qanastek/EMEA-V3 huggingface dataset:
Therefore, HAHA responses appear to be of no clinical relevance.
Għalhekk jidher li r- rispons għal HAHA ma għandu l- ebda rilevanza klinika.
5 Immunogenicity was not studied in the congenital heart disease study.
L- immunoġeniċita ’ ma gietx studjata fl- istudju dwar mard tal- qalb kongenitali.
In clinical studies, three children received an overdose of more than 15 mg/ kg.
Fi studji kliniċi 3 itfal ingħataw doża eċċessiva ta ’ iktar minn 15mg/ kg.
These doses were 20.25 mg/ kg, 21.1 mg/ kg and 22.27 mg/ kg.
Dawn id- dożi kienu ta ’ 20. 25 mg/ kg, 21. 1 mg/ kg u 22. 27 mg/ kg.
No medical consequences were identified in these instances.
Ma ġew identifikati l- ebda konsegwenzi mediċi f’ dawn il - każi.
Immunoglobulins; ATC Code:
Immunoglobulini, Kodiċi ATC:
Palivizumab is a humanised IgG1κ monoclonal antibody directed to an epitope in the A antigenic site of the fusion protein of respiratory syncytial virus (RSV).
Palivizumab huwa anti- korp uman IgG1κ monoklonali intenzjonat għall- epitope fis- sit A antiġeniku tal- proteina ta ’ fużjoni tal- virus sinktjali (RSV).
This humanised monoclonal antibody is composed of human (95%) and murine (5%) antibody sequences.
Dan l- anti- korp uman monoklonali huwa magħmul minn sekwenzi ta ’ anti- korpi umani (95%) u tal- ġrieden (5%).
It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains.
Għandu attivita b’ saħħitha biex jinnewtraliżża u jinibixxi fużjoni kontra l- istrains tas- sottotipi A u B tal- RSV.
Palivizumab serum concentrations of approximately 30 μ g/ ml have been shown to produce a 99% reduction in pulmonary RSV replication in the cotton rat model.
Konċentrazzjonijiet ta ’ bejn wieħed u ieħor 30 μg/ ml palivizumab fis- serum urew li jipproduċu tnaqqis ta ’ 99% fir- replikazzjoni ta ’ RSV pulmonari fil- mudell ta ’ cotton rat.
Clinical studies 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).
Studji kliniċi 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. 001).
The RSV hospitalisation rate was 10.6% in the placebo group.
Ir- rata ta ’ każijiet ta ’ sptar b ’ RSV kient ta ’ 10. 6% fil - grupp tal- plaċebo.
On this basis, the absolute risk reduction (ARR) is 5.8% which means the number needed to treat (NNT) is 17 to prevent one hospitalisation.
Abbażi ta ’ dan, it- tnaqqis assolut tar- riskju (ARR) huwa 5. 8% li jfisser li n- numru li wieħed irid jikkura( NNT) biex jiġi evitat każ ta ’ sptar wieħed, huwa ta ’ 17.
The severity of RSV disease in children hospitalised despite prophylaxis with palivizumab in terms of days in ICU stay per 100 children and days of mechanical ventilation per 100 children was not affected.
Is- severita ’ tal- mard RSV fi tfal li kellhom jittieħdu l- isptar minkejja l- profilassi b’ palivizumab, abbażi ta ’ preżenza ta ’ ġranetin li kellhom idumu l- isptar kull 100 tifel/ tifla u ġranet ta ’ ventilazzjoni b’ meżżi mekkaniċi kull 100 tifel/ tifla, ma gietx effettwata.
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.
Total ta ’ 222 tifel/ tifla ġew reġistrati f’ żewġ studji separati biex tiġi eżaminata s- sigurta ’ ta ’ palivizumab meta dan jingħata għat- tieni staġun ta ’ RSV.
One hundred and three (103) children received monthly palivizumab injections for the first time, and 119 children received palivizumab for two consecutive seasons.
Mija u tlett itfal (103) għall- ewwel darba ġew injettati b’ injezzjonijiet ta ’ palivizumab fix- xahar, u 119 – il tifel/ tifla ġew mogħtija palivizumab għall- żewġ staġuni konsekuttivi.
No difference between groups regarding immunogenicity was observed in either study.
Ma giet innutata l- ebda differenza bejn il- gruppi fiż- żewġ studji, għall dak li jirrigwarda l- immunoġeniċita ’.
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.
Iżda peress li l- effikaċja ta ’ palivizumab meta mogħti lill - pazjenti bħala t- tieni kors ta ’ kura matul staġun ta ’ RSV li jsegwi, ma ġietx formalment investigata fi studju magħmul għal dan il- għan, ir- rilevanza ta ’ din l- informazzjoni f’ termini ta ’ effikaċja m ’ hijiex magħrufa.
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.
F’ test open label prospettiv, li ġie maħsub biex ikunu evalwati l- farmakokinetika, is- sigurta u l - immunoġeniċita` 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.
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.
Livelli tranżjenti baxxi ta ’ anti- korpi ta ’ palivizumab, ġew osservati f’ tifel wieħed wara t - tieni doża ta palivizumab li waqgħet f’ livelli li ma ’ tistax taqrhom fil- ħames u s- seba ’ doża.
In a placebo-controlled trial in 1287 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).
Fi prova kkontrollata bil- plaċebo f’ 1287 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
Groups were equally balanced between cyanotic and acyanotic patients.
Il- gruppi kienu bilanċjati ugwalment bejn pazjenti ċijanotiċi u aċyanotici.
The RSV hospitalisation rate was 9.7% in the placebo group and 5.3% in the Synagis group.
Il- każijiet ta ’ sptar b’ RSV kienu jammontaw għal 9. 7% fil- grupp tal- plaċebo u 5. 3% fil- grupp ta ’ Synagis.
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.
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.
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).
Fi studji fuq volontiera adulti, palivizumab kellu profil farmakokinetiku simili għall- anti- korp uman IgG1 fir- rigward tal- volum ta ’ dsitribuzzjoni (medja 57 ml/ kg) u l- half- life (medja 18 il- gurnata).
