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

amneal pharmaceuticals llc - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate capsules are 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 of calcium acetate on labor and delivery are unknown. calcium acetate capsules contain calcium acetate and is excreted in human milk. human milk feeding by a mother receiving calcium acetate is not expected to harm an infant, provided maternal serum calcium levels are appropriately monitored. safety and effectiveness in pediatric patients have not been established. clinical studies of calcium acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other clinical experience has not identified differences in responses between elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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

zydus pharmaceuticals usa 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 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

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

heritage pharmaceuticals inc. d/b/a avet 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 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)

american regent, inc. - calcium chloride (unii: m4i0d6vv5m) (calcium cation - unii:2m83c4r6zb, chloride ion - unii:q32zn48698) - calcium chloride 100 mg in 1 ml - calcium chloride is indicated in the immediate treatment of hypocalcemic tetany.  other therapy, such as parathyroid hormone or vitamin d, may be indicated according to the etiology of the tetany. it is also important to institute oral calcium therapy as soon as practicable. calcium salts have been used as adjunctive therapy in a number of conditions, including the following: - insect bites or stings, such as black widow spider bites. sensitivity reactions, particularly when characterized by urticaria. as an aid in the treatment of depression due to overdosage of magnesium sulfate. as an aid in the management of the acute symptoms in lead colic. in cardiac resuscitation, particularly after open heart surgery, calcium chloride has been used when epinephrine has failed to improve weak or ineffective myocardial contractions. insect bites or stings, such as black widow spider bites. sensitivity reactions, particularly when characterized by urticaria. as an aid in the treatment of depression due to overdo

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

hospira, inc. - calcium chloride (unii: m4i0d6vv5m) (calcium cation - unii:2m83c4r6zb, chloride ion - unii:q32zn48698) - calcium chloride 100 mg in 1 ml - calcium chloride injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. limitations of use the safety and effectiveness of calcium chloride injection for long-term use has not been established. calcium chloride injection is contraindicated in: newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment because of the risk of precipitation of ceftriaxone-calcium, regardless of whether these products would be received at different times or through separate intravenous lines [see warnings and precautions (5.1)] .       risk summary administration of calcium chloride injection for the treatment of acute symptomatic hypocalcemia during pregnancy is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. there are risks to the mother and the fetus associated with development of hypocalcemia during pregnancy (see clinical considerations) . animal reproduction studies have n

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - calcium folinate, quantity: 10.8 mg/ml (equivalent: folinic acid, qty 10 mg/ml) - injection, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; sodium chloride; water for injections - leucovorin calcium injection usp is indicated following high dose methotrexate therapy to reduce toxicity (leucovorin rescue). it is also indicated after inadvertent overdosage with methotrexate and in impaired methotrexate elimination.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - calcium folinate, quantity: 10.8 mg/ml (equivalent: folinic acid, qty 10 mg/ml) - injection, solution - excipient ingredients: water for injections; sodium hydroxide; sodium chloride; hydrochloric acid - leucovorin calcium injection usp is indicated following high dose methotrexate therapy to reduce toxicity (leucovorin rescue). it is also indicated after inadvertent overdosage with methotrexate and in impaired methotrexate elimination.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

uhc sdn. bhd. - calcium carbonate; cholecalciferol -

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - alendronic acid 70 mg (film-coated tablet); calcium carbonate 2500 mg - eq. calcium 1000 mg (effervescent tablet); cholecalciferol 22 µg (effervescent tablet) - film-coated tablet; effervescent tablet - 70 mg - 1000 mg - 800 iu - calcium carbonate 2500 mg; alendronic acid 70 mg; cholecalciferol 22 µg - alendronic acid, calcium and colecalciferol, sequential

Philippines - English - FDA (Food And Drug Administration)

sahar international trading, inc. - calcium carbonate , cholecalciferol (vitamin d3) - tablet, film coated - 500mg (as elemental calcium) + 200 iu