FrancophonIA/ELRC3.0 huggingface dataset:
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan can reduce the amount of itraconazole or posaconazole in your blood.
Slovenian: Zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan lahko zniža količino itrakonazola ali pozakonazola v krvi.
English: Itraconazole/Tenofovir disoproxil
Slovenian: Itrakonazol/dizoproksiltenofovirat
English: Efavirenz/emtricitabine/tenofovir disoproxil and sofosbuvir can be coadministered without dose adjustment.
Slovenian: Efavirenz/emtricitabin/dizoproksi ltenofovirat in sofosbuvir se lahko daje sočasno in prilagoditev odmerka ni potrebna.
English: + Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Slovenian: + Efavirenz/emtricitabin/dizoproksilten ofovirat (600 mg/200 mg/245 mg q.d.)
English: Efavirenz/emtricitabine/tenofovir disoproxil should be administered with caution to patients with mild hepatic impairment (see sections 4.3 and 4.4).
Slovenian: Pri bolnikih z blago jetrno okvaro je treba efavirenz/emtricitabin/dizoproksiltenofovirat uporabljati previdno (glejte poglavji 4.3 and 4.4).
English: CARTON AND LABEL (BOTTLE)
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA IN NALEPKA (PLASTENKA)
English: Sertraline/Tenofovir disoproxil
Slovenian: Sertralin/dizoproksiltenofovirat
English: Paroxetine/Emtricitabine
Slovenian: Paroksetin/emtricitabin
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan should be administered with caution to elderly patients (see section 4.4).
Slovenian: Pri starejših bolnikih je treba zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan dajati previdno (glejte poglavje 4.4).
English: Paroxetine/Efavirenz (20 mg q.d./600 mg q.d.)
Slovenian: Paroksetin/efavirenz (20 mg q.d./ 600 mg q.d.)
English: Close monitoring of immunosuppressant concentrations for at least two weeks (until stable concentrations are reached) is recommended when starting or stopping treatment with efavirenz/emtricitabine/tenofovir disoproxil.
Slovenian: Pri uvedbi ali prekinitvi zdravljenja z efavirenzom/emtricitabinom/dizo proksiltenofoviratom je priporočljivo skrbno spremljanje koncentracij imunosupresiva najmanj dva tedna (dokler niso dosežene stabilne koncentracije).
English: Simvastatin/Tenofovir disoproxil
Slovenian: Simvastatin/dizoproksiltenofovirat
English: Your doctor may require you to take a pregnancy test to ensure you are not pregnant before starting treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
Slovenian: Zdravnik bo morda zahteval, da pred začetkom zdravljenja z zdravilom Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan, opravite test nosečnosti, da se prepriča, da niste noseči.
English: Efavirenz/emtricitabine/tenofovir disoproxil was administered on an empty stomach (see section 4.2).
Slovenian: Efavirenz/emtricitabin/dizoproksiltenofovirat so bolniki jemali na tešče (glejte poglavje 4.2).
English: Valproic acid/Efavirenz (250 mg b.i.d./600 mg q.d.)
Slovenian: Valprojska kislina/efavirenz (250 mg b.i.d./ 600 mg q.d.)
English: Didanosine/Tenofovir disoproxil
Slovenian: Didanozin/dizoproksiltenofovirat
English: Methadone: AUC: ↔ Cmax: ↔ Cmin: ↔ Tenofovir: AUC: ↔ Cmax: ↔ Cmin: ↔
Slovenian: AUC: ↔ Cmax: ↔ Cmin: ↔ Tenofovir: AUC: ↔ Cmax: ↔ Cmin: ↔
English: Hydroxyitraconazole: AUC: ↓ 37% (↓ 14 to ↓ 55) Cmax: ↓ 35% (↓ 12 to ↓ 52) Cmin: ↓ 43% (↓ 18 to ↓ 60) Efavirenz:
Slovenian: AUC: ↓ 37 % (↓ 14 do ↓ 55) Cmax: ↓ 35 % (↓ 12 do ↓ 52) Cmin: ↓ 43 % (↓ 18 do ↓ 60) Efavirenz:
English: Monitoring of renal function is recommended for patients receiving efavirenz/emtricitabine/tenofovir disoproxil (see section 4.4).
