САЩ - английски - NLM (National Library of Medicine)

amring pharmaceuticals inc. - desmopressin acetate (unii: xb13hyu18u) (desmopressin - unii:enr1llb0fp) - desmopressin acetate 4 ug in 1 ml - desmopressin acetate injection is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. limitations of use: desmopressin acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus. desmopressin acetate injection is indicated for patients with hemophilia a with factor viii coagulant activity levels greater than 5% without factor viii antibodies to: - maintain hemostasis during surgical procedures and postoperatively - reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. desmopressin acetate injection is indicated for patients with mild to moderate von willebrand’s disease (type i) with factor viii levels greater than 5% to: - maintain hemostasis during surgical procedures and postoperatively - reduce bleeding with episodes of s

САЩ - английски - NLM (National Library of Medicine)

amring pharmaceuticals, inc. - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid 650 mg - tranexamic acid usp tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential [see clinical studies (14) ]. tranexamic acid usp tablets are contraindicated in females of reproductive potential who are [see warnings and precautions (5.1)]: - using combined hormonal contraception - known to have any of the following conditions: active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis) a history of thrombosis or thromboembolism, including retinal vein or artery occlusion an intrinsic risk of thrombosis or thromboembolism (e.g., thrombogenic valvular disease, thrombogenic cardiac rhythm disease, or hypercoagulopathy) - active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis) - a history of thrombosis or thromboembolism, including retinal vein or artery occlusion - an intrinsic risk of thrombosis or thromboembolism (e.g., thrombogenic valvul

САЩ - английски - NLM (National Library of Medicine)

amring pharmaceuticals inc. - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride is indicated in adults and pediatric patients: - as an adjunct to general anesthesia - to facilitate tracheal intubation - to provide skeletal muscle relaxation during surgery or mechanical ventilation. succinylcholine chloride is contraindicated: - in patients with skeletal muscle myopathies [see warnings and precautions (5.1)] - in patients with known hypersensitivity to succinylcholine. severe anaphylactic reactions to succinylcholine have been reported [see warnings and precautions (5.2)] - after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see warnings and precautions (5.4)] - in patients with personal or familial history of malignant hyperthermia [see warnings and precautions (5.5)] risk summary available data from published literature from case reports and case series over decades of use with succinylcholine during pregnancy h

САЩ - английски - NLM (National Library of Medicine)

amring pharmaceuticals inc. - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with apl who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m2 basis (see data). a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m2 basis and in hamsters at an intravenous dose approximately equivalent to

САЩ - английски - NLM (National Library of Medicine)

amring pharmaceuticals inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine rectal suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. mesalamine rectal suppositories are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the suppository vehicle [see warnings and precautions (5.3), adverse reactions (6.2), and description (11)] . risk summary limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. no evidence of teratogenicity was observed in rats or rabbits when treated during gestation with orally administered mesalamine at doses greater than the recommended human intra-rectal dose (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. 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 reproduction studies have been performed in rats at oral doses up to 320 mg/kg/day (about 1.7 times the recommended human intra-rectal dose of mesalamine rectal suppositories, based on body surface area) and in rabbits at oral doses up to 495 mg/kg/day (about 5.4 times the recommended human intra-rectal dose of mesalamine rectal suppositories, based on body surface area) following administration during the period of organogenesis, and have revealed no evidence of impaired fertility or harm to the fetus due to mesalamine. risk summary mesalamine and its n-acetyl metabolite are present in human milk in undetectable to small amounts (see data). there are limited reports of diarrhea in breastfed infants. there is no information on the effects of the drug on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of mesalamine rectal suppositories to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mesalamine rectal suppositories and any potential adverse effects on the breastfed child from mesalamine rectal suppositories or from the underlying maternal conditions. clinical considerations monitor breastfed infants for diarrhea. data in published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 3 g daily. the concentration of mesalamine in milk ranged from non-detectable to 0.11 mg/l. the concentration of the n-acetyl-5-aminosalicylic acid metabolite ranged from 5 to 18.1 mg/l. based on these concentrations, estimated infant daily dosages for an exclusively breastfed infant are 0 to 0.017 mg/kg/day of mesalamine and 0.75 to 2.72 mg/kg/day of n-acetyl-5-aminosalicylic acid. the safety and effectiveness of mesalamine rectal suppositories in pediatric patients for the treatment of mildly to moderately active ulcerative proctitis have not been established. mesalamine rectal suppositories were evaluated for the treatment of ulcerative proctitis in a 6-week, open-label, single-arm study in 49 patients 5 to 17 years of age, which only included 14 patients with histologically-confirmed cases of ulcerative proctitis. however, efficacy was not demonstrated. adverse reactions seen in pediatric patients in this trial (abdominal pain, headache, pyrexia, pharyngolaryngeal pain, diarrhea and vomiting) were similar to those seen in adult patients. clinical trials of mesalamine rectal suppositories did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia and pancytopenia) in patients receiving mesalamine-containing products such as mesalamine rectal suppositories who were 65 years or older compared to younger patients. monitor complete blood cell counts and platelet counts in elderly patients during treatment with mesalamine rectal suppositories. in general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concurrent disease or other drug therapy in elderly patients when prescribing mesalamine rectal suppositories [see use in specific populations (8.6)] . mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. evaluate renal function in all patients prior to initiation and periodically while on mesalamine rectal suppository therapy. monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions. discontinue mesalamine if renal function deteriorates while on therapy [see warnings and precautions (5.1), adverse reactions (6.2), drug interactions (7.1)] .

