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

state of florida doh central pharmacy - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate gelcaps is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). patients with hypercalcemia. pregnancy category c calcium acetate gelcaps contains calcium acetate. animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see warnings and precautions (5.1)] . maintenance of normal serum calcium levels is important for maternal and fetal well being. hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. the effects of calcium acetate on labor and delivery are

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

mylan pharmaceuticals inc. - glatiramer acetate (unii: 5m691hl4bo) (glatiramer - unii:u782c039qp) - glatiramer acetate 20 mg in 1 ml - glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. glatiramer acetate injection is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. available human data on the use of glatiramer acetate injection in pregnant women are not sufficient to support conclusions about drug-associated risk for major birth defects and miscarriage. administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryofetal or offspring development (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us 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 adequate and well-controlled studies of glatiramer acetate injection in pregnant women. the available postmarketing reports, case series, and small cohort studies do not provide sufficient information to support conclusions about drug-associated risk for major birth defects and miscarriage. in rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryofetal development were observed at doses up to 37.5 mg/kg/day (18 and 36 times, respectively, the therapeutic human dose of 20 mg/day on a mg/m2  basis). in rats receiving subcutaneous glatiramer acetate at doses of up to 36 mg/kg from day 15 of pregnancy throughout lactation, no significant effects on delivery or on offspring growth and development were observed. risk summary there are no data on the presence of glatiramer acetate in human milk. based on the low systemic exposure because of substantial local hydrolysis of glatiramer acetate following subcutaneous administration, breastfeeding is not expected to result in clinically relevant exposure of the infant to the drug [see clinical pharmacology (12.3)] . there are no data on the effects of glatiramer acetate on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glatiramer acetate injection and any potential adverse effects on the breastfed infant from glatiramer acetate injection or from the underlying maternal condition. the safety and effectiveness of glatiramer acetate injection have not been established in patients under 18 years of age. glatiramer acetate injection has not been studied in elderly patients. the pharmacokinetics of glatiramer acetate in patients with impaired renal function have not been determined. glatiramer acetate injection (gla tir′ a mer as′ e tate) 20 mg/ml for subcutaneous use for subcutaneous injection only. do not inject glatiramer acetate injection in your veins (intravenously). do not re-use your glatiramer acetate prefilled syringes. do not share your glatiramer acetate prefilled syringes with another person. you may give another person an infection or get an infection from them. you should receive your first dose of glatiramer acetate injection with a healthcare provider or nurse present. this might be at your healthcare provider’s office or with a visiting home health nurse who will show you how to give your own injections. glatiramer acetate injection comes in a 20 mg prefilled syringe with needle attached. how often a dose is given depends on the product strength that is prescribed. your healthcare provider will prescribe the correct dose for you. if you plan to use your glatiramer acetate product with an autoinjector, ask your healthcare provider or pharmacist to make sure that your autoinjector is meant to be used with your glatiramer acetate product. if you use an autoinjector that is not meant to be used with your glatiramer acetate product, you might not get the correct dose of your medicine. instructions for using your glatiramer acetate 20 mg prefilled syringe: how do i inject glatiramer acetate injection? step 1 : gather the supplies you will need to inject glatiramer acetate injection. see figure a. step 2 : remove only 1 blister pack from the glatiramer acetate prefilled syringe carton. see figure b. step 3 : look closely at your glatiramer acetate prefilled syringe. step 4 : choose your injection area. see figure c. see the injection areas you should use on your body. talk with your healthcare provider about the injection areas that are best for you. step 5 : prepare to give your injection. step 6 : clean your injection site. step 7 : pick up the syringe with 1 hand and hold it like a pencil. remove the needle cover with your other hand and set it aside. see figure e. step 8 : pinch about a 2 inch fold of skin between your thumb and index finger. see figure f. step 9 : giving your injection. step 10 : give your glatiramer acetate injection. to inject the medicine, hold the syringe steady and slowly push down the plunger. see figure i. step 11 : remove the needle. after you have injected all of the medicine, pull the needle straight out. see figure j. step 12 : use a clean, dry cotton ball to gently press on the injection site for a few seconds. do not rub the injection site or re-use the needle or syringe. see figure k. step 13 : dispose of your needles and syringes. this instructions for use has been approved by the u.s. food and drug administration. manufactured for: mylan pharmaceuticals inc. morgantown, wv 26505 u.s.a. manufactured by: gland pharma ltd hyderabad 500 043 india code no.: ap/drugs/10/2012 revised: 1/2024 gl:glatij:rx2

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

county line pharmaceuticals, llc - flecainide acetate (unii: m8u465q1wq) (flecainide - unii:k94fts1806) - flecainide acetate 50 mg - in patients without structural heart disease, flecainide acetate tablets is indicated for the prevention of - paroxysmal supraventricular tachycardias (psvt), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms - paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms flecainide acetate tablets are also indicated for the prevention of - documented ventricular arrhythmias, such as sustained ventricular achycardia (sustained vt), that in the judgment of the physician are life-threatening. use of flecainide acetate tablets for the treatment of sustained vt, like other antiarrhythmics, should be initiated in the hospital. the use of flecainide acetate tablets is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. because of the proarrhythmic effects of flecainide acetate tablets, its use shou

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

endo pharmaceuticals inc. - histrelin acetate (unii: qmg7hld1ze) (histrelin - unii:h50h3s3w74) - histrelin acetate 50 mg - supprelin la (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (cpp). children with cpp (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). they also show a significantly advanced bone age that can result in diminished adult height attainment. prior to initiation of treatment a clinical diagnosis of cpp should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (lh) and follicle stimulating hormone (fsh) following stimulation with a gnrh analog, and assessment of bone age versus chronological age. baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adre

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

camber pharmaceuticals, inc. - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). patients with hypercalcemia. pregnancy category c calcium acetate tablets contain calcium acetate. animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see warnings and precautions (5.1)]. maintenance of normal serum calcium levels is important for maternal and fetal well being. hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. the effects of calcium acetate on labor and delivery are unknown. a c

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

remedyrepack inc. - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate capsule is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). patients with hypercalcemia. pregnancy category c calcium acetate capsules contain calcium acetate. animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see warnings and precautions (5.1)]. maintenance of normal serum calcium levels is important for maternal and fetal well being. hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. the effects of calcium acetate on labor and d

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

lupin pharmaceuticals, inc. - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate capsule is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). patients with hypercalcemia. pregnancy category c calcium acetate capsules contain calcium acetate. animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see warnings and precautions (5.1)]. maintenance of normal serum calcium levels is important for maternal and fetal well being. hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. the effects of calcium acetate on labor and delivery are unk

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

avkare, inc. - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate, usp is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). - patients with hypercalcemia. patients with hypercalcemia. pregnancy category c calcium acetate capsules contain calcium acetate. animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see warnings and precautions (5.1) ] . maintenance of normal serum calcium levels is important for maternal and fetal well being. hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. the effects

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

marlex pharmaceuticals inc - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate, usp is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). - patients with hypercalcemia. pregnancy category   c calcium acetate capsules contain calcium acetate. animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see warnings and precautions ( 5.1 )] . maintenance of normal serum calcium levels is important for maternal and fetal well being. hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. the effects of calcium acetate on labor and deliver

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

ncs healthcare of ky, inc dba vangard labs - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). patients with hypercalcemia. pregnancy category c: calcium acetate capsules contains calcium acetate. animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see warnings and precautions (5.1 ) ]. maintenance of normal serum calcium levels is important for maternal and fetal well being. hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. the effects of calcium acetate on labor and delivery are unknown