BOTULINUM TOXIN TYPE A FOR COSMETIC THERAPY

BOTULINUM TOXIN TYPE A FOR COSMETIC THERAPY

dosageBOTOXINA (Botulinum Toxin Type A for Therapy) is a sterile, lyophilized form of purified C. botulinum toxin type A, produced from the crude toxin of the culture of the Hall strain of Clostridium botulinum grown in a mediumcontaining trypticase and yeast extract. A series of purifying procedure were taken to form a crystalline complex consisting of the active high molecular weight toxin protein and an associated hemagglutinin. After re-dissolved and dialyzed the crystalline toxin, an accurate amount of the sterile filtered (0.2 microns) toxin were added to a solution containing gelatine-dextran-sucrose, then lyophilized.Each vial of β0ToxinA® contains 100 units (U) of C. botulinum toxin type A, 5mg of gelatine, 25mg of dextran and 25mg of sucrose. Dilute with sterile normal saline according to different needs before using. The white loose production turns to be colourless or yellowish transparent solution after the reconstitution.One unit (U) of β0ToxinA® corresponds to 1 LD50 of Botulinum Toxin Type A while being intraperitoneally injected into mouse. β0ToxinA® could block neuromuscular conduction by inhibiting the release of acetylcholine and therefore causes local muscle flaccid paralysis.

Indications for injectable therapies

β0ToxinA® is indicated for the treatment of blepharospasm, hemifacial spasm in adults and some types of strabismus and strabismus which can not be corrected through operation in the patients 12 years of age and above.

Usage and Dosage

  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 chosen the 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 ml Volume 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 hyperplexia and myasthaenia 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 adrenaline should be prepared in case of accident. A short period of observation is recommended for patients having just received β0ToxinA® therapy.

The report of thermal stabilization test for freeze dried BTX-A

Product no.
Original Efficiency
(LD50/bottle)
Preservative Temperature
(centigrade)
Preservative
Time
Efficiency
(LD50/bottle)
Loss of
Efficiency
9002 200 35-36 1 month 162 19%
9002 200 35-36 2 months 162.50 19%
9002 200 35-36 3 months 144.50 <28%
9002 200 approx. 25 3 months 170 15%
9002 200 approx. 25 6 months 164 18%
9002 200 approx. 25 1 year 162.50 19%
4002 195 approx. 25 3 days 225 ---
4002 195 approx. 25 7 days 200 ---
4002 195 approx. 25 10 days 180 7.7%

The results show that Freeze Dried BTX-A will keep its efficiency at room temperature for one week, a little bit drop in efficiency for 10 days, 15~20% drop in the efficiency for 3~12 months.

How Supplied

Dose

100 U / vial

Shelf Life

3 years from the date of freeze-drying

Storage

Store at temperature of -5 to -20° C.
Maximum solution temperature 36° C.

WEB

www.botoxina.com

E-mail

botoxin@botoxina.com

Licensing Manufacturer:

E.M.B. Service by E.O.S.
Marie Celeste off. Grytviken, South Georgia and South Sandwich I, (United Kingdom)

Production Management:

MobiLab Pharmanagement Ltd. - Coastal House, 180 Bridge Road, Sarisbury Green Southampton, S031 7EH, (United Kingdom)

Supply:

SeaLab Europe LLP - Suite 36, 88-90 Hatton Garden, Hoborn, London, (United Kingdom) - EC1N 8PN - Tel. +447077077606 - Fax +447077077653

NOTES ON THE ENGLISH LANGUAGE SITE

By concession of Sealab LLC, the publishing, on this web-site of information in Italian is only directed at Italian speaking researchers for promotional purposes and, is intended only for research and pharmaceutical certification laboratories in Canada, Australia and the USA. Elsewhere, the sale of promotion samples is forbidden, as it is also forbidden to sell to the public (for further information see Order section).

Clostridium botulinum: extraction-production and extraction centrals: Chile (also in areas where there is a particular modifying glucose), Ukrayna, Kazakistan, (Asiatic Area) 349 Syrdaria Dzambul (DZ) KAZAKISTAN.