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 μ g/ ml after the first injection, approximately 60 μ g/ ml after the second injection, approximately 70 μ g/ ml after the third injection and fourth injection.
Fi studji profilattiċi f’ pazjenti pedjatriċi prematuri u f’ pazjenti pedjatriċi li jbatu minn displażja bronkopulmonari, il- half- life medja ta ’ palivizumab kienet 20 ġurnata u dożi intramuskolari ta ’ 15 mg/ kg mogħtija kull xahar pproduċew medja ta ’ konċentrazzjoni minimali tas- sustanza attiva fis - serum fi 30 gurnata, ta ’ bejn wieħed u ieħor 40 μg/ ml wara l- ewwel injezzjoni, bejn wieħed u ieħor 60 μg/ ml wara t- tieni injezzjoni, u bejn wieħed u ieħor 70 μg/ ml wara it- tielet u r- raba` injezzjoni.
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.
Fl - istudju 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.
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 μ g/ ml pre-cardiac bypass and declined to approximately 40 μ g/ ml after bypass.
Fi studju ta ’ mard tal- qalb kongenitali fost 139 tifel/ tifla li kienu qed jingħataw palivizumab, liema tfal kellhom baypass kardjo- pulmonari u setgħu jutilizzaw kampjuni ta ’ serum koppjati, l - konċentrazzjoni medja ta ’ palivizumab fis- serum kienet ta ’ bejn wieħed u ieħor 100 μg/ ml qabel il - baypas kardijaku li naqset għal bejn wieħed u ieħor 40 μg/ ml wara l- baypas.
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).
Studji tossikologiċi dwar meta tittieħed doża waħda ġew magħmula fuq xadini ċinomologi (doża massima ta ’ 30 mg/ kg), fniek (doża massima ta ’ 50 mg/ kg) u firien (doża massima ta ’ 840mg/ kg).
No significant findings were observed.
Ma ġew innutati l- ebda riżultati sinifikanti.
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.
Studji li saru fuq rodenti ma taw l- ebda indikazzjoni ta ’ żieda fir- replikazzjoni ta ’ RSV, jew fil - patologija indotta mill- RSV, jew fil- ġenerazzjoni tal - virus escape mutants fil- preżenza ta ’ palivizumab taħt il- kundizzjonijiet esperimentali magħżula.
Water for injections
Ilma għall- injezzjonjiet
Palivizumab should not be mixed with any medicinal products or diluents other than water for injections.
Palivizumab m’ għandux jitħallat ma ’ prodotti mediċinali oħra jew diluwenti ħlief ilma għall - injezzjonjiet
6.3 Shelf-life
7 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
After reconstitution according to instructions:
Wara li jiġi mħallat skond l- istruzzjonijiet:
3 hours
3 sigħat
Store in a refrigerator (2ºC to 8ºC).
Aħżen fil- friġġ (2°C – 8°C).
For storage conditions of the reconstituted medicinal product, see section 6.3.
Għal tagħrif dwar il- ħażna tal- prodott mediċinali mħallat, ara sezzjoni 6. 3.
7 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Synagis powder in a clear, colourless, type I glass 4ml vial with bromobutyl rubber stopper and aluminium flip-off seal containing 50 mg palivizumab, providing 100 mg/ ml of palivizumab when reconstituted.
Trab ta ’ Synagisf’ kunjett tal- ħġieġ tat- tip I, ċar u bla kulur li jesa ’ 4 ml, b’ tapp tal- lastku bromobutyl u siġill ta ’ l- aluminju li tiftħu b’ daqqa ta ’ saba`, u li fih 50 mg palivizumab, u jipprodiċi 100 mg/ ml ta ’ palivizumab meta jitħallat.
Water for injections in a clear, colourless type I glass ampoule containing 1 ml of water for injections.
Ilma għall- injezzjonjiet f’ ampulla tal- ħġieġ tat- tip I, ċar u bla kulur, li fiha 1 ml ta ’ ilma għall - injezzjonjiet.
One vial of Synagis powder and one ampoule of water for injections per pack.
Kunjett wieħed ta ’ trab Synagis u ampulla waħda ta ’ ilma għall- injezzjonjiet f’ kull pakkett.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġjar ieħor
SLOWLY add 0.6 ml of water for injections along the inside wall of the vial to minimise foaming.
BIL- MOD żid 0. 6 ml ta ’ ilma għall- injezzjonjiet tul il- ħajt ta ’ ġewwa tal- kunjett biex tnaqqas ir- rawa.
After the water is added, tilt the vial slightly and gently rotate the vial for 30 seconds.
Wara li żżid l- ilma mejjel il- kunjett kemm kemm u bil- mod dawwar il- kunjett għal 30 sekonda.
Palivizumab solution should stand at room temperature for a minimum of 20 minutes until the solution clarifies.
Is- soluzzjoni ta ’ Palivizumab għanda toqgħod f’ temperatura tal- kamra għal minimu ta ’ 20 minuta sakemm is- soluzzjoni tiċċjara.
Palivizumab solution does not contain a preservative and should be administered within 3 hours of preparation.
Is- soluzzjoni ta ’ Palivizumab ma fihiex preservativ u għandha tingħata fi żmien 3 sigħat wara li titħallat.
When reconstituted as recommended, the final concentration is 100 mg/ ml.
Meta jiġi rikostitwit kif indikat, il- konċentrazzjoni finali tkun ta ’ 100 mg/ ml.
13 August 1999 Date of latest renewal:
13 ta ’ Awissu 1999 Data ta ’ l- aħħar tiġdid:
13 August 2004
12 ta ’ Awissu 2004
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /
Synagis 100 mg powder and solvent for solution for injection
Synagis 100 mg trab u solvent għal soluzzjoni għall- injezzjoni
Each vial contains 100 mg palivizumab, providing 100 mg/ ml of palivizumab when reconstituted as recommended.
Kull kunjett fih 100 mg palivizumab, li, meta jitħallat kif inhu rrakkommandat, jipproduċi 100 mg/ ml ta ’ palivizumab.
• Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season • Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months. • Children less than 2 years of age and with haemodynamically significant congenital heart disease.
• Tfal li fil- bidu tal- istaġun ta ’ RSV ikunu twieldu wara 35 gimgħa jew inqas ta ’ gestazzjoni fit - tqala jew ikunu ta ’ eta ’ ta ’ inqas minn 6 xhur. • Tfal ta ’ taħt is- sentejn fl- eta ’, li tul l- aħħar 6 xhur kellhom bżonn il- kura għal displażja bronkopulmonari. • Tfal ta ’ taħt is- sentejn fl- eta ’, li jsofru minn mard tal- qalb kongenitali li huwa emodinamikament sinifikanti.
Data, although limited, are available on greater than 5 doses (see sections 4.8 and section 5.1), therefore the benefit in terms of protection beyond 5 doses has not been established.
Għalkemm it- tagħrif hu limitat, tista ’ ssibu għal aktar min ħames dożi (ara sezzjoni 4. 8 u 5. 1), għalhekk il- benefiċċju rigward il- protezzjoni b’ aktar minn 5 dożi għadu ma ġiex stabbilit.
9 Method of administration Palivizumab is administered in a dose of 15 mg/ kg of body weight once a month intramuscularly, preferably in the anterolateral aspect of the thigh.
10 Metodu ta ’ kif jingħata Palivizumab jingħata fil- muskolu f’ doża ta ’ 15 mg/ kg ta ’ piż tal- ġisem darba fix- xahar, preferibbilment fil- parti anterolaterali tal- koxxa.
10 4.8 Undesirable effects
11 4. 8 Effetti mhux mixtieqa
11 Table 2 Undesirable effects in the prophylactic paediatric congenital heart disease clinical study
12 Tabella 2 Effetti mhux mixtieqa fi studju kliniku profilattiku f’ pazjenti pedjatriċi b’ mard tal- qalb konġenitali
Human anti-human antibody (HAHA) response:
13 Rispons uman għall- anti- korpi anti- umani, (HAHA):
12 Immunogenicity was not studied in the congenital heart disease study.
L- immunoġeniċita ’ ma gietx studjata fl- istudju dwar mard tal- qalb kongenitali.
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.
F’ test open label prospettiv, li ġie maħsub biex ikunu evalwati l- farmakokinetika, is- sigurta u l - immunoġeniċita` 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.
6.3 Shelf-life
15 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Synagis powder in a clear, colourless, type I glass 10ml vial with bromobutyl rubber stopper and aluminium flip-off seal containing 100 mg palivizumab, providing 100 mg/ ml of palivizumab when reconstituted as recommended.
Trab ta ’ Synagisf’ kunjett tal- ħġieġ tat- tip I, ċar u bla kulur li jesa ’ 4 ml, b’ tapp tal- lastku bromobutyl u siġill ta ’ l- aluminju li tiftħu b’ daqqa ta ’ saba`, u li fih 100 mg palivizumab, u jipprodiċi 100 mg/ ml ta ’ palivizumab meta jitħallat kif irrakkommandat.
Water for injections in a clear, colourless type I glass ampoule containing 1 ml of water for injections
Ilma għall- injezzjonjiet f’ ampulla tal- ħġieġ tat- tip I, ċar u bla kulur, li fiha 1 ml ta ’ ilma għall - injezzjonjiet.
SLOWLY add 1.0 ml of water for injections along the inside wall of the vial to minimise foaming.
BIL- MOD żid 0. 6 ml ta ’ ilma għall- injezzjonjiet tul il- ħajt ta ’ ġewwa tal- kunjett biex tnaqqas ir- rawa.
Abbott Laboratories Limited Queenborough, Kent ME11 5EL United Kingdom
Abbott Laboratories Limited Queenborough Kent ME11 5EL Renju Unit
15 ANNEX II
17 ANNESS II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT B.
KG D-88397 Biberach an der Riss Germany
KG D- 88397 Biberach an der Riss Ġermanja
Abbott SRL I 104010 Campoverdi di Aprilia (Latina) Italy
Abbott SRL I 104010 Campoverdi di Aprilia (Latina) Italja
17 ANNEX III
19 ANNESS III
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
SYNAGIS 50 mg Outer Carton
SYNAGIS 50 mg Il- Kartuna ta ’ Barra
SYNAGIS 50 mg powder and solvent for solution for injection Palivizumab
SYNAGIS 50 mg trab u solvent għal soluzzjoni għall- injezzjoni Palivizumab
Each vial contains 50 mg palivizumab, providing 100 mg/ ml of palivizumab when reconstituted as recommended.
Kull kunjett fih 50 mg ta ’ palivizumab, li jipprovdi 100 mg/ ml ta ’ palivizumab meta jiġi rikostitwit kif inhu rakkommandat.
Also contains histidine, glycine and mannitol.
Fih ukoll histidine, glycine u mannitol.
Powder and solvent for solution for injection Contents:
Trab u solvent għal soluzzjoni għall- injezzjoni Kontenut:
1 Vial SYNAGIS 50 mg 1 ampoule 1 ml Water for Injections
Kunjett wieħed SYNAGIS 50 mg Ampulla waħda ta ’ 1 ml Ilma għall- Injezzjonijiet
Reconstitute SLOWLY with 0.6 ml Water for Injections.
Irrikostitwixi BIL- MOD b’ 0. 6 ml Ilma għall- Injezzjonijiet.
Swirl gently.
Dawwar bil- ġentilezza.
DO NOT SHAKE.
TĦAWWADX.
Let stand for 20 minutes.
Ħalliha toqgħod għal 20 minuta.
Use within 3 hours of reconstitution.
Uża fi żmien 3 sigħat wara r- rikostituzzjoni.
For intramuscular use.
Għall- użu għal ġol- muskoli.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Expiry date:
Data ta ’ skadenza:
Store in the original container.
