natgillin/translations-raw huggingface dataset:
The safety and efficacy of axitinib in children and adolescents &lt; 18 years have not been established.
Sigurnost i djelotvornost aksitiniba u djece i adolescenata &lt; 18 godina nisu ustanovljene.
The safety and efficacy of cabozantinib in children aged &lt; 18 years have not yet been established.
Sigurnost i djelotvornost kabozantiniba u djece mlađe od 18 godina nije utvrđena.
The safety and efficacy of cabozantinib in children and adolescents aged &lt; 18 years have not yet been established.
Sigurnost i djelotvornost kabozantiniba u djece i adolescenata u dobi do 18 godina nisu još ustanovljene.
The safety and efficacy of conversion from calcineurin inhibitors to Rapamune in maintenance renal transplant patients (6-120 months after transplantation) was assessed in a randomised, multicentre, controlled trial, stratified by calculated GFR at baseline (20-40 -mL/min vs above 40 mL/min).
Sigurnost i djelotvornost prebacivanja s inhibitora kalcineurina na Rapamune u bolesnika koji održavaju presadak bubrega (6-120 mjeseci nakon presađivanja) procijenjena je u randomiziranom, multicentričnom, kontroliranom ispitivanju u kojem su ispitanici podijeljeni u skupine prema izračunatoj početnoj vrijednosti brzine glomerularne filtracije (20-40 ml/min nasuprot &gt; 40 ml/min).
The safety and efficacy of conversion from calcineurin inhibitors to Rapamune in maintenance renal transplant patients (6-120 months after transplantation) was assessed in a randomised, multicentre, controlled trial, stratified by calculated GFR at baseline (20-40 mL/min vs. above 40 mL/min).
Sigurnost i djelotvornost prebacivanja s inhibitora kalcineurina na Rapamune u bolesnika koji održavaju presadak bubrega (6-120 mjeseci nakon presađivanja) procijenjena je u randomiziranom, multicentričnom, kontroliranom ispitivanju u kojem su ispitanici podijeljeni u skupine prema izračunatoj početnoj vrijednosti brzine glomerularne filtracije (20-40 ml/min nasuprot &gt; 40 ml/min).
The safety and efficacy of Cyramza in children and adolescents ( &lt; 18 years) has not been established.
Sigurnost i djelotvornost lijeka Cyramza u djece i adolescenata ( &lt; 18 godina) nisu ustanovljene.
The safety and efficacy of dabrafenib have not yet been established in children and adolescents ( &lt; 18 years).
Sigurnost i djelotvornost dabrafeniba u djece i adolescenata u dobi do 18 godina nisu još ustanovljene.
The safety and efficacy of Dacogen in children aged &lt; 18 years have not yet been established.
Sigurnost primjene i djelotvornost Dacogena u djece dobi &lt; 18 godina, još nije ustanovljena.
The safety and efficacy of Daklinza in children and adolescents aged &lt; 18 years have not yet been established.
Sigurnost i djelotvornost lijeka Daklinza u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
The safety and efficacy of dalbavancin in children aged from birth to &lt; 18 years has not yet been established.
Sigurnost i djelotvornost dalbavancina u djece u dobi od rođenja do &lt; 18 godina još nije ustanovljena.
The safety and efficacy of dapagliflozin in children aged 0 to &lt; 18 years have not yet been established.
Sigurnost i djelotvornost dapagliflozina u djece od rođenja do &lt; 18 godina još nisu ustanovljene.
The safety and efficacy of Descovy in children younger than 12 years of age, or weighing &lt; 35 kg, have not yet been established.
Sigurnost i djelotvornost lijeka Descovy u djece mlaĎe od 12 godina ili teţine &lt; 35 kg nisu još ustanovljene.
The safety and efficacy of Ebymect in children and adolescents aged 0 to &lt; 18 years have not yet been established.
Sigurnost i djelotvornost lijeka Ebymect u djece i adolescenata od rođenja do &lt; 18 godina još nisu ustanovljene.
The safety and efficacy of Edarbi in children and adolescents aged 0 to &lt; 18 years have not yet been established.
