FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the benefit/risk profile of Clavudale 50 mg tablet for cats and dogs and associated
Slovenian: Na podlagi ovrednotenja poročevalčeve ocene podatkov, ki so trenutno na voljo, je CVMP menil, da je profil razmerja med koristmi in tveganji za zdravilo Clavudale 50 mg tablete za mačke in pse in stran 2/2
English: Clavudale 50 mg is intended for the treatment of pathogen-specific skin infections, infections of the oral cavity, urinary tract infections, respiratory disease and enteritis.
Slovenian: Zdravilo Clavudale 50 mg se uporablja za zdravljenje kožnih okužb, okužb ustne votline, okužb sečil, bolezni dihal in enteritis, ki jih povzročajo določeni povzročitelji bolezni.
English: Ref. EMEA/CHMP/384877/2008
Slovenian: : EMEA/CHMP/556329/2008
English: Risperdal and associated names is as an antipsychotic, indicated for the treatment of schizophrenia, manic episodes associated with bipolar disorders, persistent aggression in patients with moderate to severe Alzheimer's dementia and treatment of persistent aggression in conduct disorder in children.
Slovenian: Zdravilo Risperdal in z njim povezana imena je antipsihotično zdravilo, indicirano za zdravljenje shizofrenije, manične epizode, povezane z bipolarnimi motnjami, persistentne agresivnosti pri bolnikih z zmerno do hudo Alzheimerjevo demenco in zdravljenje persistentne agresivnosti pri otrocih z vedenjskimi motnjami.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Risperdal and associated names International Non-Proprietary Name (INN): risperidone
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 30 ZA Risperdal in z njim povezana imena Mednarodno nelastniško ime (INN): risperidon
English: It is available as film coated tablets, oro-dispersible tablets (rapidly disintegrating) and oral solution.
Slovenian: Zdravilo je na voljo v obliki filmsko obloženih orodisperzibilnih (hitro razkrajajočih se) tablet in peroralne raztopine.
English: On 24 July 2007 the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Risperdal and associated names.
Slovenian: Evropska komisija je dne 24. julija 2007 agenciji EMEA predložila napotitev v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, da bi uskladila nacionalno odobrene povzetke glavnih značilnosti zdravila, označevanje in navodilo za uporabo zdravila Risperdal in z njim povezana imena.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Risperdal and associated names approved across EU Member States, with respect to the indications, the posology and method of administration, the contra-indications, the special warnings and precautions for use and the interaction with other medicinal products and other forms of interaction.
Slovenian: Osnova za napotitev so bile razlike med povzetki glavnih značilnosti zdravila Risperdal in z njim povezanih imen v državah članicah EU pri indikacijah, odmerjanju in načinu uporabe, kontraindikacijah, posebnih opozorilih in previdnostnih ukrepih ter medsebojnem delovanju z drugimi zdravili in drugih vrstah interakcij.
English: The CHMP gave a positive opinion on 24 July 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Risperdal and associated names.
Slovenian: V CHMP so podali pozitivno mnenje 24. julija 2008, s katerim so priporočili uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo za zdravilo Risperdal in z njim povezana imena.
English: ● At the request of the European Medicines Agency
Slovenian: • na zahtevo Evropske agencije za zdravila;
English: Date of first authorization: 19 September 2005 Date of latest renewal: 2 July 2010
Slovenian: Datum prve odobritve: 19. september 2005 Datum zadnjega podaljšanja: 2. julij 2010
English: Caution should be exercised in such situations.
Slovenian: V takih primerih je potrebna previdnost.
English: Independent Review **
Slovenian: neodvisni pregled **
English: You should tell your doctor:
Slovenian: Obvestite zdravnika, če:
English: In some cases dose reduction may be necessary.
Slovenian: V nekaterih primerih bo morda potrebno zmanjšanje odmerka.
English: - corresponds to percentage below threshold.
