FrancophonIA/ELRC3.0 huggingface dataset:
English: Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly- le- roi Cedex France
Slovenian: Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly- le- roi Cedex, Francija
English: GOAL showed more patients treated with Viani achieved asthma control than patients treated with ICS alone and this control was attained at a lower corticosteroid dose.
Slovenian: Študija GOAL je pokazala, da je obvladanje simptomov astme doseglo več bolnikov, ki so dobivali Viani, kot bolnikov, ki so dobivali samo IKS (inhalacijski kortikosteroid) in da je bilo to obvladanje doseženo pri nižjih odmerkih kortikosteroida.
English: Well Controlled asthma was achieved more rapidly with Viani than with ICS alone.
Slovenian: Z zdravilom Viani je bila dobra nadzorovanost astme dosežena hitreje kot z inhalacijskim kortikosteroidom samim.
English: - patients already adequately controlled on both inhaled corticosteroid and long-acting beta
Slovenian: ali - pri bolnikih, ki so že ustrezno urejeni z inhalacijskima kortikosteroidom in dolgodelujočim agonistom beta-2.
English: Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-roi Cedex France
Slovenian: Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-roi Cedex, Francija
English: Children 4 to 12 years of age Viani 50/100 Diskus
Slovenian: Otroci v starosti od 4 do 12 let Viani 50/100 Diskus en vdih dvakrat na dan
English: Viani Diskus and associated names (see Annex I of Opinion) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β-agonist (LABA) salmeterol and the inhaled corticosteroid (ICS) fluticasone propionate (FP) indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate:patients not adequately controlled with inhaled corticosteroids and ‘as needed' inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and longacting beta-2-agonist.
Slovenian: Zdravilo Viani Diskus in z njim povezana imena (glejte Dodatek I Mnenja) vsebujejo salmeterol in flutikazon propionat, kombinacijo fiksnih odmerkov dolgo delujočega β-agonista (LABA) salmeterola in inhalacijskega kortikosteroida (ICS) flutikazon propionata (FP), indicirano za običajno zdravljenje astme, kjer je uporaba kombiniranega izdelka (dolgo delujočega β-agonista in inhalacijskega kortikosteroida) ustrezna: - pri bolnikih, pri katerih z inhalacijskimi kortikosteroidi in »po potrebi« z inhalacijskim kratko delujočim beta-2-agonistom ni mogoče doseči zadostnega nadzora bolezni, alipri bolnikih, pri katerih je bilo mogoče že z inhalacijskimi kortikosteroidi in dolgo delujočim beta-2agonistom vzpostaviti zadosten nadzor bolezni.
English: Angioedema (mainly facial and oropharyngeal oedema), Respiratory symptoms (dyspnoea and/or bronchospasm), Anaphylactic reactions
Slovenian: kožne preobčutljivostne reakcije angioedem (predvsem edem obraza in orofaringealni edem), dihalni simptomi (dispneja in/ali bronhospazem), anafilaktične reakcije občasno zelo redko
English: GlaxoSmithKline GmbH & Co KG Theresienhoehe 11
Slovenian: GlaxoSmithKline GmbH & Co KG, Theresienhoehe 11, D-80339 Muenchen
English: The time on treatment for 50% of subjects to achieve a first individual Well Controlled week was 16 days for Viani compared to 37 days for the ICS group.
Slovenian: Pri 50 % oseb je bil prvi posamezni teden z dobro nadzorovanostjo dosežen po 16 dneh zdravljenja z zdravilom Viani oziroma po 37 dneh zdravljenja z inhalacijskim kortikosteroidom.
English: Do not take Viani
Slovenian: Ne uporabljajte zdravila Viani
English: Your doctor will check you regularly for any of these side effects and to make sure you are taking the lowest dose of Viani to control your asthma.
Slovenian: Zdravnik vas bo redno kontroliral glede teh neželenih učinkov, tako da boste za obvladanje astme dobivali najmanjši odmerek zdravila Viani.
English: In the subset of steroid naive asthmatics the time to an individual Well Controlled week was 16 days in the Viani treatment compared to 23 days following treatment with ICS.
