FrancophonIA/ELRC3.0 huggingface dataset:
English: A further study compared Arepanrix containing the pandemic flu strain H1N1 with Pandemrix H1N1 in 334 adults.
Slovenian: V nadaljnji študiji so primerjali zdravilo Arepanrix, ki vsebuje sev H1N1 pandemske gripe, z zdravilom Pandemrix H1N1 pri 334 odraslih.
English: The study comparing Arepanrix H1N1 with Pandemrix H1N1 showed that one dose was able to trigger immunity to a satisfactory level.
Slovenian: Študija, v kateri so primerjali zdravilo Arepanrix H1N1 z zdravilom Pandemrix H1N1, je pokazala, da je enkratni odmerek zagotovil zadostno raven imunosti.
English: The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Slovenian: Ob ponovni izpostavitvi virusu bo imunski sistem sposoben hitreje tvoriti protitelesa.
English: For the full list of all side effects reported with Arepanrix, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Arepanrix, glejte navodilo za uporabo.
English: Arepanrix is a vaccine.
Slovenian: Zdravilo Arepanrix je cepivo.
English: What information is still awaited for Arepanrix?
Slovenian: Katere informacije o zdravilu Arepanrix še pričakujemo?
English: Arepanrix is a vaccine to protect against ‘pandemic' flu.
Slovenian: Zdravilo Arepanrix je cepivo proti „pandemski“ gripi.
English: What is the risk associated with Arepanrix?
Slovenian: Kakšna tveganja so povezana z zdravilom Arepanrix?
English: Why has Arepanrix been approved?
Slovenian: Zakaj je bilo zdravilo Arepanrix odobreno?
English: The same level of protection was obtained with Arepanrix as with Pandemrix.
Slovenian: Zdravili Arepanrix in Pandemrix sta vzpostavili enako raven zaščite.
English: Both contain the same adjuvant, In Arepanrix, a different method is used to prepare the haemagglutinins used in the vaccine.
Slovenian: Pri zdravilu Arepanrix se za pripravo hemaglutininov v cepivu uporablja drugačna metoda.
English: Arepanrix is a vaccine that is given by injection.
Slovenian: Arepanrix je cepivo za injiciranje.
English: The full EPAR for Arepanrix can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Arepanrix je na voljo tukaj.
English: What is Arepanrix used for?
Slovenian: Za kaj se zdravilo Arepanrix uporablja?
English: How has Arepanrix been studied?
Slovenian: Kako je bilo zdravilo Arepanrix raziskano?
English: How does Arepanrix work?
Slovenian: Kako zdravilo Arepanrix deluje?
English: What is Arepanrix?
Slovenian: Kaj je zdravilo Arepanrix?
English: How is Arepanrix used?
Slovenian: Kako se zdravilo Arepanrix uporablja?
English: This summary was last updated in July-2015.
Slovenian: Povzetek je bil nazadnje posodobljen julija 2015.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom day.
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Pregabalin Zentiva is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Pregabalin Zentiva je na voljo v obliki kapsul (25, 50, 75, 100, 150, 200, 225 in 300 mg) in se izdaja le na recept.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Zentiva on 17 July 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Pregabalin Zentiva, veljavno po vsej Evropski uniji, izdala 17. julija 2015.
English: The full EPAR and risk management plan summary for Pregabalin Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Pregabalin Zentiva sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Pregabalin Zentiva?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pregabalin Zentiva?
English: Pregabalin Zentiva is a medicine used to treat adults with the following conditions:
Slovenian: Pregabalin Zentiva je zdravilo, ki se uporablja za zdravljenje odraslih z naslednjimi boleznimi:
English: The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Slovenian: Natančno delovanje pregabalina ni popolnoma jasno, vendar pa naj bi vplival na način vstopanja kalcija v živčne celice.
English: This means that Pregabalin Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Lyrica.
English: What are the benefits and risks of Pregabalin Zentiva?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Pregabalin Zentiva?
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Zentiva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pregabalin Zentiva.
English: A risk management plan has been developed to ensure that Pregabalin Zentiva is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Pregabalin Zentiva je bil pripravljen načrt obvladovanja tveganj.
English: The Committee recommended that Pregabalin Zentiva be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Pregabalin Zentiva odobri za uporabo v EU.
