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Dysport
Overview
What is Dysport?
Botulinum toxin type A, the active ingredient in DYSPORT (abobotulinumtoxinA), is a purified neurotoxin type A complex produced by fermentation of the bacterium type A, Hall Strain. It is purified from the culture supernatant by a series of precipitation, dialysis, and chromatography steps. The neurotoxin complex is composed of the neurotoxin, hemagglutinin proteins and non-toxin non-hemagglutinin protein.
DYSPORT is supplied in a single-use, sterile vial for reconstitution intended for intramuscular injection. Each vial contains 300 Units or 500 Units of lyophilized abobotulinumtoxinA, human serum albumin (125 mcg) and lactose (2.5 mg). DYSPORT may contain trace amounts of cow's milk proteins [].
One unit of DYSPORT corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. The method for performing the assay is specific to Ipsen's product DYSPORT. Due to differences in specific details such as vehicle, dilution scheme and laboratory protocols for various mouse LD50 assays, Units of biological activity of DYSPORT are not interchangeable with Units of any other botulinum toxin or any toxin assessed with any other specific assay method [].
What does Dysport look like?
What are the available doses of Dysport?
• For Injection: 300 Units or 500 Units lyophilized powder in a single-use vial for reconstitution with preservative–free 0.9% Sodium Chloride Injection, USP ()
What should I talk to my health care provider before I take Dysport?
• Pregnancy: Based on animal data, may cause fetal harm ()• Administer DYSPORT with care in elderly patients, reflecting the greater frequency of concomitant disease and other drug therapy ()
How should I use Dysport?
DYSPORT is indicated for the treatment of adults with cervical dystonia.
The potency Units of DYSPORT® are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of DYSPORT® cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method [
].
Reconstituted DYSPORT® is intended for intramuscular injection only.
Reconstitution instructions are specific for each of the 300 Unit vial and the 500 Unit vial. These volumes yield concentrations specific for the use for each indication (Table 1).
After reconstitution, DYSPORT® should be used for only one injection session and for only one patient. Once reconstituted, DYSPORT® should be stored in the original container, in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF), protected from light for up to 24 hours. It must be discarded if not used within 24 hours. Do not freeze reconstituted DYSPORT®. Discard the vial and needle in accordance with local regulations.
What interacts with Dysport?
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What are the warnings of Dysport?
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What are the precautions of Dysport?
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What are the side effects of Dysport?
Sorry No records found
What should I look out for while using Dysport?
DYSPORT is contraindicated in patients with:
Postmarketing reports indicate that the effects of DYSPORT and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including upper limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose. []
What might happen if I take too much Dysport?
Excessive doses of DYSPORT may be expected to produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of respiratory muscles. In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis []. Symptomatic treatment may be necessary.
Symptoms of overdose are likely not to be present immediately following injection. Should accidental injection or oral ingestion occur, the person should be medically supervised for several weeks for signs and symptoms of excessive muscle weakness or paralysis.
There is no significant information regarding overdose from clinical studies.
In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration. In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 770-488-7100. More information can be obtained at .
How should I store and handle Dysport?
DYSPORT for Injection is supplied in a sterile, single-use, glass vial. Unopened vials of DYSPORT must be stored under refrigeration at 2°C to 8°C (36°F to 46°F). Protect from light.Do not use after the expiration date on the vial. All vials, including expired vials, or equipment used with DYSPORT should be disposed of carefully as is done with all medical waste.DYSPORT contains a unique hologram on the carton. If you do not see the hologram, do not use the product. Instead contact 877-397-7671.DYSPORT for Injection is supplied in a sterile, single-use, glass vial. Unopened vials of DYSPORT must be stored under refrigeration at 2°C to 8°C (36°F to 46°F). Protect from light.Do not use after the expiration date on the vial. All vials, including expired vials, or equipment used with DYSPORT should be disposed of carefully as is done with all medical waste.DYSPORT contains a unique hologram on the carton. If you do not see the hologram, do not use the product. Instead contact 877-397-7671.DYSPORT for Injection is supplied in a sterile, single-use, glass vial. Unopened vials of DYSPORT must be stored under refrigeration at 2°C to 8°C (36°F to 46°F). Protect from light.Do not use after the expiration date on the vial. All vials, including expired vials, or equipment used with DYSPORT should be disposed of carefully as is done with all medical waste.DYSPORT contains a unique hologram on the carton. If you do not see the hologram, do not use the product. Instead contact 877-397-7671.Diphenhydramine Hydrochloride Injection, USP 50 mg/mLNDC 68071-1786-1 Glass Bottle 1mLDiphenhydramine Hydrochloride Injection, USP 50 mg/mLNDC 68071-1786-1 Glass Bottle 1mL
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
DYSPORT inhibits release of the neurotransmitter, acetylcholine, from peripheral cholinergic nerve endings. Toxin activity occurs in the following sequence: Toxin heavy chain mediated binding to specific surface receptors on nerve endings, internalization of the toxin by receptor mediated endocytosis, pH-induced translocation of the toxin light chain to the cell cytosol and cleavage of SNAP25 leading to intracellular blockage of neurotransmitter exocytosis into the neuromuscular junction. This accounts for the therapeutic utility of the toxin in diseases characterized by excessive efferent activity in motor nerves.
Recovery of transmission occurs gradually as the neuromuscular junction recovers from SNAP25 cleavage and as new nerve endings are formed.
Non-Clinical Toxicology
DYSPORT is contraindicated in patients with:Postmarketing reports indicate that the effects of DYSPORT and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including upper limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose. []
Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.)
MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
The potency Units of DYSPORT are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of DYSPORT cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method [].
The following serious adverse reactions are discussed below and elsewhere in labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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