qanastek/EMEA-V3 huggingface dataset:
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ Ġestjoni tar- Riskji Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu li jwettaq l- istudji u l - attivitajiet addizzjonali ta ’ farmakoviġilanza dettaljati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil - verżjoni 3. 0 tal- Pjan ta ’ Ġestjoni tar- Riskji (RMP) ppreżentat fil- Modulu 1. 8. 2. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġornamenti suċċessivi miftiehma mill - CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tal- CHMP dwar is- Sistemi ta ’ Ġestjoni tar- Riskji għal prodotti mediċinali għal prodotti mediċinali li jintużaw mill- bniedem, il- Pjan aġġornat ta ’ Ġestjoni tar- Riskji għandu jiġi sottomess fl- istess ħin tar- Rapport ta ’ Aġġornament Perjodiku li jmiss dwar is- Sigurtà (PSUR).
In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.
Barra minn hekk, għandu jiġi ppreżentat RMP: • Meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni attwali tas - Sigurtà, il- Pjan ta ’ Farmakoviġilanza jew l- attivitajiet għat- tnaqqis tar- riskji • Fi żmien 60 jum minn meta jinkiseb riżultat importanti (farmakoviġilanza jew tnaqqis tar - riskji) • Fuq talba ta ’ l- EMEA.
56 ANNEX III
60 ANNESS III
{HDPE BOTTLE OUTER CARTON - 12.5 MG CAPSULES}
62 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA {Pakkett ta ’ Barra Flixkun HDPE - 12. 5 mg kapsuli}
SUTENT 12.5 mg hard capsules Sunitinib
SUTENT 12. 5 mg kapsuli iebsin Sunitinib
Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib
Kull kapsula fiha sunitinib malate, ekwivalenti għal 12. 5 mg ta ’ sunitinib
Ingredients of the capsules include mannitol and propylene glycol
Is- sustanza tal- kapsuli jinkludu mannitol u propylene glycol
Use only as directed by a doctor
Uża biss hekk kif jgħidlek it- tabib
This medicinal product does not require any special storage conditions
Dan il- prodott mediċinali ma jeħtieġ ebda kundizzjoni speċjali ta ’ ħżin
Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ Ir- Renju Unit
Batch
< Lott > numru}
60 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {HDPE BOTTLE – 12.5 MG CAPSULES}
64 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN {Flixkun Tal- HDPE – 12. 5 mg kapsuli}
SUTENT 12.5 mg hard capsules Sunitinib Oral use
SUTENT 12. 5 mg kapsuli iebsin sunitinib Użu orali
EXP
< JIS >
Batch
< Lott > < {numru}
{HDPE BOTTLE OUTER CARTON - 25 MG CAPSULES}
65 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA (PAKKETT TA ’ BARRA FLIXKUN HDPE – 25 mg KAPSULI)
SUTENT 25 mg hard capsules Sunitinib
SUTENT 25 mg kapsuli iebsin Sunitinib
Each capsule contains sunitinib malate, equivalent to 25.0 mg of sunitinib
Kull kapsula fiha sunitinib malate, ekwivalenti għal 25. 0 mg ta ’ sunitinib
Ingredients of the capsules include mannitol and propylene glycol
Is- sustanzi tal- kapsuli jinkludu mannitol u propylene glycol
Use only as directed by a doctor
Uża biss skond kif jgħidlek it- tabib
Batch
< Lott > {numru}
63 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {HDPE BOTTLE – 25 MG CAPSULES}
67 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN {FLIXKUN TAL- HDPE – 25 mg KAPSULI}
SUTENT 25 mg hard capsules Sunitinib Oral use
SUTENT 25 mg kapsuli iebsin Sunitnib Użu orali
{HDPE BOTTLE OUTER CARTON - 50 MG CAPSULES}
68 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA {PAKKETT TA ’ BARRA FLIXKUN HDPE – 50 mg KAPSULI}
SUTENT 50 mg hard capsules Sunitinib
SUTENT 50 mg kapsuli iebsin Sunitinib
Each capsule contains sunitinib malate, equivalent to 50.0 mg of sunitinib
Kull kapsula fiha sunitinib malate, ekwivalenti għal 50. 0 mg ta ’ sunitinib.
Ingredients of the capsules include mannitol and propylene glycol
Is- sustanzi tal- kapsuli jinkludu mannitol u propylene glycol.
66 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {HDPE BOTTLE – 50 MG CAPSULES}
70 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN {FLIXKUN TAL- HDPE – 50 mg KAPSULI}
SUTENT 50 mg hard capsules Sunitinib Oral use
SUTENT 50 mg kapsuli iebsin, Sunitinib Użu orali
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING< AND > < THE IMMEDIATE PACKAGING>
71 TAGĦRIF LI GĦANDU JIDHER FUQ < IL- PAKKETT TA ’ BARRA > < U > < IL- PAKKETT LI JMISS MAL- PRODOTT >
{ACLAR/ PVC BLISTER OUTER CARTON - 12.5 MG CAPSULES}
{PAKKETT TA ’ BARRA B’ FOLJA ACLAR/ PVC - 12. 5 MG KAPSULA}
SUTENT 12.5 mg hard capsules Sunitinib
SUTENT 12. 5 mg kapsuli iebsin, Sunitinib
Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib
Kull kapsula fiha sunitinib malate, ekwivalenti għal 12. 5mg ta ’ sunitinib.
28 hard capsules
28 kapsula iebsa
69 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
73 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
{ACLAR/ PVC BLISTER – 12.5 MG CAPSULES}
{FOLJA TA ’ ACLAR/ PVC – 12. 5 MG KAPSULI}
MON TUE WED THU FRI SAT SUN
MON TUE WED THU FRI SAT SUN
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING< AND > < THE IMMEDIATE PACKAGING>
74 TAGĦRIF LI GĦANDU JIDHER FUQ < IL- PAKKETT TA ’ BARRA > < U > < IL- PAKKETT LI JMISS MAL- PRODOTT >
{ACLAR/ PVC BLISTER OUTER CARTON - 25 MG CAPSULES}
{PAKKETT TA ’ BARRA B’ FOLJA ACLAR/ PVC – 25 MG KAPSULA}
SUTENT 25 mg hard capsules Sunitinib
SUTENT 25 mg kapsuli iebsin, Sunitinib
Each capsule contains sunitinib malate, equivalent to 25.0 mg of sunitinib
Kull kapsula fiha sunitinib malate, ekwivalenti għal 25mg ta ’ sunitinib.
