natgillin/translations-raw huggingface dataset:
Varenicline pharmacokinetics were unchanged in subjects with mild renal impairment (estimated creatinine clearance &gt; 50 ml/min and  80 ml/min).
Farmakokinetika vareniklina pri osebah z blago okvaro ledvic (ocenjeni očistek kreatinina &gt; 50 ml/min in  80 ml/min) ni bila spremenjena.
Variants V36A/M, T54A/S, R155K/T, and A156S conferred lower levels of in vitro resistance to telaprevir (3- to 25-fold increase in telaprevir IC50), and the A156V/T and V36M+R155K variants conferred higher levels of in vitro resistance to telaprevir ( &gt; 25-fold increase in telaprevir IC50).
Variante V36A/M, T54A/S, R155K/T in A156S so pokazale nižje stopnje rezistence na telaprevir in vitro (3-kratno do 25-kratno zvečanje IC50 za telaprevir), varianti A156V/T in V36M+R155K sta imeli višjo stopnjo rezistence in vitro za telaprevir ( &gt; 25-kratno zvečanje IC50 za telaprevir).
Vectra 3D for dogs &gt; 40 kg
Vectra 3D za pse &gt; 40 kg
Vectra 3D spot-on (1.5–4 kg) Vectra 3D spot-on (4–10 kg) Vectra 3D spot-on (10–25 kg) Vectra 3D spot-on (25–40 kg) Vectra 3D spot-on ( &gt; 40 kg)
Vectra 3D kožni nanos (1.5–4 kg) Vectra 3D kožni nanos (4–10 kg) Vectra 3D kožni nanos (10–25 kg) Vectra 3D kožni nanos (25–40 kg) Vectra 3D kožni nanos ( &gt; 40 kg)
Vectra 3D spot-on solution for dogs 1.5–4 kg Vectra 3D spot-on solution for dogs 4–10 kg Vectra 3D spot-on solution for dogs 10–25 kg Vectra 3D spot-on solution for dogs 25–40 kg Vectra 3D spot-on solution for dogs &gt; 40 kg
Vectra 3D kožni nanos, raztopina za pse 1.5–4 kg Vectra 3D kožni nanos, raztopina za pse 4–10 kg Vectra 3D kožni nanos, raztopina za pse 10–25 kg Vectra 3D kožni nanos, raztopina za pse 25–40 kg Vectra 3D kožni nanos, raztopina za pse &gt; 40 kg
VELCADE therapy should be withheld when the platelet count is &lt; 25,000/l or, in the case of combination with melphalan and prednisone, when the platelet count is ≤ 30,000/l (see section 4.2).
Zdravljenje je treba prekiniti, kadar se bolnik zdravi z zdravilom VELCADE in je število trombocitov &lt; 25.000/l, ali če se bolnik zdravi z zdravilom VELCADE v kombinaciji z melfalanom in prednizonom in je število trombocitov &lt; 30.000/l (glejte poglavje 4.2).
Velmetia should not be used in patients with moderate or severe renal impairment (creatinine clearance &lt; 60 mL/min) (see sections 4.3 and 4.4).
Zdravila Velmetia se ne sme uporabljati pri bolnikih z zmerno ali hudo ledvično okvaro (kreatininski očistek &lt; 60 ml/min) (glejte poglavji 4.3 in 4.4).
Velpatasvir is &gt; 99.5% bound to human plasma proteins and binding is independent of drug concentration over the range of 0.09 μg/mL to 1.8 μg/mL.
Velpatasvir se &gt; 99,5-odstotno veže na humane beljakovine v plazmi, kar ni odvisno od koncentracije zdravila v razponu 0,09–1,8 μg/ml.
Very common ( &gt; 1/10); common ( &gt; 1/100, &lt; 1/10); uncommon ( &gt; 1/1,000, &lt; 1/100); rare ( &gt; 1/10,000, &lt; 1/1,000); very rare ( &lt; 1/10,000), including isolated reports.
Zelo pogosti ( &gt; 1/10); pogosti ( &gt; 1/100, &lt; 1/10); občasni ( &gt; 1/1.000, &lt; 1/100); redki ( &gt; 1/10.000, &lt; 1/1.000); zelo redki ( &lt; 1/10.000), vključno s posameznimi primeri.
