Approved date: November 14, 2006
Pediatric Compound Amino Acid Injection (19AA-I) Instructions
Please read the instructions carefully and use them under the guidance of a physician.
Generic Name: Pediatric Compound Amino Acid Injection (19AA-I)
English name: Pediatric Compound Amino Acid Injection (19AA-I)
Pinyin: Xiao’er Fufang Anjisuan Zhusheye (19AA-I)
[Ingredients] This product is a compound preparation, a sterile aqueous solution prepared from 19 kinds of amino acids. Its composition is per 1000ml containing:
Isoleucine (C6H13NO2) 4.9g Leucine (C6H13NO2) 8.4g
Lysine acetate (C6H14N2O2·C2H4O2) 4.9g Methionine (C5H11NO2S) 2.0g
Phenylalanine (C9H11NO2) 2.9g threonine (C4H9NO3) 2.5g
Tryptophan (C11H12N2O2) 1.2g Proline (C5H11NO2) 4.7g
Cysteine (C3H7NO2S) <0.2g Histidine (C6H9N3O2) 2.9g
Tyrosine (C9H11NO3) 1.4g alanine (C3H7NO2) 3.2g
Arginine (C6H14N4O2) 7.3g Proline (C5H9NO2) 4.1g
Serine (C3H7NO3) 2.3g Aspartate (C4H7NO4) 1.9g
Glutamate (C5H9NO4) 3.0g Glycine (C2H5NO2) 2.2g
Taurine (C2H7NO3S) 0.15 g
Total amino acid amount: 60g/L Total nitrogen amount: 9.3g/L Electrolyte (mmol/L): Na+ about 5 CH3COO-about 56 Cl-<3 PH value: 5.5-7.0 Osmotic pressure (mOsm/L): about 525 ya Amount of sodium hydrogen sulfate: 0.6g/L
The auxiliary material is: sodium hydrogen sulfite.
【Properties】 This product is a colorless or almost colorless clear liquid.
[Indications] This product is an intravenous parenteral nutrition infusion, which can be used in the following aspects:
1. Premature infants, low birth weight infants, and neonates that cannot be orally ingested or have insufficient intake due to various causes.
2, a variety of trauma: such as burns, trauma and post-operative high metabolic status of children.
3, a variety of acute and chronic malnutrition children who can not eat or eat insufficiently, such as necrotizing enterocolitis, acute necrotizing pancreatitis, chemotherapy and drug reactions.
[Specification] 100ml: 6.0g (total amino acid)
1. Use central venous cannula or peripheral vein administration but all require slow infusion.
2, use 20 ~ 35ml per kilogram of body weight per day or as directed by your doctor.
3. Each gram of nitrogen should be supplied with 150-200 kcal of non-protein calories (glucose, fat milk), plus vitamins and trace elements.
[Adverse reactions] Infusion of this product is too fast, can cause adverse reactions such as nausea, vomiting, palpitations, fever.
[Contraindications] Amino acid metabolism disorders, azotemia patients are banned.
1. Patients with severe liver and kidney function should be used with caution.
2. When applying this product, it is necessary to monitor metabolism, electrolyte and acid-base balance on time to prevent complications.
3. If an allergic rash is found, stop the drug immediately.
4, intravenous drip rate should not be too fast, 20Kg children generally should not exceed 20 drops / minute.
5. Once the liquid medicine is turned on, it should be used up once. Do not store it.
6. Do not use if turbidity or precipitation occurs. When the crystal is precipitated by cold, it can be dissolved in a water bath of 50 to 60 ° C and cooled to 37 ° C to be used again.
[Pregnant women and lactating women] is not clear.
[Child medication] See [Usage and Dosage].
[Geriatric medication] is not clear.
[Drug interactions] are not clear.
[Drug overdose] is not clear.
【Pharmacology and Toxicology】
1. A high concentration of essential amino acids in children, including histidine, tyrosine, and cysteine.
2. Phenylalanine can be metabolized to tyrosine, but because the liver enzyme system in children is not perfect, metabolism cannot be effectively carried out. Therefore, the balance of the concentration in plasma is maintained by increasing the amount of tyrosine and reducing phenylalanine.
3. Methionine is a precursor of cysteine and taurine. It is also because the liver enzyme system in children is not perfect. Therefore, adding taurine and adding appropriate amount of cysteine in the body condition of the child is applied. The content of methionine is low.
4, low glycine content, anti-blood ammonia is too high.
5, contains the right amount of glutamic acid and aspartic acid, is due to high levels of human milk.
6. Taurine is a metabolite of methionine and cysteine. It is rich in human milk, which protects cell membrane, promotes brain development, maintains normal function of retina, prevents cholestasis and enhances cardiomyocyte function.
[Pharmacokinetics] Amino acids provide a source of nitrogen for human synthetic proteins and other tissues, and are essential for the maintenance of human life. In addition to providing a nitrogen source for synthetic proteins, some amino acids can be converted into energetic substances by oxidation, and a small amount of amino acids can be converted into some physiologically active substances, thereby maintaining the functions of some tissues and organs. Various amino acids can be passed through the blood. Transfer between tissues to ensure amino acid metabolism in tissues.
Normal human plasma amino acid concentration is not high, the total concentration is about 2 millimoles / liter, most of them in the cells, children are lower, may be faster with children, more amino acid intake tissue. Therefore, children should have higher intake of amino acids than adults.
[Storage] Sealed, stored in a cool dark place (protected from light not exceeding 20 ° C).
[Package] Glass bottles for infusion, 100ml per bottle.
[Validity Period] 24 months
[Executive Standards] National Food and Drug Administration National Drug Standard WS1-(X-507)-2003Z
[Approval No.] National Drug Standard H44023492
Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
Address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
Postal code: 529331
Phone number: (0750) 2789348
400-8899-328 (National Service Phone)
Fax number: (0750) 2789348