Preotact

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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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:

obščitnični hormon (rDNA)

Available from:

NPS Pharma Holdings Limited

ATC code:

H05AA03

INN (International Name):

parathyroid hormone (rDNA)

Therapeutic group:

Kalcij homeostaza

Therapeutic area:

Osteoporoza, postmenopavz

Therapeutic indications:

Zdravljenje osteoporoze pri ženskah po menopavzi z visokim tveganjem za zlome (glejte poglavje 5). Dokazano je bilo znatno zmanjšanje pojavnosti vretenčnih, toda ne zlomov kolka.

Product summary:

Revision: 4

Authorization status:

Umaknjeno

Authorization date:

2006-04-24

Patient Information leaflet

                                18
EXP
Pripravljena raztopina: 28 dni
9. POSEBNA NAVODILA ZA SHRANJEVANJE
Napolnjen injekcijski peresnik (pred pripravo): Shranjujte pri
temperaturi do 25
°
C. Ne zamrzujte. Za
zagotovitev zaščite pred svetlobo shranjujte napolnjen injekcijski
peresnik v zunanji škatli.
Napolnjen injekcijski peresnik (po pripravi): Shranjujte v hladilniku
(2 °C - 8 °C). Ne zamrzujte. Ne
stresajte. Ko je raztopina v vložku pripravljena, lahko zdravilo
shranjujete pri temperaturi do 25 °C do
7 dni v 28-dnevnem obdobju uporabnosti.
10. POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11. IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
NPS Pharma Holdings Limited
Grand Canal House
1 Grand Canal Street Upper
Dublin 4
Irska
12. ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
EU/1/06/339/003
13. ŠTEVILKA SERIJE
Lot
14. N
AČIN IZDAJANJA ZDRAVILA
Predpisovanje in izdaja zdravila je le na recept.
15. NAVODILA ZA UPORABO
16. PODATKI V BRAILLOVI PISAVI
Preotact
Zdravilo nima veā dovoljenja za promet
19
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
NAPOLNJEN INJEKCIJSKI PERESNIK
1. IME ZDRAVILA IN POT(I) UPORABE
Preotact 100 mikrogramov prašek in vehikel za raztopino za
injiciranje
obščitnični hormon
subkutana uporaba
2. POSTOPEK UPORABE
Pred uporabo preberite priloženo navodilo.
3. DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4. ŠTEVILKA SERIJE
Lot
5. VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
1,61 mg obščitničnega hormona in 1,13 ml vehikla (14 odmerkov)
6. DRUGI PODATKI
Zdravilo nima veā dovoljenja za promet
20
B. NAVODILO ZA UPORABO
Zdravilo nima veā dovoljenja za promet
21
NAVODILO ZA UPORABO
PREOTACT 100 MIKROGRAMOV PRAŠEK IN VEHIKEL ZA RAZTOPINO ZA
INJICIRANJE V NAPOLNJENEM
INJEKCIJSKEM PERESNIKU
obščitnični hormon
PRED ZAČETKOM UPORABE ZDRAVILA NATANČNO PREBERITE NAV
ODILO, KER VSEBUJE ZA VAS POMEMBNE
PODATKE!
-
Navodilo shranite. Morda ga boste želeli ponovno prebrati.
-
Če imate dodatna vp
                                
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Summary of Product characteristics

                                1
DODATEK I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Zdravilo nima veā dovoljenja za promet
2
1.
IME ZDRAVILA
Preotact 100 mikrogramov prašek in vehikel za raztopino za
injiciranje v napolnjenem injekcijskem
peresniku
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
En napolnjen injekcijski peresnik vsebuje 1,61 mg obščitničnega
hormona, kar ustreza 14 odmerkom.
Po rekonstituciji en odmerek z 71,4 mikrolitri vsebuje 100 mikrogramov
obščitničnega hormona, ki je
pridobljen v
_Escherichia coli_
s tehnologijo rekombinantne DNA.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Prašek in vehikel za raztopino za injiciranje.
Bel do umazano bel prašek in bister, brezbarven vehikel.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Preotact je indicirano za zdravljenje osteoporoze pri
ženskah po menopavzi, ki imajo
povečano tveganje za zlome (glejte poglavje 5.1).
Dokazano je bilo zmanjšanje pojavnosti vretenčnih zlomov, ne pa
zlomov kolka.
4.2
ODMERJANJE IN NAČIN UPORABE
Priporočeni odmerek je 100
µ
g obščitničnega hormona enkrat dnevno.
Odmerjanje
Če bolnice s prehrano ne zaužijejo zadosti kalcija in vitamina D,
morajo prejemati dodatke teh snovi.
Podatki podpirajo neprekinjeno zdravljenje z zdravilom Preotact do 24
mesecev (glejte poglavje 4.4).
Po zdravljenju z zdravilom Preotact lahko bolnice zdravimo z
difosfonatom, da še povečamo
mineralno gostoto kosti (glejte poglavje 5.1).
_Ledvična okvara_
_ _
_Posebne skupine bolnikov _
Pri bolnicah z blago do zmerno okvaro ledvic (očistek kreatinina od
30 do 80 ml/min) ni treba
prilagajati odmerka. O odmerjanju pri bolnicah s hudo okvaro delovanja
ledvic ni podatkov. Zato
zdravila Preotact ne smemo uporabljati pri bolnicah s hudo okvaro
ledvic (glejte poglavje 4.3).
_Jetrna okvara _
Pri bolnicah z blago do zmerno okvaro jeter (skupno število točk po
lestvici Child-Pugh od 7 do 9) ni
treba prilagajati odmerka. O odmerjanju pri bolnicah s hudo okvaro
jeter ni podatkov. Zato zdravila
Preotact ne smemo uporabljati pri bolnicah s h
                                
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Active ingredient obščitnični hormon (rDNA)

obščitnični hormon (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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