Very common ( ≥ 1/10) Common ( ≥ 1/100 to &lt; 1/10)
Zelo pogosti (≥ 1/10) Pogosti (≥ 1/100 do &lt; 1/10)
very common ( &gt; 1/10)
zelo pogosti ( &gt; 1/10)
very common ( &gt; 1/10)
zelo pogosti (≥1/10)
very common ( &gt; 1/10), common ( &gt; 1/100 to &lt; 1/10), uncommon ( &gt; 1/1000 to &lt; 1/100), rare ( &gt; 1/10,000 to &lt; 1/1000), very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Zelo pogosti ( &gt; 1/10), pogosti (≥ 1/100 do &lt; 1/10), občasni (≥ 1/1.000 do &lt; 1/100), redki ( &gt; 1/10.000 do &lt; 1/1000), zelo redki ( &lt; 1/10.000), nezanana(ni mogoče oceniti na podlagi podatkov, ki so na voljo).
Very common (≥ 1/10)
Zelo pogosti ( &gt; 1/10)
Very common (≥ 1/10)
Zelo pogosti (≥ 1/10) Pogosti (≥ 1/100 do &lt; 1/10)
Very common (≥ 1/10) Common (≥ 1/100 to &lt; 1/10)
zelo pogosti (≥ 1/10) pogosti (≥ 1/100 do &lt; 1/10)
Very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100), rare (≥ 1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data), including isolated reports
zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do &lt; 1/10), občasni (≥ 1/1.000 do &lt; 1/100), redki (≥ 1/10.000 do &lt; 1/1.000), zelo redki ( &lt; 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov), vključno s posameznimi poročili.
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)
Razvrščeni so po organskih sistemin in pogostnosti v naslednje skupine: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do &lt; 1/10); občasni (≥ 1/1.000 do &lt; 1/100); redki (≥ 1/10.000 do &lt; 1/1.000).
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)
zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do &lt; 1/10); občasni (≥ 1/1.000 do &lt; 1/100); redki (≥ 1/10.000 do &lt; 1/1.000).
Very common (≥ 1/10); Common (≥ 1/100 to &lt; 1/10);
zelo pogosti (≥1/10); pogosti (≥1/100 do &lt; 1/10);
Very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do &lt; 1/10); občasni (≥ 1/1.000 do &lt; 1/100); redki (≥ 1/10.000 do &lt; 1/1.000); zelo redki ( &lt; 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare( &lt; 1/10,000), not known (cannot be estimated from the available data).
Zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do &lt; 1/10); občasni (≥ 1/1.000 do &lt; 1/100); redki (≥ 1/10.000 do &lt; 1/1.000); zelo redki ( &lt; 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Very common (≥ 1/10); Common (≥ 1/100, &lt; 1/10); Uncommon (≥ 1/1,000, &lt; 1/100)
KS, razporejeni po kategorijah pogostnosti v skladu s CIOMS III zelo pogosti (≥ 1/10); pogosti (≥ 1/100, &lt; 1/10); občasni (≥ 1/1.000, &lt; 1/100)
Very common (≥ 1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000).
zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do &lt; 1/10), občasni (≥ 1/1.000 do &lt; 1/100), redki (≥ 1/10.000 do &lt; 1/1.000), zelo redki ( &lt; 1/10.000).
Very common (≥1/10 patient-years); Common (≥1/100 to &lt; 1/10 patient-years);
Pogosti (≥1/100 do &lt; 1/10 bolnikov-let);
Very common (≥1/10)
Zelo pogoste ( &gt; 1/10)
Very Common (≥1/10)
Zelo pogosti ( &gt; 1/10)
Very common (≥1/10) Common (≥1/100 and &lt; 1/10)
Zelo pogosti ≥ 1/10) Pogosti (≥ 1/100 in &lt; 1/10)
Very common (≥1/10) Common (≥1/100 to &lt; 1/10)
zelo pogosti (1/10) pogosti (1/100 do &lt; 1/10)
Very common (≥1/10) Common (≥1/100 to &lt; 1/10)
Zelo pogosti (≥ 1/10) Pogosti (≥ 1/100 do &lt; 1/10)
Very common (≥1/10) Common (≥1/100 to &lt; 1/10)
Zelo pogosti (≥ 1/10) Pogosti (≥1/100 do &lt; 1/10)
Very common (≥1/10) Common (≥1/100 to &lt; 1/10)
Zelo pogosti (≥1/10) Pogosti (≥1/100 do &lt; 1/10)
Very common (≥1/10), Common (≥1/100 to &lt; 1/10), Uncommon (≥1/1,000 to &lt; 1/100), Rare (≥1/10,000 to
Zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do &lt; 1/10), občasni (≥ 1/1.000 do &lt; 1/100), redki (≥ 1/10.000 do &lt; 1/1.000), zelo redki ( &lt; 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Very common (≥1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
&lt; 1/10), občasni (≥ 1/1.000 do &lt; 1/100), redki (≥ 1/10.000 do &lt; 1/1.000), zelo redki ( &lt; 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Very common (≥1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do &lt; 1/10), občasni (≥ 1/1.000 do &lt; 1/100), redki (≥ 1/10.000 do &lt; 1/1.000), zelo redki ( &lt; 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Very common (≥1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do &lt; 1/10); občasni (≥ 1/1.000 do &lt; 1/100); redki (≥ 1/10.000 do &lt; 1/1.000); zelo redki ( &lt; 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Very common (≥1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000).
Zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do &lt; 1/10); občasni (≥ 1/1.000 do &lt; 1/100); redki (≥ 1/10.000 do &lt; 1/1.000); zelo redki ( &lt; 1/10.000).
Very common (≥1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data).
zelo pogosti (≥ 1/10); pogosti (≥ 1/100, &lt; 1/10); občasni (≥ 1/1000, &lt; 1/100); redki (≥ 1/10.000,
Very common (≥1/10); Common (≥1/100, &lt; 1/10); Uncommon (≥1/1,000, &lt; 1/100); Rare (≥1/10,000,
Zelo pogosti ( 1/10), pogosti ( 1/100, &lt; 1/10), občasni ( 1/1.000, &lt; 1/100), redki ( 1/10.000,
Very common ( 1/10) Common ( 1/100 to &lt; 1/10)
Zelo pogosti (1/10) Pogosti (1/100 do &lt; 1/10)
Very common (1/10) Common (1/100 to &lt; 1/10)
Zelo pogosti (≥ 1/10) Pogosti (≥ 1/100 do &lt; 1/10)
Very common (1/10); common (1/100 to &lt; 1/10); uncommon (1/1,000 to &lt; 1/100); rare (1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do &lt; 1/10); občasni (≥ 1/1.000 do &lt; 1/100); redki (≥ 1/10.000 do &lt; 1/1.000); zelo redki ( &lt; 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Very common (1/10); common (1/100 to &lt; 1/10); uncommon (1/1,000 to &lt; 1/100); rare (1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do &lt; 1/10); občasni (≥ 1/1000 do &lt; 1/100); redki (≥ 1/10.000 do &lt; 1/1.000); zelo redki ( &lt; 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Very common symptoms in overdose ( &gt; 10 % incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Zelo pogosti simptomi pri prevelikem odmerjanju (incidenca &gt; 10 %) vključujejo tahikardijo, vznemirjenost/nasilnost, dizartrijo, različne ekstrapiramidne simptome in motnje zavesti v razponu od sedacije do kome.
Very common symptoms in overdose ( &gt; 10 % incidence) include tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Zelo pogosti simptomi pri prevelikem odmerjanju (incidenca &gt; 10 %) vključujejo tahikardijo, vznemirjenost/nasilnost, dizartrijo, različne ekstrapiramidne simptome in motnje zavesti v razponu od sedacije do kome.
Very common symptoms in overdose ( &gt; 10% incidence) include tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Zelo pogosti simptomi pri prevelikem odmerjanju (incidenca &gt; 10 %) vključujejo tahikardijo, vznemirjenost/agresivnost, dizartrijo, različne ekstrapiramidne simptome in motnje zavesti v razponu od sedacije do kome.
Very common symptoms in overdose ( &gt; 10% incidence) include tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Zelo pogosti simptomi pri prevelikem odmerjanju (incidenca &gt; 10 %) vključujejo tahikardijo, vznemirjenost/nasilnost, dizartrijo, različne ekstrapiramidne simptome in motnje zavesti v razponu od sedacije do kome.