English: The active substance in Pregabalin Zentiva, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Slovenian: Zdravilna učinkovina v zdravilu Pregabalin Zentiva, pregabalin, ima podobno strukturo kot telesu lastni živčni prenašalec („nevrotransmitor“) gama-aminomaslena kislina (GABA), vendar pa ima bistveno drugačne biološke učinke.
English: Because Pregabalin Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Pregabalin Zentiva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Zentiva has been shown to have comparable quality and to be bioequivalent to Lyrica.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pregabalin Zentiva primerljivo raven kakovosti kot zdravilo Lyrica ter da mu je biološko enakovredno.
English: What is Pregabalin Zentiva and what is it used for?
Slovenian: Kaj je zdravilo Pregabalin Zentiva in za kaj se uporablja?
English: For more information about treatment with Pregabalin Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Pregabalin Zentiva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Pregabalin Zentiva is a ‘generic medicine'.
Slovenian: Zdravilo Pregabalin Zentiva je „generično zdravilo“.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pregabalin Zentiva, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Stopping treatment with Pregabalin Zentiva should also be done gradually, over at least a week.
Slovenian: Največji odmerek je 600 mg na dan. Tudi prenehanje zdravljenja z zdravilom Pregabalin Zentiva mora potekati postopno in mora trajati najmanj en teden.
English: Other information about Pregabalin Zentiva
Slovenian: Druge informacije o zdravilu Pregabalin Zentiva
English: It is not intended to provide practical advice on how to use Pregabalin Zentiva.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: For practical information about using Pregabalin Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Pregabalin Zentiva naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: • epilepsy, where it is used as an ‘add-on' to existing treatment in patients who have partial seizures
Slovenian: • epilepsijo, pri čemer se uporablja kot „dodatek“ obstoječemu zdravljenju pri bolnikih s parcialnimi napadi (epileptičnimi napadi, ki izvirajo iz določenega dela možganov), ki jih ni mogoče nadzorovati s trenutnim zdravljenjem;
English: Because Pregabalin Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Lyrica.
Slovenian: Ker je zdravilo Pregabalin Zentiva generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Lyrica.
English: Why is Pregabalin Zentiva approved?
Slovenian: Zakaj je bilo zdravilo Pregabalin Zentiva odobreno?
English: How has Pregabalin Zentiva been studied?
Slovenian: Kako je bilo zdravilo Pregabalin Zentiva raziskano?
English: How is Pregabalin Zentiva used?
Slovenian: Kako se zdravilo Pregabalin Zentiva uporablja?
English: Pregabalin Zentiva contains the active substance pregabalin.
Slovenian: Zdravilo Pregabalin Zentiva vsebuje zdravilno učinkovino pregabalin.
English: How does Pregabalin Zentiva work?
Slovenian: Kako zdravilo Pregabalin Zentiva deluje?
English: CONCLUSIONS ON <SIMILARITY AND DEROGATION> <AND> < THE REQUEST FOR ONE-YEAR <MARKETING PROTECTION> <DATA EXCLUSIVITY>> PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Slovenian: SKLEPNE UGOTOVITVE O <PODOBNOSTI> <IN> <ODSTOPANJU> <IN> <ZAHTEVKU ZA ENOLETNO <TRŽNO ZAŠČITO> <EKSKLUZIVNOST PODATKOV>>, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: <the applicant could establish in the application that the medicinal product, although similar to <authorised orphan medicinal product>, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication>.
Slovenian: <predlagatelj je v svoji vlogi lahko utemeljil, da je zdravilo, čeprav je podobno <odobrenemu zdravilu siroti,>, varnejše, učinkovitejše ali kako drugače klinično boljše (kot je opredeljeno v členu 3 Uredbe Komisije (ES) št. 847/2000) za isto terapevtsko indikacijo>; <in>
English: [Art 74(a)- legal status switch]<Furthermore, the CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 74(a) of Directive 2001/83/EC, and considers that the data submitted in support of the classification of {specify medicinal product name} as ‘medicinal product not subject to medical prescription' were significant as further explained in the European Public Assessment Report.>
Slovenian: [Art 74(a)- legal status switch] <Odbor za zdravila za uporabo v humani medicini (CHMP) je prav tako pregledal podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, pri čemer je upošteval določbe iz člena 74(a) Direktive 2001/83/ES), in meni, da so bili podatki, posredovani v podporo razvrstitvi zdravila {navedite ime zdravila} kot „zdravila, ki se izdaja brez recepta“ pomembni, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.
