FrancophonIA/ELRC3.0 huggingface dataset:
English: 100 mg of powder in a 10 ml vial (type I glass) with a stopper (butyl rubber) and a flip-off seal (aluminium).
Croatian: 100 mg praška u bočici od 10 ml (staklo tip I) sa čepom (butil guma) i sa „flip-off“ zatvaračem (aluminij).
English: Τηλ: +30 214 4165 555
Croatian: AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. Τηλ: + 30 214 4165 555
English: The possible risk of enhanced RSV infection in the season following the season in which the patients were treated with palivizumab has not been conclusively ruled out by studies performed aiming at this particular point.
Croatian: Mogućnost povećanog rizika infekcije RSV-om u sezoni nakon one u kojoj je bolesnik primao palivizumab nije izričito isključena ispitivanjima koja su provedena s tim ciljem.
English: Your child can then go back to the original planned injection.
Croatian: Nakon toga treba nastaviti s primanjem injekcija prema prvobitno propisanom rasporedu.
English: 50 mg of powder in a 4 ml vial (type I glass) with a stopper (butyl rubber) and a flip-off seal (aluminium).
Croatian: 50 mg praška u bočici od 4 ml (staklo tip I) sa čepom (butil guma) i sa „flip-off“ zatvaračem (aluminij).
English: 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.
Croatian: U jednog su djeteta nakon druge doze palivizumaba pronađene prolazne niske razine antitijela protiv palivizumaba koja su se nakon pete i sedme doze smanjila na razine koje se više ne mogu otkriti.
English: 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).
Croatian: U ovom ispitivanju bolesnici su randomizirani i dobivali su 5 mjesečnih injekcija od 15 mg/kg tekućeg palivizumaba (N=612) kao aktivnu kontrolu ispitivanom monoklonskom protutijelu (N=624).
English: (3 x 0.15) ml = 0.45 ml palivizumab per month.
Croatian: (3 x 0,15) ml = 0,45 ml palivizumaba mjesečno.
English: 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).
Croatian: Palivizumab je humanizirano IgG1 monoklonsko antitijelo usmjereno protiv epitopa na A antigenskom mjestu fuzijskog proteina respiracijskog sincicijskog virusa (RSV).
English: Antibody to palivizumab was evaluated in four additional studies in 4337 patients (children born at 35 weeks of gestation or less and 6 months of age or less, or 24 months of age or less with bronchopulmonary dysplasia, or with haemodynamically significant congenital heart disease were included in these studies) and was observed in 0% - 1.5% of patients at different study timepoints.
Croatian: Antitijela na palivizumab ocijenjena su u četiri dodatna ispitivanja u 4337 bolesnika (u ta ispitivanja su bila uključena djeca rođena u 35. tjednu gestacije ili ranije koja su pri uključivanju imala 6 mjeseci ili manje, ili djeca u dobi od 24 mjeseca ili manje s bronhopulmonalnom displazijom ili hemodinamski značajnom kongenitalnom bolešću srca), a zabilježena su u 0% - 1,5% bolesnika u različitim vremenskim točkama tijekom ispitivanja.
English: The incidences of these reactions in these studies showed no difference between the palivizumab and placebo groups and the reactions were not drug related.
Croatian: Incidencija navedenih nuspojava u tim ispitivanjima nije se razlikovala između skupina koje su primale palivizumab odnosno placebo, a nuspojave nisu bile uzročno povezane s primjenom lijeka.
English: What do you need to know before Synagis is given to your child
Croatian: Što morate znati prije nego vaše dijete primi Synagis
English: 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.
Croatian: Sekundarne mjere ishoda djelotvornosti pokazale su značajno smanjenje u skupini liječenoj lijekom Synagis u usporedbi sa skupinom na placebu u ukupnim danima trajanja hospitalizacije zbog RSV-a (smanjenje 56%, p = 0,003) te ukupnim brojem dana s dodatnom opskrbom kisikom tijekom bolesti uzrokovane RSV-om na 100 djece (smanjenje 73%, p = 0,014).
English: 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).
Croatian: U ovom ispitivanju bolesnici su randomizirani i dobivali su 5 mjesečnih injekcija od 15 mg/kg tekućeg palivizumaba (N=3306) kao aktivnu kontrolu ispitivanom monoklonskom protutijelu (N=3329).
