natgillin/translations-raw huggingface dataset:
Immunogenicity was not studied in the congenital heart disease study.
Imunogenost nije ispitivana u ispitivanju kongenitalne bolesti srca.
Patients with hemodynamically significant congenital heart disease were excluded from enrollment in this study and were studied in a separate study.
Bolesnici s hemodinamski značajnom kongenitalnom bolesti srca nisu uključeni u ovo ispitivanje te su proučavani u zasebnom ispitivanju.
Therefore, diagnostic test results, when obtained, should be used in conjunction with clinical findings to guide medical decisions.
Stoga pri donošenju medicinskih odluka dobivene rezultate dijagnostičkih testova treba koristiti u kombinaciji s kliničkim nalazima.
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.
Djelotvornost palivizumaba u dozama različitima od 15 mg/kg ili doziranju različitom od jednom mjesečno tijekom cijele sezone RSV-a nije ustanovljena.
The frequency for these "ADRs" as presented in the table below was estimated using the safety data of the two registration clinical studies.
Učestalost tih „nuspojava“ prikazana u sljedećoj tablici procijenjena je na temelju sigurnosnih podataka iz dvaju registracijskih kliničkih ispitivanja.
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.
Ukupna stopa i uzorak štetnih događaja, prekid primjene ispitivanog lijeka zbog štetnih događaja te broj smrtnih slučajeva prijavljenih u ovim kliničkim ispitivanjima bili su u skladu s onima zabilježenim tijekom kliničkog razvoja liofilizirane formulacije.
It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains.
Ima snažni neutralizirajući učinak i inhibitorno djelovanje na fuzijsku aktivnost sojeva oba RSV podtipa A i B.
These adverse reactions are similar in character to those after the initial five doses.
Te su nuspojave po karakteristikama bile slične onima zabilježenima nakon prvih pet doza.
What should you do if your child misses an injection of Synagis?
Što učiniti ako Vaše dijete propusti primiti injekciju lijeka Synagis?
Your child is at high risk of getting an illness caused by a virus called respiratory syncytial virus (RSV).
Kod Vašeg djeteta postoji velik rizik nastanka bolesti uzrokovane virusom koji se zove respiratorni sincicijski virus (RSV).
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.
Kako bi se smanjio rizik od ponovne hospitalizacije, preporučuje se da djeca koja dobivaju palivizumab, a hospitalizirana su zbog infekcije RSV-om, nastave primati mjesečne doze palivizumaba tijekom cijele sezone RSV-a.
For example, for a baby with a body weight of 3 kg, the calculation becomes:
Na primjer, za dijete tjelesne težine 3 kg, doza se izračunava na sljedeći način:
If you are not sure about how this product will be given to your child, ask your doctor or pharmacist.
Ako niste sigurniu vezi s time kako će ovaj lijek biti primijenjen Vašem djetetu, obratite se liječniku ili ljekarniku.
Synagis is a white to off-white cake.
Synagis je bijeli do gotovo bijeli kolačić.
Synagis will be given by injection to your child into a muscle, usually in the outer part of the thigh.
Synagis će se primijeniti Vašem djetetu injekcijom u mišić, najčešće u vanjski dio bedra.
In addition, palivizumab inhibits virus replication in cell culture and, therefore, may also interfere with viral culture assays.
Osim toga, palivizumab inhibira replikaciju virusa u staničnoj kulturi pa stoga može utjecati i na testove u virusnim kulturama.
The appearance of the reconstituted solution is clear to slightly opalescent.
Rekonstituirana otopina je izgledom bistra do lagano opalescentna.
The powder is a white to off-white cake.
Prašak je bijeli do gotovo bijeli „kolačić“.
Assay interference could lead to false-negative RSV diagnostic test results.
Utjecaj na testove može dovesti do lažno negativnih rezultata dijagnostičkih testova na RSV.
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
Što je Synagisi za što se koristi Što morate znati prijenego Vaše dijete primi Synagis Kako će moje dijete primiti Synagis Moguće nuspojave
Ninetyeight percent of all subjects receiving palivizumab completed the study and 97% received all five injections.