Sigurnost i djelotvornost Edarbija u djece i adolescenata u dobi od 0 do &lt; 18 godina još nisu ustanovljene.
The safety and efficacy of EDURANT in children aged &lt; 12 years have not yet been established.
Sigurnost i djelotvornost EDURANTA u djece mlađe od 12 godina nisu još ustanovljene.
The safety and efficacy of Efficib in children and adolescents from birth to &lt; 18 years of age have not been established.
Sigurnost i djelotvornost lijeka Efficib u djece i adolescenata od rođenja do &lt; 18 godina nisu ustanovljene.
The safety and efficacy of eltrombopag has not been established in children and adolescents ( &lt; 18 years) with chronic HCV related thrombocytopenia or SAA.
Sigurnost i djelotvornost eltrombopaga u djece i adolescenata ( &lt; 18 godina) s trombocitopenijom povezanom s kroničnim HCV-om ili teškom aplastičnom anemijom nisu ustanovljene.
The safety and efficacy of Epclusa has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] &lt; 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis (see section 5.2).
Sigurnost i djelotvornost lijeka Epclusa nije procijenjena u bolesnika s teškim oštećenjem bubrega (procijenjena brzina glomerularne filtracije [eGFR] &lt; 30 ml/min/1,73 m2) ili završni stadij bolesti bubrega koji zahtijeva hemodijalizu (vidjeti dio 5.2).
The safety and efficacy of erlotinib has not been studied in patients with severe hepatic dysfunction (AST/SGOT and ALT/SGPT &gt; 5 x ULN).
Sigurnost i djelotvornost erlotiniba u bolesnika s teškim poremećajima funkcije jetre (AST/SGOT i ALT/SGPT &gt; 5 x gornja granica normalnih vrijednosti) nije ispitana.
The safety and efficacy of Eucreas in children and adolescents ( &lt; 18 years) have not been established.
Sigurnost i djelotvornost Eucreasa u djece i adolescenata ( &lt; 18 godina) nisu ustanovljene.
The safety and efficacy of filgrastim administration in de novo AML patients aged &lt; 55 years with good cytogenetics [t (8; 21), t (15; 17), and inv (16)] have not been established.
Sigurnost i djelotvornost primjene filgrastima u bolesnika s de novo AML u dobi &lt; 55 godina s dobrim citogenetskim nalazom [t (8; 21), t (15; 17), i inv (16)] nisu ustanovljene.
The safety and efficacy of filgrastim administration in de novo AML patients aged &lt; 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Sigurnost i djelotvornost primjene filgrastima nije utvrđena u bolesnika mlađih od 55 godina s de novo akutnom mijeloičnom leukemijom i povoljnim citogenetskim obilježjima [t(8;21), t(15;17) i inv(16)].
The safety and efficacy of filgrastim administration in de novo AML patients aged &lt; 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Sigurnost i djelotvornost primjene filgrastima u bolesnika s de novo AML u dobi od &lt; 55 godina s povoljnim citogenetskim nalazom [t(8;21), t(15;17), i inv(16)] nisu ustanovljene.
The safety and efficacy of filgrastim administration in de novo AML patients aged &lt; 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Sigurnost i djelotvornost primjene filgrastima u bolesnika s de novo AML-om mlađima od 55 godina i povoljnim citogenetskim nalazom [t(8;21), t(15;17) i inv(16)] nisu provjerene.
The safety and efficacy of filgrastim have not been assessed in normal donors &lt; 16 years or &gt; 60 years.
Sigurnost i djelotvornost primjene filgrastima u zdravih davatelja mlađih od 16 i starijih od 60 godina nisu ispitane.
The safety and efficacy of Galvus in children and adolescents ( &lt; 18 years) have not been established.
Sigurnost i djelotvornost Galvusa u djece i adolescenata ( &lt; 18 godina) nisu još ustanovljene.
The safety and efficacy of Gazyvaro has not been established in patients with severe renal impairment (CrCl &lt; 30 mL/min).
Sigurnost i djelotvornost lijeka Gazyvaro u bolesnika s teškim oštećenjem funkcije bubrega (CrCl &lt; 30 ml/min) nisu ustanovljene.