English: Patients should be closely monitored.
Slovenian: Bolnike je treba skrbno spremljati.
English: This change may have led to the development of melanoma.
Slovenian: Ta sprememba je morda povzročila nastanek vašega melanoma.
English: On average, 94% of the dose was recovered within 17 days.
Slovenian: V povprečju se je v 17 dneh pojavilo 94 % odmerka.
English: Efficacy results are summarized in Table 5.
Slovenian: Rezultati o učinkovitosti so povzeti v preglednici 5.
English: The majority of events were Grade 1 or 2 and non-serious.
Slovenian: Večina dogodkov je bila stopnje 1 ali 2 in niso bili resni.
English: Continue at current dose
Slovenian: Nadaljujte s trenutnim odmerkom
English: Study NO25395 (BRIM7)
Slovenian: Študija NO25395 (BRIM7)
English: Grade (CTC-AE)*
Slovenian: Stopnja (CTC-AE)*
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1048/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1048/001
English: · Take the tablets every day for 21 days (called a “treatment period”).
Slovenian: • Tablete jemljite vsak dan 21 dni (to imenujemo "obdobje zdravljenja").
English: Grade 4:
Slovenian: Stopnja 4:
English: Once the dose has been reduced, it should not be increased at a later time.
Slovenian: Ko je bil odmerek enkrat zmanjšan, se ga kasneje ne sme več povečati.
English: No dose reduction.
Slovenian: Brez zmanjšanja odmerka.
English: Symptomatic regardless of LVEF Permanent discontinuation
Slovenian: Simptomatski ne glede na LVEF Trajno prenehanje
English: They can be taken with or without food.
Slovenian: Lahko se jemljejo skupaj s hrano ali brez nje.
English: Cotellic is not recommended for children and adolescents.
Slovenian: Zdravilo Cotellic ni priporočljivo za otroke in mladostnike.
English: Before starting treatment, your doctor will test for this mutation.
Slovenian: Pred začetkom zdravljenja vam bo zdravnik opravil test za to mutacijo.
English: If doses are omitted for toxicity, these doses should not be replaced.
Slovenian: Če so odmerki izpuščeni zaradi toksičnosti, se teh odmerkov ne sme nadomeščati.
English: Mortality occurred in juvenile animals at a dose (3 mg/kg) which did not lead to mortalities in adult animals.
Slovenian: Umrljivost se je pri mladih podganah pojavila ob odmerku (3 mg/kg), ki ni povzročil umrljivosti odraslih živali.
English: The difference in ORR was 22.9 % (p-value<0.0001).
Slovenian: Razlika v ORR je bila 22,9 % (vrednost p < 0,0001).
English: Your doctor will discuss with you the benefits and risks of taking Cotellic, if you are breast-feeding.
Slovenian: Zdravnik se bo z vami pogovoril o koristih in tveganjih jemanja zdravila Cotellic, če dojite.
English: Patients with ECOG performance status 2 or higher were excluded from the study.
Slovenian: Bolniki s stanjem zmogljivosti po ECOG 2 ali več so bili iz študije izključeni.
English: Follow your doctor's instructions for what to do to help prevent or treat diarrhoea.
Slovenian: Upoštevajte zdravnikova navodila, kako ukrepati, da boste pomagali preprečiti ali zdraviti drisko.
English: These data show that the efficacy of the combination will be lower in these patients (see section 5.1).
Slovenian: Ti podatki kažejo, da je učinkovitost kombinacije pri teh bolnikih manjša (glejte poglavje 5.1).
English: The effects of Cotellic in people younger than 18 years old are not known.
Slovenian: Učinki zdravila Cotellic pri osebah, mlajših od 18 let, niso znani.
English: Transparent PVC/PVDC blisters containing 21 tablets.
Slovenian: Prosojni pretisni omoti iz PVC/PVDC, ki vsebujejo 21 tablet.
English: The magnitude of interaction could potentially be lower in patients.
Slovenian: Izrazitost medsebojnega delovanja je pri bolnikih morda lahko manjša.