72 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
76 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
{ACLAR/ PVC BLISTER – 25 MG CAPSULES}
{FOLJA TA ’ ACLAR/ PVC – 25MG KAPSULI}
SUTENT 25 mg hard capsules Sunitinib
SUTENT 25mg kapsuli iebsin, Sunitinib
Pfizer Ltd
Pfizer Ltd.
73 PARTICULARS TO APPEAR ON THE OUTER PACKAGING< AND > < THE IMMEDIATE PACKAGING>
77 TAGĦRIF LI GĦANDU JIDHER FUQ < IL- PAKKETT TA ’ BARRA > < U > < IL- PAKKETT LI JMISS MAL- PRODOTT >
{ACLAR/ PVC BLISTER OUTER CARTON - 50 MG CAPSULES}
{FOLJA TA ’ ACLAR/ PVC – 50MG KAPSULI}
SUTENT 50 mg hard capsules Sunitinib
SUTENT 50mg kapsuli iebsin, Sunitinib
Each capsule contains sunitinib malate, equivalent to 50.0 mg of sunitinib
Kull kapsula fiha sunitinib malate, ekwivalenti għal 50. 0 mg sunitinib
Read the package leaflet before use
Użu orali Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ Ir- Renju Unit
SUTENT 50 mg
SUTENT 50mg
75 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
79 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
{ACLAR/ PVC BLISTER – 50 MG CAPSULES}
{FOLJA TA ’ ACLAR/ PVC – 50 MG KAPSULI}
77 PACKAGE LEAFLET:
81 FULJETT TA ’ TAGĦRIF:
SUTENT 12.5 mg hard capsules SUTENT 25 mg hard capsules SUTENT 50 mg hard capsules Sunitinib Malate
SUTENT 12. 5 mg kapsuli iebsin SUTENT 25 mg kapsuli iebsin SUTENT 50 mg kapsuli iebsin Sunitinib Malate
Read all of this leaflet carefully before you start taking this medicine.
Aqra dan il- fuljett qabel tibda tieħu din il- mediċina.
- If you have any further questions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet staqsi lit- tabib jew lill- ispiżjar tiegħek.
Do not pass it on to others.
TAGĦTIIHIEX lil persuni oħra.
symptoms are the same as yours.
ħsara, anke jekk ikollhom l- istess sintomi bħal tiegħek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
- Jekk xi wieħed mill- effetti jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
tell your doctor.
imsemmijin f’ dan il- fuljett, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
What SUTENT is and what it is used for 2.
X’ inhu SUTENT u għalxiex jintuża 2.
Before you take SUTENT 3.
Qabel ma tieħu SUTENT 3.
How to take SUTENT 4.
Kif għandek tieħu SUTENT 4.
How to store SUTENT 6.
Kif taħżen SUTENT 6.
WHAT SUTENT IS AND WHAT IT IS USED FOR
X’ INHU SUTENT U GĦALXIEX JINTUŻA
SUTENT is a medicinal product used to treat cancer by preventing the activity of a special group of proteins which are known to be involved in the growth and spread of cancer cells.
SUTENT huwa prodott mediċinali li jintuża biex jittratta l- kanċer billi jimpedixxi l- attività ta ’ grupp ta ’ proteini speċjali li huma magħrufa li huma involuti fl- iżvilupp u t- tifrix ta ’ ċelloli tal- kanċer.
SUTENT will only be prescribed to you by a doctor with experience in medicines to treat renal cell cancer or gastrointestinal stromal tumours.
SUTENT jingħatalek biss fuq riċetta minn tabib b’ esperjenza f’ mediċini li jittrattaw il- kanċer taċ- ċellola renali jew tumuri stromali gastrointestinali.
SUTENT is a medicinal product used in the treatment of renal cell carcinoma, a form of kidney cancer that involves cancerous changes in the cells of the renal tubule.
SUTENT huwa prodott mediċinali użat fit- trattament ta ’ karċinoma taċ- ċellola renali, forma ta ’ kanċer tal- kilwa li jinvolvi bidliet kanċerużi fiċ- ċelloli tat- tubulu renali.
SUTENT is also used in the treatment of malignant gastrointestinal stromal tumour (GIST).
SUTENT huwa użat ukoll fit- trattament ta ’ tumur stromali gastrointestinali (GIST) malinn.
GIST is a cancer of the stomach and bowels.
GIST huwa kanċer ta ’ l- istonku u l- imsaren.
It arises from uncontrolled cell growth of the supporting tissues of these organs.
Huwa jifforma minn żvilupp mhux ikkontrollat ta ’ ċelloli tat - tessuti ta ’ sapport ta ’ dawn l- organi.
SUTENT inhibits the growth of these cells.
SUTENT jimpedixxi l- iżvilupp ta ’ dawn iċ- ċelloli.
If you have any questions about how SUTENT works or why this medicine has been prescribed for you, ask your doctor.
Jekk għandek xi mistoqsijiet fuq kif jaħdem SUTENT jew għaliex din il- mediċina ġiet mgħotija lilek b’ riċetta, staqsi lit- tabib tiegħek.
BEFORE YOU TAKE SUTENT
QABEL MA TIEĦU SUTENT
Follow all your doctor’ s instructions carefully, even if they differ from the general information contained in this leaflet
Segwi bir- reqqa l- istruzzjonijiet kollha tat- tabib tiegħek, anke jekk huma differenti mit- tagħrif ġenerali li fih dan il- fuljett.
Do not take SUTENT
Tieħux SUTENT:
- If you are allergic to sunitinib or any of the other ingredients of SUTENT.
Jekk inti allerġiku għal sunitinib jew kwalunkwé mill- ingredjenti l- oħra ta ’ SUTENT.
