FrancophonIA/ELRC3.0 huggingface dataset:
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Slovenian: Obloga tablete polivinilalkohol titanov dioksid (E171) makrogol smukec indigotin (E 132) polisorbat 80
English: Varuby helps prevent feeling sick and being sick when you have chemotherapy.
Slovenian: Zdravilo Varuby preprečuje slabost in siljenje na bruhanje pri kemoterapiji.
English: Varuby 90 mg film-coated tablets
Slovenian: Varuby 90 mg filmsko obložene tablete
English: Rolapitant is eliminated mainly through the hepatobiliary route, with minor contributions from renal elimination.
Slovenian: Rolapitant se izloča prek jeter/žolča, v manjši meri se izloča skozi ledvice.
English: No dose adjustment is needed in patients with mild or moderate hepatic impairment.
Slovenian: Prilagoditev odmerka pri bolnikih z blago ali zmerno okvaro jeter ni potrebna.
English: At the 180 mg dose of rolapitant, the mean NK1 receptor occupancy in the cortical regions was greater than 90% for at least 120 hours.
Slovenian: Pri odmerku 180 mg rolapitanta je bila povprečna zasedenost receptorjev NK1 v kortikalnih območjih nad
English: Adverse reactions per system organ class
Slovenian: Neželeni učinki glede na organski sistem Organski sistem Pogosti
English: Decreases in the number of corpora lutea and implantation sites were observed in the female rat fertility and early embryonic development study (see section 5.3).
Slovenian: V študiji plodnosti podganjih samic in zgodnjega razvoja zarodka so opazili zmanjšano število rumenih telesc in mest ugnezditve (glejte poglavje 5.3).
English: Delayed Acute Overall
Slovenian: Zapoznela faza Akutna faza Celotna faza
English: Varuby 90 mg film-coated tablets Rolapitant
Slovenian: Varuby 90 mg filmsko obložene tablete rolapitant
English: A total of 2,798 subjects received oral rolapitant at any dose, including 1,567 subjects in the CINV (chemotherapy-induced nausea and vomiting) studies.
Slovenian: med drugim 1.567 oseb v študijah CINV (s kemoterapijo povzročena navzea in bruhanje).
English: Varuby is not recommended in patients who require chronic administration of strong (e.g. rifampicin, carbamazepine, phenobarbital, enzalutamide, phenytoin) or moderate enzyme inducers (e.g. efavirenz, rifabutin) (see section 4.5)
Slovenian: rifampicin, karbamazepin, fenobarbital, enzalutamid, fenitoin) ali zmernih encimskih induktorjev (npr. efavirenz, rifabutin) (glejte poglavje 4.5).
English: In vitro studies suggest that rolapitant is not an inhibitor of CYP2E1.
Slovenian: Študije in vitro kažejo, da rolapitant ni zaviralec
English: Overall
Slovenian: Celotna faza
English: How Varuby works
Slovenian: Kako deluje zdravilo Varuby
English: Oral fungal infection Candidiasis Oral candidiasis
Slovenian: Infekcijske in parazitske bolezni glivična okužba ust kandidoza kandidoza ust
English: Balance disorder Movement disorder Syncope
Slovenian: Bolezni živčevja glavobol omotičnost motnje pozornosti disgevzija somnolenca motnje ravnotežja motnje gibanja sinkopa
English: No clinically significant effect was seen on the pharmacokinetics of rolapitant when ketoconazole, a strong CYP3A4 inhibitor was administered with rolapitant.
Slovenian: Pri sočasni uporabi ketokonazola, močnega zaviralca CYP3A4, in rolapitanta niso opazili klinično pomembnega učinka na farmakokinetiko rolapitanta.