English: Both the 0.5 ml and 1 ml vials contain an overfill to allow the withdrawal of 50 mg or 100 mg, respectively.
Croatian: Bočice od 0,5 ml i 1 ml sadrže suvišak kako bi se omogućilo izvlačenje 50 mg odnosno 100 mg lijeka.
English: 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.
Croatian: Nedonoščad i djeca s kroničnom plućnom bolesti zbog prematuriteta (engl. chronic lung disease of prematurity, CLDP): u ovom ispitivanju, provedenom u 347 centara u Sjevernoj Americi, Europskoj Uniji i 10 ostalih zemalja, proučavani su bolesnici od 24 mjeseca ili mlađi s CLDP-om i prijevremeno rođeni bolesnici (35 tjedana gestacije ili ranije) koji su bili u dobi od 6 mjeseci ili mlađi prilikom ulaska u studiju.
English: 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.
Croatian: U opservacijskom ispitivanju prikupljenih podataka nakon stavljanja lijeka u promet zabilježeno je malo povećanje učestalosti astme u prijevremeno rođenih bolesnika koji su primali palivizumab, međutim uzročno posljedična veza nije jasna.
English: In the phase III IMpactRSV study in the premature and bronchopulmonary dysplasia paediatric populations, the proportions of patients in the placebo and palivizumab groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents.
Croatian: U ispitivanju faze III IMpactRSV u nedonoščadi i djece s bronhopulmonalnom displazijom, postotak bolesnika koji su dobivali uobičajena dječja cjepiva, cjepivo protiv gripe, bronhodilatatore ili kortikosteroide bio je sličan u skupinama liječenim placebom i palivizumabom i nije zabilježeno povećanje učestalosti nuspojava u bolesnika koji su uzimali navedene lijekove.
English: Do not dilute the product.
Croatian: Ne razrjeđujte lijek.
English: 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.
Croatian: Palivizumab se veže za dobro očuvano područje na izvanstaničnoj domeni zrelog proteina RSV F, koje se naziva antigenskim mjestom II ili antigenskim mjestom A, a obuhvaća aminokiseline 262 do 275.
English: Mannitol (E421)
Croatian: Prašak: histidin glicin manitol (E421)
English: 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.
Croatian: U prospektivnom otvorenom ispitivanju osmišljenom za istraživanje farmakokinetike , sigurnosti i imunogenosti nakon primjene 7 doza palivizumaba unutar jedne sezone RSV-a, farmakokinetički podaci pokazali su da su u sve 18 uključene djece postignute odgovarajuće srednje razine palivizumaba.
English: Reconstitute slowly with 0.6 ml water for injections.
Croatian: Pripremiti polako s 0,6 ml vode za injekcije.
English: 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%.
Croatian: Analiza 254 klinička izolata RSV-a prikupljena u ispitanika koji nikada nisu primili imunoprofilaksu otkrila je supstitucije povezane s rezistencijom na palivizumab u 2 slučaja (jedan N262D i jedan S275F), što čini učestalost mutacija povezanih s rezistencijom od
English: Powder and solvent for solution for injection Contents:
Croatian: Prašak i otapalo za otopinu za injekciju Sadržaj:
English: This medicinal product should not be mixed with other medicinal products or diluents other than water for injections.
Croatian: Lijek se ne smije miješati s drugim lijekovima ili otapalima osim s vodom za injekcije.
English: Among 139 children in the congenital heart disease study receiving palivizumab who had cardio-pulmonary bypass and for whom paired serum samples were available, the mean serum palivizumab concentration was approximately 100 g/ml pre-cardiac bypass and declined to approximately 40 g/ml after bypass.
Croatian: U ispitivanju kongenitalne bolesti srca kod 139 djece koja su primala palivizumab i koja su podvrgnuta operaciji ugradnje srčanih premosnica i za koje su bili dostupni parni uzorci seruma, srednja serumska koncentracija palivizumaba bila je približno 100 μg/ml prije ugradnje srčanih premosnica, a smanjila se na približno 40 μg/ml nakon premosnica.
English: Solution for injection 100 mg/1 ml
Croatian: Otopina za injekciju 100 mg/1 ml
English: Please tell your doctor if your child is unwell, as the use of Synagis may need to be delayed.
