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Anterferon® Eyedrop--Recombinant Human Interferon alpha 2b (rIFN a2b, rDNA Origin) Eyedrop

SPECIFICATION AND INTRODUCTION

[PRODUCT NAME]

Generic name: Recombinant Human Interferon alpha 2b Eyedrop

Trade name: Anterferon®

Chinese phoneticize: Chongzu Ren Ganraosu alpha 2b Diyanye

[COMPOSITION]

Recombinant Human Interferon alpha 2b

[DESCRIPTION]

Colorless or light yellow transparent solution

[INDICATIONS]

Herpes simplex keratitis

[VIAL SIZE]

1 million IU/5ml/bottle, 0.5 million IU/2.5ml/bottle

[ADMINISTRATION and DOSAGE]

Apply to affected conjunctival sac six times daily. 1~2 drops per time and keep eyes close for 1~2 minutes after dropping. A normal treatment course is 2 weeks. Use under medical supervision if necessarily.

[ADVERSE REACTIONS]

Temporal adverse reactions such as prickle or itch of eyes may occur to a few patients and may disappear after discontinued the drug.

[CONTRAINDICATIONS]

It is contraindicated in those patients who have hypersensitivity to the drugs.

[PRECAUTIONS]

1.      Cautions dosage is advised in patients who hypersensitivity to interferon.

2.      The product is colorless or light yellow transparent solution. Discard it if there is any solid or opalescence.

3.      Avoid the bottle to touching eyes to prevent pollution.

4.      This drug is sterile, do no store for long time after open. Close tightly the cap of bottle after use.

[PREGNANT AND BREASTFEEDING WOMEN]

Use under advice of medical supervision.

[PEDIATRICS]

Experience is limited.

[OLD PATIENTS]

Experience is limited.

[INTERACTION]

1.      Use together with AGG, IDU, CC to grant therapy.

2.      Use under medical supervision with other medicine.

[OVERDOSAGE]

No serious adverse reactions for overdosage have been reported. Attention should be given to dosage during therapy.

[PHARMACOLOGICAL ACTIONS]

Interferon α 2b exert actions of antiviral and regulating immunity. Such immunomodulation activities include enhancement of the phagocytes for targets cells, and enhancement of the NK cells activities.

[PHARMACOKINETICS]

There is no study on this item. Please see The Pharmacokinetics Instruction of Recombinant Human Interferon alpha 2b for reference: Cmax of Anterferon in serum occurred at 3.5~8 hours after intramuscular or subcutaneous injection; the half-life 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.

[STORAGE]

Dark at 2~8ºC, keep dry.

[EXPIRY]

24 months

[LICENCES NUMBER]

GYZZS 20020102

[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