Canada - engelsk - Health Canada

fresenius kabi canada ltd - calcium gluconate - solution - 100mg - calcium gluconate 100mg - replacement preparations

Canada - engelsk - Health Canada

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

Irland - engelsk - HPRA (Health Products Regulatory Authority)

animedica gmbh - calcium gluconate monohydrate; calcium borogluconate; calcium hydroxide; magnesium chloride hexahydrate - solution for injection/infusion - 1.55, 21.45, 0.66, 3.25 grams/100 millilitres - calcium - cattle - vitamins and minerals

Irland - engelsk - HPRA (Health Products Regulatory Authority)

animedica gmbh - calcium gluconate monohydrate; calcium borogluconate; calcium hydroxide; magnesium chloride hexahydrate - solution for injection/infusion - 3.10, 42.960, 1.32, 6.50 grams/100 millilitres - calcium - cattle - vitamins and minerals

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

psm healthcare ltd trading as api consumer brands - calcium gluconate monohydrate 450mg;  ;  ; ergocalciferol 0.015mg - tablet - 0.015mg/450mg - active: calcium gluconate monohydrate 450mg     ergocalciferol 0.015mg

Australia - engelsk - APVMA (Australian Pesticides and Veterinary Medicines Authority)

abbey laboratories pty ltd - calcium gluconate monohydrate - unknown - calcium gluconate monohydrate mineral-calcium active 0.0 - active constituent

USA - engelsk - NLM (National Library of Medicine)

a-s medication solutions - 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

USA - engelsk - 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%, 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 25 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.

USA - engelsk - NLM (National Library of Medicine)

b. braun medical 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-asso

USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceuticals usa 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