Croatian: Recite liječniku ako Vaše dijete nije dobro jer će možda trebati odgoditi primjenu lijeka Synagis. ako Vaše dijete ima poremećaje krvarenja jer se Synagis obično ubrizgava u bedro.
English: Palivizumab should not be mixed with any medicinal products or diluents other than water for injections.
Croatian: Palivizumab se ne smije miješati s drugim lijekovima ili otapalima osim s vodom za injekcije.
English: How often will Synagis be given to my child?
Croatian: Koliko puta će moje dijete primiti Synagis?
English: 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.
Croatian: U profilaktičkim ispitivanjima u nedonoščadi i djece s bronhopulmonalnom displazijom, poluvrijeme eliminacije palivizumaba bilo je u prosjeku 20 dana, a mjesečnim intramuskularnim dozama od 15 mg/kg postignute najniže srednje serumske koncentracije djelatne tvari u 30-dnevnom razdoblju bile su približno 40 μg/ml nakon prve injekcije, približno 60 μg/ml nakon druge injekcije i približno 70 μg/ml nakon treće i četvrte injekcije.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTUR ER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Also contains histidine, glycine and mannitol.
Croatian: Također sadrži histidin, glicin i manitol.
English: Boehringer Ingelheim Pharma GmbH & Co. KG D-88397 Biberach an der Riss Germany
Croatian: KG D-88397 Biberach an der Riss Njemačka
English: 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).
Croatian: U ukriženom ispitivanju uspoređivane su farmakokinetika i sigurnost tekućeg i liofiliziranog oblika palivizumaba nakon intramuskularne primjene doze od 15 mg/kg u 153 dojenčadi u dobi od 6 mjeseci ili mlađe rođene prijevremeno (35 tjedana gestacije ili ranije).
English: Adverse reactions both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/10; common ≥ 1/100 to < 1/10; uncommon ≥ 1/1,000 to < 1/100; rare ≥ 1/10,000 to <1/1,000 ) in studies conducted in premature and bronchopulmonary dysplasia paediatric patients, and paediatric congenital heart disease patients.
Croatian: Nuspojave, i kliničke i laboratorijske, razvrstane su prema organskom sustavu i učestalosti (vrlo često ≥ 1/10; često ≥1/100 i <1/10; manje često ≥1/1000 i <1/100; rijetko ≥ 1/10 000 i < 1/1000) u studijama provedenim kod nedonoščadi i djece s bronhopulmonalnom displazijom te djece s kongenitalnom bolesti srca.
English: Palivizumab does not interfere with reverse transcriptase polymerase chain reaction-based assays.
Croatian: Palivizumab ne utječe na testove lančane reakcije polimeraze nakon reverzne transkripcije.
English: 1 vial Synagis 100 mg.
Croatian: 1 bočica Synagis 100 mg.
English: 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.
Croatian: Djelotvornost palivizumaba u bolesnika koji bi ga primili u drugom ciklusu tijekom sljedeće sezone RSV infekcija nije formalno ispitana u istraživanju s tako postavljenim ciljem.
English: 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.
Croatian: Kongenitalna bolest srca Ispitivanje 2: u ovom ispitivanju, provedenom u 162 centra u Sjevernoj Americi, Europskoj Uniji i 4 ostale zemlje tijekom 2 sezone RSV-a, proučavani su bolesnici od 24 mjeseca ili mlađi s hemodinamski značajnom kongenitalnom bolesti srca.
English: Uncommon (affects less than 1 user in 100): fits hives
Croatian: Manje često (javlja se u manje od 1 korisnika na 100): napadaji koprivnjača
English: How to store Synagis
Croatian: Kako čuvati Synagis
English: Reconstitute slowly with 1.0 ml water for injections.
Croatian: Pripremiti polako s 1,0 ml vode za injekcije.
English: 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).
Croatian: Ako je rizik obolijevanja od RSV bolesti i dalje visok, treba nastaviti s mjesečnim davanjem lijeka tijekom cijele sezone RSV-a (vidjeti dio 5.2).
English: Solution for injection 50 mg/0.5 ml
Croatian: Otopina za injekciju 50 mg/0,5 ml
English: Palivizumab should not be mixed with any medicinal products or diluents.
Croatian: Palivizumab se ne smije miješati s drugim lijekovima ili otapalima.
