FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are not sure about how this product will be given to your child, ask your doctor or pharmacist.
Slovenian: Če ste negotovi glede uporabe zdravila pri vašem otroku, se posvetujte z zdravnikom ali s farmacevtom.
English: In the congenital heart disease study, monthly intramuscular doses of 15 mg/kg achieved mean 30 day trough serum active substance concentrations of approximately 55 µg/ml after the first injection and approximately 90 µg/ml after the fourth injection.
Slovenian: V raziskavi prirojenih bolezni srca je bila z mesečnimi intramuskularnimi odmerki 15 mg/kg dosežena povprečna 30-dnevna najmanjša koncentracija zdravilne učinkovine v serumu približno 55 µg/ml po prvi injekciji in približno 90 µg/ml po četrti injekciji.
English: If your child gets any side effects, talk to your doctor.
Slovenian: Če se otroku pojavijo kateri koli neželeni učinki, se posvetujte z zdravnikom.
English: Please tell your doctor if your child is unwell, as the use of Synagis may need to be delayed.
Slovenian: Če vaš otrok ni povsem zdrav, morate to povedati zdravniku; morda bo treba uporabo zdravila Synagis odložiti.
English: Detailed information on this product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: The pharmacokinetics and safety of palivizumab liquid formulation and palivizumab lyophilised formulation, following 15 mg/kg intramuscular administration, were compared in a cross-over trial of 153 infants less than or equal to 6 months of age with a history of prematurity (less than or equal to 35 weeks gestational age).
Slovenian: Farmakokinetiko in varnost palivizumaba v tekoči obliki in palivizumaba v obliki liofilizata, po intramuskularni aplikaciji 15 mg/kg, so primerjali v navskrižnem preskušanju pri 153 dojenčkih, starih 6 mesecev ali manj, ki so bili rojeni prezgodaj (v 35 mesecu nosečnosti ali manj).
English: In this trial, patients were randomized to receive 5 monthly injections of 15mg/kg of liquid palivizumab (N=3306) used as active control for an investigational monoclonal antibody (N=3329).
Slovenian: V tem preskušanju so bili bolniki randomizirani za prejemanje 5 mesečnih injekcij palivizumaba v tekoči obliki po 15 mg/kg (N=3306), ki so ga uporabili kot aktivno primerjavo za preiskovano monoklonsko protitelo (N=3329).
English: Palivizumab may interfere with immune-based RSV diagnostic tests, such as some antigen detection based assays.
Slovenian: Palivizumab lahko moti nekatere imunsko osnovane RSV diagnostične teste, kot so nekateri testi, ki temeljijo na detekciji antigenov.
English: In prophylactic studies in premature and bronchopulmonary dysplasia paediatric populations, the mean half-life of palivizumab was 20 days and monthly intramuscular doses of 15 mg/kg achieved mean 30 day trough serum active substance concentrations of approximately 40 g/ml after the first injection, approximately 60 g/ml after the second injection, approximately 70 g/ml after the third injection and fourth injection.
Slovenian: V profilaktičnih raziskavah pri nedonošenčkih in otrocih z bronhopulmonalno displazijo je bil povprečni razpolovni čas palivizumaba 20 dni, z mesečnimi intramuskularnimi odmerki 15 mg/kg pa je bila dosežena povprečna 30-dnevna najmanjša koncentracija zdravilne učinkovine v serumu približno 40 g/ml po prvi injekciji, približno 60 g/ml po drugi injekciji in približno 70 g/ml po tretji in četrti injekciji.
English: Transient, low levels of antipalivizumab antibody were observed in one child after the second dose of palivizumab that dropped to undetectable levels at the fifth and seventh dose.
Slovenian: Pri enem otroku so po drugem odmerku palivizumaba ugotovili prehodno, nizko raven protiteles proti palivizumabu; raven teh protiteles je ob petem in sedmem odmerku padla na nemerljivo.
English: Single-use vial.
Slovenian: Vial aza enkratno uporabo.
English: Your child should not be given Synagis
Slovenian: Otrok ne sme dobiti zdravila Synagis
English: In this trial, patients were randomized to receive 5 monthly injections of 15mg/kg of liquid palivizumab (N=612) used as active control for an investigational monoclonal antibody (N=624).
