Amino Acid Infusion for Hepatic Encephalopathy - 200 ml

DESCRIPTION

1. Composition: MORIHEPAMIN contains the following ingredients : L-Isoleucine 1.840 g, L-Leusine 1.890 g, L-Lysine acetate 0.790 g, L-Methionine 0.880 g, L-Phenylalanine 0.060 g, L-Threonine 0.428 g, L-Tryptophan 0.140 g, L-Valine 1.780 g, L-Alanine 1.680 g, L-Arginine 3.074 g, L-Aspartic acid 0.040 g, L-Cysteine 0.050 g, L-Histidine 0.620g, L-Proline 1.060 g, L-Serine 0.520 g, L-Tyrosine 0.080 g, Glycine 1.080 g, Total Amino Acid content: 15.170 g, Amino acid concentration: 7.585 w/v%, Sodium bisulfite: 0.050 g, Glacial acetic acid (pH adjuster): proper, Total nitrogen content: 13.18 mg/ml, Total free amino acid concentration: 7.470 w/v%, Branched chain amino acid concentration: 2.755 w/v%, Fischer’s ratio: 54.13, Electrolytes Na+: Approx. 3 mEq/L, CH3COO-: Approx. 100 mEq/L.

2.Product description: MORIHEPAMIN is a clear and colorless aqueous solution. The pH and osmotic pressure ratio are as follow: pH 6.6-7.6, Osmotic pressure ratio Approx. 3.

INDICATIONS

MORIHEPAMIN is indicated for supportive treatment for hepatic encephalopathy syndrome in patients with chronic liver disorder.

DOSAGE AND ADMINISTRATION

MORIHEPAMIN is usually intravenously drip-infused at a single dose of 500 ml in adult patients. The standard infusion rate in adults is 180 minutes or longer per 500 ml. If MORIHEPAMIN is administered via a central venous line, a 500 ml of MORIHEPAMIN should be mixed with carbohydrate-containing solution and be infused continuously via a central vein for 24 hours. The dosage may be adjusted according to the patient’s age, symptoms and body weight.

ADVERSE REACTIONS

Among 243 cases studied prior to the time of approval, 9 adverse reactions (3.7%) were reported in 9 cases (3.7%). The commonly reported adverse reactions by the time of approval included nausea/queasy (0.8% each), sweaty, transient increased blood ammonia level, vascular pain, urticaria, tremor limb by hypoglycemia (0.4% each).

CONTRAINDICATIONS

MORIHEPAMIN is contraindicated in the following patients:
1. Patients with serious renal disorder (The symptoms may be aggravated due to overload of nitrogen compounds).
2. Patients with amino acid metabolism abnormality other than liver disorder (Imbalance of amino acids may be aggravated).

PRECAUTIONS

1. Careful Administration (MORIHEPAMIN should be administered with caution in the following patients)
(1) Patients with severe acidosis (The high doses of the product may aggravate acidosis.)
(2) Patients with congestive heart failure (An increase in the circulating blood volume may worsen cardiac stress in such patients).

2. Important Precautions
If blood ammonia level increase and psychoneurotic symptoms aggravate following administration of MORIHEPAMIN which should be interrupted or changed to another therapy.

3. Use in Elderly
In general, since physiological function is decreased in the elderly, MORIHEPAMIN should be carefully administered and taking measures such as dose reduction.

4. Pediatric Use
The safety of MORIHEPAMIN in children has not been established. (No clinical experience).

5. Use in pregnancy and lactation
The safety of MORIHEPAMIN in pregnant woman and nursing mothers has not been established. Therefore, the product should not be used in pregnant woman, woman suspected of being pregnant, and nursing mothers unless the expected benefit outweigh the potential risks.

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.