Slovenian: Pri bolnikih, ki prejemajo efavirenz/emtricitabin/dizoproksiltenofovirat, je priporočljivo nadziranje ledvične funkcije (glejte poglavje 4.4).
English: Fluoxetine/Emtricitabine
Slovenian: Fluoksetin/emtricitabin
English: Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Slovenian: Efavirenz/emtricitabin/dizoproksilten ofovirat (600 mg/200 mg/245 mg q.d.)
English: Saquinavir/ritonavir/Tenofovir disoproxil
Slovenian: Sakvinavir/ritonavir/dizoproksiltenof ovirat
English: Efavirenz/emtricitabine/tenofovir disoproxil and fosamprenavir/ritonavir can be coadministered without dose adjustment.
Slovenian: Efavirenz/emtricitabin/dizoproksi ltenofovirat in fosamprenavir/ritonavir se lahko daje sočasno in prilagoditev odmerka ni potrebna.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as maleate).
Slovenian: Ena filmsko obložena tableta vsebuje 600 mg efavirenza, 200 mg emtricitabina in 245 mg dizoproksiltenofovirata (v obliki maleata).
English: Atorvastatin/Tenofovir disoproxil
Slovenian: Atorvastatin/dizoproksiltenofovirat
English: How to take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Slovenian: Kako jemati zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan
English: Your doctor may need to consider giving you a different antifungal.
Slovenian: Zdravnik vam bo morda moral predpisati drug antimikotik.
English: * When compared to atazanavir 300 mg/ritonavir 100 mg q.d.
Slovenian: 300 mg/ritonavirja 100 mg q.d.
English: As a fixed combination, efavirenz/emtricitabine/tenofovir disoproxil should not be administered concomitantly with other medicinal products containing the components, emtricitabine or tenofovir disoproxil.
Slovenian: Efavirenz/emtricitabin/dizoproksiltenofovirat se kot fiksna kombinacija odmerkov ne sme uporabljati sočasno z drugimi zdravili, ki vsebujejo učinkovini emtricitabin ali dizoproksiltenofovirat.
English: carbamazepine has not been studied.
Slovenian: Karbamazepin/dizoproksiltenofovirat Medsebojnega delovanja niso preučevali.
English: Voriconazole/Tenofovir disoproxil
Slovenian: Vorikonazol/dizoproksiltenofovirat
English: Effects on drug levels
Slovenian: Učinki na koncentracije učinkovin
English: If your doctor decides to stop one of the components of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, you may be given efavirenz, emtricitabine and/or tenofovir disoproxil separately or with other medicines for the treatment of your HIV infection.
Slovenian: Če se zdravnik odloči za prenehanje zdravljenja z eno od učinkovin zdravila Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan, vam bo morda predpisal učinkovino efavirenz,
English: Valproic acid/Tenofovir disoproxil
Slovenian: Valprojska kislina/dizoproksiltenofovirat
English: Atazanavir/ritonavir/Emtricitabine
Slovenian: Sakvinavir/ritonavir/emtricitabin
English: of antimalarial efficacy, caution is recommended when efavirenz/emtricitabine/tenofovir disoproxil and artemether/lumefantrine tablets are co-administered.
Slovenian: Ker lahko zmanjšane koncentracije artemetra, dihidroartemizinina ali lumefantrina povzročijo zmanjšanje učinkovitosti proti malariji, je potrebna previdnost pri sočasnem dajanju efavirenza/emtricitabina/dizoprok siltenofovirata in tablet artemetra/lumefantrina.
English: Efavirenz/emtricitabine/tenofovir disoproxil and valproic acid can be co-administered without dose adjustment.
Slovenian: Efavirenz/emtricitabin/dizoproksi ltenofovirat in valprojsko kislino se lahko daje sočasno in prilagoditev odmerka ni potrebna.
