Intrinsa
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
18-06-2012
Summary of Product characteristics
(SPC)
18-06-2012
Public Assessment Report
(PAR)
18-06-2012
Active ingredient:
Testosterone
Available from:
Warner Chilcott UK Ltd.
ATC code:
G03BA03
INN (International Name):
testosterone
Therapeutic group:
Sex hormones and modulators of the genital system,
Therapeutic area:
Sexual Dysfunctions, Psychological
Therapeutic indications:
Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.
Product summary:
Revision: 6
Authorization status:
Withdrawn
Authorization date:
2006-07-28
Patient Information leaflet
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Intrinsa 300 micrograms/24 hours transdermal patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each patch of 28 cm
2
contains 8.4 mg testosterone and provides 300 micrograms of
testosterone per
24 hours.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch.
Thin, clear, oval matrix-type transdermal patch consisting of three
layers: a translucent backing film,
an adhesive matrix drug layer, and a protective release liner that is
removed prior to application. Each
patch surface is stamped with T001.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Intrinsa is indicated for the treatment of hypoactive sexual desire
disorder (HSDD) in bilaterally
oophorectomised and hysterectomised (surgically induced menopause)
women receiving concomitant
estrogen therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended daily dose of testosterone is 300 micrograms. This is
achieved by applying the
patch twice weekly on a continuous basis. The patch should be replaced
with a fresh patch every 3 to
4 days. Only one patch is to be worn at a time
_._
_Concomitant estrogen treatment _
The appropriate use and restrictions associated with estrogen therapy
should be considered before
Intrinsa therapy is initiated and during routine re-evaluation of
treatment. Continued use of Intrinsa is
only recommended while concomitant use of estrogen is considered
appropriate (i.e. the lowest
effective dose for the shortest possible duration).
Patients treated with conjugated equine estrogen (CEE) are not
recommended to use Intrinsa, as
efficacy has not been demonstrated (see sections 4.4 and 5.1).
_Duration of treatment _
Intrinsa treatment response should be evaluated within 3-6 months of
initiation, to determine if
continued therapy is appropriate. Patients who do not experience a
meaningful benefit should be re-
evaluated and discontinuation of therapy be considered.
As t
Read the complete document
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Intrinsa 300 micrograms/24 hours transdermal patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each patch of 28 cm
2
contains 8.4 mg testosterone and provides 300 micrograms of
testosterone per
24 hours.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch.
Thin, clear, oval matrix-type transdermal patch consisting of three
layers: a translucent backing film,
an adhesive matrix drug layer, and a protective release liner that is
removed prior to application. Each
patch surface is stamped with T001.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Intrinsa is indicated for the treatment of hypoactive sexual desire
disorder (HSDD) in bilaterally
oophorectomised and hysterectomised (surgically induced menopause)
women receiving concomitant
estrogen therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended daily dose of testosterone is 300 micrograms. This is
achieved by applying the
patch twice weekly on a continuous basis. The patch should be replaced
with a fresh patch every 3 to
4 days. Only one patch is to be worn at a time
_._
_Concomitant estrogen treatment _
The appropriate use and restrictions associated with estrogen therapy
should be considered before
Intrinsa therapy is initiated and during routine re-evaluation of
treatment. Continued use of Intrinsa is
only recommended while concomitant use of estrogen is considered
appropriate (i.e. the lowest
effective dose for the shortest possible duration).
Patients treated with conjugated equine estrogen (CEE) are not
recommended to use Intrinsa, as
efficacy has not been demonstrated (see sections 4.4 and 5.1).
_Duration of treatment _
Intrinsa treatment response should be evaluated within 3-6 months of
initiation, to determine if
continued therapy is appropriate. Patients who do not experience a
meaningful benefit should be re-
evaluated and discontinuation of therapy be considered.
As t
Read the complete document
