Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

mayo clinic - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 91.5 mci in 1 ml - sodium fluoride f 18 injection usp is indicated for diagnostic positron emission tomography (pet) imaging of bone to define areas of altered osteogenic activity. none pregnancy category c any radiopharmaceutical including sodium fluoride f 18 injection usp has the potential to cause fetal harm. the likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. animal reproductive and developmental toxicity studies have not been conducted with sodium fluoride f 18 injection usp. prior to the administration of sodium fluoride f 18 injection usp to women of childbearing potential, assess for presence of pregnancy. sodium fluoride f 18 injection usp should be given to a pregnant woman only if clearly needed. it is not known whether sodium fluoride f 18 injection usp is excreted into human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of sodium fluoride f 18 injection usp or not to administer sodium fluoride f 18 injection usp, taking into account the importance of the drug to the mother. the body of scientific information related to radioactivity decay, drug tissue distribution and drug elimination shows that less than 0.01% of the radioactivity administered remains in the body after 24 hours (10 half-lives). to minimize the risks to a nursing infant, interrupt nursing for at least 24 hours. in reported clinical experience in approximately 100 children, weight-based doses (2.1 mbq/kg) ranging from 19 mbq-148 mbq (0.5-4 mci) were used. sodium fluoride f 18 was shown to localize to areas of bone turnover including rapidly growing epiphyses in developing long bones. children are more sensitive to radiation and may be at higher risk of cancer from sodium fluoride f 18 injection usp.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

biomedical research foundation of northwest louisiana - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 200 mci in 1 ml - sodium fluoride f 18 injection, usp is indicated for diagnostic positron emission tomography (pet) imaging of bone to define areas of altered osteogenic activity. none. pregnancy category c any radiopharmaceutical including sodium fluoride f 18 injection has a potential to cause fetal harm. the likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. animal reproduction studies have not been conducted with sodium fluoride f 18 injection. prior to the administration of sodium fluoride f 18 injection to women of childbearing potential, assess for presence of pregnancy. sodium fluoride f 18 injection should be given to a pregnant woman only if clearly needed. it is not known whether sodium fluoride f 18 injection is excreted into human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of sodium fluoride f

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

cardinal health 414, llc - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 200 mci in 1 ml - sodium fluoride f-18 injection, usp, is indicated for diagnostic positron emission tomography (pet) imaging of bone to define areas of altered osteogenic activity. none any radiopharmaceutical including sodium fluoride f-18 injection, usp, has a potential to cause fetal harm. the likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. animal reproductive and developmental toxicity studies have not been conducted with sodium fluoride f-18 injection, usp. prior to the administration of sodium fluoride f-18 injection, usp, to women of childbearing potential, assess for presence of pregnancy. sodium fluoride f-18 injection, usp, should be given to a pregnant woman only if clearly needed. it is not known whether sodium fluoride f-18 injection, usp, is excreted into human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration o

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

petnet solutions, inc. - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 200 mci in 1 ml - sodium fluoride f 18 injection is indicated for diagnostic positron emission tomography (pet) imaging of bone to define areas of altered osteogenic activity. none. pregnancy category c any radiopharmaceutical including sodium fluoride f 18 injection has a potential to cause fetal harm. the likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. animal reproductive and developmental toxicity studies have not been conducted with sodium fluoride f 18 injection. prior to the administration of sodium fluoride f 18 injection to women of childbearing potential, assess for presence of pregnancy. sodium fluoride f 18 injection should be given to a pregnant woman only if clearly needed. it is not known whether sodium fluoride f 18 injection is excreted into human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of sodium fl