CERTIFICATION: the clinical trials of the biological product started in 1994 and continued for over 2 years. After almost ten years, there aren't any serious problems at all. The Ministry of Health, for the National Institute for the control of pharmaceutical products, certified the product five years later. Observations and conclusions on the important results of our research. The molecular structure of β0ToxinA®, intended for use in specific regions, will vary every seven months or so. This can facilitate the weaning from the product in patients who are often subjected to the treatments. The manufacturer reserves the right to point out the possible variation of the composition.

Important: contraindications and collateral effects. Not to be given to those suffering from eyebrow hyperplexia, myastenia or eggs allergy etc.

staff henryFor assistance and formation of study groups for the learning of injective operative techniques, quick supply service of antidote, it is possible to contact corresponding also in Italian with our reference medical staff: Dr. Henry Brent in Sealab LLC

staff johnsonAdministration: responsible accounting markets, reference: John Fred Johnson.

Determining of sale concession and distributive order, personal engagement responsible:

General area manager and Promoter manager: John Smithson Questo indirizzo email è protetto dagli spambots. E' necessario abilitare JavaScript per vederlo.

β0ToxinA® 100

Samples request

stafftotIt must first be stated that sale of samples to the public is forbidden,Sealab LLC advises that from March 2006, it shall start a promotional service, out of the USA, Canada and Australia, to send samples of β0ToxinA® Topical against payment in advance. The date of sufficient production of β0ToxinA® for delivery of present demand is expected for the end of 2006 and beginning of 2007, and it will coincide with the completion of the new manufacturing facility in India. The estimated investment, completely deposited, is $ 3.000.000. It will be financed by "Medical and Paramedical Centre for Research and Global Development" and by financing from the state partner, owner of 10% of CCDL BANK shares (25%). From that moment, Ermex, will become a mixed share capital corporation and shall seek listing on the Stock Mark.
For more information or reply on the prevision of possible samples delivery on your area, e-mail: Questo indirizzo email è protetto dagli spambots. E' necessario abilitare JavaScript per vederlo. .

Job opportunites with Sealab LLC

equipeOther products will be sold alongside β0ToxinA®. Please send us a note about your background, specifying your kind of professional activity.
(Example: Medical Hospital Management, Product-Manager, Training Expert, Legal Certification, Research and Development, Mass marketing, Adviser, Lawyer etc...)

Packing

Shipments over 500 vials: for space reasons, it can happen that the labels and the plastic packaging that surrounds the vials, will be in the same package but in another part (it can happen on larger shipments too). Vial size may vary at the convenience of the manufacturer between two formats now available.

Requests

The access to the product order form for biological samples is reserved only for Certification Corporations, Medical Research in institutes which are recognized suitable for certification and only by prior end-user declaration and a no sale declaration of the product, and commitment to its destruction at the end of the trial. If you are aware of any irregularities, please let us know at our call center or at Questo indirizzo email è protetto dagli spambots. E' necessario abilitare JavaScript per vederlo. . The sending and training cost of the practice and composition of your document kit, with the sending of a vial sample β0ToxinA® "A" of 100 units is € 415. The lowest request for the practice training with the costs of sending of 10 samples is € 4150 free USA/Canada/Australia.

Vial samples of 50 and 150 units will be available from 2003. Antidote "Antiβ0ToxinA®": €985 for each vial of 100 units.

It is possible to order samples by e-mail, if you send us your request. We reply quickly and can direct you to the bank we use For your area. The only methods of payment authorized are, irrevocable letter of credit, Bank guarantee, and payment-with-order.No samples shall be shipped COD.

For hospital tender, special deals, especially large quantities of material made to order, to donate to charity, please contact our sales director. We ship within 2 working days of order placement, however, in case of temporary lack of stock, our system will automatically to stop the debit.

staff rossiSealab LLC thanks Dr. John Rossi Perkins from Philadelphia (USA) for the consultancy and assistance for the translation in Italian for the doctors that have made request.

Contatti

SeaLab Europe LLP - Suite 36, 88-90 Hatton Garden, Holborn, EC1N 8PN, Londra (Regno Unito)

Telefono: +44 7077073252

Fax: +44 7077077606

Newsletter

Per ricevere la nostra newsletter registrati al nostro esclusivo "botoxina Foundation members Club" inserendo la tua email:

sottomarino newsletter

Potrai aggiudicarti un tour sul nostro battiscafo marino e nel nostro laboratorio.