natgillin/translations-raw huggingface dataset:
The safety and efficacy of Orkambi in patients aged 65 years or older have not been evaluated.
Varnosti in učinkovitosti zdravila Orkambi pri bolnikih, starih 65 let ali več, niso ovrednotili.
The safety and efficacy of Oxyglobin have not been evaluated in dogs with, thrombocytopenia with active bleeding, oliguria or anuria, or advanced cardiac disease.
Varnosti in učinkovitosti uporabe Oxyglobina niso ocenjevali pri psih s trombocitopenijo in aktivno krvavitvijo, oligurijo ali anurijo, ali z napredujočo srčno boleznijo.
The safety and efficacy of Palonosetron i.v at single doses of 1µg/kg and 3µg/kg was compared in the first clinical study in 150 patients in the following age groups, >28 days to 23 months (7 patients), 2 to 11 years (96 patients), and 12 to 16 years of age (47 patients) undergoing elective surgery.
Varnost in učinkovitost palonosetrona i.v. pri enojnem odmerku 1 µg/kg in 3 µg/kg so primerjali v prvi klinični študiji s 150 bolniki v naslednjih starostnih skupinah: > 28 dni do 23 mesecev (7 bolnikov), 2 do 11 let (96 bolnikov) in 12 do 16 let (47 bolnikov) z elektivno operacijo.
The safety and efficacy of Palonosetron i.v at single doses of 3 µg/kg and 10 µg/kg was investigated in the first clinical study in 72 patients in the following age groups, >28 days to 23 months (12 patients), 2 to 11 years (31 patients), and 12 to 17 years of age (29 patients), receiving highly or moderately emetogenic chemotherapy.
Varnost in učinkovitost palonosetrona i.v. pri enojnem odmerku 3 µg/kg in 10 µg/kg so raziskovali v prvi klinični študiji z 72 bolniki v naslednjih starostnih skupinah: >28 dni do 23 mesecev (12 bolnikov), 2 do 11 let (31 bolnikov) in 12 do 17 let (29 bolnikov), ki so prejemali zelo ali zmerno emetogeno kemoterapijo.
The safety and efficacy of Palonosetron i.v at single doses of 3µg/kg and 10µg/kg was investigated in the first clinical study in 72 patients in the following age groups, >28 days to 23 months (12 patients), 2 to 11 years (31 patients), and 12 to 17 years of age (29 patients), receiving highly or moderately emetogenic chemotherapy.
Varnost in učinkovitost palonosetrona i.v. pri enojnem odmerku 3 µg/kg in 10 µg/kg so raziskovali v prvi klinični študiji z 72 bolniki v naslednjih starostnih skupinah: >28 dni do 23 mesecev (12 bolnikov), 2 do 11 let (31 bolnikov) in 12 do 17 let (29 bolnikov), ki so prejemali zelo ali zmerno emetogeno kemoterapijo.
The safety and efficacy of pazopanib in children aged 2 to 18 years of age have not yet been established (see section 5.1).
Varnost in učinkovitost pazopaniba pri otrocih, starih 2 do 18 let, še nista bili dokazani (glejte poglavje 5.1).
The safety and efficacy of pazopanib in RCC were evaluated in a randomised, double-blind, placebo- controlled multi-centre study.
Varnost in učinkovitost pazopaniba pri karcinomu ledvičnih celic je bila ovrednotena z randomizirano, dvojno slepo, s placebom nadzorovano multicentrično študijo.
The safety and efficacy of Perjeta have not been studied in patients with hepatic impairment.
Varnost in učinkovitost zdravila Perjeta pri bolnikih z jetrno okvaro nista raziskani.
The safety and efficacy of Pixuvri as single-agent therapy were evaluated in a multicentre, randomised, active controlled trial in patients with relapsed or refractory aggressive NHL after receiving at least two prior therapies (PIX301).
Varnost in učinkovitost zdravila Pixuvri kot učinkovine pri samostojnem zdravljenju so ocenili v multicentričnem, randomiziranem, aktivno nadzorovanem preskušanju pri bolnikih s ponovljenimi ali refraktorno agresivnimi ne-Hodgkinovimi limfomi, ki so predhodno prejeli vsaj dve terapiji (PIX301).