English: Other CYPs
Slovenian: Druge učinkovine CYP
English: Serious side effects:
Slovenian: Resni neželeni učinki
English: No Emesis
Slovenian: PRETISNI OMOTI
English: - feeling dizzy, difficulty concentrating, lack of energy, feeling sleepy (somnolence) or trouble sleeping (insomnia) - stomach problems including stomach discomfort, bloating, nausea, pain, indigestion, and diarrhoea - low levels of white blood cells which fight infections (shown in blood tests) - infection in the mouth - mouth sores - decreased appetite - hiccups - weakness
Slovenian: • omotičnost, težave s koncentracijo, pomanjkanje energije, občutek zaspanosti (dremavost) ali težave s spanjem (nespečnost),
English: How to store Varuby
Slovenian: Shranjevanje zdravila Varuby
English: Abdominal distension Abdominal pain Stomatitis
Slovenian: Psihiatrične motnje nespečnost anksioznost bruksizem
English: Study 1 and Study 2 (HEC)
Slovenian: (študiji 1 in 2 - ločeno prikazani rezultati HEC)
English: 83.7 73.7 0.005 83.4 79.5 N.S.
Slovenian: 85,7 N. Z.
English: A 70% increase in Cmax and 30% increase in AUC of digoxin, a P-gp substrate, were observed when administered with a single dose of 180 mg rolapitant.
Slovenian: Ob sočasnem dajanju z enkratnim odmerkom 180 mg rolapitanta so opazili 70-% povečanje Cmax in 30-% povečanje AUC za digoksin, substrat P-gp.
English: Ear and labyrinth disorders
Slovenian: Ušesne bolezni, vključno z motnjami labirinta naglušnost tinitus
English: Metabolism and nutrition disorders
Slovenian: obmodek in maternica.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serij
English: Delayed Acute
Slovenian: Zapoznela faza Akutna faza
English: Constipation Diarrhoea Dyspepsia
Slovenian: Srčne bolezni pospešen srčni utrip
English: Heart rate increased
Slovenian: Odmerjanje Odrasli
English: Rolapitant (N=264) Rate (%)
Slovenian: Študija 1 in študija 2 združeno rolapitant (N = 264) delež (%)
English: Arthralgia Back pain Muscular weakness Rhabdomyolysis
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva mialgija artralgija bolečine v hrbtu mišična oslabelost rabdomioliza
English: Uncommon: may affect up to 1 in 100 people - sore or painful muscles
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 ljudi:
English: Rolapitant This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Varuby 90 mg filmsko obložene tablete rolapitant Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Patients with severe hepatic impairment
Slovenian: zlasti pri bolnikih z okvaro ledvic.
English: Hypoacusis Tinnitus
Slovenian: Neptunus 12
English: Nervous system disorders
Slovenian: • mišična oslabelost,
English: 86.4 79.4 0.035 90.0 85.7 N.S.
Slovenian: 68,9 N. Z.
English: 73.5 64.9 0.034 74.5 68.9 N.S.
Slovenian: 79,5 N. Z.
English: 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 4.5).
Slovenian: aprepitanta in kombinacije netupitanta in palonosetronijevega klorida) ni dokazana, zato tega ne priporočamo (glejte poglavje 4.5).
English: 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)
Slovenian: • 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),
English: 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).
Slovenian: aprepitanta in kombinacije netupitanta in palonosetronijevega klorida) ni dokazana, zato tega ne priporočamo (glejte poglavje 4.4).
English: Cardiac disorders
Slovenian: • dehidracija,
English: Table 1: Proportion of patients receiving cisplatin chemotherapy responding by treatment group and phase (Studies 1 and 2 - HEC Individual Results)
Slovenian: Delež odzivnih bolnikov, ki so prejemali kemoterapijo s cisplatinom, po skupinah zdravljenja in fazah
English: P-Valueb
Slovenian: vrednost Pb
English: B. PACKAGE LEAFLET
Slovenian: • zamegljen vid,
English: 86.4 76.0 0.002 85.6 81.7 N.S.
Slovenian: 67,8 N. Z.
English: 70.1 56.5 0.001 67.5 60.4 N.S.
Slovenian: 64,1 N. Z.
English: BCRP substrates
Slovenian: BCRP).
English: The usual dose is two tablets.
Slovenian: Če ste vzeli večji odmerek zdravila Varuby, kot bi smeli Običajni odmerek sta dve tableti.
