Alanyl Glutamine Injection BBCA Pharmaceutical Transfusion Glass Bottle 100ml

Instruction of Alanyl Glutamine Injection

Please read the instructions carefully and use only directed by a physician

Prescription drug caution:

This product is a high concentration solution and cannot be infused directly.

Check before use. Do not use when the liquid is turbid or discolored; foreign matter appears; seal is loose; the bottle is slightly broken.

[Product Name]

Generic name:Alanyl Glutamine Injection

English Name:Alanyl Glutamine Injection

Chinese Spelling:Bing’anxian Gu’anxian’an Zhusheye

[Composition]The active substance and chemical name is N(2)-L-alanyl-L-glutamine.

Molecular formula: C₈H₁₅N₃O₄

Molecular weight: 217.23

The excipient is water for injection.

[Character] Colorless and clear liquid.

[Indication] Alanyl Glutamine Injection is administered as parenteral nutrition in patients who need to supplement glutamine, including patients in catabolic and hypermetabolic conditions.

[Specification] 100ml:20g

[Dosage and Administration]

This product is a high concentration solution and cannot be infused directly. Before infusion, it must be mixed with a compatible amino acid solution or an amino acid-containing infusion liquid and then infused with a carrier solution. 1 volume of this product should be mixed with at least 5 volumes of carrier solution (for example: at least 500ml of carrier solution should be added to 100ml of this product ), and the maximum concentration of this product in the mixture should not exceed 3.5%.

The dosage depends on the catabolism degree of the product and the amino acid requisite amount. The maximum daily dose of parenteral nutrition for amino acids is 2g / kg body weight. The amount of alanine and glutamine supplied through this product should be calculated. The amount of amino acids supplied through this product should not exceed 20% of the total amino acid supply.

Daily dose: 1.5~2.0ml per kg body weight, which is equivalent to 0.3 ~ 0.4g of N (2) -L-alanyl-L-glutamine per kg body weight

(for example: 70kg body weight patients need this product 100 ~140ml).

Maximum daily dose: 2.0ml per kg body weight.

Adjust the amount of this product when adding the carrier solution:

When an amino acid requisite amount is 1.5 g per kg body weight per day:

1.2 g of the amino acid is taken from the carrier solution, and 0.3 g of the amino acid is taken from the product.

When an amino acid requisite amount is 2g per kg body weight per day:

1.6g of the amino acid is taken from the carrier solution, and 0.4g of the amino acid is taken from the product.

The infusion rate depends on the carrier solution, but should not exceed 0.1 g amino acids per kg body weight per hour.

The continuous use of this product should not exceed three weeks.

[Adverse Effects] No adverse reactions have been found when used correctly. When the infusion rate of this product is too fast, chills, nausea, and vomiting will occur. In this case, the drug should be stopped immediately.

[Contraindications]Prohibited in the following patients:

1. Severe renal insufficiency (means creatinine clearance <25ml / min)
2. Severe liver dysfunction.
3. Severe metabolic acidosis.
4. Allergic to any ingredient in this product.

[Warnings & Precautions]

(1)Patients should be monitored for alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and acid-base balance during the use of this product.

(2)Regular monitoring of liver function is recommended for patients with compensated liver dysfunction .

(3)It should be compatible with each other when this product is dissolved in the carrier solution, make ensure that the mixing operation should be performed in a clean environment, and the solution must be completely mixed.

(4)Do not add other drugs to the mixed solution.

(5)This product cannot be stored after adding other ingredients.

(6)The osmolality is 900 ～ 1180mOsmol / kg.

[Pregnant and lactating women]The clinical data on the use of this product among pregnant and lactating women is insufficient, so it is not recommended for women during pregnancy and lactation.

[Children] The clinical data of children using this product is insufficient, so it is not recommended for children.

[Elder]Elderly patients, except those with severe renal insufficiency or severe liver dysfunction, can use this product under directed by a doctor.

[Drug Interactions] This product can only be infused into patients after being added to a compatible carrier solution. No interaction has been found between this product and other drugs.

[Overdose]As other infusions, symptoms of chills, nausea and vomiting will occur when this product is infused too quickly. Therefore, the administration must be stopped immediately under these conditions.

[Clinical Pharmacology] This product is an integral part of parenteral nutrition, and N (2)-L-alanyl-L-glutamine can be broken down into glutamine and alanine in the body. Its characteristics is that it can supplement glutamine through parenteral nutrition infusion; the released amino acids of this kinds of dipeptide can be stored in the corresponding parts of the body as a nutrient and metabolized in response to the demands of the body. For symptoms that can possibly cause in vivo glutamine depletion, the product can be supplemented for parenteral nutrition support.

[Pharmacokinetics] Ater infusion, N(2)-L-alanyl-L-glutamine is rapidly decomposited into glutamine and alanine in vivo with its human half-life of 2.4 to 3.8 minutes (being 4.2 minutes for late renal dysfunction patients), and the plasma elimination rate is 1.6 to 2.7 L/min. The disappearance of this dipeptide is accompanied by an increase in the number of free amino acids of equal molar number. Its hydrolysis process may only occur in the extracellular. When the infusion volume is constant, N (2)-L-alanyl-L-glutamine excreted through the urine is less than 5%, being identical to the other infused amino acids.

[Storage]Keep it in a closed and cool place.

[Packaging] Soda-lime glass infusion bottle and halogenated butyl rubber stopper for injection. 100ml / bottle.

[Expiry]2 years