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P: 877-845-6371For Intravenous Use Only. A HYPERTONIC SOLUTION IN A 10 ML SINGLE DOSE VIAL FOR PROMPT INTRAVENOUS INJECTION. CAUTION: This solution should not be injected intramuscularly or subcutaneously. Administer only by slow injection. INDICATIONS AND USAGE 10% calcium chloride injection is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Calcium chloride is contraindicated for cardiac resuscitation in the presence of ventricular fibrillation or in patients with the risk of existing digitalis toxicity. Calcium chloride is not recommended in the treatment of asystole and electromechanical dissociation. WARNINGS 10% calcium chloride injection is irritating to veins and must not be injected into tissues, since severe necrosis and sloughing may occur. Great care should be taken to avoid extravasation or accidental injection into perivascular tissues. This product contains aluminum that may be toxic. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. PRECAUTIONS Because of its additive effect, calcium should be administered very cautiously to a patient who is digitalized or who is taking effective doses of digitalis or digitalis-like preparations. It is particularly important to prevent a high concentration of calcium from reaching the heart because of the danger of cardiac syncope. Pregnancy: Calcium chloride should be given to a pregnant woman or a woman of childbearing potential only if clearly needed. Pediatric Use: Safety and effectiveness are based on similar clinical conditions in children and adults. Geriatric Use: In general, dosing for a geriatric patient should be cautious. ADVERSE REACTIONS Rapid injection may cause the patient to complain of tingling sensations, a calcium taste, a sense of oppression or “heat wave.” Injections of calcium chloride are accompanied by peripheral vasodilatation as well as a local “burning” sensation and there may be a moderate fall in blood pressure. OVERDOSAGE Too rapid injection may produce lowering of blood pressure and cardiac syncope. For additional safety information, please see Full Prescribing Information. You are encouraged to report Adverse Drug Events (ADEs) to American Regent Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/MedWatch or calling 1-800-FDA-1088.