98% ispitanika koji su dobivali palivizumab je završilo ispitivanje, dok je 97% dobilo svih pet injekcija.
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.
Nuspojave prikupljene tijekom praćenja nakon stavljanja lijeka u promet obuhvaćaju dobrovoljne prijave iz populacije neodređene veličine; stoga nije uvijek moguće pouzdano procijeniti njihovu učestalost ili utvrditi uzročnu povezanost s izloženošću palivizumabu.
The primary endpoint was a summary of adverse events and serious adverse events, and the secondary endpoint was the incidence of RSV hospitalisation.
Primarna mjera ishoda bio je sažetak štetnih događaja i ozbiljnih štetnih događaja, dok je sekundarna mjera ishoda bila incidencija hospitalizacije zbog RSV-a.
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.
Retrospektivno opservacijsko ispitivanje provedeno je u male djece s hemodinamski značajnom kongenitalnom bolešću srca radi usporedbe pojavnosti primarnih ozbiljnih štetnih događaja (infekcija, aritmija i smrt) između onih koji jesu (1009) i onih koji nisu primili profilaksu lijekom Synagis (1009), a podudarali su se po dobi, vrsti srčane lezije i prethodnoj korektivnoj operaciji.
After the water is added, tilt the vial slightly and gently rotate the vial for 30 seconds.
Nakon što je voda dodana, nagnite lagano bočicu i nježno ju okrećite 30 sekundi.
Since the monoclonal antibody is specific for RSV, palivizumab is not expected to interfere with the immune response to vaccines.
Budući da je monoklonsko antitijelo specifično za RSV, ne očekuje se da palivizumab utječe na imunološki odgovor na cjepiva.
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.
Podaci o primjeni više od 5 doza su dostupni (vidjeti dijelove 4.8 i 5.1), ali ograničeni te stoga nije utvrđena korist u smislu zaštite s više od 5 doza.
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.
Preporučena doza palivizumaba je 15 mg/kg tjelesne težine, dana jednom mjesečno tijekom očekivanog razdoblja rizika od RSV-a u zajednici.
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:
Synagis je indiciran za prevenciju ozbiljne bolesti donjeg dišnog sustava koja zahtijeva hospitalizaciju, a prouzrokovana je respiratornim sincicijskim virusom (RSV) u djece s visokim rizikom pojave RSV bolesti:
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.
Vaše dijete treba primati Synagis u dozi od 15 mg/kg tjelesne težine jednom mjesečno sve dok postoji opasnost od zaraze virusom RSV.
Antibody to palivizumab was observed in approximately 1% of patients in the IMpact-RSV during the first course of therapy.
IMpact-RSV antitijela protiv palivizumaba otkrivena su kod približno 1 % bolesnika tijekom prve primjene lijeka.
Do not mix the palivizumab liquid and lyophilised formulations.
Ne miješajte tekući i liofilizirani oblik palivizumaba.
The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve.
Glutealni mišić treba izbjegavati kao rutinsko mjesto primjene injekcije zbog opasnosti od oštećenja ishijadičnog živca.
Pharmacotherapeutic group: immune sera immunoglobulins, specific immunoglobulins; ATC Code: J06BB16
Farmakoterapijska skupina: imunoserumi i imunoglobulini, specifični imunoglobulini; ATK oznaka: J06BB16
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.
Otopina palivizumaba za injekciju ne sadrži konzervanse, za jednokratnu je uporabu te se mora primijeniti odmah nakon uvlačenja doze u štrcaljku.
A mild febrile illness, such as mild upper respiratory infection, is not usually reason to defer administration of palivizumab.
Blaga febrilna bolest, kao što je blaga infekcija gornjeg dišnog sustava, obično nije razlog za odgodu primjene palivizumaba.
Your child should not be given Synagis
Vaše dijete ne bi smjelo primiti Synagis
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or other humanised monoclonal antibodies.
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na druga humanizirana monoklonska antitijela.