Slovenian: Pri podskupini bolnikov z astmo, ki se predhodno še niso zdravili s kortikosteriodi, je bil posamezni teden z dobro nadzorovanostjo dosežen po 16 dneh zdravljenja z zdravilom Viani oziroma po 23 dneh zdravljenja z inhalacijskim kortikosteroidom.
English: The possible side effects associated with Viani are unlikely to affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi možni neželeni učinki, povezani z jemanjem zdravila Viani, neugodno vplivali na vašo sposobnost upravljanja vozil in strojev.
English: United Kingdom Glaxo Wellcome UK Limited Stockley Park West, Uxbridge Middlesex UB11 1BT
Slovenian: Stockley Park West, Uxbridge, Middlesex UB11 1BT, Velika Britanija
English: Adults and adolescents 12 years and over Viani 50/100 Diskus
Slovenian: Odrasli in mladostniki, starejši od 12 let Viani 50/100 Diskus en vdih dvakrat na dan
English: 1 x Diskus 28 inhalations or 1, 2, 3 or 10 x Diskus each containing 60 inhalations Not all pack sizes may be marketed.
Slovenian: 1, 2, 3 ali 10 Diskusov, od katerem je v vsakem 60 vdihov
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET <[Izpolni država članica]>
English: Lactose monohydrate (which contains milk proteins).
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Laktoza monohidrat (ki vsebuje mlečne beljakovine).
English: - The active substance(s) are 50 micrograms salmeterol (as xinafoate) and 100, 250 or 500
Slovenian: Kaj vsebuje zdravilo Viani - Zdravilni učinkovini sta 50 mikrogramov salmeterola (kot ksinafoata) in 100, 250 ali 500
English: Very rarely side effects may occur if you have taken high doses of Viani for a long time and you stop or reduce your dose suddenly.
Slovenian: Če ste dolgo uporabljali velike odmerke zdravila Viani, pa ga nenadoma nehate uporabljati ali močno zmanjšate odmerek, se lahko v zelo redkih primerih pojavijo neželeni učinki.
English: Your doctor will supervise your treatment more closely if you have medical conditions such as heart disease including an irregular or fast heart beat, overactive thyroid gland, high blood pressure, diabetes mellitus (Viani may increase your blood sugar), low potassium in your blood or if you are being, or have been treated for tuberculosis (TB).
Slovenian: Bodite posebno pozorni pri uporabi zdravila Viani Zdravnik bo vaše zdravljenje spremljal natančneje, če imate kakšno zdravstveno težavo, npr. bolezen srca (vključno z nerednim ali hitrim srčnim utripom), čezmerno dejavno ščitnico, visok krvni tlak,
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM <[Glejte Dodatek I - Izpolni država članica]> 12.
English: PHARMACEUTICAL FORM AND CONTENTS Inhalation powder, pre-dispensed 1 x 28 inhalations
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Prašek za inhaliranje, odmerjen
English: Luxembourg GlaxoSmithKline s.a./n.v.
Slovenian: Luksemburg GlaxoSmithKline s.a./n.v., Rue du Tilleul 13,
English: Viani COPD clinical trials
Slovenian: Klinična preskušanja zdravila Viani pri KOPB
English: What Viani looks like and contents of the pack Inhalation powder, pre-dispensed.
Slovenian: Izgled zdravila Viani in vsebina pakiranja
English: Inhalation powder, predispensed
Slovenian: Prašek za inhaliranje, odmerjen.
English: A short term trial of Viani may be considered as initial maintenance therapy in patients adults or adolescents with moderate persistent asthma (defined as patients with daily symptoms, daily rescue use and moderate to severe airflow limitation) for whom rapid control of asthma is essential.
Slovenian: Pri bolnikih z zmerno, persistentno astmo (to je z vsakodnevnimi simptomi, vsakodnevno uporabo zdravila za olajšanje dihanja in zmerno do hudo obstrukcijo zračnega pretoka), za katere bi bilo bistveno hitro obvladanje astme, je mogoče poskusiti z uvodnim 12-tedenskim vzdrževalnim zdravljenjem z zdravilom Viani.
