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

aidarex pharmaceuticals llc - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate 2.5 mg - medroxyprogesterone acetate tablets usp are a progestin 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. medroxyprogesterone acetate tablets usp are also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets. medroxyprogesterone acetate tablets usp should not be used in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of cancer of the breast. - known or suspected estrogen- or progesterone-dependent neoplasia. - active deep vein thrombosis, pulmonary embolism or a history of these conditions. - active or recent (within the past year) arterial thromboembolic disease (for example, stroke and myocardial infarction). - known liver dysfunction or disease. - missed abortion. - as a diagnostic test for pregnancy. -

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

mylan pharmaceuticals inc. - glatiramer acetate (unii: 5m691hl4bo) (glatiramer - unii:u782c039qp) - glatiramer acetate 40 mg in 1 ml - glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. glatiramer acetate injection is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. available human data on the use of glatiramer acetate injection in pregnant women are not sufficient to support conclusions about drug-associated risk for major birth defects and miscarriage. administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryofetal or offspring development (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. there are no adequate and well-controlled studies of glatiramer acetate injection in pregnant women. the available postmarketing reports, case series, and small cohort studies do not provide sufficient information to support conclusions about drug-associated risk for major birth defects and miscarriage. in rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryofetal development were observed at doses up to 37.5 mg/kg/day (18 and 36 times, respectively, the therapeutic human dose of 20 mg/day on a mg/m2 basis). in rats receiving subcutaneous glatiramer acetate at doses of up to 36 mg/kg from day 15 of pregnancy throughout lactation, no significant effects on delivery or on offspring growth and development were observed. there are no data on the presence of glatiramer acetate in human milk. based on the low systemic exposure because of substantial local hydrolysis of glatiramer acetate following subcutaneous administration, breastfeeding is not expected to result in clinically relevant exposure of the infant to the drug [see clinical pharmacology (12.3)] . there are no data on the effects of glatiramer acetate on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glatiramer acetate injection and any potential adverse effects on the breastfed infant from glatiramer acetate injection or from the underlying maternal condition. the safety and effectiveness of glatiramer acetate injection have not been established in patients under 18 years of age. glatiramer acetate injection has not been studied in elderly patients. the pharmacokinetics of glatiramer acetate in patients with impaired renal function have not been determined. glatiramer acetate injection (gla tir′ a mer as′ e tate) 40 mg/ml for subcutaneous use for subcutaneous injection only. do not inject glatiramer acetate injection in your veins (intravenously). do not re-use your glatiramer acetate prefilled syringes. do not share your glatiramer acetate prefilled syringes with another person. you may give another person an infection or get an infection from them. you should receive your first dose of glatiramer acetate injection with a healthcare provider or nurse present. this might be at your healthcare provider’s office or with a visiting home health nurse who will show you how to give your own injections. glatiramer acetate injection comes in a 40 mg prefilled syringe with needle attached. how often a dose is given depends on the product strength that is prescribed. your healthcare provider will prescribe the correct dose for you. if you plan to use your glatiramer acetate product with an autoinjector, ask your healthcare provider or pharmacist to make sure that your autoinjector is meant to be used with your glatiramer acetate product. if you use an autoinjector that is not meant to be used with your glatiramer acetate product, you might not get the correct dose of your medicine. instructions for using your glatiramer acetate 40 mg prefilled syringe: how do i inject glatiramer acetate injection? step 1 : gather the supplies you will need to inject glatiramer acetate injection. see figure a. step 2: remove only 1 blister pack from the glatiramer acetate prefilled syringe carton. see figure b . step 3: look closely at your glatiramer acetate prefilled syringe. step 4: choose your injection area. see figure c . see the injection areas you should use on your body. talk with your healthcare provider about the injection areas that are best for you. step 5: prepare to give your injection. step 6: clean your injection site. step 7: pick up the syringe with 1 hand and hold it like a pencil. remove the needle cover with your other hand and set it aside. see figure e . step 8: pinch about a 2 inch fold of skin between your thumb and index finger. see figure f . step 9: giving your injection. step 10: give your glatiramer acetate injection. to inject the medicine, hold the syringe steady and slowly push down the plunger. see figure i. step 11: remove the needle. after you have injected all of the medicine, pull the needle straight out. see figure j. step 12: use a clean, dry cotton ball to gently press on the injection site for a few seconds. do not rub the injection site or re-use the needle or syringe. see figure k . step 13: dispose of your needles and syringes. this instructions for use has been approved by the u.s. food and drug administration. manufactured for: mylan pharmaceuticals inc. morgantown, wv 26505 u.s.a. manufactured by: mylan institutional galway, ireland 50097157 revised: 1/2024 mi:glat40:r11

