AFOLIA follitropin alfa (rch) 75 IU/0.125 mL (5.5 microgram) solution for injection cartridge in a pre-filled pen

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Follitropin alfa, Quantity: 75 IU

Available from:

Gedeon Richter Australia Pty Ltd

INN (International Name):

Follitropin alfa

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: poloxamer; sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate dihydrate; methionine; phosphoric acid; thymidine; Trypsin

Administration route:

Subcutaneous

Units in package:

10, 1, 5

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

In adult women:,- Afolia is indicated for the treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated,- Controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies,- Afolia in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 IU/L.,In adult men:,- Afolia is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-11-27