干扰素

INGREDIENT
The main ingredient of SINOGEN is recombinant human interferon α1b, a highly purified, sterile lyophilized protein, produced after the fermentation and separation processes of a strain of Escherichia coli featured with high-efficiency expression of human interferon α1b gene.
Excipients: human albumin, sodium chloride.

CHARACTER
SINOGEN is white lyophilized powder, which will turn into clear solution shortly after being dissolved with 1mL of sterile water for injection.

INDICATION
SINOGEN is used to treat viral disease and various cancers. It has been approved for the treatment of chronic hepatitis B, hepatitis C and hairy cell leukemia. Clinical trials and literatures show that SINOGEN is effective for the treatment of viral diseases such as herpes zoster, condyloma acuminata, epidemic hemorrhagic fever, pediatric respiratory syncytial virus pneumonia, etc. Can also be used to treat malignant tumor such as chronic granulocytic leukemia, melanoma, lymphoma, etc.

STRENGTH
10μg/vial
20μg/vial
30μg/vial
40μg/vial
50μg/vial
60μg/vial


USAGE
Dissolve each vial with 1mL sterile water for injection, inject intramuscularly or subcutaneously.
Dosage and treatment courses as follow:
Chronic hepatitis B: 30~50μg a time, once every other day, inject intramuscularly or subcutaneously, 4~6 months as one treatment course. May extend to 1 year according to the patient's condition. May be treated with induction therapy, i.e. take it once a day at the beginning of the therapy. Change to once every other day after 0.5~1 month till the end of the treatment.
Chronic hepatitis C: 30~50μg a time, once every other day, inject intramuscularly or subcutaneously, 4~6 months as one treatment course. Stop using if it has no effect. For the patients showed effectiveness, may continue the treatment to 12 months. The treatment course may extend to 18 months according to the patient's condition. During the first month, take it once a day. Follow-up for 6~12 months is required after the treatment ended. Acute hepatitis C patients should use SINOGEN earlier to decrease chronicity rate.
Chronic granulocyte leukemia: 30~50μg a time, once every day, inject intramuscularly or subcutaneously for more than 6 months. May adjust the dosage according to the patient's condition. May choose to inject once every other day after remission.
Hairy cell leukemia: 30~50μg a time, once every day, inject intramuscularly or subcutaneously for more than 6 months. May adjust the dosage according to the patient's condition. May choose to inject once every other day after remission.
Condyloma acuminata: 10~30μg a time, inject intramuscularly or subcutaneously. Or 10μg a time, local injection in the wart, once every other day, 3 weeks for a course of treatment. May extend or repeat the treatment course according to the patient's condition.
Tumor: 30~50μg a time, once a day or once every other day, inject intramuscularly or subcutaneously for more than 6 months. May extend the treatment course according to the patient's condition. If the patient does not have a rapid deterioration or serious adverse reactions, continue to take SINOGEN at an appropriate dosage.

ADVERSE REACTION
Mild adverse reactions may occur occasionally. The most common reactions are fever and fatigue, often occurring at the early stage of medication, mostly one-time and reversible reactions. Other possible adverse reactions include headache, myalgia, joint pain, loss of appetite, nausea and hair loss. A small number of patients may have abnormal hemogram such as leukopenia and thrombocytopenia, which will be recovered after stopping the drug. In the case of serious adverse reactions that the above-mentioned patients cannot tolerate, the dosage should be reduced or discontinued, and the necessary symptomatic treatment should be given.

CONTRAINDICATION
Patients known to be allergic to interferon products.
Patients with history of angina pectoris, myocardial infarction and other serious cardiovascular diseases.
Patients with other serious diseases and cannot tolerate the adverse reactions of this product.
Patients with epilepsy and other central nervous system disorder.
PRECAUTION
Allergies, especially those who are allergic to various antibiotics, should use this product with caution. If a serious allergic reaction occurs during use, the drug should be stopped immediately and given appropriate treatment.
The bottle should be inspected carefully before use. If the bottle cap or stopper is cracked or damaged, it cannot be used. After adding the sterile water for injection and shake it slightly, it should be well dissolved. If there is insoluble lump or floc, it cannot be used.
This product should be used up once after dissolution. Do not use it partially for multiple times.
The osmolality of this product is: 250-330mOsmol/Kg.
USE IN SPECIFIC POPULATIONS
Pregnant and lactating women: This product has little experience in pregnant and lactating women and should be used with caution. It should be used under the doctor's instruction when necessary.
Pediatric use: It's feasible for the treatment of viral diseases in children. No toxic or side effects have been found. However, there is not much experience at present. It should be used under the close observation of pediatrician with proper dosage control to accumulate more experience.
Geriatric use: It can be used for elderly patients, except those with contraindications. For those who cannot tolerate the possible adverse reactions, they should use this product with caution and under the close observation of physician. Extra caution should be taken when using larger dosage. If necessary, use a small dosage first and gradually increase the dosage to reduce adverse reactions.

DRUG INTERACTION
Hypnotics and sedatives should be used with caution when using this product.

OVERDOSAGE
Not clear.

PHARMACOLOGY AND TOXICOLOGY
This product has a broad spectrum of antiviral, anti-tumor and immune regulation functions. Interferon binds to cell surface receptors, induces cells to produce a variety of antiviral proteins, thereby inhibiting viral replication in cells. It can enhance the specific cytotoxic effects of macrophages and lymphocytes on target cells by regulating immune function to effectively prevent viral invasion and infections. It inhibits the growth of tumor cells and eliminate early malignant cells by enhancing the activity of natural killer cells. Acute toxicity test: Inject this product 3 times the human dosage into the tail vein of mice (based on body weight), no acute toxicity was observed. Long-term toxicity test: Inject this product 5.6 and 28 times the human dosage in dogs; inject this product 5.6, 28 and 140 times the human dosage in rats (all based on body weight), continuous injection for 3 months and 6 months respectively; all animals survived and no toxicity was observed. Blood and bone marrow smears, pathological sections of organs showed no pathological changes related with toxicological significance.

PHARMACOKINETIC
Single subcutaneous injection of 60μg SINOGEN in healthy volunteers, the blood concentration reached the highest peak at 3.99 hours after injection. The absorption half-life was 1.86 hours, and the relative elimination half-life was 4.53 hours. The product is distributed in various organs after absorption, with the highest concentration at the injection site, followed by kidney, spleen, lung, liver, heart, brain and adipose tissue and then degraded in the body. Few amount excreted in urine, feces and bile.

STORAGE AND TRANSPORT
2-8ºC protected from light.

PACKAGE
Penicillin bottle, 1 vial/box.
Penicillin bottle, 1 vial/box, with 1mL of sterile water for injection and 1 disposable sterilized syringe (with needle).
Penicillin bottle, 10 vials/box.

PERIOD OF VALIDITY
30 months

EXECUTIVE STANDARD
Pharmacopoeia of the People's Republic of China (2015), Volume III

CHINESE APPROVAL NUMBER
10μg/vial: CFDA approval No. S10960058
20μg/vial: CFDA approval No. S20033034
30μg/vial: CFDA approval No. S10960059
40μg/vial: CFDA approval No. S20033039
50μg/vial: CFDA approval No. S10970070
60μg/vial: CFDA approval No. S20033035

MANUFACTURER
Name: Shenzhen Kexing Pharmaceutical Co.,Ltd.
Address: Tongfuyu Industrial Park, Xiangxing Road, Shajing, Baoan District, Shenzhen, China. Postcode: 518104
Telephone: (0755) 26631280
 
Website: www.kexing.com.cn