The safety and efficacy of Pradaxa in children from birth to less than 18 years of age have not yet been established.
Varnost in učinkovitost zdravila Pradaxa pri otrocih od rojstva do nedopolnjenega 18. leta še nista raziskani.
The safety and efficacy of Pramipexole Accord in children below 18 years has not been established.
Klinična učinkovitost in varnost pri Tourettovem sindromu
The safety and efficacy of pregabalin in children below the age of 12 years and in adolescents (12 – 17 years of age) have not been established.
Varnost in učinkovitost pregabalina pri otrocih, starih do 12 let, in pri mladostnikih (12-17 let) nista bili dokazani.
The safety and efficacy of pregabalin in children below the age of 12 years and in adolescents (12- 17 years of age) have not been established.
Varnost in učinkovitost pregabalina pri otrocih, starih do 12 let, in pri mladostnikih (12-17 let) nista bili dokazani.
The safety and efficacy of Pregabalin Mylan in children below the age of 12 years and in adolescents (12-17 years of age) have not been established.
Varnost in učinkovitost zdravila Pregabalin Mylan pri otrocih, starih do 12 let, in pri mladostnikih (12- 17 let) nista bili dokazani.
The safety and efficacy of Prepandrix in children aged less than 3 years and in children and adolescents aged 10 to 17 years have not been established.
Varnost in učinkovitost cepiva Prepandrix pri otrocih, mlajših od treh let, in pri otrocih in mladostnikih v starosti od 10 do 17 let, nista ugotovljeni.
The safety and efficacy of Privigen was evaluated in 5 prospective, open-label, single-arm, multicenter studies performed in Europe (ITP, PID and CIDP studies) and the USA (PID study).
Varnost in učinkovitost zdravila Privigen je bila ocenjena v 5 prospektivnih, odprtih, multicentričnih študijah z eno skupino, ki so bile opravljene v Evropi (študije z ITP, PID in CIDP) in ZDA (študija s PID).
The safety and efficacy of prophylactic doses in obese patients (with BMI > 30 kg/m2) has not been fully determined and there is no consensus for dose adjustment.
Varnost in učinkovitost profilaktičnih odmerkov pri bolnikih s prekomerno telesno težo (z ITM > 30 kg/m2) še nista v celoti dokazani, zato ni enotnega mnenja glede prilagajanja odmerka.
The safety and efficacy of prophylactic doses in obese patients (with BMI > 30 kg/m2) has not been fully determined and there is no consensus for dose adjustment.
Varnost in učinkovitost profilaktičnih odmerkov pri debelih bolnikih (z ITM > 30 kg/m2) še nista v celoti dokazani, zato ni enotnega mnenja glede prilagajanja odmerka.
The safety and efficacy of PROTELOS in children aged below 18 years have not been established.
Varnost in učinkovitost zdravila PROTELOS pri otrocih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of ProZinc in breeding, pregnant and lactating cats has not been evaluated.
Varnost in učinkovitost zdravila ProZinc v obdobju parjenja, brejosti in laktacije mačk nista bili ugotovljeni.
The safety and efficacy of ProZinc in breeding, pregnant and lactating cats has not been evaluated.
Varnost in učinkovitost zdravila ProZinc v obdobju razmnoževanja, brejosti in laktacije mačk nista bili ugotovljeni.
The safety and efficacy of ranibizumab have not yet been studied in paediatric patients.
Varnosti in učinkovitosti ranibizumaba pri pediatričnih bolnikih še niso preučevali.
The safety and efficacy of Rapamune as immunosuppressive therapy have not been established in liver or lung transplant patients, and therefore such use is not recommended.
Varnosti in učinkovitosti zdravila Rapamune za imunosupresivno zdravljenje pri bolnikih s presadki jeter ali ledvic niso dokazali, zato taka uporaba ni priporočljiva.
The safety and efficacy of RAVICTI for the treatment of patients with N-acetylglutamate synthase (NAGS) and CITRIN (citrullinaemia type 2) deficiency have not been established.
Varnost in učinkovitost zdravila RAVICTI pri zdravljenju bolnikov s pomanjkanjem N-acetilglutamat sintaze in citrulinemijo tipa 2 nista bili dokazani.
The safety and efficacy of re- administration after an infliximab-free interval of more than 16 weeks has not been established.
Varnost in učinkovitost ponovne uporabe zdravila Flixabi po premoru brez infliksimaba, daljšem od 16 tednov, še nista bili dokazani.
The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8).
Varnost in učinkovitost ponovne uporabe zdravila, razen na vsakih 6 do 8 tednov, še nista bili dokazani (glejte poglavji 4.4 in 4.8).
The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8).
Varnosti in učinkovitosti ponovne uporabe zdravila, razen na vsakih 6 do 8 tednov, nista bili dokazani (glejte poglavji 4.4 in 4.8).
The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8).
Varnosti in učinkovitosti ponovne uporabe zdravila, razen na vsakih 6 do 8 tednov, še niso ugotovili (glejte poglavji 4.4 in 4.8).
The safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Varnost in učinkovitost ponovne uporabe zdravila, razen na vsakih 8 tednov, še nista bili dokazani (glejte poglavji 4.4 in 4.8).
The safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Varnost in učinkovitost ponovne uporabe, razen na vsakih 8 tednov, nista bili dokazani (glejte poglavji 4.4 in 4.8).
The safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Varnosti in učinkovitosti ponovne uporabe zdravila, razen na vsakih 8 tednov, še niso ugotovili (glejte poglavji 4.4 in 4.8).
The safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Varnosti in učinkovitosti ponovne uporabe, razen na vsakih 8 tednov, še niso ugotovili (glejte poglavji 4.4 in 4.8).
The safety and efficacy of Rebif in children below 2 years of age have not yet been established.
Varnost in učinkovitost zdravila Rebif pri otrocih, starih manj kot 2 let, še nista bili dokazani.
The safety and efficacy of regorafenib in patients below 18 years of age in the indication gastrointestinal stromal tumors (GIST) have not been established.
Varnost in učinkovitost regorafeniba pri bolnikih, starih do 18 let, z indikacijo za zdravljenje gastrointestinalnih stromalnih tumorjev (GIST), nista bili dokazani.
The safety and efficacy of Relistor in children less than 18 years has not been established.
Varnosti in učinkovitost metilnaltreksonijevega bromida pri otrocih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of Remicade have not been studied in children with Crohn’s disease below the age of 6 years.
Varnosti in učinkovitosti zdravila Remicade pri otrocih s Crohnovo boleznijo, mlajših od 6 let, niso preučevali.
The safety and efficacy of Remicade in children and adolescents younger than 18 years in the indication juvenile rheumatoid arthritis have not been established.
Varnost in učinkovitost zdravila Remicade pri otrocih in mladostnikih, mlajših od 18 let, za indikacijo juvenilni revmatoidni artritis nista bili dokazani.
The safety and efficacy of Remicade in children and adolescents younger than 18 years in the indication psoriasis have not been established.
Varnost in učinkovitost zdravila Remicade pri otrocih in mladostnikih, mlajših od 18 let, za indikacijo psoriaza nista bili dokazani.
The safety and efficacy of Remicade in children and adolescents younger than 18 years in the indications juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Varnost in učinkovitost zdravila Remicade pri otrocih in mladostnikih, mlajših od 18 let, za indikacije juvenilni idiopatski artritis, psoriatični artritis in ankilozirajoči spondilitis nista bili dokazani.
The safety and efficacy of Remsima have not been studied in children with Crohn’s disease below the age of 6 years.
Varnosti in učinkovitosti zdravila Remsima pri otrocih s Crohnovo boleznijo, mlajših od 6 let, niso preučevali.
The safety and efficacy of Remsima have not been studied in children with ulcerative colitis below the age of 6 years.
