natgillin/translations-raw huggingface dataset:
The majority of experience including the pivotal phase III clinical trials with palivizumab has been gained with 5 injections during one season (see section 5.1).
Večina izkušenj s palivizumabom, tudi tistih v ključnih kliničnih preskušanjih III. faze, je bila pridobljenih s 5 injekcijami v eni sezoni (glejte poglavje 5. 1).
Data, although limited, are available on greater than 5 doses (see sections 4.8 and 5.1), therefore the benefit in terms of protection beyond 5 doses has not been established.
Podatki o več kot 5 odmerkih so sicer na voljo, vendar so omejeni (glejte poglavji 4. 8 in 5. 1), zato koristi glede zaščite pri uporabi več kot 5 odmerkov niso ugotovljene.
For children undergoing cardiac bypass, it is recommended that a 15 mg/ kg of body weight injection of palivizumab be administered as soon as stable after surgery to ensure adequate palivizumab serum levels.
Otroci, operirani na srcu z zunajtelesnim obtokom, naj injekcijo palivizumaba 15 mg/ kg telesne teže dobijo, čim se jim stanje po operaciji stabilizira; tako je zagotovljena ustrezna koncentracija palivizumaba v serumu.
Subsequent doses should resume monthly through the remainder of the RSV season for children that continue to be at high risk of RSV disease (see section 5.2).
Otroci, ki jih bolezen RSV še naprej zelo ogroža, morajo nadaljnje odmerke dobivati vsak mesec med preostalo sezono RSV (glejte poglavje 5. 2).
2 Method of administration Palivizumab is administered in a dose of 15 mg/ kg of body weight once a month intramuscularly, preferably in the anterolateral aspect of the thigh.
Način uporabe Palivizumab se injicira enkrat na mesec v odmerku 15 mg/ kg telesne teže intramuskularno, po možnosti v anterolateralni predel stegna.
For information on reconstituting Synagis, see section 6.6.
2 Za informacije o rekonstituciji Synagisa glejte poglavje 6. 6.
Known hypersensitivity to the active substance or to any of the excipients (see section 6.1), or other humanised monoclonal antibodies.
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavje 6. 1) ali za katero od humaniziranih monoklonskih protiteles.
Allergic reactions including very rare cases of anaphylaxis have been reported following palivizumab administration (see section 4.8).
Po aplikaciji palivizumaba so bile opisane alergijske reakcije, vključno z zelo redkimi primeri anafilaksije (glejte poglavje 4. 8).
Medicinal products for the treatment of severe hypersensitivity reactions, including anaphylaxis, should be available for immediate use following administration of palivizumab.
Zdravila za zdravljenje hudih preobčutljivostnih reakcij, vključno z anafilaksijo, morajo biti na voljo za takojšnjo uporabo po aplikaciji palivizumaba.
As with any intramuscular injection, palivizumab should be given with caution to patients with thrombocytopaenia or any coagulation disorder.
Viala palivizumaba za enkratno uporabo ne vsebuje konzervansa, zato je treba injekcijo dati v 3 urah po pripravi.
No formal interactions studies with other medicinal products were conducted, however no interactions have been described to date.
Formalnih raziskav medsebojnega delovanja z drugimi zdravili ni bilo, vendar doslej ni opisanih interakcij.
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.
Med bolniki, ki so dobivali ta sredstva, niso opazili več neželenih učinkov.
Synagis is not indicated for use in adults.
Synagis ni indiciran za uporabo pri odraslih.
Data on pregnancy and lactation are not available.
Podatkov o uporabi pri nosečnicah in doječih materah ni na voljo.
Adverse drug reactions (ADRs) reported in the prophylactic paediatric studies were similar in the placebo and palivizumab groups.
Neželeni učinki, opisani v profilaktičnih pediatričnih raziskavah, so bili podobni med prejemniki placeba in palivizumaba.
The majority of ADRs were transient and mild to moderate in severity.
