United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

hameln pharma ltd - calcium gluconate - solution for injection - 100mg/1ml

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

american regent, inc. - calcium gluconate monohydrate (unii: czn0mi5r31) (calcium - unii:sy7q814vup) - calcium gluconate is used to treat conditions arising from calcium deficiencies such as hypocalcemic tetany, hypocalcemia related to hypoparathyroidism and hypocalcemia due to rapid growth or pregnancy. it is also used in the treatment of black widow spider bites to relieve muscle cramping and as an adjunct in the treatment of rickets, osteomalacia, lead colic and magnesium sulfate overdosage. calcium gluconate has also been employed to decrease capillary permeability in allergic conditions, nonthrombocytopenic purpura and exudative dermatoses such as dermatitis herpetiformis and for pruritus of eruptions caused by certain drugs. in hyperkalemia, calcium gluconate may aid in antagonizing the cardiac toxicity provided the patient is not receiving digitalis therapy. calcium salts are contraindicated in patients with ventricular fibrillation or hypercalcemia. intravenous administration of calcium is contraindicated when serum calcium levels are above normal. if neonates are required, or expected to require, trea

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

fresenius kabi usa, llc - calcium gluconate monohydrate (unii: czn0mi5r31) (calcium cation - unii:2m83c4r6zb) - calcium gluconate injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. limitations of use the safety of calcium gluconate injection for long term use has not been established. calcium gluconate injection is contraindicated in: - hypercalcemia - neonates (28 days of age or younger) receiving ceftriaxone [see warnings and precautions (5.2)] risk summary limited available data with calcium gluconate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. there are risks to the mother and the fetus associated with hypocalcemia in pregnancy [see clinical considerations] . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal

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

hf acquisition co llc, dba healthfirst - calcium gluconate monohydrate (unii: czn0mi5r31) (calcium cation - unii:2m83c4r6zb) - calcium gluconate injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. limitations of use the safety of calcium gluconate injection for long term use has not been established. calcium gluconate injection is contraindicated in: hypercalcemia neonates (28 days of age or younger) receiving ceftriaxone [see warnings and precautions ( 5-5.2)] 8.1 pregnancy risk summary limited available data with calcium gluconate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. there are risks to the mother and the fetus associated with hypocalcemia in pregnancy [see clinical considerations]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal risk maternal hypocalcemia can result in an increased rate of spontaneous abortion, premature and dysfunctional labor, and possibly preeclampsia. fetal/neonatal adverse reactions infants born to mothers with hypocalcemia can have associated fetal and neonatal hyperparathyroidism, which in turn can cause fetal and neonatal skeletal demineralization, subperiosteal bone resorption, osteitis fibrosa cystica and neonatal seizures. infants born to mothers with hypocalcemia should be carefully monitored for signs of hypocalcemia or hypercalcemia, including neuromuscular irritability, apnea, cyanosis and cardiac rhythm disorders. 8.2 lactation risk summary calcium is present in human milk as a natural component of human milk. it is not known whether intravenous administration of calcium gluconate injection can alter calcium concentration in human milk. there are no data on the effects of calcium gluconate injection on the breastfed infant, or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for calcium gluconate injection and any potential adverse effects on the breastfed child from calcium gluconate injection or from the underlying maternal condition. 8.4 pediatric use the safety and effectiveness of calcium gluconate injection have been established in pediatric patients for the treatment of acute, symptomatic hypocalcemia. pediatric approval for calcium gluconate injection, including doses, is not based on adequate and well-controlled clinical studies. safety and dosing recommendations in pediatric patients are based on published literature and clinical experience [see dosage and administration ( 2-2.2)]. concomitant use of ceftriaxone and calcium gluconate injection is contraindicated in neonates (28 days of age or younger) due to reports of fatal outcomes associated with the presence of lung and kidney ceftriaxone-calcium precipitates. in patients older than 28 days of age, ceftriaxone and calcium gluconate injection may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid [see contraindications ( 4) and warnings and precautions ( 5-5.2)]. this product contains up to 512 mcg/l aluminum which may be toxic, particularly for premature neonates due to immature renal function. parenteral administration of aluminum greater than 4 to 5 mcg/kg/day is associated with central nervous system and bone toxicity [see warnings and precautions ( 5-5.5)]. 8.5 geriatric use in general dose selection for an elderly patient should start at the lowest dose of the recommended dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 8.6 renal impairment for patients with renal impairment, initiate calcium gluconate injection at the lowest dose of the recommended dose ranges across all age groups. monitor serum calcium levels every 4 hours [see dosage and administration ( 2-2.4)]. 8.7 hepatic impairment hepatic function does not impact the availability of ionized calcium after calcium gluconate intravenous administration. dose adjustment in hepatically impaired patients may not be necessary.