Slovenian: V preskušanju so bili bolniki naključno izbrani za prejemanje 5 mesečnih injekcij palivizumaba v tekoči obliki po 15 mg/kg (N=612), ki so ga uporabili kot aktivno primerjavo za preiskovano monoklonsko protitelo (N=624).
English: How often will Synagis be given to my child?
Slovenian: Kako pogosto bo otrok dobil zdravilo Synagis?
English: Other medicines and Synagis
Slovenian: Druga zdravila in zdravilo Synagis
English: 100 mg of powder in a 10 ml vial (type I glass) with a stopper (butyl rubber) and a flip-off seal (aluminium).
Slovenian: 100 mg praška v 10 ml viali (steklo tipa I) z zamaškom (butil) in pretržno zaporko (aluminij).
English: Children who are more likely to get severe RSV disease (high risk children) include babies born prematurely (35 weeks or less) or babies born with certain heart or lung problems.
Slovenian: Otroci, pri katerih je večja verjetnost, da bodo dobili resno okužbo z RSV (npr: otroci z velikim tveganjem) so nedonošenčki (stari 35 tednov ali manj) ali dojenčki, rojeni z nekaterimi srčnimi in pljučnimi težavami.
English: A review of clinical findings did not reveal an association between A antigenic site sequence changes and RSV disease severity among children receiving palivizumab immunoprophylaxis who develop RSV lower respiratory tract disease.
Slovenian: Pregled kliničnih odkritij ni odkril povezave med sekvenčnimi spremembami v A antigenskem mestu in stopnjo RSV bolezni med otroki, ki so prejemali profilakso s palivizumabom in pri katerih se je razvila RSV bolezen spodnjih dihal.
English: Convulsion
Slovenian: Konvulzije
English: *Palivizumab is a recombinant humanised monoclonal antibody produced by DNA technology in mouse myeloma host cells.
Slovenian: * Palivizumab je rekombinantno humanizirano monoklonsko protitelo, pridobljeno z DNA tehnologijo v mielomskih celicah miši.
English: 50 mg of powder in a 4 ml vial (type I glass) with a stopper (butyl rubber) and a flip-off seal (aluminium).
Slovenian: 50 mg praška v 4 ml viali (steklo tipa I) z zamaškom (butil) in pretržno zaporko (aluminij).
English: - for the solvent: water for injections.
Slovenian: - v vehiklu: voda za injekcije.
English: Reconstitute slowly with 0.6 ml water for injections.
Slovenian: Počasi pripravite z 0,6 ml vode za injekcije.
English: Slowly add 1.0 ml of water for injections along the inside wall of the vial to minimise foaming.
Slovenian: Počasi dodajte 1,0 ml vode za injekcije, in sicer vzdolž notranje stene viale, da boste čim bolj omejili penjenje.
English: Palivizumab should not be mixed with any medicinal products or diluents other than water for injections.
Slovenian: Palivizumaba se ne sme mešati z nobenim drugim zdravilom in nobenim drugim vehiklom kot z vodo za injekcije.
English: Both the 0.5 ml and 1 ml vials contain an overfill to allow the withdrawal of 50 mg or 100 mg, respectively.
Slovenian: Obe viali, 0,5 ml in 1 ml, vsebujeta presežek za zagotovitev odvzema 50 mg ali 100 mg.
English: Slowly add 0.6 ml of water for injections along the inside wall of the vial to minimise foaming.
Slovenian: Počasi dodajte 0,6 ml vode za injekcije, in sicer vzdolž notranje stene viale, da boste čim bolj omejili penjenje.
English: Two clinical studies were conducted to directly compare liquid and lyophilised formulations of palivizumab.
Slovenian: Študije, v katerih so uporabljali palivizumab v tekoči obliki Dve klinični študiji sta bili izvedeni za neposredno primerjavo palivizumaba v tekoči in liofilizirani obliki.
English: In studies in adult volunteers, palivizumab had a pharmacokinetic profile similar to a human IgG1 antibody with regard to volume of distribution (mean 57 ml/kg) and half-life (mean 18 days).
