Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - larotrectinib (unii: pf9462i9hx) (larotrectinib - unii:pf9462i9hx) - vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that: select patients for therapy based on an fda-approved test [see dosage and administration (2.1)]. this indication is approved under accelerated approval based on overall response rate and duration of response [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. none. risk summary based on literature reports in human subjects with congenital mutations leading to changes in trk signaling, findings from animal studies, and its mechanism of action [see clinical pharmacology (12.1)] , vitrakvi can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on vitrakvi use in pregnant women. administration of larotrectinib to pregnant rats and rabbits during the period of organogenesis resulted in malformations at maternal exposures that were approximately 11- and 0.7-times, respec

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - nifurtimox (unii: m84i3k7c2o) (nifurtimox - unii:m84i3k7c2o) - lampit is indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of chagas disease (american trypanosomiasis) caused by trypanosoma cruzi [see clinical studies (14)]. lampit tablets are contraindicated in: based on animal studies, lampit may cause fetal harm when administered to a pregnant woman. published postmarketing reports on nifurtimox use during pregnancy are insufficient to inform a drug-associated risk of birth defects and miscarriage. there are risks to the fetus associated with chagas disease (see clinical considerations). nifurtimox administered orally to pregnant rats, and rabbits during organogenesis was associated with reduced maternal body weights in rats, and abortions, reduced maternal weight gain, and reduced numbers of live fetuses in rabbits when nifurtimox was administered orally during organogenesis at doses approximately equal to the mrhd in rats and 2-times the mrhd in rabbits. an increased incidence of a fetal skeletal malf

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.025 mg in 1 d - 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 climara is contraindicated in women with any of the following conditions: climara is not indicated for use in pregnancy. there are no data with the use of climara 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. 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 climara and any potential adverse effects on the breastfed child from climara or from the underlying maternal condition. in general, climara 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 metabolism and effects on epiphyseal centers is recommended during estrogen administration. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing climara to determine whether those over 65 years of age differ from younger subjects in their response to climara. 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 (14.3)] . 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 clinical studies (14.3)] . 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)] .

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 14 ug in 1 d - menostar is indicated for: menostar is contraindicated in women with any of the following conditions: risk summary menostar is not indicated for use in pregnancy. there are no data with the use of menostar in pregnant women, however, epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital 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 menostar and any potential adverse effects on the breastfed child from menostar or from the underlying maternal condition. menostar is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. a total of 417 postmenopausal women 61 to 79 years old, with an intact uterus, participated in the osteoporosis trial. more than 50 percent of women receiving study drug, were 65 years of age or older. efficacy in older (≥ 65 years of age) and younger (<65 years of age) postmenopausal women in the osteoporosis treatment trial was comparable both at 12 and 24 months. safety in older (≥ 65 years of age) and younger (<65 years of age) postmenopausal women in the osteoporosis treatment trial was also comparable throughout the 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 (14.2)] . 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)] . 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 (14.3)] . 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 (5.3), and clinical studies (14.3)].

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - praziquantel (unii: 6490c9u457) (praziquantel - unii:6490c9u457) - praziquantel 600 mg - biltricide is indicated in patients aged 1 year and older for the treatment of the following infections: biltricide is contraindicated in:

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levomefolate calcium (unii: a9r10k3f2f) (levomefolic acid - unii:8s95dh25xc) - drospirenone 3 mg - beyaz® is indicated for use by females of reproductive potential to prevent pregnancy. beyaz is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in females of reproductive potential who choose to use an oral contraceptive as their method of contraception. the effectiveness of beyaz for pmdd when used for more than three menstrual cycles has not been evaluated. the essential features of pmdd according to the diagnostic and statistical manual-4th edition (dsm-iv) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. physical symptoms associated with pmdd include breast tenderness, headache, joint and muscle pain, bloating and weight gain. in this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of m

