אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

orion laboratories pty ltd t/a perrigo australia - calcium gluconate monohydrate, quantity: 25 mg/g - gel - excipient ingredients: propylene glycol; purified water; methyl hydroxybenzoate; hyetellose - for treatment of the tissue destruction decalcification of bone and accompanying severe pain resulting from the penetration of the skin and underlying tissues with hydrogen fluoride following hydrofluoric acid burns.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

general injectables and vaccines, inc. - calcium gluconate monohydrate (unii: czn0mi5r31) (calcium cation - unii:2m83c4r6zb) - calcium gluconate monohydrate 98 mg in 1 ml - these highlights do not include all the information needed to use calcium gluconate injection safely and effectively. see full prescribing information for calcium gluconate injection.calcium gluconate injection, for intravenous use initial u.s. approval: 1941 calcium gluconate injection is indicationd 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 )] 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 an

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

phebra pty ltd - calcium gluconate monohydrate, quantity: 95.3 mg/ml - injection, solution - excipient ingredients: calcium saccharate; water for injections - calcium gluconate is a calcium salt used primarily for the prevention and treatment of calcium deficiency. parenteral administation of calcium gluconate is needed in acute hypocalcaemia and hypocalcsemic tetany. it can be given intravenously in the treatment of severe hyper-kalaemia and in overdosage of magnesium sulphate, as calcium is the antagonist of magnesium toxicity. iv injections have been used in the treatment of acute renal biliary and intestinal colic. calcium has been used as an inotrope in cardiac resuscitation. they may also be used for the prevention of hypocalcaemia in exchange transfusions, and in long term electrolyte replacement therapy.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

phebra pty ltd - calcium gluconate monohydrate, quantity: 931 mg - injection, solution - excipient ingredients: calcium saccharate; water for injections - calcium gluconate is a calcium salt used primarily for the prevention and treatment of calcium deficiency. parenteral administation of calcium gluconate is needed in acute hypocalcaemia and hypocalcsemic tetany. it can be given intravenously in the treatment of severe hyper-kalaemia and in overdosage of magnesium sulphate, as calcium is the antagonist of magnesium toxicity. iv injections have been used in the treatment of acute renal biliary and intestinal colic. calcium has been used as an inotrope in cardiac resuscitation. they may also be used for the prevention of hypocalcaemia in exchange transfusions, and in long term electrolyte replacement therapy.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - calcium gluconate monohydrate 100 mg/ml;   - solution for injection - 1000 mg/10ml - active: calcium gluconate monohydrate 100 mg/ml   excipient: calcium saccharate water for injection - parenteral administration of calcium gluconate is required in acute hypocalcaemia and hypocalcaemic tetany. it may be administered intravenously as an adjunct in the treatment of severe hyperkalaemia and as an aid in the treatment of depression due to overdose of magnesium sulphate (calcium is the antagonist of magnesium toxicity). intravenous injections of calcium have been used in the treatment of acute renal, biliary and intestinal colic. calcium has been used as an inotrope in cardiac resuscitation. calcium salts may also be used in the prevention of hypocalcaema in exchange transfusions and in long term electrolyte replacement therapy.

אוסטרליה - אנגלית - APVMA (Australian Pesticides and Veterinary Medicines Authority)

virbac (australia) pty ltd - calcium gluconate monohydrate - unknown - calcium gluconate monohydrate mineral-calcium active 0.0 - active constituent

ארצות הברית - אנגלית - 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.

ארצות הברית - אנגלית - 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

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

phebra pty ltd - calcium gluconate monohydrate, quantity: 95.3 mg/ml - injection, solution - excipient ingredients: calcium saccharate; water for injections - calcium gluconate is a calcium salt used primarily for the prevention and treatment of calcium deficiency. parenteral administation of calcium gluconate is needed in acute hypocalcaemia and hypocalcsemic tetany. it can be given intravenously in the treatment of severe hyper-kalaemia and in overdosage of magnesium sulphate, as calcium is the antagonist of magnesium toxicity. iv injections have been used in the treatment of acute renal biliary and intestinal colic. calcium has been used as an inotrope in cardiac resuscitation. they may also be used for the prevention of hypocalcaemia in exchange transfusions, and in long term electrolyte replacement therapy.

ארצות הברית - אנגלית - 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.