natgillin/translations-raw huggingface dataset:
These include: - propafenone (used to treat irregular or abnormal heart beat) - tamoxifen (used to treat breast cancer) - metoprolol (used to treat high blood pressure and heart conditions) - thioridazine (used to treat psychiatric conditions like schizophrenia) - pimozide (used to treat psychiatric conditions like schizophrenia) - morphine (used to treat moderate to severe pain) - methotrexate (used to treat cancer, psoriasis, and rheumatoid arthritis) - irinotecan (used to treat cancer) - topotecan (used to treat cancer) - mitoxantrone (used to treat cancer) - sulfasalazine (used to treat bowel disease and rheumatoid arthritis) - doxorubicin (used in cancer chemotherapy) - bendamustine (used in the treatment of leukaemia) - digoxin (used to treat heart conditions) - dabigatran (used to prevent blood clots) - colchicine (used to treat gout) - medicines called ‘statins,' such as atorvastatin, fluvastatin, rosuvastatin and simvastatin, that are used in the treatment of high levels of fats (such as cholesterol) in the blood - bosentan (used to treat high blood pressure in the pulmonary artery) - fexofenadine (used to treat allergy symptoms)
• zdravila, imenovana "statini", kot so atorvastatin, fluvastatin, rosuvastatin in simvastatin, ki se uporabljajo pri zdravljenju visokih ravni maščob (kot je holesterol) v krvi, • bosentan (za zdravljenje visokega krvnega tlaka v pljučni arteriji),
The efficacy and safety of rolapitant with concurrent use of another NK1 receptor antagonist (e.g. aprepitant and a combination of netupitant and palonosetron hydrochloride) is not established and therefore not recommended (see section 4.4).
aprepitanta in kombinacije netupitanta in palonosetronijevega klorida) ni dokazana, zato tega ne priporočamo (glejte poglavje 4.4).
Cardiac disorders
• dehidracija,
Table 1: Proportion of patients receiving cisplatin chemotherapy responding by treatment group and phase (Studies 1 and 2 - HEC Individual Results)
Delež odzivnih bolnikov, ki so prejemali kemoterapijo s cisplatinom, po skupinah zdravljenja in fazah
P-Valueb
vrednost Pb
B. PACKAGE LEAFLET
• zamegljen vid,
86.4 76.0 0.002 85.6 81.7 N.S.
67,8 N. Z.
70.1 56.5 0.001 67.5 60.4 N.S.
64,1 N. Z.
BCRP substrates
BCRP).
The usual dose is two tablets.
Če ste vzeli večji odmerek zdravila Varuby, kot bi smeli Običajni odmerek sta dve tableti.
Abdominal discomfort Change of bowel habit Dry mouth
Splošne težave in spremembe na mestu aplikacije utrujenost astenija motnje hoje
Tablet content
FARMAKOLOŠKE LASTNOSTI
Comparison based on historic control.
Primerjava temelji na zgodovinski kontroli.
- Main inclusion criteria:
- Glavni vključitveni kriteriji:
Date of first authorisation: 28 August 2008 Date of latest renewal: 23 August 2018
Datum prve odobritve: 28. avgust 2008 Datum zadnjega podaljšanja: 23. avgust 2018
A limited number of females were included in the studies.
V študije je bilo vključeno manjše število žensk.
V179F was never present without Y181C.
V179F ni bila nikoli navzoča brez Y181C.
Typically, such reactions have been observed within the first weeks or months of initiation of CART.
Običajno so takšne reakcije opažali v prvih tednih ali mesecih po uvedbi CART.
Treatment difference (95% CI)
Razlika po zdravljenju (95% CI)
With an associated boosted PI:
Skupaj z okrepljenim PI:
The terminal elimination half-life of etravirine was approximately 30-40 hours.
Končna razpolovna doba izločanja etravirina je znašala približno 30 do 40 ur.
Your doctor will discuss with you which combination of medicines is best for you.
Zdravnik se bo z vami pogovoril o tem, katera kombinacija zdravil je najprimernejša za vas.
Tell your doctor about your situation
Zdravnika obvestite o svojem stanju
The clinical relevance of this interaction has not been demonstrated.
Klinični pomen te interakcije ni znan.
- Tell your doctor immediately if you notice any symptoms of infections.
- Nemudoma povejte svojemu zdravniku, če opazite kakršnekoli simptome in znake okužbe.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
What INTELENCE is and what it is used for
Kaj je zdravilo INTELENCE in za kaj ga uporabljamo
These individual mutations occurred in the presence of other NNRTI RAMs.