Aħżen fil- kontenitur oriġinali
Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom
Abbott Laboritories Ltd Queenborough Kent ME11 5EL Renju Unit
21 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SYNAGIS 50 mg Vial Label
SYNAGIS 50 mg Tikketta tal- Kunjett
SYNAGIS 50 mg powder for solution for injection Palivizumab Intramuscular use
SYNAGIS 50 mg trab u solvent għal soluzzjoni għall- injezzjoni Palivizumab Għall- użu għal ġol- muskoli
SYNAGIS 100 mg Outer Carton
24 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA SYNAGIS 100 mg Il- Kartuna ta ’ Barra
SYNAGIS 100 mg powder and solvent for solution for injection Palivizumab
SYNAGIS 100 mg trab u solvent għall- soluzzjoni għall- injezzjoni Palivizumab
100 mg palivizumab, providing 100 mg/ ml of palivizumab when reconstituted as recommended.
100 mg palivizumab, li jipprovdi 100 mg/ ml ta ’ palivizumab meta jiġi rikostitwit kif inhu rakkommandat.
Also contains: histidine, glycine and mannitol.
Fih ukoll: histidine, glycine u mannitol.
1 Vial SYNAGIS 100 mg 1 ampoule 1 ml Water for Injections
Kunjett wieħed SYNAGIS 100 mg Ampulla waħda ta ’ 1 ml Ilma għall- Injezzjonijiet
Reconstitute SLOWLY with 1.0 ml Water for Injections.
Irrikostitwixi BIL- MOD b’ 0. 6 ml Ilma għall- Injezzjonijiet.
Let stand for 20 minutes.
Ħaliha toqgħod għal 20 minuta.
Use within 3 hours of reconstitution.
Uża fi żmien 3 sigħat wara rikostituzzjoni.
Expiry date:
Data ta ’ skadenza
24 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
26 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SYNAGIS 100 mg Vial Label
SYNAGIS 100 mg Tikketta tal- Kunjett
SYNAGIS 100 mg powder for solution for injection Palivizumab Intramuscular
SYNAGIS 100 mg trab u solvent għall- soluzzjoni għall- injezzjoni Palivizumab Użu għal ġol- muskoli
25 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SYNAGIS Water for injections Ampoule Label Text
Il- Kitba tat- Tikketta ta ’ l- Ampulla ta ’ SYNAGIS Ilma għall- Injezzjonijiet
OTHER
28 B.
27 PACKAGE LEAFLET:
29 FULJETT TA ’ TAGĦRIF:
Synagis 50 mg powder and solvent for solution for injection Palivizumab
Synagis 50 mg trab u solvent għal soluzzjoni għall- injezzjoni Palivizumab
Read all of this leaflet carefully because it contains important information for you and your child.
Aqra sew dan il- fuljett kollu, għax fih tagħrif importanti għalik u għal uliedek.
You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for your child.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
It may harm them, even if their symptoms are the same as those of your child. − 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.
anki jekk ikollhom l- istess sintomi bħal tat- tifel/ tifla tiegħek.
In this leaflet:
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Synagis is and what it is used for 2.
X’ inhu Synagis u għalxiex jintuża 2.
Before Synagis is given to your child 3.
Qabel ma tuża Synagis 3.
How will my child receive Synagis 4.
Kif għandek tuża Synagis 4.
How to store Synagis 6.
Kif taħżen Synagis 6.
WHAT SYNAGIS IS AND WHAT IT IS USED FOR
X’ INHU SYNAGIS U GĦALXIEX JINTUŻA
Synagis contains an active ingredient called palivizumab which is an antibody that works specifically against a virus called respiratory syncytial virus, RSV.
Synagis fih is- sustanza attiva msejħa palivizumab, li huwa anti- korp li jaħdem speċifikament kontra l - virus li jissejjaħ virus sinktjali respiratorju, RSV.
Your child is at high risk of getting an illness caused by a virus called respiratory syncytial virus (RSV).
It- tifel/ tifla tiegħek qiegħed f’ riskju kbir li taqbdu marda ikkawżata minn virus li jissejjaħ virus sinktjali respiratorju (RSV).
Synagis is a medicine to help protect your child from getting severe RSV illness.
Synagis hija mediċina li tgħin tipprevjeni lit- tifel/ tifla tiegħek minn mard RSV serju ħafna.
BEFORE SYNAGIS IS GIVEN TO YOUR CHILD
QABEL MA TUŻA SYNAGIS
Your child should not be given Synagis:
It- tifel/ tifla tiegħek m’ għandux/ m’ għandhiex tuża Synagis
− if he/ she has ever had an allergic (hypersensitive) reaction to the active ingredient of Synagis (palivizumab) or to any of the other ingredients of Synagis (see a full list of ingredients in Section 6)
Synagis (palivizumab) jew għal xi wieħed mis- sustanzi l- oħra ta ’ Synagis (ara l- lista sħiħa ta ’ sustanzi f’ Sezzjoni 6)
Take special care with Synagis:
Oqgħod attent ħafna b’ Synagis
− if your child is unwell.
Jekk jogħġbok għid lit- tabib tiegħek
Please tell your doctor if your child is unwell, as the use of Synagis may need to be delayed. − if your child has any bleeding disorders as Synagis is usually injected into the thigh.
jekk it- tifel/ tifla tiegħek iħossu/ tħossha ma jiflaħx/ tiflaħx, għax jista ’ jkun hemm bżonn li l- użu ta ’ Synagis jiġi ttardjat.
Taking other medicines:
Meta tuża mediċini oħra
Synagis is not known to interact with other medicines, however, you should inform your doctor of all medicines your child is currently taking before starting Synagis.
Mhux magħruf li hemm interazzjonijiet bejn Synagis u mediċini oħra, madanakollu għandek tgħarraf lit- tabib tiegħek dwar il- mediċini kollha li qed jieħu/ tieħu t- tifel/ tifla tiegħek qabel ma jinbeda Synagis.
HOW WILL MY CHILD RECEIVE SYNAGIS
KIF GĦANDEK TUŻA SYNAGIS
Instructions for proper use
Struzzjonijiet għall- użu
How often will Synagis be given to my child?
Synagis, kemm il- darba ser jingħata lit- tifel/ tifla tiegħi?
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.