English: Abdominal discomfort Change of bowel habit Dry mouth
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost astenija motnje hoje
English: Tablet content
Slovenian: FARMAKOLOŠKE LASTNOSTI
English: Comparison based on historic control.
Slovenian: Primerjava temelji na zgodovinski kontroli.
English: - Main inclusion criteria:
Slovenian: - Glavni vključitveni kriteriji:
English: Date of first authorisation: 28 August 2008 Date of latest renewal: 23 August 2018
Slovenian: Datum prve odobritve: 28. avgust 2008 Datum zadnjega podaljšanja: 23. avgust 2018
English: A limited number of females were included in the studies.
Slovenian: V študije je bilo vključeno manjše število žensk.
English: V179F was never present without Y181C.
Slovenian: V179F ni bila nikoli navzoča brez Y181C.
English: Typically, such reactions have been observed within the first weeks or months of initiation of CART.
Slovenian: Običajno so takšne reakcije opažali v prvih tednih ali mesecih po uvedbi CART.
English: Treatment difference (95% CI)
Slovenian: Razlika po zdravljenju (95% CI)
English: With an associated boosted PI:
Slovenian: Skupaj z okrepljenim PI:
English: The terminal elimination half-life of etravirine was approximately 30-40 hours.
Slovenian: Končna razpolovna doba izločanja etravirina je znašala približno 30 do 40 ur.
English: Your doctor will discuss with you which combination of medicines is best for you.
Slovenian: Zdravnik se bo z vami pogovoril o tem, katera kombinacija zdravil je najprimernejša za vas.
English: Tell your doctor about your situation
Slovenian: Zdravnika obvestite o svojem stanju
English: The clinical relevance of this interaction has not been demonstrated.
Slovenian: Klinični pomen te interakcije ni znan.
English: - Tell your doctor immediately if you notice any symptoms of infections.
Slovenian: - Nemudoma povejte svojemu zdravniku, če opazite kakršnekoli simptome in znake okužbe.
English: 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.
Slovenian: 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.
English: What INTELENCE is and what it is used for
Slovenian: Kaj je zdravilo INTELENCE in za kaj ga uporabljamo
English: These individual mutations occurred in the presence of other NNRTI RAMs.
Slovenian: Te posamezne mutacije so se pojavile v navzočnosti drugih NNRTI RAM.
English: Based on animal data the malformative risk is unlikely in humans.
Slovenian: Na osnovi podatkov pri živalih je tveganje za pojav malformacij pri ljudeh malo verjetno.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Pregnant women should not take INTELENCE unless specifically directed by the doctor.
Slovenian: Noseče ženske ne smejo jemati zdravila INTELENCE, razen če jim ga izrecno predpiše zdravnik.
English: Your doctor will explain these to you.
Slovenian: Zdravnik vam bo pojasnil te izvide.
English: Each carton contains one bottle.
Slovenian: Vsaka škatla vsebuje eno plastenko.
English: Combining two NNRTIs has not been shown to be beneficial.
Slovenian: Sočasna uporaba dveh NNRTI ni koristna.
English: If you have been told by your doctor that you have an intolerance to some sugars (lactose), contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje (laktozo), se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Lactose intolerance and lactase deficiency
Slovenian: Laktozna intoleranca in pomanjkanje laktaze
English: * based on population pharmacokinetic analyses
Slovenian: * na osnovi analiz populacijske farmakokinetike
English: Lopinavir/ritonavir (tablet)
Slovenian: lopinavir/ritonavir (tableta)
English: Treatment of overdose with INTELENCE consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Slovenian: Zdravljenje prevelikega odmerjanja zdravila INTELENCE naj sestoji iz splošnih podpornih ukrepov, vključno s spremljanjem bolnikovih vitalnih znakov in opazovanjem njegovega kliničnega stanja.
English: - 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.
Slovenian: - 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.
English: The tablet can be divided into two equal doses.
Slovenian: Tableto lahko razdelite na dva enaka odmerka.
