Canada - English - Health Canada

sandoz canada incorporated - medroxyprogesterone acetate - suspension - 150mg - medroxyprogesterone acetate 150mg - progestins

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

noven therapeutics, llc - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - estradiol 0.05 mg in 1 d - combipatch is indicated in a woman with a uterus for: - treatment of moderate to severe vasomotor symptoms due to menopause. - treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. combipatch 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-dependent neoplasia. - active dvt, pe, or history of these conditions. - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions. - known anaphylactic reaction or angioedema or hypersensitivity with combipatch. - known liver impairment or disease. - known protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders. - known or suspected pregnancy. combipatch (käm-bē `pach) (estradiol/norethindrone acetate transdermal system) step 1. pick the days you will change your combipatch. - you will need to change your patch every 3 to 4 days (twice weekly). step 2. remove combipatch from the pouch. - tear open the protective pouch at the slit (do not use scissors) and remove the patch. see figure a. - the pouch should not be opened until you are ready to put the patch on. step 3. remove the adhesive liner. - peel off one side of the protective liner. see figure b. - do not touch the sticky part of the patch with your fingers. see figure b. step 4. placing the combipatch on your skin. - put the sticky side of the patch on the lower abdomen (below the panty line). see figure c. - peel off the second side of the protective liner. see figure c. - press the patch firmly in place with your hand for about 10 seconds. see figure d. note: - avoid the waistline, since clothing and belts may cause the combipatch to be rubbed off. - do not apply the combipatch to or near your breasts. - only apply the combipatch to skin that is clean, dry, and free of any powder, oil, or lotion. - you should not apply the combipatch to injured, burned, or irritated skin, or areas with skin conditions (such as birth marks, tattoos, or that is very hairy). step 5. press the combipatch firmly onto your skin. - rub the edges of the combipatch with your fingers to make sure that it will stick to your skin. see figure e. note: - bathing, swimming, or showering will not affect the combipatch. - once in place, the patch should not be exposed to the sun for prolonged periods of time. - if your combipatch falls off reapply it. if you cannot reapply the combipatch, apply a new combipatch to another area (see figures c , d and e) and continue to follow your original placement schedule. - if you stop using your combipatch or forget to apply a new combipatch as scheduled you may have spotting, or bleeding, and your symptoms may come back. step 6. throwing away your used combipatch. - when it is time to change your combipatch, remove the old combipatch before you apply a new one. - to throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. used patches should not be flushed in the toilet. this patient information and instructions for use have been approved by the u.s. food and drug administration. manufactured by: noven pharmaceuticals inc. miami, fl 33186 distributed by: noven therapeutics, llc miami, fl 33186 for more information call 1-800-455-8070 or visit www.combipatch.com. © 2024 noven pharmaceuticals, inc. 102538-5 02/2024

