FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: Il-farmakokinetika u s-sigurtà ta' formulazzjoni likwida ta' palivizumab u formulazzjoni lipofilizzata ta' palivizumab, wara amministrazzjoni intramuskolari ta' 15mg/kg, kienu imqabbla fi prova crossover ta' 153 tfal li kellhom 6 xhur jew inqas bi storja ta' primaturità (35 ġimgħa jew inqas ta' ġestazzjoni).
English: No formal interactions studies with other medicinal products were conducted.
Maltese: Ma sar l-ebda studju formali dwar l-interazzjonijiet ma' prodotti mediċinali oħra.
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).
Maltese: Fi prova kontrollata bil-plaċebo ta' profilassi ta' mard RSV (prova IMpact-RSV) f'1502 tfal b'riskju għoli (1002 Synagis; 500 plaċebo), 5 dożi fix-xahar ta' 15 mg/kg naqqsu l-inċidenza ta' każijiet ta' sptar relatata mal-RSV b' 55% (p= -<0.
English: 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.
Maltese: Konċentrazzjonijiet ta' bejn wieħed u ieħor 30 g/ml palivizumab fis-serum urew li jipproduċu tnaqqis ta' 99% fir-replikazzjoni ta' RSV pulmonari fil-mudell ta' cotton rat.
English: 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.
Maltese: Studju osservattiv li jmur lura fiż-żmien sar fi tfal żgħar b'mard tal-qalb konġenitali emodinamikament sinifikanti (HSCHD) li jqabbel l-okkorrenza ta' avvenimenti avversi serji primarji (PSAEs: infezzjoni, arritmija, u mewt) f'dawk li rċivew (1009) jew ma rċivewx profilassi b'Synagis (1009) li jkunu jaqblu fl-età, fit-tip ta' leżjoni fil-qalb, u li għamlu kirurġija ta' korrezzjoni.
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).
Maltese: Fi prova kkontrollata bil-plaċebo f'1,287 pazjent ta' eta' ta'  24 xahar b'mard tal-qalb kongenitali emodinamikament sinifikanti (639 Synagis; 648 plaċebo), 5 dożi fix-xahar ta' 15 mg/kg Synagis naqqsu l-inċidenza ta' każijiet ta' sptar b'RSV b'45% (p = 0.003) (studju ta' mard tal-qalb kongenitali).
English: Your child is at high risk of getting an illness caused by a virus called respiratory syncytial virus (RSV).
Maltese: It-tifel/tifla tiegħek qiegħed f'riskju kbir li taqbdu marda ikkawżata minn virus li jissejjaħ virus sinktjali respiratorju (RSV).
English: 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).
Maltese: III, inġabret b' 5 injezzjonijiet li ngħataw fi staġun wieħed (ara sezzjoni 5.1).
English: Synagis 50 mg/0.5 ml solution for injection Synagis 100 mg/1 ml solution for injection
Maltese: Synagis 50 mg/0.5 ml soluzzjoni għall-injezzjoni Synagis 100 mg/1 ml soluzzjoni għall-injezzjoni
English: Synagis is not known to interact with other medicines.
Maltese: Mhux magħruf li hemm interazzjonijiet bejn Synagis u mediċini oħra.
English: Synagis solution for injection is a ready to use formulation.
Maltese: Synagis soluzzjoni għall-injezzjoni huwa formulazzjoni lesta għall-użu.
English: Subjects were stratified by cardiac lesion (cyanotic vs. other) and were followed for safety and efficacy for 150 days.
Maltese: Is-suġġetti komplew jiġu eżaminati għas-sigurtà u l-effikaċja għal 150 ġurnata.
English: Synagis 100 mg vial label
Maltese: Synagis 100 mg Tikketta tal-Kunjett
English: 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.
Maltese: Kien hemm total ta 1,291 rapport serju fejn palivizumab kien mogħti kif indikat u għal staġun wieħed.
English: In the phase III IMpact-RSV 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.
