Rx Prescription drug
Total Amino Acids Preparation
Designated Drug
PRESCRIPTION ONLY MEDICINEREAD THE LEAFLET CAREFULLY BEFORE USING.
IF YOU HAVE ANY QUESTIONS, ASK YOUR DOCTOR.
CONTRAINDICATIONS (This product is contraindicated in the following
patients.)
1. Patients with hepatic coma or possibility of hepatic coma [it is possible topromote 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 aminoacid imbalance].
COMPOSITION & DESCRIPTION
1. Composition
This product contains the following ingredients.
Ingredients
L-Isoleucine
L-Leucine
L-Lysine acetate
L-Methionine
L-Phenylalanine
L-Threonine
L-Tryptophan
L-Valine
L-Alanine
L-Arginine
L-Aspartic acid
L-Cysteine
L-Glutamic acid
L-Histidine
L-Proline
L-Serine
L-Tyrosine
GlycineTotal amino acid content
Amino acid concentration

Per 1 bag (200mL)
1.820g2.580g2.000g0.880g1.400g1.500g0.260g2.800g1.420g1.800g0.200g0.070g0.100g1.000g1.000g
0.340g0.080g1.400g20.650g10.325w/v%

Additives
Sodium bisulfite
Glacial acetic acid (pH adjuster)
Water for injection

Per 1 bag (200mL)
0.060gProper
ProperTotal nitrogen content
Total free amino acid concentration
Branched chain amino acid concentration
EAA/NEAAElectrolytes
Na+ClCH3COO-: 15.2mg/mL: 10.035w/v%: 35.9w/v%: 1.71: <2.9mEq/L: Not contained: ca. 80mEq/L

2. Product description
This product is a colorless and clear aqueous solution for injection.
pHOsmotic pressure ratio
6.8 – 7.8ca. 3
3. Description Containers
The standard of bag being used is as follows.
200mL plastic bag(Fill solution with vertical distance of 75 cm)

Total capacity of plastic bag
ca. 380mL

INDICATIONS
Supply of amino acid in the following conditions:Hypoproteinemia, malnutrition, pre- and post-operation
DOSAGE AND ADMINISTRATION
Administer into the peripheral vein
Usually 200-400mL 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 theirutilization in the body, usually on the standard of 200mL in ca. 120 min. for anadult, and more slowly for a child, elderly and serious patient.
It may be adjusted properly depending on the age, symptom and body weight. Itis desirable to be administered simultaneously with a saccharide infusion for theefficient utilization of amino acids in the body.
Administer into the central vein
Usually 400-800mL 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.

PRECAUTIONS
1. Careful administration (This product should be administered with caution in
the following patients.)(1) Patients with serious acidosis [it is possible to aggravate acidosis byadministration 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 ispossible to aggravate hyponatremia]
2. 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 hepaticfunctional disorder (0.08%), 1 case of vascular pain (0.04%) and 1 case of chest
discomfort (0.04%).
Frequencyis unknown
Hypersensitivity*
Digestive organs
Circulatory organs
LiverKidneys
OthersLess than
5% - 0.1%

Less than 0.1 %[Rash, etc.]
Nausea[Palpitation][Chill, Heat,
Headache][Acidosis]

Vomiting
Chest discomfort
Hepatic functionaldisorder
Renal functional disorder
Vascular painRapidadministration,
large dose
* : Discontinue administration if such symptom is observed.
[ ]: Basing on the adverse reactions which are generally observed in total aminoacid preparations.
Inform your doctor in case of any adverse reactions related to drug use.
3. Use in the Elderly
Since the elderly often have a physiological hypofunction, it is advisable to takesuch measures as the reduction in the administration speed or dose under careful
supervision.
4. Use during Pregnancy, Delivery or Lactation(1) The product should only be used in pregnant women, women suspected ofbeing pregnant, and nursing mothers, provided that the expected therapeutic
benefits are evaluated to outweigh the possible risk of treatment. [Safetyof 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 isunavoidable, avoid nursing. [Safety during nursing has not been established].
5. Pediatric Use
Safety in children has not been established [few clinical experiences].
6. Cautions in Use(1) Before administration
1) Crystals may precipitate. In this case, heat the solution to 50-60oC todissolve the crystals. Then, allow the solution to cool down to about thebody temperature, and use it.
2) Don't use if the solution is not completely clear.
3) Use immediately after unpacking, and discard any remainder.
(2) During administration
The product contains about 80mEq/L of acetic acid. In case of a large doseor combination with an electrolyte solution, therefore, be careful about theelectrolyte balance.
(3)Administration speed
Administer slowly into the vein.
DRUG INTERACTIONS
Scientific data is not available.
CLINICAL STUDIES
1. General Clinical Studies
AMINIC was administered to 243 patients with operation requiring TPN,
infective disease, injury, burn and advanced cancer for more than 1 week. The
percentage of effectiveness (more than effective) according to the evaluation
for the improvement of nutritional status (objective and subjective symptoms,somatometry, protein nutritional indices) is 99.3% (189/191) in adult and 100%
(52/52) in pediatric, respectively, thus the efficacy for severe hypercatabolic at thesurgical stress was confirmed.

