Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Testosterone
Warner Chilcott Deutschland GmbH
G03BA03
testosterone
Sex hormones and modulators of the genital system,
Sexual Dysfunctions, Psychological
Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.
Revision: 6
Withdrawn
2006-07-28
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Livensa 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 Livensa 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 _._ Livens _Concomitant estrogen treatment _ The appropriate use and restrictions associated with estrogen therapy should be considered before Livensa therapy is initiated and during routine re-evaluation of treatment. Continued use of Livensa 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 Livensa, as efficacy has not been demonstrated (see sections 4.4 and 5.1). _Duration of treatment_ _ _ Livensa 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 Прочетете целия документ
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Livensa 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 Livensa 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 _._ Livens _Concomitant estrogen treatment _ The appropriate use and restrictions associated with estrogen therapy should be considered before Livensa therapy is initiated and during routine re-evaluation of treatment. Continued use of Livensa 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 Livensa, as efficacy has not been demonstrated (see sections 4.4 and 5.1). _Duration of treatment_ _ _ Livensa 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 Прочетете целия документ