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FAQS

Is BTXA™ eligible for all ages?

BTXA™ is eligible for patients from children to the elderly. However, patients should consult their doctors before they receive the injection.

What is the contraindication?

BTXA™ is contraindicated in individuals with the anaphylactic constitution, known hypersensitivity to this preparation, pregnancy, breast milk feeding, motor neuron disease, neuromuscular joint disease, and taking medications of aminoglycosides, d-penicillamine, quinine, and warfarin/heparin. If serious immediate hypersensitivity reactions such as anaphylaxis, urticaria, edema, and dyspnea occur, stop further BTXA™ injection and receive appropriate medical therapy at once.

Are there any side effects?

There is no systemic side effect in all patients who received BTXA™ injection, even the ones who received it repeatedly in long term. Some local side effects might occur in a small number of patients. The most common ones are edema of eyelid, droopy eyelid, lacrimation, lagophthalmos, and muscle weakness. Occasionally, dyspnea or dysphagia may occur in individuals after injection. However, the side effect is mild, temporary, and will disappear spontaneously within a few weeks. The percentage of occurrence is like other similar products.

How to apply BTXA™ and how long is the treatment?

BTXA™ is applied non-surgically by a syringe with an ultra-fine needle to inject into muscle. Using the ultra-fine needle and the small dose of BTXA™, pain is minimized. The treatment time depends on the site of injection and the number of injection sites.  The treatment usually takes around 15 minutes.

When does BTXA™ start to work?

The onset time varies individually and depends on the site of injection. In general, the effects of BTXA can be observed and become noticeable a few days or to a week after injection.

How long does the effect last?

The effect of BTXA™ will last up to 3 to 6 months or more and it also depends on individual response. To carry on the effect, a second injection is required after fading of the previous effect.

How to maintain the best response to BTXA™?

In order to minimize the potential of neutralizing antibody formation, it is suggested to inject the lowest effective dose as less frequent as possible. In this way, the response to BTXA™ could be maintained satisfactorily.

Why should we trust the quality of BTXA™?

BTXA™ is produced by the GMP licensed manufacturer with more than 70 years of experience in biological product research and production. The product is manufactured under a strict quality control system in which routine inspections and surveillance were performed by the local authorities. As well as the authorities from export countries to assure the products' quality is up to satisfactory standard and safety level.

 

Since BTXA™ was officially launched onto the market in 1997, BTXA™ has been used safely for over 15 years and developed with millions of cases treated. A more than five years of continuous safety monitoring on BTXA™ application was carried out and the respective Periodic Safety Update Report (PSUR) was issued in Jan 2009. Nowadays, around 30 countries have approved applications of BTXA™. Its quality is then recognized as well as its efficacy and safety in clinical uses.

Why is gelatin used in BTXA™ formulation instead of using human albumin?

Gelatin was chosen in the BTXA™ formulation as a stabilizer because of the concern of potential viral contamination (e.g. HIVs and Hepatitis) in botulinum toxin by the human serum albumin of which other brands were employed. Gelatin indeed is a commonly used stabilizer in lyophilized biological products. It is good at keeping the product's stability. The origin of the gelatin used in BTXA™ was extracted from bovine skin and it is sourced from BSE (Bovine Spongiform Encephalopathy)-Free regions with certifications verified. Strict quality control tests are done before the gelatin is put into BTXA™ production to ensure the product quality is maintained at a high level.

Why should we choose 50 Units?

50 Units provides flexibility for treatment operation. Doctors would be able to consume the whole vial at a single operation without further concern of storage, potency lost, and possible contamination when it is opened for long.

What brand name had been employed with the product?

BTXA™ has been employed for registration in most of the countries. Alternative brand names like Prosigne in Brazil, Redux in Peru, Lantox in Russia and Colombia, Lanzox in Indonesia are employed as well.

BTXA™ should be kept cool for storage. Would the quality of BTXA™ be affected in global shipment?

Cold chain is used for any BTXA™ shipments. Storage conditions are closely monitored for the whole shipment process. Quality is thus guaranteed.

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