Slovenian: - ustreza odstotku pod pragom
English: Demographic characteristics were well balanced between the two treatment groups.
Slovenian: Demografske značilnosti so bile med obema zdravljenima skupinama dobro uravnotežene.
English: Talk to your doctor, he will need to regularly monitor you with some blood tests.
Slovenian: Posvetujte se z zdravnikom, ki vas bo moral redno spremljati z nekaterimi krvnimi testi;
English: Second and Further Line Treatment
Slovenian: Druga in nadaljnje linije zdravljenja
English: Plasma protein binding is approximately 95%.
Slovenian: Vezava na plazemske proteine znaša približno 95 %.
English: This disease can also be linked to the natural progression of your medical condition and can have a fatal outcome in some cases.
Slovenian: Ta bolezen je lahko povezana tudi z naravnim poslabšanjem vašega zdravstvenega stanja in se lahko v nekaterih primerih konča s smrtnim izidom.
English: A study in normal healthy volunteers provided an estimate of the absolute bioavailability of 59%.
Slovenian: Študija pri zdravih prostovoljcih je pokazala oceno absolutne biološke uporabnosti 59 %.
English: See also section 4 “Possible side effects”.
Slovenian: Glejte tudi poglavje 4 “Možni neželeni učinki”.
English: Patients in this study were not selected based on EGFR mutation status.
Slovenian: Bolniki v tej študiji niso bili izbrani glede na status mutacij EGFR.
English: This protein is known to be involved in the growth and spread of cancer cells.
Slovenian: Za to beljakovino je znano, da sodeluje pri rasti in razširjanju rakavih celic.
English: Red blood cell parameters were decreased and white blood cells, primarily neutrophils, were increased.
Slovenian: Parametri rdečih krvnih celic so bili znižani, parametri belih krvnih celic, v glavnem nevtrofilcev, pa so bili zvišani.
English: Placebo (months)
Slovenian: Placebo (meseci)
English: The effect on overall survival was explored across different patient subsets.
Slovenian: Učinek na celokupno preživetje so preiskovali v različnih podskupinah bolnikov.
English: 1 In clinical study PA.3.
Slovenian: 1 V kliničnem preskušanju PA.3.
English: The efficacy results are summarized in Table 3.
Slovenian: Rezultati o učinkovitosti so povzeti v preglednici 3.
English: ** Can lead to dehydration, hypokalemia and renal failure.
Slovenian: ** Lahko vodi v dehidracijo, hipokaliemijo in ledvično odpoved.
English: There was no change to Tmax or half-life.
Slovenian: Spremembe tmax ali razpolovnega časa ni bilo.
English: Tell your doctor if you have severe pain in your abdomen.
Slovenian: Zdravniku povejte, če imate hude bolečine v trebuhu.
English: Also, tell your doctor if you had peptic ulcers or diverticular disease in the past, as this may increase this risk.
Slovenian: Prav tako mu povejte, če ste v preteklosti imeli peptično razjedo ali divertikularno bolezen, ker lahko to poveča tveganje.
English: It is not known whether Tarceva has a different effect if your liver or kidneys are not functioning normally.
Slovenian: Ni znano, ali ima zdravilo Tarceva drugačen učinek, če vaša jetra ali ledvice ne delujejo normalno.
English: Tarceva has not been studied in patients under the age of 18 years.
Slovenian: Zdravila Tarceva niso proučevali pri bolnikih, mlajših od 18 let.
English: Symptoms started from a few days to several months after initiating Tarceva therapy.
Slovenian: Simptomi so se pojavili od nekaj dni do več mesecev po začetku zdravljenja z zdravilom Tarceva.
English: Including fatalities.
Slovenian: 6 Vključno s smrtnimi primeri.
English: The first 330 patients were centrally assessed (response rate 6.2%); 401 patients were investigatorassessed (response rate 11.2%).
