbjegavanja prijenosa HIVa.
In rats, there was no effect on mating or fertility with etravirine treatment (see section 5.3).
U štakora liječenje etravirinom nije imalo učinka na parenje ili plodnost (vidjeti dio 5.3).
Study TMC114HIV3015 evaluated etravirine 200 mg twice daily in combination with other antiretroviral medicinal products in 15 pregnant women during the second and third trimesters of pregnancy and postpartum.
Ispitivanje TMC114HIV3015 procijenilo je etravirin u dozi od 200 mg dva puta dnevno u kombinaciji s drugim antiretrovirusnim lijekovima kod 15 trudnica tijekom drugog i trećeg tromjesečja trudnoće i u postpartalnom razdoblju.
4.8 log10 copies/ml
4,8 log10kopija/ml 4,8 log10kopija/ml
Adverse reactions reported in patients treated with etravirine are summarised in Table 2.
Nuspojave koje su prijavljene kod bolesnika liječenih etravirinom sažete su u tablici 2.
Rash was reported more frequently in female subjects than in male subjects (rash ≥ grade 2 was reported in 13/64 [20.3%] females versus 2/37 [5.4%] males; discontinuations due to rash were reported in 4/64 [6.3%] females versus 0/37 [0%] males) (see section 4.4).
Osip je češće prijavljen u ženskih ispitanika nego u muških ispitanika (osip ≥ stupnja 2 bio je prijavljen u 13/64 [20,3%] žena naspram 2/37 [5,4%] muškaraca; prekidi zbog osipa bili su prijavljeni u 4/64 [6,3%] žena naspram 0/37 [0%] muškaraca)
Etravirine is primarily metabolised and eliminated by the liver and highly bound to plasma proteins.
Etravirin se metabolizira i eliminira prvenstveno putem jetre te se u velikoj mjeri veže na proteine plazme.
Age at screening Treatment group
Dob prilikom probira Skupina liječenja
No dose adjustment is suggested in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B); INTELENCE should be used with caution in patients with moderate hepatic impairment.
Nije potrebna prilagodba doze kod bolesnika s blagim ili umjerenim oštećenjem jetre (Child-Pugh stadij A ili B), međutim, INTELENCE treba primjenjivati s oprezom u bolesnika s umjerenim oštećenjem jetre.
Exposure in mice was equivalent to human exposure while in rats it was below the clinical exposure at the recommended dose.
Izloženost u miševa bila je jednaka izloženosti u čovjeka, dok je u štakora bila manja od kliničke izloženosti pri preporučenoj dozi.
Raltegravir 400 mg twice daily raltegravir
Raltegravir 400 mg dva puta dnevno raltegravir
There are no data with regard to symptomatic overdose with etravirine, but it is possible that the most frequent adverse reactions of etravirine, i.e. rash, diarrhoea, nausea, and headache would be the most common symptoms noted.
Nema podataka vezanih uz simptomatsko predoziranje s etravirinom, ali moguće je da će najčešći zabilježeni simptomi biti najčešće nuspojave etravirina, npr. osip, proljev, mučnina i glavobolja.
If you have stopped treatment due to a hypersensitivity reaction, you should not restart therapy with INTELENCE.
Ako ste prekinuli liječenje zbog reakcije preosjetljivosti, ne smijete ponovo početi uzimati INTELENCE.
Disopyramide Flecainide Lidocaine (systemic) Mexiletine Propafenone Quinidine
Lidokain (sistemski) Meksiletin Propafenon Kinidin
300/100 mg once daily atazanavir
300/100 mg jedanput dnevno atazanavir
Since etravirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
S obzirom da se etravirin u velikoj mjeri veže na proteine, nije vjerojatno da bi dijaliza značajno uklonila djelatnu tvar.
ANTICONVULSANTS Carbamazepine Phenobarbital Phenytoin
Karbamazepin Fenobarbital Fenitoin
In healthy subjects, the absorption of etravirine is not affected by co-administration of oral ranitidine or omeprazole, medicinal products that are known to increase gastric pH.
U zdravih ispitanika na apsorpciju etravirina ne utječe istodobna peroralna primjena ranitidina ili omeprazola, lijekova za koje se zna da povećavaju pH u želucu.
50 mg once daily
50 mg jedanput dnevno
Median CD4 cell count
Medijan broja CD4 stanica
In a study comparing 8 patients with mild (Child-Pugh Class A) hepatic impairment to 8 matched controls and 8 patients with moderate (Child-Pugh Class B) hepatic impairment to 8 matched controls, the multiple dose pharmacokinetic disposition of etravirine was not altered in patients with mild to moderate hepatic impairment.
U ispitivanju koje uspoređuje 8 bolesnika s blagim (Child-Pugh stadij A) oštećenjem jetre s 8 odgovarajućih kontrolnih ispitanika i 8 bolesnika s umjerenim (Child-Pugh stadij B) oštećenjem jetre s 8 odgovarajućih kontrolnih ispitanika, farmakokinetička raspoloživost etravirina kod višestruke doze nije izmijenjena kod bolesnika s blagim do umjerenim oštećenjem jetre.
Cardiac disorders common myocardial infarction uncommon atrial fibrillation, angina pectoris
Srčani poremećaji često infarkt miokarda manje često fibrilacija atrija, angina pektoris
Therefore, the pharmacokinetic parameter estimates shown in the table account for reductions in the pharmacokinetic parameters of etravirine due to co-administration of etravirine with darunavir/ritonavir.
Stoga, procjene farmakokinetičkih parametara koje su prikazane u tablici uzimaju u obzir smanjenje farmakokinetičkih prametara etravirina radi istodobne primjene etravirina s darunavirom/ritonavirom.
Pivotal studies
Pivotalna ispitivanja
Patients should be informed to seek medical advice if severe rash or hypersensitivity reactions occur.
Bolesnike treba uputiti da potraže liječnički savjet u slučaju pojave teškog osipa ili reakcija preosjetljivosti.
There are insufficient data at this time to recommend a dose in paediatric patients less than 6 years of age or weighing less than 16 kg (see section 4.2).
Trenutno ne postoji dovoljno podataka za preporuku doze u pedijatrijskih bolesnika dobi manje od 6 godina i težine manje od 16 kg (vidjeti dio 4.2).
The DRESS syndrome is characterised by rash, fever, eosinophilia and systemic involvement (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and eosinophilia).
DRESS sindrom karakteriziran je osipom, vrućicom, eozinofilijom i sistemskom reakcijom (uključuje, ali se ne ograničava na težak osip ili osip praćen vrućicom, opće slabo stanje, umor, bolove u mišićima ili zglobovima, mjehuriće, oralne lezije, konjunktivitis, hepatitis i eozinofiliju).
There was no gender difference in severity or treatment discontinuation due to rash.
Razlika u spolu nije bilo kod procjene težine ili prestanka liječenja zbog osipa.
In the rat, the key target organs identified were the liver, the thyroid and the coagulation system.
U štakora su ključni ciljni organi bili jetra, štitnjača i koagulacijski sustav.