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Product Instructions - Type A

Product Instructions - β0ToxinA® Injectable - Type A

  1. Position for injection: The injection should be administered intramuscularly perpendicular to the centre of the age wrinkle, about 1 mm from the bone taking a total of 4 to 16 points of injection for the whole visum.
  2. Dosage: Up to 100 U can be evenly distributed in the chosen points. The injecting volume into each muscle should not exceed 0.1 ml. In case of unsatisfactory response, a supplementary injection may be given. In case of relapse, the dose can be repeated or increased even at irregular intervals, but for each muscle the maximum dose should be less than 5 U/injection.
  3. Dilution of β0ToxinA®: The dilution of β0ToxinA® with sterile physiological saline should be done carefully on the basis of the actual requirement.

Following is a reference table of recommended dilutions:

U / 0.1 mlVolume of
solvent (ml)
10.0 1.0
5.0 2.0
2.5 4.0
1.25 8.0

Shake the vial gently after adding sterile physiological saline until completely dissolved. The reconstituted β0ToxinA® should be used at once or stored in refrigerator at 2 to 8°C and be used within 4 hours. The container and the syringe used with the drug as well as the residual β0ToxinA® solution should be disposed of after sterilization.

Side Effects

Temporary 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 β0ToxinA® therapy on the visus, however, all such symptoms disappear spontaneously within 3 to 8 weeks.Temporary and different degree of ptosis of the eyelid, vertical deviation and rarely mydriasis, related to the diffusion of the toxin to the muscles adjacent to the eye, may occur in some patients who receive β0ToxinA® therapy near the eye, however, all such symptoms disappear spontaneously within 3 to 8 weeks.

Contraindications

β0ToxinA® is contraindicated in individuals with anaphylactic tendency and known hypersensitivity to this preparation.The injection should be postponed in patients who have fever, acute infectious diseases and administered more carefully to patients with blood, heart, liver, lung diseases, active tuberculosis, pregnant women and never to children below 12 years of age.β0ToxinA® must not to be given to those suffering from eyebrow hyperplasia and myasthenia gravis, it is ineffective in patients with serious muscle fiber contracture.

Drug interactions

β0ToxinA® may be potentiated by aminoglycoside antibiotic (such as gentamycin) therapy and so should not be administered while under such therapy.

Precautions

  1. Administering physicians must have good knowledge of extraocular and facial muscle anatomy and be proficient at electromyographic amplifier technique.
  2. 1:1000 adrenalin should be prepared in case of accident. A short period of observation is recommended for patients having just received β0ToxinA®therapy.

The range available at present is:
35U 50U 55U 100U classic and Neoβ0ToxinA® 100U 110 U 150 U 200U 250U 500U.

Contact

SeaLab Europe LLP, Suite 36, 88-90 Hatton Garden, Holborn, EC1N 8PN, London (UK)

Telephone:+ 44 7077073252

Fax: +44 7077077653

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