The safety and efficacy of Genvoya in children younger than 12 years of age, or weighing &lt; 35 kg, have not yet been established.
Sigurnost i djelotvornost lijeka Genvoya u djece mlađe od 12 godina ili težine &lt; 35 kg nisu još ustanovljene.
The safety and efficacy of Humira was assessed in an open-label, multicenter study in 32 children (2 - &lt; 4 years old or aged 4 and above weighing &lt; 15 kg) with moderately to severely active polyarticular JIA.
Sigurnost i djelotvornost primjene lijeka Humira ocijenjena je u otvorenom, multicentričnom ispitivanju koje je uključivalo 32 djece (u dobi od 2 do manje od 4 godine ili u dobi od 4 godine i više i tjelesne težine manje od 15 kg) s umjerenim do teškim aktivnim poliartikularnim JIA.
The safety and efficacy of Icandra in children and adolescents ( &lt; 18 years) have not been established.
Sigurnost i djelotvornost Icandre u djece i adolescenata ( &lt; 18 godina) nisu ustanovljene.
The safety and efficacy of INCIVO in children aged &lt; 18 years have not yet been established.
Sigurnost i djelotvornost lijeka INCIVO u djece u dobi &lt; 18 godina nisu još ustanovljene.
The safety and efficacy of Incresync in children and adolescents &lt; 18 years old have not been established.
Sigurnost i djelotvornost lijeka Incresync u djece i adolescenata &lt; 18 godina starosti nisu utvrđene.
The safety and efficacy of Ipreziv in children and adolescents 0 to &lt; 18 years have not yet been established.
Sigurnost i djelotvornost Ipreziva u djece i adolescenata u dobi od 0 do &lt; 18 godina još nisu ustanovljene.
The safety and efficacy of Jalra in children and adolescents ( &lt; 18 years) have not been established.
Sigurnost i djelotvornost Jalre u djece i adolescenata ( &lt; 18 godina) nisu još ustanovljene.
The safety and efficacy of Janumet in children and adolescents from birth to &lt; 18 years of age have not been established.
Sigurnost i djelotvornost lijeka Janumet u djece i adolescenata od rođenja do &lt; 18 godina nisu ustanovljene.
The safety and efficacy of lenalidomide was assessed in a Phase III multicenter, randomized double blind 3 arm study (MM-015) of patients who were 65 years or older and had a serum creatinine &lt; 2.5 mg/dL.
Sigurnost i djelotvornost lenalidomida procijenjena je u multicentričnom, randomiziranom, dvostruko slijepom ispitivanju faze III (MM-015) na 3 skupine bolesnika u dobi od 65 godina ili starijih, koji su imali kreatinin u serumu &lt; 2,5 mg/dL.
The safety and efficacy of lenvatinib in children aged 2 to &lt; 18 years have not yet been established (see section 5.1).
Sigurnost i djelotvornost lenvatiniba u djece u dobi od 2 do &lt; 18 godina nisu još ustanovljene (vidjeti dio 5.1).
The safety and efficacy of Lojuxta in children &lt; 18 years have not been established and the use of this medicinal product in children is therefore not recommended.
Sigurnost i djelotvornost Lojuxte u djece &lt; 18 godina nije ustanovljena pa se stoga u djece ne preporučuje upotreba ovog lijeka.
The safety and efficacy of naloxegol in children &lt; 18 years of age has not yet been established.
Sigurnost i djelotvornost naloksegola u djece &lt; 18 godina nisu još ustanovljene.
The safety and efficacy of Nordimet in children &lt; 3 years of age have not been established (see section 4.4).
Sigurnost i djelotvornost Nordimeta u djece u dobi &lt; 3 godine nisu ustanovljene (vidjeti dio 4.4).
The safety and efficacy of Odefsey in children younger than 12 years of age, or weighing &lt; 35 kg, have not yet been established.
Sigurnost i djelotvornost lijeka Odefsey u djece mlađe od 12 godina ili težine &lt; 35 kg nisu još ustanovljene.
The safety and efficacy of Onglyza in children aged birth to &lt; 18 years have not yet been established.
Sigurnost i djelotvornost lijeka Onglyza u djece od rođenja do &lt; 18 godina nisu još ustanovljene.