Slovenian: Prvih 330 bolnikov so ocenili centralno (odziv na zdravljenje 6,2 %); 401 bolnika pa so ocenili raziskovalci (odziv na zdravljenje 11,2 %).
English: The median duration of response was 34.3 weeks, ranging from 9.7 to 57.6+ weeks.
Slovenian: Mediana trajanja odgovora je bila 34,3 tedna v razponu od 9,7 do 57,6+ tedna.
English: Tell your doctor or pharmacist if you are taking, have recently taken any other medicines or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The study did not meet its primary endpoint.
Slovenian: Primarni cilj študije ni bil dosežen.
English: • Inflammatory reactions around the fingernail
Slovenian: • vnetne reakcije okrog nohtov,
English: 5 Including increased alanine aminotransferase [ALT], aspartate aminotransferase [AST] and bilirubin.
Slovenian: Vključno z zvišano alanin-aminotransferazo [ALT], aspartat-aminotransferazo [AST] in bilirubinom.
English: Cigarette smoking has been shown to reduce erlotinib exposure by 50-60%.
Slovenian: Pokazalo se je, da kajenje zmanjša izpostavljenost erlotinibu za 50 do 60 %.
English: Infections and infestations Infection*
Slovenian: Infekcijske in parazitske bolezni okužba*
English: The clinical relevance of this increase has not been established.
Slovenian: Klinični pomen tega povečanja ni znan.
English: It is important to keep taking Tarceva every day, as long as your doctor prescribes it for you.
Slovenian: Pomembno je, da vzamete zdravilo Tarceva vsak dan, dokler vam ga je zdravnik predpisal.
English: Erlotinib and smokers
Slovenian: Erlotinib in kadilci
English: Including fatalities (see section 4.4).
Slovenian: Vključno s smrtnimi primeri (glejte poglavje 4.4).
English: The treatment with this medicine is not recommended for children and adolescents.
Slovenian: Zdravljenje otrok in mladostnikov s tem zdravilom ni priporočljivo.
English: Results are shown in the table below (results for the group of metastatic and locally advanced patients are derived from exploratory subgroup analysis).
Slovenian: Izsledki so prikazani v spodnji preglednici (izsledki za skupini bolnikov z metastatsko in lokalno napredovalo boleznijo so iz eksplorativne analize podskupin).
English: What Tarceva is and what it is used for
Slovenian: Kaj je zdravilo Tarceva in za kaj ga uporabljamo
English: If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered.
Slovenian: V primeru, da se postavi diagnoza keratitisa, je treba skrbno razmisliti o koristih in tveganjih nadaljnjega zdravljenja.
English: EGFR is expressed on the cell surface of normal cells and cancer cells.
Slovenian: EGFR se izraža na celični površini normalnih in rakavih celic.
English: When dose adjustment is necessary, the dose should be reduced in 50 mg steps (see section 4.4).
Slovenian: Kadar je potrebno odmerek prilagoditi, ga je treba zmanjševati v korakih po 50 mg (glejte poglavje 4.4).
English: The clinical relevance of these differences is unclear.
Slovenian: Klinični pomen teh razlik ni znan.
English: The inhibition of glucuronidation may cause interactions with medicinal products which are substrates of UGT1A1 and exclusively cleared by this pathway.
Slovenian: Inhibicija glukuronidacije lahko povzroči interakcije z zdravili, ki so substrati UGT1A1 in se izločajo samo po tej poti.
English: In clinical practice, there may be other co-factors leading to an increased exposure to carboplatin like renal impairment.
Slovenian: V klinični praksi lahko obstajajo drugi dejavniki, ki vodijo k večji izpostavljenosti karboplatinu, kot je npr. ledvična okvara.
English: * Severe infections, with or without neutropenia, have included pneumonia, sepsis, and cellulitis.
Slovenian: * Hude okužbe z nevtropenijo ali brez nje so vključevale pljučnico, sepso in celulitis.