Synagis għandu jingħata lit- tifel/ tifla tiegħek f’ doża ta ’ 15 mg/ kg ta ’ piż tal- ġisem darba fix- xahar sakemm jibqa ir- riskju ta ’ infezzjoni b’ RSV.
For your child’ s best protection, it is necessary to take the doctor’ s advice about when to return for additional doses of Synagis.
Għall- aħjar mod ta ’ protezzjoni għat- tifel/ tifla tiegħek, huwa neċċessarju li inti timxi fuq il- parir tat- tabib dwar meta għandek terġa ’ tmur biex tingħata dożi addizzjonali ta ’ Synagis.
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.
Jekk it- tifel/ tifla tiegħek se jagħmel/ tagħmel operazzjoni tal- qalb (kirurġija tal- bajpass kardijaka), wara l- operazzjoni, hu jew hi jista ’ / tista ’ jingħata/ tingħata doża żejda ta ’ Synagis.
Your child can then go back to the original planned injection.
Wara dan, it- tifel/ tifla tiegħek ikun/ tkun jista ’ / tista ’ jerġa ’ / terġa ’ lura għat- teħid tal- injezzjoni bil- mod kif oriġinarjament ippjanat.
How will my child receive Synagis?
Kif ser jingħata Synagis lit- tifel/ tifla tiegħi?
Synagis will be given by injection to your child into a muscle, usually in the outer part of the thigh.
Synagis jingħata lit- tifel/ tifla tiegħek permezz ta ’ injezzjoni ġo muskolu, normalment fuq in- naħa ta ’ barra tal- koxxa.
What should you do if you feel that your child has become ill while being treated with Synagis?
X’ għandek tagħmel jekk tħoss li t- tifel/ tifla tiegħek marad/ mardet waqt li kien/ et qed jiġi/ tiġi kkurat/ a b’ Synagis?
If your child becomes ill, please contact your doctor immediately.
Jekk it- tifel/ tifla tiegħek jimrad/ timrad, kellem lit- tabib tiegħek immedjatament.
What should you do if your child misses an injection of Synagis?
X’ għandek tagħmel jekk it- tifel/ tifla tiegħek jinsa/ tinsa jieħu/ tieħu injezzjoni ta ’ Synagis?
If your child misses an injection, you should contact your doctor as soon as possible.
Jekk it- tifel/ tifla tiegħek jinsa/ tinsa jieħu/ tieħu injezzjoni għandek tkellem lit- tabib tiegħek mill- aktar fis possibli.
Each injection of Synagis can only help protect your child for about one month before another injection is needed.
Kull injezzjoni ta ’ Synagis tista ’ tgħin biex tipproteġi lit- tifel/ tifla tiegħek għal madwar xhar qabel ikun hemm bżonn ta ’ injezzjoni oħra.
If you have any further questions on how this product will be given to your child, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Synagis can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Synagis jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
What side effects may occur while taking Synagis?
X’ effetti oħra jistgħu jinqalgħu waqt li qed tieħu Synagis?
Common (affects 1 to 10 users in 100): fever; nervousness; redness or swelling at the injection site; diarrhoea.
Komuni (jaffetwaw minn 1 sa 10 pazjenti minn 100):
Uncommon (affects 1 to 10 users on 1000): colds coughs runny nose wheeze, vomiting rash pain; viral infection; bleeding; weakness; constipation; drowsiness; hyperactivity; decrease in white blood cell counts; increase in liver function tests which will be seen in blood tests.
Mhux komuni (jaffetwaw minn 1 sa 10 pazjenti minn 1000): irjiħat; sogħla; imnieħer iqattar; tħarħir, remettar; raxx; uġigħ; infezzjoni virali; ħruġ ta ’ demm; dgħufija; stitikezza; ngħas; attività eċċessiva;
29 Rare (affects 1 to 10 users in 10,000):
Rari (jaffetwaw minn 1 sa 10 pazjenti minn 10, 000):
a pause in breathing or other breathing difficulties.
pawża fin- nifs jew diffikultajiet oħra biex tieħu n- nifs.
Very rare (affects less than 1 user in 10,000); severe allergic reactions.
Rari ħafna (jaffetwaw inqas minn 1 minn 10, 000):
What should you do if side effects occur?
X’ għandek tagħmel jekk l- effetti oħra jseħħu?
If your child shows any side effects after receiving Synagis you should contact your doctor.
Jekk it- tifel/ tifla tiegħek ikollu/ ikollha xi effetti oħra wara t- teħid ta ’ Synagis għandek tkellem lit- tabib tiegħek.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, contact your doctor.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek
HOW TO STORE SYNAGIS
KIF TAĦŻEN SYNAGIS
Do not use Synagis after the expiry date which is stated on the label.
Tużax Synagis wara d- data ta ’ skadenza li tidher fuq it- tikketta.
Store in a refrigerator (2ºC-8°C) until used.
Aħżen Synagis fi friġġ (2°C – 8°C) sakemm jintuża.
What Synagis contains
X’ fih Synagis:
- The active substance is palivizumab.
- Is- sustanza attiva hi palivizumab.
- Each vial contains 50 mg palivizumab, providing 100 mg/ ml of palivizumab when reconstituted
Kull kunjett fih 50 mg palivizumab, li jipproduċi 100 mg/ ml ta ’ palivizumab meta jitħallat kif irrakkommandat.
as recommended.
- Is- sustanzi l- oħra huma histidine, glycine u mannitol.
- The other ingredients are histidine, glycine and mannitol.
Id- Dehra tal- prodott u d- daqs tal- pakkett:
What Synagis looks like and contents of the pack Synagis is a white to off-white uniform dry cake in a 4 ml vial.
Synagis huwa trab niexef magħqud u uniformi ta ’ kulur abjad li jagħti fl- abjad maħmuġ f’ kunjett ta ’ 4 ml.
This cake is reconstituted with the Water for Injections before being injected.
Qabel tiġi injettata, din it- taħlita tiġi mħallta bl- Ilma għall- Injezzjonijiet.
Marketing Authorisation holder:
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Abbott Laboratories, Limited Queenborough Kent ME11 5EL United Kingdom
Abbott Laboratories, Limited Queenborough Kent ME11 5EL Renju Unit
AbbottSRL I 04011 Campoverde di Aprilia, (Latina) Italy
Abbott SRL I 04011 Campoverde di Aprilia, (Latina) Italja
Danmark Abbott Laboratories A/ S Emdrupvej 28CDK 2100 København ØTlf: + 45 39 77-00-00
Danmark Abbott Laboratories A/ S Emdrupvej 28CDK 2100 København Ø Tlf: + 45 39 77- 00- 00
Avenida de Burgos, 91 E-28050 Madrid Tel: + 34 9 1 337-5200
Avenida de Burgos, 91 E- 28050 Madrid Tel: + 34 9 1 337- 5200 France Abbott France 10, rue d’ Arcueil BP 90233 F- 94528 Rungis Cedex Tél: + 33 (0) 1 45 60 25 00
Estrada de Alfragide, nº 67 Alfrapark, Edifício D, 2610-008 Amadora Tel: + 351 (0) 21 472 7100
Estrada de Alfragide, nº 67 Alfrapark, Edifício D, 2610- 008 Amadora Tel: + 351 (0) 21 472 7100 România Abbott Laboratories S. A.
Lietuva Abbott Laboratories Baltics Vienī bas 87h LV-1004, Rī ga Latvija Tel: + 371 67605580
Lietuva Abbott Laboratories Baltics Vienības 87h LV- 1004, Rīga Latvija Tel: + 371 67605580
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /
32 --------------------[perforation to separate from patient information]------------------
34 ……………….. [Perforazzjoni biex tissepara mill- informazzjoni għal pazjent] ………………
The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- mediċina jew fil- qasam tas- saħħa
ADMINISTRATOR’ S INSTRUCTIONS
STRUZZJONIJIET GĦAL MIN SER JAGĦTI L- INJEZZJONI
DO NOT SHAKE VIAL.
TĦAWWADX IL- KUNJETT.
Palivizumab solution should stand at room temperature for a minimum of 20 minutes until the solution clarifies.
Is- soluzzjoni ta ’ Palivizumab għanda toqgħod f’ temperatura tal- kamra għal minimu ta ’ 20 minuta sakemm is- soluzzjoni tiċċara.
Any remaining contents should be discarded after use.
Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa wara l- użu tal - prodott għandu jintrema.
When reconstituted as recommended the final concentration is 100 mg/ ml.
Meta jiġi rikostitwit kif indikat, il- konċentrazzjoni finali tkun ta ’ 100 mg/ ml.
Palivizumab should not be mixed with any medicinal products or diluents other than water for injections.
Palivizumab m’ għandux jitħallat ma’ prodotti mediċinali oħra jew dilwenti ħlief l- ilma għall - injezzjonjiet
Palivizumab is administered once a month intramuscularly, preferably in the anterolateral aspect of the thigh.
Palivizumab jingħata fil- muskolu darba fix- xahar, preferibbilment fil- parti anterolaterali tal- koxxa.
The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve.
Il - muskolu glutejali ma għandhux jiġi użat b’ mod regolari bħala sit fejn tingħata injezzjoni, minħabba r - riskju ta ’ ħsara lin- nerv xjatiku.
Injection volumes over 1 ml should be given as a divided dose.
Meta l - volum ta ’ l- injezzjoni jeċċedi il- 1ml, id- doża għandha tinqasam.
Palivizumab dose per month (ml) = patient weight (kg) x dose (15 mg/ kg) 100 mg/ ml palivizumab
Id- doża ta ’ Palivizumab kull xahar (ml) = il- piż tal- pazjent (kg) x doża (15mg/ kg) 100 mg/ ml palivizumab
For example, for a baby with a bodyweight of 3 kg, the calculation becomes:
Eżempju, għal tarbija b’ piż tal- gisem ta ’ 3kg, il- kalkulazzjoni tinħadem:
100
3 x 15 = 0. 45 ml doża ta ’ palivizumab li għandha tingħata kull xahar 100
33 PACKAGE LEAFLET:
35 FULJETT TA ’ TAGĦRIF:
Synagis 100 mg powder and solvent for solution for injection Palivizumab
Synagis 100 mg trab u solvent għal soluzzjoni għall- injezzjoni Palivizumab
You may need to read it again. − If you have any further questions, ask your doctor or your pharmacist. − This medicine has been prescribed for your child.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
How will my child receive Synagis 6.
Kif għandek tuża Synagis 4.
Possible side effects 7.
Effetti sekondarji li jista ’ jkollu 5.
For your child’ s best protection, it is necessary to take the doctor’ s advice about when to return for additional doses of Synagis.
Għall- aħjar mod ta 'protezzjoni għat- tifel/ tifla tiegħek, huwa neċċessarju li inti timxi fuq il- parir tat- tabib dwar meta għandek terġa ’ tmur biex tingħata dożi addizzjonali ta ’ Synagis.
Your child can then go back to the original planned injections.
Wara dan, it- tifel/ tifla tiegħek ikun/ tkun jista ’ / tista ’ jerġa ’ / terġa ’ lura għat- teħid tal- injezzjoni bil- mod kif oriġinarjament ippjanat.
What should you do if you feel that your child has become ill while being treated with Synagis?
X’ għandek tagħmel jekk tħoss li t- tifel/ tifla tiegħek marad/ mardet waqt li kien/ et qed jiġi/ tiġi kkurat/ a b ’ Synagis?
Common (affects 1 to 10 users in 100):
Komuni (jaffetwaw minn 1 sa 10 pazjenti minn 100):
• • • •
deni; nervi; ħmura jew nefħa fis- sit ta ’ l- injezzjoni; u dijarea.
