Amino Acid Infusion for Renal Failure - 200 ml
DESCRIPTION
1. Composition: NEOAMIYU contains the following ingredients : L-Isoleucine 1.500 g, L-Leusine 2.000 g, L-Lysine acetate 1.400 g, L-Methionine 1.000 g, L-Phenylalanine 1.000 g, L-Threonine 0.500 g, L-Tryptophan 0.500 g, L-Valine 1.500 g, L-Alanine 0.600 g, L-Arginine 0.600 g, L-Aspartic acid 0.050 g, L-Cysteine 0.050 g, L-Glutamic acid 0.050 g, L-Histidine 0.500 g, L-Proline 0.400 g, L-Serine 0.200 g, L-Tyrosine 0.100 g, Glycine 0.300 g, Total Amino Acid content: 12.250 g, Total Amino acid concentration: 6.100 w/v%, Sodium hydrogen sulfite: 0.050 g, Glacial acetic acid (pH adjuster): q.s, Total nitrogen content: 8.1 mg/ml, Total free amino acid concentration: 5.90 w/v%, EAA/NEAA: 3.21, Electrolytes: Na+: ca. 2 mEq/L, CH3COO-: ca. 47 mEq/L.
2. Product description: NEOAMIYU is a clear and colorless aqueous solution for infusion. The pH and osmotic pressure ratio are as follow: pH 6.6-7.6, Osmotic pressure ratio Approx. 2.
3. Description containers (plastic bag): The standard of bag being used is as follows: 200 ml plastic bag, Reserve capacity of plastic bag Approx. 250 ml.
INDICATIONS
NEOAMIYU is indicated for the provision of amino acid in the following instances in patients with acute or chronic renal failure: hypoproteinemia, malnutrition, and before and after surgery.
DOSAGE AND ADMINISTRATION
1. Chronic Renal Failure
(1). When administered via a peripheral intravenous line in adults, NEOAMIYU should be injected slowly at 200 ml once daily in patients with chronic renal failure. The usual intravenous infusion rate is 120 to 180 min. per 200 ml, and a slower rate is recommended for children, elderly patients, and patients with a serious condition. The dose may be adjusted according to the patient’s age, condition, and body weight. In patients on dialysis, NEOAMIYU should be injected into the venous side of the dialysis circuit from 90 to 60 minutes before completion of dialysis. Regarding calories, more than 1500 kcal per day is recommended to be provided for the efficiency of amino acid utilization.
(2). When administered via total parenteral nutrition in adults, NEOAMIYU should be injected in the central vein by intravenous drip at 400 ml once daily. The dose may be adjusted according to the patient’s age, condition, and body weight. More than 500 kcal of nonprotein calories should be administered per 1.6 g of nitrogen (200 ml of this product) for the efficiency of amino acid utilization.
2. Acute Renal Failure
In adults, NEOAMIYU should be administered via total parenteral nutrition in the central vein by intravenous drip at 400 ml once daily. The dose may be adjusted according to the patient’s age, condition, and body weight. More than 500 kcal of nonprotein calories should be administered per 1.6 g of nitrogen (200 ml of this product) for the efficiency of amino acid utilization.
PRECAUTIONS
1. Careful Administration (NEOAMIYU should be administered with caution in the following patients.)
(1). Patients with impaired cardiovascular function (The use of the product is associated with increased amount of blood circulation, which may lead to overload of the heart and resultant aggravation of the patient’s condition).
(2). Patients with impaired hepatic function or gastrointestinal hemorrhage (Excessive accumulation of amino acids or hyperammonemia may develop with the use of the product).
(3). Patients with marked electrolyte abnormality or abnormal acid-base balance (The patient’s condition may aggravate with the use of the product).
2. Important Precautions
(1). NEOAMIYU should be used in patients who need parenteral nutrition due to inability or insufficience of oral food intake.
(2). It has been reported that the use of essential amino acid products for renal failure may be associated with hyperammonemia or loss of consciousness if these products are used as the only source of nitrogen. Therefore, the use of this products should be discontinued immediately if poor response to voice or other abnormalities such as decreased spontaneous speech and activities are noted during treatment.
ADVERSE REACTIONS
In clinical studies of NEOAMIYU, 15 adverse reactions (4.7%) were reported in 10 (3.1%) of 318 patients. At the time of approval of the drug, main adverse reactions included nausea queasy (1.9%), vomiting (0.6%), headache (0.6%), and metabolic acidosis (0.6%). Abnormal laboratory changes included decreased bicarbonate ion level 3 events (0.9%), increased AST (GOT) 1 event (0.3%), and increased blood ammonia level 1 event (0.3%). (As of the end of approval) In post-marketing surveillance, adverse reactions (including abnormal laboratory changes) were reported in 98 (3.34%) of 2,936 patients. Main adverse reactions included increased blood urea nitrogen 23 events (0.78%), increased AST (GOT) 20 events (0.68%), increased ALT (GPT) 17 events (0.58%), hepatic disorder 13 events (0.44%), nausea 11 events (0.37%), increased blood creatinine level 8 events (0.27%), hyperammonemia 7 events (0.24%), metabolic acidosis 6 events (0.20%), vomiting 4 events (0.14%), and anorexia 4 events (0.14%). (As of the end of the re-examination)
Use in the Elderly: Since the elderly have a physiological hypofunction in general, NEOAMIYU should be carefully administered, such as reducing the dose.
Use during Pregnancy, Delivery or Lactation:
(1). NEOAMIYU should be used in pregnant women or women having possibilities of being pregnant only if the expected therapeutic benefit is evaluated to outweigh the possible risks. (The safety of this product in pregnant women has not been established.)
(2). Use of NEOAMIYU in nursing mothers is not recommended. If use of NEOAMIYU is judged to be essential, breast feeding must be discontinued during treatment. (The safety of this product in nursing mothers has not been established.)
Pediatric Use:
(1). The safety of NEOAMIYU in children has not been established. (No sufficient clinical data has been available in this population.)
(2). Infants, especially low birth weight babies and neonates, have immature amino acid metabolism. Caution should be exercised if NEOAMIYU is used in such patients, by monitoring the patient’s clinical condition and laboratory results, as well as administrating the product at a slower rate and a reduced dose.
CONTRAINDICATIONS
NEOAMIYU is contraindicated in the following patients:
1. Patients with hepatic coma or possibility of hepatic coma (it is possible to promote amino acid imbalance and aggravate or induce hepatic coma).
2. Patients with hyperammonemia (Hyperammonemia may aggravate due to nitrogen overload).
3. Patients with congenital amino acid metabolism abnormality (The condition may aggravate due to failure of the metabolism of amino acid administered).
PACKING SIZE
Box of 30 bags x 200 ml
STORAGE
Store below 30°C
SHELF-LIFE
36 months from the manufacturing date. The product should be used before the expiration date specified on the outer package and plastic bag.