natgillin/translations-raw huggingface dataset:
*For full study description, see Section 5.1 Clinical studies # ADRs identified from post-marketing surveillance 
*Za celoten opis študije glejte poglavje 5.1 Klinične študije # Neželeni učinki iz obdobja trženja zdravila
In the second study, 211 and 202 premature infants or children with chronic lung disease received liquid and lyophilised palivizumab, respectively. 
V drugi študiji je 211 in 202 nedonošenčkov ali otrok s kronočno pljučno boleznijo prejemalo palivizumab v tekoči oziroma liofilizirani obliki.
No significant findings were observed. 
Pokazale niso ničesar pomembnega.
if your child has any bleeding disorders as Synagis is usually injected into the thigh. 
- če ima otrok kakšne motnje strjevanja krvi, kajti zdravilo Synagis se ponavadi injicira v stegno.
No deaths were considered related to palivizumab and no new ADRs were identified in these studies. 
Nobena smrt ni veljala za povezano s palivizumabom in v teh študijah novih neželenih učinkov niso ugotovili.
The incidence of RSV hospitalisation was 16 of 612 (2.6%) in the palivizumab group. 
Incidenca hospitalizacij zaradi RSV je bila 16 od 612 (2,6 %) v skupini s palivizumabom.
Post-marketing serious spontaneous adverse reactions 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 obdobju trženja zdravila med letoma 1998 in 2002; zdravljenje je zajemalo štiri sezone RSV.
No difference between groups regarding immunogenicity was observed in either study. 
Ne v eni ne v drugi raziskavi med skupinama niso opazili razlik v imunogenosti.
Ninety-seven percent of all subjects receiving palivizumab completed the study and 95% received all five injections. 
Sedemindevetdeset odstotkov vseh oseb, ki so prejemale palivizumab, je študijo zaključilo in 95 % jih je prejelo vseh 5 injekcij.
Histidine Glycine 
Histidin Glicin
The results of this trial indicated that the trough serum concentrations of palivizumab were similar between the liquid formulation and the lyophilised formulation and bioequivalence of the liquid and the lyophilised formulation was demonstrated. 
Rezultati tega preskušanja so pokazali, da so bile koncentracije palivizumaba v serumu podobne med tekočo in liofilizirano obliko in, da je bila bioekvivalenca tekoče in liofilizirane oblike dokazana.
The most serious adverse reactions occurring with palivizumab are anaphylaxis and other acute hypersensitivity reactions. 
Najbolj resni neželeni učinki, ki se pojavijo pri palivizumabu so anafilaksija in druge akutne preobčutljivostne reakcije.
If any ofthe side effects get serious, or if you notice that your child has any side effects not listed in this leaflet, please tell your doctor or pharmacist. 
Če katerikoli neželeni učinek postane resen ali če pri vašem otroku opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Synagis will be given by injection to your child into a muscle, usually in the outer part of the thigh. 
Zdravilo Synagis bo injicirano v mišico otroka, ponavadi na zunanjem delu stegna.
Since the monoclonal antibody is specific for RSV, palivizumab is not expected to interfere with the immune response to vaccines. 
Ker je palivizumab za RSV specifično monoklonsko protitelo, ni pričakovati, da bi oviral imunski odziv na cepiva.
Pharmacotherapeutic group: immune sera immunoglobulins, specific immunoglobulins; ATC Code: J06BB16 
Farmakoterapevtska skupina: imunski serumi in imunoglobulini, specifični imunoglobulini, oznaka ATC: J06BB16
Synagis should be given to your child at a dose of 15 mg/kg body weight once a month for as long as the risk of RSV infection remains. 
Otrok mora zdravilo Synagis dobivati v odmerku 15 mg/kg telesne mase enkrat na mesec, dokler obstaja tveganje za okužbo z RSV.
Synagis is indicated for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease: 
Zdravilo Synagis je indicirano za preprečevanje resne, hospitalizacije potrebne bolezni spodnjih dihal zaradi respiratornega sincicijskega virusa (RSV) pri otrocih, ki jih takšna bolezen zelo ogroža:
In a genotypic analysis of 126 clinical isolates from 123 children who failed immunoprophylaxis, all RSV mutants that exhibited resistance to palivizumab (n=8) were shown to contain amino acid changes in this region of the F protein. 
V genotipski analizi 126-ih kliničnih izolatov 123 otrok, ki jim imunoprofilaksa ni pomagala, so vsi RSV mutanti, ki so izkazovali odpornost na palivizumab (n=8) pokazali, da vsebujejo aminokislinske spremembe v tem območju F proteina.
What should you do if your child misses an injection of Synagis? 
Kaj storiti, če otrok zamudi injekcijo zdravila Synagis?
To reduce risk of rehospitalisation, it is recommended that children receiving palivizumab who are hospitalised with RSV continue to receive monthly doses of palivizumab for the duration of the RSV season. 
