and ADVERSE REACTIONS). The infusion must be stopped immediately if any signs or symptoms of a reaction develop. , uremia). Nitrogen tolerance may be altered and dosage may have to be adjusted. Fluid and electrolyte status should be closely monitored in these patients.
Azotemia has been reported with parenteral administration of solutions containing amino acids, and may occur in particular in the presence of renal impairment. Patients with azotemia from any cause should not be infused with amino acids without regard to total nitrogen intake.
Respiratory Pulmonary vascular precipitates have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes have occurred. Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates.
Precipitates have been reported even in the absence of phosphate salt in the solution. Precipitation distal to the in‐line filter and suspected in vivo precipitate formation has also been reported. If signs of pulmonary distress occur, the infusion should be stopped and medical evaluation initiated.
In addition to inspection of the solution, the infusion set and catheter should also periodically be checked for precipitates.
Special Populations Pregnant Women:
There are no adequate data on the use of PRIMENE 10% (Amino Acid Injection 10% w/v) in pregnant women. Healthcare professionals should carefully consider the potential risks and benefits for each specific patient before prescribing the product.
Nursing Women:
There are no adequate data on the use of PRIMENE 10% (Amino Acid Injection 10% w/v) in nursing women. Healthcare professionals should carefully consider the potential risks and benefits for each specific patient before administering the product.
Pediatrics:
The product is specifically indicated for the pediatric population. Monitoring and Laboratory Tests Monitoring should be appropriate to the patient’s clinical situation and condition, and may include determinations of fluid balance, water and electrolyte balance, serum osmolarity, and acid / base balance, blood glucose, serum proteins, blood ammonia levels, kidney and liver function tests, electrolytes, hemogram, arterial blood gases, and blood cultures.
PRIMENE 10% (Amino Acid Injection) Page 9 of 26 ADVERSE REACTIONS Adverse Drug Reaction Overview Adverse reaction information is based on postmarketing experiences. Post-Market Adverse Drug Reactions The adverse reactions listed below have been identified from post-marketing reports of PRIMENE 10% (Amino Acid Injection) administered as a component of parenteral nutrition.
They are listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity, where feasible.
IMMUNE SYSTEM DISORDERS:
Hypersensitivity reaction: Face edema Eyelid edema Rash Other adverse reactions reported with parenteral amino acid products include: RENAL AND URINARY DISORDERS: Azotemia METABOLISM AND NUTRITION DISORDERS: Hyperammonemia Adverse reactions reported with parenteral nutrition to which the amino acid component may play a causal or contributory role include: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Chills Infusion site discolouration Injection site erythema Infusion site extravasation Infusion site induration Infusion site phlebitis Infusion site swelling Infusion site thrombosis Infusion site warmth Necrosis Pyrexia Swelling PRIMENE 10% (Amino Acid Injection) Page 10 of 26 IMMUNE SYSTEM DISORDER: Anaphylactic / anaphylactoid reactions, including skin, gastrointestinal and respiratory manifestations Hypersensitivity reaction INJURY, POISONING AND PROCEDURAL COMPLICATIONS: Infusion related reaction Scar INVESTIGATIONS: Blood bilirubin increased Hepatic enzyme increased HEPATOBILIARY DISORDERS: Cholecystitis Cholelithiasis Cholestasis Hepatic cirrhosis Hepatic failure Hepatic fibrosis Hepatic steatosis METABOLISM AND NUTRITION DISORDERS: Metabolic acidosis MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS: Arthralgia Myalgia NERVOUS SYSTEM DISORDERS: Headache PRIMENE 10% (Amino Acid Injection) Page 11 of 26 RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS: Pulmonary Vascular disorder SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Blister Erythema Pruritus Urticaria VASCULAR DISORDER: Hypertension Hypotension Infusion site pain Shock Vein disorder DRUG INTERACTIONS Overview No interaction studies have been performed by Baxter Healthcare Corporation with PRIMENE 10% (Amino Acid Injection 10% w/v).
Drug-Drug Interactions Because of its antianabolic activity, concurrent administration of tetracycline may reduce the protein-sparing effects of infused amino acids. Drug-Food Interactions No drug-food interaction studies have been evaluated.
Drug-Laboratory Interactions No drug-laboratory interaction studies have been evaluated. Drug-Lifestyle Interactions Interactions with lifestyle have not been evaluated. DOSAGE AND ADMINISTRATION PRIMENE 10% (Amino Acid Injection 10% w/v) is intended for intravenous use.
The product PRIMENE 10% (Amino Acid Injection) Page 12 of 26 is in Pharmacy Bulk Package and not for direct infusion. PRIMENE 10% (Amino Acid Injection 10% w/v) is not intended for fluid or volume replacement. Dosing Considerations The total daily dose of PRIMENE10% (Amino Acid Injection 10% w/v) depends on daily protein requirements and on the patient's metabolic and clinical response.
The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements. Dosage should also be guided by the patient's fluid intake limits and glucose and nitrogen tolerances, as well as by metabolic and clinical response.
When used in neonates and children below 2 years, the solution (in containers and administration sets) should be […]