Varnost in učinkovitost zdravila Remsima pri otrocih z ulceroznim kolitisom, mlajših od 6 let, niso preučevali.
The safety and efficacy of Remsima in children and adolescents younger than 18 years in the indication juvenile rheumatoid arthritis have not been established.
Varnost in učinkovitost zdravila Remsima pri otrocih in mladostnikih, mlajših od 18 let, za indikacijo juvenilni revmatoidni artritis nista bili dokazani.
The safety and efficacy of Remsima in children and adolescents younger than 18 years in the indication psoriasis have not been established.
Varnost in učinkovitost zdravila Remsima pri otrocih in mladostnikih, mlajših od 18 let, za indikacijo psoriaza nista bili dokazani.
The safety and efficacy of Remsima in children and adolescents younger than 18 years in the indications juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Varnost in učinkovitost zdravila Remsima pri otrocih in mladostnikih, mlajših od 18 let, za indikacije juvenilni idiopatski artritis, psoriatični artritis in ankilozirajoči spondilitis nista bili dokazani.
The safety and efficacy of Renvela have not been established in adult patients with chronic kidney disease not on dialysis with serum phosphorus < 1.78 mmol/l.
Varnosti in učinkovitosti zdravila Renvela pri odraslih s kronično boleznijo ledvic, ki niso na dializi, z ravnijo fosforja v serumu < 1,78 mmol/l, niso ugotavljali.
The safety and efficacy of Renvela have not been established in children below the age of 18 years.
Varnosti in učinkovitosti zdravila Renvela pri otrocih pod 18 let niso ugotavljali.
The safety and efficacy of Renvela have not been established in patients with the following disorders:
Varnosti in učinkovitosti zdravila Renvela niso ugotavljali pri bolnikih z naslednjimi boleznimi:
The safety and efficacy of Replagal was assessed in two randomised, double blind, placebo controlled studies and open label extension studies, in a total of forty patients with a diagnosis of Fabry Disease based on clinical and biochemical evidence.
Varnost in učinkovitost zdravila Replagal so ovrednotili v dveh randomiziranih dvojno slepih, s placebom kontroliranih študijah in odprtih nadaljevalnih študijah, pri 40 bolnikih z diagnozo Fabryjeve bolezni, ki je temeljila na kliničnih in biokemičnih dokazih.
The safety and efficacy of Resolor for use in patients with severe and clinically unstable concomitant disease (e.g. cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders) have not been established in controlled clinical trials.
Varnost in učinkovitost zdravila Resolor za uporabo pri bolnikih s hudimi in klinično nestabilnimi spremljevalnimi boleznimi (tj. srčno-žilnimi boleznimi ali pljučnimi boleznimi, nevrološkimi ali psihiatričnimi motnjami, rakom ali aidsom in drugimi boleznimi endokrinega sistema) nista bili ugotovljeni v kontroliranih kliničnih preskušanjih.
The safety and efficacy of Respreeza was evaluated in a randomized, double-blind, placebo- controlled, multi-center study (RAPID) followed by a 2-year open-label extension study (RAPID extension study).
Varnost in učinkovitost zdravila Respreeza so ocenili v randomizirani, dvojno slepi, s placebom nadzorovani multicentrični študiji (RAPID), ki ji je sledil 2-letni odprt podaljšek študije (podaljšek študije RAPID).
The safety and efficacy of retigabine in children below 18 years of age has not yet been established (see section 5.2).
Varnost in učinkovitost retigabina pri otrocih, mlajših od 18 let, še nista ugotovljeni (glejte poglavje 5.2).
The safety and efficacy of retigabine in children below 18 years of age has not yet been established (see section 5.2).
Varnost in učinkovitost retigabina pri otrocih, mlajših od 18. let, še nista ugotovljeni (glejte poglavje 5.2).
The safety and efficacy of ribavirin used together with direct-acting-anti-virals in these patients has not been established.
Varnost in učinkovitost zdravila Ribavirin Mylan s pegilirano ali drugimi oblikami interferona (ki ni alfa-2b) pri teh bolnikih niso ovrednotili
The safety and efficacy of riociguat in children and adolescents below 18 years have not been established.
Varnost in učinkovitost riociguata pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
The safety and efficacy of RoActemra in children below 2 years of age has not been established.
Varnost in učinkovitost zdravila RoActemra pri otrocih, mlajših od 2 let, ni dokazana.
The safety and efficacy of RoActemra subcutaneous formulation in children from birth to less than 18 years have not been established.
Varnost in učinkovitost zdravila RoActemra v subkutani obliki pri bolnikih od rojstva do 18. leta nista dokazani.
The safety and efficacy of Romiplostim in children aged under 18 years has not yet been established.
Varnost in učinkovitost romiplostima pri otrocih, starih do 18 let, še nista bili dokazani.
The safety and efficacy of Ruconest in children (age 0 to 12 years) have not yet been established.
Varnost in učinkovitost zdravila Ruconest pri otrocih, starih 0 do 12 let, še nista dokazani.
The safety and efficacy of rufinamide of children aged 4 years and less have not yet been established.
Varnost in učinkovitost rufinamida pri otrocih, starih 4 leta ali manj, še nista bili dokazani.
The safety and efficacy of rufinamide of children aged 4 years and less have not yet been established.
Varnost in učinkovitost rufinamida pri otrocih, starih 4 leta in manj, še nista bili dokazani.
The safety and efficacy of saxagliptin as triple oral therapy in combination with metformin and a thiazolidinedione has not been established.
Varnost in učinkovitost saksagliptina v kombinirani tritirni peroralni terapiji z metforminom in tiazolidindionom nista ugotovljeni.
The safety and efficacy of Sevelamer carbonate Zentiva have not been established in children below the age of 18 years.
Varnosti in učinkovitosti zdravila Sevelamer carbonate Zentiva pri otrocih pod 18 let niso ugotavljali.
The safety and efficacy of Sevelamer carbonate Zentiva have not been established in patients with the following disorders:
Varnosti in učinkovitosti zdravila Sevelamer carbonate Zentiva niso ugotavljali pri bolnikih z naslednjimi boleznimi:
The safety and efficacy of sildenafil was maintained in long term studies.
Varnost in učinkovitost sildenafila sta se ohranili tudi v dolgoročnih preizkušanjih.
The safety and efficacy of siltuximab have not been established in paediatric patients.
Varnost in učinkovitost siltuksimaba pri pediatričnih bolnikih nista bili dokazani.
The safety and efficacy of SIMBRINZA in children and adolescents aged 2 to 17 years has not been established.
Varnost in učinkovitost zdravila SIMBRINZA pri otrocih in mladostnikih, starih od 2 do 17 let, še nista bili dokazani.
The safety and efficacy of Simponi were evaluated in a multi-centre, randomised, double-blind, placebo-controlled study (GO-REVEAL) in 405 adult patients with active PsA (≥ 3 swollen joints and
Učinkovitost zdravila Simponi so ocenili v dveh randomiziranih, dvojno slepih, s placebom kontroliranih kliničnih študijah pri odraslih bolnikih.
The safety and efficacy of Simponi were evaluated in a multi-centre, randomised, double-blind, placebo-controlled study (GO-REVEAL) in 405 adult patients with active PsA (≥ 3 swollen joints and
Varnost in učinkovitost zdravila Simponi so ovrednotili v multicentrični, randomizirani, dvojno slepi in s placebom nadzorovani študiji (GO-REVEAL) pri 405 odraslih bolnikih z aktivnim PsA (z
The safety and efficacy of Soliris have not been studied in patients with hepatic impairment.
Varnost in učinkovitost zdravila Soliris pri bolnikih z okvaro jeter ni bila preučena.
The safety and efficacy of Soliris in PNH patients with haemolysis were assessed in a randomized, double-blind, placebo-controlled 26 week study (C04-001).
Varnost in učinkovitost zdravila Soliris pri bolnikih s PNH s hemolizo so preučevali v okviru 26- tedenske randomizirane dvojno slepe, s placebom kontrolirane študije (C04-001).