English: Antimycobacterials Rifabutin/Efavirenz (300 mg q.d./600 mg q.d.)
Slovenian: Zdravila za zdravljenje okužb z mikobakterijami Rifabutin/efavirenz (300 mg q.d./ 600 mg q.d.)
English: Ritonavir/Tenofovir disoproxil
Slovenian: Ritonavir/dizoproksiltenofovirat
English: Bupropion/Tenofovir disoproxil
Slovenian: Bupropion/dizoproksiltenofovirat
English: Efavirenz/emtricitabine/tenofovir disoproxil and rosuvastatin can be coadministered without dose adjustment.
Slovenian: Efavirenz/emtricitabin/dizoproksi ltenofovirat in rosuvastatin se lahko daje sočasno in prilagoditev odmerka ni potrebna.
English: Do not breast-feed during treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
Slovenian: Med zdravljenjem z zdravilom Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan ne smete dojiti.
English: AUC: ↑ 21% (↑ 10 to ↑ 34) Cmax: ↑ 14% (↑ 4 to ↑ 26) Cmin: ↑ 25% (↑ 7 to ↑ 46) (inhibition of CYP-mediated oxidative metabolism) When efavirenz was given with ritonavir 500 mg or 600 mg twice daily, the combination was not well tolerated (for example, dizziness, nausea, paraesthesia and elevated liver enzymes occurred).
Slovenian: AUC: ↑ 21 % (↑ 10 do ↑ 34) Cmax: ↑ 14 % (↑ 4 do ↑ 26) Cmin: ↑ 25 % (↑ 7 do ↑ 46) (zaviranje oksidativne presnove, pri katerem posreduje encim CYP)
English: Artemether/Lumefantrine/Tenofovir disoproxil
Slovenian: Artemeter/lumefantrin/dizoproksilten ofovirat
English: No dose recommendation can be made for the use of efavirenz/emtricitabine/tenofovir disoproxil with carbamazepine.
Slovenian: Za kombinacijo efavirenza/emtricitabina/dizoprok siltenofovirata in karbamazepina ni mogoče dati priporočila za odmerjanje.
English: Efavirenz/emtricitabine/tenofovir disoproxil and raltegravir can be coadministered without dose adjustment.
Slovenian: Efavirenz/emtricitabin/dizoproksi ltenofovirat in raltegravir se lahko uporabljata sočasno in prilagoditev odmerka ni potrebna.
English: Women should not get pregnant during treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan and for 12 weeks thereafter.
Slovenian: Ženske med jemanjem in 12 tednov po prenehanju jemanja zdravila Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan ne smejo zanositi.
English: K65R
Slovenian: Antagonist CCR5
English: AUC0-last
Slovenian: Antimikotiki
English: Co-administration of atazanavir/ritonavir and efavirenz/emtricitabine/tenofovir disoproxil is not recommended.
Slovenian: Sočasne uporabe atazanavirja/ritonavirja in efavirenza/emtricitabina/dizoprok siltenofovirata ne priporočamo.
English: Efavirenz/emtricitabine/tenofovir disoproxil and fluoxetine can be coadministered without dose adjustment.
Slovenian: Efavirenz/emtricitabin/dizoproksi ltenofovirat in fluoksetin se lahko daje sočasno in prilagoditev odmerka ni potrebna.
English: Paroxetine/Tenofovir disoproxil
Slovenian: Paroksetin/dizoproksiltenofovirat
English: Indinavir: AUC: ↔ Cmax: ↔ Tenofovir: AUC: ↔ Cmax: ↔
Slovenian: AUC: ↔ Cmax: ↔ Tenofovir: AUC: ↔ Cmax: ↔
English: Efavirenz/emtricitabine/tenofovir disoproxil and paroxetine can be coadministered without dose adjustment.
Slovenian: Efavirenz/emtricitabin/dizoproksi ltenofovirat in paroksetin se lahko daje sočasno in prilagoditev odmerka ni potrebna.
