Drug Name]

Generic Name: Disodium Cantharidinate and Vitamin Bs Iniection

Ingredients】This product is a compound preparation, the components are: sodium cantharidinate and vitamin B6, each containing sodium cantharidinate 0.05mg, vitamin B61.25mg. excipients: sodium hydroxide, water for injection.

Properties】This product is colorless clear liquid.

Indications】Applicable to primary hepatocellular carcinoma, lung cancer and leukocytosis, can also be used for hepatitis, cirrhosis and hepatitis B carriers.

Specification】5ml:0.05mg[Usage]Intravenous drip, once a day. Each time 10~50m1, with 0.9% sodium chloride or 5%~10% dextrose injection wave diluted with the appropriate amount of drip.

Adverse reactions] The following clinical manifestations can be seen in post-marketing adverse reaction case reports: site of administration: occasional patients with localized phlebitis; skin: occasional rash, itching; digestive system: occasional nausea, vomiting; cardiovascular system: rare panic, palpitations, chest tightness. Contraindications] Not yet clear.

Cautions】Renal insufficiency should be used with caution, urinary irritation symptoms, the drug should be suspended, diluted solution to 0.9% sodium chloride or 5% 6 ~ 10% glucose injection wave diluted 5 ~ 10 times the drip, drip rate of less than 40 drops per minute.

Pregnant&Nursing】Pregnant women and nursing mothers should be cautious.

Children] Not yet known.

Elderly] Not known.

Drug interactions] is not clear.

Overdose] Not known.

Pharmacology and toxicology] This product is an anti-tumor injection formulated with sodium zanthate and vitamin B6. Its pharmacological effects are as follows: inhibit the synthesis of protein and nucleic acid1 and pharmacology in tumor cells, then affect the biosynthesis of RNA and DNA, and finally inhibit the generation and division of cancer cells; it can reduce the activity of cAMP phosphodiesterase in tumor cells, increase the vitality of catalase, and improve the energy metabolism of the cells, and at the same time, reduce the level of pain toxin: it can directly inhibit the synthesis of DNA and RNA and the precursor of the cancer cells. It can directly inhibit DNA and RNA synthesis and precursor infiltration in cancer cells, change the morphology and function of cancer cells, and directly kill the cells. It has no inhibitory effect on osteoblasts and can elevate white blood cells.2. Toxicology The LDs0 of this product in mice injected intravenously is 4.42mg/kg (4.04~4.84mg/kg); the LD50 of this product in mice injected intraperitoneally is 4.59mg/kg (4.10~5.13mg/kg). The product has mild irritation to free eyes, no irritation to rabbit and mouse muscle, no in vitro hemolytic reaction.

Pharmacokinetics] Experiments show that mice orally administered with sodium H-riboflavanate lmg/kg, the drug is absorbed quickly and completely from the digestive tract, and only a trace amount of radioactivity can be measured after 24 hours; after oral and static injection, the bladder and bile radioactivity is high, followed by the kidneys, liver, heart, lungs, and stomach and other tissues. Most of the drug is excreted in urine.

Storage] Keep in a sealed place and keep it away from light.

Packing]: Glass ampoule, 5pcs/box.

Expiry date]: 24 months

Executive Standard】WS-10001-(HD-0046)-2002-2011

Approval number]: State Drug License H20053862