Very common ≥ 1/10 Common ≥ 1/100 to &lt; 1/10
Zelo pogosti ≥ 1/10 Pogosti ≥ 1/100 do &lt; 1/10
Very common ≥ 1/10 Common ≥ 1/100 to &lt; 1/10
Zelo pogosti: ≥ 1/10 Pogosti: ≥ 1/100 do &lt; 1/10
Very common: ( &gt; 1/10)
Zelo pogosti: ( &gt; 1/10)
Very common: ≥1/10; common: ≥1/100 to &lt; 1/10; uncommon: ≥1/1,000 to &lt; 1/100; rare: ≥1/10,000 to
Zelo pogosti (≥1/10); pogosti (≥1/100 do &lt; 1/10); občasni (≥1/1.000 do &lt; 1/100); redki (≥1/10.000 do
Very limited data are available in patients &gt; 75 years of age.
Za bolnike, starejše od 75 let, je na voljo le zelo malo podatkov.
Very limited data in seronegative subjects &gt; 80 years of age (N=5) showed that no subject achieved seroprotection rate following two administrations of a single dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1).
Zelo omejeni podatki pri seronegativnih preiskovancih, starejših od 80 let (n = 5) so pokazali, da noben preiskovanec ni dosegel serološke zaščite po dvakratni uporabi enega odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 (H5N1).
Very limited safety data are available for patients aged &gt; 75 years or patients with major cardiovascular co-morbidities.
O varnosti zdravila pri bolnikih, ki so stari več kot 75 let ali imajo sočasno pomembno kardiovaskularno bolezen, je na voljo le malo podatkov.
very premature infants ( &lt; 28 weeks gestational age and/or body weight &lt; 1000 g) particularly when receiving parenteral nutrition
zelo zgodaj rojeni nedonošenčki ( &lt; 28 tedni nosečnostne starosti in/ali s telesno maso &lt; 1000 g), še posebej v primeru parenteralnega prehranjevanja
Very rare ( &lt; 1/10,000)
Zelo redki ( &lt; 1/10.000
Very rare ( &lt; 1/10,000)
Zelo redki ( 1/10.000)
Very rare ( &lt; 1/10,000) elevations in liver function tests (LFTs) for ALT (alanine aminotransferase) or AST (aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy.
Zelo redko ( &lt; 1/10.000) so se bolnikom, ki so po citotoksični kemoterapiji dobili pegfilgrastim, pojavila zvišanja jetrnih funkcijskih testov ALT (alanin-aminotransferaze) ali AST (aspartat- aminotransferaze).
Very rare ( &lt; 1/10,000) events of cutaneous vasculitis have been reported in patients treated with Neupopeg.
Pri bolnikih, zdravljenih z Neupoegom, so zelo redko ( &lt; 1/10.000) poročali o primerih kožnega vaskulitisa.
Very rare ( &lt; 1/10,000) events of cutaneous vasculitis have been reported in patients treated with Neupopeg.
Pri bolnikih, zdravljenih z Neupopegom, so zelo redko ( &lt; 1/10.000) poročali o primerih kožnega vaskulitisa.
Very rare ( &lt; 1/10,000)
zelo redki ( &lt; 1/10.000)
Very rare ( &lt; 1/10,000) adverse reactions were reported post-marketing.
V študijah po prihodu zdravila na trg so poročali o zelo redkih ( &lt; 1/10.000) neželenih učinkih.
Very rare ( &lt; 1/10,000):
Zelo redki ( &lt; 1/10.000):
Very rare (1/10,000)
redki (≥1/10.000 do &lt; 1/1000) zelo redki ( &lt; 1/10.000)
Very rare &lt; 1/10,000 including isolated reports
redki  1/10.000, &lt; 1/1.000 zelo redki &lt; 1/10.000, vključno s posameznimi primeri
very rare &lt; 1/10,000 not known cannot be estimated from the available data
zelo redki &lt; 1/10.000 neznana ni mogoče oceniti iz razpoložljivih podatkov
Very rare ARs° ( &lt; 1/10,000)
zelo redki neželeni učinki° ( &lt; 1/10.000)
Very rare: ( &lt; 1/10,000)
Zelo redki: ( &lt; 1/10.000)
Very rare: ( &lt; 1/10,000) including isolated reports
Zelo redki: ( &lt; 1/10.000), vključno s posameznimi primeri
Veterinary medicinal product subject to prescription.
Na veterinarski recept. &gt; &lt; Rp-Vet &gt; .
