Amino Acid Infusion for general well-being - 200 ml
DESCRIPTION
1. Composition: MORIAMIN-Ace contains the following ingredients : L-Isoleucine 1.820 g, L-Leusine 2.580 g, L-Lysine acetate 2.000 g, L-Methionine 0.880 g, L-Phenylalanine 1.400 g, L-Threonine 1.500 g, L-Tryptophan 0.260 g, L-Valine 2.800 g, L-Alanine 1.420 g, L-Arginine 1.800 g, L-Aspartic acid 0.200 g, L-Cysteine 0.070 g, L-Glutamic acid 0.100 g, L-Histidine 1.000 g, L-Proline 1.000 g, L-Serine 0.340 g, L-Tyrosine 0.080 g, Glycine 1.400 g, Total Amino Acid content: 20.650 g, Amino acid concentration: 10.325 w/v%, Sodium bisulfite: 0.060 g, Glacial acetic acid (pH adjuster): proper, Total nitrogen content: 15.2 mg/ml, Total free amino acid concentration: 10.035 w/v%, Branched chain amino acid concentration: 35.9 w/v%, EAA/NEAA: 1.71, Electrolytes Na+: <2.9 mEq/L, CH3COO-: ca. 80 mEq/L.
2. Product description: MORIAMIN-Ace is a clear and colorless aqueous solution. The pH and osmotic pressure ratio are as follow: pH 6.8-7.8, Osmotic pressure ratio Approx. 3.
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
MORIAMIN-Ace is indicated for supply of amino acid in the following condition: Hypoproteinemia, Malnutrition, Pre- and Post-operation.
DOSAGE AND ADMINISTRATION
1. Administer into the peripheral vein: usually 200-400 ml is given slowly by an intravenous drip at a time for an adult. The speed of administration is preferably ca. 10g amino acids in 60 min. for their utilization in the body, usually on the standard of 200ml in ca. 120 min. for an adult, and more slowly for a child, elderly and serious patient. It may be adjusted properly depending on the age, symptom and body weight. It is desirable to be administered simultaneously with a saccharide infusion for the efficient utilization of amino acid in the body.
2. Administer into the central vein: usually 400-800 ml is given into the central vein by a continuous drip in a day for an adult by means of total parenteral nutrition. It may be adjusted properly depending on the age, symptom and body weight.
CONTRAINDICATIONS
MORIAMIN-Ace 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 serious kidney disorders or azotemia (it is possible to aggravate symptoms due to nitrogen load).
3. Patients with amino acid metabolism abnormality (it is possible to promote amino acid imbalance).
PRECAUTIONS
MORIAMIN-Ace should be administered with caution in the following patients:
(1) Patients with serious acidosis (it is possible to aggravate acidosis by administration of large dose).
(2) Patients with congestive heart failure (it is possible to increase cardiac load due to an increase of the circulating blood volume).
(3) Patients with hyponatremia (Since this product scarcely contains sodium, it is possible to aggravate hyponatremia).
ADVERSE REACTIONS
Out of a total of 2,668 patients, 16 cases in 12 patients (0.45%) presented adverse reactions in including abnormality on laboratory values. The primary reactions were 5 cases of nausea (0.19%), 2 cases of vomiting (0.08%), 2 cases of hepatic functional disorder (0.08%), 1 case of vascular pain (0.04%) and 1 case of chest discomfort (0.04%).
Use in the Elderly: Since the elderly often have a physiological hypofunction, it is advisable to take such measures as the reduction in the administration speed or dose under careful supervision.
Use during Pregnancy, Delivery or Lactation: (1) The product should only be used in pregnant women, women suspected of being pregnant, and nursing mothers, provided that the expected therapeutic benefits are evaluated to outweight the possible risk of treatment. (Safety of the product in pregnant women and nursing mothers has not been established). (2) It is desirous not to administer to women who are nursing. If administration is unavoidable, avoid nursing (Safety during nursing has not been established).
Pediatric Use: Safety in children has not been established (few clinical experiences).
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.