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

gland pharma limited - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ).  acute pain in adult patients ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration , and adverse rea

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

gland pharma limited - haloperidol decanoate (unii: ac20pj4101) (haloperidol - unii:j6292f8l3d) - haloperidol 50 mg in 1 ml - haloperidol decanoate injection, 50 mg/ml and haloperidol decanoate injection, 100 mg/ml are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. since the pharmacologic and clinical actions of haloperidol decanoate injection, 50 mg/ml and 100 mg/ml are attributed to haloperidol as the active medication, contraindications, warnings, and additional information are those of haloperidol, modified only to reflect the prolonged action. haloperidol is contraindicated in patients with: • severe toxic central nervous system depression or comatose states from any cause. • hypersensitivity to this drug – hypersensitivity reactions have included anaphylactic reaction and angioedema (see warnings, hypersensitivity reactions and adverse reactions ). • parkinson’s disease (see warnings, neurological adverse reactions in patients with parkinson’s disease or dementia with lewy bodies ). • dementia with lewy bodies (see warnings, neurological adverse

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

gland pharma limited - levoleucovorin calcium (unii: 778xl6vbs8) (levoleucovorin - unii:990s25980y) - levoleucovorin injection is indicated for: - rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. - diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. - the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. limitations of use levoleucovorin injection is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin b12 , because of the risk of progression of neurologic manifestations despite hematologic remission. levoleucovorin is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid or folinic acid [see adverse reactions (6.2)] . risk summary there are limited data with levoleucovorin use in pregnant women. animal reproduction studies have not been conducted with levoleucovorin. levoleucovorin is administered in combination with methotrexate or fluorouracil,

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

gland pharma limited - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non­-depolarizing neuromuscular blocking agents after surgery.  neostigmine methylsulfate injection is contraindicated in patients with:        • known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis).         • peritonitis or mechanical obstruction of the intestinal or urinary tract. risk summary there are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women. it is not known whether neostigmine methylsulfate injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. the incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited. all preg

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

gland pharma limited - 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 known or suspected genetic susceptibility to malignant hyperthermia [see warnings and precautions (5.5), clinical pharmacology (12.5)]   risk summary   available data from published literatur

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

gland pharma limited - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin injection is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: septicemia in the neonate, child, and adult caused by p. aeruginosa , e. coli , and klebsiella sp lower respiratory tract infections caused by p. aeruginosa, klebsiella sp, enterobacter   sp, serratia sp, e. coli , and s. aureus (penicillinase- and non-penicillinase-producing strains). serious central-nervous-system infections (meningitis) caused by susceptible organisms. intra-abdominal infections, including peritonitis, caused by e. coli, klebsiella sp, and enterobacter sp. skin, bone, and skin structure infections caused by p. aeruginosa, proteus sp, e. coli, klebsiella sp, enterobacter sp and s. aureus. complicated and recurrent urinary tract infections caused by p. aeruginosa, proteus sp, (indole-positive and indole- negative), e. coli, klebsiella sp, enterobacter sp, serratia sp, s. aureus, providen

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

gland pharma limited - furosemide (unii: 7lxu5n7zo5) (furosemide - unii:7lxu5n7zo5) - parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. edema: furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. furosemide is particularly useful when an agent with greater diuretic potential is desired. furosemide is indicated as adjunctive therapy in acute pulmonary edema. the intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema.  if gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. parenteral use should be replaced with oral furosemide as soon as practical. furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

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

gland pharma limited - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 15 mg in 1 ml - carefully consider the potential benefits and risks ketorolac tromethamine and other treatment options before deciding to use ketorolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). acute pain in adult patients ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration , and adverse reactions ). pa

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

gland pharma limited - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 5 mg in 100 ml - zoledronic acid injection is indicated for treatment of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, diagnosed by bone mineral density (bmd) or prevalent vertebral fracture, zoledronic acid injection reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). in patients at high risk of fracture, defined as a recent low-trauma hip fracture, zoledronic acid injection reduces the incidence of new clinical fractures [see clinical studies (14.1)]. zoledronic acid injection is indicated for prevention of osteoporosis in postmenopausal women [see clinical studies (14.2)]. zoledronic acid injection is indicated for treatment to increase bone mass in men with osteoporosis [see clinical studies (14.3)]. zoledronic acid injection is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater

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

gland pharma limited - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid injection is indicated for treatment of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, diagnosed by bone mineral density (bmd) or prevalent vertebral fracture, zoledronic acid injection reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). in patients at high risk of fracture, defined as a recent low-trauma hip fracture, zoledronic acid injection reduces the incidence of new clinical fractures [see clinical studies (14.1) ]. zoledronic acid injection is indicated for prevention of osteoporosis in postmenopausal women [see clinical studies (14.2) ]. zoledronic acid injection is indicated for treatment to increase bone mass in men with osteoporosis [see clinical studies (14.3) ]. zoledronic acid injection is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or grea