Victrelis in combination with peginterferon alfa and ribavirin is not recommended in patients who have platelet count &lt; 100,000/mm3 and/or serum albumin &lt; 35 g/L and/or signs of coagulapathy (International Normalized Ratio (INR) &gt; 1.7) at baseline.
Uporaba zdravila Victrelis v kombinaciji s peginterferonom alfa in ribavirinom ni priporočljiva pri bolnikih, ki imajo v izhodišču število trombocitov &lt; 100.000/mm3 in/ali serumski albumin &lt; 35 g/l in/ali znake koagulopatije (internacionalno normalizirano razmerje (INR) &gt; 1,7).
Viekirax with ribavirin &amp; without dasabuvir was evaluated for 12 weeks in genotype 1 treatment naive and treatment experienced non-cirrhotic subjects in a phase 2 study M11-652 (AVIATOR).
Zdravilo Viekirax z ribavirinom in brez dasabuvirja so preučevali 12 tednov pri preiskovancih, okuženih z genotipom 1, brez ciroze, in sicer takih, ki še niso bili zdravljeni kot tudi takih, ki so že bili zdravljeni v študiji 2. faze M11-652 (AVIATOR).
Vinflunine clearance was significantly decreased in patients ≥ 80 years old as compared to a control group of younger patients &lt; 70 years.
Očistek vinflunina se je, glede na kontrolno skupino mlajših bolnikov &lt; 70 let, bistveno zmanjšal pri bolnikih, starejših od 80 let.
Vinflunine has not been evaluated in patients with severe hepatic impairment (Child-Pugh grade C), or in patients with a prothrombin time &lt; 50%NV or with bilirubin &gt; 5xULN or with isolated transaminases &gt; 2.5xULN ( ≥ 5xULN only in case of liver metastases) or with GGT &gt; 15xULN.
Uporaba vinflunina ni raziskana pri bolnikih s hudo okvaro jeter (C po lestvici Child-Pugh) niti pri bolnikih s protrombinskim časom &lt; 50 % NV ali ravnijo bilirubina &gt; 5x ZMNR ali transaminaz &gt; 2,5 x ZMNR (≥ 5x ZMNR samo v primeru jetrnih metastaz) ali z CGT &gt; 15x ZMNR.
Vipdomet is not recommended for use in patients with moderate and severe renal impairment and end-stage renal disease (creatinine clearance &lt; 60 mL/min)(see section 4.3).
Pri bolnikih z zmerno ali hudo okvaro ledvic in bolnikih s končno ledvično odpovedjo (kreatininski očistek &lt; 60 ml/min), uporaba zdravila Vipdomet ni priporočljiva (glejte poglavje 4.3).
Viral load &lt; 400 copies/ml at week 24, n (%)
Virusno breme &lt; 400 kopij/ml po 24. tednu, n (%)
Viral load &lt; 50 copies/ml at week 24, n (%)
Virusno breme &lt; 50 kopij/ml po 24. tednu, n (%)
Viral load remained &lt; 200 copies/mL for 48 weeks in all patients.
Količina virusov po 48-ih tednih je bila pri vseh bolnikih še vedno &lt; 200 kopij/ml.
Viread 123 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to &lt; 12 years who weigh from 17 kg to less than 22 kg.
Zdravilo Viread 123 mg filmsko obložene tablete je indicirano v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje pediatričnih bolnikov, okuženih s HIV-1, odpornih na NRTI ali s toksičnostjo, ki onemogoča uporabo zdravil prve izbire, starih 6 do &lt; 12 let, s telesno maso 17 kg do manj kot 22 kg.
Viread 163 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to &lt; 12 years who weigh from 22 kg to less than 28 kg.
Zdravilo Viread 163 mg filmsko obložene tablete je indicirano v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje pediatričnih bolnikov, okuženih s HIV-1, odpornih na NRTI ali s toksičnostjo, ki onemogoča uporabo zdravil prve izbire, starih 6 do &lt; 12 let, s telesno maso 22 kg do manj kot 28 kg.
Viread 204 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to &lt; 12 years who weigh from 28 kg to less than 35 kg.
Zdravilo Viread 204 mg filmsko obložene tablete je indicirano v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje pediatričnih bolnikov, okuženih s HIV-1, odpornih na NRTI ali s toksičnostjo, ki onemogoča uporabo zdravil prve izbire, starih 6 do &lt; 12 let, s telesno maso 28 kg do manj kot 35 kg.
