Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

yandilla mustard oil enterprise pty. limited - mustard powder - unknown - mustard powder food-plant active 0.0 - active constituent

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

b. braun medical inc. - hydroxyethyl starch 130/0.4 (unii: 1gvo236s58) (hydroxyethyl starch 130/0.4 - unii:1gvo236s58), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - hydroxyethyl starch 130/0.4 6 g in 100 ml - 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection is indicated for the treatment and prophylaxis of hypovolemia in adults and children. it is not a substitute for red blood cells or coagulation factors in plasma. - do not use hydroxyethyl starch (hes) products, including 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, in critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (rrt).  - do not use hes products, including 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, in patients with severe liver disease. - do not use hes products, including 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, in patients with known hypersensitivity to hydroxyethyl starch [see general warnings and precautions (5.1) ] - do not use hes products in clinical conditions with volume overload.  - do not use hes products in patients with pre-existing coagulation or bleeding disorders.  - do not use h

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

h and p industries, inc. dba triad group - starch, corn (unii: o8232ny3sj) (starch, corn - unii:o8232ny3sj) - starch, corn 0.51 g - protectant - provides temporary relief of the itching, burning and discomfort associated with hemorrhoids and other anorectal disorders - provides a coating to protect irritated tissue

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

sandoz inc - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate 0.25 mg - estarylla™ (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . do not prescribe norgestimate and ethinyl estradiol to women who are known to have the following conditions: - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations [seewarnings and precautions (5.3) ] there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy. 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 low dose cocs prior to conception or during early pregnancy. do not administer cocs to induce withdrawal bleeding as a test for pregnancy. do not use cocs during pregnancy to treat threatened or habitual abortion. advise the nursing mother to use other f

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

allergan, inc. - triptorelin pamoate (unii: 08an7wa2g0) (triptorelin - unii:9081y98w2v) - triptorelin 3.75 mg in 2 ml - trelstar is indicated for the palliative treatment of advanced prostate cancer [see  clinical studies (14) ]. trelstar is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other gnrh agonists or gnrh [see warnings and precautions (5.1) ]. risk summary based on findings in animal studies and mechanism of action, trelstar can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ] . expected hormonal changes that occur with trelstar treatment increase the risk for pregnancy loss. in animal developmental and reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. advise pregnant patients and females of reproductive potential of the potential risk to the fetus. dat

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

xiromed, llc. - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate 0.25 mg - estarylla (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . estarylla is contraindicated in females who are known to have or develop the following conditions: - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations [seewarnings and precautions (5.3)] there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy. 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 low dose cocs prior to conception or during early pregnancy. do not administer cocs to induce withdrawal bleeding as a test for pregnancy. do not use cocs during pregnancy to treat threatened or habitual abortion. advise the nursing mother to use other forms of cont

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

verity pharmaceuticals inc. - triptorelin pamoate (unii: 08an7wa2g0) (triptorelin - unii:9081y98w2v) - trelstar is indicated for the treatment of advanced prostate cancer [see  clinical studies (14) ]. trelstar is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other gnrh agonists or gnrh [see warnings and precautions (5.1) ]. risk summary based on findings in animal studies and mechanism of action, trelstar can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ] . expected hormonal changes that occur with trelstar treatment increase the risk for pregnancy loss. in animal developmental and reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. advise pregnant patients and females of reproductive potential of the potential risk to the fetus. data animal data studies in pregnant rats administered triptorelin at doses of 2, 10, and 100 mcg/kg/day (approximately equivalent to 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area) during the period of organogenesis demonstrated maternal toxicity and embryo-fetal toxicities.  embryo-fetal toxicities consisted of pre-implantation loss, increased resorption, and reduced mean number of viable fetuses at the high dose.  teratogenic effects were not observed in viable fetuses in rats or mice.  doses administered to mice were 2, 20, and 200 mcg/kg/day (approximately equivalent to 0.1, 0.7, and 7 times the estimated human daily dose based on body surface area).     the safety and efficacy of trelstar have not been established in females.  there are no data on the presence of triptorelin in human milk, the effects of the drug on milk production, or the effects of the drug on the breastfed child.  because of the potential for serious adverse reactions in a breastfed child from trelstar, a decision should be made to either discontinue breastfeeding, or discontinue the drug taking into account the importance of the drug to the mother. infertility males based on mechanism of action, trelstar may impair fertility in males of reproductive potential [see clinical pharmacology (12.1)] . safety and effectiveness in pediatric patients have not been established. prostate cancer occurs primarily in an older population.  clinical studies with trelstar have been conducted primarily in patients ≥ 65 years [see  clinical pharmacology (12.3) and clinical studies (14) ]. subjects with renal impairment had higher exposure than young healthy males [see  clinical pharmacology (12.3) ]. subjects with hepatic impairment had higher exposure than young healthy males [see  clinical pharmacology (12.3) ].

