Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

wyeth pharmaceutical division of wyeth holdings llc - streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen (unii: 54ec0se5pz) (streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen - unii:54ec0se5pz), streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen (unii: 2vf3v7175u) (streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen - unii:2vf3v7175u), streptococcus pneumoniae type - streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen 2.2 ug in 0.5 ml - in children 6 weeks through 5 years of age (prior to the 6th birthday), prevnar 13® is indicated for: in children 6 years through 17 years of age (prior to the 18th birthday), prevnar 13 is indicated for: 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 and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. available data on prevnar 13 administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. a developmental toxicity study has been performed in female rabbits administered prevnar 13 prior to mating and during gestation. each dose was approximately 20 times the human dose. this study revealed no evidence of harm to the fetus due to prevnar 13 (see 8.1 data). data animal in a developmental toxicity study, female rabbits were administered prevnar 13 by intramuscular injection twice prior to mating (17 days an

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - temsirolimus (unii: 624kn6gm2t) (temsirolimus - unii:624kn6gm2t) - temsirolimus 25 mg in 1 ml - torisel is indicated for the treatment of advanced renal cell carcinoma. torisel is contraindicated in patients with bilirubin >1.5×uln [see warnings and precautions (5.2)] . risk summary based on findings in animal studies and its mechanism of action, temsirolimus can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . although there are no data on the use of torisel in pregnant women, there are limited data on the use of sirolimus, the active metabolite of temsirolimus, during pregnancy; however, these data are insufficient to inform a drug-associated risk of adverse developmental outcomes. in animal reproductive studies, oral daily administration of temsirolimus to pregnant rats and rabbits during organogenesis caused adverse embryo-fetal effects at approximately 0.04 and 0.12 times the auc in patients at the recommended dose, respectively (see data) . advise pregnant women of the potential hazard to a fetus. the estimated background risk of major birth defects and m

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 75 mg - effexor xr (venlafaxine hydrochloride) extended-release capsules are indicated for the treatment of major depressive disorder (mdd). efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. effexor xr is indicated for the treatment of generalized anxiety disorder (gad). efficacy was established in two 8-week and two 26-week placebo-controlled trials. effexor xr is indicated for the treatment of social anxiety disorder (sad), also known as social phobia. efficacy was established in four 12-week and one 26-week, placebo-controlled trials. effexor xr is indicated for the treatment of panic disorder (pd), with or without agoraphobia. efficacy was established in two 12-week placebo-controlled trials. hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation the use of maois (intended to treat psychiatric disorders) concomitantly with effexor xr or within 7 days of discontinuing treatment with effexor xr is contrai