Za zmanjšanje tveganja za ponovno hospitalizacijo naj otroci, hospitalizirani zaradi RSV, ki dobivajo palivizumab, tega še naprej dobivajo vsak mesec vso sezono RSV.
Assay interference could lead to false-negative RSV diagnostic test results. 
Motenje testov lahko vodi do lažno-negativnih rezultatov RSV diagnostičnih testov.
The severity of RSV disease in children hospitalised despite prophylaxis with palivizumab in terms of days in ICU stay per 100 children and days of mechanical ventilation per 100 children was not affected. 
Izrazitost bolezni RSV pri otrocih, hospitaliziranih kljub profilaksi s palivizumabom, izražena z dnevi v EIN (enoti za intenzivno nego) na 100 otrok in z dnevi mehanične ventilacije na 100 otrok, se ni spremenila.
The results of the study indicate no increased risk of serious infection, serious arrhythmia, or death in children with HSCHD associated with Synagis prophylaxis compared with children who did not receive prophylaxis. 
Rezultati raziskave ne nakazujejo povečanega tveganja za resne okužbe, resne aritmije ali smrt pri otrocih s HSCHD v povezavi s profilakso z zdravilom Synagis v primerjavi z otroci, ki niso prejeli profilakse.
A moderate to severe acute infection or febrile illness may warrant delaying the use of palivizumab, unless, in the opinion of the physician, withholding palivizumab entails a greater risk. 
V primeru zmerne do hude akutne okužbe ali vročinske bolezni je treba uporabo palivizumaba odložiti, razen če ta odlog po zdravnikovi presoji pomeni večje tveganje.
In an open label prospective trial designed to evaluate pharmacokinetics, safety and immunogenicity after administration of 7 doses of palivizumab within a single RSV season, pharmacokinetic data indicated that adequate mean palivizumab levels were achieved in all 18 children enrolled. 
V odprtem prospektivnem preskušanju, namenjenem oceni farmakokinetike, varnosti in imunogenosti po aplikaciji 7 odmerkov palivizumaba v eni sami sezoni RSV, so farmakokinetični podatki pokazali, da je bila pri vseh 18 vključenih otrocih dosežena ustrezna povprečna raven palivizumaba.
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 zdravilo Synagis, 5,3%.
No polymorphic or non-polymorphic sequence variations outside of the A antigenic site on the RSV F protein were shown to render RSV resistant to neutralisation by palivizumab. 
Opazili niso nobenih polimorfnih ali ne-polimorfnih sekvenčnih sprememb izven A antigenskega mesta na RSV F proteinu, zaradi katerih bi RSV postal odporen na nevtralizacijo s palivizumabom.
Palivizumab exhibited median EC50 values of 0.65 g/ml (mean [standard deviation] = 0.75 [0.53] g/ml; n=69, range 0.07-2.89 g/ml) and 0.28 g/ml (mean [standard deviation] = 0.35 [0.23] g/ml; n=35, range 0.03-0.88 g/ml) against clinical RSV A and RSV B isolates, respectively. 
Palivizumab je pokazal mediane vrednosti EC50 0,65g/ml (povprečje [standardna deviacija] = 0,75 [0,53] g/ml; n=69, razpon 0,07-2,89 g/ml) in 0,28 g/ml (povprečje [standardna deviacija] = 0,35 [0,23] g/ml; n=35, razpon 0,03-0,88 g/ml) proti kliničnim izolatom RSV A in RSV B, v tem zaporedju.
Therefore, anti-drug antibody (ADA) responses appear to be of no clinical relevance. 
Po tem sodeč odziv protiteles proti zdravilu ni klinično pomemben.
Analysis of 254 clinical RSV isolates collected from immunoprophylaxis-naïve subjects revealed palivizumab resistance-associated substitutions in 2 (1 with N262D and 1 with S275F), resulting in a resistance associated mutation frequency of 0.79%. 
Analiza 254 kliničnih izolatov RSV, zbranih od osebkov brez imunoprofilakse, je pokazala z odpornostjo proti palivizumabu povezane substitucije pri 2 (1 z N262D in 1 s S275F), kar je vodilo v pogostnost z odpornostjo povezanih mutacij 0,79%.
This was transient, low titre, resolved despite continued use (first and second season), and could not be detected in 55 of 56 infants during the second season (including 2 with titres during the first season). 
Odziv, ki 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).V študiji prirojenih bolezni srca imunogenosti niso proučevali.
The incidence of infection PSAEs was lower in children who received prophylaxis as compared to those children who did not receive prophylaxis. 
Incidenca okužbe je bila nižja pri otrocih, ki so prejeli profilakso v primerjavi z otroki, ki niso prejeli profilakse.