English: This may be either once at night if you have night-time symptoms or once in the morning if you have daytime symptoms.
Slovenian: To je lahko enkrat na dan zvečer, če imate simptome ponoči, ali enkrat na dan zjutraj, če imate simptome čez dan. Zelo pomembno je, da upoštevate zdravnikova navodila o številu potrebnih vdihov in pogostnosti uporabe zdravila.
English: It is important to take Viani as your doctor recommended.
Slovenian: Če ste vzeli večji odmerek zdravila Viani, kot bi smeli Važno je, da Viani uporabljate, kot vam je naročil zdravnik.
English: Viani 50/100 micrograms strength is not appropriate in adults and children with severe asthma; it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed combination can be used in patients with severe asthma.
Slovenian: Jakost zdravila Viani, 50/100 mikrogramov, ni primerna za odrasle in otroke s hudo astmo.
English: Viani Diskus and associated names (see Annex I) 50/250 microgram/dose inhalation powder, predispensed.
Slovenian: Viani Diskus in povezana imena (glejte Dodatek I) 50/250 mikrogramov/odmerek, prašek za inhaliranje, odmerjen.
English: HOW TO STORE VIANI
Slovenian: SHRANJEVANJE ZDRAVILA VIANI
English: Viani Diskus and associated names (see Annex I) 50/250 microgram/dose inhalation powder, predispensed [See Annex I - To be completed nationally]
Slovenian: Viani Diskus in povezana imena (Glejte Dodatek I) 50/250 mikrogramov/odmerek prašek za inhaliranje, odmerjen [Glejte Dodatek I - Izpolni država članica]
English: You should ask your doctor for advice before taking Viani whilst you are pregnant or breastfeeding.
Slovenian: Če ste noseči ali dojite, se pred uporabo zdravila Viani posvetujte z zdravnikom.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 50 micrograms of salmeterol (as xinafoate) and 100 micrograms of fluticasone propionate per actuation
Slovenian: v enem odmerku je 50 mikrogramov salmeterola (kot ksinafoat) in 100 mikrogramov flutikazonijevega propionata
English: Viani Diskus and associated names (see Annex I) 50/500 microgram/dose inhalation powder, predispensed.
Slovenian: Viani Diskus in povezana imena (glejte Dodatek I) 50/500 mikrogramov/odmerek, prašek za inhaliranje, odmerjen.
English: Viani Diskus and associated names (see Annex I) 50/500 microgram/dose inhalation powder, predispensed [See Annex I - To be completed nationally]
Slovenian: Viani Diskus in povezana imena (Glejte Dodatek I) 50/500 mikrogramov/odmerek prašek za inhaliranje, odmerjen [Glejte Dodatek I - Izpolni država članica]
English: Viani Diskus and associated names (see Annex I) 50/100 microgram/dose inhalation powder, predispensed.
Slovenian: Viani Diskus in povezana imena (glejte Dodatek I) 50/100 mikrogramov/odmerek, prašek za inhaliranje, odmerjen.
English: Viani Diskus and associated names (see Annex I) 50/100 microgram/dose inhalation powder, predispensed [See Annex I - To be completed nationally]
Slovenian: Viani Diskus in povezana imena (Glejte Dodatek I) 50/100 mikrogramov/odmerek prašek za inhaliranje, odmerjen [Glejte Dodatek I - Izpolni država članica]
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: 5.1 Farmakodinamične lastnosti
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 28 doses
Slovenian: 1 Diskus z 28 odmerki ali
English: These are the side effects reported by people taking Viani.
Slovenian: Bolniki, ki so uporabljali Viani, so navajali naslednje neželene učinke.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: [See Annex I - To be completed nationally] Manufacturer:
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec [Glejte Dodatek I - Izpolni država članica]
English: c Patients also have LVDr substitutions.
Slovenian: c Bolniki imajo tudi substitucije LVDr.
English: ATC code: J05AF10
Slovenian: oznaka ATC: J05AF10
English: All doses should be taken once daily orally (by mouth).
Slovenian: Vse odmerke je potrebno zaužiti enkrat dnevno (skozi usta).
English: Protein binding to human serum protein in vitro is ≈ 13%.