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

glaxosmithkline llc - dostarlimab (unii: p0gvq9a4s5) (dostarlimab - unii:p0gvq9a4s5) - jemperli, in combination with carboplatin and paclitaxel, followed by jemperli as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer (ec) that is mismatch repair deficient (dmmr), as determined by an fda-approved test, or microsatellite instability-high (msi-h) [see dosage and administration ( 2.1)]. jemperli, as a single agent, is indicated for the treatment of adult patients with dmmr recurrent or advanced endometrial cancer, as determined by an fda-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation [see dosage and administration ( 2.1)]. jemperli, as a single agent, is indicated for the treatment of adult patients with dmmr recurrent or advanced solid tumors, as determined by an fda-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options [see dosage and administration ( 2.1)]. this indication is approved under accelerated approval based on tumor response rate and durability of response [see clinical studies ( 14.2)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). none. risk summary based on its mechanism of action, jemperli can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of jemperli in pregnant women. animal studies have demonstrated that inhibition of the pd-1/pd-l1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death (see data). human igg4 immunoglobulins (igg4) are known to cross the placental barrier; therefore, dostarlimab-gxly has the potential to be transmitted from the mother to the developing fetus. advise women 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 is 2% to 4% and 15% to 20%, respectively. data animal data: animal reproduction studies have not been conducted with jemperli to evaluate its effect on reproduction and fetal development. a central function of the pd-1/pd-l1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. in murine models of pregnancy, blockade of pd-l1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering jemperli during pregnancy include increased rates of abortion or stillbirth. as reported in the literature, there were no malformations related to the blockade of pd-1/pd-l1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in pd-1 and pd-l1 knockout mice. based on its mechanism of action, fetal exposure to dostarlimab-gxly may increase the risk of developing immune-mediated disorders or altering the normal immune response. risk summary there is no information regarding the presence of dostarlimab-gxly in human milk or its effects on the breastfed child or on milk production. maternal igg is known to be present in human milk. the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to jemperli are unknown. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 4 months after the last dose of jemperli. jemperli can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating jemperli [see use in specific populations (8.1)]. contraception females: advise females of reproductive potential to use effective contraception during treatment with jemperli and for 4 months after the last dose. the safety and efficacy of jemperli have not been established in pediatric patients. in combination with carboplatin and paclitaxel of the 241 patients treated with jemperli in ruby, 52.3% were younger than 65 years, 36.5% were aged 65 through 75 years, and 11.2% were 75 years or older. no overall differences in safety or effectiveness were observed between these patients and younger patients. as a single agent of the 605 patients treated with jemperli in garnet, 51.6% were younger than 65 years, 36.9% were aged 65 through 75 years, and 11.5% were 75 years or older. no overall differences in safety or effectiveness were observed between these patients and younger patients.

Australia - English - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - dostarlimab, quantity: 500 mg/ml - injection, intravenous infusion - excipient ingredients: sodium citrate dihydrate; arginine hydrochloride; sodium chloride; polysorbate 80; water for injections; citric acid monohydrate - jemperli is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent mismatch repair deficient (dmmr)/microsatellite instability-high (msi-h) endometrial cancer.,jemperli is indicated as monotherapy for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dmmr) endometrial cancer (ec) that has progressed on or following prior treatment with a platinum-containing regimen.

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

hospira, inc. - hydroxyethyl starch 130/0.4 (unii: 1gvo236s58) (hydroxyethyl starch 130/0.4 - unii:1gvo236s58) - hydroxyethyl starch 130/0.4 6 g in 100 ml - voluven ® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is indicated for the treatment and prophylaxis of hypovolemia in adults and children. it is not a substitute for red blood cells or coagulation factors in plasma. - do not use hydroxyethyl starch (hes) products, including voluven ® , in critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (rrt). - do not use hes products, including voluven ® , in patients with severe liver disease. - do not use hes products, including voluven ® , in patients with known hypersensitivity to hydroxyethyl starch [see general warnings and precautions (5.1) ] - do not use hes products in clinical conditions with volume overload. - do not use hes products in patients with pre-existing coagulation or bleeding disorders. - do not use hes products in patients with renal failure with oliguria or anuria not related