Te posamezne mutacije so se pojavile v navzočnosti drugih NNRTI RAM.
Based on animal data the malformative risk is unlikely in humans.
Na osnovi podatkov pri živalih je tveganje za pojav malformacij pri ljudeh malo verjetno.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Pregnant women should not take INTELENCE unless specifically directed by the doctor.
Noseče ženske ne smejo jemati zdravila INTELENCE, razen če jim ga izrecno predpiše zdravnik.
Your doctor will explain these to you.
Zdravnik vam bo pojasnil te izvide.
Each carton contains one bottle.
Vsaka škatla vsebuje eno plastenko.
Combining two NNRTIs has not been shown to be beneficial.
Sočasna uporaba dveh NNRTI ni koristna.
If you have been told by your doctor that you have an intolerance to some sugars (lactose), contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje (laktozo), se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
Lactose intolerance and lactase deficiency
Laktozna intoleranca in pomanjkanje laktaze
* based on population pharmacokinetic analyses
* na osnovi analiz populacijske farmakokinetike
Lopinavir/ritonavir (tablet)
lopinavir/ritonavir (tableta)
Treatment of overdose with INTELENCE consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Zdravljenje prevelikega odmerjanja zdravila INTELENCE naj sestoji iz splošnih podpornih ukrepov, vključno s spremljanjem bolnikovih vitalnih znakov in opazovanjem njegovega kliničnega stanja.
- Tell your doctor if you have or have had problems with your liver, including hepatitis B and/or C. Your doctor may evaluate how severe your liver disease is before deciding if you can take INTELENCE.
- Povejte svojemu zdravniku, če imate ali ste imeli kdaj v preteklosti težave z jetri, vključno s hepatitisom B in/ali C. Zdravnik bo ocenil resnost vaše jetrne bolezni in se potem odločil, ali smete jemati zdravilo INTELENCE.
The tablet can be divided into two equal doses.
Tableto lahko razdelite na dva enaka odmerka.
If you forget to take INTELENCE
Če ste pozabili vzeti zdravilo INTELENCE
What you need to know before you take INTELENCE
Kaj morate vedeti, preden boste vzeli zdravilo INTELENCE
For instructions on dispersion of the medicinal product before administration, see section 6.6.
Za navodila glede dispergiranja zdravila pred dajanjem glejte poglavje 6.6.
≥ 50 and < 200 ≥ 200 and < 350
≥ 50 in < 200 ≥ 200 in < 350
Other medicines and INTELENCE
Druga zdravila in zdravilo INTELENCE
However, some combinations are not recommended.
vendar nekatere kombinacije niso priporočljive.
In rare instances, very serious rash has been reported which can be potentially life-threatening.
V redkih primerih so poročali o zelo hudem izpuščaju, ki je lahko življenjsko nevaren.
Possible side effects').
Možni neželeni učinki').
The frequency of this is unknown (see section 4.4).
Pogostnost tega pojava ni znana (glejte poglavje 4.4).
Use in adults Other form(s) of this medicine may be more suitable for adults.
Uporaba pri odraslih Za odrasle so lahko bolj primerne druge oblike tega zdravila.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Po pogostnosti so neželeni učinki opredeljeni kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
INTELENCE has only been used in a limited number of patients of 65 years or older.
Zdravilo INTELENCE so doslej uporabili šele pri majhnem številu bolnikov, starih 65 let ali več.
The use of warm (> 40°C) or carbonated beverages should be avoided.
Toplim napitkom (> 40°C) in gaziranim pijačam se je treba izogibati.
The doctor will inform you exactly how much INTELENCE the child should take.
Zdravnik vam bo povedal koliko zdravila mora vzeti otrok.
N = number of subjects with data; n = number of observations.
N = št. preskušancev z razpoložljivimi podatki ; n = št. dogodkov.
Furthermore, it is important that you carefully read the package leaflets that are provided with these medicines.
Poleg tega je pomembno, da natančno preberete navodila za uporabo teh zdravil, ki so jim priložena.
H2-RECEPTOR ANTAGONISTS Ranitidine
ANTAGONISTI RECEPTORJEV H2 ranitidin
For further information on interactions with medicinal products see section 4.5.
Za dodatne informacije o medsebojnem delovanju z drugimi zdravili glejte poglavje 4.5.
Any AIDS defining illness and/or death n (%)
Katerakoli bolezen, povezana z aidsom, in/ali smrt bolnika n (%)
Talk to your doctor first.
