Canada - English - Health Canada

germiphene corporation - fluoride (sodium fluoride) - aerosol - 1.23% - fluoride (sodium fluoride) 1.23% - dental agents

Canada - English - Health Canada

abj custom packaging - sodium fluoride - aerosol - 1.23% - sodium fluoride 1.23% - dental agents

Canada - English - Health Canada

abj custom packaging - fluoride (sodium fluoride) - aerosol - 1.23% - fluoride (sodium fluoride) 1.23% - dental agents

Canada - English - Health Canada

lever pond's, a division of u l canada inc. - sodium fluoride - gel - 0.23% - sodium fluoride 0.23% - dental agents

Canada - English - Health Canada

lever pond's, a division of u l canada inc. - sodium fluoride - gel - 0.23% - sodium fluoride 0.23% - dental agents

Canada - English - Health Canada

teledyne water pik - sodium fluoride - paste - 1.23% - sodium fluoride 1.23% - dental agents

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

bluepoint laboratories - etoposide (unii: 6plq3cp4p3) (etoposide - unii:6plq3cp4p3) - etoposide 20 mg in 1 ml - etoposide injection usp is indicated in the management of the following neoplasms: etoposide injection usp in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy. etoposide injection usp in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. etoposide injection usp is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.

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

hikma pharmaceuticals usa inc. - capecitabine (unii: 6804dj8z9u) (capecitabine - unii:6804dj8z9u) - capecitabine 150 mg - capecitabine is indicated for the: capecitabine is indicated for the adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. capecitabine is contraindicated in patients with history of severe hypersensitivity reaction to fluorouracil or capecitabine [see adverse reactions ( 6.1)] . risk summary: based on findings in animal reproduction studies and its mechanism of action [see clinical pharmacology (12.1)] , capecitabine can cause fetal harm when administered to a pregnant woman. available human data with capecitabine use in pregnant women is not sufficient to inform the drug-associated risk. in animal reproduction studies, administration of capecitabine to pregnant animals during the period of organogenesis caused embryolethality and teratogenicity in mice and embryolethality in monkeys at 0.2 and 0.6 times the exposure (auc) in patients receiving the recommended dose of 1,250 mg/m2 twice daily, respectively (see data) . advise pregnant women of the

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)

amneal pharmaceuticals llc - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 10 ug - yuvafem is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.3)] . - breast cancer or a 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 yuvafem [see warnings and precautions (5.16)] . - hepatic impairment or disease. - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders. risk summary yuvafem is not indicated for use in pregnancy. there are no data with the use of yuvafem 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 yuvafem and any potential adverse effects on the breastfed child from yuvafem or from the underlying maternal condition. yuvafem 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 yuvafem to determine whether those over 65 years of age differ from younger subjects in their response to yuvafem. 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)]. yuvafem (estradiol vaginal inserts) read this instructions for use before you start using yuvafem 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 yuvafem? - yuvafem is an insert for use only in the vagina. do not take by mouth. - wash and dry your hands well before handling yuvafem. step 1: tear off a single applicator. step 2: pull apart the plastic wrap and remove the applicator (see figure a). if after opening the package you see that the yuvafem 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 (figure b).  figure b step 4: select the best position for vaginal insertion of yuvafem (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 yuvafem (estradiol vaginal inserts). if you have any questions, please ask your healthcare provider or pharmacist. how should i store yuvafem? - store yuvafem at room temperature between 68ºf to 77ºf (20ºc to 25ºc). - do not refrigerate. keep yuvafem and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 rev. 01-2024-01