Večina neželenih učinkov je bila prehodnih in blagih do zmerno izrazitih.
Adverse events at least possibly causally-related to palivizumab, both clinical and laboratory, are displayed by system organ class and frequency (common ≥ 1/ 100 to < 1/ 10; uncommon ≥ 1/ 1,000 to < 1/ 100) in studies conducted in premature and bronchopulmonary dysplasia paediatric patients, and congenital heart disease patients (Tables 1 and 2, respectively).
3 Klinični in laboratorijski neželeni učinki, ki so vsaj potencialno lahko vzročno povezani s palivizumabom, so prikazani v naslednjih tabelah po organskih sistemih in pogostnosti (pogosti: ≥1/ 100 do < 1/ 10, občasni: ≥1/ 1. 000 do < 1/ 100).
Within each frequency grouping, adverse reactions have been presented in order of decreasing seriousness.
Podatki so iz raziskav pri nedonošenčkih in otrocih z bronhopulmonalno displazijo (preglednica 1) in pri otrocih s prirojeno srčno boleznijo (preglednica 2). V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Table 1 Undesirable effects in prophylactic clinical studies with premature and bronchopulmonary dysplasia paediatric populations
Preglednica 1 Neželeni učinki v profilaktičnih kliničnih raziskavah nedonošenčkov in otrok z bronhopulmonalno displazijo
AST increase ALT increase Abnormal liver function test
zvišanje AST zvišanje ALT nenormalni testi jetrne funkcije
Leucopaenia
levkopenija
Wheeze Rhinitis Cough
piskajoče dihanje rinitis kašelj
Common
pogosto občasno
Diarrhoea
driska bruhanje
Vomiting
izpuščaj
Rash
virusne okužbe okužbe zgornjih dihal
Infections and infestations
Splošne težave in spremembe na mestu aplikacije
General disorders and administration site conditions
zvišana telesna temperatura reakcije na mestu injiciranja
Common Uncommon
občasno
Fever Injection site reaction Pain
bolečine
No medically important differences were observed during the prophylactic studies carried out in the premature and bronchopulmonary dysplasia paediatric populations in ADRs by body system or when evaluated in subgroups of children by clinical category, gender, age, gestational age, country, race/ ethnicity or quartile serum palivizumab concentration.
Neželeni učinki v profilaktičnih raziskavah pri nedonošenčkih in otrocih z bronhopulmonalno displazijo se niso medicinsko pomembno razlikovali po telesnih sistemih ali po podskupinah otrok glede na klinično kategorijo, spol, starost, gestacijsko starost, državo, raso/ etnično pripadnost ali kvartilno koncentracijo palivizumaba v serumu.
No significant difference in safety profile was observed between children without active RSV infection and those hospitalised for RSV.
Profil varnosti se ni pomembno razlikoval med otroki brez aktivne okužbe z RSV in otroki, hospitaliziranimi zaradi RSV.
Permanent discontinuation of palivizumab due to ADRs was rare (0.2%).
Le redko je bilo treba uporabo palivizumaba zaradi neželenih učinkov dokončno prekiniti (0, 2%).
Deaths were balanced between the integrated placebo and palivizumab groups and were not drug-related.
Smrtni primeri niso bili povezani z zdravilom in so bili enako pogosti med prejemniki placeba in palivizumaba.
4 Table 2 Undesirable effects in the prophylactic paediatric congenital heart disease clinical study
4 Preglednica 2 Neželeni učinki v profilaktični klinični raziskavi otrok s prirojenimi boleznimi srca
Nervous System
Bolezni živčevja
Somnolence Hyperkinesia
zaspanost hiperkinezija
Vomiting Diarrhoea
bruhanje driska zaprtje
Constipation
izpuščaj ekcem
Rash Eczema
gasteroenteritis okužbe zgornjih dihal
Gastroenteritis Upper respiratory infection
Splošne težave in spremembe na mestu aplikacije
Vascular disorders General disorders and administration site conditions
zvišana telesna temperatura reakcije na mestu injiciranja
Uncommon Common Uncommon
občasno
Haemorrhage Fever Injection site reaction Asthenia
astenija
In the congenital heart disease study no medically important differences were observed in ADRs by body system or when evaluated in subgroups of children by clinical category.
