April 2017April 2017
New Product - Bemfola
Bemfola (follitropin alfa (rch) (recombinant human FSH)) is indicated in adult women for the treatment of anovulatory infertility in those who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated. It is also indicated in the controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies. Bemfola 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. Bemfola is also indicated in adult men with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin deficient men in whom hCG alone is ineffective. Bemfola is contraindicated for safety reasons in tumours of the hypothalamus or pituitary gland. FSH therapy is contraindicated for safety reasons where the following exist in women: pregnancy and lactation; ovarian enlargement or ovarian cyst of unknown aetiology; gynaecological haemorrhages of unknown aetiology; and in ovarian, uterine or breast carcinoma. FSH is contraindicated when an effective response cannot be obtained, such as, in women: primary ovarian failure as indicated by high levels of FSH (ovarian dysgenesis, premature menopause); malformations of sexual organs incompatible with pregnancy; and in fibroid tumours of the uterus incompatible with pregnancy. Bemfola is contraindicated in men with: elevated gonadotrophin levels that indicate primary testicular failure; and in infertility disorders other than hypogonadotrophic hypogonadism. Bemfola should not be used in the elderly or children. Bemfola is available as a solution for injection (prefilled pen containing cartridge) in the following presentations in packs of 5’s. 75 IU/0.125 mL (≡ 5.5 microgram follitropin alfa), 150 IU/0.25 mL (≡ 11 microgram follitropin alfa), 225 IU/0.375 mL (≡ 16.5 microgram follitropin alfa), 300 IU/0.50 mL (≡ 22 microgram follitropin alfa) and 450 IU/0.75 mL (≡ 33 microgram follitropin alfa).
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