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Home > Product > Health & Medical > Drugs > Other Drugs > sss Botulinum Toxin | s Botulinum Toxin Type A | sh BOTULINUM TOXIN,BOTULINUM TOXIN A
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sss Botulinum Toxin | s Botulinum Toxin Type A | sh BOTULINUM TOXIN,BOTULINUM TOXIN A

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TRINITY UNIVERSAL VENTURES ENTERPRISE
Malaysia Malaysia
1997
Total Stuff:51 - 100 People
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Specifications

ANTI AGE (Botulinum Toxin Type A for Therapy) is the sterile, lyophilized exotoxin of Cloristidium Botulinum.

ANTI AGE (Botulinum Toxin Type A for Therapy) is the sterile, lyophilized exotoxin of Cloristidium Botulinum. It is a dichain polypeptide molecule consisting of a 50-kD light chain and 100-kD heavy chain linked by disulfide bonding. It is grown in a medium containing trypticase and yeast extract. A series of purifying procedure were taken to form a crystalline complex. After re-dissolved and dialyzed the crystalline toxin, an accurate amount of sterile filtered (0.2 microns) toxin were added to a solution containing albumim-dextran-mannitol-NaCl, the lyophilized.

Each vial of ANTI AGE contains 100 or 50 units (IU) of Cloristidium Botulinum Toxin Type A, 0.5mg human albumin, 30mg dextran, 30mg mannitol and 0.9mg NaCl. Dilute with non-pyrogen and sterile normal saline according to different needs before using. The white loose powder turns to be colorless or yellowish transparent solution after the reconstitution.

One unit (IU) of ANTI AGE corresponds to 1 LD50 of Botulinum Toxin type A while being intraperitoneally injected into mouse.

ANTI AGE could block neuromuscular conduction by inhibiting the release of acetylcholine and therefore causes local muscle flaccid paralysis.

INDICATIONS

ANTI AGE is indicated for:

1.Treatment of blepharospasm, hemi facial spasm in adults and some type of strabismus, especially for acute paralytic strabismus, comitant strabismus, strabismus caused by endocrine myopathy and strabismus.

2.Hyperhidrosis.

3.Cosmetic use.

USAGE AND DOSAGE

1.Position for injection.

a)For blepharospasm, injection should be given intramuscularly at several points of upper and lower lids, i.e., taking 4 or 5 points of injection into orbicular is oculi of medial and lateral or lateral Canthus temporal.

b)For hemi facial spasm: Besides the points mentioned above, three other points on middle, lower face and cheek should be given intramuscularly. ANTI AGE may be given at points of two sides of eyebrow, upper lip or the lower jaw according to the diseases.

c)For strabismus: ANTI AGE is injected using coaxial electrode needle with electromyography guidance or amplifier under topical anesthesia of 0.5% Decarine.

d)For hyperhidrosis the ANTI AGE is injected in multiple points in the affected areas.

e)For cosmetic use the ANTI AGE is infiltrated into the muscles or by subcutaneous and intradermal.

2.Dosage

a)For blepharospasm and hemi facial spasm: the injection could be given following above instructions. The initial does each point is 2.5IU/0.05ml or 2.5IU/0.1ml. If the initial treatment is considered insufficient one week later, a supplementary injection may be given. Double dose of 5IU/0.1ml could be given to recrudescent patients. But the limitation of total dose of 55IU for one injection and 200 IU for one month should not be exceeded.

b)For strabismus: For vertical and horizontal muscle strabismus of less tan 20 prism diopters, the initial dose into each muscle is 1.25-2.5IU. For Horizontal strabismus of 20-40 prism diopters, the initial dose into each muscle is 2.5IU and can be increased (to 5.0IU each time) depending on the response; for persistent VI nerve paralysis lasted for more than one month, 1.25-2.5IU dose could be injected into medial rectos.

The injecting volume into each muscle should not exceed 0.1ml. To patients having an insufficient response, supplementary injection could be given. To recrudescent patients, the dose can be repeated or increased irregularly. But for each muscle the maximum dose should be less than 5IU/inj.

The dilution of ANTI AGE

The dilution of ANTI AGE with sterile normal saline should be done carefully on the basis of real needs.

Rotate the vial gently after adding sterile normal saline to complete the dissolving. Avoid bubbling and excessive shaking.

The reconstituted ANTI AGE should be used at once or stored in a refrigerator at 2°C to 8°C to be used within 4 hours. The containers and the syringe used with the drug as well as the residual ANTI AGE solution should be disposed after sterilization.

SIDE EFFECTS

1.Localized pain and hematoma can occur after intramuscular or subcutaneous injection of the toxin.

2.Temporarily ptosis of the eyelid, drawback of the lower eyelid, reduced blinking, eyelid close incompletely, weakness of facial muscles, etc. may occur to a few patients who received ANTI AGE therapy for blepaharospasm and hemi facial spasm. However, all the symptoms will disappear without any therapy within 3 to 8 weeks.

3.Temporary and different degree of ptosis of the eyelid, vertical deviation and rarely mydriasis, which related to the diffusion of the toxin to the muscles adjacent, may occur to some patients who received ANTI AGE therapy for strabismus. The symptoms will disappear without any therapy within a few weeks.

CONTRAINDICATIONS

1.ANTI AGE is contraindicated in individuals with anaphylactic constitution and known hypersensitivity to the preparation.

2.Pregnancy and breast feeding.

3.Myasthenia Gravis

4.Lambert-Eaton syndrome.

5.Blood coagulations disorders.

PRECAUTIONS

1.ANTI AGE must be kept, issued and registered by special person and administered only to the patients with above indications. Physicians administering especially during the treatment of strabismus, have to be trained prior, know extra ocular and facial muscles anatomy and be good at electromyography amplifier.

2.The injection procedure should not be given to patients who have fever and acute infection diseases.

3.During the treatment of blepharospasm and facial spasm, a small percentage may present temporarily ptosis, lower eyelid fallback, winking decrease, imperfect closure of palpebral fissure, and decrease of facial muscle dynamics. All side effects will be recovered naturally within 3-8 weeks.

4. During the treatment of strabismus, some patients may present temporally different degrees of ptosis, vertical strabismus and most individual mydriasis, which is related to the reason that the Botulinum is diffused to neighboring muscles. It will be recovered naturally within several weeks.

HOW SUPPLIED:

100 IU/vial, 50IU/vial

SHELF LIFE:

3 years from the date of lyophilization.

STORAGE:

Store at a temperature of -5°C to -20°

Sole Agent: ANTI AGE CORP.

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