Amerikas Savienotās Valstis - angļu - 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.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx), bazedoxifene acetate (unii: j70472ud3d) (bazedoxifene - unii:q16tt9c5bk) - estrogens, conjugated 0.45 mg - duavee is indicated in women with a uterus for: duavee is contraindicated in women with any of the following conditions: risk summary duavee is contraindicated for use in pregnant women and is not indicated for use in females of reproductive potential [see contraindications (4), warnings and precautions (5.15)]. conjugated estrogens (ce) there are no data with the use of conjugated estrogens in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital and non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives before conception or during early pregnancy. bazedoxifene there are no available data on bazedoxifene use in pregnant women to inform a drug associated risk of adverse developmental outcomes. animal studies have shown that oral bazedoxifene administered during the period of organogenesis to pregnant rats or rabbits at 0.3 and 2 times, respectively, the exposure at the maximum recommended dose, can cause fetal harm [see data]. based on mechanism of action, bazedoxifene may block the important functions that estrogen has during all stages of pregnancy [see clinical pharmacology (12.1)] . data animal data bazedoxifene administration of bazedoxifene to rats at maternally toxic dosages ≥1 mg/kg/day (≥ 0.3 times the human area under the curve (auc) at the 20 mg dose) resulted in reduced numbers of live fetuses and/or reductions in fetal body weights. no fetal developmental anomalies were observed. in studies conducted with pregnant rabbits treated with bazedoxifene, abortion and an increased incidence of heart (ventricular septal defect) and skeletal system (ossification delays, misshapen or misaligned bones, primarily of the spine and skull) anomalies in the fetuses were present at maternally toxic dosages of ≥ 0.5 mg/kg/day (≥ 2 times the human auc at the 20 mg dose). risk summary duavee is not indicated for use in females of reproductive potential [see warnings and precautions (5.15)] . conjugated estrogens 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. bazedoxifene there are no data on the presence of bazedoxifene in either human or animal breast milk, the effect on the breastfed infant, or the effects on milk production. based on mechanism of action, bazedoxifene may block the important functions that estrogen has in mammary tissue during lactation [see clinical pharmacology (12.1)]. infertility bazedoxifene based on animal data, bazedoxifene administration may adversely affect female fertility. however, clinical fertility studies with bazedoxifene have not been conducted [see nonclinical toxicology (13.1)] . duavee is not indicated for use in children [see indications and usage (1)] . duavee is not recommended for use in women greater than 75 years of age [see dosage and administration (2.7) and clinical pharmacology 12.3)] . of the total number of women in phase 3 clinical studies who received duavee, 4.60% (n=224) were 65 years and over. duavee was not studied in women aged 75 and over. no overall differences in safety or effectiveness were observed between women 65–74 years of age and younger women, and other reported clinical experience has not identified differences in responses between the elderly and younger women, but greater sensitivity of some older women cannot be ruled out. an increased risk of probable dementia in women over 65 years of age was reported in the women's health initiative memory ancillary studies of the women's health initiative using daily conjugated estrogens (0.625 mg) [see clinical studies (14.6)]. duavee is not recommended for use in patients with renal impairment [see dosage and administration (2.6) and clinical pharmacology (12.3)]. the pharmacokinetics, safety, and efficacy of duavee have not been evaluated in women with renal impairment. duavee is contraindicated in patients with hepatic impairment [see contraindications (4) and clinical pharmacology (12.3)]. the pharmacokinetics, safety, and efficacy of duavee have not been evaluated in women with hepatic impairment. in a pharmacokinetics study of bazedoxifene 20 mg alone, the cmax and auc of bazedoxifene increased 67% and 143%, respectively, in women with mild hepatic impairment (child pugh class a), compared to healthy women. the cmax and auc of bazedoxifene increased 32% and 109%, respectively, in women with moderate hepatic impairment (child pugh class b). the cmax and auc of bazedoxifene increased 20% and 268%, respectively, in women with severe hepatic impairment (child pugh class c). no pharmacokinetic studies with conjugated estrogens were conducted in women with hepatic impairment. following duavee administration, the systemic exposures of conjugated estrogens and bazedoxifene were lower in obese subjects, compared to non-obese subjects [see pharmacokinetics (12.3)] . a single dose of duavee (conjugated estrogens 0.45 mg/bazedoxifene 20 mg) was administered to 12 obese bmi ≥ 30 [mean (sd) = 32.7 (2.7) kg/m2 ] and 12 non-obese bmi < 30 [mean (sd) 25.3 (2.6) kg/m2 ] postmenopausal women. in obese subjects, systemic exposures of total estrone, total equilin, and bazedoxifene were 2%, 32%, and 13% lower, respectively, compared to non-obese subjects. a greater reduction in bazedoxifene exposure compared to conjugated estrogens may be associated with decreased protection from endometrial hyperplasia. monitor and evaluate women with postmenopausal or unexplained genital bleeding for possible endometrial hyperplasia or malignancy [see warnings and precautions (5.3)] .

Amerikas Savienotās Valstis - angļu - 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.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - estrogens, conjugated 25 mg in 5 ml - premarin intravenous (conjugated estrogens, usp) for injection is indicated in the treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology. premarin intravenous is indicated for short-term use only, to provide a rapid and temporary increase in estrogen levels. premarin intravenous therapy should not be used in individuals with any of the following conditions:

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - gemtuzumab ozogamicin (unii: 8gzg754x6m) (gemtuzumab ozogamicin - unii:8gzg754x6m) - gemtuzumab ozogamicin 5 mg in 5 ml - mylotarg is indicated for the treatment of newly-diagnosed cd33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older. mylotarg is indicated for the treatment of relapsed or refractory cd33-positive acute myeloid leukemia in adults and pediatric patients 2 years and older. mylotarg is contraindicated in patients with a history of hypersensitivity to the active substance in mylotarg or any of its components or to any of the excipients. reactions have included anaphylaxis [see warnings and precautions (5.2), adverse reactions (6)] . risk summary based on its mechanism of action and findings from animal studies [see clinical pharmacology (12.1), nonclinical toxicology (13.1)] , mylotarg can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on mylotarg use in pregnant women to evaluate for a drug-associated risk. in animal reproduction studies, gemtuzumab ozogamicin caused embryo-fetal toxicity, including structural abnormalities and alteration

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - tigecycline (unii: 70je2n95kr) (tigecycline - unii:70je2n95kr) - tigecycline 50 mg in 5 ml - tygacil is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of escherichia coli, enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus agalactiae, streptococcus anginosus grp. (includes s. anginosus, s. intermedius, and s. constellatus ), streptococcus pyogenes, enterobacter cloacae, klebsiella pneumoniae, and bacteroides fragilis. tygacil is indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal infections caused by susceptible isolates of citrobacter freundii, enterobacter cloacae, escherichia coli, klebsiella oxytoca, klebsiella pneumoniae, enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus anginosus grp. (includes s. anginosus, s. intermedius, and s. constellatus ), bacteroides f