Maltese: III ta' listudju Impact-RSV f'pazjenti pedjatriċi li huma prematuri u li jsofru minn displażja bronkopulmonari, il-proporzjonijiet ta' pazjenti fil-gruppi tal-plaċebo u ta' palivizumb li ngħataw injezzjonijiet ta' rutina fi tfulithom, tilqim ta' l-influwenza, bronkodilaturi jew kortikosterojdi, kienu simili u ma giet innutata l-ebda żieda ta' reazzjonijiet avversi f'pazjenti li kienu qed jircievu dawn ilprodotti.
English: Synagis contains an active ingredient called palivizumab which is an antibody that works specifically against a virus called respiratory syncytial virus, RSV.
Maltese: Synagis fih is-sustanza attiva msejħa palivizumab, li huwa anti-korp li jaħdem speċifikament kontra lvirus li jissejjaħ virus sinktjali respiratorju, RSV.
English: 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.
Maltese: Ir-rata u ssekwenza totali ta' dawn l-avvenimenti avversi, twaqqif tal-mediċina tal-istudju minħabba l-AEs, u nnumru ta' mwiet rrapurtati f'dawn l-istudji kliniċi kienu konsistenti ma' dawk osservati waqt ilprogrammi tal-iżvilupp kliniku għal formulazzjoni lipofilizzata.
English: Synagis 50 mg/0.5 ml solution for injection palivizumab
Maltese: Synagis 50 mg/0.5 ml soluzzjoni għall-injezzjoni palivizumab
English: What isin this leaflet
Maltese: DATA TA' SKADENZA
English: 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).
Maltese: F'żewġ studji addizzjonali, palivizumab likwidu kien użat bħala kontroll attiv (3918 suġġetti pedjatriċi) biex jevalwa antikorp monoklonali investigattiv għal profilassi ta' mard RSV serju fi trabi prematuri jew tfal bi BPD jew CHD emodinamikament sinifikanti (ara hawn taħt għal aktar dettalji fuq dawn iż-żewġ studji).
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.
Maltese: Punti finali dwar effikaċja sekondarja wrew tnaqqis sinifikanti fil-grupp ta' Synagis meta kkomparat ma dak tal-plaċebo fit-total ta' granet li l-pazjenti kellhom idumu l-isptar b'RSV (56% tnaqqis, p = 0.003) u total ta' granet b'RSV b'żieda ta'ossiġnu supplimentali (73% tnaqqis, p = 0.014) f'kull 100 tifel/tifla.
English: Reconstitute slowly with 0.6 ml water for injections.
Maltese: Irrikostitwixi bil-mod b'0.6 ml ilma għall-injezzjonijiet.
English: Palivizumab is administered intramuscularly, preferably in the anterolateral aspect of the thigh.
Maltese: Palivizumab jingħata fil-muskolu darba fix-xahar, preferibbilment fil-parti anterolaterali tal-koxxa.
English: 1ml of water for injections in an ampoule (type I glass).
Maltese: 1 ml ta' ilma għall-injezzjonjiet f'ampulla (tal-ħġieġ tat-tip I).
English: Synagis 100 mg/1 ml solution for injection palivizumab
Maltese: Synagis 100 mg/1 ml soluzzjoni għall-injezzjoni palivizumab
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to other humanised monoclonal antibodies.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal xi waħda mis-sustanzi mhux attivi elenkati f'sezzjoni 6.1, jew għal anti-korpi monklonali umaniżżati oħra.
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.
Maltese: Reazzjonijiet avversi kemm kliniċi kif ukoll ta' laboratorju, li almenu possibbilment huma każwalment relatati ma' palivizumab huma indikati skond il-klassi tal-organi u l-frekwenza (komuni ħafna ≥ 1/10; komuni ≥ 1/100 sa < 1/10; mhux komuni ≥ 1/1,000 sa < 1/100; rari ≥ 1/10,000 to < 1/1,000) fi studji li saru fuq pazjenti pedjatriċi li kienu prematuri u pazjenti pedjatriċi li jsofru minn displażja bronkopulmonari u pazjenti pedjatriċi li jsofru mill-mard tal-qalb konġenitali.
