Preotact

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
02-07-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
02-07-2014
Public Assessment Report Public Assessment Report (PAR)
02-07-2014

Active ingredient:

ormon tal-paratirojde (rDNA)

Available from:

NPS Pharma Holdings Limited

ATC code:

H05AA03

INN (International Name):

parathyroid hormone (rDNA)

Therapeutic group:

Homeostasi tal-kalċju

Therapeutic area:

L-osteoporożi, il-menopawża

Therapeutic indications:

Trattament ta 'l-osteoporożi f'nisa wara l-menopawża f'riskju għoli ta' ksur (ara sezzjoni 5. Ġie muri tnaqqis sinifikanti fl-inċidenza ta 'ksur vertebrali, iżda mhux tal-ġenbejn.

Product summary:

Revision: 4

Authorization status:

Irtirat

Authorization date:

2006-04-24

Patient Information leaflet

                                20
B. FULJETT TA’ TAG
ĦRIF
Prodott mediċinali li m’għadux awtorizzat
21
FULJETT TA’ TAG
ĦRIF: INFORMAZZJONI G
ĦALL
-UTENT
PREOTACT 100 MIKROGRAMM TRAB U SOLVENT G
ĦAL SOLUZZJONI GĦALL
-INJEZZJONI F’PINNA MIMLIJA G
ĦAL
-
LEST
ORMON TAL-PARATIROJDE
AQRA SEW DAN IL-
FULJETT KOLLU QABEL TIBDA TUŻA DIN IL
-MEDI
ĊINA PERESS LI FIH INFORMAZZJONI
IMPORTANTI G
ĦALIK.
-
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 sintomi 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.
F’DAN IL-FULJETT
1.
X’inhu Preotact u għal xiex jintuża
:
2.
X’għandek tkun taf qabel ma tuża Preotact
3.
Kif għandek tuża Preotact
4.
Effetti sekondarji possibbli
5.
Kif taħżen Preotact
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU PREOTACT U G
ĦAL XIEX JINTUŻA
Preotact jintuża biex tiġi ttrattata l-osteoporożi f’nisa
fil-fażi ta’ wara l-menopawsa f’riskju għoli ta’
ksur. L-osteoporożi hija marda li twassal biex l-għadam jirqaq u
jsir fraġli. Hija komuni l-aktar f’nisa
li qabżu l-menopawsa. Il-marda tavvanza b’mod gradwali u għalhekk,
għall-ewwel, inti tista’ ma tħoss
l-ebda sintomi. Iżda jekk ikollok l-osteoporożi, din tagħmlek aktar
suxxettibbli li tikser l-għadam,
speċjalment fis-sinsla tiegħek, ġenbek u l-polz. Tista’ tikkawża
wkoll uġigħ fid-dahar, telf tat-tul, u
dahar mgħawweġ.
Preotact inaqqas ir-riskju li tikser l-għadam tas-sinsla minħabba li
jżid il-kwalità u s-saħħa ta’ l-
għadam tiegħek.
Intwera li Preotact inaqqas ir-riskju ta’ ksur għal ġenbejk.
2.
X’G
ĦANDEK TKUN TAF QABEL MA TUŻA PREOTACT
TUŻAX PREOTACT:
•
Jekk int allerġiku/a għall-ormon tal-paratirojde 
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTI
ĊI TAL
-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM IL-PRODOTT MEDI
ĊINALI
Preotact 100 mikrogramm trab u solvent għal soluzzjoni
għall-injezzjoni f’pinna mimlija għal-lest.
2.
G
ĦAMLA KWALITATTIVA U KWANTIT
ATTIVA
Kull pinna mimlija għal-lest fih 1.61 mg ormon tal-paratirojde li
jikkorispondi għal 14-il doża.
Wara r-rikostituzzjoni, kull doża ta’ 71.4 mikrolitru fiha 100
mikrogramm ta’ ormon tal-paratirojde li
jiġi prodott minn
_Escherichia _
coli b’tekonoloġija rikombinanti tad-DNA.
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
G
ĦAMLA FARMAĊEWTIKA
Trab u solvent għal soluzzjoni għall-injezzjoni.
Trab abjad għal offwajt u solvent ċar, bla kulur.
4.
TAG
ĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTI
ĊI
Preotact huwa indikat għat-trattament ta’ osteoporożi f’nisa li
qabżu l-menopawsa f’riskju għoli ta’
ksur (ara sezzjoni 5.1).
Ġie muri tnaqqis sinifikanti fl-inċidenza ta’ ksur tal-vertebra
iżda mhux tal-ġenb.
4.2
POŻOLOĠI
JA U METODU TA’ KIF G
ĦANDU JINGĦATA
Id-doża rakkomandata hija 100 mg ta’ ormon tal-paratirojde
mogħtija darba kuljum.
Pożoloġija
Il-pazjenti għandhom jirċievu kalċju u vitamina D supplimentari
jekk l-ammont li jieħdu fid-dieta
tagħhom ma jkunx biżżejjed.
L-informazzjoni ssostni trattament kontinwu bi Preotact sa perjodu
ta’ 24 xahar (ara sezzjoni 4.4).
Wara l-kura bi Preotact il-pazjenti jistgħu jiġu ttrattati
b’bisphosphonate biex iżidu aktar id-densità
tal-minerali fl-għadam (ara sezzjoni 5.1).
_Indeboliment renali _
_Popolazzjonijiet spe_
_ċjali _
_ _
M’hemmx bżonn ta’ aġġustament fid-doża f’pazjenti
b’indeboliment renali ħafif għal moderat
(tneħħija tal-kreatinina ta’ 30 sa 80 ml/min). M’hemmx
informazzjoni disponibbli dwar pazjenti
b’indeboliment sever renali. Preotact għalhekk m’għandux
jintuża f’pazjenti b’indeboliment sever
renali (ara sezzjoni 4.3).
_ _
_Indeboliment epatiku _
M’hemmx bżonn ta’ aġġustament
                                
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Active ingredient ormon tal-paratirojde (rDNA)

ormon tal-paratirojde (rDNA)

ATC code H05AA03

H05AA03

Marketed by NPS Pharma Holdings Limited

NPS Pharma Holdings Limited

INN (International Name) parathyroid hormone (rDNA)

parathyroid hormone (rDNA)

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Public Assessment Report Public Assessment Report Spanish 02-07-2014
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