natgillin/translations-raw huggingface dataset:
The safety and efficacy of Mozobil in children less than 18 years have not yet been established.
Sigurnost i djelotvornost primjene lijeka Mozobil u djece mlađe od 18 godina još nije utvrđena.
The safety and efficacy of multiple doses of Humira were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Sigurnost i djelotvornost višestrukih doza lijeka Humira ispitivane su u randomiziranim, dvostruko slijepim, placebom kontroliranim kliničkim ispitivanjima u odraslih bolesnika sa srednje teškim do teškim oblikom aktivnog ulceroznog kolitisa (Mayo rezultat od 6 do 12 uz endoskopski podrezultat od 2 do 3).
The safety and efficacy of Myocet in children aged up to 17 years has not been established.
Djelotvornost i sigurnost Myoceta u djece u dobi do 17 godina ustanovljena.
The safety and efficacy of Naglazyme was assessed in a randomised, double blind, placebo controlled, Phase 3 study of 39 MPS VI patients, ranging in age from 5 to 29 years.
Sigurnost i djelotvornost Naglazyme je procijenjena kroz randomiziranu, dvostruko-slijepu placebo- kontroliranu studiju faze 3 na 39 MPS VI bolesnika u dobi od 5 do 29 godina.
The safety and efficacy of Neulasta administration in de novo AML patients aged  55 years with cytogenetics t(15;17) have not been established.
Sigurnost i djelotvornost primjene Neulaste u bolesnika s de novo AML mlađih od 55 godina s citogenetskim nalazom t(15;17) nisu utvrđeni.
The safety and efficacy of Neulasta have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Sigurnost i djelotvornost Neulaste nisu ispitivani u bolesnika koji primaju kemoterapiju povezanu s odgođenom mijelosupresijom, npr. nitrozoureju.
The safety and efficacy of Neulasta have not been investigated in patients receiving high dose chemotherapy.
Nisu provedena ispitivanja sigurnosti i djelotvornosti Neulaste u bolesnika koji primaju visokodoznu kemoterapiju.
The safety and efficacy of Neulasta have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary Acute Myeloid Leukaemia (AML); therefore, it should not be used in such patients.
Sigurnost i djelotvornost Neulaste nije ispitivana u bolesnika s mijelodisplastičnim sindromom, kroničnom mijeloičnom leukemijom te u bolesnika sa sekundarnom akutnom mijeloičnom leukemijom (AML), stoga se lijek ne smije primjenjivati u tih bolesnika.
The safety and efficacy of NeuroBloc in children aged 0-18 years have not yet been established.
Sigurnost i djelotvornost lijeka NeuroBloc u djece u dobi od 0 do 18 godina nisu još ustanovljene.
The safety and efficacy of NEVANAC in children and adolescents have not been established.
Sigurnost i djelotvornost NEVANAC-a kod djece i adolescena nisu ustanovljene.
The safety and efficacy of Nimenrix in children under 12 months of age has not yet been established.
Sigurnost i djelotvornost cjepiva Nimenrix u djece u dobi do 12 mjeseci nisu još ustanovljene.
The safety and efficacy of nintedanib have not been investigated in patients with hepatic impairment classified as Child Pugh B and C. Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Ofev is not recommended (see section 5.2).
Sigurnost i djelotvornost nintedaniba nisu ispitani u bolesnika s oštećenjem funkcije jetre klasificiranim kao Child Pugh B i C. Liječenje Ofevom ne preporučuje u bolesnika s umjerenim (Child Pugh B) i teškim (Child Pugh C) oštećenjem funkcije jetre (vidjeti dio 5.2).
The safety and efficacy of nivolumab in combination with ipilimumab or nivolumab vs. ipilimumab monotherapy for the treatment of advanced (unresectable or metastatic) melanoma were evaluated in a phase 3, randomised, double-blind study (CA209067).
Sigurnost i djelotvornost nivolumaba u kombinaciji s ipilimumabom ili nivolumaba u monoterapiji naspram monoterapije ipilimumabom za liječenje uznapredovalog (neresektabilnog ili metastatskog) melanoma ispitivane su u randomiziranom, dvostruko slijepom ispitivanju faze 3 (CA209067).
The safety and efficacy of Nonafact in children less than 6 years of age has not been established.