Neželeni učinki v raziskavi prirojenih bolezni srca se niso medicinsko pomembno razlikovali po telesnih sistemih ali po podskupinah otrok glede na klinično kategorijo.
The incidence of serious adverse events was significantly lower in the palivizumab group compared to the placebo group.
Incidenca resnih neželenih učinkov je bila v skupini s palivizumabom značilno manjša kot v skupini s placebom.
No serious adverse events related to palivizumab were reported.
S palivizumabom ni bilo opisanih resnih neželenih učinkov.
The incidences of cardiac surgeries classified as planned, earlier than planned or urgent were balanced between the groups.
Incidenca operacij na srcu, opredeljenih kot načrtovane, zgodnejše od načrtovanega ali nujne, je bila med skupinama uravnotežena.
Deaths associated with RSV infection occurred in 2 patients in the palivizumab group and 4 patients in the placebo group and were not drug-related.
Smrt, povezana z okužbo RSV, je doletela 2 bolnika v skupini s palivizumabom in 4 bolnike v skupini s placebom; smrti niso bile povezane z zdravilom.
Post-marketing experience:
Pomarketinške izkušnje:
The following events were reported during post-marketing experience of palivizumab:
Med obdobjem pomarketinške uporabe palivizumaba so bili opisani naslednji pojavi:
Rare ADRs (> 1/ 10,000, < 1/ 1,000): apnoea Very rare ADRs (< 1/ 10,000): anaphylaxis, urticaria
Redki neželeni učinki (> 1/ 10. 000, < 1/ 1. 000): apneja Zelo redki neželeni učinki (< 1/ 10. 000): anafilaksija, urtikarija
Post-marketing serious spontaneous adverse events reported during palivizumab treatment between 1998 and 2002 covering four RSV seasons were evaluated.
Ocenili so resne spontane neželene učinke med zdravljenjem s palivizumabom, o katerih so poročali v pomarketinškem obdobju med letoma 1998 in 2002; zdravljenje je zajemalo štiri sezone RSV.
A total of 1291 serious reports were received where palivizumab had been administered as indicated and the duration of therapy was within one season.
Vsega skupaj je bilo prejetih 1. 291 poročil o resnih učinkih v primerih, ko je bil palivizumab uporabljen, kot je indicirano, in je trajanje zdravljenja potekalo znotraj ene sezone.
The onset of the adverse event occurred after the sixth or greater dose in only 22 of these reports (15 after the sixth dose, 6 after the seventh doses and 1 after the eight dose).
Ta poročila so prvi pojav neželenih učinkov navajala po šestem ali nadaljnjih odmerkih le v 22 primerih (15 primerov po šestem odmerku, 6 po sedmem in 1 po osmem).
These events are similar in character to those after the initial five doses.
Učinki so bili po značilnostih podobni tistim po prvih petih odmerkih.
Palivizumab treatment schedule and adverse events were monitored in a group of nearly 20,000 infants tracked through a patient compliance registry between 1998 and 2000.
Shemo zdravljenja s palivizumabom in neželene učinke so spremljali v skupini skoraj 20. 000 dojenčkov, ki so jih prek registra o sodelovanju bolnikov spremljali med letoma 1998 in 2000.
Of this group 1250 enrolled infants had 6 injections, 183 infants had 7 injections, and 27 infants had either 8 or 9 injections.
V tej skupini je 1. 250 vključenih dojenčkov dobilo 6 injekcij, 183 dojenčkov 7 injekcij in 27 dojenčkov 8 ali 9 injekcij.
Adverse events observed in patients after a sixth or greater dose were similar in character and frequency to those after the initial 5 doses.
