Singapore - English - HSA (Health Sciences Authority)

fresenius kabi (singapore) pte ltd - glycerin; potassium chloride; sodium lactate - solution, sterile - 57 g/100 ml - glycerin 57 g/100 ml; potassium chloride 30 mg/100 ml; sodium lactate 1.6 g/100 ml

Canada - English - Health Canada

therapex division de e-z-em canada inc - sodium bicarbonate; tartaric acid - tablet - 52.5mg; 52.5mg - sodium bicarbonate 52.5mg; tartaric acid 52.5mg - other diagnostic agents

Canada - English - Health Canada

therapex division de e-z-em canada inc - sodium bicarbonate; tartaric acid - powder - 1.05g; 1.05g - sodium bicarbonate 1.05g; tartaric acid 1.05g - other diagnostic agents

Canada - English - Health Canada

e-z-em inc. - hypromellose - solution - 1g - hypromellose 1g - other diagnostic agents

Canada - English - Health Canada

tyco healthcare - sodium bicarbonate; tartaric acid - powder (effervescent) - 460mg; 420mg - sodium bicarbonate 460mg; tartaric acid 420mg - other diagnostic agents

Canada - English - Health Canada

therapex division de e-z-em canada inc - sodium bicarbonate; tartaric acid - powder - 1.808g; 1.648g - sodium bicarbonate 1.808g; tartaric acid 1.648g - other diagnostic agents

Canada - English - Health Canada

beutlich l.p. - d&c red no. 28 - swab - 1.5% - d&c red no. 28 1.5% - dental agents

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

janssen biotech, inc. - teclistamab (unii: 54534mx6z9) (teclistamab - unii:54534mx6z9) - tecvayli is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody. this indication is approved under accelerated approval based on response rate [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none. risk summary based on the mechanism of action, tecvayli may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of tecvayli in pregnant women to evaluate for a drug associated risk. no animal reproductive or developmental toxicity studies have been conducted with tecvayli. teclistamab-cqyv causes t-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. human immunoglobulin g (igg) is known to cross the placenta; therefore, teclistamab-cqyv has the potential to be transmitted from the mother to the developing fetus. advise women of the potential risk to the fetus. tecvayli is associated with hypogammaglobulinemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with tecvayli should be considered. 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 there are no data on the presence of teclistamab-cqyv in human milk, the effect on the breastfed child, or the effects 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 tecvayli are unknown. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with tecvayli and for 5 months after the last dose. tecvayli may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status of females of reproductive potential prior to initiating tecvayli. contraception females advise females of reproductive potential to use effective contraception during treatment and for 5 months after the last dose of tecvayli. the safety and efficacy of tecvayli have not been established in pediatric patients. of the 165 patients with relapsed or refractory multiple myeloma treated with tecvayli in majestec-1 at the recommended dosage, 48% were 65 years of age or older, and 15% were 75 years of age or older. no overall differences in safety or effectiveness were observed between patients 65 to 74 years of age compared to younger patients. there is an insufficient number of patients 75 years of age or older to assess whether there are differences in safety or effectiveness.

