Intrinsa

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
18-06-2012
Summary of Product characteristics Summary of Product characteristics (SPC)
18-06-2012
Public Assessment Report Public Assessment Report (PAR)
18-06-2012

Active ingredient:

Testosteron

Available from:

Warner Chilcott UK Ltd.

ATC code:

G03BA03

INN (International Name):

testosterone

Therapeutic group:

Køn hormoner og modulatorer af den genitale system,

Therapeutic area:

Seksuelle dysfunktioner, psykologiske

Therapeutic indications:

Intrinsa er indiceret til behandling af hypoaktiv seksuel lyst lidelse (HSDD) i bilateralt oophorectomised og hysterectomised (kirurgisk induceret overgangsalderen) kvinder modtager samtidig østrogenbehandling.

Product summary:

Revision: 6

Authorization status:

Trukket tilbage

Authorization date:

2006-07-28

Patient Information leaflet

                                1
BILAG I
PRODUKTRESUME
Lægemidlet er ikke længere autoriseret til salg
2
1.
LÆGEMIDLETS NAVN
Intrinsa 300 mikrogram/24 timer depotplaster
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
_ _
Hvert plaster på 28 cm
2
indeholder 8,4 mg testosteron og afgiver 300 mikrogram testosteron på
24 timer.
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Depotplaster.
Tyndt, gennemsigtigt, ovalt depotplaster af matrixtypen, bestående af
tre lag: et gennemsigtigt
bagsidelag, et klæbende matrixlag med lægemiddel og en
beskyttelsesfilm, som fjernes før brug.
Overfladen på hvert plaster er påtrykt T001.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Intrinsa er indiceret til behandling af hypoaktiv seksuel lyst
_(Hypoactive sexual desire disorder, _
_HSDD)_
hos kvinder med bilateral ovariektomi og hysterektomi (kirurgisk
induceret menopause) i
samtidig østrogenbehandling.
4.2
DOSERING OG INDGIVELSESMÅDE
Dosering
Den anbefalede daglige testosterondosis er 300 mikrogram. Dosis opnås
ved vedvarende applicering af
plastret to gange ugentligt. Plastret bør erstattes med et nyt
plaster hver 3. eller 4. dag. Der må kun
anvendes et plaster ad gangen.
_Samtidig østrogenbehandling _
Relevant brug af og restriktioner forbundet med østrogenbehandling
bør overvejes, før behandlingen
med Intrinsa indledes og ved rutinemæssig revurdering af
behandlingen. Fortsat anvendelse af Intrinsa
anbefales kun, mens samtidig brug af østrogen menes at være relevant
(dvs. den laveste, effektive
dosis i kortest mulige tid).
Det anbefales, at patienter, der er behandlet med konjugeret ekvint
østrogen
_(conjugated equine _
_estrogen, CEE),_
undlader at anvende Intrinsa, da effekten ikke er påvist (se pkt. 4.4
og 5.1).
_Varighed af behandlingen _
Respons på behandlingen med Intrinsa bør vurderes inden for 3-6
måneder efter behandlingsstart for at
afgøre, om det er relevant at fortsætte behandlingen. Patienter, som
ikke oplever en fordel af
behandlingen, der kan betegnes som meningsfuld, bør revurderes, og
det b
                                
                                Read the complete document

Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUME
Lægemidlet er ikke længere autoriseret til salg
2
1.
LÆGEMIDLETS NAVN
Intrinsa 300 mikrogram/24 timer depotplaster
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
_ _
Hvert plaster på 28 cm
2
indeholder 8,4 mg testosteron og afgiver 300 mikrogram testosteron på
24 timer.
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Depotplaster.
Tyndt, gennemsigtigt, ovalt depotplaster af matrixtypen, bestående af
tre lag: et gennemsigtigt
bagsidelag, et klæbende matrixlag med lægemiddel og en
beskyttelsesfilm, som fjernes før brug.
Overfladen på hvert plaster er påtrykt T001.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Intrinsa er indiceret til behandling af hypoaktiv seksuel lyst
_(Hypoactive sexual desire disorder, _
_HSDD)_
hos kvinder med bilateral ovariektomi og hysterektomi (kirurgisk
induceret menopause) i
samtidig østrogenbehandling.
4.2
DOSERING OG INDGIVELSESMÅDE
Dosering
Den anbefalede daglige testosterondosis er 300 mikrogram. Dosis opnås
ved vedvarende applicering af
plastret to gange ugentligt. Plastret bør erstattes med et nyt
plaster hver 3. eller 4. dag. Der må kun
anvendes et plaster ad gangen.
_Samtidig østrogenbehandling _
Relevant brug af og restriktioner forbundet med østrogenbehandling
bør overvejes, før behandlingen
med Intrinsa indledes og ved rutinemæssig revurdering af
behandlingen. Fortsat anvendelse af Intrinsa
anbefales kun, mens samtidig brug af østrogen menes at være relevant
(dvs. den laveste, effektive
dosis i kortest mulige tid).
Det anbefales, at patienter, der er behandlet med konjugeret ekvint
østrogen
_(conjugated equine _
_estrogen, CEE),_
undlader at anvende Intrinsa, da effekten ikke er påvist (se pkt. 4.4
og 5.1).
_Varighed af behandlingen _
Respons på behandlingen med Intrinsa bør vurderes inden for 3-6
måneder efter behandlingsstart for at
afgøre, om det er relevant at fortsætte behandlingen. Patienter, som
ikke oplever en fordel af
behandlingen, der kan betegnes som meningsfuld, bør revurderes, og
det b
                                
                                Read the complete document

Similar products

Active ingredient Testosteron

Testosteron

ATC code G03BA03

G03BA03

Marketed by Warner Chilcott UK Ltd.

Warner Chilcott UK Ltd.

INN (International Name) testosterone

testosterone

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Patient Information leaflet Patient Information leaflet Bulgarian 18-06-2012
Summary of Product characteristics Summary of Product characteristics Bulgarian 18-06-2012
Public Assessment Report Public Assessment Report Bulgarian 18-06-2012
Patient Information leaflet Patient Information leaflet Spanish 18-06-2012
Summary of Product characteristics Summary of Product characteristics Spanish 18-06-2012
Public Assessment Report Public Assessment Report Spanish 18-06-2012
Patient Information leaflet Patient Information leaflet Czech 18-06-2012
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Public Assessment Report Public Assessment Report Czech 18-06-2012
Patient Information leaflet Patient Information leaflet German 18-06-2012
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Patient Information leaflet Patient Information leaflet Estonian 18-06-2012
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Public Assessment Report Public Assessment Report Estonian 18-06-2012
Patient Information leaflet Patient Information leaflet Greek 18-06-2012
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Public Assessment Report Public Assessment Report Greek 18-06-2012
Patient Information leaflet Patient Information leaflet English 18-06-2012
Summary of Product characteristics Summary of Product characteristics English 18-06-2012
Public Assessment Report Public Assessment Report English 18-06-2012
Patient Information leaflet Patient Information leaflet French 18-06-2012
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Public Assessment Report Public Assessment Report French 18-06-2012
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Summary of Product characteristics Summary of Product characteristics Slovak 18-06-2012
Public Assessment Report Public Assessment Report Slovak 18-06-2012
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Summary of Product characteristics Summary of Product characteristics Slovenian 18-06-2012
Public Assessment Report Public Assessment Report Slovenian 18-06-2012
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Summary of Product characteristics Summary of Product characteristics Finnish 18-06-2012
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Public Assessment Report Public Assessment Report Swedish 18-06-2012
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