A retrospective observational study was conducted in young children with hemodynamically significant congenital heart disease (HSCHD) comparing the occurrence of primary serious adverse events (PSAEs: infection, arrhythmia, and death) between those who did (1009) and did not receive Synagis prophylaxis (1009) matched by age, type of cardiac lesion, and prior corrective surgery. 
Pri majhnih otrocih s hemodinamično pomembno prirojeno boleznijo srca (HSCHD) so izvedli retrospektivno opazovalno raziskavo, v kateri so primerjali pojav primarnih resnih neželenih učinkov (PSAEs: okužba, aritmija in smrt) med tistimi, ki so (1009) in ki niso prejeli profilakse z zdravilom Synagis (1009) razvrščeno po starosti, tipu srčne lezije in predhodne korekcijske operacije.
Synagis contains an active ingredient called palivizumab which is an antibody that works specifically against a virus called respiratory syncytial virus, RSV. 
Zdravilo Synagis vsebuje zdravilno učinkovino, ki se imenuje palivizumab in je protitelo, ki specifično deluje proti virusu, imenovanemu respiratorni sincicijski virus, RSV.
In two additional studies, liquid palivizumab was used as an active control (3918 pediatric subjects) to evaluate an investigational monoclonal antibody for prophylaxis of serious RSV disease in premature infants or children with BPD or hemodynamically significant CHD (see below for further details of these two studies). 
V dveh dodatnih študijah so palivizumab v tekoči obliki uporabili kot aktivno primerjavo (3918 pediatričnih bolnikov) za oceno preiskovanega monoklonskega protitelesa za profilakso resnih okužb z RSV pri nedonošenčkih ali otrocih z bronhopulmonalno displazijo ali hemodinamično pomembno prirojeno srčno boleznijo (dodatne podrobnosti o teh dveh študijah so navedene v nadaljevanju).
Palivizumab serum concentrations of approximately 30 g/ml have been shown to produce a 99% reduction in pulmonary RSV replication in the cotton rat model. 
V serumski koncentraciji približno 30 g/ml je palivizumab v modelu z bombažno podgano zmanjšal replikacijo RSV v pljučih za 99%.
Synagis Water for injections ampoule label 
Synagis voda za injekcije - nalepka na ampuli
(3 x 0.15) ml = 0.45 ml palivizumab per month. 
(3 x 0,15) ml = 0,45 ml palivizumaba na mesec.
• Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season. 
• pri otrocih, ki so se rodili z največ 35 gestacijskimi tedni in so na začetku sezone RSV mlajši od 6 mesecev,
In addition, palivizumab inhibits virus replication in cell culture and, therefore, may also interfere with viral culture assays. 
Poleg tega palivizumab zavira replikacijo virusov v celičnih kulturah in zato lahko moti nekatere teste na virusnih kulturah.
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).
The recommended dose of palivizumab is 15 mg/kg of body weight, given once a month during anticipated periods of RSV risk in the community. 
Priporočeni odmerek palivizumaba je 15 mg/kg telesne mase enkrat na mesec med predvidenimi obdobji tveganja za RSV v otrokovem okolju.
What Synagis looks like and contents of the pack 
Izgled zdravila Synagis in vsebina pakiranja
Synagis is a medicine to help protect your child from getting severe RSV illness. 
Zdravilo Synagis je zdravilo, ki otroka pomaga zaščititi pred hudo obliko bolezni RSV.
Synagis solution for injection is a clear or slightly opalescent solution and is available in vials of either 0.5 ml or 1 ml. 
Zdravilo Synagis raztopina za injiciranje je bistra do rahlo opalescentna raztopina in je na voljo v vialah z 0,5 ml ali 1 ml raztopine.
Synagis solution for injection is a ready to use formulation. 
Zdravilo Synagis raztopina za injiciranje je pripravljeno za uporabo.
However, as 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, the relevance of these data in terms of efficacy is unknown. 
Ker pa učinkovitost palivizumaba, uporabljenega kot drugi ciklus zdravljenja med naslednjo sezono RSV, ni bila formalno raziskana v kakšni raziskavi, opravljeni v ta namen, ni znano, kaj ti podatki pomenijo glede učinkovitosti.
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.
1ml of water for injections in an ampoule (type I glass). 
1 ml vode za injekcije v ampuli (steklo tipa I).
The incidences of these reactions in these studies showed no difference between the palivizumab and placebo groups and the reactions were not drug related. 
V pogostnosti teh dogodkov v teh študijah med skupinama na palivizumabu in placebu ni bilo razlik in dogodki niso bili povezani z zdravilom.
When reconstituted as recommended, the final concentration is 100 mg/ml. 
Če je raztopina pripravljena po navodilu, je končna koncentracija 100 mg/ml.
Single-use vials: 3 ml capacity, clear, colourless type I glass vial with a chlorobutyl stopper and flipoff seal containing either 0.5 ml or 1 ml of solution for injection. 