Slovenian: Vezava na humane serumske proteine in vitro je ≈ 13 %.
English: Clinical resistance in adults
Slovenian: Klinična odpornost pri odraslih
English: Your doctor may prescribe a lower dose for you or instruct you to take it less often than once a day.
Slovenian: V tem primeru vam zdravnik lahko predpiše manjši odmerek ali pa vam svetuje jemanje zdravila manj pogosto kot enkrat na dan.
English: common: increased transaminases
Slovenian: pogosti: povečane vrednosti transaminaz
English: Rare (at least 1 in 10,000 patients): severe allergic reaction.
Slovenian: Redki (pri več kot 1 od 10.000 bolnikov): huda alergijska reakcija.
English: Resistance in cell culture
Slovenian: Odpornost na celičnih kulturah
English: This medicinal product does not require any special storage conditions.
Slovenian: Za to zdravilo niso potrebna posebna navodila za shranjevanje.
English: Frequency is defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000).
Slovenian: Pogostnost je definirana kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000).
English: Gender and race: no dosage adjustment based on gender or race is required.
Slovenian: Spol in rasa: prilagajanje odmerka glede na spol ali raso ni potrebno.
English: 117 Allée des Parcs 69800 Saint Priest France
Slovenian: 117 Allée des Parcs 69800 Saint Priest Francija
English: The randomization was stratified by age group (2 to 6 years; >6 to 12 years; and >12 to <18 years).
Slovenian: Randomizacija je bila razslojena po starostnih skupinah (2 do 6 let, > 6 do 12 let in > 12 do < 18 let).
English: Diameter: approximately 6.8 mm.
Slovenian: Premer: približno 6,8 mm.
English: ALT normalisation (≤1 times ULN)
Slovenian: Normalizacija ALT (≤ 1 krat ULN)
English: *p<0.05 ULN=upper limit of normal, LLN=lower limit of normal.
Slovenian: * p<0,05 ULN=zgornja meja normalne vrednosti, LLN=spodnja meja normalne vrednosti.
English: if you have previously received treatment for chronic hepatitis B, please inform your doctor.
Slovenian: • če ste se predhodno že zdravili zaradi kroničnega hepatitisa B, o tem obvestite svojega zdravnika.
English: Duration of therapy for paediatric patients
Slovenian: Trajanje zdravljenja pri pediatričnih bolnikih
English: Results beyond 48 weeks of treatment
Slovenian: Rezultati zdravljenja, ki je trajalo nad 48 tednov
English: Treatment discontinuation may be considered as follows:
Slovenian: Pri prekinitvi zdravljenja je treba upoštevati naslednje:
English: Serious adverse events were generally liver-related, with an on-study cumulative frequency of 69%.
Slovenian: Resni neželeni učinki so bili običajno povezani z jetri, njihova kumulativna pogostnost med študijo pa je bila 69-odstotna.
English: The estimated volume of distribution for entecavir is in excess of total body water.
Slovenian: Ocenjeni volumen porazdelitve entekavirja je večji od skupne količine telesne tekočine.
English: HAART regimens did not include emtricitabine or tenofovir disoproxil fumarate.
Slovenian: HAART režim ni vključeval emtricitabina ali tenofovir dizoproksil fumarata.
English: Diameter: approximately 8.8 mm.
Slovenian: Premer: približno 8,8 mm.
English: e ETVr occurring in any year; virologic breakthrough in specified year.
Slovenian: e Pojav ETVr v kateremkoli letu; povečanje virusnega bremena v določenem letu.
English: The on-study cumulative rate of hepatocellular carcinoma (HCC) was 12% (12/102).
Slovenian: Kumulativni delež pojavnosti hepatocelularnega karcinoma (HCC) med študijo je znašal 12 % (12/102).
English: if you are also infected with HIV (human immunodeficiency virus) be sure to tell your doctor.
Slovenian: • če imate sočasno okužbo z virusom HIV (virusom humane imunske pomanjkljivosti), morate o tem obvestiti svojega zdravnika.
English: Patients in response were followed for an additional 24 weeks off-treatment.
