Ceprotin

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
02-02-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
02-02-2023
Public Assessment Report Public Assessment Report (PAR)
02-02-2023

Active ingredient:

proteina umana C

Available from:

Takeda Manufacturing Austria AG

ATC code:

B01AD12

INN (International Name):

human protein C

Therapeutic group:

Aġenti antitrombotiċi

Therapeutic area:

Purpura Fulminans; Protein C Deficiency

Therapeutic indications:

CEPROTIN is indicated for prophylaxis and treatment of  purpura fulminans  coumarin-induced skin necrosis and venous thrombotic events in patients with severe congenital protein C deficiency.

Product summary:

Revision: 19

Authorization status:

Awtorizzat

Authorization date:

2001-07-16

Patient Information leaflet

                                31
B. FULJETT TA' TAGĦRIF
32
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
CEPROTIN 500 IU TRAB U SOLVENT GĦAL SOLUZZJONI GĦALL-INJEZZJONI
proteina Ċ tal-bniedem
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 jew lill-ispiżjar
tiegħek.
-
Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha
lil persuni oħra. Tista'
tagħmlilhom il-ħsara, anki jekk ikollhom l-istess sinjali ta’ mard
bħal tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib 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 CEPROTIN u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tuża CEPROTIN
3.
Kif għandek tuża CEPROTIN
4.
Effetti sekondarji possibbli
5.
Kif taħżen CEPROTIN
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU CEPROTIN U GЋALXIEX JINTUŻA
CEPROTIN jagħmel parti minn klassi ta' mediċini msejħa
antitrombotiċi. Din il-mediċina fiha
l-proteina Ċ, proteina naturali li ssir fil-fwied u hija preżenti
fid-demm tiegħek. Il-proteina Ċ għandha
rwol importanti fil-prevenzjoni tal-ħolqien eċċessiv ta' emboli u
b'hekk, timpedixxi u/jew tikkura
trombożi intravaskulari.
CEPROTIN jintuża fil-kura u l-prevenzjoni ta' feriti trombotiċi u
emorraġiċi tal-ġilda (imsejħa purpura
fulminans) f'pazjenti b'defiċjenza konġenita severa ta' proteina Ċ.
CEPROTIN jista’ jintuża wkoll fit-
trattament u l-prevenzjoni ta’ komplikazzjoni rari ta’ mediċina
li traqqaq id-demm (mediċina kontra
l-koagulazzjoni tad-demm imsejħa coumarin) li tista' tirriżulta
f'leżjonijiet severi tal-ġilda (nekrożi).
Barra minn hekk, CEPROTIN jista’ jintuża fit-trattament ta’
avvenimenti ta’ emboli tad-demm
(trombotiċi fil-vini).
2.
X'GĦANDEK TKUN TAF QABEL MA TUŻA
CEPROTIN
TUŻAX CEPROTIN
-
jekk int all
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
CEPROTIN 500 IU trab u solvent għal soluzzjoni għall-injezzjoni
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Proteina Ċ mill-plażma tal-bniedem ppurifikata b’antikorpi
monoklonali tal-ġurdien.
CEPROTIN 500 IU* huwa ppreparat bħala trab li jkun fih b’mod
nominali 500 IU ta' proteina Ċ
tal-bniedem f'kull kontenitur. Il-prodott li jiġi rikostitwit b’5
ml ilma għall-injezzjoni jkun fih
madwar 100 IU/ml ta’ proteina Ċ.
Il-qawwa (IU) tiġi stabbilita billi jintuża metodu tas-sostratt
kromoġeniku li jitqabbel mal-istandard
Internazzjonali tal-Organizzazzjoni Dinjija tas-Saħħa (WHO).
*Unità Internazzjonali Waħda (IU) ta’ proteina Ċ tikkorispondi
għall-attività mkejla b’mod
amidolitikali ta’ proteina Ċ f’1 ml ta’ plażma normali.
Eċċipjenti b’effett magħruf:
Dan il-prodott mediċinali fiha 22.5 mg sodium kull kunjett.
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Proteina Ċ tal-bniedem, trab u solvent għal soluzzjoni
għall-injezzjoni.
Trab xott abjad jew kulur il-krema jew solidu li jista' jitfarrak.
Wara rikostituzzjoni s-soluzzjoni
jkollha pH ta' bejn 6.7 u 7.3 u osmolalità ta' mhux anqas minn 240
mosmol/kg.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI

CEPROTIN huwa indikat għall-profilassi u t-trattament ta’ purpura
fulminans, nekrożi tal-ġilda
kkaġunata minn kumarina u avvenimenti trombotiċi fil-vini
f’pazjenti li għandhom defiċjenza
konġenitali serja tal-Proteina Ċ.
4.2
POŻOLOĠIJA U METODU TA' KIF GĦANDU JINGĦATA
It-trattament b’CEPROTIN għandu jinbeda taħt superviżjoni ta’
tabib b’esperjenza f’terapija ta’
sostituzzjoni b’fatturi/inibitturi ta’ koagulazzjoni fejn
sorveljanza tal-attività tal-proteina Ċ hija
possibbli.
Pożoloġija
Id-doża għandha tiġi aġġustata fuq il-bażi ta' valutazzjoni
fil-laboratorju għal kull każ individwali.
_Trattament ta’ episodji akuti u profilassi fuq perjodu qasir
(in
                                
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Active ingredient proteina umana C

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ATC code B01AD12

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Marketed by Takeda Manufacturing Austria AG

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INN (International Name) human protein C

human protein C

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