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金路捷(注射用鼠神经生长因子)
[name of Jinlujie drug]
Common name: nerve growth factor for injection
Trade name: Jinlujie
English Name: mouse nerve growth factor for infection
Chinese Pinyin: ABCD Yinzi
[Jinlujie ingredients]
The active component of this product is the nerve growth factor (mNGF) extracted and purified from mouse submandibular gland. The finished product contains 5% mannitol and 0.1% human blood protein as protective agent.
[Jinlujie character]
This product is a white freeze-dried loose body. The solution is colorless and clear liquid according to the marked amount of the bottle, without foreign matters, turbidity and precipitation.
Indications of Jinlujie
Toxic peripheral neuropathy in n-hexane.
[specifications of Jinlujie]
20 μ g (≥ 9000au) / piece
[usage and dosage of Jinlujie]
This product is dissolved with 2ml injection water, intramuscular injection, once a day, one bottle at a time (20 μ g), four weeks as a course of treatment, according to the severity of the disease can follow the doctor's instructions for multiple courses of continuous administration.
[adverse reactions of Jinlujie]
1. No serious adverse reactions were found. Transient transaminase elevation was found in some patients.
2. The common injection site pain or injection side lower extremity pain (the incidence was 85% and 29%, respectively) after the treatment, generally do not need to be treated, and some severe symptoms can be relieved by oral analgesics.
3. Other symptoms (such as dizziness, insomnia, etc.) were occasionally seen, and the incidence was not significantly different from that of placebo group.
[Jinlujie taboo]
Do not use if you are allergic to this product.
[precautions for Jinlujie]
1. Use with caution if you are allergic.
2. This product can be completely dissolved after shaking with water for injection. It is not available in case of insoluble precipitation, turbidity or floccules.
3. Before use, the medicine bottle should be checked carefully. It can not be used in case of any crack or damage.
4. In the process of medication, if there is any discomfort, please contact the doctor in time.
[medication for pregnant women and lactating women]
This product can promote the growth and development of nerve cells. It is recommended that pregnant women and lactating women use it with caution.
[Jinlujie for children]
Since there is no information about children's use of this product at present, please follow the doctor's advice for children's medication.
[Jinlujie elderly medication]
It is not clear.
[drug interaction of Jinlujie]
It is not clear.
[Jinlujie overdose]
There is no report of excessive use of this product.
[pharmacology and toxicology of Jinlujie]
Pharmacological effect: the results of in vivo test in rats showed that the product could improve the limb motor dysfunction caused by toxic peripheral neuropathy in rats caused by hexanedione and acrylamide, shorten the latency of nerve muscle action potential, and increase the amplitude of nerve muscle action potential. Histopathological examination showed that the product could reduce the incidence of myelin swelling and the number of degenerated tibial nerve fibers. The above results suggest that this product may promote the recovery of injured nerves.
Toxicology study: the results of repeated toxicity test showed that: (1) Wister rats were injected with 30 μ g / kg, 60 μ g / kg and 120 μ g / kg intramuscularly for 12 weeks. Only animals in the 120 μ g / kg dose group had appetite loss, body weight increase delay and activity decrease after 28 days. (2) The high dose of the product was 17.8 μ g / kg. After 60 days of continuous administration, no obvious toxic reaction was found in the animals.
The results of general reproductive toxicity, teratogenicity sensitive period and perinatal toxicity tests in Shanghai mice showed that the dose of 200 μ g / kg had no significant effect on the fertility, embryogenesis and development of F1 offspring.
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[pharmacokinetics of Jinlujie]
The experiment was not carried out and there was no reliable reference.
[Jinlujie storage]
Keep away from light at 2-8 ℃.
[Jinlujie packaging]
Xilin bottle, 20 μ g (≥ 9000au) / tube × 1 tube.
[valid period of Jinlujie]
30 months
[Jinlujie executive standard]
YBS00992006
[approval No. of Jinlujie]
Gyzz s20060051
[Jinlujie production enterprise]
Company name: Wuhan Haite biopharmaceutical Co., Ltd