Yhdysvallat - englanti - NLM (National Library of Medicine)

major pharmaceuticals - megestrol acetate (unii: tj2m0fr8es) (megestrol - unii:ea6ld1m70m) - megestrol acetate 40 mg - megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). it should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy. history of hypersensitivity to megestrol acetate or any component of the formulation.

Yhdysvallat - englanti - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - megestrol acetate (unii: tj2m0fr8es) (megestrol - unii:ea6ld1m70m) - megestrol acetate 40 mg in 1 ml - megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids). history of hypersensitivity to megestrol acetate or any component of the formulation. known or suspected pregnancy.

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical, inc. - megestrol acetate (unii: tj2m0fr8es) (megestrol - unii:ea6ld1m70m) - megestrol acetate 40 mg in 1 ml - megestrol acetate oral suspension, usp is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids). history of hypersensitivity to megestrol acetate or any component of the formulation. known or suspected pregnancy.

Yhdysvallat - englanti - 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 revised: 1/2024 mi:glat40:rx1

Yhdysvallat - englanti - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 5 mg - norethindrone acetate is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. norethindrone acetate is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.

Yhdysvallat - englanti - 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

Yhdysvallat - englanti - 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

Yhdysvallat - englanti - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - cortisone acetate (unii: 883wkn7w8x) (cortisone - unii:v27w9254fz) - cortisone acetate 25 mg - - 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 - 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 - collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus acute rheumatic carditis systemic dermat

Yhdysvallat - englanti - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 5 mg - norethindrone acetate tablets usp are indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. norethindrone acetate tablets usp are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection. - known or suspected pregnancy. there is no indication for norethindrone acetate in pregnancy. (see precautions .) - undiagnosed vaginal bleeding - known, suspected or history of cancer of the breast - active deep vein thrombosis, pulmonary embolism or history of these conditions - active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction) - impaired liver function or liver disease - as a diagnostic test for pregnancy - hypersensitivity to any of the drug components

Yhdysvallat - englanti - NLM (National Library of Medicine)

cameron pharmaceuticals, llc - hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone acetate 30 mg - hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani. hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components. drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.