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

kvk-tech, inc. - sodium polystyrene sulfonate (unii: 1699g8679z) (polystyrene sulfonic acid - unii:70ko0r01ry) - sodium polystyrene sulfonate 1 g in 1 g - sodium polystyrene sulfonate is indicated for the treatment of hyperkalemia. limitation of use : sodium polystyrene sulfonate should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see clinical pharmacology (12.2)]. sodium polystyrene sulfonate is contraindicated in patients with the following conditions: • hypersensitivity to polystyrene sulfonate resins • obstructive bowel disease • neonates with reduced gut motility risk summary sodium polystyrene sulfonate is not absorbed systemically following oral or rectal administration and maternal use is not expected to result in fetal risk. risk summary sodium polystyrene sulfonate is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant. studies of safety and efficacy have not been conducted in pediatric patients. in pediatric patients, as in adults, sodium polystyrene sulfonate is expected to bind potassium at the practical exchange ratio of 1 meq potassium per 1 gram of resin. in neonates, sodium polystyrene sulfonate should not be given by the oral route. in both children and neonates, excessive dosage or inadequate dilution could result in impaction of the resin. premature infants or low birth weight infants may have an increased risk for gastrointestinal adverse effects with sodium polystyrene sulfonate use [see warnings and precautions (5.4)] .

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

par pharmaceutical, inc. - sodium phenylbutyrate (unii: nt6k61736t) (phenylbutyric acid - unii:7wy7ybi87e) - sodium phenylbutyrate 500 mg - sodium phenylbutyrate tablets 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 tablets 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, ne

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

puracap laboratories, llc - sodium polystyrene sulfonate (unii: 1699g8679z) (polystyrene sulfonic acid - unii:70ko0r01ry) - sodium polystyrene sulfonate 4.1 meq in 1 g - sodium polystyrene sulfonate powder, for suspension is indicated for the treatment of hyperkalemia. limitation of use: sodium polystyrene sulfonate powder, for suspension should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see clinical pharmacology (12.2)] . sodium polystyrene sulfonate powder, for suspension is contraindicated in patients with the following conditions: ● hypersensitivity to polystyrene sulfonate resins ● obstructive bowel disease ● neonates with reduced gut motility risk summary sodium polystyrene sulfonate powder, for suspension is not absorbed systemically following oral or rectal administration and maternal use is not expected to result in fetal risk. risk summary sodium polystyrene sulfonate powder, for suspension is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant. studies of safety and efficacy have not been conducted in pediatric patients. in pediatric patients,

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

general injectables & vaccines, inc. - sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - sodium bicarbonate 75 mg in 1 ml - sodium bicarbonate injection, usp is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydratin, extracorporeal circulation of blood, cardiac arrest and in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments.  sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis-e.g., insulin in uncomplicated diabetes, blood volume restoration in shock.  but since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

general injectables & vaccines, inc - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - sodium chloride 234 mg in 30 ml - sodium chloride injection, usp, 23.4%, is indicated as an additive in parenteral fluid therapy for use in patents who have special problems of sodium electrolyte intake or excretion. it is intended to meet the specific requirements of the patient with unusual fluid and electrolyte needs. after available clinical and laboratory information is considered and correlated, the appropriate number of milliequivalents of sodium chloride required can be withdrawn from sodium chloride injection, usp, 23.4% and diluted for use. sodium chloride injection is indicated for the treatment of sodium, chloride and water deficiencies that commonly occur in many diseases. isotonic sodium chloride injection should be limited to cases in which the chloride loss is greater than the sodium loss, as in vomiting from pyloric obstruction, or in which the loss is about equal, as in vomiting from duodenal, jejunal or ileal obstruction and in the replacement of aspirated gastrointestinal fluids. the toxic symptoms that follow various form

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

cipla usa inc. - alendronate sodium (unii: 2uy4m2u3ra) (alendronic acid - unii:x1j18r4w8p) - alendronic acid 35 mg - alendronate sodium tablets, usp are indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women, alendronate sodium tablets, usp increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [see clinical studies (14.1).] alendronate sodium tablets, usp are indicated for the prevention of postmenopausal osteoporosis [see clinical studies (14.2)]. alendronate sodium tablets, usp are indicated for treatment to increase bone mass in men with osteoporosis [see clinical studies (14.3)]. alendronate sodium tablets, usp are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see clinical studies (14.4)]. alendronate sodium tablets, usp are indicated for the treatment of paget's disease of bone in men and women. treatment is indicated in patients with page