Take special care with SUTENT
Oqgħod attent ħafna b’ SUTENT:
- If you have or had liver or kidney problems
- Jekk għandek jew kellek problemi fil- fwied jew fil- kliewi
- If you have high blood pressure
- Jekk għandek pressjoni għolja
- If you have an underactive thyroid gland before starting treatment with Sutent, or if your thyroid
- Jekk għandek il- glandola tat- tirojd ipoattiva qabel ma tibda trattament b’ Sutent, jew jekk il -
gland becomes less active during treatment
glandola tat- tirojd ssir anqas attiva waqt it- trattament.
- If you have an abnormality of your heart trace known as Prolonged QT interval
- Jekk għandek rittmu tal- qalb li mhux normali, mgħaruf bħala intervall QT imtawwal
- If you are pregnant or think you may be (see details below)
- Jekk inti tqila jew taħseb li tista ’ tkun (ara dettalji hawn taħt)
- If you are breast-feeding (see detail below)
- Jekk qed treddgħa (ara dettal hawn taħt)
If any of those apply to you, tell you doctor before you take SUTENT
Jekk xi waħda minn dawn tapplika għalik, għid lit- tabib tiegħek qabel ma tieħu SUTENT
Taking other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed, including herbal medicines (, any medicines that could increase SUTENT concentration like ketoconazole, ritonavir, itraconazole, erythromycin, clarithromycin; or any medicines that could decrease SUTENT concentration like dexamethasone, pheytoin, carbamazepine rifampin, phenobarbital or Hypericum perforatum known also as St.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anke dawk mingħajr riċetta, inklużi mediċini erbali (kwalunkwé mediċini li jistgħu jżiedu l- konċentrazzjoni ta ’ SUTENT bħal ketoconazole, ritonavir, itraconazole, erythromycin, clarithromycin; jew kwalunkwé mediċini li jistgħu jnaqqsu l- konċentrazzjoni ta ’ SUTENT bħal dexamethasone, pheytoin, carbamazepine rifampin, phenobarbital jew Hypericum perforatum magħrufa wkoll bħala St.
John’ s Wort).
John’ s Wort).
Taking SUTENT with food and drink SUTENT can be taken with or without food; however do not take SUTENT with grapefruit juice.
Meta tieħu SUTENT ma ’ l- ikel jew xorb SUTENT jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt; madankollu tieħux SUTENT mal- meraq tal - grejpfrut.
Pregnancy and breast-feeding If you are pregnant or think you may be, tell your doctor.
Tqala u treddigħ Jekk inti tqila jew taħseb li tista ’ tkun, għid lit- tabib tiegħek.
SUTENT is not to be used during pregnancy unless clearly necessary.
SUTENT m’ għandux jintuża waqt it- tqala sakemm ma jkunx meħtieġ tagħmel hekk.
Your doctor will discuss with you the potential risk of taking SUTENT during pregnancy.
It- tabib tiegħek għandu jiddiskuti miegħek ir- riskju potenzjali tat- teħid ta ’ SUTENT waqt it- tqala.
Women who might get pregnant are advised to use effective contraception during treatment with SUTENT.
Nisa li jistgħu jinqabdu tqal huma avżati biex jużaw kontraċezzjoni effettiva waqt trattament b’ SUTENT.
If you are breast-feeding, tell your doctor.
Jekk tkun qed tredda ’, għid lit- tabib tiegħek.
Do not breast-feed during treatment with SUTENT.
Treddgħax waqt trattament b’ SUTENT.
Driving and using machines If you experience dizziness or you feel unusually tired, take special care when driving or using machines.
Jekk tħoss sturdament jew tħoss għeja mhux tas- soltu, agħti attenzjoni speċjali waqt is- sewqan jew tħaddim ta ’ magni.
HOW TO TAKE SUTENT
KIF GĦANDEK TIEĦU SUTENT
Your doctor will prescribe a dose that is right for you.
It- tabib tiegħek jagħtik doża li tkun tgħodd għalik.
It is recommended that SUTENT be taken for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (no medicine) given as a 6-weeks cycle.
Huwa rrakkomandat li SUTENT jittieħed għal 28 jum (4 ġimgħat), segwiti minn 14- il jum (2 ġimgħat) ta ’ mistrieħ (mingħajr mediċina) mogħti bħala ċiklu ta ’ 6- ġimgħat.
Your doctor will determine how many cycles of treatment you will need.
It- tabib tiegħek jidditermina kemm il- ċiklu ta ’ trattament ikollok bżonn.
If you take more SUTENT than you should If you have accidentally taken too many capsules, talk to your doctor straight away.
Jekk tieħu SUTENT aktar milli suppost Jekk aċċidentalment ħadt aktar kapsuli milli suppost, kellem lit- tabib tiegħek minnufih.
You may require medical attention.
Tista ’ teħtieġ attenzjoni medika.
If you forget to take SUTENT Do not take a double dose to make up for a forgotten dose.
Jekk tinsa tieħu SUTENT M’ għandekx tieħu doża doppja biex tpatti għal doża li tkun insejt tieħu.