Slovenian: V raziskavah odraslih prostovoljcev so bile farmakokinetične lastnosti palivizumaba glede volumna distribucije (povprečno 57 ml/kg) in razpolovnega časa (povprečno 18 dni) podobne kot pri človeških protitelesih IgG1.
English: If he/she is allergic to palivizumab or any of the other ingredients of this medicine(listed in section 6).
Slovenian: Če je alergičen na palivizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Palivizumab should not be mixed with any medicinal products or diluents.
Slovenian: Palivizumaba se ne sme mešati z drugimi zdravili ali topili.
English: What do you need to know before Synagis is given to your child
Slovenian: Kaj morate vedeti, preden bo vaš otrok dobil zdravilo Synagis
English: The RSV hospitalisation rate was 10.6% in the placebo group.
Slovenian: V placebni skupini je bil delež hospitalizacij zaradi RSV 10,6%.
English: - The other ingredients are, - for the powder: histidine, glycine and mannitol.
Slovenian: - Druge sestavine so - v prašku: histidin, glicin in manitol.
English: What Synagis contains
Slovenian: Kaj vsebuje zdravilo Synagis
English: How will my child receive Synagis?
Slovenian: Kako bo otrok dobival zdravilo Synagis?
English: Boehringer Ingelheim Pharma GmbH & Co. KG D-88397 Biberach an der Riss Germany
Slovenian: KG D-88397 Biberach an der Riss Nemčija
English: Concentration of 100 mg/ml solution for injection.
Slovenian: Koncentracija 100 mg/ml raztopine za injiciranje.
English: At least one of the palivizumab resistance-associated substitutions, N262D, K272E/Q, or S275F/L was identified in these 8 clinical RSV isolates resulting in a combined resistance-associated mutation frequency of 6.3% in these patients.
Slovenian: V teh 8 kliničnih izolatih RSV so identificirali vsaj eno od substitucij, ki so povezane z odpornostjo na palivizumab, N262D, K272E/Q ali S275F/L, skupna pogostnost z odpornostjo povezanih mutacij pri teh bolnikih je bila 6,3%.
English: In the phase III IMpact-RSV study in the premature and bronchopulmonary dysplasia paediatric populations, the proportions of patients in the placebo and palivizumab groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents.
Slovenian: V raziskavi III. faze IMpactRSV pri nedonošenčkih in otrocih z bronhopulmonalno displazijo so bili deleži prejemnikov rednih otroških cepiv, cepiva proti gripi, bronhodilatatorjev ali kortikosteroidov podobni med otroki, ki so dobili placebo, in tistimi, ki so dobili palivizumab.
English: Synagis may cause serious side effects including: severe allergic reactions, such reactions may be life threatening or fatal (see "Your child should not be given Synagis" for a list of signs and symptoms).
Slovenian: • hudo alergijsko reakcijo; take reakcije lahko ogrozijo življenje ali so smrtne (glejte ''Otrok ne sme dobiti zdravila Synagis'' za seznam znakov in simptomov).
English: Additional side effects Very common (affects at least 1 user in 10): rash fever
Slovenian: Zelo pogosti (pojavijo se pri vsaj 1 bolniku od 10 bolnikov):
English: Antibody to palivizumab was evaluated in four additional studies in 4337 patients (children born at 35 weeks of gestation or less and 6 months of age or less, or 24 months of age or less with bronchopulmonary dysplasia, or with haemodynamically significant congenital heart disease were included in these studies) and was observed in 0% - 1.5% of patients at different study timepoints.
Slovenian: Protitelesa proti palivizumabu so bila ocenjena v štirih dodatnih študijah pri 4337 bolnikih (v to študijo so bili vključeni otroci, rojeni v 35. tednu gestacije ali manj in stari 6 mesecev ali manj ali otroci, stari 24 mesecev ali manj, z bronhopulmonalno displazijo ali s hemodinamično pomembno prirojeno boleznijo srca).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or other humanised monoclonal antibodies.
Slovenian: Preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 ali na katero od humaniziranih monoklonskih protiteles.
English: Reconstitute slowly with 1.0 ml water for injections.
Slovenian: Počasi pripravite z 1,0 ml vode za injekcije.