English: Due to the blocking of downstream-signaling, the proliferation of cells is stopped, and cell death is induced through the intrinsic apoptotic pathway.
Slovenian: Zaradi blokade nadaljnjega signaliziranja (downstream-signaling) se proliferacija celic ustavi in preko intrinzične apoptotične poti se sproži celična smrt.
English: It can also be prescribed if previous chemotherapy has not helped to stop your disease.
Slovenian: Lahko vam ga predpiše tudi, če predhodna kemoterapija ni ustavila bolezni.
English: België/Belgique/Belgien
Slovenian: België/Belgique/Belgien N.V.
English: -Stevens-Johnson syndrome/Toxic epidermal necrolysis7
Slovenian: - StevensJohnsonov sindrom/ toksična epidermalna nekroliza
English: Based on population pharmacokinetic analysis, the presence of an opioid appeared to increase exposure by about 11%.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da lahko prisotnost opioida poveča izpostavljenost za približno 11 %.
English: When prescribing Tarceva, factors associated with prolonged survival should be taken into account.
Slovenian: Pri predpisovanju zdravila Tarceva je treba upoštevati dejavnike, povezane s podaljšanim preživetjem.
English: PVC blister sealed with aluminium foil containing 30 tablets.
Slovenian: PVC pretisni omot, zavarjen z aluminijevo folijo, ki vsebuje 30 tablet.
English: The safety and efficacy of erlotinib in the approved indications has not been established in patients under the age of 18 years.
Slovenian: Varnost in učinkovitost erlotiniba za odobrene indikacije pri otrocih, mlajših od 18 let, še nista bili dokazani.
English: -Keratitis -Conjunctivitis1
Slovenian: - keratitis - konjunktivitis1
English: A higher incidence has been observed in patients in Japan (see section 4.4).
Slovenian: Pri bolnikih na Japonskem so opazili višjo incidenco (glejte poglavje 4.4).
English: Psychiatric disorders Depression very common
Slovenian: Psihiatrične motnje depresija zelo pogosti
English: The consequences of this interaction for e.g. CNS toxicity have not been established.
Slovenian: Posledice tega medsebojnega delovanja na npr. toksičnost za CŽS niso znane.
English: If necessary the dose of erlotinib should be reduced, particularly if toxicity is observed.
Slovenian: Če je treba, odmerek erlotiniba zmanjšamo, še posebno pri pojavu toksičnosti.
English: Elderly population There have been no specific studies in elderly patients.
Slovenian: Starejši bolniki Specifičnih študij pri starejših bolnikih niso izvedli.
English: These were very common in clinical study PA.3 and common in clinical study BR.21.
Slovenian: Zvišanja so bila zelo pogosta v kliničnem preskušanju PA.3 ter pogosta v kliničnem preskušanju BR.21.
English: Tarceva or placebo was taken orally once daily until disease progression or unacceptable toxicity.
Slovenian: Zdravilo Tarceva ali placebo so bolniki jemali peroralno enkrat na dan do napredovanja bolezni ali nesprejemljive toksičnosti.
English: Treatment should only be continued in pregnant women if the potential benefit to the mother outweighs the risk to the foetus.
Slovenian: Pri nosečnicah se lahko zdravljenje nadaljuje le, če korist za mater upravičuje tveganje za plod.
English: Hypromellose (E464)
Slovenian: makrogol hipromeloza (E464)
English: Tarceva with food and drink Do not take Tarceva with food.
Slovenian: Zdravilo Tarceva skupaj s hrano in pijačo Zdravila Tarceva ne jemljite skupaj s hrano.