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

daiichi sankyo inc. - edoxaban tosylate (unii: 32w99ue810) (edoxaban - unii:ndu3j18apo) - edoxaban 15 mg - savaysa is indicated to reduce the risk of stroke and systemic embolism (se) in patients with nonvalvular atrial fibrillation (nvaf). limitation of use for nvaf savaysa should not be used in patients with crcl > 95 ml/min because of an increased risk of ischemic stroke compared to warfarin [see dosage and administration (2.1), warnings and precautions (5.1) and clinical studies (14.1)] . savaysa is indicated for the treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) following 5 to 10 days of initial therapy with a parenteral anticoagulant. savaysa is contraindicated in patients with: - active pathological bleeding [see warnings and precautions (5.3) and adverse reactions (6.1)] . risk summary available data about savaysa use in pregnant women are insufficient to determine whether there are drug-associated risks for adverse developmental outcomes. in animal developmental studies, no adverse developmental effects were seen when edoxaban was administered orally to pregnant rats and rabbits during organogenesis at up to 16-times and 8-times, respectively, the human exposure, when based on body surface area and auc, respectively (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnancy confers an increased risk of thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions. published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy. fetal/neonatal adverse reactions use of anticoagulants, including edoxaban, may increase the risk of bleeding in the fetus and neonate. monitor neonates for bleeding [see warnings and precautions (5.3)] . labor or delivery all patients receiving anticoagulants, including pregnant women, are at risk for bleeding. savaysa use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. consider use of a shorter acting anticoagulant as delivery approaches [see warnings and precautions (5.3)] . data animal data embryo-fetal development studies were conducted in pregnant rats and rabbits during the period of organogenesis. in rats, no malformation was seen when edoxaban was administered orally at doses up to 300 mg/kg/day, or 49 times the human dose of 60 mg/day normalized to body surface area. increased post-implantation loss occurred at 300 mg/kg/day, but this effect may be secondary to the maternal vaginal hemorrhage seen at this dose. in rabbits, no malformation was seen at doses up to 600 mg/kg/day (49 times the human exposure at a dose of 60 mg/day when based on auc). embryo-fetal toxicities occurred at maternally toxic doses, and included absent or small fetal gallbladder at 600 mg/kg/day, and increased post-implantation loss, increased spontaneous abortion, and decreased live fetuses and fetal weight at doses equal to or greater than 200 mg/kg/day, which is equal to or greater than 20 times the human exposure. in a rat pre- and post-natal developmental study, edoxaban was administered orally during the period of organogenesis and through lactation day 20 at doses up to 30 mg/kg/day, which is up to 3 times the human exposure when based on auc. vaginal bleeding in pregnant rats and delayed avoidance response (a learning test) in female offspring were seen at 30 mg/kg/day. risk summary there are no data on the presence of edoxaban in human milk, or its effects on the breastfeeding infant or on milk production. edoxaban was present in rat milk. because of the potential for serious adverse reactions in nursing infants, including hemorrhage, advise patients that breastfeeding is not recommended during treatment with savaysa. females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. the risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including savaysa should be assessed in females of reproductive potential and those with abnormal uterine bleeding. the safety and effectiveness of savaysa have not been established in pediatric patients with confirmed vte (pe and/or dvt). effectiveness was not demonstrated in an adequate and well-controlled study conducted in 145 savaysa-treated pediatric patients, from birth to less than 18 years of age with confirmed vte (pe and/or dvt), treated for 3 months up to a maximum of 12 months. of the total patients in the engage af-timi 48 study, 5182 (74%) were 65 years and older, while 2838 (41%) were 75 years and older. in hokusai vte, 1334 (32%) patients were 65 years and older, while 560 (14%) patients were 75 years and older. in the hokusai vte cancer study, 539 (52%) patients were 65 years and older and 176 (17%) were 75 years and older. in clinical trials the efficacy and safety of savaysa in elderly (65 years or older) and younger patients were similar [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . renal clearance accounts for approximately 50% of the total clearance of edoxaban. consequently, edoxaban blood levels are increased in patients with poor renal function compared to those with higher renal function. reduce savaysa dose to 30 mg once daily in patients with crcl 15-50 ml/min. there are limited clinical data with savaysa in patients with crcl < 15 ml/min; savaysa is therefore not recommended in these patients. hemodialysis does not significantly contribute to savaysa clearance [see dosage and administration (2.1, 2.2) and clinical pharmacology (12.3)] . as renal function improves and edoxaban blood levels decrease, the risk for ischemic stroke increases in patients with nvaf [see indications and usage (1.1), dosage and administration (2.1), and clinical studies (14.1)] . the use of savaysa in patients with moderate or severe hepatic impairment (child-pugh b and c) is not recommended as these patients may have intrinsic coagulation abnormalities. no dose reduction is required in patients with mild hepatic impairment (child-pugh a) [see clinical pharmacology (12.3)] . based on the clinical experience from the hokusai vte study, reduce savaysa dose to 30 mg in patients with body weight less than or equal to 60 kg [see dosage and administration (2.2) and clinical studies (14.2)] .

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

janssen-cilag pty ltd - teclistamab, quantity: 30 mg - injection, solution - excipient ingredients: glacial acetic acid; sucrose; disodium edetate; sodium acetate trihydrate; polysorbate 20; water for injections - tecvayli as monotherapy has provisional approval in australia and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody.,the decision to approve this indication has been made on the basis of the overall response rate in a single arm study. continued approval of this indication depends on verification and description of benefit in confirmatory trials.