English: M=Failure 181/203 (89.2%)
Slovenian: PVR (KM) M = izključeno 181/181 (100 %) M = neuspeh 181/203 (89,2 %) PVR (KM): čisti virološki odziv, ocenjen po metodi Kaplan Meier (KM).
English: • decreases in potassium in the blood
Slovenian: • znižanje ravni kalija v krvi;
English: DMPA/Tenofovir disoproxil
Slovenian: DMPA/dizoproksiltenofovirat
English: DATE OF REVISION OF THE TEXT
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA {DD. mesec LLLL}
English: Dosage adjustments of atorvastatin may be required when co-administered with efavirenz/emtricitabine/tenofovir disoproxil (refer to the Summary of Product Characteristics for atorvastatin).
Slovenian: Pri sočasnem dajanju atorvastatina z efavirenzom/emtricitabinom/dizo proksiltenofoviratom je treba odmerek atorvastatina prilagoditi (glejte Povzetek glavnih značilnosti zdravila za atorvastatin).
English: Pregnancy should be avoided in women receiving efavirenz/emtricitabine/tenofovir disoproxil.
Slovenian: Ženske, ki prejemajo efavirenz/emtricitabin/dizoproksiltenofovirat, naj ne zanosijo.
English: Dose adjustment of warfarin or acenocoumarol may be required when co-administered with
Slovenian: Pri sočasni uporabi z efavirenzom/emtricitabinom/dizo proksiltenofoviratom bo morda treba prilagoditi odmerek varfarina ali acenokumarola.
English: Vascular disorders: Uncommon flushing
Slovenian: Žilne bolezni: Občasni zardevanje
English: If the patient vomits within 1 hour of taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, another tablet should be taken.
Slovenian: Če bolnik tableto izbruha v 1 uri po zaužitju zdravila Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan, mora vzeti še eno tableto zdravila Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan.
English: - If you have any further questions, ask your doctor or pharmacist - This medicine has been prescribed for you only.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: Ethinyloestradiol: AUC: ↔ Cmax: ↔
Slovenian: Etinilestradiol: AUC: ↔ Cmax: ↔ Tenofovir:
English: Uncommon:
Slovenian: Pozakonazol:
English: CCR5 antagonist Maraviroc/Efavirenz (100 mg b.i.d./600 mg q.d.)
Slovenian: Maravirok/efavirenz (100 mg b.i.d./ 600 mg q.d.)
English: Dosage adjustments of simvastatin may be required when co-administered with efavirenz/emtricitabine/tenofovir disoproxil (refer to the Summary of Product Characteristics for simvastatin).
Slovenian: Pri sočasnem dajanju simvastatina z efavirenzom/emtricitabinom/dizo proksiltenofoviratom je treba odmerek simvastatina prilagoditi (glejte Povzetek glavnih značilnosti zdravila za simvastatin).
English: * p-value < 0.05, Fisher's Exact test comparing efavirenz + emtricitabine + tenofovir disoproxil group to efavirenz + lamivudine/zidovudine group among all patients.
Slovenian: K103N K101E G190A/S Y188C/H V108I P225H M184V/I K65R K70E TAM2 * p-vrednost < 0,05, primerjava skupine, ki je prejemala efavirenz + emtricitabin + dizoproksiltenofovirat, s skupino, ki je prejemala efavirenz + lamivudin/zidovudin, s Fisherjevim testom natančnosti pri vseh bolnikih.
English: Fluoxetine/Tenofovir disoproxil
Slovenian: Fluoksetin/dizoproksiltenofovirat
English: 10 ml (30 mg/ml) 2 vials
Slovenian: 2 viali
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Slovenian: (Izmišljeno) ime Jakost
English: Date of first authorisation: 26th September 2017
Slovenian: Datum prve odobritve: 26. septembra 2017
English: Age/gender:
Slovenian: Starost/spol:
English: If you are allergic to soya, do not use this medicinal product.
Slovenian: Če ste alergični na sojo, tega zdravila ne uporabljajte.
English: Your doctor will tell you if and when you should stop the treatment.
