Zoledronic acid Teva Generics

Country: European Union

Language: Estonian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
08-08-2016
Summary of Product characteristics Summary of Product characteristics (SPC)
08-08-2016
Public Assessment Report Public Assessment Report (PAR)
08-08-2016

Active ingredient:

zoledroonhappe monohüdraat

Available from:

Teva Generics B.V

ATC code:

M05BA08

INN (International Name):

zoledronic acid

Therapeutic group:

Bisfosfonaadid

Therapeutic area:

Osteoporosis; Osteitis Deformans

Therapeutic indications:

Ravi osteoporosisin post-menopausis womenin täiskasvanud menat suurenenud risk luumurdude, sealhulgas hiljutine väike-trauma hip-murd. Ravi osteoporoosi seotud pikaajalise süsteemse glükokortikoidi therapyin post-menopausis womenin täiskasvanud menat suurenenud risk luumurdude. Ravi Paget tõbi, luu täiskasvanutel.

Product summary:

Revision: 2

Authorization status:

Endassetõmbunud

Authorization date:

2014-03-27

Patient Information leaflet

                                51
B. PAKENDI INFOLEHT
Ravimil on müügiluba lõppenud
52
PAKENDI INFOLEHT: TEAVE KASUTAJALE
ZOLEDRONIC ACID TEVA GENERICS 5 MG INFUSIOONILAHUS PUDELIS
Zoledroonhape (Acidum zoledronicum)
ENNE RAVIMI KASUTAMIST, LUGEGE HOOLIKALT INFOLEHTE, SEST SIIN ON TEILE
VAJALIKKU TEAVET.
-
Hoidke infoleht alles, et seda vajadusel uuesti lugeda.
-
Kui teil on lisaküsimusi, pidage nõu oma arsti, apteekri või
meditsiiniõega.
-
Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti,
apteekri või meditsiiniõega.
Kõrvaltoime võib olla ka selline, mida selles infolehes ei ole
nimetatud. Vt lõik 4.
INFOLEHE SISUKORD
1.
Mis ravim on Zoledronic acid Teva Generics ja milleks seda kasutatakse
2.
Mida on vaja teada enne Zoledronic acid Teva Generics’i kasutamist
3.
Kuidas Zoledronic acid Teva Generics’it kasutada
4.
Võimalikud kõrvaltoimed
5.
Kuidas Zoledronic acid Teva Generics’it säilitada
6.
Pakendi sisu ja muu teave
1.
MIS RAVIM ON ZOLEDRONIC ACID TEVA GENERICS JA MILLEKS SEDA KASUTATAKSE
Zoledronic acid Teva Generics’i toimeaine on zoledroonhape. Ravim
kuulub bisfosfonaatide
ravimigruppi ja seda kasutatakse osteoporoosi raviks täiskasvanud
meestel ja postmenopausis naistel
või steroidravist põhjustatud osteoporoosi raviks ja Pageti luutõve
raviks täiskasvanutel.
OSTEOPOROOS
Osteoporoos on haigus, mis on seotud luude hõrenemise ja
nõrgenemisega ning esineb sageli naistel
pärast menopausi, kuid võib esineda ka meestel. Pärast menopausi
lõpetavad naiste munasarjad
naissuguhormoon östrogeeni tootmise, mis aitab luudel tervena
püsida. Pärast menopausi tekib luude
hõrenemine, luud muutuvad nõrgemaks ning murduvad kergemini.
Osteoporoos võib meestel ja
naistel tekkida ka hormoonide pikaajalise kasutamise tõttu, mis võib
mõjutada luude tugevust. Paljudel
osteoporoosi põdevatel patsientidel ei ole ühtki sümptomit, kuid
neil on siiski luumurdude tekke risk,
kuna osteoporoosi tõttu on nende luud nõrgemad. Ringlevate
suguhormoonide, peamiselt
androgeenidest tekkinud östrogeenide tasem
                                
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Summary of Product characteristics

                                1
I LISA
RAVIMI OMADUSTE KOKKUVÕTE
Ravimil on müügiluba lõppenud
2
1.
RAVIMPREPARAADI NIMETUS
Zoledronic acid Teva Generics 5 mg infusioonilahus pudelis
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
_ _
Iga pudel sisaldab 5 mg zoledroonhapet (
_Acidum zoledronicum_
) (monohüdraadina).
Üks ml lahust sisaldab 0,05 mg zoledroonhapet (monohüdraadina).
Abiainete täielik loetelu vt lõik 6.1.
3.
RAVIMVORM
Infusioonilahus
Selge ja värvitu lahus.
4.
KLIINILISED ANDMED
4.1
NÄIDUSTUSED
Osteoporoosi ravi
•
postmenopausis naistel
•
täiskasvanud meestel
suurenenud riskiga luumurdude tekke korral, sh madalast asendist
kukkumise tagajärjel tekkinud
reieluu proksimaalse osa murru korral.
Süsteemse pikaajalise glükokortikoidraviga seotud osteoporoosi ravi
•
postmenopausis naistel
•
täiskasvanud meestel
kellel on suurenenud luumurdude tekke risk.
Pageti luutõve ravi täiskasvanutel.
4.2
ANNUSTAMINE JA MANUSTAMISVIIS
Annustamine
Patsiendid peavad olema enne zoledroonhappe manustamist piisavalt
hüdreeritud. See on eriti oluline
eakate ja diureetilist ravi saavate patsientide puhul.
Zoledroonhappe ravi ajal on soovitatav kasutada piisavas koguses
kaltsiumi ja D-vitamiini preparaate.
_Osteoporoos _
Osteoporoosi raviks postmenopausis naistel, osteoporoosi raviks
meestel ja süsteemsest pikaajalisest
glükokortikoidravist põhjustatud osteoporoosi raviks on soovitatav
annus üks 5 mg zoledroonhappe
intravenoosne infusioon manustatuna üks kord aastas.
Optimaalne bisfosfonaatravi kestus osteoporoosi korral ei ole
määratud. Ravi jätkamise vajadust tuleb
taashinnata perioodiliselt kaaludes võimalikke zoledroonhappe riske
ja kasu individuaalsetele
patsientidele, eriti viie või enama kasutusaasta järel.
Hiljutise seisvast või madalamast asendist kukkumise tagajärjel
tekkinud reieluu proksimaalse osa
murruga patsientidele on soovitatav manustada zoledroonhappe
infusiooni vähemalt kaks nädalat
Ravimil on müügiluba lõppenud
3
pärast reieluu proksimaalse osa murru paranemist (vt lõik 5.1).
Hiljutise seisvast 
                                
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Active ingredient zoledroonhappe monohüdraat

zoledroonhappe monohüdraat

ATC code M05BA08

M05BA08

Marketed by Teva Generics B.V

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INN (International Name) zoledronic acid

zoledronic acid

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