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

hikma pharmaceutical - cortisone acetate (unii: 883wkn7w8x) (cortisone - unii:v27w9254fz) - cortisone acetate 25 mg - 1. endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post-traumatic osteoarthritis synovitis of osteoarthritis epicondylitis 3. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus acute rheumatic carditis systemic dermatomyositis

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

hikma pharmaceuticals usa inc. - cortisone acetate (unii: 883wkn7w8x) (cortisone - unii:v27w9254fz) - cortisone acetate 25 mg - 1.  endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2.  rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post-traumatic osteoarthritis synovitis of osteoarthritis epicondylitis 3.  collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus acute rheumatic carditis systemic dermatomyosit

United States - English - 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.

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

strides pharma science pty ltd - cyproterone acetate, quantity: 100 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate - inoperable prostatic carcinoma. to suppress flare with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

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

strides pharma science pty ltd - cyproterone acetate, quantity: 100 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate - inoperable prostatic carcinoma. to suppress flare with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

United States - English - 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

United States - English - 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 organogenesis (gestational days 6 to 17). findings included embryo-fetal lethality (increased post implantation loss and resorptions and decreased number of live fetuses), fetal developmental delay (skeletal effects) and urogenital effects (bilateral ureter dilation) at doses ≥10 mg/kg/day, decreased fetal ano-genital distance at ≥30 mg/kg/day, and decreased fetal body weight at 100 mg/kg/day. doses ≥10 mg/kg/day caused maternal toxicity. the doses tested in rats resulted in systemic exposures (auc) approximately 0.03, 0.1 and 0.3 times, respectively, the auc in patients. risk summary the safety and efficacy of abiraterone acetate have not been established in females. there is no information available on the presence of abiraterone in human milk, or on the effects on the breastfed child or milk production. contraception males based on findings in animal reproduction studies and its mechanism of action, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 weeks after the final dose of abiraterone acetate [see use in specific populations (8.1)] . infertility based on animal studies, abiraterone acetate may impair reproductive function and fertility in males of reproductive potential [see nonclinical toxicology (13.1)] . safety and effectiveness of abiraterone acetate in pediatric patients have not been established. of the total number of patients receiving abiraterone acetate in randomized clinical trials, 70% of patients were 65 years and over and 27% were 75 years and over. no overall differences in safety or effectiveness were observed between these elderly patients and younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetics of abiraterone were examined in subjects with baseline mild (n=8) or moderate (n=8) hepatic impairment (child-pugh class a and b, respectively) and in 8 healthy control subjects with normal hepatic function. the systemic exposure (auc) of abiraterone after a single oral 1,000 mg dose of abiraterone acetate increased by approximately 1.1-fold and 3.6-fold in subjects with mild and moderate baseline hepatic impairment, respectively compared to subjects with normal hepatic function. in another trial, the pharmacokinetics of abiraterone were examined in subjects with baseline severe (n=8) hepatic impairment (child-pugh class c) and in 8 healthy control subjects with normal hepatic function. the systemic exposure (auc) of abiraterone increased by approximately 7-fold and the fraction of free drug increased 2-fold in subjects with severe baseline hepatic impairment compared to subjects with normal hepatic function. no dosage adjustment is necessary for patients with baseline mild hepatic impairment. in patients with baseline moderate hepatic impairment (child-pugh class b), reduce the recommended dose of abiraterone acetate to 250 mg once daily. do not use abiraterone acetate in patients with baseline severe hepatic impairment (child-pugh class c). if elevations in alt or ast >5 x uln or total bilirubin >3 x uln occur in patients with baseline moderate hepatic impairment, discontinue abiraterone acetate treatment [see dosage and administration (2.4)  and clinical pharmacology (12.3)] . for patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required [see dosage and administration (2.4), warnings and precautions (5.3), and clinical pharmacology (12.3)] . no dosage adjustment is necessary for patients with renal impairment [see clinical pharmacology (12.3)] .

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

hikma pharmaceuticals usa inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. limitations of use : the use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see dosage and administration (2.1) and warnings and precautions (5.1)]. the use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: medroxyprogesterone acetate injectable suspension should not be administered during pregnancy. [see contraindications and warnings and precautions (5.17).] medroxyprogesterone acetate injectable suspension is not indicated before menarche. use of medroxyprogesterone acetate injectable suspension is associated with significant loss of bmd. this loss of bmd is of particular concern during adolescence and early adulthood, a critical period of bone accretion. in adolescents, interpretation of bm