Ribavirin for injection

Pharmacological action: Ribavirin is a synthetic nucleoside antiviral drug. In vitro cell culture tests show that this product has a selective inhibitory effect on respiratory syncytial virus (RSV). The mechanism of action of this product is still unclear, but the results that its in vitro antiviral activity can be reversed by guanine nucleosides and xanthine nucleosides suggest that this product may act as a metabolic analog of these cells. Toxicological studies Repeated dose toxicity: When mice, rats and monkeys are given this product orally at doses of 30, 36 and 120 mg/kg for 4 weeks or longer, heart damage can be caused. Genetic toxicity: This product can increase the cell transformation and mutation of mouse Balb/a3T3 (fibroblasts) and L5178Y (lymphoma) in the absence of metabolic activators at concentrations of 0.015 and 0.03-5.0 mg/ml, respectively. The concentration range is 3.75-10.0 mg/ml. Under the condition of adding metabolic activators, the mutation rate of L5178Y cells is increased to a certain extent (3-4 times). The results of the mouse micronucleus test indicate that the intravenous injection of this product has a clastogenic effect at a dose range of 20 to 200 mg/kg. In the dominant lethal test, rats were intraperitoneally injected with this product at a dose of 50 to 200 mg/kg for 5 consecutive days, and no mutagenic effect was observed. Reproductive toxicity: When male mice were given a dose range of 35 to 150 mg/kg, it could cause obvious atrophy of the seminiferous tubules, decreased sperm concentration, and increased number of sperm with abnormal morphology. Spermatogenesis was partially restored 3 to 6 months after discontinuation of the drug. Several other toxicity tests also indicate that adult rats can cause testicular damage (atrophy of the seminiferous tubules) when given orally at a dose as low as 16 mg/kg, and no studies have been conducted at lower doses. The reproductive capacity of male animals has not yet been studied. Animal studies of different species have confirmed that this product has obvious teratogenic and/or embryocidal potential toxicity. Hamsters were given a single oral dose of 2.5 mg/kg or more, and rabbits or rats were given doses of 0.3 and 1.0 mg/kg, respectively. The results have confirmed that it has teratogenic effects. Malformations mainly occur in the skull, palate, eyes, limbs, jaws, bones and gastrointestinal tract, and the incidence and severity increase with increasing doses. The survival rate of the fetus and offspring is reduced. The dose of this product that causes embryonic lethality in rabbits and rats is 1 mg/kg, and the dose without teratogenicity is 0.1 and 0.3 mg/kg, respectively (calculated based on the surface area, equivalent to the human equivalent dose of 0.015 and 0.04 mg/kg, respectively). Carcinogenicity: The results of long-term studies on rats given this product at a dose of 16-200 mg/kg by feeding indicate that this product may induce benign breast, pancreatic duct, pituitary and adrenal tumors. The preliminary carcinogenicity tests on mice and rats for 18 to 24 months are not final results, but these tests confirm that the vascular damage and retinal reductase denaturation in mice and rats, respectively, at doses of 20-75 and 10-40 mg/kg, are related to the long-term administration of this product.

Ribavirin.

This product is white freeze-dried block.

Antiviral drug. Used for viral pneumonia and bronchitis caused by respiratory syncytial virus.

Slow intravenous drip. Adults: 0.25-0.5g once, twice a day; children: 5-7.5mg/kg once, twice a day according to body weight. Drip for more than 20 minutes each time, 3-7 days of treatment. Dilute with sodium chloride injection or 5% glucose injection to a solution containing 1mg per 1ml and drip slowly intravenously.

Common adverse reactions include anemia and fatigue, which disappear after stopping the drug. Less common adverse reactions include fatigue, headache, insomnia, loss of appetite, nausea, vomiting, etc., and can cause a decrease in red blood cells, white blood cells and hemoglobin.

It is forbidden for people who are allergic to this product and pregnant women.

Precautions for children: This product can be used in children, see [Usage and Dosage]. Precautions for pregnancy and lactation: 1. This product has a strong teratogenic effect and is contraindicated for pregnant women and women who may become pregnant (this product is eliminated very slowly from the body and cannot be completely eliminated from the body 4 weeks after discontinuation of the drug). 2. A small amount of the drug is excreted through breast milk and is toxic to both mother and offspring; therefore, breastfeeding women should stop breastfeeding during medication and breast milk should be discarded. Since respiratory syncytial virus infection in breastfeeding women is self-limiting, this product is not used in such cases.

This product has an antagonistic effect when used together with zidovudine, because this product can inhibit the conversion of zidovudine into active zidovudine phosphate.

Keep sealed.

0.25g

24 months

Hainan Tongyong Kangli Pharmaceutical Co., Ltd.

• Founded in:

  2000-05-16

• Address:

  Room 221-226, Building 1, No. 269, Nanhai Avenue, National High-tech Industrial Development Zone, Haikou City, Hainan Province

• Tax NO.:

  914600007212236930

• Registered Funds:

  50 million yuan

• Email:

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