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Incobotulinumtoxina (Xeomin)

Trade Name : Xeomin

Merz Pharmaceuticals, LLC

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 50 [USP'U]/1

BOTULINUM TOXIN TYPE A Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Incobotulinumtoxina (Xeomin) which is also known as Xeomin and Manufactured by Merz Pharmaceuticals, LLC. It is available in strength of 50 [USP'U]/1 per ml. Read more

Incobotulinumtoxina (Xeomin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Postmarketing reports indicate that the effects of XEOMIN 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 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 .
  • WARNING: DISTANT SPREAD OF TOXIN EFFECT
  • See full prescribing information for complete boxed warning.
  • The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. 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, particularly in those patients who have underlying conditions that would predispose them to these symptoms. n
  • No data
  • XEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment or improvement of adult patients with:
  • chronic sialorrhea ()
  • upper limb spasticity ()
  • cervical dystonia ()
  • blepharospasm ()
  • temporary improvement in the appearance of moderate to severe glabellar lines with corrugator and/or procerus muscle activity ()
  • Chronic Sialorrhea: the recommended total dose is 100 Units per treatment session consisting of 30 Units per parotid gland and 20 Units per submandibular gland, no sooner than every 16 weeks ()
  • Upper limb spasticity, cervical dystonia, and blepharospasm: the optimum dose, frequency, and number of injection sites in the treated muscle(s) should be based on severity and prior treatment response; individualize dosing for each patient:
  • Glabellar Lines: the recommended dose is 20 Units per treatment session divided into five equal intramuscular injections of 4 Units each (two injections in each corrugator muscle and one injection in the procerus muscle; wait a minimum of three months before retreatment ()
  • Reconstituted XEOMIN:
  • For injection: 50 Units, 100 Units, or 200 Units lyophilized powder in a single-dose vial for reconstitution only with preservative-free 0.9% Sodium Chloride Injection, USP.
  • For injection: 50 Units, 100 Units, or 200 Units lyophilized powder in a single-dose vial ()
  • XEOMIN is contraindicated in patients with:
  • Known hypersensitivity to the active substance botulinum neurotoxin type A or to any of the excipients (, )
  • Infection at the proposed injection sites ()
  • No data
  • Respiratory, speech, or swallowing difficulties: Increased risk if bilateral neck muscle injections are needed or with pre-existing muscular disorders; immediate medical attention may be required (, )
  • The potency Units of XEOMIN are not interchangeable with other preparations of botulinum toxin products ()
  • Corneal exposure and ulceration: protective measures may be required ()
  • Risk of ptosis: follow dosage recommendations ()
  • The following adverse reactions to XEOMIN are discussed in greater detail in other sections of the labeling:
  • The most commonly observed adverse reactions at rates specified below and greater than placebo are:
  • To report SUSPECTED ADVERSE REACTIONS, contact Merz Pharmaceuticals, LLC at 888-493-6646 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Chronic Sialorrhea:
  • Upper Limb Spasticity:n- u2265
  • Cervical Dystonia:
  • Blepharospasm:
  • Glabellar Lines:
  • Aminoglycosides or other agents that interfere with neuromuscular transmission may potentiate the effect of XEOMIN; co-administer only with caution and close observation ()
  • No data
  • Pregnancy: based on animal data, may cause fetal harm ()
  • Excessive doses of XEOMIN may be expected to produce neuromuscular weakness with a variety of symptoms, particularly when treated intramuscularly. Respiratory support may be required where excessive doses cause paralysis of the 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 not likely 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 of XEOMIN.
  • 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 .
  • The active ingredient of XEOMIN is botulinum toxin type A produced from fermentation of Hall strain serotype A. The botulinum toxin complex is purified from the culture supernatant and then the active ingredient is separated from the proteins (hemagglutinins and non-hemagglutinins) through a series of steps yielding the active neurotoxin with molecular weight of 150 kDa, without accessory proteins. XEOMIN is a sterile white to off-white lyophilized powder intended for intramuscular or intra-salivary gland injection after reconstitution with preservative-free 0.9% Sodium Chloride Injection, USP (3). One vial of XEOMIN contains 50 Units, 100 Units, or 200 Units of incobotulinumtoxinA, human albumin (1 mg), and sucrose (4.7 mg).
  • The primary release procedure for XEOMIN uses a cell-based potency assay to determine the potency relative to a reference standard. One Unit corresponds to the median intraperitoneal lethal dose (LD) in mice. As the method for conducting the assay is specific to XEOMIN, Units of biological activity of XEOMIN cannot be converted into Units of any other botulinum toxin assessed with other specific assays.
  • No data
  • No data
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Manufactured by:Merz Pharmaceuticals GmbHEckenheimer Landstrasse 100Frankfurt GermanyU.S. License Number 1830
  • Distributed by:Merz Pharmaceuticals, LLC6501 Six Forks RoadRaleigh, NC 27615
  • and
  • Merz North America, Inc.4133 Courtney Street, Suite 10Franksville, WI 53126
  • u00a9 2019 Merz Pharmaceuticals, LLC ttttttXEOMIN is a registered trademark of Merz Pharma GmbH & Co KGaA. All trademarks are the property of their respective owners. Patent www.merzusa.com/patents/
  • EM00451-05
  • No data
  • 1 vialRx OnlyNDC 0259-1605-01
  • incobotulinumtoxinA
  • XEOMINn for Injection
  • For Intramuscularand Intraglandular Use
  • WARNING: Dosing Units of botulinum toxins arenot interchangeable between commercial products.
  • MERZ
  • 50units/vial
  • 1 vialRx OnlyNDC 0259-1610-01
  • incobotulinumtoxinA
  • XEOMINn for Injection
  • For Intramuscularand Intraglandular Use
  • WARNING: Dosing Units of botulinum toxins arenot interchangeable between commercial products.
  • MERZ
  • 100units/vial
  • 1 vialRx OnlyNDC 0259-4150-01
  • incobotulinumtoxinA
  • XEOMINn for Injection
  • For Intramuscularand Intraglandular Use
  • WARNING: Dosing Units of botulinum toxins arenot interchangeable between commercial products.
  • MERZ
  • 50units/vial
  • 1 vialRx OnlyNDC 0259-4110-01
  • incobotulinumtoxinA
  • XEOMINn for Injection
  • For Intramuscularand Intraglandular Use
  • WARNING: Dosing Units of botulinum toxins arenot interchangeable between commercial products.
  • MERZ
  • 100units/vial
  • 1 vialRx OnlyNDC 0259-1620-01
  • incobotulinumtoxinA
  • XEOMINn for Injection
  • For Intramuscularand Intraglandular Use
  • MERZ
  • 200units/vial

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