The safety and efficacy of oritavancin in children and adolescents ( &lt; 18 years) has not yet been established.
Sigurnost i djelotvornost oritavancina u djece i adolescenata ( &lt; 18 godina) nisu još ustanovljene.
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, &gt; 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.
Sigurnost i djelotvornost palonosetrona u jednokratnim i.v. dozama od 1 µg/kg i 3 µg/kg uspoređivala se u prvom kliničkom ispitivanju provedenom na 150 bolesnika dobnih skupina &gt; 28 dana do 23 mjeseca (7 bolesnika), 2 do 11 godina (96 bolesnika) i 12 do 16 godina (47 bolesnika), koji su podvrgnuti elektivnom kirurškom zahvatu.
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, &gt; 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.
Sigurnost i djelotvornost palonosetrona u jednokratnim i.v. dozama od 3 µg/kg i 10 µg/kg ispitivane su u prvom kliničkom ispitivanju provedenom na 72 bolesnika dobnih skupina &gt; 28 dana do 23 mjeseca (12 bolesnika), 2 do 11 godina (31 bolesnik) i 12 do 17 godina (29 bolesnika) koji su primali visoko ili umjereno emetogenu kemoterapiju.
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, &gt; 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.
Sigurnost i djelotvornost palonosetrona u jednokratnim i.v. dozama od 3 µg/kg i 10 µg/kg ispitivane su u prvom kliničkom ispitivanju provedenom na 72 bolesnika dobnih skupina &gt; 28 dana do 23 mjeseca (12 bolesnika), 2 do 11 godina (31 bolesnik) i 12 do 17 godina (29 bolesnika), koji su primali visoko ili umjereno emetogenu kemoterapiju.
The safety and efficacy of palonosetron intravenously at single doses of 3 mcg/kg and 10 mcg/kg was investigated in the first clinical study in 72 patients in the following age groups, &gt; 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.
Sigurnost i djelotvornost primjene jedne intravenske doze palonozetrona od 3 µg/kg i 10 µg/kg ispitivane su u prvom kliničkom ispitivanju provedenom na 72 bolesnika dobnih skupina &gt; 28 dana do 23 mjeseca (12 bolesnika), 2 do 11 godina (31 bolesnik) i 12 do 17 godina (29 bolesnika) koji su primali visoko ili umjereno emetogenu kemoterapiju.
The safety and efficacy of palonosetron intravenously 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, &gt; 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.
Sigurnost i djelotvornost palonosetrona u jednokratnim i.v. dozama od 3 µg/kg i 10 µg/kg ispitivane su u prvom kliničkom ispitivanju provedenom na 72 bolesnika dobnih skupina &gt; 28 dana do 23 mjeseca (12 bolesnika), 2 do 11 godina (31 bolesnik) i 12 do 17 godina (29 bolesnika) koji su primali visoko ili umjereno emetogenu kemoterapiju.
The safety and efficacy of Pixuvri in children aged &lt; 18 years has not yet been established.
Sigurnost i djelotvornost Pixuvria u djece u dobi &lt; 18 godine nije još ustanovljena.
The safety and efficacy of prophylactic doses in obese patients (with BMI &gt; 30 kg/m2) has not been fully determined and there is no consensus for dose adjustment.
Sigurnost i djelotvornost profilaktičkih doza u pretilih bolesnika (s ITM &gt; 30 kg/m2) još nije u potpunosti utvrđena i stoga nema usuglašenog mišljenja o prilagodbi doze.
The safety and efficacy of Renvela have not been established in adult patients with chronic kidney disease not on dialysis with serum phosphorus &lt; 1.78 mmol/l.
Nije ustanovljena sigurnost primjene i djelotvornost lijeka Renvela u odraslih bolesnika s kroničnom bubrežnom bolešću koji nisu na dijalizi, a koji imaju razinu fosfora u serumu &lt; 1,78 mmol/l.
The safety and efficacy of rilpivirine in children aged &lt; 12 years have not yet been established.
Djelotvornost i sigurnost primjene rilpivirina u djece mlađe od 12 godina još nisu utvrđene.