English: Powder and solvent for solution for injection Contents:
Slovenian: Prašek in vehikel za raztopino za injiciranje Vsebina:
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to other humanised monoclonal antibodies.
Slovenian: Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 ali na katero od humaniziranih monoklonskih protiteles.
English: In a placebo-controlled trial in 1,287 patients  24 months of age with haemodynamically significant congenital heart disease (639 Synagis; 648 placebo), 5 monthly doses of 15 mg/kg Synagis reduced the incidence of RSV hospitalisations by 45% (p = 0.003) (congenital heart disease study).
Slovenian: V preskušanju, ki je bilo kontrolirano s placebom in je zajelo 1.287 bolnikov, starih  24 mesecev in s hemodinamično pomembno prirojeno boleznijo srca (639 jih je dobivalo zdravilo Synagis, 648 placebo), je 5 mesečnih odmerkov zdravila Synagis 15 mg/kg zmanjšalo incidenco hospitalizacij zaradi RSV za 45% (p = 0,003) (raziskava prirojenih bolezni srca).
English: Swirl gently.
Slovenian: Obzirno vrtite.
English: How will my child receive Synagis
Slovenian: Kako bo otrok dobival zdravilo Synagis
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja Zelo pogosti
English: The 100 mg vial contains an overfill to allow the withdrawal of 100 mg when reconstituted if following the directions described below.
Slovenian: 100 mg viala vsebuje presežek za zagotovitev odvzema 100 mg pri rekonstituciji, če se sledi spodnjim navodilom.
English: A total of 222 children were enrolled in two separate studies to examine the safety of palivizumab when it is administered for a second RSV season.
Slovenian: Dve ločeni raziskavi varnosti palivizumaba, uporabljenega v drugi sezoni RSV, sta zajeli skupno 222 otrok.
English: Palivizumab is administered once a month intramuscularly, preferably in the anterolateral aspect of the thigh.
Slovenian: Palivizumab se aplicira enkrat na mesec intramuskularno, po možnosti v anterolateralni predel stegna.
English: The efficacy of palivizumab when administered to patients as a second course of treatment during an ensuing RSV season has not been formally investigated in a study performed with this objective.
Slovenian: Učinkovitost palivizumaba pri bolnikih, ki ga dobijo v ponovnem ciklusu naslednjo sezono RSV, ni bila formalno raziskana v kakšni študiji, opravljeni s tem namenom.
English: The 50 mg vial contains an overfill to allow the withdrawal of 50 mg when reconstituted if following the directions described below.
Slovenian: 50 ml viala vsebuje presežek za zagotovitev odvzema 50 mg pri rekonstituciji, če se sledi spodnjim navodilom.
English: Also contains histidine, glycine and mannitol.
Slovenian: Vsebuje tudi histidin, glicin in manitol.
English: - The active substance is palivizumab.
Slovenian: - Zdravilna učinkovina je palivizumab.
English: It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains.
Slovenian: Palivizumab močno nevtralizira seve RSV podtipov A in B in zavira njihovo fuzijsko aktivnost.
English: Label of 0.5 ml vial
Slovenian: Nalepka na 0,5 ml viali
English: Label of 1.0 ml vial
Slovenian: Nalepka na 1,0 ml viali
English: However, you should inform your doctor of all medicines your child is currently taking before starting Synagis.
Slovenian: Ni znano, da bi imelo zdravilo Synagis medsebojne učinke z drugimi zdravili, vendar morate zdravniku pred začetkom uporabe zdravila Synagis povedati za vsa zdravila, ki jih vaš otrok trenutno dobiva.
English: Synagis 100 mg vial label
Slovenian: Synagis 100 mg - nalepka na viali
English: One ml of Synagis solution for injection contains 100 mg of palivizumab.
Slovenian: 1 ml zdravila Synagis raztopina za injiciranje vsebuje 100 mg palivizumaba.
English: Studies carried out in rodents gave no indication of enhancement of RSV replication, or RSV-induced pathology or generation of virus escape mutants in the presence of palivizumab under the chosen experimental conditions.
Slovenian: Raziskave na glodalcih v izbranih eksperimentalnih pogojih in v navzočnosti palivizumaba niso odkrile zvečane replikacije RSV, z RSV izzvane patologije ali nastanka ubežnih virusnih mutantov.
