natgillin/translations-raw huggingface dataset:
Palivizumab solution does not contain a preservative and should be administered within 3 hours of preparation.
Raztopina palivizumaba ne vsebuje konzervansa in jo je treba uporabiti v 3 urah po pripravi.
The adverse reactions identified via post-marketing surveillance are reported voluntarily from a population of uncertain size; it is not always possible to reliably estimate their frequency or establish a causal relationship to palivizumab exposure.
Neželeni učinki iz obdobja spremljanja zdravila na trgu so bili poročani prostovoljno iz neznano velike populacije; ni vedno možno zanesljivo izračunati njihove pogostnosti ali vzpostaviti vzročne povezave z izpostavljenostjo palivizumabu.
No formal interactions studies with other medicinal products were conducted.
Formalnih raziskav medsebojnega delovanja z drugimi zdravili ni bilo.
For instructions on special handling requirements, see section 6.6.
Za navodila glede posebnih zahtev za ravnanje z zdravilom, glejte poglavje 6.6.
After the water is added, tilt the vial slightly and gently rotate the vial for 30 seconds.
Ko ste dodali vodo, vialo rahlo nagnite in jo obzirno vrtite 30 sekund.
Call your doctor or get medical help right away if your child has any of the serious side effects listed above after receiving any dose of Synagis.
Nemudoma pokličite zdravnika ali poiščite zdravniško pomoč, če ima vaš otrok katerega od zgoraj navedenih resnih neželenih učinkov po prejemu katerega koli odmerka zdravila Synagis.
These adverse reactions are similar in character to those after the initial five doses.
Ti neželeni učinki so bili po značilnostih podobni tistim po prvih petih odmerkih.
• Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.
• pri otrocih, mlajših od 2 let, ki so v zadnjih 6 mesecih potrebovali zdravljenje zaradi bronhopulmonalne displazije,
Palivizumab treatment schedule and adverse reactions 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.
Your child can then go back to the original planned injection.
Vaš otrok lahko potem preide na prvoten urnik injekcij.
Injection volumes over 1 ml should be given as a divided dose.
Količine, večje od 1 ml, je treba injicirati v deljenem odmerku.
Synagis is not indicated for use in adults.
Zdravilo Synagis ni indicirano za uporabo pri odraslih.
Adverse reactions 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.
Your child is at high risk of getting an illness caused by a virus called respiratory syncytial virus (RSV).
Vašega otroka zelo ogroža bolezen, ki jo povzroča virus, imenovan respiratorni sincicijski virus (RSV).
The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing a uthorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
There was no association observed between the presence of antibody and adverse events.
Niso opazili povezave med prisotnostjo protiteles in neželenimi učinki.
What Synagis is and what it is used for
Kaj je zdravilo Synagis in za kaj ga uporabljamo
The solution is clear or slightly opalescent.
Raztopina je bistra ali rahlo opalescentna.
Each injection of Synagis can only help protect your child for about one month before another injection is needed.
Vsaka injekcija zdravila Synagis pomaga varovati otroka le približno en mesec, potem je potrebna naslednja injekcija.
Any remaining contents should be discarded after use.
Morebitni neporabljeni ostanek je treba po uporabi zavreči.
The overall rate and pattern of adverse events, study drug discontinuation due to AEs, and the number of deaths reported in these clinical studies were consistent with those observed during the clinical development programs for the lyophilised formulation.
Splošna stopnja in vzorec neželenih dogodkov, prekinitev študije zaradi neželenih dogodkov in število smrtnih primerov, o katerih so poročali v teh kliničnih študijah, so bili skladni s tistimi, ki so jih opazovali v kliničnih razvojnih programih za liofilizirano obliko.
This medicinal product should not be mixed with other medicinal products.
Tega zdravila se ne sme mešati z drugimi zdravili.
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.
To ensure the correct volume is reconstituted for Synagis, see section 6.6.
Za zagotovilo, da bo rekonstituirana pravilna količina zdravila Synagis, glejte poglavje 6.6.
From the post-marketing experience, overdoses with doses up to 85 mg/kg have been reported and in some cases, adverse reactions were reported which did not differ from those observed with 15 mg/kg dose (see section 4.8).
Med obdobjem trženja zdravila so bili opisani primeri prevelikega odmerjanja pri odmerkih do 85 mg/kg in v nekaterih primerih so poročali o neželenih učinkih, ki se niso razlikovali od neželenih učinkov, opaženih pri odmerku 15 mg/kg (glejte poglavje 4.8).
The injection should be given using standard aseptic technique.
Za injiciranje je treba uporabiti standardni aseptični postopek.
A total of 1,291 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.
Ninetyeight percent of all subjects receiving palivizumab completed the study and 97% received all five injections.
Osemindevetdeset odstotkov vseh oseb, ki so prejemale palivizumab, je študijo zaključilo in 97 % je prejelo vseh 5 injekcij.
Palivizumab should be given with caution to patients with thrombocytopaenia or any coagulation disorder.
Palivizumab je treba dajati previdno bolnikom s trombocitopenijo ali katero koli motnjo koagulacije.
Therefore, diagnostic test results, when obtained, should be used in conjunction with clinical findings to guide medical decisions.
Zato je potrebno za zdravniško odločitev uporabljati rezultate diagnostičnih testov, kadar so izvedeni, v povezavi s kliničnimi znaki.
The onset of the adverse reactions 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).