English: • Reduced kidney function (when given outside the approved indications in combination with chemotherapy)
Slovenian: • zmanjšano delovanje ledvic (ko se zdravilo daje izven odobrenih indikacij skupaj s kemoterapijo).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Tarceva in all subsets of the paediatric population in Non Small Cell Lung Cancer and Pancreatic cancer indications (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Tarceva za vse podskupine pediatrične populacije pri indikacijah nedrobnoceličnega raka pljuč ter raka trebušne slinavke (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Cut-off date: April 2012
Slovenian: podatki do aprila 2012
English: A validated, robust, reliable and sensitive test with a prespecified positivity threshold and demonstrated utility for the determination of EGFR mutation status, using either tumor DNA derived from a tissue sample or circulating free DNA (cfDNA) obtained from a blood (plasma) sample, should be performed according to local medical practice.
Slovenian: Uporabiti je treba validiran, robusten, zanesljiv in občutljiv test z vnaprej določenim pragom za pozitivnost in dokazano uporabnostjo za določanje statusa mutacij EGFR z uporabo bodisi tumorske DNA, pridobljene iz vzorca tkiva, ali krožeče proste DNA (cfDNA, circulating free DNA), pridobljene iz vzorca krvi (plazme) v skladu z lokalno medicinsko prakso.
English: Concomitant use of CYP3A4 substrates and modulators may require dose adjustment (see section 4.5).
Slovenian: Pri sočasnem jemanju substratov in modulatorjev CYP3A4 bo morda potrebna prilagoditev odmerka (glejte poglavje 4.5).
English: 90% of patients on Tarceva developed rash within the first 44 days.
Slovenian: Pri 90 % bolnikov, ki so se zdravili z zdravilom Tarceva, se je kožni izpuščaj pojavil v prvih 44 dneh.
English: Current smokers should be advised to stop smoking (see sections 4.4, 4.5, 5.1 and 5.2).
Slovenian: Bolnikom kadilcem je treba svetovati, naj prenehajo kaditi (glejte poglavja 4.4, 4.5, 5.1 in 5.2).
English: Patients with bullous and exfoliative skin disorders should be tested for skin infection and treated according to local management guidelines.
Slovenian: Pri bolnikih s kožnimi boleznimi z mehurji in luščenjem kože je treba preveriti prisotnost okužbe kože in jih zdraviti v skladu z lokalnimi smernicami.
English: Based on population pharmacokinetic analysis, no clinically significant relationship between predicted apparent clearance and patient age, bodyweight, gender and ethnicity were observed.
Slovenian: Na osnovi populacijske farmakokinetične analize niso opazili klinično pomembnih povezav med predvidenim navideznim očistkom in bolnikovo starostjo, telesno maso, spolom ali etničnim poreklom.
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: A. IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: Abnormal blood tests for the liver function
Slovenian: • nenormalni krvni testi za jetrno funkcijo,
English: EGFR mutations may lead to constitutive activation of anti-apoptotic and proliferation signaling pathways.
Slovenian: Mutacije EGFR lahko vodijo v bistveno aktivacijo anti-apoptotičnih in proliferacijskih signalnih poti.
English: However, an adverse effect on the fertility can not be excluded as animal studies have shown effects on reproductive parameters (see section 5.3).
Slovenian: Vendar pa škodljivega učinka na plodnost ni mogoče izključiti, ker so študije na živalih pokazale vpliv na reproduktivne parametre (glejte poglavje 5.3).
English: Such influence is supported by limited clinical data and preclinical studies showing EGFR degradation through the proteasome.
Slovenian: Takšen vpliv podpira majhno število kliničnih podatkov in predkliničnih študij, ki kažejo na s proteasomi povzročen razpad EGFR.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, 4.2).
English: Rare side effects (may affect up to 1 in 1,000 people): • Flushed or painful palms or soles (Palmar plantar erythrodysaesthesia syndrome)
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1000 bolnikov): • pordele ali boleče dlani ali podplati (sindrom palmarno-plantarne eritrodisestezije).
English: • Cracked skin (skin fissures)
Slovenian: • razpokana koža (fisure na koži),
English: There are three main metabolic pathways identified: 1) O-demethylation of either side chain or both, followed by oxidation to the carboxylic acids; 2) oxidation of the acetylene moiety followed by hydrolysis to the aryl carboxylic acid; and 3) aromatic hydroxylation of the phenyl-acetylene moiety.