English: Cotellic is taken on a 28 day cycle.
Slovenian: Zdravilo Cotellic je treba uporabljati v 28-dnevnem ciklu.
English: Interrupt treatment for 4 weeks
Slovenian: Prekinite zdravljenje za 4 tedne
English: Continue to take Cotellic as normal, the next day.
Slovenian: Nadaljujte z jemanjem zdravila Cotellic kot običajno, naslednji dan.
English: Ask your doctor about the best contraception for you.
Slovenian: Z zdravnikom se pogovorite o tem, katera kontracepcija je najprimernejša za vas.
English: This is available without prescription.
Slovenian: Na voljo je brez recepta.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Učinki drugih zdravil na kobimetinib
English: Take the medicine package and this leaflet with you.
Slovenian: S seboj vzemite pakiranje zdravila in to navodilo.
English: Talc (E553b)
Slovenian: Smukec (E553b)
English: · After the 21 days, do not take any Cotellic tablets for 7 days.
Slovenian: • Po 21 dneh naslednjih 7 dni ne vzemite nobene tablete zdravila Cotellic.
English: LVEF value following treatment break
Slovenian: Vrednost LVEF po prekinitvi zdravljenja
English: Interrupt treatment for 2 weeks
Slovenian: Prekinite zdravljenje za 2 tedna
English: · Do not throw away any medicines via wastewater or household waste.
Slovenian: • Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: Your doctor will do blood tests to check these amounts and monitor how well your liver is working.
Slovenian: Zdravnik bo opravil preiskave krvi, da bo preveril raven teh encimov in da bo spremljal, kako dobro vam delujejo jetra.
English: The decision on whether to reduce the dose for either or both treatments should be based on the prescriber's assessment of individual patient safety or tolerability.
Slovenian: Odločitev za zmanjšanje odmerka enega ali obeh zdravil mora temeljiti na zdravnikovi oceni varnosti in prenašanja pri posameznem bolniku.
English: There were no apparent trends in the time of onset of Grade ≥3 events.
Slovenian: Glede časa do pojava dogodkov stopnje ≥ 3 ni bilo opaznih trendov.
English: Avoid driving or using machines if you have problems with your vision or other problems that might affect your ability e.g. if you feel dizzy or tired.
Slovenian: Ne upravljajte vozil ali strojev, če imate težave z vidom ali druge težave, ki lahko vplivajo na vaše sposobnosti, npr. če ste omotični ali utrujeni.
English: · It is used in combination with another anti-cancer medicine called vemurafenib.
Slovenian: • Uporablja se v kombinaciji z drugim zdravilom proti raku, imenovanim vemurafenib.
English: Study GO28141 (coBRIM)
Slovenian: Študija GO28141 (coBRIM)
English: Severe diarrhoea can cause loss of body fluid (dehydration).
Slovenian: Huda driska lahko povzroči izgubljanje tekočine iz telesa (dehidracijo).
English: Cotellic should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the foetus.
Slovenian: Zdravila Cotellic se med nosečnostjo ne sme uporabljati, razen če je nujno potrebno in po skrbnem pretehtanju potreb matere in tveganja za plod.
English: Fatigue was observed at similar frequencies in both arms.
Slovenian: Utrujenost je bila v obeh skupinah podobno pogosta.
English: Global health status / health-related quality of life by patient-report were measured using the EORTC Quality of Life Questionnaire - Core 30 (QLQ-C30).
Slovenian: Splošno zdravstveno stanje/kakovost življenja, povezano z zdravjem, po navedbi bolnika so merili z vprašalnikom EORTC QLQ-C30 (Quality of Life Questionnaire - Core 30).
English: · It is not known if Cotellic passes into breast milk.
Slovenian: • Ni znano, ali zdravilo Cotellic prehaja v materino mleko.
English: Patients with a baseline LVEF either below institutional lower limit of normal (LLN) or below 50% have not been studied.
Slovenian: Bolnikov z izhodiščnim LVEF pod spodnjo mejo normalne vrednosti (SMN) za ustanovo ali pod 50 % niso proučevali.
English: Please refer to the vemurafenib SmPC for complete descriptions of all undesirable effects associated with vemurafenib treatment.