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - estradiol 1 mg - angeliq is contraindicated in women with any of the following conditions: angeliq is not indicated for use in pregnancy. there are no data with the use of angeliq in pregnant women, however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies or limb-reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy. in reproduction studies in rats, rabbits and monkeys with oral administration of drsp either as single compound or in combination with ee, no non-genital teratogenicity was observed. adverse developmental outcomes like an increase in fetal mortality and a retardation of fetal maturation were seen in rats and rabbits at exposures to drsp exceeding the human exposure by a factor of >15 (in rats) or >60 (rabbits). related to the antiandrogenic activity of drospirenone, a feminization of male fetuses and an impairment of male fertility was observed in rats (>150 times the human exposure to drospirenone) but not in monkeys (at up to more than 300 times the human exposure to drospirenone). due to the large safety margins observed in the animal studies only a low likelihood of an increased risk for human pregnancy was concluded (see data). 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. in an embryo-fetal toxicity study in pregnant rats, drsp was given from day 6 to 15 of gestation orally at doses of 5, 15 and 45 mg/kg/day, more than 60 times the human exposure starting from the low dose based on auc of drsp. a slight increase in postimplantational loss and a slight increase in retardation of fetal development (e.g. delayed ossification of bones of the feet) was seen in the two higher doses. no teratogenicity was observed in rats. in an embryo-fetal study in rabbits, drsp was given from day 6 to 18 of gestation orally at doses of 10, 30 and 100 mg/kg/day, about 20, 60 and 250 times the human exposure based on auc. this resulted in a retardation of fetal development (delayed ossification of small bones, multiple fusions of ribs) at the high dose only and in an increase in fetal loss from the mid dose level. no compound-related teratogenicity was seen in rabbits. in a further embryo-fetal toxicity study in pregnant rats, drsp was orally administered in combination with ethinyl estradiol (100:1) from day 6 to 17 of gestation at doses of 1, 3 and 10 mg/kg/day drsp, at about 1, 3 and 23 times the human exposure to drsp on basis of auc. maternal toxicity (decreased body weight gain and food consumption) was seen starting at the low dose and an increase of early resorptions at the high dose level. skeletal variations and retardations were seen in fetuses at the high dose. no malformed fetuses and no effect on the external genitalia of the fetuses were observed. drsp was administered with ethinyl estradiol (100:1) orally to pregnant rats during late pregnancy from day 14 to 21 of gestation (the period of genital development) at doses of 5, 15 and 45 mg/kg of drsp, more than 60 times the human exposure starting from the low dose based on auc of drsp. maternal toxicity (decreased body weight gain) and fetal retardation (decreased fetal body weights) were seen starting at the low dose. there was a dose dependent increase in feminization of male rat fetuses starting at the mid dose level (that is, >150 times the human exposure to drsp). drsp was administered with ethinyl estradiol (100:1) orally to pregnant cynomolgus monkeys at doses up to 10 mg/kg drsp, more than 300 times the human exposure based on auc from day 20 to 90 of gestation. a dose-dependent increase of abortions was observed. no teratogenic or feminization effects were seen in any dose group. drsp was administered with ethinyl estradiol (100:1) in a peri-postnatal study in rats from day 6 to 16 of gestation and day 1 to 22 postpartum at doses of 5, 15 and 45 mg/kg; more than 60 times the human exposure starting from the low dose based on auc of drsp. there was a dose dependent delay in fetal development and an increase in mortality of the f1-generation during the lactational phase. fertility was impaired in the male offspring at the high dose level. estrogens plus progestogens 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. after administration of an oral contraceptive containing drsp about 0.02% of the drsp dose was excreted into the breast milk of postpartum women within 24 hours. this results in a maximal daily dose of about 3 mcg drsp in an infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for angeliq and any potential adverse effects on the breastfed infant from angeliq or from the underlying maternal condition. angeliq 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 angeliq to determine whether those over 65 years of age differ from younger women in their response to angeliq. 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, 5.3) and clinical studies (14.4)] . in the whi estrogen-alone substudy (daily ce [0.625 mg] 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 (14.4)] . 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 (5.4), and clinical studies (14.5)] . 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 (14.5)]. angeliq is contraindicated in patients with renal impairment because of the risk of hyperkalemia [see contraindications (4), warnings and precautions (5.2 )  and clinical pharmacology (12.3)]. angeliq is contraindicated in patients with hepatic impairment because of the risk of increased drsp exposure and subsequent hyperkalemia [see contraindications (4), warnings and precautions (5.10)   and clinical pharmacology (12.3)]. angeliq is contraindicated in patients with adrenal insufficiency because of the risk of hyperkalemia [see contraindications (4) and warnings and precautions (5.2)].

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - estradiol 0.045 mg in 1 d - climara pro is indicated for: 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. climara pro is contraindicated in women with any of the following conditions: climara pro is not indicated for use in pregnancy. there are no data with the use of climara pro 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. estrogens plus progestogens 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 climara pro and any potential adverse effects on the breastfed child from climara pro or from the underlying maternal condition. climara pro 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 climara pro to determine whether those over 65 years of age differ from younger subjects in their response to climara pro. 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 (14.5)] . 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 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 (14.6)] . 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)] .

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - levonorgestrel 52 mg - mirena is indicated for prevention of pregnancy for up to 8 years; replace after the end of the eighth year. mirena is indicated for the treatment of heavy menstrual bleeding for up to 5 years in women who choose to use intrauterine contraception as their method of contraception; replace after the end of the fifth year if continued treatment of heavy menstrual bleeding is needed. the use of mirena is contraindicated when one or more of the following conditions exist: the use of mirena is contraindicated in pregnancy or with a suspected pregnancy and mirena may cause adverse pregnancy outcomes [see contraindications (4 ), warnings and precautions (5.1 , 5.2 )]. if a woman becomes pregnant with mirena in place, the likelihood of ectopic pregnancy is increased and there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery. remove mirena, if possible, if pregnancy occurs in a woman using mirena. if mirena cannot be removed, follow the pregnancy closely [see warnings and precautio

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - levonorgestrel 13.5 mg - skyla® is indicated to prevent pregnancy for up to 3 years. replace the system after 3 years if continued use is desired. the use of skyla is contraindicated when one or more of the following conditions exist: the use of skyla is contraindicated in pregnancy or with a suspected pregnancy and skyla may cause adverse pregnancy outcomes [see contraindications (4), warnings and precautions (5.1, 5.2)]. if a woman becomes pregnant with skyla in place, the likelihood of ectopic pregnancy is increased and there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery. remove skyla, if possible, if pregnancy occurs in a woman using skyla. if skyla cannot be removed, follow the pregnancy closely [see warnings and precautions (5.1, 5.2)]. there have been isolated cases of virilization of the external genitalia of the female fetus following local exposure to lng during pregnancy with an lng ius in place. animal reproduction studies have not been conducted with skyla. published studies repo