Products

Key Product

Leuprorelin Acetate sterile lyophilized microspheres sustained release for injection, 3.75mg with 2ml solution

Features

1. Essential excipients are imported from US, fully compliant with US FDA standard.

2. Encapsulation efficiency reaches 95%, product dry weight 45mg, drug loading 8.3%.

3. Stable 28 days sustained release.

4. Monograph of Leuprorelin Acetate microspheres in China Pharmacopeia was drafted by the company.

5. The first approved Leuprorelin Acetate microspheres for injection by China FDA.

 

INDICATIONS AND USAGE

Endometriosis

Leuprorelin Acetate microspheres 3.75 mg is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. Leuprorelin Acetate monthly with norethindrone acetate 5 mg daily is also indicated for initial management of endometriosis and for management of recurrence of symptoms.Duration of initial treatment or retreatment should be limited to 6 months.

Uterine Leiomyoma (Fibroids)

Leuprorelin Acetate microspheres 3.75 mg concomitantly with iron therapy is indicated for the preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata. The clinician may wish to consider a one-month trial period on iron alone inasmuch as some of the patients will respond to iron alone. Leuprorelin Acetate may be added if the response to iron alone is considered inadequate. Recommended duration of therapy with Leuprorelin Acetate 3.75 mg is up to three months.

Experience with Leuprorelin Acetate in females has been limited to women 18 years of age and older.

Breast Cancer

Essential listed medicine

Prostate Cancer

Essential listed medicine

Central precocious puberty

Listed medicine for standard treatment