Viale za enkratno uporabo: 3 ml viala iz prozornega, brezbarvnega stekla tipa I s klorobutilnim zamaškom in pretržno zaporko, ki vsebuje 0,5 ml ali 1 ml raztopine za injiciranje.
Signs and symptoms of a severe allergic reaction include: severe rash, hives, or itching skin swelling of the lips, tongue, or face closing of the throat, difficulty swallowing difficult, rapid, or irregular breathing bluish colour of skin, lips, or under fingernails muscle weakness or floppiness a drop in blood pressure unresponsiveness 
- hud izpuščaj, koprivnico ali srbečo kožo - otekanje ustnic, jezika ali obraza - zamašitev grla, težave s požiranjem - težko, hitro ali neredno dihanje - modrikasta barva kože, ustnic ali pod nohti - šibkost ali ohlapnost mišic - padec krvnega tlaka - neodzivnost
This medicinal product should not be mixed with other medicinal products or diluents other than water for injections. 
Tega zdravila se ne sme mešati z drugimi zdravili ali vehikli razen z vodo za injekcije.
Pre-term infants and children with Chronic Lung Disease of Prematurity (CLDP): this trial, conducted at 347 centers in the North America, European Union and 10 other countries, studied patients less than or equal to 24 months of age with CLDP and patients with premature birth (less than or equal to 35 weeks gestation) who were less than or equal to 6 months of age at study entry. 
Nedonošenčki in otroci s kronično pljučno boleznijo nedonošenčkov (CLDP): v tem preskušanju, izvedenem na 347 centrih v Severni Ameriki, Evropski Uniji in 10 drugih državah, so proučevali bolnike s CLDP, stare 24 mesecev ali manj in prezgodaj rojene bolnike (v 35. tednu nosečnosti ali prej), ki so bili ob vključitvi v študijo stari 6 mesecev ali manj.
Also contains: histidine, glycine and water for injections. 
Vsebuje tudi: histidin, glicin in vodo za injekcije.
In an observational, post-marketing, database study, a small increase in the frequency of asthma was observed among preterm palivizumab recipients; however, the causal relationship is uncertain. 
V obdobju trženja zdravila so v opazovalni študiji po zbirkah podatkov opazili majhen porast v pogostnosti astme pri nedonošenčkih, ki so prejemali palivizumab, vendar vzročna povezava ni gotova.
Immune system disorders Not known 
Bolezni imunskega sistema Neznana pogostnost
Palivizumab is a humanised IgG1 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 IgG1, usmerjeno na epitop antigenskega mesta A fuzijske beljakovine respiratornega sincicijskega virusa (RSV).
Palivizumab binds a highly conserved region on the extracellular domain of mature RSV F protein, referred to as antigenic site II or A antigenic site, which encompasses amino acids 262 to 275. 
Palivizumab se veže na dobro ohranjeno območje na zunajcelični domeni zrelega RSV F proteina, znanega kot antigensko mesto II ali A antigensko mesto, ki obsega aminokisline 262 do 275.
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. 
Sekundarne končne točke učinkovitosti so pokazale, da je bilo v skupini, ki je dobivala zdravilo 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
- The other ingredients are histidine, glycine and water for injections. 
- Druge sestavine zdravila so histidin, glicin in voda za injekcije.
If you are not sure about how this product will be given to your child, ask your doctor or pharmacist. 
Če ste negotovi glede uporabe zdravila pri vašem otroku, se posvetujte z zdravnikom ali s farmacevtom.
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.
If your child gets any side effects, talk to your doctor. 
Če se otroku pojavijo kateri koli neželeni učinki, se posvetujte z zdravnikom.
Please tell your doctor if your child is unwell, as the use of Synagis may need to be delayed. 
Če vaš otrok ni povsem zdrav, morate to povedati zdravniku; morda bo treba uporabo zdravila Synagis odložiti.
Detailed information on this product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
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). 
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).
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). 
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).
Palivizumab may interfere with immune-based RSV diagnostic tests, such as some antigen detection based assays. 
Palivizumab lahko moti nekatere imunsko osnovane RSV diagnostične teste, kot so nekateri testi, ki temeljijo na detekciji antigenov.
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. 
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.
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. 
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.
Single-use vial. 
Vial aza enkratno uporabo.
Your child should not be given Synagis 
Otrok ne sme dobiti zdravila Synagis
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). 
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).
How often will Synagis be given to my child? 
Kako pogosto bo otrok dobil zdravilo Synagis?
Other medicines and Synagis 
Druga zdravila in zdravilo Synagis
100 mg of powder in a 10 ml vial (type I glass) with a stopper (butyl rubber) and a flip-off seal (aluminium). 
100 mg praška v 10 ml viali (steklo tipa I) z zamaškom (butil) in pretržno zaporko (aluminij).
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. 
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.