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Interferon Alfa-2b Vaginal Effervescent Tablet

  • Spec:0.5 MIU

Indications and Dosage:

INGREDIENTS
Main Components: Recombinant Human Interferon α-2b.
This products is made from Recombinant human interferon α-2b with fully mixed pharmaceutical adjuvant by crushing, granulating, mixing, Tableting, packaging, testing.

DESCRIPTION
White or off white oval tablet, the appearance should be complete and smooth, in uniform color.

INDICATION
For the treatment of cervical erosion caused by virus infection; prevention and treatment of HPV infection.

ADMINISTRATION AND DOSAGE
Place tablet into vaginal dome, one tablet for each time prior to sleep, once every other day. 9 times is one course of treatment or under supervision of a physician.

1.) Washing hands and perineum before administration, removing the tablet and dosing device from the package, releasing dosing device and placing half of one tablet into the dosing device. (Picture A)


                         Picture A

2.) Supine position is better. Supining on a bed, genuflecting up knees so that can insert the device easily.
3.) Place the dosing device into vaginal dome gently, push the bottom of device and make the tablet into the deep vagina inside. (Picture B)

                          Picture B

4.) Releasing and discarded dosing device after using.

ADVERSE REACTIONS
Slight vulca vagina swelling, broiling, pruritus and soreness can occur in very few patients for the first medication, and it will disappear after discontinuation.

CONTRAINDICATIONS
The patient who is hypersensitive to recombinant human interferon α-2b and other pharmaceutical adjuvant in this drug is prohibited.

PRECAUTIONS
Hip bath and sexual life should be prohibited during the course of medication and discontinue medication during menstruation.
This product is only for external use.
Place the drug where children hard to get.

PREGNANCY AND LACTATION
It is prohibited to use this product in pregnant or lactation women.

PEDIATRIC
Children are prohibited to use this product.

GERIATRIC
Senile patients can use this product normally.

OVERDOSAGE
It is local administration, overdose will not occur generally. Discontinue administration immediately for those who are incompliant.

DRUG INTERACTIONS
It hasn't been researched yet and no applicable references.

PHARMACOLOGY AND TOXICOLOGY
Pharmacology:
Pharmacology: interferon has multi-pharmaceutical effects, including immune regulation, inhibiting virus reproduction and antiproliferative. Through immune regulation Interferon can adjust the immune function of human body (including three basic functions of immune surveillance and immune protection and immune self-stabilization), main shown by the function of immune effector cells: 1) by adjusting the killing activity of NK cells and K, to kill cancerous cells and virus infection; (2) to act on the B lymphocyte to regulate the antibody formation; (3) to enhance the lymphocyte surface histocompatibility antigen and the Fc receptor expression, which is advantageous to the effector cells; (4) to activate phagocytosis of mononuclear macrophage. Interferon can also through cytokine network adjusting, induce ILs, TNF, CSF and other cytokines to exert synergy in immune regulation.
Interferon is a broad-spectrum broad antiviral agent, which has inhibiting effect on RNA and DNA of all virus known until now, including all types of HPV, HSV and HCMV, and which also has effect on chlamydia, mycoplasma, protozoon and so on parasitized in cell. Interferon can activate cellular 2',5'-oligoadenylate synthetase and kinase by binding with the receptor composed by special ganglion glucoside and glycoprotein on cell surface, to damage viral mRNA so that the viral protein synthesis is blocked, thus the virus proliferation is inhibited. Interferon can also make the target cell inhibit viral decladding, DNA replication and mRNA transcription, but don’t affect binding of the host cell mRNA and ribosomal, therefore it has very little toxicity to human. Interferon has anti-proliferative effect, which is used to cure various malignant tumor. By means of inhibiting tumor cell growth, interferon can inhibit oncogene expressing and transforming, and activate antitumor immunity so that it has comprehensive antineoplastic effect.

Toxicity:
Acute toxicity test: administrate 40000 times of clinical dosage on mice and rats, once a day, for 5 consecutive weeks, no abnormal reactions and toxicity symptoms occur.

PHARMACOKINETICS
It is administrated by vaginal. This production is absorbed by vaginal epithelium mucosa and play anti-virus function; Part of Interferon entering in the body will be hydrolyzed by protease; the other part will be eliminated out of the body through urine by means of prototype drug.

STORAGE
Store and transport at 2-8 centigrade and dry place, protected from light.

PACKAGE
Cold forming composite aluminum blister package. 3 tablets/box, or 9 tablets/box. There is sterilized finger-bag or dosing device in each unit of package.

SHELF LIFE
18 months