Slovenian: Prosimo, glejte povzetek glavnih značilnosti vemurafeniba za popoln opis vseh neželenih učinkov, povezanih z zdravljenjem z vemurafenibom.
English: Some of these eye problems may be a result of “serous retinopathy” (a build-up of fluid under the retina in the eye).
Slovenian: Nekatere od teh težav z očmi so lahko posledica "serozne retinopatije" (kopičenja tekočine pod očesno mrežnico).
English: Each pack contains 63 tablets.
Slovenian: Eno pakiranje vsebuje 63 tablet.
English: The BRAFi-naïve patients (n=63) attained an 87% objective response rate, including a complete response in 16% of patients.
Slovenian: Bolniki, predhodno še nezdravljeni z BRAFi (n = 63), so dosegli 87-% delež objektivnega odziva, vključno s popolnim odzivom pri 16 % bolnikov.
English: The median duration of response was 6.8 months.
Slovenian: Mediana trajanja odziva je bila 6,8 meseca.
English: Increased GGT
Slovenian: Zvišanje GGT
English: Cotellic is used to treat adult patients with a type of skin cancer called melanoma, that has spread to other parts of the body or cannot be removed by surgery.
Slovenian: Zdravilo Cotellic uporabljamo za zdravljenje odraslih bolnikov s posebno vrsto kožnega raka, imenovanega melanom, ki se je razširil v druge dele telesa ali ga ni mogoče odstraniti z operacijo.
English: Patients should be advised not to drive or use machines if they experience visual disturbances or any other adverse effects that may affect their ability.
Slovenian: Bolnikom je treba naročiti, naj ne upravljajo vozil ali strojev, če se jim pojavijo motnje vida ali kakršni koli drugi neželeni učinki, ki lahko vplivajo na to sposobnost.
English: PHARMACEUTICAL FORM AND CONTENTS 63 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 63 filmsko obloženih tablet
English: · It can only be used in patients whose cancer has a change (mutation) in a protein called “BRAF”.
Slovenian: • Uporabljati ga je mogoče le pri bolnikih, katerih rak ima spremembo (mutacijo) v beljakovini,
English: Treatment with Cotellic should continue until the patient no longer derives benefit or until the development of unacceptable toxicity (see Table 1 below).
Slovenian: Zdravljenje z zdravilom Cotellic je treba nadaljevati, dokler bolniku ne koristi več oziroma do pojava nesprejemljive toksičnosti (glejte preglednico 1 spodaj).
English: The intracranial activity of cobimetinib is currently unknown (see sections 5.1 and 5.2).
Slovenian: Intrakranialna aktivnost kobimetiniba trenutno ni poznana (glejte poglavji 5.1 in 5.2).
English: The safety and efficacy of Cotellic in children and adolescents below 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Cotellic pri otrocih in mladostnikih, mlajših od 18 let, nista ugotovljeni.
English: Caution should be used in patients with additional risk factors for bleeding, such as brain metastases, and/or in patients that use concomitant medications that increase the risk of bleeding (including antiplatelet or anticoagulant therapy).
Slovenian: Previdnost je potrebna pri bolnikih z dodatnimi dejavniki tveganja za krvavitve, kot so zasevki v možganih, in/ali pri bolnikih s sočasnimi zdravili, ki povečajo tveganje za krvavitve (vključno z antitrombotično ali antikoagulantno terapijo).
English: One pack size is available: 63 tablets (3 blisters of 21 tablets).
Slovenian: Na voljo je ena velikost pakiranja: 63 tablet (3 pretisni omoti po 21 tablet).
English: A decision should be made whether to discontinue breast-feeding or discontinue Cotellic therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja z zdravilom Cotellic, z upoštevanjem koristi dojenja za otroka in koristi zdravljenja za žensko.
English: However, sensitivity analysis suggests neither of these covariates had clinically significant impact on steady state exposure.
Slovenian: Vendar analiza občutljivosti ne kaže, da bi katera od teh dveh sospremenljivk klinično pomembno vplivala na izpostavljenost v stanju dinamičnega ravnovesja.
English: The primary analysis for Study GO28141 was conducted with a data cut-off date of 09 May 2014.
Slovenian: Primarna analiza za študijo GO28141 je bila izvedena s podatki s presečnim datumom 9. maj 2014.