Slovenian: Znane so tri glavne poti presnove: 1) O-demetiliranje ene stranske verige ali obeh, ki mu sledi oksidacija v karboksilno kislino; 2) oksidacija acetilenske skupine, ki ji sledi hidroliza v arilkarboksilno kislino in 3) aromatska hidroksilacija fenilacetilenske skupine.
English: Hydroxypropyl cellulose (E463) Titanium dioxide (E171)
Slovenian: Obloga tablete hidroksipropilceluloza (E463) titanov dioksid (E171)
English: No survival advantage could be shown for patients with locally advanced disease.
Slovenian: Koristnega vpliva na podaljšanje preživetja niso dokazali za bolnike z lokalno napredovalo boleznijo.
English: In general, rash manifests as a mild or moderate erythematous and papulopustular rash, which may occur or worsen in sun exposed areas.
Slovenian: Na splošno se kožni izpuščaj kaže kot blag ali zmeren eritematozni in papulopustulozni izpuščaj, ki se lahko pojavi ali poslabša na delih, ki so izpostavljeni soncu.
English: Erlotinib has a mean apparent volume of distribution of 232 l and distributes into tumour tissue of humans.
Slovenian: Erlotinib ima srednji navidezni volumen porazdelitve 232 l in se porazdeljuje v tumorska tkiva pri ljudeh.
English: Other medicines and Tarceva
Slovenian: Druga zdravila in zdravilo Tarceva
English: Persistent and severe diarrhoea may lead to low blood potassium and impairment of your kidney function, particularly if you receive other chemotherapy treatments at the same time.
Slovenian: Dolgotrajna in huda driska lahko povzroči nizek kalij v krvi in motnje delovanja ledvic, še posebno, če sočasno prejemate drugo kemoterapijo.
English: If a plasma-based cfDNA test is used and the result is negative for activating mutations, perform a tissue test wherever possible due to the potential for false negative results from a plasma-based test.
Slovenian: Če uporabite test za plazemsko cfDNA in je rezultat za aktivirajoče mutacije negativen, zaradi možnih lažno negativnih rezultatov tega testa opravite tudi test tkiva, v kolikor je mogoče.
English: If a diagnosis of ulcerative keratitis is confirmed, treatment with Tarceva should be interrupted or discontinued.
Slovenian: V primeru, da je diagnoza ulcerativnega keratitisa potrjena, je treba zdravljenje z zdravilom Tarceva prekiniti ali ukiniti.
English: The degree of reduction is likely to be clinically significant (see sections 4.2, 4.5, 5.1 and 5.2).
Slovenian: Verjetno je, da je velikost zmanjšanja klinično pomembna (glejte poglavja 4.2, 4.5, 5.1 in 5.2).
English: CI of Δ HR
Slovenian: interval zaupanja Δ HR
English: It is not known whether erlotinib is excreted in human milk.
Slovenian: Ni znano, ali se erlotinib izloča v materino mleko.
English: This was evidenced by a hazard ratio for death of 0.82 (95% CI, 0.68 to 0.99) among patients whose best response was stable disease or progressive disease.
Slovenian: To je bilo dokazano z razmerjem ogroženosti za smrt 0,82 (95-% interval zaupanja: 0,68-0,99) pri bolnikih, pri katerih je bil najboljši odgovor stabilna bolezen ali napredovanje bolezni.
English: Therefore, the time to reach steady state plasma concentration would be expected to occur in approximately 7-8 days.
Slovenian: Čas do dosega plazemskih koncentracij v stanju dinamičnega ravnovesja bi bil po tej oceni približno 7 do 8 dni.
English: • Bleeding from the stomach or the intestines
Slovenian: • krvavitev iz želodca ali črevesja,