Australië - Engels - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - doxorubicin hydrochloride, quantity: 2 mg/ml - injection - excipient ingredients: hydrochloric acid; sodium hydroxide; sucrose; histidine; cholesterol; sodium methoxy peg-40-carbonyl-distearoylphosphatidylethanolamine; hydrogenated soy phosphatidylcholine; ammonium sulfate; ethanol; water for injections - liposomal doxorubicin sun, as monotherapy, is indicated for the treatment of metastatic breast cancer.,liposomal doxorubicin sun is also indicated for the treatment of:,? advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.,? aids-related kaposi's sarcoma (ks) in patients with low cd4 counts (<200 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.,liposomal doxorubicin sun may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and doxorubicin (or other anthracycline).,liposomal doxorubicin sun is also indicated, in combination with bortezomib, for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - doxorubicin hydrochloride, quantity: 2 mg/ml - injection - excipient ingredients: water for injections; cholesterol; ethanol; hydrogenated soy phosphatidylcholine; ammonium sulfate; sodium methoxy peg-40-carbonyl-distearoylphosphatidylethanolamine; histidine; hydrochloric acid; sodium hydroxide; sucrose - liposomal doxorubicin sun, as monotherapy, is indicated for the treatment of metastatic breast cancer.,liposomal doxorubicin sun is also indicated for the treatment of:,? advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.,? aids-related kaposi's sarcoma (ks) in patients with low cd4 counts (<200 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.,liposomal doxorubicin sun may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and doxorubicin (or other anthracycline). liposomal doxorubicin sun is also indicated, in combination with bortezomib, for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.

Verenigde Staten - Engels - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - 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 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 du

Verenigde Staten - Engels - NLM (National Library of Medicine)

onpharma, inc. - sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - sodium bicarbonate 84 mg in 1 ml - sodium bicarbonate inj., 8.4% usp neutralizing additive solution is indicated to hasten onset of analgesia and reduce injection pain, by adjusting commercial preparations of lidocaine w/ epinephrine anesthetic solution to a more physiologic ph. not for use as a systemic alkalizer. barash pg, cullen bf, stoelting rk, clinical anesthesia (4th ed. 2001 lippincott williams and wilken). bhatt h, powell kj, jean da, first aid for the anesthesiology boards, an insider's guide (2011, mcgraw-hill medical). cepeda ms, tzortzopoulou a, thackrey m, hudcova j, arora gandhi p, schumann r., adjusting the ph of lidocaine for reducing pain on injection. cochrane database of systematic reviews 2010, issue 12. art. no.: cd006581. chu lf, clinical anesthesiology board review(2005, mcgraw-hill medical). malamed sf,handbook of local anesthesiology(5th ed. 2004, elsevier mosby). miller rd, miller's anesthesia (6th ed. 2004). stoelting rk, miller rd,basics of anesthesia(5th ed. 2007, churchill livingstone el

Verenigde Staten - Engels - NLM (National Library of Medicine)

preferred 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 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 du

Verenigde Staten - Engels - NLM (National Library of Medicine)

mylan institutional llc - sodium phenylacetate (unii: 48n6u1781g) (phenylacetic acid - unii:er5i1w795a), sodium benzoate (unii: oj245fe5eu) (benzoic acid - unii:8skn0b0mim) - sodium phenylacetate 100 mg in 1 ml - sodium phenylacetate and sodium benzoate injection is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. during acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [see warnings and precautions (5) ]. none. available data with sodium phenylacetate and sodium benzoate injection use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with sodium phenylacetate and sodium benzoate injection. 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. there are no data on the presence of sodium phenylacetate, sodium benzoate in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sodium phenylacetate and sodium benzoate injection and any potential adverse effects on the breastfed infant from sodium phenylacetate and sodium benzoate injection or from the underlying maternal condition. sodium phenylacetate and sodium benzoate injection has been used as a treatment for acute hyperammonemia in pediatric patients including patients in the early neonatal period [see dosage and administration (2) ]. clinical studies of sodium phenylacetate and sodium benzoate injection did not include any patients aged 65 and over to determine whether they respond differently from younger patients. urea cycle disorders are presently diseases of the pediatric and younger adult populations. no pharmacokinetic studies of sodium phenylacetate and sodium benzoate injection have been performed in geriatric 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 concomitant disease or other drug therapy in this patient population. pharmacokinetic parameters of sodium phenylacetate and sodium benzoate injection were compared in healthy males and females. bioavailability of both benzoate and phenylacetate was slightly higher in females than in males. however, conclusions cannot be drawn due to the limited number of subjects in this study. limited information is available on the metabolism and excretion of sodium phenylacetate and sodium benzoate in patients with impaired hepatic function. however, metabolic conjugation of sodium phenylacetate and sodium benzoate is known to take place in the liver and kidney. therefore, caution should be used in administering sodium phenylacetate and sodium benzoate injection to patients with hepatic insufficiency. the drug metabolites of sodium phenylacetate and sodium benzoate injection (phenylacetylglutamine and hippurate) and subsequently ammonia are primarily excreted by the kidney. therefore, use caution and closely monitor patients with impaired renal function who receive sodium phenylacetate and sodium benzoate injection.

Verenigde Staten - Engels - NLM (National Library of Medicine)

cardinal health - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok) - dextrose monohydrate 50 g in 1000 ml - dextrose injection, usp is indicated as a source of water and calories. solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Verenigde Staten - Engels - NLM (National Library of Medicine)

akorn - sodium nitroprusside (unii: eao03pe1tc) (nitroprusside - unii:169d1260km) - sodium nitroprusside 50 mg in 2 ml - sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. sodium nitroprusside is also indicated for the treatment of acute congestive heart failure. sodium nitroprusside should not be used in the treatment of compensatory hypertension, where the primary hemodynamic lesion is aortic coarctation or arteriovenous shunting. sodium nitroprusside should not be used to produce hypotension during surgery in patients with known inadequate cerebral circulation, or in moribund patients (a.s.a. class 5e) coming to emergency surgery. patients with congenital (leber's) optic atrophy or with tobacco amblyopia have unusually high cyanide/thiocyanate ratios. these rare condition

Verenigde Staten - Engels - NLM (National Library of Medicine)

par pharmaceutical, inc. - sodium phenylbutyrate (unii: nt6k61736t) (phenylbutyric acid - unii:7wy7ybi87e) - sodium phenylbutyrate 0.94 g in 1 g - sodium phenylbutyrate powder is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (cps), ornithine transcarbamylase (otc), or argininosuccinic acid synthetase (as). it is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). it is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. it is important that the diagnosis be made early and treatment initiated immediately to improve survival. any episode of acute hyperammonemia should be treated as a life-threatening emergency. sodium phenylbutyrate powder must be combined with dietary protein restriction and, in some cases, essential amino acid supplementation. (see nutritional supplementation subsection of the dosage and administration section.) previously, neona

Verenigde Staten - Engels - NLM (National Library of Medicine)

sigmapharm laboratories, llc - sodium phenylbutyrate (unii: nt6k61736t) (phenylbutyric acid - unii:7wy7ybi87e) - sodium phenylbutyrate 0.94 g in 1 g - sodium phenylbutyrate powder is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (cps), ornithine transcarbamylase (otc), or argininosuccinic acid synthetase (as). it is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). it is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. it is important that the diagnosis be made early and treatment initiated immediately to improve survival. any episode of acute hyperammonemia should be treated as a life-threatening emergency. sodium phenylbutyrate powder must be combined with dietary protein restriction and, in some cases, essential amino acid supplementation. (see nutritional supplementation subsection of t