GMP Certified / Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection

• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 500ml
• Model NO.: injection
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

 

Generic Name	Hydroxyethyl starch 130/0.4 and Sodium Chloride Injection
Strength	500ml*6%
Packing	1 bottle / box
Origin	China

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
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Product name:
Hydroxyethyl starch 130/0.4 and Sodium Chloride Injection

Character:
 This product is colorless or light yellow and slightly viscous clear liquid.

Indications:
Treatment and prevention of hypovolemic, acute isovolemic hemodilution (ANH).

Matters needing attention
Avoid excessive use caused by excessive fluid load, especially in patients with cardiac insufficiency and severe renal insufficiency, the risk of excessive fluid load is increased, and the dose should be adjusted. To prevent severe dehydration, a crystal solution should be given before use. It should be used with caution in patients with severe liver disease or severe coagulation disorders, such as severe Willebrand disease. Adequate fluids should be supplemented and kidney function and fluid balance should be regularly monitored. Serum electrolyte levels should be closely monitored. For the occurrence of anaphylactoid reactions, see [Adverse reactions]. Avoid mixing with other drugs. If it is necessary to mix with other drugs in special circumstances, pay attention to compatibility (no flocculation or precipitation), sterility and uniform mixing. The bottle or bag should be used immediately after opening. Cannot be used after expiration date; Unused medicine should be discarded. Use only when the solution is clear and the container is not damaged. Keep out of reach of children. If any adverse events and/or adverse reactions occur during the use of this product, consult your doctor. Please inform your doctor if you are using other drugs. Athletes use with caution.

Adverse reactions:
Very few patients may experience anaphylaxis, moderate flu-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiogenic pulmonary edema when using drugs containing hydroxyethyl starch. In the course of infusion, if the patient has an intolerable reaction, the administration should be terminated immediately and appropriate treatment should be given. When hydroxyethyl starch is administered, the patient's blood amylase concentration will increase, which may interfere with the diagnosis of pancreatitis. Long-term use of large doses of hydroxyethyl starch, patients will appear itching. When used in large doses, due to the dilution effect, it may cause dilution of blood components such as coagulation factors, plasma proteins, and a decrease in hematocrit. Dose-related blood clotting abnormalities may occur when hydroxyethyl starch is used.

Pharmacology and toxicology:
This product is a blood volume expansion agent, and its capacity expansion effect and blood dilution effect depend on the molecular weight, degree of substitution, substitution mode and drug concentration, as well as the dose and infusion speed. After 500ml of this product was injected into healthy volunteers within 30 minutes, the volume expansion effect was 100% of the infusion volume of this product, and the 100% volume effect could be stable for 4-6 hours. Isovolumic blood replacement with this product can maintain blood volume for at least 6 hours. In the subchronic toxicity test studies in dogs and rats, the daily intravenous infusion of this product at the weight of 9g/kg was administered continuously for 3 months, and no toxic effects were found. During administration, the uptake and metabolism of hydroxyethyl starch in the reticuloendothelial system, liver parenchyma and other tissues of the test animals increased due to the increased stress response of liver and kidney under non-physiological conditions. The lowest toxic dose for daily intravenous infusion of this product is higher than 9g/kg by body weight, which is equivalent to more than 3 times the maximum therapeutic dose in humans. Studies in rats or rabbits have shown no teratogenic toxicity. When the rabbits were injected with 10% hydroxyethyl starch 130/0.4 solution 50ml/kg daily, embryo death was observed. In pregnant and lactating rats, a single push injection at the above dose can be observed to delay the weight gain and growth of the pups, and increase the fluid load in the mother. The effects of this product on fertility have not been studied.

Storage:
Store tightly and do not freeze.