Insulin aspart Sanofi

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
07-07-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
07-07-2023
Public Assessment Report Public Assessment Report (PAR)
07-07-2020

Active ingredient:

insulin aspart

Available from:

Sanofi Winthrop Industrie

ATC code:

A10AB05

INN (International Name):

insulin aspart

Therapeutic group:

Drogi użati fid-dijabete

Therapeutic area:

Diabetes Mellitus

Therapeutic indications:

Insulin aspart Sanofi is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Product summary:

Revision: 4

Authorization status:

Awtorizzat

Authorization date:

2020-06-25

Patient Information leaflet

                                33
B. FULJETT TA’ TAGĦRIF
34
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
INSULIN ASPART SANOFI 100 UNITÀ/ML SOLUZZJONI GĦALL-INJEZZJONI
F’KUNJETT
insulina aspart
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, jekk jogħġbok staqsi lit-tabib,
lill-infermier jew lill-ispiżjar
tiegħek.
-
Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara, anki jekk għandhom l-istess sinjali ta’
mard bħal tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib, lill-infermier jew
lill-ispiżjar tiegħek. Dan
jinkludi xi effett sekondarju possibbli li mhuwiex elenkat f’dan
il-fuljett. Ara sezzjoni 4.
F’DAN IL-FULJETT
1.
X’inhu Insulin aspart Sanofi u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tuża Insulin aspart Sanofi
3.
Kif għandek tuża Insulin aspart Sanofi
4.
Effetti sekondarji possibbli
5.
Kif taħżen Insulin aspart Sanofi
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU INSULIN ASPART SANOFI U GĦALXIEX JINTUŻA
Insulin aspart Sanofi huwa insulina moderna (analogu tal-insulina) li
jibda jaħdem malajr. Prodotti
moderni tal-insulina huma verżjonijiet imtejba tal-insulina umana.
Insulin aspart Sanofi jintuża biex tnaqqas il-livell għoli ta’
zokkor fid-demm fl-adulti, fl-adolexxenti u
fit-tfal minn sena ’l fuq li għandhom id-dijabete mellitus
(id-dijabete). Id-dijabete hija marda fejn il-
ġisem tiegħek ma jagħmilx biżżejjed insulina biex jikkontrolla
l-livell taz-zokkor fid-demm tiegħek.
Tratta
                                
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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
Insulin aspart Sanofi 100 unità/ml soluzzjoni għall-injezzjoni
f’kunjett
Insulin aspart Sanofi 100 unità/ml soluzzjoni għall-injezzjoni fi
skartoċċ
Insulin aspart Sanofi 100 unità/ml soluzzjoni għall-injezzjoni
f’pinna mimlija għal-lest
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Millilitru wieħed ta’ soluzzjoni fih 100 unità insulina aspart*
(ekwivalenti għal 3.5 mg).
Insulin aspart Sanofi 100 unità/ml soluzzjoni għall-injezzjoni f
’kunjett
Kull kunjett fih 10 ml ekwivalenti għal 1,000 unità insulina aspart.
Insulin aspart Sanofi 100 unità/ml soluzzjoni għall-injezzjoni fi
skartoċċ
Kull skartoċċ fih 3 ml ekwivalenti għal 300 unità insulina aspart.
Insulin aspart Sanofi 100 unità/ml soluzzjoni għall-injezzjoni
f’pinna mimlija għal-lest
Kull pinna mimlija għal-lest fiha 3 ml ekwivalenti għal 300 unità
insulina aspart.
Kull pinna mimlija għal-lest tagħti unità 1-80 unità f’żidiet
ta’ unità 1.
* magħmul f’
_Escherichia coli_
permezz tat-teknoloġija tad-DNA rikombinanti.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Soluzzjoni għall-injezzjoni (injezzjoni).
Soluzzjoni ċara, mingħajr kulur, akweja.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Insulin aspart Sanofi huwa indikat għall-kura tad-dijabete mellitus
fl-adulti, fl-adolexxenti u fit-tfal
minn sena ’l fuq.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Poż
oloġija
Il-qawwa tal-analogi tal-insulina, inkluż insulina aspart, hija
mfissra f’unitajiet, waqt li l-qawwa tal-
insulina umana hija mfissra f’unitajiet internazzjon
                                
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Active ingredient insulin aspart

insulin aspart

ATC code A10AB05

A10AB05

Marketed by Sanofi Winthrop Industrie

Sanofi Winthrop Industrie

INN (International Name) insulin aspart

insulin aspart

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