Zato se morate najprej posvetovati s svojim zdravnikom.
The results below are pooled data from the two trials.
Spodnji izsledki predstavljajo združene podatke iz teh dveh preskušanj.
Pivotal studies
Ključne študije
There were no new clinically relevant safety findings in the mothers or in the newborns in this trial.
Novih, klinično pomembnih ugotovitev o varnosti pri materah ali novorojencih, vključenih v študijo, ni bilo.
INTELENCE must always be given in combination with other antiretroviral medicinal products.
Zdravilo INTELENCE morate vedno uporabljati v kombinaciji z drugimi protiretrovirusnimi zdravili.
Not studied.
Niso preiskovali.
Instructions for taking INTELENCE for all patients It is important that you take INTELENCE following a meal.
Navodila za jemanje zdravila INTELENCE za vse bolnike Pomembno je, da zdravilo INTELENCE jemljete po jedi.
4.8 log10 copies/ml
4,8 log10 kopij/ml
BENZODIAZEPINES Diazepam
BENZODIAZEPINI diazepam
Animal toxicology studies have been conducted with etravirine in mice, rats, rabbits and dogs.
Študije toksičnosti etravirina za živali so bile opravljene pri miših, podganah, kuncih in psih.
Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Študije pri živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na nosečnost, razvoj zarodka in ploda, porod ali poporodni razvoj (glejte poglavje 5.3).
• on a stable antiretroviral regimen for at least 8 weeks.
• najmanj 8 tednov zdravljenja s stabilno protiretrovirusno shemo.
INTELENCE works by reducing the amount of HIV in your body.
Zdravilo INTELENCE deluje tako, da zmanjšuje količino virusa HIV v telesu.
Trial characteristics - Design: randomised (1:1), double-blinded, placebo-controlled.
Značilnosti preskušanja - Načrt: randomizirano (1:1), dvojno slepo in s placebom nadzorovano preskušanje.
Do not give this medicine to children less than 6 years of age and weighing less than 16 kg because the potential benefits and risks have not yet been established.
Tega zdravila ne dajajte otrokom, mlajšim od 6 let in s telesno maso manj kot 16 kg, ker potencialne koristi in tveganja še niso bili potrjeni.
An intravenous formulation of etravirine is unavailable, thus, the absolute bioavailability of etravirine is unknown.
Oblika etravirina za intravensko uporabo ni na voljo, zato absolutna biološka uporabnost etravirina ni znana.
This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.
Tako izboljša delovanje imunskega sistema in zmanjša tveganje za pojav bolezni, ki so povezane s to okužbo.
After oral administration with food, the maximum plasma concentration of etravirine is generally achieved within 4 hours.
Po peroralni uporabi zdravila s hrano je največja plazemska koncentracija etravirina običajno dosežena v 4 urah.
There is limited information regarding the use of INTELENCE in patients > 65 years of age (see section 5.2), therefore caution should be used in this population.
Podatki o uporabi zdravila INTELENCE pri bolnikih, starih > 65 let, so omejeni (glejte poglavje 5.2), zato je pri uporabi v tej populaciji bolnikov potrebna previdnost.
Unchanged etravirine accounted for 81.2% to 86.4% of the administered dose in faeces.
Nespremenjen etravirin je zajemal od 81,2% do 86,4% danega odmerka v blatu.
If you take INTELENCE on an empty stomach, only half the amount of INTELENCE is absorbed.
Če bi ga zaužili na prazen želodec, bi se absorbirala samo polovica zaužite količine zdravila.
The type and incidence of adverse reactions in patients > 55 years of age were similar to the ones in younger patients (see sections 4.2 and 5.2).
Vrsta in incidenca neželenih učinkov pri bolnikih, starih > 55 let, sta bili podobni kot pri mlajših bolnikih (glejte poglavji 4.2 in 5.2).
Then take the next dose as usual.
Naslednji odmerek vzemite ob običajnem času.
Close monitoring for virologic response and for rifabutin related adverse reactions is recommended.
Priporočeno je skrbno spremljanje virološkega odziva in neželenih učinkov, povezanih z rifabutinom.
• 3 or more primary PI mutations at screening
• 3 ali več primarnih mutacij PI pri presejalnem testiranju,
With no associated boosted PI (out of the recommended indication for etravirine): rifabutin
Brez okrepljenega PI (ni indicirano za etravirin): rifabutin
FC subgroups are based on the select patient populations in DUET-1 and DUET-2 and are not meant to represent definitive clinical susceptibility breakpoints for etravirine.
