Aa - Ⅰ pediatric compound amino acid injection (19)
Approval date: 14 November 2006
Aa - Ⅰ pediatric compound amino acid injection (19) specification
Please read the instructions carefully and use them under the guidance of your physician.
[name of drug]
Common name: pediatric compound amino acid injection (aa - Ⅰ 19)
English name: Pediatric Compound Amino Acid Injection (19 aa - Ⅰ)
Chinese pinyin: Xiao er "Fufang Anjisuan Zhusheye aa - Ⅰ (19)
[ingredients] this product is a compound preparation, a sterilized aqueous solution prepared by 19 kinds of amino acids. Its component per 1000ml contains:
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 valine (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 aspartic acid (C4H7NO4) 1.9g
Glutamate (C5H9NO4) 3.0g glycine (C2H5NO2) 2.2g
Taurine (C2H7NO3S) 0.15g
Total amino acid content: 60g/L total nitrogen content: 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 sodium bisulfite: 0.6g/L
The auxiliary material is sodium bisulfite.
[properties] this product is colorless or almost colorless clear liquid.
[indications] this product is intravenous parenteral nutrition infusion, which can be used in the following aspects:
1. Premature infants, infants with low body weight and neonates who cannot take protein through mouth or do not take enough due to various causes.
2. Various traumas: children with high metabolic status after burns, trauma and surgery.
3. All kinds of children with acute or chronic malnutrition who cannot be fed by mouth, such as necrotizing enterocolitis, acute necrotizing pancreatitis, chemotherapy drug reactions, etc.
[specification] 100ml: 6.0g (total amino acid)
[usage and dosage]
1. Use central venous cannula or peripheral vein to administer the drug but slowly drip.
2. Use 20 ~ 35ml per kg of body weight per day or as directed by the doctor.
3. When dripping, each gram of nitrogen should provide 150 ~ 200 kcal of non-protein heat (glucose, fat milk), plus vitamins, trace elements, etc.
[adverse reactions] the rapid infusion of this product may cause nausea, vomiting, palpitations, fever and other adverse reactions.
[contraindication] patients with disorder of amino acid metabolism and patients with azotopaemia should not be allowed.
1. Use with caution for patients with severe liver and kidney dysfunction.
2. When using this product, it is necessary to timely monitor metabolism, electrolyte and acid-base balance to prevent complications.
3. Stop the medicine immediately if allergic rash is found.
4. The intravenous drip rate should not be too fast. Generally, it should not exceed 20 drops per minute for children of 20Kg.
5. Do not store the liquid once after it is opened.
6. Do not use when turbidity or precipitation occurs. It can be put in water bath of 50 ~ 60℃ to dissolve and cool to 37℃ and clear before use.
[medication for pregnant and lactating women] is not clear.
[medicines for children] see usage and dosage.
[geriatric medication] is not clear.
[drug interactions] are unclear.
[drug overdose] is unclear.
【 pharmacology and toxicology 】
1. Contains high concentrations of essential amino acids, including histidine, tyrosine, and cysteine.
2. Phenylalanine can be metabolized into tyrosine, but the metabolism cannot be carried out effectively due to the unsound liver enzyme system in children. Thus, the balance of plasma concentration is maintained by increasing the amount of tyrosine and decreasing phenylalanine.
3. Methionine is the precursor of cysteine and taurine, which is also due to the unsound liver enzyme system in children. Therefore, taurine is added and an appropriate amount of cysteine is added in the application of taurine to improve the physical conditions of children, so the content of methionine in this product is low.
4. Lower glycine content and too high blood ammonia.
5. Moderate amount of glutamate and aspartic acid is contained in human milk.
6. Taurine, a metabolite of methionine and cysteine, is abundant in human milk, which can protect cell membrane, promote brain development, maintain normal function of retina, prevent cholestasis and enhance function of cardiac muscle cells.
[pharmacokinetics] amino acids provide nitrogen sources for the synthesis of proteins and other tissues in the human body, and are essential substances for the maintenance of human life. In addition to providing nitrogen source for protein synthesis, some amino acids can be used as energy-supplying substances through oxidation decomposition, and a small amount of amino acids can be converted into some physiological active substances, so as to maintain the functions of some tissues and organs. Various amino acids can be transferred between tissues through blood, so as to ensure the metabolism of amino acids in tissues.
Normal person plasma amino acid concentration is not high, total concentration is about 2 milligram molecule/litre, great majority is inside the cell, children is lower, may grow fast with children, amino acid takes in organization to be concerned more. Therefore, children should consume more amino acids than adults.
[storage] sealed and stored in a cool and dark place (no more than 20℃).
[packaging] bottle for infusion, each bottle is 100ml.
[validity period] 24 months
[executive standard] state food and drug administration national drug standard WS1-(x-507)-2003Z
[approval document no.] Chinese medicine approval number H44023492
Company name: guangdong peidi pharmaceutical co., LTD
Address: 66 peidi avenue, yueshan town, kaiping city, guangdong province
Telephone number :(0750)2789348
400-8899-328 (national service telephone number)
Fax number :(0750)2789348