Spojené štáty - angličtina - NLM (National Library of Medicine)

amring pharmaceuticals, inc. - desmopressin acetate (unii: xb13hyu18u) (desmopressin - unii:enr1llb0fp) - desmopressin acetate 10 ug in 0.1 ml - desmopressin acetate nasal spray is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older. limitations of use : desmopressin acetate nasal spray is not indicated for: - treatment of nephrogenic diabetes insipidus, - treatment of primary nocturnal enuresis [see warnings and precautions (5.1) ], - use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see warnings and precautions (5.2)], - use in patients with an impaired level of consciousness, - use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see dosage forms and strengths (3)]. desmopressin acetate nasal spray is contraindicated in patients with: - known hypersensitivity to desmopressin acetate or to any of the components of desmopress

Spojené štáty - angličtina - NLM (National Library of Medicine)

impax generics - desmopressin acetate (unii: xb13hyu18u) (desmopressin - unii:enr1llb0fp) - desmopressin acetate 0.1 mg - desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus. patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality. desmopressin acetate tablets are indicated for the management of primary nocturnal enuresis. desmopressin acetate may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention. desmopressin acetate tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate tablets. desmopressin a

Spojené štáty - angličtina - NLM (National Library of Medicine)

bryant ranch prepack - desmopressin acetate (unii: xb13hyu18u) (desmopressin - unii:enr1llb0fp) - desmopressin acetate 0.2 mg - desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. desmopressin acetate tablets are ineffective for the treatment of nephrogenic diabetes insipidus. patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality. desmopressin acetate tablets are indicated for the management of primary nocturnal enuresis. desmopressin acetate tablets may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention. desmopressin acetate tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate tablet

Spojené štáty - angličtina - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj), pramoxine hydrochloride (unii: 88ayb867l5) (pramoxine - unii:068x84e056) - hydrocortisone acetate 2.5 g in 100 g - topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Spojené štáty - angličtina - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate 150 mg in 1 ml - medroxyprogesterone acetate injectable suspension is indicated only for the prevention of pregnancy. the loss of bone mineral density (bmd) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in bmd that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use medroxyprogesterone acetate injectable suspension long-term [ see warnings and precautions ( 5.1) ]. the use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: - known or suspected pregnancy or as a diagnostic test for pregnancy. - active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [ see warnings and precautions ( 5.2) ]. - known or suspected malignancy of breast [ see warnings and precautions ( 5.3) ]. - known hypersensitivity to medroxyprogesterone acetate injectable suspension or any of its other ingredients [ see warnings and precautions ( 5.5)

Spojené štáty - angličtina - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate 5 mg - medroxyprogesterone acetate tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. they are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets. mpa tablets is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of breast cancer. - known or suspected estrogen- or progesterone-dependent neoplasia. - active dvt, pe, or a history of these conditions. - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions. - known anaphylactic reaction or angioedema to mpa. - known liver impairment or disease. - known or suspected pregnancy.

Európska únia - angličtina - EMA (European Medicines Agency)

gedeon richter plc. - ulipristal acetate - leiomyoma - sex hormones and modulators of the genital system, - ulipristal acetate is indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.

Spojené štáty - angličtina - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate tablets usp are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. they are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets. medroxyprogesterone acetate is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of breast cancer. - known or suspected estrogen- or progesterone-dependent neoplasia. - active dvt, pe, or a history of these conditions - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions. - known anaphylactic reaction or angioedema to medroxyprogesterone acetate. - known liver impairment or disease. - known or suspected pregnancy.

Spojené štáty - angličtina - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - desmopressin acetate (unii: xb13hyu18u) (desmopressin - unii:enr1llb0fp) - desmopressin acetate injection is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. limitations of use: desmopressin acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus. desmopressin acetate injection is indicated for patients with hemophilia a with factor viii coagulant activity levels greater than 5% without factor viii antibodies to: ·         maintain hemostasis during surgical procedures and postoperatively ·         reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. desmopressin acetate injection is indicated for patients with mild to moderate von willebrand’s disease (type i) with factor viii levels greater than 5% to: ·         maintain hemostasis during surgical procedures and postoperatively ·     

Spojené štáty - angličtina - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - abiraterone acetate (unii: em5ocb9yj6) (abiraterone - unii:g819a456d0) - abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with - metastatic castration-resistant prostate cancer (crpc) - metastatic high-risk castration-sensitive prostate cancer (cspc) none. risk summary the safety and efficacy of abiraterone acetate have not been established in females. based on findings from animal studies and the mechanism of action, abiraterone acetate  can cause fetal harm and potential loss of pregnancy. there are no human data on the use of abiraterone acetate in pregnant women. in animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures approximately ≥ 0.03 times the human exposure (auc) at the recommended dose (see data) . animal data in an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organ