ABOUT FEMARELLE® (DT56a)
MENOPAUSE SYMPTOMS & FEMARELLE®
BONE HEALTH SUPPORT:
*Health Canada has not approved Femarelle for vaginal atrophy. Using Femarelle for vaginal atrophy would be considered off-label use.
*Femarelle is not recommended for use in breast cancer patients.
About Femarelle® (DT56a)
Produced under strict pharmaceutical conditions, Femarelle® is a standardized substance from plant origin. Each capsule contains 322 mg fermented soybean extract (DT56a) & 108 mg of flaxseed (excipient).
Femarelle® is encapsulated in transparent gelatin capsules, size 0. The contents are beige with brown specks. Disintegration time is within one hour after swallowing.
Femarelle® is intended for menopausal and postmenopausal women. The therapeutic indication is the relief of menopausal symptoms and to support bone health.
The recommended intake of Femarelle® is one capsule taken twice daily (morning and evening), with or without food.
Femarelle® has been available in the worldwide market since the year 2000. It is well tolerated, and no serious adverse events have been reported to date. Femarelle® was introduced to the Canadian market in November 2014.
The manufacturing procedure of Femarelle® provides this unique proprietary compound. The manufacturing follows the industry standards for drugs; comprehensive microbiological and biochemical testing are rigorously performed throughout the process. The pharmacological efficacy and the shelf life of the product are constantly monitored, and state-of-the-art technology is used to maintain the long-term stability of the active ingredient in the product.
The manufacturing procedure is subject to the strictest quality control standards with ISO 9001-2008, HAACP, cGMP and BVQI certificates as well as the environmental ISO 14001.
Se-cure Pharmaceuticals Ltd. is committed to ensuring that each capsule produced is characterized by identical therapeutic features according to the accepted standards of the pharmaceutical industry.
The uniqueness of Femarelle® derives from its origin as a plant-based SERM (Selective Estrogen Receptor Modulator) that targets specific tissue sites, while having no effect on others.
Femarelle® relieves menopausal symptoms both in the short and long term and increases bone mineral density, while having no effect on the uterus or on breast tissue (Figure 2). This tissue-selective mechanism of activity has been demonstrated and confirmed in clinical and pre-clinical studies (see next section).
Femarelle® represents the new generation of treatment for menopause management, providing a safe and effective solution for the relief of vasomotor symptoms and to support bone health.