Scenesse

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
12-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
12-01-2022
Public Assessment Report Public Assessment Report (PAR)
12-02-2015

Active ingredient:

afamelanotide

Available from:

Clinuvel Europe Limited

ATC code:

D02BB02

INN (International Name):

afamelanotide

Therapeutic group:

Emolljenti u protettivi

Therapeutic area:

Protoporphyria, Eritropoetika

Therapeutic indications:

Prevenzjoni ta 'fototossiċità f'pazjenti adulti bi protoporfija eritropojetika (EPP).

Product summary:

Revision: 9

Authorization status:

Awtorizzat

Authorization date:

2014-12-22

Patient Information leaflet

                                20
B.
FULJETT TA’ TAGĦRIF
_ _
_ _
21
FULJETT TA’ TAGĦRIF:
INFORMAZZJONI GĦALL-PAZJENT
SCENESSE 16 MG IMPJANT
afamelanotide
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Inti tista’ tgħin billi tirrapporta
kwalunkwe effett sekondarju li jista’ jkollok. Ara t-tmiem ta’
sezzjoni 4 biex tara kif għandek
tirrapporta effetti sekondarji.
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TUŻA DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib tiegħek. Dan
jinkludi xi effett sekondarju
possibbli li mhuwiex elenkat f’dan il-fuljett. Ara sezzjoni 4.
F’DAN IL-FULJETT
1.
X’inhu SCENESSE u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tirċievi SCENESSE
3.
Kif għandu jingħata SCENESSE
4.
Effetti sekondarji possibbli
5.
Kif taħżen SCENESSE
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU SCENESSE U GĦALXIEX JINTUŻA
SCENESSE fih is-sustanza attiva afamelanotide (bħala acetate).
Afamelanotide hija forma sintetika ta’
ormon tal-ġisem imsejjaħ
_alpha-melanocyte stimulating hormone_
(α-MSH) . Afamelanotide jaħdem
b’mod simili għall-ormon naturali, billi jġiegħel liċ-ċelluli
tal-ġilda jipproduċu eumelanin li hija tip
kannella-iswed tal-pigment tal-melanin fil-ġisem.
Afamelanotide jintuża biex tiżdied it-tolleranza għad-dawl tax-xemx
fl-adulti b’dijanjożi kkonfermata
ta’ erythropoietic protoporphyria (EPP). EPP hija kundizzjoni li
fiha l-pazjenti għandhom sensittività
ikbar għad-dawl tax-xemx, li tista’ tikkawża effetti tossiċi
bħal uġigħ u ħruq. Billi jżid l-ammont ta’
eumelanin, SCENESSE jista’ jgħin biex idewwem il-feġġa
tal-uġigħ minħabba l-fotosensittività tal-
ġilda (sensittività għad-dawl tax-xemx).
2.
X’GĦANDEK TKUN TAF QABE
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Il-professjonisti tal-kura tas-saħħa
huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata. Ara
sezzjoni 4.8 dwar kif
għandhom jiġu rappurtati reazzjonijiet avversi.
1.
ISEM IL-PRODOTT MEDIĊINALI
SCENESSE 16 mg impjant
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
L-impjant fih 16 mg ta’ afamelanotide (bħala acetate).
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Impjant.
Virga solida bajda għal offwajt twila madwar 1.7 cm u b’dijametru
ta’ madwar 1.5 mm.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
SCENESSE huwa indikat għall-prevenzjoni ta’ fototossiċità
f’pazjenti adulti bi protoporfirja
eritropojetika (EPP).
_ _
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
SCENESSE għandu jingħata biss minn tobba speċjalisti f’ċentri
ta’ porfirja rikonoxxuti u t-tqegħid
għandu jitwettaq minn tabib imħarreġ u akkreditat biex iqiegħed
l-impjant mid-detentur tal-
awtorizzazzjoni għat-tqegħid fis-suq.
_ _
Pożoloġija
Impjant wieħed jitqiegħed kull xahrejn qabel jew matul żieda
mistennija fl-espożizzjoni għad-dawl
tax-xemx, eż. mir-Rebbiegħa sal-bidu tal-Ħarifa. Huma rakkomandati
tlett impjanti fis-sena, skont it-
tul meħtieġ ta’ protezzjoni. In-numru massimu rakkomandat ta’
impjanti huwa ta’ erbgħa fis-sena. It-
tul totali tal-kura huwa fid-diskrezzjoni tat-tabib speċjalista (ara
sezzjoni 4.4).
Popolazzjonijiet speċjali
Għal pazjenti b’indeboliment renali u epatiku, ara sezzjonijiet 4.3
u 5.2.
_ _
_Popolazzjoni anzjana _
Minħabba
_data_
limitata dwar trattament ta’ pazjenti anzjani, l-użu ta’
afamelanotide mhux
rakkomandat (ara sezzjoni 4.4).
_Popolazzjoni pedjatrika _
_ _
Is-sigurtà u l-effikaċja ta’ afamelanotide fit-tfal u adolexxenti
minn età ta’ 0 sa 17-il sena għadhom ma
ġe
                                
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Active ingredient afamelanotide

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ATC code D02BB02

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Marketed by Clinuvel Europe Limited

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INN (International Name) afamelanotide

afamelanotide

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