[Name of drug]
Ribavirin Injection

Chinese Name: 利巴韦林注射液

Chinese Pinyin: Liba weilin zhusheye

[Ingredients] Ribavirin

Chemical name: 1-, β - D-, furan ribose, -1H-1, 2, 4-, three, triazole, -3-, carboxy amide.
Chemical formula:

Molecular formula: C8H12N4O5
Molecular weight: 244.21
All auxiliary components: dilute hydrochloric acid. 
 

[Character]  This product is a colorless and transparent liquid.

[Indications] Antiviral agents. Viral pneumonia and bronchitis caused by respiratory syncytial virus.

[Specification] 1m1：0.1g

[Usage and Dosage]

With Sodium Chloride Injection or 5% Glucose Injection diluted into each 1m1 containing 1mg solution, intravenous infusion of slowly, adults once 0.5g (5), 2 times a day, children by weight 10 to 15mg/kg a day, 2 times. Each infusion for more than 20 minutes, treatment for 3~7 days.

[Adverse Effects] Common adverse reactions are anemia, fatigue, and so on, disappear after withdrawal. The less adverse reactions were fatigue, headache, insomnia, anorexia, nausea, vomiting, and decreased red blood cells, white blood cells and hemoglobin.

[Contraindicated] Allergy to the drug, pregnant women.

[Matters Needing Attention]

1. Those with severe anemia and abnormal liver function are used with caution.

2. The interference of diagnosis: after oral administration, the increase of serum bilirubin may be up to 25 %, and the large dosage can cause the decrease of hemoglobin. 
3. Use the medicine as soon as possible. Respiratory syncytial virus pneumonia in the first 3 days of the drug delivery is generally effective. This product is not suitable for patients with respiratory syncytial virus infection without laboratory diagnosis. 
4. Long - term or large doses of the liver function, hemogram have adverse reactions.

[Medication for pregnant women and lactating women]

1. This product has a strong teratogenic effect, the rabbit daily dose of 1 mg / kg causes embryo damage, it is prohibited in pregnant women and pregnant women ( this product is slow in the body, the four weeks after the withdrawal of the drug is not completely removed from the body ). 
2. A small amount of the drug is excreted by milk and is toxic to both the mother and the second generation. therefore, during the period of medication, lactating women need to suspend breastfeeding, and the milk should also be discarded. Because of the zi of respiratory syncytial virus infection in lactating women, this product is not used in this case.

[Child Medication] The experiment was not conducted and there was no reference.

[Senile Medication] Older adults are not recommended for use.

[Drug Interactions] This product has an antagonistic effect on Zidorf, because this product inhibits the conversion of zidovudine into an active type of Zidorf phosphate.

[Overdose] High dose use can cause heart damage and can cause dyspnea, chest pain, etc. in patients with respiratory problems (COPD or asthma).

[Pharmacology and Toxicology]

Pharmacology: broad-spectrum antiviral agents. In vitro, it can inhibit the growth of many viruses such as respiratory syncytial virus, influenza virus, hepatitis A virus, adenovirus and so on, but its mechanism is not clear. This product does not change viral adsorption, invasion and shelling, nor does it induce interferon production. The drug into the infected cells after rapid phosphorylation, a competitive inhibitor of the product as the virus synthetase, inhibition of inosine monophosphate dehydrogenase, influenza virus RNA polymerase and guanosine mRNA transferase, which caused the decrease of intracellular guanosine phosphate three, virus damage RNA and protein synthesis, the inhibition of virus replication and transmission. Respiratory syncytial virus may also act as an immune agent and neutralizing antibodies.

Toxicology: animal experiments have shown that this product can induce benign tumors in the breast, pancreas, pituitary and adrenal gland, but the carcinogenicity of the human body is not certain. Drugs such as hamsters can cause deformities of the skull, palate, eye, jaw, skeleton and gastrointestinal tract, but the offspring survived less. However, the effects of drugs on fetal litter have not been found in primate experiments. Mice, rats and monkeys oral doses were Ribavirin, 30, 36 and 4 weeks (120mg/kg or equivalent dose given weight for 5kg children 4.8, 12.3 and 111.4mg/kg, or 2.5, 5.1 adult weight was 60kg and 40mg/kg), heart injury.

[Pharmacokinetics]

Intravenous infusion of this product 0.8g, after 5 minutes, the plasma concentration was (17.8 + 5.5) Mu mol, and after 30 minutes the plasma concentration was (42.3 + 10.4) Mu mol. Enter the body rapidly spread to all parts of the body, and through the blood - cerebrospinal fluid barrier. The concentrations of drugs in respiratory tract secretions were much higher than those in serum. Drugs can enter red blood cells and accumulate large quantities. After long-term medication, the concentration of cerebrospinal fluid can reach 67% of the serum concentration at the same time. This product can penetrate the placenta, but also into the milk. Almost no binding to plasma proteins. Intrahepatic metabolism. Plasma drug elimination half-life (t1/2 beta) is about 0.5 to 2 hours. Mainly through renal excretion, within 48 hours, from the urine can be detected (16.7 + 10.3%) of the drug excreted in the prototype, (6.2 + 1.7%) of drugs excreted in metabolites. Drugs can accumulate in red blood cells for several weeks.

[Storage] Airtight preservation.

[Packing] Ampoule packing, 10 pcs / boxes

[Validity]  36 months

[Implementation Criteria] Chinese Pharmacopoeia, 2010 edition, two parts

[Approval Number] SFDA approval number H19993829

[Production Enterprise]

Name of enterprise:  Zhejiang Chengyi Pharmaceutical Co., Ltd

Production address: No. 118, Chemical Road, Dongtou District, Wenzhou city,Zhejiang province,China

Phone number: 86-577-6348-3979

Fax number: 86-577-6348-5135

URL:http://en.chengyipharma.com