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

zydus pharmaceuticals usa inc. - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride 5 mg - buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association’s diagnostic and statistical manual, iii1 as follows: generalized, persistent anxiety (of at least 1 month continual d

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

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride 5 mg - buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association’s diagnostic and statistical manual, iii1 as follows: generalized, persistent anxiety (of at least 1 month continual durat

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

baxter healthcare corporation - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok) - dextrose monohydrate 50 g in 1000 ml - dextrose injection is indicated as source of water and calories. the use of dextrose injection is contraindicated in patients with: risk summary appropriate administration of dextrose injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. animal reproduction studies have not been conducted with injectable dextrose solutions. 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 to 4% and 15 to 20%, respectively. risk summary there are no data on the presence of dextrose in human milk, the effects on a breastfed infant, or the effects on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of dextrose injection to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dextrose injection and any potential adverse effects on the breastfed infant from dextrose injection or from the underlying maternal condition. the safety profile of dextrose injection in pediatric patients is similar to adults. neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects. closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. in very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and risk of intracerebral hemorrhage. children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see warnings and precautions (5.4)] . clinical studies of dextrose injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see warnings and precautions (5.4)] . other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. dextrose is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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

wockhardt bio pty ltd - sodium valproate, quantity: 1000 mg - injection, solution - excipient ingredients: dibasic sodium phosphate dodecahydrate; monobasic sodium phosphate dihydrate; phosphoric acid; sodium hydroxide; water for injections - sodium valproate wockhardt is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

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

wockhardt bio pty ltd - sodium valproate, quantity: 400 mg - injection, solution - excipient ingredients: dibasic sodium phosphate dodecahydrate; monobasic sodium phosphate dihydrate; phosphoric acid; sodium hydroxide; water for injections - sodium valproate wockhardt is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

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

hope pharmaceuticals - sodium nitrite (unii: m0kg633d4f) (nitrite ion - unii:j39976l608) - sodium nitrite 30 mg in 1 ml - sodium nitrite injection, an antidote, is indicated for sequential use with sodium thiosulfate for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. when the diagnosis of cyanide poisoning is uncertain, the potentially life-threatening risks associated with sodium nitrite injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis. none risk summary life-sustaining therapy should not be withheld. cyanide poisoning is a medical emergency in pregnancy, which can be fatal for the pregnant woman and fetus if left untreated (see clinical considerations). therefore, if a pregnant woman has known or suspected cyanide poisoning, sodium nitrite injection for sequential use with sodium thiosulfate injection is recommended [see indications and usage (1)]. there are no available data on sodium nitrite injection use in pregnant women to establish a drug-associated risk for major birth defects, miscarriage, or adverse maternal

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

fresenius kabi usa, llc - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - sodium chloride 9 mg in 1 ml - this parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

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

b. braun medical inc. - dextrose, unspecified form (unii: iy9xdz35w2) (anhydrous dextrose - unii:5sl0g7r0ok) - dextrose 5 g in 100 ml - these intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration. solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products. there is no specific pediatric dose. the dose is dependent on weight, clinical condition, and laboratory results. follow recommendations of appropriate pediatric reference text. (see warnings and precautions .)

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

b. braun medical inc. - dextrose (unii: iy9xdz35w2) (dextrose - unii:iy9xdz35w2), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - dextrose 2.5 g in 100 ml - these intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes, calories and water for hydration. these solutions are contraindicated where the administration of sodium or chloride could be clinically detrimental. solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

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

b. braun medical inc. - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), sodium lactate (unii: tu7hw0w0qt) (lactic acid - unii:33x04xa5at), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698), calcium chloride (unii: m4i0d6vv5m) (calcium cation - unii:2m83c4r6zb, chloride ion - unii:q32zn48698) - dextrose monohydrate 5 g in 100 ml - this solution is indicated for use in adults and pediatric patients as a source of electrolytes, calories and water for hydration. the use of 5% dextrose in lactated ringer’s injection is contraindicated in neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream [see warnings, drug interactions, pediatric use ]. this solution is contraindicated where the administration of sodium, potassium, calcium, chloride or lactate could be clinically detrimental. lactate administration is contraindicated in severe metabolic acidosis or alkalosis, and in severe liver disease or anoxic states which affect lactate metabolism. solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.