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Anterferon®--Recombinant Human Interferon (rIFN alpha 2b, rDNA Origin)alpha 2b Liquid for Injection

[BRIEF INTRODUCTION]

Exerts actions of anti-viral, inhibiting proliferation of tumors cell and increasing immunity such as treatment to hepatitis, leukemia and variety of cancers. Having undergone clinical trails,  has been accepted for its higher efficiency, lower side-effect and less neutralizing antibodies. Our manufacturing plants of  are certified for GMP Standard by SFDA.

SPECIFICATION AND INTRODUCTION

[PRODUCT NAME]

Generic name: Recombinant Human Interferon alpha 2b for injection

Trade name: Anterferon®

Composition in effect: Recombinant Human Interferon alpha 2b.

[DESCRIPTION]

The product is colorless and clearing liquid and has no insoluble substance visible to naked eyes.

[PHARMACOLOGY AND TOXICLOGY]

Pharmacological Actions: Recombinant interferon alpha 2b exerts many biological actions including broad-spectrum antiviral effect, inhibition of tumor cells proliferation and enhancement of immune function. Combination of interferon to receptors on cell surface can induce syntheses of many kinds of antiviral proteins: these proteins inhibit replication of virus in cell. Interferon regulates immune function via enhancing activity of macrophages, cytotoxicity of lymphocytes against targets cells, and activity of NK cells.

Toxicology: 1) Acute toxicity test: Interferon® was intravenously and intra-abdomen administered to mice at dose of 1.5*109 IU/kg and 1.5*108 IU/kg respectively, which were 105 or 104 times of human's dosage. No any acute toxicological reaction or death occurred to animals. 2) Long-term toxicity test:

Interferon® was intramuscularly administered to rats 5 times a week at does of 1.5*107 IU/kg, 1.5*106 IU/kg and 1.5*105 IU/kg for 6 months, respectively. There was no abnormal reaction on rat's general cases, body weight and behavior. Experiment was repeat on rabbits for 3 months, there was also no pathological change on rabbits' internal organs due to toxicity of Anterferon®.

[PHARMACOKINETICS]

Cmax of Anterferon® in serum occurred at 3.5~8 hours after intramuscular or subcutaneous injection; the half of clearance is about 4-12 hours. Kidney is the main organ of clearance. Biliation and metabolism in liver are also important way for elimination of interferon. More than 80% Interferon can be absorbed via intramuscular or subcutaneous injection.

[INDICATIONS]

Acute and chronic hepatitis (B or C), Condylomata acuminate, Hairy cell leukemia, and chronic granulocytic leukemia

[ADMINISTRATION and DOSAGE]

Anterferon® can be administered via intramuscular, subcutaneous or local injection.

1.        Chronic hepatitis B: 3~6*106 IU intramuscular or subcutaneous daily injection for 4 weeks, then 3 times a week   for more than 16 weeks.

2.        Choronic and acute hepatitis C: 3~6*106 IU intramuscular or subcutaneous daily injection for 4 weeks, then 3 times a week for more than 16 weeks.

3.      Condylomata acuminata: 1~3*106 IU intramuscular daily injection for 4 weeks. Anterferon® can be also inject daily at dosage of 1*106 IU together with laser or electric therapy.

4.        Hairy cell leukemia: 2~8*106 IU/m2 intramuscular daily injection for at least for 3 months.

5.        Chronic granulocytic leukemia: 3~5*106 IU intramuscular daily injection along with hydrxyurea and Ara-c chemotherapy.

[ADVERSE REACTION]

The most common adverse reactions include fever, headache, shiver, tire, myalgia, and arthralgia. These reactions occur at the first week of treatment and may disappear in 48 hours after injection. If severe adverse reactions occurred, administration regimen should be modified or stopped. If any allergic reactions occurred, administration should be terminated immediately. Leucocytopenia and thrombocytopenia may occur for a few patients and may disappear after cessation of therapy. Anorexia, nausea, diarrhea, vomiting, alopecia, lower or higher blood pressure, and CNS disorders may rarely occur.

[CONTRAINDICATINS]

1.      Anterferon® is contraindicated in patients with a history of hypersensitivity to interferon alpha 2b or any component of the injection.

2.      Anterferon® is contraindicated in patients who suffer from serious heart disease.

3.      Anterferon® is contraindicated in patients who suffer from epilepsy function abnormality of liver, kidney or marrow.

4.      Anterferon® is contraindicated in patients who suffer from epilepsy and CNS damage.

5.      Anterferon® is contraindicated in patients with other serious diseases who cannot tolerate Anterferon therapy.

[PRECAUTIONS]

1.      Anterferon® is white loose powder, when dissolved with water for injection, the solution should be clear and transparent. Discard it if there is any solid or opalescence visible to eyes. Don't use it if bottle is spilled or product is expired.

2.      Water for reconstitution should be injected along the inner side of bottle to avoid developing bubbles. The product should be used within one day after dissolved.

[PREGNANT AND BABY-NURSING WOMEN]

Experience of Anterferon therapy in pregnant women is limited, and in such cases the expected benefits and risk should be carefully weighed by experienced doctor.

[PEDIATRICS]

Experience of Anterferon therapy in pediatric patients is limited, and in such cases the expected benefits and risk should be carefully weighed by experienced doctor.

[OLD PATIENTS]

For old patients who have pre-existing cardiac abnormalities and in advanced stages of canner, electrocardiograms should be taken prior to and during the course of treatment, and the dosage could be modified or the therapy could be

terminated according to doctor's suggestion.

[INTERACTION WITH OTER DRUGS]

Interferon may change activities of some enzymes, especially inhibit cytochrome P450; thus it can affect the metabolism of some medicine such as cimetiding, diphenlhydantoin, warfarin, hyphyline, apavvin. Interferon may also interact with central nerve medicine.

[OVERDOSAGE]

There was no report about over dosage, high dose of Anterferon® may lead to severe tiredness and weakness.

[VIAL SIZE]

Anterferon® lyophilized powder is supplied as 1,3 or 5 million IU/vial.

[STORAGE]

2~8ºC and away from light.

[EXPIRY]

2 years.

[LICENCES NUMBER]

GYZZS 20000013 (3 million IU/vial)

GYZZS 20040010 (6 million IU/vial)

[MANUFACTURED BY]

Anhui Anke Biotechnology (Group) Co., Ltd

[ADDRESS]

Ankebio Buildings, 669 Changjiang Road, West,Hefei, 230088, P.R. China.

tel: +86-551-65319890, 65318811

fax:+86-551-65319895

e-mail:info@ctdgc.com

http://www.ctdgc.com