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.
Maltese: Reazzjonijiet avversi kemm kliniċi kif ukoll ta' laboratorju, li almenu possibbilment huma każwalment relatati ma' palivizumab huma indikati skond il-klassi tal-organi u l-frekwenza (komuni ħafna ≥ 1/10; komuni ≥1/100 sa < 1/10; mhux komuni ≥1/1,000 sa < 1/100; rari ≥ 1/10,000 to < 1/1,000) fi studji li saru fuq pazjenti pedjatriċi li kienu prematuri u pazjenti pedjatriċi li jsofru minn displażja bronkopulmonari u pazjenti pedjatriċi li jsofru mill-mard tal-qalb konġenitali.
English: Other medicinesand Synagis
Maltese: Mediċini oħra u Synagis
English: RSV hospitalisations occurred among 62 of 3306 (1.9%) patients in the palivizumab group.
Maltese: Dħul fl-isptar minħabba RSV seħħ fost 62 minn 3306 (1.9%) pazjenti fil-grupp ta' palivizumab.
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.
Maltese: F'test open label prospettiv, li ġie maħsub biex ikunu evalwati l-farmakokinetika, is-sigurta u limmunoġeniċita` wara li jingħataw 7 dożi ta' palivizumab fi staġun wieħed ta' RSV, informazzjoni farmakokinetika indikat li ntlaħqu livelli medji adegwati ta' palivizumab fit-18-il tifel/tifla kollha li ħadu sehem.
English: • Children less than 2 years of age and with haemodynamically significant congenital heart disease.
Maltese: • Tfal ta' taħt is-sentejn fl-eta', li jsofru minn mard tal-qalb kongenitali li huwa emodinamikament sinifikanti.
English: The majority of clinical RSV isolates tested (n=96) were collected from subjects in the United States.
Maltese: Ilmaġġoranza tal-iżolati kliniċi tal-RSV ttestjati ( n = 96 ) kienu miġbura minn suġġetti fl-Istati Uniti.
English: Synagis 100 mg powder and solvent for solution for injection Active substance: palivizumab
Maltese: Synagis 100 mg trab u solvent għal soluzzjoni għall-injezzjoni Sustanza attiva: palivizumab
English: Ltd Τηλ.
Maltese: Tħawwadx.
English: 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.
Maltese: F'analiżi ġenotipika ta' 126 iżolati kliniċi minn 123 tfal li fallew l-immunoprofilassi, l-mutanti kollha tal-RSV li wrew reżistenza għal palivizumab (n = 8) kellhom tibdil fl-aċidi amminiċi f'dan il-post talproteina F.
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.
Maltese: L-antikorp għalpalivizumab ġie evalwat f' erbgħa studji addizzjonali b'4337 pazjent (tfal li twieldu wara 35 ġimgħa ta' ġestazzjoni u ta' 6 xhur jew inqas, jew li għandhom 24 xhar jew inqas li għandhom dysplasia bronkopulmunari, jew li għandhom mard tal-qalb kongenitali li hu sinjifikanti b'mod emodinamiku, kienu inklużi f'dawn l-istudji) u ġie osservat f' 0% - 1.5% tal-pazjenti fi żminijiet differenti waqt listudju.
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
Maltese: Meta tkun qed tuża Palivizumab 100mg/1 mL, il-volum (f'ml) ta' Palivizumab li jrid jiġi amministrat f'intervalli ta' xahar = [il-piż tal-pazjent f'kg] immultiplikat b'0.15.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar il-mediċini: http://www.ema.europa.eu.
English: Outer Carton of 1.0 ml vial
Maltese: Tikketta tal-kunjett ta' 1.0 ml
English: Synagis 50 mg powder and solvent for solution for injection Active substance: palivizumab
Maltese: Synagis 50 mg trab u solvent għal soluzzjoni għall-injezzjoni Sustanza attiva: palivizumab
English: In some cases, fatalities have been reported (see section 4.8).
Maltese: Mwiet ġew irrapurtati f'xi każijiet (ara sezzjoni 4.8).
