Hydroxyethyl starch (200/0.5) sodium chloride injection

1. Pharmacological action Blood volume expander. The volume expansion effect and blood dilution effect of hydroxyethyl starch solution depend on the molecular weight, degree of substitution, substitution mode and drug concentration of hydroxyethyl starch, as well as the dosage and speed of administration. Rapid infusion of this product has a volume expansion effect of 100% of the infusion amount and lasts for 3 to 4 hours, after which the blood volume continues to decrease. At least within 3 to 4 hours, blood volume, hemodynamics and tissue oxygen supply will be improved. At the same time, due to the reduction of red blood cell aggregation, hematocrit and blood viscosity, blood rheology indicators will be improved, thereby improving the circulation and microcirculation system. 2. Toxicological study The median lethal dose (D50) of hydroxyethyl starch with a molecular weight of 200,000 Daltons for mice exceeds 6 grams/kilogram, which is equivalent to using 420 grams of hydroxyethyl starch for patients weighing 70 kilograms. This dose far exceeds the commonly used clinical dose. The results of chronic and subacute toxicity experiments on dogs show that the daily dosage of 4 g/kg of hydroxyethyl starch, except for the increase of organ weight and the temporary vacuolar degeneration of the reticuloendothelial system shown in histopathology, has no irreversible toxic side effects on the liver, spleen, lungs and lymph nodes. This product is not teratogenic.

This product is a compound preparation, its components are: hydroxyethyl starch (200/0.5) and sodium chloride. Each bottle (or bag) contains 30 grams of hydroxyethyl starch (200/0.5) and 4.5 grams of sodium chloride.

This product is a colorless or slightly yellow clear liquid.

This product is a plasma volume expander. 1. Treat and prevent hypovolemia or shock related to the following conditions: surgery, hemorrhagic shock, trauma, traumatic shock, infection, septic shock, burns, burn shock; 2. Reduce the need for blood supply during surgery and save blood: for example, acute isovolumetric hemodilution (ANH); 3. Therapeutic hemodilution.

Intravenous drip. The first 10 to 20 ml should be slowly infused, and the patient should be closely observed (because of the possibility of anaphylactic reactions). The daily dosage and drip rate depend on the amount of blood loss, the degree of hemoconcentration and its hemodilution effect. When patients with normal heart and lung function use colloid volume expanders, the hematocrit should not be less than 30%. Circulatory overload caused by too fast drip and excessive dosage must be avoided. Recommended dose: 1. Recommended dose for the treatment and prevention of insufficient circulating blood volume or shock (volume replacement therapy): Maximum daily dose: 33 ml/kg per day based on body weight (approximately 2500 ml per day based on 75 kg body weight) (approximately 2.0 g hydroxyethyl starch/kg per day based on body weight) Maximum drip rate: 20 ml/kg per hour based on body weight (approximately 1500 ml per hour based on 75 kg body weight) (approximately 1.2 g hydroxyethyl starch/kg per hour based on body weight) 2. Recommended dose for reducing blood supply during surgery (acute isovolumetric hemodilution-ANH): Perform acute isovolumetric hemodilution (ANH) immediately before surgery, replacing autologous blood with this product at a ratio of 1:1. After ANH, the hematocrit should not be less than 30%. Daily dose: 2-3×500 ml (this product) Bloodletting: 2-3×500 ml (autologous blood) Infusion rate: 1000 ml/15-30 minutes Bloodletting rate: 1000 ml/15-30 minutes 3. Recommended dose for therapeutic hemodilution: The purpose of therapeutic hemodilution is to reduce the hematocrit, which can be divided into isovolumetric hemodilution (bloodletting) and hypervolumetric hemodilution (no bloodletting). According to the dosage, it can be divided into three types: low (250 ml), medium (500 ml), and high (2×500 ml). Daily dose: 250 ml (low): 500 ml (medium); 2×500 ml (high). Infusion rate: 250 ml within 0.5-2 hours; 500 ml within 4-6 hours; 2×500 ml within 8-24 hours. Duration of use: 1. Treatment and prevention of insufficient circulating blood volume or shock (volume replacement therapy) There is no pharmacological and clinical evidence that this product cannot be used repeatedly. The duration and dosage of treatment depends on the duration and degree of hypovolemia. Acute isovolumetric hemodilution (ANH) is usually performed once before surgery. It can be repeated if the hematocrit is normal. 2. Therapeutic hemodilution When therapeutic hemodilution is performed, 10 days of treatment is recommended.

1. A small number of patients may experience allergic reactions to hydroxyethyl starch, manifested as eyelid edema, urticaria, and asthma. Fever, chills, and flu-like symptoms may also occur. Vomiting, enlargement of the submandibular and parotid glands, and lower limb edema may also be seen. In this case, the drug should be stopped immediately and emergency measures should be taken if necessary. 2. Tachycardia may occur, with or without a drop in blood pressure, dizziness, nausea, and vomiting; 3. Shock or bronchospasm may occur; 4. There have been reports of respiratory and cardiac arrest when using this drug; 5. Long-term medium- and high-dose infusions of hydroxyethyl starch often cause patients to experience intractable itching. Even after stopping the drug for several weeks, this symptom may still occur and may last for several months, causing emotional tension in the patient. 6. In some cases, renal pain may occur after infusion of hydroxyethyl starch. Once this symptom occurs, it should be treated with caution.

The following conditions prohibit the use of this product: 1. Severe congestive heart failure (heart failure); 2. Renal decompensation and renal failure (serum creatinine >2 mg/dL or >177 μmol/L); 3. Cerebral hemorrhage; 4. Severe coagulation disorders; 5. Excessive fluid load (too much water) or severe fluid loss (dehydration); 6. Starch allergy.

Precautions for children: There is no definitive data on the use of 6% hydroxyethyl starch (200/0.5) in children. Precautions for pregnancy and lactation: There is no data on the use of 6% hydroxyethyl starch (200/0.5) in pregnant and lactating women. Precautions for the elderly: No special requirements.

No interactions with other drugs have been found.

Keep tightly closed.

500ml: 30g hydroxyethyl starch (200/0.5) and 4.5g sodium chloride

Tentative 36 months

China Resources Double-Crane Pharmaceutical Co., Ltd.

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  1997-05-16

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  No. 1, Lize East 2nd Road, Wangjing, Chaoyang District, Beijing

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