Introduction of new products of thymus injection
Generic name: thymalfasin for injection
Manufacturer: Hainan Shuangcheng Pharmaceutical Co., Ltd.
Approval number: National Medicine Zhunzi H20030407
Drug specification: 1.6mg*2 bottles.
Drug price: 269 yuan.
Drug name
Generic name: thymalfasin for injection
English name: thymalfasin for injection
Product name: Ji Tai
Name of use: thymosin α 1 for injection.
The main component of Ji Tai is thymosin, and the auxiliary materials are mannitol, disodium hydrogen phosphate and sodium dihydrogen phosphate.
Ji Tai is white or white-like, loose and massive.
indicate
1, chronic hepatitis B.
2. As a vaccine immune response enhancer for patients with immunodeficiency. For those whose immune system function is suppressed, including those who receive long-term hemodialysis and senile diseases, Ji Tai can enhance patients' immune response to virus vaccines, such as influenza vaccine or hepatitis B vaccine.
dosage
Before use, dissolve each bottle of thymalfasin * * * 1.6 mg * * in 1ml water for injection, and then immediately inject it subcutaneously * * * instead of intramuscular injection or intravenous injection * *. The recommended dosage for the treatment of chronic hepatitis B: 65438+ 0.6mg each time, twice a week, with an interval of 3-4 days. Continuous administration for 6 months * * * * 52 needles * * *, and the period should be uninterrupted.
As a vaccine immune response enhancer for immunocompromised patients: once 1.6mg, twice a week, with an interval of 3-4 days. * * * * 8 stitches * * * for 4 weeks. The first injection should be given subcutaneously immediately after vaccination.
counteraction
Thymalfasin was well tolerated. Some patients may feel uncomfortable at the injection site. When patients with chronic hepatitis B receive Ji Tai treatment, the ALT level may temporarily fluctuate to more than twice the basic value. At this time, they should usually continue to use it unless there are symptoms and signs of liver failure.
Taboo for those who are allergic to Ji Tai ingredients; Patients receiving immunosuppressive therapy (such as organ transplantation) are prohibited.
Matters needing attention
1. When it is used to treat chronic hepatitis B, liver function tests, including serum ALT, albumin and bilirubin, should be evaluated regularly during the treatment. Hepatitis B E antigen ***HBeAg***, surface antigen ***HBsAg***, HBV-DNA and ALT enzyme should be detected after treatment, because the patient may be under treatment.
2. Ji Tai should be applied under the guidance of a doctor. If patients use it outside the hospital by themselves, they should pay attention to the disinfection and treatment of injection instruments.
Medication for pregnant and lactating women
Basic research shows that Ji Tai has no effect on animal embryos, but it is not clear whether Ji Tai will have an effect on pregnant women's embryos and whether it will be excreted through milk. Therefore, some patients should be cautious and follow the doctor's advice.
Children's medication
For patients under 0/8 years old, the safety and efficacy of Ji Tai have not been determined, so it is not recommended.
The medication for the elderly is unclear.
drug interaction
Ketai combined with interferon α can improve immune response. It should be used with caution when combined with other drugs. Kitai should not be mixed with any drugs for injection.
Drug overdose At present, there is no report about the treatment or accident of human drug overdose.
Toxicological study
Genotoxicity: The result of genotoxicity test in Ji Tai was negative.
Reproductive toxicity: Ji Tai has no obvious teratogenic effect on animal fetuses. At present, it is not clear whether the use of Ketai by pregnant women will affect their reproductive ability or cause damage to the fetus. Pregnant women can only use Ketakang when they really need it. Similarly, it is not clear whether breast milk can be secreted in Ji Tai, so lactating women should be cautious when using Ji Tai.
pharmacological action
The mechanism of Ji Tai in treating chronic hepatitis B and enhancing immune system responsiveness has not been fully clarified. Many experiments in vitro showed that Ji Tai promoted the maturation of T lymphocytes through mitogen of peripheral blood lymphocytes, increased the lymphatic factor levels of interferon α, interferon γ, interleukin 2 and interleukin 3 secreted by T cells after activation of antigen or mitogen, and increased the level of lymphatic factor receptor on the surface of T cells.
Kitai can also enhance the human mixed lymphocyte reaction of allogeneic and autologous cells by activating CD4 cells. Ketai can increase the aggregation of pre-NK cells, while interferon can enhance its cytotoxicity. In vivo experiments show that Ji Tai can increase the expression level of interleukin -2 receptor in mouse lymphocytes activated by concanavalin A, and at the same time increase the secretion level of interleukin -2.
pharmacokinetics
A single subcutaneous injection of thymalfasin (1.6mg) was given to healthy people. The peak plasma concentration was 37.5 1ng/ml, the peak time was about 1.67 hours, and the AUC0- 15 was about152./kl.
Store in the dark, sealed and stored at 2-8℃.
Specification1.6mg *2 bottles
Valid for 24 months.
Approval number: National Medicine Zhunzi H20030407
Hainan Shuangcheng Pharmaceutical Co., Ltd.
Efficacy and effect of Ji Tai: Ji Tai is used for: 1, chronic hepatitis B. As a vaccine immune response enhancer for patients with immunodeficiency. Immune system function is inhibited, including chronic hemodialysis patients and elderly patients. This product can enhance the immune response of patients to viral vaccines, such as influenza vaccine or hepatitis B vaccine.
Frequently asked questions of thymofacin for injection
Q: What should I pay attention to when using thymidine for injection?
Answer: 1. When used to treat chronic hepatitis B, liver function tests, including serum ALT, albumin and bilirubin, should be evaluated regularly during the treatment. After treatment, hepatitis B E antigen ***HBeAg***, surface antigen * * * HBsAg * *, HBV-DNA and ALT enzyme should be tested, and it should also be tested 2, 4 and 6 months after treatment, because
2. Ji Tai should be applied under the guidance of a doctor. If patients use it outside the hospital by themselves, they should pay attention to the disinfection and treatment of injection instruments.