English: (2ºC-8
Maltese: (ara sezzjoni 5.2).
English: 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.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talawtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: - The other ingredients are, - for the powder: histidine, glycine and mannitol.
Maltese: - Is-sustanzi l-oħra huma - Għat-trab: histidine, glycine u mannitol.
English: 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:
Maltese: Synagis huwa indikat għall-prevenzjoni ta' mard serju fil-passaġġ respiratorju t'isfel, li jirrikjedi kura fl-isptar, liema mard huwa kkawżat mill-virus sinktjali respiratorju (RSV), fi tfal li qegħdin f'riskju għoli li jimirdu bil-marda RSV, jiġifieri:
English: 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).
Maltese: IgG1 fir-rigward tal-volum ta' dsitribuzzjoni (medja 57 ml/kg) u l-half-life (medja 18 il-gurnata).
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.
Maltese: Fi studju ta' mard tal-qalb kongenitali fost 139 tifel/tifla li kienu qed jingħataw palivizumab, liema tfal kellhom bypass kardjo-pulmonari u setgħu jutilizzaw kampjuni ta' serum koppjati, lkonċentrazzjoni medja ta' palivizumab fis-serum kienet ta' bejn wieħed u ieħor 100 g/ml qabel ilbaypas kardijaku li naqset għal bejn wieħed u ieħor 40 g/ml wara l-baypas.
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
Maltese: Meta tkun qed tuża Palivizumab 100mg/ml, il-volum (f'ml) ta' Palivizumab li jrid jiġi amministrat f'intervalli ta' xahar = [il-piż tal-pazjent f'kg] immultiplikat b'0.15.
English: For instructions on special handling requirements, see section 6.6.
Maltese: Għall-istruzzjonijiet dwar ħtieġa ta' immaniġjar speċjali, ara sezzjoni 6.6.
English: Powder and solvent for solution for injection Contents:
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni Kontenut:
English: Outer Carton of 0.5 ml vial
Maltese: Tikketta tal-kunjett ta' 0.5 ml
English: Synagis 50 mg powder and solvent for solution for injection palivizumab
Maltese: Synagis 50 mg trab u solvent għal soluzzjoni għall-injezzjoni palivizumab
English: 50 mg Outer Carton
Maltese: 50 mg Il-Kartuna ta' Barra
English: The volume (expressed in mL) of // Palivizumab // to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15
Maltese: Il-volum (f' mL) ta' //Palivizumab// li jrid jiġi amministrat f'intervalli ta' xahar = [il-piż tal-pazjent f'kg] immultiplikat b'0.15.
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).
Maltese: F'din il-prova, il-pazjenti kienu magħżula b'ordni addoċċ biex jirċievu 5 injezzjonijiet kull xahar ta' 15mg/kg ta' palivizumab likwidu (N=3306) użat bħala kontroll attiv tal-antikorp monoklonali investigattiv (N=3329).
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji.
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.
Maltese: Flistudju dwar il-mard tal-qalb kongenitali, dożi intramuskolari ta' 15 mg/kg mogħtija kull xahar pproduċew medja ta' konċentrazzjonijiet minimali tas-sustanza attiva fis-serum fi 30 ġurnata ta' bejn wieħed u ieħor 55 µg/ml wara l-ewwel injezzjoni u ta' bejn wieħed u ieħor 90 µg/ml wara r-raba` injezzjoni.
English: • Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.
Maltese: • Tfal ta' taħt is-sentejn fl-eta', li tul l-aħħar 6 xhur kellhom bżonn il-kura għal displażja bronkopulmonari.
English: Post-marketing serious spontaneous adverse reactions reported during palivizumab treatment between 1998 and 2002 covering four RSV seasons were evaluated.
Maltese: Wara li ġie ntrodott fis-suq, ġew evalwati, reazzjonijiet avversi spontanji u serji li ġew rappurtati waqt il-kura b'palivizumab bejn 1998 u 2002, li jkopru erba staġuni ta' RSV.
