Dynepo

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
13-03-2008
Summary of Product characteristics Summary of Product characteristics (SPC)
13-03-2008
Public Assessment Report Public Assessment Report (PAR)
13-03-2008

Active ingredient:

epoetin delta

Available from:

Shire Pharmaceutical Contracts Limited

ATC code:

B03XA

INN (International Name):

epoetin delta

Therapeutic group:

Preparazzjonijiet antianemiċi

Therapeutic area:

Kidney Failure, Chronic; Anemia

Therapeutic indications:

Dynepo huwa indikat għall-kura ta 'anemija sintomatika assoċjata ma' insuffiċjenza renali kronika (CRF) f'pazjenti adulti. Jista 'jintuża f'pazjenti fuq id-dijaliżi u f'pazjenti mhux fuq id-dijalisi.

Product summary:

Revision: 9

Authorization status:

Irtirat

Authorization date:

2002-03-18

Patient Information leaflet

                                Prodott mediċinali li m’għadux awtorizzat
102
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
103
FULJETT TA’ TAGĦRIF: TAGĦRIF GĦAL MIN QED JAGĦMEL UŻU MINNHA
DYNEPO 1,000 IU/0.5 ML SOLUZZJONI GĦALL-INJEZZJONI F’SIRINGA
MIMLIJA GĦAL-LEST
DYNEPO 2,000 IU/0.5 ML SOLUZZJONI GĦALL-INJEZZJONI F’SIRINGA
MIMLIJA GĦAL-LEST
DYNEPO 3,000 IU/0.3 ML SOLUZZJONI GĦALL-INJEZZJONI F’SIRINGA
MIMLIJA GĦAL-LEST
DYNEPO 4,000 IU/0.4 ML SOLUZZJONI GĦALL-INJEZZJONI F’SIRINGA
MIMLIJA GĦAL-LEST
DYNEPO 5,000 IU/0.5 ML SOLUZZJONI GĦALL-INJEZZJONI F’SIRINGA
MIMLIJA GĦAL-LEST
DYNEPO 6,000 IU/0.3 ML SOLUZZJONI GĦALL-INJEZZJONI F’SIRINGA
MIMLIJA GĦAL-LEST
DYNEPO 8,000 IU/0.4 ML SOLUZZJONI GĦALL-INJEZZJONI F’SIRINGA
MIMLIJA GĦAL-LEST
DYNEPO 10,000 IU/0.5 ML SOLUZZJONI GĦALL-INJEZZJONI F’SIRINGA
MIMLIJA GĦAL-LEST
Epoetin delta
AQRA DAN IL-FULJETT KOLLU QABEL TIBDA TUŻU DIN IL-MEDIĊINA.
-
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. TAGĦTIHIEX lil persuni oħra.
Tista’ tagħmlilhom il-ħsara,
anki jekk ikollhom l-istess sintomi bħal tiegħek.
- 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 jew lill-ispiżjar tiegħek.
F’DAN IL-FULJETT
:
1.
X’inhu Dynepo u għalxiex jintuża
2.
Qabel ma tuża Dynepo
3.
Kif għandek tuża Dynepo
4.
Effetti sekondarji li jista’ jkollu
5.
Kif għandek tahżen Dynepo
6.
Aktar tagħrif
1.
X’INHU DYNEPO U GĦALXIEX JINTUŻA
Epoetin delta hu erythropoietin uman magħmul minn proċess
tat-teknoloġija msejjaħ attivazzjoni tal-
ġeni, li juża linja ta’ ċelluli umani.
Epoetin delta hu ormon li jistimula l-produzzjoni taċ-ċelluli ħomor
tad-demm fl-għadma tal-mudullun.
Iċ-ċelluli ħomor tad-demm huma importanti ħafna għax fihom
l-emoglobina, proteina li tqassam l-
ossiġnu f’ġ
                                
                                Read the complete document

Summary of Product characteristics

                                Prodott mediċinali li m’għadux awtorizzat
1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM TAL-PRODOTT MEDIĊINALI
Dynepo 1,000 IU/0.5 ml soluzzjoni għall-injezzjoni f’siringa
mimlija għal-lest.
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
_ _
Siringa mimlija għal-lest li fiha 1,000 IU f’kull doża ta’ 0.5
ml (2,000 IU/ml) tas-sustanza attiva epoetin
delta.
Epoetin delta hu prodott fiċ-ċelluli tal-bniedem (HT-1080)
bit-teknoloġija ta’ l-attivazzjoni tal-ġeni.
Għal-lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Soluzzjoni għall-injezzjoni f’siringa mimlija għal-lest.
Soluzzjoni ċara, bla kulur u qisha ilma.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Dynepo hu indikat għall-kura ta’ anemija sintomatika assoċjata
ma’ insuffiċjenza renali kronika (CRF)
f’pazjenti adulti. Jista’ jintuża kemm f’pazjenti li huma fuq
id-dijaliżi kif ukoll f’pazjenti li mhumiex fuq
id-dijaliżi.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Il-kura b’Dynepo għandha tinbeda minn tobba li għandhom esperjenza
fil-kura ta’ anemija assoċjata
ma’ CRF.
Id-dożaġġ ta’ Dynepo jrid ikun aġġustat individwalment biex
iżomm il-livell ta’ l-emoglobina fil-
medda tal-mira ta’ 10 sa 12g/dl.
Sintomi ta’ anemija u kundizzjonijiet jew mard b’konsegwenza
tagħha jistgħu jvarjaw
ma’ l-età, sess,
u l-gravità totali tal-marda; hemm bżonn ta’ evalwazzjoni ta’
tabib tal-kors kliniku u tal-kundizzjoni
tal-pazjent individwali. Dynepo għandu jingħata minn taħt il-ġilda
jew ġol-vina biex iżid l-emoglobina
għal mhux iktar minn 12 g/dL (7.5 mmol/l). L-użu taħt il-ġilda hu
preferibbli f’pazjenti li mhux qed
jirċievu l-emodijalisi biex jevitaw li jtaqqbu vini periferali
Minħabba l-varjabilità bejn il-pazjenti, okkażjonalment jistgħu
jkunu osservati valuri ‘il fuq u ‘l isfel
mil-livell mixtieq ta’ l-emoglobina għal pazjent. Il-varjabilità
ta’ l-emoglobina għan
                                
                                Read the complete document

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Active ingredient epoetin delta

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ATC code B03XA

B03XA

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Shire Pharmaceutical Contracts Limited

INN (International Name) epoetin delta

epoetin delta

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Patient Information leaflet Patient Information leaflet Bulgarian 13-03-2008
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-03-2008
Public Assessment Report Public Assessment Report Bulgarian 13-03-2008
Patient Information leaflet Patient Information leaflet Spanish 13-03-2008
Summary of Product characteristics Summary of Product characteristics Spanish 13-03-2008
Public Assessment Report Public Assessment Report Spanish 13-03-2008
Patient Information leaflet Patient Information leaflet Czech 13-03-2008
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Public Assessment Report Public Assessment Report Czech 13-03-2008
Patient Information leaflet Patient Information leaflet Danish 13-03-2008
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Public Assessment Report Public Assessment Report Danish 13-03-2008
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Patient Information leaflet Patient Information leaflet Estonian 13-03-2008
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Patient Information leaflet Patient Information leaflet Greek 13-03-2008
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Patient Information leaflet Patient Information leaflet English 13-03-2008
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Patient Information leaflet Patient Information leaflet French 13-03-2008
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