Podskupine FC temeljijo na izbranih populacijah bolnikov v preskušanjih DUET-1 in DUET-2 in ni mišljeno, da bi predstavljale dokončne mejne vrednosti klinične občutljivosti za etravirin.
Stevens-Johnson Syndrome a, erythema multiforme very rare toxic epidermal necrolysis a, DRESS
Stevens-Johnsonov sindrom a, multiformnii eritem zelo redki toksična epidermalna nekroliza a, sindrom DRESS
The evidence of efficacy of etravirine is based on 48-week data from 2 Phase III trials DUET-1 and DUET-2.
Dokazi za učinkovitost etravirina temeljijo na podatkih za obdobje 48 tednov iz dveh preskušanj III. faze DUET-1 in DUET-2.
Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Morebitne vnetne simptome je treba oceniti in po potrebi uvesti ustrezno zdravljenje.
No studies on the effects of INTELENCE on the ability to drive or operate machines have been performed.
Študij o vplivu zdravila INTELENCE na sposobnost vožnje in upravljanja strojev niso izvedli.
Etravirine is approximately 99.9% bound to plasma proteins, primarily to albumin (99.6%) and α1-acid glycoprotein (97.66%-99.02%) in vitro.
In vitro je etravirin je približno 99,9% vezan na plazemske beljakovine, predvsem na albumin (99,6%) in na α1-kisli glikoprotein (97,66% do 99,02%).
rd trimester of pregnancy mean values of these parameters were comparable.
Med drugim in tretjim trimesečjem nosečnosti so bile povprečne vrednosti teh parametrov primerljive.
Concomitant use of PDE-5 inhibitors with INTELENCE may require dose adjustment of the PDE-5 inhibitor to attain the desired clinical effect.
Pri sočasni uporabi zaviralcev PDE-5 z zdravilom INTELENCE je lahko potrebna prilagoditev odmerka zaviralca PDE-5 za doseganje želenega kliničnega učinka.
• 1 or more NNRTI resistance-associated mutations (RAMs) at screening or from prior genotypic analysis (i.e., archived resistance)
• 1 ali več mutacij, povezanih z odpornostjo na NNRTI (RAM) pri presejalnem testiranju ali od predhodne analize genotipov (t.j.
As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women, and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account in order to characterise the safety for the foetus.
V splošnem je pri odločanju uporabe protiretrovirusnega zdravila za zdravljenje infekcije z virusom HIV pri nosečnicah in posledično zmanjšanje tveganja vertikalnega prenosa virusa HIV na novorojenčka potrebno upoštevati tako podatke pri živalih kot tudi klinične izkušnje pri nosečnicah, da se oceni varnost za fetus.
Patients who are unable to swallow the tablet(s) whole may disperse the tablet(s) in a glass of water.
Bolniki, ki ne morejo pogoltniti cele tablete (celih tablet), jo (jih) lahko dispergirajo v kozarcu vode.
In addition, etravirine demonstrates a fold change (FC) in EC50 ≤ 3 against 60% of 6,171 NNRTI-resistant clinical isolates.
Poleg tega je etravirin pokazal spremembo stopnje (FC - fold change) v vrednosti EC50 ≤ 3 proti 60% od 6.171 kliničnih izolatov, odpornih za NNRTI.
Exposure to etravirine was lower (35-50%) in HIV-1 infected patients than in healthy subjects.
Stopnja izpostavljenosti etravirinu je bila pri bolnikih, okuženih s HIV-1 manjša (35-50%), kot pri zdravih preiskovancih.
Alternatives to diazepam should be considered.
Premisliti je treba o uporabi nadomestnih zdravil za diazepam.
Treatment differences are based on Least Square Means from an ANCOVA model including the stratification factors.
Razlika po zdravljenju se izračuna iz srednjih vrednosti najmanjših kvadratov iz modela ANCOVA, vključno s stratifikacijskimi faktorji.
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy.
Poročali so o primerih osteonekroze, še posebej pri bolnikih s splošno priznanimi dejavniki tveganja, napredovalo okužbo s HIV in/ali dolgotrajno izpostavljenostjo kombinirani protiretrovirusni terapiji.
The European Medicines Agency has deferred the obligation to submit the results of studies with INTELENCE in one or more subsets of the paediatric population in human immunodeficiency virus infection, as per Paediatric Investigation Plan (PIP) decision in the granted indication (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom INTELENCE za eno ali več podskupin pediatrične populacije okužene z virusom humane imunske pomanjkljivosti pod pogoji, ki so za odobreno indikacijo zdravila navedeni v izvedbenem načrtu za pediatrično populacijo (PIP) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Treatment with INTELENCE should be discontinued if a severe cutaneous reaction develops.