English: 100 mg Outer Carton
Maltese: 100 mg Il-Kartuna ta' Barra
English: To administer, remove the tab portion of the vial cap and clean the stopper with 70 % ethanol or equivalent.
Maltese: Biex tamministrah, neħħi l-parti matta tal-għatu tal-kunjett u naddaf it-tapp tal-lastiku b'70% ethanol jew ekwivalenti.
English: Synagis 100 mg powder and solvent for solution for injection palivizumab
Maltese: Synagis 100 mg trab u solvent għall-soluzzjoni għall-injezzjoni palivizumab
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.
Maltese: Trabi li twieldu qabel iż-żmien u tfal bil-Marda tal-Pulmun Kronika tal-Prematurità (CLDP): din ilprova, li saret fi 347 ċentri fl-Amerika ta' Fuq, fl-Unjoni Ewropeja u 10 pajjiżi oħra, studjat pazjenti li għandhom 24 xahar jew anqas b'CLDP u pazjenti li twieldu prematuri (35 ġimgħa ta' ġestazzjoni jew anqas) u li kellhom 6 xhur jew anqas fil-bidu tal-istudju.
English: Palivizumab does not interfere with reverse transcriptase polymerase chain reaction-based assays.
Maltese: Palivizumab ma jagħmilx effett fuq testijiet li jaħdmu fuq reverse transcriptase polymerase chain reaction.
English: How to storeSynagis
Maltese: KG Knollstrasse
English: 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.
Maltese: Ir-riżultati ta' din il-prova indikaw li l-konċentrazzjonijiet minimali ta' palivizumab fisserum kienu simili bejn il-formulazzjoni likwida u l-formulazzjoni lipofilizzata u ntweriet ukoll bijoekwivalenza tal-likwidu u l-formulazzjoni lipofilizzata.
English: AbbVie Spain, S.L.U Tel: +34 9 1 384 09 10
Maltese: AbbVie Biofarmacevtska družba d.o.o. Tel: +386 (1)32 08 060
English: Groups were equally balanced between cyanotic and acyanotic patients.
Maltese: Il-gruppi kienu bilanċjati ugwalment bejn pazjenti ċijanotiċi u aċyanotici.
English: 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.
Maltese: Infezzjoni li tvarja minn moderata għall severament akuta jew mard bid-deni jistgħu jirrikjedu li palivizumab jingħata aktar tard, sakemm, fl-opinjoni tat-tabib, ma jkunx hemm riskju akbar jekk wieħed ma jingħatax palivizumab.
English: The incidence of RSV hospitalisation was 16 of 612 (2.6%) in the palivizumab group.
Maltese: Linċidenza ta' dħul fl-isptar minħabba RSV kienet ta' 16 minn 612 (2.6%) fil-grupp ta' palivizumab.
English: Also contains: histidine, glycine and water for injections.
Maltese: Fih ukoll: histidine, glycine u ilma għall-injezzjonijiet.
English: Each vial contains: 100 mg palivizumab, providing 100 mg/ml of palivizumab when reconstituted as recommended.
Maltese: Kull kunjett fih: 100 mg palivizumab, li jipprovdi 100 mg/ml ta' palivizumab meta jiġi rikostitwit kif inhu rakkommandat.
English: Synagis 100 mg powder and solvent for solution for injection
Maltese: Synagis 100 mg trab u solvent għal soluzzjoni għall-injezzjoni
English: Uncommon (affects less than 1 user in 100): fits hives
Maltese: Komuni (jaffetwaw minn 1 sa 10 pazjenti minn 100):
English: When reconstituted as recommended, the final concentration is 100 mg/ml.
Maltese: Meta jiġi rikostitwit kif indikat, il-konċentrazzjoni finali tkun ta' 100 mg/mL.
English: 50 mg of powder in a 4 ml vial (type I glass) with a stopper (butyl rubber) and a flip-off seal (aluminium).
Maltese: 50 mg ta' trab f' kunjett (tal-ħġieġ tat-tip I) li jesa' 4 ml, b'tapp (tal-lastku butyl) u siġill (ta' laluminju) li tiftħu b'daqqa ta' saba`.