The safety and efficacy of SOMAVERT in patients with renal or hepatic insufficiency has not been established.
Pri bolnikih z okvaro ledvic ali jeter varnost in učinkovitost zdravila SOMAVERT nista bili dokazani.
The safety and efficacy of Sovaldi in children and adolescents aged <18 years have not yet been established.
Varnost in učinkovitost zdravila Sovaldi pri otrocih in mladostnikih, starih < 18 let, še nista bili dokazani.
The safety and efficacy of SPRYCEL in children and adolescents below 18 years of age have not yet been established.
Varnost in učinkovitost zdravila SPRYCEL pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
The safety and efficacy of STELARA in children with psoriasis less than 12 years of age or in children with psoriatic arthritis less than 18 years of age have not yet been established.
Učinkovitosti in varnosti zdravila STELARA pri otrocih, mlajših od 12 let, niso ugotovili.
The safety and efficacy of Stivarga in children and adolescents in the indication of gastrointestinal stromal tumors (GIST) have not been established.
Varnost in učinkovitost regorafeniba pri bolnikih, starih do 18 let, z indikacijo za zdravljenje gastrointestinalnih stromalnih tumorjev (GIST), nista bili dokazani.
The safety and efficacy of Stribild in children aged 6 to less than 18 years have not yet been established.
Varnost in učinkovitost zdravila Stribild pri otrocih, starih 6 do manj kot 18 let, še nista bili dokazani.
The safety and efficacy of Strimvelis in children less than six months of age or over 6 years 1 month has not been established (see section 4.4).
Varnost in učinkovitost zdravila Strimvelis pri otrocih, mlajših od 6 mesecev ali starejših od 6 let in 1 meseca, nista bili ugotovljeni (glejte poglavje 4.4).
The safety and efficacy of SUTENT in patients below 18 years of age have not been established.
Varnost in učinkovitost zdravila SUTENT pri bolnikih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of Taltz in children and adolescents aged 6 to 18 years have not yet been established.
Varnost in učinkovitost zdravila Taltz pri otrocih in mladostnikih, starih od 6 do 18 let, še nista bili dokazani.
The safety and efficacy of Tasigna in children from birth to less than 18 years have not yet been established (see section 5.1).
Varnost in učinkovitost zdravila Tasigna pri otrocih od rojstva do starosti manj kot 18 let še nista bili dokazani (glejte poglavje 5.1).
The safety and efficacy of Taxespira in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Varnost in učinkovitost zdravila Taxespiraza zdravljenje nazofaringealnega karcinoma pri otrocih od 1 meseca do manj kot 18 let starosti nista ugotovljeni.
The safety and efficacy of Tecfidera in children and adolescents aged 10 to 18 years have not been established.
Varnosti in učinkovitosti zdravila Tecfidera pri otrocih in mladostnikih, starih 10 do 18 let, niso dokazali.
The safety and efficacy of tedizolid phosphate in patients with neutropenia (neutrophil counts
Varnost in učinkovitost tedizolid fosfata pri bolnikih z nevtropenijo (število nevtrofilcev
The safety and efficacy of tedizolid phosphate when administered for periods longer than 6 days have not been established in patients (see section 4.4).
Varnost in učinkovitost tedizolid fosfata pri uporabi, daljši od 6 dni, pri bolnikih nista bili dokazani (glejte poglavje 4.4).
The safety and efficacy of Telmisartan Teva in children and adolescents aged below 18 have not been established.
Varnost in učinkovitost zdravila Telmisartan Teva pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
The safety and efficacy of Telmisartan Teva Pharma in children and adolescents aged below 18 have not been established.
Varnost in učinkovitost zdravila Telmisartan Teva Pharma pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
The safety and efficacy of tenofovir disoproxil fumarate in children with chronic hepatitis B aged 2 to < 12 years or weighing < 35 kg have not been established.
Varnost in učinkovitost dizoproksiltenofovirijevega fumarata pri otrocih s kroničnim hepatitisom B, starih 2 leti do < 12 let ali s telesno maso < 35 kg, še nista bili dokazani.