Like all medicines, SUTENT can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, SUTENT jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very commonly reported side effects, likely to affect more than 10 in 100 people:
Effetti sekondarji rrapportati komunement ħafna, li x’ aktarx jeffettwaw aktar minn 10 f’ kull 100 persuna: • uġigħ / irritazzjoni fil- ħalq, uġigħ fil- ħalq, disturbi tat- togħma, stonku mħawwad, dardir, remettar, dijarea, stitikezza, uġigħ addominali, tnaqqis fl- aptit, telf tas- saħħa
• mouth pain/ irritation, mouth soreness, taste disturbances, upset stomach, nausea, vomiting, diarrhoea, constipation, abdominal pain, loss/ decrease of appetite, loss of strength • Yellow skin/ skin discoloration, hair colour change, rash on the palms of the hands and soles of the feet, blisters, rash, dryness of the skin • tiredness, high blood pressure, migraine • reduction in the number of: red blood cells and / or white blood cells
83 • ġilda safra/ tibdil fil- kulur tal- ġilda, bidla fil- kulur tax- xagħar, raxx fil- qiegħan ta ’ l- idejn u s - saqajn, nfafet, raxx, xuttaġni tal- ġilda • għejja, pressjoni għolja, emigranja • tnaqqis fl- għadd ta’ ċelloli tad- demm ħomor u/ jew ċelloli tad- demm bojod
• decreased activity of the thyroid gland • reduced ability of the heart to pump blood • nose bleeding, abnormally coloured urine, excessive tears flow • joint pain, muscular pain, excessive fluids in tissues including the eye area • abnormal sensation of the skin, shortness of breath • hair loss, weight loss • depression • difficulty in falling asleep
Effetti sekondarji oħra possibbli, li x’ aktarx jeffettwaw bejn 1 u 10 f’ kull 100 persuna: • attività mnaqqsa tal- glandola tirojde • tnaqqis fil- funzjoni tal- qalb li tippompja d- demm • fġir, kulur mhux tas- soltu ta ’ l- awrina, ħruġ eċċessiv ta ’ dmugħ • uġigħ fil- ġoġi, uġigħ muskolari, eċċess ta ’ fluwidi fit- tessuti nkluż l- erja ta ’ l- għajn • sensazzjoni annormali tal- ġilda, qtugħ ta ’ nifs • telf ta ’ xagħar, telf ta ’ piż • depressjoni • diffikultà biex torqod
If any of the side effect gets serious or if you notice any side effect not listed in this leaflet, please tell 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 SUTENT
KIF TAĦŻEN SUTENT
- Keep out of reach and sight of children
- Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal
- This medicinal product does not require any special storage conditions
- Dan il- prodott mediċinali ma jeħtieġx xi kundizzjonijiet ta ’ ħażna speċjali
- Do not use after the expiry date (EXP) which is stated on the outer pack and label
- Tużax wara d- data ta ’ skadenza (EXP) li tidher fuq il- pakkett ta ’ barra u t- tiketta
- Do not use any pack that is damaged or shows signs of tampering
- Tużax l- ebda pakkett li jkollu xi ħsara jew juri sinjali ta ’ tbagħbis
What SUTENT contains
X’ fih SUTENT
- The active substance is sunitinib (as malate salt)
- Is- sustanza attiva hija sunitinib (bħala melħ ta ’ malate)
- The other ingredients is are
- Is- sustanzi l- oħra huma
SUTENT 12.5 mg hard capsule Mannitol, croscarmellose sodium, povidone and magnesium stearate The capsule shell is composed of gelatin, red iron oxide (E 172) and titanium dioxide (E 171).
Mannitol, croscarmellose sodium, povidone u magnesium stearate Il- qoxra tal- kapsula hija magħmula minn ġelatina, red iron oxide (E 172) u titanium dioxide (E 171).
The imprinting ink contains shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide (E171).
Il- linka ta ’ l- ittimbrar fiha shellac, propylene glycol, sodium hydroxide, povidone u titanium dioxide (E171).
SUTENT 25 mg hard capsule Mannitol, croscarmellose sodium, povidone and magnesium stearate The capsule shell is composed of gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172), black iron oxide (E172).
SUTENT 25 mg kapsula iebsa Mannitol, croscarmellose sodium, povidone u magnesium stearate Il- qoxra tal- kapsula hija magħmula minn ġelatina, red iron oxide (E 172) u titanium dioxide (E 171).
SUTENT 50 mg hard capsule Mannitol, croscarmellose sodium, povidone and magnesium stearate The capsule shell is composed of gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172) and black iron oxide (E172).
SUTENT 50 mg kapsula iebsa Mannitol, croscarmellose sodium, povidone u magnesium stearate Il- qoxra tal- kapsula hija magħmula minn ġelatina, red iron oxide (E 172) u titanium dioxide (E 171).
80 What SUTENT looks like and contents of the pack SUTENT 12.5 mg is supplied as hard gelatin capsules with orange cap and orange body, printed with white ink “ Pfizer” on the cap, “ STN 12,5 mg” on the body.
Jiġi fi fliexken ta ’ 30 pillola.
SUTENT 25 mg is supplied as hard gelatin capsules with caramel cap and orange body, printed with white ink “ Pfizer” on the cap, “ STN 25 mg” on the body.
SUTENT 25mg jiġi bħala kapsuli iebsin tal- ġelatina b’ kapp kulur il- karamella u parti ewlenija oranġjo, bil- kelma “ Pfizer ” miktuba b’ linka bajda fuq il- kappa, u “ STN 25mg ” fuq il- parti ewlenija.
SUTENT 50 mg is supplied as hard gelatin capsules with caramel cap and caramel body, printed with white ink “ Pfizer” on the cap, “ STN 50 mg” on the body.
SUTENT 50mg jiġi bħala kapsuli iebsin tal- ġelatina b’ kapp kulur il- karamella u parti ewlenija oranġjo, bil- kelma “ Pfizer ” miktuba b’ linka bajda fuq il- kappa, u “ STN 50mg ” fuq il- parti ewlenija.
It is available in bottles of 30 capsules and in blister packs of 28 capsules (4x7).
Jiġi fi fliexken ta ’ 30 pillola u f’ folji ta ’ 28 kapsula (4x7).
Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom
Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ Ir- Renju Unit
Via del Commercio – Zona Industriale 63046 Marino del Tronto (Ascoli Piceno) Italy
Via del Commercio – Zona Industriale - 63046 Marino del Tronto (Ascoli Piceno) L- Italja
81 Ελλάδα Pfizer Hellas A. E.
85 Ελλάδα Pfizer Hellas A. E.
România Pfizer Romania S. R. L.
Pfizer Romania S. R. L.
Detailed information on this medicine is available on the European Medicine Agency (EMEA) website: http: / /www. emea. europa. eu/.
Dan il- fuljett kien approvat l- aħħar f 'Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta' l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu.
What is Synagis?
X’ inhu Synagis?
Synagis is a powder and solvent, which are made into a solution for injection.
Synagis hu trab u solvent, li jitħalltu biex jiffurmaw soluzzjoni għall- injezzjoni.
It contains 50 mg or 100 mg of the active substance palivizumab.
Jikkonsisti minn 50 mg jew 100 mg tas- sustanza attiva palivizumab.
What is Synagis used for?