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

hf acquisition co llc, dba healthfirst - calcium gluconate monohydrate (unii: czn0mi5r31) (calcium cation - unii:2m83c4r6zb) - calcium gluconate injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. limitations of use the safety of calcium gluconate injection for long term use has not been established. calcium gluconate injection is contraindicated in: hypercalcemia neonates (28 days of age or younger) receiving ceftriaxone [see warnings and precautions ( 5-5.2)] 8.1 pregnancy risk summary limited available data with calcium gluconate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. there are risks to the mother and the fetus associated with hypocalcemia in pregnancy [see clinical considerations]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-

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

wg critical care, llc - calcium gluconate monohydrate (unii: czn0mi5r31) (calcium cation - unii:2m83c4r6zb) - calcium gluconate in sodium chloride injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. limitations of use the safety of calcium gluconate in sodium chloride injection for long term use has not been established. calcium gluconate in sodium chloride injection is contraindicated in: •hyperca lcemia • neonates (28 days of age or younger) receiving ceftriaxone [see warnings and precautions (5.2)] risk summary limited available data with calcium gluconate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. there are risks to the mother and the fetus associated with hypocalcemia in pregnancy [see clinical considerations] . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respecti

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

medical purchasing solutions, llc - calcium gluconate monohydrate (unii: czn0mi5r31) (calcium cation - unii:2m83c4r6zb) - calcium gluconate injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. limitations of use the safety of calcium gluconate injection for long term use has not been established. calcium gluconate injection is contraindicated in: - hypercalcemia - neonates (28 days of age or younger) receiving ceftriaxone [see warnings and precautions ( 5.2)] risk summary limited available data with calcium gluconate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. there are risks to the mother and the fetus associated with hypocalcemia in pregnancy [see clinical considerations] . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recogniz

Canada - English - Health Canada

baxter corporation - calcium gluconate - solution - 100mg - calcium gluconate 100mg

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

nivagen pharmaceuticals, inc. - calcium gluconate monohydrate (unii: czn0mi5r31) (calcium cation - unii:2m83c4r6zb) - calcium gluconate injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. limitations of use the safety of calcium gluconate injection for long term use has not been established. calcium gluconate injection is contraindicated in: - hypercalcemia - neonates (28 days of age or younger) receiving ceftriaxone [see warnings and precautions (5.2)] risk summary limited available data with calcium gluconate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. there are risks to the mother and the fetus associated with hypocalcemia in pregnancy [see clinical considerations] . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical  considerations disease-associated matern

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

amneal pharmaceuticals private limited - calcium gluconate monohydrate (unii: czn0mi5r31) (calcium cation - unii:2m83c4r6zb) - calcium gluconate in sodium chloride injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. limitations of use the safety of calcium gluconate injection for long term use has not been established. calcium gluconate in sodium chloride injection is contraindicated in: - hypercalcemia - neonates (28 days of age or younger) receiving ceftriaxone [see warnings and precautions (5.2)] risk summary limited available data with calcium gluconate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. there are risks to the mother and the fetus associated with hypocalcemia in pregnancy [see clinical considerations] . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. clinical considerations disease-associated maternal risk maternal hypocalcemia can result in an increased rate of spontaneous abortion, premature and dysfunctional labor and possibly preeclampsia. fetal/neonatal adverse reactions infants born to mothers with hypocalcemia can have associated fetal and neonatal hyperparathyroidism, which in turn can cause fetal and neonatal skeletal demineralization, subperiosteal bone resorption, osteitis fibrosa cystica and neonatal seizures. infants born to mothers with hypocalcemia should be carefully monitored for signs of hypocalcemia or hypercalcemia, including neuromuscular irritability, apnea, cyanosis and cardiac rhythm disorders. risk summary calcium is present in human milk as a natural component of human milk. it is not known whether intravenous administration of calcium gluconate in sodium chloride injection can alter calcium concentration in human milk. there are no data on the effects of calcium gluconate injection on the breastfed infant, or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for calcium gluconate in sodium chloride injection and any potential adverse effects on the breastfed child from calcium gluconate in sodium chloride injection or from the underlying maternal condition. the safety and effectiveness of calcium gluconate in sodium chloride injection have been established in pediatric patients for the treatment of acute, symptomatic hypocalcemia. pediatric approval for calcium gluconate in sodium chloride injection, including doses, is not based on adequate and well-controlled clinical studies. safety and dosing recommendations in pediatric patients are based on published literature and clinical experience [see dosage and administration (2.2)] . concomitant use of ceftriaxone and calcium gluconate in sodium chloride injection is contraindicated in neonates (28 days of age or younger) due to reports of fatal outcomes associated with the presence of lung and kidney ceftriaxone-calcium precipitates. in patients older than 28 days of age, ceftriaxone and calcium gluconate injection may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid [see contraindications (4)  and warnings and precautions (5.2)] . this product contains up to 100 mcg/l aluminum which may be toxic, particularly for premature neonates due to immature renal function. parenteral administration of aluminum greater than 4 mcg/kg/day to 5 mcg/kg/day is associated with central nervous system and bone toxicity [see warnings and precautions (5.5)] . in general dose selection for an elderly patient should start at the lowest dose of the recommended dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. for patients with renal impairment, initiate calcium gluconate in sodium chloride injection at the lowest dose of the recommended dose ranges across all age groups. monitor serum calcium levels every 4 hours [see dosage and administration (2.4)]. hepatic function does not impact the availability of ionized calcium after calcium gluconate intravenous administration. dose adjustment in hepatically impaired patients may not be necessary.