মার্কিন যুক্তরাষ্ট্র - ইংরেজি - 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.

অস্ট্রেলিয়া - ইংরেজি - 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.

ইউরোপীয় ইউনিয়ন - ইংরেজি - EMA (European Medicines Agency)

sandoz gmbh - pregabalin - anxiety disorders; epilepsy - antiepileptics, - epilepsypregabalin sandoz gmbh is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.generalised anxiety disorderpregabalin sandoz gmbh is indicated for the treatment of generalised anxiety disorder (gad) in adults.

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

abbott australasia pty ltd diagnostic division - ct943 - instrument/analyser ivds - instrument/analyser intended to be used as an in-vitro diagnostic medical device(ivd)

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

zoetis inc. - hydroxyethyl starch 130/0.4 (unii: 1gvo236s58) (hydroxyethyl starch 130/0.4 - unii:1gvo236s58) - hydroxyethyl starch 130/0.4 6000 mg in 100 ml - vetstarch™ (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is indicated for the treatment and prophylaxis of hypovolemia. it is not a substitute for red blood cells or coagulation factors in plasma. the use of vetstarch™ is contraindicated in the following conditions: • known hypersensitivity to hydroxyethyl starch [see general warnings and precautions (5.1)]  • fluid overload (hyperhydration) and especially in cases of pulmonary edema and congestive heart failure • renal failure with oliguria or anuria not related to hypovolemia • patients receiving dialysis treatment • severe hypernatremia or severe hyperchloremia • intracranial bleeding the type of hydroxyethyl starch present in vetstarch had no teratogenic properties in rats or rabbits. at 5 g/kg of body weight per day, administered as a bolus injection, fetal retardations and embryolethal effects were observed in rats and rabbits, respectively. in rats, a bolus injection of this dose during pregnancy and lactation reduced body

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

e-house korea holdings international - starch, corn (unii: o8232ny3sj) (starch, corn - unii:o8232ny3sj) - starch, corn 3.16 g in 4 g

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

e-house korea holdings international - starch, corn (unii: o8232ny3sj) (starch, corn - unii:o8232ny3sj) - starch, corn 3.16 g in 4 g

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

bayer healthcare llc - starch, corn (unii: o8232ny3sj) (starch, corn - unii:o8232ny3sj) - starch, corn 837 mg in 1 g - skin protectant temporarily protects and helps relieve minor skin irritation

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - hydroxyethyl starch 130/0.4, quantity: 60 g/l - injection, solution - excipient ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide - treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient. the use of voluven is not a substitute for the appropriate use of packed red blood cells or fresh frozen plasma.

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - hydroxyethyl starch 130/0.4, quantity: 60 g/l - injection, solution - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid; sodium chloride - treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient. the use of voluven is not a substitute for the appropriate use of packed red blood cells or fresh frozen plasma.