Għal x’ hiex jintuża Synagis?
Synagis is used to prevent serious lower respiratory tract (lung) disease caused by respiratory syncytial virus (RSV) that would require hospitalisation.
Synagis jintuża għall- prevenzjoni ta ’ infezzjonijiet serji fil- parti t’ isfel tas- sistema tan- nifs (fil - pulmun) ikkawżati minn respiratory syncytial virus (RSV) li minħabba f’ hekk, il- pazjent ikollu jiddaħħal l- isptar.
Synagis is used in the following groups of children, who are at high risk for this disease: • children who are less than 6 months old and were born prematurely at 35 weeks gestation or less (five or more weeks too early), • children who are less than 2 years of age and have had treatment for bronchopulmonary dysplasia (abnormal lung tissue, usually found babies who were born prematurely) within the last 6 months, • children who are less than 2 years of age and were born with a serious heart disease.
Synagis jintuża għal dawn il- gruppi ta ’ tfal, li jkollhom riskju kbir li jinħakmu minn din il- marda: • tfal ta ’ inqas minn 6 xhur u li kienu twieldu qabel iż- żmien wara 35 ġimgħa fil- ġuf jew inqas (ħames ġimgħat jew iktar qabel iż- żmien), • tfal ta ’ inqas minn sentejn li jkunu ħadu trattament għad- displasja bronkopulmonari (tessut anormali fil- pulmun, li ġeneralment jinstab fi trabi li jkunu twieldu qabel iż- żmien) fl- aħħar sitt xhur, • tfal ta ’ inqas minn sentejn u li jkunu twieldu b’ marda serja f’ qalbhom.
How is Synagis used?
Kif jintuża Synagis?
Synagis is given once a month when there is a risk of RSV infection in the community: in the northern hemisphere, this is from November to April.
Synagis jingħata darba f’ xahar meta jkun hemm riskju ta ’ infezzjoni ta ’ l- RSV fil- komunità: fl - emisfera tat- tramuntana, dan idum minn Novembru sa April.
If possible, the first dose should be given before this season starts.
Jekk ikun possibbli, l- ewwel doża għandha tingħata qabel ma jibda dan l- istaġun.
Patients generally receive a total of five monthly injections, given as an intramuscular injection (into the muscle of the thigh) at a dose of 15 mg per kilogram body weight.
Il- pazjenti ġeneralment jingħataw total ta ’ ħames injezzjonijiet fil- muskolu tal- koxxa kull xahar b’ doża ta ’ 15- il mg għal kull kilogramma li jiżen il - pazjent.
How does Synagis work?
Kif jaħdem Synagis?
The active substance in Synagis, palivizumab, is a monoclonal antibody.
Is- sustanza attiva f’ Synagis, palivizumab, hu antikorp monoklonali.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells.
L- antikorpi monoklonali huma antikorpi (tip ta ’ proteini) iddisinjati biex jagħrfu u jeħlu ma ’ struttura speċifika (magħrufa bħala antiġen) li tinstab f’ ċerti ċelloli.
Palivizumab has been designed to bind to a protein called ‘ fusion protein A ’ on the surface of RSV.
Palivizumab ġie ddisinjat biex jeħel ma ’ proteina magħrufa bħala ‘ proteina tal- fużjoni A ’ fuq is - superfiċje ta ’ l- RSV.
When palivizumab is bound to the fusion protein, the virus becomes unable to enter the body’ s cells, especially those in the lungs.
Meta palivizumab jeħel mal- proteina tal- fużjoni, il- vajrus ma jkunx jista ’ jidħol fiċ- ċelloli tal- ġisem, speċjalment dawk tal- pulmun.
This helps to prevent RSV infection.
Dan jgħin biex tiġi pprevenuta infezzjoni mill - RSV.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged comparing Synagis with placebo in 1,287 children with congenital (inborn) heart disease.
L- istudju ewlieni fuq Synagis sar fuq 1, 502 itfal b’ riskju għoli u qabbel l- effettività tiegħu ma ’ dak ta ’ plaċebo (trattament finta) matul staġun wieħed ta ’ l- RSV.
In both studies, the main measure of effectiveness was the number of children who had to be admitted to hospital because of RSV infection.
Fiż- żewġ studji, il - mezz ewlieni tal- kejl ta ’ l- effettività kien l- għadd ta ’ tfal li kellhom jiddaħħlu l- isptar minħabba infezzjoni ta ’ l- RSV.
What benefit has Synagis shown during the studies?
X’ inhuma l- benefiċċji ta ’ Synagis li ntwerew f’ dawn l- istudji?
Synagis was more effective than placebo in reducing RSV-related hospitalisations:
Synagis kien iktar effettiv mill- plaċebo biex inaqqas l- għadd ta ’ tfal li kellhom jiddaħħlu l- isptar minħabba infezzjoni bl- RSV:
4.8% of the children who received Synagis were admitted to hospital for RSV infection during the study, compared with 10.6% of those who received placebo.
4. 8% tat- tfal li kienu ngħataw Synagis kellhom jiddaħħlu l- isptar minħabba infezzjoni ta ’ l- RSV matul l- istadju, meta mqabbla ma ’ 10. 6% ta ’ dawk li kienu ngħataw plaċebo.
This was a decrease of 55%.
Dan ifisser tnaqqis ta ’ 55%.
In children with congenital heart disease, there was a reduction of 45%.
Fit- tfal b’ mard konġenitali tal- qalb, kien hemm tnaqqis ta ’ 45%.
What is the risk associated with Synagis?
X’ riskji huma assoċjati ma ’ Synagis?
The most common side effects with Synagis (seen in between 1 and 10 patients in 100) are diarrhoea, fever, injection site reactions (pain and inflammation at the site of injection) and nervousness.
L- iktar effetti sekondarji komuni ma ’ Synagis (li dehru f’ pazjent 1 sa 10 minn kull 100) kienu dijarrea, deni, reazzjonijiet fis- sit ta ’ l- injezzjoni (uġigħ u infjammazzjoni fis- sit ta ’ l- injezzjoni) u nervożiżmu.