Slovenian: Bolnike, pri katerih je bil dosežen odziv, so spremljali še dodatnih 24 tednov po zdravljenju.
English: This is important because Entecavir Mylan is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.
Slovenian: To je pomembno, ker se zdravilo Entekavir Mylan iz telesa izloča skozi ledvice in vam bo zdravnik morda moral odmerek ali odmerno shemo prilagoditi.
English: Age/gender
Slovenian: Starost/spol
English: Exacerbations after discontinuation of treatment
Slovenian: Poslabšanja po prekinitvi zdravljenja
English: Your child's doctor will decide the right dose based on your child's weight.
Slovenian: Otrokov zdravnik bo določil pravilen odmerek na osnovi telesne mase otroka.
English: Therefore, clinical and laboratory parameters should be closely monitored in this patient population (see also sections 4.8 and 5.1).
Slovenian: Pri tej skupini bolnikov je treba skrbno nadzirati klinične in laboratorijske parametre (glejte tudi poglavji 4.8 in 5.1).
English: After adjusting for differences in creatinine clearance and body weight, elderly subjects had a 12.5% higher AUC than young subjects.
Slovenian: Po prilagoditvi glede na razlike kreatininskega očistka in telesne mase so bile pri starostnikih vrednosti AUC za 12,5 % večje od vrednosti pri mlajših osebah.
English: There are no adequate data from the use of entecavir in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi entekavirja pri nosečnicah.
English: Entecavir Mylan reduces the amount of virus in your body, and improves the condition of the liver.
Slovenian: Zdravilo Entekavir Mylan zmanjša količino virusa v telesu in izboljša stanje jeter.
English: Do not take Entecavir Mylan if you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Entekavir Mylan • če ste alergični na entekavir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: A 4-hour period of haemodialysis removed ≈ 13% of the dose, and 0.3% was removed by CAPD.
Slovenian: Pri 4-urni hemodializi se je odstranilo ≈ 13 % odmerka, pri CAPD pa 0,3 %.
English: Co-infection with hepatitis C or D
Slovenian: Sočasna okužba z virusom hepatitisa C ali D
English: Baseline demographics and HBV disease characteristics were comparable between the 2 treatment arms and across age cohorts.
Slovenian: Demografske značilnosti in lastnosti HBV bolezni so bile v izhodišču med obema skupinama zdravljenja in starostnimi skupinami primerljive.
English: Patients should be advised that therapy with entecavir has not been proven to reduce the risk of transmission of HBV and therefore appropriate precautions should still be taken.
Slovenian: Bolnikom je treba pojasniti, da ni dokazov, da bi zdravljenje z entekavirjem zmanjšalo tveganje za prenos HBV na druge in da morajo zato še naprej skrbeti za ustrezne varnostne ukrepe.
English: d ≥1 log10 increase above nadir in HBV DNA by PCR, confirmed with successive measurements or at the end of the windowed time point.
Slovenian: d ≥ 1 log10 povečanje nad najnižjo vrednostjo HBV DNA, določene s PCR, potrjeno z zaporednimi meritvami ali ob koncu časovnega okvira.
English: • decompensated liver disease (see section 4.4)
Slovenian: • z dekompenzirano boleznijo jeter (glejte poglavje 4.4).
English: For patients who are not able to swallow tablets, or for whom a dose reduction is recommended, other entecavir-containing products with more suitable formulations may be available.
Slovenian: Za bolnike, ki ne morejo pogoltniti tablet ali za katere je priporočen zmanjšan odmerek, so morda na voljo druga zdravila, ki vsebujejo entekavir in so v primernejši farmacevtski obliki/jakosti.
English: Substitutions observed in clinical isolates (rtT184A, C, F, G, I, L, M or S; rtS202 C, G or I; and/or rtM250I, L or V) further decreased entecavir susceptibility 16- to 741-fold relative to wild-type virus.
Slovenian: Substitucije, ki so jih opazili pri kliničnih izolatih (rtT184A, C, F, G, I, L, M ali S; rtS202 C, G ali I; in/ali rtM250I, L ali V), v primerjavi z divjim tipom virusa še dodatno zmanjšajo občutljivost za entekavir za 16- do 741-krat.
