Hydroxyethyl starch 130/0.4 sodium chloride injection

This product is a blood volume expander. Its volume expansion effect and blood dilution effect depend on the molecular weight, degree of substitution, substitution mode and drug concentration, as well as the dosage and infusion rate. After 500ml of this product was infused into healthy volunteers within 30 minutes, its volume expansion effect was 100% of the infusion volume of this product, and this 100% volume effect can be stably maintained for 4-6 hours. This product can maintain blood volume for at least 6 hours by isovolumetric blood replacement. In the subchronic toxicity test study of dogs and rats, this product was intravenously infused at 9g/kg body weight daily for 3 consecutive months, and no toxic reaction was found. During the administration period, due to the increase in liver and kidney stress response under non-physiological conditions, it can be observed that the reticuloendothelial system, liver parenchyma and other tissues of the test animals have increased uptake and metabolism of hydroxyethyl starch. The minimum toxic dose of this product for daily intravenous infusion is higher than 9g/kg body weight, which is equivalent to more than 3 times the maximum therapeutic dose of humans. Studies conducted in rats or rabbits have shown that this product has no teratogenic toxicity. When rabbits were infused with 10% hydroxyethyl starch 130/0.4 solution 50ml/kg daily, embryonic death was observed. When pregnant and lactating rats were given a single bolus of the above dose, delayed weight gain and growth of the pups were observed, and increased fluid load was observed in the mother. No studies have been conducted on the effects of this product on fertility.

This product is a compound preparation, its components are: 500ml: 130/0.430g hydroxyethyl starch and 4.5g sodium chloride. The auxiliary materials are medicinal carbon and hydrochloric acid.

This product is a colorless or light yellow slightly viscous clear liquid with a slight opalescence and a salty taste.

Treatment and prevention of hypovolemia, acute isovolumetric hemodilution (ANH).

For intravenous infusion. The initial 10-20ml should be infused slowly and the patient should be closely observed (to prevent possible allergic reactions). The daily dose and infusion rate should be determined based on the patient's blood loss, maintenance or recovery of hemodynamic parameters and dilution effect. When patients without cardiovascular or pulmonary function risks use colloid volume expanders, the hematocrit should not be less than 30%. The maximum daily dose is 33ml/kg body weight. Depending on the patient's needs, this product can be used continuously for several days. The duration of treatment depends on the duration and degree of hypovolemia, hemodynamic parameters and dilution effect. There is currently only limited experience in long-term daily maximum dose treatment. Or follow the doctor's advice.

Very few patients may experience allergic-like reactions (anaphylactic reactions, moderate flu-like symptoms, tachycardia, bronchospasm, non-cardiogenic pulmonary edema) when using drugs containing hydroxyethyl starch. During the infusion process, if the patient has an intolerable reaction, the drug should be stopped 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. When hydroxyethyl starch is used for a long time and in large doses, the patient will experience skin itching. When used in large doses, due to the dilution effect, it may cause dilution of blood components such as coagulation factors and plasma proteins, as well as a decrease in hematocrit. When hydroxyethyl starch is used, dose-related blood coagulation abnormalities may occur.

Fluid overload (water overload), including pulmonary edema Renal failure with oliguria or anuria Intracranial hemorrhage in patients receiving dialysis Severe hypernatremia or hyperchloremia Known hypersensitivity to hydroxyethyl starch and/or other ingredients in this product.

Precautions for children: There is no data for use in children. It can only be used in children when the possible benefits of treatment outweigh the risks. Precautions for pregnancy and lactation: There is no clinical data for use in pregnant patients. Animal studies have shown that this product has no direct or indirect effects on conception, embryonic development, delivery or postpartum development, and no teratogenic results. It can only be used in pregnant patients when the possible benefits of treatment outweigh the risks. There is no clinical data for use in lactating patients.

No interactions with other drugs or parenteral nutrition products have been found. When hydroxyethyl starch is given, the patient's blood amylase concentration will increase, which may interfere with the diagnosis of pancreatitis. For more information on this, see

Keep in a dark place, sealed and do not freeze

500 ml: Hydroxyethyl starch 130/0.4, 30 g and sodium chloride 4.5 g

24 months

PKU HealthCare Corp., Ltd.

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  1993-05-18

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  No. 21, Fangzheng Avenue, Shuitu Town, Beibei District, Chongqing

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