Australia - English - Department of Health (Therapeutic Goods Administration)

gedeon richter australia pty ltd - follitropin alfa, quantity: 450 iu - injection, solution - excipient ingredients: poloxamer; sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate dihydrate; methionine; phosphoric acid; thymidine; trypsin - in adult women:,- bemfola 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,- 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.,in adult men:,- bemfola is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.

Australia - English - Department of Health (Therapeutic Goods Administration)

gedeon richter australia pty ltd - follitropin alfa, quantity: 300 iu - injection, solution - excipient ingredients: poloxamer; sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate dihydrate; methionine; phosphoric acid; thymidine; trypsin - in adult women:,- bemfola 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,- 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.,in adult men:,- bemfola is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.

Australia - English - Department of Health (Therapeutic Goods Administration)

gedeon richter australia pty ltd - follitropin alfa, quantity: 225 iu - injection, solution - excipient ingredients: poloxamer; sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate dihydrate; methionine; phosphoric acid; thymidine; trypsin - in adult women:,- bemfola 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,- 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.,in adult men:,- bemfola is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.

Australia - English - Department of Health (Therapeutic Goods Administration)

gedeon richter australia pty ltd - follitropin alfa, quantity: 150 iu - injection, solution - excipient ingredients: poloxamer; sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate dihydrate; methionine; phosphoric acid; thymidine; trypsin - in adult women:,- bemfola 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,- 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.,in adult men:,- bemfola is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.

Australia - English - Department of Health (Therapeutic Goods Administration)

gedeon richter australia pty ltd - follitropin alfa, quantity: 75 iu - injection, solution - excipient ingredients: poloxamer; sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate dihydrate; methionine; phosphoric acid; thymidine; trypsin - in adult women:,- bemfola 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,- 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.,in adult men:,- bemfola is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.

Australia - English - Department of Health (Therapeutic Goods Administration)

organon pharma pty ltd - corifollitropin alfa, quantity: 0.2 mg/ml - injection, solution - excipient ingredients: sodium citrate dihydrate; sodium hydroxide; sucrose; polysorbate 20; water for injections; methionine; hydrochloric acid - controlled ovarian stimulation (cos) for the development of multiple follicles and pregnancy in women undergoing in-vitro fertilisation techniques.

Australia - English - Department of Health (Therapeutic Goods Administration)

organon pharma pty ltd - corifollitropin alfa, quantity: 0.3 mg/ml - injection, solution - excipient ingredients: sodium citrate dihydrate; sucrose; hydrochloric acid; polysorbate 20; water for injections; sodium hydroxide; methionine - controlled ovarian stimulation (cos) for the development of multiple follicles and pregnancy in women undergoing in-vitro fertilisation techniques.

United States - English - NLM (National Library of Medicine)

organon llc - follitropin (unii: 076whw89tw) (follitropin - unii:076whw89tw) - follistim® aq cartridge (follitropin beta) injection, is indicated: in women for: prior to initiation of treatment with follistim aq cartridge: - women should have a complete gynecologic and endocrinologic evaluation. - primary ovarian failure should be excluded. - the possibility of pregnancy should be excluded. - tubal patency should be demonstrated. - the fertility status of the male partner should be evaluated. prior to initiation of treatment with follistim aq cartridge: - women should have a complete gynecologic and endocrinologic evaluation and diagnosis of cause of infertility. - the possibility of pregnancy should be excluded. - the fertility status of the male partner should be evaluated. in men for: prior to initiation of treatment with follistim aq cartridge: - men should have a complete medical and endocrinologic evaluation. - hypogonadotropic hypogonadism should be confirmed and primary testicular failure should be excluded. - serum testosterone levels should be normalized with human chorionic gonadotropin (hcg) treatment. - the fertility status of the female partner should be evaluated. follistim aq cartridge is contraindicated in women and men who exhibit: - prior hypersensitivity to recombinant hfsh products - high levels of fsh indicating primary gonadal failure - presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see indications and usage (1.1, 1.2, 1.3)] - hypersensitivity reactions to streptomycin or neomycin. follistim aq may contain traces of these antibiotics - tumors of the ovary, breast, uterus, testis, hypothalamus or pituitary gland follistim aq cartridge is also contraindicated in women who exhibit: - pregnancy [see use in specific populations (8.1)] - heavy or irregular vaginal bleeding of undetermined origin - ovarian cysts or enlargement not due to polycystic ovary syndrome (pcos) risk summary follistim aq cartridge is contraindicated for use in pregnant women and offers no benefit during pregnancy. risk summary it is not known whether this drug is excreted in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for follistim aq cartridge and any potential adverse effects on the breastfed child from follistim aq cartridge or from the underlying maternal condition. follistim aq cartridge is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. clinical studies of follistim aq cartridge have not been conducted in patients 65 years of age and older.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - urofollitropin - powder for solution for injection - urofollitropin 75 iu/vial - urofollitropin - urofollitropin - a treatment with fsh followed by the administration of human chronic gonadotrophin (hcg) is indicated to induce ovulation in infertile women suffering from hypothalamus or hypophyseal disorders and in spanomenorrhoeic or amenorrhoeic women. these women belong to the who group ii and have generally already been treated with clomiphene citrate. most have polycystic ovarian syndrome. fsh offers good therapeutic prospects for patients whose lh:fsh ratio has to be adjusted, avoiding an exogenous supply of lh fsh may be used alone or in concomitance with human menopausal gonadotropin (hmg) in order to stimulate multiple follicular growth in patients involved in medically assisted reproduction programs (ivf-et,gift).

Israel - English - Ministry of Health

tzamal bio-pharma ltd - urofollitropin - powder for solution for injection - urofollitropin 150 iu/vial - urofollitropin - urofollitropin - a treatment with fsh followed by the administration of human chronic gonadotrophin (hcg) is indicated to induce ovulation in infertile women suffering from hypothalamus or hypophyseal disorders and in spanomenorrhoeic or amenorrhoeic women. these women belong to the who group ii and have generally already been treated with clomiphene citrate. most have polycystic ovarian syndrome. fsh offers good therapeutic prospects for patients whose lh:fsh ratio has to be adjusted, avoiding an exogenous supply of lh fsh may be used alone or in concomitance with human menopausal gonadotropin (hmg) in order to stimulate multiple follicular growth in patients involved in medically assisted reproduction programs (ivf-et,gift).