Edaravone Injection

Edaravone is a brain protective agent (free radical scavenger). Clinical studies have shown that N-acetylaspartate (NAA) is a specific marker of surviving neurons, and its content decreases sharply in the early stages of cerebral infarction. When patients with acute cerebral infarction are given edaravone, the decrease in local cerebral blood flow around the infarction is inhibited, and the NAA content in the brain on the 28th day after onset is significantly higher than that in the glycerol control group. Preclinical studies have shown that intravenous administration of edaravone to rats after ischemia/ischemia-reperfusion can prevent the progression of cerebral edema and cerebral infarction, relieve the accompanying neurological symptoms, and inhibit delayed neuronal death. Mechanism studies have shown that edaravone can scavenge free radicals and inhibit lipid peroxidation, thereby inhibiting oxidative damage to brain cells, vascular endothelial cells, and neurons.

The main ingredient of this product is edaravone.

This product is a colorless or almost colorless clear liquid.

Acute cerebral infarction neuroprotective agent, mainly used to treat neurological damage caused by acute cerebral infarction, improve neurological symptoms and daily life movement disorders.

30 mg (3 vials) at a time, twice a day, diluted in an appropriate amount of normal saline and administered intravenously within 30 minutes. One course of treatment is within 14 days, and administration should be started within 24 hours after onset if possible.

According to the observation of 569 clinical cases in Japan, 26 cases (4.57%) had adverse reactions. The main manifestations were abnormal liver function 16 times (2.81%) and rash 4 times (0.70%). Among the 569 cases, 122 cases (21.4%) had abnormal changes in clinical test values, mainly abnormal liver function test values such as AST increased by 7.71% (43/558) and ALT increased by 8.23% (46/559). Serious adverse reactions include: 1. Acute renal failure (degree unknown) During medication, multiple renal function tests were performed and close observation was performed. When symptoms such as low renal function or oliguria appeared, the medication was stopped and properly handled. 2. Abnormal liver function, jaundice (all degrees unknown) Accompanied by abnormal liver function and jaundice such as increased AST, ALT, ALP, YGT, and LDH. Liver function needs to be tested and closely observed during medication. If abnormal conditions occur, the medication should be stopped and properly handled. 3. Thrombocytopenia (extent unknown): If there is thrombocytopenia, close observation is required during medication. If any abnormality occurs, stop medication and handle it correctly. 4. Disseminated intravascular coagulation (DIC) (extent unknown): Symptoms of disseminated intravascular coagulation may occur, and regular testing is required during medication. When laboratory manifestations and clinical symptoms suspected of disseminated intravascular coagulation occur, stop medication and handle it correctly. Other adverse reactions (incidence) and main manifestations are: 1. Allergies (0.1%-5%): mainly manifested as rash, flushing, swelling, herpes, and itching; 2. Blood cell system (0.1%-5%): mainly manifested as erythropenia, leukocytosis, leukocytosis, hematocrit decrease, hemoglobin decrease, thrombocytosis, and thrombocytopenia; 3. Injection site (0.1%-5%): mainly manifested as rash, redness, swelling, etc. at the injection site; 4. Liver (incidence >5%): mainly manifested as increased AST, increased ALT, increased LDH, increased ALP, and increased YGT. (Incidence rate 0.1%~5%): total bilirubin increased, urobilinogen positive, bilirubin active. 5. Kidney (0.1%~5%): Mainly manifested as increased BUN, increased serum active acid, decreased serum uric acid, increased proteinuria, hematuria, and creatinine (to unknown extent); 6. Digestive system (0.1%~5%): belching; 7. Others (0.1%~5%): fever, hot feeling, increased blood pressure, increased serum cholesterol, decreased serum cholesterol, increased triglycerides, decreased serum total protein, increased CK (CPK), decreased CK (CPK), decreased serum potassium, and decreased serum calcium.

1. Patients with severe renal failure (possible aggravation of renal failure). 2. Patients with a history of allergy to this product.

Precautions for children: Children should not use this product (because there is no experience with its use, the safety of its use in children cannot be determined). Precautions for pregnancy and lactation: 1. Pregnant women or women who may become pregnant are prohibited from using this product (the safety of its use during pregnancy cannot be determined). 2. Women who are lactating are prohibited from using this product. If it must be used, breastfeeding should be stopped during the administration of this drug (there are reports of its distribution in breast milk in animal experiments). Precautions for the elderly: Due to the low physiological function of the elderly, the drug should be stopped and properly handled when adverse reactions occur. In general, elderly patients (over 80 years old) should use this product with caution.

1. When used in combination with antibiotics such as oxazolidinone sodium, piperacillin sodium hydrochloride, and cefotiam sodium, renal failure may be aggravated. Therefore, multiple renal function tests and other observations are required when the drugs are used in combination. 2. In principle, this product must be diluted with normal saline (when mixed with various infusions containing sugar, the concentration of edaravone can be reduced). 3. It cannot be mixed with high-energy infusions or amino acid preparations or dripped through the same channel (mixing may reduce the concentration of edaravone). 4. Do not mix with anti-epileptic drugs (diazepam, phenytoin sodium, etc.) (produce turbidity). 5. Do not mix with potassium canrenoate (produce turbidity).

Keep in airtight container.

5ml:10mg

18 months

Simcere Pharmaceutical Co., Ltd.

• Founded in:

  1998-09-10

• Address:

  No. 99, Huakang Road, Jiangbei New District, Nanjing, Jiangsu Province

• Tax NO.:

  91320100135665907G

• Registered Funds:

  1.60281382 million yuan

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