ארצות הברית - אנגלית - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - irbesartan (unii: j0e2756z7n) (irbesartan - unii:j0e2756z7n) - irbesartan 75 mg - avapro® is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (cv) events, primarily strokes and myocardial infarction. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanis

ארצות הברית - אנגלית - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - sodium ferric gluconate complex (unii: cc9149u2qx) (ferric cation - unii:91o4lml611) - ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. ferrlecit is contraindicated in patients with known hypersensitivity to sodium ferric gluconate or any of its components. reactions have included anaphylaxis [see warnings and precautions (5.1)] . risk summary parenteral iron administration may be associated with hypersensitivity reactions [see warnings and precautions (5.1)] , which may have serious consequences, such as fetal bradycardia (see clinical considerations) . advise pregnant women of the potential risk to the fetus. available data from postmarketing reports with ferrlecit use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage. ferrlecit contains benzyl alcohol as a preservative. because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus i

ארצות הברית - אנגלית - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - flomax (tamsulosin hydrochloride, usp) capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14)] . flomax capsules are not indicated for the treatment of hypertension. flomax capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of flomax capsules. reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see adverse reactions (6.2)]. risk summary flomax is not indicated for use in women. there are no adequate data on the developmental risk associated with the use of flomax in pregnant women. no adverse developmental effects were observed in animal studies in which tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (gd 7 to 17 in the rat and gd 6 to 18 in the rabbit) [see data]. in the u.s. g

ארצות הברית - אנגלית - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - isatuximab (unii: r30772kcu0) (isatuximab - unii:r30772kcu0) - sarclisa is indicated: - in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. - in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. sarclisa is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients [see warnings and precautions (5.1)] . risk summary sarclisa can cause fetal harm when administered to a pregnant woman. the assessment of isatuximab-irfc-associated risks is based on the mechanism of action and data from target antigen cd38 knockout animal models (see data). there are no available data on sarclisa use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction toxicity studies have not been conducted with isatuximab-irfc. 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, miscarriage, 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% to 4% and 15% to 20%, respectively. the combination of sarclisa and pomalidomide is contraindicated in pregnant women because pomalidomide may cause birth defects and death of the unborn child. refer to the pomalidomide prescribing information on use during pregnancy. pomalidomide is only available through a rems program. clinical considerations fetal/neonatal reactions immunoglobulin g1 monoclonal antibodies are known to cross the placenta. based on its mechanism of action, sarclisa may cause depletion of fetal cd38-positive immune cells and decreased bone density. defer administration of live vaccines to neonates and infants exposed to sarclisa in utero until a hematology evaluation is completed. data animal data mice that were genetically modified to eliminate all cd38 expression (cd38 knockout mice) had reduced bone density which recovered 5 months after birth. data from studies using cd38 knockout animal models also suggest the involvement of cd38 in regulating humoral immune responses (mice), feto-maternal immune tolerance (mice), and early embryonic development (frogs). risk summary there are no available data on the presence of isatuximab-irfc in human milk, milk production, or the effects on the breastfed child. maternal immunoglobulin g is known to be present in human milk. the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to sarclisa are unknown. because of the potential for serious adverse reactions in the breastfed child from isatuximab-irfc administered in combination with pomalidomide and dexamethasone, advise lactating women not to breastfeed during treatment with sarclisa. refer to pomalidomide prescribing information for additional information. sarclisa can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing with the combination of sarclisa with pomalidomide, refer to the pomalidomide labeling for pregnancy testing requirements prior to initiating treatment in females of reproductive potential. contraception females advise female patients of reproductive potential to use effective contraception during treatment and for 5 months after the last dose of sarclisa. additionally, refer to the pomalidomide labeling for contraception requirements prior to initiating treatment in females of reproductive potential. males refer to the pomalidomide prescribing information. safety and effectiveness of sarclisa in pediatric patients have not been established. of the total number of subjects in clinical studies of sarclisa, 56% (586 patients) were 65 and over, while 16% (163 patients) were 75 and over. no overall differences in safety or effectiveness were observed between subjects 65 and over and younger subjects, and other reported clinical experience has not identified differences in responses between the adults 65 years and over and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - fexinidazole (unii: 306erl82ir) (fexinidazole - unii:306erl82ir) - fexinidazole tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human african trypanosomiasis (hat) due to trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg. limitations of use due to the decreased efficacy observed in patients with severe second stage hat (cerebrospinal fluid white blood cell count (csf-wbc) >100 cells/µl) due to t. brucei gambiense disease, fexinidazole tablets should only be used in these patients if there are no other available treatment options [see warnings and precautions (5.1)] . fexinidazole tablets are contraindicated in: - patients with known hypersensitivity to fexinidazole tablets and/or any nitroimidazole-class drugs (e.g., metronidazole, tinidazole). - patients with hepatic impairment [see warnings and precautions (5.5), adverse reactions

ארצות הברית - אנגלית - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 300 u in 1 ml - toujeo is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus. limitations of use: toujeo is not recommended for the treatment of diabetic ketoacidosis. toujeo is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] . - in patients with hypersensitivity to insulin glargine or any excipients in toujeo [see warnings and precautions (5.5)] . risk summary published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dose of 0.2 unit/kg/day. overall, the effects of insulin glargine did not generally differ from those obser

ארצות הברית - אנגלית - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - enoxaparin sodium 30 mg in 0.3 ml - lovenox® is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): - in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see clinical studies (14.1)] - in patients undergoing hip replacement surgery, during and following hospitalization - in patients undergoing knee replacement surgery - in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness lovenox is indicated for: - the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism , when administered in conjunction with warfarin sodium - the outpatient treatment of acute deep vein thrombosis without pulmonary embolism , when administered in conjunction with warfarin sodium lovenox is indicated for the prophylaxis of ischemic complications of unstable angina and non–q-wave myocardial infarction, when concurrently administered with aspirin. lovenox, when administered concurren

ארצות הברית - אנגלית - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - insulin glulisine (unii: 7xiy785azd) (insulin glulisine - unii:7xiy785azd) - insulin glulisine 100 [iu] in 1 ml - apidra is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. apidra is contraindicated: - during episodes of hypoglycemia - in patients with known hypersensitivity to insulin glulisine or to any of the excipients in apidra; systemic allergic reactions have occurred with apidra [see adverse reactions (6.1)] . risk summary available pharmacovigilance data have not established an association with insulin glulisine use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . animal reproduction studies have been conducted with insulin glulisine in rats and rabbits using regular human insulin as a comparator. insulin glulisine was given to female rats throughout pregnancy at subcutaneous doses up to 10 units/kg/day (2 times the average human dose, based on body surface area comparison) and to rabbits during org

ארצות הברית - אנגלית - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro 100 u in 1 ml - admelog is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. admelog is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] . - in patients who are hypersensitive to insulin lispro or to any of the excipients in admelog [see warnings and precautions (5.5)]. risk summary published studies with another insulin lispro product used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes [see data] . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . pregnant rats and rabbits were exposed to another insulin lispro product in animal reproduction studies during organogenesis. fetal growth retardation was observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1.0 unit/kg/day. no adverse effe

ארצות הברית - אנגלית - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - lovenox® is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): - in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see clinical studies (14.1)] - in patients undergoing hip replacement surgery, during and following hospitalization - in patients undergoing knee replacement surgery - in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness lovenox is indicated for: - the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism , when administered in conjunction with warfarin sodium - the outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium lovenox is indicated for the prophylaxis of ischemic complications of unstable angina and non–q-wave myocardial infarction, when concurrently administered with aspirin. lovenox, when administered concurren