舒泰神注射用鼠神經生長因子英文說明書2020

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蘇肽生（注射用鼠神經生長因子）

[name of supin raw drug]
General name: nerve growth factor for injection
Trade name: supisheng
English Name: mouse curve factor injection
Chinese Pinyin: ABCD Yinzi
[Su peptide raw ingredients]
The main ingredient of this product is nerve growth factor extracted from mouse submandibular gland, which is a kind of bioactive protein with molecular weight of 26.5kd. Name of auxiliary materials: sodium dihydrogen phosphate, disodium hydrogen phosphate, human albumin, mannitol.
[Su peptidogenic character]
This product is white or similar white loose body or powder. Add 2ml of normal saline or sterile water for injection and dissolve into colorless clear liquid rapidly.
[indications of Su peptide]
This product can promote the recovery of nerve injury. For the treatment of optic nerve injury.
[specification of Su peptide]
30 μ g (biological activity ≥ 15000au) / bottle.
[usage and dosage of Su peptide]
Before use, 2ml sodium chloride injection (or sterile water for injection) is dissolved in each bottle. Intramuscular injection, 30 μ g / day, once a day, 3-6 weeks as a course of treatment.
[adverse reactions caused by threonide]
The incidence of local pain was 10.68% in the control group and 13.47% in the treatment group. Urticaria can recover itself or be treated with anti allergy. No other adverse reactions were found.
[contraindications to supithin]
Do not use if you are allergic to this product
[precautions for supitonin]
1. Before use, the medicine bottle should be checked carefully, and it should not be used in case of cracks or damages. 2. The product can be completely dissolved after adding sodium chloride injection (or sterilized water for injection) with slight vibration. It shall not be used in case of insoluble precipitation, turbidity or floccules. 3. In case of any discomfort during the medication, please contact the doctor in time.
[drugs for pregnant women and lactating women]
Because the pre clinical trial of this product shows that it can inhibit the lactation of mother rats, pregnant women, perinatal and lactating women should use it carefully or follow the doctor's advice.
[administration of SULTIDE for children]
In the study of this drug, there is no data of children's medication.
[use of sulithin in elderly patients]
In the study of this drug, there is no data of drug use for patients over 65 years old.
[pharmacokinetic interaction of threonide]
There is no research report on the interaction between this product and other drugs.
[supin overdose]
This product should be used according to the dosage specified in the manual.
[clinical trial of Sullivan]
A randomized, double-blind, clinical multicenter equal control trial was used. This product was injected intramuscularly, 30 μ g / time, once a day for 6 weeks. The visual acuity, visual field and P-VEP recovery rate of patients with optic nerve contusion were observed. The results showed that this product had obvious curative effect after three weeks and six weeks. The comprehensive effective rate (58.55% and 77.96%) in the three week and six week groups was significantly higher than that in the control group. The results show that this product has a positive effect on optic nerve injury.
[pharmacology and toxicology]
Pharmacological effect: This product can promote the recovery of injury by intramuscular injection in rats or mice with sciatic nerve injury, peripheral nerve injury caused by acrylamide and sympathetic nerve ending injury caused by intraperitoneal injection of 6-hydroxydopa. After intramuscular or retrobulbar injection of the product, the latency of flash visual evoked potential (PREP) and pattern reversal evoked potential (FEP) of the model rats with carbon disulfide induced optic nerve damage were shortened (P < 0.05). Toxicological study: repeated administration of the product to the muscles of Beagle dogs and Wistar rats, with the dose of 60 μ g/kg and 200 μ g/kg, was carried out for 8 weeks in dogs and 12 weeks in rats. Reproductive toxicity: Kunming mice were injected intramuscularly with doses of 40, 80 and 160 μ g / kg. The results of general reproductive toxicity test, teratogenic sensitive toxicity test and perinatal toxicity test showed that no deformity was found in the appearance, skeleton and viscera of the fetus, and the pregnancy rate was normal. However, the secretion of the juice was different.
[pharmacokinetic study of Sulin]
The blood concentration time curve of 125I-NGF injected 10 μ g / kg intramuscularly was in accordance with the two compartment open model. T1 / 2 (b) was 4.83hr, Tmax was 0.71hr, Cmax was 1.74ng/ml and bioavailability was 52.7%. The concentration of stomach, intestine and kidney was the highest, followed by heart, liver, spleen, submandibular gland, brain and spinal cord. The binding rate of 125I-NGF to human plasma protein was 25.1%.
[storage of Su peptide]
Store at 2-8 ℃ in dark.
[supin packaging]
2ml antibiotic glass bottle 1 bottle / box; 10 bottles / medium box
[effective period of Su peptide]
24 months.
[executive standard for supitonin]
YBS00492006
[approval No. of supisheng]
Gyzz s20060023
[Su peptide production enterprise]
Company name: shutaishen (Beijing) biopharmaceutical Co., Ltd