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).
Toksikološka ispitivanja jednokratne doze provedena su u cinomolgus majmuna (maksimalna doza 30 mg/kg), kunića (maksimalna doza 50 mg/kg) i štakora (maksimalna doza 840 mg/kg).
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).
U ispitivanjima kod odraslih dobrovoljaca, farmakokinetički profil palivizumaba bio je sličan profilu ljudskog IgG1 antitijela s obzirom na volumen raspodjele (prosječno 57 ml/kg) i poluvrijeme eliminacije (prosječno 18 dana).
For instructions on special handling requirements, see section 6.6.
Za upute o posebnom rukovanju lijekom vidjeti dio 6.6.
No difference between groups regarding immunogenicity was observed in either study.
U niti jednom od ispitivanja nisu zabilježene razlike između skupina s obzirom na imunogenost.
Common (affects 1 to 10 users in 100): pain, redness or swelling at the injection site a pause in breathing or other breathing difficulties
Često (javlja se u 1 do 10 korisnika na 100): bol, crvenilo ili oteklina na mjestu primjene injekcije pauza u disanju ili druge poteškoće s disanjem
After incubation for 4-5 days, RSV antigen was measured in an enzyme-linked immunosorbent assay (ELISA).
Nakon 4-5 dana inkubacije izmjerene su razine RSV antigena enzimski vezanim imunosorbentnim testom (ELISA).
The RSV hospitalisation rate was 9.7% in the placebo group and 5.3% in the Synagis group.
Postotak hospitalizacija zbog RSV-a u skupini na placebu bio je 9,7%, a u skupini liječenoj lijekom Synagis 5,3%.
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.
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
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 ovog ispitivanja upućuju da su najniže koncentracije palivizumaba u serumu bile slične između tekućeg i liofiliziranog oblika te je dokazana bioekvivalencija tekuće i liofilizirane formulacije.
Undesirable effects in clinical studies* and post-marketing reports in paediatric patients MedDRA system organ class
Nuspojave u kliničkim ispitivanjima* i nakon stavljanja lijeka u promet u pedijatrijskih bolesnika
When reconstituted as recommended, the final concentration is 100 mg/ml.
Ako se rekonstituira prema navedenim uputama, konačna koncentracija je 100 mg/ml.
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.
Ukupno je primljena 1291 ozbiljna prijava za palivizumab kada je primjenjivan prema indikacijama, a trajanje liječenja je bilo unutar jedne sezone.
Palivizumab solution does not contain a preservative and should be administered within 3 hours of preparation.
Otopina palivizumaba ne sadrži konzervanse pa je treba upotrijebiti unutar 3 sata od pripreme.
The most serious adverse reactions occurring with palivizumab are anaphylaxis and other acute hypersensitivity reactions.
Najozbiljnije nuspojave koje se javljaju kod liječenja palivizumabom su anafilaksija i ostale akutne reakcije preosjetljivosti.
The incidence of RSV hospitalisation was 16 of 612 (2.6%) in the palivizumab group.
Incidencija hospitalizacije zbog RSV-a bila je 16 od 612 (2,6%) u skupini koja je dobivala palivizumab.
Other medicines and Synagis
Drugi lijekovi i Synagis
The primary endpoint was the incidence of RSV hospitalisation.
Primarna mjera ishoda bila je incidencija hospitalizacije zbog RSV-a.
Post-marketing serious spontaneous adverse reactions reported during palivizumab treatment between 1998 and 2002 covering four RSV seasons were evaluated.
Ocijenjene su ozbiljne nuspojave prijavljene spontano tijekom liječenja palivizumabom nakon stavljanja lijeka u promet između 1998. i 2002. godine što pokriva četiri sezone RSV-a.
This medicinal product should not be mixed with other medicinal products.
Lijek se ne smije miješati s drugim lijekovima.
RSV hospitalisations occurred among 62 of 3306 (1.9%) patients in the palivizumab group.
Hospitalizacija zbog RSV-a dogodila se u 62 od 3306 bolesnika (1,9%) u skupini koja je dobivala palivizumab.
1 ml Water for injections
1 ml vode za injekcije
The incidence of infection PSAEs was lower in children who received prophylaxis as compared to those children who did not receive prophylaxis.
Incidencija infekcije bila je niža u djece koja su primila profilaksu u usporedbi s djecom koja profilaksu nisu primila.
Palivizumab should be given with caution to patients with thrombocytopaenia or any coagulation disorder.
Palivizumab treba davati oprezno bolesnicima s trombocitopenijom ili poremećajima koagulacije.
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.
U genotipskoj analizi 126 kliničkih izolata prikupljenih u 123 djece u kojih imunoprofilaksa nije bila uspješna, pokazalo se da svi mutanti RSV-a koji su pokazivali rezistenciju na palivizumab (n=8) imaju promjene na aminokiselinama u tom području F proteina.
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%).
Stopa hospitalizacije zbog RSV-a kod bolesnika koji su imali dijagnozu CLDPa prilikom ulaska u studiju bila je 28/723 (3,9%), a kod nedonoščadi bez CLDP-a prilikom ulaska u studiju bila je 34/2583 (1,3%).
Synagis is a medicine to help protect your child from getting severe RSV illness.
Synagis je lijek koji će pomoći zaštititi Vaše dijete od dobivanja teške bolesti uzrokovane RSV-om.
Synagis Water for injections ampoule label
Synagis voda za injekciju naljepnica na ampuli
Anaphylaxis, anaphylactic shock (in some cases, fatalities have been reported.)
Poremećaji imunološkog sustava nepoznato anafilaksija, anafilaktički šok (u nekim slučajevima prijavljen je smrtni ishod)
Synagis solution for injection is a clear or slightly opalescent solution and is available in vials of either 0.5 ml or 1 ml.
Synagis otopina za injekciju je bistra ili blago opalescentna otopina i dostupna je u bočicama od 0,5 ml ili 1 ml.
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.
Medijan EC50 vrijednosti palivizumaba protiv kliničkih izolata RSV A iznosio je 0,65 µg/ml (srednja vrijednost [standardno odstupanje] = 0,75 [0,53] µg/ml; n=69, raspon: 0,07-2,89 µg/ml), a protiv izolata RSV B 0,28 µg/ml (srednja vrijednost [standardno odstupanje] = 0,35 [0,23] µg/ml; n=35, raspon: 0,03-0,88 µg/ml).
Insert the needle into the vial and withdraw into the syringe an appropriate volume of solution.
Umetnuti iglu u bočicu te uvući odgovarajući volumen otopine u štrcaljku.
Adverse reactions observed in patients after a sixth or greater dose were similar in character and frequency to those after the initial 5 doses.
Nuspojave zabilježene u bolesnika nakon šeste ili kasnije doze bile su po svojim karakteristikama i učestalosti slične onima zabilježenima nakon prvih 5 doza.
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.
Djeci podvrgnutoj operaciji ugradnje srčanih premosnica preporučuje se dati injekciju palivizumaba od 15 mg/kg tjelesne težine čim se postoperativno stanje stabilizira kako bi se održale odgovarajuće serumske koncentracije palivizumaba.
The RSV hospitalisation rate was 10.6% in the placebo group.
Postotak hospitalizacija zbog RSV-a u skupini na placebu bio je 10,6%.
The incidence of arrhythmia and death PSAEs was similar in children who did and did not receive prophylaxis.
Incidencija aritmije i smrti bila je slična u djece koja jesu i one koja nisu primila profilaksu.
Palivizumab may interfere with immune-based RSV diagnostic tests, such as some antigen detection based assays.
Palivizumab može utjecati na imunološke testove za dijagnosticiranje RSV-a, poput nekih testova koji se temelje na detekciji antigena.
Name and address of the manufacturer(s) of the biological active substance
Naziv(i) i adresa(e) proizvođača biološke djelatne tvari
Groups were equally balanced between cyanotic and acyanotic patients.