English: Synagis is presented as a powder and solvent for solution for injection (100 mg of powder in vial) + 1 ml of solvent in ampoule - Pack size of 1.
Slovenian: Zdravilo Synagis sestavljata prašek in vehikel za raztopino za injiciranje (100 mg praška v viali) + 1 ml vehikla v ampuli - pakiranje vsebuje 1 vialo in 1 ampulo.
English: 100 mg Outer Carton
Slovenian: 100 mg - zunanja škatla
English: 50 mg Outer Carton
Slovenian: 50 mg - zunanja škatla
English: In a placebo-controlled trial of RSV disease prophylaxis in (IMpact-RSV trial) 1502 high-risk children (1002 Synagis; 500 placebo), 5 monthly doses of 15 mg/kg reduced the incidence of RSV related hospitalisation by 55% (p = < 0.001).
Slovenian: Študije, v katerih so uporabljali palivizumab v liofilizirani oblikiV preskušanju profilakse bolezni RSV, kontroliranem s placebom, (preskušanje IMpact-RSV) pri 1.502 zelo ogroženih bolnikih (1.002 sta dobivala zdravilo Synagis, 500 placebo) je 5 mesečnih odmerkov 15 mg/kg zmanjšalo incidenco hospitalizacij zaradi RSV za 55% (p = < 0,001).
English: When using Palivizumab 100 mg/1 ml, the volume (expressed in ml) of Palivizumab to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15
Slovenian: Ko se uporablja palivizumab 100 mg/1 ml, je potrebna količina palivizumaba (izražena v ml), ki se injicira v enomesečnih intervalih = (bolnikova telesna masa v kg) pomnožena z 0,15
English: Lyophilised formulation of palivizumab
Slovenian: Palivizumab v tekoči obliki
English: Palivizumab is administered intramuscularly, preferably in the anterolateral aspect of the thigh.
Slovenian: Palivizumab se injicira intramuskularno, po možnosti v anterolateralni predel stegna.
English: Synagis is presented as a powder and solvent for solution for injection (50 mg of powder in vial) + 1 ml of solvent in ampoule - Pack size of 1.
Slovenian: Zdravilo Synagis sestavljata prašek in vehikel za raztopino za injiciranje (50 mg praška v viali) + 1 ml vehikla v ampuli - pakiranje vsebuje 1 vialo in 1 ampulo.
English: Administrator's Instructions
Slovenian: Navodila za zdravstveno osebje
English: Uncommon (affects less than 1 users in 100): fits hives
Slovenian: Občasni (pojavijo se pri manj kot 1 bolniku od 100 bolnikov):
English: Do not dilute the product.
Slovenian: Zdravila ne redčite.
English: Synagis 50 mg/0.5 ml solution for injection Synagis 100 mg/1 ml solution for injection Active substance: palivizumab
Slovenian: Synagis 50 mg/0,5 ml raztopina za injiciranje Synagis 100 mg/1 ml raztopina za injiciranje učinkovina: palivizumab
English: Synagis 50 mg vial label
Slovenian: Synagis 50 mg - nalepka na viali
English: Common adverse reactions occurring with palivizumab are fever, rash and injection site reaction.
Slovenian: Pogosti neželeni učinki, ki se pojavijo pri palivizumabu so povišana telesna temperatura, izpuščaj in reakcije na mestu injiciranja.
English: Also contains: histidine, glycine and mannitol.
Slovenian: Vsebuje tudi: histidin, glicinin manitol.
English: Synagis 50 mg/0.5 ml solution for injection Synagis 100 mg/1 ml solution for injection
Slovenian: Synagis 50 mg/0,5 ml raztopina za injiciranje Synagis 100 mg/1 ml raztopina za injiciranje
English: How to storeSynagis
Slovenian: KG Knollstrasse
English: When using Palivizumab 100 mg/ml, the volume (expressed in ml) of Palivizumab to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15
Slovenian: Ko se uporablja palivizumab 100 mg/ml, je potrebna količina palivizumaba (izražena v ml), ki se injicira v enomesečnih intervalih = (bolnikova telesna masa v kg) pomnožena z 0,15
English: The powder is a white to off-white cake.
