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

amneal pharmaceuticals llc - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - dotti is indicated for: limitations of use : when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products. limitations of use : 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. dotti is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.2)] . - breast cancer or a history of breast cancer [see warnings and precautions (5.2)] . - estrogen-dependent neoplasia [see warnings and precautions (5.2)] . - active dvt, pe, or a history of these conditions [see warnings and precautions (5.1)] . - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions [see warnings and precautions (5.1)] . - known anaphylactic reaction, or angioedema, or hypersensitivity to dotti - hepatic impairment or disease - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders risk summary dotti is not indicated for use in pregnancy. there are no data with the use of dotti 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 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 women. 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 dotti and any potential adverse effects on the breastfed child from dotti or from the underlying maternal condition. dotti is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. if estrogen is administered to patients whose bone growth is not complete, periodic monitoring of bone maturation and effects on epiphyseal centers is recommended during estrogen administration.  there have not been sufficient numbers of geriatric women involved in clinical studies utilizing dotti to determine whether those over 65 years of age differ from younger subjects in their response to dotti. 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 warnings and precautions (5.1), and clinical studies (14.3)] . 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 warnings and precautions (5.1), and clinical studies (14.3)] . 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 (5.3), and clinical studies (14.4)] . 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 (5.3), and clinical studies (14.4)] . dotti (dah ʹ tee) (estradiol transdermal system) read this instructions for use before you start using dotti 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. 1. determine your schedule for your twice-a-week application - decide upon which 2 days you will change your patch. - your dotti (estradiol transdermal system) individual carton contains a calendar card printed on its inner flap. mark the 2-day schedule you plan to follow on your carton’s inner flap. - be consistent. - if you forget to change your patch on the correct date, apply a new one as soon as you remember. - no matter what day this happens, stick to the schedule you have marked on the inner flap of your carton (your calendar card). 2. where to apply dotti - apply patch to a dry area of the skin of the trunk of the body, including the lower abdomen, or buttocks. avoid the waistline, since clothing may cause the patch to rub off. - do not apply patch to breasts. - when changing your patch, based on your twice-a-week schedule, apply your new patch to a different site. do not apply a new patch to that same area for at least 1 week. 3. before you apply dotti make sure your skin is: - clean (freshly washed), dry and cool. - free of any powder, oil, moisturizer or lotion. - free of cuts or irritations (rashes or other skin problems). 4. how to apply dotti - each patch is individually sealed in a protective pouch. - tear open the pouch at the tear notch (do not use scissors). - remove the patch. - apply the patch immediately after removing from the pouch. - holding the patch with the rigid protective liner facing you, remove half  of the liner, which covers the sticky surface of the patch. - avoid touching the sticky side of the patch with your fingers. - using the other half of the rigid protective liner as a handle, apply the sticky side of the patch to the selected area of the abdomen or buttocks. - press the sticky side of the patch firmly into place. - smooth it down. - while still holding the sticky side down, fold back the other half of the patch. - grasp an edge of the remaining protective liner and gently pull it off. - avoid touching the sticky side of the patch with your fingers. - press the entire patch firmly into place with the palm of your hand. - continue to apply pressure, with the palm of your hand over the patch, for approximately 10 seconds. - make sure that the patch is properly adhered to your skin. - go over the edges with your finger to ensure good contact around the patch. note: - showering will not cause your patch to fall off. - if your patch falls off reapply it. if you cannot reapply the patch, apply a new patch to another area and continue to follow your original placement schedule. - if you stop using your dotti patch or forget to apply a new patch as scheduled, you may have spotting, or bleeding, and recurrence of symptoms. 5. throwing away your used patch - when it is time to change your patch, remove the old patch before you apply a new patch. - to throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place the 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. distributed by: amneal pharmaceuticals  llc bridgewater, nj 08807 rev. 03-2022-02

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

bryant ranch prepack - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - dotti is indicated for: limitations of use : when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products. limitations of use : 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. dotti is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.2)] . - breast cancer or a history of breast cancer [see warnings and precautions (5.2)] . - estrogen-dependent neoplasia [see warnings and precautions (5.2)] . - active dvt, pe, or a history of these conditions [see warnings and precautions (5.1)] . - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions [see warnings and precautions (5.1)] . - known anaphylactic reaction, or angioedema, or hypersens

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

bryant ranch prepack - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - dotti is indicated for: limitations of use : when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products. limitations of use : 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. dotti is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.2)] . - breast cancer or a history of breast cancer [see warnings and precautions (5.2)] . - estrogen-dependent neoplasia [see warnings and precautions (5.2)] . - active dvt, pe, or a history of these conditions [see warnings and precautions (5.1)] . - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions [see warnings and precautions (5.1)] . - known anaphylactic reaction, or angioedema, or hypersens

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

bryant ranch prepack - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - dotti is indicated for: limitations of use : when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products. limitations of use : 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. dotti is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.2)] . - breast cancer or a history of breast cancer [see warnings and precautions (5.2)] . - estrogen-dependent neoplasia [see warnings and precautions (5.2)] . - active dvt, pe, or a history of these conditions [see warnings and precautions (5.1)] . - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions [see warnings and precautions (5.1)] . - known anaphylactic reaction, or angioedema, or hypersens

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

bryant ranch prepack - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - dotti is indicated for: limitations of use : when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products. limitations of use : 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. dotti is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.2)] . - breast cancer or a history of breast cancer [see warnings and precautions (5.2)] . - estrogen-dependent neoplasia [see warnings and precautions (5.2)] . - active dvt, pe, or a history of these conditions [see warnings and precautions (5.1)] . - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions [see warnings and precautions (5.1)] . - known anaphylactic reaction, or angioedema, or hypersens

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

bryant ranch prepack - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - dotti is indicated for: limitations of use : when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products. limitations of use : 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. dotti is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.2)] . - breast cancer or a history of breast cancer [see warnings and precautions (5.2)] . - estrogen-dependent neoplasia [see warnings and precautions (5.2)] . - active dvt, pe, or a history of these conditions [see warnings and precautions (5.1)] . - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions [see warnings and precautions (5.1)] . - known anaphylactic reaction, or angioedema, or hypersens

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

23-32mmhg) thigh length closed toe with dotted silicone band lymphoedema garment standard petite size i black (bsn medical ltd -

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

23-32mmhg) thigh length closed toe with dotted silicone band lymphoedema garment standard petite size ii black (bsn medical ltd -

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

23-32mmhg) thigh length closed toe with dotted silicone band lymphoedema garment standard petite size iii black (bsn medical ltd -

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

23-32mmhg) thigh length closed toe with dotted silicone band lymphoedema garment standard petite size iv black (bsn medical ltd -