Uncommon (affects 1 to 10 users in 1000):
Mhux komuni (jaffetwaw minn 1 sa 10 pazjenti minn 1000):
• • • • • • • • • • • • • • •
irjiħat; sogħla; imnieħer iqattar; tħarħir, remettar; raxx; uġigħ; infezzjoni virali; ħruġ ta ’ demm; dgħufija; stitikezza; ngħas;
colds; coughs; runny nose; wheeze; vomiting; rash; pain; viral infection; bleeding; weakness; constipation; drowsiness; hyperactivity; decrease in white blood cell counts; increase in liver function tests which will be seen in blood tests.
37 attività eċċessiva; tnaqqis fl- għadd taċ- celloli bojod; żieda fit- testijiet tal- funzjoni tal- fwied li jidhru fit- testijiet tad- demm.
35
Rari (jaffetwaw minn 1 sa 10 pazjenti minn 10, 000):
Rare (affects 1 to 10 users in 10,000) • a pause in breathing or other breathing difficulties.
pawża fin- nifs jew diffikultajiet oħra biex tieħu n- nifs.
Very rare (affects less than 1 user in 10,000) • severe allergic reactions.
reazzjonijiet allerġiċi serji ħafna.
HOW TO STORE SYNAGIS Keep out of the reach and sight of children
KIF TAĦŻEN SYNAGIS
Do not use Synagis after the expiry date which is stated on the label.
Żomm fejn ma ’ jintlaħaqx u ma ’ jidhirx mit- tfal.
Stored in a refrigerator (2ºC-8°C) until used.
Aħżen Synagis fi friġġ (2°C – 8°C) sakemm jintuża.
- Each vial contains 100 mg palivizumab, providing 100 mg/ml of palivizumab when
Kull kunjett fih 100 mg palivizumab, li jipproduċi 100 mg/ ml ta ’ palivizumab meta jitħallat kif irrakkommandat.
reconstituted as recommended.
- Is- sustanzi l- oħra huma histidine, glycine u mannitol.
What Synagis looks like and contents of the pack Synagis is a white to off-white uniform dry cake in a 10 ml vial.
Synagis huwa trab niexef magħqud u uniformi ta ’ kulur abjad li jagħti fl- abjad maħmuġ f’ kunjett ta ’ 10 ml.
Abbott Laboratories Limited, Queenborough, Kent ME11 5EL, United Kingdom
Abbott Laboratories, Limited Queenborough Kent ME11 5EL Renju Unit
Abbott SRL, I 04010 Campoverde di Aprilia, (Latina) Italy
Abbott SRL I 04011 Campoverde di Aprilia, (Latina) Italja
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
38 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Danmark Abbott Laboratories A/S Emdrupvej 28 C DK-2100 København Ø Tlf: + 45 39 77-00-00
Danmark Abbott Laboratories A/ S Emdrupvej 28C DK 2100 København Ø Tlf: + 45 39 77- 00- 00
Lietuva Abbott Laboratories Baltics Vienības 87h LV-1004, Riga Latvia Tel: + 371 67605580
Lietuva Abbott Laboratories Baltics Vienības 87h LV- 1004, Rīga Latvija Tel: + 371 67605580
This leaflet was last approved in
40 Dan il- fuljett kien approvat l- aħħar f ’
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /
38 --------------------[perforation to separate from patient information]------------------
41 ……………….. [Perforazzjoni biex tissepara mill- informazzjoni għal pazjent] ………………
ADMINISTRATOR’S INSTRUCTIONS
STRUZZJONIJIET GĦAL MIN SER JAGĦTI L- INJEZZJONI
When reconstituted as recommended the final concentration is 100 mg/ml.
Meta jiġi rikostitwit kif indikat, il- konċentrazzjoni finali tkun ta ’ 100 mg/ ml.
Palivizumab should not be mixed with any medicinal products or diluents other than water for injections.
Palivizumab m’ għandux jitħallat ma ’ prodotti mediċinali oħra jew dilwenti ħlief l- ilma għall - injezzjonjiet
Palivizumab dose per month (ml) = patient weight (kg) x dose (15 mg/kg) 100 mg/ml palivizumab
Id- doża ta ’ Palivizumab kull xahar (ml) = il- piż tal- pazjent (kg) x doża (15mg/ kg) 100 mg/ ml palivizumab
3 x 15 = 0.45 ml palivizumab dose per month 100
3 x 15 = 0. 45 ml doża ta ’ palivizumab li għandha tingħata kull xahar 100
Medicated sponge
Sponża medikata
Local use
Użu lokali
Blister (alu)
Folja (alu)
1 sponge of 9.5 x 4.8 cm
Sponża 1 ta ’ 9. 5 x 4. 8 ċm
2 sponges of 4.8 x 4.8 cm
2 sponoż ta ’ 4. 8 x 4. 8 ċm
1 sponge of 3.0 x 2.5 cm
Sponża 1 ta ’ 3. 0 x 2. 5 ċm
5 sponges of 3.0 x 2.5 cm
5 sponoż ta ’ 3. 0 x 2. 5 ċm
TachoSil medicated sponge.
TachoSil sponża medikata.
Qualitative and Quantitative composition:
Għamla kwalitattiva u kwantitattiva:
TachoSil contains per cm2:
Għal kull ċm2, TachoSil fiha:
Human Fibrinogen Human Thrombin
Fibrinogen tal- bniedem 5. 5 mg Thrombin tal- bniedem
5.5 mg 2.0 IU
2. 0 IU
Medicated sponge TachoSil is an off-white sponge.
TachoSil hija sponża ta ’ kulur offwajt.
The active side of the sponge, which is coated with fibrinogen and thrombin, is marked by a yellow colour.
In- naħa attiva ta ’ l- isponża, li hija miksija b’ fibrinogen u bi thrombin, hija mmarkata b’ kulur isfar.
TachoSil is indicated for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient (see section 5.1).
TachoSil hija indikata għal trattament ta ’ sostenn fil- kirurġija għal titjib ta ’ l- emostasi, sabiex jiġi inkoraġġut l- għeluq ta ’ tessuti korporali u għal sostenn ta ’ punti f’ kirurġija vaskulari meta l- metodi ta ’ teknika standard ma jkunux biżżejjed (ara sezzjoni 5. 1).