Neželeni učinki, ugotovljeni pri bolnikih po šestem ali nadaljnjih odmerkih so bili po značilnostih in pogostnosti podobni tistim po prvih 5 odmerkih.
Human anti-human antibody (HAHA) response:
5 Človeški odziv z antihumanimi protitelesi:
Antibody to palivizumab was observed in approximately 1% of patients in the IMpact-RSV during the first course of therapy.
Protitelesa proti palivizumabu so v raziskavi Impact- RSV med prvim ciklusom zdravljenja odkrili pri približno 1% bolnikov.
This was transient, low titre, resolved despite continued use (first and second season), and could not be detected in 55/ 56 infants during the second season (including 2 with titres during the first season).
Odziv je bil prehoden in z nizkim titrom, je kljub nadaljnji uporabi (prvo in drugo sezono) izginil in ga med drugo sezono ni bilo mogoče odkriti pri 55 od 56 dojenčkov (vključujoč 2 s titri med prvo sezono).
Therefore, HAHA responses appear to be of no clinical relevance.
Po tem sodeč človeški odziv z antihumanimi protitelesi ni klinično pomemben.
5 Immunogenicity was not studied in the congenital heart disease study.
V raziskavi prirojenih bolezni srca imunogenosti niso proučevali.
In clinical studies, three children received an overdose of more than 15 mg/ kg.
V kliničnih raziskavah so trije otroci dobili prevelike odmerke, večje od 15 mg/ kg.
These doses were 20.25 mg/ kg, 21.1 mg/ kg and 22.27 mg/ kg.
Ti odmerki so bili 20, 25 mg/ kg, 21, 1 mg/ kg in 22, 27 mg/ kg.
Immunoglobulins; ATC Code:
Farmakoterapevtska skupina: imunoglobulini, oznaka ATC:
Palivizumab is a humanised IgG1κ monoclonal antibody directed to an epitope in the A antigenic site of the fusion protein of respiratory syncytial virus (RSV).
Palivizumab je humanizirano monoklonsko protitelo IgG1κ, usmerjeno na epitop antigenskega mesta A fuzijske beljakovine respiratornega sincicijskega virusa (RSV).
Palivizumab serum concentrations of approximately 30 μ g/ ml have been shown to produce a 99% reduction in pulmonary RSV replication in the cotton rat model.
V serumski koncentraciji približno 30 μg/ ml je palivizumab v modelu z bombažno podgano zmanjšal replikacijo RSV v pljučih za 99%.
Clinical studies 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).
Klinične raziskave V preskušanju profilakse bolezni RSV, kontroliranem s placebom, (preskušanje IMpact- RSV) pri 1. 502 zelo ogroženih bolnikih (1. 002 sta dobivala Synagis, 500 placebo) je 5 mesečnih odmerkov 15 mg/ kg zmanjšalo incidenco hospitalizacij zaradi RSV za 55% (p = < 0, 001).
The RSV hospitalisation rate was 10.6% in the placebo group.
V placebni skupini je bil delež hospitalizacij zaradi RSV 10, 6%.
On this basis, the absolute risk reduction (ARR) is 5.8% which means the number needed to treat (NNT) is 17 to prevent one hospitalisation.
Glede na to je absolutno zmanjšanje tveganja 5, 8%, kar pomeni, da je število potrebnih zdravljenj za preprečitev ene hospitalizacije 17.
In a placebo-controlled trial in 1287 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).
V preskušanju, ki je bilo kontrolirano s placebom in je zajelo 1. 287 bolnikov, starih ≤ 24 mesecev in s hemodinamsko pomembno prirojeno boleznijo srca (639 jih je dobivalo Synagis, 648 placebo), je 5 mesečnih odmerkov Synagisa 15 mg/ kg zmanjšalo incidenco hospitalizacij zaradi RSV za 45% (p = 0, 003) (raziskava prirojenih bolezni srca).