Viread 245 mg film-coated tablets are also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to &lt; 18 years.
Zdravilo Viread 245 mg filmsko obložene tablete je indicirano tudi za zdravljenje mladostnikov, okuženih s HIV-1, odpornih na NRTI ali s toksičnostjo, ki onemogoča uporabo zdravil prve izbire, starih 12 do &lt; 18 let.
Viread 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to &lt; 18 years of age with:
Zdravilo Viread 245 mg filmsko obložene tablete so indicirane za zdravljenje kroničnega hepatitisa B pri mladostnikih, starih 12 do &lt; 18 let:
Viread 33 mg/g granules are also indicated for the treatment of chronic hepatitis B in adolescents 12 to &lt; 18 years of age for whom a solid dosage form is not appropriate with:
Zdravilo Viread 33 mg/g zrnca je indicirano tudi za zdravljenje kroničnega hepatitisa B pri mladostnikih, starih 12 do &lt; 18 let, pri katerih ni mogoče uporabiti trdne farmacevtske oblike:
Viread 33 mg/g granules are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, from 2 to &lt; 6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate.
Zdravilo Viread 33 mg/g zrnca je indicirano v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje pediatričnih bolnikov, okuženih s HIV-1, odpornih na NRTI ali s toksičnostjo, ki onemogoča uporabo zdravil prve izbire, starih 2 do &lt; 6 let, in starih več kot 6 let, pri katerih ni mogoče uporabiti trdne farmacevtske oblike.
Viread is also available as 123 mg, 163 mg, 204 mg film-coated tablets for use in HIV-1 infected paediatric patients aged 6 to &lt; 12 years who weigh ≥ 17 and &lt; 35 kg for whom a solid dosage form is appropriate.
Zdravilo Viread je na voljo tudi v obliki 123 mg, 163 mg, 204 mg filmsko obloženih tablet za uporabo pri pediatričnih bolnikih, okuženih s HIV-1, starih 6 do &lt; 12 let, s telesno maso ≥ 17 in &lt; 35 kg, pri katerih je mogoče uporabiti trdo obliko zdravila.
Viread is also available as 33 mg/g granules for the treatment of HIV-1 infection and chronic hepatitis B in adolescents aged 12 to &lt; 18 years for whom a solid dosage form is not appropriate.
Zdravilo Viread je na voljo tudi v obliki 33 mg/g zrnc za zdravljenje okužbe s HIV-1 in za zdravljenje kroničnega hepatitisa B pri mladostnikih, starih 12 do &lt; 18 let, pri katerih ni mogoče uporabiti trdne farmacevtske oblike.
Viread is also available as granules for use in HIV-1 infected paediatric patients aged 2 to &lt; 12 years and as reduced tablet strengths for use in HIV-1 infected paediatric patients aged 6 to &lt; 12 years (see section 5.1).
Zdravilo Viread je na voljo tudi v obliki zrnc za uporabo pri pediatričnih bolnikih, okuženih s HIV-1, starih 2 do &lt; 12 let ter v obliki tablet manjše jakosti za uporabo pri prediatričnih bolnikih, okuženih s HIV-1, starih 6 do &lt; 12 let (glejte poglavje 5.1).
Virologic failure (HIV RNA &gt; 200 copies/ml)
Virološki neuspeh (HIV RNA &gt; 200 kopij/ml)
Virologic responder (HIV-1 RNA &lt; 50 copies/ml)
Bolnik z virološkim odzivom (HIV-1 RNK &lt; 50 kopij/ml)
Virologic Response at Week 48 ITT-Exposed Population &lt; 50 copies/ml TLOVR
Virusni odziv po 48 tednih ITT-izpostavljene populacije z &lt; 50 kopij/ml TLOVR
Virologic Response Based on Plasma HIV-1 RNA &lt; 50 copies/ml ITT-Exposed Population M=F switch included
Virusni odziv glede na HIV-1 RNA v plazmi &lt; 50 kopij/ml
Virologic response rate was evaluated in both treatment arms and virologic response was defined as achieving an undetectable viral load ( &lt; 50 HIV-1 RNA copies/ml).
Stopnja virološkega odziva je bila ocenjena v obeh krakih zdravljenja, virološki odziv je bil opredeljen kot dosežena nezaznavna virusna obremenitev ( &lt; 50 RNA HIV-1 kopij/ml).