4.2 Posology and method of administration
4. 2 Pożoloġija u metodu ta ’ kif għandu jintuża
Posology The use of TachoSil is restricted to experienced surgeons.
Pożoloġija L- użu ta ’ TachoSil huwa ristrett għal kirurgi b’ esperjenza.
There is insufficient information for use in paediatric patients.
M’ hemmx biżżejjed informazzjoni dwar l- użu fit- tfal.
The number of TachoSil sponges to be applied should always be oriented towards the underlying clinical need for the patient.
In- numru ta ’ sponoż TachoSil li għandhom jintużaw għandu dejjem ikun iffukat fuq il- ħtieġa klinika tal - pazjent.
The number of TachoSil sponges to be applied is governed by the size of the wound area.
In- numru ta ’ sponoż TachoSil li għandhom jintużaw jiddependi mid- daqs taż- żona tal- ferita.
Application of TachoSil must be individualised by the treating surgeon.
L- applikazzjoni ta ’ TachoSil għandha tkun individwalizzata mill- kirurgu li jkun qiegħed japplika t - trattament.
In clinical trials, the individual dosages have typically ranged from 1-3 sponges (9.5 cm x 4.8 cm); application of up to 7 sponges has been reported.
Fil- provi kliniċi, id- dożi individwali normalment varjaw bejn sponża waħda sa tlieta (9. 5 ċm x 4. 8 ċm); ġiet irrappurtata applikazzjoni b’ 7 sponoż.
For smaller wounds, e. g. in minimal invasive surgery the smaller size sponges (4.8 cm x 4.8 cm or 3.0 cm x 2.5 cm) are recommended.
Għal feriti iżgħar, eż. f’ kirurġija invażiva minima, huma rrakkomandati l- isponoż ta ’ daqs iżgħar (4. 8 ċm x 4. 8 ċm jew 3. 0 ċm x 2. 5 ċm).
Method and route of administration For local use only.
Metodu ta ’ kif u mnejn għandu jingħata Għal użu lokali biss.
See section 6.6 for more detailed instructions.
Ara sezzjoni 6. 6 għal struzzjonijiet aktar dettaljati.
2 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
For local use only.
Għal użu lokali biss.
Do not use intravascularly.
Tużahiex b’ mod intravaskulari.
Specific data have not been obtained on the use of this product in neurosurgery or in gastrointestinal anastomoses surgery.
Ma ġietx miksuba informazzjoni speċifika dwar l- użu ta ’ dan il- prodott fin- newrokirurġija jew fil- kirurġija ta ’ anastomożi gastrointestinali.
Life threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly.
Jistgħu jseħħu kumplikazzjonijiet trombo- emboliċi li jkunu ta ’ periklu għall- ħajja jekk il- preparazzjoni bi żball tiġi applikata b’ mod intravaskulari.
As with any protein product, allergic type hypersensitivity reactions are possible.
Bħalma jista ’ jiġri b’ kull prodott li fih il- proteini, jista ’ jkun hemm reazzjonijiet ta ’ sensittività eċċessiva tat - tip allerġiċi.
Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Is- sinjali ta ’ reazzjonijiet ta ’ sensittività eċċessiva jinkludu ħorriqija, urtikarja ġeneralizzata, tagħfis fis- sider, tħarħir, pressjoni baxxa u anafilassi.
In case of shock, the current medical standards for shock treatment should be observed.
F’ każ ta ’ xokk, għandhom jiġu osservati l- istandards mediċi kurrenti għal trattament ta ’ xokk.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.
Miżuri standard għall- prevenzjoni ta ’ infezzjonijiet li jirriżultaw mill- użu ta ’ prodotti mediċinali mħejjija mid- demm jew mill- plażma tal- bniedem jinkludu l- għażla tad- donaturi, eżaminazzjoni tad- donazzjonijiet individwali u tal- ġabriet ta ’ plażma għal markers speċifiċi ta ’ infezzjoni u l- inklużjoni ta ’ fażijiet effettivi ta ’ manifattura għall- inattivazzjoni/ tneħħija tal- viruses.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Minkejja dan, meta jiġu amministrati prodotti mediċinali mħejjija mid- demm jew mill- plażma tal- bniedem, il- possibilità li jiġu trasmessi aġenti infettivi ma tistax tiġi eskluża għal kollox.
This also applies to unknown or emerging viruses and other pathogens.
Dan japplika wkoll għal viruses u patoġeni oħra mhux magħrufa jew li għadhom qed jiżviluppaw.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV.
Il- miżuri meħuda jitqiesu li huma effettivi għal enveloped viruses bħall- HIV, HBV u HCV u għall- virus HAV li mhux enveloped.
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Il- miżuri meħuda jistgħu jkunu ta ’ valur limitat kontra non- enveloped viruses bħall- parvovirus B19.
Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e. g. haemolytic anaemia).
L- infezzjoni tal- parvovirus B19 tista ’ tkun serja għal nisa tqal (infezzjoni tal- fetu) u għal individwi b’ immunodefiċjenza jew eritropojeżi miżjuda (eż. anemija emolitika).
It is strongly recommended that every time that TachoSil is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Huwa rrakkomandat ħafna li kull darba li TachoSil tiġi amministrata lil pazjent, l- isem u n- numru tal- lott tal - prodott jiġu rreġistrati sabiex tinżamm konnessjoni bejn il- pazjent u l- lott tal- prodott.
No formal interaction studies have been performed.
Ma sarux studji formali dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott.
Similar to comparable products or thrombin solutions, the sealant may be denaturated after exposure to solutions containing alcohol, iodine or heavy metals (e. g. antiseptic solutions).
Bħalma jiġri bi prodotti komparabbli jew b’ soluzzjonijiet ta ’ thrombin, is- siġillant jista ’ jitħassar wara esponiment għal soluzzjonijiet li fihom l- alkoħol, il- jodju jew metalli tqal (eż. soluzzjonijiet antisettiċi).
Such substances should be removed to the greatest possible extent before applying the sealant.
Sustanzi bħal dawn għandhom jitneħħew kemm jista ’ jkun, qabel ma jiġi applikat is- siġillant.