The safety and efficacy of Ristfor in children and adolescents from birth to &lt; 18 years of age have not been established.
Sigurnost i djelotvornost lijeka Ristfor u djece i adolescenata od rođenja do &lt; 18 godina nisu ustanovljene.
The safety and efficacy of Selincro in children and adolescents &lt; 18 years of age have not been established.
Sigurnost i djelotvornost Selincra u djece i adolescenata u dobi &lt; 18 godina nisu još ustanovljene.
The safety and efficacy of SIRTURO in children aged &lt; 18 years have not yet been established.
Sigurnost i djelotvornost lijeka SIRTURO u djece u dobi &lt; 18 godina nisu još ustanovljene.
The safety and efficacy of Sovaldi in children and adolescents aged &lt; 18 years have not yet been established.
Sigurnost i djelotvornost Sovaldija u djece i adolescenata u dobi &lt; 18 godina nisu još ustanovljene.
The safety and efficacy of tenofovir disoproxil fumarate in children with chronic hepatitis B aged 2 to &lt; 12 years or weighing &lt; 35 kg have not been established.
Sigurnost i djelotvornost tenofovirdizoproksilfumarata u djece s kroničnim hepatitisom B u dobi od 2 do &lt; 12 godina ili tjelesne težine &lt; 35 kg nisu ustanovljene.
The safety and efficacy of tenofovir disoproxil fumarate in children with chronic hepatitis B aged 2 to &lt; 12 years or weighing &lt; 35 kg have not been established.
Sigurnost i djelotvornost tenofovirdizoproksilfumatara u djece s kroničnim hepatitisom B u dobi od 2 do &lt; 12 godina ili tjelesne težine &lt; 35 kg nisu ustanovljene.
The safety and efficacy of tenofovir disoproxil fumarate in children with chronic hepatitis B aged 2 to &lt; 12 years or weighing &lt; 35 kg have not been established.
Sigurnost i djelotvornost tenofovirdizoproksilfumatara u djece s kroničnim hepatitisom B u dobi od 2 do &lt; 12 godina ili tjelesne težine ≥ 35 kg nisu ustanovljene.
The safety and efficacy of the dose interval adjustments to every 72 or 96 hours in patients with creatinine clearance &lt; 30 ml/min have not been clinically evaluated.
Sigurnost i djelotvornost prilagodbi intervala doziranja na svaka 72 ili 96 sati u pacijenata s klirensom kreatinina &lt; 30 ml/min nisu klinički analizirane.
The safety and efficacy of this medicinal product in children and adolescents aged 0 to &lt; 18 years have not yet been established.
Sigurnost i djelotvornost ovog lijeka kod djece i adolescenata u dobi od 0 do &lt; 18 godina još nisu ustanovljene.
The safety and efficacy of this medicinal product in children and adolescents from birth to &lt; 18 years of age have not been established.
Sigurnost i djelotvornost ovog lijeka Komboglyze u djece i adolescenata od rođenja do &lt; 18 godina starosti nisu ustanovljene.
The safety and efficacy of this medicinal product in children and adolescents from birth to &lt; 18 years of age have not been established.
Sigurnost i djelotvornost ovog lijeka u djece i adolescenata od rođenja do &lt; 18 godina starosti nisu ustanovljene.
The safety and efficacy of trametinib has not been established in children and adolescents ( &lt; 18 years).
Sigurnost i djelotvornost trametiniba u djece i adolescenata ( &lt; 18 godina) nisu ustanovljene.
The safety and efficacy of TREVICTA in children and adolescents &lt; 18 years of age have not been established.
Sigurnost i djelotvornost primjene lijeka TREVICTA u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
The safety and efficacy of Velmetia in children and adolescents from birth to &lt; 18 years of age have not been established.
Sigurnost i djelotvornost lijeka Velmetia u djece i adolescenata od rođenja do &lt; 18 godina nisu ustanovljene.
The safety and efficacy of vemurafenib has not been yet established in children and adolescents ( &lt; 18 years).
Sigurnost i djelotvornost vemurafeniba u djece i adolescenata ( &lt; 18 godina) nisu još ustanovljene.
The safety and efficacy of Vipdomet in children and adolescents &lt; 18 years old have not been established.
