The indication of Thymalfasin for Injection is 1. Chronic hepatitis B. 2. As a vaccine immune response enhancer for patients with immune impairment. The product can enhance the immune response of patients to viral vaccines, such as influenza vaccine or hepatitis B vaccine.

The main components of this product are: Thymalfasin for Injection

Chemical structure formula: ac-ser-asp-ala-ala-val-asp-thr-ser-ser-glu-ile-thr-lys-asp-leu-lys-glu-lys-glu-val-glu-glu-ala-glu-asn-oh

Molecular formula: c129h215n33o55

Molecular weight: 3108.28

Auxiliary material: mannitol.

character

This product is white loose block.

indication

  1. Chronic hepatitis B.

  2. As a vaccine immune response enhancer for patients with immune impairment. The product can enhance the immune response of patients to viral vaccines, such as influenza vaccine or hepatitis B vaccine.

Specifications

1.6mg。

Usage and dosage

Before use, each bottle of thymus method (1.6mg) was dissolved with 1ml of water for injection and injected subcutaneously immediately (no intramuscular injection or intravenous injection).

Recommended dose for chronic hepatitis B: 1.6mg per time, twice a week, 3-4 days apart. The drug was administered continuously for 6 months (52 needles in total) without interruption.

As a vaccine immune response enhancer for immunocompromised patients: 1.6mg/time, twice a week, 3-4 days apart. The first injection should be given subcutaneously immediately after the vaccination.

Adverse reactions

The thymus method is well tolerated. Some patients may have discomfort at the injection site. When patients with chronic hepatitis B are treated with this product, the ALT level may fluctuate temporarily to more than twice the basic value. At this time, they should continue to use it, unless there are symptoms and omens of liver failure.

taboo

It is forbidden for those who are allergic to the ingredients of this product, and for those who are receiving immunosuppressive treatment, such as organ transplant.

matters needing attention

  1. When it is used to treat chronic hepatitis B, the liver function test, including serum ALT, albumin and bilirubin, should be evaluated regularly during the treatment period. After the treatment, the hepatitis B e antigen (HBeAg), surface antigen HBsAg, HBV-DNA and ALT enzyme should be detected, as well as 2, 4 and 6 months after the treatment, because the patient may respond in the follow-up period after the treatment.

  2. This product should be used under the guidance of doctors. If patients use it outside the hospital, they should pay attention to the disinfection and treatment of injection equipment.

Medication for pregnant and lactating women

Basic research shows that this product has no effect on animal embryos, but it is not clear whether this product will affect pregnant women's embryos, and whether it is excreted through milk, so this part of patients should be cautious and follow the doctor's advice.

Medication for children

For patients under 18 years old, the safety and efficacy of this product have not been determined, so it is not recommended.

Geriatric medication

This product has not been tested and there is no reliable reference.

Drug interactions

This product can be used in combination with interferon alpha, which can improve the immune response. It should be careful when used in combination with other immune drugs.

This product should not be mixed with any medicine for injection. This product should not be mixed with any medicine for injection.

Drug overdose

At present, there is no report of overdose (treatment or accident) in human body.

Pharmacology and Toxicology

pharmacological action

The mechanism of this product in the treatment of chronic hepatitis B and the enhancement of immune system response has not been fully elucidated. A number of in vitro tests showed that the product promoted the maturation of T-lymphocytes by stimulating the mitosis of peripheral blood lymphocytes, increased the level of IFN α, IFN γ, IL-2, IL-3 and other lymphokines secreted by T-cells after antigen or mitogen activation, and increased the level of lymphokines receptor on the surface of T-cells. It can also enhance the mixed lymphocyte reaction of allogeneic and autogenous human by activating CD4 cells. This product may increase the accumulation of pre NK cells, while interferon can enhance its cytotoxicity. In vivo experiments showed that the product can improve the expression level of IL-2 receptor and the secretion level of IL-2 in mice lymphocytes activated by concanavalin A.

Toxicological study

Genotoxicity: the result of genotoxicity test is negative.

Reproductive toxicity: This product has no obvious teratogenic effect on animal fetus. It is not clear whether the use of this product will affect the reproductive capacity of pregnant women or cause damage to the fetus. Pregnant women can use this product only when they really need it. Similarly, it is not clear whether this product can be secreted by human milk, so lactating women should be careful when using this product.

Pharmacokinetics

The single subcutaneous injection of thymus was 1.6mg, the peak concentration of blood drug was about 37.51ng/ml, the peak time was about 1.67h, auc0-15 was about 152.15ng/ml · h, and the half-life was about 1.65h.

Storage

Airtight, dark, stored at 2-8 ℃.

packing

Glass tube injection bottle, two bottles per box (with two bottles of sterile injection water for dissolving drugs).

term of validity

24 months.

Executive standard

Chinese Pharmacopoeia, 2010 edition, Part II (pH value, clarity and color of solution) in accordance with the national drug standard ybh2682205 [1] reference

  1. Thymus injection method new. Yimaitong - drug reference [reference date: December 6, 2017]