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - inotuzumab ozogamicin (unii: p93ruu11p7) (inotuzumab ozogamicin - unii:p93ruu11p7) - inotuzumab ozogamicin 0.25 mg in 1 ml - besponsa is indicated for the treatment of relapsed or refractory cd22-positive b-cell precursor acute lymphoblastic leukemia (all) in adult and pediatric patients 1 year and older . none. risk summary based on its mechanism of action and findings from animal studies [see clinical pharmacology (12.1), nonclinical toxicology (13.1)] , besponsa can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on besponsa use in pregnant women to inform a drug-associated risk. in rat embryo-fetal development studies, inotuzumab ozogamicin caused embryo-fetal toxicity at maternal systemic exposures that were ≥ 0.4 times the exposure in patients at the maximum recommended dose, based on auc [see data] . advise patients of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2–4% and 15–20%, respectively. data animal data in embryo-fetal development studies in rats, pregnant animals received daily intravenous doses of inotuzumab ozogamicin up to 0.36 mg/m2 during the period of organogenesis. embryo-fetal toxicities including increased resorptions and fetal growth retardation as evidenced by decreased live fetal weights and delayed skeletal ossification were observed at ≥ 0.11 mg/m2 (approximately 2 times the exposure in patients at the maximum recommended dose, based on auc). fetal growth retardation also occurred at 0.04 mg/m2 (approximately 0.4 times the exposure in patients at the maximum recommended dose, based on auc). in an embryo-fetal development study in rabbits, pregnant animals received daily intravenous doses up to 0.15 mg/m2 (approximately 3 times the exposure in patients at the maximum recommended dose, based on auc) during the period of organogenesis. at a dose of 0.15 mg/m2 , slight maternal toxicity was observed in the absence of any effects on embryo‑fetal development. risk summary there are no data on the presence of inotuzumab ozogamicin or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with besponsa and for 2 months after the last dose. based on its mechanism of action and findings from animal studies, besponsa can cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating besponsa. contraception females advise females of reproductive potential to use effective contraception during treatment with besponsa and for 8 months after the last dose [see nonclinical toxicology (13.1)] . males advise males with female partners of reproductive potential to use effective contraception during treatment with besponsa and for 5 months after the last dose [see nonclinical toxicology (13.1)] . infertility females based on findings in animals, besponsa may impair fertility in females of reproductive potential [see nonclinical toxicology (13.1)] . males based on findings in animals, besponsa may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)] . the safety and effectiveness of besponsa in pediatric patients 1 year and older with relapsed or refractory cd22-positive b-cell precursor all have been established. the use of besponsa for this indication is supported by evidence of safety and effectiveness in study wi203581 (itcc-059) [see adverse reactions (6.1), clinical studies (14.1)] . the study included patients in the following age groups: 2 patients 1 year to < 2 years old, 10 patients 2 years to < 6 years old, 20 patients 6 years to < 12 years old, and 20 patients 12 years to < 17 years old. compared to adults, pediatric patients had a higher incidence of liver test abnormalities; with grade 3-4 increases in ast, alt, and total bilirubin in 21%, 21%, and 9%, respectively, in pediatric patients treated with besponsa compared to 4%, 4%, and 5% in adults. the safety and effectiveness of besponsa in patients < 1 year of age with relapsed or refractory cd22-positive b-cell precursor all have not been established. in the ino-vate all trial, 30/164 patients (18%) treated with besponsa were ≥ 65 years of age. no differences in responses were identified between older and younger patients. based on a population pharmacokinetic analysis in 765 patients, no adjustment to the starting dose is required based on age [see clinical pharmacology (12.3)] . based on a population pharmacokinetic analysis, the clearance of inotuzumab ozogamicin in patients with mild hepatic impairment (total bilirubin less than or equal to uln and ast greater than uln, or total bilirubin greater than 1.0–1.5 × uln and ast any level; n=150) was similar to patients with normal hepatic function (total bilirubin/ast less than or equal to uln; n=611). in patients with moderate (total bilirubin greater than 1.5–3 × uln and ast any level; n=3) and severe hepatic impairment (total bilirubin greater than 3 × uln and ast any level; n=1), inotuzumab ozogamicin clearance did not appear to be reduced [see clinical pharmacology (12.3)]. no adjustment to the starting dose is required when administering besponsa to patients with total bilirubin less than or equal to 1.5 × uln and ast/alt less than or equal to 2.5 × uln [see dosage and administration (2.3)]. there is limited safety information available in patients with total bilirubin greater than 1.5 × uln and/or ast/alt greater than 2.5 × uln prior to dosing. interrupt dosing until recovery of total bilirubin to less than or equal to 1.5 × uln and ast/alt to less than or equal to 2.5 × uln prior to each dose unless due to gilbert's syndrome or hemolysis. permanently discontinue treatment if total bilirubin does not recover to less than or equal to 1.5 × uln or ast/alt does not recover to less than or equal to 2.5 × uln [see dosage and administration (2.3), warnings and precautions (5.1)] .