Slovenian: Zdravnik vam bo povedal, če morate in kdaj morate zdravljenje prekiniti.
English: Patients in specific year with:
Slovenian: Bolniki v določenem letu:
English: All 57 patients remained positive for HBsAg.
Slovenian: Vseh 57 bolnikov je ostalo pozitivnih na HBsAg.
English: Your dose will depend on:
Slovenian: Vaš odmerek je odvisen od:
English: HBeAg Negative (study 027)
Slovenian: HBeAg negativni (študija 027)
English: However, the no effect levels could not be precisely established.
Slovenian: Vrednosti brez učinka niso mogli natančno določiti.
English: This leaflet was last revised in {MM/YYYY} Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano {MM/YYYY} Drugi viri informacij
English: Wait and take the next dose at the regular time.
Slovenian: V tem primeru počakajte in vzemite naslednji odmerek ob običajnem času.
English: Protein binding to human serum protein in vitro is ≈ 13%.
Slovenian: Vezava na humane serumske proteine in vitro je ≈ 13-odstotna.
English: In most cases you may take Entecavir Accord with or without food.
Slovenian: V večini primerov lahko zdravilo Entecavir Accord jemljete skupaj s hrano ali brez nje.
English: As entecavir is a nucleoside analogue, this risk cannot be excluded.
Slovenian: Ker je entekavir nukleozidni analog, takšnega tveganja ne moremo izključiti.
English: The proposed dose modifications are based on extrapolation of limited data, and their safety and effectiveness have not been clinically evaluated.
Slovenian: Predlagane prilagoditve odmerka temeljijo na ekstrapolaciji majhnega števila podatkov, pri čemer njihova varnost in učinkovitost nista bili klinično ovrednoteni.
English: A risk to the infants cannot be excluded.
Slovenian: Tveganja za dojenega otroka ne moremo izključiti.
English: c Patients also have LVDr substitutions.
Slovenian: Bolniki imajo tudi substitucije LVDr.
English: This rare but serious side effect has occasionally been fatal.
Slovenian: Ta redek, vendar hud neželeni učinek je včasih lahko tudi smrten.
English: Haemodialysis or CAPD**
Slovenian: Hemodializa ali CAPD**
English: Therefore, virological response should be closely monitored.
Slovenian: Virusni odziv je treba zato skrbno nadzirati.
English: rare (at least 1 in 10,000 patients): severe allergic reaction.
Slovenian: redki (pri več kot 1 od 10.000 bolnikov): hude alergijske reakcije.
English: The absolute bioavailability has not been determined.
Slovenian: Absolutna biološka uporabnost ni bila določena.
English: These patients should be followed closely.
Slovenian: Takšne bolnike je treba skrbno nadzirati.
English: It is important that you do not miss any doses.
Slovenian: Pomembno je, da ne pozabite vzeti nobenega odmerka.
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: Pregnancy: there are no adequate data from the use of entecavir in pregnant women.
Slovenian: Nosečnost: Ni zadostnih podatkov o uporabi entekavirja pri nosečnicah.
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: Contact your doctor at once.
Slovenian: Nemudoma se posvetujte s svojim zdravnikom.
English: Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Slovenian: Poročanje o domnevnih neželenih učinkih: Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
English: Results beyond 48 weeks of treatment:
Slovenian: Rezultati zdravljenja, ki je trajalo nad 48 tednov:
English: ANNEX II A. MANUFACTURER(S) 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 (-CI), ODGOVOREN (-NI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
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: An updated RMP should be submitted: At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: Posodobljen RMP je treba predložiti: na zahtevo Evropske agencije za zdravila; ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Treatment was discontinued when prespecified response criteria were met either at 48 weeks or during the second year of treatment.
Slovenian: Zdravljenje je bilo prekinjeno, ko so bili doseženi vnaprej določeni kriteriji odziva, bodisi v 48. tednu bodisi med drugim letom zdravljenja.
English: During Year 2, genotypic resistance to ETV was detected in 2 patients (1.1% cumulative probability of resistance through Year 2).
Slovenian: Med 2. letom so genotipsko odpornost proti ETV odkrili pri 2 bolnikih (1,1 % kumulativne verjetnosti za odpornost do 2. leta).
English: If it is almost time for your next dose, do not take the missed dose.
Slovenian: Če je že skoraj čas, da vzamete naslednji odmerek, pozabljenega odmerka ne smete vzeti.
English: Entecavir should be used in these patients only if the potential benefit justifies the potential risk to the child (e.g. resistance).
Slovenian: Pri teh bolnikih se entekavir lahko uporablja le, če možna korist upravičuje možno tveganje za otroka (npr. razvoj odpornosti).
English: Entecavir Accord reduces the amount of virus in your body, and improves the condition of the liver.
Slovenian: Zdravilo Entecavir Accord zmanjša količino virusa v telesu in izboljša stanje jeter.
English: Each carton contains one bottle.
Slovenian: Ena škatla vsebuje eno plastenko.
English: Distribution: the estimated volume of distribution for entecavir is in excess of total body water.
Slovenian: Porazdelitev: Ocenjeni volumen porazdelitve entekavirja je večji od skupne količine telesne tekočine.
English: By 48 weeks of post-treatment follow-up, a substantial number of HBeAg negative patients lost response.
Slovenian: Pri 48-tedenskem spremljanju po zdravljenju se je pri znatnem številu HBeAg negativnih bolnikov odziv izgubil.
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: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Slovenian: EDINSTVENA OZNAKA - ČLOVEKU BERLJIVI PODATKOVNI ELEMENTI
English: See leaflet for further information.
Slovenian: Za dodatne informacije glejte navodila za uporabo.
English: In accordance with current paediatric practice guidelines, treatment discontinuation may be considered as follows:
Slovenian: V skladu s trenutnimi smernicami za zdravljenje pediatričnih bolnikov je pri prekinitvi zdravljenja treba upoštevati naslednje:
English: Patients who did not have a virologic response were offered alternative treatment.
Slovenian: Bolnikom brez virološkega odziva je bilo predlagano alternativno zdravljenje.
English: - emerging genotypic ETVr c
Slovenian: - pojav genotipske ETVr c
English: Week 24
Slovenian: 24. teden
English: Children and adolescents (from 2 to less than 18 years of age) can take Entecavir Accord with or without food.
Slovenian: Otroci in mladostniki (stari od 2 leti do manj kot 18 let) lahko zdravilo Entecavir Accord jemljejo skupaj s hrano ali brez nje.
English: The two trials provide resistance data in 183 patients treated and monitored in Year 1 and 180 patients treated and monitored in Year 2.
Slovenian: Iz teh dveh preskušanj so na voljo podatki o odpornosti pri 183 bolnikih, ki so jih zdravili in nadzirali v 1. letu, in 180 bolnikih, ki so jih zdravili in nadzirali v 2. letu.
English: Healthy subjects who received up to 20 mg/day for up to 14 days, and single doses up to 40 mg had no unexpected adverse reactions.
Slovenian: Pri zdravih osebah, ki so do 14 dni prejemale odmerke do 20 mg/dan in enkratne odmerke do 40 mg, se nepričakovani neželeni učinki niso pojavili.
English: With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.
Slovenian: Pri dolgotrajnem zdravljenju, ki traja več kot 2 leti, priporočamo redna preverjanja, če je nadaljevanje z izbrano obliko zdravljenja za bolnika še vedno primerno.
English: Regardless of baseline characteristics, the majority of patients showed histological and virological responses to treatment.
Slovenian: Ne glede na značilnosti v izhodišču je pri večini bolnikov prišlo do histološkega in virološkega odziva na zdravljenje.
English: After adjusting for differences in creatinine clearance and body weight there was no difference in exposure between male and female subjects.
Slovenian: Po prilagoditvi glede na razlike v kreatininskem očistku in telesni masi se izpostavljenost pri osebah moškega in ženskega spola ni razlikovala.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o izdelku so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.