For the full list of all side effects reported with Synagis, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrappurtati ma ’ Synagis, ara l- Fuljett ta ’ Tagħrif.
Synagis should not be used in people who may be hypersensitive (allergic) to palivizumab or any of the other ingredients, or to other humanised monoclonal antibodies.
Synagis m’ għandux jintuża minn persuni allerġiċi għal palivizumab jew għal xi sostanza oħra tiegħu, jew għal antikorpi monoklonali oħra.
Why has Synagis been approved?
Għaliex ġie approvat Synagis?
The Committee for Medicinal products for Human Use (CHMP) decided that Synagis’ s benefits are greater than its risks for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by RSV in children at high risk for RSV disease.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Synagis għandu iktar benefiċċji milli riskji fil- prevenzjoni ta ’ mard fin- naħa t’ isfel tas- sistema tan- nifs ikkawżati mill - RSV u li minħabba f’ hekk, tfal b’ mard ta ’ l- RSV ikollhom jiddaħħlu l- isptar.
They recommended that Synagis be given marketing authorisation.
Huma rrakkomandaw li Synagis jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Synagis:
Aktar tagħrif dwar Synagis:
The European Commission granted a marketing authorisation valid throughout the European Union for Synagis to Abbott Laboratories Limited on 13 August 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Synagis lil Abbott Laboratories Limited fit- 13 ta ’ Awwissu 1999.
The marketing authorisation was renewed on 13 August 2004.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fit- 13 ta ’ Awwissu 2004.
The full EPAR for Synagis can be found here.
L- EPAR sħiħ għal Synagis huwa disponibbli minn hawnhekk.
Synagis 50 mg powder and solvent for solution for injection
Synagis 50 mg trab u solvent għal soluzzjoni għall- injezzjoni
Each vial contains 50 mg palivizumab, providing 100 mg/ ml of palivizumab when reconstituted as recommended.
Kull kunjett fih 50 mg palivizumab, li, meta jitħallat kif inhu rrakkommandat, jipproduċi 100 mg/ ml ta ’ palivizumab.
White to off-white uniform dry cake.
Sustanza tat- trab magħquda ta ’ kulur abjad li jagħti fl- abjad maħmuġ.
Synagis is indicated for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease:
Synagis 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:
• 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.
Recommended dose The recommended dose of palivizumab is 15 mg/ kg of body weight, given once a month during anticipated periods of RSV risk in the community.
Doża rakkommandata Id- doża rakkomandata ta ’ palivizumab hija ta ’ 15 mg/ kg tal- piż tal- ġisem, li għandha tingħata darba fix- xahar matul il- perijodi antiċipati bħala ta ’ riskju għall- kommunita ’ li jaqbadhom RSV.
Where possible, the first dose should be administered prior to commencement of the RSV season.
Fejn hu possibbli l- ewwel doża għandha tingħata qabel il- bidu tal- istaġun ta ’ RSV.
Subsequent doses should be administered monthly throughout the RSV season.
Dożi sussegwenti għandhom jingħataw kull xahar matul l- istaġun ta ’ RSV.
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).
Il- maġġor parti tal- esperjenza miksuba b’ palivizumab li tinkudi l- provi klinici ta ’ fażi III, inġabret b ’ 5 injezzjonijiet li ngħataw fi staġun wieħed (ara sezzjoni 5. 1).
Data, although limited, are available on greater than 5 doses (see sections 4.8 and 5.1), therefore the benefit in terms of protection beyond 5 doses has not been established.
Għalkemm it- tagħrif hu limitat, tista ’ ssibu għal aktar min ħames dożi (ara sezzjonijiet 4. 8 u 5. 1), għalhekk il- benefiċċju rigward il - protezzjoni b’ aktar minn 5 dożi għadu ma ġiex stabbilit.
To reduce risk of rehospitalisation, it is recommended that children receiving palivizumab who are hospitalised with RSV continue to receive monthly doses of palivizumab for the duration of the RSV season.
Biex wieħed inaqqas ir- riskju li jkollhom jerġgħu jiddaħħlu l- isptar, huwa rakkomandat li tfal li jkun qed jingħataw palivizumab u li jinsabu fl- isptar bl- RSV, jibqgħu jirċievu dożi ta ’ palivizumb kull xahar, tul l- istaġun ta ’ RSV.
For children undergoing cardiac bypass, it is recommended that a 15 mg/ kg of body weight injection of palivizumab be administered as soon as stable after surgery to ensure adequate palivizumab serum levels.
Għal tfal li jkunu se jiġu operati għall baypas kardijaku, sabiex wieħed jassigura livelli adegwati ta ’ palivizumab fis- serum, huwa rakkomandat li tingħatalhom injezzjoni ta ’ palivizumab ta ’ 15 mg/ kg ta ’ piż tal- ġisem, meta jkunu fi stat stabbli wara l- intervent kirurġiku.
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).
(ara sezzjoni 5. 2).
2 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.
2 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.
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.
The injection should be given using standard aseptic technique.
L- injezzjoni għandha tingħata bil- metodu aseptiku standard.
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.
For information on reconstituting Synagis, see section 6.6.
Għal informazzjoni biex jiġi rikostitwit Synagis ara sezzjoni 6. 6.
Known hypersensitivity to the active substance or to any of the excipients (see section 6.1), or other humanised monoclonal antibodies.
Huwa magħruf li teżisti sensittività eċċessiva għas- sustanza attiva jew għal xi waħda mis- sustanzi mhux attivi (ara sezzjoni 6. 1), jew għal anti- korpi monklonali umaniżżati oħra.
Allergic reactions including very rare cases of anaphylaxis have been reported following palivizumab administration (see section 4.8).
Meta ngħata palivizumab ġew irrapurtati reazzjonijiet allergiċi, inlkużi każi rari ħafna ta ’ anafilassi (ara sezzjoni 4. 8).
Medicinal products for the treatment of severe hypersensitivity reactions, including anaphylaxis, should be available for immediate use following administration of palivizumab.
Prodotti mediċinali għall- kura ta ’ reazzjonijiet severi ta ’ ipersensittivita, inkluża l- anafilassi, għandhom ikunu disponibbli għall- użu immedjat, wara li jingħata palivizumab.