English: The population pharmacokinetic analysis covering patients in the age range 16-75 years did not identify age as significantly influencing entecavir pharmacokinetics.
Slovenian: Analiza populacijske farmakokinetike pri bolnikih, starih od 16 do 75 let, ne kaže, da bi starost pomembneje vplivala na farmakokinetiko entekavirja.
English: For adults the recommended dose is either 0.5 mg or 1 mg once daily orally (by mouth).
Slovenian: Priporočeni odmerek za odrasle je 0,5 mg ali 1 mg enkrat na dan peroralno (skozi usta).
English: Take Entecavir Mylan as long as your doctor has told you.
Slovenian: Zdravilo Entekavir Mylan jemljite tako dolgo, kot vam je predpisal zdravnik.
English: This finding was not observed in repeat-dose studies in other species, including monkeys administered entecavir daily for 1 year at exposures ≥100 times those in humans.
Slovenian: Teh ugotovitev niso zasledili pri študijah s ponavljajočimi se odmerki pri drugih vrstah, vključno z opicami, ki so 1 leto prejemale entekavir dnevno in pri katerih je bila izpostavljenost ≥ 100-kratni izpostavljenosti človeka.
English: The demonstration of benefit is based on histological, virological, biochemical, and serological responses after 48 weeks of treatment in active-controlled clinical trials of 1,633 adults with chronic hepatitis B infection, evidence of viral replication and compensated liver disease.
Slovenian: Dokaz koristi temelji na histološkem, virološkem, biokemičnem in serološkem odzivu po 48tedenskem zdravljenju v aktivno nadzorovanih kliničnih preskušanjih pri 1.633 odraslih s kronično okužbo z virusom hepatitisa B, dokazi replikacije virusa in s kompenzirano boleznijo jeter.
English: <200 cells/mm3).
Slovenian: CD4 < 200 celic/mm3).
English: It is important that women of childbearing age receiving treatment with Entecavir Mylan use an effective method of contraception to avoid becoming pregnant.
Slovenian: Pomembno je, da ženske v rodni dobi med zdravljenjem z zdravilom Entekavir Mylan za preprečitev nosečnosti uporabljajo učinkovito metodo kontracepcije.
English: Entecavir is not a substrate, inhibitor or inducer of the CYP450 enzyme system.
Slovenian: Entekavir ni substrat, induktor ali zaviralec encimskega sistema CYP450.
English: If you miss a dose of Entecavir Mylan, take it as soon as possible, and then take your next scheduled dose at its regular time.
Slovenian: Pozabljeni odmerek zdravila Entekavir Mylan vzemite takoj, ko je to mogoče, naslednji odmerek pa nato vzemite ob običajnem času.
English: Some patients must take Entecavir Mylan on an empty stomach (see Entecavir Mylan with food and drink in Section 2).
Slovenian: Nekateri bolniki morajo jemati zdravilo Entekavir Mylan na prazen želodec (glejte Zdravilo Entekavir Mylan skupaj s hrano in pijačo v poglavju 2).
English: Study 038 included 67 HBeAg positive and 1 HBeAg negative patients co-infected with HIV.
Slovenian: V študijo 038 je bilo vključenih 67 HBeAg pozitivnih bolnikov in 1 HBeAg negativen bolnik.
English: Entecavir Mylan tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years.
Slovenian: Tablete Entekavir Mylan uporabljamo tudi za zdravljenje kronične (dolgotrajne) okužbe s HBV pri otrocih in mladostnikih, starih od 2 leti do manj kot 18 let.
English: For children and adolescents (from 2 to less than 18 years of age), your child's doctor will decide the right dose based on your child's weight.
Slovenian: Za otroke in mladostnike (stare od 2 leti do manj kot 18 let) bo pravilen odmerek določil zdravnik na osnovi telesne mase otroka.
English: In some cases, selection of HIV variant M184V has been observed, which has implications for the selection of HAART regimens that the patient may take in the future.
Slovenian: Pri nekaterih bolnikih so poročali o selekciji variante M184V virusa HIV, kar lahko vpliva na izbor režima HAART za prihodnje zdravljenje.