2. Comparative clinical studies1)
The clinical comparative studies were conducted to 80 patients after the operationof subtotal or total gastrectomy with the commercially available total aminoacid preparation as a control. As the results of overall judgement considering
daily changes of the protein nutritional indices (total protein, albumin, retinolbinding protein, prealbumin, transferrin), cumulative nitrogen balance etc., it
was concluded that AMINIC is more useful and superior in protein metabolism
efficiency for hypercatabolism as compared with the conventional amino acidpreparation being marketed.
PHARMACOLOGY2), 3)
In surgical stress model rats and beagles, it was observed that AMINIC had bloodbiochemical indices such as serum protein level well maintain, and had nitrogenbalance, synthesis of body protein and healing of wound improve.
PHARMACOKINETICS
Adult patients who underwent surgery and needed nutritional support were treatedwith AMINIC, which was administered at 600 to 800 mL once daily via total
parenteral nutrition from the 1st postoperative day. The nutritional treatment wasprovided for at least 2 weeks in principle. No food intake was allowed for 1 weekof treatment, followed by energy supply of at least 70% of total caloric intake via
the intravenous route for 1 week. The plasma concentration of branched chainamino acids was maintained at a high level from the 2nd to the 14th postoperative
day and returned to the baseline level on the day after discontinuation of AMINIC
treatment. In particular, the plasma level of valine increased significantly fromthe 2nd postoperative day (P<0.001) and surpassed the upper limit of the normal
range. In contrast, the plasma concentrations of isoleucine and leucine increased
within the normal range although the increase was significant for the former fromthe 2nd (P<0.05) and 3rd (P<0.001) postoperative days and for the latter from the3rd postoperative day (P<0.001) until the 14th postoperative day. The ratios ofessential amino acids to non-essential amino acids, branched chain amino acids tototal amino acids, and branched chain amino acids to aromatic amino acids were all
significantly high during treatment (P<0.001). The plasma levels of glutamic acidand phenylalanine increased above the normal range while that of glutamine wasbelow the normal range. Changes in the plasma concentrations of other amino acids
remained in the normal range.
STORAGE AND HANDLING
1. Cautions(1) Air-needle is not needed.
(2) Do not unpack until ready for use in order to prevent solution from coloration.
(An oxygen absorber is enclosed in order to keep the stability of the product.)(3) Do not use in case the solution, normally clear, becomes colored, or if leak ofsolution or waterdrops are found inside of the overwrap.
(4) Do not use in the case that film sealing on the rubber stopper is peeled off.
(5) Insert the injection needle straight at the O-marked point on the rubberstopper. If the needle is inserted diagonally, it may penetrate the container andcause a leak.
(6) Handle with care the overwrap because solution becomes colored, if it isdamaged.
(7) Read measures on the container as a reference.
(8) AMINIC cannot be administered by the tandem system using a connecting
U-shaped tube. If two plastic bags of this product are used at the same time orsequentially, use a Y-shaped transfusion set.
2. Storage
Store at temperature between 1oC - 30oC.
PACKAGING
200mL x 30 bags (plastic bag)Specifications: Manufacturer's
EXPIRATION DATE
Shelf-life: 36 months from the manufacturing date.
The product should be used before the expiration date specified on the outer
package and label.
REFERENCE
1) Shozo Mori et al.
: Jpn. Pharmacol. Ther. 14(10),6341, 1986
2) Takeo Kikuchi et al. : Jpn. Pharmacol. Ther. 14(10),6145, 1986
3) Takao Fujimura et al. : Jpn. Pharmacol. Ther. 14(10),6135, 1986
Follow exactly your physician's prescription
MANUFACTURER:AY PHARMA CEUTICALS CO., LTD.
Head office: 31-1, Nihonbashi-hamacho 2-chome, Chuo-ku, Tokyo, Japan.
Plant: 6-8, Hachiman, Kawajima-machi, Hiki-gun, Saitama 350-0151, Japan.
REQUESTS FOR LITERATURE SHOULD BE MADE TO:
Drug Information
AJINOMOTO PHARMACEUTICALS CO., LTD.
Head office: 1-1, Irifune 2-chome, Chuo-ku, Tokyo, Japan
Fax: +81-03-6280-9930