Sigurnost i djelotvornost lijeka Nonafact u djece starosti manje od 6 godina nisu još ustanovljene.
The safety and efficacy of Norvir in childred aged below 2 years has not been established.
Sigurnost i djelotvornost lijeka Norvir u djece u dobi manjoj od 2 godine nisu još ustanovljene.
The safety and efficacy of Norvir in children aged below 2 years has not been established.
Sigurnost i djelotvornost lijeka Norvir u djece u dobi do 2 godine nisu još ustanovljene.
The safety and efficacy of NovoEight in previously untreated patients have not yet been established.
Sigurnost i djelotvornost lijeka NovoEight u bolesnika koji prethodno nisu bili liječeni još nisu ustanovljene.
The safety and efficacy of Nucala in children and adolescents under 18 years of age has not yet been established.
Sigurnost i djelotvornost lijeka Nucala u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
The safety and efficacy of Nuwiq in previously untreated patients have not yet been established.
Sigurnost i djelotvornost lijeka Nuwiq u bolesnika koji prethodno nisu liječeni nisu još ustanovljene.
The safety and efficacy of Odefsey in patients co-infected with HIV-1 and HBV or HCV has not been established.
Sigurnost i djelotvornost primjene lijeka Odefsey u bolesnika istodobno zaraženih virusom HIV-1 i virusom hepatitisa B (HBV) ili C (HCV) nisu ustanovljene.
The safety and efficacy of olaparib as a maintenance therapy in the treatment of platinum-sensitive relapsed (PSR) high grade serous ovarian, including fallopian tube or primary peritoneal cancer patients, following treatment with two or more platinum containing regimens, was studied in a Phase II randomised, double-blind, placebo-controlled trial (study 19).
Sigurnost i djelotvornost olapariba kao terapije održavanja u liječenju recidiva na platinu osjetljivog seroznog karcinoma jajnika visokog stupnja nediferenciranosti, uključujući karcinom jajovoda ili primarni peritonealni karcinom, nakon liječenja s dva ili više protokola koja su uključivala platinu, ocijenjene su u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze II (Ispitivanje 19).
The safety and efficacy of OLYSIO for the treatment of HCV infection in patients co-infected with HBV have not been studied.
Sigurnost i djelotvornost lijeka OLYSIO u liječenju HCV infekcije u bolesnika koji su istovremeno zaraženi HBV-om, nisu ispitane.
The safety and efficacy of Oncaspar was evaluated in an open-label, multicenter, randomized, active-controlled study (Study 1).
Sigurnost i djelotvornost Oncaspara procijenjena je u otvorenom, multicentričnom, randomiziranom, aktivno kontroliranom ispitivanju (Ispitivanje 1).
The safety and efficacy of ONIVYDE in children and adolescents aged ≤ 18 years have not yet been established.
Sigurnost i djelotvornost lijeka ONIVYDE u djece i adolescenata u dobi ≤ 18 godina nisu još ustanovljene.
The safety and efficacy of ONIVYDE were investigated in a multinational, randomized, open label, controlled clinical trial (NAPOLI–1) that tested two treatment regimens for patients with metastatic pancreatic adenocarcinoma who had documented disease progression after gemcitabine or gemcitabine-containing therapy.
Sigurnost i djelotvornost lijeka ONIVYDE ispitivane su u multinacionalnom, randomiziranom, otvorenom, kontroliranom kliničkom ispitivanju (NAPOLI–1) u kojem su se ispitivala dva režima liječenja za bolesnike s metastatskim adenokarcinomom gušterače za koje je dokumentirana progresija bolesti nakon gemcitabina ili terapije koja je sadržavala gemcitabin.
The safety and efficacy of OPATANOL in children aged under 3 years has not been established.
Sigurnost i djelotvornost OPATANOLA u djece u dobi ispod 3 godine starosti nisu ustanovljene.
The safety and efficacy of Oprymea in children below 18 years has not been established.
Sigurnost i djelotvornost lijeka Oprymea u djece ispod 18 godina starosti nije ustanovljena.
The safety and efficacy of Oprymea in children below 18 years has not been established.
Sigurnost i djelotvornost lijeka Oprymea u djece ispod 18 godina starosti nisu ustanovljene.
The safety and efficacy of ORENCIA in children below 6 years of age have not been studied and therefore, ORENCIA is not recommended for use in children under six years old.
