Product Description
| Generic Name |
Edaravone Injection |
| Strength |
20ml/30mg |
| Packing |
4 ampoules/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:
Edarvaone Injection 20ml/30mg
Character:
The product is colorless or almost colorless clear liquid.
Indications:
It is used to improve neurological symptoms, activities of daily living and dysfunction caused by acute cerebral infarction
Adverse reactions:
1. During the administration of acute renal failure (unknown degree), renal function should be tested for several times and closely observed. When symptoms such as low renal function or oliguria occur, medication should be stopped and properly handled.
2. Abnormal liver function and jaundice (all degrees unknown) accompanied by increased AST, ALT, ALP, Y-GTP, LDH and other liver function abnormalities and jaundice, liver function should be detected and closely observed during the course of medication. If abnormal conditions occur, medication should be stopped and properly treated.
3. thrombocytopenia {degree unknown) have thrombocytopenia, the process of medication need to be closely observed, abnormal situation, stop the administration and correct treatment.
4, diffuse intravascular coagulation (DIC)(unknown degree) may appear in the manifestations of diffuse intravascular coagulation, regular testing during the drug process, suspected of diffuse intravascular coagulation laboratory findings and clinical symptoms, stop the drug administration and correct treatment.
Other adverse reactions (incidence) and main manifestations are:
1, allergy (0.1-5%) : mainly manifested as rash, flushing, swelling, herpes, itching;
2. Blood cell system (0.1-5%) : the main manifestations are erythrocytopenia, leukocytosis, leukopenia, decreased hematocrit value, decreased hemoglobin, thrombocytosis, thrombocytopenia;
3. Injection site (0.1-5%) : The main manifestations are rash, redness and swelling at the injection site;
4, liver (incidence > 5%) : The soil showed increased AST, ALT, LDH, ALP, Y-GTP;
5, kidney (0.1-5%) : the main manifestations are increased BUN, increased serum uric acid, decreased serum uric acid, proteinuria, hematuria, creatinine increased (unknown degree);
6. Digestive system (0.1-5%) : Belching.
7, others (0.1-5%) : fever, heat sensation, increased blood pressure, increased serum cholesterol, decreased serum cholesterol, increased triglyceride, decreased serum total protein, increased CK(CPK), decreased CK(CPK), decreased serum potassium, decreased serum calcium.
Matters needing attention:
1. Use with caution in patients with mild or moderate renal function impairment (it may aggravate renal failure).
2. Use with caution in patients with liver function impairment (it may aggravate liver function impairment).
3. Use with caution in patients with heart disease (may aggravate heart disease, or may be accompanied by renal insufficiency).
4. Use with caution in elderly patients. According to the safety notice of the Ministry of Health, Labor and Welfare of Japan on October 28, 2002, within 15 months of the product being marketed in Japan, a total of 146,000 patients were used, 29 cases of aggravated acute renal insufficiency or renal failure were reported (about 0.02%), of which 12 died. They are 1 person aged 50-60, 3 people aged 70-80, 7 people aged 80-90, and 1 person over 90 years old, whether there is a causal relationship with the use of this product can not be confirmed; Since then, there have been no similar reports. It is recommended that patients' renal function should be closely observed during clinical use of this product. Multiple renal function tests should be conducted during administration. In case of decreased renal function or oliguria and other symptoms, administration should be stopped immediately and appropriate treatment should be carried out. Especially for patients older than 80 years, special attention should be paid.
Storage:
Keep away from light and tightly sealed
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