Refinex

INSTRUCTION

REFINEX (Botulinum Toxin type A for Therapy) is a sterile, lyophilized form of purified botulinum toxin type A produced from the crude toxin Iff the culture of the Hall strain of Clostridium botulinum grown in a medium containing trypticase and yeast extract A series of purifying procedure were taken to obtain a crystalline complex. After re-dissolved and dialyzed the crystalline toxin, an accurate amount of the sterile filtered (0.2microns) toxin were added to a solution containing gelatin-dextran-sucrose, then lyophilized.

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DESCRIPTION

Each vial of REFINEX contains 100 or 50 or 35 units LDof Clostridium botulinum toxin type A, 0.5 mg human albumin, 30 mg dextran dflti 30 mg mannitol. Dilute with non-pyrogen and sterile normal saline according to different needs before using. The while loose product turns to be colorless or yellowish transparent solution after the reconstitution. One unit (U) of REFINEX corresponds to 1 LDso of Botulinum Toxin Type A while being intraperitoneally injected into mouse. Reeuld block neuromuscular conduction by inhibiting the release of acetylcholine and therefore causes local muscle flaccid paralysis.

Botox

INDICATIONS

REFINEX is indicated for 1. Treatment of blepharospasm, hemifacial spasm in adults some type of strabismus, especially for acute paralytic 2. Hyperhidrosis 3. Cosmetic use

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USAGE AND DOSAGE

A. Position for injection

  1. For blepharospasm injection shouldbe taken intramuscular at several points of upper and lower lids, i.e., taking 4 to 5 points of injection into orbicularis couli of medical and lateral or lateral oanthus temporal.
  2. For hemifacial spasm: besides the points mentioned above, three other points on middle, lower face and cheek should be given intramuscular. May be given at the points of two sides of eyebrow, upper-lip or the lower jaw according to the diseases.
  3. For strabismus: is injected using a coaxial electrode needle with etectromyogrhphio guidance or amplifier under topicak anesthesia of 0,5 % Decarine.
  4. For hyperhidrosis is injected in multiple points in the affected areas.
  5. For cosmetic use is infiltrated into the muscles.

B. Dosage

For bW barospasm and hemifagal spasm: the injection could be given following above instructions. Themitial does of each point is 2.5 U/0.05ml or 2.5U/0.1 ml If the initial treatment is considered insufficient one week later. A supplementary injection may be given. Double does of 5U/0.1 ml could be given toftorudescent patients. But the limitation of total does of 55U for one injection and 200 U for one month should not be exceeded.

vertical and horizontal muscle strabismus for less than 20 prism diopters, the initial dose into each musole is 1.23-2.5U: for horizontal strabismus of 20-40 prism diopters, the initial does into each muscle is 2.5U; for horizontal strabismus of 40-50 prism dioters, the Initial dose into each muscle is 2.5U and can be increased (to 5.0U each time) depending on the response: for persistent VI nerve psralysis lasted for more than one mounth, 1.25-2.5

The injecting volume into each muscle should not axceed 0.1 ml. To patients, having 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 5U/inj.

C. The Dilution of "R"

The dilution of "R" with sterile normal saline should be done carefully on the basis of real needs. Following U/vial

  • 50 100
  • U/O.lml the volume of diluent (ml)
  • 10.0 0,5 1.0
  • 5.0 1.0 2r0
  • 2.5 2.0 4.0
  • 1.25 4.0 8.0

Shaking the vial gently after adding sterile normal saline to the complete dissolving. The reconstituted "R" should be used at once or stored in a refrigerator at 2 to 8 ℃ to be used within 4 hours. The container and syringe used with the drag as well as the residual "R" solution should be disposed after sterilization.