English: Also contains: histidine, glycine and mannitol.
Croatian: Također sadrži: histidin, glicin i manitol.
English: 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.
Croatian: Rezultati ispitivanja ne ukazuju na povećan rizik od ozbiljne infekcije, ozbiljne aritmije ili smrti u djece s hemodinamski značajnom kongenitalnom bolešću srca povezan s profilaksom lijekom Synagis u usporedbi s djecom koja nisu primila profilaksu.
English: 1 vial Synagis 50 mg.
Croatian: 1 bočica Synagis 50 mg.
English: At least one of the palivizumab resistance-associated substitutions, N262D, K272E/Q, or S275F/L was identified in these 8 clinical RSV isolates resulting in a combined resistance-associated mutation frequency of 6.3% in these patients.
Croatian: U tih 8 kliničkih izolata RSV-a utvrđena je barem jedna supstitucija povezana s rezistencijom na palivizumab: N262D, K272E/Q ili S275F/L, što znači da kombinirana učestalost mutacija povezanih s rezistencijom u tih bolesnika iznosi 6,3%.
English: One ml of Synagis solution for injection contains 100 mg of palivizumab.
Croatian: Jedan ml Synagis otopine za injekciju sadrži 100 mg palivizumaba.
English: Common adverse reactions occurring with palivizumab are fever, rash, and injection site reaction.
Croatian: Česte nuspojave koje se javljaju kod liječenja palivizumabom su vrućica, osip i reakcija na mjestu injekcije.
English: Synagis is presented as a powder and solvent for solution for injection (100 mg of powder in vial) + 1 ml of solvent in ampoule - Pack size of 1.
Croatian: Synagis dolazi kao prašak i otapalo za otopinu za injekciju (100 mg praška u bočici ) + 1 ml otapala u ampuli - Veličina pakiranja je 1.
English: 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.
Croatian: Djeca koja imaju veću vjerojatnost nastanka teške bolesti uzrokovane RSV-om (djeca s visokim rizikom) su djeca rođena prerano (35. tjedantrudnoće ili ranije) ili djeca rođena s određenim poteškoćama sa srcem ili plućima.
English: In a placebo-controlled trial of RSV disease prophylaxis in (IMpact-RSV trial) 1502 high-risk children (1002 Synagis; 500 placebo), 5 monthly doses of 15 mg/kg reduced the incidence of RSV related hospitalisation by 55% (p = < 0.001).
Croatian: U placebom kontroliranom ispitivanju prevencije bolesti uzrokovane RSV-om (ispitivanje IMpact RSV) kod 1502 visoko rizične djece (1002 Synagis; 500 placebo), 5 mjesečnih doza od 15 mg/kg smanjilo je incidenciju hospitalizacija zbog RSV-a za 55% (p = < 0,001).
English: 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.
Croatian: U ispitivanju kongenitalne bolesti srca, mjesečnim intramuskularnim doza od 15 mg/kg najniže postignute srednje serumske koncentracije djelatne tvari bile su približno 55 μg/ml nakon prve injekcije i približno 90 μg/ml nakon četvrte injekcije.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijekmože uzrokovati nuspojaveiako se one neće javiti kod svakoga.
English: - The active substance is palivizumab.
Croatian: - Djelatna tvar je palivizumab.
English: Synagis is presented as a powder and solvent for solution for injection (50 mg of powder in vial) + 1 ml of solvent in ampoule - Pack size of 1.
Croatian: Synagis dolazi kao prašak i otapalo za otopinu za injekciju (50 mg praška u bočici ) + 1 ml otapala u ampuli - Veličina pakiranja je 1.
English: Solvent for Synagis
Croatian: Otapalo za Synagis
English: A total of 222 children were enrolled in two separate studies to examine the safety of palivizumab when it is administered for a second RSV season.
Croatian: Sigurnost palivizumaba primijenjenog za drugu sezonu RSV-a istraživana je u dva odvojena ispitivanja kojima je obuhvaćeno ukupno 222 djece.
English: Allergic reactions including very rare cases of anaphylaxis and anaphylactic shock have been reported following palivizumab administration.