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

amneal pharmaceuticals of new york llc - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 10 ug - estradiol is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.3)] . - breast cancer or history of breast cancer [see warnings and precautions (5.3)] . - estrogen-dependent neoplasia [see warnings and precautions (5.3)] . - active dvt, pe, or history of these conditions [see warnings and precautions (5.2)] . - active arterial thromboembolic disease (for example, stroke or mi), or a history of these conditions [see warnings and precautions (5.2)] . - known anaphylactic reaction, or angioedema, or hypersensitivity to estradiol [see warnings and precautions (5.16)] . - hepatic impairment or disease. - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders. risk summary estradiol is not indicated for use in pregnancy. there are no data with the use of estradiol in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy. in the u.s. 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. risk summary estrogens are present in human milk and can reduce milk production in breast-feeding females. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for estradiol and any potential adverse effects on the breastfed child from estradiol or from the underlying maternal condition. estradiol is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing estradiol to determine whether those over 65 years of age differ from younger subjects in their response to estradiol. the women’s health initiative studies in the whi estrogen-alone substudy (daily ce [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see clinical studies (14.2) ] . in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see clinical studies (14.2) ] . the women’s health initiative memory study in the whims ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see warnings and precautions (5.4) and clinical studies (14.3) ] . since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8  [see warnings and precautions (5.4) and clinical studies (14.3) ] . estradiol (ess-tra-dye-ole) vaginal inserts read this instructions for use before you start using estradiol vaginal inserts and  each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment. how should i use estradiol vaginal inserts? - estradiol vaginal insert is an insert for use only in the vagina. do not take by mouth. - wash and dry your hands well before handling estradiol vaginal insert. step 1: tear off 1 applicator. step 2: pull apart the plastic wrap and remove the applicator (see figure a). if after opening the package you see that the estradiol vaginal insert has come out of the applicator but has not fallen out of the package, carefully put the insert back into the applicator for insertion. figure a step 3: hold the applicator between your thumb and middle finger. leave your index (pointer) finger free to press the applicator plunger (see figure b). figure b step 4: select the best position for vaginal insertion of estradiol vaginal inserts that is most comfortable for you. for insertion in the lying down position, see figure c. for insertion in the standing position, see figure d figure c figure d step 5: gently insert the end of the applicator into your vagina as far as it will comfortably go or until half of the applicator is inside your vagina, whichever is less. do not use force. if the insert falls out of the applicator before insertion, throw away (dispose of) the insert and applicator. get a new applicator. step 6: while holding the applicator in place, gently press the applicator plunger with your index (pointer) finger until it stops, to release the insert into your vagina. the insert will dissolve. step 7: gently remove the applicator from your vagina and throw away (dispose of) after use. insertion may be done at any time of the day. it is advisable to use the same time daily for all applications of estradiol vaginal inserts. if you have any questions, please ask your healthcare provider or pharmacist. how should i store estradiol vaginal inserts? - store estradiol vaginal inserts at room temperature between 68ºf to 77ºf (20ºc to 25ºc). - do not refrigerate. keep estradiol vaginal inserts and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: amneal pharmaceuticals of new york, llc brookhaven, ny 11719 rev. 01-2024-01

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

mylan pharmaceuticals inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.025 mg in 1 d - estradiol transdermal system (twice-weekly) is indicated for:       when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products.       when prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. consider estrogen therapy only for women at significant risk of osteoporosis. estradiol transdermal system (twice-weekly) is contraindicated in women with any of the following conditions: estradiol transdermal system (twice-weekly) is not indicated for use in pregnancy. there are no data with the use of estradiol transdermal system (twice-weekly) in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogen and progestins) before conception or during early pregna

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

pd-rx pharmaceuticals, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 1 mg - estradiol tablets are indicated in the: - treatment of moderate to severe vasomotor symptoms associated with the menopause. - treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. - treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). - prevention of osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (see clinical pharmacology: clinical studies). - the mainstays for decreasing the risk of

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

physicians total care, inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone 400 mg in 1 ml - adjunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial or renal carcinoma. - known or suspected pregnancy or as a diagnostic test for pregnancy - undiagnosed vaginal bleeding - known or suspected malignancy of breast - active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease - liver dysfunction or disease - known sensitivity to depo-provera (medroxyprogesterone acetate or any of its other ingredients).

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

golden state medical supply, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.5 mg - estradiol tablets usp are indicated in the: - treatment of moderate to severe vasomotor symptoms associated with the menopause. - treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. - treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). - prevention of osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (see clinical pharmacology , clinical studies .) the mainstays for d

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

readymeds - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 1 mg - estradiol tablets are indicated in the: 1.    treatment of moderate to severe vasomotor symptoms associated with the menopause.  2.    treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. when prescribed solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.  3.    treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4.    treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. 5.    treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). 6.    prevention of osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (see clinical pharmacology, clinical studies .) the mainstays for decreasing the

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

teva pharmaceuticals usa, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.1 mg in 1 g - estradiol vaginal cream usp 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. estradiol vaginal cream usp 0.01% 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-dependent neoplasia. - active dvt, pe or history of these conditions. - active arterial thromboembolic disease (for example, stroke, mi) or a history of these conditions. - known anaphylactic reaction or angioedema to estradiol vaginal cream usp 0.01%. - known liver dysfunction or disease. - known protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders. - known or suspected pregnancy.

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

mylan pharmaceuticals inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.025 mg in 1 d - estradiol transdermal system continuous delivery (once-weekly) is indicated for:     when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.       when prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. consider estrogen therapy only for women at significant risk of osteoporosis. estradiol transdermal system continuous delivery (once-weekly) is contraindicated in women with any of the following conditions: estradiol transdermal system continuous delivery (once-weekly) is not indicated for use in pregnancy. there are no data with the use of estradiol transdermal system continuous delivery (once-weekly) in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined