AODEJIN®（Deproteinised Calf Serum Enteric Capsules）
AODEJIN®（Deproteinised Calf Serum Enteric Capsules）
AODEJIN®（Deproteinised Calf Serum Enteric Capsules）
AODEJIN®（Deproteinised Calf Serum Enteric Capsules）
【Ingredients】
The main ingredients of this product is deproteinsed calf serum extract, which mainly contains free amino acids and small molecular peptides.
【Description】
【Description】
The contents of this product are light yellow to yellow brown particles.
【Indications】
【Indications】
The product is used to improve the neurological deficit caused by cerebral blood supply insufficiency and traumatic brain injury.
【Strength】
【Strength】
5.0mg (calculated on polypeptide).
【Dosage and Administration】
【Dosage and Administration】
Oral administration. 20mg (4 capsules) three times per day for two weeks. After that, to maintain the dosage, 10mg (2 capsules) three times per day, and the course of treatment will continue for 2-4 weeks depending on the conditions.
【Adverse Reactions】
【Adverse Reactions】
Allergic reactions (such as urticaria, skin flushing, drug fever, shock, etc.) may occur to allergic patients in rare cases. If any adverse event and/or adverse reaction occurs during the treatment of this product, please contact with the doctor.
【Contradictions】
【Contradictions】
The following patients should be prohibited:
1.Patients with severe renal dysfunction.
2.Patients who have allergic reactions to similar drugs.
【Precautions】
1.Patients with severe renal dysfunction.
2.Patients who have allergic reactions to similar drugs.
【Precautions】
If contraindications or adverse reactions occur, please inform the doctor.
Please also inform the doctor if pregnancy occurs during the use of this product.
Take care to prevent children from taking the product by mistake.
【Medication for pregnant women and lactating women】
Please also inform the doctor if pregnancy occurs during the use of this product.
Take care to prevent children from taking the product by mistake.
【Medication for pregnant women and lactating women】
Use with caution.
【Pediatric Use】
【Pediatric Use】
The safety and efficacy of drug use in children have not been determined.
【Geriatric Use】
【Geriatric Use】
Please follow the doctor's advice.
【Drug Interactions】
【Drug Interactions】
Not clearly yet.
【Overdosage】
【Overdosage】
There are no reports of overdose for the product yet. In case of overdose, symptomatic and supportive treatment should be given.
【Clinical Studies】
In a randomized, double-blind, placebo-controlled, multicenter clinical trial of neurological deficit caused by acute ischemic brain damage, 225 subjects were included in the study. On the 14th and 28th day after treatment, deproteinised calf serum enteric capsules can significantly improve NIHSS, BI and mRS scores of patients, which was superior to placebo; on the 90th day after treatment, it can significantly improve BI and mRS scores of patients, which was superior to placebo. It is suggested that deproteinised calf serum enteric capsules can improve the neurological deficit, as well as improve living ability and quality of life. During the treatment, mild gastrointestinal adverse reactions such as skin pruritus (incidence: 0.4%), nausea and vomiting (incidence: 0.4%) may occasionally occur, which could be relieved after drug withdrawal or symptomatic treatment. No serious adverse reactions occurred. There was no significant difference in laboratory auxiliary examination, including blood routine, urine routin, liver and kidney function and ECG compared with the control group.
【Clinical Pharmacology】
This product is a protein-free calf serum extract. It improves the use of oxygen and promotes the uptake of nutrients into cells. Therefore, in the conditions of low blood oxygen and increased energy, it can promote the process of wound healing and repair. It can also increase blood supply in ischemic tissue areas. The toxicological study of its main components showed that the Maximum Tolerance Dose (MTD) of mice was more than 4000mg/kg.BW, equivalent to 300 times of human dose, indicating that the toxicity of this product is very weak.
【Pharmacokinetics】
【Clinical Studies】
In a randomized, double-blind, placebo-controlled, multicenter clinical trial of neurological deficit caused by acute ischemic brain damage, 225 subjects were included in the study. On the 14th and 28th day after treatment, deproteinised calf serum enteric capsules can significantly improve NIHSS, BI and mRS scores of patients, which was superior to placebo; on the 90th day after treatment, it can significantly improve BI and mRS scores of patients, which was superior to placebo. It is suggested that deproteinised calf serum enteric capsules can improve the neurological deficit, as well as improve living ability and quality of life. During the treatment, mild gastrointestinal adverse reactions such as skin pruritus (incidence: 0.4%), nausea and vomiting (incidence: 0.4%) may occasionally occur, which could be relieved after drug withdrawal or symptomatic treatment. No serious adverse reactions occurred. There was no significant difference in laboratory auxiliary examination, including blood routine, urine routin, liver and kidney function and ECG compared with the control group.
【Clinical Pharmacology】
This product is a protein-free calf serum extract. It improves the use of oxygen and promotes the uptake of nutrients into cells. Therefore, in the conditions of low blood oxygen and increased energy, it can promote the process of wound healing and repair. It can also increase blood supply in ischemic tissue areas. The toxicological study of its main components showed that the Maximum Tolerance Dose (MTD) of mice was more than 4000mg/kg.BW, equivalent to 300 times of human dose, indicating that the toxicity of this product is very weak.
【Pharmacokinetics】
There is no data of pharmacokinetics for this product till now.
【Storage】
【Storage】
Prevent from light, sealed and preserve under 25 ℃.
【Packaging】
【Packaging】
Aluminum Composite Panel. 6 capsules/panel × 2 panels.
【Expiry Date】
【Expiry Date】
24 months
【Standard】
【Standard】
Standard approved by NMPA YBH08852009
【Approval Number】
【Approval Number】
GYZZ H20090346