Reviews Abobotulinumtoxin A Injection


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Dysport Drug Description
DYSPORT™
(abobotulinumtoxinA) for Injection

Distant Spread of Toxin Effect
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 spasticity in children and adults,
and in approved indications, cases of spread of effect have been reported at
doses comparable to those used to treat cervical dystonia and at lower doses.

DRUG DESCRIPTION
Botulinum toxin type A, the active ingredient in DYSPORT™ (abobotulinumtoxinA),
is a purifed neurotoxin type A complex produced by fermentation of the bacterium
Clostridium botulinumtype A, Hall Strain. It is purifed 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 500 or 300 Units of
lyophilized abobotulinumtoxinA, 125 micrograms human serum albumin and 2.5 mg
lactose. DYSPORT™ may contain trace amounts of cow's milk proteins [see
CONTRAINDICATIONS].
One unit of DYSPORT™ corresponds to the calculated median lethal intraperitoneal
dose (LD50) in mice. The method for performing the assay is specifc to Ipsen's
product DYSPORT™ Due to differences in specifc 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 specifc assay
method [see Dosage Forms and Strengths].
Last reviewed on RxList: 5/22/2009




Dysport Drug Description
DYSPORT™
(abobotulinumtoxinA) for Injection

Distant Spread of Toxin Effect
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 spasticity in children and adults,
and in approved indications, cases of spread of effect have been reported at
doses comparable to those used to treat cervical dystonia and at lower doses.

DRUG DESCRIPTION
Botulinum toxin type A, the active ingredient in DYSPORT™ (abobotulinumtoxinA),
is a purifed neurotoxin type A complex produced by fermentation of the bacterium
Clostridium botulinumtype A, Hall Strain. It is purifed 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 500 or 300 Units of
lyophilized abobotulinumtoxinA, 125 micrograms human serum albumin and 2.5 mg
lactose. DYSPORT™ may contain trace amounts of cow's milk proteins [see
CONTRAINDICATIONS].
One unit of DYSPORT™ corresponds to the calculated median lethal intraperitoneal
dose (LD50) in mice. The method for performing the assay is specifc to Ipsen's
product DYSPORT™ Due to differences in specifc 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 specifc assay
method [see Dosage Forms and Strengths].
Last reviewed on RxList: 5/22/2009




Dysport Drug Description
DYSPORT™
(abobotulinumtoxinA) for Injection

Distant Spread of Toxin Effect
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 spasticity in children and adults,
and in approved indications, cases of spread of effect have been reported at
doses comparable to those used to treat cervical dystonia and at lower doses.

DRUG DESCRIPTION
Botulinum toxin type A, the active ingredient in DYSPORT™ (abobotulinumtoxinA),
is a purifed neurotoxin type A complex produced by fermentation of the bacterium
Clostridium botulinumtype A, Hall Strain. It is purifed 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 500 or 300 Units of
lyophilized abobotulinumtoxinA, 125 micrograms human serum albumin and 2.5 mg
lactose. DYSPORT™ may contain trace amounts of cow's milk proteins [see
CONTRAINDICATIONS].
One unit of DYSPORT™ corresponds to the calculated median lethal intraperitoneal
dose (LD50) in mice. The method for performing the assay is specifc to Ipsen's
product DYSPORT™ Due to differences in specifc 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 specifc assay
method [see Dosage Forms and Strengths].
Last reviewed on RxList: 5/22/2009




Dysport Drug Description
DYSPORT™
(abobotulinumtoxinA) for Injection

Distant Spread of Toxin Effect
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 spasticity in children and adults,
and in approved indications, cases of spread of effect have been reported at
doses comparable to those used to treat cervical dystonia and at lower doses.

DRUG DESCRIPTION
Botulinum toxin type A, the active ingredient in DYSPORT™ (abobotulinumtoxinA),
is a purifed neurotoxin type A complex produced by fermentation of the bacterium
Clostridium botulinumtype A, Hall Strain. It is purifed 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 500 or 300 Units of
lyophilized abobotulinumtoxinA, 125 micrograms human serum albumin and 2.5 mg
lactose. DYSPORT™ may contain trace amounts of cow's milk proteins [see
CONTRAINDICATIONS].
One unit of DYSPORT™ corresponds to the calculated median lethal intraperitoneal
dose (LD50) in mice. The method for performing the assay is specifc to Ipsen's
product DYSPORT™ Due to differences in specifc 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 specifc assay
method [see Dosage Forms and Strengths].
Last reviewed on RxList: 5/22/2009




Dysport Drug Description
DYSPORT™
(abobotulinumtoxinA) for Injection

Distant Spread of Toxin Effect
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 spasticity in children and adults,
and in approved indications, cases of spread of effect have been reported at
doses comparable to those used to treat cervical dystonia and at lower doses.

DRUG DESCRIPTION
Botulinum toxin type A, the active ingredient in DYSPORT™ (abobotulinumtoxinA),
is a purifed neurotoxin type A complex produced by fermentation of the bacterium
Clostridium botulinumtype A, Hall Strain. It is purifed 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 500 or 300 Units of
lyophilized abobotulinumtoxinA, 125 micrograms human serum albumin and 2.5 mg
lactose. DYSPORT™ may contain trace amounts of cow's milk proteins [see
CONTRAINDICATIONS].
One unit of DYSPORT™ corresponds to the calculated median lethal intraperitoneal
dose (LD50) in mice. The method for performing the assay is specifc to Ipsen's
product DYSPORT™ Due to differences in specifc 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 specifc assay
method [see Dosage Forms and Strengths].
Last reviewed on RxList: 5/22/2009





Other reviews about Abobotulinumtoxin A Injection on wordpress

FDA Requires Boxed Warning for All Botulinum Toxin Products
  by thassodotcom
June 10, 2009 - From a todays' press release by the FDA, we learn the following concerning botulinum toxin products: Prompted by reports of serious adverse events, the American […]



Other reviews about Abobotulinumtoxin A Injection on web:

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