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.
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.
A mild febrile illness, such as mild upper respiratory infection, is not usually reason to defer administration of palivizumab.
Marda ħafifa bid- deni bħal infezzjoni ħafifa fil- passaġġ respiratorju ta ’ fuq, generalment ma hijiex raġuni li tiġġustifika l- posponiment ta ’ palivizumab.
As with any intramuscular injection, palivizumab should be given with caution to patients with thrombocytopaenia or any coagulation disorder.
Bħal fil- każ ta ’ kull injezzjoni li tingħata fil- muskolu, palivizumab għandu jingħata b’ kawtela f’ pazjenti li jbatu minn tromboċitopenija jew għandhom xi problema ta ’ koagulazzjoni.
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.
L- effikaċja ta ’ palivizumab, meta dan jingħata lill pazjenti bħala t- tieni kors ta ’ kura matul l- istaġun ta ’ RSV ta ’ wara, ma gietx formalment investigata fi studju speċifikament magħmul għal dan il- għan.
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.
Il- possibilita ’ ta ’ riskju ta ’ infezzjoni aktar intensa fl- istaġun ta ’ wara l- istaġun li fih l- pazjenti jkunu ġew ittrattati b’ palivizumab, ma gietx eliminata definittivament mill- istudji li saru speċifikatament biex jipprovdu risposta għal dan il- punt partikolari.
No formal interactions studies with other medicinal products were conducted, however no interactions have been described to date.
Għalkemm ma sar l- ebda studju formali dwar l- interazzjonijiet ma ’ prodotti mediċinali oħra, sa llum ma ġew deskritti l- ebda interazzjonijiet.
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.
Fil- fażi III ta ’ l- istudju 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 il- prodotti.
Since the monoclonal antibody is specific for RSV, palivizumab is not expected to interfere with the immune response to vaccines.
Peress li l- anti- korp monoklonali hu specifiku għal RSV, palivizumab ma huwiex mistenni li jfixkel ir- rispons ta ’ immunita ’ għat- tilqim.
Synagis is not indicated for use in adults.
Synagis m’ huwiex indikat għall- użu minn persuni adulti.
Data on pregnancy and lactation are not available.
M’ hemmx tagħrif dwar l - użu fi tqala u t- treddiegħ.
Adverse drug reactions (ADRs) reported in the prophylactic paediatric studies were similar in the placebo and palivizumab groups.
Reazzjonijiet avversi għall- mediċini (ADRs) li kienu rrapurtati fl- istudju profilattiku fuq pazjenti pedjatriċi kienu simili fil- gruppi tal- plaċebo u ta ’ palivizumab.
The majority of ADRs were transient and mild to moderate in severity.
Il- maġġoranza tal- ADRs kienu ta ’ natura li jgħaddu malajr u li jvarjaw minn ħafif għall- moderat fis- severita ’ tagħhom.
Adverse events at least possibly causally-related to palivizumab, both clinical and laboratory, are displayed by system organ class and frequency (common ≥ 1/ 100 to < 1/ 10; uncommon ≥ 1/ 1,000 to < 1/ 100) in studies conducted in premature and bronchopulmonary dysplasia paediatric patients, and congenital heart disease patients (Tables 1 and 2, respectively).
Sitwazzjonijiet 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 ≥1/ 100 sa < 1/ 10; mhux komuni ≥1/ 1, 000 sa < 1/ 100) fi studji li saru fuq pazjenti pedjatriċi li kienu prematuri u pazjenti pedjatriċi li jsofru minn displażja bronkopulmonari u pazjenti li jsofru mill- mard tal- qalb konġenitali (Tabelli 1 u 2, rispettivament).
Within each frequency grouping, adverse reactions have been presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa ġew imniżżla skond is- serjetata ’ tagħhom.
Table 1 Undesirable effects in prophylactic clinical studies with premature and bronchopulmonary dysplasia paediatric populations
Tabella 1 Effetti mhux mixtieqa fi studji kliniċi profilattiċi fuq gruppi ta ’ pazjenti pedjatriċi prematuri u pazjenti pedjatriċi li jbatu minn displażja bronkopulmonari
AST increase ALT increase Abnormal liver function test
Żieda fl- AST Żieda fl- ALT Test tal- funzjoni tal- fwied abnormali
Leucopaenia
Lewkopenija
Wheeze Rhinitis Cough
Tisfir Rinite Sogħla
Uncommon
Rimettar Mhux komuni
Viral infection Upper respiratory infection
Infezzjoni ikkawżata minn virus Infezzjoni fin- naħa ta ’ fuq tas- sistema respiratorja
Fever Injection site reaction Pain
Reazzjoni fil- post ta ’ l- injezzjoni Uġigħ
Nervousness
Nervożità
No medically important differences were observed during the prophylactic studies carried out in the premature and bronchopulmonary dysplasia paediatric populations in ADRs by body system or when evaluated in subgroups of children by clinical category, gender, age, gestational age, country, race/ ethnicity or quartile serum palivizumab concentration.
Ma ġew innutati l- ebda differenzi mediċi importanti waqt studji profilattiċi li saru fuq pazjenti pedjatriċi prematuri u pazjenti pedjatriċi li jbatu minn displazja bronkopulmonari, rigward l - ADRs skond is- sistema tal- gisem jew meta evalwati f’ sottogruppi ta ’ tfal skond il- kategorija klinika, sess, eta ’, eta ’ ta ’ gestazzjoni, pajjiż, razza / etniċita ’ jew konċentrazzjoni kwartili ta ’ palivizumab fis - serum.
No significant difference in safety profile was observed between children without active RSV infection and those hospitalised for RSV.
Ma giet innutata l- ebda differenza sinifikanti fil- profil ta ’ sigurta ’ bejn tfal li ma għandhomx infezzjoni attiva ta ’ RSV u dawk li kellhom jittieħdu l- isptar minħabba l- RSV.
Permanent discontinuation of palivizumab due to ADRs was rare (0.2%).
It- twaqqif permanenti ta ’ palivizumab minħabba l- ADRs kienet rari (0. 2%).
Deaths were balanced between the integrated placebo and palivizumab groups and were not drug-related.