Croatian: Nakon primjene palivizumaba prijavljene su alergijske reakcije, uključujući vrlo rijetke slučajeve anafilaksije i anafilaktičkog šoka.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava manje često trombocitopenija
English: When using Palivizumab 100 mg/1 ml, the volume (expressed in ml) of Palivizumab to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15
Croatian: Kada se koristi palivizumab 100 mg/1 ml, volumen (izražen u ml) palivizumaba koji će se primijeniti u jednomjesečnim intervalima = [težina bolesnika u kg] pomnožena s 0,15.
English: 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.
Croatian: Ako primijetite bilo koju nuspojavu kod Vašeg djeteta, uključujućii svaku moguću nuspojavu koja nije navedena u ovoj uputi, potrebno je obavijestiti liječnika ili ljekarnika.
English: If your child gets any side effects, talk to your doctor.
Croatian: Ako kod Vašeg djeteta primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
English: Outer Carton of 1.0 ml vial
Croatian: Vanjska kutija za bočicu od 1,0 ml
English: Synagis contains an active ingredient called palivizumab which is an antibody that works specifically against a virus called respiratory syncytial virus, RSV.
Croatian: Palivizumab je protutijelo, a djeluje specifično protiv virusa koji se zove respiratorni sincicijski virus, RSV.
English: If any of the 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.
Croatian: Ako primijetite bilo koju nuspojavukod Vašeg djeteta, uključujućii svaku moguću nuspojavu koja nije navedena u ovoj uputi, potrebno je obavijestiti liječnika ili ljekarnika.
English: To reconstitute, remove the tab portion of the vial cap and clean the rubber stopper with 70% ethanol or equivalent
Croatian: Za rekonstituciju, ukloniti dio s jezičcem na zatvaraču bočice i očistiti gumeni čep 70%-tnim etanolom ili ekvivalentom.
English: In a placebo-controlled trial in 1,287 patients  24 months of age with haemodynamically significant congenital heart disease (639 Synagis; 648 placebo), 5 monthly doses of 15 mg/kg Synagis reduced the incidence of RSV hospitalisations by 45% (p = 0.003) (congenital heart disease study).
Croatian: ≤ 24 mjeseca, s hemodinamski značajnom kongenitalnom bolesti srca (639 Synagis; 648 placebo), 5 mjesečnih doza od 15 mg/kg lijeka Synagis smanjilo je incidenciju hospitalizacija zbog RSV-a za 45% (p = 0,003) (ispitivanje kongenitalne bolesti srca).
English: When using Palivizumab 100 mg/ml, the volume (expressed in ml) of Palivizumab to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15
Croatian: Kada se koristi palivizumab 100 mg/ml, volumen (izražen u ml) palivizumaba koji će se primijeniti u jednomjesečnim intervalima = [težina bolesnika u kg] pomnožena s 0,15
English: The volume (expressed in ml) of // Palivizumab // to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15.
Croatian: Volumen (izražen u ml) palivizumaba koji će se primijeniti u jednomjesečnim intervalima = [težina bolesnika u kg] pomnožena s 0,15.
English: Synagis is not known to interact with other medicines.
Croatian: Nisu poznata međudjelovanja između lijeka Synagisi drugih lijekova.
English: To administer, remove the tab portion of the vial cap and clean the stopper with 70 % ethanol or equivalent.
Croatian: Za primjenu, ukloniti dio s jezičcem na zatvaraču bočice i očistiti gumeni čep 70%-tnim etanolom ili ekvivalentom.
English: The 50 mg vial contains an overfill to allow the withdrawal of 50 mg when reconstituted if following the directions described below.
Croatian: Bočica od 50 mg sadrži suvišak kako bi se omogućilo izvlačenje 50 mg lijeka kada se rekonstituira prema uputama opisanima u nastavku.
English: unusual bruising or groups of tiny red spots on the skin.
Croatian: “Vaše dijete ne bi smjelo primiti Synagis“ za popis znakova i simptoma). neuobičajene modrice ili skupine malih crvenih točkica na koži.
English: Studies carried out in rodents gave no indication of enhancement of RSV replication, or RSV-induced pathology or generation of virus escape mutants in the presence of palivizumab under the chosen experimental conditions.
Croatian: U ispitivanjima kod glodavaca koji su u određenim eksperimentalnim uvjetima dobivali palivizumab nije zabilježeno povećanje replikacije RSV-a, niti patološke promjene prouzrokovane RSV-om ili razvoj virusnih mutanti.