English: If you forget to take INTELENCE
Slovenian: Če ste pozabili vzeti zdravilo INTELENCE
English: What you need to know before you take INTELENCE
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo INTELENCE
English: For instructions on dispersion of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede dispergiranja zdravila pred dajanjem glejte poglavje 6.6.
English: ≥ 50 and < 200 ≥ 200 and < 350
Slovenian: ≥ 50 in < 200 ≥ 200 in < 350
English: Other medicines and INTELENCE
Slovenian: Druga zdravila in zdravilo INTELENCE
English: However, some combinations are not recommended.
Slovenian: vendar nekatere kombinacije niso priporočljive.
English: In rare instances, very serious rash has been reported which can be potentially life-threatening.
Slovenian: V redkih primerih so poročali o zelo hudem izpuščaju, ki je lahko življenjsko nevaren.
English: Possible side effects').
Slovenian: Možni neželeni učinki').
English: The frequency of this is unknown (see section 4.4).
Slovenian: Pogostnost tega pojava ni znana (glejte poglavje 4.4).
English: Use in adults Other form(s) of this medicine may be more suitable for adults.
Slovenian: Uporaba pri odraslih Za odrasle so lahko bolj primerne druge oblike tega zdravila.
English: 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).
Slovenian: 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).
English: INTELENCE has only been used in a limited number of patients of 65 years or older.
Slovenian: Zdravilo INTELENCE so doslej uporabili šele pri majhnem številu bolnikov, starih 65 let ali več.
English: The use of warm (> 40°C) or carbonated beverages should be avoided.
Slovenian: Toplim napitkom (> 40°C) in gaziranim pijačam se je treba izogibati.
English: The doctor will inform you exactly how much INTELENCE the child should take.
Slovenian: Zdravnik vam bo povedal koliko zdravila mora vzeti otrok.
English: N = number of subjects with data; n = number of observations.
Slovenian: N = št. preskušancev z razpoložljivimi podatki ; n = št. dogodkov.
English: Furthermore, it is important that you carefully read the package leaflets that are provided with these medicines.
Slovenian: Poleg tega je pomembno, da natančno preberete navodila za uporabo teh zdravil, ki so jim priložena.
English: H2-RECEPTOR ANTAGONISTS Ranitidine
Slovenian: ANTAGONISTI RECEPTORJEV H2 ranitidin
English: For further information on interactions with medicinal products see section 4.5.
Slovenian: Za dodatne informacije o medsebojnem delovanju z drugimi zdravili glejte poglavje 4.5.
English: Any AIDS defining illness and/or death n (%)
Slovenian: Katerakoli bolezen, povezana z aidsom, in/ali smrt bolnika n (%)
English: Talk to your doctor first.
Slovenian: Zato se morate najprej posvetovati s svojim zdravnikom.
English: The results below are pooled data from the two trials.
Slovenian: Spodnji izsledki predstavljajo združene podatke iz teh dveh preskušanj.
English: Pivotal studies
Slovenian: Ključne študije
English: There were no new clinically relevant safety findings in the mothers or in the newborns in this trial.
Slovenian: Novih, klinično pomembnih ugotovitev o varnosti pri materah ali novorojencih, vključenih v študijo, ni bilo.
English: INTELENCE must always be given in combination with other antiretroviral medicinal products.
Slovenian: Zdravilo INTELENCE morate vedno uporabljati v kombinaciji z drugimi protiretrovirusnimi zdravili.
English: Not studied.
Slovenian: Niso preiskovali.
English: Instructions for taking INTELENCE for all patients It is important that you take INTELENCE following a meal.
Slovenian: Navodila za jemanje zdravila INTELENCE za vse bolnike Pomembno je, da zdravilo INTELENCE jemljete po jedi.
English: 4.8 log10 copies/ml
Slovenian: 4,8 log10 kopij/ml
English: BENZODIAZEPINES Diazepam
Slovenian: BENZODIAZEPINI diazepam
English: Animal toxicology studies have been conducted with etravirine in mice, rats, rabbits and dogs.
Slovenian: Študije toksičnosti etravirina za živali so bile opravljene pri miših, podganah, kuncih in psih.
English: 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).
