Adverse Event Report
Unit 603 and 604, 6th Floor, Ryan Vanak Building, No. 18, West Side of Sheikh Baha'i Square, Tehran, Iran
(+98) 21 45395
Clostridium botulinum toxin interferes with the release of acetylcholine, which is responsible for muscle stimulation and contraction, resulting in lack of muscle stimulation that causes temporary paralysis and muscle relaxation. This drug was approved by the Iran Food and Drug Administration in 2019 and is offered in two doses of 300 and 500 units.
The indications of Dyston®:
Dyston® is used in muscle cramps of the upper and lower limbs, improvement of skin wrinkles, frown lines between the eyebrows, chronic headache, excessive salivation, excessive sweating, neck dystonia, etc.
You need to know about Dyston®
Dyston® should be stored in the refrigerator (at 2 to 8 ° C) and away from light. It should reach room temperature (25 ° C) before injection. It is used by a doctor as an intramuscular injection in the desired location. use of Dyston®?
Do not use Dyston® if you:
• Are allergic to the botulinum toxin containing products.
• Are allergic to any other ingredients in Dyston®.
Consult your doctor if you have any of the following conditions:
• have or have had breathing problems
• have or have had swallowing problems.
• have or have had bleeding problems.
• have allergies to any botulinum toxin product.
• have a disease that affects your muscles and nerves such as myasthenia gravis.
• Take any antibiotic for an infection (e.g., aminoglycosides such as gentamicin or amikacin)
• Take any muscle relaxant
Seek urgent medical help if you experience any of the following side effects:
• trouble breathing
• trouble swallowing
• muscle weakness all over the body
• double vision
• blurred vision and drooping eyelids
• trouble saying words clearly (dysarthria)
• loss of bladder control
Characteristics Chemical-P of Dyston®:
• Vial: each vial contains 300 or 500 IU of abobotulinumtoxinA (as an active ingredient), human serum albumin and lactose (as excipients) for IM injection
• Color: lyophilized white cake
• Solvent: reconstitute with preservative- free 0.9% sodium chloride (NaCl) for injection
• Storage: in a refrigerator (2-8 ° C) for two years
Pregnancy and lactation:
Dyston® is not recommended during pregnancy, unless clearly necessary. High dose of Dyston® may affect pregnancy.
Dyston® is not recommended in breast-feeding women
For adverse event report and contact with patient support unit
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Arta Pharmed Company, located in Tehran, Iran, is one of the new pharmaceutical companies that focuses on clinical studies, sales, marketing, market development, market access and scientific activities. This company, which was established in 2018, currently cooperates with more than 15 companies in various fields.
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