Loading…
PRIMENE is a brand name for Histidine, supplied as a liquid. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE 3 CONTRAINDICATIONS ........................................................................................................ 3 WARNINGS AND PRECAUTIONS ...................................................................................... 4 ADVERSE…
Verbatim from this product's HC label. Tap a section to expand.
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.
General This solution is for compounding only, not for direct infusion. Proper administration of this injection requires knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise in recognition and treatment of the complications which may occur.
The IV administration of these solutions can lead to fluid or solute overload resulting in hyper or hypoosmolal states. The risk of hypoosmolal states is especially present in conditions associated with ADH secretion and is proportional to the infusion rate.
Severe water and electrolyte disorders, severe fluid overload states, and severe metabolic disorders should be corrected before starting the infusion. Hyperammonemia is of special significance in infants. This reaction appears to be related to a deficiency of the urea cycle enzymes of genetic or product origin.
It is essential that blood ammonia be measured frequently in infants. Administration of amino acids in the presence of impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. It is essential to provide adequate calories concurrently if parenterally administered amino acids are to be retained by the body and utilized for protein synthesis.
Concentrated dextrose solutions are an effective source of such calories. With the administration of PRIMENE 10% (Amino Acid Injection 10% w/v) in combination with highly concentrated dextrose solutions, hyperglycemia, glycosuria and hyperosmolar syndrome may result.
Blood and urine glucose should be monitored on a routine basis in patients receiving this therapy Special care must be taken when giving hypertonic dextrose to a diabetic or pre-diabetic patient. To prevent severe hyperglycemia in such patients, insulin may be required.
Strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava. Solutions ideally should be prepared in the hospital pharmacy under a laminar flow hood.
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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Histidine in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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 protected from light exposure after admixture through administration. Any unused portion of PRIMENE 10% (Amino Acid Injection 10% w/v) should be discarded and should not be used for subsequent admixing.
Recommended Dose and Dosage Adjustment Parenteral nutrition initiation and duration as well as dosage (dose and rate of administration) depends on a patient’s age, weight, clinical condition, nitrogen requirements, ability to metabolize the constituents of PRIMENE 10% (Amino Acid Injection 10% w/v), additional nutrition that may be provided parenterally and/or enterally.
5 grams of amino acids per kilogram of body weight per day. Typically, PRIMENE10% (Amino Acid Injection 10% w/v) is admixed with 50% dextrose and supplemented with electrolytes and administered continuously over a 24 hour period. 2 g/kg of protein and 120 Kcal/kg/day.
For premature infants, especially those in catabolic state, these requirements could be even higher. Total daily fluid intake should be appropriate for the patient's age and size. A fluid dose of 125 mL per kilogram body weight per day is appropriate for most infants on TPN.
Provision of additional nitrogen may not be possible due to fluid intake limits, nitrogen, or glucose intolerance. In addition, the provision of sufficient intracellular electrolytes, principally potassium, magnesium, and phosphate, is required for optimum utilization of amino acids, and sufficient quantities of the major extracellular electrolytes sodium, calcium, and chloride, must be given.
Therefore, if oral feeding is not possible or advisable and TPN is necessary, the volume restrictions dictate how to administer Primene, dextrose and most electrolytes in the same hypertonic solution through intravenous lines. Even such hypertonic solutions will not provide the required daily calories.
If prolonged TPN is required (5 days or more), intravenous lipid emulsions will also have to be administered. The following scenario can serve as an example. 5 g/kg of amino acid per day and 125 cc/kg/day fluid volume. 5 g 10 20 Dextrose 50% 42 mL 21 g 71 110 Water for Injection […]
The key factor in their preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients. Infection and sepsis may occur as a result of intravenous catheters used to administer parenteral formulations, poor maintenance of catheters or contaminated solutions.
Immunosuppression and other factors such as hyperglycemia, malnutrition and/or their underlying disease state may predispose patients to infectious complications. PRIMENE 10% (Amino Acid Injection) Page 5 of 26 Careful symptomatic and laboratory monitoring for fever/chills, leukocytosis, technical complications with the access device, and hyperglycemia can help recognize early infections.
The occurrence of septic complications can be decreased with heightened emphasis on aseptic technique in catheter placement, maintenance, as well as aseptic technique in nutritional formula preparation. Refeeding severely undernourished patients may result in the refeeding syndrome that is characterized by the shift of potassium, phosphorus, and magnesium intracellularly as the patient becomes anabolic.
Thiamine deficiency and fluid retention may also develop. Careful monitoring and slowly increasing nutrient intakes while avoiding overfeeding can prevent these complications. During administration of amino acids in the absence of supporting carbohydrate metabolism, an accumulation of ketone bodies in the blood often occurs.
Correction of ketonemia usually can be accomplished by administering some carbohydrates. Peripheral administration of PRIMENE10% (Amino Acid Injection 10% w/v) requires appropriate dilution and provision of adequate calories. Hypertonic infusion solutions may cause irritation of the vein, vein damage, and thrombosis when administered into a peripheral vein (see ADVERSE REACTIONS).
Care should be taken to assure proper placement of the needle within the lumen of the vein. The venipuncture site should be inspected frequently for signs of infiltration. If venous thrombosis or phlebitis occurs, discontinue infusions or change infusion site and initiate appropriate treatment.
Infusion site reactions have occurred with the use of parenteral nutrition. , necrosis and blistering) when associated with extravasation. See Other Reactions. Patients should be monitored accordingly. PRIMENE 10% (Amino Acid Injection 10% w/v) contains no added electrolytes.
Patients, especially those with hypophosphatemia, may require the addition of phosphate. To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration. To assure adequate intake, serum levels should be monitored frequently.
Unit must be used with a vented set or a non vented set with a vented spike adapter. Administration of amino acid solutions and other nutrients via central or peripheral venous catheter may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure.
This includes attention to solution preparation, administration and patient monitoring. It is essential that a carefully prepared protocol, based on current medical practices, be followed, preferably by an experienced team. Although a detailed discussion of the complications is beyond the scope of this insert, the following summary lists those based on current literature: PRIMENE 10% (Amino Acid Injection) Page 6 of 26 Technical: The placement of a central venous catheter should be regarded as a surgical procedure.
The physician should be fully acquainted with various techniques of catheter insertion as well as recognition and treatment of complications. For details of techniques and placement sites consult the medical literature. X-ray is the best means of verifying catheter placement.
Complications known to occur from the placement of central venous catheters are […]
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 […]