natgillin/translations-raw huggingface dataset:
100 ml 
Boca (staklo) 100 ml
Let stand for 20 minutes. 
Ostaviti stajati 20 minuta.
04011 Campoverde di Aprilia (LT) Italy 
04011 Campoverde di Aprilia (LT) Italija
Not relevant. 
Nije primjenjivo.
Any remaining contents should be discarded after use. 
Preostali sadržaj treba baciti nakon uporabe.
However in-use stability has been demonstrated for 3 hours at 20 - 24oC. 
Ipak, dokazana je stabilnost pri korištenju tijekom 3 sata na 20 - 24°C.
In some cases, fatalities have been reported (see section 4.8). 
U nekim su slučajevima prijavljeni smrtni ishodi (vidjeti dio 4.8).
No significant findings were observed. 
Nisu dobivena značajna zapažanja.
No medical consequences were identified in these instances. 
Nisu zabilježene nikakve medicinske posljedice u tim slučajevima.
Where possible, the first dose should be administered prior to commencement of the RSV season. 
Ako je moguće, prvu dozu treba dati prije početka sezone RSV-a.
There was no association observed between the presence of antibody and adverse events. 
Nije primijećena povezanost između prisutnosti antitijela i štetnih događaja.
These doses were 20.25 mg/kg, 21.1 mg/kg and 22.27 mg/kg. 
Te doze su bile 20,25 mg/kg, 21,1 mg/kg i 22,27 mg/kg.
Date of first authorisation: 13 August 1999 Date of latest renewal: 27 July 2009 
Datum posljednje obnove odobrenja: 27. srpnja 2009.
AstraZeneca Pharmaceuticals Limited Partnership (AZPLP) 660 MedImmune Court / 633 Research Court, Frederick, Maryland, USA 
AstraZeneca Pharmaceuticals Limited Partnership (AZPLP) 660 MedImmune Court / 633 Research Court, Frederick, Maryland, SAD
In the first study, all 153 premature infants received both formulations in different sequences. 
U prvom ispitivanju je svih 153 nedonoščadi dobivalo obje formulacije u različitim sekvencama.
Injection volumes over 1 ml should be given as a divided dose. 
Injekcijske volumene veće od 1 ml treba dati kao podijeljenu dozu.
If your child misses an injection, you should contact your doctor as soon as possible. 
Ako Vaše dijete propusti injekciju, obratite se liječniku što je prije moguće.
Subjects were followed for safety and efficacy for 150 days. 
Kod ispitanika je 150 dana praćena sigurnost i djelotvornost.
The injection should be given using standard aseptic technique. 
Injekciju treba dati koristeći standardnu aseptičku tehniku.
Data on fertility, pregnancy and lactation are not available. 
Podaci o plodnosti, trudnoći i dojenju nisu dostupni.
After reconstitution, the product should be used immediately. 
Nakon rekonstitucije, lijek treba odmah upotrijebiti.
For your child's best protection, it is necessary to take the doctor's advice about when to return for additional doses of Synagis. 
Za najbolju zaštitu Vašeg djeteta, nužno je da slijedite liječnikove upute o tome kada se treba vratiti po dodatne doze lijeka Synagis.
What Synagis is and what it is used for 
Što je Synagis i za što se koristi
Use within 3 hours of reconstitution. 
Upotrijebiti unutar 3 sata od pripreme.
The majority of clinical RSV isolates tested (n=96) were collected from subjects in the United States. 
Većina ispitanih kliničkih izolata RSV-a (n=96) prikupljena je od ispitanika u Sjedinjenim Američkim Državama.
Store in a refrigerator (2ºC to 8ºC). 
Čuvati u hladnjaku (2ºC - 8ºC).
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). 
Nuspojave su se javile nakon šeste ili kasnije doze samo u 22 od tih prijava (15 nakon šeste doze, 6 nakon sedme doze i 1 nakon osme doze).
Pack size of 1. 
Veličina pakiranja je 1.
Do not use this medicine after the expiry date which is stated on the label after ‘EXP'. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake ‘EXP'.
• Children less than 2 years of age and with haemodynamically significant congenital heart disease. 
• Djeca mlađa od 2 godine s hemodinamski značajnom kongenitalnom bolesti srca.
One hundred and three (103) children received monthly palivizumab injections for the first time, and 119 children received palivizumab for two consecutive seasons. 
Stotinu i troje djece (103) dobivalo je mjesečne injekcije palivizumaba po prvi put, dok je preostalih 119 dobivalo palivizumab već drugu sezonu zaredom.