Slovenian: Prašek je bel do sivo bel z enakomernimi delci.
English: 1 ml of Synagis solution contains 100 mg of palivizumab*.
Slovenian: 1 ml raztopine zdravila Synagis vsebuje 100 mg palivizumaba*.
English: Intramuscular use.
Slovenian: intramuskularna uporaba viala za enkratno uporabo
English: The volume (expressed in ml) of // Palivizumab // to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15.
Slovenian: Količina palivizumaba (izražena v ml), ki jo je potrebno injicirati v enomesečnih intervalih = [telesna masa bolnika v kg] pomnožena z 0,15.
English: Allergic reactions including very rare cases of anaphylaxis and anaphylactic shock have been reported following palivizumab administration.
Slovenian: Po aplikaciji palivizumaba so bile opisane alergijske reakcije in anafilaktični šok, vključno z zelo redkimi primeri anafilaksije.
English: Each 0.5 ml vial contains 50 mg of palivizumab.
Slovenian: Ena 0,5 ml viala vsebuje 50 mg palivizumaba.
English: Palivizumab does not interfere with reverse transcriptase polymerase chain reaction-based assays.
Slovenian: Palivizumab ne moti testov, ki temeljijo na metodi obratne transkripcije in verižne reakcije s polimerazo (RT-PCR).
English: Synagis 100 mg/1 ml solution for injection palivizumab
Slovenian: Synagis 100 mg/1 ml raztopina za injiciranje palivizumab
English: Take special care with Synagis if your child is unwell.
Slovenian: Bodite posebno pozorni pri uporabi zdravila Synagis
English: - Each 1 ml vial contains 100 mg of palivizumab.
Slovenian: - Vsaka 1 ml viala vsebuje 100 mg palivizumaba.
English: How to store Synagis
Slovenian: Shranjevanje zdravila Synagis
English: To administer, remove the tab portion of the vial cap and clean the stopper with 70 % ethanol or equivalent.
Slovenian: Za uporabo odstranite del z zanko na pokrovčku viale in očistite zamašek s 70 % etanolom ali ekvivalentom.
English: OTHER
Slovenian: OSTALO
English: Synagis 50 mg/0.5 ml solution for injection palivizumab
Slovenian: Synagis 50 mg/0,5 ml raztopina za injiciranje palivizumab
English: Among 139 children in the congenital heart disease study receiving palivizumab who had cardio-pulmonary bypass and for whom paired serum samples were available, the mean serum palivizumab concentration was approximately 100 g/ml pre-cardiac bypass and declined to approximately 40 g/ml after bypass.
Slovenian: Pri teh 139 otrocih je bila povprečna koncentracija palivizumaba v serumu pred zunajtelesnim obtokom približno 100 g/ml, po njem pa se je zmanjšala na približno 40 g/ml.
English: To reconstitute, remove the tab portion of the vial cap and clean the rubber stopper with 70% ethanol or equivalent.
Slovenian: Za rekonstitucijo odstranite del z zanko na pokrovčku viale in očistite kavčukovo zaporko s 70% etanolom ali ekvivalentom.
English: Adverse reactions both clinical and laboratory, are displayed by system organ class and frequency (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) in studies conducted in premature and bronchopulmonary dysplasia paediatric patients, and paediatric congenital heart disease patients.
Slovenian: Klinični in laboratorijski neželeni učinki, so prikazani v naslednjih tabelah po organskih sistemih in pogostnosti (zelo pogosti ≥1/10; pogosti  1/100 do  1/10; občasni  1/1.000 do  1/100; redki ≥ 1/10.000 do < 1/1.000).
English: Adverse reactions both clinical and laboratory, are displayed by system organ class and frequency (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 ) in studies conducted in premature and bronchopulmonary dysplasia paediatric patients, and paediatric congenital heart disease patients.
Slovenian: Klinični in laboratorijski neželeni učinki so prikazani v naslednjih tabelah po organskih sistemih in pogostnosti (zelo pogosti ≥ 1/10; pogosti  1/100 do 1/10; občasni  1/1.000 do  1/100; redki ≥ 1/10.000 do < 1/1.000).