L- imwiet imqabbla bejn il- gruppi integrati ta ’ plaċebo u dawk ta ’ palivizumab, kienu bilanċjati u ma kienux relatati mal - mediċina.
4 Table 2 Undesirable effects in the prophylactic paediatric congenital heart disease clinical study
4 Tabella 2 Effetti mhux mixtieqa fi studju kliniku profilattiku f’ pazjenti pedjatriċi b’ mard tal- qalb konġenitali
Nervous System
Is- sistema nervuża
Somnolence Hyperkinesia
Ngħas Iperkineżja
Vomiting Diarrhoea
Rimettar Dijarea Stitikezza
Rash Eczema
Mhux komuni
Infections and infestations
Gastro- enterite Infezzjoni fin- naħa ta ’ fuq tas- sistema respiratorja
Gastroenteritis Upper respiratory infection
Emorraġġija
Uncommon Common Uncommon
Komuni
Haemorrhage Fever Injection site reaction Asthenia
Deni Reazzjoni fil- post ta ’ l- injezzjoni
In the congenital heart disease study no medically important differences were observed in ADRs by body system or when evaluated in subgroups of children by clinical category.
Fl- istudju tal- mard tal- qalb kongenitali ma ġew innutati l- ebda differenzi ta ’ importanza medica f’ ADRs skond is- sistema tal- ġisem jew meta evalwati f’ sottogruppi ta ’ tfal abbażi tal- kategorija klinika.
The incidence of serious adverse events was significantly lower in the palivizumab group compared to the placebo group.
L- inċidenza ta ’ avvenimenti avversi u serji kienet partikolarment inqas fil- grupp ta ’ palivizumab meta imqabbla mall- grupp tal- plaċebo.
No serious adverse events related to palivizumab were reported.
Ma ġew irrapurtati l- ebda avvenimenti avversi serji relatati ma ’ palivizumab.
The incidences of cardiac surgeries classified as planned, earlier than planned or urgent were balanced between the groups.
L- inċidenza ta ’ interventi kardijaċi ikklassifikati bħala ippjanati, aktar kmieni minn kif pjanat jew urgenti, kienet bbilanċjati bejn il- gruppi.
Deaths associated with RSV infection occurred in 2 patients in the palivizumab group and 4 patients in the placebo group and were not drug-related.
Imwiet assoċjati ma ’ l - infezzjoni RSV seħħew f’ zewġ pazjenti fil- grupp ta ’ palivizumab u f’ 4 pazjenti fil- grupp tal - plaċebo u ma kienux relatati mal- mediċina.
Post-marketing experience:
Esperjenza wara l- introduzzjoni tal- prodott fis- suq:
The following events were reported during post-marketing experience of palivizumab:
Dawn l- okkorrenzi ġew irrapurtati wara li palivizumab gie introdott fis- suq:
Rare ADRs (> 1/ 10,000, < 1/ 1,000): apnoea Very rare ADRs (< 1/ 10,000): anaphylaxis, urticaria
ADRs Rari (> 1/ 10, 000, < 1/ 1, 000): apneja ADRs Rari Ħafna (< 1/ 10, 000): anafilassi, urtikarja
Post-marketing serious spontaneous adverse events reported during palivizumab treatment between 1998 and 2002 covering four RSV seasons were evaluated.
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.
A total of 1291 serious reports were received where palivizumab had been administered as indicated and the duration of therapy was within one season.
Kien hemm total ta 1291 rapport serju fejn palivizumab kien mogħti kif indikat u għal staġun wieħed.
The onset of the adverse event occurred after the sixth or greater dose in only 22 of these reports (15 after the sixth dose, 6 after the seventh doses and 1 after the eight dose).
L- avveniment avvers ġara wara s- sitt doża jew aktar fi 22 biss minn dawn ir- rapporti (15 wara is- sitt doża, sitta wara s- seba ’ doża u 1 wara t- tmien doża).
These events are similar in character to those after the initial five doses.
Dawn l- avvenimenti kienu simili għal dawk li dehru wara l- ħames dożi tal - bidu.
Palivizumab treatment schedule and adverse events were monitored in a group of nearly 20,000 infants tracked through a patient compliance registry between 1998 and 2000.
L- iskeda tal- kura b’ Palivizumab u l- avvenimenti avversi kienu mħarsa fi grupp ta madwar 20, 000 tifel u tifla żagħar, li ġew traċċati min reġistru ta pazjenti bejn 1998 u 2000.
Of this group 1250 enrolled infants had 6 injections, 183 infants had 7 injections, and 27 infants had either 8 or 9 injections.
Minn dan il- grupp 1250 tifel u tifla ħadu 6 injezzjonijiet, 183 tifel u tifla ħadu 7 injezzjonijiet u 27 tifel u tifla ħadu 8 jew 9 injezzjonijiet.
Adverse events observed in patients after a sixth or greater dose were similar in character and frequency to those after the initial 5 doses.
L- avvenimenti avversi li ġew osservati f’ pazjenti wara s- sitt doza jew iżjed, kienu simili għal dawk ta wara l- 5 doża, kemm fin- natura tagħhom kif ukoll fil- frekwenza.
Human anti-human antibody (HAHA) response:
5 Rispons uman għall- anti- korpi anti- umani, (HAHA):
Antibody to palivizumab was observed in approximately 1% of patients in the IMpact-RSV during the first course of therapy.
Fl- istudju IMpact- RSV, matul l- ewwel kors ta ’ kura ġew innutati anti- korpi għal Palivizumab f’ bejn wieħed u ieħor 1% tal- pazjenti.
This was transient, low titre, resolved despite continued use (first and second season), and could not be detected in 55/ 56 infants during the second season (including 2 with titres during the first season).
Dawn kienu ta ’ tip li jgħaddu malajr, b’ konċentrazzjoni baxxa, li għaddew minkejja li l- prodott baqa ’ jintuża (l- ewwel u t- tieni staġun) u ma setax jiġi rintraċċat f ’ 55/ 56 tifel u tifla matul it- tieni staġun (inklużi 2 b ’ konċentrazzjonijiet matul l- ewwel staġun).