Sigurnost i djelotvornost lijeka ORENCIA u djece mlađe od 6 godina nisu ispitane te se stoga primjena lijeka ORENCIA ne preporučuje kod djece mlađe od 6 godina.
The safety and efficacy of ORENCIA intravenous administration have been studied in children.
Ispitane su sigurnost i djelotvornost intravenske primjene lijeka ORENCIA u djece.
The safety and efficacy of ORENCIA subcutaneous administration in children below 18 years of age have not been established.
Sigurnost i djelotvornost supkutane primjene lijeka ORENCIA u djece mlađe od 18 godina nisu ustanovljene.
The safety and efficacy of oritavancin in children and adolescents (<18 years) has not yet been established.
Sigurnost i djelotvornost oritavancina u djece i adolescenata (<18 godina) nisu još ustanovljene.
The safety and efficacy of Orkambi in children aged less than 12 years have not yet been established.
Sigurnost i djelotvornost lijeka Orkambi u djece mlađe od 12 godina nisu još ustanovljene.
The safety and efficacy of Orkambi in patients aged 65 years or older have not been evaluated.
Sigurnost i djelotvornost lijeka Orkambi u bolesnika u dobi od 65 i više godina nisu bile procijenjene.
The safety and efficacy of Oxyglobin have not been evaluated in dogs with, thrombocytopenia with active bleeding, oliguria or anuria, or advanced cardiac disease.
Neškodljivost i djelotvornost proizvoda Oxyglobin nisu procijenjene kod pasa s trombocitopenijom s aktivnim krvarenjem, oligurijom ili anurijom ili uznapredovanom srčanom bolesti.
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.
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 >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, >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 >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, >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 >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 Panretin gel in children under 18 years has not been established.
Sigurnost i djelotvornost Panretina u djece u dobi manjoj od 18 godina starosti nisu ustanovljene.
The safety and efficacy of pazopanib in children aged 2 to 18 years of age have not yet been established (see section 5.1).
Sigurnost i djelotvornost pazopaniba u djece u dobi od 2 do 18 godina nisu još ustanovljene (vidjeti dio 5.1).
The safety and efficacy of pazopanib in RCC were evaluated in a randomised, double-blind, placebo- controlled multi-centre study.
Sigurnost primjene i djelotvornost pazopaniba u RCC procjenjivani su u randomiziranom, dvostruko slijepom, multicentričnom ispitivanju koje je bilo kontrolirano placebom.
The safety and efficacy of pembrolizumab were investigated in KEYNOTE-002, a multicentre, controlled study for the treatment of advanced melanoma in patients previously treated with ipilimumab and if BRAF V600 mutation-positive, with a BRAF or MEK inhibitor.
Sigurnost i djelotvornost pembrolizumaba ispitivane su u multicentričnom, kontroliranom ispitivanju KEYNOTE-002 u liječenju uznapredovalog melanoma u bolesnika koji su prethodno bili liječeni ipilimumabom i, ako su bili pozitivni na mutaciju BRAF V600, BRAF ili MEK inhibitorom.
The safety and efficacy of pembrolizumab were investigated in KEYNOTE-006, a multicentre, controlled, Phase III study for the treatment of advanced melanoma in patients who were naïve to ipilimumab.
Sigurnost i djelotvornost pembrolizumaba ispitivane su u ispitivanju KEYNOTE-006, multicentričnom, kontroliranom ispitivanju faze III u liječenju uznapredovalog melanoma u bolesnika koji prethodno nisu liječeni ipilimumabom.
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).
Sigurnost i djelotvornost Pixuvria kao monoterapijskog agensa procijenjivana je u multicentričnom, randomiziranom, aktivno kontroliranom ispitivanju u bolesnika s relapsnim ili refraktornim agresivnim ne-Hodgkinovim limfomom (NHL), nakon što su već primili najmanje dvije prethodne terapije (PIX301).
The safety and efficacy of Pixuvri in children aged < 18 years has not yet been established.
Sigurnost i djelotvornost Pixuvria u djece u dobi < 18 godine nije još ustanovljena.
The safety and efficacy of Pixuvri in patients with impaired hepatic function has not been established.
Sigurnost i djelotvornost Pixuvria u bolesnika s oštećenom funkcijom jetre još nije ustanovljena.