Sigurnost i djelotvornost lijeka Vipdomet u djece i adolescenata &lt; 18 godina starosti nisu utvrđene.
The safety and efficacy of Vipidia in children and adolescents &lt; 18 years old have not been established.
Sigurnost i djelotvornost lijeka Vipidia u djece i adolescenata &lt; 18 godina starosti nisu ustanovljene.
The safety and efficacy of Voncento in children &lt; 12 years with haemophilia A have not been established.
Sigurnost i djelotvornost lijeka Voncento u djece u dobi &lt; 12 godina s hemofilijom A još nije ustanovljena.
The safety and efficacy of Voncento in children &lt; 12 years with haemophilia A have not been established.
Sigurnost i djelotvornost lijekaVoncento u djece u dobi &lt; 12 godina s hemofilijom A nije utvrđena.
The safety and efficacy of Voncento in children &lt; 12 years with haemophilia A have not been established.
Sigurnost lijeka Voncento u djece u dobi &lt; 12 godina s hemofilijom A još nije ustanovljena.
The safety and efficacy of Xeplion in children and adolescents &lt; 18 years of age have not been established.
Sigurnost i djelotvornost lijeka Xeplion u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
The safety and efficacy of XGEVA have not been established in paediatric patients (age &lt; 18) other than skeletally mature adolescents with giant cell tumour of bone.
Liječenje koštano sazrelih adolescenata s gigantocelularnim tumorom kosti koji je neresektabilan ili gdje kirurška resekcija može rezultirati teškim morbiditetom: doziranje je isto kao u odraslih.
The safety and efficacy of Xigduo in children and adolescents aged 0 to &lt; 18 years have not yet been established.
Sigurnost i djelotvornost lijeka Xigduo u djece i adolescenata od rođenja do &lt; 18 godina još nisu ustanovljene.
The safety and efficacy of Xiliarx in children and adolescents ( &lt; 18 years) have not been established.
Sigurnost i djelotvornost Xiliarxa u djece i adolescenata ( &lt; 18 godina) nisu još ustanovljene.
The safety and efficacy of Xydalba in children aged from birth to &lt; 18 years have not yet been established.
Sigurnost i djelotvornost lijeka Xydalba u djece u dobi od rođenja do &lt; 18 godina još nije ustanovljena.
The safety and efficacy of Zinforo in children aged birth to &lt; 2 months have not been established.
Sigurnost i djelotvornost lijeka Zinforo u djece od rođenja do &lt; 2 mjeseca nisu ustanovljene.
The safety and efficacy of Zomarist in children and adolescents ( &lt; 18 years) have not been established.
Sigurnost i djelotvornost Zomariste u djece i adolescenata ( &lt; 18 godina) nisu ustanovljene.
The safety assessment of rilpivirine is based on Week 48 data from one single-arm open-label study (TMC278-C213) in 36 paediatric patients 12 to &lt; 18 years and weighing at least 32 kg.
Sigurnosno ocjenjivanje rilpivirina utemeljeno je na podacima 48. tjedna iz otvorenog ispitivanja s jednom skupinom (TMC278-C213) u 36 pedijatrijskih bolesnika u dobi od 12 do &lt; 18 godina s tjelesnom težinom od najmanje 32 kg.
The safety data from this study in patients aged 6 to &lt; 18 years appeared generally similar to that observed in adults.
Podaci o sigurnosti iz ovog ispitivanja na bolesicima u dobi od 6 do &lt; 18 godina starosti smatrale su se općenito sličnima onima primijećenima kod odraslih osoba.
The safety data from this study in patients aged 6 to &lt; 18 years appeared generally similar to that observed in adults.
Podaci o sigurnosti iz ovog ispitivanja u bolesnika u dobi od 6 do &lt; 18 godina općenito su bili slični onima uočenim u odraslih.
The safety data from this study in patients aged 6 to &lt; 18 years appeared generally similar to that observed in adults.
Sigurnost i djelotvornost podataka iz ovog ispitivanja na bolesicima u dobi 6 do &lt; 18 godina starosti smatrale su se općenito sličnima onima primijećenima kod odraslih osoba.