САЩ - английски - NLM (National Library of Medicine)

amring pharmaceuticals inc. - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride is indicated in adults and pediatric patients: - as an adjunct to general anesthesia - to facilitate tracheal intubation - to provide skeletal muscle relaxation during surgery or mechanical ventilation. succinylcholine chloride is contraindicated: - in patients with skeletal muscle myopathies [see warnings and precautions (5.1)] - in patients with known hypersensitivity to succinylcholine. severe anaphylactic reactions to succinylcholine have been reported [see warnings and precautions (5.2)] - after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see warnings and precautions (5.4)] - in patients with personal or familial history of malignant hyperthermia [see warnings and precautions (5.5)] risk summary available data from published literature from case reports and case series over decades of use with succinylcholine during pregnancy

САЩ - английски - NLM (National Library of Medicine)

amring pharmaceuticals inc. - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - lysteda® is indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential [see clinical studies (14)]. lysteda is contraindicated in females of reproductive potential who are [see warnings and precautions (5.1)]: - using combined hormonal contraception - known to have any of the following conditions: active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis) a history of thrombosis or thromboembolism, including retinal vein or artery occlusion an intrinsic risk of thrombosis or thromboembolism (e.g., thrombogenic valvular disease, thrombogenic cardiac rhythm disease, or hypercoagulopathy) - active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis) - a history of thrombosis or thromboembolism, including retinal vein or artery occlusion - an intrinsic risk of thrombosis or thromboembolism (e.g., thrombogenic valvular disease, thrombogenic cardiac rhythm

САЩ - английски - NLM (National Library of Medicine)

amring pharmaceuticals inc. - desmopressin acetate (unii: xb13hyu18u) (desmopressin - unii:enr1llb0fp) - desmopressin acetate injection is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. limitations of use: desmopressin acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus. desmopressin acetate injection is indicated for patients with hemophilia a with factor viii coagulant activity levels greater than 5% without factor viii antibodies to: - maintain hemostasis during surgical procedures and postoperatively - reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. desmopressin acetate injection is indicated for patients with mild to moderate von willebrand’s disease (type i) with factor viii levels greater than 5% to: - maintain hemostasis during surgical procedures and postoperatively - reduce bleeding with episodes of s

САЩ - английски - NLM (National Library of Medicine)

amring pharmaceuticals inc. - desmopressin acetate (unii: xb13hyu18u) (desmopressin - unii:enr1llb0fp) - desmopressin acetate injection is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. limitations of use: desmopressin acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus. desmopressin acetate injection is indicated for patients with hemophilia a with factor viii coagulant activity levels greater than 5% without factor viii antibodies to: - maintain hemostasis during surgical procedures and postoperatively - reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. desmopressin acetate injection is indicated for patients with mild to moderate von willebrand’s disease (type i) with factor viii levels greater than 5% to: - maintain hemostasis during surgical procedures and postoperatively - reduce bleeding with episodes of s

САЩ - английски - NLM (National Library of Medicine)

amring pharmaceuticals inc. - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride injection is indicated in adults and pediatric patients: - as an adjunct to general anesthesia - to facilitate tracheal intubation - to provide skeletal muscle relaxation during surgery or mechanical ventilation. succinylcholine chloride injection is contraindicated: - in patients with skeletal muscle myopathies [see warnings and precautions (5.1)] - in patients with known hypersensitivity to succinylcholine. severe anaphylactic reactions to succinylcholine have been reported [see warnings and precautions (5.2)] - after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see warnings and precautions (5.4)] - in patients with personal or familial history of malignant hyperthermia [see warnings and precautions (5.5)] risk summary available data from published literature from case reports and case series over decades of use with succinylcholin