Ringers
Generic: SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE
Basic Information
Manufacturer
ICU Medical, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
a926f913-18fa-4a3e-bfd6-210e1e427960
Indications & Usage
1 INDICATIONS AND USAGE Ringer's Injection is indicated for use as a source of water and electrolytes in adults and pediatric patients.
Ringer's Injection is indicated for use as a source of water and electrolytes in adults and pediatric patients.
( 1 )
Ringer's Injection is indicated for use as a source of water and electrolytes in adults and pediatric patients.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Serious Risk with Concomitant Use with Ceftriaxone [see Warnings and Precautions (5.1) ] Air Embolism [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Potassium Imbalances [see Warnings and Precautions (5.4) ] Hyponatremia [see Warnings and Precautions (5.5) ] Hypercalcemia [see Warnings and Precautions (5.6) ] Fluid Overload [see Warnings and Precautions (5.7) ] The following adverse reactions have been identified during post approval use of Ringer's Products.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: General Disorders and Administration Site Conditions : Phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site burning, and infusion site hypoesthesia.
Hypersensitivity Reactions and Infusion Reactions : Angioedema, chest pain/discomfort, bradycardia or tachycardia, hypotension, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthesia, oral hypoesthesia, dysgeusia, nausea, anxiety, pyrexia, headache, laryngeal edema, sneezing, and injection site infection.
Metabolism and Nutrition Disorders : Hyperkalemia, hyponatremia, and hypervolemia.
Nervous System Disorders : Hyponatremic encephalopathy.
Common adverse reactions include infusion site reactions and symptoms of hypersensitivity reactions (e.g., pruritus, dyspnea, urticaria, rash, cough).
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ICU Medical, Inc.
at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: General Disorders and Administration Site Conditions : Phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site burning, and infusion site hypoesthesia.
Hypersensitivity Reactions and Infusion Reactions : Angioedema, chest pain/discomfort, bradycardia or tachycardia, hypotension, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthesia, oral hypoesthesia, dysgeusia, nausea, anxiety, pyrexia, headache, laryngeal edema, sneezing, and injection site infection.
Metabolism and Nutrition Disorders : Hyperkalemia, hyponatremia, and hypervolemia.
Nervous System Disorders : Hyponatremic encephalopathy.
Common adverse reactions include infusion site reactions and symptoms of hypersensitivity reactions (e.g., pruritus, dyspnea, urticaria, rash, cough).
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ICU Medical, Inc.
at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .