Canada - English - Health Canada

pfizer canada ulc - conjugated estrogens - tablet (extended-release) - 1.25mg - conjugated estrogens 1.25mg - estrogens

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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx), medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - estrogens, conjugated 0.625 mg - prempro or premphase therapy should not be used in women with any of the following conditions: prempro and premphase should not be used during pregnancy [see contraindications (4)] . there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. prempro and premphase should not be used during lactation. estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. detectable amounts of estrogen and progestin have been identified in the breast milk of women receiving these drugs. caution should be exercised when prempro or premphase is administered to a nursing woman. prempro and premphase are not indicated in children. clinical studies have not been conducted in the pediatric population. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing prempro or premphase to determine whether those over 65 years of age differ from younger subjects in their response to prempro or premphase. the women's health initiative studies 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 (14.6)] . 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 (14.6)] . 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 plus progestin or estrogen-alone when compared to placebo [see warnings and precautions (5.3), and clinical studies (14.7)] . 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 (14.7)] . the effects of renal impairment on the pharmacokinetics of prempro or premphase have not been studied. the effects of hepatic impairment on the pharmacokinetics of prempro or premphase have not been studied.

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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - estrogens, conjugated 0.625 mg in 1 g -             premarin vaginal cream therapy should not be used in women with any of the following conditions: premarin vaginal cream should not be used during pregnancy [see contraindications (4)] . there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. premarin vaginal cream should not be used during lactation. estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. detectable amounts of estrogens have been identified in the breast milk of women receiving estrogen therapy. caution should be exercised when premarin vaginal cream is administered to a nursing woman. premarin vaginal cream is not indicated in children. clinical studies have not been conducted in the pediatric population. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing premarin vaginal cream to determine whether those over 65 years of age differ from younger subjects in their response to premarin vaginal cream. 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 (5.2), and 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 warnings and precautions (5.2, 5.3), and 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)] . the effect of renal impairment on the pharmacokinetics of premarin vaginal cream has not been studied. the effect of hepatic impairment on the pharmacokinetics of premarin vaginal cream has not been studied.

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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - estrogens, conjugated 0.45 mg - limitation of use when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered. limitation of use when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered premarin therapy is contraindicated in individuals with any of the following conditions: premarin should not be used during pregnancy [see contraindications (4)] . there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. premarin should not be used during lactation. estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. detectable amounts of estrogens have been identified in the breast milk of mothers receiving estrogen-alone therapy. caution should be exercised when premarin is administered to a nursing woman. estrogen therapy has been used for the induction of puberty in adolescents with some forms of pubertal delay. safety and effectiveness in pediatric patients have not otherwise been established. large and repeated doses of estrogen over an extended time period have been shown to accelerate epiphyseal closure, which could result in short stature if treatment is initiated before the completion of physiologic puberty in normally developing children. 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. estrogen treatment of prepubertal girls also induces premature breast development and vaginal cornification, and may induce vaginal bleeding. in boys, estrogen treatment may modify the normal pubertal process and induce gynecomastia. there have not been sufficient numbers of geriatric patients involved in studies utilizing premarin to determine whether those over 65 years of age differ from younger subjects in their response to premarin. the women's health initiative study 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 (14.5)] . in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg]), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see clinical studies (14.5)] . 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 (14.6)] . 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 (14.6)]. the effect of renal impairment on the pharmacokinetics of premarin has not been studied. the effect of hepatic impairment on the pharmacokinetics of premarin has not been studied.

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

avera mckennan hospital - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx), medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - estrogens, conjugated 0.625 mg - prempro or premphase therapy should not be used 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 a history of these conditions - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions - known anaphylactic reaction or angioedema to prempro/premphase - known liver dysfunction or disease - known protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders - known or suspected pregnancy prempro and premphase should not be used during pregnancy [see contraindications (4)] . there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. prempro and premphase should not be used during lactation. estrogen administration to nursing women has been shown t

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

aphena pharma solutions - tennessee, inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - estrogens, conjugated 0.625 mg - premarin therapy is indicated in the: - 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. - 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 postmenopausal osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered. the mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin d in

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

sanofi pasteur inc. - neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen (unii: re9a0h8oab) (neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen - unii:re9a0h8oab), neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen (unii: 2j57k2523t) (neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen - unii:2j57k2523t), neisseria meningitidis group y capsular polysaccharide diphtheria - neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen 4 ug in 0.5 ml - menactra® , meningococcal (groups a, c, y and w-135) polysaccharide diphtheria toxoid conjugate vaccine, is indicated for active immunization to prevent invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, y and w-135. menactra is approved for use in individuals 9 months through 55 years of age. menactra does not prevent n meningitidis serogroup b disease. severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or crm197 -containing vaccine, or to any component of menactra [see description (11) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to menactra during pregnancy. to enroll in or obtain information about the registry, call sanofi pasteur at 1-800-822-2463. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects an

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

merck sharp & dohme llc - haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen (unii: luy6p8763w) (haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen - unii:luy6p8763w) - haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen 7.5 ug in 0.5 ml - liquid pedvaxhib is indicated for routine vaccination against invasive disease caused by haemophilus influenzae type b in infants and children 2 to 71 months of age. liquid pedvaxhib will not protect against disease caused by haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis. as with any vaccine, vaccination with liquid pedvaxhib may not result in a protective antibody response in all individuals given the vaccine. because of the potential for immune tolerance, liquid pedvaxhib is not recommended for use in infants younger than 6 weeks of age. (see precautions.) infants completing the primary two-dose regimen before 12 months of age should receive a booster dose (see dosage and administration). hypersensitivity to any component of the vaccine or the diluent. persons who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine.

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

physicians total care, inc. - estrogens, conjugated synthetic a (unii: jm2621p2ls) (estrogens, conjugated synthetic a - unii:jm2621p2ls) - estrogens, conjugated synthetic a 0.45 mg - cenestin therapy is indicated for the: 1. treatment of moderate-to-severe vasomotor symptoms associated with the menopause. - 0.45 mg cenestin - 0.625 mg cenestin - 0.9 mg cenestin - 1.25 mg cenestin 2. 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. - 0.3 mg cenestin cenestin 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 deep vein thrombosis, pulmonary embolism or a history of these conditions. - active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). - liver dysfunction or disease. - cenestin therapy should not be used in patients with known hypersensitivity to its ingredients. - known or su

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

state of florida doh central pharmacy - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - estrogens, conjugated 0.625 mg - premarin therapy is indicated in the: - 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. - 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 postmenopausal 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 studies .) the mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exe