The safety and efficacy of Plegridy in children and adolescents aged 0 to 18 years have not been established in multiple sclerosis.
Sigurnost i djelotvornost Plegridyja u djece i adolescenata u dobi od 0 do 18 godina nije ustanovljena u multiploj sklerozi.
The safety and efficacy of Plegridy in patients over the age of 65 have not been sufficiently studied due to the limited number of such patients included in clinical trials.
Sigurnost i djelotvornost Plegridyja u bolesnika preko 65 godina starosti nisu dovoljno ispitani zbog ograničenog broja takvih bolesnika u kliničkim ispitivanjima.
The safety and efficacy of Pradaxa in children from birth to less than 18 years of age have not yet been established.
Sigurnost i učinkovitost Pradaxe kod djece, od njihova rođenja do manje od 18 godina starosti, još uvijek nisu utvrđene.
The safety and efficacy of Praxbind in children below the age of 18 years have not yet been established.
Sigurnost i djelotvornost Praxbinda u djece u dobi do 18 godina nije još ustanovljena.
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.
Sigurnost i djelotvornost pregabalina u djece mlađe od 12 godina i adolescenata (12-17 godina) nisu ustanovljene.
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.
Sigurnost i djelotvornost pregabalina u djece mlađe od 12 godina i adolescenata (12-17 godina) nisu ustanovljene.
The safety and efficacy of Pregabalin Mylan Pharma in children below the age of 12 years and in adolescents (12-17 years of age) have not been established.
Sigurnost i djelotvornost lijeka Pregabalin Mylan Pharma u djece mlađe od 12 godina i adolescenata (12–17 godina) nisu ustanovljene.
The safety and efficacy of Pregabalin Pfizer in children below the age of 12 years and in adolescents (12-17 years of age) have not been established.
Sigurnost i djelotvornost lijeka Lyrica u djece mlađe od 12 godina i adolescenata (12–17 godina) nisu ustanovljene.
The safety and efficacy of Preotact in patients under 18 years have not been studied.
Sigurnost i djelotvornost Preotacta u djece u dobi do 18 godina nije ispitana.
The safety and efficacy of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in subjects under 18 years of age have not yet been established.
Sigurnost i djelotvornost Prepandemijskog cjepiva protiv influence (H5N1) (površinski antigen, inaktivirano, adjuvantirano) Novartis Vaccines and Diagnostics u ispitanika mlađih od 18 godina nisu još ustanovljene.
The safety and efficacy of Pritor in children and adolescents aged below 18 years have not been established.
Sigurnost i djelotvornost Pritora nije utvrđena u djece i adolescenata mlađih od 18 godina.
The safety and efficacy of Pritor in children and adolescents aged below 18 years have not been established.
Sigurnost i djelotvornost Pritora u djece i adolescenata u dobi ispod 18 godina još uvijek nisu utvrđene.
The safety and efficacy of PritorPlus in children and adolescents aged below 18 have not been established.
Nisu utvrđeni sigurnost i djelotvornost PritorPlusa kod djece i adolescenata do 18 godina starosti.
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).
Sigurnost i djelotvornost Privigena procijenjena je u 5 prospektivna, otvorena, multicentrična ispitivanja jedne skupine ispitanika provedena u Europi (ITP, PID i KUDP ispitivanja) i SAD-u (PID ispitivanja).
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.
Sigurnost i djelotvornost profilaktičkih doza u pretilih bolesnika (s ITM > 30 kg/m2) još nije u potpunosti utvrđena i stoga nema usuglašenog mišljenja o prilagodbi doze.
The safety and efficacy of ProZinc in breeding, pregnant and lactating cats has not been evaluated.
Neškodljivost i djelotvornost ProZinc-a nije utvrđena za vrijeme parenja, graviditeta i laktacije mačaka.
The safety and efficacy of Pumarix in children aged less than 3 years and in children and adolescents aged 10 to 17 years have not been established.
Sigurnost i djelotvornost cjepiva Pumarix u djece mlađe od 3 godine, te djece i adolescenata od 10 do 17 godina još nisu ustanovljene.
The safety and efficacy of Quinsair in children aged ˂ 18 years old have not yet been established (see section 4.2).
Sigurnost i djelotvornost Quinsaira u djece u dobi ˂ 18 godina nisu još ustanovljene (vidjeti dio 4.2).
The safety and efficacy of Quinsair in children aged ˂ 18 years old have not yet been established.
Sigurnost i djelotvornost Quinsaira u djece u dobi ˂ 18 godina nisu još ustanovljene.
The safety and efficacy of ranibizumab have not yet been studied in paediatric patients.
Sigurnost primjene i djelotvornost ranibizumaba u pedijatrijskoj populaciji još nije proučavana.
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.
U bolesnika s presađenom jetrom ili plućima sigurnost i djelotvornost Rapamunea kao imunosupresivne terapije nije ustanovljena te se stoga takva primjena ne preporučuje.
The safety and efficacy of Rasilamlo in children below age 18 have not been established.
Sigurnost i djelotvornost lijeka Rasilamlo u djece u dobi do nenavršenih 18 godina nije još ustanovljena.
The safety and efficacy of Rasilez HCT in children below 18 years have not yet been established.
Sigurnost i djelotvornost Rasilez HCT-a u djece u dobi do nenavršenih 18 godina nije još ustanovljena.
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.
Sigurnost i djelotvornost lijeka RAVICTI za liječenje bolesnika s nedostatkom N-acetilglutamat sintaze (NAGS) i CITRINA (citrulinemija tipa 2) nisu ustanovljene.
The safety and efficacy of Raxone in LHON patients under 12 years of age have not yet been established.
Sigurnost i djelotvornost lijeka Raxone u bolesnika s LHON-om mlađih od 12 godina nisu još ustanovljene.
The safety and efficacy of re- administration after an infliximab-free interval of more than 16 weeks has not been established.
Nisu ustanovljene sigurnost i djelotvornost ponovne primjene ako je razdoblje u kojemu se infliksimab nije davao bilo dulje od 16 tjedana.
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).
Sigurnost i djelotvornost lijeka pri ponovnoj primjeni nije utvrđena, osim kada se daje svakih 6 do 8 tjedana (vidjeti dijelove 4.4 i 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).
Sigurnost i djelotvornost lijeka pri ponovnoj primjeni nije utvrđena, osim kada se daje svakih 8 tjedana (vidjeti dijelove 4.4 i 4.8).
The safety and efficacy of Rebif in children below 2 years of age have not yet been established.
Sigurnost i djelotvornost Rebifa u djece mlađe od 2 godine još nisu ustanovljene.
The safety and efficacy of regorafenib in patients below 18 years of age in the indication gastrointestinal stromal tumors (GIST) have not been established.
Sigurnost i djelotvornost regorafeniba u bolesnika mlađih od 18 godina u indikaciji gastrointestinalnih stromalnih tumora (GIST) nisu ustanovljene.
The safety and efficacy of Relistor in children less than 18 years has not been established.
Sigurnost i djelotvornost metilnaltreksonbromida u djece u dobi do 18 godina nije ustanovljena.
The safety and efficacy of Remicade have not been studied in children with Crohn’s disease below the age of 6 years.
Sigurnost i djelotvornost lijeka Remicade u djece mlađe od 6 godina koja boluju od Crohnove bolesti nisu ispitivani.
The safety and efficacy of Remicade in children and adolescents younger than 18 years in the indication juvenile rheumatoid arthritis have not been established.
Sigurnost i djelotvornost lijeka Remicade u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog reumatoidnog artritisa nisu još ustanovljene.
The safety and efficacy of Remicade in children and adolescents younger than 18 years in the indication psoriasis have not been established.
Sigurnost i djelotvornost lijeka Remicade u djece i adolescenata mlađih od 18 godina koji boluju od psorijaze nisu još ustanovljene.
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.
Sigurnost i djelotvornost lijeka Remicade u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog idiopatskog artritisa, psorijatičnog artritisa i ankilozantnog spondilitisa nisu još ustanovljene.
The safety and efficacy of Remsima have not been studied in children with Crohn’s disease below the age of 6 years.
Sigurnost i djelotvornost lijeka Remsima nisu ispitivani u djece mlađe od 6 godina koja boluju od Crohnove bolesti.
The safety and efficacy of Remsima have not been studied in children with ulcerative colitis below the age of 6 years.
Sigurnost i djelotvornost lijeka Remsima nisu ispitivani u djece mlađe od 6 godina koja boluju od ulceroznog kolitisa.