Moriamine^® C-2 (Solution) Instructions for Use

Marketing Authorization Holder

Europharm (UK), Co. Ltd. (United Kingdom)

Manufactured By

Taiwan Biotech Co., Ltd. (Taiwan, Republic of China)

ATC Code

B05BA10 (Combined preparations for parenteral nutrition)

Dosage Forms

	Moriamine® C-2	Solution for infusion: 20 ml amp. 5 pcs.
		Solution for infusion: fl. 200, 250 ml or 500 ml 12 or 20 pcs.

Dosage Form, Packaging, and Composition

Excipients: water for injections, cysteine hydrochloride monohydrate, sodium hydroxide.

200 ml – glass bottles (1) – polyethylene nets (12) – packs.
200 ml – glass bottles (1) – polyethylene nets (20) – packs.
250 ml – glass bottles (12) – cardboard boxes.
250 ml – glass bottles (20) – cardboard boxes.
500 ml – glass bottles (12) – cardboard boxes.
500 ml – glass bottles (20) – cardboard boxes.

Clinical-Pharmacological Group

Agent for parenteral nutrition – amino acid solution

Pharmacotherapeutic Group

Parenteral nutrition agent

Pharmacological Action

A preparation for parenteral protein nutrition, containing essential and non-essential amino acids and Sorbitol as a source of energy and for increasing glycogen reserves in the liver.

The amino acids included in the preparation are in a ratio that meets the body’s need for essential amino acids.

After parenteral administration, amino acids enter the pool of free amino acids in the body and participate in all metabolic processes, in particular, they are used for protein synthesis.

The total content of amino acids is 8.47 g per 100 ml.

Theoretical osmolarity is 1150 mosmol/l.

The total nitrogen content is 13.2 mg/ml.

Pharmacokinetics

With intravenous administration, the bioavailability is 100%.

Amino acids are distributed in the interstitial fluid and the intercellular space of organs and tissues.

When administered correctly, Moriamine^® C-2 does not disturb the amino acid balance.

A small part of the amino acids is eliminated by the kidneys.

Indications

• Partial or total parenteral nutrition together with carbohydrate solutions, fat emulsions, as well as preparations of vitamins, electrolytes and trace elements, when enteral nutrition is impossible or insufficient;
• Partial compensation of protein deficiency in diseases or conditions accompanied by protein deficiency (disorders of protein digestion or absorption due to gastrointestinal diseases, burns, trauma, postoperative period, liver cirrhosis, nephrosis, febrile conditions, acute infectious diseases, anorexia).

ICD codes

Dosage Regimen

Administered intravenously by drip primarily into central veins, at a rate of 2 ml/min (maximum 40 drops per minute).

For parenteral nutrition: maximum daily dose: children over 6 years of age and adults – 2.5 g of amino acids per 1 kg of body weight per day.

The drug is used as long as the need for parenteral nutrition persists.

For diseases or conditions accompanied by protein deficiency: children over 6 years of age and adults – 1.3-2 g of amino acids per kg/day.

Adverse Reactions

When the drug is infused into peripheral veins, signs of a local reaction may be observed: redness, phlebitis, thrombosis; allergic reactions, including bronchospasm.

If the rate of administration of the drug is exceeded, chills, nausea, vomiting, and renal aminoacidosis may occur.

Daily monitoring of the puncture site is recommended.

Contraindications

Disorders of amino acid metabolism, metabolic acidosis, overhydration, hypokalemia, childhood (under 6 years of age). In case of hepatic and renal insufficiency, individual dosing is required.

With caution. Renal/hepatic insufficiency.

Use in Pregnancy and Lactation

Use during pregnancy is possible only in situations where the potential benefit of using the drug for the mother outweighs the possible risk to the fetus. During breastfeeding, breastfeeding should be discontinued.

Special Precautions

The amino acids contained in the preparation can become a nutrient medium for microorganisms, in connection with which the equipment for intravenous infusion must be thoroughly sterilized.

Overdose

If the drug dose is exceeded, acute circulatory disorders may be noted. In this case, the administration of the drug should be stopped immediately.

Drug Interactions

Should not be mixed with medicinal products not intended for parenteral nutrition.

Storage Conditions

In a dry place, protected from light, at a temperature not exceeding 30°C (86°F). Do not freeze. Keep out of reach of children.

Shelf Life

Shelf life. 3 years. Do not use the drug after the expiration date stated on the packaging.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.