In vitro studies of antiviral activity 
In vitro ispitivanja protuvirusnog djelovanja
What Synagis looks like and contents of the pack 
Kako Synagis izgleda i sadržaj pakiranja
Synagis solution for injection is a ready to use formulation. 
Synagis otopina za injekciju je formulacija spremna za uporabu.
This humanised monoclonal antibody is composed of human (95%) and murine (5%) antibody sequences. 
Ovo humanizirano monoklonsko antitijelo se sastoji od sekvenci ljudskih (95%) i mišjih (5%) antitijela.
Subsequent doses should be administered monthly throughout the RSV season. 
Naredne doze treba davati mjesečno tijekom cijele sezone RSV-a.
What Synagis contains 
Što Synagis sadrži
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately. 
U slučaju predoziranja preporučuje se nadzirati bolesnika na znakove i simptome nuspojava ili štetnih učinaka i odmah uspostaviti primjereno simptomatsko liječenje.
Take special care with Synagis if your child is unwell. 
Budite posebno oprezni s lijekom Synagis ako se Vaše dijete ne osjeća dobro.
Synagis is not indicated for use in adults. 
Synagis nije indiciran za primjenu u odraslih.
To ensure the correct volume is reconstituted for Synagis, see section 6.6. 
Kako bi se osigurala rekonstitucija točnog volumena lijeka Synagis, vidjeti dio 6.6.
Therefore, anti-drug antibody (ADA) responses appear to be of no clinical relevance. 
Prema tome, čini se da odgovori na antitijela protiv lijeka nemaju nikakve kliničke važnosti.
If your child is to have a heart operation (cardiac bypass surgery), he or she may be given an extra dose of Synagis after the operation. 
Ako se Vaše dijete sprema na operaciju srca (ugradnja srčane premosnice), može primiti jednu dodatnu dozu lijeka Synagis nakon operacije.
Of this group 1,250 enrolled infants had 6 injections, 183 infants had 7 injections, and 27 infants had either 8 or 9 injections. 
U toj je skupini 1250 praćene dojenčadi dobilo 6 injekcija, 183 dojenčadi 7 injekcija, a 27 dojenčadi 8 ili 9 injekcija.
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). 
Većina iskustva, uključujući i ispitivanje palivizumaba u pivotalnim kliničkim ispitivanjima faze III, stečena je primjenom 5 injekcija tijekom jedne sezone (vidjeti dio 5.1).
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). 
Ta pojava je bila prolazna, niskoga titra, nestala je unatoč nastavku liječenja (u prvoj i drugoj sezoni) i nije otkrivena u 55 od 56 dojenčadi za vrijeme druge sezone (uključujući 2 s pozitivnim titrom tijekom prve sezone).
The neutralization titre (50% effective concentration [EC50]) is expressed as the antibody concentration required to reduce detection of RSV antigen by 50% compared with untreated virus-infected cells. 
Titar neutralizacije (50% djelotvorne koncentracije [EC50]) izražen je kao koncentracija antitijela potrebna da se detekcija RSV antigena smanji za 50% u usporedbi s netretiranim stanicama inficiranim virusom.
Read all of this leaflet carefully before your child is given this medicine because it contains important information for you and your child. 
Vaše dijete primi ovaj lijek jer sadrži važne informacije za Vas i Vaše dijete.
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. 
Odmah nazovite svog liječnika ili zatražite medicinsku pomoć ako Vaše dijete dobije neki od gore navedenih simptoma nakon što primi bilo koju dozu lijeka Synagis.
In clinical studies, three children received an overdose of more than 15 mg/kg. 
U kliničkim je ispitivanjima troje djece dobilo doze veće od 15 mg/kg.
Each injection of Synagis can only help protect your child for about one month before another injection is needed. 
Svaka injekcija lijeka Synagis može pomoći zaštititi Vaše dijete približno jedan mjesec prije nego što je potrebna sljedeća injekcija.
Two clinical studies were conducted to directly compare liquid and lyophilised formulations of palivizumab. 
Provedena su dva klinička ispitivanja kako bi se izravno usporedile tekuća i liofilizirana formulacija palivizumaba.
• Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months. 
• Djeca mlađa od 2 godine koja su u proteklih 6 mjeseci liječena zbog bronhopulmonalne displazije.
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). 
Nakon stavljanja lijeka u promet, prijavljena su predoziranja dozama do 85 mg/kg te su u nekim slučajevima zabilježene nuspojave koje se nisu razlikovale od onih prijavljenih za dozu od 15 mg/kg (vidjeti dio 4.8).
Palivizumab solution should stand at room temperature for a minimum of 20 minutes until the solution clarifies. 
Otopinu palivizumaba treba ostaviti na sobnoj temperaturi najmanje 20 minuta dok se ne razbistri.
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.