Slovenian: Študije pri živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na nosečnost, razvoj zarodka in ploda, porod ali poporodni razvoj (glejte poglavje 5.3).
English: • on a stable antiretroviral regimen for at least 8 weeks.
Slovenian: • najmanj 8 tednov zdravljenja s stabilno protiretrovirusno shemo.
English: INTELENCE works by reducing the amount of HIV in your body.
Slovenian: Zdravilo INTELENCE deluje tako, da zmanjšuje količino virusa HIV v telesu.
English: Trial characteristics - Design: randomised (1:1), double-blinded, placebo-controlled.
Slovenian: Značilnosti preskušanja - Načrt: randomizirano (1:1), dvojno slepo in s placebom nadzorovano preskušanje.
English: 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.
Slovenian: 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.
English: An intravenous formulation of etravirine is unavailable, thus, the absolute bioavailability of etravirine is unknown.
Slovenian: Oblika etravirina za intravensko uporabo ni na voljo, zato absolutna biološka uporabnost etravirina ni znana.
English: This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.
Slovenian: Tako izboljša delovanje imunskega sistema in zmanjša tveganje za pojav bolezni, ki so povezane s to okužbo.
English: After oral administration with food, the maximum plasma concentration of etravirine is generally achieved within 4 hours.
Slovenian: Po peroralni uporabi zdravila s hrano je največja plazemska koncentracija etravirina običajno dosežena v 4 urah.
English: 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.
Slovenian: 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.
English: Unchanged etravirine accounted for 81.2% to 86.4% of the administered dose in faeces.
Slovenian: Nespremenjen etravirin je zajemal od 81,2% do 86,4% danega odmerka v blatu.
English: If you take INTELENCE on an empty stomach, only half the amount of INTELENCE is absorbed.
Slovenian: Če bi ga zaužili na prazen želodec, bi se absorbirala samo polovica zaužite količine zdravila.
English: 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).
Slovenian: Vrsta in incidenca neželenih učinkov pri bolnikih, starih > 55 let, sta bili podobni kot pri mlajših bolnikih (glejte poglavji 4.2 in 5.2).
English: Then take the next dose as usual.
Slovenian: Naslednji odmerek vzemite ob običajnem času.
English: Close monitoring for virologic response and for rifabutin related adverse reactions is recommended.
Slovenian: Priporočeno je skrbno spremljanje virološkega odziva in neželenih učinkov, povezanih z rifabutinom.
English: • 3 or more primary PI mutations at screening
Slovenian: • 3 ali več primarnih mutacij PI pri presejalnem testiranju,
English: With no associated boosted PI (out of the recommended indication for etravirine): rifabutin
Slovenian: Brez okrepljenega PI (ni indicirano za etravirin): rifabutin
English: 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.
Slovenian: 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.
English: Stevens-Johnson Syndrome a, erythema multiforme very rare toxic epidermal necrolysis a, DRESS
Slovenian: Stevens-Johnsonov sindrom a, multiformnii eritem zelo redki toksična epidermalna nekroliza a, sindrom DRESS
English: The evidence of efficacy of etravirine is based on 48-week data from 2 Phase III trials DUET-1 and DUET-2.
Slovenian: Dokazi za učinkovitost etravirina temeljijo na podatkih za obdobje 48 tednov iz dveh preskušanj III. faze DUET-1 in DUET-2.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Slovenian: Morebitne vnetne simptome je treba oceniti in po potrebi uvesti ustrezno zdravljenje.
English: No studies on the effects of INTELENCE on the ability to drive or operate machines have been performed.
Slovenian: Študij o vplivu zdravila INTELENCE na sposobnost vožnje in upravljanja strojev niso izvedli.
English: Etravirine is approximately 99.9% bound to plasma proteins, primarily to albumin (99.6%) and α1-acid glycoprotein (97.66%-99.02%) in vitro.
Slovenian: 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%).
English: rd trimester of pregnancy mean values of these parameters were comparable.
Slovenian: Med drugim in tretjim trimesečjem nosečnosti so bile povprečne vrednosti teh parametrov primerljive.