Zdravljenje z zdravilom INTELENCE je treba ukiniti, če se pojavi huda kožna reakcija.
If you belong to this age group, please discuss the use of INTELENCE with your doctor.
Če sodite v to starostno skupino, se morate o uporabi zdravila INTELENCE posvetovati s svojim zdravnikom.
Since there was a significant interaction effect between treatment and ENF, the primary analysis was done for 2 ENF strata (patients reusing or not using ENF versus patients using ENF de novo).
Ker so ugotovili precejšen medsebojen vpliv z ENF, je bila primarna analiza opravljena na 2 skupinah ENF bolnikov (pri bolnikih, ki so ponovno jemali ENF oziroma ga niso jemali, v primerjavi z bolniki, ki so jemali ENF de novo).
HIV infected mothers must not breast-feed, as there is a possibility of infecting the baby with HIV.
Matere, ki so okužene z virusom HIV, ne smejo dojiti, ker obstaja možnost, da bodo z virusom HIV okužile svojega otroka.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolniki z redko dedno galaktozno intoleranco, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze in galaktoze ne smejo jemati tega zdravila.
The proportion of paediatric patients with < 400 HIV-1 RNA copies/ml was 63.4%.
Delež pediatričnih bolnikov z < 400 HIV-1 RNK kopij/ml je bil 63,4%.
Time to onset is usually around 3-6 weeks and the outcome in most cases is favourable upon discontinuation and after initiation of corticosteroid therapy.
Sindrom se običajno pojavi v obdobju 3-6 tednov in v večini primerov izgine po prekinitvi zdravljenja in uvedbi terapije s kortikosteroidi.
No unchanged drug was detected in urine so the impact of renal impairment on etravirine elimination is expected to be minimal.
V seču nespremenjenega zdravila niso odkrili, zato je pričakovati, da bo vpliv okvare ledvic na izločanje etravirina minimalen.
The frequency rate of the side effects associated with INTELENCE is given below.
Stopnja pogostnosti neželenih učinkov, povezanih z zdravilom INTELENCE je navedena spodaj.
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.
Priporočljivo je, da matere, okužene s HIV, v nobenem primeru ne dojijo svojih otrok, da ne bi prišlo do prenosa virusa HIV na otroka.
In clinical trials, Stevens-Johnson Syndrome and erythema multiforme have been rarely (< 0.1%) reported.
V kliničnih študijah so redko poročali o Stevens-Johnsonovem sindromu in o multiformnem eritemu (pri < 0,1% primerov).
What INTELENCE is and what it is used for What you need to know before you take INTELENCE How to take INTELENCE
Kaj je zdravilo INTELENCE in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo INTELENCE Kako jemati zdravilo INTELENCE Možni neželeni učinki
This difference between treatment arms was statistically significant.
Dobljena razlika med obema skupinama je bila statistično značilna.
Pharmacotherapeutic group: Antivirals for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code: J05AG04.
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij (nenukleozidni zaviralec reverzne transkriptaze), oznaka ATC: J05AG04.
NARCOTIC ANALGESICS Methadone individual dose ranging from 60 mg to 130 mg once daily
NARKOTIČNI ANALGETIKI metadon odmerek v razponu od 60 mg do 130 mg enkrat na dan
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Pri nekaterih bolnikih, ki imajo kombinirano protiretrovirusno zdravljenje, lahko pride do bolezni kosti, ki se imenuje osteonekroza (odmiranje kostnega tkiva, ki je posledica zmanjšanja prekrvavitve kosti).
The clinical data do not raise safety concern but are very limited.
Klinični podatki so zelo omejeni in ne predstavljajo tveganja glede varnosti.
These trials were identical in design and similar efficacy for etravirine was seen in each trial.
Ti dve preskušanji sta bili popolnoma enako načrtovani in v obeh so ugotovili podobno učinkovitost etravirina.
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 zaupanja okrog opaženih razlik v stopnjah odziva; p-vrednost iz CMH testa za nadzor stratifikacijskih faktorjev = 0,0199 za de novo, in < 0,0001 za ne de novo.
Delay in stopping INTELENCE treatment after the onset of severe rash may result in a life-threatening reaction.
Odložena prekinitev zdravljenja z zdravilom INTELENCE po pojavu hudega izpuščaja lahko povzroči življensko nevarne reakcije.