The RSV hospitalisation rate was 9.7% in the placebo group and 5.3% in the Synagis group.
Delež hospitalizacij zaradi RSV je bil v placebni skupini 9, 7% in v skupini, ki je dobivala Synagis, 5, 3%.
Secondary efficacy endpoints showed significant reductions in the Synagis group compared to placebo in total days of RSV hospitalisation (56% reduction, p = 0.003) and total RSV days with increased supplemental oxygen (73% reduction, p = 0.014) per 100 children.
6 je dobivala Synagis, v primerjavi s skupino, ki je dobivala placebo, na 100 otrok značilno manjše celotno število dni hospitalizacije zaradi RSV (56% zmanjšanje, p = 0, 003) in celotno število dni RSV z zvečanim dodajanjem kisika (73% zmanjšanje, p = 0, 014).
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).
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.
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 μ g/ ml after the first injection, approximately 60 μ g/ ml after the second injection, approximately 70 μ g/ ml after the third injection and fourth injection.
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 μg/ ml po prvi injekciji, približno 60 μg/ ml po drugi injekciji in približno 70 μg/ ml po tretji in četrti injekciji.
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.
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.
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 μ g/ ml pre-cardiac bypass and declined to approximately 40 μ g/ ml after bypass.
Pri teh 139 otrocih je bila povprečna koncentracija palivizumaba v serumu pred zunajtelesnim obtokom približno 100 μg/ ml, po njem pa se je zmanjšala na približno 40 μg/ ml.
Single dose toxicology studies have been conducted in cynomolgus monkeys (maximum dose 30 mg/ kg), rabbits (maximum dose 50 mg/ kg) and rats (maximum dose 840 mg/ kg).
Toksikološke raziskave pri enkratnem odmerku so bile opravljene pri opicah cynomolgus (največji odmerek 30 mg/ kg), kuncih (največji odmerek 50 mg/ kg) in podganah (največji odmerek 840 mg/ kg).
Histidine Glycine Mannitol
Histidin Glicin Manitol
3 hours
Raztopina: uporabiti jo je treba v 3 urah po pripravi.
Store in a refrigerator (2ºC to 8ºC).
Shranjujte v hladilniku (pri temperaturi med 2 °C in 8 °C).
Synagis powder in a clear, colourless, type I glass 4ml vial with bromobutyl rubber stopper and aluminium flip-off seal containing 50 mg palivizumab, providing 100 mg/ ml of palivizumab when reconstituted.
Prašek Synagis v 4 ml viali iz prozornega, brezbarvnega stekla tipa I z gumijastim zamaškom iz bromobutila in aluminijasto pretržno zaporko vsebuje 50 mg palivizumaba; koncentracija po navodilu pripravljene raztopine je 100 mg/ ml.
Water for injections in a clear, colourless type I glass ampoule containing 1 ml of water for injections.
Voda za injekcije v ampuli iz prozornega, brezbarvnega stekla tipa I, ki vsebuje 1 ml vode za injekcije.
One vial of Synagis powder and one ampoule of water for injections per pack.
Vsako pakiranje vsebuje eno vialo praška Synagis in eno ampulo vode za injekcije.
SLOWLY add 0.6 ml of water for injections along the inside wall of the vial to minimise foaming.
POČASI dodajte 0, 6 ml vode za injekcije, in sicer vzdolž notranje stene viale, da boste čim bolj omejili penjenje.
DO NOT SHAKE THE VIAL.
VIALE NE STRESAJTE!
When reconstituted as recommended, the final concentration is 100 mg/ ml.
Če je raztopina pripravljena po navodilu, je končna koncentracija 100 mg/ ml.
13 August 1999 Date of latest renewal:
13. avgust 1999 Datum zadnjega podaljšanja dovoljenja za promet:
Each vial contains 100 mg palivizumab, providing 100 mg/ ml of palivizumab when reconstituted as recommended.
Koncentracija po navodilu pripravljene raztopine palivizumaba je 100 mg/ ml.
• Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season • Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months. • Children less than 2 years of age and with haemodynamically significant congenital heart disease.
• pri otrocih, ki so se rodili z največ 35 gestacijskimi tedni in so na začetku sezone RSV mlajši od 6 mesecev, • pri otrocih, mlajših od 2 let, ki so v zadnjih 6 mesecih potrebovali zdravljenje zaradi bronhopulmonalne displazije, • pri otrocih, mlajših od 2 let, ki imajo hemodinamsko pomembno prirojeno bolezen srca.
Data, although limited, are available on greater than 5 doses (see sections 4.8 and section 5.1), therefore the benefit in terms of protection beyond 5 doses has not been established.
Podatki o več kot 5 odmerkih so sicer na voljo, vendar so omejeni (glejte poglavji 4. 8 in 5. 1), zato koristi glede zaščite pri uporabi več kot 5 odmerkov niso ugotovljene.
9 Method of administration Palivizumab is administered in a dose of 15 mg/ kg of body weight once a month intramuscularly, preferably in the anterolateral aspect of the thigh.
Način uporabe Palivizumab se injicira enkrat na mesec v odmerku 15 mg/ kg telesne teže intramuskularno, po možnosti v anterolateralni predel stegna.
For information on reconstituting Synagis, see section 6.6.
9 Za informacije o rekonstituciji Synagisa glejte poglavje 6. 6.
10 4.8 Undesirable effects
10 4. 8 Neželeni učinki
Adverse events at least possibly causally-related to palivizumab, both clinical and laboratory, are displayed by system organ class and frequency (common ≥ 1/ 100 to < 1/ 10; uncommon ≥ 1/ 1,000 to < 1/ 100) in studies conducted in premature and bronchopulmonary dysplasia paediatric patients, and congenital heart disease patients (Tables 1 and 2, respectively).
Podatki so iz raziskav pri nedonošenčkih in otrocih z bronhopulmonalno displazijo (preglednica 1) in pri otrocih s prirojeno srčno boleznijo (preglednica 2).
Within each frequency grouping, adverse reactions have been presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Viral infection Upper respiratory infection
Splošne težave in spremembe na mestu aplikacije
11 Table 2 Undesirable effects in the prophylactic paediatric congenital heart disease clinical study
11 Preglednica 2 Neželeni učinki v profilaktični klinični raziskavi otrok s prirojenimi boleznimi srca
Post-marketing serious spontaneous adverse events reported during palivizumab treatment between 1998 and 2002 covering four RSV seasons were evaluated.
Ocenili so resne spontane neželene učinke med zdravljenjem s palivizumabom, o katerih so poročali v postmarketinškem obdobju med letoma 1998 in 2002; zdravljenje je zajemalo štiri sezone RSV.
Human anti-human antibody (HAHA) response:
12 Človeški odziv z antihumanimi protitelesi:
Antibody to palivizumab was observed in approximately 1% of patients in the IMpact-RSV during the first course of therapy.
Protitelesa proti palivizumabu so v raziskavi IMpact- RSV med prvim ciklusom zdravljenja odkrili pri približno 1% bolnikov.
12 Immunogenicity was not studied in the congenital heart disease study.
V raziskavi prirojenih bolezni srca imunogenosti niso proučevali.
Secondary efficacy endpoints showed significant reductions in the Synagis group compared to placebo in total days of RSV hospitalisation (56% reduction, p = 0.003) and total RSV days with increased supplemental oxygen (73% reduction, p = 0.014) per 100 children.
13 je dobivala Synagis, v primerjavi s skupino, ki je dobivala placebo, na 100 otrok značilno manjše celotno število dni hospitalizacije zaradi RSV (56% zmanjšanje, p = 0, 003) in celotno število dni RSV z zvečanim dodajanjem kisika (73% zmanjšanje, p = 0, 014).
6.4 Special precautions for storage
14 6. 4 Posebna navodila za shranjevanje