Skupine su bile slične s obzirom na broj cijanotičnih i necijanotičnih bolesnika.
In the second study, 211 and 202 premature infants or children with chronic lung disease received liquid and lyophilised palivizumab, respectively.
U drugom ispitivanju je 211 nedonoščadi ili djece s kroničnom plućnom bolesti dobivalo tekući, a 202 liofilizirani palivizumab.
Ltd Τηλ: +357 22 34 74 40
Lifepharma (Z.A.M.) Ltd Τηλ.: +357 22 34 74 40
The solution is clear or slightly opalescent.
Otopina je bistra ili blago opalescentna.
*For full study description, see Section 5.1 Clinical studies # ADRs identified from post-marketing surveillance
* Za cjeloviti opis ispitivanja vidjeti dio 5.1 'Klinička ispitivanja' # Nuspojave identificirane na temelju praćenja nakon stavljanja lijeka u promet
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).
U dva dodatna ispitivanja tekući palivizumab je korišten kao aktivna kontrola (3918 pedijatrijskih ispitanika) radi ocjene ispitivanog monoklonskog protutijela u profilaksi ozbiljne bolesti uzrokovane RSV-om u nedonoščadi ili djece s bronhopulmonalnom displazijom ili hemodinamski značajnom kongenitalnom bolesti srca (dodatne pojedinosti ova dva ispitivanja vidjeti u nastavku).
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.
Bočice za jednokratnu uporabu: bočica od 3 ml, od prozirnog, bezbojnog stakla tipa I, s klorobutil čepom i „flip-off“ zatvaračem koja sadrži 0,5 ml ili 1 ml otopine za injekcije.
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.
No, s obzirom da djelotvornost palivizumaba primijenjenog bolesnicima po drugi put tijekom sljedeće sezone RSV-a nije formalno istraživana u ispitivanju s tako postavljenim ciljem, relevantnost ovih podataka za procjenu djelotvornosti nije poznata.
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.
Pri serumskim koncentracijama od približno 30 g/ml palivizumab smanjuje replikaciju RSV-a u plućima štakora za 99% (cotton rat model).
(3 x 0.15) ml = 0.45 ml palivizumab per month
(3 x 0,15) ml = 0,45 ml palivizumaba mjesečno
No deaths were considered related to palivizumab and no new ADRs were identified in these studies.
Smatra se da smrtni ishodi nisu povezani s primjenom palivizumaba te u ovim ispitivanjima nisu zabilježene nove nuspojave.
*Palivizumab is a recombinant humanised monoclonal antibody produced by DNA technology in mouse myeloma host cells.
*palivizumab je rekombinantno humanizirano monoklonsko antitijelo proizvedeno DNA tehnologijom u stanicama domaćina mišjeg mijeloma.
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.
Umjerena do teška akutna infekcija ili febrilna bolest može opravdati odgađanje primjene palivizumaba, osim ako liječnik ne procijeni da odgađanje primjene palivizumaba predstavlja još veći rizik.
1ml of water for injections in an ampoule (type I glass).
1 ml vode za injekciju u ampuli (staklo tip I).
Nervous system disorders Uncommon
Poremećaji živčanog sustava manje često konvulzije
Additional side effects Very common (affects at least 1 user in 10): rash fever
Dodatne nuspojave Vrlo često (javlja se u najmanje 1 korisnika na 10): osip vrućica
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.
Ocjena kliničkih nalaza nije otkrila asocijaciju između promjena na sekvenci antigenskog mjesta A i težine RSV bolesti u djece koja su primila imunoprofilaksu palivizumabom i razvila RSV-om uzrokovanu bolest donjeg dišnog sustava.
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.
Raspored primjene palivizumaba i nuspojave promatrani su u skupini od gotovo 20 000 dojenčadi koja su praćena kroz registar suradljivosti bolesnika između 1998. i 2000. godine.
• Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season
• Djeca rođena u 35. tjednu trudnoće ili ranije i koja su na početku sezone RSV-a bila mlađa od 6