What Synagis is and what it is used for What you need to know before Synagis is given to your child How will my child receive Synagis Possible side effects
Kaj je zdravilo Synagis in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok dobil zdravilo Synagis Kako bo otrok dobival zdravilo Synagis Možni neželeni učinki
Subjects were stratified by cardiac lesion (cyanotic vs. other) and were followed for safety and efficacy for 150 days.
Osebe so bile razdeljene v podskupini glede na poškodbo srca (cianotični ali ostali) in spremljane 150 dni glede varnosti in učinkovitosti.
Palivizumab solution for injection does not contain a preservative, is for single use and should be administered immediately after drawing the dose into the syringe.
Palivizumab raztopina za injiciranje ne vsebuje konzervansa, je za enkratno uporabo in jo je treba uporabiti takoj po odvzemu odmerka v brizgo.
Use within 3 hours of reconstitution.
Uporabite v 3 urah po pripravi.
After reconstitution use within 3 hours.
Po rekonstituciji uporabite v roku 3 ur.
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).
The appearance of the reconstituted solution is clear to slightly opalescent.
Rekonstituirana raztopina je na videz bistra do rahlo opalescentna.
The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve.
Glutealne mišice se ne sme uporabljati kot običajnega mesta injiciranja, ker obstaja tveganje za poškodbo bedrnega živca.
The primary endpoint was a summary of adverse events and serious adverse events, and the secondary endpoint was the incidence of RSV hospitalisation.
Primarni cilj opazovanja je bil povzetek neželenih dogodkov in resnih neželenih dogodkov, sekundarni cilj pa incidenca hospitalizacij zaradi RSV.
Do not mix the palivizumab liquid and lyophilised formulations.
Ne mešajte palivizumaba v tekoči in liofilizirani obliki.
The antiviral activity of palivizumab was assessed in a microneutralization assay in which increasing concentrations of antibody were incubated with RSV prior to addition of the human epithelial cells HEp-2.
Prostivirusna aktivnost palivizumaba je bila ocenjena v mikronevtralizacijskem testu, pri katerem so naraščajoče koncentracije protiteles inkubirali z RSV pred dodatkom človeških epitelnih celic HEp-2.
A mild febrile illness, such as mild upper respiratory infection, is not usually reason to defer administration of palivizumab.
Blaga vročinska bolezen, npr. blaga okužba zgornjih dihal, ponavadi ni razlog za odložitev uporabe palivizumaba.
Medicinal products for the treatment of severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, should be available for immediate use following administration of palivizumab.
Zdravila za zdravljenje hudih preobčutljivostnih reakcij, vključno z anafilaksijo in anafilaktičnim šokom, morajo biti na voljo za takojšnjo uporabo po aplikaciji palivizumaba.
PC SN NN
PC: SN:
The RSV hospitalisation rate observed in patients enrolled with a diagnosis of CLDP was 28/723 (3.9%) and in patients enrolled with a diagnosis of prematurity without CLDP was 34/2583 (1.3%).
Delež hospitalizacij zaradi RSV, ki so ga zabeležili pri bolnikih, vključenih z diagnozo CLDP, je bil 28/723 (3,9 %), pri bolnikih, vključenih zaradi prezgodnjega rojstva brez CLDP, pa 34/2583 (1,3 %).
Subsequent doses should be administered monthly throughout the RSV season.
Nadaljnje odmerke je treba dajati enkrat na mesec vso sezono RSV.
The primary endpoint was the incidence of RSV hospitalisation.
Primarni cilj opazovanja je bila incidenca hospitalizacij zaradi RSV.
RSV hospitalisations occurred among 62 of 3306 (1.9%) patients in the palivizumab group.
Do hospitalizacij zaradi RSV je prišlo pri 62 od 3306 (1,9 %) bolnikov v skupini s palivizumabom.
After incubation for 4-5 days, RSV antigen was measured in an enzyme-linked immunosorbent assay (ELISA).
Po 4-5 dneh inkubacije so izmerili RSV antigen v encimsko imunskem testu (Enzyme-Linked Immunosorbent Assay - ELISA).
CHD Study 2: this trial, conducted at 162 centers in North America, European Union and 4 other countries over two RSV seasons, studied patients less than or equal to 24 months of age with hemodynamically significant CHD.
Študija CHD 2: v tem preskušanju, izvedenem na 162 centrih v Severni Ameriki, Evropski Uniji in 4 drugih državah so v dveh sezonah RSV proučevali bolnike stare 24 mesecev ali manj s hemodinamično pomembno CHD.
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 študiji IMpact-RSV med prvim ciklusom zdravljenja odkrili pri približno 1% bolnikov.
The efficacy of palivizumab at doses other than 15 mg per kg or of dosing differently from monthly throughout the RSV season, has not been established.
Učinkovitost palivizumaba v odmerkih drugačnih od 15 mg na kg ali pri odmerjanju, ki je drugačno od enkrat mesečno, med sezono RSV ni bila dokazana.
The frequency for these "ADRs" as presented in the table below was estimated using the safety data of the two registration clinical studies.
Pogostnost teh neželenih učinkov, kot je prikazana v tabeli spodaj, je bila ocenjena s pomočjo podatkov o varnosti iz dveh registracijskih kliničnih študij.
The incidence of arrhythmia and death PSAEs was similar in children who did and did not receive prophylaxis.
Incidenca aritmije in smrti je bila podobna pri otrocih, ki so in ki niso prejeli profilakse.
*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.